Round 2 on PV29 reveals even deeper flaws in EPA’s TSCA risk evaluation of the chemical

Richard Denison, Ph.D., is a Lead Senior Scientist.

On Friday, Environmental Defense Fund (EDF) submitted a new set of extensive comments to the Environmental Protection Agency (EPA) in response to its March release of additional information on Pigment Violet 29 (PV29), the first chemical to undergo a risk evaluation under the Toxic Substances Control Act (TSCA) following the law’s amendment in 2016.

After EDF and others criticized both the dearth of health and environmental data on PV29, and EPA’s illegal withholding of those data, EPA released some additional information and opened a new comment period in mid-April.  In releasing the new information, EPA was quick to judgment, asserting that “[t]he release of these studies does not change the Agency’s proposed ‘no unreasonable risk’ determination as concluded in the draft risk evaluation published in November.”

EDF’s 100 pages of comments in Round 1 enumerated the myriad ways EPA has failed to demonstrate that PV29 does not present unreasonable risk.  Unfortunately, if anything, Round 2 has only deepened our concerns over the inadequacy of EPA’s risk evaluation.  

First, despite EPA’s release of some additional information from the 24 health and safety studies, EPA continues to illegally withhold from the public information to which it is entitled under TSCA.  While EPA backed off its initial illegal assertion that such studies can be protected from disclosure as confidential business information (CBI) under TSCA and released some additional information from some of these studies, it concocted a new, illegal theory to justify continuing to deny the public access to the full study reports.

EPA has withheld virtually all of the data from a screening-level reproductive/developmental toxicity study on which its risk evaluation heavily relies, rendering it impossible for the public to independently assess the study.  And of course, as we pointed out in Round 1, EPA’s own guidance makes clear that this screening study cannot be used to rule out such toxicity – precisely what EPA did.

For 10 of the remaining 23 studies, EPA released only brief (ca. one-page) summaries prepared by the chemical’s producer.  In doing so, EPA falsely claimed that it has released the full study reports, raising the question of whether or not EPA actually possesses the full studies.  If it does not, our new comments detail how EPA cannot possibly adequately assess the studies’ quality based on only the summaries.

Bottom line:  Despite the new release, EPA still lacks sufficient information to support its sweeping conclusions that PV29 does not present any unreasonable risks.

In the course of preparing our new comments, EDF discovered that PV29’s manufacturers had selectively altered at least two of their study summaries to remove values EDF had cited in our initial comments that call into question the value for a key physical-chemical property of PV29 EPA had repeatedly relied on to dismiss risk concerns.  This disturbing occurrence adds yet another to the long list of reasons why EPA and industry’s assertion that the public should make do with study summaries is unacceptable.

As part of its new release, EPA revised the data quality “scoring sheets” it had prepared in Round 1 using the TSCA systematic review method.  That method deviates from best practices in systematic review and has yet to be subject to any peer review.  The “good” news is that EPA’s new scores acknowledge that two studies EPA had ranked as being of medium quality are actually unacceptable – a fact that the company that did the studies had prominently flagged and EPA had initially ignored.  Based in part on these studies, EPA originally concluded PV29 posed no hazard (and hence no risk) via all routes of exposure, including inhalation.  EPA has now thrown out the only inhalation studies it reviewed to support that conclusion, and yet still maintains its original highly tenuous position that PV29 poses no risks, despite this additional serious gap in the hazard evidence.

The further bad news is that EPA’s new scoring sheets reveal further inconsistencies, inaccuracies and other deficiencies in its systematic review method and its application.  This outcome both deepens concerns over data inadequacy for PV29 and bodes ill for the other nine draft risk evaluations we expect to see very soon, as they utilize the same flawed systematic review methodology.

Finally, as we blogged about recently, in contrast to EPA’s asserted clean bill of health for PV29, authorities under the European Union’s REACH Regulation have formally declared the chemical to be a suspected substance of very high concern (SVHC).  In doing so, the authorities raised many of the same concerns about the overall inadequacy of available data on PV29 that EDF had raised in our earlier comments, as well as indications the chemical may be a very persistent and very bioaccumulative (vPvB) chemical.

See our comments for more detail on all of these concerns.


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