Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 35977 

both sections 8 and 15. The affidavit or 

declaration filed under section 15 of the 

Act may also be used as the affidavit or 

declaration required by section 71, if the 

affidavit or declaration meets the 

requirements of both sections 71 and 15. 

* * * * * 

PART 7—RULES OF PRACTICE IN 

FILINGS PURSUANT TO THE 

PROTOCOL RELATING TO THE 

MADRID AGREEMENT CONCERNING 

THE INTERNATIONAL REGISTRATION 

OF MARKS 

■ 7. The authority citation for 37 CFR 

part 7 continues to read as follows: 

Authority: 15 U.S.C. 1123, 35 U.S.C. 2, 

unless otherwise noted. 

■ 8. In § 7.6, add paragraph (a)(8) to read 

as follows: 

§ 7.6 Schedule of U.S. process fees. 

(a) * * * 

(8) For correcting a deficiency in a 

section 71 affidavit—$100.00 

* * * * * 

■ 9. Revise § 7.25(a) to read as follows: 

§ 7.25 Sections of part 2 applicable to 

extension of protection. 

(a) Except for §§ 2.22–2.23, 2.130– 

2.131, 2.160–2.166, 2.173, and 2.181– 

2.186, all sections in parts 2, 10, and 11 

of this chapter shall apply to an 

extension of protection of an 

international registration to the United 

States, including sections related to 

proceedings before the Trademark Trial 

and Appeal Board, unless otherwise 

stated. 

* * * * * 

■ 10. In § 7.36, revise paragraph (b)(2) 

and add paragraphs (b)(3) and (c) to read 

as follows: 

§ 7.36 Affidavit or declaration of use in 

commerce or excusable nonuse required to 

avoid cancellation of an extension of 

protection to the United States. 

* * * * * 

(b) * * * 

(2) Within the year before the end of 

every ten-year period after the date of 

registration in the United States. 

(3) The affidavit or declaration may be 

filed within a grace period of six months 

after the end of the deadline set forth in 

paragraphs (b)(1) and (b)(2) of this 

section, with payment of the grace 

period surcharge per class required by 

section 71(a)(3) of the Act and § 7.6. 

(c) For the requirements for the 

affidavit or declaration, see § 7.37. 

■ 11. Revise § 7.37(d)(2) to read as 

follows: 

§ 7.37 Requirements for a complete 

affidavit or declaration of use in commerce 

or excusable nonuse. 

* * * * * 

(d) * * * 

(2) If the affidavit or declaration is 

filed during the grace period under 

section 71(a)(3) of the Act, include the 

grace period surcharge per class 

required by § 7.6; 

* * * * * 

■ 12. Revise § 7.39 to read as follows: 

§ 7.39 Acknowledgment of receipt of and 

correcting deficiencies in affidavit or 

declaration of use in commerce or 

excusable nonuse. 

The Office will issue a notice as to 

whether an affidavit or declaration is 

acceptable, or the reasons for refusal. 

(a) A response to the refusal must be 

filed within six months of the date of 

issuance of the Office action, or before 

the end of the filing period set forth in 

section 71(a) of the Act, whichever is 

later. The response must be signed by 

the holder, someone with legal authority 

to bind the holder (e.g., a corporate 

officer or general partner of a 

partnership), or a practitioner qualified 

to practice under § 11.14 of this chapter, 

in accordance with the requirements of 

§ 2.193(e)(2). 

(b) If no response is filed within this 

time period, the extension of protection 

will be cancelled, unless time remains 

in the grace period under section 

71(a)(3) of the Act. If time remains in 

the grace period, the holder may file a 

complete, new affidavit. 

(c) If the affidavit or declaration is 

filed within the time periods set forth in 

section 71 of the Act, deficiencies may 

be corrected, as follows: 

(1) Correcting deficiencies in 

affidavits or declarations timely filed 

within the periods set forth in sections 

71(a)(1) and 71(a)(2) of the Act. If the 

affidavit or declaration is timely filed 

within the relevant filing period set 

forth in section 71(a)(1) or section 

71(a)(2) of the Act, deficiencies may be 

corrected before the end of this filing 

period without paying a deficiency 

surcharge. Deficiencies may be 

corrected after the end of this filing 

period with payment of the deficiency 

surcharge required by section 71(c) of 

the Act and § 7.6. 

(2) Correcting deficiencies in 

affidavits or declarations filed during 

the grace period. If the affidavit or 

declaration is filed during the six-month 

grace period provided by section 

71(a)(3) of the Act, deficiencies may be 

corrected before the expiration of the 

grace period without paying a 

deficiency surcharge. Deficiencies may 

be corrected after the expiration of the 

grace period with payment of the 

deficiency surcharge required by section 

71(c) of the Act and § 7.6. 

(d) If the affidavit or declaration is not 

filed within the time periods set forth in 

section 71 of the Act, the registration 

will be cancelled. 

Dated: June 18, 2010. 

David J. Kappos, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2010–15305 Filed 6–23–10; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2008–0920; FRL–8824–6] 

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 17 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Two of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture, import, or 

process any of these 17 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: This rule is effective on August 

23, 2010. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on July 8, 2010. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before July 26, 2010 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION). 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2008–0920, by 

one of the following methods: 


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• 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–2008–0920. 

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– 

2008–0920. 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 

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. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28 (the corresponding EPA policy 

appears at 40 CFR part 707, subpart B). 

Chemical importers must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA. Importers of 

chemicals subject to these SNURs must 

certify their compliance with the SNUR 

requirements. In addition, any persons 

who export or intend to export a 

chemical substance that is the subject of 

this rule on or after July 26, 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. 


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Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 35979 

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) (see Unit III.). Once EPA 

determines that a use of a chemical 

substance is a significant new use, 

TSCA section 5(a)(1)(B) requires persons 

to submit a significant new use notice 

(SNUN) to EPA at least 90 days before 

they manufacture, import, or process the 

chemical substance for that use. 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. 2612) 

import certification requirements 

codified 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. 2611 (b)) (see § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

III. Significant New Use Determination 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

enumerated in TSCA section 5(a)(2), the 

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 17 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 bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

17 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

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

• Basis for the TSCA section 5(e) 

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

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

SNURs without TSCA section 5(e) 

consent orders). 

• Toxicity concerns. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes 2 PMN substances 

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

orders under TSCA section 

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

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 


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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. 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) consent order usually 

requires, among other things, that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL) that is 

established by EPA to provide adequate 

protection to human health. In addition 

to the actual NCEL concentration, the 

comprehensive NCELs provisions in 

TSCA section 5(e) consent orders, 

which are modeled after Occupational 

Safety and Health Administration 

(OSHA) Permissible Exposure Limits 

(PELs) provisions, include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. 

However, no comparable NCEL 

provisions currently exist in 40 CFR 

part 721, subpart B, for SNURs. 

Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 15 

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). However, EPA 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–02–996 

Chemical name: Aliphatic triamine 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

chemical substance will be used as a 

monomer for polymers with amide or 

imide links; a crosslinker for epoxy type 

coatings, adhesives and sealants; a 

crosslinker for epoxy type composites; a 

monomer for urea and urethane urea 

polymers used in coatings; a chemical 

intermediate for functional chemicals: 

amides, imides; a chemical intermediate 

for functional chemicals: isocyanates, 

salts; and a chemical intermediate for 

functional chemicals: cyclic amines, etc. 

Based on test data on the PMN 

substance and analogous substances, 

EPA identified concerns for corrosion of 

the skin, eyes, mucous membranes and 

lungs; respiratory tract irritation; 

immunotoxicity; developmental 

toxicity; and reproductive toxicity from 

exposure to the PMN substance. In 

addition, based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 48 parts per 

billion (ppb) of the PMN substance in 

surface waters. For the use described in 

the PMN, worker inhalation and dermal 

exposures are not expected and releases 

to water are 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 

involving an application method which 

generates a vapor, mist, or aerosol may 

cause serious health effects and 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)(3)(i), (b)(3)(ii), and (b)(4)(i). 

Recommended testing: EPA has 

determined that the results of the 

following testing would help 

characterize the human health and 

environmental effects of the PMN 

substance: Either a 90–day inhalation 

toxicity test (OCSPP Harmonized Test 

Guideline 870.3465) in rodents, 

modified for a 28–day exposure, or a 

repeated dose inhalation toxicity study 

(Organization for Co-Operation and 

Development (OECD) 412 test 

guideline); a prenatal developmental 

toxicity study (OCSPP Harmonized Test 

Guideline 870.3700) via the oral route; 

a reproduction and fertility study 

(OCSPP Harmonized Test Guideline 

870.3800) via the oral route; an 

immunotoxicity test (OCSPP 

Harmonized Test Guideline 870.7800) 

via the oral route; a fish chronic toxicity 

test (OCSPP Harmonized Test Guideline 

850.1400); and a daphnid chronic 

toxicity test (OCSPP Harmonized Test 

Guideline 850.1300). All recommended 

tests should be performed on the PMN 

substance neutralized with HCl to a pH 

of 7.0. Further, a certificate of analysis 

should be included for the test 

substance. 

CFR citation: 40 CFR 721.10184. 

PMN Number P–03–106 

Chemical name: 1,2-Propanediol, 3- 

(diethylamino)-, polymers with 5- 

isocyanato-1- (isocyanatomethyl)-1,3,3- 

trimethylcyclohexane, propylene glycol 

and reduced Me esters of reduced 

polymd. oxidized tetrafluoroethylene, 2- 

ethyl-1-hexanol-blocked, acetates (salts). 

CAS number: 328389–90–8. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a surface treatment 

agent. Based on test data on analogous 

substances, EPA believes this substance 

could cause lung toxicity to workers if 

inhaled, via irritation to mucous 

membranes and cationic binding with 

membranes. For the use described in the 

PMN, significant worker dermal or 

inhalation exposure is not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance involving an application 

method which generates a vapor, mist, 

or aerosol may result in 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 90–day 

inhalation toxicity study (OCSPP 

Harmonized Test Guideline 870.3465) 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10185. 

PMN Number P–04–132 

Chemical name: Ethylhexyl oxetane 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: March 7, 2007. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 


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will be as an additive for industrial 

applications. The order was issued 

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

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

findings that this substance may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires use of dermal personal 

protective equipment, including gloves 

demonstrated by testing to be 

impervious (Polyvinyl Alcohol gloves 

with a thickness of no less than 31.3 

mils or Silvershield/4H sleeves with a 

thickness of no less than 2.7 mils have 

been shown to satisfy this requirement 

for up to 8 hours), requires the 

establishment of a hazard 

communication program, and limits 

uses to those listed in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Toxicity concern: Based on test data on 

the PMN substance, EPA identified 

concerns for liver toxicity, thyroid 

toxicity, and systemic toxicity. Further, 

based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 20 ppb of the 

PMN substance in surface waters. 

Recommended testing: EPA has 

determined that the following tests 

would help characterize the human 

health and environmental effects of the 

PMN substance: A 90–day oral toxicity 

test (OCSPP Harmonized Test Guideline 

870.3100) in rodents; a fish early-life 

stage toxicity test (OCSPP Harmonized 

Test Guideline 850.1400) with rainbow 

trout; and a daphnid chronic toxicity 

test (OCSPP Harmonized Test Guideline 

850.1300). The order does not require 

submission of the aforementioned 

information at any specified time or 

production volume. However, the 

order’s restrictions on manufacturing, 

import, processing, distribution in 

commerce, use and disposal of the PMN 

substance will remain in effect until the 

order is modified or revoked by EPA 

based on submission of that or other 

relevant information. 

CFR citation: 40 CFR 721.10186. 

PMN Number P–05–186 

Chemical names: (Chemical A) 4- 

Morpholinepropanamine, N-(1,3- 

dimethylbutylidene)-; (Chemical B) 

Fatty acids, tall-oil, reaction products 

with 4-methyl-2-pentanone and 

aliphatic polyamine (generic); 

(Chemical C) Fatty acids, tall-oil, 

reaction products with (butoxymethyl) 

oxirane formaldehyde-phenol polymer 

glycidyl ether, morpholinepropanamine, 

propylene glycol diamine and aliphatic 

polyamine, N-(1,3 -dimethylbutylidene) 

derivs (generic); and (Chemical D) 

Formaldehyde, polymer with aliphatic 

diamine and phenol, reaction products 

with 4-methyl-2-pentanone (generic). 

CAS numbers: (Chemical A) 1003863– 

30–6; (Chemical B) not available; 

(Chemical C) not available; and 

(Chemical D) not available. 

Basis for action: The PMN states that the 

substances will be used as curing agents 

for epoxy coating systems. Based on test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 10 ppb of the PMN in 

surface waters. For the uses described in 

the PMN, releases of the substances are 

not expected to result in surface waters 

concentrations that exceed 10 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substances resulting in surface water 

concentrations exceeding 10 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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 

substances: A fish acute toxicity test, 

freshwater and marine (OCSPP 

Harmonized Test Guideline 850.1075) 

using the static method with 24–hour 

renewal intervals; a fish acute toxicity 

test mitigated by humic acid (OCSPP 

Harmonized Test Guideline 850.1085) 

using the static method with 24–hour 

renewal intervals; an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OCSPP 

Harmonized Test Guideline 850.1010) 

using the static method with 24–hour 

renewal intervals; and an algal toxicity 

test, tiers I and II (OCSPP Harmonized 

Test Guideline 850.5400) using the 

static method. For all fish and daphnid 

testing, the dilution water must have a 

water hardness of less than 180 mg/L 

calcium carbonate and a total organic 

carbon (TOC) level of less than 2.0 mg/ 

L. Further, the stock solution should be 

adjusted to a pH of 7 at study initiation 

prior to the introduction of test 

organisms. Study reports must include 

chemical names, CAS numbers, and 

composition of the test substance. 

CFR citations: 40 CFR 721.10187 (P–05– 

186, Chemical A); 40 CFR 721.10188 (P– 

05–186, Chemical B); 40 CFR 721.10189 

(P–05–186, Chemical C); and 40 CFR 

721.10190 (P–05–186, Chemical D). 

PMN Numbers P–06–262, P–06–263, 

and P–06–264 

Chemical names: (P–06–262) Amides, 

coco, N-[3-(dibutylamino)propyl]; (P– 

06–263, Chemical A) Amides, coco, N- 

[3-(dibutylamino)propyl], acrylates; (P– 

06–263, Chemical B) 1-Butanaminium, 

N-(3-aminopropyl)-N-butyl-N-(2- 

carboxyethyl)-, N-coco acyl derivs., 

inner salts; and (P–06–264) 

Dialkylcocoamidoalkylpropionate 

(generic). 

CAS numbers: (P–06–262) 851544–20– 

2; (P–06–263, Chemical A) 851545–09– 

0; (P–06–263, Chemical B) 851545–17– 

0; and (P–06–264) not available. 

Basis for action: The consolidated PMN 

states that the substances will be used 

as intermediates for hydrate inhibitors 

for oil and gas wells, production 

pipelines and flowlines (P–06–262); and 

hydrate inhibitors for oil and gas wells, 

production pipelines and flowlines (P– 

06–263 and P–06–264). Based on test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 20 ppb of the PMN 

substances in surface waters. For the 

uses described in the PMNs, these 

substances will not be released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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 (OCSPP 

Harmonized Test Guideline 850.1075); 

an aquatic invertebrate acute toxicity 

test, freshwater daphnids (OCSPP 

Harmonized Test Guideline 850.1010); 

an algal toxicity test, tiers I and II 

(OCSPP Harmonized Test Guideline 

850.5400); a ready biodegradability test 

(OCSPP Harmonized Test Guideline 

835.3110); and an activated sludge 

sorption isotherm (OCSPP Harmonized 

Test Guideline 835.1110) would help 

characterize the environmental effects of 

the PMN substances. Testing should be 

performed on P–06–264. Further, a 

certificate of analysis should be 

included for the test substances. 

CFR citations: 40 CFR 721.10191 (P–06– 

262); 40 CFR 721.10192 (P–06–263, 

Chemical A); 40 CFR 721.10193 (P–06– 

263, Chemical B); and 40 CFR 

721.10194 (P–06–264). 

PMN Numbers P–06–265, P–06–266, 

and P–06–267 


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Chemical names: (P–06–265) 

Dialkylcornoilamidoalkylamine 

(generic); (P–06–266, Chemical A) 

Dialkylcornoilamidoacrylate (generic); 

(P–06–266, Chemical B) 

Dialkycornoilamidoalkylbetaine 

(generic); and (P–06–267) 

Dialkylcornoilamidopropionate 

(generic). 

CAS numbers: (P–06–265) Not available; 

(P–06–266, Chemical A) not available; 

(P–06–266, Chemical B) not available; 

and (P–06–267) not available. 

Basis for action: The consolidated PMN 

states that the substances will be used 

as intermediates for hydrate inhibitors 

for oil and gas wells, production 

pipelines and flowlines (P–06–265); and 

hydrate inhibitors for oil and gas wells, 

production pipelines and flowlines (P– 

06–266 and P–06–267). Based on test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 20 ppb of the PMN 

substances in surface waters. For the 

uses described in the PMNs, these 

substances will not be released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet 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 (OCSPP 

Harmonized Test Guideline 850.1075); 

an aquatic invertebrate acute toxicity 

test, freshwater daphnids (OCSPP 

Harmonized Test Guideline 850.1010); 

an algal toxicity test, tiers I and II 

(OCSPP Harmonized Test Guideline 

850.5400); a ready biodegradability test 

(OCSPP Harmonized Test Guideline 

835.3110); and an activated sludge 

sorption isotherm (OCSPP Harmonized 

Test Guideline 835.1110) would help 

characterize the environmental effects of 

the PMN substances. Testing should be 

performed on P–06–267. Further, a 

certificate of analysis should be 

included for the test substances. 

CFR citations: 40 CFR 721.10195 (P–06– 

265); 40 CFR 721.10196 (P–06–266, 

Chemical A); 40 CFR 721.10197 (P–06– 

266, Chemical B); and 40 CFR 

721.10198 (P–06–267). 

PMN Number P–06–702 

Chemical name: Substituted aliphatic 

amine (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 26, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a polymer curative. The order 

was issued under sections 5(e)(1)(A)(i) 

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

findings that this substance may present 

an unreasonable risk of injury to the 

environment and human health. To 

protect against these risks, the consent 

order requires use of dermal personal 

protective equipment, including gloves 

demonstrated by testing to be 

impervious (Ansell NEOX style 9–912 

gloves have been shown to satisfy this 

requirement for up to 110 minutes), use 

of respiratory personal protective 

equipment, including a National 

Institute of Occupational Safety and 

Health (NIOSH)-approved respiratory 

protection with an APF of at least 50 or 

compliance with a New Chemical 

Exposure Limit (NCEL) of 0.14 mg/m3 as 

an 8–hour time-weighted average, 

establishment of a hazard 

communication program, and restricts 

releases to water. The SNUR designates 

as a ‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on test data on 

analogous substances, EPA identified 

concerns for chronic liver toxicity, acute 

oral toxicity and corrosion to 

membranes, dermal toxicity, inhalation 

toxicity, dermal and eye irritation to 

workers exposed to the PMN substance. 

EPA set the NCEL at 0.14 mg/m3 as an 

8–hour time-weighted average. In 

addition, based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the health and environmental effects of 

the PMN substance: A primary skin 

irritation test (OECD 404 test guideline); 

a primary eye irritation test (OECD 405 

test guideline); a 28–day repeated dose 

(OECD 407 test guideline) gavage in rats, 

a fish early life stage toxicity test 

(OCSPP Harmonized Test Guideline 

850.1400); and a daphnid chronic 

toxicity test (OCSPP Harmonized Test 

Guideline 850.1300). The PMN 

submitter has agreed not to exceed the 

production volume limit without 

performing the primary skin irritation 

test (OECD 404 test guideline); primary 

eye irritation test (OECD 405 test 

guideline); and 28–day repeated dose 

test (OECD 407 test guideline) gavage in 

rats. The order does not require 

submission of the fish early life-stage 

toxicity test and the daphnid chronic 

toxicity test at any specified time or 

production volume. However, the 

order’s restrictions on manufacturing, 

import, processing, distribution in 

commerce, use and disposal of the PMN 

substance will remain in effect until the 

order is modified or revoked by EPA 

based on submission of that or other 

relevant information. 

CFR citation: 40 CFR 721.10199. 

PMN Number P–09–75 

Chemical name: Benzenacetonitrile, 

cyclohexylidene-alkyl substituted 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

PMN substance will be as a component 

of odorant compositions for highlydispersive applications. Based on test 

data on the PMN substance, EPA 

predicts chronic toxicity to aquatic 

organisms at concentrations that exceed 

123 ppb of the PMN substance in 

surface waters. For the processing and 

use scenario and production volume in 

the amended PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

123 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 that exceed 

123 ppb, or exceedance of the annual 

maximum manufacturing and 

importation limit of 10,000 kg, may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(I). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish early life stage toxicity 

test (OCSPP Harmonized Test Guideline 

850.1400) and a field testing for aquatic 

organisms test (OCSPP Harmonized Test 

Guideline 850.1950). The fish early-life 

stage test should be performed using the 

flow-through method with measured 

concentrations. Further, a certificate of 

analysis should be provided for the test 

substance. EPA recommends conducting 

the early life stage fish test first, as the 

results of this test may affect the choice 

of species for subsequent field testing. 

CFR citation: 40 CFR 721.10200. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are the 

subjects of these SNURs, EPA 


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concluded that for 2 of the 17 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 15 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 August 23, 2010 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before July 26, 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 July 

26, 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 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule June 24, 2010. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

2 chemical substances and the PMN 

submitters are prohibited by the TSCA 

section 5(e) consent orders from 

undertaking activities which EPA is 

designating as significant new uses. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 12 of the 17 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

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

§§ 720.25 and 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the Federal Register 

of April 24, 1990, EPA has decided that 

the intent of TSCA section 5(a)(1)(B) is 

best served by designating a use as a 

significant new use as of the date of 

publication of this direct final rule 

rather than as of the effective date of the 

rule. If uses begun after publication 

were considered ongoing rather than 

new, it would be difficult for EPA to 

establish SNUR notice requirements 

because a person could defeat the SNUR 

by initiating the significant new use 

before the rule became effective, and 

then argue that the use was ongoing 

before the effective date of the rule. 

Thus, persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through this SNUR will have to cease 

any such activity before the effective 

date of this rule. To resume their 

activities, these persons would have to 

comply with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires (see Unit III.). 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN, except where the chemical 

substance subject to the SNUR is also 

subject to a test rule under TSCA 

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

Persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the Harmonized 

Test Guidelines referenced in this 

document electronically, please go to 


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http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. Listings of 

the tests specified in the TSCA section 

5(e) consent orders are included in Unit 

IV. The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture, import, or 

processing. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUN submitting 

for significant new use without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI. This rule cross-references 

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

§ 721.11 for situations where the 

chemical identity of the chemical 

substance subject to a SNUR is CBI. This 

procedure is cross-referenced in each 

SNUR that includes specific significant 

new uses that are CBI. 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

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 § 720.50. SNUNs must be 

submitted to EPA, on EPA Form No. 

7710–25 in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. This form is available from the 

Environmental Assistance Division 

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

Washington, DC 20460–0001. Forms 

and information are also available 

electronically at http://www.epa.gov/ 

opptintr/newchems. 

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 


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Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 35985 

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 1,400 SNURs, the Agency 

receives on average only 5 notices per 

year. Of those SNUNs submitted from 

2006–2008, only one appears to be from 

a small entity. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit 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 

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 


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35986 Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: June 17, 2010. 

Wendy C. Hamnett, 

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 

* * * * * 

721.10184 ....................... 2070–0012 

721.10185 ....................... 2070–0012 

721.10186 ....................... 2070–0012 

721.10187 ....................... 2070–0012 

721.10188 ....................... 2070–0012 

721.10189 ....................... 2070–0012 

721.10190 ....................... 2070–0012 

721.10191 ....................... 2070–0012 

721.10192 ....................... 2070–0012 

721.10193 ....................... 2070–0012 

721.10194 ....................... 2070–0012 

721.10195 ....................... 2070–0012 

721.10196 ....................... 2070–0012 

721.10197 ....................... 2070–0012 

721.10198 ....................... 2070–0012 

721.10199 ....................... 2070–0012 

721.10200 ....................... 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10184 to subpart E to 

read as follows: 

§ 721.10184 Aliphatic triamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic triamine (PMN 

P–02–996) 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(y)(1). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

■ 5. Add § 721.10185 to subpart E to 

read as follows: 

§ 721.10185 1,2-Propanediol, 3- 

(diethylamino)-, polymers with 5- 

isocyanato-1- (isocyanatomethyl)-1,3,3- 

trimethylcyclohexane, propylene glycol and 

reduced Me esters of reduced polymd. 

oxidized tetrafluoroethylene, 2-ethyl-1- 

hexanol-blocked, acetates (salts). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-propanediol, 3-(diethylamino)-, 

polymers with 5-isocyanato-1- 

(isocyanatomethyl)-1,3,3- 

trimethylcyclohexane, propylene glycol 

and reduced Me esters of reduced 

polymd. oxidized tetrafluoroethylene, 2- 

ethyl-1-hexanol-blocked, acetates (salts) 

(PMN P–03–106; CAS No. 328389–90–8) 

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(y)(l). 

(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. 

■ 6. Add § 721.10186 to subpart E to 

read as follows: 

§ 721.10186 Ethylhexyl oxetane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as ethylhexyl oxetane (PMN 

P–04–132) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the PMN 

substance after it has been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(concentration set at 1.0 percent), and 

(c). Polyvinyl Alcohol gloves with a 

thickness of no less than 31.3 mils or 

Silvershield/4H sleeves with a thickness 

of no less than 2.7 mils have been 

shown to satisfy the requirements of 

§ 721.63(a)(3)(i) for up to 8 hours. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

1.0 percent), (f), (g)(1)(iii), (g)(1)(iv), 

(g)(2)(i), (g)(2)(v), (g)(3)(ii), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (f), (g), (h), and (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. 

■ 7. Add § 721.10187 to subpart E to 

read as follows: 

§ 721.10187 4-Morpholinepropanamine, N- 

(1,3-dimethylbutylidene)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 


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(1) The chemical substance identified as 

4-morpholinepropanamine, N-(1,3- 

dimethylbutylidene)- (PMN P–05–186, 

Chemical A; CAS No. 1003863–30–6) 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=10). However, when this 

chemical substance is released in 

combination with any of the substances 

in § 721.10188, § 721.10189, or 

§ 721.10190, then the value of N shall 

instead be adjusted according to the 

following formula: 

[(N1 x Release1) + (N2 x Release2) + 

(N3 x Release3) + (N4 x Release4)] / 

(Release1 + Release2 + Release3 + 

Release4) = Adjusted N 

Where the ‘‘N’’ variables are the N 

values for each of the four substances as 

specified in this section and 

§ 721.10188, § 721.10189, § 721.10190 

and the ‘‘Release’’ variables are the 

number of kilograms released of the 

respective four substances (in units of 

kg/site/day) per § 721.91(a). 

(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 § 721.10188 to subpart E to 

read as follows: 

§ 721.10188 Fatty acids, tall-oil, reaction 

products with 4-methyl-2-pentanone and 

aliphatic polyamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, tall-oil, 

reaction products with 4-methyl-2- 

pentanone and aliphatic polyamine 

(PMN P–05–186, Chemical B) 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=10). However, when this 

chemical substance is released in 

combination with any of the substances 

in § 721.10187, § 721.10189, or 

§ 721.10190, then the value of N shall 

instead be adjusted according to the 

following formula: 

[(N1 x Release1) + (N2 x Release2) + 

(N3 x Release3) + (N4 x Release4)] / 

(Release1 + Release2 + Release3 + 

Release4) = Adjusted N 

Where the ‘‘N’’ variables are the N 

values for each of the four substances as 

specified in this section and 

§ 721.10187, § 721.10189, § 721.10190 

and the ‘‘Release’’ variables are the 

number of kilograms released of the 

respective four substances (in units of 

kg/site/day) per § 721.91(a). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.10189 to subpart E to 

read as follows: 

§ 721.10189 Fatty acids, tall-oil, reaction 

products with (butoxymethyl) oxirane 

formaldehyde-phenol polymer glycidyl 

ether, morpholinepropanamine, propylene 

glycol diamine and aliphatic polyamine, N- 

(1,3 -dimethylbutylidene) derivs (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, tall-oil, 

reaction products with (butoxymethyl) 

oxirane formaldehyde-phenol polymer 

glycidyl ether, morpholinepropanamine, 

propylene glycol diamine and aliphatic 

polyamine, N-(1,3 -dimethylbutylidene) 

derivs (PMN P–05–186, Chemical C) 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=10). However, when this 

chemical substance is released in 

combination with any of the substances 

in § 721.10187, § 721.10188, or 

§ 721.10190, then the value of N shall 

instead be adjusted according to the 

following formula: 

[(N1 x Release1) + (N2 x Release2) + 

(N3 x Release3) + (N4 x Release4)] / 

(Release1 + Release2 + Release3 + 

Release4) = Adjusted N 

Where the ‘‘N’’ variables are the N 

values for each of the four substances as 

specified in this section and 

§ 721.10187, § 721.10188, § 721.10190 

and the ‘‘Release’’ variables are the 

number of kilograms released of the 

respective four substances (in units of 

kg/site/day) per § 721.91(a). 

(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. 

■ 10. Add § 721.10190 to subpart E to 

read as follows: 

§ 721.10190 Formaldehyde, polymer with 

aliphatic diamine and phenol, reaction 

products with 4-methyl-2-pentanone 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as formaldehyde, polymer 

with aliphatic diamine and phenol, 

reaction products with 4-methyl-2- 

pentanone (PMN P–05–186; Chemical 

D) 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=10). However, when this 

chemical substance is released in 

combination with any of the substances 

in § 721.10187, § 721.10188, or 

§ 721.10189, then the value of N shall 

instead be adjusted according to the 

following formula: 

[(N1 x Release1) + (N2 x Release2) + 

(N3 x Release3) + (N4 x Release4)] / 

(Release1 + Release2 + Release3 + 

Release4) = Adjusted N 

Where the ‘‘N’’ variables are the N 

values for each of the four substances as 

specified in this section and 

§ 721.10187, § 721.10188, § 721.10189 

and the ‘‘Release’’ variables are the 

number of kilograms released of the 

respective four substances (in units of 

kg/site/day) per § 721.91(a). 

(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. 


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35988 Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 

■ 11. Add § 721.10191 to subpart E to 

read as follows: 

§ 721.10191 Amides, coco, N-[3- 

(dibutylamino)propyl]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amides, coco, N-[3- 

(dibutylamino)propyl] (PMN P–06–262; 

CAS No. 851544–20–2) 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) 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 § 721.10192 to subpart E to 

read as follows[U1]: 

§ 721.10192 Amides, coco, N-[3- 

(dibutylamino)propyl], acrylates. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amides, coco, N-[3- 

(dibutylamino)propyl], acrylates (PMN 

P–06–263, Chemical A; CAS No. 

851545–09–0) 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) 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. 

■ 13. Add § 721.10193 to subpart E to 

read as follows: 

§ 721.10193 1-Butanaminium, N-(3- 

aminopropyl)-N-butyl-N-(2-carboxyethyl)-, 

N-coco acyl derivs., inner salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-butanaminium, N-(3-aminopropyl)-Nbutyl-N-(2-carboxyethyl)-, N-coco acyl 

derivs., inner salts (PMN P–06–263, 

Chemical B; CAS No. 851545–17–0) 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) 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. 

■ 14. Add § 721.10194 to subpart E to 

read as follows: 

§ 721.10194 

Dialkylcocoamidoalkylpropionate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

dialkylcocoamidoalkylpropionate (PMN 

P–06–264) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10195 to subpart E to 

read as follows: 

§ 721.10195 

Dialkylcornoilamidoalkylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

dialkylcornoilamidoalkylamine (PMN 

P–06–265) 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. 

■ 16. Add § 721.10196 to subpart E to 

read as follows: 

§ 721.10196 Dialkylcornoilamidoacrylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

dialkylcornoilamidoacrylate (PMN P– 

06–266, Chemical A) 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. 

■ 17. Add § 721.10197 to subpart E to 

read as follows: 

§ 721.10197 

Dialkycornoilamidoalkylbetaine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

dialkycornoilamidoalkylbetaine (PMN 

P–06–266, Chemical B) is subject to 

reporting under this section for the 


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Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Rules and Regulations 35989 

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. 

■ 18. Add § 721.10198 to subpart E to 

read as follows: 

§ 721.10198 

Dialkylcornoilamidopropionate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

dialkylcornoilamidopropionate (PMN 

P–06–267) 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. 

■ 19. Add § 721.10199 to subpart E to 

read as follows: 

§ 721.10199 Substituted aliphatic amine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted aliphatic 

amine (PMN P–06–702) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. The 

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2), (a)(3)(i), (a)(4), (a)(5), (a)(6), 

(b) (concentration set at 1.0 percent), 

and (c). Ansell NEOX style 9–912 gloves 

have been shown to satisfy the 

requirements of § 721.63(a)(3)(i) for up 

to 110 minutes. Respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. The following 

NIOSH-approved respirators meet the 

requirements for § 721.63(a)(4): Air 

purifying, tight-fitting full-face 

respirator equipped with the 

appropriate combination cartridges, 

cartridges should be tested and 

approved for the gas/vapor substance 

(i.e., organic vapor, acid gas, or 

substance-specific cartridge) and should 

include a particulate filter (N100 if oil 

aerosols are absent, R100, or P100); 

powered air-purifying respirator 

equipped with a tight-fitting facepiece 

(full-face) and the appropriate 

combination cartridges, cartridges 

should be tested and approved for the 

gas/vapor substance (i.e., organic vapor, 

acid gas, or substance-specific 

cartridges) and should include High 

Efficiency Particulate Air (HEPA) filters; 

supplied-air respirator operated in 

pressure demand or continuous flow 

mode and equipped with a tight-fitting 

face piece (full-face). As an alternative 

to the respiratory requirements listed 

here, a manufacturer, importer, or 

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the Toxic 

Substances Control Act (TSCA) section 

5(e) consent order for this substance. 

The NCEL is 0.14 mg/m3 as an 8–hour 

time-weighted average. Persons who 

wish to pursue NCELs as an alternative 

to the § 721.63 respirator requirements 

may request to do so under § 721.30. 

Persons whose § 721.30 requests to use 

the NCELs approach are approved by 

EPA will receive NCELs provisions 

comparable to those contained in the 

corresponding section 5(e) consent 

order. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

1.0 percent), (f), (g)(1)(i), (g)(1)(ii), 

(g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 

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

(g)(4)(iii), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(r). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (f), (g), (h), (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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 20. Add § 721.10200 to subpart E to 

read as follows: 

§ 721.10200 Benzenacetonitrile, 

cyclohexylidene-alkyl substituted (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzenacetonitrile, 

cyclohexylidene-alkyl substituted (PMN 

P–09–75) 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(s) (10,000 kg). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=123). 

(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. 

[FR Doc. 2010–15334 Filed 6–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 27 

[WT Docket No. 03–66; RM–10586; FCC 10– 

107] 

Facilitating the Provision of Fixed and 

Mobile Broadband Access, 

Educational and Other Advanced 

Services in the 2150–2162 and 2500– 

2690 MHz Bands 

AGENCY: Federal Communications 

Commission. 

ACTION: Correction. 


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