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 EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.”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 EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.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. Department of State (State Department) will hold a joint meeting from 2:00 p.m. to 3:30 p.m. (EDT) on September 22, 2022, to discuss United Nations Environment Assembly (UNEA) Resolution 5/8 and the related upcoming first session of the ad hoc open-ended working group (OEWG) on a science-policy panel (SPP) to contribute further to the sound management of chemicals and waste. In Resolution 5/8, UNEA states that an SPP should be established to contribute further to the sound management of chemicals and waste and to prevent pollution. UNEA further decided to convene, subject to the availability of resources, an OEWG to prepare proposals for the SPP, to begin work in 2022 with the ambition of completing it by the end of 2024. According to the resolution, the principal functions of the SPP should include:
- Undertaking “horizon scanning” to identify issues of relevance to policymakers and, where possible, proposing evidence-based options to address them;
- Conducting assessments of current issues and identifying potential evidence-based options to address, where possible, those issues, in particular those relevant to developing countries;
- Providing up-to-date and relevant information, identifying key gaps in scientific research, encouraging and supporting communication between scientists and policymakers, explaining and disseminating findings for different audiences, and raising public awareness; and
- Facilitating information sharing with countries, in particular developing countries seeking relevant scientific information.
The first session of the OEWG will be held in two parts, with the first part taking place on October 6, 2022, in a hybrid format, while the second part will be held in person in Bangkok early in the first quarter of 2023.
By Lynn L. Bergeson and Carla N. Hutton
On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.” According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of new chemical applications under the premanufacture notification (PMN) and test marketing exemption (TME) provisions. Earthjustice states that these violations impede the ability of the listed parties -- the Environmental Defense Fund, Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, Sierra Club, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO/CLC -- “to be meaningfully informed of and able to participate in EPA’s review of new chemicals.” Earthjustice asks that EPA immediately cease further violations of TSCA’s disclosure requirements for new chemicals and disclose the information to which the listed parties are legally entitled in the mandated time frames. A detailed analysis and commentary on the notice are available in our September 17, 2019, memorandum, “Earthjustice Notifies EPA of Intent to Sue for Failure to Disclose Information about New Chemical Substances.”
By Lynn L. Bergeson and Margaret R. Graham
On July 14, 2016, the Environmental Law Institute (ELI) hosted an event in which the individuals and organizations critical to Toxic Substances Control Act (TSCA) reform, discussed the intricacies and challenges faced in drafting the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), the amended law, and its ultimate enactment.
The panelists included John Pendergrass, VP of Programs & Publications, ELI (moderator), Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, PC (B&C®), Sarah Brozena, Senior Director, Regulatory & Technical Affairs, American Chemistry Council, Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund, David Goldston, Director of Government Affairs, Natural Resources Defense Council, James J. Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, U.S. Environmental Protection Agency (EPA), David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce, and Senator Tom Udall, U.S. Senate (D-NM).
The overall consensus from the panelists was that the process undertaken in getting Lautenberg passed was challenging, but also inspiring and a true group effort on both sides of the aisle. Some of the key points from the discussion included:
- On June 23, 2015, when H.R. 2576 was passed by an overwhelming 398-1, there was a great spirit of bipartisanship in the House. McCarthy observed that this spirit of bipartisanship was especially acute on June 23, a rare event in Congress these days.
- Making a strong law that could be implemented by Jones and EPA was a high priority, and Jones’ role was “absolutely indispensable,” according to Udall who also stated, “[t]he one thing we wanted to make sure we did is not to produce a law that wasn’t going to work for [Jones] and his folks over at EPA.” In answer, Jones stated that EPA Staff were “excited about implementation,” and have “hit the ground running.” The law is strong, has great potential for serious reform and applicability, and is “an elegantly written, balanced and entirely implementable law that will make the world a better place,” according to Bergeson.
- In terms of cooperation and momentum, finding champions with endurance, and rewarding that support with some compromise on bill provisions created the recipe for success. As Udall stated “[y]ou need to find champions on your environmental bills that also have political will,” who are “will to do more than just introduce a bill. They need to deal with every stakeholder.” Denison followed with “to move the bill through the legislative process – to get people to engage, to make changes in exchange for their support, and broaden that” was the only way to get the bill passed, and these actions were “not only to build support, but to sustain momentum over more than one Congress to ultimately get it done.”
More information on the event can be found in the Environment & Energy Daily article “Architects of TSCA Compromise See Hope for Polarized Congress” available online, through paid subscription. A video recording of the event and other materials from the event are available to ELI Associates on ELI’s website. ELI Associates must login to see the materials. A full analysis of Lautenberg is available in the B&C memorandum An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.