TSCA Work Plan Chemicals
On Jan. 4, 2013, EPA signed a Federal Register notice (10 pp., 79 kb.) About PDF) announcing the availability of draft risk assessments for 5 2012 Work Plan chemicals. Read or download a brief summary overview of the draft risk assessments. (2 pp., 112 kb.) About PDF) Comments are due 60 days after publication in the Federal Register. Read the press release.
- Existing Chemical Strategy and Identification of 83 Chemicals for Review
- What Chemicals Did EPA Assess in 2012?
- What Chemicals Will EPA Assess in 2013/2014?
- How Were the TSCA Workplan Chemicals Selected?
- Will EPA Consider Chemicals not on the Work Plan?
Existing Chemical Strategy and Identification of 83 Chemicals for Review
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. EPA intends to use the TSCA Work Plan Chemicals (PDF) (11 pp, 454 kb) About PDF to help focus and direct the activities of the Existing Chemicals Program over the next several years.
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 (10 pp., 79 kb.) About PDF) 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 are due no later than 60 days after publication of the Federal Register. 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.
- Antimony Trioxide
- HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[γ]-2-benzopyran)
- Methylene Chloride
- Draft Risk Assessment (PDF) (169 pp., 3.6 mb.) About PDF)
- Peer Review Plan
- Link to docket –Methylene Chloride and N-Methylpyrrolidone (EPA-HQ-OPPT-2012-0725)
- N-Methylpyrrolidone (NMP)
- Draft Risk Assessment (PDF) (166 pp., 4.4 mb.) About PDF)
- Peer Review Plan
- Link to docket – Methylene Chloride and N-Methylpyrrolidone (EPA-HQ-OPPT-2012-0725)
- NMP Physiologically Based Pharmacokinetic (PBPK) Model (.ZIP file; 3.1 MB)
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.
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.
What Chemicals Will EPA Assess in 2013/2014?
On June 1, 2012, EPA identified an additional 18 of the Work Plan chemicals for assessment during 2013 and 2014.
EPA identified these chemicals at this time for a variety of reasons, similar to those it used to identify the seven Work Plan chemicals to assess in 2012. The 18 chemicals span the range of the Work Plan screening criteria, including some chemicals associated with specific hazards such as potential carcinogenicity or reproductive or developmental toxicity; chemicals presenting persistent, bioaccumulative, and toxic potential; and chemicals found in biomonitoring or reported in consumer products. Some of these chemicals, such as the five chlorinated hydrocarbons, the three flame retardants, and the four fragrance chemicals, may present an effective opportunity to assess groups of related chemicals together.
In conducting risk assessments on these 18 chemicals, EPA will use information available through the data sources cited in the TSCA Work Plan Chemicals Methods Document, as well as other sources. EPA would welcome 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 August 31, 2012. 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.
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.