Assessing and Managing Chemicals under TSCA

Assessments for TSCA Work Plan Chemicals

Please Note

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act. EPA will update its web pages to conform to the provisions of the statute, but until then some content may be out of date. Learn more about the new law, find summary information and read frequently asked questions.

See the TSCA Work Plan Chemicals webpage for background information.

This page explains the assessment process and provides the status of EPA’s ongoing assessments of chemicals in the TSCA Work Plan and assessment-related activities and documents.

If potential risks are indicated in the final TSCA risk assessment following peer review and public comment, the Agency will take necessary risk reduction actions. If no risks are identified in the final assessment, the Agency may conclude its work on the chemical uses being assessed.

On this page:

Overview

EPA develops TSCA Work Plan Chemical assessments using the best available information and approaches. Assessments focus on those TSCA uses of the chemical with significant potential for exposure to humans and/or the environment. In some cases, EPA’s TSCA Work Plan Chemical assessments will address chemicals that are not on the TSCA Work Plan when it is advantageous to group and review related/similar chemicals together. For example, EPA may assess groups of structurally similar chemicals in order to support more informed decisions about alternative substances with similar properties and potential uses.

TSCA Work Plan Chemical Assessment Process

Problem Formulation and Initial Assessment

As a first step in evaluating TSCA Work Plan Chemicals, EPA performs problem formulation to determine if available data and current assessment approaches and tools will support the assessments. Problem formulation is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined. Problem formulation draws from regulatory, decision-making and policy context of the assessment, informs the technical approach to the assessment and systematically identifies the major factors to be considered in risk assessment. Outcomes of a problem formulation are:

  • Conceptual Model – including a visual representation and written description of actual or predicted relationships between chemicals and human or wildlife, and
  • Analysis Plan – describing the intentions regarding the technical aspects of the risk assessment

Based on on-going experience in conducting TSCA Work Plan Chemical assessments and stakeholder feedback, starting in 2015 EPA will publish a problem formulation for each TSCA Work Plan assessment as stand-alone document to facilitate public and stakeholder comment and input prior to conducting further risk analysis. Commensurate with release of a problem formulation document, EPA will open a public docket for receiving comments, data or information from interested stakeholders. EPA believes publishing problem formulations for TSCA Work Plan assessments will increase transparency of EPA’s thinking and analysis process, provide opportunity for public/stakeholders to comment on EPA approach and provide additional information/data to supplement or refine assessment approach prior to EPA conducting detailed risk analysis and risk characterization. If problem formulation indicates the need to conduct a risk assessment, and there are enough data to do so, EPA will initiate a risk assessment which is the process to estimate the nature and probability of adverse health and environmental effects in humans and ecological receptors from chemical contaminants that may be present in the environment.

Data Needs Assessment

In some instances, as a result of problem formulation, EPA identifies data gaps (uses, exposure pathways, toxicity data) so significant as to prevent conducting meaningful risk assessment. In these cases, EPA will publish a Data Needs Assessment document and provide opportunity for public/stakeholders to comment or identify/provide data or information that may fill identified data gaps prior to EPA pursing data collection via TSCA authorities.

Opportunities for Public Input

EPA issues draft risk assessments for public review and comment followed by independent peer review in accordance with Agency peer review guidelines. The Agency considers all public and peer review comments as it revises and finalizes the risk assessment. There are multiple opportunities for public input on peer review plans, chemical assessments, and opportunities to submit relevant data on assessments to the EPA docket. These opportunities for public input on chemicals may include:

  • When chemicals are listed on the annual work plan list
  • When EPA publishes a problem formulation or data needs assessment
  • When EPA publishes a data needs assessment
  • When EPA announces a peer review plan
  • When EPA releases a draft risk assessment for public comment and peer review

Draft Assessments for Peer Review and Public Comment

To date, EPA has released draft assessments for the TSCA Work Plan Chemicals listed below for peer review and public comment.

  • 1-Bromopropane (1-BP)
    This draft assessment addresses effects of 1-BP on human health from occupational and consumer uses of 1-Bromopropane (1-BP), also referred to a n-propyl bromide, in spray adhesives, dry-cleaning (including spot cleaners) and degreasing operations. EPA did not evaluate potential risks to the environment associated with 1-BP because it has a low hazard profile for ecological receptors and low persistence and bioaccumulation if released into aquatic or terrestrial environments.
    1. CASRN: 106-94-5
    2. Initiated: 2013
    3. Peer Review Plan (PDF)
    4. Peer Review Charge Questions (Draft)
    5. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2015-0084)
      Supplemental Files can be found in the docket above.
      1. Supplemental File 1:  1-BP Cancer Risk Estimates (Excel)
      2. Supplemental File 2:  1-BP Non-Cancer MOE Risk Estimates (Excel)
      3. Supplemental File 3:  1-BP Consumer Exposure Calculations (Excel)
    6. Model Averaging for Dichotomous Response Benchmark Dose (MADr-BMD) Tool Please note: This file must be downloaded before it can be opened.
    7. Fact Sheet on 1-BP

Completed Chemical Assessments

To date, EPA has completed assessments for the TSCA Work Plan Chemicals listed below.

Completed Problem Formulation and Initial Assessments

To date, EPA has released Problem Formulation and Initial Assessments for the TSCA Work Plan Chemicals listed below.

  • Chlorinated Phosphate Esters Cluster (chemical in bold is on EPA’s TSCA Work Plan)
    On August 13, 2015, EPA released a problem formulation for Chlorinated Phosphate Esters used as flame retardants in furniture foams and textiles. The goal of this problem formulation was to identify scenarios where further risk analysis may be necessary. The conclusion of this problem formulation is that EPA will assess risks to consumers, the general population and aquatic organisms exposed as a result of manufacture, processing and use of chlorinated phosphate esters cluster members.
    1. Cluster chemicals
      1. Ethanol, 2-chloro-, phosphate (3:1) (TCEP, CASRN: 115-96-8)
      2. 2-Propanol, 1-chloro-, 2,2’,2’’-phosphate (TCPP, CASRN: 13674-84-5)
      3. 2-Propanol, 1,3-dichloro-, phosphate (3:1) (TDCPP, CASRN: 13674-87-8)
    2. Initiated: 2014
    3. Problem Formulation and Initial Assessment (PDF) (Docket: EPA-HQ-OPPT-2015-0068)
    4. Fact Sheet on flame retardant clusters
  • Cyclic Aliphatic Bromides Cluster (chemical in bold is on EPA’s TSCA Work Plan)
    On August 13, 2015, EPA released a problem formulation for the Cyclic Aliphatic Bromides used as a flame retardant in extruded and expanded polystyrene foams (EPS/XPS), polystyrene (PS) products. The goal of this problem formulation was to identify scenarios where further risk analysis may be necessary. The conclusion of this problem formulation is that EPA will assess risks to workers, consumers, the general population and aquatic, terrestrial and avian wildlife exposed as a result of manufacture, processing and use of HBCD.
    1. Cluster chemicals
      1. Hexabromocyclododecane (HBCD, CASRN: 25637-99-4)
      2. 1,2,5,6,9,10-Hexabromocyclododecane (CASRN: 3194-55-6)
      3. 1,2,5,6-Tetrabromocyclooctane (CASRN: 3194-57-8)
    2. Initiated: 2014
    3. Problem Formulation and Initial Assessment (PDF) (Docket: EPA–HQ–OPPT-2015-0081)
    4. Fact Sheet on flame retardant clusters
  • Brominated Phthalate Cluster (chemical in bold is on EPA’s TSCA Work Plan)
    On August 13, 2015, EPA released a data needs assessment for the Brominated Phthalate Cluster used as flame retardants in polyurethane foams.  During problem formulation, EPA/OPPT reviewed previous assessments and identified critical gaps in toxicity, exposure, and commercial mixtures data. The data needs assessment is intended to guide the collection of additional data and information.
    1. Cluster chemicals
      1. 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1,2-bis(2-ethylhexyl) esters (TBPH, CASRN: 26040-51-7)
      2. Benzoic acid, 2,3,4,5-tetrabromo-, 2-ethylhexyl esters (TBB, CASRN: 183658-27-7)
      3. 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromobenzenedicaroxylate (CASRN: 77098-07-8)
      4. 3,4,5,6-Tetrabromo-1,2-benzenedicarboxylic acid, mixed esters with diethylene glycol and propylene glycol (CASRN: 20566-35-2)
      5. 1,2- (2,3-dibromopropyl) benzenedicarboxylate (CASRN: 7415-86-3)
    2. Two substances in the Brominated Phthalates Cluster Flame Retardants Workplan were identified as Confidential A and Confidential B.  Please be advised that these two substances refer to chemicals reported in the TSCA section 5 program as P-96-0965 and P-04-0404.
    3. Initiated: 2013
    4. Data Needs Assessment (EPA–HQ–OPPT– 2014-0491)
      1. BPC Data Needs Assessment Technical Supplement: P Chem and Fate (PDF)
      2. BPC Data Needs Assessment Technical Supplement: Use and Exposure (PDF)
      3. BPC Data Needs Assessment Technical Supplement: Hazard (PDF)
    5. Fact Sheet on flame retardant clusters
  • 1,4-Dioxane
    This problem formulation and initial assessment examined likely 1,4-Dioxane exposure and hazard scenarios to workers and consumers based on current production, use, and fate information. The goal of this problem formulation and initial assessment was to identify scenarios where further risk analysis may be necessary. On April 20, 2015, EPA released a problem formulation and initial assessment. The conclusions are: a) there are no risks to the general population through exposure to air emissions; b) an assessment of risk from drinking water is not needed at this time because 1,4-Dioxane is currently being monitored and EPA will determine whether or not regulatory action is needed as part of its Regulatory Determination Process; c) EPA/OPPT will further assess risks to workers and consumers exposed to 1,4-Dioxane through certain uses. EPA plans to review and evaluate the results of previous exposure assessments and health benchmarks for this chemical. As a result, EPA/OPPT will develop margins of exposure and cancer risk estimates to evaluate the potential risks from worker and consumer exposure to 1,4-Dioxane.
    1. CASRN: 123-91-1
    2. Initiated: 2014
  • Problem Formulation and Initial Assessment (Docket: EPA-HQ-OPPT-2015-0078)

Ongoing Chemical Assessments

To date, EPA has initiated assessments for the TSCA Work Plan Chemicals listed below.

  • Long-chained Chlorinated Paraffins (LCCPs; C 18-20)
    This assessment addresses the use of LCCPs as metal working and compounding agents and its effects on ecological receptors.
    1. Initiated: 2012
    2. These chemicals are being assessed as Premanufacture Notices (PMNs) under section 5 of TSCA, rather than as Work Plan chemicals. Learn more.
  • Medium-chained Chlorinated Paraffins (MCCPs; C 14-17)
    This assessment addresses the use of MCCPs as metal working and compounding agents and its effects on ecological receptors.
    1. Initiated: 2012
    2. These chemicals are being assessed as Premanufacture Notices (PMNs) under section 5 of TSCA, rather than as Work Plan chemicals. Learn more.
  • Octamethylcyclotetrasiloxane (D4)
    This assessment addresses down the drain releases of D4 and its effects on ecological receptors.
    1. CASRN: 556-67-2
    2. Initiated: 2012
    3. On April 2, 2014, EPA signed an Enforceable Consent Agreement with five manufacturers of D4. The testing program will be conducted over a one year period. The information gathered by the ECA will be used in conjunction with other available data to assess exposures and risks due to environmental releases from D4. (Docket: EPA-HQ-OPPT-2012-0209-0068)