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Assessments for TSCA Work Plan Chemicals

Flame Retardant Clusters
EPA is Seeking Your Input

August 13, 2015 – EPA is issuing (9 pp, 40 kb, About PDF) problem formulation documents for three flame retardant clusters: Chlorinated Phosphate Esters, Cyclic Aliphatic Bromides, Tetrabromobisphenol A. Additionally, EPA released a data needs assessment for the Brominated Phthalates cluster which identifies critical gaps in toxicity, exposure, and commercial mixtures data.

EPA is continuing its efforts to develop assessments for chemicals in the Toxic Substances Control Act (TSCA) Work Plan (PDF) (28 pp, 258 kb, About PDF).

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 on the TSCA Work Plan and assessment-related activities and documents.

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 and initial assessments to determine if available data and current assessment approaches and tools will support the assessments. Problem formulation and initial assessment 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:

Based on on-going experience in conducting TSCA Work Plan Chemical assessments and stakeholder feedback, starting in 2015 EPA will publish a problem formulation and initial assessment for each TSCA Work Plan Chemical 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 and initial assessment document, EPA will open a public docket for receiving comments, data or information from interested stakeholders. EPA believes publishing problem formulations and initial assessments for TSCA Work Plan Chemicals 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.

Data Needs Assessment

In some instances, as a result of problem formulation and initial assessment, 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.

If problem formulation and initial assessment indicates risks are not likely or that data are insufficient to conduct a risk assessment, the Agency may conclude its work on the chemical and post the analysis performed to make such a conclusion. If problem formulation and initial assessment 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 and other stressors that may be present in the environment.

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:

Completed Chemical Assessments

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

  • N-Methylpyrrolidone (NMP)
    This risk assessment addresses N-Methylpyrrolidone (NMP) in paint and coating removal products. On March 23, 2015, EPA released the final risk assessment that indicates health risks to people, particularly pregnant women and women of childbearing age, who have high exposure to NMP through paint or coating removal products. EPA is considering a range of possible voluntary and regulatory actions to address risks from the use of NMP-containing paint and coating removal products.
    1. CASRN: 872-50-4
    2. Initiated: 2012
    3. Peer Review Plan
    4. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2012-0725)
    5. Peer Review Site
    6. Peer Review Report (PDF)(68 pp, 1.0 mb, About PDF)
    7. Final Risk Assessment (281 pp, 7.0 mb, About PDF)
    8. Response to Comments (40 pp, 371 kb, About PDF)
    9. Fact Sheet on NMP (3 pp, 90 kb, About PDF)

  • Antimony Trioxide (ATO)
    This risk assessment addresses effects on ecological receptors from the use of antimony trioxide (ATO) as a synergist in halogenated flame retardants. On August 28, 2014, EPA released the final risk assessment that indicated no concern for this use of ATO.
    1. CASRN: 1309-64-4
    2. Initiated: 2012
    3. Peer Review Plan
    4. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2012-0724)
    5. Peer Review Site
    6. Peer Review Report (PDF) (64 pp, 1.7 mb, About PDF)
    7. Final Risk Assessment (87 pp, 1.4 mb, About PDF)
    8. Response to Comments (20 pp, 161 kb, About PDF)

  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[γ]-2-benzopyran (HHCB)
    This risk assessment addresses ecological risks from HHCB as a fragrance ingredient in commercial and consumer products. On August 28, 2014, EPA released the final risk assessment that indicated no concern for this use of HHCB.
    1. CASRN: 1222-05-5
    2. Initiated: 2012
    3. Peer Review Plan
    4. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2012-0722)
    5. Peer Review Site
    6. Peer Review Report (PDF) (26 pp, 265 kb, About PDF)
    7. Final Risk Assessment (136 pp, 1.1 mb, About PDF)
    8. Response to Comments (23 pp, 519 kb, About PDF)

  • Methylene Chloride
    This risk assessment addresses methylene chloride also known as dichloromethane (DCM), in paint and coating removal products. On August 28, 2014, EPA released the final risk assessment that indicates health risks to both workers and consumers who use these products, and to bystanders in workplaces and residences where methylene chloride is used. EPA is considering a range of possible voluntary and regulatory actions to address risks from the use of methylene chloride-containing paint and coating removal products.
    1. CASRN: 872-50-4
    2. Initiated: 2012
    3. Peer Review Plan
    4. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2012-0725)
    5. Peer Review Site
    6. Peer Review Report (PDF) (23 pp, 98 kb, About PDF)
    7. Final Risk Assessment (279 pp, 7.2 mb, About PDF)
    8. Response to Comments (21 pp, 598 kb, About PDF)
    9. Fact Sheet on Methylene Chloride

  • Trichloroethylene (TCE)
    This risk assessment addresses trichloroethylene (TCE) as a degreaser, a spot-cleaner in dry cleaning and a spray-on protective coating. On June 25, 2014, EPA released the final risk assessment that identified health risks to consumers using spray aerosol degreasers and spray fixatives and to workers when TCE is used as a degreaser in small commercial shops and as a stain removing agent in dry cleaning. EPA held a workshop on July 29-30 on potential TCE degreaser alternatives and possible risk reduction approaches. Additional information on the workshop can be found in the Federal Register notice (9 pp, 106 kb, About PDF).
    1. CASRN: 79-01-6
    2. Initiated: 2012
    3. Peer Review Plan
    4. Draft Assessment and Public Comments (Docket: EPA-HQ-OPPT-2012-0723)
    5. Peer Review Site
    6. Peer Review Report (PDF) (166 pp, 3.7 mb, About PDF)
    7. Final Risk Assessment (212 pp, 3.0 mb, About PDF)
    8. Response to Comments (27 pp, 296 kb, About PDF)
    9. Fact Sheet on Trichloroethylene (TCE)

  • 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 (72 pp, 924 kb, About PDF)(Docket: EPA-HQ-OPPT-2015-0068)
  • 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 (97 pp, 1.0 mb, About PDF)(Docket: EPA–HQ–OPPT-2015-0081)
  • Tetrabromobisphenol A and Related Chemicals Cluster (chemical in bold is on EPA’s TSCA Work Plan)
    On August 13, 2015, EPA released a problem formulation for TBBPA and related chemicals used as a flame retardants in plastics/printed circuit boards for electronics. 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, sediment- and soil-dwelling organisms exposed due to the manufacture, processing and use of TBBPA.
    1. Cluster chemicals
      1. Tetrabromobisphenol A (TBBPA, CASRN: 79-94-7)
      2. TBBPA-bis(dibromopropyl ether) (CASRN: 21850-44-2)
      3. TBBPA-bis(ally ether) (CASRN: 25327-89-3)
      4. TBBPA-bis(methyl ether) (CASRN: 37853-61-5)
    2. Initiated: 2014
    3. Problem Formulation and Initial Assessment (135 pp, 1.13 mb, About PDF) (Docket: EPA-HQ-OPPT-2014-0730)
      1. Supplemental File 1 TBBPA Biomonitoring (14 pp, 231 kb, About PDF)
      2. Supplemental File 2 TBBPA Environmental Monitoring (59 pp, 773 kb, About PDF)
      3. Supplemental File 3 TBBPA Residential Monitoring (16 pp, 260 kb, About PDF)
      4. Supplemental File 4 Cancer Assessment Review Committee Report (15 pp, 314 kb, About PDF)
  • 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)
      6. Chemical A – Chemical Identity claimed confidential by manufacturer
      7. Chemical B – Chemical Identity claimed confidential by manufacturer
    2. Initiated: 2013
    3. Data Needs Assessment (EPA–HQ–OPPT– 2014-0491) (40 pp, 897 kb, About PDF)
      1. BPC Data Needs Assessment Technical Supplement: P Chem and Fate (17 pp, 212 kb, About PDF)
      2. BPC Data Needs Assessment Technical Supplement: Use and Exposure (17 pp, 217 kb, About PDF)
      3. BPC Data Needs Assessment Technical Supplement: Hazard (23 pp, 389 kb, About PDF)
  • 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
    3. 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.

  • 1-Bromopropane (1-BP)
    This assessment addresses occupational uses of 1-BP in dry-cleaning and foam gluing operations, consumer uses in aerosol solvent cleaners and spray adhesives, and its effects on human health.
    1. CASRN: 106-94-5
    2. Initiated: 2013
    3. Peer Review Plan (PDF) (5 pp, 79 kb, About PDF)

  • 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
  • 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
  • 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)

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