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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
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, 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, 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 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 here. Descriptions are provided for informational purposes.
The potentially useful information identified in Unit IV. of the proposed rule will be 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, which may assist with EPAs analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. 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 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.
The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However,
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submitting a SNUN without any test data 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 which provide detailed information on the following:
Human exposure and environmental release that may result from the significant new use of the chemical substances.
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 analysis is available in the docket for this rulemaking.
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 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. Paperwork Reduction Act PRA
According to 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,
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unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control numbers for EPAs regulations in title 40
of the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if applicable.
The information collection requirements related to this action have already been approved by OMB
pursuant to PRA under OMB control number 20700012 EPA ICR No. 574.
This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMBs implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR
part 9, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is good cause under section 553b3B of the Administrative Procedure Act 5 U.S.C.
553b3B to amend this table in 40
CFR 9.1 without further notice and comment.
C. Regulatory Flexibility Act RFA
Pursuant to RFA section 605b, 5
U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person including small or large entities who intends to engage in any activity described in the final rule as a significant new use.
Because these uses are new, based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be.
However, EPAs experience to date is that, in response to the promulgation of
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