[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Rules and Regulations]
[Pages 57612-57619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23389]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2017-0560; FRL-10000-69]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (17-4)
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 eight chemical substances which
are the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to section 5(e)
of TSCA. This action requires persons who intend to manufacture
(defined by statute to include import) or process any of these eight
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. 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 December 27, 2019. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
November 12, 2019.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and Orders
under TSCA. Importers of chemicals subject to these SNURs must certify
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after November 27,
2019 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in
developing
[[Page 57613]]
the proposed and final rules. The docket for this action, identified by
docket identification (ID) number EPA-HQ-OPPT-2017-0560, is available
at http://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing these SNURs under TSCA section 5(a)(2) for eight
substances which were the subject of PMNs. These SNURs require persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
In the Federal Register of August 27, 2018 (83 FR 43606) (FRL-9982-
78), EPA proposed a SNUR for 10 chemical substances in 40 CFR part 721
subpart E. More information on the specific chemical substances subject
to this final rule can be found in the Federal Register documents for
the direct final SNUR of August 27, 2018 (83 FR 43527) (FRL-9982-77),
which is referenced in the proposed SNUR. The direct final rule was
withdrawn in the Federal Register of October 26, 2018 (83 FR 54032)
(9985-56). Note that the SNUR for PMN P-16-455 was erroneously included
as proposed 40 CFR 721.11121 and will not be finalized, because it was
already codified as 40 CFR 721.11017. In addition, the SNUR for PMN P-
16-503 was erroneously included as proposed 40 CFR 721.11122 and will
not be finalized, because it is already codified as 40 CFR 721.11018.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to 40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). These requirements include the
information submission requirements of TSCA sections 5(b) and 5(d)(1),
the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the use is not likely to present
an unreasonable risk of injury under the conditions of use for the
chemical substance or take such regulatory action as is associated with
an alternative determination before the manufacture or processing for
the significant new use can commence. In the case of a determination
other than not likely to present unreasonable risk, the applicable
review period must also expire before manufacturing or processing for
the new use may commence. If EPA determines that the 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
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 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,
likely human exposures and environmental releases associated with
possible uses, and the four TSCA section 5(a)(2) factors listed in this
unit.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from four entities on the proposed
rule. The Agency's responses are described in a separate Response to
Public Comments document contained in the public docket for this rule,
EPA-HQ-OPPT-2017-0560. In addition, EPA is withdrawing the proposed
SNURs for the substances described in PMN P-16-455 and P-16-503 because
they were previously regulated under final SNURs at 40 CFR 721.11017
and 721.11018, respectively. Furthermore, the response to comments will
describe changes to the proposed SNURs for PMN P-16-342, P16-406 and
P16-407 to include an exemption from SNUR requirements when these PMN
substances have been fully reacted (cured). This makes the SNURs
consistent with the same exemption contained in the underlying TSCA
section 5 Orders for those substances.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for eight chemical substances in 40 CFR part 721, subpart
E. In Unit IV. of the original direct final rule (83 FR 43527; August
27, 2018) (FRL-9982-77), EPA provides the following information for
each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the TSCA section 5(e) Order.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the TSCA Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.
[[Page 57614]]
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
These final rules include eight PMN substances that are subject to
Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that
activities associated with the PMN substances may present unreasonable
risk to human health or the environment. Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The 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 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 section 5(e) 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 the New Chemical Exposure Limit (NCEL). The
comprehensive NCELs provisions in TSCA section 5(e) 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 section 5(e) 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, 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. The basis for such
findings is outlined in Unit IV. Based on these findings, TSCA section
5(e) 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 section 5(e) 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 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 Orders,
consistent with TSCA section 5(f)(4).
To receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
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 section 5(e) Orders have been issued
for all the chemical substances, and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from undertaking activities which will
be designated as significant new uses. The identities of six of the
eight chemical substances subject to this rule have been claimed as
confidential. 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 August 27, 2018 (the date of public
release of the original direct final and proposed rules) as the cutoff
date for determining whether the new use is ongoing. The objective of
EPA's approach has been to ensure that a person could not defeat a SNUR
by initiating a significant new use before the effective date of the
final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of August 27, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons will 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 developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, Order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, Order, or consent agreement under TSCA
section
[[Page 57615]]
4 covering the chemical substance, persons are required only to submit
information in their possession or control and to describe any other
information known to or reasonably ascertainable (40 CFR 720.50).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing, under 40 CFR part 721, subpart E. In Unit
IV. of the original direct final rule (83 FR 43527; August 27, 2018)
(FRL-9982-77), lists potentially useful information that will be useful
to EPA's evaluation. 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 on 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).
In some of the TSCA section 5(e) Orders for the chemical substances
regulated under this rule, EPA has established production volume
limits. These limits cannot be exceeded unless the PMN submitter
submits the results of specified tests. The SNURs contain the same
production volume limits as the TSCA section 5(e) 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 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
original direct final rule may not be the only means of addressing the
potential risks of the chemical substance. However, submitting a SNUN
without any test data or other information may increase the likelihood
that EPA will take action under TSCA section 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 provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2017-0560.
XII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action establishes SNURs for several new chemical substances
that were the subject of PMNs and TSCA section 5(e) Orders. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR
[[Page 57616]]
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. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection activities in this action have already
been approved by OMB pursuant to the PRA under OMB control number 2070-
0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this SNUR will not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to
this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
XIII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
[[Page 57617]]
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 15, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11116 2070-0012
721.11117 2070-0012
721.11118 2070-0012
721.11119 2070-0012
721.11120 2070-0012
721.11123 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. Sec. 721.11116 through 721.11123 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
721.11116 Substituted carbocycle, N-[[[4-[[(4-substituted
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl-
(generic).
721.11117 Aliphatic polyester (generic).
721.11118 Modified acrylic polymer (generic).
721.11119 Functionalized polyimide and functionalized polyamide
(generic).
721.11120 Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me
3,3,4,4,5,5,6,6,6-nonafluorohexyl.
721.11121-721.11122 [Reserved]
721.11123 Carboxylic acids, C6-18 and C8-15-di-, polymers with
diethylene glycol, glycerol, oleic acid, phthalic, acid and
sorbitol.
* * * * *
Sec. 721.11116 Substituted carbocycle, N-[[[4-[[(4-substituted
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbocycle, N-[[[4-[[(4-substituted
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (PMN
P-13-307) 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), (a)(4) (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), (a)(5)
(respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor of at least 10 or
maintain workplace airborne concentrations), (a)(6) (particulate
(including solids or liquid droplets)), (b) (concentrations set at
1.0%) and (c).
(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 section 5(e) Order for this substance. The NCEL is 4 mg/m3 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
section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified inSec.
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f),
(g)(1)(iv), (viii), (ix), (g)(2)(ii), (iii), (iv) (use respiratory
protection or maintain workplace airborne concentrations below an 8-
hour timeweighted average of 4 mg/m3), (g)(2)(v), (g)(4)(i),
(ii) and (g)(5). 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(f), (k) and (q).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 30 ppb.
(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).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11117 Aliphatic polyester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
aliphatic polyester (PMNs P-16-316 and P-16-317) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the chemical substances with less than the confidential
average molecular weight identified in the Order for the chemical
substances and containing greater than the confidential percentage of
molecular weight species less than 500 daltons identified in the Order
for the chemical substances.
(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
[[Page 57618]]
applicable to manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11118 Modified acrylic polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified acrylic polymer (PMN P-16-342) 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 chemical substance after they have been completely
reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f),
(g)(1)(ii), (g)(2)(ii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use for any
use other than as a dispersant for deflocculation of pigments in
industrial paints and coatings. It is a significant new use for any use
in the paint/coating formulation at concentration greater than 1.0% by
weight or volume. It is a significant new use for any use of the
substance that would allow inhalation exposure to the substance by
vapor, dust, mist or aerosols at concentrations greater than 1.0% by
weight or volume.
(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), (b), (c), (f), (g), (h), and (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11119 Functionalized polyimide and functionalized polyamide
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
functionalized polyimide (PMN P-16-406) and functionalized polyamide
(PMN P-16-407) are 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 chemical
substances after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (y)(1) and (2). It is a significant
new use to use the substances other than for the specific uses
identified in the Order. It is a significant new use to use any
manufacturing process that results in inhalation exposure to the
substances.
(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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11120 Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me
3,3,4,4,5,5,6,6,6-nonafluorohexyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, di-Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-
nonafluorohexyl (CAS: 1610862-54-8) (PMN P-16-413) 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
are described in Sec. 721.80(f) and (p)(40,000 kilograms and 151,300
kilograms). It is a significant new use to process or use the chemical
substance in a manner that results in inhalation exposure to spray,
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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11121-721,11122 [Reserved]
Sec. 721.11123 Carboxylic acids, C6-18 and C8-15-di-, polymers with
diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carboxylic acids,
C6-18 and C8-15-di-, polymers with diethylene glycol, glycerol, oleic
acid, phthalic, acid and sorbitol (CAS No. 1877295-51-6) (PMN P-16-570)
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)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (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), (b)(concentrations set at 1.0%) and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f),
(g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (g)(4)(iii)
and (g)(5). 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(q). It is a significant new use to use the
substance other than as an aromatic polyester polyol for manufacturing
rigid foam. It is a significant new use to manufacture the substance
with residual phthalate greater than 0.1% by weight. It is a
significant new use to modify the manufacturing, processing or use
activities of the PMN substance to result in the generation of a vapor,
mist or aerosol.
(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).
[[Page 57619]]
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2019-23389 Filed 10-25-19; 8:45 am]
BILLING CODE 6560-50-P