EPA’s appalling failure to provide public access to public data on TSCA new chemicals

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D.is a Lead Senior Scientist.

Part 1               Part 2               Part 3               Part 4

At last month’s public meeting held by EPA to discuss changes it is making to its new chemical review program, the issue of public access to information about those chemicals and EPA’s review of them featured prominently.  This post describes EDF’s recent exasperating attempt to gain access to information that the Toxic Substances Control Act (TSCA) and EPA’s own regulations require be made public.

We blogged recently about how EPA is now hiding its tracks when it comes to the outcomes of its initial reviews of new chemicals.  This post details another way in which EPA is cutting the public out of the new chemicals review process.

EDF has repeatedly informed EPA that the agency’s regulations (see here and here) require EPA to promptly make premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

Despite the clear requirements for electronic access, EPA acknowledged at its December 6 meeting that it has not provided such access.  It then stated that “[s]anitized PMNs and their attachments can be requested directly from the EPA Docket Center.”  So we decided to try getting these materials by that route.

On December 13, 2017, EDF sent a letter to the EPA Docket Center requesting electronic versions of the sanitized Pre-Manufacturing Notices (PMNs), any health and safety studies, and any other supporting documentation associated with each chemical substance for which, between the law’s passage on June 22, 2016, and the date of our request, EPA had made a finding:

  • under § 5(g), in accordance with § 5(a)(3)(C), that the new chemical substance is “not likely to present an unreasonable risk of injury to health or the environment;” or
  • in accordance with §§ 5(a)(3)(A) and 5(f), that the new chemical substance “presents an unreasonable risk of injury to health or environment.”

We received a CD from the docket center two weeks later, on December 26, 2017. The CD contained file folders for 67 PMNs; a week later we requested additional file folders for two PMNs that received “not likely” findings around the time of our first request, and subsequently received a second CD.

We have been reviewing these materials.  This post is the first in a series that will describe what we got – and didn’t get.  

Overall, what is missing

PMNs are supposed to include a list of attachments that identifies the number of pages in each attachment.  The good news is that these PMNs did include such a list, and in most cases the public files we received contained a “document” corresponding to each listed attachment.

The bad news starts with what was in, or more accurately, what was not in, those documents:

Of a total of 549 attachments identified in the PMNs we received:

  • 103 of those attachments consisted of wholly blank or blacked-out pages.
  • Another 97 of those attachments consisted wholly of pages that had only a header at the top, with all other text removed.
  • Another 111 of those attachments, while retaining the skeleton of the underlying form, redacted 100% of the information entered into the form by the submitter.
  • 6 of the attachments were corrupted and could not be opened for viewing at all.
  • 10 documents were missing entirely from the files we received.
  • 101 of the attachments were partially redacted, ranging from heavy to light redactions.
  • 121 of the attachments were not redacted.

In all, 327 of the attachments – 60% – had no meaningful information whatsoever.  Across this set of PMNs, over 1,000 pages of information that should have been provided (even if redacted) was simply missing or inaccessible.

Health and safety information that is missing

Even more disturbing is the fact that a large fraction of the missing information definitely or likely consists of health and safety (H&S) information, which TSCA § 14(b)(2) precludes from being withheld from the public.

First – in keeping with historical evidence – the great majority of these PMNs had no health nor environmental safety information whatsoever.  Only 17 of the 69 PMNs – 24% – included any health and safety studies.

A total of 78 of the 549 attachments identified in the PMNs we received were clearly identified as H&S studies.  Of these 78 attachments:

  • 8 of these documents were not provided at all, including one that consisted at least partially of a H&S study, all from the same PMN. (Click here for an example.) We know that EPA relied on at least three of these studies in making its final “not likely to present an unreasonable risk” determination.
  • 25 others were blank, wholly redacted or corrupted and could not be viewed at all. For many of these, EPA provided us with only a single blank page even when the list of attachments indicated the documents consisted of multiple pages. (Click here for an example.)
  • Another 22 were partially redacted, with strong indications that information not eligible for protection from disclosure was nonetheless redacted. (Click here for an example.)
  • Only 23 were provided to us without redactions.

Beyond those 78 documents, another 62 documents were identified as safety data sheets, which likely also in whole or in part constitute health and safety information not eligible for protection from disclosure.  Yet:

  • 12 of these were blank, blacked out or wholly redacted. (Click here and here for examples.)
  • 32 were partially redacted.
  • Only 18 were provided to us without redactions.

In all, 45 of the 140 attachments constituting health and safety information – 32% – had no meaningful information whatsoever, and another 54 of these attachments – 39% – included partial redactions.  Across this set of documents containing health and safety information, over 620 pages of information that should have been provided (even if redacted) was simply missing.

This situation, in a word, is outrageous.  In another word, it is unacceptable.

We blogged recently about how EPA is now hiding its tracks when it comes to the outcomes of its initial reviews of new chemicals.  This post details another way in which EPA is cutting the public out of the new chemicals review process.

Among the reasons public access to PMNs and associated information is so important is that EPA is adopting an approach (albeit contrary to the law) to reviewing new chemicals under which it argues that the information in a PMN is a sufficient basis for making a regulatory determination that the substance is “not likely to present an unreasonable risk.”  EPA will then develop a SNUR that is supposed to closely mirror those aspects of the PMN that allowed EPA to make that determination.  Without ready and timely public access, there is simply no way for the public to be able to assess whether these assertions by EPA are sufficient and accurate, or to have any faith and trust whatsoever in the approach the agency is taking.

We’ll have to more to say about other gaping deficiencies in the public PMN files in subsequent posts to this blog.  Stay tuned.

 

This entry was posted in EPA, Health Policy, TSCA Reform and tagged , , , . Bookmark the permalink. Both comments and trackbacks are currently closed.