By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged. Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required to self-identify as a manufacturer of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA. EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA). During the 60-day comment period, the public will have the opportunity to correct errors or provide comments on the preliminary lists. According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances. Manufacturers (including importers) identified on the final lists will be subject to applicable fees.
Once the Federal Register notice is published, the preliminary lists will be available in docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA’s website at http://www.epa.gov/TSCA-fees. EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).” According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.” Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate. To include the two most recent CDR reporting cycle data (collected every four years) and to account for annual or other typical fluctuations in manufacturing (including import), EPA states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).
More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.” More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published on December 20, 2019, the final list of high-priority chemicals. These chemicals will be the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA). According to EPA, issuing the final list of high-priority chemicals for risk evaluation “represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of existing chemicals in the marketplace.” The 20 chemicals consist of seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer precursor:
- trans-1,2- Dichloroethylene;
- Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester);
- Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester;
- Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester);
- Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester);
- Dicyclohexyl phthalate;
- 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA);
- Tris(2-chloroethyl) phosphate (TCEP);
- Phosphoric acid, triphenyl ester (TPP);
- Ethylene dibromide;
- 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
- Formaldehyde; and
- Phthalic anhydride.
More information will be available in a forthcoming memorandum that will be posted on our website.
By Lynn L. Bergeson and Carla N. Hutton
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 44300. The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation 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. Comments are due November 21, 2019. More information is available in our August 26, 2019, memorandum, "EPA Proposes to Designate 20 Chemical Substances as High-Priority Substances for Risk Evaluation under TSCA."
By Lynn L. Bergeson
The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation." Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6. Industry stakeholder responses to this candidate list proposal and follow up actions with EPA related to risk evaluation work optimally will be conducted under existing or potentially newly formed chemical consortia. But what if your chemical is not on the list of 20? If you want to protect or even increase your business market advantage, consider inviting your commercial rivals to join an industry advocacy group anyway. This is particularly important if you have a chemical of commercial interest on the TSCA Work Plan Chemicals list. For more information on this issue, please see our full memorandum.
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.