Tag Archives: regulation

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

An example of why best available science is needed when setting air quality regulations

The overall relative risks reported in this study are so low they do not even support the conclusions stated by the authors. Based on these relative risk findings following accepted practice there is no difference in risk and no meaningful opportunity for risk reduction by setting strict air quality limits, contrary to what the authors claim. If I am reading the article correctly, the reported associations are much weaker than weak (essentially, none).

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Ana M Vicedo-Cabrera, et al. Short term association between ozone and mortality: global two stage time series study in 406 locations in 20 countries, BMJ, 2020; 368, https://doi.org/10.1136/bmj.m108

Objective: To assess short term mortality risks and excess mortality associated with exposure to ozone in several cities worldwide.

Design: Two stage time series analysis.

Setting: 406 cities in 20 countries, with overlapping periods between 1985 and 2015, collected from the database of Multi-City Multi-Country Collaborative Research Network.

Population: Deaths for all causes or for external causes only registered in each city within the study period.

Main outcome measures: Daily total mortality (all or non-external causes only).

Results: A total of 45 165 171 deaths were analysed in the 406 cities. On average, a 10 µg/m3 increase in ozone during the current and previous day was associated with an overall relative risk of mortality of 1.0018 (95% confidence interval 1.0012 to 1.0024). Some heterogeneity was found across countries, with estimates ranging from greater than 1.0020 in the United Kingdom, South Africa, Estonia, and Canada to less than 1.0008 in Mexico and Spain. Short term excess mortality in association with exposure to ozone higher than maximum background levels (70 µg/m3) was 0.26% (95% confidence interval 0.24% to 0.28%), corresponding to 8203 annual excess deaths (95% confidence interval 3525 to 12 840) across the 406 cities studied. The excess remained at 0.20% (0.18% to 0.22%) when restricting to days above the WHO guideline (100 µg/m3), corresponding to 6262 annual excess deaths (1413 to 11 065). Above more lenient thresholds for air quality standards in Europe, America, and China, excess mortality was 0.14%, 0.09%, and 0.05%, respectively.

Conclusions: Results suggest that ozone related mortality could be potentially reduced under stricter air quality standards. These findings have relevance for the implementation of efficient clean air interventions and mitigation strategies designed within national and international climate policies.

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).


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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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