Category Archives: EPA

Post from the past: “Justice Janice Rogers Brown gets it right on the GHG endangerment finding”

I posted this on December 12, 1012….the USEPA GHG endangerment finding was unwarranted (and incorrect).

“USEPA has embarked on issuing a variety of regulations to control emission of greenhouse gases using the Clean Air Act (CAA). This flurry of activity results from an earlier Supreme Court ruling that upheld USEPA’s GHG endangerment finding under the CAA.  The endangement finding was a clear stretch of the imagination by the court. A legal challenge to GHG rules was filed in the US District Court of Appeals, DC Circuit, and a panel of judges upheld their legality. A petition was filed requesting that the entire court rule on the appeal, which was recently denied. In her desent, Justice Janice Rogers Brown provides a good explanation of why the Supreme Court erred in their ruling on the GHG endangerment finding, which indeed they did. The broad expanse of the term “pollutant” in that ruling is well-beyond the original context and intent of the Clean Air Act statute.

I have provided the full written dissent of Justice Brown below. As during the 1990s in litigation involving the Safe Drinking Water Act, the prevailing opinion explained by Sentelle provides political cover for a lawless agency (USEPA), rather than recognizing and honoring the rule of law as intended by the CAA. If congress intended GHG emissions to be regulated, congress could have explicitly enacted legislation to do so. (Click here for the full ruling.)

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When politics override the best available science when deciding a regulatory policy…

“… overpowering influence of low dose biostatistical modeling perspectives that swayed the quantitatively overwhelmed chemical toxicologists. This resulted in the LNT policy going forward, becoming broadly institutionalized across many governmental agencies and in multiple countries. The rest is history.”

Edward J. Calabresea, Robert J. Golden. Why toxicologists resisted and radiation geneticists supported EPA’S Tadoption of LNT for cancer risk assessment Chemico-Biological Interactions Volume 310, 1 September 2019, 108736

The linear non-threshold (LNT) dose response model for cancer risk assessment has been a controversial concept since its initial proposal during the 1930s. It was long advocated by the radiation genetics community in the 1950s, some two decades prior to being generally adopted within the chemical toxicology community. This paper explores possible reasons for such major differences in the acceptance of LNT for cancer risk assessment by these two key groups of scientists.

LNT model adopted for regulatory convenience

E.J. Calabrese. EPA adopts LNT: New historical perspectives. Chemic-Biological Interactions 308 (2019) 110-112

This paper provides an historical assessment of how the linear non-threshold (LNT) model became adopted as policy by the United States Environmental Protection Agency (US EPA) in 1975 [1] and how prior United States National Academy of Sciences (US NAS) radiation advisory panels may have affected this EPA decision. The paper highlights a generally unrecognized set of recommendations of the 1960 Biological Effect of Atomic Radiation [2] Genetics and Medical/Pathology Panels that did not support LNT for cancer risk assessment due to their judgements of its scientific limitations and unacceptable uncertainties. These convergent, independent and high profile recommendations were not promoted by the sponsors (i.e., Rockefeller Foundation and the NAS), and were ignored by the media, Congress and the scientific community in contrast to the vast attention directed to the linearity recommendation for germ cell mutation by the BEAR Genetics Panel in 1956 [3,4]. The subsequent Biological Effects of Ionizing Radiation (BEIR) I Committee (1972) [5] report ignored these BEAR Panel (1960) [2] recommendations, only commenting on the BEAR 1956 linearity supporting recommendation [3,4]. These actions are documented and assessed for how they influenced why and how EPA adopted linearity for cancer risk assessment based on the BEIR I report.

Court upholds USEPA policy barring grantees from advisory panels

“This is an action arising out of a directive by the Environmental Protection Agency that prohibits scientists in receipt of certain EPA grants from serving on the agency’s federal advisory committees. The complaint alleges that the directive was arbitrary and capricious in violation of the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 701-706.

Defendants have moved to dismiss the complaint for lack of subject-matter jurisdiction under Fed. R. Civ. P. 12(b)(1), on grounds of lack of standing, finality, ripeness, and justiciability, and for failure to state a claim upon which relief can be granted under Fed. R. Civ. P. 12(b)(6).

It is perhaps worth noting at the outset what this case does not involve. It is not about the best way to develop and implement our national environmental policies, or who are the proper people to assist in that process. And of course it is not about the wisdom or effectiveness of those policies. Rather, this case involves a fairly narrow set of issues: in substance, whether a specific EPA conflict-of-interest directive violates federal law, and whether plaintiffs are the proper parties to assert such claims. Based on established federal law, and for the reasons set forth below, the challenged directive is not subject to judicial reversal, and accordingly the complaint will be dismissed.” click here

EPA Administrator Wheeler offers a responsible, measured response on climate change

Hysteria over climate changes is counterproductive. Climate is a dynamic system and is always changing. 

“On the climate change, it is an important issue that we have to be addressing, and we are addressing it, but most of the threats from climate change are 50 to 75 years out.” click here

Biologically based models unfit for perchlorate risk assessment

Clewell HH 3rd, Gentry PR, Hack CE, Greene T, Clewell RA. An evaluation of the USEPA Proposed Approaches for applying a biologically based dose-response model in a risk assessment for perchlorate in drinking water. Regulatory toxicology and pharmacology. 2019 Jan 29. pii: S0273-2300(19)30036-4. doi: 10.1016/j.yrtph.2019.01.028.

The United States Environmental Protection Agency’s (USEPA) 2017 report, “Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Contaminant Level Goal for Perchlorate in Drinking Water”, proposes novel approaches for deriving a Maximum Contaminant Level Goal (MCLG) for perchlorate using a biologically-based dose-response (BBDR) model. The USEPA (2017) BBDR model extends previously peer-reviewed perchlorate models to describe the relationship between perchlorate exposure and thyroid hormone levels during early pregnancy. Our evaluation focuses on two key elements of the USEPA (2017) report: the plausibility of BBDR model revisions to describe control of thyroid hormone production in early pregnancy and the basis for linking BBDR model results to neurodevelopmental outcomes. While the USEPA (2017) BBDR model represents a valuable research tool, the lack of supporting data for many of the model assumptions and parameters calls into question the fitness of the extended BBDR model to support quantitative analyses for regulatory decisions on perchlorate in drinking water. Until more data can be developed to address uncertainties in the current BBDR model, USEPA should continue to rely on the RfD recommended by the NAS (USEPA, 2005) when considering further regulatory action.

US District Court upholds restriction on advisory committee membership

“The U.S. Environmental Protection Agency recently issued a directive announcing new membership priorities for its federal advisory committees (the “Directive”). The Directive requires, in part, “that no member of an EPA federal advisory committee be currently in receipt of EPA grants.” The Plaintiffs complain that this requirement is arbitrary and capricious, conflicts with several statutes and regulations governing advisory committees, and is a shift in policy that EPA failed to explain.

EPA’s Acting Administrator,1 however, has moved to dismiss the suit under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). At the outset, EPA alleges that the Plaintiffs lack standing and their claims are unripe. It also argues that because the Directive is an appointment policy, it is a matter reserved to agency discretion and the Plaintiffs largely rely on statutes that are either inapposite or offer no meaningful standard for review. And even if the Plaintiffs have identified applicable statutes, EPA argues that the Plaintiffs have failed to allege a violation of any specific statutory provision. For the reasons stated below, EPA’s motion to dismiss will be granted.” click here