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By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
 
New Chemical Submissions
 
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe to stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemical submissions and common issues that cause EPA to have to reconduct risk assessments (“rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
This will be the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. As reported in our July 28, 2022, memorandum, in July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. Meeting materials are available for those who missed the first webinar.


 

By Lynn L. Bergeson

On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” Comments are due on or prior to February 18, 2020. The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
     
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
     
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
     
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
     
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
     
  • General guiding principles and concepts for making determinations;
     
  • Decision-making logic and key questions that EPA must address; and
     
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses. More information is available in B&C’s December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”