Significant New Use Rule on Certain Chemical Substances, 32879-32885 [2015-13941]
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules
Chapter I, title 40 of the Code of
Federal Regulations is amended as
follows:
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
Dated: May 28, 2015.
Mark Hague,
Acting Regional Administrator, Region 7.
2. In § 52.870 the table in paragraph
(e) is amended by adding new entry (40)
at the end of the table to read as follows:
■
§ 52.870
1. The authority citation for part 52
continues to read as follows:
■
For the reasons stated in the
preamble, EPA proposes to amend 40
CFR part 52 as set forth below:
Subpart R—KANSAS
*
Identification of plan.
*
*
(e) * * *
*
*
Authority: 42 U.S.C. 7401 et. seq.
EPA-APPROVED KANSAS NONREGULATORY PROVISIONS
Applicable geographic or
Nonattainment area
Name of nonregulatory SIP provision
*
*
*
*
(40) State Implementation Plan (SIP) Revision for Statewide .......................
the Attainment and Maintenance of National Ambient Air Quality Standards for Regional Haze
(2014 Five-Year Progress Report)
[FR Doc. 2015–13943 Filed 6–9–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2014–0390; FRL–9927–60]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 30
chemical substances which were the
subject of premanufacture notices
(PMNs). This action would require
persons who intend to manufacture
(including import) or process any of the
chemical substances for an activity that
is designated as a significant new use by
this proposed rule to notify EPA at least
90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
the activity before it occurs.
DATES: Comments must be received on
or before July 10, 2015.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0390, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov.
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SUMMARY:
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State
submittal
date
*
*
3/10/15 6/10/15 [Insert Federal
Register citation].
Follow the online instructions for
submitting comments. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
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:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
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
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EPA approval date
Explanation
*
contained in this proposed 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 (including
importers) 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 their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance to
a proposed or final rule are subject to
the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see § 721.20), and must comply with
the export notification requirements in
40 CFR part 707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
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the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
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A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) for 30 chemical
substances which were the subject of
PMNs P–13–793, P–14–72, P–14–89, P–
14–90, P–14–91, P–14–92, P–14–158, P–
14–159, P–14–161, P–14–162, P–14–
163, P–14–173, P–14–175, P–14–176, P–
14–177, P–14–178, P–14–179, P–14–
180, P–14–181, P–14–182, P–14–183, P–
14–184, P–14–185, P–14–186, P–14–
187, P–14–188, P–14–190, P–14–191, P–
14–192, and P–14–193. These SNURs
would 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 accordance
with the procedures at § 721.160(c)(3)(i),
in the Federal Register publication of
October 27, 2014 (79 FR 63821) (FRL–
9914–56) EPA issued direct final SNURs
on these chemical substances, which are
the subject of PMNs. EPA received
notices of intent to submit adverse
comments on these SNURs. Therefore,
as required by § 721.160(c)(3)(ii), EPA
withdrew the direct final SNURs in the
Federal Register of December 23, 2014
(79 FR 76900) (FRL–9920–6325), and is
now issuing this proposed rule on these
30 chemical substances. The records for
the direct final SNURs on these 30
chemical substances were established as
docket EPA–HQ–OPPT–2014–0390.
Those records include information
considered by the Agency in developing
the direct final rule. Adverse comments
received regarding these substances and
the direct final rule are discussed in
Unit IV.
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B. What is the Agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (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.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture or process the
chemical substance for that use. Persons
who must report are described in
§ 721.5.
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
final rule. Provisions relating to user
fees appear at 40 CFR part 700.
According to § 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). In
particular, these requirements include
the information submission
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA 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,
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processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorized EPA to consider any
other relevant factors.
To determine 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 bulleted TSCA section 5(a)(2)
factors listed in this unit.
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for 30
chemical substances in 40 CFR part 721,
subpart E. In this unit, 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 (assigned for nonconfidential chemical identities).
• Public comments and EPA’s
response to comments on the 30 direct
final SNURs subject to PMNs P–13–793,
P–14–72, P–14–89, P–14–90, P–14–91,
P–14–92, P–14–158, P–14–159, P–14–
161, P–14–162, P–14–163, P–14–173, P–
14–175, P–14–176, P–14–177, P–14–
178, P–14–179, P–14–180, P–14–181, P–
14–182, P–14–183, P–14–184, P–14–
185, P–14–186, P–14–187, P–14–188, P–
14–190, P–14–191, P–14–192, and P–
14–193
• Basis for the TSCA non-section 5(e)
SNURs (i.e., SNURs without TSCA
section 5(e) consent orders).
• Tests recommended by EPA to
provide sufficient information to
evaluate the chemical substance (see
Unit VII. for more information).
• CFR citation assigned in the
regulatory text section of this proposed
rule.
The regulatory text section of this
proposed rule specifies the activities
designated as significant new uses.
Certain new uses, including production
volume limits (i.e., limits on
manufacture and importation volume)
and other uses designated in this
proposed rule, may be claimed as CBI.
PMN Number P–13–793
Chemical name: Functionalized
carbon nanotubes (generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to
adversely comment has been submitted.
EPA response: EPA awaits the adverse
comment during the open comment
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period for this notice of proposed
rulemaking.
Basis for action: The PMN states that
the substance will be used as a thin film
for electronic device applications. Based
on structure activity relationship (SAR)
analysis of test data on analogous
carbon nanotubes and other respirable
poorly soluble particulates, EPA
identified potential lung effects,
developmental toxicity, and dermal
toxicity from exposure to the PMN
substance via inhalation, dermal, and
oral routes. Further, EPA predicts
toxicity to aquatic organisms via
releases of the PMN substance to surface
water. Although there is potential for
dermal exposure, EPA does not expect
significant occupational exposures due
to the use of impervious gloves, and
because the PMN is used in liquid form
and is not spray applied. Further, EPA
does not expect environmental releases
during the use identified in the PMN
submission. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk human health or the environment.
EPA has determined, however, that any
use of the substance without the use of
impervious gloves, where there is a
potential for dermal exposure;
manufacturing the PMN substance for
use other than as a thin film for
electronic device applications;
manufacturing, processing, or using the
PMN substance in a form other than a
liquid; use of the PMN substance
involving an application method that
generates a mist, vapor, or aerosol; or
any release of the PMN substance into
surface waters may cause serious health
effects or significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria in § 721.170
(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of an oral
and inhalation pharmacokinetic test
(OPPTS Test Guideline 870.7485); a 90day inhalation toxicity test (OPPTS Test
Guideline 870.3465); a fish early-life
stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a surface
charge by electrophoresis by either the
(ASTM Test Guideline E2865–12) or
measuring the zeta potential of
nanoparticles (Nanotechnology
Characterization Library (NCL) Method
PCC–2) (located in the Docket under
Docket ID number EPA–HQ–OPPT–
2014–0390); would help characterize
the human health and environmental
effects of the PMN substance.
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CFR citation: 40 CFR 721.10776.
PMN Number P–14–72
Chemical name: Propaneperoxoic
acid, 2,2-dimethyl-, 1,1,3,3tetramethylbutyl ester.
CAS number: 22288–41–1.
Public comment: A notice of intent to
adversely comment has been submitted.
EPA response: EPA awaits the adverse
comment during the open comment
period for this notice of proposed
rulemaking.
Basis for action: The PMN states that
the use of the substance will be as a
polymerization initiator for the
production of polyvinyl chloride (PVC)
and polyethylene resin. Based on test
data on the PMN substance, as well as
ecological SAR analysis of test data on
analogous peroxy esters, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 3 parts per
billion (ppb) of the PMN substance in
surface waters. As described in the
PMN, releases of the substance are not
expected to result in surface water
concentrations that exceed 3 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface waters
concentrations exceeding 3 ppb may
result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170 (b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (Organisation for
Economic Co-operation and
Development (OECD) Test Guideline
301C) with product-specific chemical
analytics to validate the degradation
products (including intermediate
products) and the rates of degradation
(including intermediate degradation
rates); and a hydrolysis as a function of
pH and temperature test (OPPTS Test
Guideline 835.2130) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10780.
PMN Numbers P–14–89, P–14–90, P–14–
91, and P–14–92
Chemical names: Fatty acid amide
hydrochlorides (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to
adversely comment has been submitted,
by the PMN submitter. The comment
expressed concern that EPA’s approach
for these SNURs changed from that
transmitted in writing by EPA during
the PMN review period. As a result, the
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PMN submitter was not given the
opportunity to discuss, provide
pertinent information on, respond to, or
comment on this change.
EPA response: EPA met with the PMN
submitter on December 17, 2014 to
discuss procedural and policy issues
raised in connection with the
withdrawn SNURs. EPA awaits formal
comment during the open comment
period for this proposed rule.
Basis for action: The consolidated
PMN states that the substances will be
used as surfactants for use in asphalt
emulsions. Based on ecological SAR
analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed the following
values of the PMN substances in surface
waters:
PMN No.
P–14–89, P–14–92 ...............
P–14–90 ................................
P–14–91 ................................
Concentration
of concern
110 ppb.
240 ppb.
53 ppb.
For the use described in the PMNs,
releases of the substances are not
expected to result in surface water
concentrations that exceed these values.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substances resulting in surface water
concentrations exceeding the
aforementioned concentrations of
concern may result in significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substances. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10781.
PMN Numbers P–14–158, P–14–159, P–
14–161, P–14–162, and P–14–163
Chemical names: Fatty acid amides
(generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to
adversely comment has been submitted,
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by the PMN submitter. The comment
expressed concern that EPA’s approach
for these SNURs changed from that
transmitted in writing by EPA during
the PMN review period. As a result, the
PMN submitter was not given the
opportunity to discuss, provide
pertinent information on, respond to, or
comment on this change.
EPA response: EPA met with the PMN
submitter on December 17, 2014 to
discuss procedural and policy issues
raised in connection with the
withdrawn SNURs. EPA awaits formal
comment during the open comment
period for this proposed rule.
Basis for action: The consolidated
PMN states that the substances will be
used as chemical intermediates and
additives for flotation products. Based
on ecological SAR analysis of test data
on analogous amides and aliphatic
amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed the following values of the
PMN substances in surface waters:
PMN No.
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P–14–158, P–14–159, P–14–
161, P–14–163.
P–14–162 ..............................
Concentration
of concern
1 ppb.
140 ppb.
For the use described in the PMNs,
releases of the substances are not
expected to result in surface water
concentrations that exceed these values.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substances resulting in surface water
concentrations exceeding the
aforementioned concentrations of
concern may result in significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of (1) a water
solubility: Column elution method;
shake flask method test (OPPTS Test
Guideline 830.7840) or a water
solubility generator column method test
(OPPTS Test Guideline 830.7860); and
(2) a determination of the partition
coefficient (n-octanol/water) by shake
flask method (OPPTS Test Guideline
830.7550), or generator column method
(OPPTS Test Guideline 830.7560), or
estimation by liquid chromatography
(OPPTS Test Guideline 830.7570) would
help characterize the physical/chemical
properties of the PMN substances.
Depending upon the results of these
data, the results of a fish early-life stage
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toxicity test (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300);
and an algal toxicity test (OCSPP Test
Guideline 850.4500) may be
recommended to help characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10782.
PMN Numbers P–14–173, P–14–175, P–
14–176, P–14–177, P–14–178, P–14–179,
P–14–180, P–14–181, P–14–182, P–14–
183, P–14–184, P–14–185, P–14–186, P–
14–187, P–14–188, P–14–190, P–14–191,
P–14–192, and P–14–193
Chemical names: Fatty acid amide
acetates (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to
adversely comment has been submitted,
by the PMN submitter. The comment
expressed concern that EPA’s approach
for these SNURs changed from that
transmitted in writing by EPA during
the PMN review period. As a result, the
PMN submitter was not given the
opportunity to discuss, provide
pertinent information on, respond to, or
comment on this change.
EPA response: EPA met with the PMN
submitter on December 17, 2014 to
discuss procedural and policy issues
raised in connection with the
withdrawn SNURs. EPA awaits formal
comment during the open comment
period for this proposed rule.
Basis for action: The PMNs state that
the substances will be used as flotation
additives for use in mineral processing.
Based on ecological SAR analysis of test
data on analogous amides and aliphatic
amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed the following values of the
PMN substances in surface waters:
Concentration
of concern
PMN No.
P–14–173, P–14–175, P–14–
178, P–14–179, P–14–181,
P–14–183, P–14–184, P–
14–192, P–14–193.
P–14–176, P–14–180, P–14–
185, P–14–186, P–14–187,
P–14–190.
P–14–177, P–14–188 ...........
P–14–191 ..............................
P–14–182 ..............................
1 ppb.
2 ppb.
3 ppb.
4 ppb.
140 ppb.
For the use described in the PMNs,
releases of the substances are not
expected to result in surface water
concentrations that exceed these values.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
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the substances resulting in surface water
concentrations exceeding the
aforementioned concentrations of
concern may result in significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) on P–14–184, and
any one of the remaining PMN
substances, would help characterize the
environmental effects of the PMN
substances. Further, EPA determined
that the results of a fish acute toxicity
mitigated by humic acid test (OPPTS
Test Guideline 850.1085) on PMN
P–14–184 would help characterize the
environmental effects of the PMN
substance. EPA also recommends that
the guidance document on aquatic
toxicity testing of difficult substances
and mixtures (OECD Test Guideline 23)
be followed.
CFR citation: 40 CFR 721.10783.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA
determined that one or more of the
criteria of concern established at
§ 721.170 were met. For additional
discussion on these chemical
substances, see Units II. and IV. of this
proposed rule.
B. Objectives
EPA is proposing these SNURs for
specific chemical substances which
have undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this proposed rule:
• EPA would 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.
• EPA would 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.
• EPA would be able to regulate
prospective manufacturers or processors
of a listed chemical substance before the
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described significant new use of that
chemical substance occurs, provided
that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
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/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
VI. Applicability of the Proposed Rule
to Uses Occurring Before the Effective
Date of the Final Rule
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed 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 proposed 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. The
identities of 29 of the 30 chemical
substances subject to this proposed rule
have been claimed as confidential and
EPA has received no post-PMN bona
fide submissions (per §§ 720.25 and
721.11). 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
proposed rule are ongoing.
Therefore, EPA designates June 10,
2015 as the cutoff date for determining
whether the new use is ongoing. Persons
who begin commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
that date would have to cease any such
activity upon the effective date of the
final rule. To resume their activities,
these persons would have to first
comply with all applicable SNUR
notification requirements and wait until
the notice review period, including any
extensions, expires. If such a person met
the conditions of advance compliance
under § 721.45(h), the person would be
considered exempt from the
requirements of the SNUR. Consult the
Federal Register document of April 24,
1990 (55 FR 17376) for a more detailed
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discussion of the cutoff date for ongoing
uses.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Descriptions of tests are provided for
informational purposes. EPA strongly
encourages persons, before performing
any testing, to consult with the Agency
pertaining to protocol selection. To
access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org. ASTM
International standards are available at
https://www.astm.org/Standard/
index.shtml.
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior PMN or SNUN submitter. EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
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32883
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VIII. SNUN Submissions
According to § 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/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule, during the
development of the direct final rule.
EPA’s complete economic analysis is
available in the docket under docket ID
number EPA–HQ–OPPT–2014–0390.
X. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish
SNURs for 30 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 Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et
seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this proposed
rule have already been approved by
OMB pursuant to PRA under OMB
control number 2070–0012 (EPA ICR
No. 574). This proposed rule would not
impose any burden requiring additional
OMB approval. If an entity were to
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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, Collection
Strategies Division, Office of
Environmental Information (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.
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C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (5 U.S.C.
601 et seq.), that promulgation of a
SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this proposed
rule.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the Economic
Analysis discussed in Unit IX. and
EPA’s experience promulgating SNURs
(discussed in the certification), EPA
believes that the following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
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 would be impacted by this
proposed rule. As such, EPA has
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determined that this proposed rule
would 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
This proposed rule would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would not significantly nor
uniquely affect the communities of
Indian Tribal governments, nor would it
involve or impose any requirements that
affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
This proposed rule is not subject to
Executive Order 13045, entitled
‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997),
because this is not an economically
significant regulatory action as defined
by Executive Order 12866, and this
proposed rule does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to
Executive Order 13211, entitled
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), because this proposed rule is
not expected to affect energy supply,
distribution, or use and because this
proposed rule is not a significant
regulatory action under Executive Order
12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this proposed rule
would not involve any technical
standards, NTTAA section 12(d) (15
U.S.C. 272 note), would not apply to
this proposed rule.
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J. Executive Order 12898
This proposed rule does not entail
special considerations of environmental
justice related issues as delineated by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: June 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10776 to subpart E to
read as follows:
■
§ 721.10776 Functionalized carbon
nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as functionalized carbon
nanotubes (PMN P–13–793) 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 § 721.63
(a)(1), (a)(2)(i), and (a)(3). When
determining which persons are
reasonably likely to be exposed as
required for § 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.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (a significant
new use is use other than as a thin film
for electronic device applications),
(v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2),
and (y)(1).
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(iii) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (e), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 3. Add § 721.10780 to subpart E to
read as follows:
§ 721.10780 Propaneperoxoic acid, 2,2dimethyl-, 1,1,3,3-tetramethylbutyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propaneperoxoic acid, 2,2-dimethyl-,
1,1,3,3-tetramethylbutyl ester (PMN P–
14–72; CAS No. 22288–41–1) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=3).
(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
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 4. Add § 721.10781 to subpart E to
read as follows:
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
§ 721.10781 Fatty acid amide
hydrochlorides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amide
hydrochlorides (PMNs P–14–89, P–14–
90, P–14–91 and P–14–92) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N = 110 for PMNs P–14–
89 and P–14–92; N = 240 for PMN P–
14–90; N = 53 for PMN P–14–91).
(ii) [Reserved]
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(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
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 5. Add § 721.10782 to subpart E to
read as follows:
§ 721.10782
Fatty acid amides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amides (PMN
P–14–158, P–14–159, P–14–161, P–14–
162, and P–14–163) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N = 1 for PMNs P–14–158,
P–14–159, P–14–161, and P–14–163; N
= 140 for PMN P–14–162).
(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
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 6. Add § 721.10783 to subpart E to
read as follows:
§ 721.10783
(generic).
Fatty acid amide acetates
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amide acetates
(PMNs P–14–173, P–14–175, P–14–176,
P–14–177, P–14–178, P–14–179, P–14–
180, P–14–181, P–14–182, P–14–183, P–
14–184, P–14–185, P–14–186, P–14–
187, P–14–188, P–14–190, P–14–191, P–
14–192 and P–14–193) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N = concentration of
concern as follows):
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PMN No.
P–14–173, P–14–175, P–14–
178, P–14–179, P–14–181,
P–14–183, P–14–184, P–
14–192, P–14–193.
P–14–176, P–14–180, P–14–
185, P–14–186, P–14–187,
P–14–190.
P–14–177, P–14–188 ...........
P–14–191 ..............................
P–14–182 ..............................
Concentration
of concern
1 ppb.
2 ppb.
3 ppb.
4 ppb.
140 ppb.
(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
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2015–13941 Filed 6–9–15; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CG Docket No. 10–210; FCC 15–58]
Relay Services for Deaf-Blind
Individuals
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Commission proposes to amend its rules
to continue the National Deaf-Blind
Equipment Distribution Program
(NDBEDP) on a permanent basis. The
NDBEDP is currently a pilot program
that supports the distribution of
communications devices to low-income
individuals who are deaf-blind.
DATES: Comments are due July 27, 2015
and reply comments are due August 10,
2015.
ADDRESSES: You may submit comments,
identified by CG Docket No. 10–210, by
any of the following methods:
• Electronic Filers: Comments may be
filed electronically using the Internet by
accessing the Commission’s Electronic
Comment Filing System (ECFS), through
the Commission’s Web site https://
fjallfoss.fcc.gov/ecfs2/. Filers should
follow the instructions provided on the
Web site for submitting comments. For
ECFS filers, in completing the
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32879-32885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13941]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2014-0390; FRL-9927-60]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 30 chemical substances which
were the subject of premanufacture notices (PMNs). This action would
require persons who intend to manufacture (including import) or process
any of the chemical substances for an activity that is designated as a
significant new use by this proposed rule to notify EPA at least 90
days before commencing that activity. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit the activity before it occurs.
DATES: Comments must be received on or before July 10, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0390, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
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: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
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 proposed
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 (including importers) 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
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance to a proposed or final rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec. 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark
[[Page 32880]]
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for 30
chemical substances which were the subject of PMNs P-13-793, P-14-72,
P-14-89, P-14-90, P-14-91, P-14-92, P-14-158, P-14-159, P-14-161, P-14-
162, P-14-163, P-14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-
179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-
186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192, and P-14-193.
These SNURs would 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 accordance with the procedures at Sec.
721.160(c)(3)(i), in the Federal Register publication of October 27,
2014 (79 FR 63821) (FRL-9914-56) EPA issued direct final SNURs on these
chemical substances, which are the subject of PMNs. EPA received
notices of intent to submit adverse comments on these SNURs. Therefore,
as required by Sec. 721.160(c)(3)(ii), EPA withdrew the direct final
SNURs in the Federal Register of December 23, 2014 (79 FR 76900) (FRL-
9920-6325), and is now issuing this proposed rule on these 30 chemical
substances. The records for the direct final SNURs on these 30 chemical
substances were established as docket EPA-HQ-OPPT-2014-0390. Those
records include information considered by the Agency in developing the
direct final rule. Adverse comments received regarding these substances
and the direct final rule are discussed in Unit IV.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (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. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use. Persons who must report are described in Sec.
721.5.
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 final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 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). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA 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 addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine 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 bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 30 chemical substances in 40 CFR part 721, subpart E. In this unit,
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 (assigned
for non-confidential chemical identities).
Public comments and EPA's response to comments on the 30
direct final SNURs subject to PMNs P-13-793, P-14-72, P-14-89, P-14-90,
P-14-91, P-14-92, P-14-158, P-14-159, P-14-161, P-14-162, P-14-163, P-
14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-179, P-14-180, P-
14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-186, P-14-187, P-
14-188, P-14-190, P-14-191, P-14-192, and P-14-193
Basis for the TSCA non-section 5(e) SNURs (i.e., SNURs
without TSCA section 5(e) consent orders).
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
CFR citation assigned in the regulatory text section of
this proposed rule.
The regulatory text section of this proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits (i.e., limits on manufacture and
importation volume) and other uses designated in this proposed rule,
may be claimed as CBI.
PMN Number P-13-793
Chemical name: Functionalized carbon nanotubes (generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment
[[Page 32881]]
period for this notice of proposed rulemaking.
Basis for action: The PMN states that the substance will be used as
a thin film for electronic device applications. Based on structure
activity relationship (SAR) analysis of test data on analogous carbon
nanotubes and other respirable poorly soluble particulates, EPA
identified potential lung effects, developmental toxicity, and dermal
toxicity from exposure to the PMN substance via inhalation, dermal, and
oral routes. Further, EPA predicts toxicity to aquatic organisms via
releases of the PMN substance to surface water. Although there is
potential for dermal exposure, EPA does not expect significant
occupational exposures due to the use of impervious gloves, and because
the PMN is used in liquid form and is not spray applied. Further, EPA
does not expect environmental releases during the use identified in the
PMN submission. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk human health or the environment. EPA has determined,
however, that any use of the substance without the use of impervious
gloves, where there is a potential for dermal exposure; manufacturing
the PMN substance for use other than as a thin film for electronic
device applications; manufacturing, processing, or using the PMN
substance in a form other than a liquid; use of the PMN substance
involving an application method that generates a mist, vapor, or
aerosol; or any release of the PMN substance into surface waters may
cause serious health effects or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria in Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an oral
and inhalation pharmacokinetic test (OPPTS Test Guideline 870.7485); a
90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a surface charge by
electrophoresis by either the (ASTM Test Guideline E2865-12) or
measuring the zeta potential of nanoparticles (Nanotechnology
Characterization Library (NCL) Method PCC-2) (located in the Docket
under Docket ID number EPA-HQ-OPPT-2014-0390); would help characterize
the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10776.
PMN Number P-14-72
Chemical name: Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
CAS number: 22288-41-1.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rulemaking.
Basis for action: The PMN states that the use of the substance will
be as a polymerization initiator for the production of polyvinyl
chloride (PVC) and polyethylene resin. Based on test data on the PMN
substance, as well as ecological SAR analysis of test data on analogous
peroxy esters, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3 parts per billion (ppb) of the PMN
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 3 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface waters concentrations exceeding 3 ppb
may result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (Organisation for Economic Co-operation and
Development (OECD) Test Guideline 301C) with product-specific chemical
analytics to validate the degradation products (including intermediate
products) and the rates of degradation (including intermediate
degradation rates); and a hydrolysis as a function of pH and
temperature test (OPPTS Test Guideline 835.2130) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10780.
PMN Numbers P-14-89, P-14-90, P-14-91, and P-14-92
Chemical names: Fatty acid amide hydrochlorides (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted, by the PMN submitter. The comment expressed concern that
EPA's approach for these SNURs changed from that transmitted in writing
by EPA during the PMN review period. As a result, the PMN submitter was
not given the opportunity to discuss, provide pertinent information on,
respond to, or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014
to discuss procedural and policy issues raised in connection with the
withdrawn SNURs. EPA awaits formal comment during the open comment
period for this proposed rule.
Basis for action: The consolidated PMN states that the substances
will be used as surfactants for use in asphalt emulsions. Based on
ecological SAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed the following values of the PMN substances in surface waters:
------------------------------------------------------------------------
PMN No. Concentration of concern
------------------------------------------------------------------------
P-14-89, P-14-92......................... 110 ppb.
P-14-90.................................. 240 ppb.
P-14-91.................................. 53 ppb.
------------------------------------------------------------------------
For the use described in the PMNs, releases of the substances are
not expected to result in surface water concentrations that exceed
these values. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substances resulting in surface water concentrations exceeding the
aforementioned concentrations of concern may result in significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10781.
PMN Numbers P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163
Chemical names: Fatty acid amides (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted,
[[Page 32882]]
by the PMN submitter. The comment expressed concern that EPA's approach
for these SNURs changed from that transmitted in writing by EPA during
the PMN review period. As a result, the PMN submitter was not given the
opportunity to discuss, provide pertinent information on, respond to,
or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014
to discuss procedural and policy issues raised in connection with the
withdrawn SNURs. EPA awaits formal comment during the open comment
period for this proposed rule.
Basis for action: The consolidated PMN states that the substances
will be used as chemical intermediates and additives for flotation
products. Based on ecological SAR analysis of test data on analogous
amides and aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed the following values of the PMN
substances in surface waters:
------------------------------------------------------------------------
PMN No. Concentration of concern
------------------------------------------------------------------------
P-14-158, P-14-159, P-14-161, P-14-163... 1 ppb.
P-14-162................................. 140 ppb.
------------------------------------------------------------------------
For the use described in the PMNs, releases of the substances are
not expected to result in surface water concentrations that exceed
these values. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substances resulting in surface water concentrations exceeding the
aforementioned concentrations of concern may result in significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of (1) a
water solubility: Column elution method; shake flask method test (OPPTS
Test Guideline 830.7840) or a water solubility generator column method
test (OPPTS Test Guideline 830.7860); and (2) a determination of the
partition coefficient (n-octanol/water) by shake flask method (OPPTS
Test Guideline 830.7550), or generator column method (OPPTS Test
Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test
Guideline 830.7570) would help characterize the physical/chemical
properties of the PMN substances. Depending upon the results of these
data, the results of a fish early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline
850.4500) may be recommended to help characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.10782.
PMN Numbers P-14-173, P-14-175, P-14-176, P-14-177, P-14-178, P-14-179,
P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-185, P-14-186,
P-14-187, P-14-188, P-14-190, P-14-191, P-14-192, and P-14-193
Chemical names: Fatty acid amide acetates (generic).
CAS numbers: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted, by the PMN submitter. The comment expressed concern that
EPA's approach for these SNURs changed from that transmitted in writing
by EPA during the PMN review period. As a result, the PMN submitter was
not given the opportunity to discuss, provide pertinent information on,
respond to, or comment on this change.
EPA response: EPA met with the PMN submitter on December 17, 2014
to discuss procedural and policy issues raised in connection with the
withdrawn SNURs. EPA awaits formal comment during the open comment
period for this proposed rule.
Basis for action: The PMNs state that the substances will be used
as flotation additives for use in mineral processing. Based on
ecological SAR analysis of test data on analogous amides and aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed the following values of the PMN substances
in surface waters:
------------------------------------------------------------------------
PMN No. Concentration of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
14-181, P-14-183, P-14-184, P-14-192, P-
14-193.
P-14-176, P-14-180, P-14-185, P-14-186, P- 2 ppb.
14-187, P-14-190.
P-14-177, P-14-188....................... 3 ppb.
P-14-191................................. 4 ppb.
P-14-182................................. 140 ppb.
------------------------------------------------------------------------
For the use described in the PMNs, releases of the substances are
not expected to result in surface water concentrations that exceed
these values. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substances resulting in surface water concentrations exceeding the
aforementioned concentrations of concern may result in significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) on P-14-184, and any one of the
remaining PMN substances, would help characterize the environmental
effects of the PMN substances. Further, EPA determined that the results
of a fish acute toxicity mitigated by humic acid test (OPPTS Test
Guideline 850.1085) on PMN P-14-184 would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed.
CFR citation: 40 CFR 721.10783.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met. For
additional discussion on these chemical substances, see Units II. and
IV. of this proposed rule.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this proposed rule:
EPA would 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.
EPA would 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.
EPA would be able to regulate prospective manufacturers or
processors of a listed chemical substance before the
[[Page 32883]]
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
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/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Proposed Rule to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed 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 proposed 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. The identities of 29 of the 30 chemical
substances subject to this proposed rule have been claimed as
confidential and EPA has received no post-PMN bona fide submissions
(per Sec. Sec. 720.25 and 721.11). 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 proposed rule are ongoing.
Therefore, EPA designates June 10, 2015 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of that date would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 (55 FR 17376) for a
more detailed discussion of the cutoff date for ongoing uses.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at
https://www.sourceoecd.org. ASTM International standards are available
at https://www.astm.org/Standard/index.shtml.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. [emsp14]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/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule, during the development of the
direct final rule. EPA's complete economic analysis is available in the
docket under docket ID number EPA-HQ-OPPT-2014-0390.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for 30 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
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this proposed
rule have already been approved by OMB pursuant to PRA under OMB
control number 2070-0012 (EPA ICR No. 574). This proposed rule would
not impose any burden requiring additional OMB approval. If an entity
were to
[[Page 32884]]
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,
Collection Strategies Division, Office of Environmental Information
(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)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.
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 would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would 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
This proposed rule would not have a substantial direct effect on
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This proposed rule is not subject to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this proposed rule does not address environmental
health or safety risks disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because this proposed rule is not expected to affect energy supply,
distribution, or use and because this proposed rule is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would
not apply to this proposed rule.
J. Executive Order 12898
This proposed rule does not entail special considerations of
environmental justice related issues as delineated by Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.10776 to subpart E to read as follows:
Sec. 721.10776 Functionalized carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
functionalized carbon nanotubes (PMN P-13-793) 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), and (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.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (a significant new use is use other
than as a thin film for electronic device applications), (v)(1),
(v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1).
[[Page 32885]]
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (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.
0
3. Add Sec. 721.10780 to subpart E to read as follows:
Sec. 721.10780 Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propaneperoxoic
acid, 2,2-dimethyl-, 1,1,3,3-tetramethylbutyl ester (PMN P-14-72; CAS
No. 22288-41-1) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=3).
(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), (b), (c), 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.
0
4. Add Sec. 721.10781 to subpart E to read as follows:
Sec. 721.10781 Fatty acid amide hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amide hydrochlorides (PMNs P-14-89, P-14-90, P-14-91 and P-14-92)
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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N = 110 for PMNs P-14-89 and P-
14-92; N = 240 for PMN P-14-90; N = 53 for PMN P-14-91).
(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), (b), (c), and (k) 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.
0
5. Add Sec. 721.10782 to subpart E to read as follows:
Sec. 721.10782 Fatty acid amides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amides (PMN P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163)
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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N = 1 for PMNs P-14-158, P-14-
159, P-14-161, and P-14-163; N = 140 for PMN P-14-162).
(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), (b), (c), and (k) 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.
0
6. Add Sec. 721.10783 to subpart E to read as follows:
Sec. 721.10783 Fatty acid amide acetates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amide acetates (PMNs P-14-173, P-14-175, P-14-176, P-14-177, P-14-
178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-
185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192 and P-
14-193) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N = concentration of concern as
follows):
------------------------------------------------------------------------
PMN No. Concentration of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
14-181, P-14-183, P-14-184, P-14-192, P-
14-193.
P-14-176, P-14-180, P-14-185, P-14-186, P- 2 ppb.
14-187, P-14-190.
P-14-177, P-14-188....................... 3 ppb.
P-14-191................................. 4 ppb.
P-14-182................................. 140 ppb.
------------------------------------------------------------------------
(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), (b), (c), and (k) 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.
[FR Doc. 2015-13941 Filed 6-9-15; 8:45 am]
BILLING CODE 6560-50-P
