Category Archives: EPA

USEPA issues supplemental notice of regulatory science transparency rule

“This supplemental notice of proposed rulemaking (SNPRM) includes clarifications, modifications and additions to certain provisions published on April 30, 2018. This SNPRM proposes that the scope of the rulemaking apply to influential scientific information as well as significant regulatory decisions. This notice proposes definitions and clarifies that the proposed rulemaking applies to data and models underlying both pivotal science and pivotal regulatory science. In this SNPRM, EPA is also proposing a modified approach to the public availability provisions for data and models that would underly significant regulatory decisions and an alternate approach. Finally, EPA is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” click here

Small epidemiological associations do not imply a significant risk

“When effects are this small, it is extremely possible that the effects are not real, but are artifacts of the statistical methods used in the original analysis.  If these findings had had Relative Risks or Risk Ratios of 4.0 or 7.9 or any value that might indicate a strong association, then I would be more convinced.  But with so many of the metrics not even passing the most basic test of significance, I am concerned that the findings represent only what John P.A. Ioannidis has termed “simply accurate measures of the prevailing bias.” “  click here

EPA “secret science” rule needed now

“EPA should ensure that the data and models underlying scientific studies that are pivotal to the regulatory action are available for review and reanalysis. The “Strengthening Transparency in Regulatory Science” rulemaking is designed to increase transparency in the preparation, identification and use of science in rule-making. When final, this action will ensure that the regulatory science underlying EPA’s actions are made available in a manner sufficient for independent validation.“ …. “…the science transparency rule will ensure that all important studies underlying significant regulatory actions at the EPA, regardless of their source, are subject to a transparent review by qualified scientists.” click here

Here’s why the Clean Air Act (CAA) needs a ‘best available science’ clause.

To avoid basing rules on marginal or flawed science (e.g. here) as described below a “best available science” clause is needed in the Clean Air Act (CAA) — and other environmental laws — as in the Safe Drinking Water Act (SDWA”)”:

“To the degree that an Agency action is based on science, the Administrator shall use (1) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (2) 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”. Public Law 104-182. Section 1412(b)(4)(D).

EPA-CASAC-20-001

Click here to read the full report.

 

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.