Category Archives: Regulations

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

PFOA/PFOS emerges as an election issue

In an election year political statements raising ‘hot button’ environmental issues like PFOA and PFOS are to be expected (e.g. click here). Ms. Dingell’s characterization of PFOA and PFOS are not based on science or even a proper understanding of environmental law.

The article below presents the only publicly available, independent peer-reviewed published paper examining the full implications of regulating of PFOA and PFOS in drinking water.

F.W. Pontius. Regulation of Perfluorooctanoic Acid (PFOA) and
Perfluorooctane Sulfonic Acid (PFOS) in Drinking
Water: A Comprehensive Review. Water 2019, 11, 2003; doi:10.3390/w11102003

Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) are receiving global attention due to their persistence in the environment through wastewater effluent discharges and past improper industrial waste disposal. They are resistant to biological degradation and if present in wastewater are discharged into the environment. The US Environmental Protection Agency (USEPA) issued drinking water Health Advisories for PFOA and PFOS at 70 ng/L each and for the sum of the two. The need for an enforceable primary drinking water regulation under the Safe Drinking Water Act (SDWA) is currently being assessed. The USEPA faces stringent legal constraints and technical barriers to develop a primary drinking water regulation for PFOA and PFOS. This review synthesizes current knowledge providing a publicly available, comprehensive point of reference for researchers, water utilities, industry, and regulatory agencies to better understand and address cross-cutting issues associated with regulation of PFOA and PFOS  contamination of drinking water.

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.

 

Even Nobel Laureates can make a mistake needing correction

Edward J. Calabrese. Muller’s Nobel Prize data: Getting the dose wrong and its significanceEnvironmental Research 176 (2019) 108528

This paper evaluates the significant historical paper of Muller and Mott-Smith (1930), which successfully disputed the proposal of Olson and Lewis (1928) that background ionizing radiation is the driving mechanism of evolution. While the present analysis supports the general conclusion that background radiation is not a quantifiable factor affecting evolution, the paper reveals methodological errors and questionable conclusions in the Muller and Mott-Smith (1930) paper, which may have impacted the acceptance of the linear non-threshold (LNT) model. Most importantly, this paper reveals that in Muller’s (1927) Nobel Prize research he used a treatment exposure (total dose) that was 95 million-fold greater than the average background exposure, a value far greater than the 200,000 fold reported by Muller and Mott-Smith (1930). Such a large exposure rate dis- crepancy may be historically important as it may have led to the over-reliance on Muller’s research in support of the derivation and use of the LNT single-hit model.

Regulatory actions effect “everyday Americans” and the national economy

“Coincident with the 2017 Presidential inauguration, real GDP growth changed from underperforming experts’ forecasts to outperforming them (Tankersley 2019). The CEA’sfindings on the aggregate effects of regulations and deregulations may help explain this state of affairs. Regulatory actions and their aggregate effects may be easily overlooked and underestimated because the actions are numerous and, if not seen through the lens of economic analysis, may appear cryptic to the general public. This report helps to narrow this information gap by showing the importance of the deregulatory agenda for everyday Americans as well as the national economy.” click here

USEPA proposes perchlorate MCLG and MCL at 56 u/L (0.056 mg/L); Comments due 08/26/2019

The Environmental Protection Agency (EPA) is proposing a drinking water regulation for perchlorate and a health-based Maximum Contaminant Level Goal (MCLG) in accordance with the Safe Drinking Water Act (SDWA). The EPA is proposing to set both the enforceable Maximum Contaminant Level (MCL) for the perchlorate regulation and the perchlorate MCLG at 0.056 mg/L (56 µg/L). The EPA is proposing requirements for water systems to conduct monitoring and reporting for perchlorate and to provide information about perchlorate to their consumers through public notification and consumer confidence reports. This proposal includes requirements for primacy agencies that implement the public water system supervision program under the SDWA. This proposal also includes a list of treatment technologies that would enable water systems to comply with the MCL, including affordable compliance technologies for small systems serving 10,000 persons or less.

Click here for proposed rule

Click here for proposed rule correction

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.