TSCA Work Plan Chemicals
On March 27, 2013, EPA announced the list of 23 chemicals it will begin assessing in 2013, including 20 flame retardant chemicals. Read the press release.
- Toxic Substances (TSCA) Work Plan
- Chemicals EPA Plans to Assess in 2013
- What Chemicals Did EPA Assess in 2012?
- How Were the TSCA Work Pan Chemicals Selected?
- Plans for Finalizing Assessments
- Will EPA Consider Chemicals not on the Work Plan?
Toxic Substances (TSCA) Work Plan
As part of EPA’s comprehensive approach to enhance the Agency’s existing chemicals management program, in March 2012, EPA identified a work plan of 83 chemicals for further assessment under the Toxic Substances Control Act (TSCA). EPA identified seven of these chemicals for risk assessment in 2012. On June 1, 2012, EPA identified 18 more of these chemicals for assessment in 2013 and 2014. On March 21, EPA identified chemicals for assessment in 2013.
Chemicals EPA Plans to Begin Assessing in 2013
March 27, 2013 - EPA announced the chemicals it will begin assessing in 2013. These include 20 flame retardant chemicals and three other non-flame retardant chemicals. EPA also made public its Plans for 2013 Assessments, which outlines the agency’s process for identifying these chemicals and the approach for assessment. Read the press release.
Flame retardant chemicals are used in a wide array of products including furniture, textiles, and electronic equipment. Some of these chemicals can persist in the environment, bioaccumulate in people and animals, and have been shown to cause adverse developmental effects in animals. Most of these chemicals have never been assessed for safety. EPA’s efforts to assess flame retardant chemicals in order to more fully understand their potential risks is part of the agency’s ongoing effort to address these chemicals and identify safer alternatives. Get additional information on efforts already underway for PBDE flame retardants. Also get information on EPA’s Design for the Environment (DfE) alternatives assessments for the DecaBDE flame retardants.
EPA will conduct a full risk assessment for four of the 20 flame retardants that have sufficient data, three of which are on the TSCA Work Plan and one that was the subject of an Action Plan developed under TSCA. The chemicals are:
- 2-Ethylhexyl ester 2,3,4,5- tetrabromobenzoate (TBB)
- 1,2- Ethylhexyl 3,4,5,6-tetrabromo-benzenedicarboxylate or (2-ethylhexyl)-3,4,5,6 tetrabromophthalate (TBPH)
- Tris(2-chloroethyl) phosphate (TCEP)
- Hexabromocyclododecane (HBCD)
EPA will utilize a structure-based approach, grouping eight other flame retardants with similar characteristics together with the chemicals targeted for full assessment in three groupings. EPA will use the information from these assessments to better understand the other chemicals in the group, which currently lack sufficient data for a full risk assessment.
The Agency will also begin environmental fate investigations, which will review how chemicals move and are transformed in the environment, of 8 other flame retardant chemicals that rank high for persistence, bioaccumulation and/or exposure potential, but for which there are not adequate data to conduct risk assessments.
During its review of data on flame retardant chemicals in commerce, EPA also identified approximately 50 flame retardant chemicals that are unlikely to pose a risk to human health, making them possible substitutes for more toxic flame retardant chemicals.
In addition to the flame retardant chemicals, EPA intends to begin risk assessment development on three other TSCA Work Plan chemicals, Octamethylcyclotetrasiloxane (D4); 1-Bromopropane; and 1,4 Dioxane.
In conducting risk assessments, EPA will use information available through the data sources cited in the TSCA Work Plan Chemicals Methods Document (39 pp., 1.0 mb.) About PDF , as well as other sources. EPA encourages the submission of additional relevant information on these chemicals, such as unpublished studies not already available through the existing literature, or information on uses and potential exposures. To meet the schedule for the completion of risk assessments, any relevant information to be included in the review process should be submitted to the Agency on or before May 30, 2013. The information can be submitted to docket, EPA-HQ-OPPT-2011-0516, online at Regulations.gov. The chemical name and CAS number involved should appear in the title of any submission to the docket. See the full list of Work Plan Chemicals (11 pp, 454 kb) About PDF.
What Chemicals Did EPA Assess in 2012?
On March 1, 2012, EPA identified an initial group of seven of the 83 Work Plan Chemicals for risk assessment in 2012. On August 17, 2012, EPA published the peer review plans for those initial risk assessments. The plans, which form part of the Agency's Peer Review Agenda, describe the focus of the risk assessment being conducted on each chemical, indicate how peer reviewers will be selected and how the peer independent scientific peer review will be conducted, and provide the time line for the reviews.
On January 4, 2013, EPA signed a Federal Register Notice announcing the availability of drafts of the first five Work Plan Chemical risk assessments, opening a 60-day period for public comment on the drafts, and requesting nominations for expert peer reviewers.
The five assessments address the following chemical uses: methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products. The draft assessments focus either on human health or ecological hazards for specific uses which are subject to regulation under TSCA. Three of the draft risk assessments— DCM, NMP, and TCE— indicate a potential concern for human health under specific exposure scenarios for particular uses. The preliminary assessments for ATO and HHCB indicate a low concern for ecological health. Read or download a brief summary overview of the draft risk assessments. (2 pp., 112 kb.) About PDF)
Copies of the draft risk assessments, the peer review plans, and docket information are outlined below. Comments on the draft assessments were due March 15, 2013 with the exception of NMP. The comment period for NMP has been extended to May 1, 2013. Nominations for the peer reviewers are due no later than 30 days after publication. Comments and nominations should be submitted to the dockets for each chemical.
EPA has issued draft risk assessments for the following chemicals:
- Antimony Trioxide
- HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[γ]-2-benzopyran)
- Methylene Chloride
- N-Methylpyrrolidone (NMP)
The draft assessments for methylene chloride and n-methylpyrrolidone are in the same docket because both assessments will be addressed by a single peer review panel. Substantive and relevant public comments will be included in the material presented with the draft assessments to the independent scientific peer review panels. The public will also be able to present comments at the panel review sessions that will be scheduled this spring. You can track the progress of the peer review process for each chemical by using the peer review plan links above.
The draft risk assessments on the chlorinated paraffins, the final two chemicals in the initial review group of seven, will be released for public comment through a separate Federal Register notice issued when those assessments are complete.
Plans for Finalizing Assessments
EPA will begin finalizing the risk assessments in the fall of 2013 following the public comment period and peer review process. If an assessment of specific uses indicates potential risk of concern, EPA will evaluate and pursue appropriate risk reduction actions, as warranted. If an assessment indicates negligible risk, EPA will conclude its current work on assessment of those specified targeted uses of that chemical. Over time, additional chemicals will be added to the work plan as more data are developed and more chemicals screened.
How Were the TSCA Work Plan Chemicals Selected?
EPA conducted an online discussion forum and webinar in 2011 to gather stakeholder input on proposed criteria and data sources to be used for identifying chemicals for further assessment. The process EPA adopted emphasized focusing on chemicals that meet one or more of the following factors:
- Potentially of concern to children’s health (for example, because of reproductive or developmental effects)
- Neurotoxic effects
- Persistent, Bioaccumulative, and Toxic (PBT)
- Probable or known carcinogens
- Used in children’s products
- Detected in biomonitoring programs
Using this process, EPA identified 83 chemicals in the TSCA Work Plan as candidates for risk assessment in the next several years, as they all scored high in this screening process based on their combined hazard, exposure, and persistence and bioaccumulation characteristics. In identifying a smaller set of chemicals for work in any given year, EPA considers a number of factors:
- Whether the chemical was identified as a “High” ranking chemical.
- Whether the chemical reflects more than one of the factors identified in Step 1 (for example, chemicals that were identified as a potential concern for children’s health and also were persistent, bioaccumulative, and toxic) and whether each of the factors was covered by the set of chemicals. These factors included health and environmental hazards, children’s health, use in consumer products and dispersive uses, persistence and bioaccumulation, and detection in biomonitoring and environmental monitoring.
- Whether certain chemicals, or groups of chemicals, would benefit from some preliminary work to assure that risk assessments are targeted and scoped appropriately, and therefore would best be addressed in an out year.
- Whether certain chemicals, or groups of chemicals, have previously been assessed and addressed by the Agency, so that risk assessment in later years may be more appropriate than in the earlier years of the work plan.
- Agency work load considerations, including scope and timing of work needed on specific chemicals, and existing commitments for assessment.
Read the TSCA Work Plan Chemicals Methods Document (39 pp., 1.0 mb.) About PDF for a detailed explanation of the approach the Agency used to identify these chemicals.
Will EPA Consider Chemicals Not on the Work Plan?
Identification of chemicals as Work Plan Chemicals (39 pp., 1.0 mb.) About PDF) does not mean that EPA would not consider other chemicals for risk assessment and potential risk management action under TSCA and other statutes. EPA will consider other chemicals if warranted by available information.
EPA will also continue to use its TSCA information collection, testing, and subpoena authorities, including sections 4, 8, and 11(c) of TSCA, to develop needed information on additional chemicals that currently have less robust hazard or exposure data.