Proposed Significant New Use Rules on Certain Chemical Substances, 23184-23192 [2013-09155]
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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Proposed Rules
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do not impose a collection of
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chapter 6) does not apply.
Pursuant to section 7805(f) of the
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submitted to the Chief Counsel for
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impact on small businesses.
Steven T. Miller,
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[FR Doc. 2013–09084 Filed 4–17–13; 8:45 am]
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Hearing
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consideration will be given to any
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submitted timely to the IRS as
prescribed in the preamble under the
‘‘ADDRESSES’’ heading. The Treasury
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comments on the clarity of the proposed
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Proposed Amendments to the
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PART 1—INCOME TAXES
Paragraph 1. The authority citation
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■
Authority: 26 U.S.C. 7805 * * * Section
1.6049–9 also issued under 26 U.S.C. 6049(a).
* * *
Par. 2. Section 1.6049–9 is added to
read as follows:
■
§ 1.6049–9 Premium subject to reporting
for a debt instrument acquired on or after
January 1, 2014.
[The text of proposed § 1.6049–9 is
the same as the text of § 1.6049–9T
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2012–0740; FRL–9377–8]
RIN 2070–AB27
Proposed Significant New Use Rules
on Certain Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for eight
chemical substances which were the
subject of premanufacture notices
(PMNs) P–11–327, P–11–328, P–11–329,
P–11–330, P–11–331, P–11–332, P–12–
298, and P–12–299. This action would
require persons who intend to
manufacture, import, or process any of
the chemical substances for an activity
that is designated as a significant new
use by this proposed rule to notify EPA
at least 90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
the activity before it occurs.
DATES: Comments must be received on
or before May 20, 2013.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2012–0740, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• 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: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave. NW.,
Washington, DC. ATTN: Docket ID
Number EPA–HQ–OPPT–2012–0740.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
SUMMARY:
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normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2012–0740. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
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the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Kenneth
Moss, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; email address:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, import,
process, or use the chemical substances
contained in this proposed rule. The
following list of North American
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, importers, or
processors of one or more subject
chemical substances (NAICS codes 325
and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 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 final 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 a chemical substance
that is the subject of a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20)
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
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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 submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing these SNURs under
section 5(a)(2) of TSCA for eight
chemical substances which were the
subject of PMNs P–11–327, P–11–328,
P–11–329, P–11–330, P–11–331, P–11–
332, P–12–298, and P–12–299. These
SNURs would require persons who
intend to manufacture, import, or
process any of these chemical
substances for an activity that is
designated as a significant new use to
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notify EPA at least 90 days before
commencing that activity.
In the Federal Register of November
2, 2012 (77 FR 66149) (FRL–9366–7),
EPA issued direct final SNURs on these
eight chemical substances in accordance
with the procedures at § 721.160(c)(3)(i).
EPA received notices of intent to submit
adverse comments on these SNURs.
Therefore, as required by
§ 721.160(c)(3)(ii), EPA removed the
direct final SNURs in a separate
document, published in the Federal
Register of December 21, 2012 (77 FR
75566) (FRL 9373–8), and is now
issuing this proposed rule on the eight
chemical substances. The record for the
direct final SNURs on these chemical
substances was established as docket
number EPA–HQ–OPPT–2012–0740.
That record includes information
considered by the Agency in developing
the direct final rule and the notice of
intent to submit adverse comments.
B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors listed in Unit III.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture, import, or
process the chemical substance for that
use. Persons who must report are
described in § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
§ 721.1(c), persons subject to these
SNURs must comply with the same
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 sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA may
take regulatory action under TSCA
section 5(e), 5(f), 6, or 7 to control the
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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 eight
chemical substances that are the subject
of this proposed rule, EPA considered
relevant information about the toxicity
of the chemical substances, likely
human exposures and environmental
releases associated with possible uses,
and the four bulleted TSCA section
5(a)(2) factors listed in this unit.
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IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for
eight chemical substances in 40 CFR
part 721, subpart E. In this unit, EPA
provides the following information for
each chemical substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
number (if assigned for non-confidential
chemical identities).
• Basis for the TSCA section 5(e)
consent order or, for non-section 5(e)
SNURs, the basis for the SNUR (i.e.,
SNURs without TSCA section 5(e)
consent orders).
• Tests recommended by EPA to
provide sufficient information to
evaluate the chemical substance (see
Unit VII. for more information).
• CFR citation assigned in the
regulatory text section of this proposed
rule.
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The regulatory text section of this
proposed rule specifies the activities
designated as significant new uses.
This proposed rule includes PMN
substances P–11–327, P–11–328, P–11–
329, P–11–330, P–11–331, and P–11–
332, that are subject to a ‘‘risk-based’’
consent order under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined
that activities associated with the PMN
substances may present unreasonable
risk to human health or the
environment. This consent order
requires protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘section 5(e) SNURs’’ on these
PMN substances are proposed pursuant
to § 721.160, and are based on and
consistent with the provisions in the
underlying consent order. The section
5(e) SNURs designate as a ‘‘significant
new use’’ the absence of the protective
measures required in the corresponding
consent order.
This proposed rule also includes a
SNUR on PMN substances P–12–298
and P–12–299 that were not subject to
a consent order under TSCA section
5(e). In this case, EPA did not find that
the use scenario described in the PMNs
triggered the determinations set forth
under TSCA section 5(e). However, EPA
does believe that certain changes from
the use scenario described in the PMNs
could result in increased exposures,
thereby constituting a ‘‘significant new
use.’’ This so-called ‘‘non-section 5(e)
SNUR’’ is proposed pursuant to
§ 721.170. EPA has determined that
every activity designated as a
‘‘significant new use’’ in all non-section
5(e) SNURs issued under § 721.170
satisfies the two requirements stipulated
in § 721.170(c)(2), i.e., these significant
new use activities, ‘‘(i) are different from
those described in the premanufacture
notice for the substance, including any
amendments, deletions, and additions
of activities to the premanufacture
notice, and (ii) may be accompanied by
changes in exposure or release levels
that are significant in relation to the
health or environmental concerns
identified’’ for the PMN substance.
PMN Numbers P–11–327, P–11–328, P–
11–329, P–11–330, P–11–331, and P–11–
332
Chemical names: Distillates
(lignocellulosic), C5–40 (P–11–327);
Paraffin waxes
(lignocellulosic) hydrotreated, C5–40branched, cyclic and linear (P–11–
328); Naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (P–11–
329); Kerosene
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(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (P–11–
330); Distillates
(lignocellulosic), hydrotreated, C8–26—
branched, cyclic, and linear (P–11–
331); and
Residual oils (lignocellulosic),
hydrotreated, C20–40- branched,
cyclic, and linear (P–11–332).
CAS numbers: 1267611–99–3 (P–11–
327), 1267611–06–2 (P–11–328),
1267611–35–7 (P–11–329), 1267611–
14–2 (P–11–330), 1267611–11–9 (P–11–
331), and 1267611–71–1 (P–11–332).
Effective date of TSCA section 5(e)
consent order: July 21, 2012.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) uses of the PMN
substances will be as a distillation
feedstock after hydrotreatment (P–11–
327), as a feedstock (P–11–328), as a
blend-stock for conventional fossil fuels
(P–11–329, P–11–330, and P–11–331),
and use in a manner comparable to gas
oil as it is currently used in industry (P–
11–332). These PMNs are complex
mixtures and have been assessed based
on the toxic components within their
mixture. The most important and
primary component present is benzene.
Based on this analysis, EPA identified
concerns for oncogenicity,
immunosuppression, and skin
sensitization (defatting of the skin
tissue) to workers exposed to the PMN
substances. The EPA Maximum
Contaminant Level for benzene in
drinking water is 5 parts per billion
(ppb). The PMNs’ New Chemical
Exposure Limit (NCEL) is 0.32
milligram/cubic meter (mg/m3) as an 8hour time-weighted average. In
addition, based on ecological structure
activity relationship (EcoSAR) analysis
of test data on analogous neutral
organics, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 82 ppb for
each of the following: P–11–329 and P–
11–331, and 180 ppb for each of the
following: P–11–327, P–11–328, P–11–
330, and P–11–332. However, EPA does
not expect risk to aquatic organisms at
the expected levels and duration of
exposure as described in the PMNs. The
consent order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I)
based on a finding that these substances
may present an unreasonable risk of
injury to human health and the
environment. To protect against these
risks, the consent order requires:
1. Use of personal protective
equipment including dermal protection
when there is potential dermal exposure
and a National Institute for
Occupational Safety and Health
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(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10,000, or compliance with a NCEL
of 0.32 mg/m3 as an 8-hour timeweighted average when there is
potential inhalation exposure.
2. No use of the substances resulting
in surface water concentrations
exceeding 5 ppb of the combination of
these PMN substances.
3. Establishment and use of a hazard
communication program. The SNUR
designates as a ‘‘significant new use’’
the absence of these protective
measures.
Recommended testing: EPA has
determined that a combined chronic
toxicity/carcinogenicity test (OPPTS
Test Guideline 870.4300); a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300); and fish early-life
stage toxicity test (OPPTS Test
Guideline 850.1400) would help
characterize the human health and
environmental effects of the PMN
substances. The order does not require
submission of the testing at any
specified time or production volume.
However, the order’s restrictions on
manufacture, import, processing,
distribution in commerce, use, and
disposal will remain in effect until the
order is modified or revoked by EPA
based on submission of that or other
relevant information.
CFR citations: 40 CFR 721.10612 (P–
11–327); 721.10613 (P–11–328);
721.10614 (P–11–329); 721.10615 (P–
11–330); 721.10616 (P–11–331); and
721.10617 (P–11–332).
PMN Numbers P–12–298 and P–12–299
Chemical name: Vinylidene ester
(generic).
CAS number: Not available.
Basis for action: The PMNs state that
the generic uses of the substances will
be adhesives. Based on EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
7 ppb of the PMN substances in surface
waters for greater than 20 days per year.
This 20-day criterion is derived from
partial life cycle tests (daphnid chronic
and fish early-life stage tests) that
typically range from 21 to 28 days in
duration. EPA predicts toxicity to
aquatic organisms may occur if releases
of the PMN substances to surface water
exceed releases from the use described
in the PMNs. For the described use in
the PMNs, significant environmental
releases are not expected because
environmental releases did not result in
surface water concentrations exceeding
7 ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing,
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processing, or use of the substances may
present an unreasonable risk. EPA has
determined, however, that combined
production volume of the two PMN
substances exceeding 20,000 kilograms
per year could result in exposures
which may cause significant adverse
environmental effects. Based on this
information, the PMN substances meet
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guidelines
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guidelines 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10623.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the eight chemical substances that
are subject to these proposed SNURs,
EPA concluded that for six of the
substances, regulation was warranted
under TSCA section 5(e), pending the
development of information sufficient to
make reasoned evaluations of the health
and environmental effects of the
chemical substances. For two of the
eight substances, where the uses are not
regulated under a TSCA section 5(e)
consent order, EPA determined that one
or more of the criteria of concern
established at § 721.170 were met. The
basis for these findings is outlined in
Unit IV.
B. Objectives
EPA is proposing these SNURs for
specific chemical substances that have
undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this proposed rule:
• EPA would receive notice of any
person’s intent to manufacture, import,
or process a listed chemical substance
for the described significant new use
before that activity begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing, or
processing a listed chemical substance
for the described significant new use.
• EPA would be able to regulate
prospective manufacturers, importers,
or processors of a listed chemical
substance before the described
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significant new use of that chemical
substance occurs, provided that
regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
• EPA would ensure that all
manufacturers, importers, and
processors of the same chemical
substance that is subject to a TSCA
section 5(e) consent order are subject to
similar requirements.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
Internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
VI. Applicability of the Significant New
Use Designation
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed rule have
undergone premanufacture review. In
cases where EPA has not received a
notice of commencement (NOC) and the
chemical substance has not been added
to the TSCA Inventory, no person may
commence such activities without first
submitting a PMN. Therefore, for
chemical substances for which an NOC
has not been submitted EPA concludes
that the designated significant new uses
are not ongoing.
When chemical substances identified
in this proposed rule are added to the
TSCA Inventory, EPA recognizes that,
before the final rule is issued, other
persons might engage in a use that has
been identified as a significant new use.
However, TSCA section 5(e) consent
orders have been issued for six of the
eight chemical substances, and the PMN
submitters are prohibited by the TSCA
section 5(e) consent orders from
undertaking activities which would be
designated as significant new uses. The
other two chemical substances
contained in this proposed rule are not
regulated with TSCA section 5(e)
consent orders. The identities of these
two chemical substances have been
claimed as confidential, and EPA has
received no post-PMN bona fide
submissions (per § 720.25 and § 721.11).
Based on this, the Agency believes that
it is highly unlikely that any of the
significant new uses described in the
regulatory text of this proposed rule are
ongoing.
If uses begun after the direct final rule
was published on November 2, 2012,
were considered ongoing rather than
new, any person could defeat the SNUR
by initiating the significant new use
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before the final rule was issued.
Therefore EPA designates November 2,
2012 as the cutoff date for determining
whether the new use is ongoing. Persons
who begin commercial manufacture,
import, or processing of the chemical
substances for a significant new use
identified as of that date would have to
cease any such activity upon the
effective date of the final rule. To
resume their activities, these persons
would have to first comply with all
applicable SNUR notification
requirements and wait until the notice
review period, including any
extensions, expires. If such a person met
the conditions of advance compliance
under § 721.45(h), the person would be
considered exempt from the
requirements of the SNUR. Consult the
Federal Register document of April 24,
1990 (55 FR 17376) for a more detailed
discussion of the cutoff date for ongoing
uses.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
In cases where EPA issued a TSCA
section 5(e) consent order that requires
or recommends certain testing, Unit IV.
lists those tests. Unit IV. also lists
recommended testing for non-5(e)
SNURs. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
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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 § 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
§ 720.50. SNUNs must be submitted on
EPA Form No. 7710–25, generated using
e–PMN software, and submitted to the
Agency in accordance with the
procedures set forth in §§ 720.40 and
721.25. E–PMN software is available
electronically at https://www.epa.gov/
opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
during the development of the direct
final rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2012–0740.
X. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish
SNURs for eight chemical substances
that were the subject of PMNs, and in
six cases, a TSCA section 5(e) consent
order. 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 the PRA, 44 U.S.C. 3501
et seq., an Agency may not conduct or
sponsor, and a person is not required to
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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 would amend the table
in 40 CFR part 9 to list the OMB
approval number for the information
collection requirements contained in
this proposed rule, if the SNUR is
subsequently issued as a final 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 would 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
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number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small
entity would not cost significantly more
than $8,300. A copy of that certification
is available in the docket for this
proposed rule.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the Economic
Analysis discussed in Unit IX. and
EPA’s experience promulgating SNURs
(discussed in the certification), EPA
believes that the following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300.
Therefore, the promulgation of these
SNURs would not have a significant
economic impact on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would not impose any enforceable duty,
contain any unfunded mandate, or
otherwise have any effect on small
governments subject to the requirements
of UMRA sections 202, 203, 204, or 205
(2 U.S.C. 1501 et seq.).
sroberts on DSK5SPTVN1PROD with PROPOSALS
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 would it
involve or impose any requirements that
affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
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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 proposed rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this 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 would
not involve any technical standards the
National Technology Transfer and
Advancement Act (NTTAA), section
12(d) (15 U.S.C. 272 note), would 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 12, 2013.
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]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10612 to subpart E to
read as follows:
■
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§ 721.10612
C5–40.
23189
Distillates (lignocellulosic),
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
distillates (lignocellulosic), C5–40 (PMN
P–11–327; CAS No. 1267611–99–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
self-contained breathing apparatus
(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
and (g).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
3); paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
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and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMNP–11–
331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (h) and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 3. Add § 721.10613 to subpart E to
read as follows:
sroberts on DSK5SPTVN1PROD with PROPOSALS
§ 721.10613 Paraffin waxes
(lignocellulosic) hydrotreated, C5–40branched, cyclic and linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
self-contained breathing apparatus
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(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
and (g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
3); paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMN P–
11–331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (h) and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 4. Add § 721.10614 to subpart E to
read as follows:
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§ 721.10614 Naphtha (lignocellulosic),
hydrotreated, C5–12-branched, cyclic and
linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
naphtha (lignocellulosic), hydrotreated,
C5–12-branched, cyclic and linear (PMN
P–11–329; CAS No. 1267611–35–7) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63 (a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
self-contained breathing apparatus
(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), and (g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
3); paraffin waxes (lignocellulosic)
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hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMN P–
11–331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (h) and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 5. Add § 721.10615 to subpart E to
read as follows:
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§ 721.10615 Kerosene (lignocellulosic),
hydrotreated, C8–16-branched, cyclic and
linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
kerosene (lignocellulosic), hydrotreated,
C8–16-branched, cyclic and linear (PMN
P–11–330; CAS No. 1267611–14–2) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
self-contained breathing apparatus
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(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
and (g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
3); paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMN P–
11–331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (h) and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 6. Add § 721.10616 to subpart E to
read as follows:
PO 00000
Frm 00030
Fmt 4702
Sfmt 4702
23191
§ 721.10616 Distillates (lignocellulosic),
hydrotreated, C8–26-branched, cyclic, and
linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
distillates (lignocellulosic),
hydrotreated, C8–26-branched, cyclic,
and linear (PMN P–11–331; CAS No.
1267611–11–9) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
self-contained breathing apparatus
(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
0.1 percent), (f), and (g).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
E:\FR\FM\18APP1.SGM
18APP1
23192
Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Proposed Rules
3); paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMN P–
11–331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 7. Add § 721.10617 to subpart E to
read as follows:
sroberts on DSK5SPTVN1PROD with PROPOSALS
§ 721.10617 Residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic, and
linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of
10,000 meet the minimum requirements
for § 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive
pressure mode (e.g., open/closed circuit)
VerDate Mar<15>2010
18:52 Apr 17, 2013
Jkt 229001
self-contained breathing apparatus
(SCBA) equipped with a hood or helmet
or a full facepiece.
(A) As an alternative to the respiratory
requirements listed in paragraph (a)(2)(i)
of this section, a manufacturer,
importer, or processor may choose to
follow the new chemical exposure limit
(NCEL) provisions listed in the TSCA
section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/
cubic meter (mg/m3) as an 8-hour timeweighted average. Persons who wish to
pursue NCELs as an alternative to the
§ 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will receive NCELs provisions
comparable to those contained in the
corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
and (g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=5 and 5 is an aggregate
of releases for the following substances:
Distillates (lignocellulosic), C5–40
(PMN P–11–327; CAS No. 1267611–99–
3); paraffin waxes (lignocellulosic)
hydrotreated, C5–40-branched, cyclic
and linear (PMN P–11–328; CAS No.
1267611–06–2); naphtha
(lignocellulosic), hydrotreated, C5–12branched, cyclic and linear (PMN P–11–
329; CAS No. 1267611–35–7); kerosene
(lignocellulosic), hydrotreated, C8–16branched, cyclic and linear (PMN P–11–
330; CAS No. 1267611–14–2); distillates
(lignocellulosic), hydrotreated, C8–26branched, cyclic, and linear (PMN P–
11–331; CAS No. 1267611–11–9); and
residual oils (lignocellulosic),
hydrotreated, C20–40-branched, cyclic,
and linear (PMN P–11–332; CAS No.
1267611–71–1)).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a) through (h) and (k) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 8. Add § 721.10623 to subpart E to
read as follows:
PO 00000
Frm 00031
Fmt 4702
Sfmt 4702
§ 721.10623
Vinylidene ester (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as vinylidene ester (PMNs
P–12–298 and P–12–299) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(s) (20,000
kilograms of the aggregate of the two
chemical substances).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), and (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2013–09155 Filed 4–17–13; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket No. 10–90; DA 13–704]
Wireline Competition Bureau Adds
New Discussion Topic to Connect
America Cost Model Virtual Workshop
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Wireline Competition Bureau adds a
new virtual workshop discussion topic,
entitled ‘‘Operating Expenses Input
Values’’ to seek public input.
DATES: Comments are due on or before
April 25, 2013.
If you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: You may submit comments,
identified by WC Docket No. 10–90, by
any of the following methods:
D Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
D Federal Communications
Commission’s Web site: https://
SUMMARY:
E:\FR\FM\18APP1.SGM
18APP1
]]>Agencies
[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Proposed Rules]
[Pages 23184-23192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09155]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2012-0740; FRL-9377-8]
RIN 2070-AB27
Proposed Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for eight chemical substances which
were the subject of premanufacture notices (PMNs) P-11-327, P-11-328,
P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299. This
action would require persons who intend to manufacture, import, or
process any of the chemical substances for an activity that is
designated as a significant new use by this proposed rule to notify EPA
at least 90 days before commencing that activity. The required
notification would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit the activity
before it occurs.
DATES: Comments must be received on or before May 20, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0740, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
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: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2012-0740. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0740. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign
[[Page 23185]]
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed rule. The following list of North American 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, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 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 final 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 a
chemical substance that is the subject of a proposed or final SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec. [emsp14]721.20) and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing these SNURs under section 5(a)(2) of TSCA for
eight chemical substances which were the subject of PMNs P-11-327, P-
11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299.
These SNURs would require persons who intend to manufacture, import, or
process any of these chemical substances for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
In the Federal Register of November 2, 2012 (77 FR 66149) (FRL-
9366-7), EPA issued direct final SNURs on these eight chemical
substances in accordance with the procedures at Sec. 721.160(c)(3)(i).
EPA received notices of intent to submit adverse comments on these
SNURs. Therefore, as required by Sec. 721.160(c)(3)(ii), EPA removed
the direct final SNURs in a separate document, published in the Federal
Register of December 21, 2012 (77 FR 75566) (FRL 9373-8), and is now
issuing this proposed rule on the eight chemical substances. The record
for the direct final SNURs on these chemical substances was established
as docket number EPA-HQ-OPPT-2012-0740. That record includes
information considered by the Agency in developing the direct final
rule and the notice of intent to submit adverse comments.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec. [emsp14]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
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the
[[Page 23186]]
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
eight chemical substances that are the subject of this proposed rule,
EPA considered relevant information about the toxicity of the chemical
substances, likely human exposures and environmental releases
associated with possible uses, and the four bulleted TSCA section
5(a)(2) factors listed in this unit.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for eight chemical substances in 40 CFR part 721, subpart E. In this
unit, EPA provides the following information for each chemical
substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) number (if assigned for
non-confidential chemical identities).
Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
CFR citation assigned in the regulatory text section of
this proposed rule.
The regulatory text section of this proposed rule specifies the
activities designated as significant new uses.
This proposed rule includes PMN substances P-11-327, P-11-328, P-
11-329, P-11-330, P-11-331, and P-11-332, that are subject to a ``risk-
based'' consent order under TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated with the PMN substances may
present unreasonable risk to human health or the environment. This
consent order requires protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``section 5(e) SNURs'' on these PMN substances are proposed pursuant to
Sec. [emsp14]721.160, and are based on and consistent with the
provisions in the underlying consent order. The section 5(e) SNURs
designate as a ``significant new use'' the absence of the protective
measures required in the corresponding consent order.
This proposed rule also includes a SNUR on PMN substances P-12-298
and P-12-299 that were not subject to a consent order under TSCA
section 5(e). In this case, EPA did not find that the use scenario
described in the PMNs triggered the determinations set forth under TSCA
section 5(e). However, EPA does believe that certain changes from the
use scenario described in the PMNs could result in increased exposures,
thereby constituting a ``significant new use.'' This so-called ``non-
section 5(e) SNUR'' is proposed pursuant to Sec. [emsp14]721.170. EPA
has determined that every activity designated as a ``significant new
use'' in all non-section 5(e) SNURs issued under Sec. [emsp14]721.170
satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e.,
these significant new use activities, ``(i) are different from those
described in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and (ii) may be accompanied by changes in
exposure or release levels that are significant in relation to the
health or environmental concerns identified'' for the PMN substance.
PMN Numbers P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, and P-11-
332
Chemical names: Distillates (lignocellulosic), C5-40 (P-11-327);
Paraffin waxes
(lignocellulosic) hydrotreated, C5-40- branched, cyclic and linear (P-
11-328); Naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-
11-329); Kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (P-
11-330); Distillates
(lignocellulosic), hydrotreated, C8-26--branched, cyclic, and linear
(P-11-331); and
Residual oils (lignocellulosic), hydrotreated, C20-40- branched,
cyclic, and linear (P-11-332).
CAS numbers: 1267611-99-3 (P-11-327), 1267611-06-2 (P-11-328),
1267611-35-7 (P-11-329), 1267611-14-2 (P-11-330), 1267611-11-9 (P-11-
331), and 1267611-71-1 (P-11-332).
Effective date of TSCA section 5(e) consent order: July 21, 2012.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) uses of the PMN substances will be as a
distillation feedstock after hydrotreatment (P-11-327), as a feedstock
(P-11-328), as a blend-stock for conventional fossil fuels (P-11-329,
P-11-330, and P-11-331), and use in a manner comparable to gas oil as
it is currently used in industry (P-11-332). These PMNs are complex
mixtures and have been assessed based on the toxic components within
their mixture. The most important and primary component present is
benzene. Based on this analysis, EPA identified concerns for
oncogenicity, immunosuppression, and skin sensitization (defatting of
the skin tissue) to workers exposed to the PMN substances. The EPA
Maximum Contaminant Level for benzene in drinking water is 5 parts per
billion (ppb). The PMNs' New Chemical Exposure Limit (NCEL) is 0.32
milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted average. In
addition, based on ecological structure activity relationship (EcoSAR)
analysis of test data on analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
82 ppb for each of the following: P-11-329 and P-11-331, and 180 ppb
for each of the following: P-11-327, P-11-328, P-11-330, and P-11-332.
However, EPA does not expect risk to aquatic organisms at the expected
levels and duration of exposure as described in the PMNs. The consent
order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that these substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the consent order requires:
1. Use of personal protective equipment including dermal protection
when there is potential dermal exposure and a National Institute for
Occupational Safety and Health
[[Page 23187]]
(NIOSH)-certified respirator with an assigned protection factor (APF)
of at least 10,000, or compliance with a NCEL of 0.32 mg/m\3\ as an 8-
hour time-weighted average when there is potential inhalation exposure.
2. No use of the substances resulting in surface water
concentrations exceeding 5 ppb of the combination of these PMN
substances.
3. Establishment and use of a hazard communication program. The
SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that a combined chronic
toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would
help characterize the human health and environmental effects of the PMN
substances. The order does not require submission of the testing at any
specified time or production volume. However, the order's restrictions
on manufacture, import, processing, distribution in commerce, use, and
disposal will remain in effect until the order is modified or revoked
by EPA based on submission of that or other relevant information.
CFR citations: 40 CFR 721.10612 (P-11-327); 721.10613 (P-11-328);
721.10614 (P-11-329); 721.10615 (P-11-330); 721.10616 (P-11-331); and
721.10617 (P-11-332).
PMN Numbers P-12-298 and P-12-299
Chemical name: Vinylidene ester (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic uses of the
substances will be adhesives. Based on EcoSAR analysis of test data on
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 7 ppb of the PMN substances in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substances to surface water exceed releases from the use described
in the PMNs. For the described use in the PMNs, significant
environmental releases are not expected because environmental releases
did not result in surface water concentrations exceeding 7 ppb for more
than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that
combined production volume of the two PMN substances exceeding 20,000
kilograms per year could result in exposures which may cause
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guidelines
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guidelines 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10623.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the eight chemical
substances that are subject to these proposed SNURs, EPA concluded that
for six of the substances, regulation was warranted under TSCA section
5(e), pending the development of information sufficient to make
reasoned evaluations of the health and environmental effects of the
chemical substances. For two of the eight substances, where the uses
are not regulated under a TSCA section 5(e) consent order, EPA
determined that one or more of the criteria of concern established at
Sec. 721.170 were met. The basis for these findings is outlined in
Unit IV.
B. Objectives
EPA is proposing these SNURs for specific chemical substances that
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA would be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
EPA would ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the final rule is
issued, other persons might engage in a use that has been identified as
a significant new use. However, TSCA section 5(e) consent orders have
been issued for six of the eight chemical substances, and the PMN
submitters are prohibited by the TSCA section 5(e) consent orders from
undertaking activities which would be designated as significant new
uses. The other two chemical substances contained in this proposed rule
are not regulated with TSCA section 5(e) consent orders. The identities
of these two chemical substances have been claimed as confidential, and
EPA has received no post-PMN bona fide submissions (per Sec. 720.25
and Sec. 721.11). Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this proposed rule are ongoing.
If uses begun after the direct final rule was published on November
2, 2012, were considered ongoing rather than new, any person could
defeat the SNUR by initiating the significant new use
[[Page 23188]]
before the final rule was issued. Therefore EPA designates November 2,
2012 as the cutoff date for determining whether the new use is ongoing.
Persons who begin commercial manufacture, import, or processing of the
chemical substances for a significant new use identified as of that
date would have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons would have to
first comply with all applicable SNUR notification requirements and
wait until the notice review period, including any extensions, expires.
If such a person met the conditions of advance compliance under Sec.
721.45(h), the person would be considered exempt from the requirements
of the SNUR. Consult the Federal Register document of April 24, 1990
(55 FR 17376) for a more detailed discussion of the cutoff date for
ongoing uses.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. 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 Sec. 720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
Sec. Sec. 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances during the development of the direct final
rule. EPA's complete economic analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2012-0740.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for eight chemical
substances that were the subject of PMNs, and in six cases, a TSCA
section 5(e) consent order. 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 the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The 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 would amend the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this proposed rule, if the SNUR is subsequently issued as a final
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 would 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
[[Page 23189]]
number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300. A copy of that certification is
available in the docket for this proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of these SNURs would not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This 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 would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This 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 proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this 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 would not involve any technical
standards the National Technology Transfer and Advancement Act (NTTAA),
section 12(d) (15 U.S.C. 272 note), would 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 12, 2013.
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. Add Sec. 721.10612 to subpart E to read as follows:
Sec. 721.10612 Distillates (lignocellulosic), C5-40.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), C5-40 (PMN P-11-327; CAS No. 1267611-99-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases
for the following substances: Distillates (lignocellulosic), C5-40 (PMN
P-11-327; CAS No. 1267611-99-3); paraffin waxes (lignocellulosic)
hydrotreated, C5-40-branched, cyclic
[[Page 23190]]
and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic),
hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No.
1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear (PMNP-11-331; CAS No. 1267611-11-9); and
residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic,
and linear (PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
3. Add Sec. 721.10613 to subpart E to read as follows:
Sec. 721.10613 Paraffin waxes (lignocellulosic) hydrotreated, C5-40-
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
4. Add Sec. 721.10614 to subpart E to read as follows:
Sec. 721.10614 Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic)
[[Page 23191]]
hydrotreated, C5-40-branched, cyclic and linear (PMN P-11-328; CAS No.
1267611-06-2); naphtha (lignocellulosic), hydrotreated, C5-12-branched,
cyclic and linear (PMN P-11-329; CAS No. 1267611-35-7); kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN
P-11-330; CAS No. 1267611-14-2); distillates (lignocellulosic),
hydrotreated, C8-26-branched, cyclic, and linear (PMN P-11-331; CAS No.
1267611-11-9); and residual oils (lignocellulosic), hydrotreated, C20-
40-branched, cyclic, and linear (PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. Add Sec. 721.10615 to subpart E to read as follows:
Sec. 721.10615 Kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as kerosene
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN
P-11-330; CAS No. 1267611-14-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12- branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.10616 to subpart E to read as follows:
Sec. 721.10616 Distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as distillates
(lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear
(PMN P-11-331; CAS No. 1267611-11-9) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), and (g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of releases
for the following substances: Distillates (lignocellulosic), C5-40 (PMN
P-11-327; CAS No. 1267611-99-
[[Page 23192]]
3); paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched,
cyclic and linear (PMN P-11-328; CAS No. 1267611-06-2); naphtha
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN
P-11-329; CAS No. 1267611-35-7); kerosene (lignocellulosic),
hydrotreated, C8-16-branched, cyclic and linear (PMN P-11-330; CAS No.
1267611-14-2); distillates (lignocellulosic), hydrotreated, C8-26-
branched, cyclic, and linear (PMN P-11-331; CAS No. 1267611-11-9); and
residual oils (lignocellulosic), hydrotreated, C20-40-branched, cyclic,
and linear (PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.10617 to subpart E to read as follows:
Sec. 721.10617 Residual oils (lignocellulosic), hydrotreated, C20-40-
branched, cyclic, and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), (a)(6), (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) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of 10,000 meet the
minimum requirements for Sec. 721.63(a)(4): Any NIOSH-certified
pressure-demand or other positive pressure mode (e.g., open/closed
circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or a full facepiece.
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i) of this section, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.32 milligram/cubic meter (mg/m\3\) as an 8-
hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use
the NCELs approach are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=5 and 5 is an aggregate of
releases for the following substances: Distillates (lignocellulosic),
C5-40 (PMN P-11-327; CAS No. 1267611-99-3); paraffin waxes
(lignocellulosic) hydrotreated, C5-40-branched, cyclic and linear (PMN
P-11-328; CAS No. 1267611-06-2); naphtha (lignocellulosic),
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329; CAS No.
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330; CAS No. 1267611-14-2);
distillates (lignocellulosic), hydrotreated, C8-26-branched, cyclic,
and linear (PMN P-11-331; CAS No. 1267611-11-9); and residual oils
(lignocellulosic), hydrotreated, C20-40-branched, cyclic, and linear
(PMN P-11-332; CAS No. 1267611-71-1)).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (h) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
8. Add Sec. 721.10623 to subpart E to read as follows:
Sec. 721.10623 Vinylidene ester (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
vinylidene ester (PMNs P-12-298 and P-12-299) are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (20,000 kilograms of the aggregate of
the two chemical substances).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2013-09155 Filed 4-17-13; 8:45 am]
BILLING CODE 6560-50-P
