[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46133-46156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17392]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2018-0627, EPA-HQ-OPPT-2018-0777, EPA-HQ-OPPT-2019-0359,
EPA-HQ-OPPT-2019-0228, EPA-HQ-OPPT-2019-0494, and EPA-HQ-OPPT-2019-
0530; FRL-8000-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
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 that were
the subject of premanufacture notices (PMNs). The SNURs require persons
who intend to manufacture (defined by statute to include import) or
process any of these chemical substances for an activity that is
designated as a significant new use by this rule to notify EPA at least
90 days before commencing that activity. The required notification
initiates EPA's evaluation of the use, under the conditions of use for
that chemical substance, 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 notice, made an appropriate
determination on the notice, and has taken such actions as are required
by that determination.
DATES: This rule is effective on October 18, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
September 1, 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 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, which would include 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 dockets?
The dockets include information considered by the Agency in
developing the proposed and final rules. The dockets for this action,
identified by docket identification (ID) numbers EPA-HQ-OPPT-2018-0627,
-2018-0777, -2019-0359, -2019-0228, -2019-0494, and -2019-0530, are
available at https://www.regulations.gov and 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.
Due to the public health concerns related to COVID-19, the EPA
Docket
[[Page 46134]]
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 certain
chemical substances which were the subject of PMNs. EPA will address
the other proposed SNURs in future Federal Register notices.
Previously, EPA proposed SNURs for these chemical substances and
established the record for these SNURs in the following Federal
Registers and docket ID numbers:
October 3, 2018 (83 FR 49903) (FRL-9983-81); Docket ID No.
EPA-HQ-OPPT-2018-0627;
July 31, 2019 (84 FR 37199) (FRL-9994-62); Docket ID No.
EPA-HQ-OPPT-2018-0777;
August 6, 2019 (84 FR 38158) (FRL-9996-62); Docket ID No.
EPA-HQ-OPPT-2019-0359;
October 11, 2019 (84 FR 54816) (FRL-9998-64); Docket ID
No. EPA-HQ-OPPT-2019-0228;
November 4, 2019 (84 FR 59335) (FRL-10000-54); Docket ID
No. EPA-HQ-OPPT-2019-0494; and
December 6, 2019 (84 FR 66855) (FRL-10001-48); Docket ID
No. EPA-HQ-OPPT-2019-0530.
The dockets include 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. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
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 and before
the manufacture or processing for the significant new use can commence,
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. 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. Considerations for Significant New Use Determinations
When the Agency issues an order under TSCA section 5(e), section
5(f)(4) requires that the Agency consider whether to promulgate a SNUR
for any use not conforming to the restrictions of the TSCA Order or
publish a statement describing the reasons for not initiating the
rulemaking. 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 possible uses of these chemical substances, in the
context of the four bulleted TSCA section 5(a)(2) factors listed in
this unit.
B. Procedures for Significant New Uses Claimed as 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 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 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.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from nine identifying entities on the
[[Page 46135]]
proposed rules. The Agency's responses are presented in the Response to
Public Comments document that is available in each of the dockets for
these rules. EPA made changes to three of the proposed rules as
described in the response to comments.
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 SNURs, EPA provided the following information
for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as confidential business information (CBI)).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA Order.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substances if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.
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.
These final rules include PMN substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as required by the determinations
made under TSCA section 5(a)(3)(B). Those TSCA Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The final SNURs identify as significant
new uses any manufacturing, processing, use, distribution in commerce,
or disposal that does not conform to the restrictions imposed by the
underlying TSCA Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs
provisions in TSCA Orders include requirements addressing performance
criteria for sampling and analytical methods, periodic monitoring,
respiratory protection, and recordkeeping. No comparable NCEL
provisions currently exist in 40 CFR part 721, subpart B, for SNURs.
Therefore, for these cases, the individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject to the SNUR who wish to
pursue NCELs as an alternative to the 40 CFR 721.63 respirator
requirements may request to do so under 40 CFR 721.30. EPA expects that
persons whose 40 CFR 721.30 requests to use the NCELs approach for
SNURs that are approved by EPA will be required to comply with NCELs
provisions that are comparable to those contained in the corresponding
TSCA Order.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs and as further discussed in Unit IV. of
the proposed rules, EPA concluded that regulation was warranted under
TSCA section 5(e), pending the development of information sufficient to
make reasoned evaluations of the health or environmental effects of the
chemical substances. Based on such findings, TSCA Orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters. As a general matter, EPA believes it is necessary to follow
TSCA Orders with a SNUR that identifies the absence of those protective
measures as significant new uses to ensure that all manufacturers and
processors--not just the original submitter--are held to the same
standard.
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.
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; and
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 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
https://www.epa.gov/tsca-inventory.
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.
When 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, TSCA Orders have been issued for all the
chemical substances that are the subject of this rule, and the PMN
submitters are prohibited by the TSCA Orders from undertaking
activities which will be designated as significant new uses. The
identities of 50 of the 57 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.
Furthermore, EPA designated the publication dates of the proposed
rules (see Unit II.) as the cutoff dates for determining whether the
new uses are 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.
[[Page 46136]]
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of the abovementioned dates, 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.
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, TSCA Order or consent agreement under
TSCA section 4, then TSCA section 5(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, TSCA 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 them 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). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
In some of the TSCA Orders for the chemical substances identified
in this rule, EPA has established production volume limits in view of
the lack of data on the potential health and environmental risks that
may be posed by the significant new uses or increased exposure to the
chemical substances. These limits cannot be exceeded unless the PMN
submitter first submits the results of specified tests that would
permit a reasoned evaluation of the potential risks posed by these
chemical substances. The SNURs contain the same production volume
limits as the TSCA Orders. Exceeding these production limits is defined
as a significant new use. Persons who intend to exceed the production
limit must notify the Agency by submitting a SNUN at least 90 days in
advance of commencement of non-exempt commercial manufacture or
processing.
Any request by EPA for the triggered and pended testing described
in the TSCA Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
The potentially useful information identified in Unit IV. of the
proposed rule may not be the only means of addressing the potential
risks of the chemical substance associated with the designated
significant new uses. However, submitting a SNUN without any test data
or other information 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. 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 analyses are
available in each docket listed in Unit II.
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 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. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.
C. 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 information
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collection requirements associated with SNURs have already been
approved by OMB pursuant to the PRA under OMB control number 2070-0012
(EPA ICR No. 574). This rule does not impose any burden requiring
additional OMB approval.
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 and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. The
Information Collection Request (ICR) covering the SNUR activities 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.
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.
D. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs 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.
E. 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.).
F. 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 (64 FR 43255,
August 10, 1999).
G. 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.
H. 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. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. 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.
J. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).
K. 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
[[Page 46138]]
Executive Order 12898 (59 FR 7629, February 16, 1994).
XII. Congressional Review Act
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: August 9, 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.
721.11150, 721.11267 through 721.11277, 721.11279 through 721.11281,
721.11284, 721.11288, 721.11305, 721.11308, 721.11315 and 721.11316,
721.11319 through 721.11321, 721.11346 through 721.11350, 721.11360 and
721.11361, 721.11372, 721.11383, 721.11390 through 721.11393,
721.11422, and 721.11426 through 721.11443 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
------------------------------------------------------------------------
* * * * *
721.11150............................................... 2070-0012
* * * * *
721.11267............................................... 2070-0012
721.11268............................................... 2070-0012
721.11269............................................... 2070-0012
721.11270............................................... 2070-0012
721.11271............................................... 2070-0012
721.11272............................................... 2070-0012
721.11273............................................... 2070-0012
721.11274............................................... 2070-0012
721.11275............................................... 2070-0012
721.11276............................................... 2070-0012
721.11277............................................... 2070-0012
* * * * *
721.11279............................................... 2070-0012
721.11280............................................... 2070-0012
721.11281............................................... 2070-0012
* * * * *
721.11284............................................... 2070-0012
* * * * *
721.11288............................................... 2070-0012
* * * * *
721.11305............................................... 2070-0012
* * * * *
721.11308............................................... 2070-0012
* * * * *
721.11315............................................... 2070-0012
721.11316............................................... 2070-0012
* * * * *
721.11319............................................... 2070-0012
721.11320............................................... 2070-0012
721.11321............................................... 2070-0012
* * * * *
721.11346............................................... 2070-0012
721.11347............................................... 2070-0012
721.11348............................................... 2070-0012
721.11349............................................... 2070-0012
721.11350............................................... 2070-0012
* * * * *
721.11360............................................... 2070-0012
721.11361............................................... 2070-0012
* * * * *
721.11372............................................... 2070-0012
* * * * *
721.11383............................................... 2070-0012
* * * * *
721.11390............................................... 2070-0012
721.11391............................................... 2070-0012
721.11392............................................... 2070-0012
721.11393............................................... 2070-0012
* * * * *
721.11422............................................... 2070-0012
* * * * *
721.11426............................................... 2070-0012
721.11427............................................... 2070-0012
721.11428............................................... 2070-0012
721.11429............................................... 2070-0012
721.11430............................................... 2070-0012
721.11431............................................... 2070-0012
721.11432............................................... 2070-0012
721.11433............................................... 2070-0012
721.11434............................................... 2070-0012
721.11435............................................... 2070-0012
721.11436............................................... 2070-0012
721.11437............................................... 2070-0012
721.11438............................................... 2070-0012
721.11439............................................... 2070-0012
721.11440............................................... 2070-0012
721.11441............................................... 2070-0012
721.11442............................................... 2070-0012
721.11443............................................... 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).
Subpart E--Significant New Uses for Specific Chemical Substances
0
4. Add Sec. 721.11150 to read as follows:
Sec. 721.11150 2-Pyrrolidinone, 1-butyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pyrrolidinone, 1-
butyl- (PMN P-14-627, CAS No. 3470-98-2) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), 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)(2)(i), butyl
or Silver Shield gloves may be used. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(i) and (ix), (g)(2)(i) through (iii) and
(v), and (g)(5).
[[Page 46139]]
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used. For purposes of Sec. 721.72(e), the concentration is set at
1.0%.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the substance in containers of less than 55 gallons when the
concentration of the confidential component identified in the TSCA
Order is greater than 5% by weight for any product either intended for
sale or distribution for consumer use, including for use in consumer
products, or both intended for commercial use and made available to
consumers for retail purchase of any kind. It is a significant new use
to use or sell the PMN substance in handheld spray applications that
generate a vapor, mist or aerosol.
(iv) Significant new use to import. It is a significant new use to
import the PMN substance other than to be processed or sold for:
(A) Dispersions for industrial coatings (e.g., polyurethane,
acrylic, epoxy);
(B) Coating for consumer and professional use;
(C) Adhesives and sealants;
(D) Solvent-borne industrial coatings;
(E) Silicon wafer cleaning in microelectronics in clean rooms;
(F) Photoresist stripping in microelectronics in clean rooms;
(G) Coatings for microelectronics (e.g., casting of polymer films)
in clean rooms;
(H) Reaction medium for polymerization, polymer coatings for
industrial and professional applications (e.g., wire enamel, non-stick
and friction reduction coating) membranes;
(I) Solvent for chemical synthesis reactions (e.g.,
pharmaceuticals);
(J) Formulation of inks;
(K) Industrial cleaner (e.g., cleaner for wind turbine, oil rigs,
large engines);
(L) Solvent for cleaning industrial reactors;
(M) Wax inhibitors (in hydrocarbon lines);
(N) Petrochemical extraction processes;
(O) Paint stripper;
(P) Solvents for production and formulation of fertilizer;
(Q) Solvent for production and formulation of active ingredients
for agriculture;
(R) Solvent for formulation of active ingredients for agriculture-
end use pesticide product).
(v) Significant new use to use or sell. It is a significant new use
to use or sell the PMN substance for:
(A) Dispersions for industrial coatings (e.g., polyurethane,
acrylic, epoxy) in a concentration greater than 18% in formulated
products;
(B) Adhesives and sealants in concentrations greater than 18% in
formulated products;
(C) Solvent-borne industrial coatings in concentrations greater
than 30% in formulated products;
(D) Coatings for microelectronics (e.g., casting of polymer films)
in clean rooms in concentrations greater than 20% in formulated
products;
(E) Reaction medium for polymerization, polymer coatings for
industrial and professional applications (e.g., wire enamel, non-stick
and friction reduction coating) membranes in concentrations greater
than 40% in formulated products;
(F) Inks in concentrations greater than 15% in formulated products;
(G) Solvent for chemical synthesis reactions (e.g.,
pharmaceuticals) in concentrations greater than 40% in formulated
products;
(H) Industrial cleaner (e.g., cleaner for wind turbine, oil rigs,
large engines) in concentrations greater than 20% in formulated
products;
(I) Wax inhibitors (in hydrocarbon lines) in concentrations greater
than 20% in formulated products;
(J) Petrochemical extraction processes in concentrations greater
than 60% in formulated products;
(K) Paint stripper only for industrial use in concentrations
greater than 20% in formulated products;
(L) Solvent for formulation of active ingredients for agriculture-
end use pesticide product) in concentrations greater than 70% in
formulated products;
(M) Paint removers in concentrations greater than 5% in formulated
products intended for sale or distribution for ``consumer'' use,
including ``commercial use'' when the ``saleable good or service''
could introduce PMN material into a ``consumer'' setting;
(N) Coatings in concentrations greater than 1% in formulated
products intended for sale or distribution for ``consumer'' use,
including ``commercial use'' when the ``sealable good or service''
could introduce PMN material into a ``consumer'' setting.
(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 (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)(iii)
of this section.
0
5. Add Sec. Sec. 721.11267 through 721.11277 to read as follows:
Sec.
* * * * *
721.11267 Silane amine carbonate (generic).
721.11268 Hydrochlorofluoroolefin (generic).
721.11269 Fatty acid modified aromatic polyester polyol (generic).
721.11270 Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl-2,2-dimethylhydracrylate,
neopentylglycol, 1,2-ethanediol, adipic acid, isophthalic acid,
terephthalic acid, 2-Oxooxopane, BayFlex 2002H and 1,1'-
methylenebis(isocyanatobenzene) (generic).
721.11271 Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-.
721.11272 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11273 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
721.11274 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol, polymers with alkanedioic acid, alkali
lignin and arylcarboxylic acid anhydride (generic).
721.11275 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol and polyol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).
721.11276 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11277 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic).
* * * * *
Sec. 721.11267 Silane amine carbonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silane
amine carbonate (PMN P-17-157) 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:
[[Page 46140]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (b). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (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(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(i) and (ii), (g)(2)(i) through (v), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(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 (h), 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. 721.11268 Hydrochlorofluoroolefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrochlorofluoroolefin (PMN P-17-295) 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)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (b). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (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 10. For
purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 23.6 mg/m\3\ (3.9 ppm) as an
8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (2). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Internal organ effects;
reproductive effects; fatality. For purposes of Sec. 721.72(g)(2),
when using this substance: Avoid skin contact; avoid breathing
substance; avoid ingestion; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 23.6 mg/m\3\ (3.9 ppm); use skin protection. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (o). For purposes of Sec.
721.80(k), the use is as a refrigerant used in closed systems for
chillers (commercial comfort air conditioners) and industrial process
refrigeration.
(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 (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. 721.11269 Fatty acid modified aromatic polyester polyol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid modified aromatic polyester polyol (PMN P-17-306 and PMN P-17-307)
are 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)(1), (a)(2)(i) and (iii), (a)(3), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), 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(b), the
concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Internal
organ effects; ocular effects. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to use an application method that generates a
vapor, mist, aerosol, or dust containing the substance resulting in
inhalation exposures.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), are applicable to manufacturers and processors
of these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11270 Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl-2,2-dimethylhydracrylate, neopentylglycol,
1,2-ethanediol, adipic acid, isophthalic acid, terephthalic acid, 2-
Oxooxopane, BayFlex 2002H and 1,1'-methylenebis(isocyanatobenzene)
(generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 46141]]
(1) The chemical substance identified generically as dodecanedioic acid
and 1,6-hexanediol polymer with 3-hydroxy-2,2-dimethylpropyl-2,2-
dimethylhydracrylate, neopentylglycol, 1,2-ethanediol, adipic acid,
isophthalic acid, terephthalic acid, 2-Oxooxopane, BayFlex 2002H and
1,1'-methylenebis(isocyanatobenzene) (PMN P-17-320) 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)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (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 50. For
purposes of Sec. 721.63(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), and (v), and
(g)(5). For purposes of Sec. 721.72(g)(1), this substance may cause:
Skin irritation; respiratory complications; mutagenicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (y)(1), and (y)(2). It is a
significant new use to manufacture the substance containing more than
1% residual isocyanate by weight.
(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 (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. 721.11271 Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanone, 1-[4-(4-
chlorophenoxy)-2-(trifluoromethyl)phenyl]- (PMN P-17-329, CAS No.
1417782-28-5) 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)(1), (a)(2)(i) through (iv), (a)(3) through (5), (a)(6)(v) and
(vi), and (c). When determining which persons are reasonably likely to
be exposed as required for Sec. 721.63(a)(1) and (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 50. For purposes of Sec. 721.63(a)(6), the airborne
form(s) of the substance include particulate (including solids or
liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), and (v),
(g)(3)(i) and (ii), and (g)(4) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: Respiratory complications,
internal organ effects, reproductive effects; sensitization. For
purposes of Sec. 721.72(g)(4), notice to users: Do not release to
water at concentrations that exceed 7 parts per billion. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System (GHS) and OSHA Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=7.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11272 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (PMN P-17-367) 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 substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11273 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics (PMN P-17-368) 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
[[Page 46142]]
the substance with greater than the confidential percentages of low
molecular weight components and less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11274 Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (PMN P-17-369) 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 substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11275 Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol and polyol, polymers with alkanedioic
acid, alkali lignin and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol and polyol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (PMN P-17-370) 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 substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11276 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (PMN P-17-371) 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 substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11277 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol-depolymd. poly(ethylene terephthalate) waste plastics and
arylcarboxylic acid anhydride (PMN P-17-372) 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 substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
0
6. Add Sec. Sec. 721.11279 through 721.11281 to read as follows:
* * * * *
[[Page 46143]]
Sec.
721.11279 Substituted propanoic acid, polymer with alkylisocyanate-
substituted carbomonocycle, dialkyl carbonate, hydroxyl alkyl
substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).
721.11280 Propanediol phosphate (generic).
721.11281 Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).
* * * * *
Sec. 721.11279 Substituted propanoic acid, polymer with
alkylisocyanate-substituted carbomonocycle, dialkyl carbonate, hydroxyl
alkyl substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted propanoic acid, polymer with alkylisocyanate-substituted
carbomonocycle, dialkyl carbonate, hydroxyl alkyl substituted
alkanediol, alkanediol, isocyanato substituted carbomonocycle, alkanol
substituted amines-blocked, compds. with (alkylamino)alkanol (PMN P-17-
394) 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(f). It is a significant new use to use the
substance for any use other than as a coating to improve chemical
resistance. It is a significant new use to import the substance with
average molecular weight greater than 1,000 daltons, containing greater
than 0.1% residual isocyanate by weight, or with greater than 4% of the
confidential chemical component specified in the Order.
(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.
Sec. 721.11280 Propanediol phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanediol phosphate (PMN P-18-23) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (2), (g)(3)(i) and (ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications;
internal organ effects; eye irritation. For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; use skin protection; use eye protection; avoid eye
contact. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) 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 substance in any manner that generates
a vapor, spray, mist, or aerosol.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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), (f) through (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. 721.11281 Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted cashew, nutshell liquid, polymer with epichlorohydrin,
phosphate (PMN P-18-24) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (2), (g)(3)(i) and (ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications; eye
irritation. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid breathing substance; use skin
protection; use eye protection; avoid eye contact. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) 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 substance in any manner that generates
a vapor, spray, mist, or aerosol.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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), (f) through (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.
0
7. Add Sec. 721.11284 to read as follows:
Sec. 721.11284 Di(substituted-1,3-trialkylammonium) dialkylammonium
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
di(substituted-1,3-trialkylammonium) dialkylammonium salt (PMN P-18-88)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (iv), (g)(2)(i) through (iii)
and (v), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may
[[Page 46144]]
be used. For purposes of Sec. 721.72(e), the concentration is set at
1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, particulate, or aerosol.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=1000.
(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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
8. Add Sec. 721.11288 to read as follows:
Sec. 721.11288 Benzene, 1-(chloromethyl)-3-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 1-
(chloromethyl)-3-methyl- (PMN P-18-134; CAS No. 620-19-9) 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)(1), (a)(2)(i) and (iii), (a)(3) through (5), (a)(6)(v) and
(vi), (b), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(1) and (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 and combination gas/vapor
and particulate. For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and
(ii), (g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 0.1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Respiratory irritation; severe skin burns and eye
damage; sensitization (respiratory and dermal); serious eye irritation;
respiratory complications; central nervous system effects; reproductive
effects; cancer; developmental effects. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to vary
the process or use methods described in the PMN such that occupational
exposure is increased.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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 (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
9. Add Sec. 721.11305 to read as follows:
Sec. 721.11305 Unsaturated polycyclic hydrocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
unsaturated polycyclic hydrocarbon (PMN P-17-419) 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)(1), (a)(2)(i), (a)(3) through (5), (a)(6)(v) and (vi), (b),
and (c). When determining which persons are reasonably likely to be
exposed as required for Sec. 721.63(a)(1) and (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 721.63(a)(5), respirators
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 50. For purposes
of 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i), (ii), (iv) and (v), (g)(3)(i)
and (ii), (g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin sensitization; specific target organ
toxicity; skin irritation; respiratory complications; reproductive
effects; developmental effects. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture the substance for more than 9 months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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 (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
10. Add Sec. 721.11308 to read as follows:
Sec. 721.11308 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as mixed
metal oxide (PMN P-18-55) 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)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g.,
[[Page 46145]]
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. For purposes of Sec. 721.63(b), the
concentration is set at 0.1%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.04 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by the EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: Allergic skin reaction;
respiratory sensitization; germ cell mutagenicity; respiratory
complications; cancer. For purposes of Sec. 721.72(g)(2), when using
this substance: Avoid skin contact; avoid breathing substance; avoid
ingestion; use skin protection; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.04 mg/m\3\. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(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 (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)(iii)
of this section.
0
11. Add Sec. 721.11315 to read as follows:
Sec. 721.11315 Lithium nickel hydride oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
hydride oxide (PMN P-18-123; CAS No. 2081933-92-6) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(ii) through (iv) and (vii) through
(ix), (g)(2), (g)(3)(ii), (g)(4)(i), and (g)(5). For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; avoid ingestion; use skin protection; use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than four
years.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(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 (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.
0
12. Add Sec. 721,11316 to read as follows:
Sec. 721.11316 Lithium nickel potassium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
potassium oxide (PMN P-18-124, CAS No. 210352-95-7) 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)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may
[[Page 46146]]
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(ii) through (iv) and (vii) through
(ix), (g)(2), (g)(3)(ii), (g)(4)(i), and (g)(5). For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; avoid ingestion; use skin protection; use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than four
years.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(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 (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.
0
13. Add Sec. Sec. 721.11319 through 721.11321 to read as follows:
Sec.
* * * * *
721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene
glycol, trimethylolalkane and polypropylene glycol (generic).
721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, phthalic
anhydride, triethylene glycol, trimethylolalkane and polypropylene
glycol (generic).
721.11321 Naphtha oils (generic).
* * * * *
Sec. 721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene glycol,
trimethylolalkane and polypropylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, triethylene glycol, trimethylolalkane
and polypropylene glycol (PMN P-18-200) 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)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (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 10. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate. For purposes of Sec. 721.63(b), the concentration is set
at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and (ii), and
(g)(4) and (5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid eye contact; use skin protection;
use respiratory protection; use eye protection. For purposes of Sec.
721.72(g)(4), notice to users: Water release restrictions apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=280.
(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 (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. 721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, phthalic anhydride,
triethylene glycol, trimethylolalkane and polypropylene glycol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, phthalic anhydride, triethylene
glycol, trimethylolalkane and polypropylene glycol (PMN P-18-201) 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)(1), (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (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 10. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate. For purposes of Sec. 721.63(b), the concentration is set
at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and (ii), and
(g)(4) and (5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid eye contact; use skin protection;
use respiratory protection; use eye protection. For purposes of Sec.
721.72(g)(4), notice to users: Water release restrictions apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=280.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 46147]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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. 721.11321 Naphtha oils (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as naphtha
oils (PMN P-18-235) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance incorporated into a gasoline or transportation fuel
formulation below the maximum confidential concentration specified in
the Order for the substance.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k).
(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 paragraphs (a)(1) and
(a)(2)(i) of this section.
0
14. Add Sec. Sec. 721.11346 through 721.11350 to read as follows:
* * * * *
Sec.
721.11346 Perfluoropolyether halide (generic).
721.11347 Perfluoropolyether aryl (generic).
721.11348 Substituted aryl perfluoropolyether (generic).
721.11349 Sulfonated perfluoropolyether aromatic transition metal
salt (generic).
721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
* * * * *
Sec. 721.11346 Perfluoropolyether halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether halide (PMN P-16-151) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture the substance for more than one year.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11347 Perfluoropolyether aryl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether aryl (PMN P-16-152) 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) Hazard Communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11348 Substituted aryl perfluoropolyether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aryl perfluoropolyether (PMN P-16-153) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
[[Page 46148]]
(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)(ii) of
this section.
Sec. 721.11349 Sulfonated perfluoropolyether aromatic transition
metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aromatic transition metal salt (PMN P-16-
154) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aryl alkali metal salt (PMN P-16-155) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
15. Add Sec. 721.11360 to read as follows:
Sec. 721.11360 Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanal,
.alpha.,.alpha.,3-trimethyl- (PMN P-18-129; CAS No. 107737-97-3) 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(t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
0
16. Add Sec. 721.11361 to read as follows:
Sec. 721.11361 Multiwalled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
multiwalled carbon nanotubes (PMN P-18-182) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance that have been:
(i) Embedded or incorporated into a polymer matrix that itself has
been reacted (cured);
(ii) Embedded in a permanent solid/polymer form that is not
intended to undergo further processing, except mechanical processing;
or
(iii) Incorporated into an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (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 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use an application method that generates a dust,
mist, or aerosol, unless such application method occurs in an enclosed
process. It is a significant new use to use the substance other than
for heat transfer, heat storage, thermal emission, and general
temperature management in heat-generating systems such as electronics,
to improve mechanical properties or electrical conductivities of other
materials or
[[Page 46149]]
products, and for light absorption properties.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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.
0
17. Add Sec. 721.11372 to read as follows:
Sec. 721.11372 Phenol-formaldehyde epoxy, polymer with an alkyl
polyether polysulfide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol-
formaldehyde epoxy, polymer with an alkyl polyether polysulfide (PMN P-
19-5) 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)(1) and (3).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), and (v), (g)(3)(i)
and (ii), and (g)(4) and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Internal organ effects; reproductive effects;
cancer; skin and respiratory sensitization; germ cell mutagenicity. For
purposes of Sec. 721.72(g)(4), notice to users: Water release
restrictions apply. Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
(iv) 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), (f) through (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.
0
18. Add Sec. 721.11383 to read as follows:
Sec. 721.11383 Triarylsulfonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triarylsulfonium salt (PMN P-16-548) 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(f), (k), and (t). It is a significant new
use to process or use the substance in a manner that generates a vapor,
mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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.
(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.
0
19. Add Sec. Sec. 721.11390 through 721.11393 to read as follows:
* * * * *
Sec.
721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
721.11391 Alkane, alkene, styrenic compounds derived from plastic
depolymerization (generic).
721.11392 Carbon compound derived from plastic depolymerization
(generic).
721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
* * * * *
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-17-398) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
alkene, styrenic compounds derived from plastic depolymerization (PMN
P-17-399) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
[[Page 46150]]
Sec. 721.11392 Carbon compound derived from plastic depolymerization
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
compound derived from plastic depolymerization (PMN P-18-1) 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 the substance containing more than
1% of the particles less than 75 microns. It is a significant new use
to manufacture the substance other than by the enclosed process
described in the premanufacture notice.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-18-28) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
0
20. Add Sec. 721.11422 to read as follows:
Sec. 721.11422 Alkanediamine, dialkyl-, polymer with .alpha.-
hydro-.omega.-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether
with substituted alkyl-substituted alkanediol, reaction products with
alkyl-alkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediamine, dialkyl-, polymer with .alpha.-hydro-.omega.-[(1-oxo-2-
propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether with substituted alkyl-
substituted alkanediol, reaction products with alkyl-alkanamine (PMN P-
17-393) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(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.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.039 mg/m\3\ as an 8-hour
time-weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) through (3) and (5). For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; eye irritation; skin
sensitization. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid breathing substance; avoid
ingestion; use skin protection; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.039 mg/m\3\. For purposes of Sec. 721.72(g)(3), this
substance may be: Toxic to aquatic organisms; hazardous to the aquatic
environment. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substance with an average molecular weight less than
1,000 daltons and with more than 10% less than 500 daltons.
(iv) 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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
21. Add Sec. Sec. 721.11426 through 721.11443 to read as follows:
* * * * *
Sec.
721.11426 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-86).
721.11427 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-87).
721.11428 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-89).
721.11429 Halogenated sodium benzoate (generic) (P-19-90).
721.11430 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
91).
721.11431 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
92).
721.11432 Halogenated benzoic acid (generic) (P-19-93).
[[Page 46151]]
721.11433 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-97).
721.11434 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-100).
721.11435 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-101).
721.11436 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-102).
721.11437 Halogenated benzoic acid, ethyl ester (generic) (P-19-
103).
721.11438 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-104).
721.11439 Halogenated benzoic acid, ethyl ester (generic) (P-19-
105).
721.11440 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-106).
721.11441 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-107).
721.11442 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-108).
721.11443 Halogenated benzoic acid, ethyl ester (generic) (P-19-
110).
* * * * *
Sec. 721.11426 Halogenated sodium benzene alkylcarboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-86) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (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)(ii) of
this section.
Sec. 721.11427 Halogenated sodium benzene alkylcarboxylate (generic)
(P-19-87).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-87) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (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)(ii) of
this section.
Sec. 721.11428 Halogenated sodium benzene alkylcarboxylate (generic)
(P-19-89).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-89) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (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)(ii) of
this section.
Sec. 721.11429 Halogenated sodium benzoate (generic) (P-19-90).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzoate (PMN P-19-90) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this
[[Page 46152]]
substance may cause: Skin irritation; respiratory complications;
central nervous system effects; internal organ effects; reproductive
effects; developmental effects; eye irritation. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (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)(ii) of
this section.
Sec. 721.11430 Halogenated benzene alkylcarboxylic acid (generic) (P-
19-91).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzene alkylcarboxylic acid (PMN P-19-91) 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)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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) as described in the
TSCA Order for this substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e) concentration set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain workplace airborne
concentrations at or below an 8-hour time-weighted average of 0.0273
mg/m\3\. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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 (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)(iii)
of this section.
Sec. 721.11431 Halogenated benzene alkylcarboxylic acid (generic)
(P-19-92).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzene alkylcarboxylic acid (PMN P-19-92) 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)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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) as described in the
TSCA Order for this substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain
[[Page 46153]]
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.0273 mg/m\3\. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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 (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)(iii)
of this section.
Sec. 721.11432 Halogenated benzoic acid (generic) (P-19-93).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid (PMN P-19-93) 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)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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) as described in the
TSCA Order for the substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain workplace airborne
concentrations at or below an 8-hour time-weighted average of 0.0273
mg/m\3\. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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 (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)(iii)
of this section.
Sec. 721.11433 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-97).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-97) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11434 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-100).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-100) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal
[[Page 46154]]
organ effects; reproductive effects; developmental effects; eye
irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11435 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-101).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-101) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11436 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-102).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-102) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11437 Halogenated benzoic acid, ethyl ester (generic) (P-19-
103).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-103) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e) concentration set at
1.0%. For purposes of Sec. 721.72(g)(1), this substance may cause:
Skin irritation; respiratory complications; central nervous system
effects; internal organ effects; reproductive effects; developmental
effects; eye irritation. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11438 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-104).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-104) is
[[Page 46155]]
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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11439 Halogenated benzoic acid, ethyl ester (generic) (P-
19-105).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-105) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11440 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-106).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-106) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i), (ii), and (iii), (g)(3)(i)
and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications;
central nervous system effects; internal organ effects; reproductive
effects; developmental effects; eye irritation. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11441 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-107).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-107) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The
[[Page 46156]]
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)(ii) of
this section.
Sec. 721.11442 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-108).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-108) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11443 Halogenated benzoic acid, ethyl ester (generic) (P-
19-110).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-110) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) 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), (f) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
[FR Doc. 2021-17392 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P