TSCA Week Ahead

The Week Ahead

SACC Weighs In On Systematic Review; Comments Due On PV29 Findings

April 18, 2022

EPA’s Science Advisory Committee on Chemicals (SACC) is set to begin its peer review of the Biden administration’s reworked approach to systematic review in TSCA chemical evaluations, after the agency dropped a Trump-era model. Public comments are closing on revised risk determinations for pigment violet 29 (PV29), including its shift to the agency’s novel “whole chemical” model that makes a single risk finding for all uses of a substance rather than considering each condition of use separately.

Systematic Review

SACC will meet April 19-21 to peer-review the Toxic Substances Control Act (TSCA) office’s new draft approach to systematic review in chemical risk evaluations. The agency is in the process of replacing a Trump-era model for the data-quality assessment practice that the National Academy of Sciences said in its 2021 peer review was deeply flawed, but some environmental and academic groups say the new approach does not go far enough to remedy those faults.

Background Reading: Groups Say TSCA Systematic Review Draft Repeats Some Trump-Era Flaws

PV29

April 21 is the deadline for comments on EPA’s draft risk findings for PV29. The agency is proposing to keep in place most of its Trump-era TSCA evaluation for the chemical but change its conclusions on PV29’s environmental and human-health risks to apply the whole-chemical model, despite claims by industry groups and others that the new approach contradicts both regulatory and statutory requirements.

Background Reading: ACC Targets TSCA ‘Whole Chemical’ Approach As EPA Doubles Down

TSCA ‘Modernization’

EPA’s chemical-safety and research offices will host a two-day meeting April 20-21 on their plan to “develop and implement a multi-year collaborative research program” designed to “modernize” TSCA risk assessments for new chemicals.

Background Reading: OPPT, ORD Kick Off Joint Research To Advance New Chemicals Reviews

Epidemiological Data

EPA will host an April 20 webinar on the use of electronic health records to support “environmental epidemiology” studies of human-health impacts from a range of chemical exposures and other environmental hazards. Such research has become a growing focus for the TSCA office, which is looking to epidemiological data as a boon to risk analyses that have historically drawn largely on animal testing.

Background Reading: As EPA Weighs PFAS Human-Health Data, Groups Spar On Study Methods

Looking Ahead

New Chemicals

Following EPA’s April 20-21 meeting on the new-chemicals research agenda, public comments are slated to close April 26 for the agency’s written “problem statement, vision and research action plan” outlining how officials intend to approach their goals. The draft would prioritize updating systems for categorizing chemicals, bolstering chemical databases, developing and improving chemical models and assessing how to increase use of non-animal test methods.

Background Reading: EPA Outlines Research Plan To ‘Modernize’ TSCA New Chemicals Reviews

Chloroform

April 29 is the Science Advisory Board’s deadline for nominees to a panel that will peer review the upcoming draft Integrated Risk Information System (IRIS) assessment of chloroform. The IRIS program is using its work on chloroform as a test case for a novel probabilistic approach developed to craft risk estimates for non-cancer health dangers that can be compared directly to cancer risks -- a long-standing problem for EPA’s chemical assessors.

Background Reading: SAB Seeks Peer Reviewers For IRIS Chloroform Assessment

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