Proposed Significant New Use Rules on Certain Chemical Substances, 81441-81447 [2011-33255]
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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules
believes that the potential economic
impacts of complying with this SNUR
are not expected to be significant or
adversely impact a substantial number
of small entities. In a SNUR that
published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL–5597–
1), the Agency presented its general
determination that final SNURs are not
expected to have a significant economic
impact on a substantial number of small
entities, which was provided to the
Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act
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 sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
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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
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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
81441
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(2)(i) and (a)(3).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), and (e) 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. 2011–33256 Filed 12–27–11; 8:45 am]
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
BILLING CODE 6560–50–P
J. Executive Order 12898
[EPA–HQ–OPPT–2010–1075; FRL–9329–4]
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).
RIN 2070–AB27
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, 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 § 721.5725 to subpart E to read
as follows:
§ 721.5725 Phenol, 2,4-dimethyl-6-(1methylpentadecyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209;
CAS No. 134701–20–5) 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:
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
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 section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the chemical substances
rutile, tin zinc, calcium-doped (CAS No.
389623–01–2) and rutile, tin zinc,
sodium-doped (CAS No. 389623–07–8)
which were the subject of
premanufacture notices (PMNs P–06–36
and P–06–37) and TSCA section 5(e)
consent orders issued by EPA. The
proposed SNURs on these substances,
which are based on and consistent with
the provisions of the underlying consent
orders, would designate as a significant
new use the absence of the protective
measures required in the consent orders.
This action would require persons who
intend to manufacture, import, or
process either 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 January 27, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
SUMMARY:
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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules
number EPA–HQ–OPPT–2010–1075, 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. Attention: Docket ID
Number EPA–HQ–OPPT–2010–1075.
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–
2010–1075. 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
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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
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.
Potentially affected entities may
include, but are not limited to:
• Manufacturers, importers, or
processors of one or more subject
chemical substances (NAICS codes 325
and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
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you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
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.
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.
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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.
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.
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the two chemical
substances that are the subject of these
proposed SNURs, EPA considered
relevant information about the toxicity
of the chemical substances, likely
human exposures and environmental
releases associated with possible uses,
taking into consideration the four
bulleted TSCA section 5(a)(2) factors
listed in this unit.
II. Background
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 section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the
regulations at 40 CFR part 720. Once
EPA receives a SNUN, EPA may take
regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities
for which it has received the SNUN. If
EPA does not take action, EPA is
required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
EPA is proposing to establish
significant new use and recordkeeping
requirements for two 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.
• Chemical Abstracts Service (CAS)
number.
• Basis for the TSCA section 5(e)
consent order.
• Toxicity concerns.
• 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.
This proposed rule concerns two
PMN substances that are subject to
‘‘risk-based’’ consent orders under
TSCA section 5(e)(1)(A)(ii)(I). Those
consent orders require protective
measures to limit exposures or
otherwise mitigate the potential
unreasonable risk. The so-called ‘‘5(e)
SNURs’’ on these PMN substances are
promulgated pursuant to § 721.160, and
are based on and consistent with the
provisions in the underlying consent
orders. The 5(e) SNURs designate as a
‘‘significant new use’’ the absence of the
protective measures required in the
corresponding consent orders.
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A. What action is the agency taking?
EPA is proposing significant new use
rules (SNURs) under section 5(a)(2) of
TSCA for two chemical substances
which were the subject of PMNs and
TSCA section 5(e) consent orders. The
two chemical substances are identified
as rutile, tin zinc, calcium-doped (PMN
P–06–36; CAS No. 389623–01–2) and
rutile, tin zinc, sodium-doped (PMN P–
06–37; CAS No. 389623–07–8). The
proposed SNUR on these substances are
based on and consistent with the
provisions in the underlying consent
orders. The proposed SNURs designate
as a significant new use the absence of
the protective measures required in the
corresponding consent orders. These
SNURs would require persons who
intend to manufacture, import, or
process either 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 October 5,
2011 (76 FR 61566) (FRL–8880–2), EPA
issued direct final SNURs on these two
chemical substances in accordance with
the procedures at § 721.160(c)(3)(i). EPA
received notice of intent to submit
adverse comments on these SNURs.
Therefore, as required by
§ 721.160(c)(3)(ii), in the Federal
Register of December 5, 2011 (76 FR
75794) (FRL–9329–5), EPA withdrew
the direct final SNURs and is now
issuing this proposed rule on the two
chemical substances. The record for the
direct final SNURs on these substances
was established as docket EPA–HQ–
OPPT–2010–1075. That record includes
information considered by the Agency
in developing the direct final rule and
the notice of intent to submit adverse
comments.
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III. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
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IV. Substances Subject to This Proposed
Rule
PMN Numbers P–06–36 and P–06–37
Chemical names: (P–06–36) Rutile, tin
zinc, calcium-doped and (P–06–37)
Rutile, tin zinc, sodium-doped.
CAS numbers: (P–06–36) 389623–01–
2 and (P–06–37) 389623–07–8.
Effective date of TSCA section 5(e)
consent order: February 17, 2009.
Basis for TSCA section 5(e) consent
order: The PMN states that the
substances will be used as colorants for
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polymers and industrial coatings. The
order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based
on a finding that the substances may
present an unreasonable risk of injury to
human health. To protect against these
risks, the consent order requires: Use of
personal respiratory equipment,
including a National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
Assigned Protection Factor (APF) of at
least 10, or compliance with a New
Chemical Exposure Limit (NCEL) of 1.5
mg/m3 as an 8-hour time weighted
average; establishment of a hazard
communication program; and restricts
the company from manufacturing the
PMN substances with a d10 particle size
less than 100 nanometers, where d10
particle size presents the particle size,
as determined by laser light scattering,
at which 10 percent by weight of the
substance measured is smaller; and
corresponding recordkeeping. The
SNUR designates as a ‘‘significant new
use’’ the absence of these protective
measures.
Toxicity concern: Based on structural
activity relationship analysis derived
from test data on structurally similar
respirable, poorly soluble particulates,
the PMN substances may cause lung
overload and fibrosis in workers
exposed to the PMN substances by the
inhalation route.
Recommended testing: EPA has
determined that the following test
would help characterize the human
health effects of the PMN substances: A
90-day inhalation toxicity test (OPPTS
Test Guideline 870.3465) in rats. The
testing should include a 60-day recovery
period to assess the progression or
regression of any lesions; and include
special attention to histopathology
(inflammation and cell proliferation) of
the lung tissues and to various
parameters of the bronchoalveolar
lavage fluid (BALF), e.g., marker
enzyme activities, total protein content,
total cell count, cell differential, and
cell viability. The order does not require
submission of the aforementioned
information at any specified time or
production volume. However, the
order’s restrictions on manufacturing,
import, processing, distribution in
commerce, use, and disposal of the
PMN substances 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 721.10230 (P–
06–36) and 40 CFR 721.10231 (P–06–
37).
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V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for these two chemical substances, EPA
concluded that regulation was
warranted under TSCA section 5(e),
pending the development of information
sufficient to make reasoned evaluations
of the human health effects of the
chemical substances. The basis for such
findings is outlined in Unit IV. Based on
these findings, TSCA section 5(e)
consent orders requiring the use of
appropriate exposure controls were
negotiated with the PMN submitters.
The proposed SNUR provisions for
these chemical substances are consistent
with the provisions of the TSCA section
5(e) consent orders. These proposed
SNURs are issued pursuant to § 721.160.
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 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.
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VI. Applicability of the Proposed Rule
to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ‘‘new’’ use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed rule have
undergone premanufacture review and
are subject to TSCA section 5(e) consent
orders. The PMN submitters are
prohibited by these TSCA section 5(e)
consent orders from undertaking
activities which EPA is proposing as
significant new uses. EPA solicits
comments on whether any of the uses
proposed as significant new uses are
ongoing.
As discussed in the Federal Register
issue of April 24, 1990 (55 FR 17376),
EPA has decided that the intent of
TSCA section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of the
proposed rule rather than as of the
effective date of the final rule. If uses
begun after publication were considered
ongoing rather than new, it would be
difficult for EPA to establish SNUR
notice requirements because a person
could defeat the SNUR by initiating the
significant new use before the rule
became final, and then argue that the
use was ongoing before the effective
date of the final rule. Thus, persons who
begin commercial manufacture, import,
or processing activities with the
chemical substances regulated through
this proposed SNUR must cease any
such activity before the effective date of
the rule, if and when finalized. To
resume their activities, these persons
would have to comply with all
applicable SNUR notice requirements
and wait until the notice review period,
including all extensions, expires.
EPA has promulgated provisions to
allow persons to comply with this
proposed SNUR before the effective
date. If a person meets the conditions of
advance compliance under § 721.45(h),
the person is considered exempt from
the requirements of the SNUR.
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)
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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.
describes those tests. 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 and test reporting. To
access the harmonized test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
In the TSCA section 5(e) consent
orders for the two chemical substances
regulated under this proposed rule, EPA
has established restrictions in view of
the lack of data on the potential human
health risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These restrictions will not be removed
until EPA determines that the
unrestricted use will not present an
unreasonable risk of injury or result in
significant or substantial exposure or
environmental release. This
determination is usually made based on
the results of the required or
recommended toxicity tests.
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.
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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 §§ 721.25 and
720.40. 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–2010–1075.
X. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish
SNURs for two chemical substances that
were the subject of PMNs and TSCA
section 5(e) consent orders. The Office
of Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (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. 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
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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
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
would not have a significant adverse
economic impact on a substantial
number of small entities. The
requirement to submit a SNUN applies
to any person (including small or large
entities) who intends to engage in any
activity described in the final rule as a
‘‘significant new use.’’ Because these
uses are ‘‘new,’’ based on all
information currently available to EPA,
it appears that no small or large entities
presently engage in such activities. A
SNUR requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN. Although some
small entities may decide to pursue a
significant new use in the future, EPA
cannot presently determine how many,
if any, there may be. However, EPA’s
experience to date is that, in response to
the promulgation of SNURs covering
over 1,000 chemicals substances, the
Agency receives only a handful of
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SNUNs per year. For example, the
number of SNUNs was four in Federal
fiscal year (FY) 2005, eight in FY 2006,
six in FY 2007, eight in FY 2008, and
seven in FY 2009. During this 5-year
period, three small entities submitted a
SNUN. In addition, the estimated
reporting cost for submission of a SNUN
(see Unit VIII.) is minimal regardless of
the size of the firm. Therefore, EPA
believes that the potential economic
impacts of complying with those SNURs
are not expected to be significant or
adversely impact a substantial number
of small entities. In a SNUR that
published in the Federal Register issue
of June 2, 1997 (62 FR 29684) (FRL–
5597–1), the Agency presented its
general determination that final SNURs
are not expected to have a significant
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
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 affect on small
governments subject to the requirements
of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
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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
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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
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, 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 § 721.10230 to subpart E to
read as follows:
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§ 721.10230
doped.
Rutile, tin zinc, calcium-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
rutile, tin zinc, calcium-doped (PMN P–
06–36; CAS No. 389623–01–2) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance that
have been incorporated into a polymer,
glass, dispersion, cementitious matrix,
or a similar incorporation.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(4), (a)(5), (a)(6)(i), (b) (concentration
set at 1.0 percent), and (c). The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of 10
meet the minimum requirements for
§ 721.63(a)(5):
(A) NIOSH-certified air-purifying,
tight-fitting half-face respirator
equipped with N100 (if oil aerosols
absent), R100, or P100 filters;
(B) NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped
with N100 (if oil aerosols absent), R100,
or P100 filters;
(C) NIOSH-certified powered airpurifying respirator equipped with a
loose- fitting hood or helmet and high
efficiency particulate air (HEPA) filters;
(D) NIOSH-certified powered airpurifying respirator equipped with a
tight-fitting facepiece (either half-face or
full-face) and HEPA filters; or
(E) NIOSH-certified supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (either half-face or full-face).
(1) As an alternative to the respiratory
requirements listed in paragraph
(a)(2)(i), 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 these substances.
The NCEL is 1.5 mg/m3 as an 8-hour
time-weighted-average for both
chemical substances combined. 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.
(2) [Reserved]
(ii) Hazard communication program.
Requirements as specified in § 721.72
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(a), (b), (c), (d), (e) (concentration set at
1.0 percent), (f), (g)(1)(ii), (g)(2)(ii),
(g)(2)(iv) (use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 1.5 mg/m3),
and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture of
the substances with a particle size less
than 100 nanometers, where d10
particle size presents the particle size,
as determined by laser light scattering,
at which 10 percent by weight of the
substance measured is smaller).
(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), (d), (f), (g), (h), 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.
3. Add § 721.10231 to subpart E to
read as follows:
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§ 721.10231
Rutile, tin zinc, sodium-doped.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
rutile, tin zinc, sodium-doped (PMN P–
06–37; CAS No. 389623–07–8) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance that
have been incorporated into a polymer,
glass, dispersion, cementitious matrix,
or a similar incorporation.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(4), (a)(5), (a)(6)(i), (b) (concentration
set at 1.0 percent), and (c). The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of 10
meet the minimum requirements for
§ 721.63(a)(5):
(A) NIOSH-certified air-purifying,
tight-fitting half-face respirator
equipped with N100 (if oil aerosols
absent), R100, or P100 filters;
(B) NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped
with N100 (if oil aerosols absent), R100,
or P100 filters;
(C) NIOSH-certified powered airpurifying respirator equipped with a
loose-fitting hood or helmet and high
efficiency particulate air (HEPA) filters;
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(D) NIOSH-certified powered airpurifying respirator equipped with a
tight-fitting facepiece (either half-face or
full-face) and HEPA filters; or
(E) NIOSH-certified supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (either half-face or full-face).
(1) As an alternative to the respiratory
requirements listed in paragraph
(a)(2)(i), 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 these substances.
The NCEL is 1.5 mg/m3 as an 8-hour
time-weighted-average for both
chemical substances combined. 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.
(2) [Reserved]
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
1.0 percent), (f), (g)(1)(ii), (g)(2)(ii),
(g)(2)(iv) (use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 1.5 mg/m3),
and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture of
the substances with a particle size less
than 100 nanometers, where d10
particle size presents the particle size,
as determined by laser light scattering,
at which 10 percent by weight of the
substance measured is smaller).
(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), (d), (f), (g), (h), 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. 2011–33255 Filed 12–27–11; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2010–0279; FRL–9326–2]
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 section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for 17 chemical substances
which were the subject of
premanufacture notices (PMNs). Fifteen
of these chemical substances are subject
to TSCA section 5(e) consent orders
issued by EPA. This action would
require persons who intend to
manufacture, import, or process any of
these 17 chemical substances for an
activity that is designated as a
significant new use by this proposed
rule to notify EPA at least 90 days before
commencing that activity. The required
notification would provide EPA with
the opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
that activity before it occurs.
DATES: Comments must be received on
or before January 27, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2010–0279, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
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, Rm.
6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2010–0279.
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–
2010–0279. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
SUMMARY:
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Agencies
[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81441-81447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33255]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2010-1075; FRL-9329-4]
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
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623-01-
2) and rutile, tin zinc, sodium-doped (CAS No. 389623-07-8) which were
the subject of premanufacture notices (PMNs P-06-36 and P-06-37) and
TSCA section 5(e) consent orders issued by EPA. The proposed SNURs on
these substances, which are based on and consistent with the provisions
of the underlying consent orders, would designate as a significant new
use the absence of the protective measures required in the consent
orders. This action would require persons who intend to manufacture,
import, or process either 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 January 27, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID)
[[Page 81442]]
number EPA-HQ-OPPT-2010-1075, 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.
Attention: Docket ID Number EPA-HQ-OPPT-2010-1075. 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-
2010-1075. 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 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. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
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.
[[Page 81443]]
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 significant new use rules (SNURs) under section
5(a)(2) of TSCA for two chemical substances which were the subject of
PMNs and TSCA section 5(e) consent orders. The two chemical substances
are identified as rutile, tin zinc, calcium-doped (PMN P-06-36; CAS No.
389623-01-2) and rutile, tin zinc, sodium-doped (PMN P-06-37; CAS No.
389623-07-8). The proposed SNUR on these substances are based on and
consistent with the provisions in the underlying consent orders. The
proposed SNURs designate as a significant new use the absence of the
protective measures required in the corresponding consent orders. These
SNURs would require persons who intend to manufacture, import, or
process either 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 October 5, 2011 (76 FR 61566) (FRL-8880-
2), EPA issued direct final SNURs on these two chemical substances in
accordance with the procedures at Sec. 721.160(c)(3)(i). EPA received
notice of intent to submit adverse comments on these SNURs. Therefore,
as required by Sec. 721.160(c)(3)(ii), in the Federal Register of
December 5, 2011 (76 FR 75794) (FRL-9329-5), EPA withdrew the direct
final SNURs and is now issuing this proposed rule on the two chemical
substances. The record for the direct final SNURs on these substances
was established as docket EPA-HQ-OPPT-2010-1075. 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
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
two chemical substances that are the subject of these proposed SNURs,
EPA considered relevant information about the toxicity of the chemical
substances, likely human exposures and environmental releases
associated with possible uses, taking into consideration the four
bulleted TSCA section 5(a)(2) factors listed in this unit.
IV. Substances Subject to This Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for two 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.
Chemical Abstracts Service (CAS) number.
Basis for the TSCA section 5(e) consent order.
Toxicity concerns.
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.
This proposed rule concerns two PMN substances that are subject to
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I).
Those consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec. 721.160, and are based on and consistent with the provisions in
the underlying consent orders. The 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
PMN Numbers P-06-36 and P-06-37
Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-
06-37) Rutile, tin zinc, sodium-doped.
CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.
Effective date of TSCA section 5(e) consent order: February 17,
2009.
Basis for TSCA section 5(e) consent order: The PMN states that the
substances will be used as colorants for
[[Page 81444]]
polymers and industrial coatings. The order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that
the substances may present an unreasonable risk of injury to human
health. To protect against these risks, the consent order requires: Use
of personal respiratory equipment, including a National Institute for
Occupational Safety and Health (NIOSH)-certified respirator with an
Assigned Protection Factor (APF) of at least 10, or compliance with a
New Chemical Exposure Limit (NCEL) of 1.5 mg/m\3\ as an 8-hour time
weighted average; establishment of a hazard communication program; and
restricts the company from manufacturing the PMN substances with a d10
particle size less than 100 nanometers, where d10 particle size
presents the particle size, as determined by laser light scattering, at
which 10 percent by weight of the substance measured is smaller; and
corresponding recordkeeping. The SNUR designates as a ``significant new
use'' the absence of these protective measures.
Toxicity concern: Based on structural activity relationship
analysis derived from test data on structurally similar respirable,
poorly soluble particulates, the PMN substances may cause lung overload
and fibrosis in workers exposed to the PMN substances by the inhalation
route.
Recommended testing: EPA has determined that the following test
would help characterize the human health effects of the PMN substances:
A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in
rats. The testing should include a 60-day recovery period to assess the
progression or regression of any lesions; and include special attention
to histopathology (inflammation and cell proliferation) of the lung
tissues and to various parameters of the bronchoalveolar lavage fluid
(BALF), e.g., marker enzyme activities, total protein content, total
cell count, cell differential, and cell viability. The order does not
require submission of the aforementioned information at any specified
time or production volume. However, the order's restrictions on
manufacturing, import, processing, distribution in commerce, use, and
disposal of the PMN substances 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 721.10230 (P-06-36) and 40 CFR 721.10231 (P-
06-37).
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for these two chemical
substances, EPA concluded that regulation was warranted under TSCA
section 5(e), pending the development of information sufficient to make
reasoned evaluations of the human health effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The proposed SNUR provisions for these chemical substances
are consistent with the provisions of the TSCA section 5(e) consent
orders. These proposed SNURs are issued pursuant to Sec. 721.160.
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 Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this proposed
rule have undergone premanufacture review and are subject to TSCA
section 5(e) consent orders. The PMN submitters are prohibited by these
TSCA section 5(e) consent orders from undertaking activities which EPA
is proposing as significant new uses. EPA solicits comments on whether
any of the uses proposed as significant new uses are ongoing.
As discussed in the Federal Register issue of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
final, and then argue that the use was ongoing before the effective
date of the final rule. Thus, persons who begin commercial manufacture,
import, or processing activities with the chemical substances regulated
through this proposed SNUR must cease any such activity before the
effective date of the rule, if and when finalized. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person meets the
conditions of advance compliance under Sec. 721.45(h), the person is
considered exempt from the requirements of the SNUR.
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)
[[Page 81445]]
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. describes those tests. 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 and test reporting. To access the harmonized test
guidelines referenced in this document electronically, please go to
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
In the TSCA section 5(e) consent orders for the two chemical
substances regulated under this proposed rule, EPA has established
restrictions in view of the lack of data on the potential human health
risks that may be posed by the significant new uses or increased
exposure to the chemical substances. These restrictions will not be
removed until EPA determines that the unrestricted use will not present
an unreasonable risk of injury or result in significant or substantial
exposure or environmental release. This determination is usually made
based on the results of the required or recommended toxicity tests.
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. 721.25 and 720.40. 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-2010-1075.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for two chemical
substances that were the subject of PMNs and TSCA section 5(e) consent
orders. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (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. 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
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all
information currently available to EPA, it appears that no small or
large entities presently engage in such activities. A SNUR requires
that any person who intends to engage in such activity in the future
must first notify EPA by submitting a SNUN. Although some small
entities may decide to pursue a significant new use in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemicals substances, the Agency receives
only a handful of
[[Page 81446]]
SNUNs per year. For example, the number of SNUNs was four in Federal
fiscal year (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY
2008, and seven in FY 2009. During this 5-year period, three small
entities submitted a SNUN. In addition, the estimated reporting cost
for submission of a SNUN (see Unit VIII.) is minimal regardless of the
size of the firm. Therefore, EPA believes that the potential economic
impacts of complying with those SNURs are not expected to be
significant or adversely impact a substantial number of small entities.
In a SNUR that published in the Federal Register issue of June 2, 1997
(62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
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 affect on small governments subject to the requirements of
sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of
1995 (UMRA) (Pub. L. 104-4).
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
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, 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 Sec. [emsp14]721.10230 to subpart E to read as follows:
Sec. 721.10230 Rutile, tin zinc, calcium-doped.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rutile, tin zinc,
calcium-doped (PMN P-06-36; CAS No. 389623-01-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this rule do not
apply to quantities of the PMN substance that have been incorporated
into a polymer, glass, dispersion, cementitious matrix, or a similar
incorporation.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0
percent), and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of 10 meet the minimum requirements for Sec.
721.63(a)(5):
(A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(C) NIOSH-certified powered air-purifying respirator equipped with
a loose- fitting hood or helmet and high efficiency particulate air
(HEPA) filters;
(D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
(E) NIOSH-certified supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet, or
tight-fitting facepiece (either half-face or full-face).
(1) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), 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 these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances combined. 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.
(2) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72
[[Page 81447]]
(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f),
(g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.5 mg/m\3\), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture of the substances with a
particle size less than 100 nanometers, where d10 particle size
presents the particle size, as determined by laser light scattering, at
which 10 percent by weight of the substance measured is smaller).
(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), (d), (f), (g), (h), 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.
3. Add Sec. [emsp14]721.10231 to subpart E to read as follows:
Sec. 721.10231 Rutile, tin zinc, sodium-doped.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as rutile, tin zinc,
sodium-doped (PMN P-06-37; CAS No. 389623-07-8) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this rule do not apply to
quantities of the PMN substance that have been incorporated into a
polymer, glass, dispersion, cementitious matrix, or a similar
incorporation.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0
percent), and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of 10 meet the minimum requirements for Sec.
721.63(a)(5):
(A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(C) NIOSH-certified powered air-purifying respirator equipped with
a loose-fitting hood or helmet and high efficiency particulate air
(HEPA) filters;
(D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
(E) NIOSH-certified supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet, or
tight-fitting facepiece (either half-face or full-face).
(1) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), 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 these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances combined. 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.
(2) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0
percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 1.5 mg/m\3\), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture of the substances with a
particle size less than 100 nanometers, where d10 particle size
presents the particle size, as determined by laser light scattering, at
which 10 percent by weight of the substance measured is smaller).
(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), (d), (f), (g), (h), 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. 2011-33255 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P