The House and Senate are in the midst of working to reconcile their two bills to amend the Toxic Substances Control Act (TSCA). There are some provisions that are only in the Senate bill or the House bill, with no equivalent on the other side. One of those is a section of the Senate bill that is titled "nomenclature," but which more broadly pertains to defining whether or not a chemical is already listed on the TSCA Inventory.
The issue is complicated but it comes down to something basic and critically important - whether changes in chemical formulas will trigger EPA reviews.
Whether a chemical is on the Inventory is a fundamental issue under TSCA. The Inventory determines how a chemical is treated under the law. Companies cannot manufacture, import, or process a chemical substance that is not on the Inventory unless EPA reviews the chemical (assuming it is covered by TSCA and is not otherwise exempt). For chemicals not on the Inventory, companies must submit a "premanufacturing notice" (PMN) to EPA, and the agency then can review the safety of the chemical and impose testing requirements and other limits on the chemicals' manufacture, processing, use and disposal.
Although the chemical industry frequently praises the new chemicals program as one of the elements of existing TSCA that works, companies have often maneuvered to avoid having to submit chemical substances to PMN review by claiming that they are already on the TSCA Inventory. Congress created the TSCA Inventory to begin with because it wanted to be sure chemicals were precisely defined. The statute is explicit that a chemical is to be defined by its exact molecular structure to assure that any changes in molecular structure - even if seemingly small - triggered a review as a new chemical. Over the past 30 years, EPA has insisted on defining inventory listings as precisely and narrowly as possible, so that changes in chemical composition that could have risk implications don't fall through the safety net of a new chemical review.
The "nomenclature" section is probably the most arcane and least carefully examined aspect of the Senate TSCA bill. It has remained unexplained, and unchanged, since it first appeared as part of the original bill introduced by Senators Vitter and Lautenberg in May 2013. The section has attracted very little public discussion, even in the trade press. My colleague Andy Igrejas, the Director of the Safer Chemicals Healthy Families coalition, has described the nomenclature section as a "black box" - practically impenetrable to many of even those most interested in TSCA policy. What would the nomenclature section do? What do its provisions actually say? What do they require EPA to do, and what will they prohibit EPA from doing in the future? Will they lead to fewer PMNs and will this weaken the effectiveness of the PMN program? Why is this rollback necessary? And where did it come from? Who wrote it, and whom does it benefit?
The nomenclature section of the bill appears to actually be several separate and to some extent un-related provisions that have been stuck together under the heading of "nomenclature." Each of those provisions, whether by design or otherwise is difficult to parse, but they clearly point to broader and more encompassing Inventory listings, which would lead to fewer PMNs. This will mean a weakening of EPA's current authority to require PMN review of new chemicals because molecular changes that could increase risks to human health and the environment would be exempt from EPA scrutiny. EPA is grappling with a host of new chemical substances that are being developed and brought to market. Some may help us in our daily lives and be safe and beneficial. Others may pose risks that need to be minimized or prevented. The new chemicals program is the primary method of ensuring that the public is protected but if the scope of the program is narrowed, this goal would not be achieved.
There are a number of recent instances where EPA and the chemical industry have disagreed over whether a chemical (or class of chemicals) is already on the Inventory. It's a reasonable assumption that the intent of the Nomenclature section of the bill is to settle these disputes in the chemical industry's favor - which is a bad result for the public, which will ultimately face more exposure to chemicals that have not been reviewed by EPA for their safety to health and the environment.
Here are some of the areas where the chemical industry is seeking to avoid more reporting and review of new chemicals:
One element of the nomenclature section appears to be industry's attempt to codify its interpretation of how EPA should deal with "statutory mixtures" - a set of chemicals that are generally combined together to make a particular product, such as cement, glass, or ceramics. The policy idea here (as I understand it) is that the industry would not have to submit each version of a mixture that will create cement, glass etc. to EPA for review, assuming that each of the individual components that comprise the mixture already exist on the TSCA inventory. However, in recent years a dispute has arisen between EPA and the industry over whether chemicals that are created as part of the manufacturing of a "statutory mixture" are themselves "new chemicals" that must undergo PMN review by EPA. There has been some lengthy correspondence between EPA and the industry (primarily the American Chemistry Council and the 3M Company) over this question. I believe the statutory mixture part of the nomenclature section in the bill is intended to resolve this dispute in industry's favor - by saying that EPA shall "treat all components of categories that are considered to be statutory mixtures" as being on the inventory, and thereby including those chemical substances created during the manufacture of those products. In addition, by codifying the categories of statutory mixtures that EPA has used as guidance until now, the bill could also limit EPA's ability to revisit and either drop or refine those existing categories and their definitions.
A second (and greater) concern with the nomenclature provision is that it attempts to "solve" the so-called "fractions" issue to industry's benefit. The best illustration of the fractions issue is the recent history over EPA's actions on short, medium and long-chain chlorinated paraffins (which are persistent, bioaccumulative toxins or PBTs). In 2012, EPA took enforcement action against two companies, Dover Chemical and INEOS, one for domestically manufacturing and one for importing various types of chlorinated paraffins, including short-chain chlorinated parrafins, which EPA alleged were not on the TSCA inventory. According to the EPA complaints against Dover and INEOS, "the TSCA Inventory currently includes some chlorinated paraffin combinations (such as C6-C18 chloroalkanes, CAS Registry Number 68920-70-7) but it does not include other combinations (such as C10-C13 chloroalkanes, CAS Registry Number 85535-84-8)." EPA has long-standing guidance that substances should be reported "as precisely descriptive as possible for the commercial chemical substance." The short-chain paraffins being domestically manufactured or imported were essentially "slices" or "fractions" of longer carbon chains that were not already listed on the inventory and which, according to EPA, should have been reported with greater specificity and submitted for review as "new chemicals."
Both companies settled with EPA, paid a fine, and stopped producing (or importing) short-chain chlorinated paraffins. In addition, both companies agreed to submit PMNs for the medium and long-chain chlorinated paraffins they are producing/importing for review, but they are allowed to keep making/importing them while they undergo an extended PMN process. One problem with allowing various individual substances - such as chemicals of differing carbon chain lengths - is that potentially important differences among the substances are lost. The evidence for concern is most extensive for the short-chain chlorinated paraffins (SCCPs), which were identified as a substance of very high concern under Europe's REACH regulation in 2008, with the use of SCCPs in most articles prohibited since 2012. There are also concerns about the environmental and health impacts of medium- and long-chain chlorinated paraffins. EPA has been gathering information on existing uses of medium- and long-chain chlorinated paraffins as part of its assessment of the MCCPs and LCCPs under PMN review. Other paraffins of combinations may not be PBTs, or may not be toxic. Simply treating all of these substances that have individual characteristics - some problematic and some benign - as the same chemical defeats the point of the inventory.
The chemical industry was alarmed by the enforcement actions against Dover and INEOS and the industry is motivated to prevent EPA's possible further restrictions on the use of MCCPs and LCCPs. In addition, industry sees EPA's enforcement of PMN requirements for "fractions" in this case as potentially the tip of the iceberg of enforcement actions and restrictions on a host of other chemicals whose "fractions" have not been properly reported as new chemicals. (See a newsletter from Bergeson and Campbell on the topic here)
More generally, there have been several write ups of the "fractions" issue by a few of the DC law firms that have TSCA business. My sense is that Bergeson and Campbell is the legal shop most deeply engaged and invested in these issues. As one example see this press release that announces Bergeson and Campbell forming the Alliance for Chemical Nomenclature, an industry coalition to advocate against enforcement over "fractions."
Note that the short-chain chlorinated paraffins were some of the first substances identified by EPA in the early Lisa Jackson/Steve Owens era as "Action Plan" chemicals that needed attention. Other such efforts to use TSCA's existing authorities to make progress included (1) use of the Chemicals of Concern list under existing TSCA 5(b)(4) - EPA's proposal was blocked from publication by OMB, and EPA's authority under 5(b)(4) was deleted in the original Lautenberg/Vitter bill and all subsequent bills; (2) use of SNUR authority to address chemicals of concern, (including in articles for some of them) -- EPA has already either finalized SNURs for several action plan chemicals including benzidine dyes and HBCD and proposed others including PBDEs and TDIs. Now industry is trying to make it more difficult, if not impossible, for EPA to issue SNURS for chemicals in articles in another provision of the Senate bill that I previously blogged about here.
A third area of concern regarding the nomenclature section is what, if anything, it will do to EPA's ability to require PMN review for nanomaterials. This has been a huge issue for EPA, with enormous pressure from industry to prevent EPA from imposing restrictions on the (already rampant) uses of nanotechnology in all kinds of products. EPA spent the past five years (!) finally getting a proposed one-time information collection rule out of OMB and it is still not final. EPA had previously sent OMB a proposed Significant New Use Rule (SNUR) for nanomaterials at the same time as the data-reporting rule, but OMB sat on it for four years. EPA ultimately withdrew the proposed SNUR from OMB, and re-submitted a revised version of the proposed Section 8(a) rule which was finally published a year later, (EPA guesstimates that it will finalize the rule in October 2016). EPA has already narrowed its own scope of what it might consider to be a "new" nano substance - only considering a nano substance "new" if it has a new chemical structure - but not if it has different physical or reactive characteristics (including its size) than an existing substance on the inventory. (See Richard Denison's blogs on the long history of industry opposition to EPA learning more about the safety of nanomaterials here.) I may be wrong, but I am concerned that this could be another area where the nomenclature provisions of the Senate bill will further constrain EPA's authority to require review of nanomaterials.
Several of these areas of dispute between EPA and the chemical industry may be "resolved" in industry's favor by one particular subsection of the "Nomenclature" section of the bill. This provision should probably win some sort of prize for its deliberate opacity. The subsection would require EPA to establish "equivalence" between EPA's nomenclature conventions for chemicals on the inventory and any other nomenclature convention "if an existing guidance allows for multiple conventions." The bill does not specify that it is referring to "an existing guidance" from EPA - as written, it could be a guidance from another federal agency, a foreign government, a chemical company or industry trade association.
The idea here seems to be that, if the "existing guidance" allows for multiple nomenclature conventions to describe a class of chemicals and perhaps allows multiple variations in chemistry to be covered by a single broad descriptor, then all the chemicals in the class should be considered "equivalent" and listed on the TSCA Inventory. This could, for example, solve the industry's "problem" of EPA requiring companies to report chemicals with carbon ranges (like the chlorinated paraffins) with greater specificity, and taking enforcement action when companies fail to do so.
How likely is it that there isn't an existing guidance somewhere that "allows for multiple conventions" since it would trigger a requirement for EPA to treat the convention(s) as equivalent with those relied upon by the agency - which would provide industry relief from reporting their chemicals with greater specificity and greater oversight?
Biotech issues -- "Renewable fuels" and enzymes and proteins
There is also a provision in the nomenclature section that codifies EPA's current practice of treating certain types of fats and oils as existing substances on the inventory. The necessity, and advisability, of locking in the existing practice and codifying particular nomenclature documents that are decades-old has not been sufficiently explored. It does seem odd that legislation being billed as "for the 21st Century" should lock in place EPA's reliance on documents from the early 1970s. Meanwhile, at least one biotechnology trade association ("BIO") is shopping language on the Hill trying to get the current provision expanded to cover other non-petroleum-based substances that they argue are "equivalent" to those captured by the 1970s guidance. This past October, a related industry group that was created by Bergeson and Campbell, the "Biobased and Renewable Products Advocacy Group" (BRAG), petitioned EPA to "establish a process to amend the list of natural sources of oil and fat in the 'Soap and Detergent Association' (SDA) nomenclature system by considering the chemical equivalency of additional natural sources." EPA denied BRAG's petition in December, and suggested in its denial letter that asking EPA to undertake a rulemaking pursuant to Section 5(h)(4) of TSCA would be more appropriate.
BIO is also seeing a "fix" to the current nomenclature language that will ensure enzymes and proteins do not have to go through PMN review - or at least not any more than they do now. I believe that language is in response to another instance of an uncompleted EPA activity - the agency issued an Advance Notice of Proposed Rulemaking (ANPRM) in 2004 floating the idea of requiring consideration of four factors (rather than the existing one) to determine if an enzyme needed to go through PMN review. The idea seemed to get vaporized in the wake of industry's hostile response, though there may still be agency activity planned or underway. I am not commenting here on the substance of these areas - "equivalent fuels" or "enzymes and proteins" - other than to say that everyone (including Congress) should be very careful about adopting policies - knowingly or otherwise - that could narrow or remove EPA's ability to require PMN review of a host of GMOs and other substances.
Other possible issues implicated
There are a host of other inventory-related issues that have arisen in recent years along the lines of those outlined above, including: isotopes (subject of an EPA enforcement case around 1994 and then a clarification of policy in June 2013), phosphors (EPA policy clarified by rule February 2010), free-radical initiators (EPA policy issued in 1989), and nonylphenols and nonylphenolethyoxolates (NPs and NPEs) - one of the original "Action Plan" chemicals (Action Plan released August 2010) and subject of a currently proposed SNUR.
Many aspects of the Senate TSCA have changed since the original version, with many improvements (and a few important additional steps backward). However, not a comma has been changed on the "nomenclature" section since it was first introduced, and there's been alarmingly little discussion or even explanation of its purpose and impact on the TSCA new chemical program even though it is clearly designed, at least in part, to make it easier for chemical companies to avoid having to submit their new chemicals to EPA for a review of their safety. That is simply unacceptable in legislation that is ostensibly intended to "reform" or "modernize" TSCA and ensure "consumer confidence" in the safety of chemicals in products used in our homes.