Quiero saber acerca de...

Federal Register / Vol. 86, No. 86 / Thursday, May 6, 2021 / Rules and Regulations the TSCA Inventory is available on the internet at https www.epa.gov/tscainventory.

khammond on DSKJM1Z7X2PROD with RULES

VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this 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 the chemical substances identified in this 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.
However, the identities of many of the chemical substances subject to this 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 rule are ongoing.
EPA designated July 31, 2019 the date of FR publication of the proposed rule 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.
Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will 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 EPA would have to take action under section 5 allowing manufacture or processing to proceed.
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
VerDate Sep<11>2014

16:26 May 05, 2021

Jkt 253001

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, 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
PO 00000

Frm 00029

Fmt 4700

Sfmt 4700

24331

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.
According to 40 CFR 725.900, persons submitting an MCAN for a significant new use of a microorganism must comply with the same notification requirements and EPA regulatory procedures as persons submitting an MCAN for a new microorganism, including submission of test data on health and environmental effects as described in 40 CFR 725.160. EPMN
software is available electronically at https www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-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 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 OMB control
E:FRFM06MYR1.SGM

06MYR1