Written by by Lawrence E. Culleen, Arnold & Porter
Prioritization of Chemicals
In its continuing quest to meet regulatory deadlines imposed by the 2016 amendments to the Toxic Substances Control Act (TSCA), the United States Environmental Protection Agency (U.S. EPA) has published a list of 40 chemicals that must be “prioritized” by the end of 2019. The announcement marks the beginning of the Agency’s process for designating the 40 listed chemicals identified as either “high” or “low” priority substances for further the U.S. EPA scrutiny. At the conclusion of the prioritization process, at least 20 of the substances likely will be designated as high priority.
A high priority designation immediately commences the U.S. EPA’s formal “risk evaluation” procedures under the amended statute. The risk evaluation process can lead to “pause preemption” under the terms of the 2016 amendments and new state laws and regulations restricting the manufacture, processing, distribution, and use of a chemical substance undergoing a risk evaluation could not be established until the evaluation process is completed. The U.S. EPA commenced its first 10 risk evaluations as required under the amended law at the close of 2016. The Agency is required to have an additional 20 risk evaluations of high priority substances ongoing by December 22, 2019. If the U.S. EPA’s risk evaluation process concludes that a substance presents an “unreasonable risk” to health or the environment under its “conditions of use,” the Agency must commence a rulemaking to prohibit or limit the use of the substance under Section 6 of TSCA.
The Agency’s announcement of the list of chemicals to undergo prioritization provides the makers and users of the listed substances an important, time limited opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals. The U.S. EPA has opened a docket for each of the 40 chemicals and the opportunity to submit information for the U.S. EPA’s consideration will close in 90 days (on June 19, 2019). The U.S. EPA will then move to propose the designation of these chemical substances as either high priority or low priority. The statute requires the U.S. EPA to complete the prioritization process, by finalizing its high priority and low priority designations, within the next nine to 12 months.
The list of 20 substances to be reviewed as high priority candidates consists entirely of substances previously identified by U.S. EPA in 2014 as “Work Plan” chemicals. Thus, the list contains few chemicals that should be considered complete “surprises.” However, the inclusion of formaldehyde may raise concerns in certain quarters given the scrutiny that has been given to the U.S. EPA’s previous struggles with assessing the potential effects of formaldehyde. The Agency has attempted to address these concerns by stating “Moving forward evaluating formaldehyde under the TSCA program does not mean that the formaldehyde work done under IRIS will be lost. In fact, the work done for IRIS will inform the TSCA process. By using our TSCA authority EPA will be able to take regulatory steps; IRIS does not have this authority.” Also included in the listing are several chlorinated solvents, phthalates, flame retardants, a fragrance additive, and a polymer pre-curser:
- 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)
- Phthalic anhydride
The U.S. EPA has signaled that it has received a manufacturer request for a EPA to undertake a risk evaluation of two additional phthalates which, if administrative requirements for such request have been met, the Agency would announce publicly in the very near term.
The 20 low priority candidate chemicals were selected from the U.S. EPA’s “Safer Chemicals Ingredients List”—a list of substances previously evaluated and considered to meet the U.S. EPA’s “Safer Choice” criteria for use in certain common product categories, such as cleaning products.
Other Recent and Impending U.S. EPA Actions Under TSCA
Given the numerous deadlines that are looming under the amendments to TSCA, it is critical that chemical manufacturers and processors of chemicals and formulations remain aware of the recent and upcoming actions under TSCA that can significantly impact their businesses. The following provides a short list of important actions of which to be aware.
Active/Inactive TSCA Inventory Designations. EPA released an updated version of the TSCA Inventory in February 2019. The Inventory is available for download here. This version of the Inventory includes chemical substances reported by manufacturers and processors by their respective reporting deadlines in 2018. The updated TSCA Inventory (confidential and non-confidential versions) includes 40,655 “active” chemical substances and 45,573 “inactive” chemical substances. Once the current 90-day “transition period” has concluded, it will be unlawful to manufacture, import or process in the US any substance that is listed as “inactive” without first providing notice to the U.S. EPA. Thus, prior to the expiration of the “transition period” on May 20, 2019, manufacturers and processors of chemical substances that are not listed as active on the February 2019 TSCA Inventory must take steps to activate the substance by filing a Notice of Activity (NOA Form B) for any chemical substance that they currently are manufacturing or processing, or anticipate manufacturing or processing within 90 days of submission.
Final TSCA Section 6(a) for Methylene Chloride in Paint and Coating Removers. EPA has released its long-awaited TSCA Section 6(a) rule restricting the use of methylene chloride in paint and coating removers. The final rule prohibits the manufacture, processing, and distribution of methylene chloride in paint removers for consumer use. The rule prohibits the sale of methylene chloride-containing paint and coating removers at retail establishments with any consumer sales (including e-commerce sales). The U.S. EPA declined to finalize its determination that the commercial use of methylene chloride-containing paint and coating removers presents an unreasonable risk. Therefore, distributors to commercial users, industrial users, and other businesses will continue to be permitted to distribute methylene chloride-containing paint and coating removers. However, given recent efforts by store-front retailers to “deselect” such products for consumer sales, it remains unclear how distributions to commercial users can or will occur.
The U.S. EPA simultaneously released an advanced notice of proposed rulemaking related to a potential certification program for commercial uses of methylene chloride-containing paint and coating removers. The U.S. EPA has similar programs in place for certain pesticides and refrigerants, and the United Kingdom currently has in place a program to certify commercial users of methylene chloride-containing paint and coating removers. The U.S. EPA is seeking comment on whether a certification program is the appropriate tool to address any potential risks that could be posed by the commercial use of methylene chloride-containing paint and coating removers.
Upcoming Draft Risk Evaluations. The U.S. EPA is expected to publish within days or weeks the highly anticipated draft Risk Evaluations for the remaining 9 of the 10 initial substances to undergo TSCA Risk Evaluations under the amended law and which have been under review since December 2016. The Agency will accept comments on the drafts for a limited period.
Proposed Rules for 5 PBT substances. The U.S. EPA is required to issue no later than June 2019 proposed TSCA Section 6 regulations for 5 persistent, bioaccumulative and toxic (PBT) substances that were identified during 2016 as priorities for regulatory action. The Agency must propose expedited rules intended to reduce exposures to the extent practicable.
*Camille Heyboer also contributed to this Advisory.
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About the Author
Lawrence Culleen represents clients on administrative, regulatory, and enforcement matters involving federal agencies such as the U.S. Environmental Protection Agency (EPA), the US Department of Agriculture, the US Food and Drug Administration, and the Consumer Product Safety Commission. Mr. Culleen has broad experience advising clients on US and international regulatory programs that govern commercial and consumer use chemicals, pesticides and antimicrobials, as well as the products of biotechnology and nanoscale materials. Prior to joining the firm, Mr. Culleen held significant positions at EPA serving as a manager in various risk-management programs which oversee pesticides, chemical substances, and biotechnology products.