[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Proposed Rules]
[Pages 19037-19050]
[FR Doc No: 2015-08090]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 80, No. 68 / Thursday, April 9, 2015 /
Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2014-0649; FRL-9924-10]
RIN 2070-AB27

Modification of Significant New Uses of Certain Chemical
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the significant new use rules
(SNURs) under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for 24 chemical substances which were the subject of
premanufacture notices (PMNs). This action would amend the SNURs to
allow certain uses without requiring a significant new use notice
(SNUN), and would extend SNUN requirements to certain additional uses.
EPA is proposing these amendments based on review of new data as
described for each chemical substance. This action would requires
persons who intend to manufacture (including import) or process any of
these 24 chemical substances for an activity that is designated as a
significant new use by this proposed rule to notify EPA at least 90
days before commencing that activity. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.

DATES: Comments must be received on or before May 11, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0649, by one of the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Alwood, Chemical Control Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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 a modified SNUR 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 the chemical
substance that is the subject of a final rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec.  721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark 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 http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the agency taking?

    EPA is proposing amendments to the SNURs for 24 chemical substances
in 40 CFR part 721 subpart E. This proposed action would require
persons who intend to manufacture or process these chemical substances
for an activity that is designated as a significant new use by these
amended rules to notify EPA at least 90 days before commencing that
activity. 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.

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. of this document. 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 notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 24
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substance,
likely human exposures and environmental releases associated with
possible uses, taking into consideration the four bulleted TSCA section
5(a)(2) factors listed in this unit.

IV. Substances Subject to a Proposed Significant New Use Rule Amendment

    EPA is proposing to amend the significant new use and recordkeeping
requirements for 24 chemical substances in 40 CFR part 721 Subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number and SNUN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for
non-confidential chemical identities).
     Federal Register publication date and reference for the
final SNUR previously issued.
     Basis for the Proposed Amendment.
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
     CFR citation assigned in the regulatory text section of
this rule.

PMN Number P-99-669, SNUN Number S-09-1, and SNUN Number S-13-29

    Chemical name: Oxirane, methyl-, polymer with oxirane, mono
(3,5,5,-trimethylhexyl) ether.
    CAS number: 204336-40-3.
    Federal Register publication date and reference: March 28, 2003 (68
FR 15061) (FRL-6758-7).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance for the PMN and the SNUN is
as a wetting agent. The original SNUR was issued based on meeting the
concern criteria at Sec.  721.170 (b)(4)(ii). The original SNUR
required notification if the chemical substance was used for uses other
than as described in the PMN. On November 12, 2008 EPA received a SNUN,
S-09-1, and on June 4, 2013 EPA received a SNUN, S-13-29 for the
chemical substance describing uses different than those in the PMN. The
90-day review period for the SNUNs expired with EPA not taking action
on the significant new uses described in the SNUNs. Based on structural
analogy to nonionic surfactants, EPA is still concerned that toxicity
to aquatic organisms may occur at a concentration of 600 parts per
billion (ppb) in surface waters. Because EPA finds that the substance
is not released to surface waters in significant quantities as
described in either the PMN or the SNUNs, EPA has not determined that
the proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the substance may cause significant adverse environmental
effects. Based on this the substance meets the concern criteria at
Sec.  721.170 (b)(4)(ii). Based on these findings, EPA is proposing to
modify the SNUR to allow the uses described in S-09-01 and S-13-29.
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity text, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the chemical substance.
    CFR citation: 40 CFR 721.522.

PMN Number P-00-618 and SNUN Numbers S-05-03 and S-11-4

    Chemical name: 1-Butanol, 3-methoxy-3-methyl-, acetate.
    CAS number: 103429-90-9.
    Federal Register publication date and reference: March 28, 2003 (68
FR 15061) (FRL-6758-7).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance for the PMN is as a
processing aid. The uses of the chemical substance for the SNUNs are as
an organic solvent of polyurethane plastic coating, an ingredient in
various kinds of paint thinner, an organic solvent of polyurethane
resin, an ingredient of cleaning agents, an organic solvent for screen
ink, an ingredient in airplane paint, and a solvent for inkjet printer
ink. EPA identified concerns for liver toxicity, kidney toxicity,
developmental neurotoxicity and carcinogenicity based on analog data.
The original SNUR was issued based on meeting the concern criteria at
Sec.  721.170 (b)(3)(i), (b)(3)(ii), and (b)(1)(i)(C). The original
SNUR required notification if the chemical substance was used for use
other than as described in the PMN. On March 23, 2005, EPA received a
SNUN, S-05-3, for the chemical substance describing

uses different than those in the PMN. Based on the activities described
in this SNUN, a TSCA section 5(e) consent order was issued for the SNUN
submitter under sections 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) based on a
finding that the substance may present an unreasonable risk of injury
to human health. On October 26, 2010, EPA received a SNUN, S-11-4, for
a new use, which was as a solvent for inkjet printer ink. The SNUN
submitter also submitted a chromosome aberration study, a mouse
lymphoma assay and a combined repeated dose study with reproductive and
developmental toxicity. Based on the test data for the chemical
substance which was submitted with S-11-4, EPA continues to have
concerns for liver toxicity and kidney toxicity for exposed workers and
consumers. In response to S-11-4, EPA allowed the new use and modified
the consent order accordingly, while continuing to protect against any
unreasonable risks of injury to human health. The modified consent
order requires:
    1. Workers to use personal protective equipment to prevent dermal
exposure.
    2. Establishment and use of a hazard communication program,
including human health, environmental hazard precautionary statements
on each label and the Material Safety Data Sheet (MSDS).
    3. Not manufacture the substance in the United States.
    4. Not use the substance in consumer products.
    5. Limit the percent concentration of the substance to 10% or less
in final products whose use involves an application method that
generates a vapor, mist, or aerosol, except for commercial/professional
inkjet printing in a commercial (excluding retail) print shop.
    The proposed SNUR designates as a significant new use the absence
of these protective measures when using the substance for any use other
than as described in the PMN.
    Recommended testing: EPA has determined that the results of a two-
year chronic toxicity study (OPPTS Test Guideline 870.4100) via the
dermal and inhalation routes would help characterize the health effects
of the PMN substance.
    CFR citation: 40 CFR 721.532.

PMN Number P-98-1275 and SNUN Number S-11-10

    Chemical name: Aluminosilicates, phospho-.
    CAS number: 201167-69-3.
    Federal Register publication date and reference: December 26, 2000
(65 FR 81386) (FRL-6592-8).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance for the PMN and the SNUN is
as a catalyst. A consent order was issued for the PMN under section
5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding
that the substance may present an unreasonable risk of injury to human
health. The original SNUR, based on the requirements in the TSCA
section 5(e) consent order, required notification if the PMN substance
was used without the respiratory protection described in the SNUR
(i.e., a National Institute of Occupational Safety and Health (NIOSH)
respirator with an Assigned Protection Factor (APF) of 2000), the
hazard communication program described in the SNUR was not used, or the
aggregate production volume in the consent order was exceeded. Upon
receipt and evaluation of the 90-day inhalation study required in the
consent order, EPA continues to find that the substance may present an
unreasonable risk of lung effects and cancer, although at a higher
dose/effect level. Based on this finding, EPA modified the consent
order to remove the production volume limit and reduce the required
protection level for the respirator to an APF of 50. On June 14, 2011,
EPA received a SNUN, S-11-10, for the chemical substance to use a
respirator with an APF of 50 and to exceed the production volume limit.
EPA permitted the new uses for the same reasons it modified the consent
order. The proposed SNUR designates as a ``significant new use'' the
absence of the respiratory protection and hazard communication measures
in the modified consent order.
    Recommended testing: EPA has determined that the results of a two-
year two-species oral carcinogenicity study (OPPTS Test Guideline
870.4200) would help characterize the health effects of the PMN
substance.
    CFR citation: 40 CFR 721.633.

PMN Number P-00-7 and SNUN Numbers S-05-1, S-06-4, S-07-3, and S-07-5

    Chemical name: D-Glucuronic acid, polymer with 6-deoxy-L-mannose
and D-glucose, acetate, calcium magnesium potassium sodium salt.
    CAS number: 125005-87-0.
    Federal Register publication date and reference: December 17, 2003
(68 FR 70155) (FRL-7307-3).
    Basis for the modified significant new use rule: The uses of the
chemical substance as described in the PMN are as an oilfield drilling
fluid, an oilfield spacer fluid, in oilfield cementing, in cementitious
packaged products, in concrete applications, and in foam applications.
Based on structural analogues and submitted test data, EPA identified
concerns for lung effects from inhalation exposure to the chemical
substance. The original SNUR was issued based on meeting the concern
criteria at Sec.  721.170(b)(3)(i) and (b)(3)(ii). The original SNUR
required notification if the chemical substance was used for any use
other than those described in PMN. EPA received SNUN S-05-1 on December
1, 2004, S-06-4 on February 28, 2006, S-07-3 on June 5, 2007, and S-07-
5 on July 17, 2007. Each SNUN described different uses for the chemical
substance than those described in the PMN: S-05-1 described use as a
sealant, S-06-4 described a generic use in pipeline transmission
systems, S-07-3 described any uses other than those already allowed in
the SNUR where less than 5 percent of the chemical substance consists
of particles below 10 microns, and S-07-05 described a generic use in a
commercial dry wash additive. As with the PMN, the Agency in its review
of the SNUNs found that significant inhalation exposure remains
unlikely when used as described in the SNUNs, and accordingly, EPA has
not determined that the proposed manufacturing, processing, and use of
the chemical substance may present an unreasonable risk. EPA has
determined, however, that use of the chemical substance where more than
5 percent of the chemical substance contains particles below 10 microns
may cause significant health effects. Based on this information, the
chemical substance meets the concern criteria at Sec.  721.170(b)(3)(i)
and (b)(3)(ii). Based on these findings EPA is proposing to modify the
SNUR to remove the notification requirement for specific end uses and
instead require notification where more than 5 percent of the chemical
substance consists of particles below 10 microns.
    Recommended testing: EPA has determined that the 90-day inhalation
toxicity study with a 60-day holding period (OPPTS Test Guideline
870.3465) would help to characterize the human health effects of the
PMN substance. Attention should be given to the lungs, including
histopathology of the lungs (inflammation, epithelial hyperplasia, and
fibrosis), (HAL) analysis for markers of lung injury, and lung burden
analysis for clearance of the test material (EPA-748-R-96-001). The
neurotoxicity components and examination of organs other than the

lungs are not required in the 90-day study.
    CFR citation: 40 CFR 721.2076.

PMN Number P-95-169 and SNUN Numbers S-08-7 and S-14-1

    Chemical name: 2-Propen-1-one, 1-(4-morpholinyl)-.
    CAS number: 5117-12-4.
    Federal Register publication date and reference: Jan. 5, 2000 (65
FR 354) (FRL-6055-2), amended May 13, 2011 (76 FR 27910) (FRL-8871-5).
    Basis for the modified significant new use rule: The use for P-95-
169 is as a diluent for ultraviolet and electron beam curable resins
for coatings, inks, and curable adhesives, and the use for S-14-1 is as
a monomer for use in ultraviolet ink jet applications. The generic
(non-confidential) use for S-08-7 is a contained use in energy
production. A consent order for the PMN was issued under sections
5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the
chemical substance may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Agency
issued a TSCA section 5(e) consent order which became effective on
November 27, 1998. The order required the use of dermal personal
protective equipment (including gloves demonstrated to be impervious)
and respiratory personal protective equipment (including a NIOSH-
approved respirator); required establishment of a hazard communication
program; prohibited domestic manufacturing; prohibited processing and
use activities in non-enclosed processes; established maximum
production volume limits for submission of required testing;
established waste disposal practices (including restrictions for no
release to surface waters and requirement of disposal only in a
Resource Conservation Recovery Act ((RCRA) hazardous waste landfill);
and prohibited use of the chemical substance involving an application
method that generates a vapor, mist, or aerosol.
    A SNUR was issued for this chemical substance on January 5, 2000.
The SNUR designated as a ``significant new use'' the absence of the
protective measures required in the consent order.
    Subsequent to issuance of the SNUR, the PMN submitter completed the
following studies under the terms of the TSCA section 5(e) consent
order: An in vivo mouse micronucleus test, a 90-day oral toxicity study
in rats, and a reproductive toxicity screening study in rats. The
results of the micronucleus test were negative. Based on the results of
the 90-day study, the Agency established a no observed adverse effect
level (NOAEL) of 20 milligram/kilogram/day (mg/kg/day) for
neurotoxicity. Further, based on the results of the reproductive
toxicity screening study, a NOAEL of 75 mg/kg/day (highest dose tested)
was established for reproductive effects. From these data, the Agency
calculated Margins of Exposure (MOEs) for predicted workplace
exposures.
    Based on these new data, concerns remained for possible effects to
the liver, testes, kidney, and blood from dermal exposure. However, EPA
no longer had substantial human health concerns for mutagenicity and
neurotoxicity. In addition, Agency concerns for carcinogenicity by
inhalation were reduced, but were further mitigated by retaining the
original consent order prohibition of industrial processing and use in
a non-enclosed process and any use application methods that generate a
vapor, mist, or aerosol form of the PMN substance.
    In addition, to account for data received on analogous substances
since the initial PMN was submitted and to address Agency environmental
concerns, a re-review of the environmental toxicity profile for the
chemical substance was conducted. The results of this evaluation
indicated a low concern for chronic aquatic toxicity. Therefore, EPA
could no longer make a ``may present unreasonable risk'' finding for
releases of the PMN substance to surface waters. As a result of this
review, EPA issued a modified TSCA section 5(e) consent order which
became effective on May 9, 2006. The modified order removed
requirements for respiratory protection, waived further required
trigger testing, removed the restriction on domestic manufacture, and
removed waste disposal restrictions. Pursuant to Sec.  721.185(a)(5),
the Agency examined new information and reexamined the test data and
other information supporting its finding under section
5(e)(1)(A)(ii)(I) of TSCA, and concluded that a rational basis no
longer existed to support findings that certain activities involving
the substance may present an unreasonable risk of injury to human
health and the environment required under section 5(e)(1)(A) of TSCA.
    To protect against the remaining potential risks, the modified
consent order:
     Requires the use of dermal personal protective equipment
(including gloves demonstrated to be impervious).
     Requires establishment of a hazard communication program.
     Prohibits processing and use activities in non-enclosed
processes.
     Prohibits the use of the chemical substance involving an
application method that generates a vapor, mist, or aerosol.
    On June 27, 2008, the Agency received a SNUN, S-08-7, for the
subject chemical substance. The significant new use identified in the
notice was release to water for the generic (non-confidential) use of
``contained use in energy production''. The 90-day review period for
the SNUN expired on October 2, 2008 with EPA not taking action on the
``significant new use'' of release of the substance to water.
    On May 13, 2011, EPA issued a modified SNUR based on and consistent
with the provisions in the underlying modified consent order which no
longer included release to water as a significant new use. In addition,
EPA included, in the regulatory text, clarifying language for those
forms of the PMN substance which are exempt from the provisions of the
proposed SNUR. The SNUR does not apply to quantities of the PMN
substance after it has been completely reacted (cured) because the PMN
substance will no longer exist.
    On October 21, 2013, EPA received a second SNUN, S-14-1, for the
subject chemical substance. The significant new use identified in the
notice was processing and use in a non-enclosed process as a monomer
for use in ultraviolet ink jet applications. The 90-day review period
for the SNUN expired on March 13, 2014, with EPA not taking action on
the significant new use of processing and use in a non-enclosed process
as a monomer for use in ultraviolet ink jet applications. When
evaluating this new use, EPA also evaluated potential environmental
releases. Based on a new review of test data on the chemical substance,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 100 ppb of the chemical substance in surface waters. As
described in the PMN and SNUNs, releases of the substance are not
expected to result in surface water concentrations that exceed 100 ppb.
EPA has determined, however, that any use of the substance resulting in
surface waters concentrations exceeding 100 ppb may result in
significant adverse environmental effects. Based on this information,
the chemical substance meets the concern criteria at Sec.  721.170
(b)(4)(i). The proposed SNUR designates as a ``significant new use''
the absence of the protective measures required in the modified consent
order, any water releases during manufacturing, processing, and use
that exceed 100

ppb, or use other than as a monomer for use in ultraviolet ink jet
applications unless the chemical substance is processed and used in an
enclosed process.
    Recommended testing: EPA has determined that the results of the
combined repeated dose toxicity with the reproductive/developmental
toxicity screening test (OPPTS Test Guideline 870.3650) would help
further characterize the human health effects of the PMN substance. The
modified TSCA section 5(e) consent order does not require submission of
the aforementioned information at any specified time or production
volume. However, the order's restrictions on manufacturing, processing,
distribution in commerce, use and disposal of the chemical substance
will remain in effect until the order is modified or revoked by EPA
based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.5185.

PMN Numbers P-88-2179 and P-89-0539 and SNUN Number S-08-3

    Chemical name: Oxirane, 2,2'-(1,6-hexanediylbis(oxymethylene))bis-.
    CAS number: 16096-31-4.
    Federal Register publication date and reference: April 25, 1991 (56
FR 19228).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance in the PMNs and the SNUN is
in coatings and as a diluent. A consent order was issued under sections
5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the
chemical substance may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Agency
issued a TSCA section 5(e) consent order which became effective on
October 12, 1990. The order required the use of dermal personal
protective equipment including impervious gloves and respiratory
personal protective equipment including a NIOSH-approved respirator;
required establishment of a hazard communication program; prohibited
non-industrial use; established maximum production volume limits for
submission of required testing; established requirements for release to
surface waters during manufacturing and allowed no release to surface
waters during processing and use. On February 4, 2008, EPA received a
SNUN, S-08-3, for the chemical substance. The significant new use
identified in the notice was a non-industrial use. The 90-day review
period for the SNUN expired on October 2, 2008, with EPA not taking
action on the ``significant new use'' of the industrial use described
in the SNUN. The proposed SNUR designates as a ``significant new use''
any non-industrial use other than as described in the SNUN and retains
the other significant new uses which are the absence of the other
protective measures required in the consent order.
    Recommended testing: EPA has determined that the results of a 90-
day oral subchronic study with special attention given to the pathology
of the reproductive organs (OPPTS Test Guideline 870.3100), a two-year
two-species oral carcinogenicity study (OPPTS Test Guideline 870.4200),
a fish acute toxicity test (OPPTS Test Guideline 850.1075), an aquatic
invertebrate acute toxicity text (OPPTS Test Guideline 850.1010) and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help further
characterize the human health and environmental effects of the PMN
substance. The consent order requires the PMN submitter to conduct the
90-day oral toxicity test (OPPTS Test Guideline 870.3100) before
exceeding the confidential production limit in the consent order.
    CFR citation: 40 CFR 721.5575.

PMN Number P-95-638 and SNUN Numbers P-97-79 and S-06-8

    Chemical name: Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
    CAS number: 138495-42-8.
    Federal Register publication date and reference: January 22, 1998
(63 FR 3394) (FRL-5720-3).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance for the PMN is as a carrier
fluid and for the two SNUNs the generic (non-confidential) use is as
test media. The original SNUR was issued based on meeting the concern
criteria at Sec.  721.170 (b)(4)(i). The original SNUR required
notification if the chemical substance was used for uses other than
described in the PMN or the first SNUN P-97-79 (at that time SNUNs were
designated with a ``P'' number; later submissions received an ``S''
designation). On February 4, 2008, EPA received a second SNUN, S-06-8,
for the subject chemical substance. The significant new use identified
in S-06-8 was the specific confidential use described in the notice.
The 90-day review period for the SNUN expired on July 17, 2006, with
EPA not taking action on the significant new use described in the SNUN.
The proposed SNUR designates as a significant new use, any use other
than the uses described in the PMN and the SNUNs.
    Recommended testing: None.
    CFR citation: 40 CFR 721.5645.

PMN Number P-00-1220 and SNUN Number S-07-2

    Chemical name: Phenol-biphenyl polymer condensate (generic).
    CAS number: Claimed confidential.
    Federal Register publication date and reference: August 20, 1998
(63 FR 44562) (FRL-5788-7).
    Basis for the modified significant new use rule: The use of the
chemical substance for the PMN is in electric molding and for the SNUN
is as a component in photoresist manufacture. The original SNUR was
issued based on meeting the concern criteria at Sec.
721.170(b)(4)(ii). The original SNUR required notification if the PMN
substance was released to water. On January 8, 2007, EPA received SNUN,
S-07-2, for the chemical substance describing releases to water. The
90-day review period for the SNUN expired with the Agency not taking
action on the significant new uses described in the SNUN because the
water releases did not exceed 1 ppb, the Agency's surface water
concentration of concern for adverse effects of the substance to
aquatic organisms. The PMN submitter subsequently submitted a fish
early-life stage ecotoxicity study for the chemical substance. Based on
this submitted study and structural analogy to phenols, EPA is still
concerned that toxicity to aquatic organisms may occur at a
concentration of 5 ppb in surface waters. Because EPA finds that the
chemical substance is not released to surface waters above 5 ppb as
described in the PMN and SNUN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance may cause significant adverse environmental effects. Based on
this the substance meets the concern criteria at Sec.  721(b)(4)(i) and
(b)(4)(ii). Based on these findings, EPA is proposing to modify the
SNUR to require notification if water releases exceed 5 ppb in surface
waters.
    Recommended testing: EPA has determined that an aquatic
invertebrate acute toxicity text (OPPTS Test Guideline 850.1010) and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help further
characterize the environmental effects of the chemical substance.
    CFR citation: 40 CFR 721.5713.

PMN Number P-01-320 and SNUN Numbers S-04-2 and S-11-1

    Chemical name: Propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy-.

    CAS number: 375-03-1.
    Federal Register publication date and reference: December 17, 2003
(68 FR 70155) (FRL-7307-3).
    Basis for the modified significant new use rule: The use of the
chemical substance for the PMN is as a heat transfer fluid and a
refrigerant. The use for S-04-2 is for aerosol spray cleaning. The use
for S-11-1 is for flush cleaning, foam blowing, deposition coatings,
histology baths, and vapor degreasing. The original SNUR was issued
based on meeting the concern criteria at Sec.  721.170 (b)(3)(i) and
(b)(3)(ii). The original SNUR required notification if the chemical
substance was used other than as a heat transfer fluid or refrigerant,
or if the annual production volume exceeded 100,000 kilograms. On March
29, 2004, EPA received SNUN, S-04-2, for the chemical substance
describing a new use of aerosol spray cleaning for industrial and
commercial use. The 90-day review period for the SNUN expired on June
26, 2004 with EPA not taking action on the significant new use of
aerosol spray cleaning for industrial and commercial use. On January 4,
2011, EPA received a SNUN, S-11-1, for the chemical substance
describing new uses of flush cleaning, foam blowing, deposition
coatings, histology baths, and vapor degreasing and exceeding an annual
production volume of 100,000 kilograms. The 90-day review period for S-
11-1 expired on September 23, 2011 with EPA not taking action on the
significant new uses described in the SNUN. EPA continues to identify
health concerns for liver and kidney toxicity based on submitted test
data on the chemical substance and cardiac sensitization and
developmental toxicity based on analog data. For the uses described in
the PMN and SNUNs, significant occupational exposure is not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use will present an unreasonable risk. EPA has
determined, however, that any uses of the substance other than those
described in the PMN and SNUNs may result in serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(3)(i) and (b)(3)(ii). The proposed SNUR
modification designates as a ``significant new use'' any use other than
the uses described in the PMN and SNUNs. The proposed SNUR modification
no longer designates the significant new use of exceeding an annual
production volume of 100,000 kilograms.
    Recommended testing: EPA has determined that the results of a 90-
day oral subchronic study (OPPTS Test Guideline 870.3100) would help to
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.8145.

PMN Number P-01-781

    Chemical name: Silane, triethoxy[3-oxiranylmethoxy)propyl]-.
    CAS number: 2602-34-8.
    Federal Register publication date and reference: Dec. 17, 2003 (68
FR 70155) (FRL-7307-3).
    Basis for the modified significant new use rule: The original SNUR
was issued resulting in listing the incorrect CAS number as 2602-34-2
for the chemical substance in the Code of Federal Regulations. The
proposed SNUR modification is designating the correct CAS number of
2602-34-8. The original findings and requirements of the SNUR are the
same.
    CFR citation: 40 CFR 721.9501.

PMN Number P-00-1132 and SNUN Number S-11-5

    Chemical name: Siloxanes and silicones, aminoalkyl, fluorooctyl,
hydroxy-terminated salt (generic).
    CAS number: Claimed confidential.
    Federal Register publication date and reference: March 28, 2003 (68
FR 15061) (FRL-6758-7).
    Basis for the modified significant new use rule: The use of the
chemical substance for the PMN is in anti-graffiti systems and for the
SNUN is as a surface treatment and additive for coatings, adhesives,
sealants, paste, insulation and textiles for porous, non-porous,
ceramic, metal, glass, plastic, wood and leather surfaces; and a
surface treatment agent for inorganic filler particles. The original
SNUR was issued based on meeting the concern criteria at Sec.  721.170
(b)(3)(ii). The original SNUR required notification if the chemical
substance was used for use other than described in PMN or for an
application that generates a vapor, mist, or aerosol. On January 5,
2011, EPA received a SNUN, S-11-5, for the chemical substance
describing uses different than those in the PMN. EPA also reviewed a
90-day inhalation study that was submitted for the substance in the
SNUN. The results of the study demonstrated a Lowest Observed Adverse
Effect Level (LOAEL) of 30 milligram/cubic meter (mg/m\3\) for lung
effects. The 90-day review period for the SNUN expired with the Agency
not taking action on the significant new uses described in the SNUN.
Since EPA continues to find that significant worker exposure is
unlikely when used as described in the PMN and SNUN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance or applications that generate
a vapor, mist, or aerosol could result in exposures which may cause
serious health effects. Based on this information the substance meets
the concern criteria at Sec.  721(b)(3)(ii). Based on these findings,
EPA is proposing to modify the SNUR to require notification for any
uses other than described in the PMN and the SNUN.
    Recommended Testing: EPA has determined that the results of a
decomposition kinetics by thermo gravimeter (ASTM Test Guideline
E1641), a compositional analysis by thermo gravimeter (ASTM Test
Guideline E1131), and a laboratory burn test by a protocol to be agreed
upon by EPA and the company conducting the study, would help to further
characterize the environmental fate of the PMN substance.
    CFR citation: 40 CFR 721.9502.

PMN Numbers P-97-296, P-97-297, P-97-298, and P-97-299 and SNUN Numbers
S-03-10, S-03-11, S-03-12, and S-03-13

    Chemical name: Benzenesulfonic acid, mono C-10-16 -alkyl
derivs., compds. with 2-propen-1-amine (PMN P-97-296 and SNUN S-03-10)
and Alkyl benzene sulfonic acids and alkyl sulfates, amine salts (PMN
P-97-297/298/299 and SNUN S-03-11/12/13).
    CAS number: 195008-77-6 (PMN P-97-296 and SNUN S-03-10) and
    Claimed confidential (PMN P-97-297/298/299 and SNUN S-03-11/12/13).
    Federal Register publication date and reference: August 20, 1998
(63 FR 44562) (FRL-5788-7).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substances for the PMNs and the SNUNs
is as a processing aid. The original SNUR was issued based on meeting
the concern criteria at Sec.  721.170 (b)(4)(i) and (b)(4)(ii). The
original SNUR required notification if the PMN substances were released
to water. On March 4, 2003, EPA received SNUNs S-03-10, S-03-11, S-03-
12, and S-03-13 for the chemical substances describing releases to
water. The 90-day review period for the SNUNs expired with EPA not
taking action on the significant new uses described in the SNUNs
because the water releases did not exceed 30 ppb. Based on submitted
data and structural analogy to anionic surfactants, EPA is still
concerned that toxicity to aquatic organisms may occur at a
concentration of 30 ppb in surface waters. Because EPA finds that the
substances are not

released to surface waters above 30 ppb as described in the PMN and
SNUN, EPA has not determined that the proposed manufacturing,
processing, and use of the substances may present an unreasonable risk.
EPA has determined, however, that other uses of the substances may
cause significant adverse environmental effects. Based on this the
substances meet the concern criteria at Sec.  721.170 (b)(4)(i) and
(b)(4)(ii). Based on these findings EPA is proposing to modify the SNUR
to require notification if water releases exceed 30 ppb in surface
waters.
    Recommended testing: EPA has determined that a fish acute toxicity
test (OPPTS Test Guideline 850.1075), an aquatic invertebrate acute
toxicity text (OPPTS Test Guideline 850.1010) and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help further characterize
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.9595.

PMN Number P-90-226 and SNUN Numbers P-96-1408, S-08-6, S-09-4, and S-
13-49

    Chemical name: Titanate [Ti6O13 (2-)],
dipotassium.
    CAS number: 12056-51-8.
    Federal Register publication date and reference: August 13, 1991
(56 FR 40204).
    Basis for the modified significant new use rule: The generic use of
the chemical substance is as a friction material. A consent order was
issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based
on a finding that the chemical substance may present an unreasonable
risk of injury to human health. To protect against these risks, EPA
issued a TSCA section 5(e) consent order which became effective on
February 21, 1991. The order required the establishment of a hazard
communication program; prohibited domestic manufacturing; prohibited
non-industrial use; established maximum production volume limits for
submission of required testing; prohibited manufacture other than by
the manufacturing method in P-90-226; and required the bulk density
measurements of the PMN substance in the pure form to be less than 0.4
gram/cubic centimeter (g/cm\3\). A SNUR was issued for this chemical
substance on August 13, 1991. The SNUR designated as a ``significant
new use'' the absence of the protective measures required in the
consent order. On July 15, 1996, EPA received a SNUN, P-96-1408 (at
that time SNUNs were designated with a ``P'' number; later submissions
received an ``S'' designation); on June 23, 2008, EPA received S-08-6;
on March 30, 2009, EPA received S-09-4; and on July 17, 2013, EPA
received S-13-49 for the chemical substance. The significant new use
for each SNUN was a manufacturing method other than described in P-90-
226. EPA took no action during the 90-day review periods for the SNUNs
and allowed the significant new uses because EPA determined that none
of the manufacturing processes produced respirable acicular fibers with
an average aspect ratio of less than 5, and as a result were not
considered by EPA to pose an unreasonable risk of lung toxicity to
workers. In addition, a 90-day inhalation study was submitted by the
PMN submitter under the terms of the TSCA section 5(e) consent order
and an intratracheal instillation study submitted by the submitter of
S-09-4 demonstrated no evidence of fibrosis in test animals. The
proposed SNUR modification designates as a significant new use any
domestic manufacture, non-industrial use, any manufacturing process
other than described in the PMN and the SNUNs, and any manufacture that
produces respirable, acicular fibers with an average aspect ratio
greater than 5. The proposed SNUR modification no longer designates
establishment of a hazard communication program or exceeding an
aggregate production volume limit as a significant new use.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) and a
carcinogenicity test (OPPTS Test Guideline 870.4200) via the inhalation
route would help characterize the potential human health effects of the
chemical substance from alternate methods of manufacture.
    CFR citation: 40 CFR 721.9675.

PMN Number P-93-1649 and SNUN Numbers S-04-3 and S-11-3

    Chemical name: 1,3-Dimethyl-2-imidazolidinone.
    CAS number: 80-73-9.
    Federal Register publication date and reference: August 30, 1995
(60 FR 45072) (FRL-4926-2).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance for the PMN is as a process
raw material and for the SNUNs is as a printing ink ingredient. The
consent order was issued under sections 5(e)(1)(A)(i) and
5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical
substance may present an unreasonable risk of injury to human health.
To protect against these risks, EPA issued a TSCA section 5(e) consent
order which became effective on August 25, 1994. The order required the
use of dermal personal protective equipment (including gloves
demonstrated to be impervious) and required establishment of a hazard
communication program; prohibited domestic manufacture; prohibited non-
industrial uses; and established maximum production volume limits for
submission of required testing. The SNUR issued for this chemical
substance on August 30, 1995, designated as a significant new use the
absence of the protective measures required in the consent order. On
August 16, 2004, EPA received S-04-3 and on October 21, 2010, EPA
received S-11-3 for the chemical substance. The significant new use for
both SNUNs was a non-industrial use. The 90-day review period for both
SNUNs expired with the Agency not taking action on the significant new
uses described in the SNUNs. The PMN submitter conducted a dermal
developmental toxicity study and a 90-day dermal subchronic study on
the PMN substance. The results of the developmental study was a
maternal chronic toxicity NOAEL of 10 mg/kg/day and a development
toxicity NOAEL of 100 mg/kg/day. The results of the 90-day dermal study
was a NOAEL of 500 mg/kg/day. Because EPA continues to find that dermal
exposures may cause an unreasonable risk of human health effects, EPA
is proposing to modify the SNUR to allow the commercial use (specific
use claimed confidential) as described in the SNUNs but is retaining
all other significant new uses and requirements in the SNUR.
    Recommended testing: None.
    CFR citation: 40 CFR 721.9892.

PMN Number P-00-1121

    Chemical name: Manganese strontium oxide (MnSrO3).
    CAS number: 12163-45-0.
    Federal Register publication date and reference: March 29, 2007 (72
FR 14681) (FRL-7699-5).
    Basis for the modified significant new use rule: The generic (non-
confidential) use of the chemical substance is as a pigment. A consent
order was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of
TSCA based on a finding that the chemical substance may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the order required establishment of a
hazard communication program; established maximum aggregate volume
limits for submission of required testing; limited release to surface
waters; and prohibited manufacture, process, or use of the PMN
substance if the particle size is less than

10 microns. EPA received a 96-hour toxicity test with rainbow trout for
the chemical substance. No mortality was observed at concentrations up
to the highest concentration tested of 16,000 milligram/Liter (mg/L).
Based on these test results, EPA modified the consent order to remove
the aggregate volume limit and the surface water release limits. The
modified consent order retains the hazard communication requirements
and the particle size limitations to continue to prevent any
unreasonable risk of injury to human health. The proposed SNUR
modification designates as a significant new use the absence of the
protective measures in the modified consent order.
    Recommended testing: EPA has determined that a 90-day inhalation
toxicity study with a 60-day holding period (OPPTS Test Guideline
870.3465) and a two-year inhalation carcinogenicity study (OPPTS Test
Guideline 870.4200) would help to characterize the human health effects
of the PMN substance.
    CFR citation: 40 CFR 721.10008.

PMN Number P-07-601 and SNUN Number S-14-11

    Chemical name: 1-Propene, 2,3,3,3-tetrafluoro-.
    CAS number: 754-12-1.
    Federal Register publication date and reference: October 27, 2010
(75 FR 65987) (FRL-8846-8) and November 1, 2013 (78 FR 65570) (FRL-
9901-97).
    Basis for modification of the SNUR: The use of the chemical
substance for the PMN was as a refrigerant in motor vehicle air
conditioning systems in new passenger cars and vehicles and the use for
the SNUN was as a refrigerant for stationary refrigeration and
stationary air conditioning. The original SNUR was issued based on
meeting the concern criteria at Sec.  721.170. The original SNUR
required notification if the chemical substance was used for uses other
than as described in the PMN. On May 12, 2014 EPA received a SNUN, S-
14-11, for the chemical substance describing uses different than those
in the PMN. The 90-day review period for the SNUN expired with EPA not
taking action on the significant new uses described in the SNUN. Based
on toxicity test data conducted on the PMN substance, EPA is still
concerned that toxicity to humans may occur at inhalation exposures of
1,900 ppm. Because EPA finds that exposures from uses described in
either the PMN or the SNUN do not result in human exposures that cause
an unreasonable risk to human health, EPA has not determined that the
proposed manufacturing, processing, and use of the substance, including
certain commercial, and consumer uses of the substance, may cause
significant adverse health effects. Based on this the substance meets
the concern criteria at Sec.  721.170. Based on these findings, EPA is
proposing to modify the SNUR to allow the uses described in S-14-11.
    CFR citation: 40 CFR 721.10182.

PMN Numbers P-10-486 and P-10-487

    Chemical name: Poly[oxy(methyl-1,2- ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium
salts (P-10-486) and Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium
salts (P-10-487).
    CAS number: 958238-81-8 (P-10-486) and 958238-82-9 (P-10-487).
    Federal Register publication date and reference: April 4, 2012 (77
FR 20296) (FRL-9333-3).
    Basis for the modified significant new use rule: The PMNs state
that the use of these substances will be for downhole injection for
enhanced oil recovery. Based on structure activity relationship
analysis of test data on analogous anionic surfactants, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
28 ppb for P10-486 and 4 ppb for P10-487 in surface waters. The order
was issued under TSCA sections 5(e)(1)(A)(i), (e)(1)(A)(ii)(I), and
(e)(1)(A)(ii)(II) based on a finding that these substances may present
an unreasonable risk of injury to the environment and will be produced
in substantial quantities and may reasonably be anticipated to enter
the environment in substantial quantities. To protect against these
risks, the Agency issued a TSCA section 5(e) consent order which became
effective on July 22, 2011. To protect against the risk, the order
requires certain hazard communication requirements, specific disposal
requirements for processing and use, and prohibits releases from
manufacture of the PMN substances resulting in surface water
concentrations exceeding 28 ppb for P-10-486 and 4 ppb for P-10-487. A
SNUR was issued for this chemical substance on April 4, 2012. The SNUR
designated as a ``significant new use'' the absence of any of these
measures required in the consent order.
    EPA had evaluated the results of a combined biodegradation and
aquatic toxicity test for P-10-486 during PMN review. The test was
submitted as part of the PMN submissions. During the review, EPA
accepted the data as valid for purposes of ascertaining the
environmental fate of the PMN substances (the overall rate of ready
biodegradation), but not for purposes of determining potential
environmental toxicity of the transformation products to aquatic
organisms. Subsequent to issuance of the SNUR, and based on discussions
with the Company and other PMN submitters, EPA re-evaluated the data
and determined that the data could be used to evaluate the aquatic
toxicity of the PMN transformation products. The combined
biodegradation/ecological toxicity testing demonstrated that,
subsequent to the biodegradation portion of the combined study, no
further ecologically toxic substances remained from the P-10-486 parent
substance. EPA also believes the results of the test data for P-10-486
apply to the structurally analogous P-10-487 substance. Based on this
evaluation EPA did not find that the PMN substances present an
unreasonable risk to the environment or human health or will be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities based on activities
described in the PMN. As a result EPA revoked the consent order. EPA
has determined, however, that other uses of the substances may cause
significant adverse environmental effects. Based on this information,
the chemical substances meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii). Based on these findings EPA is
proposing to modify the SNUR to require notification of any use of the
substances without disposal by incineration or injection into a Class I
or II waste disposal well; release to water without prior biological
treatment (activated sludge or equivalent) plus clarification; or non-
industrial use.
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10283 and 721.10284.

PMN Numbers P-10-58, P-10-59, P-10-60, and P-10-184

    Chemical names: Partially fluorinated alcohol substituted glycols
(generic).
    CAS numbers: Not available.
    Federal Register publication date and reference: September 11, 2013
(78 FR 55632) (FRL-9398-7).
    Basis for the modified significant new use rule: The PMNs state
that the

generic (non-confidential) uses of P-10-58 and P-10-59 will be as
intermediates in the manufacture of P-10-60, and the generic use of P-
10-60 and P-10-184 will be as a surface active agent or surfactant. EPA
has concerns for potential incineration or other decomposition products
of the PMN substances. These perfluorinated decomposition products may
be released to the environment from incomplete incineration of the PMN
substances at low temperatures. EPA has preliminary evidence, including
data on some fluorinated polymers, which suggests that, under some
conditions, the PMN substances could degrade in the environment. EPA
has concerns that these degradation products will persist in the
environment, could bioaccumulate or biomagnify, and could be toxic to
people, mammals, and birds. These concerns are based on data on
analogous chemical substances, including perfluorooctanoic acid (PFOA)
and other perfluorinated alkyls, including the presumed environmental
degradant. The orders were issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that
these substances may present an unreasonable risk of injury to the
environment and human health, the substances 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 substances and their potential
degradation products. To protect against these risks, the consent order
for P-10-58/59/60 requires manufacture (which includes import) of the
PMN substances according to the chemical synthesis and composition
section of the TSCA section 5(e) consent order, including analysis,
reporting, and limitations of maximum impurity levels of certain
fluorinated impurities, restricts the use of P-10-58 and P-10-59 as
intermediates to make P-10-60, and submission of testing on the PMN
substance P-10-60 at five identified aggregate manufacture volumes. A
SNUR was issued for these chemical substances on September 11, 2013
designating as significant new uses the absence of these measures. To
protect against potential risks, the consent order for P-10-184
requires manufacture of the PMN substance according to the chemical
synthesis and composition section of the TSCA section 5(e) consent
order, including analysis, reporting, and limitations of maximum
impurity levels of certain fluorinated impurities and manufacture of P-
10-184 only when the mean number of moles of the ethoxy group is
between 3 and 11 or the average number molecular weight is between 496
and 848 daltons based on the amounts of raw materials charged to the
reactor. EPA is modifying the SNUR to add P-10-184 because it is the
same chemical substance as P-10-60 and to make the SNUR requirements
consistent with both consent orders by proposing to add a significant
new use that requires reporting if P-10-60/P-10-184 are manufactured
other than when the mean number of moles of the ethoxy group is between
3 and 11 or the average number molecular weight is between 496 and 848
daltons.
    Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the TSCA
section 5(e) consent orders would help characterize possible effects of
the PMN substances and their degradation products. The TSCA section
5(e) consent order for P-10-58/59/60 contains five production volume
limits. The PMN submitter has agreed not to exceed the confidential
production volume limits without performing the specified testing on
PMN substance P-10-60. Additional testing is included in the preambles
to the TSCA section 5(e) consent orders but this testing is not
required at any specified time or production volume. However, the TSCA
section 5(e) consent order restrictions on manufacture, processing,
distribution in commerce, use, and disposal of the PMN substances will
remain in effect until the TSCA section 5(e) consent orders are
modified or revoked by EPA based on submission of that or other
relevant information.
    CFR citation: 40 CFR 721.10515.

V. Rationale for the Proposed Rule

    Pursuant to Sec.  721.185 and as described in Unit IV, this
proposed rule includes 23 chemical substances where EPA determined,
based on new information, there is no need to require additional notice
from persons who propose to engage in identical or similar activities,
or a rational basis no longer exists for the findings that activities
involving the substance may present an unreasonable risk of injury to
human health or the environment required under section 5(e)(1)(A) of
the Act.
    This proposed rule also includes a chemical substance, P-01-781,
where EPA is modifying the chemical identity information.

VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule

    To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing. As discussed in the
Federal Register issue of April 24, 1990 (55 FR 17376), EPA has decided
that the intent of TSCA section 5(a)(1)(B) is best served by
designating a use as a significant new use as of the date of
publication of the proposed SNUR rather than as of the effective date
of the final rule. If uses begun after publication were considered
ongoing rather than new, it would be difficult for EPA to establish
SNUR notice requirements, because a person could defeat the SNUR by
initiating the proposed significant new use before the rule became
effective, and then argue that the use was ongoing as of the effective
date of the final rule.
    Thus, any persons who begin commercial manufacture or processing
activities with the chemical substances that are not currently a
significant new use under the current rule but which would be regulated
as a ``significant new use'' if this proposed rule is finalized, must
cease any such activity as of the effective date of the rule if and
when finalized. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec.  721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development
of 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 Sec.  720.50). However, upon review of PMNs and SNUNs, the Agency
has the authority to require appropriate testing. In this case, EPA
recommends 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
http://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 http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. ASTM
International standards are available at http://www.astm.org/Standard/index.shtml.
    The recommended testing specified in Unit IV. of the proposed rule
may not be the only means of addressing the potential risks of the
chemical substance. However, SNUNs submitted without any test data may
increase the likelihood that EPA will take action under TSCA section
5(e), particularly if satisfactory test results have not been obtained
from a prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notice 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
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
721.25 and 40 CFR 720.40. E-PMN software is available electronically at
http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA evaluated the potential costs of SNUN requirements for
potential manufacturers and processors of the chemical substances in
the proposed rule. The Agency's complete Economic Analysis is available
in the docket under docket ID number EPA-HQ-OPPT-2014-0649.

 X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed action would modify SNURs for 24 chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA, 44 U.S.C. 3501 et seq., an Agency may not conduct
or sponsor, and a person is not required to respond to a collection of
information that requires OMB approval under PRA, unless it has been
approved by OMB and displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations in title 40 of the CFR, after
appearing in the Federal Register, are listed in 40 CFR part 9, and
included on the related collection instrument or form, if applicable.
EPA is amending the table in 40 CFR part 9 to list the OMB approval
number for the information collection requirements contained in this
rule. 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 SNUN 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
rule.
    This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this final rule.
As such, EPA has determined that this rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of sections
202, 203, 204,

or 205 of the UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et
seq.).

E. Executive Order 13132

    This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor 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 proposed rule.

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).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: April 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Amend Sec.  721.522 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.522  Oxirane, methyl-, polymer with oxirane, mono (3,5,5,-
trimethylhexyl) ether.

    (a) * * * (1) The chemical substance identified as oxirane, methyl-
, polymer with oxirane, mono (3,5,5,-trimethylhexyl) ether (PMN P-99-
669, SNUN S-09-1, and SNUN S-13-29; CAS No. 204336-40-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is use other than
as a wetting agent, dispersing agent and defoaming/deaerating agent in
waterborne coatings, inks, and paints, water based adhesives, and
ultraviolet curable coatings; wetting agent in water miscible
metalworking fluids, powdered construction additives for use in
cementitious mortars, grouts and tile adhesives, and in liquid
admixtures for concrete; and a substrate wetting and anticratering
additive for ultraviolet curable inkjet ink.
* * * * *
0
3. Amend Sec.  721.532 as follows:
0
a. Revise the section heading.
0
b. Revise paragraph (a)(1).
0
c. Revise paragraph (a)(2)(i).
0
d. Add paragraph (a)(3).
0
e. Revise paragraph (b)(1).
    The revisions and addition read as follows:

Sec.  721.532  1-Butanol, 3-methoxy-3-methyl-, acetate.

    (a) * * * (1) The chemical substance identified as 1-butanol, 3-
methoxy-3-methyl-, acetate (PMN P-00-618; SNUN S-05-03; and SNUN S-11-
4; CAS No. 103429-90-9) is subject to reporting under this section for
the significant new uses described in paragraphs (a)(2) and (a)(3) of
this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. The significant new use is any use other
than the use described in P-00-618.
* * * * *
    (3) The significant new uses for any use other than the use
described in P-00-618:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3)(i), (b) (concentration set at 0.1 percent), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec.  721.63(a)(1) engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. Butyl rubber gloves with a minimum thickness
of 16.6 mils or Silver shield gloves with a minimum thickness of 2.7
mils have been tested in accordance with the American Society for
Testing Materials (ASTM) F739 method and found by EPA to satisfy the
consent orders and Sec.  721.63(a)(2)(i) requirements for dermal
protection to 100 percent chemical substance. Silver Shield gloves with
a minimum thickness of 2.7 mils have been tested in accordance with the
American Society for Testing Materials (ASTM) F739 method and found by
EPA to satisfy the consent orders and Sec.  721.63(a)(2)(i)
requirements for dermal protection for paint formulations where
concentrations of the chemical substance is 10% or less. Gloves and
other dermal protection may not be used for a time period longer than
they are actually tested and must be replaced at the end of each work
shift.
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b) (concentration set at 0.1 percent), (c), (d), (f),
(g)(1)(iv), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (o), and any application method that
generates a vapor, mist, or aerosol when the percent concentration of
the SNUN substance in the final product exceeds 10%.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in

Sec.  721.125(a) through (i) are applicable to manufacturers and
processors of this substance.
* * * * *
0
4. Amend Sec.  721.633 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
0
c. Remove paragraph (a)(2)(iii).
0
d. Revise paragraph (b)(1).
    The revisions read as follows:

Sec.  721.633  Aluminosilicates, phospho-.

    (a) * * *. (1) The chemical substance identified as
aluminosilicates, phospho- (PMN P-98-1275 and SNUN S-11-10; CAS No.
201167-69-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (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
NIOSH-certified respirators with an APF of at least 50 meet the
requirements of Sec.  721.63(a)(4): NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped with N100 (if oil aerosols
absent), R100, or P100 filters; NIOSH-certified powered air-purifying
respirator equipped with a tight-fitting full facepiece and high
efficiency particulate air (HEPA) filters; NIOSH-certified supplied-air
respirator operated in positive pressure demand or continuous flow mode
and equipped with a hood, or helmet or tight-fitting facepiece. 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
these substances. The NCEL is 0.1 mg/m\3\ as an 8-hour time weighted
average verified by actual monitoring data.
* * * * *
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (f), (g), and (h) are applicable to
manufacturers and processors of this substance.
* * * * *
0
5. Amend Sec.  721.2076 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.2076  D-Glucuronic acid, polymer with 6-deoxy-L-mannose and
D-glucose, acetate, calcium magnesium potassium sodium salt.

    (a) * * *. (1) The chemical substance identified as D-Glucuronic
acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium
magnesium potassium sodium salt (PMN P-00-7; SNUN S-05-1; SNUN S-06-4;
SNUN S-07-03; and SNUN S-07-5; CAS No. 125005-87-0) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 The significant new use is any use other
than manufacture of the substance where greater than 5 percent of the
chemical substance consists of particle sizes below 10 microns.
* * * * *
0
6. Amend Sec.  721.5185 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(iii).
0
c. Add paragraph (a)(2)(iv).
0
d. Revise paragraph (b)(1).
    The revisions and additions read as follows:

Sec.  721.5185  2-Propen-1-one, 1-(4-morpholinyl)-.

    (a) * * * (1) The chemical substance identified as 2-Propen-1-one,
1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; and SNUN S-14-1; CAS No.
5117-12-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this rule do not apply to quantities of the chemical
substance after it has been completely reacted (cured) because 2-
Propen-1-one, 1-(4-morpholinyl)- will no longer exist.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(y)(1). It is a significant new use to use
the chemical substance for any use other than as a monomer for use in
ultraviolet ink jet applications unless the chemical substance is
processed and used in an enclosed process.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 100).
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this chemical substance.
* * * * *
0
7. Amend Sec.  721.5575 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(iii).
    The revisions read as follows:

Sec.  721.5575  Oxirane, 2,2'-(1,6-hexanediylbis (oxymethylene)) bis-.

    (a) * * * (1) The chemical substance identified as oxirane, 2,2'-
(1,6-hexanediylbis(oxymethylene))bis- (PMN P-88-2179; PMN P-89-539; and
SNUN S-08-3; CAS No. 16096-31-4) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q). A significant new use of the chemical
substance is any non-industrial use other than the commercial use
described in S-08-3.
* * * * *
0
8. Amend Sec.  721.5645 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.5645  Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.

    (a) * * * (1) The chemical substance identified as pentane
1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638, SNUN P-97-79, and SNUN
S-06-8; CAS No. 138495-42-8) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is any use of the
substance other than the uses as described in P-95-638, P-97-79, or S-
06-8.
* * * * *
0
9. Amend Sec.  721.5713 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.5713  Phenol--biphenyl polymer condensate (generic).

    (a) * * * (1) The chemical substance identified generically as a
phenol--biphenyl polymer condensate (PMN P-00-1220 and S-07-2) is
subject to reporting under this section for the significant new use
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified Sec.  721.90(a)(4),
(b)(4), and (c)(4) (N = 5).
* * * * *
0
10. Amend Sec.  721.8145 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.8145  Propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy-.

    (a) * * * (1) The chemical substance identified as
propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy- (PMN P-01-320; SNUN S-04-
2; and SNUN 11-1; CAS No. 375-03-1) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is any use of the
chemical substance other than as a heating transfer fluid, refrigerant,
flush cleaning, foam blowing, deposition coatings, histology baths,
vapor degreasing, and industrial and commercial aerosol spray cleaning.
* * * * *
0
11. Amend Sec.  721.9501 by revising paragraph (a)(1) to read as
follows:

Sec.  721.9501  Silane, triethoxy[3-oxiranylmethoxy)propyl]-.

    (a) * * * (1) The chemical substance identified as silane,
triethoxy[3-oxiranylmethoxy)propyl]- (PMN P-01-781; CAS No. 2602-34-8)
is subject to reporting under this section for the significant new use
described in paragraph (a)(2) of this section.
* * * * *
0
12. Amend Sec.  721.9502 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.9502  Siloxanes and silicones, aminoalkyl, fluorooctyl,
hydroxy-terminated salt (generic).

    (a) * * * (1) The chemical substance identified generically as
siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated
salt (PMN P-00-1132 and SNUN S-11-5) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(y)(1). A significant new use is any use of
the chemical substance other than in graffiti systems, as surface
treatment and additive for coatings, adhesives, sealants, paste,
insulation and textiles for porous, non-porous, ceramic, metal, glass,
plastic, wood and leather surfaces or a surface treatment agent for
inorganic filler particles.
* * * * *
0
13. Amend Sec.  721.9595 as follows:
0
a. Revise the section heading.
0
b. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.9595  Benzenesulfonic acid, mono C-10-16 -alkyl
derivs., compounds with 2-propen-1-amine and Alkyl benzene sulfonic
acids and alkyl sulfates, amine salts.

    (a) * * * (1) The chemical substances identified as benzenesulfonic
acid, mono C-10-16 -alkyl derivs., compds. with 2-propen-1-
amine (PMN P-97-296 and SNUN S-03-10; CAS No. 195008-77-6) and the
chemical substances identified generically as alkyl benzene sulfonic
acids and alkyl sulfates, amine salts (PMNs P-97-297/298/299 and SNUNs
S-03-11/12/13) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) N = 30.
* * * * *
0
14. Amend Sec.  721.9675 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraphs (a)(2)(i) and (a)(2)(ii).
0
c. Revise paragraph (b)(1).
    The revisions read as follows:

Sec.  721.9675  Titanate [Ti6O13 (2-)],
dipotassium.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as titanate
[Ti6O13 (2-)], dipotassium (PMN P-90-0226; SNUNs
P-96-1408, S-08-6, S-09-4, and S-13-49; CAS No. 12056-51-8)) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (f) and (l). In addition, a significant
new use of the substance is importation of the chemical substance if:
    (A) Manufactured by other than the method described in
premanufacture notice P-90-226 and significant new use notices P-96-
1408, S-08-6, S-09-4, and S-13-49.
    (B) Manufactured producing respirable, acicular fibers with an
average aspect ratio of greater than 5. The average aspect ratio is
defined as the ratio of average length to average diameter.
    (ii) [Reserved]
    (b) * * *
    (1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers and processors of this substance as
specified in Sec.  721.125(a), (b), (c) and (i).
* * * * *
0
15. Amend Sec.  721.9892 as follows:
0
a. Revise the section heading.
0
b. Revise paragraph (a)(1).
0
c. Revise paragraph (a)(2)(iii).
    The revisions read as follows:

Sec.  721.9892  1,3-Dimethyl-2-imidazolidinone.

    (a) * * * (1) The chemical substance identified as 1,3-Dimethyl-2-
imidazolidinone (PMN P-93-1649, SNUN S-04-3 and S-11-3; CAS No. 80-73-
9) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q). A significant new use is non-
industrial use other than the commercial uses described in the S-04-3
and S-11-3.
* * * * *
0
16. Amend Sec.  721.10008 as follows:
0
a. Revise paragraph (a)(2)(ii).
0
b. Remove paragraph (a)(2)(iii).
0
c. Revise paragraph (b)(1).
0
b. Remove paragraph (b)(3).
    The revisions read as follows:

Sec.  721.10008  Manganese strontium oxide (MnSrO3).

    (a) * * *
    (2) * * *
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (manufacture, processing, or use of the
PMN substance if the particle size is less than 10 microns).
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), and (i) are applicable to
manufacturers and processors of this substance.
* * * * *
0
17. Amend Sec.  721.10182 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.10182  1-Propene, 2,3,3,3-tetrafluoro-.

    (a) * * *
    (1) The chemical substance identified as 1-propene, 2,3,3,3-
tetrafluoro- (PMN P-07-601 and SNUN S-14-11; CAS No. 754-12-1) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. A significant
new use is:
    (A) Use other than as a refrigerant: In motor vehicle air
conditioning systems in new passenger cars and vehicles (i.e., as
defined in 40 CFR 82.32(c) and (d)), in stationary refrigeration, or in
stationary air conditioning.

    (B) Section 721.80(m) (commercial use other than: In passenger cars
and vehicles in which the original charging of motor vehicle air
conditioning systems with the PMN substance was done by the motor
vehicle original equipment manufacturer (OEM), in stationary
refrigeration, or in stationary air conditioning).
    (C) Section 721.80(o) (use in consumer products other than products
used to recharge the motor vehicle air conditioning systems in
passenger cars and vehicles in which the original charging of motor
vehicle air conditioning systems with the PMN substance was done by the
motor vehicle OEM).
* * * * *
0
18. Amend Sec.  721.10283 as follows:
0
a. Revise paragraph (a)(2)(i).
0
b. Revise paragraph (a)(2)(ii).
0
c. Revise paragraph (a)(2)(iii).
0
d. Remove paragraph (a)(2)(iv).
0
e. Revise paragraph (b)(1).
    The revisions read as follows:

Sec.  721.10283  Poly[oxy(methyl-1,2- ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium
salts.

    (a) * * *
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(l).
    (ii) Disposal. Requirements as specified in Sec.  721.85. A
significant new of the substances is any method of disposal of a waste
stream containing the PMN substances other than by incineration or by
injection into a Class I or II waste disposal well.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (ii) Disposal. Requirements as specified in Sec.  721.85. A
significant new of the substances is any method of disposal of a waste
stream containing the PMN substances other than by incineration or by
injection into a Class I or II waste disposal well.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (j) are applicable to manufacturers,
importers, and processors of this substance.
* * * * *
0
19. Amend Sec.  721.10284 as follows:
0
a. Revise paragraph (a)(2)(i).
0
b. Revise paragraph (a)(2)(ii).
0
c. Revise paragraph (a)(2)(iii).
0
d. Remove paragraph (a)(2)(iv).
0
e. Revise paragraph (b)(1).
    The revisions read as follows:

Sec.  721.10284  Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium
salts.

    (a) * * *
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(l).
    (ii) Disposal. Requirements as specified in Sec.  721.85. A
significant new of the substances is any method of disposal of a waste
stream containing the PMN substances other than by incineration or by
injection into a Class I or II waste disposal well.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (j) are applicable to manufacturers,
importers, and processors of this substance.
* * * * *
0
20. Amend Sec.  721.10515 as follows:
0
a. Revise paragraph (a)(1).
0
b. Revise paragraph (a)(2)(i).
    The revisions read as follows:

Sec.  721.10515  Partially fluorinated alcohol substituted glycols
(generic).

    (a) * * *
    (1) The chemical substances identified generically as partially
fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, P-10-
60, and P-10-184) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (manufacture of the PMN substances
according to the chemical synthesis and composition sections of the
TSCA section 5(e) consent order, including analysis, reporting, and
limitations of maximum impurity levels of certain fluorinated
impurities; manufacture and import of P-10-60/P-10-184 other than when
the mean number of moles of the ethoxy group is between 3 and 11 or the
average number molecular weight is between 496 and 848 daltons based on
the amounts of raw materials charged to the reactor; manufacture and
import of P-10-58 and P-10-59 only as intermediates for the manufacture
of P-10-60), and (q).
* * * * *
[FR Doc. 2015-08090 Filed 4-8-15; 8:45 am]
 BILLING CODE 6560-50-P