Stephanie Schwarz, J.D., is a Legal Fellow. Richard Denison, Ph.D., is a Lead Senior Scientist.
This is the third in a series of blog posts based on our frustrating, and frustrated, efforts to get information on premanufacture notifications (PMNs) for new chemicals under the Toxic Substances Control Act (TSCA). The saga began when we requested from the EPA Docket Center the public files on 69 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the TSCA, as amended in 2016 by the Lautenberg Act. This series of posts analyzes and describes what we did, and did not, get from the Docket Center, to which EPA staff pointed us when we raised the fact that such files are not available on EPA’s website or at www.regulations.gov, despite EPA regulations requiring they be.
TSCA and EPA’s regulations contain a number of provisions that, if reliably implemented, would give the public better access to, or at least a better understanding of, the information EPA receives on new chemicals. This includes mandates that EPA:
- publish in the Federal Register EPA’s receipt of new chemical PMNs (TSCA § 5(d)(2));
- make all PMNs and Significant New Use Notices (SNUNs) publicly available (TSCA § 5(d)(1));
- make all information submitted with the notices available to the public (TSCA § 5(b)(3) and 40 C.F.R. § 720.95); and
- make the public files electronically available (40 C.F.R. §§ 700.17(b)(1), 720.95).
EPA has repeatedly committed to increasing the transparency of its new chemicals program. Unfortunately, our review of the PMN files we received has revealed massive gaps and inconsistencies in the information EPA does provide to the public, and all too often we are finding that EPA has entirely failed to comply with the law and its own regulations. These failings are on top of efforts by the agency to actively hide information on new chemicals that it had made public for decades.
This post will focus on failings of EPA’s new chemicals program when it comes to transparency and compliance with TSCA and its own regulations with respect to the PMNs EPA receives for new chemicals. These failings make it virtually impossible for the public to gain any understanding of, or play any meaningful role in, EPA’s review of new chemicals under TSCA.
A. Multiple notices of receipt of the same PMN are published in the Federal Register
Our review of the 69 PMN files we received quickly revealed that each file included only a single PMN, even though in numerous cases it appears EPA has received more than one version of the PMN for a given chemical. For 21 of the 69 PMN files we received, that PMN number appeared in two or more of the monthly Federal Register notices EPA is required to publish listing PMNs received each month. In these cases, each listing of a given PMN displayed different dates of receipt. These 21 PMNs with “duplicate” Federal Register notices of receipt are listed below along with their differing receipt dates:
| PMN Number | Federal Register Receipt Dates |
|---|---|
| P-16-0281 | March 30, 2016 |
| April 11, 2016 | |
| P-16-0578 | October 21, 2016 |
| November 10, 2016 | |
| P-16-0587 | September 22, 2016 |
| March 23, 2017 | |
| P-17-0008 | November 2, 2016 |
| October 14, 2017 | |
| P-17-0009 | October 13, 2016 |
| October 14, 2017 | |
| P-17-0016-21 | October 27, 2016 |
| September 18, 2017 | |
| P-17-0117/18 | November 17, 2016 |
| February 14, 2017 | |
| September 13, 2017 | |
| P-17-0207 | January 23, 2017 |
| September 18, 2017 | |
| P-17-0227 | February 1, 2017 |
| July 12, 2017 | |
| P-17-0237/38 | February 23, 2017 |
| September 13, 2017 | |
| P-17-0246 | February 28, 2017 |
| September 19, 2017 | |
| P-17-0255 | March 14, 2017 |
| October 2, 2017 | |
| P-17-0256 | March 14, 2017 |
| October 10, 2017 | |
| P-17-0264 | March 22, 2017 |
| April 11, 2017 |
EPA needs to fix this problem. EPA must make clear in its Federal Register notices whether it has received multiple iterations of a PMN or if it has received supplemental information (the nature of which should be identified).
B. Required PMNs and Federal Register listings of PMNs are missing
Publishing multiple Federal Register notices of the same PMN is only the beginning of the problem, however. We compared the dates of receipt for PMN notices in the Federal Register with the dates printed directly on the 69 PMNs we received and found a number of discrepancies:
| PMN Number | Federal Register Notice PMN Receipt Date | Date on PMN we Received | “Not Likely” Decision Date |
|---|---|---|---|
| P-16-0303 | June 22, 2016 | September 8, 2017 | May 30, 2017 |
| April 7, 2016 | |||
| P-16-0426 | June 22, 2016 | November 16, 2016 | June 28, 2017 |
| P-16-0508 | None | July 8, 2017 | September 26, 2017 |
| P-16-0578 | October 21, 2016 | September 19, 2017 | September 26, 2017 |
| November 10, 2016 | |||
| P-17-0182 | None | December 30, 2016 | February 13, 2017 |
| P-17-0227 | July 12, 2017 | September 29, 2017 | April 27, 2017 |
| February 1, 2017 |
- The date marked on the PMN often does not correspond to the date(s) of receipt for that PMN in the Federal Register.
- Some of the PMNs we received were never listed as having been received in the Federal Register.
- In some cases, the date marked on the PMN we received is later than the date of EPA’s “Not Likely” determination.
- In some cases, the Federal Register notices suggest EPA received a new version of a PMN after the agency’s “Not Likely” determination.
This is a hot mess. The findings are highly problematic in a number of ways. First, TSCA requires that each PMN notice submitted under § 5 “shall be made available *** for examination by interested persons,” with no exceptions (TSCA § 5(d)(2), emphasis added). Our request to EPA’s Docket Center specifically asked for “the PMN that was initially submitted and all additional PMNs that were subsequently submitted for each chemical substance.” Yet we only received one even where there were multiple listings, and in the cases listed above, that one did not correspond to any of the published dates of receipt.
Based on the findings shown in the tables above, it appears that EPA has failed to comply with the statute and its own regulations; nor did EPA provide all of the information we identified in our request.
Second, even though EPA is required to publish a notice of receipt in the Federal Register for every PMN received, this has not always occurred. As shown in the Table above, there was no Federal Register notice of receipt for two of the 69 PMNs we examined, P-16-0508 and P-17-0182. Beyond these two, we also found that Federal Register notices of PMN receipts are missing for numerous PMNs for which EPA has published its receipt of a Notice of Commencement (NOC) since passage of the Lautenberg Act in June 2016. Here are 10 PMNs for which this is the case:
- P-16-0042
- P-16-0158
- P-16-0159
- P-16-0553
- P-16-0590
- P-17-0032
- P-17-0088
- P-17-0089
- P-17-0091
- P-17-0092
Not only is it a violation of TSCA for EPA not to publish these notices, but the notices provide information that is not otherwise readily publicly available, such as the name of the manufacturer/importer, the specific or generic intended use(s), and the specific or generic name of the new chemical. While we do not mean to suggest EPA is intentionally failing to publish these notices, their absence and the apparent absence of an internal system to track such matters are critical oversights.
Lastly, in some cases, Federal Register notices indicate a receipt date that is months after the date of EPA’s final determination on a PMN. If there is an innocent explanation for this bizarre situation, EPA needs to provide it – and take steps to ensure it is promptly remedied. In particular, EPA needs to clearly indicate in the Federal Register – and include in the public files for a PMN – the specific information it has received that is triggering each of the multiple Federal Register listings.
Why this matters
As we have noted before, the reason this matters is that EPA is embarking on an approach (albeit contrary to the law) to reviewing new chemicals under which it asserts that the specifications in a company’s PMN will often be sufficient for EPA to determine the new chemical is “not likely to present an unreasonable risk.” EPA says it will then develop a SNUR that is supposed to closely mirror those aspects of the PMN that allowed EPA to make that determination.
More specifically, EPA plans to engage in a review process that will, where necessary, work with a company to narrow its intended conditions of use until EPA believes it can justify finding that the chemical substance is “not likely” to present an unreasonable risk under those uses. EPA intends to do so even though that finding does not mean that the company is limited to the conditions of use identified in its final PMN.
Therefore, now more than ever before, it is critical for the public to have ready and timely access to each of the PMNs submitted on a chemical substance, in order to know what a company’s original intended conditions of use were and what changes were made in the course of EPA’s review. Without such access to PMNs – including both the original and modified versions and associated information – 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.
Our fourth post in this series will dive deeper into EPA’s failure to make health and safety information it generates on new chemicals publicly available and to appropriately address confidential business information (CBI) claims in industry submissions on new chemicals.
Stay tuned.