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Federal Register / Vol. 86, No. 194 / Tuesday, October 12, 2021 / Proposed Rules may be potentially useful to characterize the human health 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 developmental and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11632.
PMN Number: P19121
Chemical Name: Plant based oils, polymer with 1,1-methylenebis4isocyanatobenzene, pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol 3:1 generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as an industrial adhesive. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to all exposed tissues, dermal and respiratory sensitization, and lung effects 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 use of the PMN substance in spray applications.
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 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 eye damage, skin irritation, skin sensitization, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11633.
PMN Number: P19130
Chemical Name: Aminohydroxy naphthalenesulfonic acid, coupled with diazotizedaminophenylsulfonylethyl hydrogen sulfate and diazotized amino sulfooxyethyl sulfonylbenzenesulfonic acid, salts generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as a dye. Based
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on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, analysis of analogous acid dyes and amphoteric dyes and vinyl sulfones, and submitted test data on the PMN substance, EPA
has identified concerns for irreversible damage to eyes and irritation to mucous membranes 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:
Use of the PMN substance only for the confidential use described in the PMN.
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 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 eye damage and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11634.
V. Rationale and Objectives of the Proposed Rule A. Rationale During review of the chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances that raised potential risk concerns. EPA
determined that deviations from the limitations identified in the submissions could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the certain limitations in the submission.
B. Objectives EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:
To have an opportunity to review and evaluate data submitted in a SNUN

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before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
VI. Applicability of the Proposed Significant New Use Designation To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement NOC and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC
has not been submitted, EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates October 12, 2021 as the cutoff date for determining whether the new use is ongoing. The objective of EPAs approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR
notification requirements and wait 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.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the
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