Significant New Use Rules on Certain Chemical Substances (20-6.B), 30184-30190 [2021-11765]
Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30184-30190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11765]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2020-0251; FRL-10021-77]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-6.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 were
the subject of premanufacture notices (PMNs). This action requires
persons to 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. This action further requires that persons not
commence manufacture or processing for the significant new use until
they have submitted a Significant New Use Notice (SNUN), EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken any risk management actions as are required
as a result of that determination.
DATES: This rule is effective on August 6, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
June 21, 2021.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wysong, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; 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
[[Page 30185]]
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, which
would include the SNUR requirements. Chemical importers are subject to
the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, pursuant to 40 CFR 721.20, 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)), 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 docket identification (ID) number EPA-HQ-OPPT-2020-0251,
is available at https://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 https://www.epa.gov/dockets.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, 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-18-151, P-18-271, P-19-19,
P-19-88, P-19-109, P-20-36, P-20-37, and P-20-38. 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 June 15, 2020 (85 FR 36175)
(FRL-10010-40), EPA proposed SNURs for these chemical substances in 40
CFR part 721 subpart E. More information on the specific chemical
substances subject to this final rule can be found in the Federal
Register documents proposing the SNURs. The record for these SNURs was
established in the docket under docket ID number EPA-HQ-OPPT-2020-0251.
That docket includes information considered by the Agency in developing
the proposed and final rules. EPA received public comments on this
rule, as described in Unit IV.
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 TSCA section 5(a)(2) factors
listed in Unit III.
C. How do the of general provisions apply to this action?
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. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(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 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
A. Determination Factors
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:
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 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
designating those reasonably foreseen conditions of use as well as
certain other circumstances of use as significant new uses.
B. Procedures for Significant New Uses Claimed as Confidential Business
Information (CBI)
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) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request
[[Page 30186]]
EPA to determine whether a specific 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 production volume limit is not
exceeded by the amount 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.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from four identifying entities on the
proposed rule. The Agency's responses to three of these comments are
described in a separate Response to Public Comments document that is
available in the public docket for this rulemaking. EPA made changes to
one of the proposed rules, as described in the response to comments.
EPA also received three anonymous comments. These three anonymous
comments and the fourth identifying entity comment were general in
nature and did not pertain to the proposed rule; therefore, no response
is required.
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, 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 proposed regulatory text, and
the final citation assignment is in the regulatory text section of this
final rule.
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.
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 other reasonably
foreseen conditions of use in addition to those conditions of use
intended by the submitter. EPA has determined that the chemical under
the intended conditions of use is not likely to present an unreasonable
risk. However, EPA has not assessed risks associated with the
reasonably foreseen conditions of use. EPA is designating these
conditions of use as well as certain other circumstances of use as
significant new uses. As a result, those significant new uses cannot
occur without going through a separate, subsequent EPA review and
determination process associated with a SNUN.
B. Objectives
EPA is issuing these SNURs because the Agency wants:
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. 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.
To be able to complete its review and determination on
each of the PMN substances, while deferring analysis on the significant
new uses proposed in these rules unless and until the Agency receives a
SNUN.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the internet at https://www.epa.gov/tsca-inventory.
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 were
undergoing premanufacture review at the time of signature of the
proposed rule and were not on the TSCA inventory. 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
the chemical substances subject to these SNURs EPA concluded at the
time of signature of the proposed rule that the designated significant
new uses were not ongoing.
EPA designated June 2, 2020 (the date of the web posting of the
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's 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
[[Page 30187]]
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 here.
Descriptions are provided for informational purposes. The potentially
useful information identified in Unit IV. of the proposed rule will be
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, which may assist with EPA's 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 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 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 721.1(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 https://www.epa.gov/reviewing-new-chemicals-under-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. EPA's 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/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 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.
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.
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 OMB's
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
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice
and comment.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b) 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,
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, 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 reducing the SNUN
submission fee from
[[Page 30188]]
$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 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.
G. Executive Order 13045: Protection of Children From Environmental
Health 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).
K. Congressional Review Act (CRA)
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report containing this rule and other required
information to each House of the Congress and to the Comptroller
General of the United States. 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.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 24, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
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; 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, amend the table by adding entries for Sec. Sec.
721.11498 through 721.11505 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.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11498............................................. 2070-0012
721.11499............................................. 2070-0012
721.11500............................................. 2070-0012
721.11501............................................. 2070-0012
721.11502............................................. 2070-0012
721.11503............................................. 2070-0012
721.11504............................................. 2070-0012
721.11505............................................. 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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. 721.11498 through 721.11505 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11498 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
721.11499 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
721.11500 Haloalkane (generic).
721.11501 Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
721.11502 Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (P-19-109,
chemical A).
[[Page 30189]]
721.11503 Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]- (P-19-
109, chemical B).
721.11504 Carbonic acid, di(lithium-6Li) salt.
721.11505 Lithium chloride (6LiCl).
* * * * *
Sec. 721.11498 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and p-tert-butylphenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
reaction products with 1,3-benzenedimethanamine and p-tert-butylphenol
(PMN P-18-151; CAS No. 158800-93-2) 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 PMN 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=1.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11499 2-Propanol, 1-butoxy-, 2,2'-ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
propanol, 1-butoxy-, 2,2'-ester (PMN P-18-271) 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 PMN substance other than as a film-
forming coalescent for architectural coatings; for automotive OEM
coatings; for can and coil coatings; for industrial wood coatings; for
floor polishes, for industrial maintenance coatings; for marine and
wood coatings; for transportation coatings; for use in printing inks;
or as a chemical intermediate to prepare ester plasticizers. It is a
significant new use to process the PMN substance to a weight fraction
greater than 8% in the final formulation.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11500 Haloalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
haloalkane (PMN P-19-19) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1,000. For purposes of Sec. 721.63(a)(6), the airborne
form(s) of the substance include particulate (including solids or
liquid droplets).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=23.
(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 (d), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11501 Ethanamine, N-ethyl-, 2-hydroxy-1,2,3-
propanetricarboxylate (1:?).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanamine, N-
ethyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:?) (PMN P-19-88; CAS
No. 23251-73-2) 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 PMN 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=46.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11502 Copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper, [[2,2',2''-
(nitrilo-.kappa.N)tris[ethanolato-.kappa.O]](2-)]- (PMN P-19-109,
chemical A; CAS No. 21545-60-8) 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(o). It is a significant new use to
manufacture, process, or use the PMN 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=3.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11503 Copper, bis[2-(amino-.kappa.N)ethanolato-.kappa.O]-.
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 30190]]
(1) The chemical substance identified as copper, bis[2-
(amino-.kappa.N)ethanolato-.kappa.O]- (PMN P-19-109, chemical B; CAS
No. 14215-52-2) 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(o). It is a significant new use to
manufacture, process, or use the PMN substance in a matter 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=3.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11504 Carbonic acid, di(lithium-6Li) salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
di(lithium-6Li) salt (PMN P-20-36; CAS No. 25890-20-4) 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 other than as a
chemical intermediate 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=35.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11505 Lithium chloride (6LiCl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium chloride
(6LiCl) (PMN P-20-37; CAS No. 20227-31-0) 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(j).
(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) Limitation 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.
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[FR Doc. 2021-11765 Filed 6-4-21; 8:45 am]
BILLING CODE 6560-50-P
