[Federal Register Volume 75, Number 222 (Thursday, November 18, 2010)]
[Proposed Rules]
[Pages 70665-70670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29148]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2009-0922; FRL-8853-3]
RIN 2070-AB27
Proposed Significant New Use Rule for Cobalt Lithium Manganese
Nickel Oxide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance identified as cobalt lithium manganese nickel oxide
(CAS No. 182442-95-1) which was the subject of premanufacture notice
(PMN) P-04-269. This proposed rule would require persons who intend to
manufacture, import, or process the substance for an activity that is
designated as a significant new use 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 December 20, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0922, by one of the following methods:
Federal eRulemaking Portal: http://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 Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2009-0922. 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-
2009-0922. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://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 e-
mail. 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail 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 http://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 http://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; e-mail address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import,
[[Page 70666]]
process, or use the chemical substance 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 this proposed rule on or
after December 20, 2010 are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec.
721.20), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. 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 a significant new use rule (SNUR) under section
5(a)(2) of TSCA for the chemical substance identified as cobalt lithium
manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1). This SNUR
would require persons who intend to manufacture, import, or process the
chemical substance for any activity designated as a significant new use
to notify EPA at least 90 days before commencing the activity.
In the Federal Register of September 20, 2010 (75 FR 57169) (FRL-
8839-7), EPA issued a direct final SNUR for the substance in accordance
with the procedures at Sec. 721.160(c)(3)(i). EPA received notice of
intent to submit adverse comments on this SNUR. Therefore, as required
by Sec. 721.160(c)(3)(ii), EPA is withdrawing the direct final SNUR,
which is published elsewhere in this Federal Register and is now
issuing this proposed SNUR on this substance. The record for the direct
final SNUR on this substance was established as docket EPA-HQ-OPPT-
2009-0922. 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 those listed in TSCA section 5(a)(2) (see
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. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to this SNUR 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.
Chemical importers are subject to the TSCA section 13 (15 U.S.C.
2612) import certification requirements codified 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 chemical
substances subject to a final SNUR must certify their compliance with
the SNUR requirements. The EPA
[[Page 70667]]
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 identified in a final SNUR are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec. 721.20) and must comply with the export notification requirements
in 40 CFR part 707, subpart D.
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
chemical substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, 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. Substance Subject to This Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for the chemical substance identified as cobalt lithium
manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1). The
specific activities proposed as significant new uses and other
requirements are listed in 40 CFR 721.10201 of the proposed regulatory
text.
The chemical substance cobalt lithium manganese nickel oxide (PMN
P-04-269; CAS No. 182442-95-1), is subject to a ``risk-based'' consent
order under TSCA section 5(e)(1)(A)(ii)(I) because EPA determined that
certain activities associated with the PMN substance may present an
unreasonable risk to human health and the environment. The consent
order requires protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. The so-called ``5(e) SNUR''
on this PMN substance is proposed pursuant to Sec. 721.160, and is
based on and consistent with the provisions in the underlying consent
order. The proposed 5(e) SNUR would designate as a ``significant new
use'' the absence of the protective measures required in the
corresponding consent order.
Where EPA determines that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order requires, among other
things, that potentially exposed employees wear specified respirators
unless actual measurements of the workplace air show that air-borne
concentrations of the PMN substance are below a New Chemical Exposure
Limit (NCEL) that is established by EPA to provide adequate protection
to human health. In addition to the actual NCEL concentration, the
comprehensive NCEL provisions in TSCA section 5(e) consent orders,
which are modeled after Occupational Safety and Health Administration
(OSHA) Permissible Exposure Limit (PEL) provisions, include
requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. 721.30. EPA expects that Sec. 721.30 requests will only be
granted where the NCEL provisions are comparable to those in the TSCA
section 5(e) consent order for the same chemical substance.
PMN Number P-04-269
Chemical name: Cobalt lithium manganese nickel oxide.
CAS number: 182442-95-1.
Effective date of TSCA section 5(e) consent order: May 12, 2009.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a battery cathode material. The order was
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA,
based on findings that this substance may present an unreasonable risk
of injury to human health and the environment. To protect against these
risks, the consent order requires use of dermal personal protective
equipment, including gloves demonstrated to be impervious; requires use
of respiratory personal protective equipment, including a National
Institute of Occupational Safety and Health (NIOSH)-approved respirator
with an assigned protection factor (APF) of at least 150, or compliance
with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted average; requires
establishment of a hazard communication program; and prohibits releases
to water. The proposed SNUR would designate as a ``significant new
use'' the absence of these protective measures.
Toxicity concern: Based on test data on nickel, lithium and cobalt,
EPA has concerns for developmental toxicity, mutagenicity,
oncogenicity, pulmonary oncogenicity, and lung overload for workers
with inhalation and dermal exposure to the PMN substance. EPA set the
NCEL at 0.1 mg/m\3\ as an 8-hour time-weighted average. In addition,
based on test data on analogous nickel-containing compounds, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 part per billion (ppb) of the PMN substance in surface waters.
Recommended testing: EPA has determined that the results of the
following tests would help characterize the human health and
environmental effects of the PMN substance: A 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465); a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS
Test Guideline 850.5400). All aquatic toxicity testing should be
performed using the static method with measured concentrations. Test
reports should include protocols approved by EPA, certificate of
analysis for the test substance, raw data, and results. 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 substance will remain in effect until the order
is modified or revoked by EPA based on submission of that or other
relevant information.
CFR citation: 40 CFR 721.10201.
[[Page 70668]]
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During the review of the chemical substance P-04-269, EPA concluded
that regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health or environmental effects of the chemical substances. The
basis for such findings is outlined in Unit IV. Based on these
findings, a TSCA section 5(e) consent order requiring the use of
appropriate exposure controls was negotiated with the PMN submitter.
The proposed SNUR provisions for this chemical substance are consistent
with the provisions of the TSCA section 5(e) consent order. This SNUR
is proposed pursuant to Sec. 721.160.
B. Objectives
EPA is proposing this SNUR for a chemical substance that has
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.
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 http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.
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 substance subject to this rule has
undergone premanufacture review. A TSCA section 5(e) consent order has
been issued where the PMN submitter is prohibited from undertaking
activities which EPA is designating 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 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 of
the proposed rule 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 of the chemical
substances that would be regulated as a ``significant new use'' through
this proposed rule, 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 (see Unit III.).
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under Sec. 721.45(h), the person
would be considered to have met the requirements of the final SNUR, for
those activities.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)). In the absence of a TSCA section 4 test rule or a TSCA
section 5(b)(4) listing covering the chemical substance, persons are
required only to submit test data in their possession or control and to
describe any other data known to or reasonably ascertainable by them
(see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency
has the authority to require appropriate testing. In the case of PMN P-
04-269, EPA issued a TSCA section 5(e) consent order that requires or
recommends certain testing. See Unit IV. of the proposed rule for a
list of 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. To access the OPPTS Test Guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
In the TSCA section 5(e) consent order for the chemical substance
cobalt lithium manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-
1) EPA has established restrictions in view of the lack of data on the
potential health and environmental risks that may be posed by the
significant new uses. These restrictions cannot be removed unless the
PMN submitter first submits the results of toxicity tests that would
permit a reasoned evaluation of the potential risks posed by this
chemical substance. A listing of the tests specified in the TSCA
section 5(e) consent order is included in Unit IV. The SNUR contains
the same restrictions as the TSCA section 5(e) consent order. Persons
who intend to begin nonexempt commercial manufacture, import, or
processing for any of the restricted activities must notify the Agency
by submitting a SNUN at least 90 days in advance of commencement of
that activity.
The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, submitting a SNUN
for a significant new use 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 would 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 substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
[[Page 70669]]
VIII. SNUN Submissions
As stated in Unit II.C., 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 to EPA on EPA Form No. 7710-25 in
accordance with the procedures set forth in Sec. Sec. 721.25 and
720.40. This form is available from the Environmental Assistance
Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001 (see Sec. Sec. 721.25 and 720.40). Forms and information are also
available electronically at http://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
this chemical substance at the time of the direct final rule. The
Agency's complete economic analysis is available in the public docket
under docket ID number EPA-HQ-OPPT-2009-0922.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This action proposes a SNUR for a new chemical substance that was
the subject of 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
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 rationale supporting this
conclusion is discussed in this unit. 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 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 over 1,400 SNURs, the
Agency receives on average only 5 notices per year. Of those SNUNs
submitted from 2006-2008, only one appears to be from a small entity.
In addition, the estimated reporting cost for submission of a SNUN (see
Unit XII.) is minimal regardless of the size of the firm. Therefore,
EPA 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 will 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 or 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
[[Page 70670]]
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: November 10, 2010.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
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. 721.10201 to subpart E to read as follows:
Sec. 721.10201 Cobalt lithium manganese nickel oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cobalt lithium
manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the PMN substance after it has been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6), (b)
(concentration set at 0.1 percent), and (c). Respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 150. The following NIOSH-approved
respirators meet the requirements of Sec. 721.63(a)(4): Supplied-air
respirator operated in pressure demand or other positive pressure mode
and equipped with a tight-fitting full facepiece. As an alternative to
the respirator requirements listed here, a manufacturer, importer, or
processor may choose to follow the New Chemical Exposure Limit (NCEL)
provisions listed in the Toxic Substances Control Act (TSCA) section
5(e) consent order for this substance. The NCEL is 0.1 mg/m[sup3] as an
8-hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator 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 listed in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(1)(ix), (g)(2),
(g)(3), (g)(4)(iii), and (g)(5).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (f), (g), (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.
[FR Doc. 2010-29148 Filed 11-17-10; 8:45 am]
BILLING CODE 6560-50-P