US EPA extends PV29 TSCA evaluation comment period


US Environmental Protection Agency (EPA) extends comment period for draft risk evaluation of C.I. Pigment Violet 29 (PV29) under its TSCA regulation; new draft adds previously confidential business data, solubility testing data, workplace air monitoring; concludes 11 of 14 conditions of use for PV29 pose unreasonable risk; toxicity debate ongoing also in Europe; EPA extends comment period for the revised draft until December 19, 2020

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.

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Food Packaging Forum, 24 November 2020