On July 5, 2022, EPA finalized the rule Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (87 FR 39756). EPA made changes to SNUR requirements in the following sections 40 CFR §§ 721.11, 721.63, 721.72, and 721.91. In addition, the Agency has changed when 40 CFR 721.80(j) will be used. Most amendments only apply to SNURs issued after the rule’s effective date, September 6, 2022. However, retrospective changes are flagged throughout this report. The amendments in this Federal Register notice will also require the submission of SDS(s) with PMNs, SNUNs, and Low Volume Exemptions (LVEs).
Changes to 40 CFR § 721.63, Protection in the Workplace
EPA updated this regulation so that it will be consistent with NIOSH and OSHA requirements. For example, the amendment to 40 CFR § 721.63(a)(4) references the updated NIOSH regulations for respirator use, testing, and certification. EPA believes that most manufacturers and processors are already subject to and complying with the NIOSH regulations. This change will be retroactive and thus will apply to all previously issued SNURs that contain significant new use requirements pertaining to respiratory protection. The amended rule allows manufacturers and processors that are subject to SNURs to follow updated respiratory protection requirements without triggering a SNUN requirement.
EPA has also updated to the NIOSH-certified respirator language in 40 CFR § 721.63(a)(5). Notably, individuals will be allowed to continue using any of the fifteen older-style respirators listed under 40 CFR § 721.63(a)(5)(i-xv) to avoid triggering a SNUN requirement. In addition, EPA amended 40 CFR § 721.63(a)(6) to update the language for when the airborne form of a chemical substance implicates the respiratory requirements in 40 CFR § 721.63(a)(4).
The amendments to the SNUR regulations also include new paragraphs 40 CFR § 721.63(a)(7) and 40 CFR § 721.63(a)(8). When implicated by a SNUR, these new requirements make it a significant new use not to implement a hierarchy of controls to protect workers. These changes will require any person subject to a SNUR that calls out these requirements to identify and implement appropriate engineering and administrative controls for respiratory protection before using PPE for workers protection.
Changes to 40 CFR § 721.72, Hazard Communication Program
EPA updated the language in 40 CFR § 721.72(a) through (h) to be consistent with current OHSA requirements and the United Nations’ Globally Harmonized System of Classification and Labeling (GHS). The amendments will apply retroactively to previously issued SNURs that cite 40 CFR § 721.72(a), (c), or (d).
Paragraphs (g) and (h) were amended to include new hazard and precautionary statements to make these provisions consistent with OSHA requirements and GHS recommendations. EPA also added two new paragraphs to 40 CFR § 721.72, (i) and (j). These new paragraphs impose new hazard communication requirements. Paragraph (i) requires a written hazard communication program to be developed and implemented for the SNUR substance in each workplace. The written hazard communication program would need to meet OSHA requirements in 29 CFR 1910.1200, OSHA’s Hazard Communication Standard (HCS). Paragraph (j) provides specific statements and warnings that could be incorporated in hazard communications.
Under the revisions to § 721.72, whenever the statements in paragraphs (g), (h), and (j) are required, manufacturers and processors subject to the SNUR will also need to consider if they trigger any other corresponding hazard communication under the OSHA HCS. Any hazard and/or precautionary statements required by the SNUR would need to include a minimum set of hazard warnings.
Changes to 40 CFR § 721.80, Industrial Commercial and Consumer Activities
EPA has changed the circumstance in which it will cite 40 CFR § 721.80(j) which defines a significant new use as, “[u]se other than as described in the premanufacture notice references in subpart E of this part for the substance.” No language would be changed. Instead, the Agency is clarifying when it will identify a new use using this verbiage. The Federal Register notice explains that “To better identify the significant new use, EPA has changed this procedure to only cite 40 CFR 721.80(j) when the use described in the PMN is confidential.”
Changes to 40 CFR § 721.91, Computation of Estimated Surface Water Concentrations: Instructions
EPA has modified the instructions in 40 CFR § 721.91 for computation of estimated surface water concentrations to allow for a certain percentage of removal of a chemical substance from wastewater after undergoing control technology in accordance with the requirements in 40 CFR § 721.90.
Changes to 40 CFR § 721.11, Applicability Determination When a Specific Chemical Identity is Confidential
The amendments to 40 CFR § 721.11 subpart A modify the bona fide procedure so that it applies to all SNURs containing any CBI, including the significant new use.
Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVEs), Low Release, and Exposure Exemptions (LoREXs), and Test Marketing Exemption (TME) Applications
EPA has amended sections 40 CFR § 720.38, 40 CFR § 720.45, and 40 CFR § 723.50 to require that any safety data sheets (SDSs) that has been developed, even if it is in draft form, be submitted as part of any notification or exemption application (PMN, SNUN, LVE, LoREX, or TME). Submitters are not required to develop an SDS if one does not already exist.