Regulatory Developments

EPA Publishes First Draft TSCA Chemical Risk Evaluation

November 16, 2018

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation.  According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation.  EPA intends to publish a separate Federal Register notice containing the peer review meeting details.  Comments on the draft risk evaluation are due January 14, 2019.  EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions.

Background

As reported in our June 5, 2018, memorandum, “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety,” on June 1, 2018, EPA released the problem formulation documents for the first ten chemicals selected for review under Lautenberg, including C.I. Pigment Violet 29.  The problem formulation document for C.I. Pigment Violet 29 states that based on limited releases, low potential for environmental and human exposures, and a low toxicity profile for mammals and aquatic species, it concludes that further analysis of these exposure pathways to workers, consumers, the general population, and environmental receptors is not warranted for C.I. Pigment Violet 29.

Draft Risk Evaluation
 
The draft risk evaluation states that EPA considered all reasonably available data for C.I. Pigment Violet 29 to make a determination of whether the risk it poses is unreasonable.  EPA “concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment, without considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use.”
 
As part of the risk evaluation, EPA conducted a qualitative assessment of potential environmental, consumer, and general population exposures.  According to the draft risk evaluation, the assessment is based on a consideration of the physical-chemical properties of C.I. Pigment Violet 29, which includes low solubility, low vapor pressure, low bioaccumulation potential, and poor absorption across all routes of exposure, as well as manufacturing information, which indicates that environmental releases from the conditions of use are limited.  EPA also conducted a quantitative screening-level assessment of occupational exposure using a high end estimate of inhalation and dermal exposure.  The draft risk evaluation states that qualitative and quantitative considerations of physical chemical data, environmental fate data, manufacturing, and use information indicate that exposures of C.I. Pigment Violet 29 are expected to be limited for the conditions of use of C.I. Pigment Violet 29.

The draft risk evaluation states that reasonably available data indicate that no effects were observed in environmental hazard testing with aquatic species up to the limit of solubility of the chemical, and low hazard was reported for all routes of exposure in human health testing.  Human health testing reported that no adverse effects were observed for all routes of exposure (oral, dermal, and inhalation) and that C.I. Pigment Violet 29 is negative for genotoxicity.  Structural activity relationships (SAR) considerations support EPA’s conclusion that C.I. Pigment Violet 29 is unlikely to be a carcinogen.  Environmental hazard data available for fish, aquatic invertebrates, and aquatic plants reported that no effects were observed up to the limit of solubility of the chemical.  Based on human health and environmental toxicity testing, “EPA concludes that C.I. Pigment Violet 29 presents a low hazard to human health and the environment.”

EPA states that it uses “reasonably available information, in a fit for purpose approach, to develop risk evaluations that rely on the best available science.”  EPA obtained full study reports associated with the European Chemicals Agency (ECHA) robust summaries (some of which are also presented in summary format in U.S. Food and Drug Administration (FDA) Food Additive Petition 8B4626) and used them to make a preliminary determination of hazard during problem formulation.  While the supporting materials contain information protected as confidential business information (CBI), 20 of the 24 studies have been submitted to and summarized by ECHA, and the ECHA robust summaries are publicly available.  According to the draft risk evaluation, EPA reviewed the full study reports and confirmed that the results are consistent with the physical and chemical characteristics, environmental fate characteristics, and the determination of low environmental and human health hazards as presented in the ECHA robust summaries.  EPA assessed the quality of the methods and reporting of results of the individual studies using the evaluation strategies described in its Application of Systematic Review in TSCA Risk Evaluations and concluded that they are of high or medium quality.  In addition, EPA determined that the information presented in the full study reports is consistent with the robust summaries in the publicly available ECHA database.
 
The draft risk evaluation states:

In summary, based on reviewing the reasonably available information indicating a low hazard to human health and environmental receptors, low solubility, low vapor pressure, low bioaccumulation potential, low absorption, limited environmental releases and low potential for resulting exposures, the EPA concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment under the conditions of use.  As per the EPA’s final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), the EPA is taking comment on, and will also obtain peer review on, the draft risk evaluation for C.I. Pigment Violet 29.
Next Steps

EPA announced that it intends to publish a Federal Register notice providing details on the TSCA SACC peer review meeting.  The notice will also explain the process for submitting information and views to the peer review panel.  EPA will consider the public comments on the draft risk evaluation submitted in response to the November 15, 2018, Federal Register notice, along with peer reviewer comments and recommendations, to prepare the final risk evaluation.  EPA plans to issue the final risk evaluations for the other nine chemicals by December 2019.

Commentary

We commend EPA for its timely issuance of the first draft risk evaluation under new TSCA.  We also note the forthcoming first meeting of the SACC and look forward to seeing how it operates.  Based on our review of the draft risk evaluation, it appears to cover all of the key elements required to be evaluated under the new law.  Assuming that the available information is presented accurately and completely, we see little basis for questioning the conclusion that the substance does not present an unreasonable risk.  It will be interesting to see how the draft, specifically its approach and conclusions, fare through the public comment and peer review processes.


 
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