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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
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In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of the abovementioned dates, that person will have to cease any such activity upon the effective date of the final rule.
To resume their activities, that person 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.
VIII. Development and Submission of Information EPA recognizes that TSCA section 5
does not require development of any particular new information e.g., generating test data before submission of a SNUN. There is an exception:
If a person is required to submit information for a chemical substance pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5b1A requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to them or reasonably ascertainable by them see 40
CFR 720.50. However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing.
Unit IV. of the proposed rule lists potentially useful information for all SNURs listed in this document.
Descriptions are provided for informational purposes. The information identified in Unit IV. of the proposed rule will be potentially useful to EPAs evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance.
EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4h, which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies also called New Approach Methodologies, or NAMs, if available, to generate the recommended test data.
EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the
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data needs and the objective of TSCA
section 4h. For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
In some of the TSCA Orders for the chemical substances identified in this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances.
These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.
Any request by EPA for the triggered and pended testing described in the TSCA Orders was made based on EPAs consideration of available screeninglevel data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.
The potentially useful information identified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance associated with the designated significant new uses.
However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA sections 5e or 5f. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following:
Human exposure and environmental release that may result from the significant new use of the chemical substances.

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Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
IX. SNUN Submissions According to 40 CFR 721.1c, persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40
CFR 720.50. SNUNs must be submitted on EPA Form No. 771025, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40
and 721.25. EPMN software is available electronically at https
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
X. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPAs complete economic analyses are available in each docket listed in Unit II.
XI. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review This action establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Orders 12866
58 FR 51735, October 4, 1993 and 13563 76 FR 3821, January 21, 2011.
B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs This action is not subject to Executive Order 13771 82 FR 9339, February 3, 2017, because this action is not a significant regulatory action under Executive Order 12866.
C. Paperwork Reduction Act PRA
According to the PRA 44 U.S.C. 3501
et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB
and displays a currently valid OMB
control number. The information
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