Assessing and Managing Chemicals under TSCA

Evaluating Risk of Existing Chemicals under TSCA

Under TSCA EPA is now required to evaluate existing chemicals to determine whether they “present an unreasonable risk of injury to health or the environment.”  Under the conditions of use for each chemical, EPA will assess the hazard(s), exposure(s), and the potentially exposed or susceptible subpopulations(s) the Agency plans to consider. This information will be used to make a final determination as to whether the chemical presents an unreasonable risk.

Learn more about chemical risk evaluations under TSCA.

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Risk Evaluation Process for Existing Chemicals

The first step in the risk evaluation process, as outlined in TSCA, is to issue a scoping document for each chemical substance within six months of its designation in the Federal Register (i.e., by June 19, 2017 for the first ten chemicals selected). The scoping document will include information about the chemical substance, such as conditions of use, exposures, including potentially exposed or susceptible subpopulations, and hazards, that the Agency expects to consider in the risk evaluation. TSCA requires that these chemical risk evaluations be completed within three years of initiation, allowing for a single 6-month extension.

First 10 Chemicals Selected for Risk Evaluation

EPA announced the first 10 chemicals it will evaluate for potential risks to human health and the environment under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

These chemicals are:

1, 4 Dioxane
1-Bromopropane
Asbestos
Carbon Tetrachloride
Cyclic Aliphatic Bromide Cluster (HBCD)

Methylene Chloride
N-Methylpyrolidone
Pigment Violet 29
Trichloroethylene
Tetrachloroethylene

TSCA requires that EPA choose the first 10 chemicals from the list of 90 chemicals on the 2014 Update to the TSCA Work Plan. TSCA Work Plan chemicals were selected based on their hazard and the public’s potential exposure, as well as other considerations such as persistence and bioaccumulation. In selecting the first 10 chemicals, EPA also took into account recommendations from the public, industry, environmental and public health groups, and members of Congress and tried to give weight to chemicals where work on assessing risks were underway.

Additional Chemicals to be Selected for Risk Evaluation

Additional chemicals will be designated for evaluation. The first 10 chemical selected for initial risk evaluations are only the start of renewed efforts under amended TSCA to review the safety and mitigate the risks of chemicals already on the market. For each risk evaluation that EPA completes, TSCA requires that EPA begin another.  Additionally, by the end of 2019, EPA must have at least 20 chemical risk evaluations ongoing at any given time.  

All of the remaining Work Plan chemicals will be reviewed for their potential hazard and exposure. The law requires that at least half of all EPA-initiated risk evaluations be drawn from the TSCA Work Plan until that list has been exhausted.

Learn about EPA’s proposed process and criteria for identifying high- and low-priority chemicals for evaluation.

Learn about EPA’s proposed process for evaluating the risks of high-priority chemicals.

Opportunities for Public Input

To assist EPA in this scoping process, EPA is providing the public an opportunity to identify information specifically related to the conditions of use that would assist the Agency in identifying potential exposure scenarios. EPA has established separate dockets for each of the ten initial chemical substances for risk evaluation ) to facilitate receipt of information which may be useful to the Agency’s risk evaluations. EPA is requesting that any such information by submitted by March 1, 2017.

Information can be submitted by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting information or comments. Once submitted, this information cannot be edited or withdrawn. EPA may publish any information received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written statement or information.  The written information should include discussion of all points you wish to make. Learn more about CBI or multimedia submissions, and general guidance on making effective comments or providing useful information/.
  • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460-0001.
  • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow instructions at http://www.epa.gov/dockets/contacts.html.

Public Meetings

February 14, 2017 – Public Meeting on Risk Evaluation Scoping Efforts under TSCA for Ten Chemical Substances

EPA will hold a public meeting to receive input and information to assist the Agency in its efforts to establish the scope of risk evaluations under development for the ten chemical substances designated on December 19, 2016 for risk evaluations pursuant to the Toxic Substances Control Act (TSCA), as amended. In particular, EPA is providing the public an opportunity to identify information specifically related to the conditions of use for the ten chemical substances (i.e., the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of). Read the Federal Register notice announcing the meeting (PDF).(10 pp, 287 K, About PDF)

Meeting date: February 14, 2017 from 9:00 a.m. to 3:00 p.m.

Meeting location: Ronald Reagan Building and International Trade Center, in the Polaris Room, located at 1300 Pennsylvania Avenue Northwest, Washington, DC 20004. The meeting will also be available by remote access for registered participants. 

Meeting Registration. You may register online (preferred) or in person at the meeting.  To register online, for the meeting, go to:  https://tscachemicaluse.eventbrite.com. Advance registration for the meeting must be completed no later than February 10, 2017. On-site registration will be permitted, but seating and speaking priority will be given to those who pre-register by the deadline. For those who register to participate remotely, instructions will be emailed prior to the meeting. 

Comments.  EPA will hear oral comments at the meeting, and will accept written comments and materials submitted to the dockets on or before March 1, 2017.

Additional Information, Docket Numbers and Agency Contacts for the First 10 Chemicals

Chemical CASRN Exposure Information from 2014 Work Plan Hazard Information from 2014 Work Plan Docket ID No. Agency contact
1,4-Dioxane 123-91-1 Used in consumer products. Present in groundwater, ambient air and indoor environments. High reported releases to the environment.  Possible human carcinogen EPA-HQ-OPPT-2016-0723 Cindy Wheeler, wheeler.cindy@epa.gov, 202-566-0484
1-Bromopropane 106-94-5 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

EPA-HQ-OPPT-2016-0741

Ana Corado, corado.ana@epa.gov, 202-564-0140
Asbestos 1332-21-4 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 EPA-HQ-OPPT-2016-0736 Robert Courtnage, courtnage.robert@epa.gov, 202-566-1081
Carbon Tetrachloride  56-23-5 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 EPA-HQ-OPPT-2016-0733 Stephanie Jarmul, jarmul.stephanie@epa.gov, 202-564-6130
Cyclic Aliphatic Bromide Cluster (HBCD) 25637-99-4 Flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances. Acute aquatic toxicity EPA-HQ-OPPT-2016-0735 Sue Slotnick, slotnick.sue@epa.gov, 202-566-1973
Methylene Chloride 75-09-2 Used in consumer products. Present in drinking water, indoor environments, ambient air, groundwater, and soil.  Probable human carcinogen EPA-HQ-OPPT-2016-0742 Ana Corado, corado.ana@epa.gov, 202-564-0140
N-Methylpyrrolidone (NMP) 872-50-4 Used in consumer products.  Present in drinking water and indoor environments. High reported releases into the environment.  Reproductive toxicity EPA-HQ-OPPT-2016-0743 Ana Corado, corado.ana@epa.gov, 202-564-0140
Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d’e’f’]diisoquinoline-1,3,8,10(2H,9H)-tetrone) 81-33-4 Used in consumer products.  Estimated to have moderate releases to the environment. Aquatic toxicity EPA-HQ-OPPT-2016-0725 Hannah Braun, braun.hannah@epa.gov, 202-564-5614
Trichloroethylene (TCE) 79-01-6 Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, and soil.  Probable human carcinogen EPA-HQ-OPPT-2016-0737 Toni Krasnic, krasnic.toni@epa.gov, 202-564-0984
Tetrachloroethylene (also known as perchloroethylene) 127-18-4 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 EPA-HQ-OPPT-2016-0732

Tyler Lloyd, lloyd.tyler@epa.gov, 202-564-4016