The Environmental Protection Agency issued significant new use rules on Sept. 18 under the Toxic Substances Control Act that approve pre-manufacture notices for 10 chlorinated paraffin substances that are used in metalworking fluids.
In 2017, Dover Chemical, Inovyn and Qualice LLC signed consent orders with the EPA that approved all outstanding chlorinated paraffin pre-manufacture notices, allowing the three companies to manufacture and import a wide range of CPs, including medium, long- and very long-chain varieties. Consistent with its responsibilities under TSCA section 5(f)(4), EPA is finalizing these [significant new use rules] to ensure that other manufacturers, importers and processors of these CPs are held to the same standards as the original [pre-manufacture notice] submitters, the agency stated in its final rule published in the Federal Register. EPA notes that suppliers have been on notice of this issue for over 10 years and would have an additional five years to come into compliance under the terms of this significant new use rule.
Under the Toxic Substances Control Act, the significant new use rules, known as SNURs, require those who intend to manufacture or process any of these chemical substances for an activity that is designated a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPAs evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.
Chlorinated paraffins are chlorinated alkanes that have carbon chain lengths ranging from 10 to 38, with varying degrees of chlorination. Those with lengths from C14 to C17 are classed as medium chain; from C18 to C20 as long chain; and C21 and higher as very long-chain. CPs are used in metalworking fluids as extreme-pressure agents, especially for difficult drawing, forming and removal operations. Metalworking fluids thus fortified are often used to machine titanium alloys, stainless steels and other metals, because they protect tools and components from friction, wear and overheating at high speeds and intense pressures.
The approved pre-manufacture notices are for three medium-chain CPs, and seven long-chain and very-long chain CPs. The chemical substances are subject to consent orders issued by EPA pursuant to section 5(e) of TSCA, according to the EPAs rule documentation in the Federal Register. According to EPAs website, orders issued by the agency are consent orders negotiated with the submitter of the pre-manufacture notice.
During a Metalworking Committee session at the Independent Lubricant Manufacturers Associations annual meeting in Colorado Springs, Colorado, Chlorinated Paraffin Industry Association Executive Director Andrew Jacques noted that EPAs statement on the final significant new use rule says that … because medium-chain CPs similar to the [pre-manufacture notice] substances have been manufactured, processed and used for the uses described in the [pre-manufacture notices] for more than 40 years, manufacture, processing, distribution in commerce, use and disposal of the [pre-manufacture notice] substances in accordance with the provisions of the TSCA section 5(e) order do not create an unreasonable risk of injury to health or the environment. This EPA statement is important because TSCA Section 5 requires that the agency make a finding of no unreasonable risk before it can approve a notice, he said.
The final rule on significant new use includes a five-year limit for CP manufacturers and importers to submit the required test data and for EPA to review it. Jacques noted that during that period, the EPA is expected to make data-based decisions about the disposition of the consent orders and significant new use rules for the CP substances and can modify or revoke them. EPA can also choose to issue significant new use notices to suppliers and processors beyond the five-year period.
ILMA had submitted comments to EPA asserting that CPs should be regulated under TSCA as existing chemicals. EPA stated in its response that although the chemicals have been in commerce globally for over 70 years, the agency informed CP manufacturers in 2009 that they were using the wrong Chemical Abstracts Service numbers for the CPs that are the subject of the current rules. Those CPs were not properly listed on the TSCA inventory, and thus remained new chemical substances as defined under TSCA, the agency stated.
The rules that EPA issued Sept. 18 may be viewed online at the Federal Register website.
Caitlin Jacobs contributed to this article.