
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91927-91929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30468]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0718; FRL-9956-47]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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.

[[Page 91928]]


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

[[Page 91929]]

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.

    Dated: December 13, 2016.
James J. Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2016-30468 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P


