2017 Annual Report on Risk Evaluations

Background.

On June 22, 2016 the President signed the Frank R. Lautenberg Chemicals Safety for the 21st
Century Act, which amended the Toxic Substances Control Act (TSCA). Section 26(n)(2) of the
law requires, that EPA at the beginning of each calendar year, publish an annual plan. This plan
must identify the chemical substances that will undergo risk evaluation during that year,
chemicals for which risk evaluation will be initiated and those for which risk evaluation will be
completed. This report must also identify the resources necessary to complete these tasks. For
the ongoing risk evaluations, the report must describe the status of each evaluation and the
schedule for completion including any changes or updates to the schedule.

Initiated Chemical Risk Evaluations.

Upon signature of the amended TSCA, EPA was required to immediately implement many of
the new authorities and obligations. One of these was to identify and begin risk evaluations on
ten chemical substances. The law requires that the ten chemicals be drawn from the 2014
Update of the TSCA Work Plan for Chemical Assessments and that EPA publish this list within
180 days of enactment. EPA’s designation of the first ten chemical substances constituted the
initiation of the risk evaluation process for each of these chemical substances, pursuant to the
requirements of TSCA section 6(b)(4).

On December 19, 2016, EPA published the list of the initial ten chemicals to be evaluated to
determine whether the chemical substance presents an unreasonable risk of injury to health or
the environment. These chemicals are:

  • 1, 4 Dioxane
  • Methylene Chloride
  • 1-Bromopropane
  • N-Methylpyrolidone
  • Asbestos
  • Pigment Violet 29
  • Carbon Tetrachloride
  • Trichloroethylene
  • Cyclic Aliphatic Bromide Cluster (HBCD)
  • Tetrachloroethylene

Read the Federal Register Notice announcing these first ten chemicals.

TSCA requires that within six months from the date of initiation of a risk evaluation, EPA issue a
scoping document. This document must include the hazard(s), exposure(s), condition(s) of use,
and the potentially exposed or susceptible subpopulation(s) the Administrator expects to
consider in the evaluation. EPA expects to publish the scoping document for each of the initial
ten chemicals by June 19, 2017. Read more about the evaluation process of the initial ten
chemicals.

To inform these scoping documents, EPA has taken steps to ensure that EPA receives input and
information from the public.

  • EPA established dockets for each of these chemical substances to document each risk
    evaluation and to facilitate receipt of information that will be useful to the Agency’s risk
    evaluation. Also added to the dockets are summaries of preliminary information on
    manufacturing, processing, distribution, use and disposal.
    Find the docket numbers for each of the ten chemicals.
  • On February 14, 2017 EPA will hold a public meeting to present information on the
    initial ten chemicals specific uses and “conditions of use” (i.e., the circumstances under
    which a chemical substance is intended, known, or reasonably foreseen to be
    manufactured, processed, distributed in commerce, used, or disposed of). The public
    will also have the opportunity to identify any additional information specifically related
    to the uses and conditions of use.
    Read the Federal Register notice announcing the meeting and associated public
    comment.

After the publication of the scoping documents for these initial chemicals, EPA will continue with the risk evaluation process as described in the statute and the associated Risk Evaluation Rule (described below), with the expectation to complete the risk evaluation in the 3-3.5 year timeframe required by law.

Additional Chemical Risk Prioritization and Evaluations.

For chemicals beyond the initial ten, TSCA requires that within the first year, EPA establish by
rule:
1) a process for prioritizing chemical substances for risk evaluation and
2) a process for risk evaluation to determine if a chemical substance presents an unreasonable risk to human health or the environment.

EPA held two public meetings on August 9 and 10 to gather input on these processes.

On January 17, 2017, EPA proposed a rule on the procedures for prioritization of chemicals for
risk evaluation under TSCA. This rule proposes a risk-based screening process and criteria EPA
will use to identify chemical substances as either High-Priority Substances for risk evaluation, or
Low-Priority Substances for which risk evaluations are not warranted at the time.

Read the Federal Register Notice.

In addition, on January 19, 2017, EPA proposed a rule on procedures for chemical risk
evaluation under TSCA. This rule proposes a process for conducting risk evaluations to
determine whether a chemical substance presents an unreasonable risk of injury to health or
the environment, without consideration of costs or other non-risk factors, including
unreasonable risks to potentially exposed or susceptible subpopulations, under the conditions
of use.

Read the Federal Register Notice.

EPA will review and respond to public comments on both of these rules and develop final rules. Both of these process rules are scheduled to be finalized on or before June 22, 2017.

Resources Necessary for Risk Evaluations.

On January 18, 2017 EPA submitted an initial report to Congress, as required under section
26(m)(1) of TSCA as amended. This report includes descriptions of the EPA’s capacity to conduct
and publish risk evaluations under TSCA section 6 and the resources necessary to conduct such
risk evaluations. This report details the projected resources necessary to conduct the initial ten
risk evaluations.

Read the Initial Report to Congress on the EPA’s Capacity to Implement Certain Provisions of
the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Conclusion. 

This report serves at the first annual report on risk evaluations as required under the amended
TSCA. Work has begun on the risk evaluations for the first ten chemical substances. The
Agency is in the process of seeking public input on use information of these chemicals and will
by the end of the calendar have published scoping documents on these ten chemicals. For
chemicals beyond the first ten, EPA has proposed rules on the processes for prioritizing and
evaluating chemicals. A report has been submitted to Congress on the resources necessary to
complete this work.

To download the report, please visit https://www.epa.gov/sites/production/files/2017-02/documents/2017annualreportriskevaluations.pdf]]>

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