Document ID: EPA-HQ-OPPT-2009-0922-0152
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Cobalt Lithium Manganese Nickel Oxide
Posted Date: 2011-08-08T04:00Z

[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Rules and Regulations]
[Pages 47996-48002]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20021]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2009-0922; FRL-8878-2]
RIN 2070-AB27

Cobalt Lithium Manganese Nickel Oxide; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing 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 action requires persons who intend to manufacture, import, 
or process the chemical substance for a use that is designated as a 
significant new use by this final rule to notify EPA at least 90 days 
before commencing that activity. EPA believes that this action is 
necessary because the chemical substance may be hazardous to human 
health and the environment. 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: This final rule is effective September 7, 2011.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2009-0922. 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., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket 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: 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; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substance

[[Page 47997]]

which is the subject of this final rule. Potentially affected entities 
may include, but are not limited to:
     Manufacturers, importers, or processors of the subject 
chemical substance (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. For importers of the chemical substance subject 
to this SNUR, those requirements include the SNUR. The EPA policy in 
support of import certification appears at 40 CFR part 707, subpart B. 
In addition, any persons who export or intend to export the chemical 
substance that is the subject of this final rule are subject to the 
export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) (15 U.S.C. 
2604(a)(2)) for the chemical substance identified as cobalt lithium 
manganese nickel oxide (PMN P-04-269; CAS No. 182442-95-1). This action 
requires persons who intend to manufacture, import, or process the 
subject chemical substance for an activity that is designated as a 
significant new use by this final rule to notify EPA at least 90 days 
before commencing that activity.
    In the Federal Register issue of September 20, 2010 (75 FR 57169) 
(FRL-8839-7), EPA issued a direct final SNUR on the chemical substance. 
However, EPA received notices of intent to submit adverse comments on 
this SNUR. Therefore, as required by Sec.  721.160(c)(3)(ii), in the 
Federal Register issue of November 18, 2010 (75 FR 70583) (FRL-8853-2), 
EPA withdrew the direct final SNUR on the chemical substance and 
simultaneously proposed a SNUR using notice and comment procedures (75 
FR 70665) (FRL-8853-3). More information on the specific chemical 
substance subject to this final rule can be found in the direct final 
and proposed SNUR. The docket for this action, as well as the preceding 
direct final and proposed SNUR on this chemical substance, is found 
under docket ID number EPA-HQ-OPPT-2009-0922. That docket includes 
information considered by the Agency in developing this final rule, 
including public comments on the proposed and direct final rules.
    EPA received several comments on the proposed rule. A full 
discussion of EPA's response to these comments is included in Unit V. 
of this document. Taking into consideration these comments, EPA is 
issuing a final rule on this chemical substance that:
    1. Retains the proposed workplace protection, hazard communication, 
and release to water provisions as significant new uses.
    2. Retains the proposed recommended human health and environmental 
effects testing.
    3. Provides clarification on the exemptions from applicability of 
the SNUR. This exemption applies to quantities of the PMN substance 
after it has been completely reacted (cured).

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). 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 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.
    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. For importers of a chemical 
substance subject to a final SNUR those requirements include the SNUR. 
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 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. Rationale and Objectives of the Rule

A. Rationale

    During review of the chemical substance the subject of PMN P-04-
269, EPA concluded that regulation was warranted under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), pending the development of 
information sufficient to make reasoned evaluations of the human health 
and environmental effects of the chemical substance. 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 SNUR provisions for this chemical substance are consistent with the 
provisions of the TSCA section 5(e) consent order. This final SNUR is 
issued

[[Page 47998]]

pursuant to Sec.  721.160. For additional discussion on the rationale 
for this action, see Units II. and V. of this document.

B. Objectives

    EPA is issuing this final SNUR for a specific 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 final rule:
     EPA will 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 will 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 will be able to regulate prospective manufacture, 
import, or processing of the chemical substance before the described 
significant new use of that chemical substance occurs, provided that 
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
     EPA will ensure that all manufacturers, 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-line at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

IV. 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 subject to this final SNUR, EPA considered relevant 
information about the toxicity of the chemical substance, likely human 
exposures and environmental releases associated with possible uses, 
taking into consideration the four bulleted TSCA section 5(a)(2) 
factors listed in this unit.

V. Response to Comments on Proposed SNUR on Cobalt Lithium Manganese 
Nickel Oxide

    EPA received several public comments on the proposed rule. Of these 
comments, two commenters were supportive of EPA's findings and agreed 
with the issuance of this regulation. A discussion of the remaining 
substantive comments received and the Agency's responses follows.
    Comment 1: One commenter examined the solubility and release of 
cobalt and nickel ions in water to confirm the commenter's assumption 
that the PMN substance can be best described as an alloy, without the 
potential to release the individual ions. The commenter believes that 
the substance should therefore behave in the respiratory tract as an 
``inert'' dust, and recommended a time weighted average (TWA) of 1 mg/
m\3\ in accordance with ``similar compounds,'' rather than the 
Occupational Safety and Health Administration (OSHA) Permissible 
Exposure Level (PEL) of 0.1 mg/m\3\ for nickel. The commenter included 
solubility data with the submission for Agency review.
    Response: An alloy is a mixture of elemental metals. In contrast, 
based on submitted weight-fraction data, the PMN substance is 
characterized as a mixed-metal oxide, in which all of the metal species 
are oxidized (none exist in an elemental state) and accordingly would 
have the potential to dissociate into free metal ions upon release. 
Therefore, the Agency does not believe a change to the proposed New 
Chemicals Exposure Limit (NCEL) of 0.1 mg/m\3\ is supportable at this 
time. In addition, solubility data submitted by the commenter supports 
the Agency's predictions that the metals would be soluble well above 
the 1 part per billion (ppb) aquatic toxicity concentration of concern 
(COC) for the PMN substance in surface waters. As a result, EPA will 
retain the recommended human health and aquatic toxicity studies listed 
in the proposed rule.
    Comment 2: One commenter submitted a number of studies that were 
completed for a new chemical notification for cobalt lithium manganese 
nickel oxide for Belgium. Those studies included: An acute oral 
toxicity (Organisation for Economic Co-operation and Development (OECD) 
Test Guideline 420) in rats; an acute dermal toxicity (OECD Test 
Guideline 402) in rats; an acute dermal irritation (OECD Test Guideline 
404) in rabbits; an acute eye irritation (OECD Test Guideline 405) in 
rabbits; a local lymph node assay (OECD Test Guideline 429) in mice; a 
28-day repeated does oral (gavage) toxicity (OECD Test Guideline 407) 
in rats; a reverse mutation assay Ames Test (OECD Test Guideline 471) 
using Salmonella typhimurium and Escherichia coli; an in vitro 
chromosome aberration test (OECD Test Guideline 473) on human 
lymphocytes; and physical/chemical properties data for: melting/
freezing temperature (American Society for Testing and Materials (ASTM) 
E537-86, Method A1 of European Commission (EC) Directive 92/69/EEC); 
relative density (gas comparison pycnometer); water solubility (flask 
method); particle size distribution (OECD Test Guideline 110); 
flammability (EC Method A10); explosive properties (EC Method A14); 
oxidizing properties (EC Method A16); and relative self-ignition 
temperature for solids (EC Method A10)). The submitter stated that it 
believed information contained in the studies may be of use to the EPA 
in preparation of a final rule.
    Response: Summaries of the results of the aforementioned submitted 
data are included in the public docket at EPA-HQ-OPPT-2009-0922-0150. 
While the submitted information was informative, it did not change 
EPA's human health and environmental concerns for the chemical, for the 
reasons described as follows:
    a. Human health effects. EPA's primary human health concern for the 
PMN substance is lung carcinogenesis from respirable crystalline 
material. EPA determined that the acute oral and 28-day oral gavage 
studies had little bearing on those concerns. The physical-chemical 
data confirmed that the PMN substance is in the respirable range. The 
dermal and eye irritation studies indicate that the PMN substance is of 
low dermal toxicity, is not a skin irritant, does not pose a skin 
sensitization hazard, and is a minimal eye irritant (class 3 on a scale 
of 1 to 8). The substance is not a gene mutagen or a chromosome mutagen 
in human cells.
    b. Environmental effects. The submitted acute and chronic aquatic 
toxicity assessment was consistent with

[[Page 47999]]

the EPA toxicity profiles for the metals, from which the Agency derived 
the aquatic toxicity concern concentration of 1 ppb.
    Comment 3: One commenter believed that the release-to-water 
provision in the proposed SNUR, for requirements at Sec.  721.90 
(a)(1), (b)(1), and (c)(1), is an unreasonable and overbroad 
restriction that would lead to domestic manufacturers being subject to 
manufacturing limitations not applicable to their off-shore 
competitors. The comment stated that discharges of cobalt, lithium, 
manganese, and nickel oxide can be expected to be adequately regulated 
under a facility's pre-treatment or direct discharge permit issued 
under the Clean Water Act (CWA), which is specifically intended to 
regulate such discharges and ensure that effluent does not compromise 
aquatic organisms. Additionally, the comment stated that the PMN 
substance represents a battery technology that offers significant 
environmental benefits, based on the capability of storing much larger 
amounts of electricity, which will diminish the use of fossil fuels and 
power more sustainable and energy-efficient automobiles and other 
electronics. The comment requested that the release-to-water provision 
should either be eliminated altogether or revised to provide for no-
release-to-water without valid authorization under the CWA, or similar 
language that would allow dischargers operating under valid pre-
treatment or direct discharge permits to continue to operate as allowed 
under the terms of those CWA-issued permits.
    Response: Through the National Pollutant Discharge Elimination 
System (NPDES) Permit Program and the National Pretreatment Program, a 
component of the NPDES Permit Program, Federal, State, and local 
governments control water pollution by regulating point sources that 
discharge pollutants into waters of the United States. However, for the 
regulation of toxic pollutants, the NPDES Permit Program focuses on the 
CWA section 307(a)(1) list of priority pollutants (which do not include 
cobalt, lithium, or manganese). When a pollutant discharged by a direct 
or indirect discharging industry is not specifically limited in an 
effluent guideline or by pretreatment standards, respectively, it is up 
to the permit writer or state/local agency to utilize best professional 
judgment to establish technology-based limits or determine other 
appropriate means to control its discharge. Permit writers may not be 
aware of the discharge of certain toxic chemical substances by a 
specific facility, such as chemical substances that have been assessed 
under the TSCA New Chemicals Program and which may be discharged by 
manufacturers, processors, and users of the chemical substance. 
Therefore, EPA generally includes disposal provisions in new chemical 
SNURs when it determines that disposal of the substance may not be 
adequately addressed by existing rules under other statutes. However, 
the SNUR regulations in Sec.  721.30 provide the opportunity for 
persons who intend to manufacture, import, or process a chemical 
substance subject to a SNUR to request a ``determination of 
equivalency'' from EPA. In such a request, the person must demonstrate 
that their intended activities will provide substantially the same 
degree of protection to health and the environment as the measures 
identified in the SNUR to control environmental release. Similarly, a 
person who intends to manufacture, import, or process a chemical 
substance subject to a SNUR can submit a SNUN that provides such 
``equivalency'' information (e.g., specific NPDES or pretreatment 
limits for a specific facility or industry that will control the 
pollutants of concern).

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

    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 SNUR rather than as of the 
effective date of the final rule. If uses begun after publication were 
considered ongoing rather than new, it would be difficult for EPA to 
establish SNUR notice requirements because a person could defeat the 
SNUR by initiating the proposed significant new use before the rule 
became effective, and then argue that the use was ongoing before the 
effective date of the final rule.
    Any person who began commercial manufacture, import, or processing 
of the chemical substance PMN P-04-269 for any of the significant new 
uses designated in the proposed SNUR after the date of publication of 
the proposed SNUR must stop that activity before the effective date of 
this final rule. Persons who ceased those activities will have to meet 
all SNUR notice requirements and wait until the end of the notification 
review period, including all extensions, before engaging in any 
activities designated as significant new uses. If, however, persons who 
began manufacture, import, or processing of the chemical substance 
between the date of publication of the proposed SNUR and the effective 
date of this final SNUR meet the conditions of advance compliance as 
codified at Sec.  721.45(h), those persons would be considered to have 
met the final SNUR requirements for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. 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 Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In this case, EPA recommends 
persons, before performing any testing, to consult with the Agency 
pertaining to protocol selection.
    In the TSCA section 5(e) consent order for the chemical substance 
regulated under this final rule, EPA has established requirements for 
the use of dermal personal protective equipment, including gloves 
demonstrated to be impervious; 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 an alternative NCEL of 0.1 
mg/m\3\ as an 8-hour time weighted average; establishment of a hazard 
communication program, and prohibits releases-to-water in view of the 
lack of data on the potential health and environmental risks that may 
be posed by the significant new uses or increased exposure to the 
chemical substance. These requirements will remain until such time as 
the PMN submitter provides the results of toxicity tests that would 
permit a reasoned evaluation of the potential risks posed by the 
chemical substance. A listing of the specific human health and 
environmental toxicity tests specified in the TSCA section 5(e) consent 
order is included in Unit IV. of the proposed rule. The SNUR contains 
notification

[[Page 48000]]

requirements that mirror the restrictions in the TSCA section 5(e) 
consent order. Significant new uses under this SNUR are activities 
restricted in the TSCA section 5(e) consent order. Persons who intend 
to commence any of these activities identified as a significant new use 
must notify the Agency by submitting a SNUN at least 90 days in advance 
of commencement of non-exempt commercial manufacture, import, or 
processing.
    The recommended testing specified in Unit IV. of the proposed rule 
may not be the only means of addressing the potential risks of the 
chemical substance. However, SNUNs submitted without any test data may 
increase the likelihood that EPA will respond by taking 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 prior to submitting a SNUN.
    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 substance.
     Potential benefits of the chemical substance.
     Information on risks posed by the chemical substance 
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 
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 http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements 
for potential manufacturers, importers, and processors of the chemical 
substance during the development of the direct final rule. The Agency's 
complete economic analysis is available in the docket under docket ID 
number EPA-HQ-OPPT-2009-0922.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes a SNUR for a chemical substance that 
was the subject of a PMN and 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 is amending the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this final rule. This listing of 
the OMB control numbers and their subsequent codification in the CFR 
satisfies the display requirements of PRA and OMB's implementing 
regulations at 5 CFR part 1320. This Information Collection Request 
(ICR) was previously subject to public notice and comment prior to OMB 
approval, and given the technical nature of the table, EPA finds that 
further notice and comment to amend it is unnecessary. As a result, EPA 
finds that there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this 
table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    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 will 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, the Agency receives only a handful 
of notices 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 five-year period, three 
small entities submitted a SNUN. In addition, the estimated reporting 
cost for submission of a SNUN (see Unit IX.) is minimal regardless of 
the size of the firm. Therefore, 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

[[Page 48001]]

been impacted by these rulemakings, and EPA does not have any reasons 
to believe that any State, local, or Tribal government will be impacted 
by this final rule. As such, EPA has determined that this final rule 
does 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).

E. Executive Order 13132

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

F. Executive Order 13175

    This final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments, nor does it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply 
to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use and 
because this action is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    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).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: August 1, 2011.
Barbara A. Cunningham,
Acting Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. The table in Sec.  [emsp14]9.1 is amended by adding the following 
section in numerical order under the undesignated center heading 
``Significant New Uses of Chemical Substances'' to read as follows:

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10201...........................................           2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  [emsp14]721.10201 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-certified 
respirators meet the requirements of Sec.  721.63(a)(4): Supplied-air 
respirator operated in positive 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

[[Page 48002]]

(TSCA) section 5(e) consent order for this substance. The NCEL is 0.1 
mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue 
NCELs as an alternative to the Sec.  721.63 respirator may request to 
do as 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 chemical substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2011-20021 Filed 8-5-11; 8:45 am]
BILLING CODE 6560-50-P