Significant New Use Rules on Certain Chemical Substances, 5457-5471 [2015-01721]
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Rules and Regulations
incorporated by reference, contain additional
information about the subject of this AD. For
service information identified in this AD,
contact Airbus Helicopters, Inc., 2701 N.
Forum Drive, Grand Prairie, TX 75052;
telephone (972) 641–0000 or (800) 232–0323;
fax (972) 641–3775; or at https://
www.airbushelicopters.com/techpub. You
may review a copy of the service information
at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd.,
Room 663, Fort Worth, Texas 76137.
(2) The subject of this AD is addressed in
European Aviation Safety Agency (EASA) AD
No. 2013–0138R1, dated July 15, 2013. You
may view the EASA AD at https://
www.regulations.gov in the Docket No. FAA–
2015–0049.
(i) Subject
Joint Aircraft Service Component (JASC)
Code: 6320 Main rotor gearbox.
Issued in Fort Worth, Texas, on January 16,
2015.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft
Directorate, Aircraft Certification Service.
[FR Doc. 2015–01800 Filed 1–30–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2015–0003]
Drawbridge Operation Regulation;
Bonfouca Bayou, Slidell, LA
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the regulation
governing the operation of the State
Route 433 (SR433) Bridge across
Bonfouca Bayou, mile 7.0, at Slidell, St.
Tammany Parish, Louisiana. This
deviation provides for the bridge to
remain closed to navigation for five and
a half consecutive hours in the morning
and four and a half hours in the
afternoon with an opening in the middle
to pass vessels. There will be a two-hour
notice to pass vessels in the evenings
and a four-hour notice to pass vessels on
weekends. This deviation will last for
33 consecutive days. The purpose of the
closure is to conduct scheduled
maintenance and repairs to the
drawbridge.
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SUMMARY:
This deviation is effective from
6:30 a.m. on February 2, 2015 through
5:30 p.m. on March 6, 2015.
ADDRESSES: The docket for this
deviation, [USCG–2015–0003] is
DATES:
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available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this rulemaking. You
may also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Jim
Wetherington, Bridge Administration
Branch, Coast Guard, telephone
(504)671–2128, email
james.r.wetherington@uscg.mil. If you
have questions on viewing the docket,
call Cheryl F. Collins, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION: The
Louisiana Department of Transportation
and Development (LDOTD) requested a
temporary deviation from the normal
operation of the drawbridge at 33 CFR
117.433 in order to perform scheduled
maintenance and rehabilitation. This is
necessary for the continued operation of
the bridge. This deviation allows the
draw of the SR433 Bridge across
Bonfouca Bayou, mile 7.0, to remain
closed to navigation for five and a half
consecutive hours in the morning and
four and a half hours in the afternoon
with an opening in the middle to pass
vessels. This deviation is effective from
6:30 a.m. to noon and then again from
1 p.m. through 5:30 p.m. daily from
February 2 through March 6, 2015.
There will be two-hour notice required
in the evenings and a four-hour notice
all day on the weekends.
Broadcast Notice to Mariners will be
used to update mariners of any changes
in this deviation.
The bridge has a vertical clearance of
8 feet above high water in the closed-tonavigation position and unlimited
clearance above high water in the opento-navigation position. There is 125 feet
fender to fender horizontal clearance.
Navigation on the waterway consists of
tugs with tows, commercial fishing
vessels and mainly recreational craft.
There is no alternate route.
CEC (the contractor for the
maintenance and rehab) and the Coast
Guard have coordinated the closure
with waterway users, industry, and
other Coast Guard units. This date and
this schedule were chosen to minimize
the significant effects on vessel traffic.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
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operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: January 27, 2015.
David M. Frank,
Bridge Administrator, Eighth District.
[FR Doc. 2015–01826 Filed 1–30–15; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2014–0714; FRL–9919–68]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
EPA is promulgating
significant new use rules (SNURs) under
the Toxic Substances Control Act
(TSCA) for 27 chemical substances
which were the subject of
premanufacture notices (PMNs). Two of
these chemical substances are subject to
TSCA section 5(e) consent orders issued
by EPA. This action requires persons
who intend to manufacture (including
import) or process any of these 27
chemical substances for an activity that
is designated as a significant new use by
this rule to notify EPA at least 90 days
before commencing that activity. The
required notification will provide EPA
with the opportunity to evaluate the
intended use and, if necessary, to
prohibit or limit that activity before it
occurs.
SUMMARY:
This rule is effective on April 3,
2015. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on February 17, 2015.
Written adverse or critical comments,
or notice of intent to submit adverse or
critical comments, on one or more of
these SNURs must be received on or
before March 4, 2015 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA
receives written adverse or critical
comments, or notice of intent to submit
adverse or critical comments, on one or
more of these SNURs before March 4,
2015, EPA will withdraw the relevant
sections of this direct final rule before
its effective date.
For additional information on related
reporting requirement dates, see Units
I.A., VI., and VII. of the SUPPLEMENTARY
INFORMATION.
DATES:
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Rules and Regulations
Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0714, 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, are
available at https://www.epa.gov/
dockets.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Kenneth Moss, Chemical Control
Division (7405 M), 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
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A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this rule. The following list
of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
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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
that is the subject of 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
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 promulgating these SNURs
using direct final procedures. These
SNURs will require persons to notify
EPA at least 90 days before commencing
the manufacture or processing of a
chemical substance for any activity
designated by these SNURs as a
significant new use. Receipt of such
notices allows EPA to assess risks that
may be presented by the intended uses
and, if appropriate, to regulate the
proposed use before it occurs.
Additional rationale and background to
these rules are more fully set out in the
preamble to EPA’s first direct final
SNUR published in the Federal Register
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issue of April 24, 1990 (55 FR 17376).
Consult that preamble for further
information on the objectives, rationale,
and procedures for SNURs and on the
basis for significant new use
designations, including provisions for
developing test data.
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
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 sections
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
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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 27 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 Rule
EPA is establishing significant new
use and recordkeeping requirements for
27 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 (if assigned for nonconfidential chemical identities).
• Basis for the TSCA section 5(e)
consent order or the basis for the TSCA
non-section 5(e) SNURs (i.e., SNURs
without TSCA section 5(e) consent
orders).
• Toxicity concerns.
• Tests recommended by EPA to
provide sufficient information to
evaluate the chemical substance (see
Unit VIII. for more information).
• CFR citation assigned in the
regulatory text section of this rule.
The regulatory text section of this 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 rule, may be claimed
as CBI. Unit IX. discusses a procedure
companies may use to ascertain whether
a proposed use constitutes a significant
new use.
This rule includes two PMN
substances (P–12–17 and P–13–573) that
are subject to ‘‘risk-based’’ consent
orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined
that activities associated with the PMN
substances may present unreasonable
risk to human health or the
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environment. Those consent orders
require protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘section 5(e) SNURs’’ on these
PMN substances are promulgated
pursuant to § 721.160, and are based on
and consistent with the provisions in
the underlying consent orders. The
section 5(e) SNURs designate as a
‘‘significant new use’’ the absence of the
protective measures required in the
corresponding consent orders.
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
inhalation exposure, the underlying
TSCA section 5(e) consent order usually
requires, among other things, that
potentially exposed employees wear
specified respirators unless actual
measurements of the workplace air
show that air-borne concentrations of
the PMN substance are below a New
Chemical Exposure Limit (NCEL) that is
established by EPA to provide adequate
protection to human health. In addition
to the actual NCEL concentration, the
comprehensive NCELs provisions in
TSCA section 5(e) consent orders,
which are modeled after Occupational
Safety and Health Administration
(OSHA) Permissible Exposure Limits
(PELs) provisions, include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping.
However, no comparable NCEL
provisions currently exist in 40 CFR
part 721, subpart B, for SNURs.
Therefore, for these cases, the
individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject
to the SNUR who wish to pursue NCELs
as an alternative to the § 721.63
respirator requirements may request to
do so under § 721.30. EPA expects that
persons whose § 721.30 requests to use
the NCELs approach for SNURs are
approved by EPA will be required to
comply with NCELs provisions that are
comparable to those contained in the
corresponding TSCA section 5(e)
consent order for the same chemical
substance.
This rule also includes SNURs on 25
PMN substances that are not subject to
consent orders under TSCA section 5(e).
In these cases, for a variety of reasons,
EPA did not find that the use scenario
described in the PMN triggered the
determinations set forth under TSCA
section 5(e). However, EPA does believe
that certain changes from the use
scenario described in the PMN could
result in increased exposures, thereby
constituting a ‘‘significant new use.’’
These so-called ‘‘non-section 5(e)
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SNURs’’ are promulgated pursuant to
§ 721.170. EPA has determined that
every activity designated as a
‘‘significant new use’’ in all non-section
5(e) SNURs issued under § 721.170
satisfies the two requirements stipulated
in § 721.170(c)(2), i.e., these significant
new use activities are different from
those described in the premanufacture
notice for the substance, including any
amendments, deletions, and additions
of activities to the premanufacture
notice, and may be accompanied by
changes in exposure or release levels
that are significant in relation to the
health or environmental concerns
identified’’ for the PMN substance.
PMN Number P–12–17
Chemical name: Phosphoric acid, iron
(2+) lithium salt (1:1:1).
CAS number: 15365–14–7.
Effective date of TSCA section 5(e)
consent order: May 27, 2014.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the PMN will
be as electrode components. Based on
test data on analogous respirable, poorly
soluble particulates, EPA identified
concerns for lung overload. Further,
based on lithium (about 5 percent of the
molecular weight of the PMN), EPA
identified concerns for neurotoxicity,
developmental toxicity, and
immunotoxicity. The Order was issued
under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that
the substance may present an
unreasonable risk of injury to human
health, the substance may be produced
in substantial quantities and may
reasonably be anticipated to enter the
environment in substantial quantities,
and there may be significant (or
substantial) human exposure to the
substance. To protect against these risks,
the consent order requires:
1. Risk notification. If as a result of
the test data required, the company
becomes aware that the PMN substance
may present a risk of injury to human
health, the company must incorporate
this new information, and any
information on methods for protecting
against such risk into a Material Safety
Data Sheet (MSDS), within 90 days.
2. Use of personal protective
equipment including a National
Institute of Occupational Safety and
Health (NIOSH)-certified respirator with
an assigned protection factor (APF) of at
least 10 or compliance with a NCEL of
2.4 milligram/meter3 (mg/m3) as an 8hour time-weighted average (when there
is potential inhalation exposure), when
there is potential inhalation exposure.
3. Submission of certain testing prior
to exceeding the confidential
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production volume limits of the PMN
substance specified in the consent
order.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the test data from
certain human health testing identified
in the consent order would help
characterize possible health effects of
the substance. The company has agreed
not to exceed the first confidential
production limit without performing a
90-day inhalation toxicity test (OPPTS
Test Guideline 870.3465) in rats, with
special attention to histopathology as
described in the consent order. If the
results of the 90-day inhalation toxicity
test indicates the potential for
carcinogenicity, then the submitter has
agreed not to exceed the second
confidential production limit without
performing a carcinogenicity test
(OPPTS Test Guideline 870.4200) in rats
via the inhalation route.
CFR citation: 40 CFR 721.10793.
PMN Numbers P–13–212 and P–13–213
Chemical names: Alkenyl succinate,
amine salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the use of the substances will be as
metalworking fluid additives. Based on
test data on analogous anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 3 parts per
billion (ppb) in aggregate of the PMN
substances in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substances to surface water exceed
releases from the use described in the
PMNs. For the use described in the
PMNs, environmental releases of the
substances did not exceed 3 ppb for
more than 20 days per year. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substances may present an
unreasonable risk. EPA has determined,
however, that use of the substances
other than as described in the PMNs
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 a fish early-life stage
toxicity test (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity
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test (OPPTS Test Guideline 850.1300);
and an algal toxicity test (Office of
Chemical Safety and Pollution
Prevention (OCSPP) Test Guideline
850.4500), would help characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10794.
PMN Number P–13–559
Chemical name: Amine salt of
vegetable oil, polymer with
cycloaliphatic glycol, hydroxy
substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxyalkane
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be as a
wood sealer or concrete sealer. Based on
ecological structure activity relationship
(SAR) analysis of test data on
polyamphoteric polymers, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 60 ppb of
the PMN substance in surface waters for
greater than 20 days per year. This 20day criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substance to surface water exceed
releases from the use described in the
PMN. For the use described in the PMN,
environmental releases of the
substances did not exceed 60 ppb for
more than 20 days per year. 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
other than as described in the PMN may
result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10795.
PMN Number P–13–573
Chemical name: Polymer of
terephthalic acid and ethyl benzene
with multi-walled carbon nanotube
(generic).
CAS number: Claimed confidential.
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Effective date of TSCA section 5(e)
consent order: April 16, 2014.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the PMN will
be as dispersing agents for various resin
systems, such as thermosets, elastomers,
thermoplastics and solvents and water.
Based on test data on analogous
respirable, poorly soluble particulates,
EPA identified concerns for
immunotoxicity, oncogenicity, and
mutagenicity. Further, based on the
agglomeration potential of carbon
nanotubes, EPA identified concerns for
environmental releases to water where
the PMN may combine with dissolved
organic matter to form stable aqueous
suspensions. The Order was issued
under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that
the substance may present an
unreasonable risk of injury to human
health and the environment, the
substance may be produced in
substantial quantities and may
reasonably be anticipated to enter the
environment in substantial quantities,
and there may be significant (or
substantial) human exposure to the
substance. To protect against these risks,
the consent order requires:
1. Use of personal protective
equipment involving impervious gloves
and protective clothing (where there is
a potential for dermal exposure) and a
NIOSH-certified respirator with N–100,
P–100, or R–100 cartridges (where there
is a potential for inhalation exposure).
2. Submission of certain physicalchemical data for the PMN substance
within nine months of signing of the
consent order.
3. Submission of certain human
health testing prior to exceeding the
confidential production volume limit
specified in the consent order.
4. Processing and use of the PMN
substance only for the confidential use
specified in the consent order.
5. No use of the substance resulting in
releases to surface waters.
The SNUR would designate as a
‘‘significant new use’’ the absence of
these protective measures.
Recommended testing: EPA has
determined that the development of
data on certain physical-chemical
properties, as well as certain human
health and environmental toxicity
testing would help characterize possible
effects of the substance. The submitter
has agreed to provide the physical/
chemical properties data within the
specified time limit. In addition, the
submitter has agreed not to exceed the
confidential production limit without
performing a 90-day inhalation toxicity
test (OPPTS Test Guideline 870.3465 or
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Organisation for Economic Co-operation
and Development (OECD) Test
Guideline 413) in rats with a postexposure observation period of up to 3
months (including BALF analysis, a
determination of cardiovascular toxicity
(clinically-based blood/plasma protein
analyses), and histopathology of the
heart). Although the order does not
require the results of a fish early-life
stage toxicity test (OPPTS Test
Guideline 850.1400), a chronic daphnid
toxicity test (OPPTS Test Guideline
850.1300), and an algal toxicity test
(OCSPP Test Guideline 850.4500) at any
specified time or volume, the Order’s
restrictions on manufacture, processing,
distribution in commerce, and disposal
will remain in effect until the Order is
modified or revoked by EPA based on
submission of this or other relevant
information.
CFR citation: 40 CFR 721.10796.
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PMN Number P–13–674
Chemical name:
Polycarbamoylsulfonic acid sodium salt
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be for
leather processing. Based on test data of
the PMN substance, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 11 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 exceeding
11 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 that results in
releases to surface waters exceeding 11
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).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10797.
PMN Number P–13–864
Chemical name: Phosphonic acid
chloride, diester (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic use of the substance will be
as a chemical intermediate. Based on
ecological SAR analysis of test data on
analogous esters, EPA predicts toxicity
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to aquatic organisms may occur at
concentrations that exceed 5 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 exceeding
5 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 that results in
releases to surface waters exceeding 5
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10798.
PMN Numbers P–13–874, P–13–875,
P–13–876, and P–13–877
Chemical names: Substituted
dimethyl phenols (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic use of the substances will be
as chemical intermediates. Based on
ecological SAR analysis of test data on
analogous phenols, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 10 ppb of
the PMN substances P–13–874 or P–13–
875, and 5 ppb of the PMN substances
P–13–876 or P–13–877, in surface
waters. As described in the PMNs,
releases of the substances are not
expected to result in surface water
concentrations exceeding 10 ppb in
aggregate of the PMN P–13–874 and P–
13–875 substances or 5 ppb in aggregate
of the PMN P–13–876 and P–13–877
substances. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances that results in
releases to surface waters exceeding 10
ppb in aggregate of the PMN P–13–874
and P–13–875 substances or 5 ppb in
aggregate of the PMN P–13–876 and P–
13–877 substances 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
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acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); an algal
toxicity test (OCSPP Test Guideline
850.4500); and a ready biodegradability
test (OECD Test Guideline 301) on
either P–13–874 or P–13–875, would
help characterize the environmental
effects of these two PMN substances.
Further, EPA has determined that 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); an algal
toxicity test (OCSPP Test Guideline
850.4500); and a ready biodegradability
test (OECD Test Guideline 301) on P–
13–877 would help characterize the
environmental effects of P–13–876 and
P–13–877.
CFR citation: 40 CFR 721.10799.
PMN Number P–13–931
Chemical name: 2-propenoic acid, 4phenoxybutyl ester.
CAS number: 103969–85–3.
Basis for action: The PMN states that
the use of the substance will be a
polymerizable component in adhesive
formulations. Based on ecological SAR
analysis of test data on analogous
acrylates, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 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 exceeding
1 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 that results in
releases to surface waters exceeding 1
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a water
solubility test (OECD Test Guideline
105) and a partition coefficient (noctanol/water) test, HPLC Method
(OECD Test Guideline 117) would help
to characterize the physical-chemical
properties of the PMN substance. EPA
recommends that this testing be
performed first as the results may
mitigate the need for further testing or
change the testing recommendations.
Depending upon the results of these
data, EPA has determined that the
results of a fish acute toxicity test
(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test
(OPPTS Test Guideline 850.1010); and
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an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10800.
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PMN Number P–13–936
Chemical name: Organic phosphonate
salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic use of the substance will be
a contained use in energy production.
Based on ecological SAR analysis of test
data on analogous polyanionic
monomers, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 130 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 exceeding
130 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 that results in
releases to surface waters exceeding 130
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of an algal
toxicity test (OCSPP Test Guideline
850.4500) and a modified algal toxicity
test with equivalent calcium ion
amendments (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10801.
PMN Number P–14–39
Chemical name: Quaternized protein/
silicone copolymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic use of the substance will be
as a fabric softener additive. Based on
test data on the PMN substance, as well
as ecological SAR analysis of test data
on analogous amphoteric surfactants,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 31 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 exceeding
31 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 that results in
releases to surface waters exceeding 31
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ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10802.
PMN Number P–14–70
Chemical name: 1,5-Pentanediamine.
CAS number: 462–94–2.
Basis for action: The PMN states that
the uses of the substance will be as a
monomer for polyamides and as an
ingredient to produce metamethylene
1,5 diisocyanate. Based on ecological
SAR analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 300 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 exceeding
300 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 that results in
releases to surface waters exceeding 300
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10803.
PMN Number P–14–110
Chemical name: Cashew-nutshellliquid, polymer with formaldehyde,
reaction products with diethanolamine
and diisopropanol amine.
CAS number: 1462343–28–7.
Basis for action: The PMN states that
the generic use of the substance will be
as a polyol to be reacted with
polyisocyanates to create polyurethane
foam. Based on ecological SAR analysis
of test data on analogous aliphatic
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amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 1 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 exceeding 1 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 that results in releases to
surface waters exceeding 1 ppb may
result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a water
solubility test (OECD Test Guideline
105) and a partition coefficient (noctanol/water) test, high performance
liquid chromotography (HPLC) Method
(OECD Test Guideline 117) would help
to characterize the physical-chemical
properties of the PMN substance. EPA
recommends that this testing be
performed first as the results may
mitigate the need for further testing or
change the testing recommendations.
Depending on the results of these tests,
EPA has determined that the results of
a fish early-life stage toxicity test
(OPPTS Test Guideline 850.1400);
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline
850.4500) OR the sediment-water
chironomid life-cycle toxicity test using
spiked water or spiked sediment (OECD
Test Guideline 233) and the ready
biodegradability test (OECD Test
Guideline 301) would help characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10804.
PMN Numbers P–14–202, P–14–203, P–
14–204, P–14–205, and P–14–206
Chemical names: Fatty acid
imidazolines (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic use of the substances will be
as emulsifiers. Based on ecological SAR
analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 1 ppb in
aggregate of the PMN substances P–14–
202 and P–14–203 or 1 ppb in aggregate
of PMNs P–14–204, P–14–205, and P–
14–206 in surface waters. As described
in the PMNs, releases of the substances
are not expected to result in surface
water concentrations exceeding 1 ppb in
aggregate of P–14–202 and P–14–203 or
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1 ppb in aggregate of PMNs P–14–204,
P–14–205, and P–14–206. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substances may present an
unreasonable risk. EPA has determined,
however, that any use of the substances
that results in releases to surface waters
exceeding 1 ppb in aggregate of the
PMN substances P–14–202 and P–14–
203 or 1 ppb in aggregate of PMNs
P–14–204, P–14–205, and P–14–206
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 a water solubility test
(OECD Test Guideline 105) and a
partition coefficient (n-octanol/water)
test, HPLC Method (OECD Test
Guideline 117) for P–14–202 and P–14–
204 would help to characterize the
physical-chemical properties of the
PMN substances. EPA recommends that
this testing be performed first as the
results may mitigate the need for further
testing or change the testing
recommendations. Depending on the
results of these tests, EPA has
determined that 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); an algal toxicity test (OCSPP
Test Guideline 850.4500); as well as
either the fish acute toxicity mitigated
by humic acid test (OPPTS Test
Guideline 850.1085) or the whole
sediment acute toxicity invertebrates,
freshwater test (OPPTS Test Guideline
850.1735) on P–14–202 and P–14–204
may 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 to facilitate solubility in the
test media.
CFR citation: 40 CFR 721.10805.
PMN Number P–14–341
Chemical name: Trimellitic
anhydride, polymer with alkanolamine
and tetrahydrophthalic anhydride
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be as a
binder for gluing the individual mineral
fibres together to form a firm product,
used industrially in a closed system.
Based on test data on the PMN
substance, the EPA identified human
health concerns regarding blood toxicity
and uncertain concerns for liver and
kidney toxicity from exposure to the
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PMN substance via inhalation exposure.
As described in the PMN, exposure is
expected to be minimal for this use.
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 other than as listed in the
PMN may result in serious health
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of a
combined repeated dose toxicity study
with the reproductive/developmental
toxicity screening test (OECD Test
Guideline 422) would help characterize
the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10806.
PMN Number P–14–417
Chemical name: Aliphatic ether ethyl
alcohol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a solvent for ink.
Based on test data on analogous
ethylene glycol ethers, EPA identified
concerns for blood, liver, and kidney
toxicity, immunotoxicity, neurotoxicity,
and developmental and reproductive
toxicity to humans exposed to the PMN
substance. Because of the use described
in the PMN, significant dermal,
inhalation and drinking water exposures
are not expected for the worker, the
general population, or consumer.
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 use of the
substance other than as described in the
PMN may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of the
combined repeated dose toxicity study,
with the reproduction/developmental
toxicity screening test (OECD Test
Guideline 422) would help characterize
the health effects of the PMN substance.
CFR citation: 40 CFR 721.10807.
PMN Number P–14–513
Chemical name: Bisxylenol diglycidyl
ether polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate. Based on ecological SAR
analysis of test data on analogous
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polyepoxides, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 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
1 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 water concentrations exceeding
1 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that 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) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10808.
PMN Number P–14–518
Chemical name: Cyclotetrasiloxane,
2,4,6,8-tetrakis[3-[2-(2methoxyethoxy)ethoxy]propyl]-2,4,6,8tetramethyl-.
CAS number: 17232–95–0.
Basis for action: The PMN states that
the substance will be used in the
preparation of a triethyleneoxyterminated polymer. Based on
ecological SAR analysis of test data on
analogous neutral organic chemicals,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 8 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 8 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 water
concentrations exceeding 8 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that 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) would
help characterize the environmental
effects of the PMN substance. EPA also
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recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed to
facilitate solubility of the PMN
substance in the test media.
CFR citation: 40 CFR 721.10809.
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PMN Number P–14–544
Chemical name: Heterocyclic amine
potassium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a dishing reducer.
Based on ecological SAR analysis of test
data on structurally similar substances,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 250 ppb of the PMN
substance in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if either (1) releases of the
PMN substance to surface water, from
uses other than as described in the
PMN, exceed releases from the use
described in the PMN or (2) the
production volume increases beyond
the confidential production volume
described in the PMN. For the use and
production volume described in the
PMN, environmental releases did not
exceed 250 ppb for more than 20 days
per year. 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 other than as
described in the PMN, or any increase
in the annual production volume could
result in exposures which may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OECD Test
Guideline 301); 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) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10810.
PMN Number P–14–618
Chemical name: Heterocyclic amine
substituted acrylamide (generic).
CAS number: Claimed confidential.
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Basis for action: The PMN states that
the substance will be used as a
monomer for use in the manufacture of
a polymer or for export. Based on
ecological SAR analysis of test data on
analogous acrylamides, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 23 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
23 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 water concentrations exceeding
23 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that 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); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301) would help characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10811.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA concluded
that for 2 of the 27 chemical substances,
regulation was warranted under TSCA
section 5(e), pending the development
of information sufficient to make
reasoned evaluations of the health or
environmental effects of the chemical
substances. The basis for such findings
is outlined in Unit IV. Based on these
findings, TSCA section 5(e) consent
orders requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters. The SNUR
provisions for these chemical
substances are consistent with the
provisions of the TSCA section 5(e)
consent orders. These SNURs are
promulgated pursuant to § 721.160 (see
Unit VI.).
In the other 25 cases, where the uses
are not regulated under a TSCA section
5(e) consent order, EPA determined that
one or more of the criteria of concern
established at § 721.170 were met, as
discussed in Unit IV.
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B. Objectives
EPA is issuing 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 rule:
• EPA will 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 will 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 will be able to regulate
prospective manufacturers or processors
of a listed chemical substance before the
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.
• EPA will ensure that all
manufacturers and processors of the
same chemical substance that is subject
to a TSCA section 5(e) consent order are
subject to similar requirements.
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. Direct Final Procedures
EPA is issuing these SNURs as a
direct final rule, as described in
§ 721.160(c)(3) and § 721.170(d)(4). In
accordance with § 721.160(c)(3)(ii) and
§ 721.170(d)(4)(i)(B), the effective date
of this rule is April 3, 2015 without
further notice, unless EPA receives
written adverse or critical comments, or
notice of intent to submit adverse or
critical comments before March 4, 2015.
If EPA receives written adverse or
critical comments, or notice of intent to
submit adverse or critical comments, on
one or more of these SNURs before
March 4, 2015, EPA will withdraw the
relevant sections of this direct final rule
before its effective date. EPA will then
issue a proposed SNUR for the chemical
substance(s) on which adverse or
critical comments were received,
providing a 30-day period for public
comment.
This rule establishes SNURs for a
number of chemical substances. Any
person who submits adverse or critical
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comments, or notice of intent to submit
adverse or critical comments, must
identify the chemical substance and the
new use to which it applies. EPA will
not withdraw a SNUR for a chemical
substance not identified in the
comment.
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VII. Applicability of the Significant
New Use Designation
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this rule have undergone
premanufacture review. In cases where
EPA has not received a notice of
commencement (NOC) and the chemical
substance has not been added to the
TSCA Inventory, no person may
commence such activities without first
submitting a PMN. Therefore, for
chemical substances for which an NOC
has not been submitted EPA concludes
that the designated significant new uses
are not ongoing.
When chemical substances identified
in this rule are added to the TSCA
Inventory, EPA recognizes that, before
the rule is effective, other persons might
engage in a use that has been identified
as a significant new use. However,
TSCA section 5(e) consent orders have
been issued for 2 of the 27 chemical
substances, and the PMN submitters are
prohibited by the TSCA section 5(e)
consent orders from undertaking
activities which would be designated as
significant new uses. The identities of
22 of the 27 chemical substances subject
to this 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 rule are ongoing.
Therefore, EPA designates February 2,
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 for a more detailed discussion of
the cutoff date for ongoing uses.
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VIII. 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.
In cases where EPA issued a TSCA
section 5(e) consent order that requires
or recommends certain testing, Unit IV.
lists those tests. Unit IV. also lists
recommended testing for non-5(e)
SNURs. 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.
In the TSCA section 5(e) consent
orders for several of the chemical
substances regulated under this rule,
EPA has established production volume
limits in view of the lack of data on the
potential health and environmental
risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These limits cannot be exceeded unless
the PMN submitter first submits the
results of toxicity tests that would
permit a reasoned evaluation of the
potential risks posed by these chemical
substances. Under recent TSCA section
5(e) consent orders, each PMN submitter
is required to submit each study before
reaching the specified production limit.
Listings of the tests specified in the
TSCA section 5(e) consent orders are
included in Unit IV. The SNURs contain
the same production volume limits as
the TSCA section 5(e) consent orders.
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Exceeding these production limits is
defined as a significant new use.
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.
IX. Procedural Determinations
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1).
Under these procedures a
manufacturer or processor may request
EPA to determine whether a proposed
use would be a significant new use
under the rule. The manufacturer or
processor must show that it has a bona
fide intent to manufacture or process the
chemical substance and must identify
the specific use for which it intends to
manufacture or process the chemical
substance. If EPA concludes that the
person has shown a bona fide intent to
manufacture or process the chemical
substance, EPA will tell the person
whether the use identified in the bona
fide submission would be a significant
new use under the rule. Since most of
the chemical identities of the chemical
substances subject to these SNURs are
also CBI, manufacturers and processors
can combine the bona fide submission
under the procedure in § 721.1725(b)(1)
with that under § 721.11 into a single
step.
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If EPA determines that the use
identified in the bona fide submission
would not be a significant new use, i.e.,
the use does not meet the criteria
specified in the rule for a significant
new use, that person can manufacture or
process the chemical substance so long
as the significant new use trigger is not
met. In the case of a production volume
trigger, this means that the aggregate
annual production volume does not
exceed that identified in the bona fide
submission to EPA. Because of
confidentiality concerns, EPA does not
typically disclose the actual production
volume that constitutes the use trigger.
Thus, if the person later intends to
exceed that volume, a new bona fide
submission would be necessary to
determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to § 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.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2014–0714.
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XII. Statutory and Executive Order
Reviews
A. Executive Order 12866
This action establishes SNURs for
several new chemical substances that
were the subject of PMNs, or TSCA
section 5(e) consent orders. 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
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and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this action.
This listing of the OMB control numbers
and their subsequent codification in the
CFR satisfies the display requirements
of PRA and OMB’s implementing
regulations at 5 CFR part 1320. This
Information Collection Request (ICR)
was previously subject to public notice
and comment prior to OMB approval,
and given the technical nature of the
table, EPA finds that further notice and
comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table
without further notice and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, 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.
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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 action.
This action is within the scope of the
February 18, 2012 certification. Based
on the Economic Analysis discussed in
Unit XI. 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 will be impacted by this
action. As such, EPA has determined
that this action does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This action does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This action does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action.
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G. Executive Order 13045
This action 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 action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This action 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 action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this action does not
involve any technical standards,
NTTAA section 12(d) (15 U.S.C. 272
note), does not apply to this action.
Dated: January 21, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. In § 9.1, add the following sections
in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
OMB Control
No.
40 CFR Citation
J. Executive Order 12898
This action 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).
XIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
*
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.10793
721.10794
721.10795
721.10796
721.10797
721.10798
721.10799
721.10800
721.10801
721.10802
721.10803
721.10804
721.10805
721.10806
721.10807
721.10808
721.10809
721.10810
721.10811
*
*
*
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
*
*
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
List of Subjects
*
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40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
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*
*
*
*
PART 721—[AMENDED]
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add § 721.10793 to subpart E to
read as follows:
■
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5467
§ 721.10793 Phosphoric acid, iron (2+)
lithium salt (1:1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphoric acid, iron (2+) lithium salt
(1:1:1) (PMN P–12–17; CAS No. 15365–
14–7) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section. The SNUR does not apply to the
PMN substance when it is
manufactured, pursuant to any of the
exemptions in 40 CFR 720.30(h) with no
commercial purpose separate from the
substance, mixture, or article of which
it is a part.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi),
(b), and (c). When determining which
persons are reasonably likely to be
exposed as required for § 721.63 (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
Assigned Protection Factor (APF) of at
least 10 meet the requirements of
§ 721.63(a)(4):
(A) NIOSH-certified power airpurifying respirator with a hood or
helmet and with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges in combination with
HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a
full face piece.
(1) As an alternative to the respiratory
requirements listed here, a manufacturer
or processor may choose to follow the
New Chemical Exposure Limit (NCEL)
provisions listed in the TSCA section
5(e) consent order for this substance.
The NCEL is 2.4 mg/m3 as an 8-hour
time weighted average verified by actual
monitoring data.
(2) [Reserved]
(ii) Hazard communication program.
Requirements as specified in § 721.72.
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for this substance, the
employer becomes aware that this
substance may present a risk of injury
to human health or the environment, the
employer must incorporate this new
information, and any information on
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methods for protecting against such risk,
into a MSDS as described in § 721.72(c)
within 90 days from the time the
employer becomes aware of the new
information. If this substance is not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance from the employer, or who
have received the PMN substance from
the employer within 5 years from the
date the employer becomes aware of the
new information described in paragraph
(a)(2)(i)(A) of this section, are provided
an MSDS containing the information
required under paragraph (a)(2)(i)(A) of
this section within 90 days from the
time the employer becomes aware of the
new information.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) and (q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (f) and (i) 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) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 5. Add § 721.10794 to subpart E to
read as follows:
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§ 721.10794
(generic).
Alkenyl succinate, amine salts
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as alkenyl succinate, amine
salts (PMNs P–13–212 and P–13–213)
are subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. The significant
new use is any use other than as a
metalworking fluid additive.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
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(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) 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 § 721.10795 to subpart E to
read as follows:
§ 721.10705 Amine salt of vegetable oil,
polymer with cycloaliphatic glycol, hydroxy
substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxy alkane
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as amine salt of vegetable
oil, polymer with cycloaliphatic glycol,
hydroxy substituted carboxylic acid,
aliphatic diisocyanate and tetra hydroxy
alkane (PMN P–13–559) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. The significant
new use is any use other than as a wood
sealer or concrete sealer.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) 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.
■ 7. Add § 721.10796 to subpart E to
read as follows:
§ 721.10796 Polymer of terephthalic acid
and ethyl benzene with multi-walled carbon
nanotube (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polymer of terephthalic
acid and ethyl benzene with multiwalled carbon nanotube (PMN P–13–
573) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section. The SNUR does not apply to the
PMN substance when it is
manufactured, pursuant to any of the
exemptions in 40 CFR 720.30(h) with no
commercial purpose separate from the
substance, mixture, or article of which
it is a part.
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(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4),
(a)(6)(particulate), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63 (a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. A
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an N–100, P–100, or
R–100 cartridge meet the requirements
of § 721.63(a)(4).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k)(a significant
new use is any processing or use other
than described in the consent order) and
(q).
(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 (b).
(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) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 8. Add § 721.10797 to subpart E to
read as follows:
§ 721.10797 Polycarbamoylsulfonic acid
sodium salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polycarbamoylsulfonic
acid sodium salt (PMN P–13–674) 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=11).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
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(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.
■ 9. Add § 721.10798 to subpart E to
read as follows:
§ 721.10798 Phosphonic acid chloride,
diester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phosphonic acid chloride,
diester (PMN P–13–864) 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=5).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 10. Add § 721.10799 to subpart E to
read as follows:
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§ 721.10799
(generic).
Substituted dimethyl phenols
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as substituted dimethyl
phenols (PMNs P–13–874, P–13–875,
P–13–876, and P–13–877) 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) (N=10 in aggregate for PMN
substances P–13–874 and P–13–875,
and N=5 in aggregate for the PMN
substances P–13–876 and P–13–877).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (k) are applicable to
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manufacturers and processors of these
substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 11. Add § 721.10800 to subpart E to
read as follows:
§ 721.10800 2-Propenoic acid, 4phenoxybutyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 4-phenoxybutyl ester
(PMN P–13–931; CAS No. 103969–85–3)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 12. Add § 721.10801 to subpart E to
read as follows:
§ 721.10801
(generic).
Organic phosphonate salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organic phosphonate salt
(PMN P–13–936) 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=130).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 13. Add § 721.10802 to subpart E to
read as follows:
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§ 721.10802 Quaternized protein/silicone
copolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as quaternized protein/
silicone copolymer (PMN P–14–39) 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=31).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 14. Add § 721.10803 to subpart E to
read as follows:
§ 721.10803
1,5-Pentanediamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,5-pentanediamine (PMN P-14-70; CAS
No. 462–94–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=300).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 15. Add § 721.10804 to subpart E to
read as follows:
§ 721.10804 Cashew-nutshell-liquid,
polymer with formaldehyde, reaction
products with diethanolamine and
diisopropanol amine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cashew-nutshell-liquid, polymer with
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formaldehyde, reaction products with
diethanolamine and diisopropanol
amine (PMN P–14–110; CAS No.
1462343–28–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 16. Add § 721.10805 to subpart E to
read as follows:
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§ 721.10805
(generic).
Fatty acid imidazolines
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid imidazolines.
(PMNs P–14–202, P–14–203, P–14–204,
P–14–205, and P–14–206) 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 in aggregate for PMNs
P–14–203 and P–14–204; N=1 in
aggregate for PMNs P–14–204, P–14–
205, P–14–206).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 17. Add § 721.10806 to subpart E to
read as follows:
§ 721.10806 Trimellitic anhydride, polymer
with alkanolamine and tetrahydrophthalic
anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as trimellitic anhydride,
polymer with alkanolamine and
tetrahydrophthalic anhydride (PMN P–
14–341) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use of the PMN substance
other than as a binder for gluing the
individual mineral fibers together to
form a firm product, used industrially in
a closed system.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) 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.
■ 18. Add § 721.10807 to subpart E to
read as follows:
§ 721.10807
(generic).
Aliphatic ether ethyl alcohol
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aliphatic ether ethyl
alcohol (PMN P–14–417) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use other than the
confidential use as stated in the PMN.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) 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) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 19. Add § 721.10808 to subpart E to
read as follows:
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§ 721.10808 Bisxylenol diglycidyl ether
polymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as bisxylenol diglycidyl
ether polymer (PMN P–14–513) 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=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 20. Add § 721.10809 to subpart E to
read as follows:
§ 721.10809 Cyclotetrasiloxane, 2,4,6,8tetrakis[3-[2-(2methoxyethoxy)ethoxy]propyl]-2,4,6,8tetramethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2(2-methoxyethoxy)ethoxy]propyl]2,4,6,8-tetramethyl- (PMN P–14–518;
CAS No. 17232–95–0) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
■ 21. Add § 721.10810 to subpart E to
read as follows:
§ 721.10810 Heterocyclic amine potassium
salt (generic).
(a) Chemical substance and significant
new uses subject to reporting. (1) The
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chemical substance identified
generically as heterocyclic amine
potassium salt (PMN P–14–544) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j)(a significant
new use is any use other than the
confidential use stated in the PMN) and
(s).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) 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) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
22. Add § 721.10811 to subpart E to
read as follows:
■
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§ 721.10811 Heterocyclic amine
substituted acrylamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as heterocyclic amine
substituted acrylamide (PMN P–14–618)
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=23).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in § 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.
[FR Doc. 2015–01721 Filed 1–30–15; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2008–0636; FRL–9922–25–
Region 6]
Approval and Promulgation of Air
Quality Implementation Plans; New
Mexico; Albuquerque/Bernalillo
County; Revisions to Emissions
Inventory Requirements, and General
Provisions
Environmental Protection
Agency.
ACTION: Direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving revisions to
the Albuquerque/Bernalillo County,
New Mexico State Implementation Plan
(SIP). These revisions add definitions
and clarifying changes to the general
provisions and add a new emissions
inventory regulation that establishes
reporting requirements for stationary
sources in Albuquerque/Bernalillo
County. The EPA is approving these
revisions pursuant to section 110 of the
Clean Air Act (CAA).
DATES: This rule will be effective on
April 3, 2015 without further notice
unless EPA receives relevant adverse
comments by March 4, 2015. If EPA
receives such comments, EPA will
publish a timely withdrawal in the
Federal Register informing the public
that the rule will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R06–
OAR–2008–0636, by one of the
following methods:
• www.regulations.gov. Follow the
online instructions.
• Email: Mr. Guy Donaldson at
donaldson.guy@epa.gov. Please also
send a copy by email to the person
listed in the FOR FURTHER INFORMATION
CONTACT section below.
• Mail or Delivery: Mr. Guy
Donaldson, Chief, Air Planning Section
(6PD–L), Environmental Protection
Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202–2733.
Instructions: Direct your comments to
Docket ID No. EPA–R06–OAR–2008–
0636. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit through
www.regulations.gov or email,
SUMMARY:
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5471
information that you consider to be CBI
or otherwise protected. The
www.regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the www.regulations.gov
index and in hard copy at EPA Region
6, 1445 Ross Avenue, Suite 700, Dallas,
Texas. While all documents in the
docket are listed in the index, some
information may be publicly available
only at the hard copy location (e.g.,
copyrighted material), and some may
not be publicly available at either
location (e.g., CBI). To inspect the hard
copy materials, please schedule an
appointment with the person listed in
the FOR FURTHER INFORMATION CONTACT
paragraph below or Mr. Bill Deese at
(214) 665–7253.
FOR FURTHER INFORMATION CONTACT:
Mr.
John Walser (6PD–L), Air Planning
Section, telephone (214) 665–7128,
email: walser.john@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us,’’
and ‘‘our’’ means EPA.
Table of Contents
I. Background
A. What is a SIP?
B. What are Emissions Inventories?
II. Overview of the State Submittals
A. May 6, 2008 Submittal
B. November 6, 2009 Submittals
C. December 15, 2010 Submittal
D. October 18, 2012 Submittal
III. EPA’s Evaluation of the Submittals
IV. Final Action
V. Statutory and Executive Order Reviews
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Agencies
[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Rules and Regulations]
[Pages 5457-5471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01721]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0714; FRL-9919-68]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 27 chemical substances
which were the subject of premanufacture notices (PMNs). Two of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(including import) or process any of these 27 chemical substances for
an activity that is designated as a significant new use by this rule to
notify EPA at least 90 days before commencing that activity. The
required notification will provide EPA with the opportunity to evaluate
the intended use and, if necessary, to prohibit or limit that activity
before it occurs.
DATES: This rule is effective on April 3, 2015. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
February 17, 2015.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before March 4, 2015 (see Unit VI. of the SUPPLEMENTARY
INFORMATION). If EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments, on one or more
of these SNURs before March 4, 2015, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
[[Page 5458]]
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0714, 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, are available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405 M), 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 rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of 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. [emsp14]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 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 promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376). Consult that preamble for further information on
the objectives, rationale, and procedures for SNURs and on the basis
for significant new use designations, including provisions for
developing test data.
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 rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. [emsp14]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 sections 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
[[Page 5459]]
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 27
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 Rule
EPA is establishing significant new use and recordkeeping
requirements for 27 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 (if
assigned for non-confidential chemical identities).
Basis for the TSCA section 5(e) consent order or the basis
for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section
5(e) consent orders).
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this 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 rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
This rule includes two PMN substances (P-12-17 and P-13-573) that
are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``section 5(e) SNURs'' on these PMN substances are
promulgated pursuant to Sec. [emsp14]721.160, and are based on and
consistent with the provisions in the underlying consent orders. The
section 5(e) SNURs designate as a ``significant new use'' the absence
of the protective measures required in the corresponding consent
orders.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. [emsp14]721.30. EPA expects that persons whose Sec. 721.30
requests to use the NCELs approach for SNURs are approved by EPA will
be required to comply with NCELs provisions that are comparable to
those contained in the corresponding TSCA section 5(e) consent order
for the same chemical substance.
This rule also includes SNURs on 25 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``non-
section 5(e) SNURs'' are promulgated pursuant to Sec. [emsp14]721.170.
EPA has determined that every activity designated as a ``significant
new use'' in all non-section 5(e) SNURs issued under Sec.
[emsp14]721.170 satisfies the two requirements stipulated in Sec.
721.170(c)(2), i.e., these significant new use activities are different
from those described in the premanufacture notice for the substance,
including any amendments, deletions, and additions of activities to the
premanufacture notice, and may be accompanied by changes in exposure or
release levels that are significant in relation to the health or
environmental concerns identified'' for the PMN substance.
PMN Number P-12-17
Chemical name: Phosphoric acid, iron (2+) lithium salt (1:1:1).
CAS number: 15365-14-7.
Effective date of TSCA section 5(e) consent order: May 27, 2014.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN will be as electrode
components. Based on test data on analogous respirable, poorly soluble
particulates, EPA identified concerns for lung overload. Further, based
on lithium (about 5 percent of the molecular weight of the PMN), EPA
identified concerns for neurotoxicity, developmental toxicity, and
immunotoxicity. The Order was issued under TSCA sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) based on a finding that the substance may present
an unreasonable risk of injury to human health, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance may present a risk of
injury to human health, the company must incorporate this new
information, and any information on methods for protecting against such
risk into a Material Safety Data Sheet (MSDS), within 90 days.
2. Use of personal protective equipment including a National
Institute of Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10 or
compliance with a NCEL of 2.4 milligram/meter\3\ (mg/m\3\) as an 8-hour
time-weighted average (when there is potential inhalation exposure),
when there is potential inhalation exposure.
3. Submission of certain testing prior to exceeding the
confidential
[[Page 5460]]
production volume limits of the PMN substance specified in the consent
order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the test data from
certain human health testing identified in the consent order would help
characterize possible health effects of the substance. The company has
agreed not to exceed the first confidential production limit without
performing a 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) in rats, with special attention to histopathology as
described in the consent order. If the results of the 90-day inhalation
toxicity test indicates the potential for carcinogenicity, then the
submitter has agreed not to exceed the second confidential production
limit without performing a carcinogenicity test (OPPTS Test Guideline
870.4200) in rats via the inhalation route.
CFR citation: 40 CFR 721.10793.
PMN Numbers P-13-212 and P-13-213
Chemical names: Alkenyl succinate, amine salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the use of the substances
will be as metalworking fluid additives. Based on test data on
analogous anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 3 parts per billion
(ppb) in aggregate of the PMN substances in surface waters for greater
than 20 days per year. This 20-day criterion is derived from partial
life cycle tests (daphnid chronic and fish early-life stage tests) that
typically range from 21 to 28 days in duration. EPA predicts toxicity
to aquatic organisms may occur if releases of the PMN substances to
surface water exceed releases from the use described in the PMNs. For
the use described in the PMNs, environmental releases of the substances
did not exceed 3 ppb for more than 20 days per year. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substances may present an unreasonable risk. EPA has determined,
however, that use of the substances other than as described in the PMNs
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 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 (Office of Chemical Safety and Pollution Prevention (OCSPP) Test
Guideline 850.4500), would help characterize the environmental effects
of the PMN substances.
CFR citation: 40 CFR 721.10794.
PMN Number P-13-559
Chemical name: Amine salt of vegetable oil, polymer with
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxyalkane (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a wood sealer or concrete sealer. Based on ecological structure
activity relationship (SAR) analysis of test data on polyamphoteric
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 60 ppb of the PMN substance in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substance to surface water exceed releases from the use described
in the PMN. For the use described in the PMN, environmental releases of
the substances did not exceed 60 ppb for more than 20 days per year.
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 other than
as described in the PMN may result in significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10795.
PMN Number P-13-573
Chemical name: Polymer of terephthalic acid and ethyl benzene with
multi-walled carbon nanotube (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: April 16, 2014.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN will be as dispersing agents
for various resin systems, such as thermosets, elastomers,
thermoplastics and solvents and water. Based on test data on analogous
respirable, poorly soluble particulates, EPA identified concerns for
immunotoxicity, oncogenicity, and mutagenicity. Further, based on the
agglomeration potential of carbon nanotubes, EPA identified concerns
for environmental releases to water where the PMN may combine with
dissolved organic matter to form stable aqueous suspensions. The Order
was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I),
based on a finding that the substance may present an unreasonable risk
of injury to human health and the environment, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the consent order requires:
1. Use of personal protective equipment involving impervious gloves
and protective clothing (where there is a potential for dermal
exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100
cartridges (where there is a potential for inhalation exposure).
2. Submission of certain physical-chemical data for the PMN
substance within nine months of signing of the consent order.
3. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.
4. Processing and use of the PMN substance only for the
confidential use specified in the consent order.
5. No use of the substance resulting in releases to surface waters.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
the physical/chemical properties data within the specified time limit.
In addition, the submitter has agreed not to exceed the confidential
production limit without performing a 90-day inhalation toxicity test
(OPPTS Test Guideline 870.3465 or
[[Page 5461]]
Organisation for Economic Co-operation and Development (OECD) Test
Guideline 413) in rats with a post-exposure observation period of up to
3 months (including BALF analysis, a determination of cardiovascular
toxicity (clinically-based blood/plasma protein analyses), and
histopathology of the heart). Although the order does not require the
results of a fish early-life stage toxicity test (OPPTS Test Guideline
850.1400), a chronic daphnid toxicity test (OPPTS Test Guideline
850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500)
at any specified time or volume, the Order's restrictions on
manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.10796.
PMN Number P-13-674
Chemical name: Polycarbamoylsulfonic acid sodium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be for leather processing. Based on test data of the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 11 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 exceeding 11 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 that results in releases to
surface waters exceeding 11 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).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10797.
PMN Number P-13-864
Chemical name: Phosphonic acid chloride, diester (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be as a chemical intermediate. Based on ecological SAR
analysis of test data on analogous esters, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 5 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 exceeding 5 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 that results in releases to surface waters exceeding 5
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)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10798.
PMN Numbers P-13-874, P-13-875, P-13-876, and P-13-877
Chemical names: Substituted dimethyl phenols (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic use of the
substances will be as chemical intermediates. Based on ecological SAR
analysis of test data on analogous phenols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 10 ppb of the
PMN substances P-13-874 or P-13-875, and 5 ppb of the PMN substances P-
13-876 or P-13-877, in surface waters. As described in the PMNs,
releases of the substances are not expected to result in surface water
concentrations exceeding 10 ppb in aggregate of the PMN P-13-874 and P-
13-875 substances or 5 ppb in aggregate of the PMN P-13-876 and P-13-
877 substances. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances that results in releases to surface waters exceeding 10 ppb
in aggregate of the PMN P-13-874 and P-13-875 substances or 5 ppb in
aggregate of the PMN P-13-876 and P-13-877 substances 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 (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); an
algal toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) on either P-13-874 or
P-13-875, would help characterize the environmental effects of these
two PMN substances. Further, EPA has determined that 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) on P-13-877 would help
characterize the environmental effects of P-13-876 and P-13-877.
CFR citation: 40 CFR 721.10799.
PMN Number P-13-931
Chemical name: 2-propenoic acid, 4-phenoxybutyl ester.
CAS number: 103969-85-3.
Basis for action: The PMN states that the use of the substance will
be a polymerizable component in adhesive formulations. Based on
ecological SAR analysis of test data on analogous acrylates, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 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 exceeding 1 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 that results in releases to
surface waters exceeding 1 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)(ii).
Recommended testing: EPA has determined that the results of a water
solubility test (OECD Test Guideline 105) and a partition coefficient
(n-octanol/water) test, HPLC Method (OECD Test Guideline 117) would
help to characterize the physical-chemical properties of the PMN
substance. EPA recommends that this testing be performed first as the
results may mitigate the need for further testing or change the testing
recommendations. Depending upon the results of these data, EPA has
determined that the results of a fish acute toxicity test (OPPTS Test
Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS
Test Guideline 850.1010); and
[[Page 5462]]
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10800.
PMN Number P-13-936
Chemical name: Organic phosphonate salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be a contained use in energy production. Based on
ecological SAR analysis of test data on analogous polyanionic monomers,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 130 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 exceeding 130 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 that results in
releases to surface waters exceeding 130 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)(ii).
Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500) and a modified
algal toxicity test with equivalent calcium ion amendments (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10801.
PMN Number P-14-39
Chemical name: Quaternized protein/silicone copolymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the
substance will be as a fabric softener additive. Based on test data on
the PMN substance, as well as ecological SAR analysis of test data on
analogous amphoteric surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 31 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
exceeding 31 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 that results in releases to surface waters exceeding 31 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)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10802.
PMN Number P-14-70
Chemical name: 1,5-Pentanediamine.
CAS number: 462-94-2.
Basis for action: The PMN states that the uses of the substance
will be as a monomer for polyamides and as an ingredient to produce
metamethylene 1,5 diisocyanate. Based on ecological SAR analysis of
test data on analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 300 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 exceeding 300 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 that results in releases to surface waters
exceeding 300 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)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10803.
PMN Number P-14-110
Chemical name: Cashew-nutshell-liquid, polymer with formaldehyde,
reaction products with diethanolamine and diisopropanol amine.
CAS number: 1462343-28-7.
Basis for action: The PMN states that the generic use of the
substance will be as a polyol to be reacted with polyisocyanates to
create polyurethane foam. Based on ecological SAR analysis of test data
on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 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
exceeding 1 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 that results in releases to surface waters exceeding 1 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)(ii).
Recommended testing: EPA has determined that the results of a water
solubility test (OECD Test Guideline 105) and a partition coefficient
(n-octanol/water) test, high performance liquid chromotography (HPLC)
Method (OECD Test Guideline 117) would help to characterize the
physical-chemical properties of the PMN substance. EPA recommends that
this testing be performed first as the results may mitigate the need
for further testing or change the testing recommendations. Depending on
the results of these tests, EPA has determined that the results of a
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400);
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) OR the sediment-
water chironomid life-cycle toxicity test using spiked water or spiked
sediment (OECD Test Guideline 233) and the ready biodegradability test
(OECD Test Guideline 301) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10804.
PMN Numbers P-14-202, P-14-203, P-14-204, P-14-205, and P-14-206
Chemical names: Fatty acid imidazolines (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic use of the
substances will be as emulsifiers. Based on ecological SAR analysis of
test data on analogous aliphatic amines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb in
aggregate of the PMN substances P-14-202 and P-14-203 or 1 ppb in
aggregate of PMNs P-14-204, P-14-205, and P-14-206 in surface waters.
As described in the PMNs, releases of the substances are not expected
to result in surface water concentrations exceeding 1 ppb in aggregate
of P-14-202 and P-14-203 or
[[Page 5463]]
1 ppb in aggregate of PMNs P-14-204, P-14-205, and P-14-206. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substances may present an unreasonable risk. EPA has
determined, however, that any use of the substances that results in
releases to surface waters exceeding 1 ppb in aggregate of the PMN
substances P-14-202 and P-14-203 or 1 ppb in aggregate of PMNs P-14-
204, P-14-205, and P-14-206 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 a water solubility
test (OECD Test Guideline 105) and a partition coefficient (n-octanol/
water) test, HPLC Method (OECD Test Guideline 117) for P-14-202 and P-
14-204 would help to characterize the physical-chemical properties of
the PMN substances. EPA recommends that this testing be performed first
as the results may mitigate the need for further testing or change the
testing recommendations. Depending on the results of these tests, EPA
has determined that 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); an algal toxicity test (OCSPP Test
Guideline 850.4500); as well as either the fish acute toxicity
mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the
whole sediment acute toxicity invertebrates, freshwater test (OPPTS
Test Guideline 850.1735) on P-14-202 and P-14-204 may 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 to
facilitate solubility in the test media.
CFR citation: 40 CFR 721.10805.
PMN Number P-14-341
Chemical name: Trimellitic anhydride, polymer with alkanolamine and
tetrahydrophthalic anhydride (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a binder for gluing the individual mineral fibres together to
form a firm product, used industrially in a closed system. Based on
test data on the PMN substance, the EPA identified human health
concerns regarding blood toxicity and uncertain concerns for liver and
kidney toxicity from exposure to the PMN substance via inhalation
exposure. As described in the PMN, exposure is expected to be minimal
for this use. 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 other than as listed in the PMN may result in serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproductive/
developmental toxicity screening test (OECD Test Guideline 422) would
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10806.
PMN Number P-14-417
Chemical name: Aliphatic ether ethyl alcohol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a solvent for ink. Based
on test data on analogous ethylene glycol ethers, EPA identified
concerns for blood, liver, and kidney toxicity, immunotoxicity,
neurotoxicity, and developmental and reproductive toxicity to humans
exposed to the PMN substance. Because of the use described in the PMN,
significant dermal, inhalation and drinking water exposures are not
expected for the worker, the general population, or consumer.
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 use of the substance other than as
described in the PMN may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of the
combined repeated dose toxicity study, with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422) would
help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.10807.
PMN Number P-14-513
Chemical name: Bisxylenol diglycidyl ether polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on ecological SAR analysis of test data on analogous
polyepoxides, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 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 1 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 water concentrations exceeding 1 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that 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) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10808.
PMN Number P-14-518
Chemical name: Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.
CAS number: 17232-95-0.
Basis for action: The PMN states that the substance will be used in
the preparation of a triethyleneoxy-terminated polymer. Based on
ecological SAR analysis of test data on analogous neutral organic
chemicals, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 8 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 8 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 water concentrations exceeding 8 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that 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) would help
characterize the environmental effects of the PMN substance. EPA also
[[Page 5464]]
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed
to facilitate solubility of the PMN substance in the test media.
CFR citation: 40 CFR 721.10809.
PMN Number P-14-544
Chemical name: Heterocyclic amine potassium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dishing reducer. Based
on ecological SAR analysis of test data on structurally similar
substances, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 250 ppb of the PMN substance in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if either (1)
releases of the PMN substance to surface water, from uses other than as
described in the PMN, exceed releases from the use described in the PMN
or (2) the production volume increases beyond the confidential
production volume described in the PMN. For the use and production
volume described in the PMN, environmental releases did not exceed 250
ppb for more than 20 days per year. 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 other than as described in the PMN, or any
increase in the annual production volume could result in exposures
which may cause significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301); 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) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10810.
PMN Number P-14-618
Chemical name: Heterocyclic amine substituted acrylamide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a monomer for use in the manufacture of a polymer or for export. Based
on ecological SAR analysis of test data on analogous acrylamides, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 23 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 23 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 water
concentrations exceeding 23 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10811.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 2 of the 27
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. 721.160 (see Unit VI.).
In the other 25 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing 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 rule:
EPA will 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 will 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 will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the 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.
EPA will ensure that all manufacturers and processors of
the same chemical substance that is subject to a TSCA section 5(e)
consent order are subject to similar requirements.
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. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
[emsp14]721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective
date of this rule is April 3, 2015 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before March 4, 2015.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before March 4, 2015, EPA will withdraw the relevant sections of
this direct final rule before its effective date. EPA will then issue a
proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical
[[Page 5465]]
comments, or notice of intent to submit adverse or critical comments,
must identify the chemical substance and the new use to which it
applies. EPA will not withdraw a SNUR for a chemical substance not
identified in the comment.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 2 of the 27 chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which would be designated as significant new uses. The
identities of 22 of the 27 chemical substances subject to this 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 rule are ongoing.
Therefore, EPA designates February 2, 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 for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. 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. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. 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.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study
before reaching the specified production limit. Listings of the tests
specified in the TSCA section 5(e) consent orders are included in Unit
IV. The SNURs contain the same production volume limits as the TSCA
section 5(e) consent orders. Exceeding these production limits is
defined as a significant new use.
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.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
[emsp14]721.1725(b)(1) with that under Sec. [emsp14]721.11 into a
single step.
[[Page 5466]]
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to 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.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2014-0714.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This action establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) consent orders. 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
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
action.
This action is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. 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 will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this action.
[[Page 5467]]
G. Executive Order 13045
This action 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 action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action 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 action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action 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).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 21, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. [emsp14]9.1, add the following sections in numerical order
under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB Control
40 CFR Citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10793............................................... 2070-0012
721.10794............................................... 2070-0012
721.10795............................................... 2070-0012
721.10796............................................... 2070-0012
721.10797............................................... 2070-0012
721.10798............................................... 2070-0012
721.10799............................................... 2070-0012
721.10800............................................... 2070-0012
721.10801............................................... 2070-0012
721.10802............................................... 2070-0012
721.10803............................................... 2070-0012
721.10804............................................... 2070-0012
721.10805............................................... 2070-0012
721.10806............................................... 2070-0012
721.10807............................................... 2070-0012
721.10808............................................... 2070-0012
721.10809............................................... 2070-0012
721.10810............................................... 2070-0012
721.10811............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. [emsp14]721.10793 to subpart E to read as follows:
Sec. [emsp14]721.10793 Phosphoric acid, iron (2+) lithium salt
(1:1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
iron (2+) lithium salt (1:1:1) (PMN P-12-17; CAS No. 15365-14-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The SNUR does not apply
to the PMN substance when it is manufactured, pursuant to any of the
exemptions in 40 CFR 720.30(h) with no commercial purpose separate from
the substance, mixture, or article of which it is a part.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63 (a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
Assigned Protection Factor (APF) of at least 10 meet the requirements
of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
(1) As an alternative to the respiratory requirements listed here,
a manufacturer or processor may choose to follow the New Chemical
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e)
consent order for this substance. The NCEL is 2.4 mg/m\3\ as an 8-hour
time weighted average verified by actual monitoring data.
(2) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72.
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on
[[Page 5468]]
methods for protecting against such risk, into a MSDS as described in
Sec. 721.72(c) within 90 days from the time the employer becomes aware
of the new information. If this substance is not being manufactured,
processed, or used in the employer's workplace, the employer must add
the new information to a MSDS before the substance is reintroduced into
the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (f) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
5. Add Sec. 721.10794 to subpart E to read as follows:
Sec. 721.10794 Alkenyl succinate, amine salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkenyl succinate, amine salts (PMNs P-13-212 and P-13-213) are subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. The significant new use is any use other
than as a metalworking fluid additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.10795 to subpart E to read as follows:
Sec. 721.10705 Amine salt of vegetable oil, polymer with
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic
diisocyanate and tetra hydroxy alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amine
salt of vegetable oil, polymer with cycloaliphatic glycol, hydroxy
substituted carboxylic acid, aliphatic diisocyanate and tetra hydroxy
alkane (PMN P-13-559) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. The significant new use is any use other
than as a wood sealer or concrete sealer.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.10796 to subpart E to read as follows:
Sec. [emsp14]721.10796 Polymer of terephthalic acid and ethyl benzene
with multi-walled carbon nanotube (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polymer
of terephthalic acid and ethyl benzene with multi-walled carbon
nanotube (PMN P-13-573) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The SNUR does not apply to the PMN substance when it is manufactured,
pursuant to any of the exemptions in 40 CFR 720.30(h) with no
commercial purpose separate from the substance, mixture, or article of
which it is a part.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4),
(a)(6)(particulate), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63 (a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A National
Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an N-100, P-100, or R-100 cartridge meet the
requirements of Sec. 721.63(a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k)(a significant new use is any
processing or use other than described in the consent order) and (q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
8. Add Sec. [emsp14]721.10797 to subpart E to read as follows:
Sec. 721.10797 Polycarbamoylsulfonic acid sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polycarbamoylsulfonic acid sodium salt (PMN P-13-674) 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=11).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 5469]]
(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
9. Add Sec. [emsp14]721.10798 to subpart E to read as follows:
Sec. 721.10798 Phosphonic acid chloride, diester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid chloride, diester (PMN P-13-864) 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=5).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
10. Add Sec. [emsp14]721.10799 to subpart E to read as follows:
Sec. 721.10799 Substituted dimethyl phenols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted dimethyl phenols (PMNs P-13-874, P-13-875, P-13-876, and P-
13-877) 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) (N=10 in aggregate for PMN substances P-13-
874 and P-13-875, and N=5 in aggregate for the PMN substances P-13-876
and P-13-877).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
11. Add Sec. [emsp14]721.10800 to subpart E to read as follows:
Sec. 721.10800 2-Propenoic acid, 4-phenoxybutyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
4-phenoxybutyl ester (PMN P-13-931; CAS No. 103969-85-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
12. Add Sec. [emsp14]721.10801 to subpart E to read as follows:
Sec. 721.10801 Organic phosphonate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
phosphonate salt (PMN P-13-936) 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=130).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
13. Add Sec. [emsp14]721.10802 to subpart E to read as follows:
Sec. 721.10802 Quaternized protein/silicone copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quaternized protein/silicone copolymer (PMN P-14-39) 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=31).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
14. Add Sec. [emsp14]721.10803 to subpart E to read as follows:
Sec. 721.10803 1,5-Pentanediamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,5-pentanediamine
(PMN P-14-70; CAS No. 462-94-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=300).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
15. Add Sec. [emsp14]721.10804 to subpart E to read as follows:
Sec. 721.10804 Cashew-nutshell-liquid, polymer with formaldehyde,
reaction products with diethanolamine and diisopropanol amine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cashew-nutshell-
liquid, polymer with
[[Page 5470]]
formaldehyde, reaction products with diethanolamine and diisopropanol
amine (PMN P-14-110; CAS No. 1462343-28-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
16. Add Sec. [emsp14]721.10805 to subpart E to read as follows:
Sec. 721.10805 Fatty acid imidazolines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid imidazolines. (PMNs P-14-202, P-14-203, P-14-204, P-14-205, and P-
14-206) 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 in aggregate for PMNs P-14-203
and P-14-204; N=1 in aggregate for PMNs P-14-204, P-14-205, P-14-206).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
17. Add Sec. [emsp14]721.10806 to subpart E to read as follows:
Sec. 721.10806 Trimellitic anhydride, polymer with alkanolamine and
tetrahydrophthalic anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trimellitic anhydride, polymer with alkanolamine and tetrahydrophthalic
anhydride (PMN P-14-341) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use is any use of the PMN
substance other than as a binder for gluing the individual mineral
fibers together to form a firm product, used industrially in a closed
system.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. [emsp14]721.10807 to subpart E to read as follows:
Sec. 721.10807 Aliphatic ether ethyl alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aliphatic ether ethyl alcohol (PMN P-14-417) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any use other
than the confidential use as stated in the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
19. Add Sec. [emsp14]721.10808 to subpart E to read as follows:
Sec. 721.10808 Bisxylenol diglycidyl ether polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bisxylenol diglycidyl ether polymer (PMN P-14-513) 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=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
20. Add Sec. [emsp14]721.10809 to subpart E to read as follows:
Sec. 721.10809 Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclotetrasiloxane,
2,4,6,8-tetrakis[3-[2-(2-methoxyethoxy)ethoxy]propyl]-2,4,6,8-
tetramethyl- (PMN P-14-518; CAS No. 17232-95-0) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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
21. Add Sec. [emsp14]721.10810 to subpart E to read as follows:
Sec. 721.10810 Heterocyclic amine potassium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The
[[Page 5471]]
chemical substance identified generically as heterocyclic amine
potassium salt (PMN P-14-544) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j)(a significant new use is any use other
than the confidential use stated in the PMN) and (s).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
22. Add Sec. [emsp14]721.10811 to subpart E to read as follows:
Sec. 721.10811 Heterocyclic amine substituted acrylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterocyclic amine substituted acrylamide (PMN P-14-618) 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=23).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (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.
[FR Doc. 2015-01721 Filed 1-30-15; 8:45 am]
BILLING CODE 6560-50-P