EPA Publishes New Chemical Notices, Risks
Last week, the U.S. Environmental Protection Agency announced that it improved public access to certain reports submitted by chemical companies in its 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.
With the improvement to the application, known as ChemView, the EPA has published previously unpublicized new chemical notices received under TSCA section 5 and notices of substantial risk provided by companies under TSCA section 8(e).
TSCA section 5 requires the EPA to publish a list of new chemical submissions it has received, including premanufacture notices, significant new-use notices, microbial commercial activity notices, test market exemption applications, notices of commencement of manufacture or import and test information submitted under section 5.
This year, the EPA made more than 25,000 new chemical notice records received under section 5, including notices received between 2014 and 2019 that had not been published previously, available in ChemView.
The Agency added that it is planning to identify other older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA section 5 notices and TSCA section 8(e) reports on a near real-time basis.
In addition, the EPA has also published chemical health and safety studies received under TSCA section 8(d) on the platform. 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 50 specified chemical substances and mixtures.
More than 1,700 health and safety study records dating back to September 2021 have already been published in ChemView.
Regarding notices of substantial risk, under TSCA section 8(e), chemical companies are required to inform the EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. The EPA uses these notices to inform new and existing chemical risk assessment activities.
This year, the EPA shares that 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 Jan. 1, 2019, and Dec. 20, 2021, that were not previously published due to resource limitations.
Moving forward, the Agency will publish all non-CBI versions of 8(e) notices received from Dec. 20, 2021, to the present, as well as additional notices received that are deemed completed within a week’s time.
The latest actions reportedly build upon the Agency’s commitment to enhance the transparency of its evidence-based scientific and policymaking processes related to the evaluation of potential risks posed by certain chemicals.
TSCA Review Background
In February 2021, the EPA received a report evaluating its TSCA chemical risk evaluations system prompting the agency to announce that it will be refining its approach to selecting and reviewing the scientific studies that are used to inform its evaluations.
The peer review was contracted with the National Academies of Science, Engineering, and Medicine in December 2019. The National Academic are private, nonprofit institutions that “provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine.”
The EPA also noted that this review was being done in accordance with directives from the Biden administration, which it acknowledged previously to this announcement.
The Academies specifically reviewed the EPA’s “2018 Application of Systematic Review in TSCA Risk Evaluations,” and its biggest critique was on the statutory schedule the EPA follows to complete assessments, which is says does not meet state-of-practice standards. The Academies suggested:
The EPA noted that it is no longer using the 2018 application and has already begun to review protocol. There is currently to timetable in place for the completion of that review.
Earlier that month, the EPA sent two emailed press releases discussing both a review of its actions of the course of the previous administration, as well as announcing educational webinars that focus on the recent risk evaluations of both pigment violet 29 (PV29) and n-methylpyrrolidone (NMP).
In the general chemical safety action update, the Agency said that it’s reviewing all actions taken under the previous administration and that “this review is being done in accordance with the Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review.”
The EPA listed three rulings in particular that it will be reviewing, two of which fall under the TSCA. The first, is the expedited action on certain persistent, bioaccumulative and toxic (PBT) chemicals and the final rules that were associated with those actions that went into effect on Feb. 5, 2021.
The EPA was also looking at the risk evaluations for the first 10 chemicals that were introduced under the revamped TSCA. It said that current risk management and stakeholder activities will continue while the process is being reviewed.
Finally, the EPA listed the Dust Lead Post-Abatement Clearance Level Final Rule, which went into effect March 8, 2021.
That same month, the EPA released an emailed press release on its evaluation surrounding the policies, guidance, templates and regulations under the TSCA.
At the time, the Agency said that it had identified several instances “where the approach for making determinations and managing risks associated with new chemicals can more closely align with the requirements of TSCA to ensure protections for human health and the environment, including the use of significant new use rules (SNURs) and assumptions related to worker exposures.”
The announcement states that the EPA will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.
EPA intends to continue issuing SNURs following TSCA section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufacturers or processes the chemical in the future.
In May, the EPA released a list of 390 chemicals that are expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act inventory. According to the EPA, the identities of these chemicals were reported as non-confidential during Chemical Data Reporting cycles from the 2012, 2016 and/or 2020 reporting periods. In accordance with the CDR rule and with TSCA sections 8 and 14, the EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory. The updates will also involve expanding reporting requirements for certain chemicals and facilities, including PFAS.
That summer, the EPA made several announcements via email regarding the TSCA: namely, that new members have been appointed to the TSCA Science Advisory Committee on Chemicals, and that the EPA would be holding a webinar on the development of the proposed data reporting rule.
The TSCA SACC aims to serve as a peer review mechanism that provides recommendations to the EPA.
In August, two new updates were issued via email regarding per- and polyfluoroalkyl substances, both extending the public comment period for its proposed recordkeeping requirements and releasing data from the 2020 Toxics Release Inventory.
First, the comment period on the proposed reporting and recordkeeping requirements for manufacturers (including importers) of PFAS under section 8(a)(7) of the Toxic Substances Control Act, was extended from an Aug. 27, 2021 closing date to Sept. 27, 2021.
Second, the EPA released data from the TRI about chemical releases, chemical waste management and pollution prevention activities that took place during 2020 at nearly 21,000 federal and industrial facilities across the country. The preliminary data reportedly includes the first-ever reporting on PFAS added to the TRI by the 2020 National Defense Authorization Act.
The EPA noted that the dataset released is raw data and does not contain any summary or trend analysis and the EPA is now conducting additional quality checks on the preliminary data. The 2020 preliminary data will be updated periodically to reflect revisions to previously submitted data and late submissions of TRI reporting forms.
At the time, the data related to the PFAS added by the NDAA and received by the agency include a total of 89 TRI reporting forms for 44 discrete PFAS chemicals filed by 38 individual facilities.
The preliminary data indicate facilities managed over 700,000 pounds of production-related waste of PFAS during 2020.
In February, the EPA announced that it was inviting small businesses, governments and not-for-profit organizations to participate as Small Entity Representatives (SERs) for a Small Business Advocacy Review (SBAR) Panel.
The established SBAR is slated to help the agency develop a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since Jan. 1, 2011.
The Panel will include federal representatives from the Small Business Administration, the Office of Management and Budget and EPA. The Panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, community or organization to inform the Panel members about the potential impacts of the proposed rule on small entities.
Most recently, in March, the EPA announced a new research program under the Toxic Substances Control Act (TSCA) with the goal of modernizing the process and bringing innovative science to the review of new chemicals before they enter the market.
According to the EPA, the Office of Chemical Safety and Pollution Prevention (OCSPP) had proposed the development and implementation of a multi-year collaborative research program in partnership with the Agency’s Office of Research and Development (ORD) and other federal entities focused on approaches for performing risk assessments on new chemical substances under TSCA.
Through the partnership, the program aims to bring innovative science to new chemical reviews, modernize the approaches used and increase the transparency of the human health and ecological risk assessment process.
The multi-year research program also plans to refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.