May 18, 2020 Administrator Andrew Wheeler U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, D.C. 20460 Via Regulations.gov to docket EPA-HQ-OA-2018-0259 Cheryl A. Hawkins Office of the Science Advisor, Policy and Engagement (8104R) U.S. Environmental Protection Agency 1200 Pennsylvania Avenue NW Washington, D.C. 20460 Via email to [email protected] RE: Comments of Natural Resources Defense Council on “Strengthening Transparency in Regulatory Science (Supplemental notice of proposed rulemaking)” 85 Fed. Reg. 15396- 15406 (March 18, 2020), Docket ID No. EPA-HQ-OA-2018-0259 I. Introduction Natural Resources Defense Council (NRDC) is a national, not-for-profit public-health and environmental advocacy organiZation whose purpose is to safeguard the Earth: its people, its plants and animals, and the natural systems on which all life depends. NRDC has hundreds of thousands of members, all of whom depend on the U.S. Environmental Protection Agency (EPA) to protect them from the harms of pollution. EPA’s supplemental proposal to the original proposed rule, “Strengthening Transparency in Regulatory Science,” 85 Fed. Reg. 15396 (March 18, 2020) (the “Supplemental Proposal”) would harm these members by limiting the types of science that EPA could use to protect the environment and public health. As described in detail below, the Supplemental Proposal, just like the Proposal, is an attack on science and violates the law. EPA should withdraw it immediately. NRDC previously submitted comments on August 15, 2018 opposing the original proposed rule.1 EPA’s Supplemental Proposal fails to address the fundamental flaws with the 1 Natural Resources Defense Council, “Comment Submitted by the Natural Resources Defense Council (NRDC) on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science,” Docket No. EPA-HQ-OA-2018-0259-8283, Aug. 15, 2018 available at https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8283. We incorporate those comments on the Proposal here. NATURAL RESOURCES DEFENSE COUNCIL 40 W 20TH STREET | NEW YORK, NY | 10011 | T 212.727.2700 | F 212.727.1773 | NRDC.ORG Proposal, and the expansive scope of the Supplemental Proposal in comparison to the original Proposal introduces numerous serious errors, inconsistencies, and implementation issues. Because of these serious shortcomings and the lack of any sound legal or technical rationale, EPA should withdraw both the Proposal and Supplemental Proposal immediately. The Supplemental Proposal arbitrarily fails to address, much less explain, why prior EPA regulatory actions that relied upon studies, data, or other information did not reflect the “best available science” or why they were otherwise unreliable, despite failing to meet the Proposal’s or the Supplemental Proposal’s standards. It does not explain why all “data and models” should meet an arbitrary standard. The Supplemental Proposal, like the Proposal, is a “solution” in search of a problem. EPA, other federal agencies, EPA scientific advisory bodies, the National Academy of Science (NAS), and EPA’s Science Advisory Board (SAB) have for decades repeatedly and consistently relied upon the best available, peer-reviewed, independent, credible scientific studies—for which the underlying data are not publicly available—and found that science to be valid, reliable, trustworthy, and a reflection of the “best available science” that EPA claims as its concern in the Supplemental Proposal. The Supplemental Proposal arbitrarily excludes prior research, studies, and data that do not meet its applicability criteria based on concerns that were never announced to researchers or the public, or deemed necessary by any government agency, at the time the research, studies, or data-gathering were undertaken. The Supplemental Proposal, like the initial Proposal, is strikingly at odds with those scientific practices and their history, with nothing in the rulemaking docket to support casting aspersions on the practices or history sufficient to prohibit EPA from considering such science. EPA has unsurprisingly failed to cite a single statute that provides any basis for the original proposal or Supplemental Proposal. What statutes EPA does cite conflict with the Supplemental Proposal, because they require EPA either to consider the best available science (which may be based on data that cannot be made public) or to regulate to protect public health and the environment (which cannot be done if critical science is ignored simply because the underlying data cannot be made public). Similarly, none of the other sources EPA cites provide legal or logical support for the Proposal. Most fatal to the Supplemental Proposal’s legal viability is the Agency’s reference to its “housekeeping authority” as authority for the rulemaking. As discussed extensively below, the Supplemental Proposal is far from an “internal rule of agency procedure,” as it directly impacts how the Agency carries out its statutory mandates. EPA’s reliance on supposed housekeeping authority as the justification for this far-reaching attack on science at the Agency underscores the baselessness of the rulemaking and proves it must be withdrawn. The Supplemental Proposal also suffers from a host of other problems: its definitions are flawed and vague; it expands the scope of the original Proposal without justification; it is an unexplained reversal from prior agency policy and best practice; it handles confidential business 2 information and determinations about research quality in a capricious manner; it treats other types of agency actions inconsistently; it applies retroactively to studies completed before the rule goes into effect; it fails to analyze the disproportionate effect of the rule on people of color, low-income people, and children; it allows for arbitrary exemptions on a case-by-case basis; it places significant new burdens on researchers and the U.S. Centers for Disease Control and Prevention. Moreover, EPA did not seek adequate consultation on the Supplemental Proposal from the Science Advisory Board, and EPA has only attempted to partially clarify a small portion of key implementation questions in private briefings to Congress, entirely depriving the general public of an opportunity to meaningfully comment on EPA’s apparent plans. As explained throughout these comments, EPA’s agenda, as reflected in the Proposal and reiterated in the Supplemental Proposal, is not greater public trust or understanding; rather, the Proposal and the Supplemental Proposal aim to censor science and studies whose underlying data are not publicly available and may not be made publicly available as a matter of law or other agreement. The Supplemental Proposal, like the Proposal, is arbitrary, capricious, an abuse of the Agency’s discretion, and should be withdrawn. II. Background: The Tobacco Industry and Congressional Origins for the Censored Science Rulemaking The instant rulemaking would force EPA to ignore health science and studies needed to protect Americans and our environment—when those studies use confidential patient or business information. This strategy is drawn directly from the tobacco industry playbook, and from failed Republican-sponsored congressional legislation meant to prevent federal agencies from adopting more protective safeguards for Americans’ health, air & water quality, climate change and the environment. These attacks have specifically targeted the science EPA has used, historically, to adopt more protective safeguards for air, water, the climate, Americans’ health and the environment more broadly. In 1996, a tobacco industry lawyer named Chris Horner wrote his clients at RJ Reynolds Tobacco a memo later uncovered in tobacco lawsuits.2 He outlined a strategy to “reform agency science” to prevent EPA from targeting Environmental Tobacco Smoke. Darkly, the strategy also was designed to target EPA regulation of mercury from power plants, haZardous waste, methylene chloride, dioxins and deadly fine particle pollution. Id. pg. 2. The heart of Horner’s strategy focused on agency “process,” rather than “scientific substance” or pollutants or safeguards. This emphasis recogniZed that the tobacco industry stood “virtually no chance of affecting change” on the scientific substance and safeguards against [Environmental Tobacco Smoke], and so, designed an approach “of addressing process rather than scientific substance, ….” Id. Like the tobacco industry strategy, the focus on “internal 2 See Memo from Chris Horner (12/23/1996), attached. 3 agency process” 85 Fed. Reg. at 15,398, rather than “substance,” Id., is central to EPA’s proposed Censored Science rulemaking. In his letter, the tobacco lawyer advised that the process should demand that science and studies submitted to EPA should be ‘transparent’ and ‘able to be reproduced’—or else EPA would not consider them. Ex.1, pg. 4. This ban would happen even if science and studies relied on confidential medical, business or proprietary information that could not be made public, by law or legal agreements with third parties. The result would be that EPA could not rely on critical science to protect Americans and the environment. Mr. Horner worked for the tobacco industry, at the time, along with a former tobacco lobbyist, named Steve Milloy. Mr. Milloy has boasted that this EPA rulemaking is his “brainchild and pet project driving the communists craZy.”3 He tweeted about the proposed Censored Science rule that, “[I]f finaliZed, EPA will no longer be able