Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Rules and Regulations 47877 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions which do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves the establishment of a safety 

zone. 

An environmental analysis checklist 

and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: Authority: 33 U.S.C. 1226, 

1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 

U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04– 

6, and 160.5; Public Law 107–295; 116 Stat. 

2064; Department of Homeland Security 

Delegation No. 0170.1. 

■ 2. Add a new temporary section 

§ 165.T11–233 to read as follows: 

§ 165.T11–233 Safety Zone; Naval Training 

October and November; San Clemente 

Island, CA. 

(a) Location. The limits of the safety 

zone will be the navigable waters of the 

Pacific Ocean at the north end of San 

Clemente Island bounded by the 

following coordinates: 

33°01.09′ N, 118°36.34′ W; 

32°59.95′ N, 118°39.77′ W; 

running parallel to the shoreline at 

approximately 3 NM to 33°02.81′ N, 

118°30.65′ W; 33°01.29′ N, 118°33.88′ 

W; along the shoreline to 33°01.09′ N, 

118°36.34′ W. 

(b) Enforcement Period. This section 

will be enforced from October 1, 2009 

through November 30, 2009 during 

naval training exercises. If the training 

is concluded prior to the scheduled 

termination time, the COTP will cease 

enforcement of this safety zone and will 

announce that fact via Broadcast Notice 

to Mariners. 

(c) Definitions. The following 

definitions apply to this section: 

Designated representative, means any 

Commissioned, Warrant, or Petty 

Officers of the Coast Guard, Coast Guard 

Auxiliary, or local, state, and federal 

law enforcement vessels who have been 

authorized to act on the behalf of the 

COTP; non-authorized personnel and 

vessels, means any civilian vessels, 

fishermen, divers, and swimmers. 

(d) Regulations. (1) Entry into, transit 

through or anchoring within this safety 

zone is prohibited unless authorized by 

the COTP San Diego or his designated 

representative. 

(2) Non-authorized personnel and 

vessels requesting permission to transit 

through the safety zone may request 

authorization to do so from the COTP 

San Diego or his designated 

representative. They may be contacted 

on VHF–FM Channel 16, or at telephone 

number (619) 278–7033. 

(3) Naval units involved in the 

exercise are allowed in confines of the 

established safety zone. 

(4) All persons and vessels shall 

comply with the instructions of the 

Coast Guard COTP or his designated 

representative. 

(5) Upon being hailed by U.S. Coast 

Guard or other official personnel by 

siren, radio, flashing light, or other 

means, the operator of a vessel shall 

proceed as directed. 

(6) The Coast Guard may be assisted 

by other federal, state, or local agencies 

including the U.S. Navy. 

Dated: August 31, 2009. 

T.H. Farris, 

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

Port San Diego. 

[FR Doc. E9–22463 Filed 9–17–09; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2009–0729; FRL–8430–3] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

section 5(a)(2) of the Toxic Substances 

Control Act (TSCA) for 12 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Two of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture, import, or 

process any of these 12 chemical 

substances for an activity that is 

designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: The effective date of this rule is 

November 17, 2009 without further 

notice, unless EPA receives written 

adverse or critical comments, or notice 

of intent to submit adverse or critical 

comments before October 19, 2009. This 

rule shall be promulgated for purposes 

of judicial review at 1 p.m. (e.s.t.) on 

October 2, 2009. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

October 19, 2009, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30–day period for public 

comment. 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule September 18, 

2009. See the discussion in Unit VII. for 

more specific details. 

Any persons intending to import or 

export a chemical substance that is the 

subject of this rule on or after October 

19, 2009 are subject to the TSCA section 

13 import certification requirements and 

the export notification provisions of 

TSCA section 12(b). See the discussion 

in Unit I.A. and Unit II.C. for more 

specific details. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2009–0729, 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 


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Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2009–0729. 

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– 

2009–0729. 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 website 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 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Tracey Klosterman, 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– 

2209; e-mail address: 

klosterman.tracey@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, 

process, or use the chemical substances 

contained in this 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 and 19 CFR 

127.28 (the corresponding EPA policy 

appears at 40 CFR part 707, subpart B). 

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 these SNURs must 

certify their compliance with the SNUR 

requirements. In addition, any persons 

who export or intend to export a 

chemical substance that is the subject of 

this rule on or after October 19, 2009 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. 


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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 promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

of April 24, 1990 (55 FR 17376). Consult 

that preamble for further information on 

the objectives, rationale, and procedures 

for SNURs and on the basis for 

significant new use designations, 

including provisions for developing test 

data. 

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. The mechanism 

for reporting under this requirement is 

established under § 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 

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. 1612) 

import certification requirements 

promulgated at 19 CFR 12.118 through 

12.127, and 19 CFR 127.28 (the 

corresponding EPA policy appears at 40 

CFR part 707, subpart B). 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. 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. 2612 (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 authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 12 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four factors listed in TSCA section 

5(a)(2) and this unit. 

IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

12 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• CAS number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or, for non-section 5(e) 

SNURs, the basis for the SNUR (i.e., 

SNURs without TSCA section 5(e) 

consent orders). 

• Toxicity concerns. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes 2 PMN substances 

that are subject to ‘‘risk-based’’ consent 

orders under TSCA section 

5(e)(1)(A)(ii)(I) where EPA determined 

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The socalled ‘‘5(e) SNURs’’ on these PMN 

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 


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measures required in the corresponding 

consent orders. 

Where EPA determined 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 usually 

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 NCELs provisions in 

TSCA section 5(e) consent orders, 

which are modeled after Occupational 

Safety and Health Administration 

(OSHA) Permissible Exposure Limits 

(PELs) 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 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 10 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

EPA did not find that the use scenario 

described in the PMN triggered the 

determinations set forth under TSCA 

section 5(e). EPA, however, does believe 

that certain changes from the use 

scenario described in the PMN could 

result in increased exposures, thereby 

constituting a ‘‘significant new use.’’ 

These so-called ‘‘non-5(e) SNURs’’ are 

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

stipulated in § 721.170(c)(2), i.e., these 

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–05–775 

Chemical name: Benzeneethanol,halo- 

,halocycloalkyl-,hydrazinealkyl- 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 8, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an intermediate used in a 

closed process. The order was issued 

under sections 5(e)(1)(A)(i) and 

5(e)(1)(A)(ii)(I) of TSCA based on a 

finding that this substance may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against this risk, the consent order 

requires dermal protection, hazard 

communication, and water release 

restrictions. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data on 

the PMN substance, analogous 

hydrazines and other (confidential) 

moieties of the PMN substance, EPA 

identified concerns for mutagenicity, 

skin sensitization, liver toxicity, kidney 

toxicity, neurotoxicity, and eye 

irritation from dermal exposure. 

Further, based on test data for analogous 

hydrazines, EPA predicts aquatic 

toxicity at concentrations that exceed 

0.1 parts per billion (ppb) from releases 

of the PMN substance to the 

environment. 

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 fish 

early-life stage toxicity test (OPPTS 

Harmonized Test Guideline 850.1400); a 

daphnid chronic toxicity test (OPPTS 

Harmonized Test Guideline 850.1300); 

an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400); a repeated dose oral toxicity 

in rodents with reproductive, 

developmental and neurotoxicity 

screening (Organisation for Economic 

Co-operation and Development (OECD) 

422 test guideline) for a duration of 90– 

days; a bacterial reverse mutation test 

(OPPTS Harmonized Test Guideline 

870.5100); and a mammalian 

erythrocyte micronucleus test (OPPTS 

Harmonized Test Guideline 870.5395) 

via the intraperitoneal route. Depending 

upon the results of mutagenicity testing, 

a two year carcinogenicity study 

(OPPTS Harmonized Test Guideline 

870.4200) may be warranted. Further, a 

certificate of analysis should be 

provided for the test substance. The 

order does not require the submission of 

the aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacture, 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 721.10157. 

PMN Number P–06–16 

Chemical name: 2-Pentanone, 3,5- 

dichloro-. 

CAS number: 58371–98–5. 

Effective date of TSCA section 5(e) 

consent order: May 8, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an intermediate used in a 

closed process. The order was issued 

under sections 5(e)(1)(A)(i) and 

5(e)(1)(A)(ii)(I) of TSCA based on a 

finding that this substance may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against this risk, the consent order 

requires dermal and respiratory 

protection, hazard communication, and 

water release restrictions. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Toxicity concern: Based on test data on 

the PMN substance and analogous 

haloketones, EPA identified concerns 

for acute inhalation toxicity, 

mutagenicity, developmental toxicity, 

skin sensitization, systemic toxicity, and 

neurotoxicity from inhalation or dermal 

exposure. Further, based on test data on 

analogous neutral organic chemicals 

and haloketones, and potential excess 

toxicity due to reactivity (hydrolysis), 

EPA predicts aquatic toxicity at 

concentrations that exceed 0.1 ppb 

resulting from releases of the PMN 

substance to the environment. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

possible human health and 

environmental effects of the PMN 

substance: A fish early-life stage toxicity 

test (OPPTS Harmonized Test Guideline 

850.1400); a daphnid chronic toxicity 

test (OPPTS Harmonized Test Guideline 

850.1300); an algal toxicity test, tiers I 

and II (OPPTS Harmonized Test 

Guideline 850.5400); a repeated dose 

oral toxicity in rodents with 

reproductive, developmental and 

neurotoxicity screening (OECD 422 test 

guideline) for a duration of 90–days; a 


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bacterial reverse mutation test (OPPTS 

Harmonized Test Guideline 870.5100); 

and a mammalian erythrocyte 

micronucleus test (OPPTS Harmonized 

Test Guideline 870.5395) via the 

intraperitoneal route. Depending upon 

the results of mutagenicity testing, a 2– 

year carcinogenicity study (OPPTS 

Harmonized Test Guideline 870.4200) 

may be warranted. Further, a certificate 

of analysis should be provided for the 

test substance. The order does not 

require the submission of the 

aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacture, 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 721.10158. 

PMN Number P–07–587 

Chemical name: 1-Docosanamine, N,Ndimethyl-. 

CAS number: 21542–96–1. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on test data on the 

PMN substance and analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(4)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test mitigated by humic 

acid (OPPTS Harmonized Test 

Guideline 850.1085) would help 

characterize the environmental effects of 

the PMN substance. The test substance 

should be the chloride salt of the PMN 

substance at pH 7. Further, a certificate 

of analysis should be provided for the 

test substance. 

CFR citation: 40 CFR 721.10159. 

PMN Number P–07–629 

Chemical name: Poly(oxy-1,2- 

ethanediyl), .alpha.-[(13Z)-1-oxo-13-

docosen-1-yl]-.omega.-[[(13Z)-1-oxo-13- 

docosen-1-yl]oxy]-. 

CAS number: 56565–72–1. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a polymer additive. 

Based on test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the PMN substance in surface waters. 

For the use described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 20 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance other than as described in the 

PMN could result in exposures which 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS 

Harmonized Test Guideline 835.3110); a 

fish acute toxicity test (OPPTS 

Harmonized Test Guideline 850.1075); 

an aquatic invertebrate acute toxicity 

test with freshwater daphnids (OPPTS 

Harmonized Test Guideline 850.1010); 

and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400) would help characterize the 

environmental effects of the PMN 

substance. Aquatic toxicity testing 

should be performed using the static 

method with nominal concentrations. 

Further, a certificate of analysis should 

be provided for the test substance. 

CFR citation: 40 CFR 721.10160. 

PMN Number P–08–3 

Chemical name: Substituted silyl 

methacrylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as an 

intermediate for a paint binder. Based 

on test data on analogous acrylates and 

neutral organic chemicals, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

hydrolysis as a function of pH test 

(OPPTS Harmonized Test Guideline 

835.2120) and a ready biodegradability 

test (OPPTS Harmonized Test Guideline 

835.3110) would help characterize the 

possible fate attributes of the PMN 

substance. If the results of the ready 

biodegradation test demonstrate that the 

hydrolysis product remains intact, then 

a shake-flask die-away test (OPPTS 

Harmonized Test Guideline 835.3170) 

and a fish bioconcentration test (OPPTS 

Harmonized Test Guideline 850.1730) 

may be warranted. Further, a certificate 

of analysis should be provided for the 

test substance. 

CFR citation: 40 CFR 721.10161. 

PMN Number P–08–24 

Chemical name: 1,3 Dioxolane-4- 

butanol, 2-ethenyl-. 

CAS number: 2421–08–1. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a crosslinking agent 

to be ultimately used in the manufacture 

of automotive and aircraft coating 

materials. Based on test data on an 

expected hydrolysis product for an 

analogous chemical, EPA has concerns 

for mutagenicity, oncogenicity, 

developmental toxicity, liver toxicity, 

kidney toxicity, and skin sensitization 

and irritation for the PMN substance. As 

described in the PMN, significant 

worker exposure is not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance other than as described in the 

PMN could result in exposures which 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a repeated 

dose 28–day oral toxicity study (OPPTS 

Harmonized Test Guideline 870.3050) 

in rodents would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10162. 

PMN Number P–08–33 

Chemical name: Chloro fluoro alkane 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. EPA identified health and 

environmental concerns because the 

substance may be a persistent, 

bioaccumulative, and toxic (PBT) 

chemical, based on physical/chemical 

properties of the PMN substance, as 


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described in the New Chemicals 

Program’s PBT Category (64 FR 60194; 

November 4, 1999) (FRL–6097–7). EPA 

estimates that the PMN substance will 

persist in the environment for more than 

six months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Also, based on test 

data on analogous haloalkanes, EPA 

predicts toxicity to aquatic organisms. 

As described in the PMN, significant 

worker exposure is unlikely and the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

processing or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture, exceedance of the annual 

import volume limit of 50,000 

kilograms, or any predictable or 

purposeful release containing the PMN 

substance into the waters of the United 

States may cause serious health effects 

and significant adverse environmental 

effects, since the PMN substance has 

been characterized by EPA as a PBT. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170 (b)(3)(ii), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the tiered 

testing as described in the New 

Chemicals Program’s PBT Category 

would help characterize the PBT 

attributes of the PMN substance. The 

fish bioconcentration factor (BCF) test 

should be conducted using the flow 

through method with measured 

concentrations and include a certificate 

of analysis for the test substance 

showing percentage and level of 

impurities; measured BCF should be 

based on 100% active ingredient and 

measured concentrations. 

CFR citation: 40 CFR 721.10163. 

PMN Number P–08–36 

Chemical name: 

Benzenecarboximidamide, N-hydroxy-4- 

nitro-. 

CAS number: 1613–86–1. 

Basis for action: The PMN states that the 

substance will be used as a chemical 

intermediate. Based on test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

400 ppb of the PMN substance in 

surface waters. As described in the 

PMN, the substance is not expected to 

be released to surface waters. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in release to surface waters 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test (OPPTS Harmonized 

Test Guideline 850.1075); an aquatic 

invertebrate acute toxicity test with 

freshwater daphnids (OPPTS 

Harmonized Test Guideline 850.1010); 

and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400) would help characterize the 

environmental effects of the PMN 

substance. Fish and daphnia testing 

should be performed using the flow 

through method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10164. 

PMN Number P–08–138 

Chemical name: Carbonotrithioic acid, 

bis(phenylmethyl) ester. 

CAS number: 26504–29–0. 

Basis for action: The PMN states that the 

substance will be used as a chain 

transfer agent. EPA identified health 

and envronmental concerns because the 

substance may be a PBT chemical, based 

on physical/chemical properties of the 

PMN substance, as described in the New 

Chemicals Program’s PBT Category (64 

FR 60194, November 4, 1999). EPA 

estimates that the PMN substance will 

persist in the environment for more than 

two months and estimates a 

bioaccumulation factor of greater than 

or equal to 5,000. Also, based on test 

data for analogous esters, EPA predicts 

toxicity to aquatic organisms. As 

described in the PMN, significant 

worker exposure is unlikely and the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

processing or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture or any predictable or 

purposeful release containing the PMN 

substance into the waters of the United 

States may cause serious health effects 

and significant adverse environmental 

effects, since the PMN substance has 

been characterized by EPA as a PBT. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170 (b)(3)(ii), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the tiered 

testing described in the New Chemicals 

Program’s PBT Category would help 

characterize the PBT attributes of the 

PMN substance. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10165. 

PMN Number P–08–180 

Chemical name: 1,3-Cyclohexanedione, 

2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-

trifluoroethoxy)methyl]benzoyl]-, ion(1- 

), potassium salt (1:1). 

CAS number: 1121649–70–4. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a precursor to 

another chemical substance. Based on 

test data on the PMN substance, EPA 

has concerns for developmental and 

systemic toxicity in humans. EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

0.1 ppb of the PMN substance in surface 

waters. As described in the PMN, 

significant worker exposure is not 

expected for the use described and the 

substance will not be released to surface 

waters in amounts resulting in surface 

water concentrations that exceed 0.1 

ppb. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface waters 

concentrations that exceed 0.1 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i) and 

(b)(4)(i). 

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 porous 

pot test (OPPTS Harmonized Test 

Guideline 835.3220); and either (1) a 

sediment/water microcosm 

biodegradation test (OPPTS Harmonized 

Test Guideline 835.3180), (2) a sitespecific aquatic microcosm test, 

laboratory (OPPTS Harmonized Test 

Guideline 850.1925), or (3) a field 

testing for aquatic organisms (OPPTS 

Harmonized Test Guideline 850.1950). 

CFR citation: 40 CFR 721.10166. 

PMN Number P–08–212 

Chemical name: Tetrafluoro 

nitrotoluene (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on test data on 

analogous neutral organic chemicals, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 200 ppb of the PMN 

substance in surface waters. As 

described in the PMN, the substance is 

not expected to be released to surface 


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waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test (OPPTS Harmonized 

Test Guideline 850.1075); an aquatic 

invertebrate acute toxicity test with 

freshwater daphnids (OPPTS 

Harmonized Test Guideline 850.1010); 

and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400) would help characterize the 

environmental effects of the PMN 

substance. Fish and daphnia testing 

should be performed using the flowthrough method with measured 

concentrations. Algal testing should be 

preformed using the static method with 

measured concentrations. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10167. 

PMN Number P–08–275 

Chemical name: Cesium tungsten oxide. 

CAS number: 52350–17–1. 

Basis for action: The PMN states that the 

substance will be used as a component 

of infrared absorption material. Based 

on test data on analogous crystalline 

respirable, poorly soluble particulates, 

EPA has concerns for lung overload and 

lung cancer for the PMN substance. As 

described in the PMN, significant 

worker exposure is unlikely as dermal 

absorption is not expected and 

inhalation exposures are expected to be 

negligible because the PMN substance is 

used in aqueous form. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

manufacturing, processing, or use of the 

substance as a solid may cause serious 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

(b)(1)(i)(C) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity study (OPPTS 

Harmonized Test Guideline 870.3465) 

with a 60–day holding period in rats 

and with special attention to the 

histopathology of the lungs would help 

characterize the human health effects of 

the PMN substance. Depending on the 

results of this testing, a 2–year 

inhalation carcinogenicity study 

(OPPTS Harmonized Test Guideline 

870.4200) may be warranted. 

CFR citation: 40 CFR 721.10168. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 2 of the 12 chemical substances, 

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, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160. 

In the other 10 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this 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 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. 

• 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 the 

Internet at http://www.epa.gov/opptintr/ 

newchems/pubs/invntory.htm. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

§ 721.160(c)(3) and § 721.170(d)(4). In 

accordance with § 721.160(c)(3)(ii) and 

§ 721.170(d)(4)(i)(B), the effective date 

of this rule is November 17, 2009 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

October 19, 2009. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

October 19, 2009, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30–day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

2 chemical substances and the PMN 

submitters are prohibited by the TSCA 

section 5(e) consent orders from 

undertaking activities which EPA is 

designating as significant new uses. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 


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other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 4 of the 12 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

has received a limited number of postPMN bona fide submissions (per 

§ 720.25 and § 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the Federal Register 

of April 24, 1990, 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 this direct final rule 

rather than as of the effective date of the 

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 significant new use 

before the rule became effective, and 

then argue that the use was ongoing 

before the effective date of the rule. 

Thus, persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through this SNUR will have to cease 

any such activity before the effective 

date of this rule. 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 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN, except where the chemical 

substance subject to the SNUR is also 

subject to a test rule under TSCA 

section 4 (see TSCA section 5(b)). 

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 cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. 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. Many OPPTS Harmonized 

Test Guidelines are now available on 

the Internet at http://www.epa.gov/ 

opptsfrs/home/guidelin.htm. The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits 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 substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. Listings of 

the tests specified in the TSCA section 

5(e) consent orders are included in Unit 

IV. The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture, import, or 

processing. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUNs submitted 

for significant new uses 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 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 substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI. This rule cross-references 

§ 721.1725(b)(1) and is similar to that in 

§ 721.11 for situations where the 

chemical identity of the chemical 

substance subject to a SNUR is CBI. This 

procedure is cross-referenced in each 

SNUR that includes specific significant 

new uses that are CBI. 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

would not be a significant new use, i.e., 

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 


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EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. 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 40 CFR 720.50. SNUNs 

must be mailed to the Environmental 

Protection Agency, OPPT Document 

Control Office (7407M), 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Information must be 

submitted in the form and manner set 

forth in EPA Form No. 7710–25. 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/pubs/ 

pmnforms.htm. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this rule. EPA’s complete 

economic analysis is available in the 

docket. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or TSCA 

section 5(e) consent orders. 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 the 

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 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 these 

SNURs will 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 1,000 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 XI.) 

is minimal regardless of the size of the 

firm. Therefore, EPA believes that the 

potential economic impacts of 

complying with these SNURs 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 

rule. As such, EPA has determined that 

this rule does 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) (Public 

Law 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). 


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F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This does not 

significantly or 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 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). 

XIII. 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, which includes a 

copy of the rule, to each House of the 

Congress and to 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: September 11, 2009. 

Wendy C. Hamnett, 

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 sections 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 

* * * * * 

721.10157 ....................... 2070–0012 

721.10158 ....................... 2070–0012 

721.10159 ....................... 2070–0012 

721.10160 ....................... 2070–0012 

721.10161 ....................... 2070–0012 

721.10162 ....................... 2070–0012 

721.10163 ....................... 2070–0012 

721.10164 ....................... 2070–0012 

721.10165 ....................... 2070–0012 

40 CFR citation OMB control No. 

721.10166 ....................... 2070–0012 

721.10167 ....................... 2070–0012 

721.10168 ....................... 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. By adding new § 721.10157 to 

subpart E to read as follows: 

§ 721.10157 Benzeneethanol, 

halo-,halocycloalkyl-,hydrazinealkyl- 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzeneethanol,halo- 

,halocycloalkyl-,hydrazinealkyl (PMN 

P–05–775) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (b) 

(concentration set at 1.0%), and (c). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (e) (concentration set at 

1.0%), (f), (g)(1)(i) (eye irritation), 

(g)(1)(iii), (g)(1)(iv), (g)(1)(viii) 

(sensitization), (g)(1)(ix), (g)(2)(i), 

(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4) 

(resulting in receiving stream levels 

exceeding 0.1 parts per billion (ppb)), 

and (g)(5). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=0.1). 

(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. 

■ 5. By adding new § 721.10158 to 

subpart E to read as follows: 

§ 721.10158 2-Pentanone, 3,5-dichloro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 


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(1) The chemical substance identified as 

2-pentanone, 3,5-dichloro- (PMN P–06– 

16; CAS No. 58371–98–5) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), 

(a)(5), (a)(6), (b) (concentration set at 

1.0%), and (c). Respirators must provide 

a National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor (APF) of at least 50. 

The following NIOSH-approved 

respirator with an APF of 50 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-approved airpurifying, tight-fitting full facepiece 

respirator equipped with combination 

organic gas/vapor P100 cartridges 

(organic vapor, acid gas, or substancespecific). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(a), (b), (c), (d), (e) (concentration set at 

1.0%), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), 

(g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), 

(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 

(g)(3)(i), (g)(3)(ii), (g)(4) (resulting in 

receiving stream levels exceeding 0.1 

parts per billion (ppb)), and (g)(5). 

(iii) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=0.1). 

(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. 

■ 6. By adding new § 721.10159 to 

subpart E to read as follows: 

§ 721.10159 1-Docosanamine, N,Ndimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-docosanamine, N,N-dimethyl- (PMN 

P–07–587; CAS No. 21542–96–1) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(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), 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. 

■ 7. By adding new § 721.10160 to 

subpart E to read as follows: 

§ 721.10160 Poly(oxy-1,2-ethanediyl), 

.alpha.-[(13Z)-1-oxo-13-docosen-1-yl]-.

omega.-[[(13Z)-1-oxo-13-docosen-1-yl]oxy]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,2-ethanediyl), .alpha.-[(13Z)-

1-oxo-13-docosen-1-yl]-.omega.-[[(13Z)-

1-oxo-13-docosen-1-yl]oxy]- (PMN P– 

07–629; CAS No. 56565–72–1) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(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), and (i) 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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

■ 8. By adding new § 721.10161 to 

subpart E to read as follows: 

§ 721.10161 Substituted silyl methacrylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted silyl 

methacrylate (PMN P–08–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(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), 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. 

■ 9. By adding new § 721.10162 to 

subpart E to read as follows: 

§ 721.10162 1,3 Dioxolane-4-butanol, 2- 

ethenyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3 dioxolane-4-butanol, 2-ethenyl- 

(PMN P–08–24; CAS No. 2421–08–1) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(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), and (i) 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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to this section. 

■ 10. By adding new § 721.10163 to 

subpart E to read as follows: 

§ 721.10163 Chloro fluoro alkane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as chloro fluoro alkane 

(PMN P–08–33) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f) and (s) (50,000 

kilograms). 

(ii) Release to water. Requirements as 

specified in § 721.90 (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 


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(a), (b), (c), (i), 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. 

■ 11. By adding new § 721.10164 to 

subpart E to read as follows: 

§ 721.10164 Benzenecarboximidamide, Nhydroxy-4-nitro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenecarboximidamide, N-hydroxy-4- 

nitro- (PMN P–08–36; CAS No. 1613– 

86–1) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(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), 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. 

■ 12. By adding new § 721.10165 to 

subpart E to read as follows: 

§ 721.10165 Carbonotrithioic acid, 

bis(phenylmethyl) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

carbonotrithioic acid, bis(phenylmethyl) 

ester (PMN P–08–138; CAS No.26504– 

29–0) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(ii) Release to water. Requirements as 

specified in § 721.90 (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), (i), 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. 

■ 13. By adding new § 721.10166 to 

subpart E to read as follows: 

§ 721.10166 1,3-Cyclohexanedione, 2-[2-

chloro-4-(methylsulfonyl)-3-[(2,2,2-

trifluoroethoxy)methyl]benzoyl]-, ion(1-), 

potassium salt (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-cyclohexanedione, 2-[2-chloro-4-

(methylsulfonyl)-3-[(2,2,2-

trifluoroethoxy)methyl]benzoyl]-, ion(1- 

), potassium salt (1:1) (PMN P–08–180; 

CAS No. 1121649–70–4) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N= 0.1). 

(ii) [Reserved] 

(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), 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. 

■ 14. By adding new § 721.10167 to 

subpart E to read as follows: 

§ 721.10167 Tetrafluoro nitrotoluene 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tetrafluoro nitrotoluene 

(PMN P–08–212) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(1), (b)(1), and 

(c)(1). 

(ii) [Reserved] 

(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), 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. 

■ 15. By adding new § 721.10168 to 

subpart E to read as follows: 

§ 721.10168 Cesium tungsten oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cesium tungsten oxide (PMN P–08–275; 

CAS No. 52350–17–1) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (v)(2), (w)(2), and 

(x)(2). 

(ii) [Reserved] 

(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), and (i) 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. E9–22533 Filed 9–17–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R08–OAR–2005–0463; FRL–8957–3] 

Approval and Promulgation of State 

Implementation Plans; State of 

Colorado; Revisions to the Denver 

Emergency Episode Plan 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct Final Rule. 

SUMMARY: EPA is taking direct final 

action approving State Implementation 

Plan (SIP) revisions to the Denver 

Emergency Episode Plan submitted by 

the State of Colorado on September 16, 

1997. EPA has determined that the 

Denver Emergency Episode Plan 

revisions meet the requirements for the 

prevention of air pollution emergency 

episodes with ambient concentrations of 

air pollutants that may endanger public 

health and welfare. The intended effect 

of this action is to make Federally 

enforceable those provisions that EPA is 

approving. This action is being taken 

under section 110 of the Clean Air Act. 

DATES: This rule is effective on 

November 17, 2009 without further 

notice, unless EPA receives adverse 


sroberts on DSKD5P82C1PROD with RULES