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ACC Calls on EPA to Withdraw its Flawed PV29 Risk Evaluation and Draft Revised Risk Determination

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Telly Lovelace
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WASHINGTON (April 21, 2022) — The American Chemistry Council (ACC) today filed comments with the Environmental Protection Agency regarding its proposed revised risk determination for Colour Index Pigment Violet 29 (PV29). Of particular concern, for the second time, EPA has taken a “whole chemical approach” to a risk determination—instead of making “condition-of-use-specific” determinations. Also, the Agency continues to assume that personal protective equipment (PPE), including PPE required by OSHA, is not used in the workplace.

EPA has not adequately supported its decisions to implement a whole chemical approach in the PV29 risk evaluation, and to not assume use of PPE in TSCA risk determinations. Moreover, fatal flaws in the final risk evaluation of PV29 resulted in unwarranted determinations of unreasonable risk.

“EPA should withdraw the PV29 risk evaluation, provide clear rationale and guidance for application of the whole chemical approach and provide an opportunity for public comment on the whole chemical and no PPE policy decisions before applying these changes to any chemical substances,” said ACC Vice President of Regulatory and Scientific Affairs, Kimberly Wise White, PhD.

ACC’s comments express several key concerns with the risk evaluation and risk determination process that need to be addressed, including the below points:

PV29 Risk Evaluation

  • The occupational exposure assessment does not reflect conditions of use of PV29.
    • The exposure assessment greatly overestimates the duration, intensity, frequency, and number of exposures of PV29 during its manufacturing, processing, and use.
    • Air monitoring data submitted by the manufacturer of PV29 were not used properly.
  • EPA mischaracterized the hazard of PV29 through its erroneous use of carbon black as an analog.
  • PV29 does not presents an unreasonable risk of injury to health or the environment under its conditions of use

Whole Chemical Approach

  • The Agency has not adequately supported its proposal to implement a whole chemical approach.
  • The approach is inconsistent with TSCA and its risk evaluation regulations.
    • A single “whole chemical” unreasonable risk determination, when there are conditions of use that the Agency has determined do not present an unreasonable risk, ignores the possibility of “no unreasonable risk” determinations for a chemical under its conditions of use.
  • The approach is neither science-based nor risk-based and does not meet the science requirements of TSCA Section 26; is arbitrary, and lacks clarity, principles, and criteria, and will have substantial impacts on the regulated community as well as on the credibility of both EPA and OSHA regulations.

Assumption of no PPE

  • Assumptions regarding the lack of use of PPE are inconsistent with TSCA’s requirements that EPA determine whether a chemical presents an unreasonable risk under the chemical’s “conditions of use;” do not comply with TSCA’s Section 26 requirements that TSCA risk evaluations be consistent with best available science and based on weight of the scientific evidence and are inconsistent with the Occupational Safety and Health Act’s statutory and regulatory requirements.
  • Addressing PPE (and other OSHA requirements) only in the risk management rule, and not as part of the conditions of use in the risk evaluation, will have significant potential impacts, including the potential for duplicative and inconsistent requirements.

For a deeper dive into ACC’s comments, including ACC’s recommendations to EPA about how to address these problems and its suggestions for alternative approaches, go here to read the full comments.

American Chemistry Council

The American Chemistry Council (ACC) represents the leading companies engaged in the multibillion-dollar business of chemistry. ACC members apply the science of chemistry to make innovative products, technologies and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health, safety and security performance through Responsible Care®; common sense advocacy addressing major public policy issues; and health and environmental research and product testing. ACC members and chemistry companies are among the largest investors in research and development, and are advancing products, processes and technologies to address climate change, enhance air and water quality, and progress toward a more sustainable, circular economy.

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