Comment [48-378]: Commenter (12727) notes that in the second case EPA references for support, Boron Oil Co. v. Downie, the court held that the lower courts lacked jurisdiction to compel an EPA employee to appear and testify in a state court action to which the government is not a party as EPA was protected by sovereign immunity. While finding the grant of sovereign immunity sufficient on its own merit, the court explained that the principle of federal supremacy supports the protection of sovereign immunity such that the state court could not compel testimony in violation of EPA's housekeeping regulations. But the court provided no explication of how EPA could be construed as an "Executive department" under the Housekeeping Act with relevant authority to issue such regulations. Moreover, the EPA regulations there in question claim an assortment of authorities, not only the Housekeeping Act.
Response: See response to Comment 31-135.
Comment [48-379]: Commenter (12727) notes that the Supplemental Notice also broadly cites Chrysler Corp. v. Brown. But that case provides no additional basis to apply section 301 authority to an "independent establishment," as the case concerns the DOL -- a listed executive department under the Housekeeping Act. It also holds that the Housekeeping Act does not authorize issuance of substantive rules, as discussed infra.
Response: See response to Comment 31-135. The final rule is a rule of agency procedure and practice. The rule applies only to EPA and does not obligate or affect the rights of any outside parties. As the Supreme Court stated in Chrysler Corp., whether a rule affects individual rights and obligations is an "important touchstone" for distinguishing substantive rules from other types of rules. This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Therefore, any incidental impacts on voluntary behavior outside of the EPA do not render it a substantive rule. Nothing in this rule would prevent scientists from submitting their data and studies to EPA. Researchers may voluntarily take steps to ensure that their studies are given greater consideration by making their data and models publicly available for independent validation.
Comment [48-380]: Commenter (12727) notes that in the primary case EPA cites for its alleged authority under the Housekeeping Act to issue the proposal, Chrysler Corp. v. Brown, the Supreme Court makes explicit that the Housekeeping Act cannot authorize substantive rules such as the current proposal. Chrysler Corp. concerned a government contractor who asked the court to enjoin release of documents regarding petitioner's employment practices. The documents had been requested under the Freedom of Information Act (FOIA), and a division of the DOL had determined they should be released, consistent with FOIA and disclosure regulations from the DOL's Office of Federal Contract Compliance Programs (OFCCP). The court concluded that section 301 did not authorize the OFCCP regulations, explaining that section 301 is a "housekeeping statute," authorizing only rules of agency organization, procedure, or practice as opposed to "substantive rules." It found "nothing in the legislative history of § 301 to indicate it is a substantive grant of legislative power to promulgate rules authorizing the release of trade secrets or confidential business information." The case offers no support for a more expansive reading of what constitutes non-substantive rules of agency organization, procedure, or practice for even an executive department -- which, as explained above, EPA is not.
Response: The final rule is a procedural rule of agency procedure and practice. It does not establish requirements for outside parties, nor does it affect the rights, interests, and obligations of outside parties. Even assuming there could be downstream practical effects on the voluntary behavior of outside parties and on outside parties' interactions with EPA, such impacts do not render this procedural rule substantive. See American Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1051 (D.C. Cir. 1987) ("[A]gency rules that impose `derivative,' `incidental,' or `mechanical' burdens upon regulated individuals are considered procedural, rather than substantive.")
Comment [48-381]: Commenter (12727) writes that Congress took explicit action in 1958 to amend section 301 to "correct" agencies from abusing the Housekeeping Act by attempting to use its authority as a substantive basis to withhold information from the public. The Supreme Court noted in Chrysler Corp. "that Congress had looked carefully at the statute in 1958; that 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 that 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, including halting government's extralegal efforts to limit disclosure and inclusion of information in the scientific process. The Supplemental Notice now attempts to similarly and illegally twist the statute to withhold science from consideration in rulemakings that broadly affect the public interest.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Nothing in the final rule will lead to the suppression of scientific data and models.
Comment [48-382]: Commenter (12727) writes that the proposal is a substantive rule and hence not authorized by the Housekeeping Act.
The 2018 proposal and Supplemental Notice meet the court-determined criteria for a substantive regulation, refuting EPA's claim that it is proposing merely an "internal rule of agency procedure." A "substantive rule" is not defined in the APA, but in distinguishing between "substantive rules" and "interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice," courts have described "substantive rules" as those "affecting individual rights and obligations," a quality which helps identify which rules are "binding" or "have the force of law." By contrast, courts have held that regulations issued pursuant to the authority under the Housekeeping Act "do not have the force and effect of law," and are "directory, not mandatory in nature." Courts have not been shy in finding executive departments' regulations to be substantive rules exceeding authorities under the Housekeeping Act.
In CropLife Am. v. EPA, the D.C. Circuit Court of Appeals considered whether an EPA press release, which stated that the agency would not consider third party-controlled human exposure studies for purposes of pesticide registration subject to case-by-case consideration of individual studies, was a substantive rule. The court held that the press release bound both EPA and registrants during pesticide registrations and so was a binding "substantive rule." In reaching its decision, the court considered two established case law formulations for determining whether an agency action constitutes a substantive regulation: the effects of the agency's action; and the agency's expressed intentions regarding the action. Consistent with Chrysler Corp., the two analyses overlap in recognizing that a substantive action "binds private parties or the agency itself with the `force of law.'" In Croplife, the court determined: "EPA's stated rule is binding on petitioners, who are now barred from relying on third-party human studies (even in cases where such studies formerly were approved), and is binding on the agency because EPA has made it clear that it simply `will not consider' human studies."
Like the action at issue in Croplife, both the original proposal and the Supplemental Notice would bind EPA to not consider or to discount a scientific study it could have previously given full consideration, all else being equal, if the study fails to meet the new requirement that underlying data and models be publicly available (or available through tiered access). The only possible exception would be if an otherwise disqualified study met the proposal's exemption criteria and the Administrator exercised his or her discretion to grant an exemption. Likewise, the proposed rule would bind the public, including organizations such as the Environmental Defense Fund (EDF), who can no longer receive the benefit of EPA's full consideration of valid but non-complying studies that they submit to the agency as part of an administrative record for an agency action, which EPA would previously have been required to consider as part of the rulemaking process. 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 results from substantive choices about the scientific evidence it will consider.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Nothing in the final rule will lead to the suppression of scientific data and models. This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Therefore, any incidental impacts on voluntary behavior outside of the EPA do not render it a substantive rule.
Courts have held that an agency may bind itself to comply with a procedural rule. The Accardi doctrine holds that "government agencies are bound to follow their own rules, even self-imposed procedural rules that limit otherwise discretionary decisions." United States ex rel. Accardi v. Shaughnessy, 347 U.S. 260, 267 - 68, 74 S.Ct. 499, 98 L.Ed. 681 (1954)). Accardi applies to "gratuitous" regulations that agencies did not need to promulgate because " `[a] court's duty to enforce an agency regulation [, while] most evident when compliance with the regulation in mandated by the Constitution or federal law,' embraces as well agency regulations that are not so required." United Space Alliance, LLC v. Solis, 824 F.Supp.2d 68, 82 (D.D.C. 2011) (citing Lopez v. F.A.A., 318 F.3d 242, 247 (D.C.Cir.2003); quoting United States v. Caceres, 440 U.S. 741, 749, 99 S.Ct. 1465, 59 L.Ed.2d 733 (1979)).
Comment [48-383]: Commenter (12727) writes that when evaluating additional factors courts use to distinguish substantive rules, the proposal identifies itself even more definitively as a substantive rule than the EPA action reviewed in Croplife. First, both the 2018 proposal and the Supplemental Notice were published according to notice-and-comment procedures in the Federal Register, unlike the EPA action evaluated in Croplife. Courts have considered whether the agency used full public notice-and-comment procedures, which an agency need not use when producing an "interpretive" rule or rule of agency procedure, as an indicator of a substantive rule. While courts consider an agency's own characterization of its action, they disregard claims that conflict with the record such as EPA's contention here that the 2018 proposal as supplemented "would not regulate the conduct or determine the rights of any entity outside the federal government." "The agency's characterization of its own action is not controlling if it self-servingly disclaims any intention to create a rule with the "force of law," but the record indicates otherwise." And instead of a paragraph in a mere press release, EPA proposes to publish in the Code of Federal Regulations (CFR) criteria for barring studies from both regulatory and non-regulatory use -- a hallmark of a substantive regulation. EPA's choice to put the rule through notice-and-comment rulemaking provides further evidence that EPA regards the rule as substantive.
Response: EPA voluntarily provided notice and comment on this procedural rule to notify the public of the internal steps the agency will take to increase transparency of the science used to support significant regulatory decisions and ISI. There are no provisions in the final rule that regulate outside conduct. Nor are there any provisions that bar the use of any studies. EPA has explained that this procedural rule has limitations on its scope in terms of conflicts with other substantive requirements and that, in situations where this rule applies, EPA will give greater consideration to those studies where the underlying data and models are available for independent validation. Many procedural rules are published in the CFR. Mere publication of those rules does not convert them into substantive rules.
Comment [48-408]: Commenter (12727) writes that argued in the inverse, the 2018 proposal and Supplemental Notice do not meet the requirements for a rule of agency organization, procedure, or practice, for purposes of the APA. Agency actions in this category are the opposite of substantive rules; they are those "that do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency." An agency action that "trenches on substantial private rights and interests" cannot be a rule of agency organization, procedure, or practice. A federal court recently vacated substantive regulations issued by the Department of Health and Human Services under their "mistaken[]" claim of authority under the Housekeeping Act, finding that "[t]he challenged rule is not . . . a mere housekeeping rule. The expansive definitions in the rule depart from the federal statutes, as explained above, changing the rights and responsibilities of health care providers."
By the same framework, the 2018 proposal and Supplemental Notice must be a substantive rule, exceeding the powers of the Housekeeping Act, because they affect private rights and interests. By restricting the scientific studies on which EPA may base final significant regulatory actions, EPA severely limits parties from relying on excluded studies in advocating for particular safeguards, or petitioning the agency to take a specific action, as the statute authorizes them to do. As noted in EDF's prior comments, because the rule would substantively impact agency conclusions and regulations, it impacts private rights and interests. The proposal does not allow private individuals to submit for consideration (or renders such submittal a nullity) studies that they would have been permitted to prior to the proposal, thus impacting the substantive standards that EPA is able to justify setting -- which has implications for the regulated community as well as for public health. EPA's proposed action "encodes a substantive value judgment [and] puts a stamp of approval or disapproval on a given type of behavior" by requiring regulatory actions to be supported only by certain scientific information deemed acceptable by the proposal.
Response: The final rule is a rule of agency procedure and practice. The rule applies only to EPA and does not obligate or affect the rights of any outside parties. Procedural rules cannot alter the rights or interests of parties but they "may alter the manner in which the parties present themselves or their viewpoints to the agency." James A. Hurson Assocs. v. Glickman, 229 F.3d 277, 280 (D.C. Cir. 2000). Because the agency will consider rather than categorically exclude studies where the underlying data and models are not available for independent validation, researchers need not alter the way they conduct their studies for them to be considered by EPA. However, if those researchers want their studies to receive greater consideration, they can voluntarily take steps to ensure that the data and models are publicly available to the greatest extent possible, given any statutory limitations on data availability. EPA will evaluate studies determined to be pivotal science, using the criteria in § 30.5, which will allow all high-quality studies to be factored into the agency's development of significant regulatory decisions and ISI.
Comment [48-433]: Commenter (12727) writes that EPA has even acknowledged that the "the bulk of the responsibility for instituting new methods for access to data and models" will "fall[] on outside parties" -- including both researchers and the CDC -- according to a memorandum prepared by committee staff to capture recent briefings on the rule before the House Committee on Science, Space, and Technology. For example, the memorandum records EPA's opinion that researchers, "would be responsible for managing the logistics of making the data and models publicly available in a manner that complies with the rule, in consultation with EPA staff," and the CDC would shoulder the burden of "hosting the data and models on its own servers, with CDC personnel working at the secure data enclave reviewing research proposals submitted by members of the public seeking to conduct their own analyses of study data and determining the level of access to grant on a case-by-case basis." These substantial impacts on parties outside of EPA further confirm that the proposal is not an internal or procedural rule, but a substantive rule which cannot be issued under the Housekeeping Act.
Response: This procedural rule does not impose obligations or requirements on outside parties. Neither the CDC nor researchers are required to take any actions due to this rule. EPA discussed in the preamble of the 2020 SNPRM that it is investigating secured data access options with the pilot study using a CDC secure data enclave to host EPA datasets in a restricted use environment. Any decision whether to use CDC's data enclave to host EPA data would be issued separately from this final rule.
As previously stated, nothing in this rule would prevent scientists from submitting their data and studies to EPA. Because the agency will consider rather than categorically exclude studies where the underlying data and models are not available for independent validation, researchers need not alter the way they conduct their studies. However, if those researchers want their studies to receive greater consideration, they can voluntarily take steps to ensure that the data and models are publicly available to the greatest extent possible, given any statutory limitations on data availability.
Comment [48-438]: Commenter (12727) writes that the Housekeeping Act provides no basis to violate other statutes, including landmark environmental laws and the IQA. As discussed above, the Housekeeping Act authorizes only procedural rules regarding "the custody, use, and preservation of [agency] records, papers, and property," as opposed to "substantive rules." Regulations issued under the Housekeeping Act "do not have the force and effect of law," and have been "held to be directory, not mandatory in nature." While an agency is bound to adhere to all the laws it is required to administer, it is particularly egregious that EPA claims that a procedural housekeeping rule, which lacks legal force, would somehow supersede other binding statutory authorities and allow EPA to rewrite bedrock environmental statutes. The 2018 proposal and Supplemental Notice would require EPA to weigh the extra-statutory factor of data availability and disregard other high-quality data which EPA is required to review under the scientific standards of multiple environmental statutes. The courts have barred previous unlawful efforts to amend binding statutory and regulatory requirements via the Housekeeping Act. Treasury Department rules derived under the Housekeeping Act were found explicitly unable to "override" other binding Treasury Department regulations promulgated pursuant to specific statutory delegation. Similar logic was at work in Chrysler Corp. Concluding that section 301 did not authorize regulations limiting the scope of the Trade Secrets Act, the Supreme Court found the "greatest significance" to be "the `housekeeping' nature of § 301 itself."
As discussed above, EPA has styled the 2018 proposal and Supplemental Notice as a substantive rule that would bind the agency from considering scientific studies without publicly available datasets during rulemakings. However, even if the proposal were found to be validly issued under the Housekeeping Act, it could not in any way authorize violating environmental statutes or binding regulations implementing these statutes. Like the Trade Secrets Act, the major environmental statutes are binding authorities that cannot be limited by the regulations issued under the Housekeeping Act. Nor can the Housekeeping Act authorize rules that would supersede implementing regulations for environmental statutes which have been issued by specific statutory delegation in the same manner as the Treasury Department regulations discussed above.
Response: The final rule does not bind the agency from considering any particular studies. Nor does the rule authorize violations of the statutes and regulations EPA administers. The rule expressly 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."
Comment [54-248]: Commenter (11361) writes that this SNPRM demonstrates a disingenuous request for public input from the EPA.
The EPA is obligated through the APA to notify the public and invite public comment on proposed regulations. While fulfilling the procedural requirements of the APA through this SNPRM, the EPA downplays the public interest of this sweeping proposed regulation, repeatedly asserts that this proposed rule is an affair internal to the agency, and sets up a path for the agency to dismiss public input regarding the STRS rule.
In the first paragraph of the Executive Summary, the EPA appears to dissuade public comment by understating the interest of members of the general public in a proposed rule designed to significantly alter regulations protecting public health.
First, the EPA frames the proposed rule as internal to the agency, stating "This SNPRM does not regulate any entity outside the Federal Government. Rather, the proposed requirements would modify the EPA's internal procedures regarding the transparency of science underlying regulatory decisions." The EPA then concedes that "any entity interested in EPA's regulations may be interested in this proposal," providing an example of "entities that conduct research or another scientific activity that is likely to be relevant to EPA's regulatory activity."
The EPA claims to have authority to make extensive changes to how the agency uses science in its decision-making through the Federal Housekeeping Statute, and dwells on this point in the SNPRM for several paragraphs. Remarkably, the EPA suggests that this rule, which ignores established processes for evaluating scientific merit and would impact every regulation under the EPA's authority, is not a "substantive rule." The EPA asserts that the proposed rule "exclusively pertains to the internal practices of the EPA" and fails to mention that the EPA relies extensively on studies conducted by other entities, and indeed, is mandated to consider outside research under both the CAA and CWA. The EPA does not address how the application of the proposed rule could impact its ability to faithfully execute its statutory responsibilities under these acts; it simply makes reference to its intention to be consistent with its other statutes. As the EPA repeatedly asserts that this proposed rule deals with internal EPA processes, the EPA invites public comment about whether to pursue this proposed rule under only its housekeeping authority, or under its housekeeping authority along with its other statutory authorities, and conspicuously does not invite comment about whether or not invocation of the housekeeping authority is appropriate at all. Let it be clear: a rule of this breadth, with impacts extending into all significant agency decisions and actions, should by no means be considered a basic agency procedure and housekeeping.
Response: Rather than undermining public input, EPA voluntarily provided two opportunities for public comment and also held a public hearing on the 2018 proposal. EPA has used the criteria found in EPA's Framework for Human Health Risk Assessment to Inform Decision Making (Ref. 69) to evaluate extramural research for use in regulatory decisions. EPA has made that policy choice transparent by providing public notice before implementation.
Comment [55-272]: Commenter (10974) writes that EPA does not have the authority to use the Federal Housekeeping Statute in 5 U.S.C. § 301 to promulgate this rule.
Lower courts have since addressed what differentiates a housekeeping policy from a substantive rule. A recent U.S. District Court decision analyzed what constitute "housekeeping" versus "substantive" rules, as the APA does not define what a "substantive" rule is. The court found that a "substantive" rule "announces new rights and imposes new duties  -  one that shapes the primary conduct of regulated entities." Other courts have found that substantive rules "jeopardize or substantially affect the rights and interests of private parties", and that substantive rules are "legislative-type" rules that are described as "affecting individual rights and obligations."
The crux of EPA's purported authority to use the housekeeping rule in this case relies, at its core, on the definition of a "substantive" rule, for the following two reasons.
First, the 2018 NPRM and the SNPRM would unmistakably, and significantly, affect individuals whose private health information may become public, as well as corporate CBI submitted to the EPA as included in research findings. Entities and individuals conducting research would also be affected  -  if they did not want to release underlying data, the EPA could (and likely would) give less credence to their studies while creating regulations. In these ways, the rule would meet the definition of a substantive rule.
Second, if finalized, this rule would have sweeping implications on how EPA and non-EPA research is conducted. It is inaccurate to imply, as EPA does, that this rule would not impact the entire field of environmental health research and state policymaking  -  it would. Due to the likelihood of this far-reaching impact, which will go well-beyond the confines of the agency itself and its internal housekeeping policy, EPA is not authorized to use this housekeeping authority in this context.
Based on our legal interpretation of 5 U.S.C. § 301 and the context under which it was created, the MPCA and MDH affirm that EPA does not have the authority to promulgate this substantive rule based solely, or in part, on the agency's housekeeping authority  -  nor any of the other underlying environmental rule authorities listed in the SNPRM, corrected or as otherwise listed in the 2018 NPRM.
Response: Nothing in the final rule mandates or compels the release of private health information or CBI. EPA has been clear in § 30.5 that where the Agency is making data or models publicly available, "it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security."
Because the agency will consider rather than categorically exclude studies where the underlying data and models are not available for independent validation, researchers need not alter the way they conduct their studies. However, if those researchers want their studies to receive greater consideration, they can voluntarily take steps to ensure that the data and models are publicly available to the greatest extent possible, given any statutory limitations on data availability.
Also see the response to Comment 31-135.
Comment [59-327]: Commenter (11243) writes that the failure of EPA to identify a colorable legal basis for this rulemaking is emblematic of the Trump administration's brazen disregard for the rule of law.
The original proposal laughably gestures at EPA's various authorizing statutes as legal authority. The ridicule this claim engendered appears to have spurred one of the most significant aspects of the supplemental proposal. Namely, the new claim that this rulemaking is authorized by the federal housekeeping statute. This argument has two critical flaws though. First, the federal housekeeping statute does not apply to the EPA, only executive departments. Second, even if the statute did apply to EPA, it would not supply the legal basis for something like this rulemaking.
Response: See the response to Comment 31-135.
Comment [59-328]: Commenter (11243) notes that EPA acknowledges that it is not an executive department but argues that it was nonetheless brought within the scope of the federal housekeeping statute through Reorganization Plan Number 3 of 1970, which created the agency. The essay appended to my oral presentation explains in greater detail why this argument should be rejected. For now, I will emphasize two points. One, Reorganization Plan Number 3 conspicuously makes no mention of the federal housekeeping statute. Instead EPA has left to infer the transfer of that authority to a vague catch-all provision. In essence, then the agency claims Congress implicitly intended for EPA to be considered a department, but just hasn't gotten around to officially declaring it.
Two, while Congress has updated the list of executive departments several times since 1970, it has never included the EPA. Most recently it did so with the DHS which, like EPA, was pieced together from several existing agencies.
Response: See the response to Comment 31-135.
Comment [59-330]: Commenter (11243) writes that one, the censored science rule is a far cry from the kind of modest and noncontroversial internal operating procedures that Congress envisioned with the federal housekeeping statute. To wit: the original censored science proposal is so controversial it attracted over six hundred thousand public comments. Two, even the Supreme Court case that EPA cites to support this argument that the rulemaking is covered by the federal housekeeping statute, Chrysler Corp. versus Brown , makes clear that the censored science rule exceeds the modest authority that the law provides. Among other things, the Court in Chrysler Corp. was troubled by how the rule at issue affected the relationship between the government and private sector entities.
Significantly, the operative function of the censored science rule is to affect the relationship between EPA and members of the public. Specifically, it would fundamentally alter how the public participates in the development of new rules by limiting the kinds of views that they can share on a scientific basis per those rules. Today you will hear many reasons for why the EPA should abandon the censored science rule. As I have explained, the lack of a legal basis for the rule provides one more reason. Thank you for your attention.
Response: There is no provision of the final rule that would affect the relationship between EPA and private sector entities. No party outside of EPA is obligated to take any steps to comply with this internal agency procedure. Further, the rule will not affect the public's ability to participate in the development of new rules. The agency provides notice of all studies that it considers in regulatory decisions; a practice that was codified at § 30.4. During the comment period on a proposed rule, the public can comment on EPA's evaluation of the science and can also submit studies to EPA that it believes the agency should consider.
Comment [71-404]: Commenter (11354) writes that there is a lack of authority. The proposal has changed the authority EPA seems to rely on. And it's solely on housekeeping authority statute for executive departments, in combination with corrective environmental statutes listed in the original proposal.
This really is a backward rulemaking; proposing an action and then asking for help to determine authority. It is cited authority that doesn't authorize the rule. And -- in an event of a conflict, the proposal says that other statute or regulations may apply.
Response: See the response to Comment 31-135 and APA response to Comment 25-94.
Comment [73-409]: Commenter (11576) writes that the Agency's new standards for evaluating scientific studies are not internal "housekeeping" requirements.
As the Supreme Court has noted, the federal housekeeping statute was originally "`enacted to help General Washington get his administration underway by spelling out the authority for executive officials to set up offices and file Government documents" -- documents "pertaining to the day-to-day business of Government[.]" In its current form, which has been codified in Section 301 of Title 5, the statute provides that:
The head of an Executive department or military department may prescribe 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. This section does not authorize withholding information from the public or limiting the availability of records to the public.
Both the terms of the housekeeping statute and its legislative history accordingly demonstrate that it is "simply a grant of authority to ... agenc[ies] to regulate ... [their] own affairs." In the words of the Supreme Court, Section 301 "authoriz[es] what the ... [APA] terms `rules of agency organization[,] procedure[,] or practice' as opposed to `substantive rules.'"
With its supplemental notice, the EPA has admitted that it is "not one of the 15 `Executive Departments'" Congress has identified in Title 5. The agency argues, however, that it has "been granted full section 301 or equivalent authority" under Reorganization Plan No. 3 of 1970 -- and that this authority is sufficient, maybe, to support the proposed rule. According to the EPA, the regulation "exclusively pertains to the internal practices" of the agency, as it merely "describes 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." Because of this "internal" focus, the EPA contends, the proposed rule should be understood as an unremarkable exercise of the agency's housekeeping power.
The EPA's half-hearted attempt to cast the proposed restrictions on science as nothing more than internal "housekeeping" measures that lack substantive significance cannot be sustained. As a result, even if the agency has been granted "section 301 or equivalent authority[,]" that authority would not provide a foundation for the proposed rule.
Response: See response to Comment 31-135.
Comment [73-410]: Commenter (11576) writes that under the proposed regulation, the EPA would be required to consider a new (and sometimes dispositive) factor when deciding if it should rely on a particular scientific study: whether "the data and models underlying ... [the study] are publicly available[.]" As the EPA admits in its supplemental notice, this assessment of data availability would be separate from -- and subsequent to -- the agency's evaluation of a study's "quality[.]" It could accordingly result in the exclusion of "high-quality studies" from the agency's scientific analyses and rulemakings. In the words of the notice, if the proposed rule is finalized, the EPA:
would continue to use standard processes for identifying, evaluating, and reviewing available data, models, and studies. When the Agency has potentially identified multiple key studies or models of similar quality that could drive its subsequent decisions, the Agency will investigate the availability of the underlying data. If, for example, multiple high-quality studies exist but only two studies have data and models that are available for independent validation and reanalysis, EPA would only include those two studies as pivotal regulatory science and/or pivotal science in accordance with the 2018 proposed rulemaking. However, under the alternative approach in this supplemental proposal, EPA would consider using all available high-quality studies but give greater consideration to those two studies with data available for independent validation.
As the supplemental notice makes clear, the proposed rule would alter the EPA's substantive standards for evaluating scientific research -- undermining the agency's ability to protect public health and the environment in the process. The regulation accordingly can't be dismissed as a "housekeeping" measure that merely "govern[s] internal agency procedures." Indeed, the rule is at odds with the scientific standards that Congress has itself imposed on the agency. As the D.C. Circuit recently emphasized, the "EPA operates pursuant to multiple statutory mandates requiring that its decisions rest on various formulations of `the best available science'" -- among them, the CAA's requirement that "`[a]ir quality criteria ... accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare,'" and the TSCA's demand that the EPA's administrator "`make decisions ... based on the weight of the scientific evidence[.]'" In summarizing its own mission, the EPA has therefor acknowledged that it is obligated to "ensure that `national efforts to reduce environmental risks are based on the best available scientific information[.]'" The proposed rule is an unlawful effort to amend these standards by requiring the EPA to disregard or devalue high-quality studies based on an extra-statutory evaluation of data availability. As explained in comments on the original proposal, moreover, the regulation also promises to cause substantial harm to members of the public, who depend on the EPA to adopt safeguards based on the best available science.
In short, while the EPA has declared that it has "the authority to establish policies governing its reliance on science in the administration of its regulatory functions[,]" this authority actually lies in Congress. Because the proposed rule would require the EPA to make decisions based on a factor Congress omitted from the governing statutes, it is both arbitrary and unlawful.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Nothing in the final rule will lead to the suppression of scientific data and models. EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In the final rule, EPA does not rely on, interpret, or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. The rule expressly 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."
This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Therefore, any incidental impacts on voluntary behavior outside of the EPA do not render it a substantive rule. See response to comment 25-94.
EPA has used the criteria found in EPA's Framework for Human Health Risk Assessment to Inform Decision Making (Ref. 69) to evaluate outside research for use in regulatory decisions.
Comment [73-411]: Commenter (11576) writes that the EPA has itself confirmed the substantive nature of the proposed regulation by electing to pursue it through notice-and-comment rulemaking. As the Supreme Court has said, the only actions authorized under the federal housekeeping statute are "what the ... [APA] terms `rules of agency organization[,] procedure[,] or practice' as opposed to `substantive rules.'" And under the APA, "rules of agency organization, procedure, or practice" are exempt from the requirements of notice-and-comment rulemaking. If the proposed rule were actually an internal housekeeping measure, in other words, notice and comment wouldn't have been required. The EPA was correct in concluding otherwise. Its efforts to reframe the proposal now as one that "exclusively pertains to the internal practices" of the agency cannot be taken seriously.
During two recent briefings that were held at the request of the House Committee on Science, Space, and Technology, the EPA provided further confirmation that the proposed rule cannot be dismissed as an internal housekeeping measure. According to a memorandum prepared by the committee's staff, the EPA indicated that "the bulk of the responsibility for instituting new methods for access to data and models" under the proposed rule will "fall[] on outside parties" -- both researchers and the CDC. These responsibilities, moreover, promise to be burdensome. Researchers, for instance, "would be responsible for managing the logistics of making the data and models publicly available in a manner that complies with the rule, in consultation with EPA staff." And the CDC would be tasked with "hosting the data and models on its own servers, with CDC personnel working at the secure data enclave reviewing research proposals submitted by members of the public seeking to conduct their own analyses of study data and determining the level of access to grant on a case-by-case basis." In light of the significant burdens the rule would impose on other agencies and private parties, the proposal cannot be defended as a housekeeping measure that governs the internal operations of the EPA.
Response: See responses to Comments 31-135 and 48-433.
Comment [81-583]: Commenter (112715) writes that EPA lacks authority to promulgate the proposed rule, which conflicts with statutory requirements regarding EPA's consideration of scientific information.
As explained in the 2018 Comments, EPA lacks statutory authority to promulgate the proposed rule. Nothing in the supplemental proposal alters that conclusion. EPA's citation to the federal Housekeeping Statute, 5 U.S.C. § 301, either alone or in combination with other substantive statutes that EPA administers, does not in any way alleviate this problem. First, a rule that requires EPA to exclude or give less weight to scientific information based purely on the availability of underlying data for independent validation is inconsistent with EPA's legal duty under numerous statutes it implements to use the best available science. Second, EPA may not rely on a general grant of authority, i.e., housekeeping, to promulgate regulations or develop policies that are otherwise inconsistent with more specific statutory directives. Third, 5 U.S.C. § 301 does not apply to EPA. Fourth, even assuming EPA has some inherent housekeeping authority apart from 5 U.S.C. § 301, the proposed rule does not constitute a "housekeeping" measure given its massive substantive impact.
Response: EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In the final rule, EPA does not rely on, interpret, or apply provisions of any particular environmental statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. The rule expressly 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."
Also, see the response to Comment 31-135.
Comment [81-585]: Commenter (12715) writes that the Housekeeping Statute does not apply to EPA.
By its plain language, the federal Housekeeping Statute provides no authority to EPA. The statute states, in pertinent part, that "[t]he head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property." 5 U.S.C. § 301. Moreover, as EPA concedes, a separate statute, 5 U.S.C. § 101, provides an exclusive list of the executive departments that are covered by the Housekeeping Statute and EPA is not included in that list.
EPA instead argues that it "gained" the housekeeping authority of 5 U.S.C. § 301 through the Reorganization Plan No. 3 of 1970. That Plan created EPA by transferring certain functions from the Department of Health, Education and Welfare ("HEW") to the newly established agency. HEW was later divided into what are now the Departments of Education and Health and Human Services. What EPA fails to note, however, is that Congress then amended 5 U.S.C. § 101 to add the Departments of Education and Health and Human Services, granting those agencies the housekeeping authority of 5 U.S.C. § 301, but did not also add EPA. Congress subsequently amended 5 U.S.C. § 101 several times to add other federal entities to the list but, again, it never added EPA. It is thus clear that Congress knew how to give housekeeping authority to executive entities when it wanted to, and the absence of EPA from 5 U.S.C. § 101 reflects congressional intent to not confer the authority of 5 U.S.C. § 301 on EPA.
The inapplicability of the Housekeeping Statute here is further confirmed by a 2001 opinion by the U.S. Department of Justice (DOJ) OLC that rejected a similar attempt by the Office of Government Ethics (OGE) to arrogate to itself the housekeeping authority in 5 U.S.C. § 301. Opinion of the OLC of the DOJ, 25 Op. O.L.C. 13 (2001). As OLC observed, Congress used both "executive department" and "agency" in title 5 (see, e.g., sections 302, 305), "and we presume that that difference was intentional." Id. at 15. "The fact that Congress, in conferring particular powers, distinguished between the heads of executive departments in section 301 and the heads of agencies in section 302 counsels against assuming that Congress meant to confer the authority in section 301 on the heads of all executive agencies." Id. at 15-16. EPA thus may not use 5 U.S.C. § 301 as authority for the proposed rule.
Nor can EPA rely on the 2008 OLC opinion addressing EPA's authority to establish a policy for its employees' use of government personal property and agency-issued cell phones. Opinion of the OLC of the DOJ, 32 Op. O.L.C. 1 (2008). First, and far from supporting EPA's position, that opinion explicitly finds that "EPA is not an `Executive department' within the meaning of section 301," and that any housekeeping authority would come from EPA's organic statute. Id. at 82. Second, unlike the proposed rule here, the EPA policy addressed by the 2008 opinion had no effect outside of EPA and was not inconsistent with specific statutory directives regarding the subject matter of the policy. Thus, like the DOL regulations the Supreme Court found defective in Chrysler Corp. v. Brown, 441 U.S. 281, 310-12 (1979), the proposed rule finds no support in 5 USC § 301.
Response: In the preamble, EPA acknowledges that it is not listed as an "Executive Department" under 5 USC § 101. The 2008 OLC acknowledges the 2001 OLC opinion cited by the commenter. There, OLC finds authority for OGE's Touhy regulations in the Federal Records Act and OGE's organic statute, 5 U.S.C. app § 401. In its 2008 opinion, OLC described Reorganization Plan No. 3 as EPA's organic statute and found that the Plan provided EPA with housekeeping authority:
      The difficulty here, however, is that section 301 confers regulatory authority only on the "heads of Executive departments and military departments," and not the heads of other executive agencies, such as EPA. 5 U.S.C. § 301; see also 5 U.S.C. § 101; Authority of the Office of Government Ethics to Issue Touhy Regulations, 25 Op. O.L.C. 13, 15 (2001) (recognizing that section 301 authority is limited to the listed departments). In considering whether the EPA Administrator may exercise housekeeping authority equivalent to that under section 301, we must consider whether such authority has been conferred under EPA's organic statute.
      The Reorganization Plan establishing the EPA vests the Administrator with authority equivalent in many respects to that enjoyed by the head of an executive department. Reorganization Plan No. 3 of 1970, § 1(b), 84 Stat. 2086, 2086 (July 9, 1970) (codified at 5 U.S.C. app. 189 (2006)).2 The Reorganization Plan, which names the Administrator the "head of the agency," id., transfers to the Administrator functions previously vested by law in the heads of other executive departments, including functions of the Secretary of the Interior and the Secretary of Health, Education, and Welfare. Id. § 2(a)(1) - (4). The Administrator's authority is not limited to those designated functions but also includes "[s]o much of the functions of the transferor officers and agencies" that are "incidental to or necessary for . . . the performance of," or "primarily related to," such functions. Id. § 2(a)(9). This ancillary authority includes "authority, provided by law, to prescribe regulations relating primarily to the transferred functions." Id. At the time of the Reorganization Plan, such ancillary authority included the housekeeping authority conferred by 5 U.S.C. § 301 on the heads of those departments to enable their subordinates to carry out efficiently the statutory functions transferred to the Administrator of EPA. See 5 U.S.C. § 301 (Supp. II 1966). To perform those transferred functions, the Reorganization Plan further provides that the Director of OMB shall transfer to EPA "personnel, property, records, and unexpended balances of appropriations . . . used, held, available, or to be made available in connection with the functions transferred to the Administrator or the Agency." Reorganization Plan No. 3 of 1970, § 4(a).
      Taken together, these provisions convey to the Administrator all of the house-keeping authority available to other department heads under section 301, including authority to adopt property management regulations. Congress has vested the Administrator with the authority to run EPA, to exercise its functions, and to issue regulations incidental to the performance of those functions. This grant includes the authority to assign responsibility to others within the agency and to issue regulations prescribing the standards by which those functions are to be performed. The effective and efficient management of the agency's personnel and property is plainly "incidental to" and "necessary for" the performance of the functions that the Administrator is charged with performing. Indeed, the Reorganization Plan specifically recognizes this authority by providing the Administrator not only with transferred functions but with the personnel and equipment necessary for the effective performance of those functions.
32 Op. O.L.C. 79, 82-83 (2008).
Also see the response to Comment 31-135.
Comment [81-586]: Commenter (12715) writes that the proposed rule is not a matter of "housekeeping," but instead has broad, substantive effect.
Even assuming EPA has some inherent authority apart from 5 U.S.C. § 301 to make rules that apply exclusively to internal EPA practices, the proposed rule is not authorized by any housekeeping authority because it would unquestionably have broad impacts outside of EPA. Indeed, the very fact that EPA is engaging in notice-and-comment rulemaking is an implicit admission that the proposed rule is not a matter of housekeeping since housekeeping rules are exempt from APA requirements. "The APA exempts from [5 U.S.C. § 553's] procedural requirements: (1) interpretative rules; (2) general statements of policy; and (3) rules of agency organization, procedure, or practice." Mendoza v. Perez, 754 F.3d 1002, 1020-21 (D.C. Cir. 2014). Conversely, rules to which the notice and comment requirements do apply are considered "substantive rules." Id.
More importantly, the nature of the proposal is not, on its face, a simple matter of housekeeping. Restricting the information that EPA staff can consider in setting standards and criteria to protect public health and the environment or requiring staff to arbitrarily put a thumb on the scale when weighing information in setting such standards, will directly impact the decisions that EPA makes regarding standard setting. Those standards apply not to EPA but to the regulated community, and many have nationwide applicability. In addition, many states' environmental laws and regulations explicitly adopt EPA standards, or at the very least require an express justification for any deviation. See 2018 Comments at 18-19. Furthermore, some states lack resources to develop their own standards and federal standards therefore apply by default. Id. EPA's proposed rule would thus have far-ranging impacts outside the agency and would directly affect the health of the nation's residents and natural resources. Indeed, EPA explicitly acknowledges that the supplemental proposal will have an impact on third parties by, for example: (1) requesting comment on how to cause researchers outside of EPA to change their practices to increase access to data, 85 Fed. Reg. at 15,403; and (2) conceding that the development of ISI will have "a clear and substantial impact on important public policies or private sector decisions," id. at 15,398.
We are also aware that EPA confirmed to Staff of the House Committee on Science, Space, and Technology that "the bulk of the responsibility for instituting new methods for access to data and models falls on outside parties. The researchers would be responsible for managing the logistics of making the data and models publicly available in a manner that complies with the rule, in consultation with EPA staff." This concession flatly contradicts the SNPR's assertion that the proposed rule "pertains exclusively to internal practices at EPA." 85 Fed. Reg. at 15,398. Accordingly, EPA should set aside the pretense that the proposal is a matter of agency housekeeping and directly confront the conflict between the proposed rule and the substantive statutes that command EPA to use the best available science.
In sum, EPA has entirely failed to address the 2018 Comments regarding the lack of legal authority for the initial proposal. Whether EPA is arbitrarily barring consideration of scientific studies or information with nonpublic underlying data, or arbitrarily according such studies or information less weight, the proposed rule unquestionably has substantive impacts and conflicts with the statutory commands that EPA use the best available science; no citation to "housekeeping" authority can cure that fatal flaw.
Response: The final rule does not regulate any party outside of EPA but rather exclusively governs EPA's internal process for considering pivotal science. This rule does not require any researcher or other outside entity to provide data or models to EPA. Instead, it governs internal agency procedures for considering various studies using factors including data availability. Furthermore, the final rule gives greater consideration to studies where the data and models are available for independent validation rather than providing for a categorical exclusion, which could be considered by researchers who are developing science and deciding whether to make the underlying data and models available.
Comment [82-717]: Commenter (12464) writes that the Housekeeping Statute does not grant EPA authority to promulgate the proposal.
The Proposal is not authorized by the Housekeeping Statute, 5 U.S.C. § 301, because (i) Congress did not intend for the Housekeeping Statute to delegate rulemaking authority to independent agencies such as EPA; (ii) Reorganization Plan No. 3 does not grant EPA housekeeping or equivalent authority; and (iii) even if EPA has such housekeeping authority, the Proposal is a substantive rule that may not be promulgated under the Housekeeping Statute or equivalent authority.
Response: See response to Comment 31-135.
Comment [82-718]: Commenter (12464) writes that Congress did not Grant Independent Agencies, such as EPA, Rulemaking Authority under the Housekeeping Statute
The plain text of the Housekeeping Statute demonstrates that it applies only to Executive departments and military departments, and not to independent agencies such as EPA. The statute provides, in relevant part, that "[t]he head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property." 5 U.S.C. § 301. While the EPA is clearly not a military department, the agency also does not qualify as an "Executive department" within the meaning of the statute. An earlier provision in the same chapter of the United States Code provides an exclusive list of "the Executive departments." 5 U.S.C. § 101. EPA is not on that list.
It is a firmly established rule of statutory construction that definitions of terms included within the framework of a law usually dictate the meaning of those terms as used in the statute. Importantly, the definition of "Executive departments" does not start with the words "include" or "such as," which would indicate that the list of departments is non-exhaustive. Rather, the definition provides that "the Executive departments are" and proceeds to list those departments. Under the ordinary use of the verb "are," i.e., to be equal in meaning, the definitional list of Executive departments is exclusive. Moreover, according to the canon of negative implication, EPA's omission from this long list of departments (which has been intermittently amended) indicates that EPA is not an "Executive department" for purposes of the Housekeeping Statute.
Response: See response to Comment 31-135.
Comment [82-719]: Commenter (12464) writes that EPA is an "independent establishment," defined as "an establishment in the executive branch (other than the United States Postal Service or the Postal Regulatory Commission) which is not an Executive department, military department, Government corporation, or part thereof." 5 U.S.C. § 104. For decades, the United States Government Manual included EPA in the list of "independent establishments and government corporations" rather than in the list of "departments." Since 2010, the manual has changed the terminology to "independent agencies and government corporations," but EPA remains part of the same list. Independent establishments do not have rulemaking authority under the Housekeeping Statute.
The legislative history of the Housekeeping Statute confirms that Congress intended to grant rulemaking authority only to those executive departments listed under 5 U.S.C. § 101. When Congress enacted the current version of the Housekeeping Statute in 1958, a staff memorandum submitted to the Special Subcommittee on Government Information of the House Committee on Government Operations noted:
The statute does not apply to independent agencies, although some of the regulatory agencies cited it as authority to withhold information in answers to subcommittee questions. After the subcommittee discussed the matter with regulatory agency officials, they admitted that title 5, United States Code, section 22, [now 5 U.S.C. § 301] applies only to the executive departments of the Federal Government.
Response: See the response to Comment 31-135.
Comment [82-720]: Commenter (12464) notes that the staff memorandum recognized that such independent agencies were not listed in the definition of an executive department under what is now 5 U.S.C. § 101. Indeed, not only did the DOJ support this interpretation of the statute, but the Subcommittee also decried independent agencies' disregard of the definition when claiming such authority in the past; such claims were an "unhappy history" that pointed to the fact that "the `housekeeping' statute [had] been twisted from the original authority of the department head." Moreover, during the Subcommittee hearing, independent executive agencies, some of which have been superseded by new agencies or departments, clearly acknowledged the inapplicability of the Housekeeping Statute to their operations.
The fact that Congress intended to exclude independent agencies, such as EPA, from the Housekeeping Statute is further evidenced by the fact that one proposed version of the bill used the word "agency" rather than "Executive department" in 5 U.S.C. § 301, but that version was explicitly rejected because the "term is often used in referring to the independent regulatory agencies, to which the section does not apply, [and] it could lead to confusion and uncertainty in the future application of the section."
Response: See response to Comment 31-135.
Comment [82-722]: Commenter (12464) notes that Congress has since amended the definition of an "Executive department" under 5 U.S.C. § 101 to add two of the former independent agencies that had recognized the inapplicability of the statute to their operations in 1958 -- the Housing and Home Finance Agency (now the Department of Housing and Urban Development) and Veterans Administration (now the Department of Veterans Affairs).
Congress, by contrast, has not added EPA to the list. As these examples demonstrate, when Congress wanted to grant housekeeping authority to a former independent agency, it knew how to do so explicitly by amending Section 101. If an agency could assert housekeeping authority absent explicit congressional authorization, it would render Section 101 effectively meaningless. In sum, given that EPA is an independent establishment and acknowledges that it is "not one of the 15 `Executive Departments' listed at 5 U.S.C. 101," it cannot avail itself of the Housekeeping Statute.
Response: See the response to Comment 31-135.
Comment [82-784]: Commenter (12464) writes that Reorganization Plan No. 3 does not grant EPA housekeeping authority or equivalent authority.
Reorganization Plan No. 3, which established EPA in 1970, does not grant the agency housekeeping or equivalent authority. The Supplemental Notice asserts that although the agency "is not one of the `Executive Departments' listed at 5 U.S.C. 101," EPA gained full housekeeping or equivalent authority because Section 2(a)(9) of the Reorganization Plan transferred so much of the functions of the transferor offices and agencies, including those of the Department of the Interior (DOI) and Department of Agriculture (USDA), "as is incidental to or necessary for the performance by or under the [EPA] Administrator of the functions transferred." 85 Fed. Reg. at 15,397. According to a 2008 OLC opinion, at "the time of the Reorganization Plan, such ancillary authority included the housekeeping authority conferred by 5 U.S.C. § 301 on the heads of those Departments to enable their subordinates to carry out efficiently the statutory functions transferred to the Administrator of the EPA." Thus, the Supplemental Notice claims that the housekeeping authorities were implicitly transferred to EPA as incidental powers.
This argument is unpersuasive. As discussed above, Congress has demonstrated that it knows how to update the list of "Executive departments" to include newly created departments. Moreover, the DHS, like EPA, was created through the transfer and consolidation of various existing programs and authorities spread across several federal agencies. Indeed, similar to Reorganization Plan No. 3, the HSA of 2002 lays out in minute detail those functions and authorities that were being transferred to the new department from the Departments of Agriculture, Energy, and Treasury. However, unlike the Reorganization Plan, the HSA specifically asserts that the DHS is an executive department within the meaning of the Housekeeping Statute:
"There is established a DHS, as an executive department of the United States within the meaning of title 5, United States Code." Thus, when Congress intends to grant housekeeping authority, it does so by amending Section 101 to include a newly created department. No such mandate exists in Reorganization Plan No. 3 for EPA.
Response: See the response to Comment 31-135.
Comment [82-785]: Commenter (12464) writes that this interpretation of Reorganization Plan No. 3 is confirmed by its legislative history. When describing EPA's functions, Russell Train, Chairman of the Council on Environmental Quality, noted that "a reorganization plan cannot create any new legal authorities or functions;" thus, when EPA would come into being its functions could only be those of its constituent parts that were clearly transferred. The DOI's and USDA's housekeeping authorities were not so transferred.
Response: See the response to Comment 31-135.
Comment [82-803]: Commenter (12464) writes that although the Supplemental Notice cites certain court decisions in support of EPA's claim of housekeeping authority, the decisions were not carefully reasoned and cannot overcome the plain language of the Housekeeping Statute. For example, in Davis Enterprises v. U.S. Environmental Protection Agency, the Third Circuit concluded -- without any analysis -- that "[t]he EPA's authority to govern its internal affairs is derived from 5 U.S.C. § 301." In another case, the U.S. Court of Appeals for the Second Circuit stated that "the Federal Housekeeping Statute, 5 U.S.C. 301, authorizes government agencies such as the EPA to adopt regulations regarding `the custody, use, and preservation of [agency] records, papers, and property.'" While other federal courts have blindly followed these holdings in enforcing EPA's Touhy regulations, both the Second and Third Circuits' holdings show that the courts believed that EPA's housekeeping authority derived from 5 U.S.C. § 301 alone because the EPA was a "government agency" within the meaning of the statute -- a mistake in application that Congress attempted to avoid by enumerating the executive departments in Section 101. Such holdings are the type of "drive-by" rulings that the Supreme Court has cautioned against and deserve little to no weight.
Response: See the response to Comment 31-135.
Comment [82-807]: Commenter (12464) writes that the Transparency Rule is a substantive rule that may not be promulgated under Section 301's rulemaking authority.
Even assuming that EPA has Housekeeping Statute authority, the Proposal is a substantive rule outside the scope of the authority granted under that law. The purpose of the Housekeeping Statute is to delegate to executive and military departments the authority to prescribe rules related to their internal organization and operation; this authority does not extend to "substantive" rulemakings affecting the rights of parties and the department's implementation of its statutory duties.
The Housekeeping Statute was originally enacted in 1789 to help "General Washington get his administration underway by spelling out the authority for executive officials to set up offices and file Government documents." In the legislative history of the 1958 amendments, Congress further made clear that the laws prescribed under the statute were limited to "day-to-day business" and recordkeeping. Thus the Housekeeping Statute was never intended to be used as an authority to promulgate substantive rules with external legal consequences. The rule only authorizes what the APA "terms `rules of agency organization procedure or practice.'"
Response: As the Supreme Court stated in Chrysler Corp., whether a rule affects individual rights and obligations is an "important touchstone" for distinguishing substantive rules from other types of rules. This final rule does not regulate the rights and obligations of any party outside of the EPA let alone have legal force and effect on them. Therefore, any incidental impacts on voluntary behavior outside of the EPA do not render it a substantive rule.
Comment [82-833]: Commenter (12464) writes that although the APA does not define "substantive" rules, such rules may be recognized by negative inference from the statute's definition of "interpretative rules" (commonly known as "interpretive rules"). Interpretive rules are "general statements of policy, or rules of agency organization, procedure, or practice." 5 U.S.C. § 553(b)(A). The U.S. Supreme Court has therefore described a "substantive rule" as a "legislative-type rule" or as one "affecting individual rights and obligations." In coming to this definition, the Court relied heavily on the Attorney General's Manual on the APA because neither the House nor Senate Report for the APA attempted to expound on the distinction between substantive and interpretive rules. In a footnote, the Attorney General's Manual describes "substantive" rules as those rules "other than organizational or procedural," "issued by an agency pursuant to statutory authority and which implement the statute," and having "the force and effect of law."
Consistent with this definition, courts have forbidden executive departments from using Section 301 to implement substantive regulations. For example, last year, in New York v. U.S. Department of Health and Human Services, a district court found that the Department of Health and Human Services' (HHS) "conscience rule," recognizing the right of HHS funding recipients to abstain from participating in medical procedures on account of religious or moral objections, was a substantive rule impermissibly promulgated under the Housekeeping Statute. In coming to this conclusion, the court explained that although the rule had "housekeeping features," it was "largely substantive -- and, indeed, in key respects transformative." Specifically, the court found that the rule was substantive as the "conscience rule" would "effectively supersede Title VII in the health care field" by bypassing the undue hardship exception, "newly restrict[] the ability of employers to inquire about employees' conscience objections," newly define the term "health care entity" to apply to pharmacists and medical laboratories, and construe "the Weldon Amendment and the [Affordable Care Act], for the first time, to apply to health care plan sponsors and third-party administrators." The court held that "contrary to HHS's depiction of [the "conscience rule"] as mere housekeeping, the Rule relocates the metes and bounds -- the who, what, when, where, and how -- of conscience protection under federal law."
Response: Commenter's reliance on New York v. U.S. Dep't of Health & Human Servs., 414 F. Supp. 3d 475 (S.D.N.Y. 2019) (New York) is misplaced. The district court held that HHS could not rely on housekeeping statutes to promulgate its conscience rule provisions finding that the rule was "heavily substantive" because "[i]t shapes the rights and obligations of those subject to the Conscience Provisions." New York at 527.
      A rule that announces new rights and imposes new duties -- one that shapes the primary conduct of regulated entities -- is substantive. See N.Y.C. Emps. Ret. Sys. v. SEC, 45 F.3d 7, 12 (2d Cir. 1995) (citing White v. Shalala, 7 F.3d 296, 303 (2d Cir. 1993)); see also Chrysler Corp., 441 U.S. at 302, 99 S. Ct. 1705 (substantive rules "affect[ ] individual rights and obligations" (internal citations omitted)); Thomas v. New York, 802 F.2d 1443, 1447 (D.C. Cir. 1986) (substantive rules "jeopardize or substantially affect the rights and interests of private parties" (internal citations and quotation marks omitted)). In some contexts, the distinction between substantive and procedural rules can be elusive -- "one of degree" and not kind. Elec. Privacy Info. Ctr. v. U.S. Dep't of Homeland Sec., 653 F.3d 1, 5 (D.C. Cir. 2011). But not here. At the time the Rule was promulgated, the President stated that it conferred "new protections." And that the Rule recognizes new substantive rights and imposes new substantive duties on regulated entities in the health care sector is apparent from each of the Rule's (1) purpose, (2) definitions, and (3) assurance and certification requirements.
Id. at 522-23.
EPA's final rule does not establish rights or impose obligations on any outside parties unlike HHS's conscience rule which established rights and imposed duties on regulated entities in the health care industry.
Also see the response to Comment 31-135.
Comment [82-836]: Commenter (12464) writes that the Proposal is similarly substantive because it would establish a rule declaring that studies whose data and models are not "publicly available in a manner sufficient for independent validation" are deemed immaterial (or given less weight). 85 Fed. Reg. at 15,405. Such a rule would not only impact the ability of private parties to challenge the scientific bases for EPA's regulatory actions going forward but would also plainly restrict the agency's use of science in its determination of ISI and regulatory decisions.
Additionally, the Proposal is a substantive rule because it will impose significant burdens on researchers. As discussed above, the burden of implementing the tiered-access proposal will largely fall on researchers and universities. In particular, researchers will be responsible for determining which data and models can be made publicly available and managing the logistics of making the data and models available in a manner that complies with the rule. As the Proposal would place the bulk of the responsibility and costs for managing public access to data and models on people outside of the agency, it clearly has a binding external impact, and is substantive in effect.
Response: The purpose of the rule is to increase transparency of the science EPA uses to support its significant regulatory decisions and ISI. Nothing in the final rule will lead to the suppression of scientific data and models. As described in § 30.5, EPA will identify those studies that are given lesser consideration and provide a short description of why lesser consideration was given. The public can provide comments on that decision and can also submit additional studies that it believes the agency should have considered. Nothing in this rule would prevent scientists from submitting their data and studies to EPA. Researchers may voluntarily take steps to ensure that their studies are given greater consideration by making their data and models publicly available for independent validation. Additionally, the Administrator's exemption in § 30.9 can be used to allow greater consideration for pivotal science where the underlying data and models are not publicly available. Also see responses to Comments 34-144, 34-155, 40-193 and 48-379.
Comment [84-788]: Commenter (11390) writes that the proposed rule falls outside EPA's rulemaking authority.
Despite EPA's assertion that the amended Proposed Rule governs "internal agency procedures" and "does not regulate any entity outside the Federal government," the Proposed Rule is, in fact, a substantive regulation. It will profoundly impact how EPA interacts with regulated parties by changing how the agency performs its core functions.
"It is axiomatic that an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress." Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988). EPA steps far beyond that authority in the SNPRM, proposing a regulation that would change the way the agency engages in virtually any decision-making or scientific process -- outside of agency adjudications and enforcement activities -- whether or not that process ultimately leads to the adoption of regulations. EPA has revised the Proposed Rule to cite the agency's housekeeping authority as its basis to regulate. But EPA has no statutory authority to issue the Proposed Rule, either through the Housekeeping Statute or via other environmental statutes EPA has previously cited.
EPA now asserts "housekeeping" authority to issue the Proposed Rule, maintaining that these sweeping changes to agency practice and policy are nothing more than "procedural" rules or "internal agency procedures" that "do[] not regulate any entity outside the Federal Government," akin to how EPA manages its filing system. This is a serious mischaracterization of the Proposed Rule's import and effect.
The so-called Housekeeping Statute, 5 U.S.C. § 301 -- which does not, on its face, even apply to EPA --  was "originally adopted in 1789 to provide for the day-to-day office housekeeping in the Government departments," and courts at every level have consistently found that it does not authorize substantive rules. See, e.g., Chrysler Corp. v. Brown, 441 U.S. 281, 310 (1979); U.S. ex rel. O'Keefe v. McDonnell Douglas Corp., 132 F. 3d 1252, 1255-56 (8th Cir. 1998); City and County of San Francisco v. Azar, 411 F. Supp. 3d 1001, 1023 (N.D. Cal. 2019). While the Housekeeping Statute might appropriately authorize "a regulation that governs...the filing of government documents pertaining to the day-to-day business of government," it does not confer an "unrestricted grant of authority" allowing the agency to make broad policy changes that drastically alter the way it discharges its fundamental duties. See Respect Inc. v. Committee on Status of Women, 815 F. Supp. 1112, 1123 (N.D. Ill. 1993). Indeed, Housekeeping Statute authority is generally limited to actions that are exempt from the very notice and comment rulemaking procedures EPA has undertaken for the Proposed Rule (and that EPA has tacitly acknowledged are required by doing so). See Chrysler Corp., 441 U.S. at 310 (the Housekeeping Statute "authoriz[es] what the Administrative Procedures Act terms `rules of agency organization procedure or practice' as opposed to `substantive rules.'"); 5 U.S.C. § 553(b)(3)(A) (exempting rules of agency procedure, organization, and practice from notice and comment rulemaking).
EPA's characterization of the Proposed Rule as merely "procedural" or "internal" is erroneous and misleading. In reality, the Proposed Rule would have the effect of amending substantive and well-settled standards for decision-making under a number of the environmental statutes EPA administers, including the CAA, the TSCA, the SDWA, and others. For example, CAA § 109 mandates that EPA set air quality standards based on "air quality criteria," which must "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare." 42 U.S.C. §§ 7409, 7408(a)(2). The TSCA requires EPA to use the "best available science" when evaluating the testing and regulation of chemicals. 15 U.S.C. § 2625(h). Decisions are to be made using the "weight of the scientific evidence," and EPA is required to consider all information related to a chemical substance, including hazard and exposure information, "that is reasonably available to the Administrator." 15 U.S.C. §§ 2625(i), (k). Similarly, the SDWA mandates use of the "best available public health information" when EPA determines whether to regulate a contaminant, and reliance on the "best available, peer-reviewed science and supporting studies" when making regulatory decisions. 42 U.S.C. §§ 300g-1(b)(1)(B)(ii), 300g-1(b)(3). While EPA claims that "in the event the procedures outlined in this proposed rulemaking conflict with the statute that EPA administers, or their implementing regulations, the statutes and regulations will control," the Proposed Rule so directly conflicts with multiple statutory requirements as to render this assertion meaningless. In sum, the Proposed Rule cannot be implemented without upending statutory standards for the use of science.
Such fundamental change to agency policy is the very type of action courts have consistently characterized as substantive. See, e.g., Mendoza v. Perez, 754 F.3d 1002, 1021 (D.C. Cir. 2014) (a substantive regulation "supplements a statute, adopts a new position inconsistent with existing regulations, or otherwise effects a substantive change in existing law or policy."); Rocky Mountain Helicopters, Inc. v. F.A.A., 971 F.2d 544, 546 (10th Cir. 1992) (a rule that "changes existing law, policy, or practice" is substantive). "Misuse" of the Housekeeping Statute as purported authorization for these rules has repeatedly been rejected as an "attempt to twist this simple administrative statute into an authorization for the promulgation of substantive rules." See U.S. ex rel. O'Keefe, 132 F. 3d at 1255; see also Exxon Shipping Co. v. U.S. Dep't of Interior, 34 F. 3d 774, 776-78 (9th Cir. 1994); In re Cincinnati Radiation Litigation, 874 F. Supp. 796, 821 (S.D. Ohio 1995) (Housekeeping Statute did not authorize a Department of Defense directive mandating that the Department's experimentation on human subjects could only be conducted where the subject provided full and voluntary consent).
EPA's Proposed Rule would singlehandedly alter the way EPA discharges its core statutory responsibilities under the key environmental statutes it is tasked with administering, at significant cost to public health and safety. Far from a mere procedural dictate or internal standard, the Proposed Rule dramatically changes the nature of EPA's activities -- both regulatory and non-regulatory -- in ways that are inconsistent with existing law and a major departure from past agency policy. The Housekeeping Statute does not authorize such game-changing rulemaking.
Response: EPA disagrees with the commenter that the final rule effects a "substantive change" to existing policy. As discussed in the preamble of the 2018 proposal and the 2020 supplemental proposal, the final rule compliments and implements, but does not change, existing agency policies and OMB guidance on information quality and data availability. The study evaluation factors listed in § 30.5 and taken from existing agency guidance, the Framework for Human Health Risk Assessment to Inform Decision Making (Ref. 69). These factors will be used to evaluate studies deemed pivotal to a regulatory action or ISI. Because the rule does not categorically exclude any studies from consideration, EPA can still rely on pivotal science where the underlying data and models are not publicly available for independent validation. Additionally, an Administrator's exemption granted pursuant to § 30.9 would allow greater consideration of pivotal science lacking data and model availability.
In FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009), the Supreme Court explained that a more detailed justification is required when the "new policy rests upon factual findings that contradict those which underlay its prior policy," or "its prior policy has engendered serious reliance interests." (internal citations omitted). Assuming, arguendo, that the final rule does effect a substantive change in agency policy, EPA has provided a "detailed justification" for the change in the 2018 and 2020 proposals. Because this is a rule of internal agency procedure, outside parties could not have developed reliance interests in the prior policy.
Also see responses to Comments 31-135 and 73-410.
Comment [87-753]: Commenter (11400) writes that this rule is much broader and more substantive than a mere "housekeeping" measure.
EPA is taking comments on its authority to promulgate this rule under its housekeeping authority. In our view, this is not "administrative housekeeping". This rule creates rules to exclude scientific studies and applies to complex and studies with large price tags. This is not an "internal" matter to EPA, but instead affects broad research parameters that impact the scientific and health communities, and the affected public.
Response: See responses to Comments 31-135, 32-144 and 48-379.
Comment [88-763]: Commenter (11401) writes that like criticisms of EPA's attempts to hold itself to high scientific standards, criticisms about the use of the housekeeping authority are misplaced. The criticism extends from the fact that the Federal Housekeeping Statute should be internally focused, but that's exactly what's laudable about this proposed rule. EPA is aiming to regulate itself by holding itself to high standards in ensuring the best science is used. Some argue that it would limit EPA's ability to regulate, but EPA should be limited to only regulate when backed by sound science. Regulated communities have to meet strict standards imposed by EPA. It is only right that EPA is held to high standards itself. However, statutory authority from substantive statutes should be used in conjunction with this housekeeping authority.
Response: Thank you for your comment in support of the rule. However, EPA is relying exclusively on its housekeeping authority to promulgate this rule. In the final rule, EPA does not rely on, interpret, or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule. The rule expressly 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."
Comment [89-802]: Commenter (11403) writes that the Federal Housekeeping authority cannot be applied to substantive rulemaking The Federal Housekeeping authority is also of no help to EPA. Apparently recognizing that the previously listed environmental statutes do not provide EPA with the authority it seeks, the agency has invoked an even more tenuous argument -- that it may impose these regulations pursuant to the Federal Housekeeping statute, 5 U.S.C. § 301. That provision provides, in full:
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.
Arguing that this provision gives EPA the power to establish "internal practices," EPA claims that because these regulations govern how EPA internally treats scientific studies, the Federal Housekeeping statute is an additional source of authority. Once again, the agency is far off the mark.
In short, EPA is simply mistaken in suggesting that these rules are simply a matter of "internal practices" with no substantive effect. As we and many other commenters have detailed, the rules have enormous implications for the manner in which EPA regulates on behalf of public health and the environment, and is certain to lead to dramatic real-world effects as EPA refuses to rely on legitimate scientific studies to make regulatory decisions.
Indeed, the Supreme Court made this precise distinction in Chrysler Corp. v. Brown, noting that the Federal Housekeeping statute is "simply a grant of authority to the agency to regulate its own affairs," and provides no power for an agency to take an action with substantive effects. Given the real world impacts of these rules, EPA has no power to promulgate them under the Federal Housekeeping statute.
The single precedent on which EPA relies, United States v. Manafort, does not suggest otherwise, for the internal Special Counsel regulations at issue there concerned such matters as assignment of cases; staffing and budget matters; and reporting and compliance matters. Given that the regulations actually had no substantive effect, the Court naturally found they were duly promulgated under the Federal Housekeeping statute. Here, by contrast, again, these rules will have demonstrable substantive effect in governing how EPA treats scientific studies.
Indeed, while claiming authority under the Federal Housekeeping statute, it is apparent that EPA itself recognizes it is enacting a substantive rule, because it has subjected the rules to notice and comment rulemaking. As the Court explained in Manafort, that process is reserved for substantive rules not subject to the Federal Housekeeping statute, and an agency proceeding under that statute simply takes action, without public involvement.
Moreover, while, as explained, the rules in Manafort are completely unlike those at issue here, there is a long line of precedents expressly rejecting agency attempts to rely on the Federal Housekeeping statute to promulgate substantive rules. As another court explained in similarly rejecting an agency's reliance on the Federal Housekeeping statute, EPA's argument here "is simply one more attempt to twist this simple administrative statute into an authorization for the promulgation of substantive rules."
As the Supreme Court has emphasized, "an administrative agency's power to promulgate legislative regulations is limited to the authority delegated by Congress." Because these regulations are not permissible under any substantive grant of authority to EPA, and may not proceed under the Federal Housekeeping statute, EPA must abandon this effort to undermine the use of scientific studies in its decision-making.
Response: See responses to Comments 31-135, 32-144 and 48-383.
Comment [90-825]: Commenter (11404) writes that EPA lacks "housekeeping authority" and such authority would not justify the Proposed Rulemaking in any event.
Finally, EPA is incorrect in its assertion that it can use federal "housekeeping authority" codified in Title 5, section 301 of the United States Code as a justification for the Strengthening Transparency in Regulatory Science Proposed Rulemaking. First, EPA lacks federal housekeeping authority conferred on heads of Executive Departments. EPA is not an "Executive Department" within the meaning of the statute. See 5 USC § 101. Executive Departments, as defined, are Cabinet-level Departments of the federal government. EPA is not among those departments. EPA's assertion that it "gained housekeeping authority through the Reorganization Plan No. 3 of 1970" (85 FR 15397) which established EPA ("Plan No. 3") is legally and factually incorrect. Plan No. 3 makes no mention of such authority. Moreover, even if Plan No. 3 had addressed this issue, President Nixon lacked authority to expand the list of Executive Departments authorized by statute to exercise housekeeping authority. EPA's reliance on the Second Circuit decision in EPA v. General Electric Company, 197 F3d 592 (1999) ("GE") is misplaced. The court in GE did not analyze, much less decide, that EPA possesses housekeeping authority. Second, even if EPA had federal housekeeping authority, the Proposed Rulemaking extends far beyond the reach of housekeeping authority. The Supreme Court has made clear that housekeeping authority is only to be used to promulgate rules of agency procedure, organization, or practice -- not substantive rules. See e.g., Chrysler Corp. v. Brown, 441 US 281 (1979) (describing the purpose of housekeeping authority as being "to provide for day-to-day housekeeping" and not to include "substantive rules." Id., at 283). EPA's Proposed Rulemaking extends far beyond the modest, noncontroversial rulemaking for which housekeeping authority provides justification. The Strengthening Transparency in Regulatory Science proposal would fundamentally change how EPA uses science for regulatory purposes -- both in its future rulemakings and retroactively. Thus, even if EPA possessed such authority, the Proposed Rulemaking cannot be justified by the limited authority intended to be conferred by housekeeping authority.
Response: See response to Comment 31-135.
Comment [92-850]: Commenter (11396) writes that in addition to the lack of a scientific justification, EPA's legal authorization for the Proposed Rule, as supplemented by the SNPRM, is also wholly lacking. The limited "housekeeping" authority under 5 U.S.C. 301 (assuming it applies, which it likely does not), authorizing some federal agencies to regulate their own internal affairs, may not serve as the legal foundation for a rule that could allow EPA to exclude the best available science from its policymaking. As explained above, excluding the best available science from EPA policymaking is patently at odds with the agency's duties under multiple federal statutes. EPA is proposing here to alter the substantive standards for evaluating scientific research. But the federal housekeeping statute in no way authorizes EPA to make such substantive and impactful changes. Nor may the agency rely on the authority of the federal statutes it administers, which provide no legal basis at all for this proposal.
Response: See responses to Comments 31-135, 32-144 and 73-410.
Comment [93-853]: Commenter (11395) writes that as EPA acknowledges in the SNPRM, the Supreme Court ruled in Chrysler Corp. v. Brown, [441 U.S. 281, 309 (1979)]. that the intended purpose of the Housekeeping Statute is "to govern internal departmental affairs" and, as such, authorizes "what the [APA] terms `rules of agency organization, procedure or practice' as opposed to substantive rules." Because the proposed Strengthening Transparency rule would have far reaching substantive impacts on a wide range of EPA programs and activities, it is clearly inappropriate to invoke the Housekeeping Statute as authority applicable to this proposed rule.
Response: See response to Comment 31-135.
Comment [94-879]: Commenter (11408) writes that in the 2018 proposal, the EPA glibly asserted that authority for the rulemaking could be found in "the statutes its administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions." (The 2018 proposal goes on to cite specific provisions in various authorizing statutes that provide general rulemaking authority or that create scientific research programs to support implementation of the particular statute.) Unsurprisingly, this position met almost immediately with broad condemnation and was singled out as one of the most flawed aspects of the 2018 proposal.
The supplemental proposal now seeks to remedy this threshold weakness in the original proposal by offering a new alternative legal justification for the rulemaking. Specifically, the supplemental proposal employs a novel reading of an obscure law known as the Federal Housekeeping Statute to identify a legal basis for the rule. (The supplemental proposal also sought public comment on whether to rely on the Federal Housekeeping Statute as an independent basis for the rule or to use that statute's authority in conjunction with the specific provisions of its authorizing statutes that were cited in the 2018 proposal.)
This new attempt to find legal authority for the rule has two critical flaws. First, the Federal Housekeeping Statute doesn't apply to the EPA  -  only "Executive departments," a category that does not include the EPA. Second, even if the statute did apply to the EPA, the modest authorities it confers on covered federal agencies would not supply the legal basis for the kind of far-reaching requirements and limitations contemplated in the rulemaking. Because neither the 2018 proposal nor the supplemental proposal has identified a sound legal basis for this rulemaking, the rulemaking presents a clear case of an action that is "in "in excess of statutory . . . authority," rendering it highly vulnerable to rejection on judicial review.
Response: See response to Comment 31-135.
Comment [94-880]: Commenter (11408) writes that the operative provision of the Federal Housekeeping Statute reads: "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." A related law provides the definitive list of the "Executive departments" covered by the Federal Housekeeping Statute. Since its creation, the EPA has remained conspicuously absent from this list.
The supplemental proposal acknowledges this obvious shortcoming but asserts that the 1970 legislation that created the EPA, Reorganization Plan No. 3, still served to bring the agency within the scope of Federal Housekeeping Statute. Reorganization Plan No. 3 formally established the agency while laying out all the programs and authorities that were being transferred to it from already existing agencies, including the DOI and an agency then known as the Department of Health, Education, and Welfare.
Significantly, however, Reorganization Plan No. 3 never directly mentions the Federal Housekeeping Statute. To overcome this barrier, the supplemental proposal adopts the legal theory that the EPA's Office of General Counsel (OGC) employed in a 2008 memorandum opinion concerning an unrelated regulation. That opinion contends that Section 2(a)(9) of the Plan implicitly confers this authority through a vague "catchall" provision. Specifically, this provision calls for the transfer of "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."
In essence, then, the supplemental proposal argues that, when Congress formally approved Reorganization Plan No. 3, it has also implicitly intended to regard the EPA as an Executive department  -  or at least imbue it with some of the trappings of an Executive department  -  but in the nearly 50 year since has not gotten around to officially declaring it by updating the relevant statutory list. This argument is unpersuasive.
Since the enactment of the Federal Housekeeping Statute, Congress has amply demonstrated that it knows how to update the statutory "Executive departments" list, and it has done so on several occasions both before and after it approved Reorganization Plan No. 3. Indeed, Congress updated the list a little over a month after Reorganization Plan No. 3 to remove the Post Office Department from the list. That seemingly would have provided an ideal opportunity for Congress to take the step of explicitly adding the newly created EPA.
Congress has had several opportunities in the nearly 50 years since the EPA was created to update the statutory "Executive departments" list, and it has conspicuously failed to do so. Most notably, Congress could have done so in 1979 when it updated the list to reflect the reorganization of the old Department of Health, Education, and Welfare  -  from which many of the EPA's original functions and authorities had sprung  -  into the new Departments of Education and Health and Human Services, respectively. The fact that Congress has yet not updated the statutory "Executive departments" list to include the EPA despite ample opportunities to do so cannot be wished away by a memo from the agency's OGC.
Of greater relevance, Congress has shown that it knows how to update the statutory "Executive departments" list to include new departments that are created through the transfer and consolidation of various existing programs and authorities spread across several federal agencies, as was the case with the EPA. Congress took precisely this step when it created the DHS. Like Reorganization Plan No. 3, the HSA of 2002, adopted in response to the September 11th terrorist attacks, lays out those functions and authorities that were being transferred to the new DHS from where they had previously existed at agencies like the Departments of Agriculture, Energy, and Treasury. Significantly, in transferring these functions, the HSA also specifically provides in Section 101 that the DHS was being "established . . . as an executive department of the United States within the meaning of [the title of the U.S. code that contains the Federal Housekeeping Statute]."
Another problem with the supplemental proposal's argument is that the EPA has evolved as an agency in significant ways since its creation. This then raises intractable difficulties regarding the appropriate present-day application of the catchall provision contained in Reorganization Plan No. 3. Through various authorization and reauthorization acts, the present-day EPA is no longer the same agency that was established via Reorganization Plan No. 3, and it now carries out functions and authorities that were not contemplated at the time the Plan was drafted. Under the OGC's theory adopted by the supplemental proposal, it stands to reason that these new functions and authorities would not benefit from the implicit transfer of the Federal Housekeeping Statute authorities. That result would put current EPA officials (and potentially reviewing judges) in the awkward position of policing the lines between those agency functions and authorities covered by the Federal Housekeeping Statute and those that are not. Such a bizarre result weighs further against accepting the theory that the catchall provision in Reorganization Plan No. 3 served as an implicit transfer of the authorities conferred by the Federal Housekeeping Statute.
To be sure, the EPA has for decades issued regulations under claimed authority from the Federal Housekeeping Statute and the appropriateness of the legal basis for these regulations appears to have gone unchallenged. But a legal wrong cannot be made right through simple repetition. If it did, then agencies would face strong incentives to break the law as much as they could before getting caught. It is also worth noting that these previous applications involved genuinely noncontroversial internal procedures for the agency  -  the kind of procedures that the Federal Housekeeping Statute was designed to authorize, as noted below. As such, it would be unreasonable to construe the lack of a challenge to the legal basis for these actions as a broad recognition or acceptance of the appropriateness of their legal basis. Instead, it is more likely that their noncontroversial nature was such that they failed to attract the kind of intensive legal scrutiny that would have exposed their inadequate legal basis to begin with.
Response: See response to Comment 31-135.
Comment [94-881]: Commenter (11408) writes that even if the supplemental proposal was correct in its assertion that the EPA is covered by the Federal Housekeeping Statute, it does not necessarily follow that the authorities it confers would supply the legal basis for this rulemaking. On the contrary, it is clear that the modest authorities that the Federal Housekeeping Statute affords to covered agencies are insufficient to support this rule, since its primary effect is external in nature because it seeks to alter how the general public interacts with the EPA for the purpose of affecting its regulatory decision-making or informing its policy-relevant scientific determinations.
To support its contention that the Federal Housekeeping Statute provides it with authority to issue the rule, the supplemental proposal curiously cites the Supreme Court case Chrysler Corp. v. Brown. The citation of this case is curious because the Court's reasoning there cuts unmistakably against this argument. At issue in Chrysler Corp. was a DOL regulation that sought to compel the public disclosure of reports provided to the government by government contractors concerning their workforce composition, even though such disclosures would seemingly run afoul of the Trade Secrets Act. The Court struck down this regulation, finding that the modest reach of the Federal Housekeeping Statute was too limited to empower the DOL to displace the mandates imposed on it by Trade Secrets Act.
Crucially, in reaching its decision, the Court emphasized the essential "`housekeeping' nature" of the Federal Housekeeping Statute and characterized the law as "simply a grant of authority to the agency to regulate its own affairs." The Court had little trouble contrasting this understanding of the statute's modest reach with the DOL's regulation. Indeed, the material impacts of this regulation unavoidably extended well beyond what might be considered routine internal agency operating procedures given that its function was to alter the application of the Trade Secrets Act, a law that Congress enacted to govern privacy issues that arise from the federal government's interactions with private sector businesses. Accordingly, the Court concluded that Congress had not intended the Federal Housekeeping Statute to authorize something like the DOL's workforce composition disclosure regulation.
The logic employed by the Court in Chrysler Corp. is readily applicable to this rulemaking. As was the case there, this rulemaking cannot be reasonably understood as governing the EPA's internal operating procedures. That is because the provisions in this rulemaking are directly and inextricably tied to the implementation of the EPA's various authorizing statutes, as well as to its adherence to the APA. The rulemaking's impact on the APA is significant in this regard because the function of that law is to govern how the federal government interacts with members of the public in the development of new regulations. As such, this rulemaking is practically indistinguishable from the one at issue in Chrysler Corp., which, as noted above, sought to alter the DOL's adherence to the Trade Secrets Act, a law that similarly seeks to manage certain kinds of interactions between the government and the general public. In relevant part, the APA directs agencies to "give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments." It further directs them to develop a final rule based on the "consideration of the relevant matter presented."
The rulemaking would undeniably impact the EPA's compliance with these public participation requirements under the APA. In particular, its function is to fundamentally alter how members of the public are able to contribute to the development of the EPA's regulations and policy-relevant scientific determinations. Among other things, it would limit the kinds of "written, data, views, or arguments" that "interested persons" can submit to the EPA during the public comment process, while also drastically overhauling what the EPA can regard as "relevant matter presented" for its "consideration" in developing a final rule. As such, because this rulemaking goes well beyond routine internal housekeeping procedures, it plainly exceeds the authority that could be granted to the EPA by the Federal Housekeeping Statute.
That the rulemaking would have such a significant impact on how the public interacts with the EPA on matters important to the public can also be seen in the considerable controversy it has provoked since its inception. The 2018 proposal received nearly 600,000 public comments, nearly all of which were in opposition. At a recent House Science Committee hearing on the rulemaking, none of the committee members present and none of the non-agency invited witnesses offered support for the 2018 proposal. It is also noteworthy in this regard that Congress has rejected several bills in recent years that have sought to impose limitations on the EPA's consideration of science in developing new rules that are similar to those contained in this rulemaking. It would be hard to believe that the kind of modest and mundane authorities supplied by the Federal Housekeeping Statute could provide the legal basis for a rulemaking that has engendered such widespread opposition and controversy.
Response: See responses to Comments 31-135, 40-193 and 48-408.
Comment [97-899]: Commenter (11479) writes that the supplemental notice offers a different source of authority for the proposed rule, changing from a range of statutes to the Federal Housekeeping Act. The Act reads that "The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property" (emphasis added). EPA is not an "executive department" of the federal government. Even if the Federal Housekeeping Act applied here, it is meant to cover procedural rules, which the APA defines as "rules of agency organization, procedure or practice," not substantive rules, like this proposed rule, that would prevent an agency from fulfilling its statutory duties.
Response: See response to Comment 31-135.
Comment [98-942]: Commenter (11500) writes that for the reasons discussed in the Supplemental Notice, they support EPA's proposal to rely on its internal Housekeeping authority as a basis for these proposed regulations. However, they also note EPA's statement 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." As discussed in their Comments on the proposal, the CAA requires the maximum practicable scientific transparency in NAAQS proceedings. Accordingly, while EPA's Housekeeping authority is one appropriate basis for this proposal, the agency should make it clear that other statutes such as the CAA not only permit but require the actions EPA has proposed. This is necessary to ensure that future administrations cannot repeal or modify the rule simply by changing the agency's interpretation of the Housekeeping statute.
Response: Thank you for your comment in support of the final rule. EPA is relying exclusively on its housekeeping authority to promulgate this purely procedural rule. In this rule, EPA does not rely on, interpret, or apply provisions of a particular statute or statutes that it administers. EPA will undertake such efforts in forthcoming substantive actions, which will be either statute-specific science transparency regulations or programmatic regulations implementing this procedural rule.
Comment [99-951]: Commenter (11480) writes that they have been a strong defender of EPA's authority to issue public health protections. Decisions made by EPA under a variety of statutes, from the CAA to the EPCRA to the TSCA, have impacted our members. EPA decisions to reduce hazardous pollutants have reduced workplace exposures and protected the health of workers and their families. And EPA decisions have advanced manufacturing technologies in the United States to ensure that the processes and products are less polluting and more globally competitive. In some cases, their members have opposed EPA decisions due to concerns over job security. Since EPA's creation they have evaluated regulatory decision-making by taking a hard look at the science used to justify regulatory proposals under a variety of statutes.
However, we question EPA's authority to issue this proposal. The cited authority  - the federal housekeeping statute -  was originally enacted for executive departments a century prior to the modern civil service. This supplemental proposal acknowledges that EPA is not an executive department, but it claims that the agency can use this authority anyway based on the Reorganization Plan No. 3 of 1970. The use of this supposed authority is dubious for this reason and because the implementation of this proposal would go beyond the internal organization or functioning of the agency by significantly impacting the implementation of statutes that the EPA is carrying out at the direction of the United States Congress.
Response: See the response to Comment 31-135.
Comment [113-994]: Commenter (11391) writes that EPA lacks legal authority to adopt the proposed rule.
In addition to being unsupported and unjustified, the Proposed Rule also lacks any statutory basis. Administrative agencies, such as EPA, have only the power conferred on them by Congress. Agencies may, therefore, only adopt regulations where authorized to do so by Congressional statute. In the 2020 SNPRM, EPA claims that the Proposed Rule is authorized under the Federal Housekeeping Statute but, as the Agency itself recognizes, that statute only authorizes the adoption of procedural rules governing agencies' internal affairs. The Proposed Rule goes beyond this, regulating the conduct of outside parties, and thus amounts to a substantive rule, which the courts have repeatedly held cannot be adopted under the Federal Housekeeping Statute. The courts have interpreted the Federal Housekeeping Statute as a "narrow" grant of authority to agencies to deal with internal "housekeeping" matters. In Chrysler Corp. v. Brown, the Supreme Court held that the Federal Housekeeping Statute "authoriz[es] what the APA terms rules of agency organization, procedure or practice as opposed to substantive rules." The court defined "substantive rules" as those that "affect[] individual rights and obligations." Building on that definition, in American Hospital Association v. Bowen, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) identified several key features of substantive rules. According to the court, substantive rules typically establish binding standards that create rights, impose obligations, or otherwise "significantly impact" private interests, for example, by "put[ting] a stamp of [agency] approval or disapproval on a given type of behavior."
Contrary to EPA's claim, the Proposed Rule is not merely an "internal rule of agency procedure," but rather a substantive rule, which binds parties outside the Agency. In this regard, we note that the Proposed Rule is similar to EPA's 2001 directive banning agency consideration of third-party human studies ("2001 Directive"), which was held to be a substantive rule in Croplife America v. EPA ("Croplife"). In that case, the D.C. Circuit reasoned that the 2001 Directive used "clear and unequivocal language," stating that EPA "will not consider . . . any human studies in its regulatory decision-making." Based on that language, the court concluded that the 2001 Directive bound both EPA and third parties, who were "concretely injured" because they could no longer rely on human studies that had previously been accepted by the Agency. Similarly, the Proposed Rule mandates that EPA "will only use," or under the alternative proposal "will . . . give greater consideration to," studies for which the underlying data are available. As such, the Proposed Rule will prevent or severely impede third parties from relying on other studies, previously accepted by EPA. Those parties are bound by the Proposed Rule, which "put[s] a stamp of . . . disapproval" on their reliance on certain studies, thus significantly affecting their interests.
Given the above, EPA's characterization of the Proposed Rule as non-binding is plainly incorrect and does not undo its substantive effect. EPA points to dicta from U.S. v. Manafort to argue that its characterization of the Proposed Rule is determinative. However, as the D.C. Circuit held in Croplife, "an agency's characterization of its own action is not controlling if it self-servingly disclaims any intention to create a binding rule with the force of law, but the record indicates otherwise." Here, the record makes clear that the Proposed Rule "impose[s] requirements," which are expressed in mandatory terms. The Proposed Rule thus leaves EPA and third parties with no choice in how to deal with scientific studies.
By preventing the use of studies for which the underlying data are not available, the Proposed Rule reverses long-standing EPA policy, which further indicates that it is a substantive rule not authorized under the Federal Housekeeping Statute. Indeed, in Alcarez v. Block, the U.S. Court of Appeals for the Ninth Circuit held that a key feature of substantive rules is that they "create[] new" or "change existing law or policy." EPA implies that it has not previously had a coherent, existing policy regarding the use of scientific studies, but that is not the case. For at least the last two decades, EPA has consistently relied on studies for which the underlying data are not available, and repeatedly rejected claims that it cannot or should not do so. As far back as 1997, EPA concluded that it was "impractical and unnecessary" to exclude such studies from its review and that doing so "would make it extremely difficult, if not impossible, for EPA to regulate in complex technical areas at the forefront of science." EPA reiterated that view in 2016 and affirmed that it would continue to rely on all relevant studies (i.e., regardless of the availability of the underlying data). The Proposed Rule effects a sudden and, as discussed in Part I above, unjustified reversal of that twenty-year policy.
Response: See responses to Comments 31-135, 32-144, 48-379, 48-380, 48-382 and 48-408.
Comment [114-1008]: Commenter (11392) notes that the EPA is proposing the option of using its housekeeping authority independently as authority for taking this action or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in this supplemental proposal). The Agency continues to consider whether it is appropriate to rely on its authority in the above-referenced environmental statutory provisions (potentially in conjunction with its housekeeping authority). The Agency will consider comments on this issue submitted in response to the 2018 proposal and in response to this SNPRM.
EPA does not possess the legal authority to promulgate this rule. As Members of Congress, we can affirm that Congress has never authorized the Agency to use any "housekeeping authority" in this manner. Furthermore, Congress explicitly rejected the legislative precursors to this rule in the failed Secret Science Reform Acts of 2014 and 2015 and HONEST Act of 2017. In its desperate search for a statutory basis, EPA is attempting to redefine the rule as a procedural matter rather than a change in policy. The federal housekeeping statute was never meant to be used this way, and EPA's verbal sleight-of-hand to justify its use only demonstrates the tenuous nature of the Agency's position.
First, the plain language of the Federal Housekeeping Statute at 5 U.S.C. 301 excludes EPA. The Agency is not one of the 15 Executive Departments listed at 5 U.S.C. 101, which are the Departments explicitly authorized to act pursuant to the Housekeeping Statute. The Agency asserts that it acquired housekeeping authority under the Reorganization Plan of 1970, as determined by the OLC in a 2008 memorandum opinion. That memorandum opinion was written in response to a narrow question, "whether the [EPA] may hold its employees liable for the negligent loss, damage, or destruction of government personal property or for the unauthorized personal use of agency-issued cell phones", which is in no rational conception related to the action proposed in the SNPRM. Whether the underlying assertion is correct or not, any housekeeping authority possessed by EPA must be narrow and limited in nature, consistent with the Agency's absence from 5 U.S.C. 101 and the language of the Housekeeping Statute itself. Congress established specific criteria for the housekeeping authority in 5 U.S.C. 301, namely that the authority extends to "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, paper, and property." This is not catch-all language: it is meant to limit the authority to internal department affairs of a procedural nature, separate from the Agency policymaking process. In other words, the Federal Housekeeping Statute does not provide any authority to enact policies, but merely to manage internal affairs such as record-retention, employee behavior, and property management.
Despite these limitations, EPA is determined to invoke the housekeeping authority for the "Strengthening Transparency" rule because it lacks any other authority. The SNPRM characterizes the rulemaking as "a rule of agency procedure to establish an agency wide approach to handling studies when the data and models underlying EPA's significant regulatory decisions and influential scientific information are publicly available and when those data and models are not publicly available." This characterization contains critical conceptual errors. Most importantly, the phrase "handling studies" is misleading. The rule does not concern how the Agency "handles" scientific studies procedurally; it concerns how the Agency considers and uses studies in its policymaking process. Additionally, the rule would not create a procedure for an agency wide approach to scientific studies; it would create a new policy to categorically change the way certain studies are considered in the regulatory process where no such distinction existed before. EPA seeks to portray a sweeping policy change that would impact every aspect of Agency regulatory activity as a modest procedural change, akin to a change in procedure for record retention or the management of Agency property. Congress never provided any such "housekeeping authority" for this purpose.
EPA's own prior characterizations of the rule undermine its newfound depiction as a mere internal agency procedure. In a press release announcing the proposed rule on April 24, 2018, then-Administrator Scott Pruitt declared "the era of secret science at EPA is coming to an end" because the rule would allow Americans to "assess the legitimacy of the science underpinning EPA decisions that may impact their lives." EPA stated that the proposed rule was "designed to increase transparency in the preparation, identification, and use of science in policymaking." The end of an era, the legitimacy of EPA's science, the use of science in policymaking: these are hardly matters of internal agency procedure. They are fundamental questions about the Agency's policy for the consideration of science in its regulatory process, and they must be governed by the statutory authorities that Congress has enacted for that purpose. EPA cannot claim the authority to implement this policy under the Federal Housekeeping Statute by pretending that the rule is not a sweeping change in policy.
Response: See responses to Comments 31-135, 32-144, 48-379, 48-381, 48-382 and 73-410.
Comment [115-1018]: Commenter (11393) writes that EPA lacks authority for the proposed rule and SNPRM.
AARST challenges the authority EPA claims to rely on for the proposal. 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. Housekeeping does not allow any federal agency to ask the public whether it has the authority to change the goals of a given statute and thereby, through a rushed rulemaking comment period, adopt the proposed 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).
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. AARST 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 [118-1021]: Commenter (11407) writes that EPA lacks authority for the proposed rule and SNPRM.
The SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C. § 301. 85 Fed. Reg. at 15404. The preamble says EPA is taking comment on whether to use 5 U.S.C. § 301, which the SNPRM calls EPA's housekeeping authority, independently or in conjunction with statutory provisions cited in the proposed rule and corrected in the SNPRM's preamble. 85 Fed. Reg. at 15398. The fact that EPA is still considering and asking what authority it can rely on for the proposed rule, twenty-two months after the initial proposed rule, shows that EPA does not have such authority. The SNPRM's statements on authority continues EPA's pattern of making rules first and searching for a justification later (which it still has not provided for this rulemaking). As the NTAA explained in its 2018 comments: In order to protect human health and environment, EPA must have a solid foundation before it proposes rules and rulemaking as such portrays the agency's naiveté in seeking answers for questions about its own authority.