October 13, 2019

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Announcement and Implications of First 10 Chemicals to Undergo Risk Evaluation

Fulfilling another of its mandates under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended the Toxic Substances Control Act (TSCA) effective June 22, 2016, the U.S. Environmental Protection Agency (EPA) announced the first 10 chemical substances on which it will conduct risk evaluations under section 6 of TSCA. Section 6(b)(2)(A) requires EPA to ensure that risk evaluations are being conducted on 10 chemicals drawn from EPA’s 2014 TSCA Work Plan Chemicals Assessment List by December 19, 2016, and to publish this “List of 10” within the same timeframe. 

EPA’s November 29, 2016 announcement, available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca, included the following table setting forth the List of 10 as well as existing hazard and exposure information for each chemical, which EPA compiled as part of the Work Plan.   

Chemical

Exposure   

Hazard

1,4-Dioxane

Used in consumer products. Present in groundwater, ambient air and indoor environments. High reported releases to the environment. 

Possible human carcinogen

1-Bromopropane

Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, soil. Estimated to have high releases to the environment. 

Possible human carcinogen

Asbestos

Used in chlor-alkali production, consumer products, coatings and compounds, plastics, roofing products, and other applications.  Also found in certain imported products such as brakes, friction products, gaskets, packing materials and building materials.

Known human carcinogen; Acute and chronic toxicity from inhalation exposures

Carbon Tetrachloride 

Used in commercial/industrial products. Present in biomonitoring, drinking water, indoor environments, surface water, ambient air, groundwater, soil. High reported releases to the environment.

Probable human carcinogen

Cyclic Aliphatic Bromide Cluster (HBCD)

Flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances.

Acute aquatic toxicity

Methylene Chloride (MC)

Used in consumer products. Present in drinking water, indoor environments, ambient air, groundwater, and soil. 

Probable human carcinogen

N-methylpyrrolidone (NMP)

Used in consumer products.  Present in drinking water and indoor environments. High reported releases into the environment. 

Reproductive toxicity

“Pigment Violet 29,” Anthra[2,1,9-def:6,5,10-d’e’f’]diisoquinoline-1,3,8,10(2H,9H)-tetrone 

Used in consumer products.  Estimated to have moderate releases to the environment.

Aquatic toxicity

Trichloroethylene (TCE)

Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, and soil. 

Probable human carcinogen

Tetrachloroethylene (also known as perchloroethylene)

Used in consumer products and dry cleaning. Present in biomonitoring, drinking water, indoor environments, ambient air, groundwater, soil. High reported releases to the environment. 

Probable human carcinogen

In selecting the first 10 chemicals, EPA indicated that it took into account recommendations from the public, industry, environmental and public health groups, and members of Congress. It is no surprise that asbestos is on the list. Vacatur of the previously proposed section 6 rule on asbestos in the 1991 Corrosion Proof Fittings case caused many to believe that section 6 was too challenging to implement and was the primary impetus for TSCA reform.[1] With the passage of the Lautenberg Act, many senators, including Senator Barbara Boxer (D-CA), have called on EPA to act on asbestos first.[2] 

EPA also indicated that in creating the list it attempted to prioritize chemicals for which it had already performed considerable work. Indeed, EPA has already initiated risk assessments for many of these chemicals under the Work Plan program and, thus, it could move forward with the notice and comment process quickly if it does not expand the scope of uses under evaluation. With respect to the subject substances
 

  • The Agency has completed risk assessments on three of these chemicals – MC, NMP and TCE – and, as we discussed here, has sent proposed section 6 risk management rules for them to the Office of Management and Budget for approval prior to publication in the Federal Register. Section 26(l)(4) of TSCA authorizes EPA to publish proposed and final section 6 rules for chemicals on which a risk assessment was completed under the Work Plan prior to June 22, 2016, which are consistent with the scope of such risk assessment and with other applicable requirements of section 6.  

  • A Draft Risk Assessment has been completed and peer reviewed, but not finalized, for 1-Bromopropane.

  • EPA has completed Work Plan Problem Formulation and Initial Assessments on HBCD and 1,4-dioxane. These documents may satisfy the scoping element of the new law. 

  • EPA has initiated no activity under the Work Plan for asbestos, carbon tetrachloride, Pigment Violet 29, or perchlorethylene.

Publication of this list in the Federal Register will trigger a series of statutory deadlines. Pursuant to section 6(b)(4)(D), EPA must release a risk evaluation scoping document between three and six months for at least the four chemicals for which no action has been initiated, which identifies the hazard(s), exposure(s), conditions of use, and the potentially exposed or susceptible subpopulation(s) the Agency plans to consider in the evaluation of each chemical. 

Section 6(b)(4)(G) requires EPA to complete the risk evaluations for all 10 chemicals within three years.  One of the major changes to TSCA was that these risk evaluations must not take into consideration cost or other non-risk factors. If EPA concludes that any of these chemicals presents an unreasonable risk, then the Agency must promulgate a risk management rule within two years of completing the risk evaluation, as mandated by section 6(c)(1)(B). Notably, Section 18(b)(1) entirely exempts chemicals in the List of 10 from preemption until the final section 6 rule is issued, so that states can continue to regulate these chemicals until such time. By contrast, chemicals designated by EPA as “high-priority” are subject to what is known as “pause preemption.”[3]  


[1] Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).

[2] See Senator Barbara Boxer’s August 26, 2016 letter to EPA, available at http://www.epw.senate.gov/public/index.cfm/2016/8/senator-barbara-boxer-.... On September 28, 2016, Sen. Boxer also introduced S. 3427, which would require EPA to identify and assess the known uses of, and exposures to, all forms of asbestos and then eliminate all human or environmental exposures. 

[3] See also https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-....

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 Thomas C. Berger, Keller Heckman, Environmental Protection lawyer, Product Liability Management Attorney
Partner

Tom Berger joined Keller and Heckman in 1993. Mr. Berger is a partner in Keller and Heckman's Washington DC office and heads Keller and Heckman's Indianapolis satellite office.

Mr. Berger has extensive experience in representing foreign and domestic companies, large and small, in a broad range of areas, including counseling, advocacy, and rulemaking in environmental law, occupational safety and health law, contracts, EPA enforcement proceedings, and chemical and product liability management. Mr. Berger assists clients in bringing new products to...

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Adrienne M. Timmel, Keller Heckman, Pre-Market Chemical Approval Lawyer, Products Safety Attorney
Associate

Adrienne Timmel practices in all areas of environmental law and also advises clients on product safety and energy performance matters. In particular, Ms. Timmel assists clients in obtaining pre-market approval of chemicals and pesticides in the U.S. and international markets. She has helped clients navigate and comply with the Federal fuels regulations and Federal energy efficiency regulations for residential appliances and commercial equipment.  Her work has also included counseling clients in the development of biofuels and engaging in settlement negotiations with the...

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