Document ID: EPA-HQ-OPPT-2018-0604-0053
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-06-10T04:00Z

EPA SCIENTIFIC ADVISORY COMMITTEE ON CHEMICALS
         UPDATED CHARGE TO THE PANEL - PV 29 REVIEW, JUNE 18-21, 2019

As amended by the Frank R. Lautenberg Chemical Safety for the 21[st] Century Act on June 22, 2016, the Toxic Substances Control Act (TSCA), requires the U.S. Environmental Protection Agency (EPA) to conduct risk evaluations on existing chemicals. In December of 2016, EPA published a list of the initial ten chemical substances that are the subject of the Agency's chemical risk evaluation process (81 FR 91927), as required by TSCA. C.I. Pigment Violet 29 is one of the first ten chemical substances and the first of the ten to undergo a peer review by the SACC (Science Advisory Committee on Chemicals). In response to this requirement, EPA has prepared and published a draft risk evaluation for C.I. Pigment Violet 29 which solicited comments from the public and incorporated them as appropriate in the documents considered in this review. C.I. Pigment Violet 29 is an organic pigment that has a low solubility, low volatility, expected to be highly persistent, has low hazard concerns, limited exposure potential and has low bioaccumulation potential in fish and other animals. The pigment is utilized as an intermediate to create or adjust color of other pigments, as well as in commercial paints, coatings, plastics, and rubber products.    
The draft risk evaluation contains the following components:
 Discussion of chemistry and physical-chemical properties.
 Characterization of uses.
 Environmental fate and transport assessment.
 Engineering release(s) and occupational exposure assessment.
 General population and consumer exposure assessment.
 Environmental exposure assessment.
 Human health hazard assessment.
 Environmental hazard assessment.
 Risk characterization.
 Risk determination.
 A detailed description of the systematic review process developed by the Office of Pollution Prevention and Toxics to search, screen, and evaluate scientific literature for use in the risk evaluation process.

The focus of this meeting is to conduct the peer review of the Agency's draft risk evaluation of C.I. Pigment Violet 29.  At the conclusion of the peer review process, EPA will consider the reviewers' comments/recommendations, as well as public comment, to finalize the risk evaluation.

CHARGE QUESTIONS: 

 Content and Organization:

EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726) stipulates the process by which EPA is to complete risk evaluations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, To that end, EPA has completed a draft risk evaluation for C.I. Pigment Violet 29.   
As part of this risk evaluation for C.I. Pigment Violet 29, EPA conducted an assessment of potential environmental, occupational, consumer, and general population exposures. This analysis considered best available science and reasonably available information, including manufacture, use, and release information, and physical-chemical characteristics. It is important that the information presented in the risk evaluation and accompanying documents are clear and concise and describe the process in a scientifically credible manner.
Please comment on the overall content, organization, and presentation of the draft risk evaluation of C.I. Pigment Violet 29. Please provide suggestions for improving the clarity and transparency of the information presented in the documents.  

 Systematic Review:

The Toxic Substances Control Act (TSCA) requires that EPA use data and/or information in a manner consistent with the "best available science" and that EPA base decisions on the "weight of the scientific evidence". The EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), defines ``best available science'' as science that is reliable and unbiased. This involves the use of supporting studies conducted in accordance with sound and objective science practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). The Final Rule also defines the "weight of the scientific evidence" as a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance (Note: For PV29 integration was limited because of its overall low risk profile when compared to other more complex cases).

To meet these scientific standards, EPA applied systematic review approaches and methods to support the draft risk evaluation of C.I. Pigment Violet 29. Information on the approaches and/or methods is described in the draft risk evaluation as well as the following documents:

 Application of Systematic Review in TSCA Risk Evaluations
 Strategy for Conducting Literature Searches for Pigment Violet 29 (PV29): Supplemental file for the TSCA Scope Document
 Pigment Violet 29 (CASRN: 81-33-4) Bibliography: Supplemental File for the TSCA Scope Document
 Pigment Violet 29 and the Pigment Violet 29 (81-33-4) Systematic Review: Supplemental File for the TSCA Risk Evaluation
 The updated version of Pigment Violet 29 (81-33-4) Systematic Review: Supplemental File for the TSCA Risk Evaluation (Published April 17[th], 2019) 
         https://www.regulations.gov/document?D=EPA-HQ-OPPT-2018-0604-0040
         
Please comment on the approaches and/or methods used to support and inform the gathering, screening, evaluation, and integration of information used in the draft risk evaluation of C.I. Pigment Violet 29 and the updated Pigment Violet 29 (81-33-4) Systematic Review: Supplemental File for the TSCA Risk Evaluation (Published April 17[th], 2019). Please also comment on the clarity of the information as presented related to systematic review and suggest improvements as it applies to PV29.

 Physical Chemical Properties/ Environmental Fate: 

C.I. Pigment Violet 29 is an organic pigment that has a low solubility, low volatility and is expected to be highly persistent and has low bioaccumulation potential in fish and other animals.
No acceptable studies are available to describe the environmental fate characteristics of C.I. Pigment Violet 29 with respect to characterizing the Log KOW, KOC and, bioaccumulation.

     Please comment on the characterization of Log Kow, Koc and bioaccumulation for C.I. Pigment Violet 29, including any suggestions for alternative sources or methods to obtain or derive better estimates of the properties (e.g. use of specific analogs).

     Please comment on characterization of the physical chemical properties of C.I. Pigment Violet 29, especially with regard to the determination by the European Chemicals Agency (ECHA) to include C.I. Pigment Violet 29 on the 2019-2021 Community Rolling Action Plan (CoRAP) update as a "suspected PBT/vPvB [Potentially Persistent, Bioaccumulative and Toxic/very Persistent and very Bioaccumulative substance]." The CoRAP justification document for C.I. Pigment Violet 29 is available at: 

 https://echa.europa.eu/documents/10162/13628/corap_justification_201-344-6_226-866-1_be_12079_en.pdf/cf312ff9-6b18-8b76-bc66-d86320faa24a 

 Exposure and Releases:
 
   To estimate the exposure and environmental releases during manufacturing, EPA used information provided by the manufacturer of C.I. Pigment Violet 29. For the processing and uses, no readily available C.I. Pigment Violet 29 specific information was found. EPA quantitatively evaluated the high-end occupational exposures using airborne monitoring data provided by the manufacturer and an EPA standard approach for occupational dermal exposure. Based on the worker activities, chemical concentration and amount handled, EPA determined that the exposure during the manufacturing will likely to represent a high-end exposure scenario. These occupational exposure estimates were proposed to be protective of downstream users of C.I. Pigment Violet 29, which includes exposures to consumers and to the general population. Based on the recommendation by NIOSH, additional characterization of inhalation exposures to workers using OSHA standard for particles not otherwise regulated (PNOR) will be added as a high-end scenario inhalation exposure to workers.
 Please comment on the characterization of occupational exposures (inhalation and dermal) for the manufacturing workers. Is the panel aware of other additional relevant information, including C.I. Pigment Violet 29 specific data, that could be considered? 
     
 Please comment on the environmental release characterization for the manufacturing and use as a site limited intermediate. Is the panel aware of other relevant additional information, if any, that could be considered? 

 Please comment on the exposure and release characterization for the downstream processors and users. Is the panel aware of other C.I. Pigment Violet 29 specific data and/or information that could be considered?

 Please comment on the screening level approach used in the context of the conclusions associated with potentially exposed susceptible subpopulations (e.g., to children, workers, or pregnant women). Please comment on other additional information or analyses that could be conducted, if any, in light of the screening level approach used in this case? 

 Please comment on the conclusion regarding the need for aggregate exposure. 

 Environmental Effects: 

Given the limited nature of the dataset describing the potential environmental hazards from the manufacture and use of C.I. Pigment Violet 29, there are uncertainties associated with risk conclusions to environmental receptors from exposure to C.I. Pigment Violet 29 from the uses described in the document.  

 Please comment on the evidence used to support the characterization of hazard to ecological receptors from acute and chronic exposure as presented in the document. 

 Strong sorption to sediment is indicated as a result of the estimated Koc of 5.0 based on estimations from EPI Suite[TM]. While this indicates that exposures to aquatic organisms in the water column are likely to be low, this also indicates that potential water releases could result in exposure to sediment-dwelling organisms. The EPA assumed low hazard to these organisms due to the lack of toxicity observed in the tests conducted with all other aquatic species, particularly Daphnia magna. Given the acute hazard profile for this chemical, limited releases, and the physical-chemical characteristics of C.I. Pigment Violet 29, please comment on the risk characterization for sediment-dwelling invertebrates. 

 Human Health:

C.I. Pigment Violet 29 is an organic pigment found in a wide variety of commercial uses EPA believes has a low hazard potential to human health across all possible routes of exposure.

 Please comment on the toxicological study which was used to identify the endpoint of concern and derive the associated point of departure (POD). Also, please comment on alternative approaches to estimate the potential for lung effects using analogs for poorly absorbable particles to calculate an inhalation toxicity POD and the screening-level calculation to estimate the potential for lung overload. Please comment on this approach and whether this analog represents useful information to quantify risk for the inhalation route and whether oral developmental study is appropriate for all routes of exposure. If not, please describe what other alternative approaches could be used in lieu of these approaches to serve as the basis for completing the hazard assessment and subsequent risk evaluation for C.I. Pigment Violet 29.

 Please comment on the use and interpretation of Multiple-Path Particle Dosimetry Model (MPPD v. 3.04), which has not been formally peer-reviewed, to predict lung deposition of aerosolized C.I. Pigment Violet 29. 

 Please comment on the evidence available to support the agency's conclusion of negligible absorption via oral, dermal and inhalation routes. 
  
 Given the varied nature of the consumer uses, please comment on the agency's characterization of hazard to consumers via inhalation and dermal exposure for different durations of exposure. 
      
 Similarly, please comment on the Agency's characterization of hazard to workers via inhalation and dermal exposure for different durations of exposure.  
   
 Please comment on the Agency's consideration of health hazard concerns for potentially exposed susceptible subpopulations given the constraints of the available information (e.g., children, workers, or pregnant women). 

 Risk Characterization/Risk Determination: 

After consideration of all information identified by the EPA that pertains to C.I. Pigment Violet 29, 
Please comment on whether the information presented to the panel supports these conclusions outlined in the draft risk characterization section concerning C.I. Pigment Violet 29. If not, please suggest alternative approaches or information that could be used to develop a risk finding in the context of the requirements of EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726).

 Supplemental Analysis

Following the publication of the draft risk evaluation, EPA received comments from the Center for Disease Control and Preventions' National Institute for Occupational Safety and Health (NIOSH) on the risk characterization from inhalation exposure. As a result of these comments, two updated approaches are presented to characterize the potential occupational risks from inhalation exposure. The first approach involves utilizing analog inhalation toxicity data from poorly-soluble, non-reactive dusts with a similar particle size to C.I. Pigment Violet 29, while the second approach uses a screening-level calculation to estimate lung overload incorporating the particle size data for C.I. Pigment Violet 29 as explained in Oberdörster (1994). Use of these approaches will provide a more appropriate toxicological response to characterize the risks of inhalation of C.I. Pigment Violet 29 dust. The exposure limit for this characterization will be based on a nuisance dust standard adjusted for the deposition fraction of C.I. Pigment Violet to the alveolar region, as predicted by the Multiple Path Particle Dosimetry Model (MPPD, v. 3.04). Please note that the MPPD model has not undergone a formal peer review.     

 Please comment on whether the use of point of departure from analog data used in conjunction with the adjusted NIOSH-recommended exposure limit or the Occupational Safety and Health Administration (OSHA) standard for Particles Not Otherwise Regulated (PNOR) to develop an MOE provides utility in risk characterization concerning C.I. Pigment Violet 29. If not, please suggest alternative approaches or information that could be used to incorporate these values into the human health risk characterization. 

 Please comment on whether the screening-level estimate for the potential for lung overload with the NIOSH-recommended exposure limit or the Occupational Safety and Health Administration (OSHA) standard for Particles Not Otherwise Regulated (PNOR) and the predicted deposition fraction to the alveolar region predicted by the MPPD model (v3.04) from Orberdörster (1994), and whether this provides utility in risk characterization concerning C.I. Pigment Violet 29.

 Oberdörster, G. (1994). Lung particle overload: implications for occupational exposures to particles. Regulatory Toxicology and Pharmacology, 21(1), 123-135

 Content for Closed Session as Described in FRN for this Meeting:

This is the first time the TSCA program is making non-TSCA confidential business information (CBI) available to peer reviewers to conduct a review by the SACC. The panel should comment on the process, integration, and clarity related to the use of the CBI which was provided.

Following the CBI substantiation and review process for C.I. Pigment Violet 29, the Agency made publicly available partially redacted (sanitized) copies of nine full study reports used to characterize the physical chemical characteristics, environmental fate, environmental hazard, and human health hazard of C.I. Pigment Violet 29. More details as to how these studies, which were previously claimed in full as CBI, became partially redacted (sanitized) can be accessed in the docket:  

 https://www.regulations.gov/document?D=EPA-HQ-OPPT-2018-0604-0022

The final confidentiality determination by the Agency on the CBI claims can be accessed at FOIAonline at:
 
 https://foiaonline.gov/foiaonline/action/public/submissionDetails?trackingNumber=EPA-HQ-2019-001853&type=request 

Please comment on whether or not the information contained in the CBI materials provided to the panel is accurately reflected in the sanitized data that are made publicly available and robust summaries used in the risk evaluation for C.I. Pigment Violet 29.