[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Rules and Regulations]
[Pages 46550-46556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15014]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2019-0495 FRL-10009-78]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-5.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances which are
the subject of premanufacture notices (PMNs). This action requires
persons to
[[Page 46551]]
notify EPA at least 90 days before commencing manufacture (defined by
statute to include import) or processing of any of these chemical
substances for an activity that is designated as a significant new use
by this rule. The required notification initiates EPA's evaluation of
the chemical under the conditions of use within the applicable review
period. Persons may not commence manufacture or processing for the
significant new use until EPA has conducted a review of the Significant
New Use Notice (SNUN), made an appropriate determination on the SNUN,
and has taken such actions as are required as a result of that
determination.
DATES: This rule is effective on October 2, 2020. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
August 17, 2020.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9232; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA. Importers of chemicals subject to these SNURs must certify their
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by the docket identification (ID) number listed at the top
of this document, is available at http://www.regulations.gov or at the
Office of Pollution Prevention and Toxics Docket (OPPT Docket),
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.
Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical
substances which were the subject of PMNs P-17-324, P-18-109, P-18-276,
P-18-358, P-18-384, and P-19-24. These SNURs require persons who intend
to manufacture or process any of these chemical substances for an
activity that is designated as a significant new use to notify EPA at
least 90 days before commencing that activity.
Previously, in the Federal Register of September 11, 2019 (84 FR
47923) (FRL-9999-27), EPA proposed SNURs for these chemical substances
and established the record for these SNURs in the docket under docket
ID number EPA-HQ-OPPT-2019-0495. That docket includes information
considered by the Agency in developing the proposed and final rules,
including public comments and EPA's responses to the public comments
received.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to 40 CFR 721.1(c), persons subject to these SNURs must comply with the
same significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must
either determine that the significant new use is not likely to present
an unreasonable risk of injury or take such regulatory action as is
associated with an alternative determination before the manufacture or
processing for the significant new use can commence. If EPA determines
that the significant new use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
[[Page 46552]]
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit. During its review of
these chemicals, EPA identified certain conditions of use that are not
intended by the submitters, but reasonably foreseen to occur. EPA is
finalizing its proposed designation of those reasonably foreseen
conditions of use as well as certain other circumstances of use as
significant new uses.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from two identifying entities on the
proposed rule. The Agency's responses are presented in the Response to
Public Comments document that is available in the docket for this rule.
In response to public comment, EPA has modified the significant new use
in the SNUR at 40 CFR 721.11379 to refer more generally to the
manufacture of 6-lithium halide scintillation crystals.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E. In
Unit IV. of the proposed SNUR (see Unit II.A.), EPA provided the
following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR.
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
these rules.
The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.
The chemical substances that are the subject of the SNURs addressed
in this document completed premanufacture review. In addition to those
conditions of use intended by the submitter, EPA has identified certain
other reasonably foreseen conditions of use as well as other
circumstances of use. EPA has preliminarily determined that the
chemicals under their intended conditions of use are not likely to
present an unreasonable risk. However, EPA has not assessed risks
associated with the reasonably foreseen conditions of use for these
chemicals. EPA is designating these reasonably foreseen and other
circumstances of use as significant new uses. As a result, those
significant new uses cannot occur without first going through a
separate, subsequent EPA review and determination process associated
with the SNUN.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these SNURs and as further discussed in Unit
IV. of the proposed rule, EPA identified certain reasonably foreseen
conditions of use as well as certain other circumstances of use
different from the intended conditions of use identified in the PMNs
and determined that those changes 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.
B. Objectives
EPA is issuing these SNURs because the Agency wants:
To receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use before the significant new use may commence. The Agency will
either determine under TSCA section 5(a)(3)(C) that the significant new
use is not likely to present an unreasonable risk, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by the Administrator under the conditions of
use, or make a determination under TSCA section 5(a)(3)(A) or (B) and
take the required regulatory action associated with the determination,
before manufacture or processing for the significant new use of the
chemical substance can occur.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VII. Applicability of the 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 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.
EPA designated September 4, 2019 (the date of web posting of the
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach has been to ensure that a
person could not 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, 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.
[[Page 46553]]
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 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) 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 in this
document. Descriptions are provided for informational purposes. The
information identified in Unit IV. of the proposed rule will be
potentially useful to EPA's 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 4(h),
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 4(h).
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 5(e) or 5(f).
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.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to 40 CFR 721.1(c), 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. 7710-25, 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. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. 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. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2019-0495.
XII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-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. 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 EPA's 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers
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and their subsequent codification in the CFR satisfies the display
requirements of PRA and OMB's implementing regulations at 5 CFR part
1320. This Information Collection Request (ICR) was previously subject
to public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without
further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (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.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies 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, EPA has concluded 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, EPA's 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, EPA
received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in
FY2015, 10 in FY2016, 14 in FY2017, and 11 in FY2018 and only a
fraction of these were from small businesses. In addition, the Agency
currently offers relief to qualifying small businesses by 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)
(FRL-5597-1), 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 EPA's 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 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, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribe Governments
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it 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.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
XIII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
[[Page 46555]]
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 7, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR parts 9 and 721 as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add entries for Sec. Sec. 721.11375 through 721.11380
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
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* * * * *
721.11375................................................. 2070-0012
721.11376................................................. 2070-0012
721.11377................................................. 2070-0012
721.11378................................................. 2070-0012
721.11379................................................. 2070-0012
721.11380................................................. 2070-0012
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* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. Sec. 721.11375 through 721.11380 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11375 2,4-Hexadien-1-ol, 1-acetate, (2E,4E)-.
721.11376 2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-
(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate
and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl),
[(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated
(generic).
721.11377 Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino]
phenyl]-.
721.11378 1H-Imidazole-1-propanenitrile, 2-ethyl-ar-methyl-.
721.11379 Lithium, isotope of mass 6.
721.11380 Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl Me Pr,
polymers with silicic acid (H4SiO4) tetra-Et
ester, (2-hydroxyethoxy)- and methoxy-terminated, chlorides.
Sec. 721.11375 2,4-Hexadien-1-ol, 1-acetate, (2E,4E)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,4-hexadien-1-ol,
1-acetate, (2E,4E)- (PMN P-17-324, CAS No. 57006-69-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=24.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11376 2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with
2-(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate
and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl),
[(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-
(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate and
a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), [(1-
alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (PMN P-18-109)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the chemical
substance in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11377 Benzenesulfonamide, N-[2-
[[(phenylamino)carbonyl]amino]phenyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenesulfonamide,
N-[2-[[(phenylamino)carbonyl]amino]phenyl]- (PMN P-18-276, CAS No.
215917-77-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the chemical substance for other than as a
developer for thermal paper.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11378 1H-Imidazole-1-propanenitrile,2-ethyl-ar-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-imidazole-1-
propanenitrile,2-ethyl-
[[Page 46556]]
ar-methyl- (PMN P-18-358, CAS No. 568591-00-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1). It is a significant new use to use
the chemical substance for other than as a curing agent within carbon
fiber reinforced plastics prepreg or a curing agent in industrial
adhesives for electronics.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11379 Lithium, isotope of mass 6.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium, isotope of
mass 6 (P-18-384, CASRN 14258-72-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process or use the chemical
substance without the workplace engineering controls described in the
PMN. It is a significant new use to use the chemical substance other
than as a starting material for manufacture of 6-Lithium halide
scintillation crystals for use in radiation detection.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 8.5.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11380 Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl Me
Pr, polymers with silicic acid (H4SiO4) tetra-Et
ester, (2-hydroxyethoxy)- and methoxy-terminated, chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silsesquioxanes, 3-
(dimethyloctadecylammonio)propyl Me Pr, polymers with silicic acid
(H4SiO4) tetra-Et ester, (2-hydroxyethoxy)- and
methoxy-terminated, chlorides. (PMN P-19-24, CAS No. 35501-23-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as an asphalt
additive or asphalt emulsion additive. It is a significant new use to
use the chemical substance as an asphalt additive in a manner that
results in inhalation exposure to respirable particles or droplets
containing the chemical substance.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=8.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2020-15014 Filed 7-31-20; 8:45 am]
BILLING CODE 6560-50-P