Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 4983 

Administrator of the Drug Enforcement 

Administration. 

The redelegation of signature 

authority for the regulations in part 

1314 is consistent with the signature 

authority already redelegated to the 

Deputy Assistant Administrator of the 

Office of Diversion Control pertaining to 

the promulgation of regulations related 

to the registration of manufacturers, 

distributors, dispensers, importers, and 

exporters of controlled substances and 

List I chemicals in parts 1301 and 1309, 

respectively (28 CFR Appendix to 

Subpart R, 7(a), 7(h)). 

Regulatory Certifications 

Congressional Review Act 

The DEA has determined that this 

action pertains to DEA management and 

is a rule relating to DEA organization, 

procedure or practice that does not 

substantially affect the rights or 

obligations of non-agency parties, and, 

accordingly, is not a ‘‘rule’’ as that term 

is used by the Congressional Review Act 

(Subtitle E of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (Pub. L. 104–121). 

Therefore, the reporting requirement of 

5 U.S.C. 801 does not apply. 

Administrative Procedure Act 

This rule redelegates signature 

authority for the promulgation of certain 

regulations related to the retail sale of 

scheduled listed chemical products 

from the Deputy Administrator of the 

DEA to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration. Since the rule relates to 

agency organization, procedure, or 

practice, it is excepted from the general 

notice requirements of the 

Administrative Procedure Act (5 U.S.C. 

553(b) pursuant to 5 U.S.C. 553(b)(A). 

The redelegation of signature authority 

for the regulations in part 1314 is 

consistent with the signature authority 

already redelegated to the Deputy 

Assistant Administrator, Office of 

Diversion Control, pertaining to the 

promulgation of regulations related to 

the registration of manufacturers, 

distributors, dispensers, importers, and 

exporters of controlled substances and 

List I chemicals in parts 1301 and 1309, 

respectively (28 CFR Appendix to 

Subpart R, 7(a), 7(h)). 

Further, the Administrative Procedure 

Act permits an agency to make this rule 

effective upon the date of publication as 

provided by the agency for good cause 

found and published with the rule (5 

U.S.C. 553(d)(3)). As this rule merely 

redelegates signature authority for 

certain regulations and has no impact 

on regulated entities, DEA finds good 

cause to make this rule effective upon 

publication. 

Regulatory Flexibility Act 

The Acting Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612). This rule will not have a 

significant economic impact on a 

substantial number of small entities 

because it pertains to administrative 

matters affecting the DEA. Further, a 

Regulatory Flexibility Analysis was not 

required to be prepared for this final 

rule because DEA was not required to 

publish a general notice of proposed 

rulemaking for this matter. 

Executive Order 12866 

The Acting Administrator certifies 

that this rulemaking has been drafted in 

accordance with the principles in 

Executive Order 12866 § 1(b). This rule 

is limited to agency organization, 

management and personnel as described 

by Executive Order 12866 section 

(3)(d)(3) and, therefore, is not a 

‘‘regulation’’ or ‘‘rule’’ as defined by that 

Executive Order. Therefore, this action 

has not been reviewed by the Office of 

Management and Budget. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988, Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law; nor 

does it impose enforcement 

responsibilities on any State; nor does it 

diminish the power of any state to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

List of Subjects in 28 CFR Part 0 

Authority delegations (Government 

agencies), Government employees, 

Organizations and functions 

(Government agencies), Privacy, 

Reporting and recordkeeping 

requirements, Whistleblowing. 

■ For the reasons set forth above, and 

pursuant to the authority vested in the 

Administrator of the Drug Enforcement 

Administration by 28 CFR 0.100 and 

0.104, and 21 U.S.C. 871, 28 CFR, part 

0 is amended as follows: 

PART 0—ORGANIZATION OF THE 

DEPARTMENT OF JUSTICE 

■ 1. The authority citation for part 0 

continues to read as follows: 

Authority: 5 U.S.C. 301; 28 U.S.C. 509, 

510, 515–519. 

■ 2. Section 7 of the Appendix to 

subpart R is amended by adding a new 

paragraph (m) to read as follows: 

Appendix to Subpart R of Part 0— 

Redelegation of Functions 

* * * * * 

Sec. 7. Promulgation of regulations. 

* * * * * 

(m) Part 1314, incident to the retail sale of 

scheduled listed chemical products by 

regulated sellers and distributors required to 

submit reports under section 310(b)(3) of the 

Act (21 U.S.C. 830(b)(3)), except that final 

orders in connection with suspension or 

revocation of the regulated seller’s or mail 

order distributor’s right to sell scheduled 

listed chemical products shall be made by 

the Deputy Administrator of the Drug 

Enforcement Administration. 

* * * * * 

Dated: January 21, 2010. 

Michele M. Leonhart, 

Acting Administrator. 

[FR Doc. 2010–1967 Filed 1–29–10; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2008–0918; FRL–8438–4] 

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 15 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Three 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action requires 

persons who intend to manufacture, 


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4984 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

import, or process any of these 15 

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 

April 2, 2010 without further notice, 

unless EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments 

before March 3, 2010. This rule shall be 

promulgated for purposes of judicial 

review at 1 p.m. (e.s.t.) on February 16, 

2010. 

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 

March 3, 2010, 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 February 1, 2010. 

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 March 3, 

2010 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–2008–0918, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2008–0918. 

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– 

2008–0918. 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 


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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 March 3, 2010 are subject 

to the export notification provisions of 

TSCA section 12(b) (15 U.S.C. 2611(b)) 

(see § 721.20), and must comply with 

the export notification requirements in 

40 CFR part 707, subpart D. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM as CBI and then 

identify electronically within the disk or 

CD-ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What Action is the Agency Taking? 

EPA is 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 15 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. 


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IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

15 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 3 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 

measures required in the corresponding 

consent orders. 

This rule also includes SNURs on 12 

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–03–141 

Chemical name: Cyclopentane, 

methoxy-. 

CAS number: 5614–37–9. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an industrial 

solvent. Based on test data on the PMN 

substance, EPA has identified concerns 

for systemic toxicity and neurotoxicity. 

For the use 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 

any use of the substance other than as 

described in the PMN may cause serious 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the human health effects of the PMN 

substance: A 90–day oral toxicity test in 

rodents (OPPTS Harmonized Test 

Guideline 870.3100); a flammability test 

(OPPTS Harmonized Test Guideline 

830.6315); a sediment and soil 

adsorption/desorption isotherm test 

(OPPTS Harmonized Test Guideline 

835.1220); and a standard practice for 

determination of odor and taste 

threshold by a forced-choice ascending 

concentration series method of limits 

(American Society for Testing and 

Materials (ASTM) E679–04 test 

guideline). 

CFR citation: 40 CFR 721.10169. 

PMN Number P–03–197 

Chemical name: Polyoxyethylene 

polyalkylarylphenylether sulfate 

ammonium salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a surface active 

agent for emulsion polymerization. 

Based on test data on analogous anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 5 parts per 

billion (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 waters 

concentrations that exceed 5 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 other than as described in 

the PMN 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, freshwater and 

marine (OPPTS Harmonized Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

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. All aquatic toxicity testing 

should be performed using the flowthrough method with measured 

concentrations. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10170. 

PMN Number P–03–285 

Chemical name: 1H-benz(e)indolium, 

1,1,2,3-tetramethyl-, 4- 

methylbenzenesulfonic acid (1:1). 

CAS number: 141914–99–0. 

Basis for action: The PMN states that the 

substance will be used as a chemical 

intermediate for the manufacture of a 

dye in imaging media/products. Based 

on test data on the PMN substance, EPA 

identified concerns for acute lethality 

from inhalation of the PMN substance. 

As described in the PMN, worker 

inhalation exposure will be minimal 

due to the use of adequate personal 

protective equipment. 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 without the use of 

a National Institute for Occupational 

Safety and Health (NIOSH)-approved 

respirator with an assigned protection 

factor (APF) of at least 10 where there 

is a potential for inhalation exposure, or 

exceedance of the 11,000 kilogram 

annual manufacture and import volume 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(i). 


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Recommended testing: EPA has 

determined that the results of a repeated 

dose 28–day oral toxicity in rodents 

(OPPTS Harmonized Test Guideline 

870.3050 or Organisation for Economic 

Co-operation and Development (OECD) 

407 test guideline) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10171. 

PMN Number P–03–633 

Chemical name: Alkylamide derivative 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a raw material for 

the manufacture of photosensitive 

materials. Based on test data on 

analogous substances, 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, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

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 water concentrations exceeding 

1 ppb 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 

early-life stage toxicity test (OPPTS 

Harmonized Test Guideline 850.1400); a 

daphnid chronic toxicity test (OPPTS 

Harmonized Test Guideline 850.1300); 

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 

performed using the static method with 

measured concentrations. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10172. 

PMN Number P–03–793 

Chemical name: Silanamine,1,1,1- 

triethoxy-N,N-diethyl-. 

CAS number: 35077–00–0. 

Basis for action: The PMN states that the 

substance will be used as an external 

donor for olefin polymerization. Based 

on submitted test data, EPA has 

identified health concerns for corrosion. 

Also, based on test data on analogous 

alkoxysilanes and aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

10 ppb of the PMN substance in surface 

waters. As described in the PMN, 

significant worker exposure is unlikely 

and releases to surface waters are not 

expected. Therefore, EPA has not 

determined that the proposed import, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture of the substance could 

result in exposures which 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)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Harmonized Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

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 daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. Algal toxicity testing 

should be performed using the static 

method with measured concentrations. 

No human health testing is 

recommended at this time. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10173. 

PMN Number P–04–139 

Chemical name: 1-Propanaminium, 3- 

amino-N-(carboxymethyl)-N,Ndimethyl-, N-peanut-oil acyl derivs., 

inner salts. 

CAS number: 691401–28–2. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an oil well additive. 

Based on test data on analogous 

substances, EPA identified concerns for 

irritation, possible corrosion, and 

developmental toxicity. For the use 

described in the PMN, worker 

inhalation exposure is not expected and 

worker dermal exposures will be 

minimal due to the use of adequate 

personal protective equipment. 

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 without the use of impervious 

gloves where there is a potential for 

dermal exposure, or use of the substance 

other than as described in the PMN 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 prenatal 

developmental toxicity test (OPPTS 

Harmonized Test Guideline 870.3700) 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10174. 

PMN Number P–04–141 

Chemical name: 1-Propanaminium, N- 

(3-aminopropyl)-2-hydroxy-N,Ndimethyl-3-sulfo-, N-(C12-18 and C18- 

unsatd. acyl) derivs., inner salts. 

CAS number: 691400–36–9. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be used as an additive for 

various cleaners. Based on test data on 

analogous amphoteric surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

6 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 6 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 water 

concentrations exceeding 6 ppb 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 porous 

pot test (OPPTS Harmonized Test 

Guideline 835.3220); an aquatic 

invertebrate acute toxicity test, 

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. Daphnid 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 

material. 

CFR citation: 40 CFR 721.10175. 

PMN Number P–04–144 

Chemical name: Amides, peanut-oil, N- 

[3-(dimethylamino)propyl]. 

CAS number: 691400–76–7. 

Basis for action: The PMN states that the 

generic (non-confidential) use of 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 


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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 the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS 

Harmonized Test Guideline 850.1075); a 

fish acute toxicity test mitigated by 

humic acid (OPPTS Harmonized Test 

Guideline 850.1085) with the chloride 

salt adjusted to a pH of 7; an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS 

Harmonized Test Guideline 850.1010); 

and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400). All aquatic toxicity 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 721.10176. 

PMN Number P–04–153 

Chemical name: Phosphoric acid, 

yttrium(3+) salt (1:1). 

CAS number: 13990–54–0. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a phosphor. Based 

on test data on analogous inorganic 

phosphates and soluble yttrium 

compounds, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 6 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

6 ppb. Therefore, EPA has not 

determined that the proposed import, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture or any use of the substance 

resulting in surface water 

concentrations exceeding 6 ppb 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, freshwater and 

marine (OPPTS Harmonized Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

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. All aquatic toxicity testing 

should be performed using the static 

method with measured concentrations 

of yttrium. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10177. 

PMN Number P–04–319 

Chemical name: Distillates (FischerTropsch), hydroisomerized middle, C10- 

13-branched alkane fraction. 

CAS number: 642928–30–1. 

Basis for action: The PMN states that the 

substance will be used as industrial/ 

commercial paint and ink formulations; 

indoor industrial heating oil; and 

solvent blend for industrial cleaning. 

Based on test data on structurally 

similar chemicals with a carbon chain 

range of C5 to C21, EPA has identified 

health concerns for liver toxicity, 

kidney toxicity, developmental toxicity, 

mutagenicity, cancer, neurotoxicity, 

skin sensitization, hydrocarbon 

pneumonia, and irritation to mucous 

membranes. Also, based on test data on 

analogous neutral organic compounds, 

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, worker dermal and inhalation 

exposure will be minimal due to the use 

of adequate personal protective 

equipment, and releases to water are not 

expected. Therefore, EPA has not 

determined that the proposed import, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance without the use of impervious 

gloves where there is the potential for 

dermal exposure, use of the substance 

without the use of a NIOSH-approved 

respirator with an APF of at least 100 

where there is potential for inhalation 

exposure, domestic manufacturing, or 

any use of the substance resulting in 

release to surface waters, 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)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). 

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 prenatal 

developmental toxicity test (OPPTS 

Harmonized Test Guideline 870.3700), 

using one species via the oral route; a 

fish early-life stage toxicity test (OPPTS 

Harmonized Test Guideline 850.1400) 

with fathead minnows, a daphnid 

chronic toxicity test (OPPTS 

Harmonized Test Guideline 850.1300); 

and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400). Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. Dilution water total 

organic carbon (TOC) concentration 

should be less than 2.0 mg TOC per 

liter. 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 721.10178. 

PMN Numbers P–04–346 and P–04–347 

Chemical name: Copolymers of phenol 

and aromatic hydocarbon (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: November 15, 2004. 

Basis for TSCA section 5(e) consent 

order: The consolidated PMN states that 

the generic (non-confidential) use of the 

substances will be as binder 

components. 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 these substances may 

present an unreasonable risk of injury to 

the environment. To protect against this 

risk, the consent order requires the 

company to not manufacture or import 

the PMN substances unless the average 

molecular weight is greater than 500 

daltons. To ensure compliance, the 

consent order also requires that the 

substances be analyzed both at the time 

of initial commencement and annually 

thereafter. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms varies with 

the average number molecular weight of 

the PMN substances. As the average 

number molecular weight decreases, the 

aquatic toxicity of the substances 

increases. When the average molecular 

weight is 366 daltons, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substances in surface waters. 

The PMN substances with a molecular 

weight greater than 500 daltons are of 

lower concern for toxicity because the 

expected water solubility is estimated to 

be less than 1 ppb. 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS 

Harmonized Test Guideline 850.1400), a 

daphnid chronic toxicity test (OPPTS 

Harmonized Test Guideline 850.1300); 


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and an algal toxicity test, tiers I and II 

(OPPTS Harmonized Test Guideline 

850.5400) would help characterize 

possible environmental effects of the 

PMN substances. Fish and daphnid 

testing should be performed using the 

flow-through method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. EPA should 

be consulted to determine what form of 

the chemical substances should be 

tested. The order does not require 

submission of the testing at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use and 

disposal of the chemical substances 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 721.10179. 

PMN Number P–04–692 

Chemical name: Trifunctional acrylic 

ester (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: December 6, 2004. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used in lacquer/dry 

film manufacture. 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 the 

environment. To protect against this 

risk, the consent order requires the 

company to not manufacture or import 

the PMN substance unless the mean 

number of moles of the ethoxy group is 

greater than or equal to 8. To ensure 

compliance, the consent order also 

requires that the substance be analyzed 

both at the time of initial 

commencement and annually thereafter. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Toxicity concern: Based on test data on 

analogous esters, EPA predicts toxicity 

to aquatic organisms varies with the 

average number of moles of the ethoxy 

group. As the number of moles of 

ethoxy group decreases, the aquatic 

toxicity of the substance increases. For 

the PMN substance with an average of 

3 moles of ethoxy, EPA predicts toxicity 

to aquatic organisms at concentrations 

that exceed 40 ppb of the PMN 

substance in surface waters. 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Harmonized Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

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 daphnid testing 

should be performed using flow-through 

method with measured concentrations. 

Algal testing should be performed using 

the static method with measured 

concentrations. EPA should be 

consulted to determine what form of the 

chemical substance should be tested. 

The order does not require submission 

of the testing at any specified time or 

production volume. However, the 

order’s restrictions on manufacture, 

import, processing, distribution in 

commerce, use and disposal of the 

chemical 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 721.10180. 

PMN Number P–07–453 

Chemical name: Halide salt of an 

alkylamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a solder adjuvant, 

an open, non-dispersive use. Based on 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms 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 any use of 

the substance other than as described in 

the PMN could result in release to 

surface waters 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 fish 

acute toxicity test, freshwater and 

marine (OPPTS Harmonized Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

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. All 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 721.10181. 

PMN Number P–07–601 

Chemical name: 1-Propene, 2,3,3,3- 

tetrafluoro-. 

CAS number: 754–12–1. 

Basis for action: The PMN states that the 

substance will be used as a motor 

vehicle air conditioning (MVAC) 

refrigerant in new passenger cars and 

vehicles (i.e., as defined in 40 CFR 82.32 

(c) and (d)). Initial charging of MVAC 

units with the PMN substance will be 

done by the motor vehicle original 

equipment manufacturer. All servicing, 

maintenance, and disposal involving the 

PMN substance will be done only by 

Clean Air Act (CAA) section 609 

certified technicians using CAA section 

609 certified refrigerant handling 

equipment. Based on test data on the 

PMN substance, EPA identified health 

concerns for developmental toxicity and 

lethality to workers and consumers if 

they were exposed to a significant 

amount of the PMN substance via 

inhalation. The PMN substance has an 

ozone depletion potential of zero, and 

based on test data, has a low global 

warming potential (GWP100 of about 4). 

For the use scenario described in the 

PMN, significant industrial or 

commercial worker exposure is unlikely 

due to the use of CAA section 609 

certified refrigerant handling equipment 

and other protective measures. Potential 

consumer (vehicle passenger) exposure 

from refrigerant leaks into the passenger 

compartment of a vehicle is not 

expected to present significant risk of 

serious health effects. Flammability 

concerns with the PMN substance are 

being addressed through regulatory 

actions by EPA’s Office of Air and 

Radiation (see the following paragraph). 

Further, ‘‘do-it-yourself’’ consumer 

exposures are not expected because the 

PMN substance only will be sold or 

distributed in 20-pound containers or 

larger. Therefore, EPA has not 

determined that the manufacturing, 

processing, or use of the substance as 

described in the PMN may present an 

unreasonable risk. EPA has determined, 

however, that (1) use of the substance 

other than as a MVAC refrigerant in new 

passenger cars and vehicles as defined 

in 40 CFR 82.32 (c) and (d), (2) initial 

charging of MVAC units with the PMN 

substance by any person other than 

CAA section 609 certified technicians 

without using CAA section 609 certified 

refrigerant handling equipment, (3) 

servicing, maintenance, and disposal 

involving the PMN substance by 

persons other than CAA section 609 

certified technicians without using CAA 

section 609 certified refrigerant 


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handling equipment, or (4) sale or 

distribution of the PMN substance in 

containers smaller than 20-pounds (net 

weight) may cause serious health effects 

in accordance with 40 CFR 

721.170(b)(3)(i). 

This SNUR is intended to 

complement recently proposed and 

forthcoming regulations on the PMN 

substance under the CAA in that this 

SNUR addresses health risk issues of the 

subject refrigerant. On October 19, 2009, 

EPA published a proposed rule on the 

PMN substance entitled ‘‘Protection of 

Stratospheric Ozone: New Substitute in 

the Motor Vehicle Air Conditioning 

Sector under the Significant New 

Alternatives Policy (SNAP) Program’’ 

(74 FR 53445) (FRL–8969–7). The SNAP 

Program, mandated under section 612 of 

the CAA, requires EPA to develop a 

program for evaluating alternatives to 

ozone-depleting substances and to 

create lists of substitutes for specific 

uses that do not present greater overall 

risk to human health and the 

environment than other alternatives that 

are available. In the October 19, 2009, 

action, EPA proposed to find HFO1234yf acceptable, subject to certain use 

conditions, as a substitute for CFC-12 in 

new motor vehicle air conditioning 

systems (passenger cars and trucks). The 

proposed use conditions include 

incorporation of engineering strategies 

and/or devices to mitigate flammability 

risks for this substance (see Unit V. of 

the proposed rule). Use of most 

flammable refrigerants, including the 

PMN substance, in existing MVAC 

systems as a retrofit has previously been 

determined by EPA to be unacceptable. 

The proposed rule would require a 

petition and a new SNAP submission 

specifically for the use of the PMN 

substance in existing MVAC equipment 

as a retrofit before EPA would consider 

allowing such use (see Unit VI. of the 

proposed rule). EPA also intends to 

promulgate a follow-on rulemaking 

under section 609 of the CAA to address 

service equipment, technician 

certification, and end-of-life disposal 

specifications. 

Recommended testing: EPA has 

determined that the results of an acute 

inhalation toxicity study (OPPTS 

Harmonized Test Guideline 870.1300 or 

OECD 403 test guideline) with rabbits 

would help characterize the human 

health effects of the PMN substance. 

Exposure concentrations of 10,000, 

50,000, and 100,000 parts per million 

(ppm) should be used. Further, rabbits 

should be exposed for 1 hour, and 

pregnant rabbits should be exposed on 

Gravid Day 12. 

CFR citation: 40 CFR 721.10182. 

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 3 of the 15 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 12 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 April 2, 2010 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before March 3, 2010. 

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 

March 3, 2010, 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 

3 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, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 6 of the 15 chemical 

substances contained in this rule have 


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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. Please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines’’ on the leftside navigation menu. 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. The American 

Society for Testing and Materials 

(ASTM) test guidelines are available at 

http://www.astm.org/standard/ 

index.shtml. 

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 many 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). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 


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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: January 13, 2010. 

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 

* * * * * 

721.10169 ....................... 2070–0012 

721.10170 ....................... 2070–0012 

721.10171 ....................... 2070–0012 

721.10172 ....................... 2070–0012 

721.10173 ....................... 2070–0012 

721.10174 ....................... 2070–0012 

721.10175 ....................... 2070–0012 

721.10176 ....................... 2070–0012 

721.10177 ....................... 2070–0012 

721.10178 ....................... 2070–0012 

721.10179 ....................... 2070–0012 

721.10180 ....................... 2070–0012 

721.10181 ....................... 2070–0012 

721.10182 ....................... 2070–0012 

40 CFR citation OMB control No. 

* * * * * 

* * * * * 

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 § 721.10169 to subpart E to 

read as follows: 

§ 721. 10169 Cyclopentane, methoxy-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cyclopentane, methoxy- (PMN P–03– 

141; CAS No. 5614–37–9) 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. 

■ 5. Add § 721.10170 to subpart E to 

read as follows: 

§ 721.10170 Polyoxyethylene 

polyalkylarylphenylether sulfate ammonium 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyoxyethylene 

polyalkylarylphenylether sulfate 

ammonium salt (PMN P–03–197) 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. 


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(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. 

■ 6. Add § 721.10171 to subpart E to 

read as follows: 

§ 721.10171 1H-benz(e)indolium, 1,1,2,3- 

tetramethyl-, 4-methylbenzenesulfonic acid 

(1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1H-benz(e)indolium, 1,1,2,3- 

tetramethyl-, 4-methylbenzenesulfonic 

acid (1:1) (PMN P–03–285; CAS No. 

141914–99–0) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(5), (b) (concentration set at 1 

percent), and (c). Respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. The following 

NIOSH-approved respirators with an 

APF of 10–25 meet the minimum 

requirements for § 721.63(a)(4): Airpurifying, tight-fitting respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters (either 

half- or full-face); powered air-purifying 

respirator equipped with a loose-fitting 

hood or helmet and High Efficiency 

Particulate Air (HEPA) filters; powered 

air-purifying respirator equipped with a 

tight-fitting facepiece (either half- or 

full-face) and HEPA filters; supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half- or full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(s) (11,000 

kilograms). 

(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), 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. 

■ 7. Add § 721.10172 to subpart E to 

read as follows: 

§ 721.10172 Alkylamide derivative 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylamide derivative 

(PMN P–03–633) 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 =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. 

■ 8. Add § 721.10173 to subpart E to 

read as follows: 

§ 721.10173 Silanamine,1,1,1-triethoxyN,N-diethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

silanamine,1,1,1-triethoxy-N,N-diethyl- 

(PMN P–03–793; CAS No. 35077–00–0) 

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) [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. 

■ 9. Add § 721.10174 to subpart E to 

read as follows: 

§ 721.10174 1-Propanaminium, 3-amino-N- 

(carboxymethyl)-N,N-dimethyl-, N-peanut-oil 

acyl derivs., inner salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-Propanaminium, 3-amino-N- 

(carboxymethyl)-N,N-dimethyl-, Npeanut-oil acyl derivs., inner salts (PMN 

P–04–139; CAS No. 691401–28–2) 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)(3), (b) (concentration 

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(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), 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. Add § 721.10175 to subpart E to 

read as follows: 

§ 721.10175 1-Propanaminium, N-(3- 

aminopropyl)-2-hydroxy-N,N-dimethyl-3- 

sulfo-, N-(C12-18 and C18-unsatd. acyl) 

derivs., inner salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-Propanaminium, N-(3-aminopropyl)- 

2-hydroxy-N,N-dimethyl-3-sulfo-, N- 

(C12-18 and C18-unsatd. acyl) derivs., 

inner salts (PMN P–04–141; CAS No. 

691400–36–9) 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=6). 

(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. 


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(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 721.10176 to subpart E to 

read as follows: 

§ 721.10176 Amides, peanut-oil, N-[3- 

(dimethylamino)propyl]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amides, peanut-oil, N-[3- 

(dimethylamino)propyl] (PMN P–04– 

144; CAS No. 691400–76–7) 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. Add § 721.10177 to subpart E to 

read as follows: 

§ 721.10177 Phosphoric acid, yttrium(3+) 

salt (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphoric acid, yttrium(3+) salt (1:1) 

(PMN P–04–153; CAS No. 13990–54–0) 

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)(4) and (c)(4) 

(N=6). 

(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. Add § 721.10178 to subpart E to 

read as follows: 

§ 721.10178 Distillates (Fischer-Tropsch), 

hydroisomerized middle, C10-13-branched 

alkane fraction. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

distillates (Fischer-Tropsch), 

hydroisomerized middle, C10-13- 

branched alkane fraction (PMN P–04– 

319; CAS No. 642928–30–1) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (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 100. The 

following NIOSH-approved respirator 

meets the minimum requirements for 

§ 721.63(a)(4): Supplied-air respirator 

operated in pressure demand or 

continuous flow mode and equipped 

with a tight-fitting full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(iii) 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), (d), (e), (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. 

■ 14. Add § 721.10179 to subpart E to 

read as follows: 

§ 721.10179 Copolymers of phenol and 

aromatic hydocarbon (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as copolymers of phenol and 

aromatic hydocarbon (PMNs P–04–346 

and P–04–347) are 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(k) (no manufacture 

or import of the PMN substances unless 

the average molecular weight is greater 

than 500 daltons). Representative 

samples of the PMN substances must be 

analyzed and determined to comply 

with these requirements both at the time 

of initial commencement and annually 

thereafter. 

(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 these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10180 to subpart E to 

read as follows: 

§ 721.10180 Trifunctional acrylic ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trifunctional acrylic ester 

(PMN P–04–692) 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. Requirement as 

specified in § 721.80(k) (no manufacture 

or import of the PMN substance unless 

the mean number of moles of the ethoxy 

group is greater than or equal to 8). 

Representative samples of the PMN 

substance must be analyzed and 

determined to comply with these 

requirements both at the time of initial 

commencement and annually thereafter. 

(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. 

■ 16. Add § 721.10181 to subpart E to 

read as follows: 

§ 721.10181 Halide salt of an alkylamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halide salt of an 

alkylamine (PMN P–07–453) is subject 


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4996 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

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. 

■ 17. Add § 721.10182 to subpart E to 

read as follows: 

§ 721.10182 1-Propene, 2,3,3,3-tetrafluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propene, 2,3,3,3-tetrafluoro- (PMN P– 

07–601; CAS No. 754–12–1; also known 

as HFO–1234yf) 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) (use as a motor 

vehicle air conditioning (MVAC) 

refrigerant in new passenger cars and 

vehicles as defined in 40 CFR 82.32 (c) 

and (d). The initial charging of MVAC 

units with the PMN substance will be 

done by the motor vehicle original 

equipment manufacturer. All servicing, 

maintenance, and disposal involving the 

PMN substance will be done only by 

Clean Air Act (CAA) section 609 

certified technicians using CAA section 

609 certified refrigerant handling 

equipment. The PMN substance only 

will be sold or distributed in 20–pound 

(net weight) containers or larger). 

(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. 2010–1936 Filed 1–29–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 390 

[Docket No. FMCSA–2009–0127] 

RIN 2126–AA98 

Safety Requirements for Operators of 

Small Passenger-Carrying Commercial 

Motor Vehicles Used in Interstate 

Commerce 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Final rule. 

SUMMARY: The FMCSA amends the 

Federal Motor Carrier Safety 

Regulations (FMCSRs) to require that 

motor carriers operating commercial 

motor vehicles (CMVs), designed or 

used to transport between 9 and 15 

passengers (including the driver), in 

interstate commerce for direct 

compensation comply with the safety 

regulations regardless of the distance 

traveled. Specifically, this rule makes 

certain FMCSRs applicable to the 

operation of such vehicles when they 

are operated within a 75 air-mile radius 

(86.3 statute miles or 138.9 kilometers) 

from the driver’s normal work-reporting 

location. Motor carriers, drivers, and the 

vehicles operated by them will be 

subject to the same safety requirements 

imposed upon such vehicles when they 

are operated beyond a 75-air-mile 

radius. This action is required by the 

Safe, Accountable, Flexible, Efficient 

Transportation Equity Act: A Legacy for 

Users (SAFETEA–LU). 

DATES: Effective: This rule is effective 

May 3, 2010. Compliance: Motor 

carriers must be in compliance with this 

rule no later than June 1, 2010. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Loretta Bitner, Chief, Commercial 

Passenger Carrier Safety Division, Office 

of Enforcement and Compliance; (202) 

385–2428; loretta.bitner@dot.gov. 

Docket: For access to the docket to 

read background documents including 

those referenced in this document go to 

http://www.regulations.gov at any time 

or visit the U.S. Department of 

Transportation Dockets located on the 

ground floor, Room W12–140, 1200 

New Jersey Avenue, SE., Washington, 

DC, between 9 a.m. and 5 p.m. ET., 

Monday through Friday, except Federal 

holidays. 

SUPPLEMENTARY INFORMATION: 

Legal Basis for the Rulemaking 

Section 4136 of SAFETEA–LU [Pub. 

L. 109–59, 119 Stat. 1144, 1745, August 

10, 2005] (set out as a note to 49 U.S.C. 

31136) states that ‘‘[t]he Federal motor 

carrier safety regulations that apply to 

interstate operations of commercial 

motor vehicles designed to transport 

between 9 and 15 passengers (including 

the driver) shall apply to all interstate 

operations of such carriers regardless of 

the distance traveled.’’ 

The FMCSA notes that the legislative 

history of this provision of SAFETEA– 

LU is sparse and, in some respects, 

inconsistent with the mandate of section 

4136. The Senate bill (S. 1567, 109th 

Cong. 1st Sess. (July 29, 2005)) that 

contained the provisions relating to 

motor carrier safety that became part of 

SAFETEA–LU included the following 

provisions, in section 106(2): ‘‘The 

Secretary of Transportation shall * * * 

ensure that Federal motor carrier safety 

regulations that apply to interstate 

operations of commercial motor 

vehicles designed to transport between 

9 and 15 passengers (including the 

driver) apply to all interstate operations 

of such carries [sic] regardless of the 

distance traveled.’’ 

The committee report accompanying 

this bill said that this provision ‘‘would 

ensure that the Secretary enforces 

Federal motor carrier safety regulations 

that apply to interstate CMVs designed 

to transport between 9 and 15 

passengers, regardless of the distance 

traveled.’’ Sen. Report No. 109–120 

(109th Cong. 1st Sess., July 29, 2005), at 

20. 

In the House of Representatives, 

similar language was found in section 

4130 of an early version H.R. 3 (109th 

Cong, 1st Sess., 2005), which stated 

‘‘[t]he Federal motor carrier safety 

regulations (other than regulations 

relating to commercial drivers license 

and drug and alcohol testing 

requirements) shall apply to all 

interstate operations of commercial 

motor vehicles used to transport 

between 9 and 15 passengers (including 

the driver), regardless of the distance 

traveled.’’ House Report 109–12 (109th 

Cong., 1st Sess., March 7, 2005), at 306. 

The House committee report 

described the purpose of this provision 

as follows: 

• ‘‘This section directs the Secretary to 

extend the Federal motor carrier safety 

regulations found in 49 Code of Federal 

Regulations, Parts 387, 390 through 399 to all 

operations of commercial motor vehicles 

designed to transport between nine and 


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