Date: Oct 23, 2001
On June 27, 2001, the Environmental Protection Agency (EPA) issued a final nomenclature correction to the Toxic Substances Control Act (TSCA) Chemical Substance Inventory (Inventory) for the substance monomer acid and its derivatives. 66 Fed. Reg. 34193-98. (An article on the proposed notice can be found at www.khlaw.com/currtfr.htm.) The notice declares erroneous an EPA letter of August 2, 1985, to Keller and Heckman, and states that, for Inventory purposes, monomer acid is not equivalent to tall oil fatty acid (TOFA), oleic acid, or octadecenoic acid, as initially determined by EPA in the 1985 letter.
As a result, beginning June 27, 2002, any person who manufactures or imports a monomer acid derivative or other downstream substance based on monomer acid that is not specifically listed on the TSCA inventory using the correct nomenclature for the monomer acid component of the chemical substance name will be in violation of TSCA unless a pre-manufacture notice (PMN) has been submitted at least 90 days earlier. The corrected index name for monomer acid is Fatty acids, C16-18 and C18-unsatd., branched and linear (CASRN 68955-98-6). All derivatives and downstream products made from monomer acid must be named consistently with this nomenclature. Affected products include paints, coatings, plasticizers, synthetic lubricants, and surfactants.
EPAs notice did not address whether hydrogenated monomer acid, which is generally known as isostearic acid, is affected by the new correction or whether isostearic acid derivatives fall under the new nomenclature correction for monomer acids. Presumably, since EPAs notice does not state otherwise, producers of isostearic acid will need to file PMNs. However, it can be argued that isostearic acid should be included under the new nomenclature. For example, EPA could have described isostearic acid with the nomenclature, Fatty acids, C16-18 and C18, branched and linear.
Prior to June 27, 2002, EPA will allow manufacturers and importers to continue commercial production of existing monomer acid derivatives and downstream products under the old nomenclature. The last date to file a PMN for producers impacted by this notice is 90-days before, or on March 27, 2002. EPA has also established the following policy, in order to facilitate compliance and encourage the submission of PMNs:
Although the PMN fee will be waived, the submitter must nonetheless check the box for the $2,500 user fee certification statement and type in the following statement: No fee required, per EPAs Correction to Chemical Nomenclature for Monomer Acid Derivatives for TSCA Inventory Purposes. Further, although there is no limit on the number of chemicals that may be consolidated, the process for consolidation remains the same, in that EPA must approve their batching. Thus, the submitter must obtain approved names from Chemical Abstracts Services, and EPA must approve the consolidation of specific substances. Further, consolidated PMNs must have individual PC numbers assigned by the EPA.
If a company intends to manufacture or import a monomer acid derivative or downstream product for the first time prior to the effective date of the new nomenclature interpretation and the substance is not listed on the TSCA Inventory using the old nomenclature, then it will be required to submit a regular PMN at least 90 days before the manufacture or import of the substance. In this situation, the company will not be able to take advantage of the consolidated reporting process or the fee waiver.
If you have any questions regarding this nomenclature correction, or desire assistance with preparing the necessary PMN submittals, or if you wish to discuss any other TSCA issue, please contact Tom Berger at 202-434-4285 or via e-mail at email@example.com, Rhys Daniels at 202-434-4270 or firstname.lastname@example.org, or Mike Novak at 202-434-4485 or via e-mail at email@example.com.