By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.
During the webinar, EPA presented an example of a rework case. According to EPA, from its analysis, it observes that:
- Information on material balance parameters, environmental releases, environmental release media, and engineering controls cause nearly 80 percent of all rework;
- In most cases, companies provide additional information that deviates from EPA model defaults and assumptions; and
- Companies often lack understanding on what information is needed for a Section 5 engineering assessment, including the level of detail needed to support their statements relating to environmental release and worker exposure.
As noted in the meeting slides, EPA plans to hold two additional webinars in fall 2022 that will cover:
- How EPA evaluates quantitative and qualitative information, with examples on the level of detail needed to support the submitted information to be accepted by EPA; and
- The types of information commonly missing in Section 5 submissions, how EPA evaluates environmental release information on sites not controlled by the submitter, and their impact on engineering assessment.
More information is available in our July 28, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:
- Chemistry Assessment:
- Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
- Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
- Complete characterization of the new chemical substance is often unavailable;
- Environmental Fate and Transport Assessment:
- Analysis of constituents may not represent the properties of the new chemical substance;
- Engineering Assessment: Environmental Releases:
- EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
- Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
- Release estimates have limitations -- examples:
- Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
- Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
- Engineering Assessment: Occupational Exposures:
- The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
- Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
- Exposure models do not account for some engineering controls (vapor capture/reduction);
- Exposure Assessment: General Population and Consumer Exposures:
- The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
- The confidence of the exposure estimates are affected by:
- Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
- Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
- Hazard Assessment:
- Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
- EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
- There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.
For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).
By Lynn L. Bergeson
On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA accepted comments until November 3, 2021.
The initial meeting will be held over a two-day period via videoconference on November 4 and 5, 2021, 12:00 p.m. to 5:00 p.m. (EDT). Registration was required by November 3, 2021. The following meetings are also scheduled:
- BOSC Deliberation Videoconference: November 18, 2021, 11:00 a.m. to 2:00 p.m. (EST) -- Registration is required by November 17, 2021.
- Final BOSC Deliberation Videoconference: December 10, 2021, 11:00 a.m. to 2:00 p.m. (EST) -- Registration is required by December 9, 2021.
Meeting times are subject to change.
By Lynn L. Bergeson
On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a period of two days on May 12, 2020, from 12:30 p.m. to 5:00 p.m. (EDT), and May 13, 2020, from 12:30 p.m. to 5:00 p.m. (EDT). The meeting is open to the public. Those interested in participating must register by May 8, 2020.
By Lynn L. Bergeson
On September 3, 2019, the Chinese Ministry of Ecology and Environment (MEE) and National Health Commission (NHC) jointly issued a final Technical Framework Guideline for Environmental Risk Assessment of Chemical Substances (Trial). This Trial Guideline provides a basic framework, including evaluation steps, technical requirements, and report preparation, for the environmental risk assessment of a single chemical substance under standard production and uses. The Trial Guideline does not apply to mixtures or exposures due to accidents or leakages. The “four-step” evaluation includes hazard identification, dose-response assessment, exposure assessment, and risk characterization. It also outlines uncertainty analysis, data quality assessment, spatial scale of exposure assessment, risk assessment of persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) chemical substances, and consideration for risk assessment of metals and their compounds. For further details, see The ACTA Group’s commentary here.