Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 57169 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

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

involves the establishment of a 

temporary safety zone. An 

environmental analysis checklist and a 

categorical exclusion determination are 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and record keeping 

requirements, Security measures, 

Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165, as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1 

■ 2. Add § 165.T13–162 to read as 

follows: 

§ 165.T13–162 Safety Zone; Composite 

Laminate Specialties Fall Championship 

Hydroplane Race, Lake Sammamish, WA 

(a) Location. All waters encompassed 

on the waters of Lake Sammamish, WA, 

south to land from a line starting at 47° 

33.810′ N 122° 04.810′ W then east to 

47° 33.810′ N 122° 03.674′ W. 

(b) Regulations. In accordance with 

the general regulations in 33 CFR Part 

165, Subpart C, no vessel operator may 

enter or remain in the safety zone 

without the permission of the Captain of 

the Port or Designated Representative. 

The Captain of the Port may be assisted 

by other federal, state, or local agencies 

with the enforcement of the safety zone. 

(c) Authorization. All vessel operators 

who desire to enter the safety zone must 

obtain permission from the Captain of 

the Port or Designated Representative by 

contacting the on-scene patrol craft. 

Vessel operators granted permission to 

enter the zone will be escorted by the 

on-scene patrol craft until they are 

outside of the safety zone. 

(d) Enforcement Period. This rule is 

effective from 9 a.m. to 7 p.m. on 

October 1 through October 3, 2010, 

unless canceled sooner by the Captain 

of the Port, Puget Sound. 

Dated: September 2, 2010. 

S.J. Ferguson, 

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

Port, Puget Sound. 

[FR Doc. 2010–23358 Filed 9–17–10; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2009–922; FRL–8839–7] 

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 25 chemical 

substances which were the subject of 

premanufacture notices (PMNs). One of 

these chemical substances is subject to 

a TSCA section 5(e) consent order 

issued by EPA. This action requires 

persons who intend to manufacture, 

import, or process any of these 25 

chemical substances for an activity that 

is designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: This rule is effective on 

November 19, 2010. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (e.s.t.) on October 

4, 2010. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before October 20, 2010 (see Unit VI. of 

the SUPPLEMENTARY INFORMATION). 

For additional information on related 

reporting requirement dates, see Units 

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

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2009–922, 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–2009–922. The 

DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2009–922. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD-ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 


jdjones on DSK8KYBLC1PROD with RULES
57170 Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; e-mail address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

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

SUPPLEMENTARY INFORMATION: 

I. 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; see also 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to these SNURs 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of this rule on or after 

October 20, 2010 are subject to the 

export notification provisions of TSCA 

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

§ 721.20), and must comply with the 

export notification requirements in 40 

CFR part 707, subpart D. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD-ROM as CBI and then 

identify electronically within the disk or 

CD-ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What Action is the Agency Taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

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

that preamble for further information on 

the objectives, rationale, and procedures 

for SNURs and on the basis for 

significant new use designations, 

including provisions for developing test 

data. 

B. What is the Agency’s Authority for 

Taking this Action? 

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

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

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2) (see Unit III.). Once EPA 

determines that a use of a chemical 

substance is a significant new use, 

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

to submit a significant new use notice 

(SNUN) to EPA at least 90 days before 

they manufacture, import, or process the 

chemical substance for that use. The 

mechanism for reporting under this 

requirement is established under 

§ 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 


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Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 57171 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

Chemical importers are subject to the 

TSCA section 13 (15 U.S.C. 2612) 

import certification requirements 

promulgated at 19 CFR 12.118 through 

12.127; see also 19 CFR 127.28. 

Chemical importers must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA. Importers of 

chemicals subject to these SNURs must 

certify their compliance with the SNUR 

requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

identified in a proposed or final SNUR 

are subject to the export notification 

provisions of TSCA section 12(b) (15 

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

comply with the export notification 

requirements in 40 CFR part 707, 

subpart D. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 25 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Substances Subject to this Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

25 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

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

• Basis for the TSCA section 5(e) 

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

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

SNURs without TSCA section 5(e) 

consent orders). 

• Toxicity concerns. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes one PMN 

substance (P–04–269) that is subject to 

a ‘‘risk-based’’ consent order under 

TSCA section 5(e)(1)(A)(ii)(I) where EPA 

determined that activities associated 

with the PMN substance may present 

unreasonable risk to human health and 

the environment. The consent order 

requires protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The socalled ‘‘5(e) SNUR’’ on this PMN 

substance is promulgated pursuant to 

§ 721.160, and is based on and 

consistent with the provisions in the 

underlying consent order. The 5(e) 

SNUR designates as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent order. 

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 24 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

EPA did not find that the use scenario 

described in the PMN triggered the 

determinations set forth under TSCA 

section 5(e). However, EPA does believe 

that certain changes from the use 

scenario described in the PMN could 

result in increased exposures, thereby 

constituting a ‘‘significant new use.’’ 

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

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

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

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 


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57172 Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 

concerns identified’’ for the PMN 

substance. 

PMN Number P–04–269 

Chemical name: Cobalt lithium 

manganese nickel oxide. 

CAS number: 182442–95–1. 

Effective date of TSCA section 5(e) 

consent order: May 12, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a battery 

cathode material. The order was issued 

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

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

findings that this substance may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires use of dermal personal 

protective equipment, including gloves 

demonstrated to be impervious, use of 

respiratory personal protective 

equipment, including a National 

Institute of Occupational Safety and 

Health (NIOSH)-approved respirator 

with an assigned protection factor (APF) 

of at least 150 or compliance with a 

NCEL of 0.1 mg/m3 as an 8–hour timeweighted average, establishment of a 

hazard communication program, and 

prohibits releases to water. The SNUR 

designates as a ‘‘significant new use’’ the 

absence of these protective measures. 

Toxicity concern: Based on test data on 

nickel, lithium and cobalt, EPA has 

concerns for developmental toxicity, 

mutagenicity, oncogenicity, pulmonary 

oncogenicity, and lung overload for 

workers with inhalation and dermal 

exposure to the PMN substance. EPA set 

the NCEL at 0.1 mg/m3 as an 8–hour 

time-weighted average. In addition, 

based on test data on analogous nickel 

containing compounds, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 part per 

billion (ppb) of the PMN substance in 

surface waters. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the human health and environmental 

effects of the PMN substance: A 90–day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); an 

aquatic invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400). All aquatic 

toxicity testing should be performed 

using the static method with measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. The 

order does not require submission of the 

aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacturing, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10201. 

PMN Number P–08–701 

Chemical name: Benzoic acid, 4-chloro2- [(substituted)azo]-, strontium salt 

(1:1) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a pigment for 

plastics. Based on test data on analogous 

substances, EPA has concerns for 

oncogenicity, developmental toxicity, 

and blood and spleen effects from 

exposure to the azo reduction products 

of the PMN substance via inhalation. 

Since significant worker exposure is 

unlikely for the uses described in the 

PMN, EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that use of the substance other 

than as described in the PMN 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 results from the 

following tests would help characterize 

the human health effects of the PMN 

substance: A bacterial reverse mutation 

test (OPPTS Test Guideline 870.5100) 

with prival modification, and an 

unscheduled DNA synthesis in 

mammalian cells in culture test (OPPTS 

Test Guideline 870.5550) for the azo 

reduction product of the PMN 

substance. Test reports should include 

protocols approved by EPA, certificate 

of analysis for the test substance, raw 

data, and results. 

CFR citation: 40 CFR 721.10202. 

PMN Number P–08–742 

Chemical name: Phosphonium, 

tetrabutyl-, hydroxide (1:1). 

CAS number: 14518–69–5. 

Basis for action: The PMN states that the 

substance will be used as a chemical 

intermediate for manufacturing 

tetrabutylphosphonium salt, as an 

export for industrial use, and additional 

confidential chemical intermediate uses. 

Based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(i). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish early-life stage toxicity 

test (OPPTS Test Guideline 850.1400); a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400). Fish and daphnid 

testing should be performed using the 

flow-through method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10203. 

PMN Number P–08–754 

Chemical name: Aryloxyacrylate 

(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 ecological structural activity 

relationship (EcoSAR) analysis of test 

data on analogous acrylates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

3 ppb of the PMN substance in surface 

waters. As described in the PMN, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 3 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 3 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that results of the following 

tests would help characterize the 

environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) using the flowVerDate Mar<15>2010 13:28 Sep 17, 2010 Jkt 220001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\20SER1.SGM 20SER1

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through method with measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with measured 

concentrations; and an algal toxicity 

test, tiers I and II (OPPTS Test Guideline 

850.5400) using the static method with 

measured concentrations. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10204. 

PMN Number P–09–4 

Chemical name: Formaldehyde, 

polymer with 1,3-benzenediol and 1,1′- 

methylenebis[isocyanatobenzene]. 

CAS number: 1067881–45–1. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a rubber additive. 

Based on EcoSAR analysis of test data 

on analogous esters and polyphenols, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance 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 results of the following 

tests would help characterize the 

environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) using the flowthrough method with mean measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10205. 

PMN Number P–09–19 

Chemical name: 4-Cyclohexene-1,2- 

dicarboxylic acid, 1,2-bis(2- 

oxiranylmethyl) ester. 

CAS number: 21544–03–6. 

Basis for action: The PMN states that the 

substance will be used as an epoxy resin 

for filament winding and electrical 

encapsulation of motors and generators. 

Based on test data on analogous esters 

and epoxides, EPA identified concerns 

for lung and dermal sensitization, 

mutagenicity, oncogenicity, male 

reproductive toxicity, liver and kidney 

toxicity, and eye corrosion to workers 

exposed to the PMN substance. As 

described in the PMN, worker 

inhalation exposure is expected to be 

negligible and dermal exposure is 

expected to be minimal due to the use 

of adequate personal protective 

equipment. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance without the use of 

dermal protection where there is 

potential for dermal exposure, or 

without the appropriate hazard 

communication may result in 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 results of the following 

tests would help characterize the human 

health effects of the PMN substance: A 

90–day dermal toxicity study (OPPTS 

Test Guideline 870.3250) with attention 

to the pathology of the reproductive 

organs and a carcinogenicity study 

(OPPTS Test Guideline 870.4200). Test 

reports should include protocols 

approved by EPA, certificate of analysis 

for the test substance, raw data, and 

results. 

CFR citation: 40 CFR 721.10206. 

PMN Number P–09–38 

Chemical name: 1,3- 

Cyclohexanedimethanamine, N1,N3- 

bis(2-methylpropylidene)-. 

CAS number: 173904–11–5. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a curing agent for 

polyurethane systems. Based on 

EcoSAR analysis of test data on 

analogous Schiff bases and aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance is not expected to 

be released to surface waters. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in release to surface waters 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that results of the following 

tests would help characterize the 

environmental effects of the PMN 

substance: A water solubility: column 

elution method; shake flask method 

(OPPTS Test Guideline 830.7840); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) using the flow-through 

method with mean measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method and mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10207. 

PMN Number P–09–71 

Chemical name: Amines, di-C11-14- 

isoalkyl, C13-rich. 

CAS number: 1005516–89–1. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on EcoSAR analysis 

of test data on analogous aliphatic 

amines, EPA predicts that toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 2 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 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that results of the following 

tests would help characterize the 

environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) using the flowthrough method with mean measured 

concentrations or a fish acute toxicity 

mitigated by humic acid (OPPTS Test 

Guideline 850.1085) using the flowthrough method with measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 


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measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10208. 

PMN Number P–09–120 

Chemical name: Epoxy terminated, 

hydrolyzed trialkoxysilane and glycidyl 

ether of phenol-formaldehyde resin 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a 

polymerizable component of adhesive 

formulations. Based on EcoSAR analysis 

of test data on analogous alkoxysilanes 

and polyepoxides, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 81 ppb of the 

PMN substance in surface waters. As 

described in the PMN, the substance is 

not expected to be released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) using the flowthrough method with mean measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10209. 

PMN Number P–09–130 

Chemical name: Soybean oil, 

epoxidized, reaction products with 

diethanolamine. 

CAS number: 1002761–12–7. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a polyol for flexible 

and rigid polyurethane foam 

applications. Based on EcoSAR analysis 

of test data on analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 6 ppb of the PMN substance 

in surface waters. As described in the 

PMN, 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 the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A ready biodegradability test 

(OPPTS Test Guideline 835.3110); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) using the flow-through 

method with mean measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10210. 

PMN Number P–09–172 

Chemical name: Octadecanoic acid, 

reaction products with 

diethylenetriamine and urea, acetates. 

CAS number: 84962–05–0. 

Basis for action: The PMN states that the 

substance will be used as a softener 

padded on cotton fabrics. Based on 

EcoSAR analysis of test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. For the annual manufacture and 

import volume described in the PMN, 

the substance is not expected to be 

released to water. 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 

exceedance of the annual maximum 

manufacture and import limit of 10,000 

kilograms, could result in releases to 

water, which may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

followings tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400). Fish and daphnid 

testing should be performed using the 

flow-through method with mean 

measured concentrations. Algal testing 

should be formed using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10211. 

PMN Number P–09–241 

Chemical name: 1,2-Ethanediol, 

reaction products with epichlorohydrin. 

CAS number: 705265–31–2. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an industrial 

reactant. Based on test data on 

analogous epoxides, EPA identified the 

following toxicity concerns from 

exposure to the PMN substance: 

Irritation and sensitization to eyes, skin, 

and lungs; mutagenicity; oncogenicity; 

and developmental, liver, kidney, and 

male reproductive toxicity. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). At the production 

volume stated in the PMN, worker 

exposure and general population 

exposure are limited. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk under TSCA section 5(e). However, 

EPA has determined in accordance with 

TSCA section 5(a)(2)(A) and (C) and 40 

CFR 721.170(a), that exceedance of the 

annual maximum manufacture and 

import limit of 100,000 kilograms may 

result in significant human exposures or 

environmental release. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the human health effects of the PMN 

substance: Aerobic mineralization in 

surface water - simulation 

biodegradation test (Organisation for 

Economic Co-operation and 

Development (OECD) 309 test guideline) 

using the receiving water where the 

discharge will occur; an acute oral 

toxicity test (OPPTS Test Guideline 

870.1100 or OECD 425 test guideline); a 

bacterial reverse mutation test (OPPTS 


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Test Guideline 870.5100); a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395) using the 

intraperitoneal route; and a repeated 

dose 28–day oral toxicity test (OPPTS 

Test Guideline 870.3050 or OECD 407 

test guideline) in rodents. The 28–day 

oral study should include, for all test 

doses, a neurotoxicity functional 

observational battery (FOB), as 

described in neurotoxicity screening 

battery (OPPTS Test Guideline 

870.6200). Test reports should include 

protocols approved by EPA, certificate 

of analysis for the test substance, raw 

data, and results. 

CFR citation: 40 CFR 721.10212. 

PMN Number P–09–253 

Chemical name: Polyether polyester 

copolymer phosphate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as an additive for 

molding compounds. Based on EcoSAR 

analysis of test data on analogous 

organic phosphates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 22 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 results of the following 

tests would help characterize the 

environmental effects of the PMN 

substance: Ready biodegradability test 

(OPPTS Test Guideline 835.3110); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) using the flow-through 

method with mean measured 

concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10213. 

PMN Number P–09–286 

Chemical name: Poly(oxyalkylenediyl), 

.alpha.-substituted carbomonocycle- 

.omega.-substituted carbomonocycle 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a coatings resin. 

Based on EcoSAR analysis of test data 

on analogous esters, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A ready biodegradability - 

CO2 in sealed vessels (headspace test) 

(OECD 310 test guideline); a fish earlylife stage toxicity test (OPPTS Test 

Guideline 850.1400) using the flowthrough method with measured 

concentrations; a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300) using the flow-through 

method with measured concentrations; 

and an algal toxicity test, tiers I and II 

(OPPTS Test Guideline 850.5400) using 

the static method with measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10214. 

PMN Number P–09–385 

Chemical name: Benzenepropanol, 

.beta.-methyl-. 

CAS number: 7384–80–7. 

Basis for action: The PMN states that the 

substance will be used as a raw material 

to manufacture another chemical. Based 

on test data on the PMN substance, EPA 

identified possible skin sensitization 

concerns from dermal exposure to the 

PMN substance. Based on test data on 

analogous substances, the Agency 

identified concerns for liver toxicity, 

kidney toxicity, neurotoxicity, and 

possible developmental toxicity to 

workers exposed dermally to the PMN 

substance. For the uses described in the 

PMN, worker inhalation exposure is not 

expected and EPA does not expect 

significant dermal exposure due to the 

use of impervious gloves. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

other than as an intermediate, or 

without the use of impervious gloves 

where there is potential for dermal 

exposure, may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(i) and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90–day 

oral toxicity test (OPPTS Test Guideline 

870.3100) in rodents would help 

characterize the human health effects of 

the PMN substance. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10215. 

PMN Number P–09–411 

Chemical name: 2-Propenoic acid, 3- 

(5,5,6-trimethylbicyclo[2.2.1]hept-2- 

yl)cyclohexyl ester. 

CAS number: 903876–45–9. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a thermoset 

adhesive component. EPA has identified 

health and environmental concerns 

because the substance may be a 

persistent, bio-accumulative, and toxic 

(PBT) chemical, based on physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemical 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 5,000. Also, 

based on test data on analogous 

acrylates, EPA believes exposure to the 

PMN substance may cause systemic 

human health effects and predicts 

toxicity to aquatic organisms. As 

described in the PMN, significant 

worker exposure is unlikely, and the 

substance is neither released to surface 

waters nor landfilled. 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 or any 

disposal of the manufacturing, process, 

or use stream of the PMN substance 

other than by incineration may cause 

serious health effects and significant 

adverse environmental effects, since the 

PMN substance has been characterized 

by EPA as a PBT substance that can 

migrate to ground water. Based on this 


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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. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10216. 

PMN Number P–09–426 

Chemical name: Branched and linear 

alcohols (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a site-limited 

raw material. Based on structure activity 

relationship analysis of test data on 

analogous neutral organic chemicals, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

in surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 1 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: Based on the results of the 

potential solubility pretest either a 

water solubility: column elution 

method; shake flask method test (OPPTS 

Test Guideline 830.7840) or a water 

solubility: generator column method test 

(OPPTS Test Guideline 830.7860) and 

an algal toxicity test, tiers I and II 

(OPPTS Test Guideline 850.5400) using 

static method and mean measured 

concentrations. Based on the results of 

these tests, a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075), and an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010) may also be 

recommended. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10217. 

PMN Number P–09–436 

Chemical name: 2-Propenoic acid, 2- 

methyl-, C12-15-branched and linear 

alkyl esters, telomers with alkyl 2- 

[[(alkylthio)thioxomethyl]thio]-2- 

alkanoate, aminoalkyl methacrylate and 

alkyl methacrylate, tert-Bu 2- 

ethylhexanoperoxoate-initiated 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a lubricant 

additive. Based on EcoSAR analysis of 

test data on analogous polycationic 

polymers, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 410 ppb of 

the PMN substance in surface waters. As 

described in the PMN, during 

manufacturing the substance will not be 

released to surface waters. During 

processing and use, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

410 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 predictable or purposeful release to 

surface waters of a manufacturing 

stream associated with any use of the 

substance may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); a fish acute 

toxicity test mitigated by humic acid 

(OPPTS Test Guideline 850.1085); an 

aquatic invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400). Fish and daphnid 

tests should be performed using the 

flow-through method with mean 

measured concentrations. Algal testing 

should be performed using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10218. 

PMN Number P–09–451 

Chemical name: Butanamide,N- 

[substituted phenyl]- 

[(alkoxynitrophenyl)diazenyl]-3-oxo- 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a dispersion 

additive. Based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. 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)(i). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish early-life stage toxicity 

test (OPPTS Test Guideline 850.1400) 

and a daphnid chronic toxicity test 

(OPPTS Test Guideline 850.1300). Both 

tests should be performed using the 

flow-through method with mean 

measured concentrations. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10219. 

PMN Number P–09–478 

Chemical name: Phosphoric acid, 

polymer with cycloaliphatic diglycidyl 

ether, alkylethers (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a component of a 

coating. Based on EcoSAR analysis of 

test data on analogous polynonionic 

phosphate polymers, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 8 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 the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075) using the flowthrough method with mean measured 


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concentrations; an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) using 

the flow-through method with mean 

measured concentrations; and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) using the static 

method with mean measured 

concentrations. EPA also recommends 

that the special considerations for 

conducting aquatic laboratory studies 

(OPPTS Test Guideline 850.1000) be 

followed to facilitate solubility in the 

test media, because of the PMN’s low 

water solubility. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10220. 

PMN Number P–09–542 

Chemical name: 3-Nonen-1-ol, 1- 

acetate, (3Z)-. 

CAS number: 13049–88–2. 

Basis for action: The PMN states that the 

substance will be used as a fragrance in 

the manufacture of scented consumer 

products. Based on EcoSAR analysis of 

test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

9 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 9 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 9 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the environmental effects of the PMN 

substance: A fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400). Fish and daphnid 

testing should be performed using the 

flow-through method with mean 

measured concentrations. Algal testing 

should be performed using the static 

method with mean measured 

concentrations. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10221. 

PMN Number P–09–581 

Chemical name: Styrenyl surface treated 

manganese ferrite (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a raw material 

intermediate used in the manufacture of 

polymerized pigments. Based on test 

data on analogous respirable, poorly 

soluble particles, subcategory titanium 

dioxide, EPA identified concerns for 

lung toxicity from lung overload if 

workers inhale the PMN substance. As 

described in the PMN, worker 

inhalation exposure will be minimal 

due to the use of adequate personal 

protective equipment. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

serious health effects may result from 

use of the substance without a NIOSHapproved respirator with an APF of at 

least 10 where there is potential 

inhalation exposure or use of the 

substance other than as a raw material 

intermediate used in the manufacture of 

polymerized pigments. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60–day 

holding period would help characterize 

the human health effects of the PMN 

substance. A carcinogenicity test 

(OPPTS Test Guideline 870.4200) 

conducted via inhalation may be 

recommended, if the 90–day inhalation 

toxicity test indicates carcinogenic 

potential. Test reports should include 

protocols approved by EPA, certificate 

of analysis for the test substance, raw 

data, and results. 

CFR citation: 40 CFR 721.10222. 

PMN Number P–09–582 

Chemical name: Styrenyl surface treated 

manganese ferrite with acrylic ester 

polymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a polymerized 

pigment used in the manufacture of 

electronic inks. Based on test data on 

analogous respirable, poorly soluble 

particles, subcategory titanium dioxide, 

EPA identified concerns for lung 

toxicity from lung overload if workers 

inhale the PMN substance. As described 

in the PMN, worker inhalation exposure 

will be minimal due to the use of 

adequate personal protective 

equipment. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

serious health effects may result from 

use of the substance without a NIOSHapproved respirator with an APF of at 

least 10 where there is potential 

inhalation exposure or use of the 

substance other than as a polymerized 

pigment used in the manufacture of 

electronic inks may result in serious 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60–day 

holding period would help characterize 

the health effects of the PMN substance. 

A carcinogenicity test (OPPTS Test 

Guideline 870.4200) conducted via 

inhalation may be recommended, if the 

90–day inhalation toxicity test indicates 

carcinogenic potential. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10223. 

PMN Number P–10–9 

Chemical name: Diglycidylaniline 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

substance will be used as a reactive 

epoxide for use in producing reinforced 

composites (open/non-dispersive use). 

Based on test data on the PMN 

substance, EPA identified concerns for 

mutagenicity. Based on test data on 

analogous epoxides, EPA identified 

concerns for oncogenicity, mutagenicity, 

developmental toxicity, reproductive 

toxicity, liver and kidney toxicity, and 

skin and lung sensitization. As 

described in the PMN, worker 

inhalation exposure is not expected and 

dermal exposure will be minimal due to 

the use of adequate personal protective 

equipment. Additionally, based on test 

data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

5 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 

1) any use of the substance without the 

use of impervious gloves where there is 

potential for dermal exposure may cause 

serious health effects, 2) manufacture, 

processing, or use of the substance in a 

powder form may cause serious health 

effects, and 3) any use of the substance 


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resulting in release to surface waters 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), 

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

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the human health and environmental 

effects of the PMN substance: A 

carcinogenicity test (OPPTS Test 

Guideline 870.4200); a 90–day dermal 

toxicity test (OPPTS Test Guideline 

870.3250) in rats, with attention to 

pathology of the reproductive organs; a 

fish early-life stage toxicity test (OPPTS 

Test Guideline 850.1400); and a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300). All aquatic 

toxicity testing should be performed 

using the flow-through method with 

mean measured concentrations. Test 

reports should include protocols 

approved by EPA, certificate of analysis 

for the test substance, raw data, and 

results. 

CFR citation: 40 CFR 721.10224. 

PMN Number P–10–14 

Chemical name: Quino[2,3-b] acridine7,14-dione, 2,9-dichloro-5,12-dihydro 

[4-[[2-(sulfooxy) ethyl] substituted] 

phenyl]-, sodium salt (1:1) (generic). 

CAS number: Not available. 

Basis for action: The PMN states that the 

generic (non-confidential) use of the 

substance will be as a colorant raw 

material. Based on test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects from inhalation exposure to 

the PMN substance. Based on physical 

properties of the PMN substance, EPA 

identified concerns for potential 

systemic effects from dermal exposure 

to the PMN substance. For the use 

described in the PMN, dermal and 

inhalation exposures are not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance by workers not wearing 

impervious gloves and eye protection, 

use of the substance other than as 

described in the PMN, or use of the 

substance in powder form may cause 

serious health effects. Based on this 

information, the PMN substances meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90–day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. The test should be 

modified to add a post-exposure 

observation period of up to 3 months. In 

addition to the standard requirements in 

the test guideline, evaluation should 

include markers of damage, oxidant 

stress, cell proliferation, the degree/ 

intensity and duration of pulmonary 

inflammation, cytotoxic effects and 

histopathology of pulmonary tissues. 

Test reports should include protocols 

approved by EPA, certificate of analysis 

for the test substance, raw data, and 

results. 

CFR citation: 40 CFR 721.10225. 

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 one of the 25 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 

substance. The basis for such findings is 

outlined in Unit IV. Based on these 

findings, a TSCA section 5(e) consent 

order requiring the use of appropriate 

exposure controls was negotiated with 

the PMN submitter. The SNUR 

provisions for this chemical substance 

are consistent with the provisions of the 

TSCA section 5(e) consent order. This 

SNUR is promulgated pursuant to 

§ 721.160. 

In the other 24 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6, or 7. 

• EPA will ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

newchems/pubs/invntory.htm. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

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

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

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

of this rule is November 19, 2010 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

October 20, 2010. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

October 20, 2010, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30–day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule September 20, 

2010. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. A TSCA section 

5(e) consent order has been issued for 

one chemical substance and the PMN 


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submitters are prohibited by the TSCA 

section 5(e) consent order 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, 13 of the 25 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 the development of any 

particular test data before submission of 

a SNUN. There are two exceptions: 1) 

development of test data is required, 

where the chemical substance subject to 

the SNUR is also subject to a test rule 

under TSCA section 4 (see TSCA 

section 5(b)(1)); and 2) development of 

test data may be necessary where the 

chemical substance has been listed 

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

section 5(b)(2)). In the absence of a 

section 4 test rule or a section 5(b)(4) 

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). 

However, upon review of PMNs and 

SNUNs, the Agency has the authority to 

require appropriate testing. In cases 

where EPA issued a TSCA section 5(e) 

consent order that requires or 

recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

order for one of the chemical substances 

regulated under this rule, EPA has 

established restrictions in view of the 

lack of data on the potential health and 

environmental risks that may be posed 

by the significant new use or increased 

exposure to the chemical substance. 

These restrictions cannot be removed 

unless the PMN submitter first submits 

the results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by this chemical 

substance. A listing of the tests specified 

in the TSCA section 5(e) consent order 

is included in Unit IV. The SNUR 

contains the same restrictions as the 

TSCA section 5(e) consent order. 

Persons who intend to begin nonexempt commercial manufacture, 

import, or processing for any of the 

restricted activities must notify the 

Agency by submitting a SNUN at least 

90 days in advance of commencement of 

that activity. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUN submitting 

for significant new use without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI. This rule cross-references 

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

§ 721.11 for situations where the 

chemical identity of the chemical 

substance subject to a SNUR is CBI. This 

procedure is cross-referenced in each 

SNUR that includes specific significant 

new uses that are CBI. 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 


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submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. SNUN Submissions 

As stated in Unit II.C., according to 

§ 721.1(c), persons submitting a SNUN 

must comply with the same notice 

requirements and EPA regulatory 

procedures as persons submitting a 

PMN, including submission of test data 

on health and environmental effects as 

described in § 720.50. SNUNs must be 

submitted to EPA, on EPA Form No. 

7710–25 in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. This form is available from the 

Environmental Assistance Division 

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

Washington, DC 20460–0001. Forms 

and information are also available 

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

opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this rule. EPA’s complete 

economic analysis is available in the 

docket. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act 

According to the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this rule. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

cause’’ under section 553(b)(3)(B) of the 

Administrative Procedure Act, 5 U.S.C. 

553(b)(3)(B), to amend this table without 

further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of these 

SNURs will not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The rationale supporting this 

conclusion is discussed in this unit. The 

requirement to submit a SNUN applies 

to any person (including small or large 

entities) who intends to engage in any 

activity described in the rule as a 

‘‘significant new use.’’ Because these 

uses are ‘‘new,’’ based on all information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activities. A SNUR 

requires that any person who intends to 

engage in such activity in the future 

must first notify EPA by submitting a 

SNUN. Although some small entities 

may decide to pursue a significant new 

use in the future, EPA cannot presently 

determine how many, if any, there may 

be. However, EPA’s experience to date 

is that, in response to the promulgation 

of over 1,400 SNURs, the Agency 

receives on average only 5 notices per 

year. Of those SNUNs submitted from 

2006–2008, only one appears to be from 

a small entity. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit XII.) is minimal regardless of 

the size of the firm. Therefore, EPA 

believes that the potential economic 

impacts of complying with these SNURs 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register of 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that final SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

rule. As such, EPA has determined that 

this rule does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any affect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). 


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Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 57181 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This does not 

significantly or uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note), does not 

apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

XIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: September 10, 2010. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

■ Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. The table in § 9.1 is amended by 

adding the following sections in 

numerical order under the undesignated 

center heading ‘‘Significant New Uses of 

Chemical Substances’’ to read as 

follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control No. 

* * * * * 

.

40 CFR citation OMB control No. 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10201 ....................... 2070–0012 

721.10202 ....................... 2070–0012 

721.10203 ....................... 2070–0012 

721.10204 ....................... 2070–0012 

721.10205 ....................... 2070–0012 

721.10206 ....................... 2070–0012 

721.10207 ....................... 2070–0012 

721.10208 ....................... 2070–0012 

721.10209 ....................... 2070–0012 

721.10210 ....................... 2070–0012 

721.10211 ....................... 2070–0012 

721.10212 ....................... 2070–0012 

721.10213 ....................... 2070–0012 

721.10214 ....................... 2070–0012 

721.10215 ....................... 2070–0012 

721.10216 ....................... 2070–0012 

721.10217 ....................... 2070–0012 

721.10218 ....................... 2070–0012 

721.10219 ....................... 2070–0012 

721.10220 ....................... 2070–0012 

721.10221 ....................... 2070–0012 

721.10222 ....................... 2070–0012 

721.10223 ....................... 2070–0012 

721.10224 ....................... 2070–0012 

721.10225 ....................... 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10201 to subpart E to 

read as follows: 

§ 721.10201 Cobalt lithium manganese 

nickel oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cobalt lithium manganese nickel oxide 

(PMN P–04–269; CAS No. 182442–95–1) 

is subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after it has been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(b) (concentration set at 0.1 percent), 

and (c). Respirators must provide a 

National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor (APF) of at least 150. 

The following NIOSH-approved 

respirators meet the requirements of 

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


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operated in pressure demand or other 

positive pressure mode and equipped 

with a tight-fitting full facepiece. As an 

alternative to the respirator 

requirements listed here, a 

manufacturer, importer, or processor 

may choose to follow the New Chemical 

Exposure Limit (NCEL) provisions listed 

in the Toxic Substances Control Act 

(TSCA) section 5(e) consent order for 

this substance. The NCEL is 0.1 mg/m3

as an 8–hour time-weighted average. 

Persons who wish to pursue NCELs as 

an alternative to the § 721.63 respirator 

may request to do so under § 721.30. 

Persons whose § 721.30 requests to use 

the NCELs approach are approved by 

EPA will receive NCELs provisions 

comparable to those listed in the 

corresponding section 5(e) consent 

order. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

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

(g)(1)(vii),(g)(1)(ix), (g)(2), (g)(3), 

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

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10202 to subpart E to 

read as follows: 

§ 721.10202 Benzoic acid, 4-chloro-2- 

[(substituted)azo]-, strontium salt (1:1) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzoic acid, 4-chloro-2- 

[(substituted)azo]-, strontium salt (1:1) 

(PMN P–08–701) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

■ 6. Add § 721.10203 to subpart E to 

read as follows: 

§ 721.10203 Phosphonium, tetrabutyl-, 

hydroxide (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonium, tetrabutyl-, hydroxide 

(1:1) (PMN P–08–742; CAS No. 14518– 

69–5) 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) 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. Add § 721.10204 to subpart E to 

read as follows: 

§ 721.10204 Aryloxyacrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aryloxyacrylate (PMN P– 

08–754) 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=3). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.10205 to subpart E to 

read as follows: 

§ 721.10205 Formaldehyde, polymer with 

1,3-benzenediol and 1,1′- 

methylenebis[isocyanatobenzene]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

formaldehyde, polymer with 1,3- 

benzenediol and 1,1′- 

methylenebis[isocyanatobenzene] (PMN 

P–09–4; CAS No. 1067881–45–1) 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. 

■ 9. Add § 721.10206 to subpart E to 

read as follows: 

§ 721.10206 4-Cyclohexene-1,2- 

dicarboxylic acid, 1,2-bis(2-oxiranylmethyl) 

ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

4-cyclohexene-1,2-dicarboxylic acid, 

1,2-bis(2-oxiranylmethyl) ester (PMN P– 

09–19; CAS No. 21544–03–6) 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)(2)(iii), (a)(3), (b) 

(concentration set at 0.1 percent), and 

(c). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

(c), (e) (concentration set at 0.1 percent), 

(g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), 

(g)(2)(i) and (g)(2)(v). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 


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Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 57183 

(a), (b), (c), (d), (e), (f), and (h) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 721.10207 to subpart E to 

read as follows: 

§ 721.10207 1,3- 

Cyclohexanedimethanamine, N1,N3-bis(2- 

methylpropylidene)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-cyclohexanedimethanamine, N1,N3- 

bis(2-methylpropylidene)- (PMN P–09– 

38; CAS No. 173904–11–5) 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) 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. Add § 721.10208 to subpart E to 

read as follows: 

§ 721.10208 Amines, di-C11-14-isoalkyl, 

C13-rich. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

amines, di-C11-14-isoalkyl, C13-rich 

(PMN P–09–71; CAS No. 1005516–89–1) 

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)(4), (b)(4), and 

(c)(4) (N=2). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.10209 to subpart E to 

read as follows: 

§ 721.10209 Epoxy terminated, hydrolyzed 

trialkoxysilane and glycidyl ether of phenolformaldehyde resin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as epoxy terminated, 

hydrolyzed trialkoxysilane and glycidyl 

ether of phenol-formaldehyde resin 

(PMN P–09–120) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.10210 to subpart E to 

read as follows: 

§ 721.10210 Soybean oil, epoxidized, 

reaction products with diethanolamine. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

soybean oil, epoxidized, reaction 

products with diethanolamine (PMN P– 

09–130; CAS No. 1002761–12–7) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10211 to subpart E to 

read as follows: 

§ 721.10211 Octadecanoic acid, reaction 

products with diethylenetriamine and urea, 

acetates. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

octadecanoic acid, reaction products 

with diethylenetriamine and urea, 

acetates (PMN P–09–172; CAS No. 

84962–05–0) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(s) (10,000 

kilograms). 

(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. 

■ 15. Add § 721.10212 to subpart E to 

read as follows: 

§ 721.10212 1,2-Ethanediol, reaction 

products with epichlorohydrin. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-ethanediol, reaction products with 

epichlorohydrin (PMN P–09–241; CAS 

No. 705265–31–2) 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(s) (100,000 

kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10213 to subpart E to 

read as follows: 


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57184 Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 

§ 721.10213 Polyether polyester 

copolymer phosphate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyether polyester 

copolymer phosphate (PMN P–09–253) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10214 to subpart E to 

read as follows: 

§ 721.10214 Poly(oxyalkylenediyl),.alpha.- 

substituted carbomonocycle-.omega.- 

substituted carbomonocycle (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

poly(oxyalkylenediyl),.alpha.- 

substituted carbomonocycle-.omega.- 

substituted carbomonocycle (PMN P– 

09–286) 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. 

■ 18. Add § 721.10215 to subpart E to 

read as follows: 

§ 721.10215 Benzenepropanol, .beta.- 

methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenepropanol, .beta.-methyl- (PMN 

P–09–385; CAS No.7384–80–7) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1.0 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(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. 

■ 19. Add § 721.10216 to subpart E to 

read as follows: 

§ 721.10216 2-Propenoic acid, 3-(5,5,6- 

trimethylbicyclo[2.2.1]hept-2-yl)cyclohexyl 

ester]. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 3-(5,5,6- 

trimethylbicyclo[2.2.1]hept-2- 

yl)cyclohexyl ester (PMN P–09–411; 

CAS No. 903876–45–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Disposal. Requirements as 

specified in § 721.85 (a)(1), (b)(1), and 

(c)(1). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

■ 20. Add § 721.10217 to subpart E to 

read as follows: 

§ 721.10217 Branched and linear alcohols 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched and linear 

alcohols (PMN P–09–426) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.10218 to subpart E to 

read as follows: 

§ 721.10218 2-Propenoic acid, 2-mehtyl-, 

C12-15-branched and linear alkyl esters, 

telomers with alkyl 2- 

[[(alkylthio)thioxomethyl]thio]-2-alkanoate, 

aminoalkyl methacrylate and alkyl 

methacrylate, tert-Bu 2- 

ethylhexanoperoxoate-initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl-, C12-15-branched and linear 

alkyl esters, telomers with alkyl 2- 

[[(alkylthio)thioxomethyl]thio]-2- 

alkanoate, aminoalkyl methacrylate and 

alkyl methacrylate, tert-Bu 2- 

ethylhexanoperoxoate-initiated (PMN 

P–09–436) 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). 

(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. 

■ 22. Add § 721.10219 to subpart E to 

read as follows: 


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Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 57185 

§ 721.10219 Butanamide,N-[substituted 

phenyl]-[(alkoxynitrophenyl)diazenyl]-3- 

oxo- (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as butanamide,N- 

[substituted phenyl]- 

(alkoxynitrophenyl)diazenyl]-3-oxo- 

(PMN P–09–451) 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. 

■ 23. Add § 721.10220 to subpart E to 

read as follows: 

§ 721.10220 Phosphoric acid, polymer with 

cycloaliphatic diglycidyl ether, alkylethers 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phosphoric acid, polymer 

with cycloaliphatic diglycidyl ether, 

alkylethers (PMN P–09–478) 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. 

■ 24. Add § 721.10221 to subpart E to 

read as follows: 

§ 721.10221 3-Nonen-1-ol, 1-acetate, (3Z)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3-nonen-1-ol, 1-acetate, (3Z)- (PMN P– 

09–542; CAS No. 13049–88–2) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=9). 

(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. 

■ 25. Add § 721.10222 to subpart E to 

read as follows: 

§ 721.10222 Styrenyl surface treated 

manganese ferrite (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as styrenyl surface treated 

manganese ferrite (PMN P–09–581) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(5), (a)(6), (b) (concentration set 

at 1.0 percent), and (c). Respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. The following 

NIOSH-approved respirators with an 

APF of 10–25 meet the minimum 

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

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters (either 

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

respirator equipped with a loose-fitting 

hood or helmet and High Efficiency 

Particulate Air (HEPA) filters; powered 

air-purifying respirator equipped with a 

tight-fitting facepiece (either half- or 

full-face) and HEPA filters; supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half- or full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (raw material 

intermediate used in the manufacture of 

polymerized pigments). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10223 to subpart E to 

read as follows: 

§ 721.10223 Styrenyl surface treated 

manganese ferrite with acrylic ester 

polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as styrenyl surface treated 

manganese ferrite with acrylic ester 

polymer (PMN P–09–582) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(5), (a)(6), (b) (concentration set 

at 1.0 percent), and (c). Respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. The following 

NIOSH-approved respirators with an 

APF of 10–25 meet the minimum 

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

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters (either 

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

respirator equipped with a loose-fitting 

hood or helmet and High Efficiency 

Particulate Air (HEPA) filters; powered 

air-purifying respirator equipped with a 

tight-fitting facepiece (either half- or 

full-face) and HEPA filters; supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half- or full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (polymerized 

pigment used in the manufacture of 

electronic inks). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 


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57186 Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Rules and Regulations 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 27. Add § 721.10224 to subpart E to 

read as follows: 

§ 721.10224 Diglycidylaniline (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diglycidylaniline (PMN 

P–10–9) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 0.1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

(x)(1). 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (e), (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. 

■ 28. Add § 721.10225 to subpart E to 

read as follows: 

§ 721.10225 Quino[2,3-b] acridine-7,14- 

dione, 2,9-dichloro-5,12-dihydro [4-[[2- 

(sulfooxy) ethyl] substituted] phenyl]-, 

sodium salt (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as quino[2,3-b] acridine7,14-dione, 2,9-dichloro-5,12-dihydro 

[4-[[2-(sulfooxy) ethyl] substituted] 

phenyl]-, sodium salt (1:1) (PMN P–10– 

14) 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)(iii), (a)(3), (b) 

(concentration set at 1.0 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. 

[FR Doc. 2010–23415 Filed 9–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2010–0203–201035; 

FRL–9202–9] 

Approval and Promulgation of 

Implementation Plans and 

Designations of Areas for Air Quality 

Planning Purposes; Alabama: 

Birmingham; Determination of 

Attaining Data for the 2006 24-Hour 

Fine Particulate Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: On February 24, 2010, the 

State of Alabama, through the Alabama 

Department of Environmental 

Management (ADEM), submitted a 

request to EPA to make a determination 

that the Birmingham, Alabama, 

nonattainment area has attained the 

24-hour fine particulate matter (PM2.5) 

National Ambient Air Quality Standard 

(NAAQS) based on quality assured, 

quality controlled monitoring data from 

2007–2009. The Birmingham, Alabama, 

2006 24-hour PM2.5 nonattainment area 

(hereafter referred to as ‘‘the 

Birmingham Area’’) is comprised of 

Jefferson and Shelby Counties in their 

entireties, and a portion of Walker 

County in Alabama. In this action, EPA 

is taking final action to determine that 

the Birmingham Area has attained the 

2006 24-hour PM2.5 NAAQS. This clean 

data determination is based upon 

complete, quality assured, quality 

controlled, and certified ambient air 

monitoring data for the years 2007–2009 

showing that the Birmingham Area has 

monitored attainment of the 2006 

24-hour PM2.5 NAAQS. 

DATES: Effective Date: This final rule is 

effective on October 20, 2010. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R04–OAR–2010–0203. All 

documents in the docket are listed in 

the http://www.regulations.gov Web 

site. Although listed in the electronic 

docket, some information is not publicly 

available, i.e., confidential business 

information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

http://www.regulations.gov or in hard 

copy for public inspection during 

normal business hours at the Regulatory 

Development Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. 

FOR FURTHER INFORMATION CONTACT: Sara 

Waterson, Regulatory Development 

Section, Air Planning Branch, Air, 

Pesticides and Toxics Management 

Division, U.S. Environmental Protection 

Agency, Region 4, 61 Forsyth Street, 

SW., Atlanta, Georgia 30303–8960. Ms. 

Waterson may be reached by phone at 

(404) 562–9061 or via electronic mail at 

waterson.sara@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. What action is EPA taking? 

II. What is the effect of this action? 

III. What is EPA’s final action? 

IV. What are the statutory and Executive 

order reviews? 

I. What action is EPA taking? 

EPA is taking final action to 

determine that the Birmingham Area 

(comprised of Jefferson and Shelby 

Counties in their entireties and a 

portion of Walker County) has attaining 

data for the 2006 24-hour PM2.5 NAAQS. 

This clean data determination is based 

upon quality assured, quality controlled 

and certified ambient air monitoring 

data that shows the Area has monitored 

attainment of the 2006 24-hour PM2.5

NAAQS based on the 2007–2009 data. 

While still preliminary, the available 

2010 24-hour PM2.5 data also monitored 

attainment for the 2006 24-hour PM2.5

standard. 

Other specific requirements of the 

clean data determination and the 

rationale for EPA’s action are explained 

in the notice of proposed rulemaking 

(NPR) published on June 14, 2010 (75 

FR 33562) and will not be restated here. 

The comment period closed on July 14, 

2010. No comments, adverse or 

otherwise, were received in response to 

the NPR. 


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