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 Ute Mountain Ute Tribe 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.
Response: See responses to Comments 31-135 and 73-410.
Comment [119-1034]: Commenter (11484) notes that EPA seeks comment on whether to use its housekeeping authority, either independently, or in conjunction with other environmental statutes, as the basis of this rule. It would be inappropriate to use housekeeping authority in this rulemaking. While it is stated in the SNPRM that "EPA is authorized to promulgate this regulation under its housekeeping authority," legal precedent cited in the same document negates this argument. The SNPRM cites the U.S. Supreme Court case Chrysler Corp v. Brown to demonstrate that EPA's housekeeping authority applies only to "`rules of agency organization, procedure or practice' as opposed to substantive rules."
A plain language reading of the proposed rule makes clear that because it governs which scientific studies EPA must consider or ignore in issuing regulations, it will affect substantive rules. However, EPA argues in the SNPRM, incorrectly, that the proposed rule "exclusively pertains to the internal practices of the EPA." If EPA's role under the proposed rule were merely to acquire, consider, and file all relevant studies, the "internal practices" argument may be correct. However, the proposed rule would require the Agency to consider some studies but not others and would give the Administrator case-by-case discretion over such consideration, potentially completely altering the outcome of future rulemakings. Thus, the proposed rule has a direct impact on substantive rules and housekeeping authority does not apply. Unless the proposed rule is revised to exclude substantive rulemakings such as setting the NAAQS, the assertion of housekeeping authority fails on its face.
In conclusion, Puget Sound Clean Air Agency (PSCAA) opposes the proposed rule in its entirety due to the fundamental flaw that it would limit EPA's access to the best available science by relying on arbitrary and nonscientific reasons to restrict studies from consideration, a flaw that the recent changes fail to correct. Further, the most recent version of the rule proposes to make inappropriate use of housekeeping authority, rendering it legally vulnerable. If enacted, this rule would result in federal regulations with a weaker evidence basis and erode the environmental and public health protections that our Agency is charged with carrying out.
I urge you to withdraw this flawed proposal that relies on dubious authority and contravenes EPA's statutory mandate to issue regulations based on the best available science.
Response: See responses to Comments 31-135, 32-144, 34-155, 38-185, 48-381 and 73-410.
Comment [124-1053]: Commenter (11492) writes that the Federal Housekeeping Statute does not give authority for this Rule: According to legislative history, the Federal Housekeeping Statute was never intended by Congress to authorize an agency to use for substantive regulations. EPA cannot now use § 301 of the Federal Housekeeping Statute to give itself authority to create substantive regulations, because it expressly contradicts the purpose of the code it is invoking.
Response: See response to Comment 31-135.
Comment [125-1078]: Commenter (11495) writes that EPA is not an Executive Department subject to the Federal Housekeeping Statute.
The Housekeeping Statute permits "what the [APA] terms `rules of agency organization, procedure, or practice,' as opposed to substantive rules." Specifically, the statute grants "the head of an executive department" the authority to govern internal departmental affairs. The statute allows for the promulgation of regulations "for the government" of the 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." Congress amended the statute in 1958 to add a second sentence stating, "[t]his section does not authorize withholding information from the public or limiting the availability of records to the public."
The Housekeeping Statute, by its express terms, applies only to the heads of "executive department[s] or military department[s]." EPA is not one of the fifteen executive departments listed in 5 U.S.C. § 101, nor is it a military department. The EPA's own OLC has agreed that 5 U.S.C. § 301 does not apply to the EPA, stating in one OLC opinion that "the difficulty here, however, is that section 301 confers regulatory authority only to `heads of Executive departments and military departments' and not the heads of other executive agencies, such as EPA." Congress used the term "executive department" in this statute, while in other provisions it uses the term "agency." Such differences are typically presumed intentional by the Supreme Court, meaning that "executive department" and "agency" do not refer to the same things. Therefore, the executive departments listed in 5 U.S.C. § 101 are the only government entities to which the Housekeeping Statute directly applies.
There are other executive branch agencies that have been found to be excluded from the Housekeeping Statute. For example, the OGE may not issue regulations pursuant to 5 U.S.C. § 301 because OGE is not an executive department. OGE may only issue regulations concerning the production of agency records pursuant to other authority, and regulations concerning employee testimony on official matters can be issued pursuant to the implied authority conferred on it by its own organic statute, 5 U.S.C. § 401. Similarly, no OLC opinion has found that EPA may issue any regulation pursuant to the Housekeeping Statute. EPA even admits that the Housekeeping Statute does not apply directly to EPA, instead arguing that "EPA gained housekeeping authority through the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970)."
Response: See response to Comment 31-135.
Comment [125-1081]: Commenter (11495) writes that the Reorganization Plan No. 3 of 1970 does not explicitly grant Housekeeping Authority to EPA.
It is not apparent anywhere in Reorganization Plan No. 3 of 1970 (the "Plan") that Congress or the President intended the Housekeeping Statute to apply to the newly created EPA. The Plan was prepared by President Richard Nixon and transmitted to the Congress on July 9, 1970 in accordance with Chapter 9 of Title 5 of the United States Code. One of the purposes of 5 U.S.C. § 901 is "to promote the better execution of the laws." The President's accompanying message to the Congress explained that the EPA was being created to rationally and systematically organize the government's environmentally related activities, specifically related to air, water, and land. The President noted that research on pollutants and their impact on the total environment was "critical" for the measurement of the success or failure of the country's pollution abatement efforts. One of the primary functions of EPA established under the Plan is "[t]he conduct of research on the adverse effects of pollution and on methods and equipment for controlling it, the gathering of information on pollution, and the use of this information in strengthening environmental protection programs and recommending policy changes."
Section 1 of the Plan establishes the EPA's existence. Section 2 of the Plan transfers to the EPA Administrator various functions of other agencies, such as the DOI's jurisdiction over the Federal Water Quality Administration and the Federal Water Pollution Control Act. Sections 2(a)(2) - (8) transfer other various discrete functions to EPA, while retaining some environmentally related functions in the Department of Health, Education, and Welfare, the DOI, and the USDA. Section 2(a)(9) transfers "[s]o much of the functions of the transferor officers and agencies referred to in or affected by the foregoing provisions of this section as is incidental to or necessary for the performance by or under the Administrator of the functions transferred by those provisions or relates primarily to those functions."
Section 2(a)(9) is not a catch-all provision that would allow the EPA Administrator broad housekeeping authority, as EPA now appears to assert. By its express terms, Section 2(a)(9) only grants the EPA Administrator authority "incidental to or necessary for" carrying out the functions detailed in the "foregoing provisions of this section" -- that is, Section 2(a)(1) through (8). This position is supported by the fact that Section 2(a)(9) specifies some functions that fall under the authority of Section 2 and some specific functions that should be "excluded," including the functions of the Bureau of Reclamation under section 3(b)(1) of the Water Pollution Control Act. Section 2(b) of the Plan goes on to specify some functions that will be transferred under this authority, including the DOI's Water Pollution Control Advisory Board, the boards provided for by the Federal Water Pollution Control Act, and the Department of Health, Education, and Welfare's Air Quality Advisory Board. The specificity of the language used throughout Section 2 of the Plan, and particularly in Section 2(a)(9), demonstrates that the Plan was not intended to transfer every imaginable function from DOI and other agencies to the EPA.
Nowhere in the Plan is the Housekeeping Statute mentioned, nor is the transfer of housekeeping authority to EPA mentioned. As already stated, the Housekeeping Statute applies only to the heads of military departments and the heads of the 15 "executive departments" listed in 5 U.S.C. § 101. The Plan does not explicitly add EPA to this list of executive departments. EPA offers no support for its broad claim of housekeeping authority other than noting that the Administrator is the head of the EPA, and that the Plan transferred functions and authorities of "various agencies and executive departments" to EPA.
However, the transfer of discrete functions, boards, and authorities to EPA does not equate to the transfer of sweeping housekeeping authority. Section 2(a)(9) only transfers those functions "incidental to or necessary for" the performance of the previously mentioned transferred functions. The authority to promulgate rules such as the Strengthening Transparency in Regulatory Science rule -- which drastically alters the agency's process for considering scientific studies in its decision-making process -- does not follow from the grant of "incidental to" or "necessary" functions authorized under Section 2(a)(9) of the Plan.
Response: See response to Comment 31-135.
Comment [125-1084]: Commenter (11495) writes that these substantive rules are not authorized under the Housekeeping Statute. In Chrysler Corp., this meant that the confidential information given to the government in the form of trade secrets could not be released under the authority of a § 301 regulation because to do so properly would require the agency to exercise substantive legislative power. Similarly, here, the use of the notice and comment process and the nature of the Supplemental Notice -- which limits the types of scientific information considered by EPA in all standard setting, and any preliminary scientific assessments, reports, and enforcements that use externally generated peer-reviewed science as a basis for reporting, action, or decision -- indicate that the Strengthening Transparency rule is "substantive," rather than merely "procedural" or "interpretive," and therefore cannot be authorized by the Housekeeping Statute.
The very cases and authorities that EPA cites in its Supplemental Notice, among others, are distinguishable from the Proposed Rule. For example, the EPA's OLC opinion, "Authority of EPA to Hold Employees Liable for Negligent Loss, Damage, or Destruction of Government Personal Property," concluded that the EPA Administrator could set rules for employee conduct on the job as well as outside of the workplace that might undermine the "efficient operation of the Department." This scenario regarding liability for breaching personnel and property rules is clearly a matter of "internal departmental affairs." The management of employees and personal property is clearly "incidental to" and "necessary for" the effective performance of the agency. The rule did not relate to the substantive work of the EPA, like the Supplemental Notice at issue here does.
Additionally, in Boron Oil Co. v. Downie, the Fourth Circuit held that an EPA regulation under 5 U.S.C. § 301 allowing employees to resist subpoenas to testify in state court was valid. US ex rel. Touhy v. Ragen, a case oft-cited by courts interpreting § 301, the Supreme Court held that the DOJ could resist a subpoena for documents pursuant to an intra-agency rule promulgated under the authority of 5 U.S.C. § 22, the predecessor to the current Housekeeping Statute. Clearly, the scenarios in Boron Oil and Touhy relating to an agency's discretion to resist subpoenas are authorized under the housekeeping statute because they directly relate to "preservation of agency records and papers." However, just because the DOJ may resist subpoenas with the help of § 301, does not make § 301 applicable to the EPA broadly or authorize the promulgation of the Supplemental Notice specifically.
More recently, in United States v. Manafort, the District Court for the District of Columbia (D.C.) held that DOJ special counsel regulations were not "substantive rules" that created individual rights but were merely statements of internal departmental policy. Citing Chrysler Corp., the court agreed with the DOJ that the regulations were not intended to create any rights and were "matters of agency management or personnel." DOJ did not seek notice and comment for the special counsel regulations, and DOJ even used language in those regulations stating that they did not create "any rights, substantive or procedural, enforceable at law . . . by any person or entity, in any matter, civil, criminal, or administrative." This type of language has been found by courts to effectively disclaim the creation of any enforceable rights.
Clearly, here, EPA has not followed the same steps as DOJ did in the promulgation of the special counsel regulations at issue in United States v. Manafort. EPA's Supplemental Notice is distinguishable from DOJ's special counsel regulations and other procedural rules because it is being promulgated under the notice and comment process, does not use language disclaiming the creation of any rights enforceable at law, and creates a new qualitative measure for the agency's consideration and use of science in the agency's fundamental functions. Accordingly, the Supplemental Notice is a substantive rule that falls outside the scope of the Housekeeping Statute.
Response: Throughout the rule's preamble, EPA clearly states that rule does not impact the rights or obligations of outside parties. Additionally, the regulatory provisions include mandates applicable only to EPA. See responses to Comments 31-135, 32-144, 48-382 and 48-383.
Comment [125-1092]: Commenter (11495) writes that just as EPA cannot base the Supplemental Notice on the general rulemaking authority granted by environmental statutes, it also cannot justify its action on the authority, if any, granted under 5 U.S.C. § 301. First, as detailed above, the Housekeeping Statute likely does not apply to EPA. Further, even assuming that it does apply, the authority granted by the Housekeeping Statute is not broad enough to override EPA's specific environmental statutory directives. Simply put, the EPA cannot use the guise of an internal procedural rule -- which this rule clearly is not -- to contravene explicit quality of information provisions in the substantive environmental statutes the agency is responsible for administering.
The Housekeeping Statute is "simply a grant of authority to the agency to regulate its own affairs." The statute does not provide a general, independent basis for deviating from a specific statutory mandate or limiting the scope of other provisions. Where the SDWA, for example, requires EPA to consider the "best available, peer-reviewed science," EPA cannot use this rule to effectively alter the statutory text to require the best, publicly available, peer-reviewed science. Thus, even if the Proposed Rule were limited to regulation of internal agency procedures, which it is not, EPA cannot use such housekeeping as a pretext for modifying the statutory provisions requiring consideration of the best available science.
EPA must base its decisions on such criteria as the latest scientific knowledge, the best available, peer-reviewed science, and/or generally accepted scientific principles or laboratory tests. 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 31-135, 32-144, 34-155 and 73-410.
Comment [130-1135]: Commenter (11884) writes that in a nutshell, there is no reasonable way the Rule or any part of the Trio could be adopted pursuant to the EPA's so called "housekeeping" powers. Good or bad, the Trio marks a dramatic "sea change" for the world of environmental regulation. The term "housekeeping" connotes trivial changes that do not require a second thought. To quote administrative judge K. Bresler: "'housekeeping' refers to minor matters". K. Bresler, Legal Housekeeping Clear Writing (2014).
In Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979), the Supreme Court emphasized that nothing in the housekeeping statute permits an agency to "withhold information from the public or to limit the availability of records to the public." Id. (quoting the housekeeping statute's legislative history). With the Trio, EPA hopes to stifle good science. To use paraphrase the Court, EPA seeks to "twist" its housekeeping authority "into a claim of authority to withhold information". Id. n. 41 at 310; cf. id. (referencing "numerous" similar comments in the legislative history).
Response: See the responses to Comments 31-135, 32-144 and 48-381.
Comment [130-1136]: Commenter (11884) writes that even if the Trio were to be mischaracterized as a few "procedural" changes, they could not be considered as within the housekeeping statute because, when aggregated, they affect the public's substantive rights. The housekeeping law does not allow an agency to curtail "substantive rights". Id. at 310.
By the same token, myriad purely procedural changes could eviscerate substantive rights. Those procedural changes are invalid. For example, EPA could adopt a procedural rule that no party can make a submission unless it first deposits a million dollars in the EPA's bank account to cover any potential administrative costs. Or EPA could bar submission of documents by anyone who has a technical degree (e.g., a B.S. or M.D.) to avoid unduly influencing agency executives. Both of these purely procedural rules would have a substantive effect that go far beyond a permissible housekeeping rule.
Response: See responses to Comments 31-135, 40-193, and 48-379.
Comment [133-1166]: Commenter (11894) writes that all courts considering the issue, starting with the Supreme Court, have held that the Housekeeping Statute cannot be used as a basis for a legislative rule. Chrysler Corp. v. Brown, 441 U.S. at 310; see also, e.g. United States ex rel. O'Keefe v. McDonnell Douglas Corp., 132 F.3d 1252, 1255 (8th Cir. 1998) (applying Chrysler Corp. and finding that the Housekeeping Statute did not provide authority for substantive regulations); Exxon Shipping Co. v. United States Dept. of Interior, 34 F.3d 774, 776-78 (9th Cir. 1994) (Housekeeping Statute did not authorize regulations allowing that agency to withhold deposition testimony of federal employees).
EPA's proposals (both the original and supplemental proposals) have every indicia of a substantive, legislative rule: codification in the CFR, adoption through notice and comment proceedings, and mandatory language of command (e.g., "the agency will only use" in proposed section 30.5), See Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158, 172 - 73 (2007) (adoption through notice and comment procedures); American Mining Congress v. Mine Safety and Health Admin., 995 F. 2d 1106, 1112 (D.C. Cir. 1993) (codification in Federal Register); General Electric Co. v. EPA, 290 F. 3d 377, 383 (D.C. Cir. 2002) (binding language).
Rules that bind an agency itself are legislative rules. In CropLife Am. v. EPA, 329 F. 3d 876 (D.C. Cir. 2003), the D.C. Circuit held that an EPA press release which stated that the agency would not consider third party-controlled human exposure studies for purposes of pesticide registration was a legislative rule. Like the supplemental proposal, the press release in CropLife purported to establish exceptions to its binding language to accommodate situations in which use of a study might be legally compelled. 329 F. 3d at 881-82. The court held that the press release bound both EPA and registrants during pesticide registrations and so was a binding "substantive rule;" it "binds private parties or the agency itself with the `force of law." 329 F. 3d at 883 (emphasis supplied).
The current "housekeeping" proposal, like the press release in Croplife, would set binding rules governing how EPA uses science in its decision processes. Its hollow assurances of later action to consider studies when legally compelled to do so does not alter its status as a legislative rule any more than the similar assurances in CropLife. Since the Housekeeping Statute provides no authority for issuing legislative rules, it cannot provide a basis for either the supplemental or initial proposal. Both would bind EPA, under the conditions set out by EPA, namely that underlying data and models be publicly available (with some proposed exemptions and a grant to the Administrator of discretion) to not consider a scientific study it could have previously considered. The proposed rules would also bind the public. Furthermore, EPA's rule would require researchers interested in contributing to regulatory protections and ISI to alter their conduct or risk having their efforts deemed unusable. Ultimately, the rule would diminish the public's statutorily protected interests in regulations informed by the best available science, an outcome that EPA itself has recently contended results from substantive choices about the scientific evidence it will consider.
The Housekeeping Statute's "antecedents go back to the beginning of the Republic, when statutes were enacted to give heads of early Government departments authority to govern internal department affairs." Chrysler Corp. v. Brown, 441 U.S. 281, 309 (1979). It authorizes what the APA "terms `rules of agency organization, procedure, or practice' as opposed to substantive rules," Id. at 310, and enables "department heads to make regulations governing day-to-day operation of the department," id. n 41. A typical housekeeping rule would govern purely internal agency procedures and practices such as storage and transport of records. The bottom line is that the Housekeeping Statute authorizes only rules of agency organization, procedure, or practice -- not "legislative" or "substantive" rules. That is not what EPA is doing with this regulation. Courts have found nothing in the legislative history to support a different reading. No case law offers support for an alternative reading.
Congress took explicit action in 1958 to amend Section 301 to "correct" agencies from abusing the Housekeeping Statute by attempting to use its authority as a substantive basis to withhold information from the public. As the Supreme Court noted in Chrysler Corp., Congress had looked carefully at the statute in 1958. The Special Subcommittee on Government Information had "unanimously agreed that [§ 301] originally was adopted in 1789 to provide for the day-to-day office housekeeping in the Government departments," and attempts to construe it as something more was "misuse," which "twisted" the statute. The courts have repeatedly checked subsequent agency attempts to "twist" the statute to a range of substantive purposes and found those efforts illegal. The supplemental proposal now attempts, similarly and illegally, to twist the statute to withhold science from consideration in rulemakings that broadly affect the public interest.
There is no merit to EPA's claim that this fits into the Housekeeping authority because it addresses how the agency "handles" information. Every EPA activity during the rulemaking process, as the agency receives, evaluates, and responds to information submitted to the record, and considers it in regulatory decisions, could be said to involve "handling" information in the sense EPA is using it. Under EPA's reasoning, those would all be "housekeeping" actions, and could be governed by housekeeping rules, rather than rules promulgated under the rulemaking provisions of the APA. EPA also argues that the proposal neither regulates nor affects "any entity outside the federal government." But EPA goes on to concede that the rule governs information that may have "a substantial impact" on important "private sector decisions" and a potential impact on the public or private sector impact of more than $500 million. 85 FR at 5398. And the regulation will, as also noted, impose substantive limits on the use of science in rulemaking under the eight environmental laws identified in the proposal.
The proposal, if finalized, would make major changes in how EPA conducts rulemakings that affect major segments of the economy - compelling EPA to ignore information regardless of its relevance and probity, based only on the public availability of the underlying data, and nullifying procedural rights under the APA, which ensures "interested persons an opportunity to participate in [a] rule making through submission of written data, or arguments" and directs that the agency consider "relevant matter presented." 5 USC § Section 553(c). To then claim that authority to do this is predicated on a law intended to make sure that federal agencies make their internal trains run on time would be laughable, if it were not tragic -- and part of the tragedy is that the proposed rule would effectively deprive commenters of the right to have their information given due consideration, and would deprive agency decision-makers of research and data -- of science -- essential to good decision-making.
The COVID-19 crisis, underway at this very moment as we write and file comments, has put into stark relief what happens when science is minimized, excluded, or ignored. But the rule is not about procedural rights. The decision to preclude full consideration of relevant and reliable information in developing regulations affects important "private sector decisions" and the level of environmental protection provided to the public alike. Thus, it is sad to read EPA's earnest assurances that the proposed rule "would not regulate the conduct or determine the rights of any entity outside the federal government," an assertion that is palpably wrong. One might as well say that a restriction on the evidence that a prisoner can use to prove his or her innocence does not affect his rights. The only sense in which the rule will have no effect outside the federal government is the narrow, hyper-literal sense in which firing a gun has no non-auditory effects because it is the fired bullets that cause such effects.
Response: See responses to Comments 31-135, 31-144, 34-155, 40-193, 48-379, 48-382, 48-383.
Comment [133-1167]: Commenter (11894) notes that EPA's supplemental proposal posits that the agency could use its housekeeping authority without "exercising substantive rulemaking authority delegated to it by a particular statute or statutes that it administers" to issue these rules. 85 FR at 15398. That begs the question of where the authority for the rule comes from because, as already explained, the Housekeeping Statute provides no legal basis for the proposed rule. Moreover, the supplemental proposal completely ignores the question of how a regulation not issued under the rulemaking authority of a statute can govern agency regulatory actions under the statute. What is plain and beyond refute is that the Housekeeping Statute, even as EPA rationalizes it, provides no authority for anything more than purely internal actions, certainly not for measures that have profound impacts beyond the agency and into society, much less for rules that authorize or mandate EPA to disregard relevant and reliable information in formulating rules or in responding to public comments on those rules.
Response: See responses to Comments 31-135, 32-144, 48-381 and 73-410.
Comment [133-2208]: 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 Fed. Reg. 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 the responses to Comments 31-135 and 73-410.
Comment [135-1217]: Commenter (11895) writes that EPA lacks authority for the proposed rule and SNPRM.
The SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C. § 301. The preamble says EPA is taking comments 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. None of the initial or corrected environmental statutes provide EPA authority for the proposed rulemaking.
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." 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 Tribe 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 15 "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.
Response: See the responses to Comments 31-135 and 73-410.
Comment [136-1289]: Commenter (11907) writes that EPA is using a 19th-century statute giving department heads (Administrators) the right to manage personnel and internal record keeping so that it can contain the science it uses when drafting regulations. This statute (5 USC 301/Departmental Regulations), which was passed in 1874, is referred to by the EPA as giving it "housekeeping" authority to make internal decisions regarding what data, information, and studies it wants to use. The law states:
"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."
Furthermore, upon investigation into subsequent codes and statutes relating to this law, it appears to be a precursor to laws relating to national security. This law may give EPA broad discretionary powers that could be used to eliminate the use of confidential PII based epidemiology studies regarding the effects of pollutants of human and environmental health.
EPA could claim that the information is not "transparent" and therefore cannot be reproduced or only "quasi-reproduced" in a scientific setting. Simultaneously, the EPA could determine that CBI based studies are "exempt" from the transparency rule for reasons of corporate or even national security, thereby completely providing protection and "non-transparency" to industry-based science. This appears to be precisely the intent of this supplementary rule.
Pursuant to these concerns The Skokomish Tribe strongly objects to this supplementary rule to the Proposed Rule on Strengthening Transparency in Regulatory Science. We do not agree with the use of discretionary "housekeeping authority" under 5 USC 301 to make high level internal decisions regarding what constitutes science and to choose what data, information, or studies can, or cannot be used. The Tribe holds that policy and regulatory outcomes based on this rulemaking will have harmful human health effects within our tribal community and by extension will also have harmful effects on treaty protected habitat and ecosystems within our "usual and accustomed" (U&A) treaty protected hunting, fishing and gathering grounds. This rulemaking does not support "transparency" in science but quite the reverse. It supports secrecy in science. This is in direct opposition of EPA's mission, which is to "protect human and environmental health".
Response: See responses to Comments 31-135, 32-144, 38-185, 40-193 and 48-381.
Comment [138-1262]: Commenter (11922) writes that I.EPA has broad authority under the Federal Housekeeping Statute consistent with or in addition to the authorities in the environmental statutes it administers to adopt this internal agency procedural transparency rule.
EPA specifically seeks comment as to whether the Federal Housekeeping Statute (5 U.S.C. § 301) independently or in combination with substantive statutes it administers can serve as legal authority for this transparency proposal. As the preamble states, the Federal Housekeeping Statute is a general grant of authority to heads of executive departments to prescribe regulations governing their departments. NRECA agrees with EPA's conclusion that, although EPA is not an executive department, the statute nevertheless applies to the agency and, consistent with the case law cited, that the Housekeeping Statute alone can serve as ample authority to implement a procedural transparency rule. 85 Fed. Reg. at 15,397-98.
EPA has acknowledged that, in some instances, requirements in the substantive statutes and regulations it administers may supersede a transparency rule. 85 Fed. Reg. at 15,398. Nevertheless, certain provisions within EPA's regulatory mandate support the underlying goals of this Transparency Rule. Below are highlighted provisions within the substantive statutes EPA cites (including and beyond those specific provisions EPA cites in the Supplemental's preamble) that are useful references to bolster the Transparency Rule, both in terms of reliance on housekeeping authority and in substance.
CAA
:: Section 103, 42 U.S.C. § 7403: This provision directs EPA to establish a national research and development program. As part of this program, the Administrator is authorized to "collect and make available . . . the results of and other information . . . pertaining to such research and other activities," to "develop effective and practical processes, methods, and prototype devices for the prevention or control of air pollution," and to "develop methods and techniques necessary to identify and assess the risks to human health from both routine and accidental exposures to individual air pollutants and combinations thereof," among other activities. 42 U.S.C. § 7403(b), (d). Implicit in this authority is that the Administrator should have access to all pertinent information, and the ability to evaluate how that information is collected and analyzed. These requirements correspond directly to the proposed Transparency Rule's requirement to "describe and document any assumptions and methods used" and to "describe variability and uncertainty" with regard to EPA's use of data and models underlying pivotal science or regulatory science. See 85 Fed. Reg. at 15,406.
:: Section 301(a), 42 U.S.C. § 7601(a): This provision authorizes the EPA Administrator to promulgate regulations "necessary to carry out his functions under this chapter," including regulations "establishing general applicable procedures and policies for regional officers and employees" designed to "assure fairness and uniformity in the criteria, procedures, and policies applied by the various regions" and "provide a mechanism for identifying and standardizing inconsistent or varying criteria, procedures, and policies . . ." This authority reinforces the general housekeeping authority upon which EPA proposes to rely by confirming that Congress authorized EPA to promulgate regulations governing its delegated functions.
:: Section 307(d)(3), 42 U.S.C. § 7607(d)(3): This provision requires that, when proposing a rule pursuant to that subsection, EPA must summarize "the factual data on which the proposed rule is based," as well as "the methodology used in obtaining the data and in analyzing the data. . . . All data, information, and documents referred to in this paragraph on which the proposed rule relies shall be included in the docket on the date of publication of the proposed rule." As with Section 103, these requirements support the Transparency Rule's goals. See 85 Fed. Reg. at 15,406.
CWA
:: Section 101(e), 33 U.S.C. § 1251(e): Part of Congress's purpose in enacting the Clean Water Act was to encourage "[p]ublic participation in the development, revision, and enforcement" of any regulation or program established by EPA or a State under the CWA. The Transparency Rule's goal of increasing the ability of the public to participate fully is thus directly responsive to this declaration of policy.
:: Section 104, 33 U.S.C. § 1254: This provision requires EPA to establish national research programs for pollution "prevention, reduction, and elimination," and as part of that mandate to "collect and make available, through publications and other appropriate means, the results of and other information . . . pertaining to such research." Similar to EPA's authority under the CAA, this provision encourages transparency to allow EPA to carry out the functions Congress prescribed.
:: Section 501, 33 U.S.C. § 1361: Similar to the housekeeping statute upon which EPA proposes to rely, this provision generally authorizes EPA to promulgate regulations to effectuate the goals and requirements of the Act, reinforcing that Congress has given EPA broad authority as to the research and data EPA uses in administering the CWA.
SDWA
:: Section 1442, 42 U.S.C. § 300j-1: This section provides EPA authority to conduct research regarding water contamination, including "improved methods to identify and measure the health effects of contaminants in drinking water . . . and assessing the health-related hazards of drinking water." Similar to the CAA and CWA, EPA is also authorized to "collect and make available" information regarding this research.
:: Section 1445(a)(1), 42 U.S.C. § 300j-4(a)(1): This provision requires regulated persons and grantees to "establish and maintain such records . . . and provide such information as the Administrator may reasonably require by regulation to assist the Administrator in establishing regulations[,] . . . in evaluating the health risks of unregulated contaminants, or in advising the public of such risks." EPA thus has the ability to determine what information it requires to best implement the SDWA, consistent with the goals of the Transparency Rule.
:: Section 1450(a)(1), 42 U.S.C. § 300j-9(a)(1): Similar to the housekeeping statute upon which EPA proposes to rely, this provision generally authorizes EPA to promulgate regulations to effectuate the goals and requirements of the SDWA, reinforcing that Congress has given EPA broad authority as to the research and data EPA uses in administering the SDWA.
RCRA
:: Section 2002(a)(1), 42 U.S.C. § 6912(a)(1): This provision generally authorizes EPA to promulgate regulations to administer RCRA, similar to the housekeeping statute EPA cites as authority for the Transparency Rule, and the other general authority provisions described above.
:: Section 7004, 42 U.S.C. § 6974(b): This provision requires EPA to provide for and encourage public participation in the development of regulations and programs under RCRA, reinforcing the goal of the Transparency Rule to facilitate such participation.
:: Section 8001, 42 U.S.C. § 6981: Similar to other statutes EPA administers, this provision requires EPA to conduct research. For RCRA, such research includes "adverse health and welfare effects of the release into the environment of material present in solid wastes," and this provision directs EPA to establish a management program to coordinate such research activities. EPA's promulgation of the Transparency Rule is consistent with EPA's authority to coordinate and manage the research it uses to administer RCRA.
CERCLA
:: Section 115, 42 U.S.C. § 9615: Through this provision Congress authorizes the President to delegate duties or powers under CERCLA and to promulgate necessary regulations, again similar to other general grants of authority and the housekeeping statute.
:: Section 311, 42 U.S.C. § 9660: The Secretary of Health and Human Services, consulting with the EPA Administrator, is directed to establish a research program that includes epidemiologic studies into the human health effects of hazardous substances and methods to assess human health risk. Implicit in this mandate is the ability of the Administrator to access all pertinent information, and the ability to evaluate how that information is collected and analyzed. As with the CAA, this provision of CERCLA corresponds to the proposed requirements of the Transparency Rule regarding research assumptions and methods.
FIFRA
:: Section 20, 7 U.S.C. § 136r: This general research section of FIFRA directs EPA to undertake research to administer the statute, and to ensure that the research is not duplicative of research other Federal agencies are undertaking. To this end, having an accurate picture of the content, methods, and validity of existing research is critical, and aligns with the purpose of the Transparency Rule.
:: Section 25, 7 U.S.C. § 136w: Congress authorized EPA to promulgate regulations to implement FIFRA, like other statutes. One nuance in the FIFRA general authorization is that these 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." More specifically than other statutes, then, this mandate recognizes the importance of data in the ability to regulate with precision and accuracy, supporting EPA's goals in proposing the Transparency Rule. Additionally, this section requires EPA to provide for peer review of the studies conducted under FIFRA, which the Transparency Rule would facilitate.
EPCRA
:: Section 328, 42 U.S.C. § 11048: As a statute geared toward the provision of information, instead of the gathering of information and promulgation of specific standards, EPCRA contains less specific directives regarding research, but nevertheless contains in this section the same general grant of authority EPA has under the Federal Housekeeping Statute to promulgate regulations necessary to administer the program.
TSCA
:: Section 2, 15 U.S.C. § 2601: Congress declared as policy of the United States to develop "adequate information . . . with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such information should be the responsibility of those who manufacture and those who process such chemical substances and mixtures." It makes eminent sense that EPA should be able to require the information manufacturers and processors develop to conform to standards that allow EPA to make use of that information in promulgating regulations, as EPA intends through the Transparency Rule.
:: Section 4, 15 U.S.C. § 2603: Congress authorized EPA to require testing and development of information regarding substances the agency determines lack sufficient information. Requests for and agreements to provide such information must include "protocols and methodologies" to be submitted to EPA. TSCA therefore explicitly recognizes the importance of not just receiving the results of studies, but also information about how they are conducted, which the Transparency Rule is intended to enhance. See also id. § 2626 (authorizing EPA and HHS to conduct and contract with others to conduct projects to develop test methods to meet the requirements of section 2603).
:: Section 10, 15 U.S.C. § 2609: Similar to other general research-and-development provisions, in this section TSCA directs EPA to conduct research necessary to administer TSCA. Additionally, this section directs EPA, in conjunction with other agencies, to develop a system to retrieve information useful to administer TSCA. Implicit in these requirements is the discretion to determine what information is necessary, consistent with the proposed Transparency Rule.
:: Section 26(h), 15 U.S.C. § 2625(h): Congress has directed EPA, when promulgating TSCA regulations and requiring testing and other information gathering, to "use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science." In doing so, EPA is also to consider "the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;" "the degree of clarity and completeness" of documentation of data, assumptions, and methods; and "the extent of independent verification or peer review of the information . . . ." Congress thus clearly contemplated, and expected, rigorous standards for data gathering and validation. TSCA's requirements confirm the ability of EPA to harness its general rulemaking authority to ensure consistency of data gathering throughout EPA's regulatory mandate.
These statutory summaries demonstrate that Congress has both authorized and directed EPA to facilitate and conduct research throughout the range of statutes the agency administers. Both implicitly and explicitly, and in general and specific terms, these statutes reinforce the need for accurate and complete information, supporting EPA's authority to promulgate the Transparency Rule, whether under the general Federal Housekeeping Statute or EPA's more specific statutory mandates, or both.
Response: See responses to Comments 31-135 and 73-410.
Comment [144-1307]: Commenter (11915) notes that the proposal seeks comment on whether it is appropriate to rely on EPA's authority found in a variety of environmental statutes to promulgate this rulemaking, or to also cite the Federal Housekeeping Statute independently or in conjunction with these statutes. We recommend that EPA rely on the housekeeping statute in conjunction with overarching environmental authorities. The proposal is clearly intended to institute internal agency practices for the use of data and models, and is thus appropriate for and consistent with the housekeeping statute's authorization of agencies to "prescribe regulations for the government of his department, the distribution and performance of its business, and the...use...of its records, papers, and property." This is particularly fitting if the agency chooses the modified approach that does not exclude use of non-public data and models but rather allows use of all information while providing greater consideration to publicly available materials
Response: Thank you for your comment in support of the final rule. The final rule addresses how EPA will consider the relevant scientific studies when promulgating significant regulatory decisions or developing ISI. EPA will give greater consideration to studies where the underlying data and models are available for independent validation. See responses to Comments 31-135 and 73-410.
Comment [159-1405]: Commenter (12430) notes that in the NPRM, U.S EPA attempted to justify the proposed rule on the basis of several substantive statutes. Presumably out of recognition that these statutes do not support the proposal, the agency is now attempting to frame the proposal as a mere "housekeeping" measure. It invokes the Federal Housekeeping Statute, 5 U.S.C. section 301, which states in relevant part:
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.
As a threshold matter, the Federal Housekeeping Statute does not apply to U.S. EPA for the reasons explained in the comment submitted on the SNPRM by California Attorney General Xavier Becerra and other attorneys general. Even if the Federal Housekeeping Statute applied to U.S. EPA, it would be cabined by substantive environmental statutes, which Congress enacted after the Federal Housekeeping Statute. Most significantly, by its terms, the Federal Housekeeping Statute only authorizes (other) agencies to adopt regulations for purely internal matters, such as record retention and employee conduct. It cannot redeem the SNPRM.
Response: See responses to Comments 31-135 and 73-410.
Comment [159-1407]: Commenter (12430) notes that U.S. EPA contends that the proposed regulation should qualify as a housekeeping measure because, allegedly, it "exclusively pertains to the internal practices of the EPA[,]" and would simply "establish an agency wide approach to handling studies[.]" To date, U.S. EPA has cited the Federal Housekeeping Statute as authority for regulations covering such topics as subpoenaed employees, subpoenas duces tecum, the handling of CBI, agency practices under the FOIA and the Privacy Act of 1974, and agency-sponsored research involving human subjects. Such regulations affect how U.S. EPA employees conduct internal procedural and administrative tasks. The SNPRM, by contrast, would govern the science that U.S. EPA would be permitted to consider when implementing a range of substantive environmental laws. The SNPRM would directly limit the public's ability to provide effective comment on future agency proposals, as it would force U.S. EPA to summarily reject public comments referencing studies or models relying on non-publicly available data. As detailed throughout the remainder of this comment, the SNPRM would profoundly affect future U.S. EPA regulatory decisions and "influential scientific information" -- which, per U.S. EPA's proposed definition, is information that would have a "clear and substantial impact on important public policies or private sector decisions." The amount of attention the proposal has attracted -- from the scientific community, elected officials, the media, and nonprofit organizations -- reflects the extent of its impacts. In response to the NPRM, for example, U.S. EPA received nearly 600,000 comments and more than 9,000 unique substantive comments. Many of these were comments from scientific organizations, scientists, and public health officials explaining the dire impacts the NPRM would have on public health and the environment. A purely internal housekeeping measure would not have drawn such widespread stakeholder interest.
Response: See responses to Comments 31-135, 32-144, 40-193, and 48-381.
Comment [159-1408]: Commenter (12430) writes that even if the Federal Housekeeping Statute somehow applied (which it does not), it could not authorize the proposal set forth in SNRPM. The Federal Housekeeping Statute does not compel U.S. EPA to adopt the SNPRM or authorize it to issue regulations counter to the substantive statutes it administers. These statutes consistently require U.S. EPA to use the best available science; there is no reasonable way that the general Federal Housekeeping Statute could be read as impliedly repealing the more specific and later-enacted substantive statutes.
Response: See responses to Comments 31-135 and 73-410.
Comment [162-1467]: Commenter (12435) writes that the 5 U.S.C. 301 "housekeeping authority" does not authorize EPA to internalize decisions with high consequence for policy, such as this one. The proposed rule has broad implications for and potential impacts on external stakeholders, including specific repercussions in Colorado. The Supreme Court has held that Section 301 is a "`housekeeping statute,' authorizing what the [APA] terms `rules of agency organization, procedure, or practice' as opposed to `substantive rules.'" Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979). In Chrysler, the Court analyzed whether 5 U.S.C. 301 authorized the DOL to pass regulations limiting the scope of the Trade Secrets Act and found that it did not. Similarly, the proposed rule, with its supplemental, constitutes the type of "substantive rule" excluded in this opinion. For example, the proposed rule may dictate what kind of evidence may be used to support CWA standards, which are the heart of the substance of this federal law. See 40 CFR Part 131. Similarly, this rule would set parameters around the "best available science" required to substantiate CAA standards. The EPA is not justified in attempting to use federal housekeeping statutes to internalize decisions of this type with broad consequences in order to shelter them from scrutiny and opposition.
Response: See response to Comments 31-135 and 73-410.
Comment [166-1511]: Commenter (12454) writes that the final rule would constitute regulations "for the government" of EPA, "performance of [EPA's] business", and "use . . . of [EPA's] records, papers, and property." NACoal recommends that EPA consider the Federal Housekeeping Statute as additional support for the final rule. While EPA is not an "executive department" within the meaning of the Federal Housekeeping Statute, the DOJ concluded in a formal opinion that the EPA Administrator has the same "housekeeping" authority under EPA's organic statute.
Response: Thank you for your comment in support of the final rule. See the response to Comment 31-135.
Comment [172-1549]: Commenter (12465) writes that the authority for the rule under the provisions of the housekeeping rule is a novel interpretation of the Federal Housekeeping Statute and as such the Agency would be well served by carefully considering stakeholder input on the underlying authority and the applicability under consideration.
Response: Thank you for your comment. In drafting the final rule, EPA carefully considered all of comments received on 2018 and 2019 proposals.
Comment [175-1573]: Commenter (12471) writes that in establishing this procedural framework to increase transparency, the Transparency Rule can rely solely on 5 U.S.C. § 301, the "Federal Housekeeping Statute" for authority. That statute states, "The head of an Executive department or military department may prescribe regulations for the government of his department . . .[concerning] the custody, use, and preservation of its records, papers, and property." Procedural regulations to "govern[]" EPA's framework to increase the transparency of ISI and the "use" of studies in EPA's possession would fall squarely within the Agency's authority under the Federal Housekeeping Statute. For additional support, the Agency might consider referencing authorities granted to the Agency under individual environmental statutes.
[...]
The Federal Housekeeping Statute authorizes neither the broad disclosure or withholding of information by government agencies. The Supreme Court has noted that given the Federal Housekeeping Statute's "long and relatively uncontroversial history, and the terms of the statute itself, it seems to be simply a grant of authority to the agency to regulate its own affairs." The Court further determined that "there is nothing in the legislative history of § 301 to indicate it is a substantive grant of legislative power."
Rather, the Federal Housekeeping Statute authorizes "what the [APA] terms `rules of agency organization, procedure or practice' as opposed to substantive rules." A procedural framework to increase the transparency of ISI would be such a non-substantive and internal rule of agency organization, procedure or practice authorized by the Federal Housekeeping Statute.
Response: Thank you for your comment in support of the final rule. See the responses to Comments 31-135 and 73-410.
Comment [177-1594]: Commenter (12596) notes that the Supplemental Transparency Proposal relies exclusively on the Federal Housekeeping Statute, citing the DOJ opinion for "housekeeping" authority. EPA retains the option to promulgate a Final Transparency Rule using substantive authority under environmental statutes, as it proposed in the original Transparency Proposal, while citing the Federal Housekeeping Statute for supplemental support. That said, we believe that the procedural transparency assessment framework discussed herein is well-tailored for the Supplemental Transparency Proposal's exclusive reliance on the Federal Housekeeping Statute.
[...]
A Final Transparency Rule that establishes a procedural transparency assessment framework would fall well within this standard. It would, consistent with the Federal Housekeeping Statute, simply prescribe rules for the performance of EPA assessment of studies within the Agency's custody. Such a procedural approach would not rely on a substantive grant of legislative power. The Administrator may be influenced by transparency assessments resulting from the Final Transparency Rule when taking separate substantive action under the CAA. Yet the procedural framework used to develop that assessment would still remain well within the Federal Housekeeping Statute's "surely ample legislative authority."
Response: EPA agrees with the commenter that it has adequate authority to promulgate this rule. See the response to Comment 31-135. EPA has decided to rely solely on its housekeeping authority and not the substantive environmental statutes cited in the 2018 and 2020 proposals.
Comment [184-2206]: 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 doesn't 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 responses to Comments 31-135, 32-144 and 73-410.
Comment [186-1700]: Commenter (12716) writes that EPA's assertion that it is authorized to promulgate this regulation under the Federal Housekeeping Statute is without merit. The statute provides that "[t]he head of an Executive department or military department may proscribe 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." As noted by EPA in its notice, the purpose of the Section 301 was to "grant early Executive departments the authority `to govern internal departmental affairs.'" Even if we were to accept EPA's argument that it was granted authority to use the Housekeeping Statute under the Reorganization Plan, it is not authorized to justify the promulgation of substantive regulations under the statute. A change in the way that the agency fulfills its obligations and promulgates regulations under the CAA and CWA that will impact public health and the environment is substantive in nature. This is not what was intended by the Housekeeping Statute.
Response: See response to Comments 31-135 and 73-410.
Comment [186-1845]: Commenter (12716) writes that EPA's assertion that it is authorized to promulgate this regulation under the Federal Housekeeping Statute is without merit. The statute provides that "[t]he head of an Executive department or military department may proscribe 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." As noted by EPA in its notice, the purpose of the Section 301 was to "grant early Executive departments the authority `to govern internal departmental affairs.'" Even if we were to accept EPA's argument that it was granted authority to use the Housekeeping Statute under the Reorganization Plan, it is not authorized to justify the promulgation of substantive regulations under the statute. A change in the way that the agency fulfills its obligations and promulgates regulations under the CAA and CWA that will impact public health and the environment is substantive in nature. This is not what was intended by the Housekeeping Statute.
Response: See response to Comments 13-135 and 73-410.
Comment [187-1710]: Commenter (12720) writes, finally, and equally problematic in the Agency's quest to find authority for the rulemaking, is the assertion that authority for the Proposal may be found under the Agency's so-called "housekeeping authority." EPA first floated this claim in its notice extending the comment period for the initial rulemaking, stating that "EPA is proposing this rule under authority of 5 U.S.C. § 301, in addition to the authorities listed in the April 30th document." See 83 Fed. Reg. 24,255, 24,256 (May 25, 2018). This statute, by its own terms, does not apply to EPA. 5 U.S.C. § 301. In citing this authority, EPA implicitly admits that the statutory authorities invoked in the original Proposal are lacking and reveals that the rulemaking lacks a basis in any statute.
The Agency again cites the federal housekeeping authority as a supposed statutory basis for the rulemaking in the Supplemental Proposal. 85 Fed. Reg. 15,396, 15,397 (March 18, 2020). EPA states that Section 301 of Title 5 provides "[t]he head of an Executive department or military department" authority to "prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property." Id. The Agency then quotes the Supreme Court's description of section 301 as designed to "grant early Executive Departments the authority `to govern internal department affairs'" and "authorizes `what the [APA] terms `rules of agency organization, procedure or practice, as opposed to substantive rules.'" 85 Fed. Reg. at 15,397 (citing Chrysler Corp. v. Brown, 441 U.S. 281, 308- 12 (1979)).
The fatal problem with the Agency's citation to this authority is that, under plain statutory language, EPA is "not one of the 15 `Executive Departments' listed at 5 U.S.C. § 101, to which section 301 applies. Id. 5 U.S.C. § 101. As such, the Agency has invoked a statute as a source of authority that by its own terms does not apply to EPA. Congress has had ample opportunity since 1970 to add EPA to the list of "Executive Departments" defined in 5 U.S.C. section 101. Congress has not done so. This is dispositive and fatal to the rulemaking's reliance on the Federal Housekeeping statute. See, e.g., Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842 - 43 (1984)("First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, [] as well as the agency, must give effect to the unambiguously expressed intent of Congress."); Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988) ("It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress.")
Response: See response to Comment 31-135.
Comment [187-1711]: Commenter (12720) notes that the Agency acknowledges that 5 U.S.C. § 301 does not apply to EPA in the Supplemental Proposal. 85 Fed. Reg. at 15,397. However, the Supplemental Proposal then claims that EPA "gained housekeeping authority through the Reorganization Plan No. 3 of 1970." Id. The agency suggests that this housekeeping authority is sufficient to authorize the instant rulemaking. Id. This suggestion is wrong.
The Supplemental Proposal starts its inapposite line of argument by noting that "[t]he Reorganization Plan created EPA, established the Administrator as `head of the agency' and transferred functions and authorities of various agencies and Executive departments to EPA." Id. at 15,397/3. The Supplemental Proposal does not argue, nor could it, that creation of EPA or establishment of the Administrator as its head authorizes the instant rulemaking. Id. Instead, the Supplemental Proposal appears to argue that the transfer of "functions and authorities of various agencies and Executive departments to EPA" somehow authorizes the current rulemaking. Id. This is wrong.
EPA first argues that "[s]ection 2(a)(1) - (8) of the Reorganization Plan transferred to EPA functions previously vested in several agencies and executive departments including the Departments of Interior and Agriculture." Id. Notably, however, EPA does not and cannot identify any subsection(s) in section 2 that even pretend to authorize the instant rulemaking and its myriad of restrictions and exemptions and other provisions. Id. EPA ducks the issue and simply references section 2(a)(1) - (8). This is understandable. There is no congressional delegation, no legislative history, no factual evidence and no suggestion of authorization for EPA to adopt the instant rulemaking via the transfer of the listed functions from the Secretary of the Interior, the Secretary of Health, Education and Welfare, the Council of Environmental Quality, the Atomic Energy Commission, the Federal Radiation Council or the Secretary of Agriculture to the EPA. See the section 2(a)(1) - (8), Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970) ("Reorganization Plan"). EPA's struggle to find authority for the instant rulemaking in 2(a)(1) - (8) of the Reorganization Plan fails badly.
Next, EPA argues that "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.'" 85 Fed. Reg. at 15,297/3. Section 2(a)(9) transfers to EPA:
So much of the functions of the transferor officers and agencies referred to in or affected by the foregoing provisions of this section as is incidental to or necessary for the performance by or under the Administrator of the functions transferred by those provisions or relates primarily to those functions. The transfers to the Administrator made by this section shall be deemed to include the transfer of (1) authority, provided by law, to prescribe regulations relating primarily to the transferred functions, ....
Reorganization Plan, section 2(a)(9) (emphasis added). EPA's inability to identify any specific transferred function that authorizes the instant rulemaking is fatal. 85 Fed. Reg. at 15,297/3. EPA's tautological argument about section 2(a)(9) fails for the same reason as the argument about section 2(a)(1) - (8): the transferred functions in no way provided authority for the instant rulemaking. EPA is unable to identify any authority for the rulemaking in the actual text of the Reorganization Plan or its legislative history, or in the actual text of any of the transferred functions, their referenced statutes, or their legislative history. EPA's own silence speaks volumes about this inability.
EPA's argument, here, about section 2(a)(9) echoes the original Proposal's reliance on the general authority to prescribe regulations in section 301 of the CAA. But as NRDC noted in its comments on the Proposal:
EPA cites 42 U.S.C. § 7601(a) of the CAA as one basis for the Proposal. But that section merely authorizes the Administrator to "prescribe such regulations as are necessary to carry out his functions under this chapter." The courts have made clear that "EPA cannot rely on its gap-filling authority to supplement the CAA'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 American Petroleum Institute v. EPA, 52 F.3d 1113, 1119 (D.C. Cir. 1995) ("the general grant of rulemaking power to EPA cannot trump specific portions of the CAA"); NRDC v. Reilly, 976 F.2d 36, 41 (D.C. Cir. 1992) (EPA cannot use its general rulemaking authority as justification for adding to a statutorily specified list); Sierra Club v. EPA, 719 F.2d 436, 453 (D.C. Cir. 1983) (same); Gonzales v. Oregon, 546 U.S. 243, 264 - 65 (2006) ("It would go . . . against the plain language of the text to treat a delegation for the `execution' of [the Attorney General's] functions as a further delegation to define other functions well beyond the statute's specific grants of authority."). Here, not only is there no statutory gap to fill, as explained further below, the Proposal is in direct conflict with other provisions of the Act. EPA cannot rely on 42 U.S.C. § 7601(a) to support this rule.
NRDC Comments on Proposal, at 36. Federal courts have held, repeatedly and resoundingly, that congressional grants of general authority to issue regulations to carry out functions of a statute provide no additional authority to "trump" portions of a law (American Petroleum Institute, 52 F.3d at 1119); to "define other functions well beyond the statute's specific grants of authority," (Gonzales, 546 U.S. at 264 - 65); or to "supplement" statutory provisions "when Congress has not left the agency a gap to fill." NRDC, 749 F.3d at 1064. Yet, this is precisely what EPA is doing, here, by purporting to "prescribe regulations relating primarily to the transferred functions" under the Reorganization Plan. See section 2(a)(9), Reorganization Plan. Reliance on section 2(a)(9) for this authority is unlawful for the same reasons that courts have found it unlawful for EPA and other agencies to rely on congressional grants of general authority to issue regulations to carry out functions of a statute.
Response: See response to Comments 13-135 and 73-410.
Comment [187-1712]: Commenter (12720) writes that finding no support in the Reorganization Plan itself, EPA must resort to citing a 2008 DOJ OLC memo "opin[ing]" that the "Reorganization Plan `convey[s] to the [EPA] Administrator all of the housekeeping authority available to other department heads under section 301.'"
First, the OLC memo itself reiterates that 5 U.S.C. 301 does not apply to EPA. OLC memo, p.81. Accordingly, EPA's reliance on 5 U.S.C. 301, or any interpretations made in the OLC memo, itself, as any authority for the instant rulemaking is completely inapposite, arbitrary, and capricious. See e.g., 85 Fed. Reg. at 15,404/3 (citing 5 U.S.C. 301 as statutory authority for proposed 40 C.F.R. part 30). This defect, by itself, is fatal to the lawfulness of the entire proposed rulemaking.
Second, the interpretations offered in the OLC memo supply no authority for the instant rulemaking, and obviously lack the force of law. See, e.g., Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988) ("It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress.") Congress has delegated no authority to EPA to adopt the instant rulemaking. Neither the OLC memo, nor EPA's reliance on it, will receive any deference from a reviewing court.
Third, the OLC was not reviewing or analyzing any facts or activities remotely similar to the subject of the instant rulemaking when the OLC issued the memo on which EPA now relies. Rather, the OLC was addressing the inherently internal issue of "destruction of government personal property [and] the unauthorized personal use of agency-issued cell phones," which bore no relation to an agency's performance of its substantive, statutory and regulatory responsibilities. OLC Memo, 79.
Response: See response to Comment 31-135.
Comment [187-1713]: Commenter (12720) writes that even in the narrow bureaucratic situation present there, while the OLC concluded that "[t]he Reorganization Plan establishing the EPA vests the Administrator with authority equivalent in many respects to that enjoyed by the head of an executive department" OLC memo at 82, neither the Reorganization Plan nor 5 U.S.C. 301 authorizes the instant rulemaking. Nowhere in the Supplemental Proposal can EPA identify any passage in the OLC memo that purports to authorize a rulemaking that impacts EPA's performance of its substantive, statutory responsibilities as sweepingly as the instant rulemaking would. Instead, the OLC memo fully supports the opposite conclusion, that neither 5 U.S.C. 301 nor the EPA "Reorganization Plan" supports "substantive rules" like the instant rulemaking. Footnote 4 of the OLC memo states unambiguously that:
As a general matter, regulations that "directly affect the rights and obligations of private parties" or regulate the "citizenry at large" constitute "substantive rules" under the APA and usually must be promulgated in accordance with notice and comment procedures. Authority to Prescribe Regulations, 28 Op. O.L.C. at 107. In contrast, agency rules "govern[ing] only the conduct of government employees" are not substantive rules within the meaning of the APA and are specifically excluded from publication and notice and comment requirements. Id. The EPA policies at issue here pertain solely to the conduct of EPA employees and have no application to the "citizenry at large." Those policies are therefore not "substantive rules" that must be published under the APA.
OLC memo, pg. 84, n. 4.
Faced with this fatal restriction, EPA attempts to claim that both the Proposal and the Supplemental Proposal "would not regulate the conduct or determine the rights of any entity outside the federal government" as it "exclusively pertains to the internal practices of the EPA." 85 Fed. Reg. at 15,398. Ironically, EPA offers up this preposterous assertion in the sentence immediately following a sentence "describ[ing] how EPA will handle studies when data and models underlying science that is pivotal to EPA's significant regulatory decisions or influential scientific information are or are not publicly available in a manner sufficient for independent validation and analysis." Id. Even the Agency's own description of the Proposal and Supplemental Proposal make clear that the rulemaking is intrinsically substantive in nature --  "pivotal to EPA's significant regulatory decisions or influential scientific information." Id.
The EPA claim that this rulemaking addresses only internal practices at the Agency does not even pass the laugh test. As noted extensively in the now hundreds of pages of comments submitted by NRDC alone, the rulemaking would dramatically and "directly affect the rights and obligations of private parties" and regulate the "citizenry at large" by rewriting how science is considered, used, and ignored in the Agency's substantive rulemakings. Further, the fact that EPA originally relied (without any basis), 83 Fed. Reg. at 18,769, and still relies, 85 Fed. Reg. at 15,397, on the agency's eight substantive environmental statutes, proves this point. As noted above, these statutes themselves dictate EPA's obligation to use the highest-quality scientific information to inform the agency's work, in various different ways specific to each statute. Only once it was abundantly clear that the rulemaking lacks any authority in these substantive environmental statutes, did the Agency offer a wildly different, opposing theory that pretends this rulemaking governs "only the conduct of government employees."
Courts have made abundantly clear what constitutes a substantive rule versus one of entirely internal effect under the housekeeping statute (were the housekeeping statute applicable here, which it is not). Courts have found, based on both "§ 301's text and its "long and relatively uncontroversial" history, []that § 301 "is indeed a `housekeeping statute,' authorizing what the APA terms `rules of agency organization procedure or practice' as opposed to `substantive rules.' [] Subsequent courts have repeatedly rejected agency attempts [] to "twist this simple administrative statute into an authorization for the promulgation of substantive rules." [] New York v. United States Dep't of Health & Human Servs., 414 F. Supp. 3d 475, 521 (S.D.N.Y. 2019)(internal citations omitted).
Response: See response to Comments 31-135, 48-379, 48-383 and 73-410.
Comment [198-2217]: Commenter (13549) 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 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 responses to Comment 31-135, 32-144, and 73-410.
Comment [199-1935]: Commenter (12403) writes that the Federal Housekeeping Statute is not an appropriate legal authority for this action. The proposal is also inconsistent with provisions in the TSCA and would hamper implementation of CAA requirements.
Response: Implementation of the final rule should not impact compliance with CAA and TSCA requirements. As stated in § 30.3, if there is a conflict between this rule and any of the statutes that EPA administers, the rule would yield to those statutes.
Comment [200-1965]: 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 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. 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 Comments 31-135, 32-144, 48-382, 73-410.
Comment [201-2219]: 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 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 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: See responses to Comments 31-135, 32-144, 38-185 and 73-410.
Comment [205-2035]: Commenter (13788) writes that as EPA admits in the SNPRM, the Agency "is not one of the 15 `Executive Departments' listed at 5 U.S.C. 101." Therefore, on its face the Federal Housekeeping Statute does not even apply to EPA. EPA claims authority based on Reorganization Plan No. 3 of 1970, which transferred functions previously vested in other agencies to EPA, as well as functions "incidental to or necessary for the performance by or under the Administrator of the functions transferred." However, EPA provides no reason to believe this rule is incidental or necessary for performance of the functions transferred.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Transparency of the underlying data, models, and process upon which the EPA makes its decisions is integral to demonstrating accountability and our dedication to public health and the environment. Also see the response to Comment 31-135.
Comment [207-2071]: Commenter (14397) notes that in the SNPRM, the EPA seeks comments on whether to use its housekeeping authority independently or in conjunction with "appropriate environmental statutory provisions." EPA proposes using the Federal Housekeeping Statute, found at 5 U.S.C. § 301 (see 85 Fed Reg at 15404), which states 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, paper, and property." It appears that the EPA itself does not believe that it has this authority, otherwise why would they still be seeking comments on this aspect of the proposal two years after it was first proposed. And EPA should well doubt the use of this provision in this instance - since the EPA was not one of the fifteen "Executive Departments" listed under 5 U.S.C. § 301 it is doubtful whether this provision is applicable. Additionally, the proposed rule and the SNPRM both go well beyond internal housekeeping provisions - they would dramatically impact every aspect of the EPA's regulatory responsibilities. Use of this provision would unnecessarily prevent the EPA from carrying out its mission under the CAA, as the EPA itself seems to recognize when it states "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." (see 85 Fed Reg at 15398).
To illustrate the above argument, the CAA (Section 108(a)(2)) requires the EPA to set pollutant levels that "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 EPA, in this SNPRM, does not attempt to argue that the studies under attack for not providing all underlying data don't accurately reflect the latest scientific knowledge. Therefore, if the EPA elects to exclude this data, it would be in clear violation of the CAA.
Response: See the response to Comments 31-135 and 73-410.
1.3 Specific Environmental Statues
1.3.1 Clean Air Act (CAA) (NPRM and SNPRM Comments).
Comment: Sections <IP_ADDRESS> and <IP_ADDRESS> of this Chapter present comments received on the NPRM (Section <IP_ADDRESS>) and SNPRM (Section <IP_ADDRESS>) related to the EPA's legal authority for the rule under the CAA. The EPA provides the following general response to these comments:
Response: The EPA appreciates your comments. As discussed in Section I.C of the final rule preamble and in this RTC document in Section 1.2, EPA has decided it is most appropriate to rely on its authority to promulgate housekeeping regulations, rather than any of the substantive environmental statutes cited in the 2018 proposal or the 2020 supplemental proposal as legal authority for the rule. EPA intends to promulgate future science transparency rules under its substantive environmental statutes. Additionally, the final rule states in § 30.3 that "[i]n the event the procedures outlined in this rule conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control."
<IP_ADDRESS> CAA (NPRM Comments)
Comment [37-36]: Commenter (0046) states that the proposal amends the air quality criteria, adopted under §108 (b) of the CAA, for particulate matter (PM) and lead. See proposed rule fn. 3 final sentence which states that the proposed rule would "preclude" "future regulatory actions" using the Lanphear study which is part of the criteria for the NAAQS for lead, and the Harvard Six Cities and American Cancer Society II study (Dockery and Pope) which are part of the criteria for the PM NAAQS. Air quality criteria cannot be amended without review by Clean Air Scientific Advisory Committee (CASAC). See CAA §109 (d)(2)(B). EPA consequently must submit its proposal to CASAC for its review, following all procedural requirements for public meeting and deliberations in doing so. CASAC must then submit its recommendations to the Administrator (see §109 (d)(2)(B) final clause), and the Administrator must consider these recommendations and provide a reasonable explanation for any actions that deviate significantly from those recommendations (CAA section 307 (d)(3)). EPA cannot proceed with this action until these requirements are satisfied.
Comment [657-4043] Commenter (0671) states that the impact of the proposed rule (and its obvious purpose) will be to hamstring the EPA by effectively preventing EPA from using human subject studies in rulemaking. No other federal agency has such a broad standard as the one envisioned here. The EPA knows that the IRB will not allow such studies' data to be made public, so to require public data from these studies will make them invisible to the rulemaking process. Therefore, by requiring public data the EPA will be violating the CAA's requirement to use the "best available science" by forcing it to ignore such science that happens to include PII.
The proposed regulation is a terrible idea that is contrary to the intent of the CAA and its amendments, imposes substantial administrative burdens on researchers and potentially the American people, and does not serves its stated purpose.
Comment [657-4198]: Commenter (0671) The EPA should not implement the proposed regulation. No part of the Agency should be responsible for implementing this proposed regulation because it runs counter to the text and intent of the CAA and amendments.
Comment [1535-4532]: Commenter (1550) states that, as a practicing scientist they recognize the difference between the need for supporting data, and requirements that are imposed solely to obstruct or censor evidence that an administrator finds inconvenient or which contradicts his preconceived positions.
Consider, for example, air pollution. The CAA is a bedrock environmental law that protects us from dangerous air pollutants. It would be endangered under this proposed rule because it relies on a longitudinal epidemiologic study of subjects whose participation involved a promise that the data would be used statistically without disclosing individual medical records. If the proposed rule is approved, we could lose the use of such statistical evidence and be unable to formulate valid science-based standards.
The same principles apply to many other areas of environmental health research. Once again, there is a fundamental difference between disclosure necessary to validate data and disclosure rules created solely to obstruct or censor results one dislikes. Doing so would violate the principles and traditions of science and be counter to the mission of the EPA.
Comment [1544-4546]: Commenter (1559) notes that the CAA protects us from dangerous air pollutants. We must keep this law. This proposed rule compromises the CAA, and for that reason, this rule must not be approved. We need to maintain the CAA sweeping improvements to the air we breathe, and we need to strengthen it to include all air toxics that are endocrine disruptors, mutagens, and carcinogens. We need federal regulation of the halogens---chlorine, bromine, and fluorine. We need federal regulation of the petroleum products that go airborne such as petroleum-based fragrances, pesticides, insecticides, herbicides, and airborne plastic molecule--all of which come from petroleum bases which are endocrine disruptors, mutagens, and carcinogens. It is time to ban synthetic, petroleum-based fragrances as 30% of the population has some discomfort from them, and this particularly applies to petroleum-based fragrances in dryer sheets that make it very difficult to breathe in local neighbors. We need to ban all synthetic fragrances and require substitution with 100% pure essential plant or fish oils.
Comment [1642-4554]: Commenter (1657) states that the CAA only requires EPA to use the "best available science", it doesn't not require that the EPA use only publicly available data, nor does it specify that the science on which EPA rules are based must be from the United States. Indeed, after May 25, 2018 any self-imposed requirement that the EPA use only public data on human subjects will prevent EPA from using the best available science when that science comes European Union (EU) member countries.
While the EPA has no control over statutory requirements in other jurisdictions the EPA does have a statutory obligation to obey U.S. law, and it will likely not be able to obey the CAA under the proposed rule after May 25, 2018.
Comment [1959-109]: Commenter (1973) expresses that they believe that the proposed rule would deprive policy makers of the real-world epidemiologic evidence, based on real exposures of real people, that has been and will continue to be vital for future revisions of the NAAQS, drinking water standard, pesticide standards, and other health based standards based on a false understanding of transparency and replication in science. This is direct contradiction to requirements of the CAA, for example, to consider the best available science, and would create an approach to the use of scientific evidence on the adverse health effects of air pollution by EPA that would be at odds with the World Health Organization (WHO), the Royal Society for Medicine, and other national review bodies. It would also put EPA in direct opposition to the standards for considering evidence of health effects of smoking, high cholesterol, etc. by the CDC, of the studies considered for issuing guidelines generated by the NIH, and of the Food and Drug Administration (FDA) reliance on non-publicly available studies to approve drugs for use by people.
Comment [2322-160]: Commenter (2337) notes that the EPA's core mission, reflected in numerous environmental statutes, is to protect public health and the environment. These same statutes require that EPA, in fulfilling this mission, support and rely on the best available science. While the specific terms of each statute vary, their direction is similar: EPA is charged with conducting and supporting research into the impacts of pollutants on human health and the environment, using available scientifically accepted data to determine when pollutants pose a danger to human health or the environment, and establishing standards with a sufficient margin of safety to protect public health. Indeed, this requirement that EPA use the latest or best available science is repeated in numerous environmental statutes. The CAA, for example, directs the Administrator to reflect "the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare ..." when updating air quality criteria. Notably, public availability or independent verification are not disqualifying requirements.
Comment [2480-4920]: Commenter (2495) states that the EPA must use all the available scientific information in order to meet the goals Congress identified in the CAA. This is the standard met by the ISA for Ozone and Related Photochemical Oxidants, to cite one example. The agency should also follow the advice of CASAC.
Comment [4816-4226]: Commenter (4827) states that, under the CAA, the EPA is required to establish and regularly update federal standards for hazardous air pollutants (HAP), including asthma-causing PM and ozone. These standards, the NAAQS, form the backbone of our nation's air quality protections. Although the NAAQS did not prevent my sister's asthma, they have and continue to bring about substantial improvement in our nation's air quality since their first formulation.
But EPA's proposed rule would have excluded peer-reviewed studies that form the scientific basis of the NAAQS. For example, peer-reviewed studies would be excluded because the underlying data and models cannot be disclosed even in partial form. In fact, the Standards would likely not have been issued had the proposed rule been in place when they were first enacted in the 1970s, because EPA would have tossed out the underlying studies, tying its hands from taking action on an imminent public health concern. Without a doubt, many more Southern Californians would have their lives altered, or even cut short, by dangerous levels of air pollution.
If adopted, the proposed rule will deprive EPA policymakers from real-world evidence and studies that are vital to EPA's review of the NAAQs into the future. Further, the proposal directly contravenes the comprehensive federal and state regulatory programs Congress envisioned when drafting the CAA of 1970. It reduces our public health legislation to mere declarations, as EPA would be severely delayed, if not rendered entirely unable, to establish future Standards using the "best available science."
Comment [4827-2070]: Commenter (4838) asserts that the proposed rule violates several environmental statutes because it hinders EPA's ability to rely on best available science, or the most up-to-date information, as they require. The CAA, CWA, SDWA, TSCA, and EPCRA all require certain decisions or regulatory criteria be based on the most up-to-date science. These criteria are described as "best available science," "latest scientific knowledge," and "best available public health information." The proposed rule would illegally limit EPA's ability to rely on best available science in violation of these statutes.
Comment [4829-2023]: Commenter (4840) states that many of laws authorizing the activities of the EPA require the agency to use the best science in protecting the public's health and environment. For example, the CAA mandates that air quality criteria "accurately reflect" the "latest scientific knowledge." In the past, the EPA has considered all available studies in issuing these criteria without consideration of the availability of the underlying data. Promulgation of this proposed rule would be an arbitrary and capricious violation of the provisions of these laws.
Comment [4867-2034]: Commenter (4878) notes that the CAA authorizes EPA to establish NAAQS to protect public health and to regulate emissions of HAPs. EPA works with local governments to reduce air pollution and uses scientific studies that could be impacted by the proposed rule to revise its national air quality standards and NAAQS on a regular basis.
Very little is currently known about air pollution and its impacts on the brain. Recent studies have linked particulate exposures to Parkinson's disease including a large study done in Denmark. This study used several thousand people with and without a current diagnosis of Parkinson's disease. Using extremely specific (within 5-50 meters of the front door) geo-coding to estimate participant's exposure to contaminants, the study estimated that ambient air pollution from traffic increased risk of developing Parkinson's disease by 9 percent. Researchers found an increased risk of Parkinson's disease after exposure to PM in studies from Taiwan and South Korea, as well.
In addition to concerns stated in the previous section about the usefulness of data if enough information is redacted to protect privacy, these studies raise additional challenges because they were performed internationally. In the Danish study, participants are protected by EU law. Going forward, an EU study's compliance with the proposed rule will need to be reconciled with the new General Data Protection Regulation, which is seen as more restrictive than the United States' Health Insurance Portability and Accountability Act (HIPAA) of 1996.The privacy directive raises many issues for science not discussed here, but it is clear that many studies that involve people located in the EU will have a difficult time both complying with the new directive and providing enough information to EPA to be considered.
Studies coming from other countries are vital to health determinations in the Unites States because people in other countries are exposed to chemicals at different rates than in the U.S. The ability to compare and contrast exposure to health outcome can be enlightening; average PM concentrations in South Korea and China are several times higher than in the United States, making relatively subtle effects stand out more easily. Studies done in other countries can also help researchers tease out whether an effect is dose or length of exposure dependent. The inability to review and use international research in determinations will virtually guarantee EPA is missing major findings and important data.
Comment [4870-2300]: Commenter (4881) states that, in dismissing the last-resort claim of data inaccessibility in the case of American Trucking Associations, Inc. v. EPA, the Court pointed out that the CAA imposes no obligation on the EPA to obtain and publicize the raw data underlying published studies on which the Agency relies. The Court distinguished EPA's reliance on a study's results from its reliance on the raw data underlying such results, noting that raw data often are unavailable due to proprietary interests of a study's scientific investigators or confidentiality agreements with study participants. The Court endorsed EPA's own claim submitted in that case:
"If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment․ [S]uch data are often the property of scientific investigators and are often not readily available because of ․ proprietary interests ․ or because of [confidentiality] arrangements [with study participants]."
Comment [4873-2109]: Commenter (4884) expresses that the CAA requires that NAAQS be set at levels protecting the public health without regard to cost. I believe our other federal environmental laws have the same legal requirement. Footnotes numbered one through five at pg. 18769 of the subject Federal Register frustrate the CAA legal mandate to set NAAQS at levels sufficient to protect public health. In sum, these citations call for the best available science as long as it is publicly available. This truncated scientific information now deemed "transparent" will further be vetted by advisory boards; some likely representing other vested interests. What policy recommendations these conflicted councils may make are then to be ruled upon and perhaps over-ruled by the EPA Administrator. The Administrator can discount the value of clean air to breathe without fear of contradiction.
It is the avowed intent of this proposal to make these changes only for future EPA regulations adopted under the provisions of 40 CFR Part 30. Such limitations are meaningless under the provisions of the CAA. This law calls for the NAAQS to be reestablished every five years at the latest.
Comment [5154-393]: Commenter (5165) states that the National Association of Clean Air Agencies (NACAA) appreciates this opportunity to comment on the U.S. EPA's proposed rule, "Strengthening Transparency in Regulatory Science," 83 Fed. Reg. 18,768 (Apr. 30, 2018). NACAA is the national, non-partisan, non-profit association of 156 local and state air pollution control agencies in 41 states, D.C. and four territories. The air quality professionals in our member agencies have vast experience dedicated to improving air quality in the U.S. These comments are based upon that experience. The views expressed in these comments do not represent the positions of every state and local air pollution control agency in the country.
The commenter agrees with EPA that "the best available science must serve as the foundation of EPA's regulatory actions." Indeed, reliance on best available science is a fundamental requirement of the CAA and other environmental statutes that EPA administers. For example, the CAA requires EPA to establish NAAQS at levels "requisite to protect the public health" with "an adequate margin of safety." In meeting this obligation, EPA is required to develop air quality criteria that "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, in varying quantities." Science-based decision making is at the very core of our shared mission to protect public health and the environment from the harmful effects of air pollution
Comment [5865-327]: Commenter (6111) states that the EPA's historic position is consistent with the Statutes. For example, one of EPA's core duties under the CAA is to set and periodically review the NAAQS for six common air pollutants. In carrying out this responsibility, Congress commanded EPA to use "the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects [of air pollution] on public health or welfare."
Furthermore, because EPA is required under the Statutes to assess the public health benefits of its regulations, it must take into account all relevant science and cannot arbitrarily exclude certain studies demonstrating those benefits. Under the CAA, EPA must set the NAAQS at a level "requisite to protect the public health."
Many of the fundamental public health studies on which EPA has based key rules and standards under the Statutes are studies for which the raw data were not or could not have been released. Attachment 1 to this letter contains a partial list of studies [note: included under a separate excerpt] that likely contain confidential data; these are all studies on which EPA has relied and cited as the basis for its actions under some of the Statutes. Until now, release of the underlying raw data was not an EPA criterion for determining the "best available" reports, studies, analyses, or models. Indeed, none of the Statutes invoked by EPA as support for the proposed rule limits EPA in this fashion; none of the Statutes requires EPA to make raw data publicly available.
EPA's proposed new approach, which conflicts with the agency's obligations and curtails its authority, is irrational at best and detrimental to public health and safety at worst.
Comment [5971-4586]: Commenter (5981) notes that the CAA allows the EPA via Risk Management to improve the safety protocols followed by first responders and workers at facilities which use hazardous chemicals.
The EPA historically investigates such emergency incidences involving death or injury to study causes and create Risk Management. Because these incidences and subsequent studies cannot be reproduced ethically, first responders and workers at hazardous facilities would be at greater risk. This would also negatively affect the public living near these facilities.
Comment [6099-564]: Commenter (6109) notes that the EPA cites two provisions of the CAA as legal support for its proposal: § 103 - which details research and development programs and lists authorized activities, and § 301(a) - which gives EPA authority to "prescribe such regulations as are necessary to carry out its functions under this chapter." In citing § 103, EPA fails to acknowledge that the list of authorized activities does not include arbitrarily rejecting best available science, and in referencing § 301(a) EPA does not cite judicial authority or agency precedent for using this provision to limit the evidence that can be used in rulemaking.
Comment [6099-565]: Commenter (6109] states that, interestingly, EPA does not cite § 307(d) of the CAA as a basis of legal authority for this proposed rule. Subsection (d) ("Rulemaking") refers specifically to data disclosure (§ 307(d)(3)(A)). This may be because, as EPA is aware, courts have already rejected claims that § 307 prohibits the use of nonpublic data in decision making. In American Trucking Associations, Inc. v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002), the court said, "we agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely "would be impractical and unnecessary." In doing so, the D.C. Circuit Court directly cited EPA's own argument: 'If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment... [S]uch data are often the property of scientific investigators and are often not readily available because of ... proprietary interests ... or because of [confidentiality] arrangements [with study participants].'
EPA is seeking to rescind its previous position on the use of nonpublic data without providing an explanation of how, in the absence of these data, EPA will continue to adequately develop or implement regulations that are protective of human health.
EPA also fails to acknowledge that the CAA contains provisions that contradict this proposed rule. Section 109 of the CAA requires EPA to base air quality standards on "air quality criteria," which, per (§108(a)(2)) must "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health and welfare." Section 108 does not include a provision for ignoring existing data. In addition, § 109 requires that NAAQS must allow "an adequate margin of safety" and "protect public health." If EPA chooses to ignore relevant science, how will the agency know if it is setting standards with an adequate margin of safety?
Comment [6104-612]: Commenter (6114) states that the EPA itself seems to question whether it has the authority to promulgate this rule. The FR notice asks commenters to provide information on what areas of the CAA they feel may demonstrate this type of authority. The EPA should have a solid foundation before it proposes rules and not have to seek answers for questions about its own authority.
Comment [6112-1491]: Commenter (6137) notes that the EPA cites two provisions of the CAA as authority for the Proposed Rule. As further detailed below, neither provision provides such authority.
First, EPA cites CAA § 103, 42 U.S.C. § 7403, as authority for the Proposed Rule. 83 Fed. Reg. at 18,769. However, this section provides no authority for such a rule. Instead, the section requires EPA to create a research and development program for prevention and control of air pollution and to conduct research on health effects, among other issues. Specifically:
 Section 7403(a) requires EPA to "establish a national research and development program for the prevention and control of air pollution," which includes funding or conducting studies, establishing technical advisory committees, and related activities.
 Section 7403(b) provides a list of specific "[a]uthorized activities" that EPA may take in establishing the "research and development program" under subsection (a), including, for example, collecting and making available information pertaining to the program, cooperating with other agencies, and making grants and contracts for research. Id. § 7403(b)(6).
 Section 7403(c) requires EPA to "conduct a program of research, testing, and development of methods for sampling, measurement, monitoring, analysis, and modeling of air pollutants."
 Section 7403(d) requires EPA to "conduct a research program on the short-term and long-term effects of air pollutants, including wood smoke, on human health."
 Section 7403(e) requires EPA to conduct ecosystem research.
 Section 7403(f) requires EPA to oversee an "experimental and analytical research effort, with the experimental research to be carried out at the Liquefied Gaseous Fuels Spill Test Facility."
 Section 7403(g) requires that, in carrying out purpose of subsection (a), EPA shall "conduct a basic engineering research and technology program to develop, evaluate, and demonstrate nonregulatory strategies and technologies for air pollution prevention."
 Section 7403(h) authorizes certain research by the National Institute of Environmental Health Sciences (NIEHS).
 Section 7403(i) discusses coordination of research with "other Federal ecological and air pollution research efforts."
 Section 7403(j) discusses acid rain research.
 Section 7403(k) discusses air pollution conferences.
Notably absent from this long list of explicit requirements and responsibilities is rulemaking authority, much less authority to exclude scientific studies from consideration by EPA in any "regulatory decisions" for any reason, including whether or not the underlying data is, or can be made publicly available. See 83 Fed. Reg. at 18,773-74 (proposed 40 C.F.R. §§ 30.2, 30.3, 30.5) (indicating application of Proposed Rule only to use of studies and data in "significant regulatory decisions"). Indeed, the authorized activities included in Section 7403(b) are quite specific, including actions such as collecting and disseminating information, making grants and contracts, and even "construct[ing] facilities, provid[ing] equipment, and employ[ing] staff as necessary to carry out this chapter."
Congress knew how to authorize EPA rulemaking activities elsewhere in the CAA. That § 7403 does not include such authority, much less authority to restrict science in particular, shows a clear intent not to grant such authority. Meghrig v. KFC W., Inc., 516 U.S. 479, 485 (1996). Rather, the purpose of § 7403 is plainly to promote research and to advance and increase the use and consideration of data, not to restrict it.
Equally problematic, EPA's proposed action serves none of the goals and meets none of the requirements of § 7403. The Proposed Rule is not a "research and development program" and does not include the requisite components of such a program necessary for EPA to act pursuant to its authority under this provision. EPA is not proposing any grants or research fellowships, see § 7403(b), or any air pollutant monitoring, analysis, modeling, and inventory research, see § 7403(c), or any "basic engineering research and technology program to develop, evaluate, and demonstrate nonregulatory strategies and technologies for air pollution prevention," see § 7403(g). Nor is EPA proposing to conduct any epidemiological studies on air pollution or to develop any methods or techniques for human health risk assessment, see § 7403(d).
In addition, even if EPA could otherwise act pursuant to this provision, EPA may not develop health risk assessment methods and techniques applicable to air pollutants without including the following requisite statutory elements:
 The creation of an Interagency Task Force, id. § 7403(d)(2)(A);
 An evaluation of each of the listed HAP under § 7412(b)(1) "based on reasonably anticipated toxicity to humans and exposure factors" listed therein, and which "shall be reviewed by the Interagency Task Force," id. § 7403(d)(2)(B);
 Preparation of environmental health assessments for each of the HAP, with specific deadlines, that "shall be prepared in accordance with guidelines developed by the Administrator in consultation with the Interagency Task Force and the SAB," including a specific list of scientific elements that includes "available toxicological and epidemiological information," "a determination of gaps in available information," and "where appropriate, an identification of additional activities . . . needed to identify the types or levels of exposure which may present significant risk of adverse health effects in humans." Id. § 7403(d)(2)(C).
EPA's Proposal does not include any, much less each, of these required components for an exercise of § 7403 authority. Thus, even if EPA otherwise had authority to act pursuant to this provision, the Proposed Rule is inconsistent with and contravenes the very provision which EPA itself cites.
For each and all of these reasons, § 7403 does not give EPA authority to regulate science or to exclude from EPA regulatory decisions the consideration of a subset of scientific studies.
Second, EPA cites section 301(a) of the CAA, 42 U.S.C. § 7601(a), as authority for the Proposed Rule. 83 Fed. Reg. at 18,769. This section of the CAA authorizes only "such regulations as are necessary to carry out [the Administrator's] functions under [the CAA]." 42 U.S.C. § 7601(a)(1). As discussed below, this provision does not authorize the Proposed Rule.