Need more evidence of the chemical industry’s bad faith on TSCA? Read this.

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

This story is about chemicals known as chlorinated paraffins.  They are used as flame retardants, plasticizers and lubricants, among other things.  They come in three main versions:  short, medium, and long-chain.  Short-chain chlorinated paraffins (SCCPs) have been banned or are set to be banned in a number of jurisdictions and are listed for elimination under the Stockholm Convention.  The U.S. is not a party to Stockholm and has not banned SCCPs.  However, in 2012 EPA secured agreement from their leading domestic manufacturer, Dover Chemical Corporation, and their leading importer, INOVYN (formerly INEOS Chlor Americas, Inc.), to phase them out in consent decrees issued to settle enforcement actions EPA had brought against the companies (more on that later).

Concern over the medium and long-chain variants (MCCPs and LCCPs) has been significant and growing, however.  This is because they, like SCCPs, are expected to be very persistent and very bioaccumulative (vPvB) and, given evidence of systemic toxicity as well as toxicity to aquatic and terrestrial organisms, are also expected to be PBTs (persistent, bioaccumulative, and toxic chemicals).

The regulatory history of chlorinated paraffins under TSCA has been long and taken numerous, often troubling, turns.  We’ll only touch on some highlights here.  

Regulatory history in brief

In 2009, EPA brought enforcement actions against Dover and INEOS for violating section 5 of TSCA, which bars companies from manufacturing chemicals not listed on the TSCA Inventory.  EPA said the companies had been making or importing the chemicals for many years despite their absence from the Inventory.  While the companies disputed EPA’s findings, in 2012 consent decrees were issued by the courts hearing the cases, the main elements of which were as follows:

• The companies would cease production and import of SCCPs.
• The companies would file TSCA section 5 premanufacture notices (PMNs) for each of their MCCPs and LCCPs within 30 days of the consent decrees, or cease their production and import as well.
• While the companies continued to deny EPA’s claims that they violated TSCA, Dover paid a fine of $1.4 million and INOVYN a fine of $175,000.

The companies promptly filed the PMNs and EPA initiated its review of the chemicals under its section 5 new chemicals program.  That took quite a while to play out; in fact it is still ongoing.

By 2017, EPA had determined that the PMN chemicals “may present an unreasonable risk.”  Where EPA makes such a determination, TSCA requires that EPA issue a “section 5(e) order” sufficient to address the identified risk.  EPA typically negotiates the terms of these orders with the companies, and where both parties agree to the terms, the result is a “consent order.”  This is what happened in these cases:  Dover’s consent order is here and INOVYN’s consent order is here.

During the intervening five years between the consent decrees and the consent orders, a third company – Qualice, LLC – filed PMNs for additional MCCPs it intended to make.  EPA conducted risk assessments of Dover’s, INOVYN’s, and Qualice’s chlorinated paraffins for which they had submitted PMNs.  Based on those risk assessments, EPA confirmed the expected vPvB and PBT characteristics of these chemicals and in late 2015 stated the following:

Given EPA’s preliminary risk determinations, under section 5(e) of TSCA, EPA has informed the PMN submitters that it does not believe that manufacture of these PMN substances should commence (Qualice, LLC,) or continue (Dover Chemical and INOVYN Americas, Inc.) absent the development of sufficient information to permit a reasoned evaluation of the environmental effects of the substances, as described in a testing strategy shared with the PMN submitters.

In other words, EPA said it intended to ban new or ongoing production and import of these chemicals absent receipt of additional testing information and further EPA review and potential further regulatory action.

The industry decides to fight the section 5 review process it had agreed to

The chemical industry mounted a full-court press to stop EPA.  Its main line of attack?  EPA should review these chemicals under section 6 of TSCA, not section 5.  At least one of the trade associations representing all three companies sent a letter to EPA, and they got their allies in the House to send a letter to then-EPA Administrator Gina McCarthy demanding EPA abandon the approach those same companies had already agreed to follow in the Consent Decrees they had signed in 2012.

The full-court press partly worked.  While EPA did still negotiate final section 5 Consent Orders with the three companies (Qualice’s is here), it backed entirely off of its ban-pending-testing approach.  Each of the consent orders state (emphases added):

Beginning five years following the date of submission of a Notice of Commencement of Manufacture (“NOC”), the Company is prohibited from manufacturing (which under TSCA includes importing), processing, distributing in commerce, using, or disposing of the PMN substances in the United States, for any nonexempt commercial purpose, unless the Company conducts the following studies on the PMN substances and submits all final reports and underlying data in accordance with the conditions specified in this Testing section. This information is necessary for a reasoned evaluation of the environmental effects of the substances. After that period, the activities described in this paragraph may not resume until EPA has completed review of, and taken any regulatory action deemed appropriate by EPA based on, that information, except in accordance with the conditions described in this Order.

Industry tries again, this time by fighting EPA’s proposed SNURs

That brings us almost up to the present.  In August of this year EPA proposed Significant New Use Rules (SNURs) for the chlorinated paraffins that are subject to section 5 consent orders.  Under TSCA section 5(f)(2), whenever EPA has finalized a consent order, it is required either to follow that up with a SNUR or explain why it has not done so.  Hence, the SNURs EPA proposed are fully in keeping with the requirements of TSCA section 5.

EDF filed comments on those proposed SNURs on September 17, the day the comment period closed.  Several industry commenters asked for more time to comment, however, so EPA reopened the comment period, which then closed yesterday.

EDF decided to file additional comments, available here.  We did so because we read other comments that had been submitted by industry interests, most notably the American Chemistry Council (ACC).   Bear in mind that the leading domestic manufacturer of chlorinated paraffins, Dover Chemical, is an ACC member.

In its comments, ACC resurrected yet again the industry’s earlier demand that EPA abandon the proposed SNURs – a direct outgrowth of the TSCA section 5 process to which the chemicals’ manufacturers agreed six years ago – and instead address these chemicals as existing chemicals under section 6 of TSCA.

The final (?) twist

There’s one more twist to this story that demonstrates just how much gall ACC has to demand EPA now address these chemicals under section 6.  The 2016 amendments to TSCA have a provision (section 6(h)) addressing certain PBT chemicals.  It provides that certain PBTs be subject to “expedited” risk management action to directly and promptly limit exposures without having to go through the prioritization and risk evaluation processes under TSCA, which can take years.

The MCCPs and LCCPs meet all the technical criteria in section 6(h) for being designated for expedited action.  However, industry interests led by ACC negotiated a carve-out from section 6(h) for existing chemicals for which EPA has “initiated a review under section 5.”  The only otherwise eligible PBT chemicals to which that carve-out applied were … wait for it … the very MCCPs and LCCPs described in this post.

Having succeeded in getting these chlorinated paraffins removed from expedited action under section 6 of TSCA on the basis that they were already subject to section 5, ACC now has the nerve to claim EPA’s only acceptable course is to start over and review the chemicals all over again under the decidedly un-expedited procedures of TSCA section 6.

Any wonder we say the industry has squandered any basis for claiming it is acting in good faith in TSCA implementation?  We can only say we hope this EPA shows at least a modicum of resolve here and squarely rejects ACC’s immodest demands.