EPA assessment should be called Pigment “Violate” the science

One of EPA’s core responsibilities under the Toxic Substances Control Act (TSCA) is to protect public health by evaluating chemicals and limiting the risky ones. EPA recently released step one in this process– its first chemical evaluation since TSCA was reformed in 2016, on the chemical Pigment Violet 29.  Unfortunately, our analysis found alarmingly poor science, marked departures from EPA’s own guidelines, and an ultimate conclusion not supported by the evidence.

EPA found that Pigment Violet is not risky (“does not pose an unreasonable risk” in the words of the law). But the problem is there are many similarities between EPA’s assessment and this situation:

Me: sitting on the couch.
Husband: enters and announces, “I can’t find the Advil. We must be out.”
Me (eyeing him skeptically): “Did you look in the medicine cabinet?”
Husband: “No.”
Me: Gets up, opens medicine cabinet, finds Advil.

Just like my husband (who I love dearly) falsely concluded the Advil was gone without looking, EPA concluded that Pigment Violet is not risky without even looking to see if that is true. We blogged previously about the key health hazards a chemical evaluation should assess—of the 9 shown below, EPA is missing data on 80%! The data gaps include cancer and neurotoxicity, serious diseases which Congress expressly mentions in TSCA statute. But instead of trying to look properly at these health hazards and fill the data gaps, EPA makes unsupported conclusions.

PV 29 blog Fig 1
Data is missing or inadequate on Pigment Violet’s hazards for most of the key health endpoints.

For example, despite having no tests on whether Pigment Violet causes cancer, EPA states it does not cause cancer. This is not logical, and EPA’s own Guidelines for Carcinogen Risk Assessment explain that to conclude a chemical is “Not Likely to Be Carcinogenic to Humans” requires “the available data are considered robust for deciding that there is no basis for human hazard concern…The judgment may be based on data such as: animal evidence that demonstrates lack of carcinogenic effect in both sexes in well-designed and well-conducted studies in at least two appropriate animal species.” EPA has no such data on Pigment Violet.

In another egregious example, EPA inappropriately concludes that Pigment Violet does not cause reproductive or developmental toxicity based on a short-term ‘screening’ test which the test protocol itself and multiple EPA Guidelines say is insufficient.

The test is called “OECD 421 Reproduction/Developmental Toxicity Screening Test” and you can think of it like a beta-test for software—done with small numbers as an initial way to look for problems. Because of these limitations, the protocol cautions: “This test does not provide complete information on all aspects of reproduction and development…Due (amongst other reasons) to the relatively small numbers of animals in the dose groups, the selectivity of the end points, and the short duration of the study, this method will not provide evidence for definite claims of no effects.”

Yet, EPA completely disregards this clear warning and uses the test to conclude that Pigment Violet has no effects on reproduction or development. This conclusion is also in violation of EPA’s own Guidelines for Developmental Toxicity Risk Assessment and Guidelines for Reproductive Toxicity Risk Assessment, both of which explicitly state that EPA should not use data from these short-term ‘screening’ test protocols in risk assessment because of the known shortcomings to detect developmental and reproductive toxicity.

This is just a small sampling of the many serious scientific and technical issues with the Pigment Violet assessment which leading scientists and clinicians detailed in comments to the Agency. EPA needs to go back to the drawing board and get the data it needs so it can make an informed determination on if Pigment Violet is dangerous.

While the chemical Pigment Violet 29 may seem obscure, there is a bigger concern. This first assessment is a likely indication of EPA’s approach in future assessments, and with chemicals in the pipeline like asbestos, still linked to tens of thousands of deaths a year, this substandard science will lead to inadequate controls on chemicals and real harm to the public’s health.