The U.S. Environmental Protection Agency (EPA) is scheduled to publish on October 3, 2018, a direct final rule promulgating significant new use rules (SNUR) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN). The chemical substances are subject to orders issued by EPA pursuant to Sections 5(e) and 5(f) of the Toxic Substances Control Act (TSCA). The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. The direct final rule will be effective 60 days after publication in the Federal Register. Written adverse comments on one or more of the SNURs must be received within 30 days of publication in the Federal Register. If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date. In addition to the direct final rule, EPA is scheduled to publish a proposed rule on October 3, 2018. Comments on the proposed rule are due 30 days after publication in the Federal Register.
According to the SNUR, the generic (non-confidential) use of carbon nanomaterial (generic) will be in printing applications. EPA states that it identified concerns for pulmonary toxicity and carcinogenicity based on analogy to carbon black. EPA issued an order under TSCA Sections 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substance, and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The Order requires:
- Submission to EPA of certain health testing and material characterization data before exceeding a specified confidential production volume;
- Use of personal protective equipment (PPE) where there is a potential for dermal exposure;
- Use of a National Institute for Occupational Safety and Health (NIOSH) certified air purifying, tight-fitting full-face respirator equipped with N100, P-100, or R-100 filter with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure;
- No release of the PMN substance to surface waters;
- Use of the PMN substance only for the confidential uses specified in the order;
- Limiting the manufacture, processing, and use of the PMN substance to industrial uses;
- No processing or use of the powder form of the PMN substance outside of the site of manufacture/processing; and
- No processing or use of the PMN substance in the liquid resin form using an application method that generates a vapor, mist, or aerosol.
The SNUR designates as a “significant new use” the absence of these protective measures. EPA states that it has determined that “certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR.” EPA notes that the submitter has agreed not to exceed certain time limits without performing specific physical-chemical property tests and characterization and pulmonary effects testing. According to EPA, it also determined that the results of a carcinogenicity study would help characterize the potential health effects caused by the PMN substance. Although the order does not require this test, EPA states that the order’s restrictions “will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.”