Designation of Ten Chemical Substances for Initial Risk Evaluations Under the Toxic Substances Control Act

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

As required by the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, EPA is publishing an initial list of ten (10) chemical substances that will be the subject of the Agency's chemical risk evaluations to determine whether the chemical substances present an unreasonable risk of injury to health or the environment. The law requires that EPA initiate risk evaluations on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and that EPA publish this list within 180 days of enactment (i.e., by December 19, 2016). EPA's designation of the first ten chemical substances constitutes the initiation of the risk evaluation process for each of these chemical substances, pursuant to the requirements of TSCA section 6(b)(4). For each chemical substance, within six months from the date of publication of this notice, EPA will issue a scoping document. EPA has also established dockets for each of these chemical substances to document each risk evaluation and to facilitate receipt of information that will be useful to the Agency's risk evaluation.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Sheila Canavan, Chemical Control Division (Mail Code 7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 566-1978; email address: canavan.sheila@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use or dispose of any of the ten chemical substances identified in this document for risk evaluation. This action may be of particular interest to entities that are regulated under TSCA (e.g., entities identified under North American Industrial Classification System (NAICS) codes 325 and 324110, among others). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action.

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0718, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

EPA is announcing the first 10 chemical substances that it will evaluate for potential risks to human health and the environment under TSCA section 6(b)(2)(A), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act ( https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca#chemical names). As amended, the law requires that risk evaluation be initiated on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments (Ref. 1) and that EPA publish this list within 180 days of enactment (i.e., by December 19, 2016). The 10 chemical substances for which EPA is initiating risk evaluations are as follows:

• 1,4-Dioxane;
• 1-Bromopropane;
• Asbestos;
• Carbon Tetrachloride;
• Cyclic Aliphatic Bromide Cluster (HBCD);
• Methylene Chloride;
• N-Methylpyrrolidone (NMP);
• Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone);
• Trichloroethylene (TCE);
• Tetrachloroethylene (also known as perchloroethylene).

III. What is the authority for this action?

On June 22, 2016, the President signed into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which amended TSCA (15 U.S.C. 2601 et seq.). The amendments give EPA improved authority to take actions to protect people and the environment from the effects of dangerous chemical substances. Additional information on the new law is available on EPA's Web site at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act . One of the key features of the new law is the requirement that EPA now systematically prioritize and assess existing chemical substances and manage identified risks. Through a combination of new authorities, a risk-based safety standard, mandatory deadlines for action, and minimum throughput requirements, TSCA effectively creates a pipeline by which EPA will conduct review and management of existing chemical substances. This new pipeline—from prioritization to risk evaluation to risk management (when warranted)—is intended to drive steady forward progress on evaluating and addressing risks from existing chemical substances. Risk evaluation is a key step in this process.

TSCA section 6(b) specifies the requirements for risk evaluations. Section 6(b)(2)(A) requires EPA to “ensure that risk evaluations are being conducted on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such chemical substances” not later than 180 days after enactment of the law.

IV. Initiation for Risk Evaluation

A. Statutory Requirements for Risk Evaluations

EPA's designation in this document of the first 10 chemical substances for risk evaluation constitutes the initiation of the risk evaluation process for each of these chemical substances, pursuant to the requirements of section 6(b)(4) of TSCA. These chemical substances are now in the process of risk evaluation to determine whether they “present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.”

Within six months from the date of publication of this notice (i.e., June 19, 2017), EPA will issue a scoping document that will include information about the chemical substance, such as the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Agency expects to consider in the risk evaluation. TSCA generally requires that these chemical risk evaluations be completed within three years of initiation, allowing for a single 6-month extension.

For each risk evaluation that EPA completes (other than industry-requested risk evaluations under TSCA section 6(b)(4)(C)(ii)), TSCA requires that EPA begin another risk evaluation. Additional chemical substances will be designated as high priority for risk evaluation, and have their risks evaluated under section 6(b)(4). By the end of 2019, EPA must have at least 20 chemical risk evaluations ongoing at any given time.

B. How did EPA select the first 10 chemicals?

TSCA requires that EPA choose the first 10 chemical substances from the list of 90 chemical substances on the 2014 update of the TSCA Work Plan for Chemical Assessments. TSCA Work Plan chemicals were selected based on their hazard and potential exposure, as well as other considerations such as persistence and bioaccumulation. In selecting the first 10 chemical substances, EPA took into account scientific information documented in the 2014 Work Plan, and recommendations from stakeholders and the public. EPA has established a separate docket for each of these chemical substances to document the risk evaluation process and to facilitate receipt of information which may be useful to the Agency's risk evaluations. The following list of the first 10 chemical substances includes their exposure and hazard information from the 2014 Work Plan and their docket ID number:

1,4-Dioxane. Exposure Information from 2014 Work Plan: Used in consumer products. Present in groundwater, ambient air and indoor environments. High reported releases to the environment. Hazard Information from 2014 Work Plan: Possible human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0723.

1-Bromopropane. Exposure Information from 2014 Work Plan: Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, soil. Estimated to have high releases to the environment. Hazard Information from 2014 Work Plan: Possible human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0741.

Asbestos. Exposure Information from 2014 Work Plan: 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. Hazard Information from 2014 Work Plan: Known human carcinogen; Acute and chronic toxicity from inhalation exposures. Docket ID No.: EPA-HQ-OPPT-2016-0736.

Carbon Tetrachloride. Exposure Information from 2014 Work Plan: Used in commercial/industrial products. Present in biomonitoring, drinking water, indoor environments, surface water, ambient air, groundwater, soil. High reported releases to the environment. Hazard Information from 2014 Work Plan: Probable human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0733.

Cyclic Aliphatic Bromide Cluster (HBCD). Exposure Information from 2014 Work Plan: Flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances. Hazard Information from 2014 Work Plan: Acute aquatic toxicity. Docket ID No.: EPA-HQ-OPPT-2016-0735.

Methylene Chloride. Exposure Information from 2014 Work Plan: Used in consumer products. Present in drinking water, indoor environments, ambient air, groundwater, and soil. Hazard Information from 2014 Work Plan: Probable human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0742.

N-Methylpyrrolidone (NMP). Exposure Information from 2014 Work Plan: Used in consumer products. Present in drinking water and indoor environments. High reported releases into the environment. Hazard Information from 2014 Work Plan: Reproductive toxicity. Docket ID No.: EPA-HQ-OPPT-2016-0743.

Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-de'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone). Exposure Information from 2014 Work Plan: Used in consumer products. Estimated to have moderate releases to the environment. Hazard Information from 2014 Work Plan: Aquatic toxicity. Docket ID No.: EPA-HQ-OPPT-2016-0725.

Trichloroethylene (TCE). Exposure Information from 2014 Work Plan: Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, and soil. Hazard Information from 2014 Work Plan: Probable human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0737.

Tetrachloroethylene (also known as perchloroethylene). Exposure Information from 2014 Work Plan: Used in consumer products and dry cleaning. Present in biomonitoring, drinking water, indoor environments, ambient air, groundwater, soil. High reported releases to the environment. Hazard Information from 2014 Work Plan: Probable human carcinogen. Docket ID No.: EPA-HQ-OPPT-2016-0732.

III. References

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. Office of Pollution Prevention and Toxics. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-assessments-2014-update. October 2014.

Authority: 15 U.S.C. 2601 et seq.