Document ID: EPA-HQ-OPPT-2009-0922-0144
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rule: Cobalt Lithium Manganese Nickel Oxide
Posted Date: 2010-11-18T05:00Z

[Federal Register: November 18, 2010 (Volume 75, Number 222)]
[Proposed Rules]               
[Page 70665-70670]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no10-19]                         

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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: 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. 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