Regulatory DevelopmentsMarch 11, 2013
Rosemarie Kelley, Director, Waste and Chemical Enforcement Division, U.S. Environmental Protection Agency's (EPA) Office of Enforcement and Compliance Assurance, announced during a recent industry meeting that one of EPA's enforcement priorities will be to look at how manufacturers are naming and listing fractions of existing chemicals for Toxic Substances Control Act (TSCA) Inventory purposes. Kelley stated that fractions or "slices" of existing substances could be new chemical substances for which premanufacture notifications (PMN) should have been filed. In fact, EPA has already begun that process, as several enforcement initiatives are underway derivative of information generated in connection with the action brought against Dover Chemical Company. EPA is investigating alleged violations of TSCA Section 8(a) reporting under the Inventory Update Rule (IUR)/Chemical Data Reporting (CDR) Rule and TSCA Section 5 new chemical notifications against what appears to be a growing number of companies regarding their use of Chemical Identities/Chemical Abstracts Service Registry Numbers (CI/CASRN) for substances that EPA now claims are fractionated and should have been identified with more specificity than what the CI/CASRNs listed on the TSCA Inventory provide.
While there is EPA guidance stating that Inventory entries should be reported "as precisely descriptive as possible for the commercial chemical substance," EPA's recent statements seem to ignore a historical context that developed EPA guidance, and industry understanding, permitting approaches distinct from a strict CAS approach for fractionated products.
Under TSCA Section 5(a), all chemicals used in commerce, not otherwise exempt, must be listed on the TSCA Inventory. TSCA defines chemical substances that are listed on the TSCA Inventory as "existing" chemical substances. Chemical substances that are not listed on the TSCA Inventory are considered "new" chemical substances. For a "new" chemical to be added to the Inventory, it must go through a review by EPA under Section 5, in which a PMN and subsequent notice of commencement (NOC) are submitted.
The initial TSCA Inventory compiled by EPA covered chemical substances that had been in commerce since January 1975, based on information reported to EPA in 1978. The chemicals included in the initial Inventory are sometimes referred to as "grandfathered" chemicals. Substances are listed by chemical name or definition with a corresponding CI/CASRN.
When the Inventory was first developed, EPA and industry collaborated to address issues in identifying substances for Inventory purposes. Although EPA applies CAS nomenclature in naming TSCA Inventory chemicals when applicable, EPA also developed and now follows a number of naming conventions that are or can be distinct from a strict CAS approach. These naming conventions can be based on the way that EPA approached the naming of a particular chemical (and will use a similar approach for naming other new chemicals of that type) or derivative of approaches outlined in EPA documents that provide guidance in the naming and identifying of TSCA regulated chemicals.
In the petroleum industry, for example, industry and EPA understood from the inception of the TSCA Inventory (and the reporting requirements in place at that time) that the refinery streams and products that are derived from these streams are all mixtures of many discrete chemical substances, and that the composition of each of these mixtures will also intrinsically vary from batch to batch. The guidance relied upon at that time and as published in subsequent EPA guidance (e.g., Toxic Substances Control Act Inventory Representation for Certain Chemical Substances Containing Varying Carbon Chain Lengths (Alkyl Ranges Using the CX-Y Notation)) permits chemicals to be defined by process stream with a carbon range indicative of the "predominant" composition. There are other substances of unknown or variable composition, complex reaction products and biological materials (UVCB) on the Inventory, many of which have been characterized with a similar degree of generality and arguably could also be affected by changes such as those EPA is apparently now seeking.
EPA's recent statements that it may be -- in fact, is already -- initiating enforcement actions against companies that use one CI/CASRN for fractionated products, even though guidance in play since the Inventory was created allows such generality, indicates a game-changing re-interpretation of how these fractionated substances are named for TSCA purposes.
Substances and related CI/CASRNs that could be issues to EPA include substances that have been listed on the TSCA Inventory since its inception. If EPA is seeking more specificity for fractionated products, it also may be the case that existing CI/CASRNs are defined too broadly to satisfactorily define any substance, meaning that EPA's actions could effectively be disqualifying to CI/CASRNs that are existing and on the TSCA Inventory. Moreover, CI/CASRNs are used and relied upon not only in the U.S. but worldwide, meaning there could be global implications, as changes to the EPA nomenclature scheme could cause international confusion, invite potential commercial disruptions with customers and suppliers, and impact chemical regulatory schemes involving such substances managed under other laws.
Companies that manufacture fractionated substances and UVCBs may wish to review how their substances are listed on the TSCA Inventory and get involved to make EPA aware of industry's concerns of the consequences of its newly announced enforcement initiative. If you are interested in learning more about joining a coalition of other entities that have come together to urge EPA to recognize the legal and policy issues associated with this apparent change in its approach to naming/identifying fractionated substances under the Inventory and to reconsider its enforcement priorities, please contact Kathleen M. Roberts, B&C Consortia Management, L.L.C.