{"id":8750,"date":"2019-05-02T14:19:40","date_gmt":"2019-05-02T19:19:40","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8750"},"modified":"2024-02-12T11:02:17","modified_gmt":"2024-02-12T16:02:17","slug":"industry-deletions-in-pv29-study-summaries-should-raise-alarm-bells-on-both-sides-of-the-atlantic","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/05\/02\/industry-deletions-in-pv29-study-summaries-should-raise-alarm-bells-on-both-sides-of-the-atlantic\/","title":{"rendered":"Industry deletions in PV29 study summaries should raise alarm bells on both sides of the Atlantic"},"content":{"rendered":"

Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n

[pullquote]The intentional alteration of industry study summaries under REACH that I report here should raise major alarms on both sides of the Atlantic and illustrates why public access to full studies on chemicals to which we are or may be exposed must be paramount.<\/strong><\/em>[\/pullquote]Well, I certainly wasn\u2019t expecting to find this when I started working on EDF\u2019s comments on supplemental materials the Environmental Protection Agency (EPA) recently made available on Pigment Violet 29 (PV29), the first of 10 chemicals undergoing risk evaluations under the amended Toxic Substances Control Act (TSCA).\u00a0 What I discovered \u2013 almost by chance \u2013 strongly reinforces EDF’s and others\u2019 view that the public\u2019s ability to independently assess and trust EPA chemical assessments falls flat without access to full and unredacted copies of the health and safety information EPA cites in support of its risk evaluation.\u00a0\u00a0<\/p>\n

When EPA first released a draft of its PV29 risk evaluation for comment, it refused to make public the underlying health and safety studies.\u00a0 Instead, it only provided copies of and links to brief summaries \u2013 misleadingly called \u201crobust summaries\u201d \u2013 of the studies, which were prepared by companies that make PV29.\u00a0 The companies had submitted the summaries to the European Chemicals Agency (ECHA) when they registered PV29 under the European Union\u2019s REACH Regulation.<\/p>\n

EPA first claimed the studies had to be withheld because they were protected as confidential business information (CBI) under TSCA \u2013 a position that is flatly contradicted by the plain text of the law.\u00a0 In response to the outcry that ensued, EPA recently made public more of the content of these health and safety studies.\u00a0 Unfortunately, EPA is still withholding key parts of that body of information under a different, equally flawed theory it has advanced to allow companies to hide health and safety information that TSCA requires be made public.\u00a0 For more detail, see this recent letter<\/a> sent to EPA by groups, including EDF, who sought to obtain the studies through a Freedom of Information Act (FOIA) request<\/a> that EPA now has denied<\/a> with respect to the full release of these studies.\u00a0 Stay tuned on that.<\/p>\n

Meanwhile, EPA has reopened the comment period for the PV29 risk evaluation to allow stakeholders to comment anew on the additional, but still partial, information it released.\u00a0 As I was reviewing EDF\u2019s prior comments<\/a> in preparing our new ones, I discovered that some of the \u201crobust summaries\u201d EPA placed in its PV29 docket back in November<\/a> have changed:\u00a0 The current versions of at least two of those summaries now posted on ECHA\u2019s REACH registration website show deletions of certain information that was in the versions EPA first made available.<\/p>\n

I noticed the changes because the deleted information is the same information EDF had cited in our earlier comments as undermining a key conclusion EPA had drawn about PV29<\/em>.\u00a0 When I went to ECHA\u2019s website to refresh my memory of those summaries, I sensed something had changed and, sure enough, by comparing the original and current versions of two of the summaries, I soon detected that someone has made small but significant deletions.<\/p>\n

Below I describe and document the changes I found.\u00a0 But before dragging you through that, consider what this means.<\/p>\n

Implications for public trust in EPA assessments<\/strong><\/p>\n

The Trump EPA and the chemical industry have been arguing that the public can and should make do with the \u201crobust summaries\u201d rather than have access to the full study reports that TSCA requires be made public.\u00a0 In its draft risk evaluation, EPA emphasized that the summaries could be trusted because EPA had verified that they accurately reflected the underlying studies; in short, we were told we could and should take their word for it.<\/p>\n

Now with this new development, we have learned two new things:<\/p>\n