61566 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

the applicability limitation set forth in 

section 6(c)(2) of the Nutrition Labeling 

and Education Act (NLEA), which was 

not codified. Section 6(c)(2) of the 

NLEA provided that section 403A of the 

FD&C Act ‘‘shall not be construed to 

apply to any requirement respecting a 

statement on the labeling of food that 

provides for a warning concerning the 

safety of the food or component of the 

food’’ (Pub. L. 101–535, section 6, 104 

Stat. 2353 (1990)). FDA clarifies that its 

past discussions of section 403A of the 

FD&C Act should have included the 

language of section 6(c)(2) of the NLEA. 

Dated: September 28, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–25479 Filed 10–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2010–1075; FRL–8880–2] 

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 36 chemical 

substances which were the subject of 

premanufacture notices (PMNs). Four of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture, import, or 

process any of these 36 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 

December 5, 2011. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (E.S.T.) on 

October 19, 2011. 

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 November 4, 2011 (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–2010–1075, 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–2010–1075. 

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– 

2010–1075. 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 Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

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

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

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

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 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 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61567 

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 

November 4, 2011 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 the four bulleted TSCA 

section 5(a)(2) factors listed in 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. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

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 36 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, taking 

into consideration the four bulleted 


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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 

36 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). 

• Chemical Abstracts Service (CAS) 

number (if assigned for non-confidential 

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 4 PMN substances 

(P–06–36, P–06–37, P–09–146 and P– 

09–147) for which EPA determined, 

pursuant to TSCA section 5(e), that 

uncontrolled manufacture, import, 

processing, distribution in commerce, 

use, and disposal may present an 

unreasonable risk of injury to human 

health or the environment. Accordingly, 

these substances are subject to ‘‘riskbased’’ consent orders under TSCA 

section 5(e)(1)(A)(ii)(I). Those consent 

orders require protective measures to 

limit exposures or otherwise mitigate 

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

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

consent orders. 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) consent order usually 

requires, among other things, that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL) that is 

established by EPA to provide adequate 

protection to human health. In addition 

to the actual NCEL concentration, the 

comprehensive NCELs provisions in 

TSCA section 5(e) consent orders, 

which are modeled after Occupational 

Safety and Health Administration 

(OSHA) Permissible Exposure Limits 

(PELs) provisions, include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. 

However, no comparable NCEL 

provisions currently exist in 40 CFR 

part 721, subpart B, for SNURs. 

Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 32 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

EPA did not find that the use scenario 

described in the PMN triggered the 

determinations set forth under TSCA 

section 5(e). However, EPA does believe 

that certain changes from the use 

scenario described in the PMN could 

result in increased exposures, thereby 

constituting a ‘‘significant new use.’’ 

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

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

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

significant new use activities, ‘‘(i) Are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Numbers P–06–36 and P–06–37 

Chemical names: (P–06–36) Rutile, tin 

zinc, calcium-doped and (P–06–37) 

Rutile, tin zinc, sodium-doped. 

CAS numbers: (P–06–36) 389623–01– 

2 and (P–06–37) 389623–07–8. 

Effective date of TSCA section 5(e) 

consent order: February 17, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substances will be used as colorants for 

polymers and industrial coatings. The 

order was issued under TSCA sections 

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

on a finding that the substances may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the consent order requires: Use of 

personal respiratory equipment, 

including a National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Assigned Protection Factor (APF) of at 

least 10, or compliance with a NCEL of 

1.5 mg/m3 as an 8-hour time weighted 

average; establishment of a hazard 

communication program; and restricts 

the company from manufacturing the 

PMN substances with a d10 particle size 

less than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller; and 

corresponding recordkeeping. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Toxicity concern: Based on structural 

activity relationship analysis derived 

from test data on structurally similar 

respirable, poorly soluble particulates, 

the PMN substances may cause lung 

overload and fibrosis in workers 

exposed to the PMN substances by the 

inhalation route. 

Recommended testing: EPA has 

determined that the following test 

would help characterize the human 

health effects of the PMN substances: A 

90-day inhalation toxicity test (OPPTS 

Test Guideline 870.3465) in rats. The 

testing should include a 60-day recovery 

period to assess the progression or 

regression of any lesions; and include 

special attention to histopathology 

(inflammation and cell proliferation) of 

the lung tissues and to various 

parameters of the bronchoalveolar 

lavage fluid (BALF), e.g., marker 

enzyme activities, total protein content, 

total cell count, cell differential, and 

cell viability. 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 


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commerce, use, and disposal of the 

PMN substances will remain in effect 

until the order is modified or revoked 

by EPA based on submission of that or 

other relevant information. 

CFR citations: 40 CFR 721.10230 (P– 

06–36) and 40 CFR 721.10231 (P–06– 

37). 

PMN Number P–08–694 

Chemical name: N-arylamino-phenolformaldehyde condensate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) uses of 

the substance will be as a curative to be 

used with epoxy resin; a curative to be 

used with isocyanates in urethane 

systems; and an intermediate for 

synthesis of epoxy resins. Based on 

ecological structure-activity relationship 

(EcoSAR) analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 part per 

billion (ppb) of the PMN substance in 

surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 1 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

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) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 

measured concentrations. Algal testing 

should be performed using the static 

method with measured concentrations. 

EPA recommends that the special 

considerations for conducting 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 721.10232. 

PMN Number P–08–704 

Chemical name: Linear alkyl epoxide 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) uses of 

the substance will be as site-limited 

intermediates for personal care 

ingredients and foam control agents. 

Based on EcoSAR analysis of test data 

on analogous epoxides, 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 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 1 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

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) would 

help characterize the environmental 

effects of the PMN substance. 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 721.10233. 

PMN Number P–09–61 

Chemical name: Hydroxy-chlorocyclopropyl-heteromonocyclic 

carboxylic acid (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

industrial intermediate. Based on test 

data on the PMN substance, and 

EcoSAR analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 6 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 6 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

6 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. Testing should be 

performed using the flow-through 

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 721.10234. 

PMN Number P–09–72 

Chemical name: Phenol, 2-ethoxy-4- 

(ethoxymethyl)-. 

CAS number: 71119–07–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a perfumery 

ingredient. Based on EcoSAR analysis of 

test data on analogous phenols, EPA 

predicts that 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 PMN 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 PMN substance 

may present an unreasonable risk. EPA 

has determined, however, that any use 

of the substance resulting in surface 

water concentrations exceeding 1 ppb 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

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) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 


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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 721.10235. 

PMN Number P–09–139 

Chemical name: 1-Propanamine, 3-[2- 

(2-methoxyethoxy)ethoxy]-. 

CAS number: 91933–40–3. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a dispersant. Based 

on test data on an analogous substance 

submitted under TSCA section 8(e), 

EPA identified the following toxicity 

concerns from exposure to the PMN 

substance: Irritation to eyes; 

sensitization and corrosion to skin; and 

irritation to mucous membranes, lungs, 

and the gastrointestinal tract. For the 

uses described 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. However, EPA has determined that 

use of the substance other than as 

described in the PMN, or use of the 

substance in a consumer product, may 

result in significant human exposures. 

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 an acute 

oral toxicity test (OPPTS Test Guideline 

870.1100 or Organisation for Economic 

Co-operation and Development (OECD) 

Test Guideline 425); a bacterial reverse 

mutation test (OPPTS Test Guideline 

870.5100); a mammalian erythrocyte 

micronucleus test (OPPTS Test 

Guideline 870.5395) via the 

intraperitoneal route; and a repeated 

dose 28-day oral toxicity study in 

rodents (OPPTS Test Guideline 

870.3050 or OECD Test Guideline 407) 

would help characterize the human 

health effects of the PMN substance. 

Testing should be performed on the 

neutralized 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 721.10236. 

PMN Numbers P–09–146 and P–09–147 

Chemical names: (P–09–146) 

Formaldehyde, polymers with acetonephenol reaction products and phenol, 

sodium salts and (P–09–147) 

Formaldehyde, polymers with acetonephenol reaction products and phenol, 

potassium sodium salts. 

CAS numbers: (P–09–146) 1065544– 

88–8 and (P–09–147) 1072227–60–1. 

Effective date of TSCA section 5(e) 

consent order: May 26, 2010. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of the substances 

will be as adhesives. The order was 

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

and 5(e)(1)(A)(ii)(I) based on a finding 

that the substances may present an 

unreasonable risk of injury to human 

health. To protect against these risks, 

the consent order requires: Restrictions 

on formaldehyde residuals and polymer 

composition in the PMN substances; 

testing of representative samples at new 

manufacturing facilities; development 

and implementation of a written control 

plan for analysis and compliance with 

specified chemical composition limits; 

use only as listed in the consent order; 

no processing or distribution of the 

PMNs except when processed under 

specified conditions, where the PMNs 

are irreversibly cured into a thermoset 

polymer matrix; and maintaining certain 

records. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Toxicity concern: Based on physicalchemical properties, the PMN 

substances are expected to be absorbed 

from the lung and low molecular weight 

fractions are expected to be poorly 

absorbed from the gastrointestinal tract. 

Further, the PMN substances are not 

expected to be absorbed through the 

skin. EPA identified concerns for 

respiratory tract irritation, coughing; 

skin irritation and redness; eye 

irritation, watering, and redness; 

sensitization and severe allergic 

reactions. Further, based on test data on 

formaldehyde, a component of the PMN 

substances and regarded by EPA and 

International Agency for Research on 

Cancer (IARC) to be a carcinogen, EPA 

predicts human carcinogenicity. 

Recommended testing: EPA has 

determined that the following test 

would help characterize the human 

health effects of the PMN substances: 

Determining formaldehyde 

concentration in air from wood 

products, using a large scale chamber 

(American Society for Testing and 

Materials International (ASTM) Test 

Guideline E1333–10 or its equivalent) to 

demonstrate that formaldehyde 

emissions are equal to or less than 0.04 

parts per million (ppm). 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 substances will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citations: 40 CFR 721.10237 (P– 

09–146) and 40 CFR 721.10238 (P–09– 

147). 

PMN Numbers P–09–152 and P–09–153 

Chemical names: Trivalent chromium 

complexes of a substituted betanaphthol amine azo dye (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the use of the substances will be as acid 

dyes for coloring anodized aluminum. 

Based on test data on analogous 

substances including Betanaphthylamine and chromium, EPA 

determined that the PMN substances 

may cause blood toxicity 

(methemoglobinemia), male 

reproductive toxicity, developmental 

toxicity, mutagenicity, and oncogenicity 

to workers and the general public 

exposed to the PMN substances via the 

lung or gastrointestinal tract. For the use 

described in the PMNs, worker 

inhalation exposure is unlikely, as the 

substances are imported, processed, and 

used as a wet press cake (greater than 30 

percent water). Significant general 

population exposure is unlikely, as 

significant inhalation and drinking 

water exposures are not expected. 

Therefore, EPA has not determined that 

the proposed import, processing, or use 

of the substances may present an 

unreasonable risk. EPA has determined, 

however, that domestic manufacture, 

use of the substances other than as 

described in the PMNs, or the import, 

processing, or use of the substances in 

a powder or solid form (other than as a 

wet press cake that is comprised of 

greater than 30 percent water), may 

cause serious health effects. Based on 

this information, the PMN substances 

meet the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of a bacterial 

reverse mutation test (OPPTS Test 

Guideline 870.5100) with the prival 

modification with a concurrent positive 

control; and an unscheduled DNA 

synthesis in mammalian cells in culture 

(OPPTS Test Guideline 870.5550) in rat 

hepatocytes on the Beta-naphthylamine 

reduction product would help 

characterize the human health effects of 

the PMN substances. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10239. 


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PMN Numbers P–09–154, P–09–155, 

and P–09–156 

Chemical names: (P–09–154) Olefinic 

carbocycle, reaction products with 

alkoxysilane (generic); (P–09–155) 

olefinic carbocycle, reaction products 

with alkoxysilane, sulfurized (generic); 

and (P–09–156) olefinic carbocycle, 

reaction products with alkoxysilane, 

polysulfurized (generic). 

CAS numbers: (P–09–154) Not 

available; (P–09–155) not available; and 

(P–09–156) not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) uses of 

the substances will be as a processing 

additive intermediate (P–09–154 and P– 

09–155) and as a processing additive (P– 

09–156). Based on EcoSAR analysis of 

test data on analogous alkoxysilanes, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN substance 

(P–09–154) and 6 ppb of the PMN 

substance (P–09–156) in surface waters. 

Based on test data on analogous 

alkoxysilanes and thiols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substance (P–09–155) in 

surface waters. As described in the 

PMNs, the substances will not be 

released to surface waters. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substances 

resulting in release to surface waters 

may cause significant adverse 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability—CO2 in sealed vessels 

test (OPPTS Test Guideline 835.3140); 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) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 

measured concentrations. Algal testing 

should be performed using the static 

method with measured concentrations. 

EPA recommends that the fate testing be 

performed first as the results may 

mitigate the need for further toxicity 

testing or change the testing 

recommendations. Testing should be 

performed on P–09–155. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citations: 40 CFR 721.10240 (P– 

09–154); 40 CFR 721.10241 (P–09–155); 

and 40 CFR 721.10242 (P–09–156). 

PMN Numbers P–09–193 and P–09–195 

Chemical names: (P–09–193) 

Phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, bis(2- 

chloroethyl) ester and (P–09–195) 

Phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, 2-[bis(2- 

chloroethoxy)phosphinyl]ethyl 2- 

chloroethyl ester. 

CAS numbers: (P–09–193) 55088–28– 

3 and (P–09–195) 1094213–37–2. 

Basis for action: The PMNs state that 

the substances will be used as 

intermediates in the manufacture of a 

polyurethane flame retardant. Based on 

the alkylating activity of the PMN 

substances, EPA has concerns for 

oncogenicity, mutagenicity, 

developmental toxicity, dermal and 

respiratory sensitization, and irritation 

to all tissues. Additionally, the Agency 

has concern for liver toxicity, kidney 

toxicity, heart toxicity, developmental 

toxicity, and neurotoxicity based on test 

data for analog substances submitted to 

the Agency under TSCA section 8(e). 

Based on EcoSAR analysis of test data 

on structurally similar aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms at concentrations that exceed 

8 ppb in surface waters. As described in 

the PMN, significant worker dermal and 

inhalation exposure is unlikely for the 

use described in the PMN due to the use 

of personal protective equipment and 

engineering controls. Further, 

significant general population and 

environmental exposure is unlikely as 

the substances are not released to water. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of these substances 

may present an unreasonable risk. EPA 

has determined, however, that use of the 

substances other than as intermediates 

in the manufacture of a polyurethane 

flame retardant, use of the substances 

without the use of impervious gloves 

where there is potential for dermal 

exposure, or any use of the substances 

resulting in release to surface waters 

may cause significant adverse health or 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(1)(i)(C), (b)(3)(ii), and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of 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) would help 

characterize the human health and 

environmental effects of the PMN 

substances. Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentration. Testing should 

be performed on P–09–193. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citations: 40 CFR 721.10243 (P– 

09–193) and 40 CFR 721.10244 (P–09– 

195). 

PMN Number P–09–207 

Chemical name: Branched and linear 

fatty alcohol ethoxylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate in the manufacture of 

nonionic surfactants. Based on EcoSAR 

analysis of test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 14 ppb of 

the PMN substance in surface waters. 

For the use described in the PMN, 

releases of the PMN substance are not 

expected to result in surface water 

concentrations that exceed 14 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance other than as an intermediate 

in the manufacture of nonionic 

surfactants may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS 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) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 

measured concentrations. Algal testing 

should be performed using the static 

method with measured concentrations. 

EPA recommends that the special 

considerations for conducting laboratory 


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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 721.10245. 

PMN Number P–09–234 

Chemical name: Alkylpolyhydroxy 

polymer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a drilling fluid 

additive. Based on EcoSAR analysis of 

test data on analogous alkyl ethoxylate 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 56 ppb of 

the PMN substance in surface waters. As 

described in the PMN, the substance is 

not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in release to 

surface waters may cause significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 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) would 

help characterize the environmental 

effects of the PMN substance. 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 721.10246. 

PMN Number P–09–258 

Chemical name: Bis-phenoxyethanol 

fluorene diacrylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a raw 

material in ultra violet (UV) curable inks 

and coatings. EPA identified health and 

environmental concerns because the 

substance may be a persistent, bioaccumulative, and toxic (PBT) chemical, 

based on physical/chemical properties 

of the PMN substance, as described in 

the New 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 for 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 not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any predictable or purposeful release 

containing the PMN substance into the 

waters of the United States may cause 

serious health effects and significant 

environmental effects, since the PMN 

substance has been characterized by 

EPA as a PBT. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of 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 721.10247. 

PMN Number P–09–259 

Chemical name: Aromatic bromide 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a synthetic 

intermediate. EPA identified health and 

environmental concerns because the 

substance may be a PBT chemical, based 

on physical/chemical properties of the 

PMN substance, as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999). EPA 

estimates that the PMN substance will 

persist in the environment more than 

six months and estimates a 

bioaccumulation factor of greater than 

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

data on analogous brominated aromatics 

and neutral organics (aryl halides), 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 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 

use of the substance other than as 

described in the PMN or any predictable 

or purposeful release containing the 

PMN substance into the waters of the 

United States may cause serious health 

effects and significant environmental 

effects, since the PMN substance has 

been characterized by EPA as a PBT. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii), (b)(4)(ii), and 

(b)(4)(iii). 

Recommended testing: EPA has 

determined that the results of 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 721.10248. 

PMN Number P–09–316 

Chemical name: Disubstituted phenol 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on test data on 

analogous anilines and phenols, as well 

as on test data submitted to the Agency 

under TSCA section 8(e), EPA identified 

concerns for liver toxicity, mutagenicity, 

carcinogenicity, developmental toxicity, 

neurotoxicity, and male reproductive 

system toxicity to workers from 

inhalation exposure to the PMN 

substance. Additionally, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 6 ppb of 

the PMN substance in surface waters. 

For the use described in the PMN, 

significant worker exposure is unlikely 

due to the use of personal protective 

equipment. Furthermore, significant 

environmental exposure is unlikely as 

the substance is not released to surface 

water resulting in surface water 

concentrations that exceed 6 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use other 

than as a chemical intermediate, or 

exceedance of the manufacture and 

import limit of 100 kg per year may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 


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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined chronic toxicity/ 

carcinogenicity test (OPPTS Test 

Guideline 870.4300); a bacterial reverse 

mutation test (OPPTS Test Guideline 

870.5100); a mammalian erythrocyte 

micronucleus test (OPPTS Test 

Guideline 870.5395); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300) prolonged exposure; a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400) using rainbow trout 

and a 60-day minimum duration; and an 

algal toxicity test, tiers I and II (OPPTS 

Test Guideline 850.5400) would help 

characterize the human health and 

environmental effects of the PMN 

substance. Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. 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 721.10249. 

PMN Number P–09–356 

Chemical name: Zirconium lysine 

complex (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesion 

promoter and corrosion inhibitor. Based 

on EcoSAR analysis of test data on 

analogous inorganic zirconium 

compounds, EPA predicts toxicity to 

aquatic organisms at concentrations that 

exceed 120 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 120 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 120 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS 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) would 

help characterize the environmental 

effects of the PMN substance. 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 721.10250. 

PMN Number P–09–366 

Chemical name: Fatty acids, reaction 

products with alkanolamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate for a product used as a 

component of a multipurpose additive 

in gasoline. Based on test data on the 

PMN substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 400 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 400 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as an 

intermediate could result in exposures 

which may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of an aerobic 

and anaerobic transformation in aquatic 

sediment systems (OECD Test Guideline 

308); a fish early-life stage toxicity test 

(OPPTS Test Guideline 850.1400); and a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. Fish and daphnid 

testing should be performed using the 

flow-through method with measured 

concentrations. EPA recommends that 

the special considerations for 

conducting laboratory studies (OPPTS 

Test Guideline 850.1000) be followed to 

facilitate solubility in the test media, 

because of the PMN’s low water 

solubility. EPA also recommends 

performing the fate testing first as the 

results may mitigate the need for further 

toxicity testing or change the testing 

requirements. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10251. 

PMN Number P–09–373 

Chemical name: Thiosulfuric acid 

(H2S2O3), manganese(2+) salt (1:1). 

CAS number: 1033050–53–1. 

Basis for action: The PMN states that 

the substance will be used as a 

micronutrient manganese source for 

selected agricultural crops. Based on 

EcoSAR analysis of test data on 

analogous manganese salts, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

400 ppb of the PMN substance in 

surface waters. As described in the 

PMN, releases of the substance are not 

expected to result in surface water 

concentrations that exceed 400 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 400 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS 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) would 

help characterize the environmental 

effects of the PMN substance. 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 721.10252. 

PMN Number P–09–388 

Chemical name: Butanedioic acid, 

2-methylene-, polymer with 2,5 

furanedione, copper(2+) manganese(2+) 

sodium zinc salt, hydrogen peroxideinitiated. 

CAS number: 1134078–27–5. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a seed coating to 

provide micronutrients. Based on 

EcoSAR analysis of test data on 

analogous soluble complexes of zinc, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 34 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 


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substance are not expected to result in 

surface water concentrations that exceed 

34 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 

34 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability-CO2 in sealed vessels 

(headspace test) (OECD Test Guideline 

310); 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) would help 

characterize the environmental effects of 

the PMN substance. Fish and daphnid 

testing should be performed using the 

flow-through method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. EPA 

recommends performing the fate testing 

first as the results may mitigate the need 

for further toxicity testing or change the 

testing requirements. Test reports 

should include protocols approved by 

EPA, certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10253. 

PMN Number P–09–390 

Chemical name: Substituted 

acrylamide (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a raw material. 

Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous amides and 

acrylamides, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 21 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 

21 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 

21 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) 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 would help characterize 

the environmental 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 721.10254. 

PMN Number P–09–400 

Chemical name: Vinyl carboxylic acid 

ester (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a monomer. Based 

on test data on the PMN substance and 

analogous vinyl esters, EPA identified 

concerns for dermal sensitization; 

dermal irritation; mutagenicity; 

neurotoxicity; and blood, liver, kidney, 

spleen, brain, testes, developmental, 

and reproductive toxicity to the general 

population if exposed to the PMN 

substance. In addition, based on test 

data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

15 ppb of the PMN substance in surface 

waters. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii) and 

(b)(4)(i). At the production volume 

stated in the PMN, general population 

exposure is limited. Further, as 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 15 ppb. 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 that annual 

manufacture (including importation) of 

this PMN substance at volumes greater 

than 100,000 kilograms per year may 

result in significant human exposures. 

Further, EPA has determined that any 

use of the substance resulting in surface 

water concentrations exceeding 15 ppb 

may cause significant adverse 

environmental effects. 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. Aquatic toxicity testing 

should be performed using the flowthrough 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 721.10255. 

PMN Number P–09–479 

Chemical name: Benzoic acid, 4- 

(dimethylamino)-, 1,1′- 

[(methylimino)di-2,I-ethanediyl] ester. 

CAS number: 925246–00–0. 

Basis for action: The PMN states that 

the substance will be used as a cophotoinitiator for UV-curable 

pigmentation inks; co-photoinitiator for 

photoresists, optical fibers, and printed 

plates; co-photoinitiator for UV-curable 

coatings; and co-photoinitiator for UVcurable adhesives and other coatings. 

Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous aliphatic amines and 

esters, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(i) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3100); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. Testing should be 

performed using the flow-through 

method with mean measured 

concentrations. EPA recommends that 

the special considerations for 

conducting laboratory studies (OPPTS 

Test Guideline 850.1000) be followed to 

facilitate solubility in the test media, 

because of the PMN’s low water 

solubility. EPA also recommends that 

the fate testing be performed first as the 

results may mitigate the need for further 

toxicity testing or change the testing 

recommendations. Test reports should 


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include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citation: 40 CFR 721.10256. 

PMN Number P–09–532 

Chemical name: Butyl aromatic 

bisurea (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a sealant. Based on 

EcoSAR analysis of test data on 

analogous substituted urea, 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 the results of 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) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 

measured concentrations. Algal testing 

should be performed using the static 

method with measured concentrations. 

EPA recommends that the special 

considerations for conducting 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 721.10257. 

PMN Numbers P–09–535 and P–09–540 

Chemical names: (P–09–535) 

Aromatic hydrocarbon (generic) and (P– 

09–540) Halogenated aromatic 

hydrocarbon (generic). 

CAS numbers: (P–09–535) Not 

available and (P–09–540) not available. 

Basis for action: The PMNs state that 

the substances will be used as synthetic 

intermediates. EPA has identified health 

and environmental concerns because 

the substances may be PBT chemicals, 

based on physical/chemical properties 

of the PMN substances, as described in 

the New Chemicals Program’s PBT 

Category (64 FR 60194; November 4, 

1999). EPA estimates that the PMN 

substances will persist in the 

environment more than two months and 

estimates bioaccumulation factors that 

are greater than or equal to 5,000. Also, 

based on test data on analogous polyaromatic hydrocarbons, EPA predicts 

chronic adverse human health effects. 

As described in the PMNs, significant 

worker exposure is unlikely and the 

substances are not released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any predictable or purposeful release 

containing the PMN substances into the 

waters of the United States may cause 

serious health effects and significant 

adverse environmental effects, since the 

PMN substances have been 

characterized by EPA as PBT. Based on 

this information, the PMN substances 

meet the concern criteria at 

§ 721.170(b)(3)(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 substances. Test reports should 

include protocols approved by EPA, 

certificate of analysis for the test 

substance, raw data, and results. 

CFR citations: 40 CFR 721.10258 (P– 

09–535) and 40 CFR 721.10259 (P–09– 

540). 

PMN Number P–09–552 

Chemical name: Benzene, 1,3-bis(1- 

chloro-1-methylethyl)-. 

CAS number: 37133–18–9. 

Basis for action: The PMN states that 

the substance will be used as a sitelimited starting material in novel 

polymer synthesis reactions. EPA has 

identified health and environmental 

concerns because the substance may be 

a PBT chemical, based on physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999). EPA 

estimates that the PMN substance will 

persist in the environment more than 

two months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. In addition, based on 

the potential for the PMN to be an 

alkylating agent, EPA identified 

concerns for oncogenicity, 

developmental toxicity, sensitivity, and 

corrosion to all tissues from dermal and 

respiratory exposure. Further, based on 

EcoSAR analysis of test data on 

analogous benzyl halides, EPA predicts 

toxicity to aquatic organisms at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, significant 

worker exposure is unlikely due to the 

use of adequate dermal and respiratory 

protection and 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 predictable or purposeful release 

containing the PMN substance into the 

waters of the United States may cause 

serious health effects and significant 

adverse environmental effects, since the 

PMN substance has been characterized 

by EPA as a PBT. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(1)(i)(C), (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 (64 FR 60914; 

November 4, 1999) should 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 721.10260. 

PMN Numbers P–09–589 and P–09–590 

Chemical names: (P–09–589) Oxime, 

di-Me silane (generic) and (P–09–590) 

Oxime, Me vinyl silane (generic). 

CAS numbers: (P–09–589) Not 

available and (P–09–590) not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as chain extenders. 

Based on test data on the PMN 

substances and the expected hydrolysis 

product, EPA identified concerns for 

carcinogenicity, dermal sensitization, 

blood effects, reproductive toxicity, and 

neurotoxicity to workers and the general 

population exposed dermally or by 

inhalation to the PMN substances. In 

addition, based on EcoSAR analysis of 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 ppb of the PMN 

substances in surface waters. As 

described in the PMNs, worker exposure 

will be minimal due to the use of 

adequate personal protective 

equipment, general population 

inhalation and dermal exposure is not 

expected, and the substances are not 

released to surface waters. Therefore, 


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EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substances may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substances 

without the use of impervious gloves 

where there is potential for dermal 

exposure, annual manufacture 

(including importation) of each of the 

PMN substances at volumes greater than 

20,000 kilograms, or any use of the 

substances resulting in release to surface 

waters may cause serious health effects 

and/or significant adverse 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a twogeneration reproduction toxicity test 

(OECD Test Guideline 416); a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); a porous pot test 

(OPPTS Test Guideline 835.3220); a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity mitigated 

by humic acid test (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) would help 

characterize the human health and 

environmental effects of the PMN 

substances. Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. Algal testing should be 

performed using the static method with 

measured concentrations. Testing 

should be performed on P–09–589. EPA 

recommends that the fate testing be 

performed first as the results may 

mitigate the need for further testing or 

change the testing requirements. Test 

reports should include protocols 

approved by EPA, certificate of analysis 

for the test substance, raw data, and 

results. 

CFR citations: 40 CFR 721.10261 (P– 

09–589) and 40 CFR 721.10262 (P–09– 

590). 

PMN Number P–09–634 

Chemical name: Phenol, 4-(1,1- 

dimethylethyl)-2-nitro-. 

CAS number: 3279–07–0. 

Basis for action: The PMN states that 

the substance will be used as a raw 

material (reactant) for production of 

intermediate for a photographic 

chemical. Based on test data on the 

PMN substance, and test data submitted 

under TSCA section 8(e) on analogous 

aminophenols, EPA identified concerns 

for irritation to the eye and skin, 

mutagenicity, neurotoxicity, 

developmental, liver, blood, and 

reproductive toxicities to workers and 

members of the general population if 

exposed to the PMN substance. In 

addition, based on EcoSAR analysis of 

test data on analogous phenols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. For the uses described in the 

PMN, significant worker exposure is 

unlikely, as dermal/inhalation exposure 

is not expected; the substance is not 

released to surface waters; and the 

substance is not expected to result in 

significant exposure to the general 

population. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as 

described in the PMN or any use of the 

substance resulting in release to surface 

waters may cause serious health effects 

and significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/development toxicity 

screening test (OPPTS Test Guideline 

870.3650); 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) would help 

characterize the human health and 

environmental effects of the PMN 

substance. Fish and daphnid testing 

should be performed using the flowthrough method with measured 

concentrations. 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 721.10263. 

PMN Number P–10–343 

Chemical name: Polycarbocyclic 

methacrylate (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymeric 

component. Based on EcoSAR analysis 

of test data on analogous methacrylates, 

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 is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

release to surface waters may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guidelines 835.3110); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); an 

aquatic invertebrate acute toxicity test 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test, tiers I and II 

(OPPTS Test Guideline 850.5400) would 

help characterize the environmental 

effects of the PMN substance. Fish and 

daphnid testing should be performed 

using the flow-through method with 

measured concentrations. Algal testing 

should be performed using the static 

method with measured concentrations. 

EPA recommends that the special 

considerations for conducting 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 721.10264. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 4 of the 36 chemical substances, 

regulation was warranted under TSCA 

section 5(e), pending the development 

of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160 (see 

Unit II.). 

In the other 32 cases, where the uses 

are not regulated under a TSCA section 


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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 December 5, 2011 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before November 4, 

2011. 

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 

November 4, 2011, 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, October 5, 2011. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

4 chemical substances and the PMN 

submitters are prohibited by the TSCA 

section 5(e) consent orders from 

undertaking activities which EPA is 

designating as significant new uses. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 23 of the 36 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 (55 FR 17376), 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. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

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)). 

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 TSCA section 4 

test rule or a TSCA 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 

§ 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. The 

American Society for Testing and 


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Materials International (ASTM) 

standards are available at http:// 

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

In the TSCA section 5(e) consent 

orders for four 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 uses or 

increased exposure to the chemical 

substances. These restrictions will not 

be removed until EPA determines that 

the unrestricted use will not present an 

unreasonable risk of injury or result in 

significant or substantial exposure or 

environmental release. This 

determination is usually made based on 

the results of the required or 

recommended toxicity tests. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN 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, at 40 CFR 721.1725(b)(1). Today’s 

rules cross-reference § 721.1725(b)(1) 

(which is similar to the procedure in 

§ 721.11, for situations where the 

chemical identity of the chemical 

substance subject to a SNUR is CBI) in 

each SNUR that includes specific 

significant new uses that are CBI. 

Under these procedures a 

manufacturer, importer, or processor 

may request that EPA determine 

whether a proposed use would be a 

significant new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. SNUN Submissions 

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 on 

EPA Form No. 7710–25, generated using 

e-PMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. E-PMN software is 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 under docket ID number EPA– 

HQ–OPPT–2010–1075. 

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. 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 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 


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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 this SNUR 

will not have a significant adverse 

economic impact on a substantial 

number of small entities. 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 final 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 SNURs covering 

over 1,000 chemicals, the Agency 

receives only a handful of notices per 

year. For example, the number of 

SNUNs was four in Federal fiscal year 

2005, eight in FY2006, six in FY2007, 

eight in FY2008, and seven in FY2009. 

During this five-year period, three small 

entities submitted a SNUN. In addition, 

the estimated reporting cost for 

submission of a SNUN (see Unit XI.) is 

minimal regardless of the size of the 

firm. Therefore, EPA believes that the 

potential economic impacts of 

complying with this SNUR 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 effect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This rule does not 

significantly nor 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 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 23, 2011. 

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, 


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

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

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

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

11023, 11048. 

■ 2. The table in § 9.1 is amended by 

adding the following sections in 

numerical order under the undesignated 

center heading ‘‘Significant New Uses of 

Chemical Substances’’ to read as 

follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB 

control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10230 ........................... 2070–0012 

721.10231 ........................... 2070–0012 

721.10232 ........................... 2070–0012 

721.10233 ........................... 2070–0012 

721.10234 ........................... 2070–0012 

721.10235 ........................... 2070–0012 

721.10236 ........................... 2070–0012 

721.10237 ........................... 2070–0012 

721.10238 ........................... 2070–0012 

721.10239 ........................... 2070–0012 

721.10240 ........................... 2070–0012 

721.10241 ........................... 2070–0012 

721.10242 ........................... 2070–0012 

721.10243 ........................... 2070–0012 

721.10244 ........................... 2070–0012 

721.10245 ........................... 2070–0012 

721.10246 ........................... 2070–0012 

721.10247 ........................... 2070–0012 

721.10248 ........................... 2070–0012 

721.10249 ........................... 2070–0012 

721.10250 ........................... 2070–0012 

721.10251 ........................... 2070–0012 

721.10252 ........................... 2070–0012 

721.10253 ........................... 2070–0012 

721.10254 ........................... 2070–0012 

721.10255 ........................... 2070–0012 

721.10256 ........................... 2070–0012 

721.10257 ........................... 2070–0012 

721.10258 ........................... 2070–0012 

721.10259 ........................... 2070–0012 

721.10260 ........................... 2070–0012 

721.10261 ........................... 2070–0012 

721.10262 ........................... 2070–0012 

721.10263 ........................... 2070–0012 

721.10264 ........................... 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 § 721.10230 to subpart E to 

read as follows: 

§ 721.10230 Rutile, tin zinc, calciumdoped. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

rutile, tin zinc, calcium-doped (PMN P– 

06–36; CAS No. 389623–01–2) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been incorporated into a polymer, 

glass, dispersion, cementitious matrix, 

or a similar incorporation. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(5), (a)(6)(i), (b) 

(concentration set at 1.0 percent), and 

(c). The following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10 

meet the minimum requirements for 

§ 721.63(a)(5): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

(C) NIOSH-certified powered airpurifying respirator equipped with a 

loose- fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

(1) As an alternative to the respiratory 

requirements listed in paragraph 

(a)(2)(i), a manufacturer, importer, or 

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for these substances. 

The NCEL is 1.5 mg/m3 as an 8-hour 

time-weighted-average for both 

chemical substances combined. Persons 

who wish to pursue NCELs as an 

alternative to the § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will receive NCELs 

provisions comparable to those 

contained in the corresponding section 

5(e) consent order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), (f), 

(g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 1.5 mg/m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 perecent by weight of the 

substance measured is smaller). 

(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), (f), (g), (h), and 

(i) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10231 to subpart E to 

read as follows: 

§ 721.10231 Rutile, tin zinc, sodium-doped. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

rutile, tin zinc, sodium-doped (PMN P– 

06–37; CAS No. 389623–07–8) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been incorporated into a polymer, 

glass, dispersion, cementitious matrix, 

or a similar incorporation. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(5), (a)(6)(i), (b) 

(concentration set at 1.0 percent), and 

(c). The following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10 

meet the minimum requirements for 

§ 721.63(a)(5): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

(C) NIOSH-certified powered airpurifying respirator equipped with a 


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loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

(1) As an alternative to the respiratory 

requirements listed in paragraph 

(a)(2)(i), a manufacturer, importer, or 

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for these substances. 

The NCEL is 1.5 mg/m3 as an 8-hour 

time-weighted-average for both 

chemical substances combined. Persons 

who wish to pursue NCELs as an 

alternative to the § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will receive NCELs 

provisions comparable to those 

contained in the corresponding section 

5(e) consent order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), (f), 

(g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 1.5 mg/m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller). 

(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), (f), (g), (h), and 

(i) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.10232 to subpart E to 

read as follows: 

§ 721.10232 N-arylamino-phenolformaldehyde condensate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as n-arylamino-phenolformaldehyde condensate (PMN P–08– 

694) 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. 

■ 7. Add § 721.10233 to subpart E to 

read as follows: 

§ 721.10233 Linear alkyl epoxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as linear alkyl epoxide (PMN 

P–08–704) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.10234 to subpart E to 

read as follows: 

§ 721.10234 Hydroxy-chloro-cyclopropylheteromonocyclic carboxylic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hydroxy-chlorocyclopropyl-heteromonocyclic 

carboxylic acid (PMN P–09–61) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N = 6). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.10235 to subpart E to 

read as follows: 

§ 721.10235 Phenol, 2-ethoxy-4- 

(ethoxymethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-ethoxy-4-(ethoxymethyl)- 

(PMN P–09–72; CAS No. 71119–07–8) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) 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. 

■ 10. Add § 721.10236 to subpart E to 

read as follows: 

§ 721.10236 1-Propanamine, 3-[2-(2- 

methoxyethoxy)ethoxy]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propanamine, 3-[2-(2- 

methoxyethoxy)ethoxy]- (PMN P–09– 

139; CAS No. 91933–40–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 


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(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) and (o). 

(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. 

■ 11. Add § 721.10237 to subpart E to 

read as follows: 

§ 721.10237 Formaldehyde, polymers with 

acetone-phenol reaction products and 

phenol, sodium salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

formaldehyde, polymers with acetonephenol reaction products and phenol, 

sodium salts (PMN P–09–146; CAS No. 

1065544–88–8) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

rule do not apply to quantities of the 

PMN substance that have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) including: 

(A) Manufacture or import of the PMN 

substance only where the maximum 

unbound formaldehyde residual levels 

and typical polymer weight to weight 

composition ratios are as specified in 

the TSCA section 5(e) consent order. 

(B) Upon start-up of manufacture of 

the PMN at any new facility, conduct 

the American Society for Testing and 

Materials International (ASTM) E1333– 

10 test or its equivalent on a 

representative sample of the finished 

cured resin product, demonstrating that 

formaldehyde emissions are less than or 

equal to 0.04 ppm. 

(C) Development and implementation 

of a written control plan that includes 

analysis of representative samples to 

ensure compliance with (a)(2)(i)(A) and 

(a)(2)(i)(B) of this section. 

(D) Manufacturing, processing, 

distribution, or use of the PMN 

substance only as described in the 

TSCA section 5(e) consent order. 

(E) Processing or distribution for 

processing only under the conditions 

described in the TSCA section 5(e) 

consent order and which are capable of 

irreversibly curing the PMN substance 

into a thermoset polymer matrix. 

(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. 

■ 12. Add § 721.10238 to subpart E to 

read as follows: 

§ 721.10238 Formaldehyde, polymers with 

acetone-phenol reaction products and 

phenol, potassium sodium salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

formaldehyde, polymers with acetonephenol reaction products and phenol, 

potassium sodium salts (PMN P–09– 

147; CAS No. 1072227–60–1) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) including: 

(A) Manufacture or import of the PMN 

substance only where the maximum 

unbound formaldehyde residual levels 

and typical polymer weight to weight 

composition ratios are as specified in 

the TSCA section 5(e) consent order. 

(B) Upon start-up of manufacture of 

the PMN at any new facility, conduct 

the American Society for Testing and 

Materials International (ASTM) E1333– 

10 test or its equivalent on a 

representative sample of the finished 

cured resin product, demonstrating that 

formaldehyde emissions are less than or 

equal to 0.04 ppm. 

(C) Development and implementation 

of a written control plan that includes 

analysis of representative samples to 

ensure compliance with (a)(2)(i)(A) and 

(a)(2)(i)(B) of this section. 

(D) Manufacturing, processing, 

distribution, or use of the PMN 

substance only as described in the 

TSCA section 5(e) consent order. 

(E) Processing or distribution for 

processing only under the conditions 

described in the TSCA section 5(e) 

consent order and which are capable of 

irreversibly curing the PMN substance 

into a thermoset polymer matrix. 

(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. 

■ 13. Add § 721.10239 to subpart E to 

read as follows: 

§ 721.10239 Trivalent chromium 

complexes of a substituted beta-naphthol 

amine azo dye (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trivalent chromium 

complexes of a substituted betanaphthol amine azo dye (PMNs P–09– 

152 and P–09–153) are subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (acid dye 

for coloring anodized aluminum). Also, 

requirements as specified in 

§ 721.80(v)(1), (v)(2), (w)(1), (w)(2), 

(x)(1), and (x)(2), except that importing, 

processing, and use of the PMN 

substance in the form of a wet press 

cake containing greater than 30 percent 

water does not require submission of a 

SNUN. 

(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. 

■ 14. Add § 721.10240 to subpart E to 

read as follows: 


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§ 721.10240 Olefinic carbocycle, reaction 

products with alkoxysilane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as olefinic carbocycle, 

reaction products with alkoxysilane 

(PMN P–09–154) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10241 to subpart E to 

read as follows: 

§ 721.10241 Olefinic carbocycle, reaction 

products with alkoxysilane, sulfurized 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as olefinic carbocycle, 

reaction products with alkoxysilane, 

sulfurized (PMN P–09–155) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10242 to subpart E to 

read as follows: 

§ 721.10242 Olefinic carbocycle, reaction 

products with alkoxysilane, polysulfurized 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as olefinic carbocycle, 

reaction products with alkoxysilane, 

polysulfurized (PMN P–09–156) 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 § 721.10243 to subpart E to 

read as follows: 

§ 721.10243 Phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, bis(2- 

chloroethyl) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, bis(2- 

chloroethyl) ester (PMN P–09–193; CAS 

No. 55088–28–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) 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(j) (intermediate in 

the manufacture of a polyurethane flame 

retardant). 

(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. 

■ 18. Add § 721.10244 to subpart E to 

read as follows: 

§ 721.10244 Phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, 2-[bis(2- 

chloroethoxy)phosphinyl]ethyl 2- 

chloroethyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonic acid, P-[2-[bis(2- 

hydroxyethyl)amino]ethyl]-, 2-[bis(2- 

chloroethoxy)phosphinyl]ethyl 2- 

chloroethyl ester (PMN P–09–195; CAS 

No. 1094213–37–2) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (b) 

(concentration set at 0.1 percent), and 

(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (intermediate in 

the manufacture of a polyurethane flame 

retardant). 

(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. 

■ 19. Add § 721.10245 to subpart E to 

read as follows: 

§ 721.10245 Branched and linear fatty 

alcohol ethoxylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched and linear fatty 

alcohol ethoxylate (PMN P–09–207) 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) (site-limited, 

isolated, chemical intermediate). 

(ii) [Reserved] 


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(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. 

■ 20. Add § 721.10246 to subpart E to 

read as follows: 

§ 721.10246 Alkylpolyhydroxy polymer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylpolyhydroxy 

polymer (PMN P–09–234) 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. 

■ 21. Add § 721.10247 to subpart E to 

read as follows: 

§ 721.10247 Bis-phenoxyethanol fluorene 

diacrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as bis-phenoxyethanol 

fluorene diacrylate (PMN P–09–258) 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. 

■ 22. Add § 721.10248 to subpart E to 

read as follows: 

§ 721.10248 Aromatic bromide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic bromide (PMN 

P–09–259) 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) (synthetic 

intermediate). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 23. Add § 721.10249 to subpart E to 

read as follows: 

§ 721.10249 Disubstituted phenol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as disubstituted phenol 

(PMN P–09–316) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (g) and (s) (100 

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. 

■ 24. Add § 721.10250 to subpart E to 

read as follows: 

§ 721.10250 Zirconium lysine complex 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as zirconium lysine complex 

(PMN P–09–356) 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 = 120). 

(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 § 721.10251 to subpart E to 

read as follows: 

§ 721.10251 Fatty acids, reaction products 

with alkanolamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, reaction 

products with alkanolamine (PMN P– 

09–366) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) [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. 

■ 26. Add § 721.10252 to subpart E to 

read as follows: 


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§ 721.10252 Thiosulfuric acid (H2S2O3), 

manganese(2+) salt (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

thiosulfuric acid (H2S2O3), 

manganese(2+) salt (1:1) (PMN P–09– 

373; CAS No. 1033050–53–1) 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 = 400). 

(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. 

■ 27. Add § 721.10253 to subpart E to 

read as follows: 

§ 721.10253 Butanedioic acid, 2- 

methylene-, polymer with 2,5 furanedione, 

copper(2+) manganese(2+) sodium zinc 

salt, hydrogen peroxide-initiated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

butanedioic acid, 2-methylene-, polymer 

with 2,5 furanedione, copper(2+) 

manganese(2+) sodium zinc salt, 

hydrogen peroxide-initiated (PMN P– 

09–388; CAS No. 1134078–27–5) 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)(4), (b)(4), and 

(c)(4) (N = 34). 

(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. 

■ 28. Add § 721.10254 to subpart E to 

read as follows: 

§ 721.10254 Substituted acrylamide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted acrylamide 

(PMN P–09–390) 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 = 21). 

(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. 

■ 29. Add § 721.10255 to subpart E to 

read as follows: 

§ 721.10255 Vinyl carboxylic acid ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vinyl carboxylic acid ester 

(PMN P–09–400) 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) Release to water. Requirements as 

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

(c)(4) (N = 15). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 30. Add § 721.10256 to subpart E to 

read as follows: 

§ 721.10256 Benzoic acid, 4- 

(dimethylamino)-, 1,1′-[(methylimino)di-2,1- 

ethanediyl] ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzoic acid, 4-(dimethylamino)-, 1,1′- 

[(methylimino)di-2,l-ethanediyl] ester 

(PMN P–09–479; CAS No. 925246–00–0) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) 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. 

■ 31. Add § 721.10257 to subpart E to 

read as follows: 

§ 721.10257 Butyl aromatic bisurea 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as butyl aromatic bisurea 

(PMN P–09–532) 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. 

■ 32. Add § 721.10258 to subpart E to 

read as follows: 

§ 721.10258 Aromatic hydrocarbon 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic hydrocarbon 

(PMN P–09–535) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 


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61586 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 

(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. 

■ 33. Add § 721.10259 to subpart E to 

read as follows: 

§ 721.10259 Halogenated aromatic 

hydrocarbon (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated aromatic 

hydrocarbon (PMN P–09–540) 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. 

■ 34. Add § 721.10260 to subpart E to 

read as follows: 

§ 721.10260 Benzene, 1,3-bis(1-chloro-1- 

methylethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzene, 1,3-bis(1-chloro-1- 

methylethyl)- (PMN P–09–552; CAS No. 

37133–18–9) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90(a)(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. 

■ 35. Add § 721.10261 to subpart E to 

read as follows: 

§ 721.10261 Oxime, di-Me silane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxime, di-Me silane (PMN 

P–09–589) 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(s) (20,000 

kilograms). 

(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. 

■ 36. Add § 721.10262 to subpart E to 

read as follows: 

§ 721.10262 Oxime, Me vinyl silane 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxime, Me vinyl silane 

(PMN P–09–590) 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(s) (20,000 

kilograms). 

(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. 

■ 37. Add § 721.10263 to subpart E to 

read as follows: 

§ 721.10263 Phenol, 4-(1,1-dimethylethyl)- 

2-nitro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 4-(1,1-dimethylethyl)-2-nitro- 

(PMN P–09–634; CAS No. 3279–07–0) 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(j) (raw material 

(reactant) for production of intermediate 

for a photographic chemical). 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 38. Add § 721.10264 to subpart E to 

read as follows: 

§ 721.10264 Polycarbocyclic methacrylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polycarbocyclic 

methacrylate (PMN P–10–343) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 


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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Rules and Regulations 61587 

(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. 

[FR Doc. 2011–25497 Filed 10–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0053; FRL–8884–2] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

prothioconazole in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 5, 2011. Objections and 

requests for hearings must be received 

on or before December 5, 2011, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0053. 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., Confidential Business Information 

(CBI) 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 in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; e-mail 

address: maignan.tawanda@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide 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. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0053 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before December 5, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0053, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 29, 

2011 (76 FR 17375) (FRL–8867–4), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PPs 0F7714 and 

0F7715) by Bayer CropScience, P.O. Box 

12014, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.626 

be amended by establishing tolerances 

for residues of the fungicide 

prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl-2- 

hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione and its desthio 

metabolite, in or on the raw or 

processed agricultural commodity rice, 


jlentini on DSK4TPTVN1PROD with RULES