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Assessments for TSCA Work Plan Chemicals

1,4-Dioxane

April 20, 2015 - EPA released the final TSCA Work Plan Chemical Problem Formulation and Initial Assessment for 1,4-Dioxane. The problem formulation and initial assessment examined likely exposure and hazard scenarios to workers and consumers in order to identify scenarios where further risk analysis may be necessary. The assessment found no risks to the general population from inhalation exposure and low risks to aquatic life. EPA plans to conduct additional risk analysis on potential worker and consumer exposures.

N-Methylpyrrolidone (NMP)

March 23, 2015 - EPA released the final TSCA Work Plan Chemical Risk Assessment for N-Methylpyrrolidone (NMP). The NMP assessment identified acute and chronic health risks to people, particularly pregnant women and women of childbearing age, who who are exposed to paint and coating removal products containing high concentrations of NMP, but those risks could be minimized by using NMP-resistant gloves in well ventilated work areas to reduce exposure.

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.

Problem Formulation and Initial Assessments

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

Ongoing Chemical Assessments

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


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