By Lynn L. Bergeson and Carla N. Hutton
On February 20, 2020, the U.S. Environmental Protection Agency (EPA) published a list of 20 chemical substances identified as low-priority for risk evaluation under the amended Toxic Substances Control Act (TSCA), completing another TSCA requirement. EPA notes that a final designation as “low-priority” means that risk evaluations are not warranted at this time. EPA states that it considered reasonably available information for each chemical substance under its conditions of use as specified in TSCA. Additionally, according to EPA, these 20 low-priority chemicals are on its Safer Chemical Ingredients List, which includes chemicals that meet strict criteria for both human health and the environment. The 20 chemicals are
- 1-Butanol, 3-methoxy-, 1-acetate;
- D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-;
- D-Gluconic acid;
- D-Gluconic acid, calcium salt (2:1);
- D-Gluconic acid, .delta.-lactone;
- D-Gluconic acid, potassium salt (1:1);
- D-Gluconic acid, sodium salt (1:1);
- Decanedioic acid, 1,10-dibutyl ester;
- Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-;
- Propanedioic acid, 1,3-diethyl ester;
- Propanedioic acid, 1,3-dimethyl ester;
- Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate;
- Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-;
- 2-Propanol, 1,1'-oxybis-;
- Propanol, oxybis-; and
- Tetracosane, 2,6,10,15,19,23-hexamethyl-.
EPA has posted a pre-publication version of the Federal Register notice announcing the final designation of low-priority substances. As reported in our December 20, 2019, blog item, in December 2019, EPA designated 20 chemicals as high-priority under TSCA, and those chemicals are now in the risk evaluation process. More information on the final list of low-priority chemicals will be available in a forthcoming memorandum that will be posted on our website.
By Carla N. Hutton, Richard E. Engler, Ph.D., and Amanda Bland
On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time. EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance. 84 Fed. Reg. 41712. EPA published its Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA (Approach Document), which describes the literature review process for the information used in the screening review for each proposed low-priority chemical substance. Comments on the proposed designations and on EPA’s Approach Document are due November 13, 2019.
As expected, EPA has formally proposed as low-priority substances the 20 substances that EPA proposed in March as potential low-priority substances. Stakeholders will have 90 days to comment on whether EPA has met the statutory obligation to have information “sufficient to establish” that the substances do not meet the standard for high-priority substances (that the substances may present an unreasonable risk). Comments were filed on only seven of the 20 substances initially identified as low priority, and all comments supported the designations as low priority.
More information is available in our August 14, 2019, memorandum, “EPA Proposes to Designate 20 Chemical Substances as Low-Priority Substances.”
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA). New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time. The 20 high priority candidate chemicals include:
- Seven chlorinated solvents;
- Six phthalates;
- Four flame retardants;
- Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
- A fragrance additive; and
- A polymer pre-curser.
EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates. The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria.
Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however. EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.” EPA is scheduled to publish the notice regarding this list in the Federal Register on March 21, 2019. The pre-publication notice is available here. Comments will be due 90 days after publication in the Federal Register. EPA is opening a docket for each of the 40 chemicals. EPA is then directed to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority.
Please be on the lookout for our memorandum that will contain more information regarding EPA’s list. It will be posted on our Regulatory Developments webpage.