(AGENPARL) - Roma, 23 Aprile 2024(AGENPARL) – mar 23 aprile 2024 Issued: Apr 23, 2024 (2:27pm EDT)
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EPA Finalizes Stronger Chemical Risk Evaluation Process to Protect Workers and
Communities
WASHINGTON – Today, April 23, 2024, the U.S. Environmental Protection
Agency finalized a rule that strengthens its process for conducting risk
evaluations on chemicals under the Toxic Substances Control Act (TSCA). These
improvements to EPA’s processes advance the goals of this important chemical
safety law, ensure that TSCA risk evaluations comprehensively account for the
risks associated with a chemical, and provide a solid foundation for
protecting public health, including workers and communities, from toxic
chemicals. The rule also includes changes to enhance environmental protections
in communities overburdened by pollution, complementing the Biden-Harris
Administration’s ambitious environmental justice agenda.
“Everything we do to protect our nation, including workers and communities,
from toxic chemical exposures must be comprehensive and grounded in strong
science,” said Assistant Administrator for the Office of Chemical Safety
and Pollution Prevention Michal Freedhoff. “This rule charts the path for
our risk evaluations to ensure we meet the core objective to protect public
health under our nation’s premier chemical safety law, which will in turn
lead to rules that workers and communities can count on to keep them safe.”
The 2016 TSCA amendments require that EPA establish a procedural framework
rule on the process for conducting chemical risk evaluations. TSCA risk
evaluations are the basis for EPA’s risk management rules that protect
people and the environment from harmful chemicals. Although EPA finalized a
risk evaluation framework rule in 2017, that rule was challenged in court. The
United States Court of Appeals for the Ninth Circuit remanded several
provisions of the rule back to the agency for reconsideration. Another aspect
of the litigation, related to the policy to categorically exclude the
consideration of exposures from breathing polluted air or drinking
contaminated water, was deemed not ripe for review by the court.
EPA’s final rule includes revisions made to respond to the court’s ruling,
as well as several changes to improve EPA’s process for TSCA risk
evaluations, including:
Consideration of real-world exposure scenarios such as multiple exposure
pathways (e.g., in air and water) to the same chemical, and combined risks
from multiple chemicals when EPA has the scientific information to do so,
which may be particularly important for communities who face greater exposures
or susceptibilities to chemicals than the rest of the general population.
A requirement that risk evaluations are comprehensive in scope and do not
exclude conditions of use or exposure pathways.
Clarifications to ensure EPA appropriately considers risks to all workers in
its risk evaluations.
Consideration of chemical uses that may be required for national security or
critical infrastructure by other Federal agencies.
Assurance the agency will continue to use the best available science to
conduct risk evaluations, that decisions are based on the weight of the
scientific evidence and that risk evaluations will be peer reviewed in
accordance with both federal and EPA guidance.
Discussion of chemical-specific fit-for-purpose approaches that allow for
varying types and levels of analysis so that risk evaluations focus less
rigorously on the conditions of use that are expected to pose low potential
risk and can reliably be completed within the timeframes required by the
statute.
A clear requirement for risk evaluations to culminate in a single risk
determination on the chemical substance, rather than on individual chemical
conditions of use in isolation, and improved communications regarding the uses
that significantly contribute to the unreasonable risk.
New procedures and criteria for whether and how EPA will revise scope and risk
evaluation documents, to improve transparency.
Adjustments to the process for submission and review of manufacturer requests
for risk evaluations of chemicals to better align with the process and
timeline associated with EPA-initiated risk evaluations, while also ensuring
that the agency can use the authorities provided under the law for gathering
any needed additional information on such chemicals.
A requirement that risk evaluations must explicitly consider overburdened
communities when identifying potentially exposed and susceptible populations
as relevant to the risk evaluation.
EPA announced many of the changes included in the final rule in 2021 and has
incorporated them into TSCA risk evaluation activities over the past three
years. EPA then proposed a revised procedural framework rule in October 2023
and, after carefully considering public comment on the proposed rule, released
today’s final rule. The procedures outlined in the rule apply to all risk
evaluations initiated 30 days after the date of publication of the final rule
or later. For risk evaluations that are currently in process, EPA expects to
apply the new procedures to those risk evaluations to the extent practicable,
taking into consideration the statutory requirements and deadlines.
Learn more about the TSCA risk evaluation process.
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