29982 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

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 this rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 11, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.960, the table is amended 

by adding alphabetically the following 

polymer: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

2-butenedioic acid 

(2Z)-, monobutyl 

ester, polymer with 

methoxyethene, sodium salt, minimum 

number average 

molecular weight 

(in amu), 18,200.

205193–99–3 

* * * * * 

[FR Doc. E9–14596 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2008–0252; FRL–8417–6] 

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 23 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Four 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 23 chemical 

substances for an activity that is 

designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: The effective date of this rule is 

August 24, 2009 without further notice, 

unless EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments 

before July 24, 2009. This rule shall be 

promulgated for purposes of judicial 

review at 1 p.m. (e.s.t.) on July 8, 2009. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before July 

24, 2009, EPA will withdraw the 

relevant sections of this direct final rule 

before its effective date. EPA will then 

issue a proposed SNUR for the chemical 

substance(s) on which adverse or 

critical comments were received, 

providing a 30–day period for public 

comment. 

Additionally, significant new use 

designations for a chemical substance 

are legally established as of the date of 

publication of this direct final rule June 

24, 2009. See the discussion in Unit VII. 

for more specific details. 

Further, for persons intending to 

import or export any of the chemical 

substances in this rule, they are subject 

to the TSCA section 13 import 

certification requirements and the 

export notification provisions of TSCA 

section 12(b) as of July 24, 2009. See the 

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

more specific details. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2008–0252, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2008–0252. 

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– 

2008–0252. EPA’s policy is that all 

comments received will be included in 

the public 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 public 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. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

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

Docket: All documents in the docket 

are listed in the 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 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29983 

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 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

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

TSCA-Hotline@epa.gov. 

For technical information contact: 

Tracey Klosterman, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

2209; e-mail address: 

klosterman.tracey@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., Chemical 

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28 (the corresponding EPA policy 

appears at 40 CFR part 707, subpart B). 

Chemical importers must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA. Importers of 

chemicals subject to these SNURs must 

certify their compliance with the SNUR 

requirements. In addition, any persons 

who export or intend to export a 

chemical substance that is the subject of 

this rule on or after July 24, 2009 are 

subject to the export notification 

provisions of TSCA section 12(b) (15 

U.S.C. 2611(b)) (see § 721.20), and must 

comply with the export notification 

requirements in 40 CFR part 707, 

subpart D. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM as CBI and then 

identify electronically within the disk or 

CD-ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What Action is the Agency Taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

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

that preamble for further information on 

the objectives, rationale, and procedures 

for SNURs and on the basis for 

significant new use designations, 

including provisions for developing test 

data. 

B. What is the Agency’s Authority for 

Taking this Action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture, 

import, or process the chemical 

substance for that use. The mechanism 

for reporting under this requirement is 

established under § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

29984 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6, or 7 to control the activities 

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

Chemical importers are subject to the 

TSCA section 13 (15 U.S.C. 1612) 

import certification requirements 

promulgated at 19 CFR 12.118 through 

12.127 and 19 CFR 127.28 (the 

corresponding EPA policy appears at 40 

CFR part 707, subpart B). Chemical 

importers must certify that the shipment 

of the chemical substance complies with 

all applicable rules and orders under 

TSCA. Importers of chemical substances 

subject to a proposed or 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 

proposed or final SNUR are subject to 

the export notification provisions of 

TSCA section 12(b) (15 U.S.C. 2612 (b)) 

(see § 721.20), and must comply with 

the export notification requirements in 

40 CFR part 707, subpart D. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 23 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 

above four factors listed in TSCA 

section 5(a)(2). 

IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

23 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) 

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 4 PMN substances 

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

orders under TSCA section 

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

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 

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 19 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

EPA did not find that the use scenario 

described in the PMN triggered the 

determinations set forth under TSCA 

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

that certain changes from the use 

scenario described in the PMN could 

result in increased exposures, thereby 

constituting a ‘‘significant new use.’’ 

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

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

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

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29985 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–05–1 

Chemical name: Formaldehyde, 

polymer with dialkylphenylamine, 

dialkylphenol and 

trimethylhexanediamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a curing agent 

for epoxy coating systems. Based on test 

data on analogous phenols, aliphatic 

amines, and benzyl amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 parts per billion (ppb) of the PMN 

substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS 835.3110 

test guideline); a fish acute toxicity test, 

freshwater and marine (OPPTS 850.1075 

test guideline (public draft)); an aquatic 

invertebrate acute toxicity test, fresh 

water daphnids (OPPTS 850.1010 test 

guideline (public draft)); and an algal 

toxicity test, tiers I and II (OPPTS 

850.5400 test guideline (public draft)) 

would help characterize the 

environmental effects of the PMN 

substance. All aquatic toxicity testing 

should be performed using the static 

method with nominal concentrations at 

a pH of 7. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10134. 

PMN Number P–05–11 

Chemical name: Phosphinic acid, P,Pdiethyl-, zinc salt (2:1). 

CAS number: 284685–45–6. 

Basis for action: The PMN states that the 

substance will be used as a flame 

retardant for polyamide thermoplastic 

epoxy resins. Based on test data on the 

PMN substance and analogous zinc 

salts, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 12 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

12 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

12 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 (b)(4)(i) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS 

850.1400 test guideline (public draft)) 

with rainbow trout and a daphnid 

chronic toxicity test (OPPTS 850.1300 

test guideline (public draft)) would help 

characterize the environmental effects of 

the PMN substance. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10135. 

PMN Number P–05–177 

Chemical name: 2-Propenoic acid, 2- 

methyl-, 2-hydroxyethyl ester, reaction 

products with 

hexakis(alkoxyalkyl)melamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a base resin 

in UV/EB curable and peroxide curable 

formulations. Based on test data on 

analogous methacrylates and esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 100 ppb of the PMN 

substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ZahnWellens/EMPA test (OPPTS 835.3200 

test guideline); a fish acute toxicity test, 

freshwater and marine (OPPT 850.1075 

test guideline (public draft)); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS 850.1010 

test guideline (public draft)); and an 

algal toxicity test, tiers I and II (OPPTS 

850.5400 test guideline (public draft)) 

would help characterize the 

environmental effects of the PMN 

substance. Fish and daphnia testing 

should be performed using the flowthrough method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10136. 

PMN Number P–05–329 

Chemical name: Halogenated phenoxy 

aromatic (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a fungicide 

intermediate. EPA identified health and 

environmental concerns because the 

substance may be a persistent, 

bioaccumulative, and toxic (PBT) 

chemical, based on physical/chemical 

properties of the PMN substance, as 

described in the New Chemicals 

Program’s PBT Category (64 FR 60194; 

November 4, 1999) (FRL–6097–7). EPA 

estimates that the PMN substance will 

persist in the environment more than 

two months and estimates a 

bioaccumulation factor of greater than 

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

data on analogous neutral organic 

substances, EPA predicts toxicity to 

aquatic organisms. As described in the 

PMN, significant worker exposure is 

unlikely and the substance is not 

released to surface waters. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any predictable or 

purposeful release containing the PMN 

substance into the waters of the United 

States may cause serious health effects 

and significant environmental effects, 

since the PMN substance has been 

characterized by EPA as a PBT. Based 

on this information, the PMN substance 

meets the concern criteria at § 721.170 

(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of a subset 

of the tiered testing described in the 

New Chemicals Program’s PBT Category 

would help characterize the PBT 

attributes of the PMN substance. EPA 

has determined that a ready 

biodegradability test (OPPTS 835.3110 

test guideline); a fish bioconcentration 

factor test (OPPTS 850.1730 test 

guideline (public draft)); and a 

combined repeated dose study with the 

reproductive/developmental toxicity 

screening test (OPPTS 870.3650 or 

Organisation for Economic Co-operation 

and Development (OECD) 422 test 

guidelines) would help characterize the 

human health and environmental effects 

of the PMN substance. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10137. 

29986 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

PMN Number P–05–336 

Chemical name: 3-Isoxazolecarboxylic 

acid, 4,5-dihydro-5,5-diphenyl-, ethyl 

ester. 

CAS number: 163520–33–0. 

Basis for action: The PMN states that the 

substance will be used as an herbicide 

safener in formulated pesticide 

products. Based on test data on the PMN 

substance submitted under TSCA 

section 8(e), the substance may cause 

liver, kidney, heart and spleen toxicity. 

Also, based on information submitted in 

the PMN Material Safety Data Sheet 

(MSDS), EPA has concerns for dermal 

sensitization. In addition, based on test 

data on the PMN substance and 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. As described in the PMN, 

significant worker exposure is not 

expected. Further, general population 

exposure is not expected as the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in release to surface waters 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i), (b)(4)(i), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS 

850.1400 test guideline (public draft)) 

with rainbow trout and a daphnid 

chronic toxicity test (OPPTS 850.1300 

test guideline (public draft)) would help 

characterize the environmental effects of 

the PMN substance. Further, a 

certificate of analysis should be 

provided for the test substance. No 

human health testing is recommended 

at this time. 

CFR citation: 40 CFR 721.10138. 

PMN Number P–05–776 

Chemical name: Ethanone, 1-(1- 

chlorocyclopropyl)-. 

CAS number: 63141–09–3. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an intermediate. 

Based on test data on the PMN 

substance, EPA has concerns for acute 

toxicity, strong solvent (defatting) 

irritation, and dermal sensitization. 

Also, based on test data on analogous 

chloroalkanes, EPA has concerns for 

potential mutagenicity. In addition, 

based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 500 ppb of 

the PMN substance in surface waters. As 

described in the PMN, significant 

worker exposure is unlikely due to the 

use of adequate personal protective 

equipment. Significant general 

population exposure is not expected to 

result from the identified environmental 

releases from the proposed 

manufacturing, processing, or use of the 

substance. Further, significant 

environmental exposure is unlikely as 

the substance is not released to surface 

waters resulting in stream 

concentrations that exceed 500 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance other than as an intermediate 

or any use of the substance resulting in 

surface water concentrations exceeding 

500 ppb may cause serious health 

effects and significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

(b)(3)(ii), and (b)(4)(i). 

Recommended testing: EPA has 

determined that the results of a porous 

pot test (OPPTS 835.3220 test 

guideline); a fish acute toxicity test, 

freshwater and marine (OPPTS 850.1075 

test guideline (public draft)); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS 850.1010 

test guideline (public draft)); an algal 

toxicity test, tiers I and II (OPPTS 

850.5400 test guideline (public draft)); a 

mammalian erythrocyte micronucleus 

test (OPPTS 870.5395 test guideline) by 

the intraperitoneal route; and a repeated 

dose 28–day oral toxicity study in 

rodents (OPPTS 870.3050 test guideline) 

would help characterize the human 

health and environmental effects of the 

PMN substance. Fish and daphnia 

testing should be performed using the 

flow-through method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10139. 

PMN Number P–06–33 

Chemical name: Phosphoric acid, tin 

(2+) salt (2:3). 

CAS number: 15578–32–2. 

Basis for action: The PMN states that the 

substance will be used as a pigment in 

plastic compounds for laser marking 

and laser welding. Based on test data on 

the PMN substance and on analogous 

respirable, poorly soluble particulates, 

EPA has identified concerns that the 

PMN substance may cause lung 

overload, immunotoxicity, and 

reproductive toxicity. Also, based on 

test data on the PMN substance and 

analogous inorganic phosphates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

10 ppb of the PMN substance in surface 

waters. As described in the PMN, 

significant worker exposure is unlikely 

due to the use of adequate personal 

protective equipment. Further, 

environmental exposure is unlikely, as 

the substance is not released to surface 

waters. Therefore, EPA has not 

determined that the proposed import, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that domestic 

manufacture or any use of the substance 

resulting in release to surface waters 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i), (b)(3)(ii), 

(b)(4)(i), and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS 850.1075 test guideline 

(public draft)); an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS 850.1010 test guideline (public 

draft)); an algal toxicity test, tiers I and 

II (OPPTS 850.5400 test guideline 

(public draft)); and a reproduction/ 

developmental toxicity screening test 

(OPPTS 870.3550 test guideline) would 

help characterize the human health and 

environmental effects of the PMN 

substance. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10140. 

PMN Number P–06–163 

Chemical name: Oils, ginger, zingiber 

purpureum. 

CAS number: 864662–46–4. 

Basis for action: The PMN states that the 

substance will be used in fragrance 

compositions in cosmetic products, air 

fresheners, household cleaners, 

dishwashing detergents, and laundry 

detergents. Based on test data on 

analogous methyl eugenol, EPA 

identified concerns that the PMN 

substance may cause cancer. As 

described in the PMN, significant 

worker dermal exposure is unlikely due 

to the use of adequate dermal 

protection. Although there is potential 

for consumer exposure, significant 

dermal and inhalation exposures are not 

expected. Therefore, EPA has not 

determined that the proposed import, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29987 

determined, however, that domestic 

manufacture or use of the substance 

without the use of impervious gloves, 

where there is a potential for potential 

worker dermal exposure, may cause 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

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

Recommended testing: EPA has 

determined that the results of an in vitro 

mammalian erythrocyte micronucleus 

test (OPPTS 870.5395 test guideline); a 

salmonella typhimurium reverse 

mutation assay (OPPTS.870.5265 test 

guideline); and a carcinogenicity test 

(OPPTS 870.4200 test guideline) would 

help characterize the human health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10141. 

PMN Number P–06–199 

Chemical name: Oxabicycloalkane 

carboxylic acid alkanediyl ester 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a monomer. Based 

on test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

7 ppb of the PMN substance in surface 

waters. As described in the PMN, the 

substance will not be released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS 

850.1400 test guideline (public draft)) 

with freshwater fish and a daphnid 

chronic toxicity test (OPPTS 850.1300 

test guideline (public draft)) would help 

characterize the environmental effects of 

the PMN substance. Further, a 

certificate of analysis should be 

provided for the test substance. 

CFR citation: 40 CFR 721.10142. 

PMN Number P–06–733 

Chemical name: Amines, bis (C11-14- 

branched and linear alkyl). 

CAS number: 900169–60–0. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. EPA identified health and 

environmental concerns because the 

substance may be a PBT chemical, based 

on physical/chemical properties of the 

PMN substance, as described in the New 

Chemicals Program’s PBT Category (64 

FR 60194; November 4, 1999). EPA 

estimates that the PMN substance will 

persist in the environment more than 

two months and estimates a 

bioaccumulation factor of greater than 

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

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms. As described in the PMN, 

significant worker exposure is unlikely 

and the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any predictable or purposeful release of 

the PMN substance into the waters of 

the United States may cause serious 

health effects and significant 

environmental effects, since the PMN 

substance has been characterized by 

EPA as a PBT. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170 

(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of the tiered 

testing described in the New Chemicals 

Program’s PBT Category would help 

characterize the PBT attributes of the 

PMN substance. The neutralized 

substance should be used for all human 

health testing. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10143. 

PMN Number P–06–805 

Chemical name: Modified 

thiocarbamate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a mining chemical 

reagent. Based on test data on a 

structurally similar substance, EPA 

identified human health concerns for 

toxicity to liver, thymus, spleen, kidney, 

and red blood cells from exposure via 

drinking water and fish ingestion 

resulting from releases to surface and 

ground water. Further, based on test 

data on the PMN substance and 

analogous imides, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 70 ppb of the 

PMN substance in surface waters. As 

described in the PMN, the substance 

will not be released to surface and 

ground waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(ii), (b)(4)(i), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a bacterial 

reverse mutation test (OPPTS 870.5100 

test guideline); a mammalian 

erythrocyte micronucleus test (OPPTS 

870.5395 test guideline) by the 

intraperitoneal route; a repeated dose 

28–day oral toxicity in rodents (OPPTS 

870.3050 test guideline); an acute oral 

toxicity (OPPTS 870.1100 test 

guideline); a fish early life-stage toxicity 

test (OPPTS 850.1400 test guideline 

(public draft)); a daphnid chronic 

toxicity test (OPPTS 850.1300 test 

guideline (public draft)); and either a 

ready biodegradability test (OPPTS 

835.3110 test guideline) or a sealed 

vessel carbon dioxide production test 

(OPPTS 835.3120 test guideline) would 

help characterize the human health and 

environmental effects of the PMN 

substance. Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. Further, a certificate of 

analysis should be provided for the test 

substance. 

CFR citation: 40 CFR 721.10144. 

PMN Number P–06–816 

Chemical name: Modified reaction 

products of alkyl alcohol, halogenated 

alkane, substituted epoxide, and amino 

compound (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: May 25, 2007. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be as a hydrophobic 

surface active agent for cellulosic 

substrates and similar materials. The 

order was issued under section 

5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and 

(e)(1)(A)(ii)(II) of TSCA based on a 

finding that this substance may present 

an unreasonable risk of injury to the 

environment and human health, the 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance and its potential degradation 

products. To protect against this 

exposure and risk, the consent order 

requires that the PMN substance be 

tested, before a certain production 

volume is reached, in various fate and 

physical/chemical tests to determine its 

fate and composition in various media 

and conditions in the environment. In 

addition, for the fluorinated portion of 

the polymer, the submitter has agreed to 

29988 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

analyze, report, and limit specific 

fluorinated impurities of the PMN 

substance where the carbon chain meets 

or exceeds a specified length, if these 

values exceed those reported in the 

PMN. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: EPA has concerns for 

potential incineration or other 

decomposition products of the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers that suggests that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

(P) in the environment, could 

bioaccumulate (B) or biomagnify, and 

could be toxic (T) to people, wild 

mammals, and birds, based on data on 

analog chemicals, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated alkyls, including 

the presumed environmental 

degradation product. There is 

pharmacokinetic and toxicological data 

in animals on PFOA, as well as 

epidemiological and blood monitoring 

data in humans. Toxicity studies on 

PFOA indicate developmental, 

reproductive, and systemic toxicity in 

various species. Cancer may also be of 

concern. These factors, taken together, 

raise concerns for potential adverse 

chronic effects in humans and wildlife. 

There is also limited pharmacokinetic 

data and toxicological data in animals 

on other perfluoroalkyls, including the 

presumed degradation product and 

precursors. These data indicate a 

different and less toxic profile for the 

presumed degradation product and 

precursors. EPA expects that additional 

animal data will be developed under 

various consent orders that have the 

expected common degradation product 

or analog information. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

tests would help characterize possible 

effects of the substance. The PMN 

submitter has agreed not to exceed the 

production volume limit without 

performing these tests. The consent 

order contains one production volume 

limit. The PMN submitter has agreed 

not to exceed the production volume 

limit without performing the following 

studies: A modified semi-continuous 

activated sludge (SCAS) test for 

insoluble and volatile chemicals 

(OPPTS 835.5045 or OECD 302A test 

guidelines), with analysis for 

degradation products; a UV visible light 

absorption test (OPPTS 830.7050 or 

OECD 101 test guidelines); a direct 

photolysis rate in water by sunlight test 

(OPPTS 835.2210 test guideline), if 

wavelengths greater than 290 

nanometers (nm) are absorbed in the 

previous test; an indirect photolysis 

screening test (OPPTS 835.5270 test 

guideline); a phototransformation of 

chemicals on soil surfaces test (Draft 

OECD guideline January 2002) using 

two soils; an anaerobic biodegradability 

of organic compounds in digested 

sludge test (OECD 311 test guideline); 

an aerobic and anaerobic transformation 

in aquatic sediment systems test (OECD 

308 test guideline); and an aerobic 

sewage treatment simulation test (OECD 

303A test guideline). 

CFR citation: 40 CFR 721.10145. 

PMN Number P–07–87 

Chemical name: Partially fluorinated 

condensation polymer (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: August 10, 2007. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be as an open, nondispersive carpet treatment. The order 

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

and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of 

TSCA based on a finding that this 

substance may present an unreasonable 

risk of injury to the environment and 

human health, the substance may be 

produced in substantial quantities and 

may reasonably be anticipated to enter 

the environment in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance and its potential degradation 

products. To protect against this 

exposure and risk, the consent order 

requires that the PMN substance be 

tested, before certain production 

volumes are reached, in various fate and 

physical/chemical tests to determine its 

fate and composition in various media 

and conditions in the environment. The 

order also limits the concentration of 

the PMN substance in products sold to 

non-industrial users or distributors to 

non-industrial users that could spray 

apply the substance (after further 

dilution). Also, the consent order 

forbids the sale of the PMN substance to 

consumers in a spray application 

formulation. In addition, for the 

fluorinated portion of the polymer, the 

submitter has agreed to analyze, report, 

and limit specific fluorinated impurities 

of the PMN substance where the carbon 

chain meets or exceeds a specified 

length. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: EPA has concerns for 

potential incineration or other 

decomposition products of the PMN 

substance. These perfluorinated 

products may be released to the 

environment from incomplete 

incineration of the PMN substance at 

low temperatures. EPA has preliminary 

evidence, including data on some 

fluorinated polymers that suggests that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

(P) in the environment, could 

bioaccumulate (B) or biomagnify, and 

could be toxic (T) to people, wild 

mammals, and birds, based on data on 

analog chemicals, including PFOA and 

other perfluorinated alkyls, including 

the presumed environmental degradant. 

There is pharmacokinetic and 

toxicological data in animals on PFOA, 

as well as epidemiological and blood 

monitoring data in humans. Toxicity 

studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species. 

Cancer may also be of concern. These 

factors, taken together, raise concerns 

for potential adverse chronic effects in 

humans and wildlife. There is also 

limited pharmacokinetic data and 

toxicological data in animals on other 

perfluoroalkyls, including the presumed 

degradant and precursors. These data 

indicate a different and less toxic profile 

for the presumed degradant and 

precursors. EPA expects that additional 

animal data will be developed under 

various consent orders that have the 

expected common degradant or analog 

information. EPA also has concerns that 

the PMN substance, under some 

conditions of use—particularly nonindustrial, commercial, or consumer 

use—could cause lung effects, based on 

limited data on some perfluorinated 

compounds and an acute inhalation 

study on a related polymer. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

tests would help characterize possible 

effects of the substance. The PMN 

submitter has agreed not to exceed the 

production volume limits without 

performing these tests. The consent 

order contains three production volume 

limits. The PMN submitter has agreed 

not to exceed the first production 

volume limit without performing the 

following studies: A modified SCAS test 

for insoluble and volatile chemicals 

(OPPTS 835.5045 or OECD 302A test 

guidelines), with analysis for 

degradation products; a UV visible light 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29989 

absorption test (OPPTS 830.7050 or 

OECD 101 test guidelines); a direct 

photolysis rate in water by sunlight test 

(OPPTS 835.2210 test guideline), if 

wavelengths greater than 290 nm are 

absorbed in the previous test; an 

indirect photolysis screening test 

(OPPTS 835.5270 test guideline); a 

hydrolysis as a function of pH and 

temperature test (OPPTS 835.2130 test 

guideline); an aerobic and anaerobic 

transformation in soil test (OECD 307 

test guideline); and an anaerobic 

biodegradability of organic compounds 

in digested sludge test (OECD 311 test 

guideline). The PMN submitter has also 

agreed not to exceed the second higher 

production volume limit without 

performing the following tests: A 

phototransformation of chemicals on 

soil surfaces test (Draft OECD guideline 

January 2002) using two soils; an 

aerobic sewage treatment simulation test 

(OECD 303A test guideline); and an 

aerobic and anaerobic transformation in 

aquatic sediment systems test (OECD 

308 test guideline). Finally, the PMN 

submitter has also agreed not to exceed 

the highest production volume limit 

without performing an aerobic and 

anaerobic transformation in soil test 

(OECD 307 test guideline). 

CFR citation: 40 CFR 721.10146. 

PMN Number P–07–198 

Chemical name: Acrylate derivative of 

alkoxysilylalkane ester and mixed metal 

oxides (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a film coating 

additive. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA has concerns for lung 

effects for the PMN substance. Based on 

physical properties, EPA has concerns 

for potential systemic effects from 

dermal exposure to the PMN substance. 

As described in the PMN, worker 

inhalation exposure to particulates is 

not expected and dermal exposure is 

minimal due to the use of adequate 

dermal protection. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

impervious gloves where there is a 

potential for dermal exposure; use of the 

substance other than as described in the 

PMN; or manufacture, processing, or use 

of the substance in a powder form, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10147. 

PMN Number P–07–330 

Chemical name: Acryloxy alkanoic 

alkane derivative with mixed metal 

oxides (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a film coating 

additive. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA has concerns for lung 

effects for the PMN substance. Based on 

physical properties, EPA has concerns 

for potential systemic effects from 

dermal exposure to the PMN substance. 

As described in the PMN, worker 

inhalation exposure to particulates is 

not expected and dermal exposure is 

minimal due to the use of adequate 

dermal protection. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

impervious gloves where there is a 

potential for dermal exposure; use of the 

substance other than as described in the 

PMN; or manufacture, processing, or use 

of the substance in a powder form, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10148. 

PMN Numbers P–07–0522 and P–07– 

523 

Chemical names: (P–07–522) Carbon 

black, (3-methylphenyl)-modified, 

substituted (generic) and (P–07–523) 

Carbon black, (4-methylphenyl)- 

modified, substituted (generic). 

CAS numbers: Not available. 

Basis for action: The consolidated PMN 

states that the generic (non-confidential) 

use of the substances will be as colorant 

process intermediates. Based on test 

data on analogous respirable, poorly 

soluble particulates, EPA has concerns 

for lung effects for the PMN substances. 

Based on physical properties, EPA has 

concerns for potential systemic effects 

from dermal exposure to the PMN 

substances. As described in the PMN, 

worker inhalation exposure to 

particulates is not expected and dermal 

exposure is minimal due to the use of 

adequate dermal protection. 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 use of the substances 

without the use of impervious gloves 

where there is a potential for dermal 

exposure; use of the substances other 

than as described in the PMN; or 

manufacture, processing, or use of the 

substances in a powder form, may cause 

serious health effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) with a post-observation 

period of up to 3 months would help 

characterize the human health effects of 

the PMN substances. Evaluations should 

include markers of damage, oxidant 

stress, cell proliferation, the degree/ 

intensity and duration of pulmonary 

inflammation, and a cytotoxic effects 

and histopathology of pulmonary 

tissues in addition to the standard 

requirements in the test guideline. 

CFR citations: 40 CFR 721.10149 (P–07– 

522) and 40 CFR 721.10150 (P–07–523). 

PMN Number P–07–642 

Chemical name: Modified styrene, 

divinylbenzene polymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a cleaning and 

polishing chemical for semiconductor 

manufacturing. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA has concerns for lung 

effects for the PMN substance. Based on 

physical properties, EPA has concerns 

for potential systemic effects from 

dermal exposure to the PMN substance. 

As described in the PMN, worker 

inhalation exposure to particulates is 

not expected and dermal exposure is 

minimal due to the use of adequate 

dermal protection. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

impervious gloves where there is a 

potential for dermal exposure; use of the 

substance other than as described in the 

PMN; or manufacture, processing, or use 

of the substance in a powder form, may 

cause serious health effects. Based on 

29990 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) with a post-observation 

period of up to 3 months would help 

characterize the human health effects of 

the PMN substance. Evaluations should 

include markers of damage, oxidant 

stress, cell proliferation, the degree/ 

intensity and duration of pulmonary 

inflammation, and a cytotoxic effects 

and histopathology of pulmonary 

tissues, in addition to the standard 

requirements in the test guideline. 

CFR citation: 40 CFR 721.10151. 

PMN Number P–07–674 

Chemical name: Oxirane, substituted 

silylmethyl-, hydrolysis products with 

alkanol zirconium(4+) salt and silica, 

acetates (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a protective 

coating. Based on test data on analogous 

respirable, poorly soluble particulates, 

EPA believes that the PMN substance 

may cause lung effects. Based on 

physical properties, EPA believes that 

the PMN substance may cause systemic 

effects via dermal exposure. As 

described in the PMN, significant 

worker exposure is unlikely due to use 

in an enclosed process with adequate 

personal protective equipment. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance without the use of impervious 

gloves where there is a potential for 

dermal exposure; use of the substance in 

non-enclosed processes during spray 

application; use other than as described 

in the PMN; or manufacture, processing, 

or use of the substance in a powder 

form, may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) with the addition of a postexposure observation period of up to 3 

months, and a glove permeation test 

(American Society for Testing and 

Materials (ASTM) F739 and F1194–99 

test guidelines) would help characterize 

the human health effects of the PMN 

substance. Evaluations for the 

inhalation study should include 

markers of damage, oxidant stress, cell 

proliferation, the degree/intensity and 

duration of pulmonary inflammation, 

and a cytotoxic effects and 

histopathology of pulmonary tissues, in 

addition to the standard requirements in 

the test guideline. 

CFR citation: 40 CFR 721.10152. 

PMN Number P–08–6 

Chemical name: Modified methyl 

methacrylate, 2-hydroxyethyl 

methacrylate polymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a resin for coatings. 

Based on test data on analogous 

respirable, poorly soluble particulates, 

EPA believes that the PMN substance 

might cause lung effects. Based on 

physical properties, EPA believes that 

the PMN substance may cause systemic 

effects via dermal exposure. As 

described in the PMN, worker 

inhalation exposure to particulates is 

not expected and dermal exposure is 

minimal due to the use of adequate 

dermal protection. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

impervious gloves where there is a 

potential for dermal exposure; use of the 

substance other than as described in the 

PMN; or manufacture, processing, or use 

of the substance in a powder form, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) with the addition of a postexposure observation period of up to 3 

months, and a glove permeation test 

(ASTM F739 and F1194–99 test 

guidelines) would help characterize the 

human health effects of the PMN 

substance. Evaluations for the 

inhalation study should include 

markers of damage, oxidant stress, cell 

proliferation, the degree/intensity and 

duration of pulmonary inflammation, 

and a cytotoxic effects and 

histopathology of pulmonary tissues, in 

addition to the standard requirements in 

the test guideline. 

CFR citation: 40 CFR 721.10153. 

PMN Number P–08–157 

Chemical name: Quaternary ammonium 

compounds, dicoco alkyldimethyl, 

chlorides, reaction products with silica. 

CAS number: 956147–76–5. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as raw material for the 

manufacture of release coatings. Based 

on test data on analogous respirable, 

poorly soluble particulates, EPA 

believes that the PMN substance may 

cause lung effects. Based on physical 

properties of the PMN substance, EPA 

believes that it may cause systemic 

effects via dermal exposure. As 

described in the PMN, worker 

inhalation exposure to particulates is 

not expected and dermal exposure is 

minimal due to the use of adequate 

dermal protection. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

impervious gloves where there is a 

potential for dermal exposure; use of the 

substance other than as described in the 

PMN; or manufacture, processing, or use 

of the substance in a powder form, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90–day inhalation 

toxicity test (OPPTS 870.3465 test 

guideline) with the addition of a postexposure observation period of up to 3 

months, and a glove permeation test 

(ASTM F739 and F1194–99 test 

guidelines) would help characterize the 

human health effects of the PMN 

substance. Evaluations for the 

inhalation toxicity study should include 

markers of damage, oxidant stress, cell 

proliferation, the degree/intensity and 

duration of pulmonary inflammation, 

and a cytotoxic effects and 

histopathology of pulmonary tissues, in 

addition to the standard requirements in 

the test guideline. For the glove 

permeation testing, gloves should be 

exposed to the expected conditions of 

exposure, including the likely 

combinations of chemical substances to 

which the gloves may be exposed to in 

the work area. Results should be 

recorded as a cumulative permeation 

rate as a function of time, and shall be 

documented in accordance with ASTM 

F739 using the format specified in 

ASTM F1194–99 ‘‘Guide for 

Documenting Results of Chemical 

Permeation Testing on Protective 

Clothing Materials’’ or its equivalent. 

CFR citation: 40 CFR 721.10154. 

PMN Number P–08–177 

Chemical name: Multi-walled carbon 

nanotubes (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: August 11, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29991 

will be as a property modifier in 

electronic applications and as a 

property modifier in polymer 

composites. The order was issued under 

section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of 

TSCA. Based on test data on analogous 

respirable, poorly soluble particulates 

and on other carbon nanotubes (CNTs), 

EPA believes that the PMN substance 

might cause lung effects. To protect 

against this risk, the consent order 

requires use of a National Institute for 

Occupational Safety and Health 

(NIOSH)-approved full-face respirator 

with N-100 cartridges. Based on 

physical properties of the PMN 

substance, EPA believes it may cause 

health effects via dermal exposure. To 

protect against this risk, the consent 

order requires that workers wear gloves 

and protective clothing impervious to 

the chemical substance. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

Toxicity concern: There is a concern for 

lung health effects based on data for 

poorly soluble particulates and for other 

CNTs, and for lung irritation based on 

particle size. 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity study in rats with a 

post exposure observation period of up 

to 3 months, including bronchoalveolar 

lavage fluid (BALF) analysis (OPPTS 

870.3465 or OECD 413 test guidelines) 

and certain material characterization 

data, would help characterize possible 

effects of the PMN substance. In the 

consent order, the PMN submitter has 

agreed not to exceed a specified 

production volume or production time 

limit (whichever comes first) without 

performing these tests. 

CFR citation: 40 CFR 721.10155. 

PMN Number P–08–328 

Chemical name: Single-walled carbon 

nanotubes (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: September 15, 2008. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a property modifier in 

electronic applications and as a 

property modifier in polymer 

composites. The order was issued under 

section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of 

TSCA. Based on test data on analogous 

respirable, poorly soluble particulates 

and on other carbon nanotubes (CNTs), 

EPA believes that the PMN substance 

might cause health effects. To protect 

against this risk, the consent order 

requires use of a NIOSH-approved fullface respirator with N-100 cartridges. 

Based on physical properties of the 

PMN substance, EPA believes it may 

cause health effects via dermal 

exposure. To protect against this risk, 

the consent order requires that workers 

wear gloves and protective clothing 

impervious to the chemical substance. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Toxicity concern: There is a concern for 

health effects based on data for poorly 

soluble particulates and for other CNTs 

and for lung irritation based on particle 

size. 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity study in rats with a 

post exposure observation period of up 

to 3 months, including bronchoalveolar 

lavage fluid (BALF) analysis (OPPTS 

870.3465 or OECD 413 test guidelines) 

and certain material characterization 

data, would help characterize possible 

effects of the PMN substance. In the 

consent order, the PMN submitter has 

agreed not to exceed a specified 

production volume or production time 

limit (whichever comes first) without 

performing these tests. 

CFR citation: 40 CFR 721.10156. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 4 of the 23 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 19 cases, where the 

proposed 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), this rule is 

effective August 24, 2009 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before July 24, 2009. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before July 

24, 2009, EPA will withdraw the 

relevant sections of this direct final rule 

before its effective date. EPA will then 

issue a proposed SNUR for the chemical 

substance(s) on which adverse or 

critical comments were received, 

providing a 30–day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. EPA solicits comments on 

29992 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

whether any of the uses described as 

significant new uses are ongoing. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

4 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, 16 of the 23 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

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

§ 720.25 and § 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the Federal Register 

of April 24, 1990, EPA has decided that 

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

best served by designating a use as a 

significant new use as of the date of 

publication of this direct final rule 

rather than as of the effective date of the 

rule. If uses begun after publication 

were considered ongoing rather than 

new, it would be difficult for EPA to 

establish SNUR notice requirements 

because a person could defeat the SNUR 

by initiating the significant new use 

before the rule became effective, and 

then argue that the use was ongoing 

before the effective date of the rule. 

Thus, persons who begin commercial 

manufacture, import, or processing of 

the chemical substances regulated 

through this SNUR will have to cease 

any such activity before the effective 

date of this rule. To resume their 

activities, these persons would have to 

comply with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires (see Unit III.). 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN, except where the chemical 

substance subject to the SNUR is also 

subject to a test rule under TSCA 

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

Persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. Many test guidelines are now 

available on the Internet at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. The OECD test guidelines 

are available from the OECD Bookshop 

at http://www.oecdbookshop.org or 

SourceOECD at http:// 

www.sourceoecd.org. The ASTM test 

guidelines are available at http:// 

www.astm.org/Standard/index.shtml. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. Listings of 

the tests specified in the TSCA section 

5(e) consent orders are included in Unit 

IV. The SNURs contain the same 

production volume limits as the TSCA 

section 5(e) consent orders. Exceeding 

these production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture/import or 

processing. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUNs submitted 

for significant new uses without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI. This rule cross-references 

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

§ 721.11 for situations where the 

chemical identity of the chemical 

substance subject to a SNUR is CBI. This 

procedure is cross-referenced in each 

SNUR that includes specific significant 

new uses that are CBI. 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29993 

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 40 CFR 720.50. SNUNs 

must be mailed to the Environmental 

Protection Agency, OPPT Document 

Control Office (7407M), 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Information must be 

submitted in the form and manner set 

forth in EPA Form No. 7710–25. This 

form is available from the 

Environmental Assistance Division 

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

Washington, DC 20460–0001 (see 

§ 721.25 and § 720.40). Forms and 

information are also available 

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

opptintr/newchems/pubs/ 

pmnforms.htm. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this rule. EPA’s complete 

economic analysis is available in the 

public docket. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This final 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. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to the 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 as follows. The 

requirement to submit a SNUN applies 

to any person (including small or large 

entities) who intends to engage in any 

activity described in the rule as a 

‘‘significant new use.’’ Because these 

uses are ‘‘new,’’ based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activities. A 

SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. Although some 

small entities may decide to pursue a 

significant new use in the future, EPA 

cannot presently determine how many, 

if any, there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of over 1,000 SNURs, 

the Agency receives on average only 5 

notices per year. Of those SNUNs 

submitted from 2006–2008, only one 

appears to be from a small entity. In 

addition, the estimated reporting cost 

for submission of a SNUN (see Unit XI.) 

is minimal regardless of the size of the 

firm. Therefore, EPA believes that the 

potential economic impacts of 

complying with these SNURs are not 

expected to be significant or adversely 

impact a substantial number of small 

entities. In a SNUR that published in the 

Federal Register of June 2, 1997 (62 FR 

29684) (FRL–5597–1), the Agency 

presented its general determination that 

proposed and 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). 

29994 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

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 in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: June 11, 2009. 

Barbara A. Cunningham, 

Acting Director, Office of Pollution Prevention 

and Toxics. 

■ Therefore, 40 CFR part 721 is 

amended as follows: 

PART 721—[AMENDED] 

■ 1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 2. By adding new § 721.10134 to 

subpart E to read as follows: 

§ 721.10134 Formaldehyde, polymer with 

dialkylphenylamine, dialkylphenol and 

trimethylhexanediamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as formaldehyde, polymer 

with dialkylphenylamine, dialkylphenol 

and trimethylhexanediamine (PMN P– 

05–1) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 3. By adding new § 721.10135 to 

subpart E to read as follows: 

§ 721.10135 Phosphinic acid, P,P-diethyl-, 

zinc salt (2:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphinic acid, P,P-diethyl-, zinc salt 

(2:1) (PMN P–05–11; CAS No. 284685– 

45–6) 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=12). 

(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. 

■ 4. By adding new § 721.10136 to 

subpart E to read as follows: 

§ 721.10136 2-Propenoic acid, 2-methyl-, 2- 

hydroxyethyl ester, reaction products with 

hexakis(alkoxyalkyl)melamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl-, 2-hydroxyethyl ester, reaction 

products with 

hexakis(alkoxyalkyl)melamine (PMN P– 

05–177) 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 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29995 

provisions of § 721.185 apply to this 

section. 

■ 5. By adding new § 721.10137 to 

subpart E to read as follows: 

§ 721.10137 Halogenated phenoxy 

aromatic (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated phenoxy 

aromatic (PMN P–05–329) 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. 

■ 6. By adding new § 721.10138 to 

subpart E to read as follows: 

§ 721.10138 3-Isoxazolecarboxylic acid, 

4,5-dihydro-5,5-diphenyl-, ethyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3-isoxazolecarboxylic acid, 4,5-dihydro5,5-diphenyl-, ethyl ester (PMN P–05– 

336; CAS No. 163520–33–0) 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. 

■ 7. By adding new § 721.10139 to 

subpart E to read as follows: 

§ 721.10139 Ethanone, 1-(1- 

chlorocyclopropyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethanone, 1-(1-chlorocyclopropyl)- 

(PMN P–05–776; CAS No. 63141–09–3) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=500). 

(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. 

■ 8. By adding new § 721.10140 to 

subpart E to read as follows: 

§ 721.10140 Phosphoric acid, tin (2+) salt 

(2:3). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphoric acid, tin (2+) salt (2:3) (PMN 

P–06–33, CAS No. 15578–32–2) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(ii) Release to water. Requirements as 

specified in § 721.90 (b)(1) and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. By adding new § 721.10141 to 

subpart E to read as follows: 

§ 721.10141 Oils, ginger, zingiber 

purpureum. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oils, ginger, zingiber purpureum (PMN 

P–06–163; CAS No. 864662–46–4) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(1), (a)(2)(i), (a)(3), (b), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), and (i) are applicable 

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. By adding new § 721.10142 to 

subpart E to read as follows: 

§ 721.10142 Oxabicycloalkane carboxylic 

acid alkanediyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxabicycloalkane 

carboxylic acid alkanediyl ester (PMN 

P–06–199) 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. 

■ 11. By adding new § 721.10143 to 

subpart E to read as follows: 

§ 721.10143 Amines, bis (C11-14-branched 

and linear alkyl). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amines, bis (C11-14-branched and linear 

alkyl) (PMN P–06–733; CAS No. 

900169–60–0) is subject to reporting 

29996 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. By adding new § 721.10144 to 

subpart E to read as follows: 

§ 721.10144 Modified thiocarbamate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified thiocarbamate 

(PMN P–06–805) 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. By adding new § 721.10145 to 

subpart E to read as follows: 

§ 721.10145 Modified reaction products of 

alkyl alcohol, halogenated alkane, 

substituted epoxide, and amino compound 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified reaction 

products of alkyl alcohol, halogenated 

alkane, substituted epoxide, and amino 

compound (PMN P–06–816) 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(k) (analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities) and (q). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 14. By adding new § 721.10146 to 

subpart E to read as follows: 

§ 721.10146 Partially fluorinated 

condensation polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as partially fluorinated 

condensation polymer (PMN P–07–87) 

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(k) (analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), (l) (maximum percentage of 

the PMN substance in a non-industrial 

product or distributed for use as a nonindustrial product), (o) (use in a 

consumer product that could be spray 

applied), and (q). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 15. By adding new § 721.10147 to 

subpart E to read as follows: 

§ 721.10147 Acrylate derivative of 

alkoxysilylalkane ester and mixed metal 

oxides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylate derivative of 

alkoxysilylalkane ester and mixed metal 

oxides (PMN P–07–198) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), 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. 

■ 16. By adding new § 721.10148 to 

subpart E to read as follows: 

§ 721.10148 Acryloxy alkanoic alkane 

derivative with mixed metal oxides 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acryloxy alkanoic alkane 

derivative with mixed metal oxides 

(PMN P–07–330) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of this substance. 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29997 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 17. By adding new § 721.10149 to 

subpart E to read as follows: 

§ 721.10149 Carbon black, (3- 

methylphenyl)-modified, substituted 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon black, (3- 

methylphenyl)-modified, substituted 

(PMN P–07–522) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 18. By adding new § 721.10150 to 

subpart E to read as follows: 

§ 721.10150 Carbon black, (4- 

methylphenyl)-modified, substituted 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon black, (4- 

methylphenyl)-modified, substituted 

(PMN P–07–523) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 19. By adding new § 721.10151 to 

subpart E to read as follows: 

§ 721.10151 Modified styrene, 

divinylbenzene polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified styrene, 

divinylbenzene polymer (PMN P–07– 

642) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 20. By adding new § 721.10152 to 

subpart E to read as follows: 

§ 721.10152 Oxirane, substituted 

silylmethyl-, hydrolysis products with 

alkanol zirconium(4+) salt and silica, 

acetates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxirane, substituted 

silylmethyl-, hydrolysis products with 

alkanol zirconium(4+) salt and silica, 

acetates (PMN P–07–674) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (a), (j), (v)(1), 

(w)(1), and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 21. By adding new § 721.10153 to 

subpart E to read as follows: 

§ 721.10153 Modified methyl methacrylate, 

2-hydroxyethyl methacrylate polymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified methyl 

methacrylate, 2-hydroxyethyl 

methacrylate polymer (PMN P–08–6) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

29998 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

■ 22. By adding new § 721.10154 to 

subpart E to read as follows: 

§ 721.10154 Quaternary ammonium 

compounds, dicoco alkyldimethyl, 

chlorides, reaction products with silica. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

quaternary ammonium compounds, 

dicoco alkyldimethyl, chlorides, 

reaction products with silica (PMN P– 

08–157; CAS No. 956147–76–5) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j), (v)(1), (w)(1), 

and (x)(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), and (i) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 23. By adding new § 721.10155 to 

subpart E to read as follows: 

§ 721.10155 Multi-walled carbon 

nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–08–177) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(a)(5) (National Institute for 

Occupational Safety and Health 

(NIOSH)-approved air-purifying, tightfitting full-face respirator equipped with 

N100 filters), (a)(6)(i), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), and (i) are applicable 

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 24. By adding new § 721.10156 to 

subpart E to read as follows: 

§ 721.10156 Single-walled carbon 

nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as single-walled carbon 

nanotubes (PMN P–08–328) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(a)(5) (National Institute for 

Occupational Safety and Health 

(NIOSH)-approved air-purifying, tightfitting full-face respirator equipped with 

N100 filters), (a)(6)(i), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j) and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), and (i) are applicable 

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

[FR Doc. E9–14780 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

Significant New Uses of Chemical 

Substances 

CFR Correction 

In Title 40 of the Code of Federal 

Regulations, Parts 700 to 789, revised as 

of July 1, 2008, on page 431, after the 

source note for § 721.8940 and before 

paragraph (a), reinstate the heading for 

§ 721.8950 to read as follows: 

§ 721.8950 Chromate(3-), bis[3-[[6-amino1,4-dihydro-2-[[[4-[(2-hydroxy-1- 

naphthalenyl)azo] phenyl]sulfonyl]amino]-4- 

(oxo-.kappa.O)-5-pyrimidinyl]azo-.kappaN1]- 

4-hydroxy-.kappa.O)-5- 

nitrobenzenesulfonato(3-)]-, sodium 

triethanolamine salts. 

[FR Doc. E9–14993 Filed 6–23–09; 8:45 am] 

BILLING CODE 1505–01–D 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 09–1242; MB Docket No. 08–226; RM– 

11494]. 

Radio Broadcasting Services; Mount 

Enterprise, Texas 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Audio Division, at the 

request of JER Licenses, LLC, substitutes 

Channel 279A for vacant FM Channel 

231A at Mount Enterprise, Texas. 

Channel 279A can be allotted at Mount 

Enterprise, Texas, in compliance with 

the Commission’s minimum distance 

separation requirements with a site 

restriction of 5.9 km (3.7 miles) north of 

Mount Enterprise at the following 

reference coordinates: 31–58–15 North 

Latitude and 94–41–01 West Longitude. 

DATES: Effective July 20, 2009. 

ADDRESSES: Secretary, Federal 

Communications Commission, 445 12th 

Street, SW., Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Dupont, Media Bureau, (202) 

418–2180. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 08–226, 

adopted June 3, 2009, and released June 

5, 2009. The full text of this 

Commission decision is available for 

inspection and copying during normal 

business hours in the FCC Reference 

Information Center, Portals II, 445 12th 

Street, SW., Room CY–A257, 

Washington, DC 20554. The complete 

text of this decision also may be 

purchased from the Commission’s 

duplicating contractor, Best Copy and 

Printing, Inc., 445 12th Street, SW., 

Room CY–B402, Washington, DC, 

20554, (800) 378–3160, or via the 

company’s Web site, http:// 

www.bcpiweb.com.