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Federal Register / Vol. 86, No. 194 / Tuesday, October 12, 2021 / Proposed Rules rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1c, persons subject to these SNURs must comply with the same significant new use notice SNUN
requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5a1A. These requirements include the information submission requirements of TSCA
sections 5b and 5d1, the exemptions authorized by TSCA
sections 5h1, h2, h3, and h5, and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA
must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination. If EPA
determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5g to make public, and submit for publication in the Federal Register, a statement of EPAs findings.
III. Significant New Use Determination TSCA section 5a2 states that EPAs determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a chemical substance.
The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four TSCA section 5a2 factors listed in this unit.
The proposed rules include PMN
substances that EPA has determined not likely to present an unreasonable risk under the conditions of use, EPA is proposing to identify other circumstances that, while not reasonably foreseen, would warrant
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further EPA review before manufacture or processing for such a use is commenced.
IV. Substances Subject to This Proposed Rule EPA is proposing significant new use and recordkeeping requirements for certain chemical substances in 40 CFR
part 721, subpart E. In this unit, EPA
provides the following information for each chemical substance that is identified in this unit as subject to this proposed rule:
PMN number.
Chemical name generic name, if the specific name is claimed as CBI.
Chemical Abstracts Service CAS
Registry number if assigned for nonconfidential chemical identities.
Potentially Useful Information.
CFR citation assigned in the regulatory text section of the proposed rule.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P16420
Chemical Name: Dimethyl cyclohexenyl propanol generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as a fragrance ingredient, being blended mixed with other fragrance ingredients to make fragrance oils that will be sold to industrial and commercial customers for their incorporation into soaps, detergents, cleaners and other similar household and consumer products.
Based on the estimated physical/
chemical properties of the PMN
substance, comparison to structurally analogous chemical substances, and submitted test data on the PMN
substance, EPA has identified concerns for eye irritation, systemic toxicity, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No release of the PMN substance resulting in surface water concentrations that exceed 55 ppb.
The proposed SNUR would designate as a significant new use the absence of this protective measure.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific
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target organ toxicity and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11604.
PMN Number: P16446
Chemical Name: Fatty acids, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid and alkylamine, lactates salts generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as a resin in architectural primer coatings.
Based on the estimated physical/
chemical properties of the PMN
substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to all tissues and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No release of the PMN substance resulting in surface water concentrations that exceed 38 ppb.
The proposed SNUR would designate as a significant new use the absence of this protective measure.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11605.
PMN Number: P16602
Chemical Name: Carbonic acid, dialkyl ester, polymers with 5-amino1,3,3trimethylcycloalkanemethanamine, 2ethyl-1-alcohol-blocked 1,6diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an ingredient in paints. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns
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