47996 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Rules and Regulations 

patrol personnel. On-scene U.S. Coast 

Guard patrol personnel includes 

Commissioned, Warrant, and Petty 

Officers of the U.S. Coast Guard. 

Dated: July 18, 2011. 

R.V. Timme, 

Commander, U.S. Coast Guard, Captain of 

the Port Pittsburgh. 

[FR Doc. 2011–19997 Filed 8–5–11; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0505] 

Security Zone; 2011 Seattle Seafair 

Fleet Week Moving Vessels, Puget 

Sound, WA; Correction 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule; 

correction. 

SUMMARY: On July 11, 2011 the Coast 

Guard published a temporary final rule 

in the Federal Register (76 FR 40617), 

establishing temporary security zones 

around visiting foreign and domestic 

military vessels that are participating 

the 2011 Seattle’s Seafair Fleet Week. 

This document corrects the list of 

visiting military vessels for which the 

rule will establish security zones. 

DATES: This correction is effective from 

8 a.m. on August 3, 2011 through 5 p.m. 

on August 8, 2011. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this correction 

document, call or e-mail ENS Anthony 

P. LaBoy, Coast Guard Sector Puget 

Sound, Waterways Management 

Division; telephone 206–217–6323, email SectorPugetSoundWWM@uscg.mil. 

Correction 

In the temporary final rule FR Doc. 

2011–17261, beginning on page 40617 

in the Federal Register issue of July 11, 

2011, make the following corrections: 

1. In the SUMMARY section, on page 

40617, starting at the bottom of the 2nd 

column, correct the first sentence of the 

SUMMARY to read as follows: 

The U.S. Coast Guard is establishing 

temporary security zones around the 

HMCS WHITEHORSE (NCSM 705), 

HMCS NANAIMO (NCSM 702), CCGS 

SIYAY, and the USCGC ALERT (WMEC 

630) which include all waters within 

500 yards from the vessels while each 

vessel is participating in the Seafair 

Fleet Week Parade of Ships and while 

moored following the parade until 

departing on August 8, 2011. 

2. In the SUPPLEMENTARY INFORMATION

section, under the heading of 

‘‘Discussion of Rule,’’ in the first 

column on page 40618, correct the first 

sentence to read as follows: 

The temporary security zones established 

by this rule will prohibit any person or vessel 

from entering or remaining within 500 yards 

of the HMCS WHITEHORSE (NCSM 705), 

HMCS NANAIMO (NCSM 702), CCGS 

SIYAY, and the USCGC ALERT (WMEC 630) 

while these vessels are participating in the 

Parade of Ships and while moored at Pier 66, 

Terminal 25, and Terminal 46. 

3. In the regulatory text, starting in the 

second column on page 40619, correct 

§ 165.T13–186 (a) to read as follows: 

Location: The following areas are 

security zones: All waters within the 

Captain of the Port Puget Sound Zone 

encompassed within 500 yards of the 

HMCS WHITEHORSE (NCSM 705), 

HMCS NANAIMO (NCSM 702), CCGS 

SIYAY, and the USCGC ALERT (WMEC 

630) while each vessel is participating 

in the Seafair Fleet Week Parade of 

Ships and while moored at Pier 66, 

Terminal 25, and Terminal 46, Elliott 

Bay, Seattle, WA. 

Dated: July 27, 2011. 

S.J. Ferguson, 

Captain, U.S. Coast Guard, Captain of the 

Port, Puget Sound. 

[FR Doc. 2011–19995 Filed 8–5–11; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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: TSCAHotline@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 


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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 

§ 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 § 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 

§ 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 § 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 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 § 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 


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pursuant to § 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/m3 in 

accordance with ‘‘similar compounds,’’ 

rather than the Occupational Safety and 

Health Administration (OSHA) 

Permissible Exposure Level (PEL) of 0.1 

mg/m3 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/m3 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 Cooperation 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 


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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 

§ 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 energyefficient 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-towater 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 § 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 § 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 

§ 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/m3 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 


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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 nonexempt 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 § 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 on EPA Form 

No. 7710–25, generated using e-PMN 

software, and submitted to the Agency 

in accordance with the procedures set 

forth in §§ 721.25 and 720.40. E–PMN 

software is available electronically at 

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 


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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Rules and Regulations 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] 

■ 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. 

■ 2. The table in § 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: 

§ 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] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. 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-certified 

respirators meet the requirements of 

§ 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 


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48002 Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Rules and Regulations 

1Antelope Valley Air Quality Management 

District (AQMD), Bay Area AQMD, El Dorado 

County Air Pollution Control District (APCD), 

Imperial County APCD, Mojave Desert AQMD, San 

Joaquin Valley APCD, South Coast AQMD, Ventura 

County APCD, and Yolo-Solano AQMD. 

2Feather River AQMD, Placer County APCD, and 

Sacramento Metropolitan AQMD. 

3See WildEarth Guardians v. U.S. EPA (Case No. 

4:09–CV–02453–CW), Consent Decree dated 

November 10, 2009, as amended by Notice of 

Stipulated Extensions to Consent Decree Deadlines, 

dated April 28, 2011 (establishing July 10, 2011 

deadline for final action on element (3) of the 2007 

Transport SIP). The July 10, 2011 deadline was 

further extended to July 29, 2011 by Notice of 

Stipulated Extension to Consent Decree Deadlines, 

dated July 7, 2011. 

4Eastern Kern APCD and San Diego County 

APCD. 

(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 as 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 

chemical substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–20021 Filed 8–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2011–0211; FRL–9446–6] 

Approval and Promulgation of Air 

Quality Implementation Plans; State of 

California; Interstate Transport of 

Pollution; Interference With Prevention 

of Significant Deterioration 

Requirement 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing a limited 

approval and limited disapproval of a 

state implementation plan (SIP) revision 

submitted by the State of California on 

November 17, 2007, to address the 

‘‘transport SIP’’ provisions of Clean Air 

Act (CAA) section 110(a)(2)(D)(i) for the 

1997 8-hour ozone National Ambient 

Air Quality Standards (NAAQS or 

standards) and the 1997 fine particulate 

matter (PM2.5) NAAQS. Section 

110(a)(2)(D)(i) of the CAA requires that 

each SIP contain, among other things, 

adequate measures prohibiting 

emissions of air pollutants in amounts 

which will interfere with any other 

State’s measures required under title I, 

part C of the CAA to prevent significant 

deterioration of air quality. EPA is 

approving California’s SIP revision with 

respect to those Districts that implement 

SIP-approved permit programs meeting 

the approval criteria and simultaneously 

disapproving California’s SIP revision 

with respect to those Districts that do 

not implement SIP-approved permit 

programs meeting the approval criteria, 

as discussed in our May 31, 2011 

proposed rule (76 FR 31263). 

DATES: This final rule is effective 

September 7, 2011. 

ADDRESSES: EPA has established a 

docket for this action under EPA–R09– 

OAR–2011–0211. The index to the 

docket for this action is available 

electronically at http:// 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material) and 

some may not be available in either 

location (e.g., confidential business 

information (CBI)). To inspect the hard 

copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information the 

disclosure of which 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. 

FOR FURTHER INFORMATION CONTACT: Rory 

Mays, Air Planning Office (AIR–2), U.S. 

Environmental Protection Agency, 

Region IX, (415) 972–3227, 

mays.rory@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we’’, ‘‘us’’, and ‘‘our’’ refer to EPA. 

I. Summary of the Proposed Actions 

On May 31, 2011 (76 FR 31263), EPA 

proposed a limited approval and limited 

disapproval of a SIP revision submitted 

by the California Air Resources Board 

(CARB) on November 17, 2007, to 

address the ‘‘transport SIP’’ provisions 

of CAA section 110(a)(2)(D)(i) for the 

1997 8-hour ozone NAAQS and the 

1997 PM2.5 NAAQS (2007 Transport 

SIP). Specifically, EPA proposed a 

limited approval and limited 

disapproval of the 2007 Transport SIP 

with respect to the requirement in CAA 

section 110(a)(2)(D)(i)(II) that each SIP 

contain adequate measures prohibiting 

emissions of air pollutants in amounts 

which will interfere with any other 

State’s measures required under title I, 

part C of the CAA to prevent significant 

deterioration of air quality. We refer to 

this requirement as ‘‘element (3)’’ of 

section 110(a)(2)(D)(i). 

A. Proposed Action With Respect to 

1997 8-Hour Ozone NAAQS 

We proposed the following actions 

with respect to element (3) of CAA 

section 110(a)(2)(D)(i) for the 1997 

8-hour ozone NAAQS. For nine 

Districts 1 that are designated 

nonattainment and classified under 

subpart 2 of part D, title I of the CAA 

and that have SIP-approved 

nonattainment area new source review 

(NNSR) programs meeting the approval 

criteria discussed in our May 31, 2011 

proposed rule, we proposed to approve 

the 2007 Transport SIP. 

For three Districts 2 with 

nonattainment areas classified under 

subpart 2 for which NNSR SIP revisions 

were necessary to meet the approval 

criteria, we proposed to approve the 

2007 Transport SIP if we finalized 

approval of the required NNSR SIP 

revisions by our July 10, 2011 Consent 

Decree deadline for final action on 

element (3) of the 2007 Transport SIP.3

Alternatively, for any of these Districts 

for which we could not approve the 

required NNSR SIP revision by our July 

10, 2011 deadline, we proposed to 

disapprove the 2007 Transport SIP with 

respect to element (3) of CAA section 

110(a)(2)(D)(i) for the 1997 8-hour ozone 

NAAQS and to promulgate a limited 

NNSR Federal Implementation Plan 

(FIP) addressing the relevant 

requirements. 

For two Districts 4 with ‘‘former 

subpart 1’’ nonattainment areas that 

implement SIP-approved NNSR 

programs meeting the approval criteria, 


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