# 721.12084 Thermomycolin, Malbranchea cinnamomea origin, expressed in genetically modified Trichoderma reesei.
(a) *Chemical substance and significant new uses subject to reporting.* (1) The chemical substance identified as thermomycolin, Malbranchea cinnamomea origin, expressed in genetically modified Trichoderma reesei (PMN P-22-59) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when in a formulation at a concentration of 0.1% or less.
(2) The significant new uses are:
(i) *Protection in the workplace.* Requirements as specified in § 721.63(a)(1) and (3) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (*e.g.,* enclosure or confinement of the operation, general and local ventilation) or administrative control measures (*e.g.,* workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.
(ii) *Hazard communication.* Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, respiratory sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) *Industrial, commercial, and consumer activities.* It is a significant new use to manufacture the substance other than by import into the United States (*i.e.,* no domestic manufacture) in a liquid formulation. It is a significant new use to process for use or use the substance in consumer products unless the concentration of the substance in the consumer products is less than 0.1% by weight.
(iv) *Release to water.* It is a significant new use to release the substance, or any waste stream containing the substance, into water during processing unless the substance is deactivated before releasing to water. To deactivate the New Chemical Substance, adjust the pH to 2 or below and incubate for 30 minutes.
(b) *Specific requirements.* The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) *Recordkeeping.* Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) *Limitation or revocation of certain notification requirements.* The provisions of § 721.185 apply to this section.
[90 FR 49222, Nov. 4, 2025]