Vol. 77 Friday, 

No. 184 September 21, 2012 

Part IV 

Environmental Protection Agency 

40 CFR Parts 9 and 721 

Significant New Use Rules on Certain Chemical Substances; Final Rule 

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58666 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2011–0941; FRL–9357–2] 

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 

the Toxic Substances Control Act 

(TSCA) for 107 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Eight of 

these chemical substances are subject to 

TSCA consent orders issued by EPA. 

This action requires persons who intend 

to manufacture, import, or process any 

of these 107 chemical substances for an 

activity that is designated as a 

significant new use by this rule to notify 

EPA at least 90 days before commencing 

that activity. The required notification 

will provide EPA with the opportunity 

to evaluate the intended use and, if 

necessary, to prohibit or limit that 

activity before it occurs. 

DATES: This rule is effective on 

November 20, 2012. For purposes of 

judicial review, this rule shall be 

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

5, 2012. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before October 22, 2012 (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–2011–0941, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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–2011–0941. 

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– 

2011–0941. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online 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 email comment directly 

to EPA without going through 

regulations.gov, your email 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; email 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; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58667 

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 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 email. 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 

issue of April 24, 1990 (55 FR 17376) 

(April 24, 1990 SNUR). 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 

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

5(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 107 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 

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 

107 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). 

• 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. 

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58668 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

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 8 PMN substances 

(P–00–346, P–01–470, P–02–120, P–02– 

285, P–04–834, P–10–58, P–10–59, and 

P–10–60) 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 and the environment. 

Accordingly, these substances are 

subject to ‘‘risk-based’’ 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 so-called ‘‘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 section 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 SNUR 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, 

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. 

This rule also includes SNURs on 99 

PMN substances that are not subject to 

consent orders under TSCA section 5(e). 

In these cases, for a variety of reasons, 

EPA did not find that the use scenario 

described in the PMN triggered the 

determinations set forth under TSCA 

section 5(e). However, EPA does believe 

that certain changes from the use 

scenario described in the PMN could 

result in increased exposures, thereby 

constituting a ‘‘significant new use.’’ 

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

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

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

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–96–308 

Chemical name: Aminoalkanol 

(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 structureactivity relationship (SAR) analysis of 

the potential reaction of the PMN 

substance with nitrosating agents, and 

by analogy to monoethanolamine, 

diethanolamine and 

dimethylisopropylamine, EPA 

identified concerns for skin, eye, liver, 

kidney, lung, bone marrow, brain, 

testes, heart, and blood toxicity from 

exposure to the PMN substance via 

inhalation and dermal exposures, and 

the gastrointestinal (GI) tract. In 

addition, based on ecological structureactivity relationship (EcoSAR) analysis 

of test data on analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 600 ppb of the PMN 

substance in surface waters. For the use 

described in the PMN, EPA does not 

expect dermal or inhalation exposures 

to manufacturing or processing workers 

or other targeted populations, nor does 

it expect releases 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 other than as described in 

the PMN, or any use of the substance 

resulting in surface water 

concentrations exceeding 600 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a functional 

observational battery and 

histopathology; a prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); a fish 

acute toxicity test mitigated by humic 

acid (OPPTS Test Guideline 850.1085); 

an aquatic invertebrate acute toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help to characterize 

the human health and environmental 

effect of the PMN substance. 

CFR citation: 40 CFR 721.10427. 

PMN Numbers P–96–1021 and P–96– 

1022 

Chemical names: (P–96–1021) Fatty 

acids, C18-unsatd., dimers, reaction 

products with 1-piperazineethanamine 

and (P–96–1022) Fatty acids, C18- 

unsatd., dimers, reaction products with 

1-piperazineethanamine and tall-oil 

fatty acids. 

CAS numbers: (P–96–1021) 206565– 

90–4 and (P–96–1022) 206565–89–1. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as water based epoxy curing 

agents. Based on EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the PMN 

substances in surface waters. As 

described in the PMN, the substances 

are not released to surface waters. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the PMN 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

modified semi-continuous activated 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58669 

sludge (SCAS) test (OPPTS Test 

Guideline 835.3210); 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 (OCSPP Test Guideline 

850.4500) on PMN P–96–1022 would 

help characterize the environmental 

effects of the PMN substances. 

CFR citations: 40 CFR 721.10428 (P– 

96–1021) and 40 CFR 721.10429 (P–96– 

1022). 

PMN Number P–97–823 

Chemical name: Tetra alkyl 

ammonium salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a curing agent for 

coatings. Based on test data submitted 

on the PMN substance at varying 

concentrations, EPA identified concerns 

for ocular lethality for occupational 

exposures to the PMN substance at 

concentrations greater than 25 percent. 

For the use described in the PMN, 

significant worker exposures are not 

expected as the PMN substance is used 

at concentrations no greater than 25 

percent, and the material safety data 

sheet (MSDS) provides the ocular 

lethality results from the submitted eye 

irritation studies. 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 without 

including the hazard communication 

warnings concerning the eye irritation 

test results in the MSDS, or any use of 

the substance in concentrations greater 

than 25 percent may cause serious 

health effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of an acute 

eye irritation test (OPPTS Test 

Guideline 870.2400) on the PMN 

substance at concentrations greater than 

25 percent would help characterize 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10430. 

PMN Numbers P–98–141 and P–98–142 

Chemical name: Phosphoric acid 

esters (generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as metal extractants. Based on 

EcoSAR analysis of test data on 

analogous anionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

100 ppb of the PMN substance in 

surface waters. As described in the 

PMN, the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

PMN substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in surface water 

concentrations exceeding 100 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 (OCSPP Test 

Guideline 850.4500) on the PMN 

substances would help characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10431. 

PMN Number P–98–1028 

Chemical name: 1,2,4,5,7,8- 

Hexoxonane, 3,6,9-triethyl-3,6,9- 

trimethyl-. 

CAS number: 24748–23–0. 

Basis for action: The PMN states that 

the substance will be used as a viscosity 

modifier in the manufacture of 

polypropylene, manufactured and 

supplied as a solution in at least 40 

percent mineral spirits. Based on 

EcoSAR analysis of test data on 

analogous peroxides, EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the PMN substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, where the 

PMN substance is supplied as a solution 

of at least 40 percent mineral spirits, 

significant environmental releases are 

not expected. 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 

other than as a viscosity modifier, 

manufactured and supplied as a 

solution in at least 40 percent mineral 

spirits, in the manufacture of 

polypropylene 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 porous 

pot test (OPPTS Test Guideline 

835.3220); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10432. 

PMN Number P–99–184 

Chemical name: Cyclopentene, 

1,2,3,3,4,4,5,5-octafluoro-. 

CAS number: 559–40–0. 

Basis for action: The PMN states that 

the substance will be used as a dry 

etching agent and a chemical vapor 

deposition (CVD) agent for the 

production of semiconductors. Based on 

test data on the PMN substance, EPA 

identified concerns for acute toxicity, 

systemic toxicity, developmental 

toxicity, cardiac sensitization, and 

mutagenicity from inhalation exposures. 

As described in the PMN, the substance 

will be imported and not manufactured 

in the United States. As described in the 

PMN, EPA does not expect significant 

worker exposures during processing and 

use activities for the uses described in 

the PMN nor does it expect general 

population exposures for the uses 

described in the PMN. Therefore, EPA 

has not determined that the proposed 

processing or use may present an 

unreasonable risk. EPA has determined, 

however, that domestic manufacture, or 

any use of the substance other than as 

a dry etching agent and a CVD agent for 

the production of semiconductors may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(i). 

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2011–0941), would help 

characterize the human health effects of 

the PMN substance. 

CFR citations: 40 CFR 721.10433. 

PMN Number P–99–214 

Chemical name: Cyclopentane, 

1,1,2,2,3,3,4-heptafluoro-. 

CAS number: 15290–77–4. 

Basis for action: The PMN states that 

the substance will be used as a solvent 

and a cleaning and drying agent. Based 

on test data on the PMN substance, EPA 

identified concerns for acute, systemic, 

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and developmental toxicity, cardiac 

sensitization, and mutagenicity from 

inhalation exposures. As described in 

the PMN, the substance will be 

imported and not manufactured in the 

United States. As described in the PMN, 

EPA does not expect significant worker 

exposures during processing and use 

activities for the uses described in the 

PMN nor does it expect general 

population or consumer exposures for 

the uses described in the PMN. 

Therefore, EPA has not determined that 

the proposed processing or use may 

present an unreasonable risk. EPA has 

determined, however, that any domestic 

manufacture of the substance, use of the 

substance other than as a solvent or a 

cleaning and drying agent, or use in a 

consumer product may cause serious 

health effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2011–0941), would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10434. 

PMN Number P–99–1179 

Chemical name: Phenol, 2-(1-methyl1-phenylethyl)-4-(1,1,3,3- 

tetramethylbutyl)-. 

CAS number: 73936–80–8. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an ultraviolet (UV) 

stabilizer for automotive coatings. 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. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

1 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10435. 

PMN Numbers P–99–1217 and P–99– 

1218 

Chemical name: Amine neutralized 

phosphated polyesters (generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as pigment dispersants. Based on 

EcoSAR analysis of test data on 

analogous anionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur as a result of releases of the 

PMN substances in quantities greater 

than the combined 50,000 kilograms 

(kgs) per year production volume stated 

in the PMN. At the annual production 

volume of 50,000 kgs stated in the 

consolidated PMN, there were no 

significant environmental releases. 

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 exceeding an 

annual aggregate manufacturing and 

importation volume of 50,000 kgs 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 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 substances. 

CFR citation: 40 CFR 721.10436. 

PMN Numbers P–99–1280, P–99–1281, 

and P–99–1282 

Chemical name: Sulfonic acid, linear 

xylene alkylate, mono, sodium salts 

(generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as enhanced oil recovery 

surfactants. Based on EcoSAR analysis 

of test data on analogous anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

substances in surface waters for greater 

than 20 days per year. This 20-day 

criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substances to surface water, from uses 

other than as described in the PMNs, 

exceed releases from the use described 

in the PMNs. For the use described in 

the PMNs, environmental releases did 

not exceed 2 ppb more than 20 days per 

year. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the PMN 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances other than as 

enhanced oil recovery surfactants 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 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substances. 

CFR citation: 40 CFR 721.10437. 

PMN Number P–00–346 

Chemical name: Dialkyl 

hydroxybenzenealkanoic acid ester 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: August 16, 2001. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a petroleum additive. Based 

on test data on the PMN substance and 

SAR analysis of structurally similar 

substances, EPA identified concerns for 

liver and thyroid toxicity from dermal 

exposures. The consent order was 

issued under TSCA sections 

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

5(e)(1)(A)(ii)(II), based on a finding that 

this substance may present an 

unreasonable risk of injury to human 

health, the substance may be produced 

in substantial quantities, and there may 

be significant (or substantial) human 

exposure to the substance. To protect 

against these risks, the consent order 

requires: 

1. Use of personal protective 

equipment including impervious gloves 

(when there is potential dermal 

exposure). 

2. Establishment and use of a hazard 

communication program. 

3. Submission of certain human 

health testing prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

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Recommended testing: EPA has 

determined that the results of a 28-day 

dermal toxicity test (The Organisation 

for Economic Co-operation and 

Development (OECD) Test Guideline 

410) with emphasis on the thyroid (per 

OPPTS Test Guideline 870.3465) would 

help characterize the human health 

effects of the PMN substance. The PMN 

submitter has agreed not to exceed the 

confidential production volume limit 

specified in the consent order without 

performing this test. 

CFR citation: 40 CFR 721.10438. 

PMN Number P–00–635 

Chemical name: 1,3-Dioxolan-2-one, 

4-ethenyl. 

CAS number: 4427–96–7. 

Basis for action: The PMN states that 

the generic (non-confidential) uses of 

the substance will be as a chemical 

intermediate and an industrial chemical 

additive. Based on test data on the PMN 

substance and SAR analysis of test data 

on analogous vinylene carbonate, EPA 

predicts acute toxicity, liver toxicity, 

kidney toxicity, developmental toxicity, 

immunotoxicity, and oncogenicity. For 

the uses described in the PMN, 

significant dermal exposures are not 

expected due to the use of impervious 

gloves. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without the use 

of impervious gloves where there is a 

potential for dermal exposures, or any 

use other than as described in the PMN 

may cause serious human health effects. 

Based on this information the PMN 

substance meets the concern criteria at 

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

(b)(3)(ii). 

Recommended testing: EPA has 

determined that no additional testing is 

recommended at this time as the health 

effects have been adequately 

characterized by the testing submitted 

on the PMN substance. 

CFR citation: 40 CFR 721.10439. 

PMN Number P–00–1165 

Chemical name: Diphosphoric acid, 

polymers with ethoxylated reduced Me 

esters of reduced polymd, oxidized 

tetrafluoroethylene. 

CAS number: 200013–65–6. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a surface active 

agent. Based on analogous high 

molecular weight polymers, EPA 

identified concerns from inhalation 

exposures. For the industrial uses 

described in the PMN, worker 

inhalation exposures are not expected as 

the substance is not applied by a 

method that generates a vapor, mist, or 

spray. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance in consumer products, or 

any use involving an application 

method that generates a vapor, mist, or 

spray may cause serious health effects. 

Based on the information, the PMN 

substance meets the criteria at 

721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

inhalation toxicity test (OPPTS Test 

Guideline 870.1300) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10440. 

PMN Numbers P–01–382 and P–01–383 

Chemical names: (P–01–382) 1, 2- 

Benzenedicarboxylic acid, di-C7–14- 

branched and linear alkyl esters and (P– 

01–383) 1,2-Benzenedicarboxylic acid, 

di-C6–14-branched and linear alkyl 

esters. 

CAS numbers: (P–01–382) 309934– 

68–7 and (P–01–383) 309934–69–8. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as plasticizers for flexible polyvinyl chloride. Based on SAR analysis 

of the expected ester hydrolysis product 

of the PMNs, EPA identified concerns 

for liver, developmental, and 

reproductive toxicity; and oncogenicity. 

For the use described in the PMNs, 

neither significant worker exposures nor 

general population exposures are 

expected. 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 in children’s 

toys (e.g., pacifiers, rattles, and teethers) 

may cause serious health effects. Based 

on this information, the PMN 

substances meet the criteria at 

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

Recommended testing: EPA has 

determined that the results of an acute 

oral toxicity test (OECD Test Guideline 

401 or 420); an acute dermal toxicity 

test (OECD Test Guideline 402); an 

acute inhalation toxicity test (OECD 

Test Guideline 403); a repeated dose 28- 

day oral toxicity test in rodents (OECD 

Test Guideline 407); a 28-day dermal 

toxicity test (OECD Test Guideline 410); 

a 28-day subacute inhalation toxicity 

test (OECD Test Guideline 412); a 

prenatal developmental toxicity test 

(OECD Test Guideline 414); a 1- 

generation reproduction test (OECD Test 

Guideline 415); a reproduction and 

fertility effects test (OECD Test 

Guideline 416); a reproduction/ 

development toxicity screening test 

(OECD Test Guideline 421); a combined 

repeated dose toxicity test with the 

reproduction/development toxicity 

screening test (OECD Test Guideline 

422); a bacterial reverse mutation test 

(OECD Test Guideline 471); an in vitro 

mammalian chromosome aberration test 

(OECD Test Guideline 473); a 

mammalian erythrocyte micronucleus 

test (OECD Test Guideline 474); and a 

mammalian bone marrow chromosomal 

aberration test (OECD Test Guideline 

475) would help characterize the human 

health effects of the PMN substances. 

CFR citations: 40 CFR 721.10441 (P– 

01–382) and 40 CFR 721.10442 (P–01– 

383). 

PMN Number P–01–470 

Chemical name: Ethoxylated 

alkylphenol sulfate, ammonium salt 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: August 26, 2002. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a dispersant 

for carbon black and organic pigments. 

Based on test data on the PMN 

substance, and EcoSAR analysis of test 

data on analogous ethoxylated anionic 

surfactants, EPA predicts environmental 

toxicity that varies depending on the 

average number of moles of ethoxylate. 

As the number of ethoxylate decreases, 

the aquatic toxicity of the substance 

increases. For this PMN substance, the 

average number of moles may vary. 

Based on submitted test data on the 

PMN—with an average number of 16.4 

moles of ethoxylate—EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 200 ppb of 

the PMN substance in surface waters. 

When the average number of moles of 

ethoxylate is less than or equal to 10, 

EPA expects toxicity to aquatic 

organisms may occur at concentrations 

that exceed 60 ppb of the substance in 

surface waters. The consent order was 

issued under TSCA sections 

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

5(e)(1)(A)(ii)(II), based on a finding that 

the substance may present an 

unreasonable risk of injury to the 

environment, may be produced in 

substantial quantities, and may be 

reasonably anticipated to enter the 

environment in substantial quantities. 

To protect against these risks, the 

consent order prohibits the company 

from manufacturing or importing the 

PMN substance unless either: The mean 

number of moles of the ethoxy group is 

greater than or equal to 10, or the 

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average number molecular weight is 

greater than 950 daltons. The SNUR 

designates as a ‘‘significant new use’’ 

the absence of these protective 

measures. 

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 (OCSPP Test 

Guideline 850.4500) would help 

characterize environmental effects of the 

PMN substance. Testing should be 

conducted on the PMN substance with 

less than 10 moles of ethoxylate, or an 

average number molecular weight of 

less than 950 daltons. The consent order 

does not require the submission of the 

aforementioned testing at any specified 

time or production volume. However, 

the order’s restrictions on manufacture, 

import, processing, distribution in 

commerce, use, and disposal of the 

PMN will remain in effect until the 

consent order is modified or revoked by 

EPA based on submission of that or 

other relevant information. 

CFR citation: 40 CFR 721.10443. 

PMN Number P–01–499 and P–01–500 

Chemical name: (P–01–499) Propanol, 

mercapto- and (P–01–500) 2-Propen-1- 

ol, reaction products with hydrogen 

sulfide, distn. residues. 

CAS number: (P–01–499) 63947–56–8 

and (P–01–500) 374078–75–8. 

Basis for action: The PMNs state that 

the substances will be used as chemical 

intermediates. Based on SAR analysis of 

test data on structurally similar 3- 

mercaptopropanol, EPA identified 

concerns for developmental and 

maternal effects from dermal exposures 

to the PMN substances. In addition, 

based on test data on P–01–499 and 

EcoSAR analysis of analogous thiols, 

EPA predicts toxicity to aquatic 

organisms may occur at surface water 

concentrations that exceed 11 ppb for 

P–01–499 and 1 ppb for P–01–500. For 

the chemical intermediate use described 

in the PMNs, significant worker 

exposures are not expected due to the 

use of impervious dermal protection, 

and the substances are not released to 

surface water. 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 without 

impervious dermal protection where 

there is a potential for dermal 

exposures, or any use of the substances 

resulting in surface water 

concentrations exceeding 11 ppb (P–01– 

499) or 1 ppb (P–01–500) may cause 

serious health effects and significant 

adverse environmental effects. Based on 

this information, the PMN substances 

meet the concern criteria at 

§ 721.170(b)(3)(ii), (b)(4)(i), and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010) on P–01–500 

would help to characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10444 (P– 

01–499) and 40 CFR 721.10445 (P–01– 

500). 

PMN Number P–01–762 

Chemical name: 1,9- 

Cyclohexadecadiene. 

CAS number: 4277–06–9. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as open, nondispersive use with limited employee 

exposure. Based on test data on the 

PMN substance, EPA identified 

concerns for dermal sensitization and 

irritation. In addition, based on test data 

on the PMN substance and EcoSAR 

analysis of test data on analogous 

neutral organic chemicals, 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 

dermal exposures are not expected due 

to the use of impervious gloves, and 

releases of the substance to surface 

waters are not expected in 

concentrations that exceed 1 ppb. 

Therefore, EPA has not determined that 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that use of the substance 

without impervious protective 

equipment where there is a potential for 

dermal exposures, or any use of the 

substance resulting in surface water 

concentrations exceeding 1 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria in § 721.170(b)(3)(i), (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); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10446. 

PMN Number P–01–829 

Chemical name: 17- 

Oxabicyclo[14.1.0]heptadec-8-ene. 

CAS number: 34748–97–5. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as open, nondispersive with limited employee 

exposure. Based on test data on the 

PMN substance, EPA identified 

concerns for dermal sensitization, 

respiratory sensitization, mutagenicity, 

developmental toxicity, male 

reproductive toxicity, liver toxicity, and 

kidney toxicity. In addition, based on 

test data on the PMN substance and 

EcoSAR analysis of test data on 

analogous epoxides, EPA predicts 

toxicity to aquatic organisms at 

concentrations that exceed 1 ppb of the 

substance in surface waters. As 

described in the PMN, significant 

exposures are not expected due to the 

use of protective dermal and respiratory 

equipment, and the substance is not 

released to surface waters in 

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 without impervious 

dermal and adequate respiratory 

protection where there is a potential for 

exposures, or any use of the substance 

resulting in surface water 

concentrations exceeding 1 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(i), (b)(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); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10447. 

PMN Number P–02–120 

Chemical name: Acetic acid, 

hydroxymethoxy-, methyl ester, reaction 

products with substituted alkylamine 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: September 12, 2003. 

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Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as an emulsifier. Based on 

EcoSAR analysis of test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur when the average number 

molecular weight is below 850 daltons. 

The order was issued under TSCA 

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

5(e)(1)(A)(ii)(II), based on a finding that 

this substance may reasonably be 

anticipated to enter the environment in 

substantial quantities and may present 

an unreasonable risk of injury to the 

environment. The consent order for this 

substance prohibits manufacturing or 

importing of the PMN substance unless 

the average number molecular weight is 

greater than or equal to 850 daltons. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

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 (OCSPP Test 

Guideline 850.4500), on the PMN 

substance where the average number 

molecular weight is less than 850 

daltons would help characterize 

possible environmental effects of the 

substance. The order does not require 

submission of the aforementioned 

information at any specified time or 

production volume. However, the 

order’s restrictions on manufacture, 

import, processing, distribution in 

commerce, use, and disposal of the 

PMN substance will remain in effect 

until the order is modified or revoked 

by EPA based on submission of that or 

other relevant information. 

CFR citation: 40 CFR 721.10448. 

PMN Number P–02–172 

Chemical name: Aromatic polyester 

polyol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive 

component. Based on EcoSAR analysis 

of test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

40 ppb of the PMN substance in surface 

waters. As described in the PMN, EPA 

does not expect releases to surface 

waters to exceed 40 ppb. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has, however, determined that 

any use of the substance resulting in 

surface water concentrations exceeding 

40 ppb may cause significant adverse 

environmental effects. Based on this 

information, the 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10449. 

PMN Number P–02–285 

Chemical name: Oxirane, 2-[[3- 

(trimethoxysilyl)propoxy]methyl]-, 

reaction products with wollastonite 

(Ca(SiO3)). 

CAS number: 100402–91–3. 

Effective date of TSCA section 5(e) 

consent order: October 14, 2002. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as functional 

filler for polymer systems. Based on 

SAR analysis of analogous respirable, 

poorly soluble particulates, EPA 

identified concerns for lung toxicity 

based on lung overload, and concern for 

carcinogenicity based on test data on the 

starting raw material—wollastonite. The 

consent order was issued under TSCA 

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

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health. To protect 

against this exposure and risk, the 

consent order requires the company to 

manufacture and process the PMN 

substance with an average aspect ratio 

of no greater than 5, and no more than 

15 percent of the PMN substance shall 

have an aspect ratio greater than 10. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Recommended testing: EPA had 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60-day 

holding period and a carcinogenicity 

test (OPPTS Test Guideline 870.4200) 

would help characterize the human 

health effects of the PMN substance. 

These tests should be conducted on the 

PMN substance with an average aspect 

ratio of greater than 5, and more than 15 

percent of the PMN substance with an 

aspect ratio of greater than 10. The order 

does not require submission of the 

aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10450. 

PMN Number P–02–436 

Chemical name: Alkyd amide polyol 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate for polyurethane polymers. 

Based on EcoSAR analysis of test data 

on analogous nonionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

3 ppb of the PMN substance in surface 

waters. As described in the PMN, 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 

surface water concentrations exceeding 

3 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10451. 

PMN Number P–02–659 

Chemical name: 9-Octadecenoic acid 

(9Z)-, 1,1′-(dimethylstannylene) ester. 

CAS number: 3865–34–7. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a catalyst. Based on 

EcoSAR analysis of test data on 

analogous nonionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

10 ppb of the 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 

surface water concentrations exceeding 

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10 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10452. 

PMN Number P–02–796 

Chemical name: Polyglycerin alkyl 

ether (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a lubricant 

additive. Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous nonionic surfactants, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 3 ppb of the substance in 

surface waters for greater than 20 days 

per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the PMN substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 3 

ppb more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as described in 

the PMN may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10453. 

PMN Number P–02–828 

Chemical name: Propoxylated 

ethoxylated alkylamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a concrete 

admixture. Based on EcoSAR analysis of 

analogous cationic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

80 ppb of the PMN substance in surface 

waters. As described in the PMN, the 

substance is not released to surface 

waters in concentrations that exceed 80 

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 80 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 test (OPPTS Test 

Guideline 835.3110); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10454. 

PMN Number P–03–61 

Chemical name: Oxirane, 2,2′,2′′- 

[ethylidynetris(4,1- 

phenyleneoxymethylene)]tris-. 

CAS number: 87093–13–8. 

Basis for action: The PMN states that 

the substance will be used as a highdensity cross-linked polymer in resins, 

composites, and adhesives. Based on 

test data on the PMN substance and 

SAR analysis of test data on analogous 

epoxides, EPA identified concerns for 

cancer, reproductive toxicity in males, 

developmental toxicity, and 

sensitization to lungs from worker and 

consumer inhalation exposures. As 

described in the PMN, significant 

occupational and consumer inhalation 

exposures are not expected, as the 

substance is not spray applied. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance involving an application 

method that generates a mist, vapor, or 

aerosol may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

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

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) in rats would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10455. 

PMN Number P–03–104 

Chemical name: Tristyryl phenol 

alkoxylate salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an agricultural 

inert. Based on EcoSAR analysis of test 

data on analogous cationic and anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

substance in surface waters for greater 

than 20 days per year. This 20-day 

criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, environmental releases did not 

exceed 2 ppb more than 20 days per 

year. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as described in 

the PMN may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10456. 

PMN Number P–03–154 

Chemical name: 1,2- 

Benzenedicarboxylic acid, mixed esters 

with benzyl alc., cyclohexanol, 2-ethyl1-hexanol, fumaric acid and propylene 

glycol. 

CAS number: 464920–01–2. 

Basis for action: The PMN states that 

the substance will be used as a 

monomer combined with styrene and 

unsaturated polyester resins. Based on 

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EcoSAR analysis of test data on 

analogous acrylates and esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the 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 to the 

environment. 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 ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10457. 

PMN Number P–03–238 

Chemical name: Acrylate of 

hydroxyimide (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be in adhesives. Based on 

test data on the PMN substance and 

SAR analysis of test data on analogous 

acrylates, EPA identified concerns for 

developmental toxicity and 

sensitization from inhalation exposure 

to the PMN substance. In addition, 

based on EcoSAR analysis of test data 

on analogous acrylates, EPA expects 

toxicity to aquatic organisms may occur 

at concentrations that exceed 20 ppb of 

the PMN substance in surface waters. As 

described in the PMN, significant 

worker exposures are not expected as 

the substance is used in the liquid form, 

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 manufacturing, processing, or use of 

the substance in a solid form, or any use 

resulting in surface water 

concentrations exceeding 20 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700) in rats; 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 (OCSPP Test Guideline 

850.4500) would help to characterize 

the human health and environmental 

effects of the substance. 

CFR citation: 40 CFR 721.10458. 

PMN Number P–03–282 

Chemical name: Amino-substituted 

carbopolycycle (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 SAR analysis of test data 

on analogous alpha-naphthylamine, 

aniline, aromatic amine, and 

naphthalene, EPA identified concerns 

for mutagenicity, oncogenicity, 

sensitization, developmental toxicity, 

blood effects, neurotoxicity, liver 

effects, and cancer to workers exposed 

to the PMN substance. As described in 

the PMN, significant worker exposures 

are not expected due to the use of 

adequate personal protective 

equipment. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without the use 

of impervious gloves where there is 

potential for dermal exposure, use of the 

substance without the use of a National 

Institute for Occupational Safety and 

Health (NIOSH)-certified respirator with 

an assigned protection factor (APF) of at 

least 50 where there is potential 

inhalation exposure, domestic 

manufacture, or use of the substance 

other than as described in the PMN may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

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

(b)(3)(ii). 

Recommended testing: EPA has 

determined that inhalation monitoring 

data, collected according to the EPA 

draft Inhalation Monitoring Data 

Collection Guidelines (located in the 

docket under docket ID number EPA– 

HQ–OPPT–2011–0941), would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10459. 

PMN Number P–03–307 

Chemical name: Azo nickel complex 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a colorant. EPA 

identified concerns for oncogenicity, 

pulmonary sensitization, 

immunotoxicity, developmental 

toxicity, and neurotoxicity for released 

nickel. In addition, test data for nickel 

sulfate hexahydrate has shown effects 

on the brain, kidney, liver, testes, 

thymus, and spleen. For the use 

described in the PMN, worker 

inhalation exposures from the liquid 

form of the PMN are not expected. 

Therefore, EPA has not determined that 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

other than as described in the PMN, or 

any use of the substance as a powder, 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a reproduction and 

fertility effects test (OPPTS Test 

Guideline 870.3800); and a 

carcinogenicity study (OPPTS Test 

Guideline 870.4200) would help to 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10460. 

PMN Number P–03–325 

Chemical name: Oxazolidine, 3,3′- 

methylenebis[5-methyl-. 

CAS number: 66204–44–2. 

Basis for action: The PMN states that 

the substance will be used as a 

metalworking fluid. Based on test data 

on the PMN substance, EPA identified 

concerns for systemic toxicity and 

severe skin and eye irritation. In 

addition, based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at surface water 

concentrations that exceed 40 ppb of the 

substance in saltwater, and 100 ppb of 

the substance in freshwater. For the use 

described in the PMN, worker exposures 

are not expected as the substance is 

used in an enclosed system, and the 

substance is not released to surface 

waters. Therefore, EPA has not 

determined that manufacturing, 

processing, and use of the substance 

may present an unreasonable risk. EPA 

has determined, however, that use of the 

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substance other than as a metalworking 

fluid, or any use of the substance 

resulting in surface water 

concentrations exceeding the freshwater 

and saltwater concentrations of concern 

may cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the no additional 

testing is recommended at this time as 

the human health and environmental 

effects have been adequately 

characterized by the testing submitted 

on the PMN substance. 

CFR citation: 40 CFR 721.10461. 

PMN Number P–03–354 

Chemical name: 1-Penten-3-one, 1-(4- 

chlorophenyl)-4,4-dimethyl-. 

CAS number: 1577–03–3. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate. Based on EcoSAR analysis 

of test data on analogous vinyl ketones, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 30 ppb of the substance in 

surface waters. For the use described in 

the PMN, EPA does not expect releases 

of the substance to surface waters in 

concentrations that exceed 30 ppb. 

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 any use of the 

substance other than as an intermediate, 

or any use of the substance resulting in 

surface water concentrations exceeding 

30 ppb may cause significant adverse 

environmental effects. Based on this 

information, the substance meets the 

concern criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a porous 

pot test (OPPTS Test Guideline 

835.3220); a fish early life-stage toxicity 

test (OPPTS Test Guideline 850.1400); a 

daphnid chronic toxicity test (OPPTS 

Test Guideline 850.1300); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10462. 

PMN Number P–03–388 

Chemical name: Fatty acid amides 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a paint and coating 

additive. Based on EcoSAR analysis of 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 1 ppb of the substance in 

surface waters for greater than 20 days 

per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the PMN substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 1 

ppb more than 20 days per year. 

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 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 (OCSPP Test 

Guideline 850.4500) would help to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10463. 

PMN Number P–03–461 

Chemical name: Fatty acid, reaction 

products with alkanolamine (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a petroleum 

additive. Based on EcoSAR analysis of 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 6 ppb of the substance in 

surface waters for greater than 20 days 

per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the PMN substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 6 

ppb more than 20 days per year. 

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 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10464. 

PMN Numbers P–03–561, P–03–563, P– 

03–564, P–03–565, and P–03–566 

Chemical names: (P–03–561) 2- 

Propenoic acid, 2-methyl-, 3- 

hydroxytricyclo[3.3.1.13,7]dec-1-yl 

ester; (P–03–563) 2-Propenoic acid, 2- 

methyl-, 2-ethyltricyclo[3.3.1.13,7]dec2-yl ester; (P–03–564) 2-Propenoic acid, 

3-hydroxytricyclo [3.3.1.13,7] dec-1-yl 

ester; (P–03–565) 2-Propenoic acid, 2- 

methyltricyclo[3.3.1.13,7]dec-2-yl ester; 

and (P–03–566) 2-Propenoic acid, 2- 

ethyltricyclo[3.3.1.13,7]dec-2-yl ester. 

CAS numbers: (P–03–561) 115372– 

36–6; (P–03–563) 209982–56–9; (P–03– 

564) 216581–76–9; (P–03–565) 249562– 

06–9; and (P–03–566) 303186–14–3. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as monomers. Based on test data on 

the PMN substances and SAR analysis 

of test data on analogous acrylates and 

methacrylates, EPA identified concerns 

for systemic toxicity and pulmonary 

sensitization. In addition, based on 

EcoSAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 3 ppb of 

the PMN substances in surface waters. 

For the uses described in the PMN, 

significant worker exposures are not 

expected due to the use of impervious 

gloves, protective clothing, eye 

protection, and adequate warnings in 

the MSDS; and the substance is 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 use of the substance 

without worker protection where there 

is a potential for dermal or inhalation 

exposure, or any use of the substance 

resulting in surface water 

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concentrations exceeding 3 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information the 

PMN substances meet 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 fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity test 

mitigated by humic acid (OPPTS Test 

Guideline 850.1085); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help to characterize 

the environmental effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10465 (P– 

03–561); 40 CFR 721.10466; (P–03–563); 

40 CFR 721.10467 (P–03–564); 40 CFR 

721.10468 (P–03–565); and 40 CFR 

721.10469 (P–03–566). 

PMN Number P–03–567 

Chemical name: Phosphonium, 

tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro1-butanesulfonate (1:1). 

CAS number: 220689–12–3. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymer additive. 

Based on test data on the PMN 

substance, EPA identified concerns for 

systemic toxicity and neurotoxicity from 

inhalation exposures. In addition, EPA 

identified concern for potential 

degradation products, byproducts, 

unreacted material, and low molecular 

weight species. The PMN substance is a 

derivative of perfluorobutanesulfonate 

(PFBS) and may degrade to form PFBS. 

Further, concerns for the substance are 

based on analogous 

perfluorooctanesulfonate (PFOS). For 

the use described in the PMN, 

significant exposures and 

environmental releases are not 

expected. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as described in 

the PMN may cause serious health 

effects 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)(iii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465); a 2 generation 

reproduction and fertility effects test 

(OPPTS Test Guideline 870.3200); a 

porous pot test (OPPTS Test Guideline 

835.3220); and a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10470. 

PMN Number P–03–622 

Chemical name: 2-Propenoic acid, 

1,1′-(3-methyl-1,5-pentanediyl) ester. 

CAS number: 64194–22–5. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a component of a 

UV coating agent. Based on SAR 

analysis of test data on analogous 

acrylates, EPA identified concerns for 

carcinogenicity and sensitization. In 

addition, based on EcoSAR analysis of 

test data on analogous acrylates, EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface waters, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. As described in the PMN, 

the substance will be imported and not 

manufactured in the United States. For 

the use described in the PMN, 

significant worker exposures are not 

expected during processing and use 

activities for the uses described in the 

PMN, and significant environmental 

releases are not expected. Therefore, 

EPA has not determined that the 

proposed processing or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

domestic manufacture or use of the 

substance other than as described in the 

PMN may cause serious health effects 

and significant adverse environmental 

effects. Based on this information the 

PMN substance meets the concern 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

carcinogenicity test (OPPTS Test 

Guideline 870.4200); 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 (OCSPP Test Guideline 

850.4500) would help to characterize 

the human health and environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10471. 

PMN Number P–03–645 

Chemical name: 1,3- 

Benzenedimethanamine, polymers with 

epichlorohydrin-polyethylene glycol 

reaction products. 

CAS number: 652968–34–8. 

Basis for action: The PMN states that 

the substance will be used as a water 

retention aid for ornamental plants. 

Based on analogous swellable, high 

molecular weight polymers, EPA 

identified concerns for lung toxicity and 

cancer. As described in the PMN, the 

substance will be imported and not 

manufactured in the United States. For 

the use described in the PMN, 

significant worker exposures are not 

expected during processing and use 

activities for the uses described in the 

PMN. Therefore, EPA has not 

determined that the proposed 

processing or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any domestic 

manufacture of the PMN substance may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with a 60-day 

holding period, and a teabag test for 

water retention capacity (see http:// 

www.epa.gov/oppt/newchems/pubs/ 

teabag.pdf) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10472. 

PMN Number P–03–865 

Chemical name: 1-Propanaminium, 3- 

amino-N-(2-carboxyethyl)-N,Ndimethyl-, N-coco acyl derivs., inner 

salts. 

CAS number: 499781–63–4. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a non-corrosive 

foamer in the oil and gas industry. 

Based on test data on the PMN 

substance, and EcoSAR analysis of test 

data on analogous amphoteric and 

cationic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 85 ppb of 

the PMN substance in surface waters. As 

described in the PMN, EPA does not 

expect releases of the substance to 

surface waters in concentrations that 

exceed 85 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 

85 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 

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acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10473. 

PMN Number P–04–107 

Chemical name: Substituted amino 

ethane sulfonic acid salt (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be a contained use in 

digital and imaging products. Based on 

EcoSAR analysis of test data on 

analogous anionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

4 ppb of the substance in surface waters 

for greater than 20 days per year. This 

20-day criterion is derived from partial 

life cycle tests (daphnid chronic and 

fish early life stage tests) that typically 

range from 21 to 28 days in duration. 

EPA predicts toxicity to aquatic 

organisms may occur if releases of the 

PMN substance to surface water, from 

uses other than as described in the 

PMN, exceed releases from the use 

described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 4 ppb more than 

20 days per year. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

described in the PMN may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10474. 

PMN Number P–04–118 

Chemical name: Hexanedioic acid, 

compd. with N1-(6-aminohexyl)-N1- 

methyl-1,6-hexanediamine (1:1). 

CAS number: 659733–29–6. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate for polymer manufacture. 

Based on SAR analysis of test data on 

analogous hexamethyl diamine, EPA 

identified concerns for immunotoxicity, 

systemic toxicity, developmental 

toxicity, and reproductive toxicity. 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 20 ppb of the PMN 

substance in surface waters. As 

described in the PMN, EPA does not 

expect significant worker exposures or 

releases of the substance to surface 

waters in concentrations that exceed 20 

ppb. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as intermediate 

for polymer manufacture, or any use of 

the substance resulting in surface water 

concentrations exceeding 20 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700); a reproduction and 

fertility effects test (OPPTS Test 

Guideline 870.3800); an immunotoxicity 

test (OPPTS Test Guideline 870.7800); 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. 

CFR citation: 40 CFR 721.10475. 

PMN Number P–04–275 

Chemical name: Oxetane, 3- 

(bromomethyl)-3-methyl-. 

CAS number: 78385–26–9. 

Basis for action: The PMN substance 

will be used as a chemical intermediate. 

Based on SAR analysis of test data on 

analogous chemical substances EPA 

identified concerns for cancer for the 

PMN material from dermal exposures. 

For the use described in the PMN, 

significant worker exposures are 

unlikely due to the use of impervious 

clothing. Therefore, EPA has not 

determined that manufacturing, 

processing, and use of the substance 

may present an unreasonable risk. EPA 

has determined, however, any use of the 

substance without impervious clothing 

where there is a potential for dermal 

exposures, or any use of the substance 

other than as an intermediate for the 

pharmaceutical, photographic, and 

other fine chemical industries may 

cause serious health effects. Based on 

this information the PMN substance 

meets the concern criteria at 

§ 721.170(b)(1)(i)(C). 

Recommended testing: EPA has 

determined that an in vivo micronucleus 

assay in erythrocytes (OPPTS Test 

Guideline 870.5395 or OECD Test 

Guideline 474), with exposure by the 

intraperitoneal route, would help to 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10476. 

PMN Number P–04–290 

Chemical name: Acrylate 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 in 

radiation cured inks and coatings. Based 

on EcoSAR analysis of test data on 

analogous acrylates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, environmental releases did not 

exceed 1 ppb more than 20 days per 

year. Therefore, EPA had not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as 

described in the PMN may cause 

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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10477. 

PMN Number P–04–318 

Chemical name: Polyether polyol 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate for urethane polymers. 

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Based on SAR analysis of test data on 

similar molecular structure chemicals, 

EPA identified concerns for 

developmental kidney and liver 

toxicity. In addition, based on EcoSAR 

analysis of test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 30 ppb of 

the substance in surface waters. For the 

use described in the PMN, significant 

worker exposures are not expected 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 use of the substance other than as 

an intermediate for urethane polymers, 

or any use of the substance resulting in 

surface water concentrations exceeding 

30 ppb may cause serious health effects 

and significant environmental effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii) and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

oral toxicity test (OPPTS Test Guideline 

870.1100 or OECD Test Guideline 425); 

a bacterial reverse mutation test (OPPTS 

Test Guideline 870.5100); a mammalian 

erythrocyte micronucleus test 

(intraperitoneal route) (OPPTS Test 

Guideline 870.5395); a repeated dose 

28-day oral toxicity in rodents (OPPTS 

Test Guideline 870.3050 or OECD Test 

Guideline 407), which should include, 

for all test doses, a neurotoxicity 

functional observational battery, as 

described in neurotoxicity screening 

battery test (OPPTS Test Guideline 

870.6200); a prenatal developmental 

toxicity test (one species, oral route) 

(OPPTS Test Guideline 870.3700); a 

Zahn-Wellens/EMPA test (OPPTS Test 

Guideline 835.3200); an aerobic aquatic 

biodegredation test (OPPTS Test 

Guideline 835.3100); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

human health, environmental and fate 

effects for PMN substance. 

CFR citation: 40 CFR 721.10478. 

PMN Number P–04–335 

Chemical name: Quaternary 

ammonium compounds, 

tris(hydrogenated tallow alkyl)methyl, 

chlorides. 

CAS number: 308074–73–9. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a rheology additive. 

Based on EcoSAR analysis of test data 

on analogous dialkyl cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

substance in surface waters for greater 

than 20 days per year. This 20-day 

criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, environmental releases did not 

exceed 1 ppb more than 20 days per 

year. 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 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10479. 

PMN Number P–04–384 

Chemical name: Trimethylolpropane 

polyol, aminated (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a resin curing 

agent. Based on EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 9 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing and processing of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

9 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); a fish 

acute toxicity test mitigated by humic 

acid (OPPTS Test Guideline 850.1085); 

an aquatic invertebrate acute toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10480. 

PMN Numbers P–04–429, P–04–430, P– 

04–431, and P–04–432 

Chemical names: (P–04–429) 

Siloxanes and Silicones, Me vinyl, 

hydroxy-terminated, reaction products 

with silica; (P–04–430) Siloxanes and 

Silicones, di-Me, Me vinyl, hydroxyterminated, reaction products with 

silica; (P–04–431) Siloxanes and 

Silicones, di-Me, Me vinyl, hydroxyterminated, reaction products with 

[(ethenyldimethylsilyl)oxy]-modified 

silica; and (P–04–432) Siloxanes and 

Silicones, Me vinyl, hydroxyterminated, reaction products with 

[(ethenyldimethylsilyl)oxy]-modified 

silica. 

CAS numbers: (P–04–429) 630106– 

01–3; (P–04–430) 630106–00–2; (P–01– 

431) 630106–04–6; and (P–04–432) 

630106–02–4. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as chemical fillers. Based on high 

molecular weight polymers, EPA 

identified concerns for lung overload. 

Further, based on analogy to respirable, 

poorly soluble particulates, under the 

subcategory of crystalline silica, EPA 

identified concerns for lung toxicity and 

cancer. For the use described in the 

PMN, significant worker inhalation 

exposures are not expected as the 

substance is used in a liquid form. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, and use of the substances 

may present an unreasonable risk. EPA 

has determined, however, that any use 

of the substances in a powder form may 

cause serious health effects. Based on 

this information, the PMN substances 

meet the concern criteria at 

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

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) in rats with special attention 

to histopathology (inflammation and 

cell proliferation) of the lung tissues and 

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to various parameters of the 

bronchoalveolar lavage fluid (BALF) 

with a recovery period of 60 days; and 

a carcinogenicity test (OPPTS Test 

Guideline 870.4200) in rats would help 

characterize the human health effects of 

the PMN substance. 

CFR citations: 40 CFR 721.10481 (P– 

04–429); 40 CFR 721.10482 (P–04–430); 

40 CFR 721.10483 (P–01–431); and 40 

CFR 721.10484 (P–04–432). 

PMN Number P–04–479 

Chemical name: Reaction products of 

alcohols, alkyl alcohols, amino alcohols 

and methanol sodium salts (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a cleaning agent. 

Based on EcoSAR analysis of test data 

on analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

30 ppb of the substance in surface 

waters for greater than 20 days per year. 

This 20-day criterion is derived from 

partial life cycle tests (daphnid chronic 

and fish early life stage tests) that 

typically range from 21 to 28 days in 

duration. EPA predicts toxicity to 

aquatic organisms may occur if releases 

of the PMN substance to surface water, 

from uses other than as described in the 

PMN, exceed releases from the use 

described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 30 ppb more 

than 20 days per year. 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 may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS 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. 

CFR citation: 40 CFR 721.10485. 

PMN Number P–04–591 

Chemical name: Alkyl substituted 

amino-benzamide (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

acetaldehyde scavenger for plastic bottle 

production. Based on EcoSAR analysis 

of test data on analogous anilines, EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface waters, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, significant environmental releases 

are not expected. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the substance other than as an 

acetaldehyde scavenger for plastic bottle 

production could result in exposures 

which may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria as 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10486. 

PMN Numbers P–04–599, P–04–600, P– 

04–605, and P–04–606 

Chemical name: Alkylbenzenes 

sulfonic acids, metal salts (generic). 

CAS number: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as metalworking 

detergents. Based on EcoSAR analysis of 

test data on analogous anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 60 ppb of the 

substances in surface waters for greater 

than 20 days per year. This 20-day 

criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substances to surface water, from uses 

other than as described in the PMNs, 

exceed releases from the use described 

in the PMNs. For the use described in 

the PMNs, environmental releases did 

not exceed 60 ppb more than 20 days 

per year. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

use of the substances other than as 

described in the PMNs may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria as § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10487. 

PMN Number P–04–636 

Chemical name: Cuprate, 

[[[[[[[(sulfonaphthalenyl)]azo]- 

(substitutedphenyl)]azo]- 

(substitutedsulfonaphthalenyl)]azo]- 

substituted phenyl-substituted 

heteromonocycle], sodium salts 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an ink jet 

dye. Based on SAR analysis of test data 

on structurally similar substances, EPA 

identified concerns for oncogenicity. As 

described in the PMN, inhalation 

exposures are not expected for the use 

specified due to the use of a NIOSHcertified respirator with an APF of at 

least 5. 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 

uses of the substance without 

respiratory protection where there is a 

potential for inhalation exposure may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of an 

unscheduled deoxyribonucleic acid 

(DNA) synthesis in mammalian cells in 

culture (OPPTS Test Guideline 

870.5550), and if warranted by the 

results of the first test, a carcinogenicity 

test (OPPTS Test Guideline 870.4200) 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10488. 

PMN Number P–04–718 

Chemical name: Substituted aryl 

sulfonium polyfluorophosphate salts 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a catalyst. Based on 

SAR analysis of test data on structurally 

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similar substances, EPA identified 

concerns for corrosion and ocular 

lethality. In addition, based on EcoSAR 

analysis of test data on analogous 

cationic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 6 ppb of 

the PMN substance in surface waters. As 

described in the PMN, significant 

worker exposures are not expected as 

the PMN is used in the form of a liquid 

and releases of the substance to surface 

waters are not expected. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance in the form of a powder 

or solid, or any use of the substance 

resulting in surface water 

concentrations exceeding 6 ppb may 

cause serious health effects and 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of an acute 

eye irritation test (OPPTS Test 

Guideline 870.2400); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10489. 

PMN Number P–04–834 

Chemical name: HDI biuret, 

hydroxyethyl methacrylate prepolymer 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: March 20, 2006. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as an ingredient 

in 2-component polyurethane coatings. 

Based on test data on analogous 

diisocyanates, EPA identified concerns 

for dermal and respiratory sensitization, 

pulmonary toxicity, and carcinogenicity 

from dermal and inhalation exposures. 

The consent order was issued under 

TSCA sections 5(e)(1)(A)(i), 

5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) 

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health, the substance 

may be produced in substantial 

quantities, and there may be significant 

(or substantial) human exposure to the 

substance. To protect against this 

exposure and risk, the consent order 

requires: 

1. Use of personal protective 

equipment including impervious gloves 

(when there is potential dermal 

exposure) and either a NIOSH-certified 

respirator with an APF of at least 25, or 

compliance with a NCEL of 0.05 mg/m3

as an 8-hour time-weighted average 

(when there is potential inhalation 

exposure). 

2. Establishment and use of a hazard 

communication program. 

3. Submission of certain human 

health testing prior to exceeding two 

confidential production volume limits 

specified in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a dermal 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. The PMN submitter has 

agreed not to exceed the first 

confidential production volume limit 

specified in the consent order without 

performing the dermal sensitization test, 

and has agreed not to exceed the second 

confidential production volume limit 

without performing the 90-day toxicity 

test. The order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10490. 

PMN Number P–05–55 

Chemical name: 

Benzenepropanal,.alpha.-methyl-. 

CAS number: 5445–77–2. 

Basis for action: The PMN states that 

the substance will be used as a sitelimited intermediate. Based on SAR 

analysis of test data on structurally 

similar substances, EPA has identified 

concerns for developmental toxicity. For 

the use described in the PMN, 

significant dermal and inhalation 

exposures are not expected. Therefore, 

EPA has not determined that proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the PMN substance other than as 

a site-limited intermediate may cause 

serious health effects. Based on this 

information the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700), by the dermal 

route in mice, would help characterize 

the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10491. 

PMN Number P–05–301 

Chemical name: Trisphenol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a hardener for 

epoxy resin. Based on EcoSAR analysis 

of test data on analogous phenols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

20 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 20 ppb. 

Therefore, EPA has not determined that 

manufacturing, processing, and 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 20 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 (OCSPP Test 

Guideline 850.4500) would help to 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10492. 

PMN Number P–05–417 

Chemical name: Tris-alkyl-alkoxy 

melamine 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 crosslinking resin. 

Based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 5 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

PMN substance are not expected to 

result in surface water concentrations 

that exceed 5 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

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surface water concentrations exceeding 

5 ppb 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 a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and an algal toxicity test 

(OCSPP Test Guideline 850.4500) on the 

hydrolysis products of the PMN 

substance would help to characterize 

the environmental effects of the PMN 

substance and its hydrolysis products. 

CFR citation: 40 CFR 721.10493. 

PMN Number P–05–501 

Chemical name: Reaction product of 

trimethylolpropane triacrylate and 

alkylene imine (generic). 

CAS number: Not available. 

Basis for action: The PMN substance 

will be used as an amine synergist for 

coatings and inks. Based on EcoSAR 

analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 5 ppb 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 

surface water concentrations exceeding 

5 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); a fish acute toxicity test 

mitigated by humic acid (OPPTS Test 

Guideline 850.1085); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help to characterize 

the environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10494. 

PMN Number P–05–634 

Chemical name: Metal silicate 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an additive use 

restricted to enclosed toner cartridges. 

Based on SAR analysis of test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects for the PMN substance. 

Based on physical properties, EPA 

identified concerns for potential 

systemic effects from dermal exposure 

to the PMN substance. As described in 

the PMN, the substance will be 

imported and not manufactured in the 

United States. For the use described in 

the PMN, worker dermal and inhalation 

exposures are not expected during 

processing and use activities. Therefore, 

EPA has not determined that the 

proposed processing or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

domestic manufacture, or use of the 

substance other than as described in the 

PMN may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) in rats with special attention 

to histopathology (inflammation and 

cell proliferation) of the lung tissues and 

to various parameters of the BALF with 

a recovery period of 60 days would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10495. 

PMN Number P–06–9 

Chemical name: Amino alkoxy 

polydimethylsiloxane, hydroxyterminated (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a textile additive. 

Based on EcoSAR analysis of test data 

on analogous polycationic polymers, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 10 ppb of the PMN 

substance in surface waters. As 

described in the PMN, 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 surface water 

concentrations exceeding 10 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10496. 

PMN Numbers P–06–276, P–06–277, P– 

06–278, P–06–279, P–06–280, and P–06– 

281 

Chemical names: (P–06–276 and P– 

06–279) Substituted alkyl ester, 

hydrolysis products with silica and 

substituted silane (generic); (P–06–277 

and P–06–280) Substituted alkyl ester, 

hydrolysis products with silica 

(generic); and (P–06–278 and P–06–281) 

Substituted silane, hydrolysis products 

with silica (generic). 

CAS numbers: Not available. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as components of clearcoat. Based on 

SAR analysis of test data on analogous 

respirable, poorly soluble particulates, 

EPA identified potential lung and 

systemic effects from inhalation and 

dermal exposures to the PMN 

substances. For the use described in the 

consolidated PMN, EPA does not expect 

significant worker exposures to the 

substances due to the use of appropriate 

impervious gloves and clothing; use of 

an appropriate NIOSH-certified 

respirator with an APF of at least 5; and 

no manufacturing, processing, or use in 

the form of a powder. 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 without 

impervious gloves and clothing where 

there is a potential for dermal 

exposures; any use of the substances 

without a NIOSH-certified respirator 

with an APF of at least 5 where there 

is a potential for inhalation exposures; 

use of the substances other than as 

described in the PMN; or 

manufacturing, processing, or use of the 

substances in the form of a powder may 

cause serious adverse health effects. 

Based on this information, the PMN 

substances meet the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substances. 

CFR citations: 40 CFR 721.10497 (P– 

06–276 and P–06–279); 40 CFR 

721.10498 (P–06–277 and P–06–280); 

and 40 CFR 721.10499 (P–06–278 and 

P–06–281). 

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PMN Number P–06–341 

Chemical name: Acrylated mixed 

metal oxides (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a film coating 

additive. Based on SAR analysis of test 

data on analogous respirable, poorly 

soluble particulates, EPA identified 

concerns for potential lung effects from 

inhalation exposures and potential 

systemic effects from dermal exposures. 

For the use described in the PMN, 

inhalation and dermal exposures are not 

expected due to use of the substance as 

a liquid and with impervious dermal 

protection for exposed workers. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance without the use of impervious 

dermal protection where there is 

potential for dermal exposures; any 

manufacture, processing, or use of the 

substance in the form of a powder; or 

any use of the substance other than as 

described in the PMN may cause serious 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10500. 

PMN Number P–06–542 

Chemical name: Tridecyl phthalate 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a plasticizer. Based 

on SAR analysis of test data on 

analogous phthalates, EPA identified 

concerns for developmental toxicity. For 

the use stated in the PMN, significant 

worker or consumer exposures are 

unlikely. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that any other use of the 

substance other than as described in the 

PMN may cause serious adverse human 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of an oral 

reproduction and fertility effects test 

(OPPTS Test Guideline 870.3800) would 

help characterize the human health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10501. 

PMN Number P–06–616 

Chemical name: Modified triethylene 

glycol dithiol (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a reactive 

diluent/binder in aerospace sealants. 

Based on EcoSAR analysis of test data 

on analogous thiols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the substance in surface waters. As 

described in the PMN, the substance is 

not expected to be released to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10502. 

PMN Number P–06–622 

Chemical name: 1,2-Ethanediol, 1- 

carbamate. 

CAS number: 5395–01–7. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate monomer for polymer 

synthesis. Based on test data on the 

PMN substance, and SAR analysis of 

test data on analogous urethanes and 

carbamates, EPA identified concerns for 

liver toxicity, developmental toxicity, 

and oncogenicity. For the use described 

in the PMN, EPA expects no significant 

dermal exposures due to the use of 

impervious gloves. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without 

impervious gloves where there is a 

potential for dermal exposures may 

cause serious adverse health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(1)(i)(C),(b)(3)(i), and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a prenatal 

developmental toxicity test (OPPTS Test 

Guideline 870.3700) and a 

carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10503. 

PMN Number P–06–682 

Chemical name: Surface modified 

magnesium hydroxide (generic). 

CAS number: Not available. 

Basis for action: The PMN states the 

substance will be used as a 

compatibilizer for flame retardant for 

plastics. Based on SAR analysis of test 

data on analogous respirable, poorly 

soluble particulates, EPA identified 

concerns for lung toxicity due to lung 

overload from inhalation exposure to 

the PMN substance. At the production 

volume of 100,000 kgs per year and for 

the specific use as a compatibilizer for 

flame retardant for plastics, significant 

worker exposures are not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as a 

compatibilizer for flame retardant for 

plastics, or any use of the substance in 

quantities greater than 100,000 kgs per 

year may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity test with a 60-day holding 

period (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10504. 

PMN Number P–06–694 

Chemical name: Phosphoric acid, 

mixed mono- and diesters with 2-ethyl1-hexanol and polyethylene glycol 

mono-C12–16-alkyl ethers. 

CAS number: 882693–50–7. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a hydraulic fluid. 

Based on test data on the PMN 

substance and EcoSAR analysis of test 

data on analogous anionic surfactants, 

EPA predicts toxicity to aquatic 

organisms may occur as a result of 

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releases of the PMN substance to surface 

waters from manufacture or import in 

quantities greater than 75,000 kgs per 

year, or from uses other than as stated 

in the PMN. At the annual production 

volume of 75,000 kgs per year, and for 

the use stated in the PMN, no significant 

environmental releases are expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as stated in the 

PMN, or exceeding an annual 

manufacturing and importation volume 

of 75,000 kgs 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) and an aquatic invertebrate 

acute toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10505. 

PMN Numbers P–07–11 and P–08–29 

Chemical name: Alkylated phenols 

(generic). 

CAS number: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substance will be as an antioxidant (P– 

07–11) and an intermediate (P–08–29). 

Based on test data on P–07–11 and SAR 

analysis of test data on analogous 

molecular structure chemicals, EPA 

identified concerns for liver effects, 

thyroid effects, and neurotoxicity. As 

described in the PMNs, worker dermal 

exposure to the PMN substances will be 

minimal due to impervious gloves. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substance without the use of impervious 

gloves where there is potential for 

dermal exposure may cause serious 

adverse health effects. Based on this 

information, the PMN substance meets 

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

and (b)(3)(ii). 

Recommended testing: EPA has 

determined that a repeated dose 90-day 

oral toxicity test in rodents (OPPTS Test 

Guideline 870.3100) and a 

developmental neurotoxicity test 

(OPPTS Test Guideline 870.6300) would 

help characterize the health effects of 

the PMN substances. 

CFR citation: 40 CFR 721.10506. 

PMN Number P–07–107 

Chemical name: Biphenyl substituted 

benzopyran (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a polymer additive. 

Based on EcoSAR analysis of test data 

on analogous neutral organic chemicals, 

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, releases of the PMN substance are 

not expected to result in surface water 

concentrations that exceed 2 ppb. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance resulting in surface water 

concentrations exceeding 2 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that 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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10507. 

PMN Number P–07–161 

Chemical name: Alkene substituted 

Bis 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 hardener for 

epoxy resins. EPA identified human 

health and environmental concerns 

because the PMN substance may be a 

persistent, bio-accumulative, and toxic 

(PBT) chemical, based on the physical/ 

chemical properties of the PMN 

substance, as described in the New 

Chemicals Program’s PBT category (64 

FR 60194, November 4, 1999) (FRL– 

6097–7). EPA estimates that the 

substance will persist in the 

environment for more than 2 months 

and estimates a bioaccumulation factor 

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

based on SAR analysis of test data on 

analogous safrole, methyleugenal and 

bisphenol A, EPA identified concerns 

for carcinogenicity and mutagenicity, 

systemic effects, and endocrine 

disruption. Further, 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 

substance in surface waters. As 

described in the PMN, significant 

worker exposures are not expected due 

to the use of impervious dermal 

protective equipment, 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 use of 

the substance without impervious 

dermal protection where there is a 

potential for dermal exposures, or any 

purposeful or predictable release of the 

substance to surface waters may cause 

serious health effects and significant 

adverse environmental risks. 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 a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); a fish 

bioconcentration test (OPPTS Test 

Guideline 850.1730); an oral combined 

chronic toxicity/carcinogenicity study 

(OPPTS Test Guideline 870.4300); 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 (OCSPP Test 

Guideline 850.5400) would help to 

characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10508. 

PMN Number P–07–204 

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

hexafluoro-4-(1,1,2,3,3,3- 

hexafluoropropoxy)-. 

CAS number: 870778–34–0. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a heat transfer 

fluid. Based on test data on the PMN 

substance and SAR analysis of test data 

on analogous perfluorinated substances, 

EPA identified concerns for 

neurotoxicity, liver effects, and cardiac 

sensitization from exposures to the PMN 

substance. For the use described in the 

PMN, EPA does not expect significant 

worker exposures due to the use of 

impervious gloves. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use without impervious gloves 

where there is a potential for dermal 

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exposures, or any use of the substance 

other than as described in the PMN may 

cause serious adverse health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(3)(i) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 28-day 

dermal toxicity test (OPPTS Test 

Guideline 870.3200) in rats; a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465), and a test using 

the ‘‘Standard Test Method for 

Permeation of Liquids and Gases 

through Protective Clothing Materials 

under Conditions of Continuous 

Contact’’ (ASTM International standard 

F739) as reported in the ‘‘Standard 

Guide for Documenting the Results of 

Chemical Permeation Testing of 

Materials Used in Protective Clothing’’ 

(ASTM International standard F1194) 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10509. 

PMN Number P–07–319 

Chemical name: Alkylaminoalcohol 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a raw material for 

a polymer paint additive. Based on 

EcoSAR analysis of test data on 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. 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 

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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10510. 

PMN Numbers P–07–320, P–07–321, 

P–07–322, P–07–323, and P–07–324 

Chemical name: Quaternary 

ammonium salts (generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the generic (nonconfidential) use of the substances will 

be as inhibitors for oil field 

applications. Based on EcoSAR analysis 

of test data on analogous cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 20 ppb of the 

substance in surface waters for greater 

than 20 days per year. This 20-day 

criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the PMN 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. For the use described in the 

PMN, environmental releases did not 

exceed 20 ppb more than 20 days per 

year. Therefore, EPA has not determined 

that the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that use of the 

substances other than as described in 

the PMN 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)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity test 

mitigated by humic acid (OPPTS Test 

Guideline 850.1085); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10511. 

PMN Numbers P–07–563 and P–07–564 

Chemical name: Fatty acid maleic 

acid amides (generic). 

CAS number: Not available. 

Basis for action: The consolidated 

PMN states that the substances will be 

used as emulsifiers for oil well drilling 

fluids. Based on EcoSAR analysis of test 

data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 10 ppb of the PMN 

substances in surface waters. As 

described in the PMN, 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 use of 

the substances resulting in surface water 

concentrations exceeding 10 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); a fish acute toxicity test 

mitigated by humic acid (OPPTS Test 

Guideline 850.1085); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10512. 

PMN Number P–07–599 

Chemical name: Aromatic acrylate 

monomer (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be in the production of 

polymers. Based on EcoSAR analysis of 

test data on analogous acrylates, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. As described in the PMN, the 

substance is not expected to be released 

to surface waters. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

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 (OCSPP Test 

Guideline 850.4500) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10513. 

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58686 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

PMN Number P–07–679 

Chemical name: [1,1′-Biphenyl]-2,2′- 

disulfonic acid, 4-[2-(4,5-dihydro-3- 

methyl-5-oxo-1-phenyl-1H-pyrazol-4- 

yl)diazenyl]-4′-[2-(2-hydroxy-1- 

naphthalenyl)diazenyl]-, sodium salt 

(1:2). 

CAS number: 6470–20–8. 

Basis for action: The PMN states that 

substance will be used as a dye for 

stationery ink. Based on SAR analysis of 

test data on analogs of an azo reduction 

product (pyrazole and methyl pyrazole), 

EPA identified concerns for liver, blood, 

and developmental toxicity; 

neurotoxicity; mutagenicity; and 

oncogenicity. As described in the PMN, 

inhalation exposures to workers and 

consumers are not expected as the PMN 

substance will be imported in rollerball 

pens and refills for rollerball pens. 

Therefore, EPA has not determined that 

the proposed processing or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

domestic manufacture, or any 

processing or use of the substance in the 

form of a solid may cause serious 

adverse health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

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

Recommended testing: EPA has 

determined that the results of a bacterial 

reverse mutation test (OPPTS Test 

Guideline 870.5100); a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395) via the 

intraperitoneal route; a repeated dose 

28-day oral toxicity test (OPPTS Test 

Guideline 870.3050) in rodents; and an 

acute oral toxicity test (OPPTS Test 

Guideline 870.1100) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10514. 

PMN Numbers P–10–58, P–10–59, and 

P–10–60 

Chemical name: Partially fluorinated 

alcohol substituted glycols (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: October 8, 2010. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) uses of the PMN 

substances will be as an intermediate 

(P–10–58 and P–10–59) and a surface 

active agent (P–10–60). EPA has 

concerns for potential incineration or 

other decomposition products of the 

PMN substances. These perfluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substances at low temperatures. EPA 

has preliminary evidence, including 

data on some fluorinated polymers, that 

suggests that, under some conditions, 

the PMN substances could degrade in 

the environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated alkyls, including 

the presumed environmental degradant. 

The order was issued under TSCA 

sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), 

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

that these substances may present an 

unreasonable risk of injury to the 

environment and human health, the 

substances may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these exposures and risks, the consent 

order requires submission of testing on 

the PMN substance P–10–60 at five 

identified aggregate manufacture and 

importation volumes; requires analysis 

of raw materials; and restricts the use of 

P–10–58 and P–10–59 to use as 

intermediates to manufacture P–10–60. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the TSCA section 

5(e) consent order would help 

characterize possible effects of the 

substances and their degradation 

products. The consent order contains 

five production volume limits. The 

PMN submitter has agreed not to exceed 

the confidential production volume 

limits without performing the specified 

testing on the PMN substance P–10–60. 

Additional testing is included in the 

preamble to the consent order, but this 

testing is not required at any specified 

time or production volume. However, 

the order’s restrictions on manufacture, 

import, processing, distribution in 

commerce, use, and disposal of the 

PMN will remain in effect until the 

order is modified or revoked by EPA 

based on submission of that or other 

relevant information. 

CFR citation: 40 CFR 721.10515. 

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 8 of the 107 chemical 

substances, regulation was warranted 

under TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

or environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160. 

In the other 99 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

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

• EPA will ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

existingchemicals/pubs/tscainventory/

index.html. 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58687 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

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

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

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

of this rule is November 20, 2012 

without further notice, unless EPA 

receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments before 

October 22, 2012. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before 

October 22, 2012, EPA will withdraw 

the relevant sections of this direct final 

rule before its effective date. EPA will 

then issue a proposed SNUR for the 

chemical substance(s) on which adverse 

or critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule (September 21, 

2012). 

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 

eight 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, 67 of the 108 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. 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 any 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. 

describes 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 about protocol selection and 

test reporting. 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’’ or for 

guidelines that are not currently 

available on the Web site EPA has 

placed a copy of that guideline in the 

public docket. 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 ASTM 

International standards are available at 

http://www.astm.org/Standard/ 

index.shtml. 

In the TSCA section 5(e) consent 

orders for eight 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. 

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58688 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

• 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 § 721.1725(b)(1). 

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–2011–0941. 

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 

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 

On February 18, 2012, EPA certified 

pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), that promulgation of 

a SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUN submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this rule. 

This rule is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58689 

economic impact on a substantial 

number of small entities. 

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 13, 2012. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 

■ 2. In § 14;9.1, add 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 

* * * * * 

721.10427 ................................. 2070–0012 

721.10428 ................................. 2070–0012 

721.10429 ................................. 2070–0012 

721.10430 ................................. 2070–0012 

721.10431 ................................. 2070–0012 

721.10432 ................................. 2070–0012 

721.10433 ................................. 2070–0012 

721.10434 ................................. 2070–0012 

721.10435 ................................. 2070–0012 

721.10436 ................................. 2070–0012 

721.10437 ................................. 2070–0012 

721.10438 ................................. 2070–0012 

721.10439 ................................. 2070–0012 

721.10440 ................................. 2070–0012 

721.10441 ................................. 2070–0012 

721.10442 ................................. 2070–0012 

721.10443 ................................. 2070–0012 

721.10444 ................................. 2070–0012 

721.10445 ................................. 2070–0012 

721.10446 ................................. 2070–0012 

721.10447 ................................. 2070–0012 

721.10448 ................................. 2070–0012 

721.10449 ................................. 2070–0012 

721.10450 ................................. 2070–0012 

721.10451 ................................. 2070–0012 

721.10452 ................................. 2070–0012 

721.10453 ................................. 2070–0012 

721.10454 ................................. 2070–0012 

721.10455 ................................. 2070–0012 

721.10456 ................................. 2070–0012 

721.10457 ................................. 2070–0012 

721.10458 ................................. 2070–0012 

721.10459 ................................. 2070–0012 

721.10460 ................................. 2070–0012 

721.10461 ................................. 2070–0012 

721.10462 ................................. 2070–0012 

721.10463 ................................. 2070–0012 

721.10464 ................................. 2070–0012 

721.10465 ................................. 2070–0012 

721.10466 ................................. 2070–0012 

721.10467 ................................. 2070–0012 

721.10468 ................................. 2070–0012 

721.10469 ................................. 2070–0012 

721.10470 ................................. 2070–0012 

721.10471 ................................. 2070–0012 

721.10472 ................................. 2070–0012 

721.10473 ................................. 2070–0012 

721.10474 ................................. 2070–0012 

721.10475 ................................. 2070–0012 

721.10476 ................................. 2070–0012 

721.10477 ................................. 2070–0012 

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40 CFR citation OMB 

Control No. 

721.10478 ................................. 2070–0012 

721.10479 ................................. 2070–0012 

721.10480 ................................. 2070–0012 

721.10481 ................................. 2070–0012 

721.10482 ................................. 2070–0012 

721.10483 ................................. 2070–0012 

721.10484 ................................. 2070–0012 

721.10485 ................................. 2070–0012 

721.10486 ................................. 2070–0012 

721.10487 ................................. 2070–0012 

721.10488 ................................. 2070–0012 

721.10489 ................................. 2070–0012 

721.10490 ................................. 2070–0012 

721.10491 ................................. 2070–0012 

721.10492 ................................. 2070–0012 

721.10493 ................................. 2070–0012 

721.10494 ................................. 2070–0012 

721.10495 ................................. 2070–0012 

721.10496 ................................. 2070–0012 

721.10497 ................................. 2070–0012 

721.10498 ................................. 2070–0012 

721.10499 ................................. 2070–0012 

721.10500 ................................. 2070–0012 

721.10501 ................................. 2070–0012 

721.10502 ................................. 2070–0012 

721.10503 ................................. 2070–0012 

721.10504 ................................. 2070–0012 

721.10505 ................................. 2070–0012 

721.10506 ................................. 2070–0012 

721.10507 ................................. 2070–0012 

721.10508 ................................. 2070–0012 

721.10509 ................................. 2070–0012 

721.10510 ................................. 2070–0012 

721.10511 ................................. 2070–0012 

721.10512 ................................. 2070–0012 

721.10513 ................................. 2070–0012 

721.10514 ................................. 2070–0012 

721.10515 ................................. 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 § 721.10427 to subpart E to 

read as follows: 

§ 721.10427 Aminoalkanol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aminoalkanol (PMN P– 

96–308) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=600). 

(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. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 5. Add § 721.10428 to subpart E to 

read as follows: 

§ 721.10428 Fatty acids, C18-unsatd., 

dimers, reaction products with 1- 

piperazineethanamine. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

fatty acids, C18-unsatd., dimers, reaction 

products with 1-piperazineethanamine 

(PMN P–96–1021; CAS No. 206565–90– 

4) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) 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. 

■ 6. Add § 721.10429 to subpart E to 

read as follows: 

§ 721.10429 Fatty acids, C18-unsatd., 

dimers, reaction products with 1- 

piperazineethanamine and tall-oil fatty 

acids. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

fatty acids, C18-unsatd., dimers, reaction 

products with 1-piperazineethanamine 

and tall-oil fatty acids (PMN P–96–1022; 

CAS No. 206565–89–1) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=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 § 721.10430 to subpart E to 

read as follows: 

§ 721.10430 Tetra alkyl ammonium salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tetra alkyl ammonium salt 

(PMN P–97–823) 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) Hazard communication program. 

Requirements as specified in § 721.72(a) 

and (c)(2) (the following statement must 

be included in the material safety data 

sheet (MSDS): ‘‘The results of an eye 

irritation test in rabbits resulted in 

deaths at levels of the PMN substance 

greater than 25 percent concentration’’). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (use of the 

substance as described in the PMN at 

concentrations less than or equal to 25 

percent). 

(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), (f), (h), and (i) and 

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 paragraph 

(a)(2)(ii) of this section. 

■ 8. Add § 721.10431 to subpart E to 

read as follows: 

§ 721.10431 Phosphoric acid esters 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as phosphoric acid esters 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58691 

(PMNs P–98–141 and P–98–142) 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) Release to water. Requirements as 

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

(c)(4) (N=100). 

(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 these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.10432 to subpart E to 

read as follows: 

§ 721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9- 

triethyl-3,6,9-trimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2,4,5,7,8-hexoxonane, 3,6,9-triethyl3,6,9-trimethyl-. (PMN P–98–1028; CAS 

No. 24748–23–0) 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) (viscosity 

modifier in the manufacture of 

polypropylene manufactured and 

supplied as a solution in at least 40 

percent mineral spirits). 

(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. 

■ 10. Add § 721.10433 to subpart E to 

read as follows: 

§ 721.10433 Cyclopentene, 1,2,3,3,4,4,5,5- 

octafluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cyclopentene, 1,2,3,3,4,4,5,5-octafluoro- 

(PMN P–99–184; CAS No. 559–40–0) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j) (dry 

etching agent and chemical vapor 

deposition agent for the production of 

semiconductors). 

(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. 

■ 11. Add § 721.10434 to subpart E to 

read as follows: 

§ 721.10434 Cyclopentane, 1,1,2,2,3,3,4- 

heptafluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cyclopentane, 1,1,2,2,3,3,4-heptafluoro- 

(PMN P–99–214; CAS No. 15290–77–4) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (j) (solvent and 

a cleaning and drying agent), 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. 

■ 12. Add § 721.10435 to subpart E to 

read as follows: 

§ 721.10435 Phenol, 2-(1-methyl-1- 

phenylethyl)-4-(1,1,3,3-tetramethylbutyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-(1-methyl-1-phenylethyl)-4- 

(1,1,3,3-tetramethylbutyl)- (PMN P–99– 

1179; CAS No. 73936–80–8) 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. 

■ 13. Add § 721.10436 to subpart E to 

read as follows: 

§ 721.10436 Amine neutralized phosphated 

polyesters (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as amine neutralized 

phosphated polyesters (PMN P–99–1217 

and P–99–1218) 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(s) (50,000 

kilograms combined for the substances 

identified in PMNs P–99–1217 and P– 

99–1218). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10437 to subpart E to 

read as follows: 

§ 721.10437 Sulfonic acid, linear xylene 

alkylate, mono, sodium salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as sulfonic acid, linear 

xylene alkylate, mono, sodium salts 

(PMNs P–99–1280, P–99–1281, and P– 

99–1282) 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: 

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(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (enhanced oil 

recovery surfactants). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10438 to subpart E to 

read as follows: 

§ 721.10438 Dialkyl 

hydroxybenzenealkanoic acid ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as dialkyl 

hydroxybenzenealkanoic acid ester 

(PMN P–00–346) 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)(3), (b) (concentration 

set at 1.0 percent), and (c). 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

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

(g)(1)(iv), (g)(2)(i), (g)(2)(v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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 paragraph 

(a)(2)(iii) of this section. 

■ 16. Add § 721.10439 to subpart E to 

read as follows: 

§ 721.10439 1,3-Dioxolan-2-one, 4-ethenyl. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-dioxolan-2-one, 4-ethenyl (PMN P– 

00–635; CAS No. 4427–96–7) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 0.1 percent), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 17. Add § 721.10440 to subpart E to 

read as follows: 

§ 721.10440 Diphosphoric acid, polymers 

with ethoxylated reduced Me esters of 

reduced polymd. oxidized 

tetrafluoroethylene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

diphosphoric acid, polymers with 

ethoxylated reduced Me esters of 

reduced polymd. oxidized 

tetrafluoroethylene (PMN P–00–1165; 

CAS No. 200013–65–6) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(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 (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. 

■ 18. Add § 721.10441 to subpart E to 

read as follows: 

§ 721.10441 1,2-Benzenedicarboxylic acid, 

di-C7–14-branched and linear alkyl esters. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-benzenedicarboxylic acid, di-C7–14- 

branched and linear alkyl esters (PMN 

P–01–382; CAS No. 309934–68–7) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) (use as 

plasticizers for flexible polyvinyl 

chloride not to include children’s toys 

(e.g., pacifiers, rattles, and teethers)). 

(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. 

■ 19. Add § 721.10442 to subpart E to 

read as follows: 

§ 721.10442 1,2-Benzenedicarboxylic acid, 

di-C6–14-branched and linear alkyl esters. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-benzenedicarboxylic acid, di-C6–14- 

branched and linear alkyl esters (PMN 

P–01–383; CAS No. 309934–69–8) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) (use as 

plasticizers for flexible polyvinyl 

chloride not to include children’s toys 

(e.g., pacifiers, rattles, and teethers)). 

(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. 

■ 20. Add § 721.10443 to subpart E to 

read as follows: 

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§ 721.10443 Ethoxylated alkylphenol 

sulfate, ammonium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as ethoxylated alkylphenol 

sulfate, ammonium salt (PMN P–01– 

470) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture 

and import of the PMN substance 

according to the chemical composition 

section of the consent order where the 

substance must have either a mean 

number of moles of ethoxy groups 

greater than or equal to 10, or the 

average number molecular weight is 

greater than 950 daltons). 

(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. 

■ 21. Add § 721.10444 to subpart E to 

read as follows: 

§ 721.10444 Propanol, mercapto-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

propanol, mercapto- (PMN P–01–499; 

CAS No. 63947–56–8) 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) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 1.0 percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=11). 

(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) through (e) 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 § 721.10445 to subpart E to 

read as follows: 

§ 721.10445 2-Propen-1-ol, reaction 

products with hydrogen sulfide, distn. 

residues. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propen-1-ol, reaction products with 

hydrogen sulfide, distn. residues (PMN 

P–01–500; CAS No. 374078–75–8) 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) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 1.0 percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=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) through (e) 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 § 721.10446 to subpart E to 

read as follows: 

§ 721.10446 1, 9-Cyclohexadecadiene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,9-cyclohexadecadiene (PMN P–01– 

762; CAS No. 4277–06–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 1.0 percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=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) through (e) and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10447 to subpart E to 

read as follows: 

§ 721.10447 17- 

Oxabicyclo[14.1.0]heptadec-8-ene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

17-oxabicyclo[14.1.0]heptadec-8-ene 

(PMN P–01–829; CAS No. 34748–97–5) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (a)(4) (National 

Institute for Occupational Safety and 

Health (NIOSH)-certified air purifying 

respirator equipped with a high 

efficiency particulate filter including 

disposable cartridge), (a)(5)(vii), (b) 

(concentration set at 1.0 percent), and 

(c). 

(ii) Release to water. Requirement as 

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

(c)(4) (N=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) through (e) 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 § 721.10448 to subpart E to 

read as follows: 

§ 721.10448 Acetic acid, hydroxymethoxy-, methyl ester, reaction products 

with substituted alkylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acetic acid, 

hydroxymethoxy-, methyl ester, reaction 

products with substituted alkylamine 

(PMN P–02–120) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture 

and import of the PMN substance 

according to the average number 

molecular weight section of the consent 

order where the average molecular 

weight is greater than or equal to 850 

daltons). 

(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. 

■ 26. Add § 721.10449 to subpart E to 

read as follows: 

§ 721.10449 Aromatic polyester polyol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic polyester polyol 

(PMN P–02–172) 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=40). 

(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 § 721.10450 to subpart E to 

read as follows: 

§ 721.10450 Oxirane, 2-[[3- 

(trimethoxysilyl)propoxy]methyl]-, reaction 

products with wollastonite (Ca(SiO3)). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane, 2-[[3- 

(trimethoxysilyl)propoxy]methyl]-, 

reaction products with wollastonite 

(Ca(SiO3)) (PMN P–02–285; CAS No. 

100402–91–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture 

and process the PMN substance with an 

average number aspect ratio no greater 

than 5, and no more than 15 percent of 

the PMN substance shall have an aspect 

ratio greater than 10). 

(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. 

■ 28. Add § 721.10451 to subpart E to 

read as follows: 

§ 721.10451 Alkyd amide polyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyd amide polyol (PMN 

P–02–436) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=3). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 29. Add § 721.10452 to subpart E to 

read as follows: 

§ 721.10452 9-Octadecenoic acid (9Z)-, 

1,1′-(dimethylstannylene) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

9-octadecenoic acid (9Z)-, 1,1′- 

(dimethylstannylene) ester (PMN P–02– 

659; CAS No. 3865–34–7) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=10). 

(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. 

■ 30. Add § 721.10453 to subpart E to 

read as follows: 

§ 721.10453 Polyglycerin alkyl ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyglycerin alkyl ether 

(PMN P–02–796) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 31. Add § 721.10454 to subpart E to 

read as follows: 

§ 721.10454 Propoxylated ethoxylated 

alkylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as propoxylated ethoxylated 

alkylamine (PMN P–02–828) 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=80). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

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(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.10455 to subpart E to 

read as follows: 

§ 721.10455 Oxirane, 2,2′,2′′- 

[ethylidynetris(4,1- 

phenyleneoxymethylene)]tris-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane, 2,2′,2′′-[ethylidynetris(4,1- 

phenyleneoxymethylene)]tris- (PMN P– 

03–61; CAS No. 87093–13–8) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(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 (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. 

■ 33. Add § 721.10456 to subpart E to 

read as follows: 

§ 721.10456 Tristyryl phenol alkoxylate 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tristyryl phenol 

alkoxylate salt (PMN P–03–104) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 34. Add § 721.10457 to subpart E to 

read as follows: 

§ 721.10457 1,2-Benzenedicarboxylic acid, 

mixed esters with benzyl alc., cyclohexanol, 

2-ethyl-1-hexanol, fumaric acid and 

propylene glycol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-benzenedicarboxylic acid, mixed 

esters with benzyl alc., cyclohexanol, 2- 

ethyl-1-hexanol, fumaric acid and 

propylene glycol (PMN P–03–154; CAS 

No. 464920–01–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=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 § 721.10458 to subpart E to 

read as follows: 

§ 721.10458 Acrylate of hydroxyimide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylate of hydroxyimide 

(PMN P–03–238) 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(v)(2), (w)(2), and 

(x)(2). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=20). 

(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. 

■ 36. Add § 721.10459 to subpart E to 

read as follows: 

§ 721.10459 Amino-substituted 

carbopolycycle (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amino-substituted 

carbopolycycle (PMN P–03–282) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor of at least 50), (a)(6), (b) 

(concentration set at 0.1 percent), and 

(c). Best’s Viton model 878, Best’s Butyl 

model 878, Barrier Laminated Film, and 

PVA Supported Polyvinyl Alcohol have 

been demonstrated to satisfy the 

requirements of § 721.63(a)(3)(i). Other 

demonstrated impervious gloves that 

satisfy § 721.63(a)(3)(i) are permissible. 

The following respirators meet the 

minimum requirements of 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting, half-face 

respirator equipment with N100 (if oil 

aerosols absent), R100, or P100 filters; 

NIOSH-certified air-purifying, tightfitting full-face respirator with N100 (if 

oil aerosols absent), R100, or P100 

filters; NIOSH-certified powered airpurifying respirator equipped with a 

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

NIOSH-certified powered air-purifying 

respirator equipped with a tight-fitting 

facepiece (either half-face or full-face) 

and HEPA filters; or 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). 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 0.1 percent), (f), 

(g)(1)(i), (g)(1)(vii), and (g)(2). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) are applicable to 

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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 paragraph 

(a)(2)(iii) of this section. 

■ 37. Add § 721.10460 to subpart E to 

read as follows: 

§ 721.10460 Azo nickel complex (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as azo nickel complex (PMN 

P–03–307) 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), (v)(1), (w)(1), 

and (x)(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 (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 paragraph 

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

■ 38. Add § 721.10461 to subpart E to 

read as follows: 

§ 721.10461 Oxazolidine, 3,3′- 

methylenebis[5-methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxazolidine, 3,3′-methylenebis[5- 

methyl- (PMN P–03–325; CAS No. 

66204–44–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (metalworking 

fluid). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=40 (saltwater) and N=100 

(freshwater)). 

(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. 

■ 39. Add § 721.10462 to subpart E to 

read as follows: 

§ 721.10462 1-Penten-3-one, 1-(4- 

chlorophenyl)-4,4-dimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-penten-3-one, 1-(4-chlorophenyl)-4,4- 

dimethyl- (PMN P–03–354; CAS No. 

1577–03–3) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=30). 

(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. 

■ 40. Add § 721.10463 to subpart E to 

read as follows: 

§ 721.10463 Fatty acid amides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acid amides (PMN 

P–03–388) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 41. Add § 721.10464 to subpart E to 

read as follows: 

§ 721.10464 Fatty acid, reaction products 

with alkanolamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acid, reaction 

products with alkanolamine (PMN P– 

03–461) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 42. Add § 721.10465 to subpart E to 

read as follows: 

§ 721.10465 2-Propenoic acid, 2-methyl-, 3- 

hydroxytricyclo[3.3.1.13,7]dec-1-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 2-methyl-, 3- 

hydroxytricyclo[3.3.1.13,7]dec-1-yl ester 

(PMN P–03–561; CAS No. 115372–36–6) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

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(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=3). 

(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) through (e) and (k) and 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. 

■ 43. Add § 721.10466 to subpart E to 

read as follows: 

§ 721.10466 2-Propenoic acid, 2-methyl-, 2- 

ethyltricyclo[3.3.1.13,7]dec-2-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 2-methyl-, 2- 

ethyltricyclo[3.3.1.13,7]dec-2-yl ester 

(PMN P–03–563; CAS No. 209982–56–9) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=3). 

(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) through (e) and (k) and 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. 

■ 44. Add § 721.10467 to subpart E to 

read as follows: 

§ 721.10467 2-Propenoic acid, 3- 

hydroxytricyclo[3.3.1.13,7]dec-1-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 3- 

hydroxytricyclo[3.3.1.13,7]dec-1-yl ester 

(PMN P–03–564; CAS No. 216581–76–9) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=3). 

(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) through (e) and (k) and 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. 

■ 45. Add § 721.10468 to subpart E to 

read as follows: 

§ 721.10468 2-Propenoic acid, 2- 

methyltricyclo[3.3.1.13,7]dec-2-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 2- 

methyltricyclo[3.3.1.13,7]dec-2-yl ester 

(PMN P–03–565; CAS No. 249562–06–9) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=3). 

(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) through (e) and (k) and 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. 

■ 46. Add § 721.10469 to subpart E to 

read as follows: 

§ 721.10469 2-Propenoic acid, 2- 

ethyltricyclo[3.3.1.13,7]dec-2-yl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 2- 

ethyltricyclo[3.3.1.13,7]dec-2-yl ester 

(PMN P–03–566; CAS No. 303186–14–3) 

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)(2)(iii), (a)(3), 

(a)(4) (National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 1.0 

percent), and (c). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=3). 

(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) through (e) and (k) and 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. 

■ 47. Add § 721.10470 to subpart E to 

read as follows: 

§ 721.10470 Phosphonium, tetrabutyl-, 

1,1,2,2,3,3,4,4,4-nonafluoro-1- 

butanesulfonate (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonium, tetrabutyl-, 

1,1,2,2,3,3,4,4,4-nonafluoro-1- 

butanesulfonate (1:1) (PMN P–03–567; 

CAS No. 220689–12–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 48. Add § 721.10471 to subpart E to 

read as follows: 

§ 721.10471 2-Propenoic acid, 1,1′-(3- 

methyl-1,5-pentanediyl) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propenoic acid, 1,1′-(3-methyl-1,5- 

pentanediyl) ester (PMN P–03–622; CAS 

No. 64194–22–5) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f) and (j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 49. Add § 721.10472 to subpart E to 

read as follows: 

§ 721.10472 1,3-Benzenedimethanamine, 

polymers with epichlorohydrin-polyethylene 

glycol reaction products. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-benzenedimethanamine, polymers 

with epichlorohydrin-polyethylene 

glycol reaction products (PMN P–03– 

645; CAS No. 652968–34–8) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 50. Add § 721.10473 to subpart E to 

read as follows: 

§ 721.10473 1-Propanaminium, 3-amino-N- 

(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl 

derivs., inner salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propanaminium, 3-amino-N-(2- 

carboxyethyl)-N,N-dimethyl-, N-coco 

acyl derivs., inner salts (PMN P–03–865; 

CAS No. 499781–63–4) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N=85). 

(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. 

■ 51. Add § 721.10474 to subpart E to 

read as follows: 

§ 721.10474 Substituted amino ethane 

sulfonic acid salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted amino ethane 

sulfonic acid salt (PMN P–04–107) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 52. Add § 721.10475 to subpart E to 

read as follows: 

§ 721.10475 Hexanedioic acid, compd. with 

N1-(6-aminohexyl)-N1-methyl-1,6- 

hexanediamine (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

hexanedioic acid, compd. with N1-(6- 

aminohexyl)-N1-methyl-1,6- 

hexanediamine (1:1) (PMN P–04–118; 

CAS No. 659733–29–6) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (intermediate for 

polymer manufacture). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=20). 

(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 this 

section. 

■ 53. Add § 721.10476 to subpart E to 

read as follows: 

§ 721.10476 Oxetane, 3-(bromomethyl)-3- 

methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxetane, 3-(bromomethyl)-3-methyl- 

(PMN P–04–275; CAS No. 78385–26–9) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 1.0 percent), and (c). 

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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 54. Add § 721.10477 to subpart E to 

read as follows: 

§ 721.10477 Acrylate ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylate ester (PMN P–04– 

290) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 55. Add § 721.10478 to subpart E to 

read as follows: 

§ 721.10478 Polyether polyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyether polyol (PMN P– 

04–318) 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) (intermediate for 

making urethane polymer). 

(ii) Release to water. Requirements as 

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

(c)(4) (N=30). 

(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. 

■ 56. Add § 721.10479 to subpart E to 

read as follows: 

§ 721.10479 Quaternary ammonium 

compounds, tris(hydrogenated tallow 

alkyl)methyl, chlorides. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

quaternary ammonium compounds, 

tris(hydrogenated tallow alkyl)methyl, 

chlorides (PMN P–04–335; CAS No. 

308074–73–9) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 57. Add § 721.10480 to subpart E to 

read as follows: 

§ 721.10480 Trimethylolpropane polyol, 

aminated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trimethylolpropane 

polyol, aminated (PMN P–04–384) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 58. Add § 721.10481 to subpart E to 

read as follows: 

§ 721.10481 Siloxanes and Silicones, Me 

vinyl, hydroxy-terminated, reaction 

products with silica. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Siloxanes and Silicones, Me vinyl, 

hydroxy-terminated, reaction products 

with silica (PMN P–04–429; CAS No. 

630106–01–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(x)(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 (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. 

■ 59. Add § 721.10482 to subpart E to 

read as follows: 

§ 721.10482 Siloxanes and Silicones, diMe, Me vinyl, hydroxy-terminated, reaction 

products with silica. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Siloxanes and Silicones, di-Me, Me 

vinyl, hydroxy-terminated, reaction 

products with silica (PMN P–04–430; 

CAS No. 630106–00–2) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(x)(1). 

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(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. 

■ 60. Add § 721.10483 to subpart E to 

read as follows: 

§ 721.10483 Siloxanes and Silicones, diMe, Me vinyl, hydroxy-terminated, reaction 

products with [(ethenyldimethylsilyl)oxy]- 

modified silica. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Siloxanes and Silicones, di-Me, Me 

vinyl, hydroxy-terminated, reaction 

products with 

[(ethenyldimethylsilyl)oxy]-modified 

silica (PMN P–04–431; CAS No. 

630106–04–6) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(x)(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 (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. 

■ 61. Add § 721.10484 to subpart E to 

read as follows: 

§ 721.10484 Siloxanes and Silicones, Me 

vinyl, hydroxy-terminated, reaction 

products with [(ethenyldimethylsilyl)oxy]- 

modified silica. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

Siloxanes and Silicones, Me vinyl, 

hydroxy-terminated, reaction products 

with [(ethenyldimethylsilyl)oxy]- 

modified silica (PMN P–04–432; CAS 

No. 630106–02–4) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(x)(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 (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. 

■ 62. Add § 721.10485 to subpart E to 

read as follows: 

§ 721.10485 Reaction products of 

alcohols, alkyl alcohols, amino alcohols 

and methanol sodium salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as reaction products of 

alcohols, alkyl alcohols, amino alcohols 

and methanol sodium salts (PMN P–04– 

479) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 63. Add § 721.10486 to subpart E to 

read as follows: 

§ 721.10486 Alkyl substituted aminobenzamide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl substituted aminobenzamide (PMN P–04–591) 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) (acetaldehyde 

scavenger for plastic bottle production). 

(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. 

■ 64. Add § 721.10487 to subpart E to 

read as follows: 

§ 721.10487 Alkylbenzenes sulfonic acids, 

metal salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkylbenzenes sulfonic 

acids, metal salts (PMNs P–04–599, P– 

04–600, P–04–605, and P–04–606) 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(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 65. Add § 721.10488 to subpart E to 

read as follows: 

§ 721.10488 Cuprate, 

[[[[[[[(sulfonaphthalenyl)]azo]- 

(substitutedphenyl)]azo]- 

(substitutedsulfonaphthalenyl)]azo]- 

substituted phenyl-substituted 

heteromonocycle], sodium salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as cuprate, 

[[[[[[[(sulfonaphthalenyl)]azo]- 

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(substitutedphenyl)]azo]- 

(substitutedsulfonaphthalenyl)]azo]- 

substituted phenyl-substituted 

heteromonocycle], sodium salts (PMN 

P–04–636) 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)(4) (National Institute 

for Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 5), (a)(6)(i), (a)(6)(ii), (a)(6)(v), 

(a)(6)(vi), (b) (concentration set at 0.1 

percent), and (c). 

(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) through (e) 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. 

■ 66. Add § 721.10489 to subpart E to 

read as follows: 

§ 721.10489 Substituted aryl sulfonium 

polyfluorophosphate salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted aryl 

sulfonium polyfluorophosphate salts 

(PMN P–04–718) 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 (v)(1), (v)(2), 

(w)(1), (w)(2), (x)(1), and (x)(2). 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 67. Add § 721.10490 to subpart E to 

read as follows: 

§ 721.10490 HDI biuret, hydroxyethyl 

methacrylate prepolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as HDI biuret, hydroxyethyl 

methacrylate prepolymer (PMN P–04– 

834) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the PMN 

substance that have been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2), (a)(3), (a)(4), (b) 

(concentration set at 0.1 percent), and 

(c). The following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 25 meet the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting halfface respirator equipped with N100 (if 

oil aerosols absent), R100, or P100 

filters; NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; NIOSH-certified 

powered air-purifying respirator 

equipped with a loose-fitting hood or 

helmet and high efficiency particulate 

air (HEPA) filters; NIOSH-certified 

powered air-purifying respirator 

equipped with a tight-fitting facepiece 

(either half-face or full-face) and HEPA 

filters; or 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). 

(A) 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 this substance. 

The NCEL is 0.05 mg/m3 as an 8-hour 

time-weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 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 be required to follow NCELs 

provisions comparable to those 

contained in the corresponding TSCA 

section 5(e) consent order. 

(B) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 0.1 percent), (f), 

(g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), 

(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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 paragraph 

(a)(2)(iii) of this section. 

■ 68. Add § 721.10491 to subpart E to 

read as follows: 

§ 721.10491 Benzenepropanal,.alpha.- 

methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenepropanal,.alpha.-methyl- (PMN 

P–05–55; CAS No. 5445–77–2) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h). 

(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. 

■ 69. Add § 721.10492 to subpart E to 

read as follows: 

§ 721.10492 Trisphenol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trisphenol (PMN P–05– 

301) 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 = 20). 

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(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. 

■ 70. Add § 721.10493 to subpart E to 

read as follows: 

§ 721.10493 Tris-alkyl-alkoxy melamine 

polymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tris-alkyl-alkoxy 

melamine polymer (PMN P–05–417) 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 = 5). 

(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. 

■ 71. Add § 721.10494 to subpart E to 

read as follows: 

§ 721.10494 Reaction product of 

trimethylolpropane triacrylate and alkylene 

imine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as reaction product of 

trimethylolpropane triacrylate and 

alkylene imine (PMN P–05–501) 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 = 5). 

(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. 

■ 72. Add § 721.10495 to subpart E to 

read as follows: 

§ 721.10495 Metal silicate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as metal silicate (PMN P– 

05–634) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f) and (j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 73. Add § 721.10496 to subpart E to 

read as follows: 

§ 721.10496 Amino alkoxy 

polydimethylsiloxane, hydroxy-terminated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amino alkoxy 

polydimethylsiloxane, hydroxyterminated (PMN P–06–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

(c)(4) (N = 10). 

(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. 

■ 74. Add § 721.10497 to subpart E to 

read as follows: 

§ 721.10497 Substituted alkyl ester, 

hydrolysis products with silica and 

substituted silane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as substituted alkyl ester, 

hydrolysis products with silica and 

substituted silane (PMNs P–06–276 and 

P–06–279) 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) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), (b) (concentration set 1.0 percent), 

and (c). The following National Institute 

for Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 5 meet the requirements of 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 (if oil 

aerosols absent), R100, or P100 filters; 

NIOSH-certified air-purifying respirator 

equipped with a loose-fitting hood or 

helmet and high efficiency particulate 

air (HEPA) filters; NIOSH-certified 

powered air-purifying respirator 

equipped with a tightfitting facepiece 

(full-face) and HEPA filters; or NIOSHcertified supplied-air respirator 

operated in pressure demand or 

continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

and (x)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 75. Add § 721.10498 to subpart E to 

read as follows: 

§ 721.10498 Substituted alkyl ester, 

hydrolysis products with silica (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as substituted alkyl ester, 

hydrolysis products with silica (PMNs 

P–06–277 and P–06–280) 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) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), (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 at least 5 meet the 

requirements of § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 (if 

oil aerosols absent), R100, or P100 

filters; NIOSH-certified air-purifying 

respirator equipped with a loose-fitting 

hood or helmet and high efficiency 

particulate air (HEPA) filters; NIOSHcertified powered air-purifying 

respirator equipped with a tightfitting 

facepiece (full-face) and HEPA filters; or 

NIOSH-certified supplied-air respirator 

operated in pressure demand or 

continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

and (x)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 76. Add § 721.10499 to subpart E to 

read as follows: 

§ 721.10499 Substituted silane, hydrolysis 

products with silica (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as substituted silane, 

hydrolysis products with silica (PMNs 

P–06–278 and P–06–281) 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) Protection in the workplace. 

Requirements as specified in 

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

(a)(4), (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 at least 5 meet the 

requirements of § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 (if 

oil aerosols absent), R100, or P100 

filters; NIOSH-certified air-purifying 

respirator equipped with a loose-fitting 

hood or helmet and high efficiency 

particulate air (HEPA) filters; NIOSHcertified powered air-purifying 

respirator equipped with a tight-fitting 

facepiece (full-face) and HEPA filters; or 

NIOSH-certified supplied-air respirator 

operated in pressure demand or 

continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

and (x)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 77. Add § 721.10500 to subpart E to 

read as follows: 

§ 721.10500 Acrylated mixed metal oxides 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylated mixed metal 

oxides (PMN P–06–341) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0 percent), and 

(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

and (x)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 78. Add § 721.10501 to subpart E to 

read as follows: 

§ 721.10501 Tridecyl phthalate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tridecyl phthalate (PMN 

P–06–542) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 79. Add § 721.10502 to subpart E to 

read as follows: 

§ 721.10502 Modified triethylene glycol 

dithiol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

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(1) The chemical substance identified 

generically as modified triethylene 

glycol dithiol (PMN P–06–616) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 80. Add § 721.10503 to subpart E to 

read as follows: 

§ 721.10503 1,2-Ethanediol, 1-carbamate. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,2-ethanediol, 1-carbamate (PMN P– 

06–622; CAS No. 5395–01–7) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(2)(i), (a)(3), (b) 

(concentration set at 0.1 percent), and 

(c). 

(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) through (e) 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. 

■ 81. Add § 721.10504 to subpart E to 

read as follows: 

§ 721.10504 Surface modified magnesium 

hydroxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as surface modified 

magnesium hydroxide (PMN P–06–682) 

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) (compatibilizer 

for flame retardant for plastics) and (s) 

(100,000 kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 82. Add § 721.10505 to subpart E to 

read as follows: 

§ 721.10505 Phosphoric acid, mixed 

mono- and diesters with 2-ethyl-1-hexanol 

and polyethylene glycol mono-C12–16-alkyl 

ethers. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphoric acid, mixed mono- and 

diesters with 2-ethyl-1-hexanol and 

polyethylene glycol mono-C12–16-alkyl 

ethers (PMN P–06–694; CAS No. 

882693–50–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (j) and (s) (75,000 

kilograms). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 83. Add § 721.10506 to subpart E to 

read as follows: 

§ 721.10506 Alkylated phenols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkylated phenols (PMNs 

P–07–11 and P–08–29) 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) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0 percent), and 

(c). 

(ii) [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) through (e) are applicable 

to manufacturers, importers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 84. Add § 721.10507 to subpart E to 

read as follows: 

§ 721.10507 Biphenyl substituted 

benzopyran (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as biphenyl substituted 

benzopyran (PMN P–07–107) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 85. Add § 721.10508 to subpart E to 

read as follows: 

§ 721.10508 Alkene substituted Bis phenol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkene substituted bis 

phenol (PMN P–07–161) 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: 

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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58705 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b) (concentration 

set at 0.1 percent), and (c). 

(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) through (e) 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. 

■ 86. Add § 721.10509 to subpart E to 

read as follows: 

§ 721.10509 Pentane, 1,1,1,2,3,3- 

hexafluoro-4-(1,1,2,3,3,3- 

hexafluoropropoxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

pentane, 1,1,1,2,3,3-hexafluoro-4- 

(1,1,2,3,3,3-hexafluoropropoxy)- (PMN 

P–07–204; CAS No. 870778–34–0) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0 percent), and 

(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 87. Add § 721.10510 to subpart E to 

read as follows: 

§ 721.10510 Alkylaminoalcohol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylaminoalcohol (PMN 

P–07–319) 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. 

■ 88. Add § 721.10511 to subpart E to 

read as follows: 

§ 721.10511 Quaternary ammonium salts 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as quaternary ammonium 

salts (PMNs P–07–320, P–07–321, P–07– 

322, P–07–323, and P–07–324) 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(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

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

■ 89. Add § 721.10512 to subpart E to 

read as follows: 

§ 721.10512 Fatty acid maleic acid amides 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid maleic acid 

amides (PMNs P–07–563 and P–07–564) 

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) Release to water. Requirements as 

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

(c)(4) (N=10). 

(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 these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 90. Add § 721.10513 to subpart E to 

read as follows: 

§ 721.10513 Aromatic acrylate monomer 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic acrylate 

monomer (PMN P–07–599) 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. 

■ 91. Add § 721.10514 to subpart E to 

read as follows: 

§ 721.10514 [1,1’-Biphenyl]-2,2’-disulfonic 

acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1- 

phenyl-1H-pyrazol-4-yl)diazenyl]-4’-[2-(2- 

hydroxy-1-naphthalenyl)diazenyl]-, sodium 

salt (1:2). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[1,1’-Biphenyl]-2,2’-disulfonic acid, 4- 

[2-(4,5-dihydro-3-methyl-5-oxo-1- 

phenyl-1H-pyrazol-4-yl)diazenyl]-4’-[2- 

(2-hydroxy-1-naphthalenyl)diazenyl]-, 

sodium salt (1:2) (PMN P–07–679; CAS 

No. 6470–20–8) is subject to reporting 

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58706 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (v)(2), and 

(x)(2). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (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. 

■ 92. Add § 721.10515 to subpart E to 

read as follows: 

§ 721.10515 Partially fluorinated alcohol 

substituted glycols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as partially fluorinated 

alcohol substituted glycols (PMNs P– 

10–58, P–10–59, and P–10–60) are 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (manufacture 

and import of the PMN substances 

according to the chemical synthesis and 

composition section of the consent 

order, including analysis, reporting, and 

limitations of maximum impurity levels 

of certain fluorinated impurities; 

manufacture and import of P–10–58 and 

P–10–59 only as described in the 

manufacturing section of the consent 

order), (l) (compliance with the 

maximum established percentage of the 

PMN substances in a non-industrial 

product or distributed for use as a nonindustrial product), (o) (use of P–10–60 

in a consumer product that could be 

spray applied), and (q). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of these substances, 

except the recordkeeping requirements 

for § 721.125 (b) and (c) do not apply to 

importers or processors when any one of 

the substances are contained in a 

formulation at less than 3 weight 

percent. 

(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 paragraph 

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

[FR Doc. 2012–23235 Filed 9–20–12; 8:45 am] 

BILLING CODE 6560–50–P 

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