Quiero saber acerca de...

Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Rules and Regulations 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, 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
VerDate Sep<11>2014

16:05 Sep 15, 2021

Jkt 253001

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 SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year FY 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by
PO 00000

Frm 00035

Fmt 4700

Sfmt 4700

51623

reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 62 FR 29684
FRL55971, the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act UMRA
Based on EPAs experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 2 U.S.C. 1501 et seq..
E. Executive Order 13132: Federalism This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 64 FR 43255, August 10, 1999.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175
65 FR 67249, November 9, 2000, do not apply to this action.

E:FRFM16SER1.SGM

16SER1