Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Proposed Rules 70665 

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. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. 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 either 

electronically in http:// 

www.regulations.gov or in hard copy at 

the Office of Water Docket/EPA/DC, 

1301 Constitution Ave., NW., EPA West, 

Room 3334, Washington, DC. This 

Docket Facility is open from 8:30 a.m. 

until 4:30 p.m., EST, Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the Office of 

Water Docket is (202) 566–2426. 

FOR FURTHER INFORMATION CONTACT: 

Lemuel Walker, Engineering and 

Analysis Division (4303T), U.S. EPA, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460; (202) 566–1077; 

walker.lemuel@epa.gov. 

Dated: November 9, 2010. 

Nancy K. Stoner, 

Acting Assistant Administrator for Water. 

[FR Doc. 2010–29145 Filed 11–17–10; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 email. The regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an 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: TSCAHotline@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, 


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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 

§ 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 § 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 § 721.160(c)(3)(i). EPA 

received notice of intent to submit 

adverse comments on this SNUR. 

Therefore, as required by 

§ 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 

§ 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 § 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 


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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 § 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 socalled ‘‘5(e) SNUR’’ on this PMN 

substance is proposed pursuant to 

§ 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 § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

§ 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/m3 as an 8-hour timeweighted 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/m3 as an 8-hour 

time-weighted average. In addition, 

based on test data on analogous nickelcontaining 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. 


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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 § 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 § 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. 


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VIII. SNUN Submissions 

As stated in Unit II.C., according to 

§ 721.1(c), persons submitting a SNUN 

must comply with the same notice 

requirements and EPA regulatory 

procedures as persons submitting a 

PMN, including submission of test data 

on health and environmental effects as 

described in § 720.50. SNUNs must be 

submitted to EPA on EPA Form No. 

7710–25 in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. This form is available from the 

Environmental Assistance Division 

(7408M), 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 (see 

§§ 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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
70670 Federal Register / Vol. 75, No. 222 / Thursday, November 18, 2010 / Proposed Rules 

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 § 721.10201 to subpart E to 

read as follows: 

§ 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 § 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 

§ 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/m3

as an 8–hour time-weighted average. 

Persons who wish to pursue NCELs as 

an alternative to the § 721.63 respirator 

may request to do so under § 721.30. 

Persons whose § 721.30 requests to use 

the NCELs approach are approved by 

EPA will receive NCELs provisions 

comparable to those listed in the 

corresponding section 5(e) consent 

order. 

(ii) Hazard communication program. 

Requirements as specified in § 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 § 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 § 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 § 721.185 apply to this 

section. 

[FR Doc. 2010–29148 Filed 11–17–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2009–0108] 

Final Vehicle Safety Rulemaking and 

Research Priority Plan 2010–2013 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Notice of availability of updated 

plan. 

SUMMARY: This document announces the 

availability of the Final Vehicle Safety 

Rulemaking and Research Priority Plan 

2010–2013 (Priority Plan) in Docket No. 

NHTSA–2009–0108. This Priority Plan 

is an update to the Final Vehicle Safety 

Rulemaking and Research Priority Plan 

2009–2011 (October 2009 Plan) that was 

announced in the November 9, 2009, 

version of the Federal Register (74 FR 

57623). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Joseph Carra, Director of Strategic 

Planning and Integration, National 

Highway Traffic Safety Administration, 

Room W45–336, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

Telephone: 202–366–0361. E-mail: 

joseph.carra@dot.gov. 

SUPPLEMENTARY INFORMATION: On 

November 9, 2009, NHTSA published a 

Final Notice in the Federal Register (74 

FR 57623) announcing the availability 

of the October 2009 Plan. Today’s 

document announces the availability of 

the Final Vehicle Safety Rulemaking 

and Research Priority Plan 2010–2013. 

This plan is an internal management 

tool as well as a means to communicate 

to the public NHTSA’s highest priorities 

to meet the Nation’s motor vehicle 

safety challenges. Among them are 

programs and projects involving 

rollover crashes, children (both inside 

as well as just near vehicles), 

motorcoaches and fuel economy that 

must meet Congressional mandates or 

Secretarial commitments. Since these 

are expected to consume a significant 

portion of the agency’s rulemaking 

resources, they affect the schedules of 

the agency’s other priorities listed in 

this plan. This plan lists the programs 

and projects the agency anticipates 

working on even though there may not 

be a rulemaking planned to be issued by 

2013, and in several cases, the agency 

doesn’t anticipate that the research will 

be done by the end of 2013. Thus, in 

some cases the next step would be an 

agency decision in 2013 or 2014. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS