On November 19, 2020 news provider Chemical Watch reported that the U.S. Environmental Protection Agency (EPA) is extending the comment period until December 19, 2020, for their latest risk evaluation draft of C.I. Pigment Violet 29 (PV29) previously published on October 10, 2020.
PV29 (CAS 81-33-4) is the first of 10 substances to be reevaluated under the new Toxic Substances Control Act (TSCA) that was amended on June 22, 2016 (FPF reported). The polycyclic aromatic dye compound is a food- or food contact additive, suspected to negatively affect human health and the environment.
In their first draft assessment of PV29 from November 2018, the EPA concluded 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.” However, following publication the original draft has been widely criticized by public comments (see the EPA’s summary) for (1) the lack of reproductive, developmental, and toxicity tests, (2) missing reports on physical-chemical properties, and (3) weak animal data to support claims of low risk of exposure via oral and dermal routes.
The EPA largely based their argumentation on the observed low water solubility of PV29 (0.01 mg/L), which leads to low bioavailability and therefore low risk of exposure for consumers and the environment.
Richard Denison, Lead Senior Scientist of the Environmental Defense Fund (EDF) has been following the assessment since December 2018. In one of his posts, he criticizes especially the low quality of available data regarding the water solubility of PV29, which is the basis of argumentation for PV29 being a low hazard. Denison writes that: “BASF itself labeled these two studies ‘not reliable’ due to use of an ‘unsuitable test system’ and said the studies should be ‘disregarded due to major methodological deficiencies.’”
Following the suggestions of a Scientific Advisory Committee peer review and multiple public comments, the EPA has added to the new draft version, among others, (1) previously confidential business information of manufacturers, (2) revised solubility testing and, (3) a workplace air monitoring program finding a potential “lung overload” risk.
The EPA now reports PV29 poses an unreasonable risk in 11 of 14 conditions of use, meaning this could lead to regulatory action if the risks remain in the final assessment. The comment period for the revised draft has now been extended now until December 19, 2020, and comments can be submitted to the appropriate docket (EPA-HQ-OPPT-2018-0604). The extension is reported to have been made following a request from the North America Color Pigments Manufacturers Association (CPMA), which argued that the revised draft contains significant changes including an error by the EPA in characterizing the particle size as much too small.
At the moment, PV29 is also under review by European regulators. The European Chemical Agency (ECHA) has not yet registered any hazards for this substance under its REACH regulation based on industry submitted information. However, the chemical is listed by the Food flavorings, Additives, and food Contact materials Exposure Tool (FACET) as a food contact chemical. Furthermore, it is scheduled under the current Community Rolling Action Plan (CoRAP) for reevaluation until 2021. The chemical is suspected to be persistent, bioaccumulative and toxic (PBT), or even potentially very persistent and very bioaccumulative (vPvB), which would render it a substance of very high concern (SVHC). These allegations are further explained in a document issued by the Belgian competent authority under REACH.
Andrew Turley (December 24, 2020). “US EPA publishes peer review of additional PV29 data”
Chemical Watch (November 19, 2020). “EPA extends comment deadline for revised TSCA evaluation of PV29.”
Terry Hyland (November 17, 2020). “Revised TSCA risk evaluation for PV29 contains ‘significant error’, industry says.” Chemical Watch
EPA (November 2020). “Revised Draft Risk Evaluation for C. I. Pigment Violet 29.”
Richard Dennison (December 10, 2020). “A tale of two public comment extension requests: How they fared under the Trump EPA.” EDF
Terry Hyland (October 20, 2020). “EPA revises TSCA draft evaluation for PV29, finds unreasonable risks.” Chemical Watch
Terry Hyland (December 10, 2020). “Pigment industry says EPA ‘misinterpreted’ data in PV29 draft TSCA review.” Chemical Watch
Richard Denison (May 2, 2019). “Industry deletions in PV29 study summaries should raise alarm bells on both sides of the Atlantic.” EDF
Richard Denison (May 7, 2019). “EPA says PV29 is perfectly safe. The EU, citing concerns and a dearth of data, begs to differ.” EDF
Richard Denison (December 13, 2018). “Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA.” EDF
Belgian Federal Public Service (March 19, 2020). “Justification Document for the Selection of a CoRAP Substance.” (pdf)
EPA (November 15, 2018). “Draft Risk Evaluation for C.I. Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d’e’f’]diisoquinoline1,3,8,10(2H,9H)-tetrone).” (pdf)
EPA (October 2020) “Summary of External Peer Review and Public Comments and Disposition for C.I. Pigment Violet 29 (PV29) (Anthra[2,1,9-def:6,5,10-d’e’f’]diisoquinoline- 1,3,8,10(2H,9H)-tetrone) Response to Support the Revised Draft Risk Evaluation of C.I. Pigment Violet 29.” (pdf)
EPA (June 21, 2019). “TSCA Science Advisory Committee on Chemicals Meeting Minutes and Final Report No. 2019-01 A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Peer Review for EPA Draft Risk Evaluation of C.I. Pigment Violet 29 June 18-21, 2019 TSCA Science Advisory Committee on Chemicals Meeting, Held at the Holiday Inn Rosslyn at Key Bridge, 1900 Fort Myer Drive, Arlington, Virginia.” (pdf)