By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutants in the ambient air. If EPA were to exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Comment [201-2218]: Commenter (12474) notes that the SNPRM changes the authority EPA claims to rely on for the proposal, however either way, the proposal remains unlawful. The text of the SNPRM proposes to rely solely on 5 U.S.C. § 301. 85 Fed. Reg. at 15404. The preamble says EPA is taking comment on whether to use 5 U.S.C. § 301, which the SNPRM calls EPA's housekeeping authority, independently or in conjunction with statutory provisions cited in the proposed rule and corrected in the SNPRM's preamble. 85 Fed. Reg. at 15398. The fact that EPA is still considering and asking what authority it can rely on for the proposed rule, twenty-two months after the initial proposed rule, shows that EPA does not have such authority. The SNPRM's statements on authority continues EPA's pattern of making rules first and searching for a justification later (which it still has not provided for this rulemaking). As the NTAA explained in its 2018 comments: In order to protect human health and environment, EPA must have a solid foundation before it proposes rules and rulemaking as such portrays the agency's naiveté in seeking answers for questions about its own authority.
First, none of the initial or corrected environmental statutes provide EPA authority for the proposed rulemaking. In most cases, EPA simply cites its general authority for rulemaking under the statutes. Still that general authority alone cannot provide a basis for the rule, especially when, as here, the rule would conflict with the requirements of each of the statutes. Courts have made clear that "EPA cannot rely on its gap-filling authority to supplement [a statute's] provisions when Congress has not left the agency a gap to fill." NRDC v. EPA, 749 F.3d 1055, 1064 (D.C. Cir. 2014); see also New York v. U.S. EPA, 413 F.3d 3, 40-42 (D.C. Cir. 2005). EPA otherwise cites to statutes describing research programs established by the agency, with no relation to or authorization for the requirements the SNPRM seeks to create.
The NTAA also disagrees with EPA's reliance on 5 U.S.C. § 301 as:
      1) It is questionable whether § 301 applies to EPA as EPA is not one of the fifteen "Executive Departments" listed at 5 U.S.C. § 101, and
      2) The proposed rule and SNPRM are not merely internal rules of agency procedure --  they would significantly impact every aspect of EPA's scientific and regulatory work, the individuals who contribute to that work, and the Tribes and communities who rely on it.
The NTAA appreciates the SNPRM's recognition that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." 85 Fed. Reg. at 15398. This statement alone should lead EPA to withdraw the proposed rule and SNPRM; the requirements conflict with every statute EPA administers and would cause EPA to unlawfully exclude valid scientific research from its work.
By way of example, in CAA Section 108(a)(2), Congress requires EPA to issue air quality criteria for air pollutants to "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air." 42 U.S.C. § 7408(a)(2). The SNPRM does not claim that studies that have not publicly released all their underlying data, such as those linking air pollution to mortality and disease, do not accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air. If EPA were to exclude such studies from consideration when issuing air quality criteria, it would be in violation of the CAA.
Comment [205-2036]: Commenter (13788) states that this rule is not procedural. If finalized, it will have substantial effects on EPA decisions that impact regulated entities. For example, under the CAA's NAAQS program, EPA is required to issue air quality criteria for pollutants that "accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air." If EPA were to ignore or diminish the value of the latest scientific studies because they involve human health data that cannot be made publicly available, that would significantly impact the health-protectiveness of the resulting ambient air quality standards, which would have a substantial effect on both regulatory beneficiaries and regulated industries.
In addition to the Chrysler Court's decision, the D.C. Circuit held in Pickus v. United States Bd. Of Parole, that rules of practice or procedure "should not be deemed to include any action which goes beyond formality and substantially affects the rights of those over whom the agency exercises authority," and that "adherence to congressional purpose counsels a construction of this exemption [for procedural rules] that excludes from its operation action which is likely to have considerable impact on ultimate agency decisions." By restricting EPA's consideration of science in regulatory decision-making based only on the public availability of underlying data, this rule would have a clear and substantial effect on ultimate agency decisions, including decisions that affect the rights of regulated entities, and therefore it is not a procedural rule.
Nor is this a proposed "internal rule of agency procedure" that "exclusively pertains to the internal practices of the EPA." According to details provided to staff of the House Committee on Science, Space, and Technology, EPA's proposed tiered access system would not be implemented internally at EPA, but rather the Agency expects that the bulk of the burden of implementing such a system would fall on the researchers who conduct (or conducted, as this relates to retroactive application of this new policy) the study. According to information shared with committee staff, EPA anticipates that researchers would be responsible for managing the logistics of making data and models publicly available in compliance with the rule, for judging the sensitivity of study data and models and what information can or cannot be made publicly available through tiered access, and what tier of access should be designated for different types of information. It is unclear how EPA would ensure compliance with this rule, or whether after this rule is finalized, it will in effect ban all studies based on confidential human health data. However, what is clear is that this rule would have significant impacts beyond the Agency's internal practices and procedures.
Comment [205-2051]: Commenter (13788) states that under the APA and CAA, Agency actions that are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" are to be held unlawful and set aside. Agencies are required to "articulate a satisfactory explanation for [the] action including a `rational connection between the facts found and the choice made.'" Here, however, EPA is proposing to exclude or devalue scientific studies based on criteria that are unrelated to scientific value or merit, and that would eliminate the Agency's ability to rely on research that may be the best available science.
The Agency's newly claimed statutory authority under the housekeeping statute does not save this rule, and actually undermines any transparency justification for the rule. Many of the studies EPA relies on are done outside of the Agency, and therefore must be beyond the reach of the housekeeping statute. The Agency's conflation of transparency in EPA's processes with data availability in scientific research outside the Agency cannot be used to provide satisfactory justification for this rule.
EPA seems to believe that by wielding the terms "validation" and "reanalysis" it shows concern about the quality of studies relied on by the Agency. But EPA's real intention in the SNPRM, as in the Proposal, is to limit the Agency's access to public health science, not to ensure the quality of the studies the Agency relies on. That is made abundantly clear by the Agency's statement that if "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." By acknowledging that the highest quality studies will be ignored if confidential data and models are not made available for validation and reanalysis, EPA is admitting that this rule is not concerned with improving the quality of studies relied on by the Agency. The SNPRM is instead laser-focused on information availability, even if it comes at the expense of the quality of scientific work. The best studies may not rely on available underlying data -- precisely because they are human health studies that requires the maintenance of the privacy of the study participants  -- and in those situations this rule would clearly prioritize data availability over quality.
Unlike the 2018 Proposal, the SNPRM does not include any acknowledgement that EPA must use the "best available science" for regulatory actions -- but it must. This lack of concern for quality is evident throughout the SNPRM and is particularly alarming in an agency that relies heavily on science -- as it must, given its statutory mandates. Additionally, the suggestion that the rule could apply to studies retroactively if the Administrator does not grant an exemption further illustrates the intention to undermine longstanding reliance on the human health studies that have done the most to advance air quality and public health. The SNPRM states that the "proposal would apply to reviews of data, models, and studies at the time a rule is developed or ISI is finalized, regardless of when the data and models were generated." EPA has provided no reasoning to explain how retroactive application to past studies -- including the Harvard Six Cities and American Cancer Society PM health studies and subsequent work that links exposures to air pollution with declines and damages to human health -- is justified. It certainly has not provided any information to suggest that this rule would encourage the release of more data from those studies. This proposal's focus is clearly on arbitrarily excluding or diminishing the value of quality scientific research rather than any real commitment to transparency.
Comment [205-2126]: Commenter (13788) claims that the rule conflicts with EPA's performance of its statutory duties, including under the CAA, by preventing the Agency from relying on the latest and best available science for its rulemakings.
Comment [205-2186]: Commenter (13788) states that not one of the other environmental statutes cited as potential authority by EPA actually authorizes this rule. At most, many of the provisions cited by EPA generally allow the agency to promulgate regulations in order to implement various statutes, with many requiring that the regulations be necessary. However, EPA has not shown how this rule would further the implementation of any statute, much less how the rule is necessary to fulfill any statutory responsibilities, and the fact that the Agency has not considered such a rule necessary until now suggests the opposite. Under the CAA, the most important scientific studies and models for use in evaluating the public health effects of air pollution are those that are based on actual human health data -- much of which cannot be publicly available due to the confidentiality requirements imposed by other federal statutes and the agreements under which the data is provided to researchers. For CAA rulemaking then, any of the approaches EPA is proposing actively undermine the Agency's use of the best science in making decisions that promote and protect the public health and welfare -- the fundamental purpose of the CAA.
If Congress had intended EPA to prioritize data transparency over the quality of scientific information in its regulatory decision-making, it could have written that requirement into the statutes. In the absence of such a requirement and as required by law, EPA should prioritize quality in accordance with the various "mandates requiring that its decisions rest on various formulations of the best available science."
Comment [205-2216]: Commenter (13788) asserts that, Nor the Federal Housekeeping Statute cannot be used to authorize rules that limit the scope of EPA's responsibilities under other statutes. The Chrysler Court was clear that "[section] 301 does not authorize regulations limiting the scope of [the Trade Secrets Act]" (the statute under consideration in that case), or of any other substantive statutory authority. Similarly, the Federal Housekeeping Statute cannot authorize regulations limiting the scope of environmental statutes. If finalized, this rule would limit EPA's ability to evaluate and use the best available science to support its regulatory decisions, thereby undermining its ability to fully implement its responsibilities as mandated under environmental statutes. It therefore cannot be a valid exercise of the authority granted by the Federal Housekeeping Statute.
Neither the Federal Housekeeping Statute nor the IQA provide authority or justification for a rule that would significantly impede and disrupt EPA's ability to fulfill its statutory mandates. For example, the air quality criteria EPA is required to issue when reviewing the NAAQS under the CAA takes the form of an ISA, in which the Agency evaluates the latest science on public health and environmental effects of criteria pollutants. The ISA document is considered a HISA, which is a subset of the ISI governed by the IQA guidance. Subjecting the ISA to the requirements of this rule and SNPRM would result in the exclusion of important, longstanding public health studies from consideration, because the human health data on which they are based, and which makes them of value, is not publicly available as contemplated by the proposed rule. Such a result would directly conflict with the CAA's mandate that the air quality criteria reflect the latest scientific knowledge. The Agency claims that "[i]n the event the procedures outlined in this part conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control." EPA fails, however, to explain how the Agency will define and identify such conflicts and ensure that staff do not follow the proposed rule. This is a significant question that EPA entirely fails to discuss.
1.3.2 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (NPRM and SNPRM Comments).
Comment: Sections <IP_ADDRESS> and <IP_ADDRESS> of this Chapter present comments received on the NPRM (Section <IP_ADDRESS>) and SNPRM (Section <IP_ADDRESS>) related to the EPA's legal authority for the rule under the FIFRA. The EPA provides the following general response to these comments:
Response: EPA appreciates your comments. As discussed in Section I.C of the final rule preamble and in this RTC document in Section 1.2, EPA has decided it is most appropriate to rely on its authority to promulgate housekeeping regulations, rather than any of the substantive environmental statutes cited in the 2018 proposal or the 2020 supplemental proposal as legal authority for the rule. EPA intends to promulgate future science transparency rules under its substantive environmental statutes. Additionally, the final rule states in § 30.3 that "[i]n the event the procedures outlined in this rule conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control."
<IP_ADDRESS> FIFRA (NPRM Comments)
Comment [6103-517]: Commenter (6113) asserts that the proposed regulation turns the statutory scheme of FIFRA upside down. Very limited amounts of pesticides on food products are allowed only if EPA determines the amount to be safe. Slip op. p. 7. See also slip op. at p. 9 (explaining how the EPA must meet FDA standards on this). The proposed regulation seeks to exclude much information that establishes the pesticide's harm whereas the statute requires the manufacturer to prove that the amount is safe.
Comment [6112-1556]: Commenter (6137) provides that EPA also cites to two specific provisions in the Federal Insecticide, Fungicide, Rodenticide Act ("FIFRA") as statutory support for the Proposed Rule. Upon closer examination, these provisions do not provide the necessary authority for this Rule.
First, EPA points to Section 20(a), 7 U.S.C. § 136r(a), which provides:
      (a) Research
      The Administrator shall undertake research including research by grant or contract with other Federal agencies, universities, or others as may be necessary to carry out the purposes of this subchapter, and the Administrator shall conduct research into integrated pest management in coordination with the Secretary of Agriculture. The Administrator shall also take care to ensure that such research does not duplicate research being undertaken by any other Federal agency.
By its plain language, this provision authorizes research, not the use of scientific studies in regulating pesticides. Thus, EPA's reliance on this provision as support for this rule is misplaced.
Second, the Proposed Rule cites Section 25(a)(1), 7 U.S.C. § 136w, which authorizes the EPA Administrator "to prescribe regulations to carry out the provisions of this subchapter." However, this broad authority is expressly limited to regulating "in accordance with the procedure" prescribed in FIFRA itself. Id. Yet, as discussed more fully in Section V, EPA failed to comply with these requisite procedures. Accordingly, this provision provides no authority for EPA's issuance of this rule.
Comment [6112-1567]: Commenter (6137) contends that not only does FIFRA not provide authority for the Proposed Rule, but it likewise contains provisions directly at odds with the purpose and effect of the Rule.
Under FIFRA, EPA must register a pesticide (with rare exceptions) before it may be sold or used in the United States. 7 U.S.C. § 136a(a). To register or re-register a pesticide, EPA must determine that its use "will not generally cause unreasonable adverse effects on the environment." Id. § 136a(c)(5)(D); see id. § 136(bb) (definition of "unreasonable adverse effects"). FIFRA defines "unreasonable adverse effects" as "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide." Id. § 136(bb).
EPA requires a company seeking establishment or retention of a pesticide registration to submit data and information to enable EPA to make its unreasonable adverse effects determination. In addition to a standard set of data, EPA can issue data call-in notices requiring additional testing and information. Often, EPA requires the registrant to conduct particular laboratory tests to assess the pesticide's toxicity. As Nancy Beck noted during the drafting of the rule, pesticide regulations require manufacturers to submit to EPA "a huge amount of data," and that the studies come to EPA as CBI. See Maria Hegstad, "Absent ORD Chief, Trump's Toxics Pick Expands Reach Across EPA Science," Inside EPA (May 10, 2018), https://insideepa.com/weekly-focus/absent-ord-chief-trumps-toxics-pick-expands-reach-across-epa-science. The raw data underlying the industry laboratory studies is rarely made available to the public, and the registrants would almost certainly oppose such disclosure on CBI grounds. Nor are such studies typically peer reviewed.
In addition, after a pesticide has been registered, the registrant must provide EPA all factual information regarding the pesticide's unreasonable adverse effects. 7 U.S.C. § 136d(a)(2). Such information comes in a variety of forms  -  from academic studies, poisoning incident reports, or studies conducted for other regulatory authorities at the state, federal, or international level. Often, the raw data are unavailable.
The Proposed Rule thus conflicts with FIFRA's pesticide registration requirements as it eliminates from consideration important studies used to show the unreasonable adverse effects of the pesticide toxins. As Beck herself acknowledged of an early version of the rule, the directive would "`jeopardize our entire pesticide registration/re-registration process.'" Maria Hegstad, "Absent ORD Chief, Trump's Toxics Pick Expands Reach Across EPA Science," Inside EPA (May 10, 2018). Accordingly, the Proposed Rule cannot stand.
Comment [6112-1623]: Commenter (6137) states that EPA failed to follow the specific procedures required by the FIFRA when issuing the Proposed Rule. Specifically, section 25w of FIFRA requires, among other things, that EPA provide a copy of any proposed rule or regulation to the Secretary of Agriculture for review and comment 60 days before a proposed rule is published in the Federal Register. 7 U.S.C. § 136w(a)(2)(A). EPA must then provide the Secretary a copy of the rule EPA intends to publish as a final rule no later than 30 days before publication. Id. § 136w(a)(2)(B). EPA must also consult with its own SAP in an effort to receive comments from it regarding the impact the proposed rule will have on health and the environment. Id. § 136w(d). Such consultation must occur under the same timelines sets forth for consulting with the Secretary of Agriculture. Id. § 136w(d)(1). Lastly, before a final rule can take effect, EPA is required to submit the rule to Congress and "the rule or regulation shall not become effective until the passage of 60 calendar days after the rule or regulation is so transmitted." Id. § 136w(a)(4).
Thus, FIFRA sets forth a clear process in which EPA must consult with a number of entities, including both the USDA and a SAP when issuing rules impacting pesticides. See, e.g., Nat'l Coal. Against the Misuse of Pesticides v. EPA, 867 F.2d 636 (D.C. Cir. 1989) (noting that "FIFRA generally requires the Administrator [of EPA] to consult with the Secretary of Agriculture . . . and a seven member Scientific Advisory Panel (on environmental health questions) prior to making public any notice of intent to cancel," in context of pesticide registration cancellation). Yet it is indisputable that EPA utterly failed to take these necessary steps. For this reason, too, EPA's Proposal cannot stand.
Comment [6118-1731]: Commenter (6143) asserts that EPA has issued its proposed rule on Strengthening Transparency in Regulatory Science pursuant to its authority under several environmental statutes that that it implements, including the CAA; CWA; SDWA; RCLA; CERCLA; EPCRA; FIFRA; and TSCA. This proposed action is fully consistent with the authorities and objectives laid out in those statutes. EPA must ensure that any final action it takes on this proposal continues to respect the balance reflected in those statutes between sound, transparent science, and legitimate privacy interests.
Comment [6152-651]: Commenter (6122) contends that EPA cites multiple statutory provisions in an attempt to support the proposed rule that it believes authorize this type of rulemaking, "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 . . ." None of the specific statutory provisions provided by EPA provide specific authority for EPA to fundamentally rework the foundational processes it uses to assess and include/reject science. Indeed, if such authority existed, one would have expected EPA to have discovered this authority many decades earlier. Instead, EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress...does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes."And if this is true, neither can the EPA alter the fundamental details of all of its regulatory schemes based on such vague provisions of law. We review each of the provisions listed by EPA, none of which discuss transparency, dose response, pivotal regulatory science, benefit-cost calculation, or changing "agency culture," the stated goals of this rulemaking.
Section 25(a)(1) of the FIFRA authorizes the Administrator "to prescribe regulations to carry out the provisions of this subchapter." This general authorization section of FIFRA differs from that of the other statutes listed because it actually does specify some considerations the Administrator must give when promulgating regulations. For example, it states, "Such regulations shall take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides." This provision clearly intends to provide detail and guidance on rulemaking. The fact that the section does not mention transparency indicates that it does not grant EPA authority to undertake the proposed rule.
Section 136r(a) of the FIFRA directs the Administrator to conduct research to carry out the purposes of the statute. The section states, "The Administrator shall also take care to ensure that such research does not duplicate research being undertaken by any other Federal agency." The section does not state that the EPA can ignore sound science if it does not meet its nebulous definition of transparency.
Comment [6155-664]: Commenter (6125) states that the proposal lists FIFRA sec. 25 as an authority for the rulemaking. 83 FR 18769. The agency, however, has failed to follow required procedures for issuing a valid regulation under FIFRA. FIFRA requires the agency to seek comments from the Secretary of Agriculture on all draft proposed regulations prior to signing the regulation for publication in the Federal Register; and, if the USDA provides comments, the agency must respond in writing to the comments as part of the proposed rulemaking package. See FIFRA sec. 25(a)(2); 7 U.S.C. 136w(a)(2). The statute contains a similar provision regarding consultation with the SAP --a body of independent expert scientific peer reviewers chartered under the Federal Advisory Committee Act (FACA) on all draft proposed regulations. See FIFRA sec. 25(d); 7 U.S.C. 136w(d). FIFRA further requires
EPA to publish a notice in the Federal Register simultaneously with the transmission of the proposed rule to USDA. FIFRA sec. 25(a)(2)(C); 7 U.S.C. 136w(a)(2)(C). In addition, the statute requires the agency to submit a copy of the proposed rule to the Agriculture Committees in the
House and Senate. See FIFRA sec. 25(a)(3); 7 U.S.C. 136w(a)(3). The agency did not comply with any of these requirements. A very serious consequence of these procedural mistakes is to deprive the agency of a full understanding of how the proposed rulemaking might affect the regulation of pesticides and thereby affect agriculture, human health, and the environment. Had this proposal been referred to the SAP, EPN and other interested entities would have had the opportunity, according to SAP practices, for comment, a process which assures that the decision-makers obtain the widest possible input to these critically important decisions.
Comment [6155-2725]: Commenter (6125) notes that other provisions prescribe factors EPA must use in making decisions. FIFRA, 7 USC 136a-1(g)(1) requires that EPA "shall conduct a thorough examination of all data submitted under this section concerning an active ingredient ... and of all other available data found by the Administrator to be relevant."
Like the express science provisions discussed above, both of these provisions are mandatory and prescribe specific factors EPA must assess. Neither offers any basis for failing to consider such factors or evidence regarding such factors because it is supported by science that is not "transparent." When Congress wished to limit available science to information that is publicly available, it has done so. Its failure to impose such limits on the use of data or science in the provisions discussed above is thus purposeful. As noted, the proposal does not even mention any of these relevant statutory requirements governing the use of science or data or information, much less explain how any of them could authorize EPA to make a decision without using information that is relevant to decision-making, solely for lack of transparency and regardless of reliability or relevance. None of these statutes provide EPA with any authority to pick and choose what reliable and useful science to use or ignore specific studies based on transparency. While the proposal misleadingly pays lip service to using the best available science, it would expressly "preclude" the use of reliable and available science that is not, in its characterization, "transparent," regardless of whether it is the best available science. The proposal does not even mention the governing statutory requirements, much less explain how its approach is consistent with them.
Comment [6163-1111]: Commenter (6133) provides that under the FIFRA, EPA cites 7 U.S.C. § 136r(a), which authorizes the Administrator to "undertake research." That section does not allow the restriction of what types of research EPA may consider in rulemakings or otherwise. Nor does it draw any distinction between dose-response data and other types of data. The absence of any such congressional distinction or restriction makes it all the more obvious that EPA invented and added the distinction and restrictions in the Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do.
EPA also cites 7 U.S.C. § 136w, which is the general rulemaking authority that allows the Administrator to carry out the provisions of FIFRA. As explained above, that general grant of authority cannot support the rule, especially when the rule conflicts with the Act. Moreover, the citation fails to provide sufficient notice for the public to comment on the Proposal. FIFRA does not authorize the proposed rule.
Comment [6163-1141]: Commenter (6133) states that FIFRA requires that all pesticides distributed or sold in the United States be registered by EPA. EPA cannot register pesticides that would cause "unreasonable adverse effects on the environment." 7 U.S.C. § 136a. Likewise it may "by regulation" limit the distribution, sale or use of a pesticide to prevent "unreasonable adverse effects on the environment," id. § 136a(a) and must cancel the registration of pesticides that cause such "unreasonable adverse effects." Id. § 136d. The term "unreasonable adverse effects on the environment" is defined to include unreasonable risks to human health, and dietary risks that violate the standard for pesticide residues under the Federal Food, Drug and Cosmetic Act (FFDCA). Id. § 136(bb). Given that registration decisions often depend heavily on dose-response data and models, EPA must clarify whether the Proposal will apply to registration and registration review decisions. If so, the Proposal conflicts with FIFRA's requirement that EPA determine whether pesticides proposed for registration would have unreasonable adverse effects on the environment. In light of that language, EPA cannot exclude relevant studies bearing on a pesticide's effect on human health or the environment simply because the underlying data cannot be made public.
The potential applicability of the Proposal to exclude consideration of epidemiological studies of the health impacts of pesticides where the underlying data cannot be made public also highlights the logical inconsistency and arbitrary approach in the embodied proposed rule. On the one hand, the Proposal appears to be intended to prohibit consideration of such public health studies, but on the other hand seems to envision that industry-conducted studies and models claimed to include CBI would be allowed to be considered. This highlights the arbitrary and one-sided nature of the Proposal, and the clear underlying intent, which is to undermine public health protections for the benefit of industry.
Regardless of whether the Proposal applies to registration decisions, it conflicts with FIFRA in other ways. FIFRA directs EPA, when promulgating rules, to "take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides." Id. § 136w(a) (emphasis added); see also id. § 136w(c) (setting forth some examples of rules EPA may promulgate under FIFRA). EPA may not exclude "appropriate data" in these regulatory decisions simply because those data cannot be made public. Thus, the Proposal conflicts with FIFRA.
Finally, EPA has violated FIFRA's procedural requirements. FIFRA requires EPA to provide the SAP and the Secretary of Agriculture with a copy of the Proposal at least 60 days before publication in the Federal Register. Id. § 136w(a)(2), (d). Any notification to the Secretary must be published in the Federal Register. Id. § 136w(a)(2)(D). There is no evidence in the Proposal that EPA followed these procedural requirements. (EPA also must provide the Panel and the Secretary a copy of the final rule 30 days before publication in the Federal Register. Id. § 136w(a)(2), (d).) Similarly, EPA must furnish a copy of the proposed and final regulation to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate. Id. § 136w(a)(3). Again, there is no evidence this occurred.
Comment [6340-1461]: Commenter (6362) contends that EPA cites Section 25(a)(1) of the FIFRA, which does provide the Agency with broad authority to "prescribe regulations to carry out the provisions of this subchapter [FIFRA]." It should be noted, however, that the statutory language is a bit different from the other cited statutes and does not read as "as are necessary to carry out....". In addition, FIFRA Section 136r(a) does not relate to rulemaking and instead provides the Agency broad authority to undertake research necessary to carry out the purposes of FIFRA. As such, EPA may mistakenly have included Section 136r(a) to support the proposal as cited on 83 Fed. Reg. 18769.
Comment [6352-3512]: Commenter (6374) supports EPA's efforts to strengthen the integrity of its regulatory actions and recognizes the Agency's need to be able to independently validate the data that support many of its decisions. Under the FIFRA and the FFDCA, the data submitted by pesticide applicants and registrants in support of product approvals are subject to rigorous and well-defined EPA regulatory requirements that confirm their quality, validity, and integrity. To ensure that EPA's product approval decisions are based on reliable and verifiable science, the toxicological and exposure studies submitted by registrants in support of each pesticide registration must:
 meet stringent data quality standards;
 comply with EPA's good laboratory practice quality criteria;
 use generally accepted methods, sufficient numbers of measurements (to achieve statistical reliability) and sufficient controls; and
 achieve reproducible results.
The commenter appreciates EPA's statement that when dealing with science developed outside of the Agency, "it is the charge of the regulators to ensure that key findings are valid and credible, as required by OMB's Guidelines." 83 Fed. Reg. at 18770. We also appreciate EPA's statement that it "must also ensure that its decision-making is marked by independence, objectivity, transparency, clarity, and reproducibility" relying upon regulatory science. Data submitted by registrants in support of pesticide products regulated under FIFRA and FFDCA are subject to a well-developed and effective process that meets EPA's data quality goals. CropLife America (CLA) believes that all research EPA relies on to make pesticide regulatory decisions should be required to meet the same standards.
Notably, EPA already has full access to raw data underlying studies submitted by pesticide registrants under FIFRA and FFDCA. Consistent with the requirements of EPA's Good Laboratory Practice Standards (40 C.F.R. Part 160), all raw data underlying a study that supports a pesticide product registration or tolerance action must be retained and made available to EPA for inspection and copying. 40 C.F.R. §§ 160.15(a); 160.190(a). It is equally important to ensure the quality of other scientific information used by EPA to prepare the risk assessments that form the foundation for its pesticide registration decisions. CLA has consistently suggested that EPA require all scientific information used in pesticide risk assessments, including studies from academic and other non-registrant sources, meet the same high data quality standards that the Agency applies to registrant data submissions under FIFRA and FFDCA.
Comment [6352-3516]: Commenter (6374) encourages the Agency to develop procedures to ensure that data from non-registrants that are used to make pesticide regulatory decisions meet the same data access and quality standards required of registrants. At the same time, the commenter understands that EPA's April 30, 2018 proposal is specifically directed at those data underlying final regulations determined to be "significant regulatory actions" by the OMB, consistent with definitions, formal exclusions, and practices dating to 1993. As described below, this threshold provision appropriately excludes data submitted in support of individual pesticide product registration or tolerance decisions from the scope of the Agency's proposal. In so doing, EPA also is ensuring that it complies with the statutory framework established by Congress to carefully balance the requirements of public notice and transparency (which are accomplished through several statutory provisions under FIFRA and FFDCA) with the need to incentivize pesticide product innovation through the protection of proprietary data rights (also accomplished through specific provisions of FIFRA and FFDCA).
Under these circumstances, the commenter asks EPA to expressly clarify that the proposed rule (and any final rule that EPA promulgates) does not include data submitted under FIFRA or FFDCA to support individual pesticide registration or tolerance decisions, consistent with its approach to other types of permits. By contrast, the scope would encompass more broadly applicable rulemakings under FIFRA or FFDCA that do meet the definition of "significant regulatory action."
Comment [6352-3522]: Commenter (6374) provides that the scope of EPA's newly proposed transparency regulations is set forth at proposed 40 C.F.R. § 30.3, which provides that:
([t]he provisions of this subpart apply to dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions. . . [T]he provisions of this subpart do not apply to any other type of agency action, including . . . permit proceedings.)
As separately described at proposed 40 C.F.R. § 30.2, the term "regulatory decisions" means "final regulations determined to be significant regulatory actions" by the OMB pursuant to Executive Order (EO) 12866.
Pesticides are among the most highly regulated products in the United States, and FIFRA requires the generation and submission of extensive amounts of human health and environmental data to allow EPA to make registration decisions. The amount and types of data required to register a specific pesticide are functions of both the attributes of the compound and the uses the applicant seeks to register. Even after EPA's initial approval, each pesticide product remains subject to comprehensive EPA review and oversight, requiring substantial additional data on an ongoing basis to maintain each registration. FIFRA includes requirements for public notice and access to information (see, e.g., FIFRA §§ 3(c)(2)(A), 3(c)(4), 10(d)).
Pesticide product registration actions are not, however, "significant regulatory actions" under EO 12866. Specifically, EO 12866 defines a "significant regulatory action" to mean any regulatory action that is likely to result in a rule meeting certain specified criteria (i.e., any substantive action by an agency that promulgates or is expected to lead to the promulgation of a final rule or regulation). 58 Fed. Reg. 51735 (Oct. 4, 1993).
EPA's pesticide registration approvals under FIFRA do not involve the promulgation of any rule or regulation with broad application. Instead, EPA issues individual pesticide product registrations as specific licenses or permits, based on the Agency's evaluation of the data required for the specific license. Part 158 of EPA's regulations describes "the minimum data and information EPA typically requires to support an application for pesticide registration ...." The general types of data required include:
 Product chemistry data to evaluate the chemical characteristics of the product;
 Toxicology data to measure potential human health effects of exposure to the pesticide, including tests conducted on laboratory animals;
 Ecological effects data to measure the product's potential impact on exposed biological systems, including wildlife, aquatic organisms, and non-target plant effects data;
 Human exposure data to measure the amount of direct exposure to the product experienced by agricultural workers and others who use the product;
 Environmental fate data to evaluate the product's behavior and persistence in environmental media, including soil and groundwater; and
 Residue chemistry data to measure the amounts and chemical constituents of pesticide residues remaining on treated crops used for food or animal feed.
See, e.g., 40 C.F.R. Part 158 Subparts D, F, G, K, N, and O. All pesticide data submissions must demonstrate compliance with EPA's good laboratory practice standards, as required by 40 C.F.R. § 160.12.
EPA's individual pesticide registration decisions, like other permit decisions, are not notice-and-comment rulemaking actions and, as such, have never been subject to EO 12866 review requirements.
For pesticides registered for use on food crops, EPA must also establish tolerances or tolerance exemptions as required by FFDCA. Unlike pesticide product registration decisions, these tolerance actions are issued by formal notice-and-comment regulation. FFDCA also includes requirements for public notice and access to information that are consistent with FIFRA (see, e.g., FFDCA §§ 408(d)(3), 408(e)(2), 408(i).
By virtue of longstanding OMB policy, regulatory actions regarding specific pesticide tolerances, temporary tolerances, and tolerance exemptions (with the exception of actions that make an existing tolerance more stringent) are expressly exempt from EO 12866's definition of "regulatory action." OMB, Guidance for Implementing EO 12866 (Oct. 12, 1993), at App. C. Consistent with this guidance, EPA has exempted all tolerances and tolerance exemptions from EO 12866 for decades.
The two categories of decisions above stand in contrast to more broadly applicable pesticide regulations determined by OMB to meet the definition of "significant regulatory action," and which therefore, like other non-exempt regulations, are subject to the requirements of EO 12866. See, e.g., "Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides," 76 Fed. Reg. 5735 (Feb. 2, 2011) (stating that "[u]nder Executive Order 12866, this has been identified as a `significant regulatory action'"); "Regulations Under FIFRA for Plant-Incorporated Protectants," 66 Fed. Reg. 37772 (July 19, 2001) (stating that "[p]ursuant to Executive Order 12866, OMB has determined that this proposed rule is a `significant regulatory action' because this action might raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order").
For these threshold reasons, the commenter understands that pesticide product registration data would not be subject to EPA's proposed transparency requirements. As further described below, this exclusion is mandated by law.
Comment [6352-3525]: Commenter (6374) asserts that the exclusion of pesticide product registration and tolerance data from the scope of EPA's proposal is mandated by the overriding statutory requirements that EPA is charged with administering. Specifically, EPA's disclosure of data submitted in support of pesticide registration actions must comply fully with FIFRA's special protections, which recognize the need to protect the confidentiality of certain information that relates to trade secrets or commercial or financial information and includes:
 A prohibition against EPA's disclosure of any "information which in the Agency's judgment contains or relates to trade secrets or commercial or financial information obtained from a person and privileged and confidential";
 A requirement that EPA provide advance written notice to an applicant or registrant if it proposes to disclose information claimed as confidential; and
 A prohibition against EPA's disclosure of any information that discloses: (i) "manufacturing or quality control processes," (ii) "the details of any methods for testing, detecting or measuring the quantity of any deliberately added inert ingredient of a pesticide," or (iii) "the identity or percentage quantity of any deliberately added inert ingredient of a pesticide."
Alongside these significant confidentiality protections, FIFRA also provides its own transparency mandate for pesticide registration data with two important features. First, it requires that EPA make available to the public information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered pesticide, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment. FIFRA § 10(d)(1).
Second, this broad disclosure mandate for pesticide registration data is subject to an essential limitation. Recognizing the proprietary nature of pesticide studies and the possibility that industry competitors might obtain and seek to improperly use copies of another submitter's unpublished data to satisfy its own pesticide regulatory requirements in other jurisdictions, FIFRA expressly prohibits EPA from disclosing studies submitted by an applicant or registrant to any employee or agent of a foreign or multinational pesticide company. FIFRA § 10(g)(1). Underscoring the importance of this prohibition, FIFRA requires that EPA obtain an affirmation (which must be submitted subject to criminal penalties under 18 U.S.C. § 1001) from any person seeking access to pesticide registration data to ensure that such person will not deliver or offer the data to any such business or entity. FIFRA §§ 10(g)(1), (3). Specifically, before EPA will provide a member of the public with access to a pesticide submission, the requestor must affirm that he or she:
 is not a business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United States (nor an employee or agent of any such business or entity);
 does not seek access to the information for purposes of delivering it or offering it for sale to any such business or entity or to any of its employees or agents; and
 will not purposefully deliver the information (or negligently cause it to be delivered) to any such entity or to any of its employees or agents.
EPA has confirmed that it would be unlawful for a person to execute the required affirmation while having the intent to publish or otherwise deliver a FIFRA data submitter's previously unpublished data submission to a foreign or multinational pesticide producer, explaining that "the information delivered likely could be used to satisfy a data requirement imposed by a foreign country as a condition of producing, distributing, selling, shipping, or using the product in that country." See, EPA, "Limitations on Disclosure of Information Under Pesticide Law" (available at: https://www.epa.gov/foia/limitations-disclosure-information-under-pesticide-law).
FFDCA § 408(i) extends the same protections as FIFRA's to data submitted in support of EPA tolerance decisions.
The Agency's April 30, 2018, proposed transparency requirements, like all regulations issued by EPA, must comply fully with FIFRA's and FFDCA's protections for pesticide data. EPA has successfully administered these data disclosure and confidentiality requirements for many years, ensuring that high-quality, verifiable data are available to the Agency from applicants and registrants while balancing the important need to make pesticide data available for public review and at the same time preventing disclosure to industry competitors. Accordingly, EPA's proposed transparency requirements should explicitly incorporate the protections specifically guaranteed to pesticide registration data under FIFRA and FFDCA.
Comment [6353-2329]: Commenter (6375) provides that EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II. (pg. 18,771).
The regulatory language that EPA proposes provides general requirements that apply to the Agency's use of science under the many statutes that it implements. The generality of the proposed regulations may be a function of the diverse purposes of those statutes Specifically, some of these statutes focus on the introduction of new substances into the marketplace (e.g., FIFRA and TSCA). The scientific analyses required for these different programs and the sources of the scientific information underlying those analyses differ. The Agency should consider supplementing the general language that it has proposed with statutory specific regulations. A statutory-specific rulemaking would provide greater certainty going forward.
Comment [6424-2639]: Commenter (6446) contends that the proposed rule also deviates from accepted practices that EPA routinely uses, and is required to use, to evaluate science it relies on for regulatory decisions. EPA has long recognized that proprietary CBI submitted to it cannot be shared with the public, yet it routinely relies on that information, including scientific studies and other scientific information, as the foundation for important regulatory decisions. (See, e.g., FIFRA at 7 U.S.C. 136h, subd. (b).) EPA also adheres to specific Congressional directives regarding the science it should consider for regulatory action, including directives to consider whether the scientific information is reasonable, clear, complete and whether it has been peer reviewed.
Comment [6894-3610]: Commenter (6915) provides that although Section 25 of the FIFRA directs that regulations "take into account . . . the appropriate data for evaluating [] risk," 7 U.S.C. 136w (emphasis added), it would be arbitrary and capricious to define "appropriate" to exclude from consideration relevant and valid scientific studies, as EPA proposes to do in this rulemaking. Requirements to review the "latest" and "appropriate" scientific data are not carte blanche to impose new, unscientific limits on that data.
Comment [8750-1815]: Commenter (9227) notes that the Proposal lists FIFRA section 25 as an authority for the rulemaking. The agency, however, has already failed to follow several required procedures for issuing a valid regulation under this section of FIFRA. FIFRA section 25 requires the agency to seek comments from the Secretary of Agriculture on all draft proposed regulations 60 days prior to signing a proposed regulation for publication, and 30 days prior to publication for a final rule. If the Secretary of Agriculture provides comments, the Administrator must also respond in writing as part of the proposed rulemaking package. FIFRA additionally requires EPA to publish a notice in the Federal Register simultaneously with the transmission of the proposed rule to USDA. And the statute requires the agency to submit a copy of the proposed rule for comment to the SAP, as well as a copy to the Agriculture Committees in the House and Senate any time the agency is required to consult with the Secretary of Agriculture. This means that EPA here should have provided both committees and the SAP with a copy of the proposed regulation at least 60 days prior to publication of the Proposal in the Federal Register. The agency did not comply with any of these requirements and does not indicate that it will in any final rule. The Proposal is therefore unlawful.
To be sure, in some instances the Administrator and Secretary may together agree to waive some of the consultation requirements among themselves, but there is no indication that Administrator Pruitt did that with this Proposal. And even if the Administrator and Secretary later agree to waive the consultation requirement section 25(a)(2)(A) and (B), that waiver would not alter EPA's obligation to provide the SAP and the House and Senate Committees with a copy of the regulation. Nor would it change the fact that the Administrator illegally issued the Proposal without consulting the Secretary of Agriculture. A very serious consequence of these procedural mistakes is to deprive the agency of a full understanding of how the proposed rulemaking might affect the regulation of pesticides and thereby affect agriculture, human health, and the environment. Therefore, the only lawful path forward here is for the Agency to withdraw the Proposal, consult with the entities required by FIFRA, and then subsequently re-notice the Proposal.
Comment [8750-1964]: Commenter (9227) provides that EPA arbitrarily failed to consider the far-reaching implications this Proposal could have on inter-agency coordination and consultation given that other agencies normally rely on research potentially excluded by the Proposal.
      Consultation Provisions in FIFRA
      136w(a)(2)(A)
      Authority of the Administrator: Procedure: Proposed regulations
      (A) Proposed Regulations:
      At least 60 days prior to signing any proposed regulation for publication in the Federal Register, the Administrator shall provide the Secretary of Agriculture with a copy of such regulation. If the Secretary comments in writing to the Administrator regarding any such regulation within 30 days after receiving it, the Administrator shall publish in the Federal Register (with the proposed regulation) the comments of the Secretary and the response of the Administrator with regard to the Secretary's comments. If the Secretary does not comment in writing to the Administrator regarding the regulation within 30 days after receiving it, the Administrator may sign such regulation for publication in the Federal Register any time after such 30-day period notwithstanding the foregoing 60-day time requirement.
      ***
      136w(a)(2)(B)
      Authority of the Administrator: Final Regulations
      At least 30 days prior to signing any regulation in final form for publication in the Federal Register, the Administrator shall provide the Secretary of Agriculture with a copy of such regulation. If the Secretary comments in writing to the Administrator regarding any such final regulation within 15 days after receiving it, the Administrator shall publish in the Federal Register (with the final regulation) the comments of the Secretary, if requested by the Secretary, and the response of the Administrator concerning the Secretary's comments. If the Secretary does not comment in writing to the Administrator regarding the regulation within 15 days after receiving it, the Administrator may sign such regulation for publication in the Federal Register at any time after such 15-day period notwithstanding the foregoing 30-day time requirement. In taking any final action under this subsection, the Administrator shall include among those factors to be taken into account the effect of the regulation on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy, and the Administrator shall publish in the Federal Register an analysis of such effect
      ***
      136w(a)(3)
      Authority of the Administrator: Procedure: Congressional Committees
      At such time as the Administrator is required under paragraph (2) of this subsection to provide the Secretary of Agriculture with a copy of proposed regulations and a copy of the final form of regulations, the Administrator shall also furnish a copy of such regulations to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.
      ***
      136w(a)(4)
      Authority of the Administrator
      Simultaneously with the promulgation of any rule or regulation under this subchapter, the Administrator shall transmit a copy thereof to the Secretary of the Senate and the Clerk of the House of Representatives. The rule or regulation shall not become effective until the passage of 60 calendar days after the rule or regulation is so transmitted.
      ***
      136w-3
      Identification of Pests; cooperation with USDA
      The Administrator, in coordination with the Secretary of Agriculture, shall identify those pests that must be brought under control. The Administrator shall also coordinate and cooperate with the Secretary of Agriculture's research and implementation programs to develop and improve the safe use and effectiveness of chemical, biological, and alternative methods to combat and control pests that reduce the quality and economical production and distribution of agricultural products to domestic and foreign consumers.
      ***
      136(r)(a)
      Research and Monitoring: Research
      The Administrator shall undertake research including research by grant or contract with other Federal agencies, universities, or others as may be necessary to carry out the purposes of this subchapter, and the Administrator shall conduct research into integrated pest management in coordination with the Secretary of Agriculture. The Administrator shall also take care to ensure that such research does not duplicate research being undertaken by any other Federal agency.
      ***
      136a-1(n)(2)-(3)
      Reregistration of registered pesticides: Authorization of funds to develop public health data
      (2) Consultation. In the case of a pesticide registered for use in public health programs for vector control or for other uses the Administrator determines to be human health protection uses, the Administrator shall, upon timely request by the registrant or any other interested person, or on the Administrator's own initiative may, consult with the Secretary [of HHS] prior to taking final action to suspend registration under section 3(c)(2)(B)(iv) or cancel a registration under section 4, 6(e), or 6(f). In consultation with the Secretary, the Administrator shall prescribe the form and content of requests under this section.
      (3) Benefits to support family. The Administrator, after consulting with the Secretary, shall make a determination whether the potential benefits of continued use of the pesticide for public health or health protection purposes are of such significance as to warrant a commitment by the Secretary to conduct or to arrange for the conduct of the studies required by the Administrator to support continued registration under section or reregistration under section 4
      ***
      7 USCS 136(ll) (2)
      Definitions: Minor Use
      (2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and--
      ***
      136i(a)(1)
      Use of restricted use pesticides; applicators
      Requires the Administrator to consult with Governor of each state to conduct a program for the certification of use of specific pesticides.
      ***
      136a(c)(1)(F)(ii)
      Registration of Pesticides: Procedure for registration
      The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses registered after the date of enactment of this clause [enacted Aug. 3, 1996] and within 7 years of the commencement of the exclusive use period, up to a total of 3 additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that--(I) there are insufficient efficacious alternative registered pesticides available for the use; (II) the alternatives to the minor use pesticide pose greater risks to the environment or human health; (III) the minor use pesticide plays or will play a significant part in managing pest resistance; or (IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.
      ***
      136t(b)
      Delegation and Cooperation
      (b) Cooperation. The Administrator shall cooperate with the USDA, any other Federal agency, and any appropriate agency of any State or any political subdivision thereof, in carrying out the provisions of this Act and in securing uniformity of regulations.
      ***
      136o(e)
      Imports and Exports
      Secretary of the Treasury shall prescribe regulations for this section in consultation with the Administrator.
      ***
      136p
      Exemption of Federal and State Agencies
      The Administrator may, at the Administrator's discretion, exempt any Federal or State agency from any provision of this Act if the Administrator determines that emergency conditions exist which require such exemption. The Administrator, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any State concerned if they request such determination.
      ***
      136w-7
      USDA Minor Use Program
      (A) Grant authority. The Secretary, in consultation with the Administrator, shall establish a program to make grants for the development of data to support minor use pesticide registrations and re-registrations. The amount of any such grant shall not exceed 1/2 of the cost of the project for which the grant is made.
      ***
      136i-1(a)(1)
      Pesticide Recordkeeping
      The Secretary of Agriculture, in consultation with the Administrator of the EPA, shall require certified applicators of restricted use pesticides
      ***
      136i-2(c)
      Collection of Pesticide Use Information Coordination.
      The Secretary of Agriculture shall, as appropriate, coordinate with the Administrator of the EPA in the design of the surveys and make available to the Administrator the aggregate results of the surveys to assist the Administrator.
Comment [9078-3466]: Commenter (6194) asserts that given the complexity and potentially broad-reaching impact of the Proposal, the limited time allotted for review of the Proposal by the OMB's OIRA suggests that the process was intended to be pro forma as opposed to meaningful. Yet, despite this truncated review, the Proposal was changed significantly during this period. To the extent that any of those changes were made by OIRA, it would have exceeded the office's authority under Executive Order 12,866, which charges OIRA with conducting cost benefit analyses, not changing the substantive content of agencies' regulations. To the extent the changes were made by EPA, it is unclear on what version of the proposal OIRA conducted a cost benefit analysis and whether the version of the Proposal released to the public was reviewed by OIRA. Furthermore, as reported by Greenwire, former EPA Administrator Pruitt signed the Proposal before OIRA even completed its review; raising further doubt about the opportunity for any meaningful review by the OMB. These concerns are addressed in greater detail by the Union of Concerned Scientists in a blog post from May 7, 2018.
EPA is also supposed to provide OIRA, and the public, an "assessment" and the "underlying analysis" of the anticipated benefits and costs of the proposal. E.O. 12,866, § 6(a)(3)(B)-(C), (E)(i). Yet the Proposal contains no serious attempt at assessing either. With respect to benefits, the Proposal contains a single sentence, stating that it will improve "the scientific quality of the Agency's actions and facilitate expanded data sharing and exploration of key data sets." 83 Fed. Reg. at 18,772. This assertion is questionable at best and presented without any underlying analysis. Regarding costs, the Proposal does not attempt an independent assessment, indicating only that "[t]his action should be implemented in a cost-effective way" and referencing an analysis by the Mercatus Center. Id. However, a CBO analysis of a similar legislative proposal concluded that it could cost hundreds of millions of dollars a year; the Proposal does not address or distinguish this analysis. EPA did not provide OIRA, and has not provided the public, with sufficient information for an analysis of the Proposal's benefits and costs.
Similar questions exist as to whether EPA solicited sufficient, if any, interagency review of the Proposal. For example, the Proposal cites the rulemaking provision of the FIFRA as a source of authority; this provision requires EPA to seek comments from the Secretary of Agriculture and the FIFRA SAP on draft regulations. 7 U.S.C. § 136w. EPA did not seek such input prior to publication of the Proposal. Such interagency review would be particularly important with respect to other agencies whose work could be impacted by the Proposal (see discussion in Section V below).
EPA's own SAB, which Congress created in 1978 to provide scientific advice to EPA, 42 U.S.C. § 4365(a), challenged EPA's failure to solicit SAB's input on the Proposal -- pointing out that it was not even aware of the Proposal until it was published in the Federal Register and discussed in news articles. Given that EPA should have provided the Proposal to another federal agency to review, EPA was also required to make the Proposal available to the SAB, along with any relevant scientific and technical information on which the Proposal was based. 42 U.S.C. § 4365(c). A SAB Work Group concluded that the Proposal deals with a "myriad of scientific issues for which the Agency should seek expert advice from the SAB," explaining that:
 "There are . . . sensitive situations where public access may infringe on legitimate confidentiality and privacy interests, and where exceptions from complete public access may be appropriate. In addition, there are considerations associated with the cost and effort that would be involved in making large and complex existing datasets available."
 "[T]he precise design of the rule appears to have been developed without a public process for soliciting input from the scientific community. Nor does the preamble to the rule describe precisely how the proposal builds on previous efforts to promote transparency such as the Information Quality Act and EPA's Information Quality Guidelines."
 "The proposed rule does not include any assessment of the impact of data restrictions on existing or future regulatory programs. . . Furthermore, the rule could have the effect of removing legal, ethical, and peer-reviewed studies of health effects as sources to support the agency's regulatory efforts."
Even when EPA is not required to seek SAB's opinion, failing to utilize SAB's expertise is inconsistent with the purpose of SAB, which is to "to provide independent advice and peer review to EPA's Administrator on the scientific and technical aspects of environmental issues." The SAB's expertise and input is similarly valuable to the public, and should be available well before the end of the public comment period so as to inform discussion.
Comment [9217-3563]: Commenter (9225) contends that equally problematic, the proposed rule is not authorized by any authority delegated to EPA by Congress and is contrary to a number of statutes under EPA's authority. This includes, but is not limited to, the CAA; CWA; TSCA; LCSA; SDWA; FIFRA; and more.
Comment [6857-2945]: Commenter (6879) provides that EPA rules and regulations have been critical to the protection of wildlife, natural habitats, and the ecosystem services they provide to communities and the economy. This includes protection of endangered and other wildlife from pesticides and other toxic substances under FIFRA.
These laws require EPA to use the "best available" science, or all "reasonably available" science and information. By excluding high-quality peer-reviewed and validly published science from the regulatory decision-making process, the proposed regulation directly contravenes the specific mandate of these statutes. And by deliberately excluding the best science available, the rule also contravenes the Congressional mandates for these statutes and undermines their public health and environmental protection purposes.
Comment [6163-1276]: Commenter (6133) states that in addition to addressing how and whether the agency will consider science, the Proposal also contains a seemingly unrelated provision regarding agency peer review. The Proposal, in § 30.7, reads:
      What role does independent peer review in this section?
      EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
      Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results. (83 Fed. Reg. at 18,774.)
There is no statutory authority for EPA to "conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." The federal statutes that EPA lists as putative authority for the Proposal provide no authority for proposed § 30.7. See FIFRA sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w. The claimed authorities that EPA lists do not mention peer review or even allude to the concept. Id. Neither the Proposal nor accompanying docket materials identify any provision of any federal statute that authorizes EPA to promulgate proposed § 30.7. Our own research revealed no provision of any federal statute that authorizes EPA to promulgate proposed § 30.7.
When Congress writes federal statutes, Congress knows how to create legal authority for peer review, who shall conduct that peer review, what role, if any, that EPA or other parties will play, and how that peer review may be conducted. None of the provision in the law authorize EPA's Proposal in § 30.7. Instead, the statutes require that EPA use peer-reviewed science, regardless of whether it would meet EPA's definition of the term in § 30.7. And in cases where the law requires EPA to conduct the review, the statutes often spell out specifically how that should happen.
The commenter provides provisions for peer review for several statutes. Only the section relevant to FIFRA is excerpted here.
      § 136w. Authority of Administrator
      (e) Peer review. The Administrator shall, by written procedures, provide for peer review with respect to the design, protocols, and conduct of major scientific studies conducted under this subchapter by the EPA or by any other Federal agency, any State or political subdivision thereof, or any institution or individual under grant, contract, or cooperative agreement from or with the EPA. In such procedures, the Administrator shall also provide for peer review, using the advisory panel established under subsection (d) of this section or appropriate experts appointed by the Administrator from a current list of nominees maintained by such panel, with respect to the results of any such scientific studies relied upon by the Administrator with respect to actions the Administrator may take relating to the change in classification, suspension, or cancellation of a pesticide. Whenever the Administrator determines that circumstances do not permit the peer review of the results of any such scientific study prior to the Administrator's exercising authority under section 136d(c) of this title to immediately suspend the registration of any pesticide to prevent an imminent hazard, the Administrator shall promptly thereafter provide for the conduct of peer review as provided in this sentence. The evaluations and relevant documentation constituting the peer review that relate to the proposed scientific studies and the results of the completed scientific studies shall be included in the submission for comment forwarded by the Administrator to the advisory panel as provided in subsection (d). As used in this subsection, the term "peer review" shall mean an independent evaluation by scientific experts, either within or outside the EPA, in the appropriate disciplines. (7 U.S.C. § 136w (emphasis added)).
      § 136w-8. Pesticide registration service fees
      (a) Definition of costs in this section, the term "costs", when used with respect to review and decision-making pertaining to an application for which registration service fees are paid under this section, means-- (1) costs to the extent that --
      (A) officers and employees provide direct support for the review and decision-making for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; (B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and (C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications; (2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and (3) costs of collecting registration service fees under subsections (b) and (c) and reporting, auditing, and accounting under this section. (7 U.S.C. § 136w-8 (emphasis added)).
Under longstanding federal case law, when Congress authorizes an approach in one section of a statute using specific language but does not do the same in other sections of a statute, courts presume that Congress acted purposefully and did not mean to address or authorize that approach in those other statutory sections. See, e.g., Dean v. United States, 556 U.S. 568 (2009) ("It is generally presumed that Congress acts intentionally when including particular language in one section of a statute but not in another." (citing Russello v. United States, 464 U.S. 16, 23 (1983)). Not only are there no implied grants of authority to an agency in the other statutory sections, but the congressional decisions to authorize the approach elsewhere in the statute give even greater force to the conclusion that the agency has not been given authority where Congress did not use the same or similar authorizing language.
The EPA approach proposed in § 30.7 is even more unlawful than would be the case, independently, under this case law. Proposed § 30.7 says "EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein." 83 Fed. Reg. at 18,774/2 (emphasis added). EPA proposes to bind itself ("shall") to conduct a particular form of peer review on "all pivotal regulatory science" based on an unenforceable, non-binding OMB bulletin that has never been the subject of notice and comment rulemaking and that itself is not authorized by any federal law. To the contrary, treating the content of the unenforceable bulletin as a binding regulation would itself violate the federal statutes that EPA implements, because those statutes do not codify the bulletin, and EPA would be unlawfully codifying a mere policy preference. This EPA may not do.
This Proposal is unlawful, arbitrary, and capricious, and an abuse of EPA discretion. To reiterate, the Proposal identifies no statutory authority for EPA to conduct independent peer review for any, much less all, "pivotal regulatory science" consistent with the dense content (and exceptions) of the OMB bulletin. The Proposal identifies no statutory authority for EPA to bind itself, and future administrations, to conduct peer review only in this fashion, unless and until future notice-and-comment rulemaking is undertaken. The Proposal identifies no suggestion in statutory language or legislative history that Congress intended EPA to conduct binding peer review consistent with this OMB bulletin, notwithstanding that Congress has known about this bulletin since 2005. EPA has simply made up proposed § 30.7 -- with its the link to the OMB bulletin, and the putative authority for the Proposal -- out of whole cloth. This EPA may not do.
Comment [6112-1605]: Commenter (6137) asserts that not only does the Proposed Rule contravene the statutes upon which EPA relies as statutory authority, but its limitations on science likewise conflict with core provisions of other environmental statutes. For example, the Food Quality Protection Act (FQPA), which regulates pesticide residue in conjunction with FIFRA, sets safety standards based on the consideration of all available data. Limiting the data available to conduct studies necessary to evaluate the harmful effects of pesticides runs counter to this mandate.
Specifically, Congress overhauled our food safety laws when it unanimously passed the FQPA, amending both FFDCA and FIFRA. The overhaul responded to a seminal 1993 NAS report criticizing EPA for treating children like "little adults" by failing to address the unique susceptibility of children to pesticide exposures based on the foods they eat, their play, metabolism, and sensitive stages of their development. NAS, Pesticides in the Diets of Infants and Children (1993). The NAS recommended that EPA revamp and strengthen its pesticide regulations to account for children's vulnerabilities, consumption patterns, and exposures. Because it would take time to fill gaps in knowledge, safeguards, and methodologies, the NAS recommended that additional protection be afforded in the form of "uncertainty" or "safety factors." The NAS first described how EPA has regularly used uncertainty factors and then proposed an additional uncertainty factor for fetal developmental toxicity and where data are incomplete: "In the absence of data to the contrary, there should be a presumption of greater toxicity to infants and children. To validate this presumption, the sensitivity of mature and immature individuals should be studied systematically to expand the current limited data base on relative sensitivity." Id.
The FQPA strengthened the food safety standard in several ways. First, under the FQPA, the EPA Administrator "may establish or leave in effect a tolerance for a pesticide chemical residue in or on food only if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe." 21 U.S.C. § 346a(b)(2)(A)(i). In other words, the absence of sufficient information to find a pesticide safe means it cannot be allowed in or on our food.
Second, safe "means the Administrator has determined there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." Id. § 346a(b)(2)(A)(ii). The FQPA, therefore, requires that EPA conduct an assessment based on aggregation of all exposures to a pesticide whether from eating foods, drinking water with residues of the pesticide, or uses of the pesticide in and around the home or other places where people can be exposed. 21 U.S.C. § 346a(b)(2)(A)(ii), (C)(i)(I) & (ii). The FQPA also requires EPA to assess and protect against unsafe risks posed by cumulative exposures to pesticides that share a "common mechanism of toxicity," as is the case with pesticides in the organophosphate, carbamate, and pyrethroid families. See 21 U.S.C. § 346a(b)(2)(C)-(D).
Third, EPA must make specific safety determinations for infants and children. Id. § 346a(b)(2)(C)(ii)(I) & (II). It must consider available information concerning "the special susceptibility of infants and children," including "neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals." Id. § 346a(b)(2)(C)(i)(II). EPA must also base its tolerance decisions on available information about food "consumption patterns among infants and children." Id. § 346a(b)(2)(C)(i)(I) & (III).
Fourth, EPA must account for children's sensitivities, scientific uncertainty, and gaps in available data. The statute requires that "an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre -and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children." Id. § 346a(b)(2)(C). EPA can depart from this requirement and use a different margin of safety "only if, on the basis of reliable data, such margin will be safe for infants and children." Id.; see Nw. Coal. for Alts. to Pesticides v. EPA, 544 F.3d 1043, 1046 (9th Cir. 2008) (reversing EPA's shrinkage of the safety factor in the absence of supporting data).
As an over-arching mandate, the FQPA directs EPA to make its tolerance determinations based on its assessment of the pesticide's risk. 21 U.S.C. § 346a(b)(2)(C)(i). And throughout its mandates to assess the full effects of a pesticide, the FQPA directs EPA to base its risk assessment on "available information" about consumption patterns, special susceptibility of infants and children, and cumulative effects. Id. The FQPA also expressly directs EPA to consider the validity, completeness, and reliability of the available data from studies, the nature of the toxic effect, available information about the relationship between study results and human risk, and available information about aggregate and cumulative effects. Id. § 346a(b)(2)(C)(ii).
The Proposed Rule upends these mandates by requiring EPA to put on blinders and ignore a huge and important subset of the available data. It collides squarely with the congressional direction to consider all available data and information in order to protect our food and children in particular. It also conflicts with the congressional mandate to afford greater protection to children and our food when gaps in data prevent a full quantitative assessment and establishment of a dose-response. It thus undermines EPA's ability to carry out its obligations under the FQPA.
<IP_ADDRESS> FIFRA (SNPRM Comments)
Comment [48-643]: Commenter (12727) contends that, as with the original proposal, the Supplemental Notice fails to comply with the pre-proposal review requirements set forth in the FIFRA. EPA continues to cite section 25 of FIFRA as a source of authority for this proposed action. Section 25, however, requires the agency to seek comments from the Secretary of Agriculture on all draft proposed regulations 60 days prior to signing a proposed rule. EPA is to publish this solicitation in the Federal Register, and respond to any written comments from the Secretary as part of the Federal Register proposal. FIFRA also requires that any time the EPA is required to consult with the Secretary of Agriculture, the agency must also submit a copy of the proposed rule for comment to the Agriculture Committees in the House and Senate at least 60 days prior to publication, and provide the SAP with an opportunity to provide comment on the health and environmental impacts of the proposed action.
There is no indication that EPA has satisfied any of these statutory obligations. Pre-proposal review by the Secretary, however, would at least have raised the question of what potential impacts the proposal might have on FIFRA programs -- an issue on which the Supplemental Notice is mute. Congress, by requiring these consultation steps, evidently viewed them as necessary and important. EPA's disregard of these requirements is thus consequential, arbitrary, and unlawful.
Comment [73-2080]: Commenter (11576) contends that the current rulemaking process has also violated the requirements of other statutes the EPA may or may not be relying on in attempting to issue the proposed rule. Under FIFRA, for instance, the EPA is required to provide the Secretary of Agriculture with a copy of any proposed rule for review and comment at least 60 days before a proposed rule is signed for publication in the Federal Register. The EPA's refusal to satisfy these requirements cannot be allowed to stand.
Comment [82-835]: Commenter (12464) asserts that the Supplemental Notice's claim that the Proposal is not "substantive" rests on the assertion that the rule "would not regulate the conduct or determine the rights of any entity outside the federal government" and that "it exclusively pertains to the internal practices of EPA." 85 Fed. Reg. at 15,398. Past court decisions, however, have found that EPA's refusal to consider certain scientific studies in its regulatory decision-making processes carry the force and effect of law.
In CropLife America v. U.S. EPA, for example, pesticide manufacturers and trade associations sought judicial review of an EPA directive that provided that the agency, contrary to its established practice, would no longer consider or rely on third-party human studies in evaluating the safety of pesticides under FIFRA. Petitioners argued, and the D.C. Circuit agreed, that this directive was a substantive rule with the force of law, that the rule violated FIFRA's requirement that EPA "consider all relevant reliable data," and that the rule was arbitrary and capricious in violation of the APA.
Specifically, in CropLife, the D.C. Circuit held that:
      The disputed directive constitutes a binding regulation that is directly aimed at and enforceable against petitioners. It provides that "the Agency will not consider or rely on any [third-party] human studies in its regulatory decision making." This clear and unequivocal language, which reflects an obvious change in established agency practice, creates a "binding norm" that is "finally determinative of the issues or rights to which it is addressed."
The Proposal would limit EPA's consideration of scientific studies whose data and models are not sufficiently available to the public for reanalysis. It is therefore directly analogous to the directive at issue in CropLife regarding "best available science" requirements in that it creates a binding norm.
Moreover, in CropLife, the D.C. Circuit determined that the directive was a substantive rule with binding effect as it not only impacted private parties, but also the agency's regulatory actions (as opposed to its internal practices). In particular, the court found that "there [was] little doubt" that the directive prohibiting EPA from considering third-party studies:
      "binds private parties [and] the agency itself with the `force of law,'" and thus constitutes a regulation rather than a policy statement. The directive clearly establishes a substantive rule declaring that third-party human studies are now deemed immaterial in EPA regulatory decision-making under [the Federal Food, Drug and Cosmetic Act] and FIFRA.
Comment [89-2187]: Commenter (11403) states that EPA's 2018 version of this rule cited a hodgepodge of statutory authority, none of it valid. EPA at least corrected the obvious typographical errors from the previous version. However, those edits still do not grant EPA the authority to restrict science from all regulatory decision-making processes within the agency. EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress . . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." EPA does not have the authority to alter the fundamental details of all of its regulatory schemes based on such vague provisions of law.
The commenter provides several statutory examples, however only FIFRA material is excerpted here.
      Section 25(a)(1) of the FIFRA authorizes the Administrator "to prescribe regulations to carry out the provisions of this subchapter." This general authorization section of FIFRA differs from that of the other statutes listed because it actually does specify some considerations the Administrator must give when promulgating regulations. For example, it states, "Such regulations shall take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides." Unlike the other general grants of rulemaking authority, this provision clearly intends to offer detail and guidance on the nature of the rulemaking authority that the provision grants. As it does not mention restriction of scientific data, there is no indication that EPA has authority to undertake the proposed rule under this section.
      Section 136r(a) of the FIFRA directs the Administrator to conduct research to carry out the purposes of the statute. The section states, "The Administrator shall also take care to ensure that such research does not duplicate research being undertaken by any other Federal agency." The section does not state that EPA can ignore sound science if the raw data is not publicly available.
In short, none of the statutory provisions cited by EPA provide authority for the proposed rule. The proposed rule fails at step one under Chevron v. Natural Resources Defense Council since it is unreasonable to believe that any statutory general grant of authority or any mention of EPA's oversight of other science or research programs would enable EPA to conduct rulemaking in a way that is altogether inconsistent with the rule of law. None of the cited provisions provide the authority sought by EPA, and as such the proposed rule should be withdrawn.
Comment [133-1200]: Commenter (11894) states that this supplemental notice of proposed rulemaking, like the initial proposal, is procedurally deficient because it failed to comply with the rulemaking requirements in FIFRA §25. EPA states that its supplemental proposal pertains to regulatory actions taken under the authority of FIFRA and cites FIFRA as one authority for the overall rulemaking that its supplemental proposal modifies. Thus, both the initial and supplemental proposals are subject to the procedural requirements for rulemaking imposed by FIFRA §25. FIFRA §25 requires the agency to transmit a copy of proposed rules to the USDA and HHS and to the FIFRA SAP prior to publication of the proposal for public comment. The statute gives the SAP, USDA, and HHS 30 days within which to comment, and, if any does so, EPA must publish their comments and the agency's responses in the Federal Register that announces the opportunity for public comment. FIFRA also requires that EPA provide a copy of the proposed rulemaking to the Senate and House Agriculture Committees prior to publication of the proposed rule.
The preamble of EPA's supplemental proposal contains no information concerning the agency's compliance with these essential procedural requirements for rulemaking under FIFRA; we can only conclude that EPA has flagrantly disregarded its legal responsibilities. In these congressionally imposed requirements, Congress has deemed the input of USDA, HHS, and the SAP essential to ensuring that, in issuing regulations affecting the operation of EPA's regulatory programs affecting pesticides, EPA fully considers the impacts of all proposed rules on agriculture (USDA) and human health (HHS), and that the rules are grounded in sound science (SAP). Without such input, there is a high likelihood that the rules will produce unsound outcomes from essential scientific and public policy perspectives.
Comment [151-1345]: Commenter (12405) contends that all pesticides distributed or sold in the United States must first be registered by the EPA and reregistered every 15 years. To be registered, the FIFRA requires the applicant show that its proposed pesticide does not cause unreasonable risk to human health or the environment. The applicant typically provides studies that comply with the EPA's testing guidelines along with its application materials. The EPA reviews the data provided and performs some of its own work, including human health and ecological risk assessments, on a chemical. Additionally, under the FQPA which amended FIFRA, EPA must find a pesticide poses a "reasonable certainty of no harm" before it can be registered for use on food or feed.
For example, the herbicide paraquat is currently undergoing reregistration review. As part of that process, EPA is looking at studies relevant to the chemical's health concerns, including the connection with Parkinson's disease. Over the past few decades, studies consistently show a correlation between exposure to pesticides and Parkinson's disease, but that full breadth of data may not be reviewable by EPA under the current proposal. For example, a meta-review examined 40 studies and concluded, "epidemiologic studies suggest a relatively consistent association between exposure to pesticides and an increased risk of developing [Parkinson's disease], despite differences in study design, case ascertainment and definition, control selection, and pesticide exposure assessment." Many of these studies would be excluded from consideration under the proposed rule.
In addition, relevant studies have design characteristics that make them vulnerable to noncompliance and exclusion. Specifically, two studies of California's Central Valley found years of exposure to a combination of herbicides paraquat and maneb increased the risk of Parkinson's later in life. Another study found that Central Valley residents under age 60 who lived near fields where the pesticides paraquat and maneb were used between 1974 and 1999 had a Parkinson's rate many times higher than other residents in the region.
Parkinson's is rare enough such that in many communities, data that would need to be disclosed, such as behavioral factors (occupation, tobacco, or alcohol use, how long they have lived in the area), will render individuals easily identifiable. To protect patient privacy, scientists may not want to make even de-identified data public. Without these and similarly designed studies, the EPA is likely to miss relevant information in its review.
Comment [165-1508]: Commenter (12453) states that EPA's proposed framework is consistent with existing statutory transparency mandates for pesticide registration and tolerance data. FIFRA requires EPA to make available to the public information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered pesticide, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment -- subject to important restrictions necessary to protect the proprietary nature of pesticide studies. FIFRA §§ 10(d)(1), 10(g)(1).
The framework provided under FIFRA and the FFDCA is a successful example of balancing the importance of transparency with the need to ensure protection of data submitters' proprietary rights. FIFRA and the FFDCA ensure the general public is provided secure access to pesticide studies in a manner sufficient for independent validation, while at the same time protecting the proprietary nature of those studies by prohibiting, through the required affirmation, publication or any other type of delivery of the studies to foreign or multinational pesticide producers.
Comment [165-1510]: Commenter (12453) appreciates that there are circumstances in which there may be data that contain potentially relevant information that EPA should be able to consider, but that may not meet all the standards of transparency and quality that the majority of the data meet under FIFRA and the FFDCA, for instance. Two routine examples in the FIFRA and FFDCA context include (a) benefits data (often developed by agricultural experts) that must be submitted to, and evaluated by, EPA under FIFRA § 3 and §§ 6(b-e) and (b) information that must be submitted to and evaluated by EPA under FIFRA § 6(a)(2) adverse effects reporting requirements. In some circumstances, despite EPA's best efforts, it may not have the optimum degree of access. In such circumstances, EPA should have the option to assess both the degree of access to and the attributes of the data and, based on those two factors, to determine how much consideration to give to the particular data. In doing so, it should take into account the full set of data available to the Agency and ensure that the proper relative weight is given to specific items within that data set.
This approach is consistent, for instance, with the way in which EPA has addressed FIFRA's explicit provision authorizing EPA to consider data that appear in the "public literature." FIFRA § 3(c)(1)(F). In implementing this statutory provision, EPA has long taken into account the validity of the data and other considerations about the extent to which the Agency should rely on such data, consistent with Option 2. See, e.g., 40 CFR 152.94. In this statutory example, EPA may give more or less consideration to publications, depending on the degree of access and attributes of the data.
Comment [172-2092]: Commenter (12465) provides that while the supplemental proposal notes that "in the event the procedures outlined in the proposed rulemaking conflict with the statutes that EPA administers, or their implementing regulations, the statutes and regulations will control," therein lies significant ambiguity as to the applicability and scope of regulation designed to underlie the basis of EPA regulatory science decisions. The details on how the Agency would navigate these potential regulatory conflicts should be considered and advanced concurrently with the current proposal to effect maximum stakeholder input. For example, EPA needs to fully understand the potential vulnerability this transparency rule would create for regulatory decisions made under the TSCA and the FIFRA that rely on CBI as well as the extent to which models relied on by both programs comply with the rule as proposed. It is possible that a significant number of EPA decisions under FIFRA and TSCA could be successfully challenged if this rule were finalized as proposed.
Comment [187-1708]: Commenter (12720) states that the FIFRA, EPA cites 7 U.S.C. § 136r(a), which authorizes the Administrator to "undertake research." That section does not allow the restriction of what types of research EPA may consider in rulemakings or otherwise. Nor does it draw any distinction between dose-response data, "data and models underlying pivotal regulatory science and pivotal science," or any other types of data. The absence of any such congressional distinction or restriction makes it all the more obvious that EPA invented and added the distinction and restrictions in the Proposal and Supplemental Proposal as a matter of its own policy preferences, contrary to the Act. This EPA may not do.
EPA also cites 7 U.S.C. § 136w, which is the general rulemaking authority that allows the Administrator to carry out the provisions of FIFRA. As explained above, that general grant of authority cannot support the rule, especially when the rule conflicts with the Act. Moreover, the citation fails to provide sufficient notice for the public to comment on the Proposal or Supplemental Proposal. FIFRA does not authorize the proposed rule.
1.3.3 Safe Drinking Water Act (SDWA) (NPRM and SNPRM Comments).
Comment: Sections <IP_ADDRESS> and <IP_ADDRESS> of this Chapter present comments received on the NPRM (Section <IP_ADDRESS>) and SNPRM (Section <IP_ADDRESS>) related to the EPA's legal authority for the rule under the SDWA. The EPA provides the following general response to these comments:
Response: EPA appreciates your comments. As discussed in Section I.C. of the final rule preamble and in this RTC document in Section 1.2, EPA has decided it is most appropriate to rely on its authority to promulgate housekeeping regulations, rather than any of the substantive environmental statutes cited in the 2018 proposal or the 2020 supplemental proposal as legal authority for the rule. EPA intends to promulgate future science transparency rules under its substantive environmental statutes. Additionally, the final rule states in § 30.3 that "[i]n the event the procedures outlined in this rule conflict with statutes that EPA administers, or their implementing regulations, the statutes and regulations will control."
<IP_ADDRESS> SWDA (NPRM Comments)
Comment: [37-34]: Commenter (0046) writes that although unacknowledged in the proposal including its request for comments, SDWA's standard-setting section, §1412 (42 U.S.C. § 300g - 1), addresses the use of science in decision-making under that authority:
      §1412(b)(3)(A) Use of science in decision-making.  --  In carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use --
      (i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).
So long as the data used is otherwise collected, assessed, and presented "in accordance with sound and objective scientific practices," Congress did not give the Administrator discretion to ignore the "best available, peer-reviewed science and supporting studies" based on any factor relating to the public availability or unavailability of data, as this proposal would seek to compel.
Comment [2772-2712]: Commenter (2787) writes that the proposed rule is inconsistent with EPA's statutory obligations to ground its actions on scientific evidence. The SDWA require that EPA use the "best available science."
Comment [4827-2071]: Commenter (4838) writes that the proposed rule violates several environmental statutes because it hinders EPA's ability to rely on best available science, or the most up-to-date information, as they require. The CAA, CWA, SDWA, TSCA, and EPCRA all require certain decisions or regulatory criteria be based on the most up-to-date science. These criteria are described as "best available science," "latest scientific knowledge," and "best available public health information." The proposed rule would illegally limit EPA's ability to rely on best available science in violation of these statutes.
Comment [4837-3058]: Commenter (4848) notes that administrative procedure requires that EPA consider data submitted by the public in evaluating regulations. Let's be clear. Scientific studies submitted have always been of uneven quality. EPA has processes in place (including use of a scientific advisory board, testimony and written and oral public notice and comment) using both internal and external peer review to evaluate data. Depending on context, some studies are given greater weight than others. Some studies are disregarded entirely.
It is inappropriate, and likely unlawful under the APA and the express language of numerous environmental statutes including the SDWA and the TSCA, for EPA to categorically eliminate certain types of studies, and hence certain types of data, without considering context.
Comment [5865-328]: Commenter (6111) notes that EPA's historic position is consistent with the Statutes. The SDWA
Furthermore, because EPA is required under the Statutes to assess the public health benefits of its regulations, it must take into account all relevant science and cannot arbitrarily exclude certain studies demonstrating those benefits. Under the SDWA, EPA must determine whether a contaminant "may have an adverse effect on the health of persons" before deciding to regulate it.
Many of the fundamental public health studies on which EPA has based key rules and standards under the Statutes are studies for which the raw data were not or could not have been released. Attachment 1 to the commenters' comment letter contains a partial list of studies [note: included under a separate excerpt] that likely contain confidential data; these are all studies on which EPA has relied and cited as the basis for its actions under some of the Statutes. Until now, release of the underlying raw data was not an EPA criterion for determining the "best available" reports, studies, analyses, or models. Indeed, none of the Statutes invoked by EPA as support for the proposed rule limits EPA in this fashion; none of the Statutes requires EPA to make raw data publicly available.
EPA's proposed new approach, which conflicts with the agency's obligations and curtails its authority, is irrational at best and detrimental to public health and safety at worst.
Comment [6112-1552]: Commenter (6137) writes that despite EPA's contrary contentions, the SDWA, 42 U.S.C. § 300f et seq., does not provide any authority for the adoption of a policy that would "preclude" EPA from considering all relevant scientific evidence in carrying out its duty to protect the quality of drinking water in the United States. See 83 Fed. Reg. at 18,769, n.3. In the Proposal, EPA points to two specific provisions of the SDWA as authorizing the rule, neither of which provides the necessary authority.
First, EPA points to 42 U.S.C. § 300j-1, but its reliance on this section is misplaced. Rather than authorizing the Administrator's selective exclusion of science and research, this section simply describes the Agency's responsibility to gather information -- that is, "[to] conduct research, studies, and demonstrations relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments of man resulting directly or indirectly from contaminants in water, or to the provision of a dependably safe supply of drinking water." 42 U.S.C. § 300j-1(a)(1). This section also directs EPA to study certain serious threats to drinking water, including "polychlorinated biphenyl contamination," "disposal of waste (including residential waste)," "surface spills of contaminants," "virus contamination," "abandoned injection or extraction wells," "intensive application of pesticides and fertilizers in underground water recharge areas," "surface disposal of contaminants in underground water recharge areas," and "the nature, extent, sources of and means of control of contamination by chemicals or other substances suspected of being carcinogenic." Id. § 300j-1(a)(3) -  (9). It therefore provides no legitimate basis for a rule that aims to limit the data that EPA can consider in executing the purposes of the SDWA.
Second, EPA cites the general grant of rulemaking authority in 42 U.S.C. § 300j-9(a)(1) as authorizing the Proposed Rule. However, this section likewise does not offer authorization. While this section empowers EPA "to prescribe such regulations as are necessary or appropriate to carry out [its] functions under this subchapter," the Proposed Rule is neither necessary nor appropriate to effectuate the SDWA.
The SDWA requires EPA to protect the public by limiting contaminants in public water systems. Specifically, the Act directs EPA to establish a MCLG for each contaminant "at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety." 42 U.S.C. § 300g-1(b)(4)(A). EPA must then set an enforceable Maximum Contaminant Level (MCL) as close to this goal as is feasible. Id. § 300g-1(b)(4).
To accomplish these goals, in 1996, Congress amended the SDWA to ensure that EPA's regulatory decisions were scientifically sound and adequately protective of public health. As amended, the SDWA directs EPA to base its determination about whether to regulate any particular contaminant "on the best available public health information." Id. § 300g1(b)(1)(B)(ii)(II) (emphasis added). In addition, the amended SDWA expressly requires that, "to the degree that an Agency action is based on science, [EPA] shall use . . . the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices[] and . . . data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data)." Id. § 300g1(b)(3)(A) (emphasis added). "Best available" means precisely what it says  -  the best of all that is available, not the best of some subset of what is available. The only qualifiers the SDWA places on what is "best available" are that the science be "peer-reviewed," and that the "supporting studies" be "conducted in accordance with sound and objective scientific practices." Id. Disclosure of confidential data underlying the studies plays no role in determining whether the science is the best available and is in no way required by the rule (but rather is expressly rejected by the scientific community, see infra). Any rule proposing to disregard reliable scientific information relevant to the regulation of drinking water contaminants directly conflicts with the SDWA's sound science mandate.
Given that the Proposed Rule is manifestly contrary to the SDWA, which expressly requires use of the best science available, it is not authorized by the general rulemaking authority in § 300j-9(a)(1). Mourning, 411 U.S. at 369; Ragsdale, 535 U.S. at 86. EPA is thus left without an appropriate authorizing provision under the SDWA.
Comment [6112-1589]: Commenter (6137) writes that EPA's proposal to exclude reliable, accessible, and relevant science is antithetical to the requirements of the SDWA and thus is unlawful. The SDWA was established to protect the quality of the drinking water in the United States. To accomplish this, the SDWA requires EPA to limit contaminants in public water systems. As discussed supra, it does this by establishing a MCLG for each contaminant "at the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety." 42 U.S.C. § 300g-1(b)(4)(A). And in deciding whether to regulate any particular contaminant to protect public health, EPA must rely on "the best available public health information." Id. § 300g-1(b)(1)(B)(ii)(II) (emphasis added). And to the extent EPA relies on science, it must use "the best available, peer-reviewed science and supporting studies" available. Id. § 300g-1(b)(3)(A) (emphasis added). Thus, any decision to categorically ignore or otherwise fail to consider relevant scientific information when regulating drinking water would be unlawful under the SWDA.
Comment [6118-1726]: Commenter (6143) notes that EPA has issued its proposed rule on Strengthening Transparency in Regulatory Science pursuant to its authority under several environmental statutes that that it implements, including the CAA; CWA; SDWA; RCRA; CERCLA; EPCRA; FIFRA; and TSCA. This proposed action is fully consistent with the authorities and objectives laid out in those statutes. EPA must ensure that any final action it takes on this proposal continues to respect the balance reflected in those statutes between sound, transparent science, and legitimate privacy interests.
Comment [6119-1359]: Commenter (6144) writes that the policy, as drafted, is in apparent violation of laws like the TSCA and the SDWA because of the statutory requirement to use the "best available science" and allow the agency to effectively ignore certain information regardless of the quality of that work, that would help implement these science-based laws. According to judicial precedent, "best available science" is defined as "all existing scientific evidence relevant to the decision" and a body of evidence that "cannot ignore existing data."
Comment [6147-2575]: Commenter (6172) supports the Agency's proposal to promulgate a regulation to strengthen the transparency of science utilized by EPA to support regulatory policies in regulations promulgated under the SDWA.
SDWA regulations and National Primary Drinking Water Regulations (NPDWR) result in a significant economic burden on small and rural communities and often force local communities to pay for federally mandated compliance that the communities do not believe is in their best interest for advancing public health policy. Under SDWA, this often results in a requirement to pay for treatment for nominal reductions of naturally occurring elements and compounds in drinking water supplies. Considering that rural and small communities are controlled and governed by people who are locally elected, all data, scientific studies and discretionary administrative decisions underlying federal actions that supersede local decisions should be made "publicly available in a manner sufficient for independent validation" and with clear explanation of discretionary decisions. NRWA fully supports a new regulation that requires use of peer-reviewed information, consistent data evaluation procedures, data transparency, and reproducible scientific assessments.
Comment [6147-2577]: Commenter (6172) notes that any regulations should improve the status quo and result in the following public disclosure of:
 A clear principle for implementing the discretion provided to the Administrator for selecting new contaminants for regulations under SDWA Section 1412. The lack of a clear principle or interpretation has allowed EPA to make a determination not to regulate perchlorate on October 10, 2008 and a subsequent affirmative EPA decision on February 11, 2011, that perchlorate meets the Section 1412 criteria for regulation as a contaminant. Such ambiguity in decision-making does not provide for regulatory certainty or persuasive reasoning for the local governments.
Comment [6147-2579]: Commenter (6172) references levels of regulated substances that are unsafe in drinking water as referenced in the SDWA ("unreasonable risk to health," Section 1415 and "protective of public health," Section 1412). For example, the EPA established a standard of 10 parts per billion (ppb) for arsenic in drinking water. The public naturally infers that any level above the standard is a health risk. However, when pressed by Congress to confirm this health risk, EPA failed to do so. In 2002, EPA did not find that arsenic concentrations above their standard necessarily present an "unreasonable risk to health." In their reply to a Congressional inquiry, EPA stated that it is "determining what does not pose an unreasonable risk to health with respect to arsenic, rather than address the much more complex issue of what does constitute an unreasonable risk to health." EPA should identify these public health levels for all NPDWR.
An explanation of why EPA selectively releases only certain peer-review studies to support NPDWR. In 2014, NRWA questioned the Agency about why it was not considering recent published studies that contradict the Agency's current arsenic in drinking water risk assessment findings. The new studies specifically examined the low dose range data, the behavior of the risk function across the full exposure range and developed a new methodology to be able to examine the transition range between high risk and no risk. The first study (Lamm et al., RTP 2013) demonstrates that the finding of a dose-relationship among the low dose villages is a consequence of the use of the external reference group that among the low-dose study villages there is no positive dose-response. The second study (Lamm et al., Tox 2014) demonstrates that the data from the high-dose villages show a high cancer risk, but that risk disappears at 100 ug/L and below. The methodologies of the later papers are more refined and should be appreciated by the Agency. They demonstrate that extrapolation of the risk found at high doses to lower doses is inappropriate and significantly overpredicts the risk in the range of 10-100 ug/L.
Comment [6147-2582]: Commenter (6172) references all data used to craft SDWA policy including risk assessments. For example, a recent study (Mendez et al., J Expo Sci Environ Epidemiol 2017) analyzes the dose-response slope for certain public health endpoints for certain drinking water using data from the NCI and the U.S. Geological Survey. The conclusion of this study could influence the current Integrated Risk Information System (IRIS) Program that is developing an updated assessment of inorganic arsenic. However, the Mendez complete data set includes some data that is available to government agencies but not to the general public. Release of this data would allow for further assessment and demonstrate the repeatability of conclusions and comparisons to similar studies.
The SDWA mandates that the Agency consider a detailed risk and cost assessment, as well as best available peer-reviewed science, when developing the NPDWR. Crafting a regulation that strengthens the transparency of science utilized by EPA will result in improved federal public policy and SDWA implementation. NRWA wants to ensure that the understanding of the public health risks of particular concentrations of substances (especially naturally occurring elements) in public drinking water are properly understood and applied in making public policy.
Comment [6152-639]: Commenter (6122) writes that the proposed rule is not based on any valid statutory authority and is arbitrary and capricious.
EPA cites multiple statutory provisions in an attempt to support the proposed rule that it believes authorize this type of rulemaking, "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 . . ." None of the specific statutory provisions provided by EPA provide specific authority for EPA to fundamentally rework the foundational processes it uses to assess and include/reject science. Indeed, if such authority existed, one would have expected EPA to have discovered this authority many decades earlier. Instead, EPA is attempting to use general grants of authority to create a completely novel approach to assessing science. However, as the Supreme Court has stated, "Congress...does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes." And if this is true, neither can the EPA alter the fundamental details of all of its regulatory schemes based on such vague provisions of law. We review each of the provisions listed by EPA, none of which discuss transparency, dose response, pivotal regulatory science, benefit-cost calculation, or changing "agency culture," the stated goals of this rulemaking.
Section 1442 of the SDWA generally authorizes the Administrator to "conduct research, studies, and demonstrations relating to the causes, diagnosis, . . . resulting directly or indirectly from contaminants in water, or to the provision of a dependably safe supply of drinking water. . ." This section does not authorize EPA to exclude science based on a perceived lack of transparency or support any other aspect of the proposed rule.
Section 1450(a)(1) of the SDWA states, "The Administrator is authorized to prescribe such regulations as are necessary or appropriate to carry out his functions under this subchapter." This catch-all provision provides the authority to prescribe regulations, but EPA has not provided a single rationale explaining how the proposed rule is "necessary" to the carrying out functions under the SDWA.
Comment [6155-633]: Commenter (6125) notes that the SDWA mandates national drinking water regulations setting required purity levels for water from public water supply systems. 42 U.S.C. §300g-1. Before regulating, the Administrator must conclude that the contaminant at issue "may have" an adverse effect on the health of persons. Id at (b)(1)(A)(i). In regulating, the Administrator must consider "the best available public health information." id at (b)(1)(B)(ii)(II). The section adds that in setting regulations, the Administrator "shall use ...the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices" and in addition, "data collected by accepted methods or best available methods." 42 USC section 300g-1 (3)(A). See City of Waukesha v. EPA, 320 F. 3d at 247 (D.C. Cir 2003) (agency peer review satisfies requirement to use best, peer-reviewed science and supporting studies); See City of Portland v. EPA, 507 F 3d 706, 716 (D.C. Cir 2002) (same).
Finally, to ensure that these requirements are met, and science is fully integrated into the regulatory decision, Congress specifically directed EPA to solicit the views of the SAB before proposing any drinking water regulations. 300-g (1) (e). Here again, EPA's opaque "transparency" rule includes no showing that the proposal is consistent with or authorized by the language of the SDWA.
This proposal appears to be in conflict with the directions Congress gave for the use of and communication about scientific information in enacting P.L. 104-182, the 1996 Amendments to the SDWA. The previous law had mandated expedited schedules for EPA to promulgate regulatory standards for literally dozens of drinking water contaminants, notwithstanding "significant gaps in the scientific information available for many of these contaminants." (Sen. Rpt. 104-169, at 28). "[T]o assure that future standards are based on better science," the 1996 Amendments "add[ed] to the scientific foundation of future standards by imposing [new] requirements on EPA." Id. The Report of the Senate Committee on Environment and Public Works is authoritative on these provisions, as the language adopted in the Committee bill (S.1316) on the use of science was adopted verbatim in P.L. 104-182. The most fundamental of these added requirements  -  unacknowledged in the proposal  -  addresses the use of science in decision-making under SDWA's standard-setting section, §1412 (42 U.S.C. § 300g - 1):
§1412(b)(3)(A) Use of science in decision-making.  --  In carrying out this section, and, to the degree that an Agency action is based on science, the Administrator shall use --
(i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and
(ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).
In imposing these requirements, Congress did not give the Administrator the discretion claimed in this proposal to invent novel, EPA-specific definitions of "sound and objective scientific practices," or to ignore the "best available, peer-reviewed science and supporting studies" based on any factor relating to the public availability or unavailability of data. The report further emphasizes that these are requirements by specifying that the "Administrator has a duty to seek and rely upon the best available science and information to support.... [m]any of the most important activities including selecting contaminants for regulation, setting standards, designing analytical methods, and structuring waivers, variances and exemptions." (S. Rep. 104-169, at 28) (emphasis added).
Particularly in light of this history, the requirements in this provision must be considered definitive as to the agency's permitted approach to the use of science in covered decision-making. Thus, the declaration in the preamble to the proposal that "[w]here available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments" but is "precluded" from using such information where it is not feasible to make it available (83 FR at 18770 and n.3 ), cannot be reconciled with the scope of the permissible use of science under SDWA §1412(b)(3)(A) (i).