Tag Archives: USEPA

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

Prioritizing unregulated disinfection byproducts for risk mitigation, Canadian Perspective

Mian HR, Hu G, Hewage K, Rodriguez MJ, Sadiq R. Prioritization of unregulated disinfection by-products in drinking water distribution systems for human health risk mitigation: A critical review. Water Res. 2018 Sep 29;147:112-131. doi: 10.1016/j.watres.2018.09.054

Water disinfection involves the use of different types of disinfectants, which are oxidizing agents that react with natural organic matter (NOM) to form disinfection by-products (DBPs). The United States Environmental Protection Agency (USEPA) has established threshold limits on some DBPs, which are known as regulated DBPs (R-DBPs). The human health risks associated with R-DBPs in drinking water distribution systems (DWDSs) and application of stricter regulations have led water utilities to switch from conventional disinfectant (i.e., chlorination) to alternative disinfectants. However, the use of alternative disinfectants causes formation of a new suit of DBPs known as unregulated DBPs (UR-DBPs), which in many cases can be more toxic. There is a growing concern of UR-DBPs formation in drinking water. This review prioritizes some commonly occurring UR-DBP groups and species in DWDSs based on their concentration level, reported frequency, and toxicity using an indexing method. There are nine UR-DBPs group and 36 species that have been identified based on recent published peer-reviewed articles. Haloacetonitriles (HANs) and haloacetaldehydes (HALs) are identified as important UR-DBP groups. Dichloroacetonitrile (DCAN) and trichloroacetaldehye (TCAL) are identified as critical UR-DBPs species. The outcomes of this review can help water regulators to identify the most critical UR-DBPs species in the context of drinking water safety and provide them with useful information to develop guidelines or threshold limits for UR-DBPs. The outcomes can also help water utilities in selecting water treatment processes for the mitigation of human health risk posed by UR-DBPs through drinking water.

Mr. Scott Pruitt brought USEPA back into the real world

The administrator of an Independent Agency of the US Government is particularly vulnerable to political attack regardless of party. Whatever any Administrator of USEPA does, someone in Washington will not like it, and will mount an attack. Independent Agencies are not tied to any Cabinet-level agency, and so they lack the budget, power and prestige to withstand such an unrelenting political attack for very long.

“Scott Pruitt did an outstanding job inside of the EPA. We’ve gotten rid of record breaking regulations and it’s been really,” Trump said, adding there was “no final straw. I think Scott saw that he was, he was, uh– look, Scott is a terrific guy. And he came to me and he said I have such great confidence in the administration. I don’t want to be a distraction. And I think Scott felt that he was a distraction.” click here

Environmental activist groups repeat history; refusal to meet with EPA Administrator disingenuous

Government agency representatives meeting with advocacy groups of all political sides is a normal practice within the US federal regulatory system. Ex parte communications for information exchange are certainly allowed under the Administrative Procedure Act (APA) and can be productive for both parties if done in the right manner. Concern about “transparency” is a red herring because any and all conversations of such meetings must be documented and placed in the corresponding regulatory docket. 

It is disingenuous if an advocacy group from one political side, when invited refuses to meet with EPA officials, and then later complains that groups opposing their position are meeting with the EPA officials.

These same environmental advocacy groups used similar tactics in the 1980s and 1990s where these groups filed lawsuits to drive much of EPA regulatory activity through court orders.

“An environmental group declined an offer to meet with Environmental Protection Agency (EPA) Administrator Scott Pruitt in 2017 over concerns the meeting would not be “transparent,” E&E News reports.” click here

Proposed Rule Strengthening Transparency in Regulatory Science is long overdue

“This document proposes a regulation intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation. In this notice, EPA solicits comment on this proposal and how it can best be promulgated and implemented in light of existing law and prior Federal policies that already require increasing public access to data and influential scientific information used to inform federal regulation.” click here

EPA science transparency rule a positive step

“Environmental Protection Agency Administrator Scott Pruitt signed a proposed rule on Tuesday to prevent the agency from relying on scientific studies that don’t publish the underlying data.” click here