With the recent 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of “active” substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory, the magnitude of effort needed for the TSCA Section 8(b)(4) Inventory Reset is becoming clear. Stakeholders should waste no time in preparing to meet their obligations; the final rule was issued in June.
We reviewed the substances listed in the February 2017 Inventory dataset. This roster was based on substances reported under the 2012 CDR. Of the 67,748 substances on the non-confidential portion of the Inventory, 7,291 are listed as active (10.7%). Of the remaining non-active substances, 18,637 (30.8%) are exempt from CDR reporting.
In the 2016 CDR dataset, submitters reported 7,949 non-confidential substances. Of those, 1,511 were listed inactive on the 2012 interim active list. In 2016, 200 substances were reported as exempt; 135 of those were already cited as active on the February interim active list.
In the proposed reset rule on active/inactive notification, the U.S. Environmental Protection Agency (EPA) recommends including both the 2012 and 2016 CDR as sources for active status. Combining these brings non-confidential active substances up to 8,802. This is a small portion (13%) of the 67,748 non-confidential substances listed as of February 2017.
Of the 17,758 substances listed confidential, only 472 (2.7%) were reported as active. 11,025, or 62.1% of all the chemicals listed confidential are exempt.
In the 2016 CDR dataset, submitters reported that 718 confidential substances were manufactured or imported. Of those, 350 were not listed as active on the February interim active list.
The vast majority (17,286 or 97.3%) of confidential substances aren’t included on the interim active list. If the EPA decides to identify as active those substances that were commenced during the look-back period, this total will decrease substantially. At least 12,790 (72.0%) confidential substances could be added because they were the subject of premanufacture notifications (PMN) in fiscal year 2006 or later and must have been commenced during the look-back period to appear on the Inventory. This would bring the total of interim active substances up to 13,612, which would represent 76.7% of confidential substances that appear on the Inventory.
This suggests the confidential portion presents submitters with a number of challenges. These include substantiating confidentiality claims; ensuring confidential substances have appropriate generic names; and ensuring confidential substances from suppliers are properly identified as active so that supply isn’t interrupted.
Even if the EPA adds the many recent PMN substances to the interim active list, if any substances were claimed as confidential business information prior to the updated substantiation requirements, the EPA must require re-substantiation and descriptive generic names.
Of the 85,506 substances registered on the TSCA Inventory, at least 9,080 (10.6%) should be listed as active when the EPA publishes the updated interim active list considering both the 2012 and 2016 CDR. This number would increase to 21,870 if the EPA decides to identify 2006–present commenced PMNs as active and adds them to the roster. While the current list is a good start in the Inventory reset process, and would be improved significantly if the PMNs were added, the status of the Inventory’s remaining nearly 64% (54,556 substances) is unknown and there are likely tens of thousands more substances to consider and, if necessary, notify as active. Manufacturers, importers and processors of chemical substances must carefully review records to determine which of the more than 75,000 substances not included on the current list were manufactured, imported or processed in the ten-year look-back period and prepare Form A “active” notices.
Manufacturers and importers are urged to pay careful attention to substances that are exempt from CDR, notably polymers, naturally occurring substances, and chemicals manufactured or imported below the CDR thresholds. Processors should review their records and work with their suppliers to ensure that active chemicals aren’t missed. Of particular concern are infrequently made or purchased batch chemicals that were manufactured, imported or processed during the look-back period. Searching records and preparing notices will be a significant challenge.
Similarly, managing confidential identities, including providing a structurally descriptive generic name and substantiating confidentiality claims, will add to the reporting burden. The endeavor promises to require an enormous effort on industry’s part and, once the reporting process is complete, on the EPA’s part to review the thousands of submissions and, in so doing, populate the active list.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).