This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

19037 

Vol. 80, No. 68 

Thursday, April 9, 2015 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2014–0649; FRL–9924–10] 

RIN 2070–AB27 

Modification of Significant New Uses 

of Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to amend 

the significant new use rules (SNURs) 

under section 5(a)(2) of the Toxic 

Substances Control Act (TSCA) for 24 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). This action would amend the 

SNURs to allow certain uses without 

requiring a significant new use notice 

(SNUN), and would extend SNUN 

requirements to certain additional uses. 

EPA is proposing these amendments 

based on review of new data as 

described for each chemical substance. 

This action would requires persons who 

intend to manufacture (including 

import) or process any of these 24 

chemical substances for an activity that 

is designated as a significant new use by 

this proposed rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: Comments must be received on 

or before May 11, 2015. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2014–0649, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• 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: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Jim 

Alwood, Chemical Control Division, 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8974; email address: 

alwood.jim@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, process, 

or use the chemical substances 

contained in this rule. The following list 

of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Manufacturers or processors of one 

or more subject chemical substances 

(NAICS codes 325 and 324110), e.g., 

chemical manufacturing and petroleum 

refineries. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to a modified 

SNUR 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 the chemical substance 

that is the subject of a final 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 preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. What action is the agency taking? 

EPA is proposing amendments to the 

SNURs for 24 chemical substances in 40 

CFR part 721 subpart E. This proposed 

action would require persons who 

intend to manufacture or process these 

chemical substances for an activity that 

is designated as a significant new use by 

these amended rules to notify EPA at 

least 90 days before commencing that 

activity. 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. 


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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. 

of this document. 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 or process the chemical 

substance for that use. Persons who 

must report are described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 24 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substance, 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 a Proposed 

Significant New Use Rule Amendment 

EPA is proposing to amend the 

significant new use and recordkeeping 

requirements for 24 chemical substances 

in 40 CFR part 721 Subpart E. In this 

unit, EPA provides the following 

information for each chemical 

substance: 

• PMN number and SNUN 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). 

• Federal Register publication date 

and reference for the final SNUR 

previously issued. 

• Basis for the Proposed Amendment. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

PMN Number P–99–669, SNUN Number 

S–09–1, and SNUN Number S–13–29 

Chemical name: Oxirane, methyl-, 

polymer with oxirane, mono (3,5,5,- 

trimethylhexyl) ether. 

CAS number: 204336–40–3. 

Federal Register publication date and 

reference: March 28, 2003 (68 FR 15061) 

(FRL–6758–7). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance for the 

PMN and the SNUN is as a wetting 

agent. The original SNUR was issued 

based on meeting the concern criteria at 

§ 721.170 (b)(4)(ii). The original SNUR 

required notification if the chemical 

substance was used for uses other than 

as described in the PMN. On November 

12, 2008 EPA received a SNUN, S–09– 

1, and on June 4, 2013 EPA received a 

SNUN, S–13–29 for the chemical 

substance describing uses different than 

those in the PMN. The 90-day review 

period for the SNUNs expired with EPA 

not taking action on the significant new 

uses described in the SNUNs. Based on 

structural analogy to nonionic 

surfactants, EPA is still concerned that 

toxicity to aquatic organisms may occur 

at a concentration of 600 parts per 

billion (ppb) in surface waters. Because 

EPA finds that the substance is not 

released to surface waters in significant 

quantities as described in either the 

PMN or the SNUNs, EPA has not 

determined that the proposed 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that other uses of the 

substance may cause significant adverse 

environmental effects. Based on this the 

substance meets the concern criteria at 

§ 721.170 (b)(4)(ii). Based on these 

findings, EPA is proposing to modify 

the SNUR to allow the uses described in 

S–09–01 and S–13–29. 

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 text, 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 chemical substance. 

CFR citation: 40 CFR 721.522. 

PMN Number P–00–618 and SNUN 

Numbers S–05–03 and S–11–4 

Chemical name: 1-Butanol, 3- 

methoxy-3-methyl-, acetate. 

CAS number: 103429–90–9. 

Federal Register publication date and 

reference: March 28, 2003 (68 FR 15061) 

(FRL–6758–7). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance for the 

PMN is as a processing aid. The uses of 

the chemical substance for the SNUNs 

are as an organic solvent of 

polyurethane plastic coating, an 

ingredient in various kinds of paint 

thinner, an organic solvent of 

polyurethane resin, an ingredient of 

cleaning agents, an organic solvent for 

screen ink, an ingredient in airplane 

paint, and a solvent for inkjet printer 

ink. EPA identified concerns for liver 

toxicity, kidney toxicity, developmental 

neurotoxicity and carcinogenicity based 

on analog data. The original SNUR was 

issued based on meeting the concern 

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

and (b)(1)(i)(C). The original SNUR 

required notification if the chemical 

substance was used for use other than 

as described in the PMN. On March 23, 

2005, EPA received a SNUN, S–05–3, 

for the chemical substance describing 


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uses different than those in the PMN. 

Based on the activities described in this 

SNUN, a TSCA section 5(e) consent 

order was issued for the SNUN 

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

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

that the substance may present an 

unreasonable risk of injury to human 

health. On October 26, 2010, EPA 

received a SNUN, S–11–4, for a new 

use, which was as a solvent for inkjet 

printer ink. The SNUN submitter also 

submitted a chromosome aberration 

study, a mouse lymphoma assay and a 

combined repeated dose study with 

reproductive and developmental 

toxicity. Based on the test data for the 

chemical substance which was 

submitted with S–11–4, EPA continues 

to have concerns for liver toxicity and 

kidney toxicity for exposed workers and 

consumers. In response to S–11–4, EPA 

allowed the new use and modified the 

consent order accordingly, while 

continuing to protect against any 

unreasonable risks of injury to human 

health. The modified consent order 

requires: 

1. Workers to use personal protective 

equipment to prevent dermal exposure. 

2. Establishment and use of a hazard 

communication program, including 

human health, environmental hazard 

precautionary statements on each label 

and the Material Safety Data Sheet 

(MSDS). 

3. Not manufacture the substance in 

the United States. 

4. Not use the substance in consumer 

products. 

5. Limit the percent concentration of 

the substance to 10% or less in final 

products whose use involves an 

application method that generates a 

vapor, mist, or aerosol, except for 

commercial/professional inkjet printing 

in a commercial (excluding retail) print 

shop. 

The proposed SNUR designates as a 

significant new use the absence of these 

protective measures when using the 

substance for any use other than as 

described in the PMN. 

Recommended testing: EPA has 

determined that the results of a two-year 

chronic toxicity study (OPPTS Test 

Guideline 870.4100) via the dermal and 

inhalation routes would help 

characterize the health effects of the 

PMN substance. 

CFR citation: 40 CFR 721.532. 

PMN Number P–98–1275 and SNUN 

Number S–11–10 

Chemical name: Aluminosilicates, 

phospho-. 

CAS number: 201167–69–3. 

Federal Register publication date and 

reference: December 26, 2000 (65 FR 

81386) (FRL–6592–8). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance for the 

PMN and the SNUN is as a catalyst. A 

consent order was issued for the PMN 

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

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

finding that the substance may present 

an unreasonable risk of injury to human 

health. The original SNUR, based on the 

requirements in the TSCA section 5(e) 

consent order, required notification if 

the PMN substance was used without 

the respiratory protection described in 

the SNUR (i.e., a National Institute of 

Occupational Safety and Health 

(NIOSH) respirator with an Assigned 

Protection Factor (APF) of 2000), the 

hazard communication program 

described in the SNUR was not used, or 

the aggregate production volume in the 

consent order was exceeded. Upon 

receipt and evaluation of the 90-day 

inhalation study required in the consent 

order, EPA continues to find that the 

substance may present an unreasonable 

risk of lung effects and cancer, although 

at a higher dose/effect level. Based on 

this finding, EPA modified the consent 

order to remove the production volume 

limit and reduce the required protection 

level for the respirator to an APF of 50. 

On June 14, 2011, EPA received a 

SNUN, S–11–10, for the chemical 

substance to use a respirator with an 

APF of 50 and to exceed the production 

volume limit. EPA permitted the new 

uses for the same reasons it modified 

the consent order. The proposed SNUR 

designates as a ‘‘significant new use’’ 

the absence of the respiratory protection 

and hazard communication measures in 

the modified consent order. 

Recommended testing: EPA has 

determined that the results of a two-year 

two-species oral carcinogenicity study 

(OPPTS Test Guideline 870.4200) would 

help characterize the health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.633. 

PMN Number P–00–7 and SNUN 

Numbers S–05–1, S–06–4, S–07–3, and 

S–07–5 

Chemical name: D-Glucuronic acid, 

polymer with 6-deoxy-L-mannose and 

D-glucose, acetate, calcium magnesium 

potassium sodium salt. 

CAS number: 125005–87–0. 

Federal Register publication date and 

reference: December 17, 2003 (68 FR 

70155) (FRL–7307–3). 

Basis for the modified significant new 

use rule: The uses of the chemical 

substance as described in the PMN are 

as an oilfield drilling fluid, an oilfield 

spacer fluid, in oilfield cementing, in 

cementitious packaged products, in 

concrete applications, and in foam 

applications. Based on structural 

analogues and submitted test data, EPA 

identified concerns for lung effects from 

inhalation exposure to the chemical 

substance. The original SNUR was 

issued based on meeting the concern 

criteria at § 721.170(b)(3)(i) and 

(b)(3)(ii). The original SNUR required 

notification if the chemical substance 

was used for any use other than those 

described in PMN. EPA received SNUN 

S–05–1 on December 1, 2004, S–06–4 on 

February 28, 2006, S–07–3 on June 5, 

2007, and S–07–5 on July 17, 2007. Each 

SNUN described different uses for the 

chemical substance than those 

described in the PMN: S–05–1 described 

use as a sealant, S–06–4 described a 

generic use in pipeline transmission 

systems, S–07–3 described any uses 

other than those already allowed in the 

SNUR where less than 5 percent of the 

chemical substance consists of particles 

below 10 microns, and S–07–05 

described a generic use in a commercial 

dry wash additive. As with the PMN, 

the Agency in its review of the SNUNs 

found that significant inhalation 

exposure remains unlikely when used 

as described in the SNUNs, and 

accordingly, EPA has not determined 

that the proposed manufacturing, 

processing, and use of the chemical 

substance may present an unreasonable 

risk. EPA has determined, however, that 

use of the chemical substance where 

more than 5 percent of the chemical 

substance contains particles below 10 

microns may cause significant health 

effects. Based on this information, the 

chemical substance meets the concern 

criteria at § 721.170(b)(3)(i) and 

(b)(3)(ii). Based on these findings EPA is 

proposing to modify the SNUR to 

remove the notification requirement for 

specific end uses and instead require 

notification where more than 5 percent 

of the chemical substance consists of 

particles below 10 microns. 

Recommended testing: EPA has 

determined that the 90-day inhalation 

toxicity study with a 60-day holding 

period (OPPTS Test Guideline 

870.3465) would help to characterize 

the human health effects of the PMN 

substance. Attention should be given to 

the lungs, including histopathology of 

the lungs (inflammation, epithelial 

hyperplasia, and fibrosis), (HAL) 

analysis for markers of lung injury, and 

lung burden analysis for clearance of the 

test material (EPA–748–R–96–001). The 

neurotoxicity components and 

examination of organs other than the 


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lungs are not required in the 90-day 

study. 

CFR citation: 40 CFR 721.2076. 

PMN Number P–95–169 and SNUN 

Numbers S–08–7 and S–14–1 

Chemical name: 2-Propen-1-one, 1-(4- 

morpholinyl)-. 

CAS number: 5117–12–4. 

Federal Register publication date and 

reference: Jan. 5, 2000 (65 FR 354) 

(FRL–6055–2), amended May 13, 2011 

(76 FR 27910) (FRL–8871–5). 

Basis for the modified significant new 

use rule: The use for P–95–169 is as a 

diluent for ultraviolet and electron beam 

curable resins for coatings, inks, and 

curable adhesives, and the use for S–14– 

1 is as a monomer for use in ultraviolet 

ink jet applications. The generic (nonconfidential) use for S–08–7 is a 

contained use in energy production. A 

consent order for the PMN was issued 

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

5(e)(l)(A)(ii)(I) of TSCA based on a 

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Agency 

issued a TSCA section 5(e) consent 

order which became effective on 

November 27, 1998. The order required 

the use of dermal personal protective 

equipment (including gloves 

demonstrated to be impervious) and 

respiratory personal protective 

equipment (including a NIOSHapproved respirator); required 

establishment of a hazard 

communication program; prohibited 

domestic manufacturing; prohibited 

processing and use activities in nonenclosed processes; established 

maximum production volume limits for 

submission of required testing; 

established waste disposal practices 

(including restrictions for no release to 

surface waters and requirement of 

disposal only in a Resource 

Conservation Recovery Act ((RCRA) 

hazardous waste landfill); and 

prohibited use of the chemical 

substance involving an application 

method that generates a vapor, mist, or 

aerosol. 

A SNUR was issued for this chemical 

substance on January 5, 2000. The 

SNUR designated as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the consent order. 

Subsequent to issuance of the SNUR, 

the PMN submitter completed the 

following studies under the terms of the 

TSCA section 5(e) consent order: An in 

vivo mouse micronucleus test, a 90-day 

oral toxicity study in rats, and a 

reproductive toxicity screening study in 

rats. The results of the micronucleus test 

were negative. Based on the results of 

the 90-day study, the Agency 

established a no observed adverse effect 

level (NOAEL) of 20 milligram/

kilogram/day (mg/kg/day) for 

neurotoxicity. Further, based on the 

results of the reproductive toxicity 

screening study, a NOAEL of 75 mg/kg/ 

day (highest dose tested) was 

established for reproductive effects. 

From these data, the Agency calculated 

Margins of Exposure (MOEs) for 

predicted workplace exposures. 

Based on these new data, concerns 

remained for possible effects to the 

liver, testes, kidney, and blood from 

dermal exposure. However, EPA no 

longer had substantial human health 

concerns for mutagenicity and 

neurotoxicity. In addition, Agency 

concerns for carcinogenicity by 

inhalation were reduced, but were 

further mitigated by retaining the 

original consent order prohibition of 

industrial processing and use in a nonenclosed process and any use 

application methods that generate a 

vapor, mist, or aerosol form of the PMN 

substance. 

In addition, to account for data 

received on analogous substances since 

the initial PMN was submitted and to 

address Agency environmental 

concerns, a re-review of the 

environmental toxicity profile for the 

chemical substance was conducted. The 

results of this evaluation indicated a 

low concern for chronic aquatic toxicity. 

Therefore, EPA could no longer make a 

‘‘may present unreasonable risk’’ 

finding for releases of the PMN 

substance to surface waters. As a result 

of this review, EPA issued a modified 

TSCA section 5(e) consent order which 

became effective on May 9, 2006. The 

modified order removed requirements 

for respiratory protection, waived 

further required trigger testing, removed 

the restriction on domestic manufacture, 

and removed waste disposal 

restrictions. Pursuant to § 721.185(a)(5), 

the Agency examined new information 

and reexamined the test data and other 

information supporting its finding 

under section 5(e)(1)(A)(ii)(I) of TSCA, 

and concluded that a rational basis no 

longer existed to support findings that 

certain activities involving the 

substance may present an unreasonable 

risk of injury to human health and the 

environment required under section 

5(e)(1)(A) of TSCA. 

To protect against the remaining 

potential risks, the modified consent 

order: 

• Requires the use of dermal personal 

protective equipment (including gloves 

demonstrated to be impervious). 

• Requires establishment of a hazard 

communication program. 

• Prohibits processing and use 

activities in non-enclosed processes. 

• Prohibits the use of the chemical 

substance involving an application 

method that generates a vapor, mist, or 

aerosol. 

On June 27, 2008, the Agency 

received a SNUN, S–08–7, for the 

subject chemical substance. The 

significant new use identified in the 

notice was release to water for the 

generic (non-confidential) use of 

‘‘contained use in energy production’’. 

The 90-day review period for the SNUN 

expired on October 2, 2008 with EPA 

not taking action on the ‘‘significant 

new use’’ of release of the substance to 

water. 

On May 13, 2011, EPA issued a 

modified SNUR based on and consistent 

with the provisions in the underlying 

modified consent order which no longer 

included release to water as a significant 

new use. In addition, EPA included, in 

the regulatory text, clarifying language 

for those forms of the PMN substance 

which are exempt from the provisions of 

the proposed SNUR. The SNUR does 

not apply to quantities of the PMN 

substance after it has been completely 

reacted (cured) because the PMN 

substance will no longer exist. 

On October 21, 2013, EPA received a 

second SNUN, S–14–1, for the subject 

chemical substance. The significant new 

use identified in the notice was 

processing and use in a non-enclosed 

process as a monomer for use in 

ultraviolet ink jet applications. The 90- 

day review period for the SNUN expired 

on March 13, 2014, with EPA not taking 

action on the significant new use of 

processing and use in a non-enclosed 

process as a monomer for use in 

ultraviolet ink jet applications. When 

evaluating this new use, EPA also 

evaluated potential environmental 

releases. Based on a new review of test 

data on the chemical substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

100 ppb of the chemical substance in 

surface waters. As described in the PMN 

and SNUNs, releases of the substance 

are not expected to result in surface 

water concentrations that exceed 100 

ppb. EPA has determined, however, that 

any use of the substance resulting in 

surface waters concentrations exceeding 

100 ppb may result in significant 

adverse environmental effects. Based on 

this information, the chemical substance 

meets the concern criteria at § 721.170 

(b)(4)(i). The proposed SNUR designates 

as a ‘‘significant new use’’ the absence 

of the protective measures required in 

the modified consent order, any water 

releases during manufacturing, 

processing, and use that exceed 100 


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ppb, or use other than as a monomer for 

use in ultraviolet ink jet applications 

unless the chemical substance is 

processed and used in an enclosed 

process. 

Recommended testing: EPA has 

determined that the results of the 

combined repeated dose toxicity with 

the reproductive/developmental toxicity 

screening test (OPPTS Test Guideline 

870.3650) would help further 

characterize the human health effects of 

the PMN substance. The modified TSCA 

section 5(e) consent order does not 

require submission of the 

aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacturing, processing, distribution 

in commerce, use and disposal of the 

chemical 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 721.5185. 

PMN Numbers P–88–2179 and P–89– 

0539 and SNUN Number S–08–3 

Chemical name: Oxirane, 2,2′-(1,6- 

hexanediylbis(oxymethylene))bis-. 

CAS number: 16096–31–4. 

Federal Register publication date and 

reference: April 25, 1991 (56 FR 19228). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance in the 

PMNs and the SNUN is in coatings and 

as a diluent. A consent order was issued 

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

5(e)(l)(A)(ii)(I) of TSCA based on a 

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Agency 

issued a TSCA section 5(e) consent 

order which became effective on 

October 12, 1990. The order required 

the use of dermal personal protective 

equipment including impervious gloves 

and respiratory personal protective 

equipment including a NIOSH-approved 

respirator; required establishment of a 

hazard communication program; 

prohibited non-industrial use; 

established maximum production 

volume limits for submission of 

required testing; established 

requirements for release to surface 

waters during manufacturing and 

allowed no release to surface waters 

during processing and use. On February 

4, 2008, EPA received a SNUN, S–08– 

3, for the chemical substance. The 

significant new use identified in the 

notice was a non-industrial use. The 90- 

day review period for the SNUN expired 

on October 2, 2008, with EPA not taking 

action on the ‘‘significant new use’’ of 

the industrial use described in the 

SNUN. The proposed SNUR designates 

as a ‘‘significant new use’’ any nonindustrial use other than as described in 

the SNUN and retains the other 

significant new uses which are the 

absence of the other protective measures 

required in the consent order. 

Recommended testing: EPA has 

determined that the results of a 90-day 

oral subchronic study with special 

attention given to the pathology of the 

reproductive organs (OPPTS Test 

Guideline 870.3100), a two-year twospecies oral carcinogenicity study 

(OPPTS Test Guideline 870.4200), a fish 

acute toxicity test (OPPTS Test 

Guideline 850.1075), an aquatic 

invertebrate acute toxicity text (OPPTS 

Test Guideline 850.1010) and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help further 

characterize the human health and 

environmental effects of the PMN 

substance. The consent order requires 

the PMN submitter to conduct the 90- 

day oral toxicity test (OPPTS Test 

Guideline 870.3100) before exceeding 

the confidential production limit in the 

consent order. 

CFR citation: 40 CFR 721.5575. 

PMN Number P–95–638 and SNUN 

Numbers P–97–79 and S–06–8 

Chemical name: Pentane 

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

CAS number: 138495–42–8. 

Federal Register publication date and 

reference: January 22, 1998 (63 FR 3394) 

(FRL–5720–3). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance for the 

PMN is as a carrier fluid and for the two 

SNUNs the generic (non-confidential) 

use is as test media. The original SNUR 

was issued based on meeting the 

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

The original SNUR required notification 

if the chemical substance was used for 

uses other than described in the PMN or 

the first SNUN P–97–79 (at that time 

SNUNs were designated with a ‘‘P’’ 

number; later submissions received an 

‘‘S’’ designation). On February 4, 2008, 

EPA received a second SNUN, S–06–8, 

for the subject chemical substance. The 

significant new use identified in S–06– 

8 was the specific confidential use 

described in the notice. The 90-day 

review period for the SNUN expired on 

July 17, 2006, with EPA not taking 

action on the significant new use 

described in the SNUN. The proposed 

SNUR designates as a significant new 

use, any use other than the uses 

described in the PMN and the SNUNs. 

Recommended testing: None. 

CFR citation: 40 CFR 721.5645. 

PMN Number P–00–1220 and SNUN 

Number S–07–2 

Chemical name: Phenol-biphenyl 

polymer condensate (generic). 

CAS number: Claimed confidential. 

Federal Register publication date and 

reference: August 20, 1998 (63 FR 

44562) (FRL–5788–7). 

Basis for the modified significant new 

use rule: The use of the chemical 

substance for the PMN is in electric 

molding and for the SNUN is as a 

component in photoresist manufacture. 

The original SNUR was issued based on 

meeting the concern criteria at 

§ 721.170(b)(4)(ii). The original SNUR 

required notification if the PMN 

substance was released to water. On 

January 8, 2007, EPA received SNUN, 

S–07–2, for the chemical substance 

describing releases to water. The 90-day 

review period for the SNUN expired 

with the Agency not taking action on 

the significant new uses described in 

the SNUN because the water releases 

did not exceed 1 ppb, the Agency’s 

surface water concentration of concern 

for adverse effects of the substance to 

aquatic organisms. The PMN submitter 

subsequently submitted a fish early-life 

stage ecotoxicity study for the chemical 

substance. Based on this submitted 

study and structural analogy to phenols, 

EPA is still concerned that toxicity to 

aquatic organisms may occur at a 

concentration of 5 ppb in surface 

waters. Because EPA finds that the 

chemical substance is not released to 

surface waters above 5 ppb as described 

in the PMN and SNUN, EPA has not 

determined that the proposed 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that other uses of the 

substance may cause significant adverse 

environmental effects. Based on this the 

substance meets the concern criteria at 

§ 721(b)(4)(i) and (b)(4)(ii). Based on 

these findings, EPA is proposing to 

modify the SNUR to require notification 

if water releases exceed 5 ppb in surface 

waters. 

Recommended testing: EPA has 

determined that an aquatic invertebrate 

acute toxicity text (OPPTS Test 

Guideline 850.1010) and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help further 

characterize the environmental effects of 

the chemical substance. 

CFR citation: 40 CFR 721.5713. 

PMN Number P–01–320 and SNUN 

Numbers S–04–2 and S–11–1 

Chemical name: 

Propane,1,1,1,2,2,3,3-heptafluoro-3- 

methoxy-. 


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CAS number: 375–03–1. 

Federal Register publication date and 

reference: December 17, 2003 (68 FR 

70155) (FRL–7307–3). 

Basis for the modified significant new 

use rule: The use of the chemical 

substance for the PMN is as a heat 

transfer fluid and a refrigerant. The use 

for S–04–2 is for aerosol spray cleaning. 

The use for S–11–1 is for flush cleaning, 

foam blowing, deposition coatings, 

histology baths, and vapor degreasing. 

The original SNUR was issued based on 

meeting the concern criteria at § 721.170 

(b)(3)(i) and (b)(3)(ii). The original 

SNUR required notification if the 

chemical substance was used other than 

as a heat transfer fluid or refrigerant, or 

if the annual production volume 

exceeded 100,000 kilograms. On March 

29, 2004, EPA received SNUN, S–04–2, 

for the chemical substance describing a 

new use of aerosol spray cleaning for 

industrial and commercial use. The 90- 

day review period for the SNUN expired 

on June 26, 2004 with EPA not taking 

action on the significant new use of 

aerosol spray cleaning for industrial and 

commercial use. On January 4, 2011, 

EPA received a SNUN, S–11–1, for the 

chemical substance describing new uses 

of flush cleaning, foam blowing, 

deposition coatings, histology baths, 

and vapor degreasing and exceeding an 

annual production volume of 100,000 

kilograms. The 90-day review period for 

S–11–1 expired on September 23, 2011 

with EPA not taking action on the 

significant new uses described in the 

SNUN. EPA continues to identify health 

concerns for liver and kidney toxicity 

based on submitted test data on the 

chemical substance and cardiac 

sensitization and developmental 

toxicity based on analog data. For the 

uses described in the PMN and SNUNs, 

significant occupational exposure is not 

expected. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use will 

present an unreasonable risk. EPA has 

determined, however, that any uses of 

the substance other than those described 

in the PMN and SNUNs may result in 

serious health effects. Based on this 

information, the PMN substance meets 

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

and (b)(3)(ii). The proposed SNUR 

modification designates as a ‘‘significant 

new use’’ any use other than the uses 

described in the PMN and SNUNs. The 

proposed SNUR modification no longer 

designates the significant new use of 

exceeding an annual production volume 

of 100,000 kilograms. 

Recommended testing: EPA has 

determined that the results of a 90-day 

oral subchronic study (OPPTS Test 

Guideline 870.3100) would help to 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.8145. 

PMN Number P–01–781 

Chemical name: Silane, triethoxy[3- 

oxiranylmethoxy)propyl]-. 

CAS number: 2602–34–8. 

Federal Register publication date and 

reference: Dec. 17, 2003 (68 FR 70155) 

(FRL–7307–3). 

Basis for the modified significant new 

use rule: The original SNUR was issued 

resulting in listing the incorrect CAS 

number as 2602–34–2 for the chemical 

substance in the Code of Federal 

Regulations. The proposed SNUR 

modification is designating the correct 

CAS number of 2602–34–8. The original 

findings and requirements of the SNUR 

are the same. 

CFR citation: 40 CFR 721.9501. 

PMN Number P–00–1132 and SNUN 

Number S–11–5 

Chemical name: Siloxanes and 

silicones, aminoalkyl, fluorooctyl, 

hydroxy-terminated salt (generic). 

CAS number: Claimed confidential. 

Federal Register publication date and 

reference: March 28, 2003 (68 FR 15061) 

(FRL–6758–7). 

Basis for the modified significant new 

use rule: The use of the chemical 

substance for the PMN is in anti-graffiti 

systems and for the SNUN is as a 

surface treatment and additive for 

coatings, adhesives, sealants, paste, 

insulation and textiles for porous, nonporous, ceramic, metal, glass, plastic, 

wood and leather surfaces; and a surface 

treatment agent for inorganic filler 

particles. The original SNUR was issued 

based on meeting the concern criteria at 

§ 721.170 (b)(3)(ii). The original SNUR 

required notification if the chemical 

substance was used for use other than 

described in PMN or for an application 

that generates a vapor, mist, or aerosol. 

On January 5, 2011, EPA received a 

SNUN, S–11–5, for the chemical 

substance describing uses different than 

those in the PMN. EPA also reviewed a 

90-day inhalation study that was 

submitted for the substance in the 

SNUN. The results of the study 

demonstrated a Lowest Observed 

Adverse Effect Level (LOAEL) of 30 

milligram/cubic meter (mg/m3) for lung 

effects. The 90-day review period for the 

SNUN expired with the Agency not 

taking action on the significant new 

uses described in the SNUN. Since EPA 

continues to find that significant worker 

exposure is unlikely when used as 

described in the PMN and SNUN, EPA 

has not determined that the proposed 

manufacturing, processing, and use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that other uses of the 

substance or applications that generate 

a vapor, mist, or aerosol could result in 

exposures which may cause serious 

health effects. Based on this information 

the substance meets the concern criteria 

at § 721(b)(3)(ii). Based on these 

findings, EPA is proposing to modify 

the SNUR to require notification for any 

uses other than described in the PMN 

and the SNUN. 

Recommended Testing: EPA has 

determined that the results of a 

decomposition kinetics by thermo 

gravimeter (ASTM Test Guideline 

E1641), a compositional analysis by 

thermo gravimeter (ASTM Test 

Guideline E1131), and a laboratory burn 

test by a protocol to be agreed upon by 

EPA and the company conducting the 

study, would help to further 

characterize the environmental fate of 

the PMN substance. 

CFR citation: 40 CFR 721.9502. 

PMN Numbers P–97–296, P–97–297, P– 

97–298, and P–97–299 and SNUN 

Numbers S–03–10, S–03–11, S–03–12, 

and S–03–13 

Chemical name: Benzenesulfonic 

acid, mono C-10–16 -alkyl derivs., 

compds. with 2-propen-1-amine (PMN 

P–97–296 and SNUN S–03–10) and 

Alkyl benzene sulfonic acids and alkyl 

sulfates, amine salts (PMN P–97–297/

298/299 and SNUN S–03–11/12/13). 

CAS number: 195008–77–6 (PMN P– 

97–296 and SNUN S–03–10) and 

Claimed confidential (PMN P–97– 

297/298/299 and SNUN S–03–11/12/

13). 

Federal Register publication date and 

reference: August 20, 1998 (63 FR 

44562) (FRL–5788–7). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substances for the 

PMNs and the SNUNs is as a processing 

aid. The original SNUR was issued 

based on meeting the concern criteria at 

§ 721.170 (b)(4)(i) and (b)(4)(ii). The 

original SNUR required notification if 

the PMN substances were released to 

water. On March 4, 2003, EPA received 

SNUNs S–03–10, S–03–11, S–03–12, 

and S–03–13 for the chemical 

substances describing releases to water. 

The 90-day review period for the 

SNUNs expired with EPA not taking 

action on the significant new uses 

described in the SNUNs because the 

water releases did not exceed 30 ppb. 

Based on submitted data and structural 

analogy to anionic surfactants, EPA is 

still concerned that toxicity to aquatic 

organisms may occur at a concentration 

of 30 ppb in surface waters. Because 

EPA finds that the substances are not 


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released to surface waters above 30 ppb 

as described in the PMN and SNUN, 

EPA has not determined that the 

proposed manufacturing, processing, 

and use of the substances may present 

an unreasonable risk. EPA has 

determined, however, that other uses of 

the substances may cause significant 

adverse environmental effects. Based on 

this the substances meet the concern 

criteria at § 721.170 (b)(4)(i) and 

(b)(4)(ii). Based on these findings EPA is 

proposing to modify the SNUR to 

require notification if water releases 

exceed 30 ppb in surface waters. 

Recommended testing: EPA has 

determined that a fish acute toxicity test 

(OPPTS Test Guideline 850.1075), an 

aquatic invertebrate acute toxicity text 

(OPPTS Test Guideline 850.1010) and 

an algal toxicity test (OCSPP Test 

Guideline 850.4500) would help further 

characterize the human health and 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.9595. 

PMN Number P–90–226 and SNUN 

Numbers P–96–1408, S–08–6, S–09–4, 

and S–13–49 

Chemical name: Titanate [Ti6O13 (2-)], 

dipotassium. 

CAS number: 12056–51–8. 

Federal Register publication date and 

reference: August 13, 1991 (56 FR 

40204). 

Basis for the modified significant new 

use rule: The generic use of the 

chemical substance is as a friction 

material. A consent order was issued 

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

5(e)(l)(A)(ii)(I) of TSCA based on a 

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, EPA issued a TSCA section 5(e) 

consent order which became effective 

on February 21, 1991. The order 

required the establishment of a hazard 

communication program; prohibited 

domestic manufacturing; prohibited 

non-industrial use; established 

maximum production volume limits for 

submission of required testing; 

prohibited manufacture other than by 

the manufacturing method in P–90–226; 

and required the bulk density 

measurements of the PMN substance in 

the pure form to be less than 0.4 gram/ 

cubic centimeter (g/cm3). A SNUR was 

issued for this chemical substance on 

August 13, 1991. The SNUR designated 

as a ‘‘significant new use’’ the absence 

of the protective measures required in 

the consent order. On July 15, 1996, 

EPA received a SNUN, P–96–1408 (at 

that time SNUNs were designated with 

a ‘‘P’’ number; later submissions 

received an ‘‘S’’ designation); on June 

23, 2008, EPA received S–08–6; on 

March 30, 2009, EPA received S–09–4; 

and on July 17, 2013, EPA received S– 

13–49 for the chemical substance. The 

significant new use for each SNUN was 

a manufacturing method other than 

described in P–90–226. EPA took no 

action during the 90-day review periods 

for the SNUNs and allowed the 

significant new uses because EPA 

determined that none of the 

manufacturing processes produced 

respirable acicular fibers with an 

average aspect ratio of less than 5, and 

as a result were not considered by EPA 

to pose an unreasonable risk of lung 

toxicity to workers. In addition, a 90- 

day inhalation study was submitted by 

the PMN submitter under the terms of 

the TSCA section 5(e) consent order and 

an intratracheal instillation study 

submitted by the submitter of S–09–4 

demonstrated no evidence of fibrosis in 

test animals. The proposed SNUR 

modification designates as a significant 

new use any domestic manufacture, 

non-industrial use, any manufacturing 

process other than described in the 

PMN and the SNUNs, and any 

manufacture that produces respirable, 

acicular fibers with an average aspect 

ratio greater than 5. The proposed SNUR 

modification no longer designates 

establishment of a hazard 

communication program or exceeding 

an aggregate production volume limit as 

a significant new use. 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) and a 

carcinogenicity test (OPPTS Test 

Guideline 870.4200) via the inhalation 

route would help characterize the 

potential human health effects of the 

chemical substance from alternate 

methods of manufacture. 

CFR citation: 40 CFR 721.9675. 

PMN Number P–93–1649 and SNUN 

Numbers S–04–3 and S–11–3 

Chemical name: 1,3-Dimethyl-2- 

imidazolidinone. 

CAS number: 80–73–9. 

Federal Register publication date and 

reference: August 30, 1995 (60 FR 

45072) (FRL–4926–2). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance for the 

PMN is as a process raw material and 

for the SNUNs is as a printing ink 

ingredient. The consent order was 

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

5(e)(l)(A)(ii)(I) of TSCA based on a 

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, EPA issued a TSCA section 5(e) 

consent order which became effective 

on August 25, 1994. The order required 

the use of dermal personal protective 

equipment (including gloves 

demonstrated to be impervious) and 

required establishment of a hazard 

communication program; prohibited 

domestic manufacture; prohibited nonindustrial uses; and established 

maximum production volume limits for 

submission of required testing. The 

SNUR issued for this chemical 

substance on August 30, 1995, 

designated as a significant new use the 

absence of the protective measures 

required in the consent order. On 

August 16, 2004, EPA received S–04–3 

and on October 21, 2010, EPA received 

S–11–3 for the chemical substance. The 

significant new use for both SNUNs was 

a non-industrial use. The 90-day review 

period for both SNUNs expired with the 

Agency not taking action on the 

significant new uses described in the 

SNUNs. The PMN submitter conducted 

a dermal developmental toxicity study 

and a 90-day dermal subchronic study 

on the PMN substance. The results of 

the developmental study was a maternal 

chronic toxicity NOAEL of 10 mg/kg/

day and a development toxicity NOAEL 

of 100 mg/kg/day. The results of the 90- 

day dermal study was a NOAEL of 500 

mg/kg/day. Because EPA continues to 

find that dermal exposures may cause 

an unreasonable risk of human health 

effects, EPA is proposing to modify the 

SNUR to allow the commercial use 

(specific use claimed confidential) as 

described in the SNUNs but is retaining 

all other significant new uses and 

requirements in the SNUR. 

Recommended testing: None. 

CFR citation: 40 CFR 721.9892. 

PMN Number P–00–1121 

Chemical name: Manganese strontium 

oxide (MnSrO3). 

CAS number: 12163–45–0. 

Federal Register publication date and 

reference: March 29, 2007 (72 FR 14681) 

(FRL–7699–5). 

Basis for the modified significant new 

use rule: The generic (non-confidential) 

use of the chemical substance is as a 

pigment. A consent order was issued 

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

5(e)(l)(A)(ii)(I) of TSCA based on a 

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the order 

required establishment of a hazard 

communication program; established 

maximum aggregate volume limits for 

submission of required testing; limited 

release to surface waters; and prohibited 

manufacture, process, or use of the PMN 

substance if the particle size is less than 


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10 microns. EPA received a 96-hour 

toxicity test with rainbow trout for the 

chemical substance. No mortality was 

observed at concentrations up to the 

highest concentration tested of 16,000 

milligram/Liter (mg/L). Based on these 

test results, EPA modified the consent 

order to remove the aggregate volume 

limit and the surface water release 

limits. The modified consent order 

retains the hazard communication 

requirements and the particle size 

limitations to continue to prevent any 

unreasonable risk of injury to human 

health. The proposed SNUR 

modification designates as a significant 

new use the absence of the protective 

measures in the modified consent order. 

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity study with a 60-day holding 

period (OPPTS Test Guideline 

870.3465) and a two-year inhalation 

carcinogenicity study (OPPTS Test 

Guideline 870.4200) would help to 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10008. 

PMN Number P–07–601 and SNUN 

Number S–14–11 

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

tetrafluoro-. 

CAS number: 754–12–1. 

Federal Register publication date and 

reference: October 27, 2010 (75 FR 

65987) (FRL–8846–8) and November 1, 

2013 (78 FR 65570) (FRL–9901–97). 

Basis for modification of the SNUR: 

The use of the chemical substance for 

the PMN was as a refrigerant in motor 

vehicle air conditioning systems in new 

passenger cars and vehicles and the use 

for the SNUN was as a refrigerant for 

stationary refrigeration and stationary 

air conditioning. The original SNUR 

was issued based on meeting the 

concern criteria at § 721.170. The 

original SNUR required notification if 

the chemical substance was used for 

uses other than as described in the 

PMN. On May 12, 2014 EPA received a 

SNUN, S–14–11, for the chemical 

substance describing uses different than 

those in the PMN. The 90-day review 

period for the SNUN expired with EPA 

not taking action on the significant new 

uses described in the SNUN. Based on 

toxicity test data conducted on the PMN 

substance, EPA is still concerned that 

toxicity to humans may occur at 

inhalation exposures of 1,900 ppm. 

Because EPA finds that exposures from 

uses described in either the PMN or the 

SNUN do not result in human exposures 

that cause an unreasonable risk to 

human health, EPA has not determined 

that the proposed manufacturing, 

processing, and use of the substance, 

including certain commercial, and 

consumer uses of the substance, may 

cause significant adverse health effects. 

Based on this the substance meets the 

concern criteria at § 721.170. Based on 

these findings, EPA is proposing to 

modify the SNUR to allow the uses 

described in S–14–11. 

CFR citation: 40 CFR 721.10182. 

PMN Numbers P–10–486 and P–10–487 

Chemical name: Poly[oxy(methyl-1,2- 

ethanediyl)], .alpha.-sulfo-.omega.- 

hydroxy-, C12–13-branched and linear 

alkyl ethers, sodium salts (P–10–486) 

and Poly[oxy(methyl-1,2-ethanediyl)], 

.alpha.-sulfo-.omega.-hydroxy-, C14–15- 

branched and linear alkyl ethers, 

sodium salts (P–10–487). 

CAS number: 958238–81–8 (P–10– 

486) and 958238–82–9 (P–10–487). 

Federal Register publication date and 

reference: April 4, 2012 (77 FR 20296) 

(FRL–9333–3). 

Basis for the modified significant new 

use rule: The PMNs state that the use of 

these substances will be for downhole 

injection for enhanced oil recovery. 

Based on structure activity relationship 

analysis of test data on analogous 

anionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 28 ppb for 

P10–486 and 4 ppb for P10–487 in 

surface waters. The order was issued 

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

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

on a finding that these substances may 

present an unreasonable risk of injury to 

the environment and will be produced 

in substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities. 

To protect against these risks, the 

Agency issued a TSCA section 5(e) 

consent order which became effective 

on July 22, 2011. To protect against the 

risk, the order requires certain hazard 

communication requirements, specific 

disposal requirements for processing 

and use, and prohibits releases from 

manufacture of the PMN substances 

resulting in surface water 

concentrations exceeding 28 ppb for P– 

10–486 and 4 ppb for P–10–487. A 

SNUR was issued for this chemical 

substance on April 4, 2012. The SNUR 

designated as a ‘‘significant new use’’ 

the absence of any of these measures 

required in the consent order. 

EPA had evaluated the results of a 

combined biodegradation and aquatic 

toxicity test for P–10–486 during PMN 

review. The test was submitted as part 

of the PMN submissions. During the 

review, EPA accepted the data as valid 

for purposes of ascertaining the 

environmental fate of the PMN 

substances (the overall rate of ready 

biodegradation), but not for purposes of 

determining potential environmental 

toxicity of the transformation products 

to aquatic organisms. Subsequent to 

issuance of the SNUR, and based on 

discussions with the Company and 

other PMN submitters, EPA re-evaluated 

the data and determined that the data 

could be used to evaluate the aquatic 

toxicity of the PMN transformation 

products. The combined 

biodegradation/ecological toxicity 

testing demonstrated that, subsequent to 

the biodegradation portion of the 

combined study, no further ecologically 

toxic substances remained from the P– 

10–486 parent substance. EPA also 

believes the results of the test data for 

P–10–486 apply to the structurally 

analogous P–10–487 substance. Based 

on this evaluation EPA did not find that 

the PMN substances present an 

unreasonable risk to the environment or 

human health or will be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities 

based on activities described in the 

PMN. As a result EPA revoked the 

consent order. EPA has determined, 

however, that other uses of the 

substances may cause significant 

adverse environmental effects. Based on 

this information, the chemical 

substances meets the concern criteria at 

§ 721.170(b)(4)(i) and (b)(4)(ii). Based on 

these findings EPA is proposing to 

modify the SNUR to require notification 

of any use of the substances without 

disposal by incineration or injection 

into a Class I or II waste disposal well; 

release to water without prior biological 

treatment (activated sludge or 

equivalent) plus clarification; or nonindustrial use. 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater (OPPTS 

Test Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II (OPPTS Test 

Guideline 850.5400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10283 and 

721.10284. 

PMN Numbers P–10–58, P–10–59, P–10– 

60, and P–10–184 

Chemical names: Partially fluorinated 

alcohol substituted glycols (generic). 

CAS numbers: Not available. 

Federal Register publication date and 

reference: September 11, 2013 (78 FR 

55632) (FRL–9398–7). 

Basis for the modified significant new 

use rule: The PMNs state that the 


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generic (non-confidential) uses of P–10– 

58 and P–10–59 will be as intermediates 

in the manufacture of P–10–60, and the 

generic use of P–10–60 and P–10–184 

will be as a surface active agent or 

surfactant. 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, 

which 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, mammals, and birds. These 

concerns are based on data on analogous 

chemical substances, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated alkyls, including 

the presumed environmental degradant. 

The orders were 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 risks, the consent order for P–10– 

58/59/60 requires manufacture (which 

includes import) of the PMN substances 

according to the chemical synthesis and 

composition section of the TSCA 

section 5(e) consent order, including 

analysis, reporting, and limitations of 

maximum impurity levels of certain 

fluorinated impurities, restricts the use 

of P–10–58 and P–10–59 as 

intermediates to make P–10–60, and 

submission of testing on the PMN 

substance P–10–60 at five identified 

aggregate manufacture volumes. A 

SNUR was issued for these chemical 

substances on September 11, 2013 

designating as significant new uses the 

absence of these measures. To protect 

against potential risks, the consent order 

for P–10–184 requires manufacture of 

the PMN substance according to the 

chemical synthesis and composition 

section of the TSCA section 5(e) consent 

order, including analysis, reporting, and 

limitations of maximum impurity levels 

of certain fluorinated impurities and 

manufacture of P–10–184 only when the 

mean number of moles of the ethoxy 

group is between 3 and 11 or the 

average number molecular weight is 

between 496 and 848 daltons based on 

the amounts of raw materials charged to 

the reactor. EPA is modifying the SNUR 

to add P–10–184 because it is the same 

chemical substance as P–10–60 and to 

make the SNUR requirements consistent 

with both consent orders by proposing 

to add a significant new use that 

requires reporting if P–10–60/P–10–184 

are manufactured other than when the 

mean number of moles of the ethoxy 

group is between 3 and 11 or the 

average number molecular weight is 

between 496 and 848 daltons. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the TSCA section 

5(e) consent orders would help 

characterize possible effects of the PMN 

substances and their degradation 

products. The TSCA section 5(e) 

consent order for P–10–58/59/60 

contains five production volume limits. 

The PMN submitter has agreed not to 

exceed the confidential production 

volume limits without performing the 

specified testing on PMN substance P– 

10–60. Additional testing is included in 

the preambles to the TSCA section 5(e) 

consent orders but this testing is not 

required at any specified time or 

production volume. However, the TSCA 

section 5(e) consent order restrictions 

on manufacture, processing, distribution 

in commerce, use, and disposal of the 

PMN substances will remain in effect 

until the TSCA section 5(e) consent 

orders are modified or revoked by EPA 

based on submission of that or other 

relevant information. 

CFR citation: 40 CFR 721.10515. 

V. Rationale for the Proposed Rule 

Pursuant to § 721.185 and as 

described in Unit IV, this proposed rule 

includes 23 chemical substances where 

EPA determined, based on new 

information, there is no need to require 

additional notice from persons who 

propose to engage in identical or similar 

activities, or a rational basis no longer 

exists for the findings that activities 

involving the substance may present an 

unreasonable risk of injury to human 

health or the environment required 

under section 5(e)(1)(A) of the Act. 

This proposed rule also includes a 

chemical substance, P–01–781, where 

EPA is modifying the chemical identity 

information. 

VI. Applicability of the Proposed Rule 

to Uses Occurring Before Effective Date 

of the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. EPA solicits comments on 

whether any of the uses proposed as 

significant new uses are ongoing. As 

discussed in the Federal Register issue 

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 the 

proposed SNUR rather than as of the 

effective date of the final 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 

proposed significant new use before the 

rule became effective, and then argue 

that the use was ongoing as of the 

effective date of the final rule. 

Thus, any persons who begin 

commercial manufacture or processing 

activities with the chemical substances 

that are not currently a significant new 

use under the current rule but which 

would be regulated as a ‘‘significant 

new use’’ if this proposed rule is 

finalized, must cease any such activity 

as of the effective date of the rule if and 

when finalized. To resume their 

activities, these persons would have to 

comply with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person were to meet the conditions of 

advance compliance under § 721.45(h), 

the person would be considered to have 

met the requirements of the final SNUR 

for those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require the development of any 

particular test data before submission of 

a SNUN. 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 


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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 this case, EPA recommends persons, 

before performing any testing, to consult 

with the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. ASTM 

International standards are available at 

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

index.shtml. 

The recommended testing specified in 

Unit IV. of the proposed rule may not 

be the only means of addressing the 

potential risks of the chemical 

substance. However, SNUNs submitted 

without any test data may increase the 

likelihood that EPA will take action 

under TSCA section 5(e), particularly if 

satisfactory test results have not been 

obtained from a prior PMN or SNUN 

submitter. EPA recommends that 

potential SNUN submitters contact EPA 

early enough so that they will be able 

to conduct the appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be on EPA 

Form No. 7710–25, generated using ePMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in 40 CFR 721.25 

and 40 CFR 720.40. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

IX. Economic Analysis 

EPA evaluated the potential costs of 

SNUN requirements for potential 

manufacturers and processors of the 

chemical substances in the proposed 

rule. The Agency’s complete Economic 

Analysis is available in the docket 

under docket ID number EPA–HQ– 

OPPT–2014–0649. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed action would modify 

SNURs for 24 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 (PRA) 

According to 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 (RFA) 

On February 18, 2012, EPA certified 

pursuant to RFA section 605(b) (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 proposed rule is within the 

scope of the February 18, 2012 

certification. Based on the Economic 

Analysis discussed in Unit IX. 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 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

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 

final rule. As such, EPA has determined 

that this rule would 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, 


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or 205 of the UMRA sections 202, 203, 

204, or 205 (2 U.S.C. 1501 et seq.). 

E. Executive Order 13132 

This action would 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 proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would 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 proposed 

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 (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

NTTAA 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). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: April 1, 2015. 

Maria J. Doa, 

Director, Chemical Control Division, Office 

of Pollution Prevention and Toxics. 

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows: 

PART 721—[AMENDED] 

■ 1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 2. Amend § 721.522 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.522 Oxirane, methyl-, polymer with 

oxirane, mono (3,5,5,-trimethylhexyl) ether. 

(a) * * * (1) The chemical substance 

identified as oxirane, methyl-, polymer 

with oxirane, mono (3,5,5,- 

trimethylhexyl) ether (PMN P–99–669, 

SNUN S–09–1, and SNUN S–13–29; 

CAS No. 204336–40–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is use other than as a wetting agent, 

dispersing agent and defoaming/

deaerating agent in waterborne coatings, 

inks, and paints, water based adhesives, 

and ultraviolet curable coatings; wetting 

agent in water miscible metalworking 

fluids, powdered construction additives 

for use in cementitious mortars, grouts 

and tile adhesives, and in liquid 

admixtures for concrete; and a substrate 

wetting and anticratering additive for 

ultraviolet curable inkjet ink. 

* * * * * 

■ 3. Amend § 721.532 as follows: 

■ a. Revise the section heading. 

■ b. Revise paragraph (a)(1). 

■ c. Revise paragraph (a)(2)(i). 

■ d. Add paragraph (a)(3). 

■ e. Revise paragraph (b)(1). 

The revisions and addition read as 

follows: 

§ 721.532 1-Butanol, 3-methoxy-3-methyl-, 

acetate. 

(a) * * * (1) The chemical substance 

identified as 1-butanol, 3-methoxy-3- 

methyl-, acetate (PMN P–00–618; SNUN 

S–05–03; and SNUN S–11–4; CAS No. 

103429–90–9) is subject to reporting 

under this section for the significant 

new uses described in paragraphs (a)(2) 

and (a)(3) of this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. The significant 

new use is any use other than the use 

described in P–00–618. 

* * * * * 

(3) The significant new uses for any 

use other than the use described in P– 

00–618: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3)(i), (b) 

(concentration set at 0.1 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. Butyl rubber 

gloves with a minimum thickness of 

16.6 mils or Silver shield gloves with a 

minimum thickness of 2.7 mils have 

been tested in accordance with the 

American Society for Testing Materials 

(ASTM) F739 method and found by EPA 

to satisfy the consent orders and 

§ 721.63(a)(2)(i) requirements for dermal 

protection to 100 percent chemical 

substance. Silver Shield gloves with a 

minimum thickness of 2.7 mils have 

been tested in accordance with the 

American Society for Testing Materials 

(ASTM) F739 method and found by EPA 

to satisfy the consent orders and 

§ 721.63(a)(2)(i) requirements for dermal 

protection for paint formulations where 

concentrations of the chemical 

substance is 10% or less. Gloves and 

other dermal protection may not be used 

for a time period longer than they are 

actually tested and must be replaced at 

the end of each work shift. 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b) (concentration set at 0.1 

percent), (c), (d), (f), (g)(1)(iv), (g)(1)(iv), 

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

(g)(2)(v), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (o), and any 

application method that generates a 

vapor, mist, or aerosol when the percent 

concentration of the SNUN substance in 

the final product exceeds 10%. 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 


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

manufacturers and processors of this 

substance. 

* * * * * 

■ 4. Amend § 721.633 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

■ c. Remove paragraph (a)(2)(iii). 

■ d. Revise paragraph (b)(1). 

The revisions read as follows: 

§ 721.633 Aluminosilicates, phospho-. 

(a) * * *. (1) The chemical substance 

identified as aluminosilicates, phospho- 

(PMN P–98–1275 and SNUN S–11–10; 

CAS No. 201167–69–3) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4) engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 50 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 powered air-purifying 

respirator equipped with a tight-fitting 

full facepiece and high efficiency 

particulate air (HEPA) filters; NIOSHcertified supplied-air respirator 

operated in positive pressure demand or 

continuous flow mode and equipped 

with a hood, or helmet or tight-fitting 

facepiece. As an alternative to the 

respiratory requirements listed here, a 

manufacturer or processor may choose 

to follow the New Chemical Exposure 

Limit (NCEL) provisions listed in the 

TSCA section 5(e) consent order for 

these substances. The NCEL is 0.1 mg/ 

m3 as an 8-hour time weighted average 

verified by actual monitoring data. 

* * * * * 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (f), (g), and (h) 

are applicable to manufacturers and 

processors of this substance. 

* * * * * 

■ 5. Amend § 721.2076 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.2076 D-Glucuronic acid, polymer 

with 6-deoxy-L-mannose and D-glucose, 

acetate, calcium magnesium potassium 

sodium salt. 

(a) * * *. (1) The chemical substance 

identified as D-Glucuronic acid, 

polymer with 6-deoxy-L-mannose and 

D-glucose, acetate, calcium magnesium 

potassium sodium salt (PMN P–00–7; 

SNUN S–05–1; SNUN S–06–4; SNUN 

S–07–03; and SNUN S–07–5; CAS No. 

125005–87–0) is subject to reporting 

under this section for the significant 

new use described in paragraph (a)(2) of 

this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 The significant 

new use is any use other than 

manufacture of the substance where 

greater than 5 percent of the chemical 

substance consists of particle sizes 

below 10 microns. 

* * * * * 

■ 6. Amend § 721.5185 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(iii). 

■ c. Add paragraph (a)(2)(iv). 

■ d. Revise paragraph (b)(1). 

The revisions and additions read as 

follows: 

§ 721.5185 2-Propen-1-one, 1-(4- 

morpholinyl)-. 

(a) * * * (1) The chemical substance 

identified as 2-Propen-1-one, 1-(4- 

morpholinyl)- (PMN P–95–169; SNUN 

S–08–7; and SNUN S–14–1; CAS No. 

5117–12–4) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this rule do 

not apply to quantities of the chemical 

substance after it has been completely 

reacted (cured) because 2-Propen-1-one, 

1-(4-morpholinyl)- will no longer exist. 

(2) * * * 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(1). It is a 

significant new use to use the chemical 

substance for any use other than as a 

monomer for use in ultraviolet ink jet 

applications unless the chemical 

substance is processed and used in an 

enclosed process. 

(iv) Release to water. Requirements as 

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

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

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this chemical substance. 

* * * * * 

■ 7. Amend § 721.5575 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(iii). 

The revisions read as follows: 

§ 721.5575 Oxirane, 2,2′-(1,6-hexanediylbis 

(oxymethylene)) bis-. 

(a) * * * (1) The chemical substance 

identified as oxirane, 2,2′-(1,6- 

hexanediylbis(oxymethylene))bis- (PMN 

P–88–2179; PMN P–89–539; and SNUN 

S–08–3; CAS No. 16096–31–4) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). A significant 

new use of the chemical substance is 

any non-industrial use other than the 

commercial use described in S–08–3. 

* * * * * 

■ 8. Amend § 721.5645 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.5645 Pentane 1,1,1,2,3,4,4,5,5,5,- 

decafluoro. 

(a) * * * (1) The chemical substance 

identified as pentane 1,1,1,2,3,4,4,5,5,5,- 

decafluoro (PMN P–95–638, SNUN P– 

97–79, and SNUN S–06–8; CAS No. 

138495–42–8) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use of the substance other 

than the uses as described in P–95–638, 

P–97–79, or S–06–8. 

* * * * * 

■ 9. Amend § 721.5713 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.5713 Phenol—biphenyl polymer 

condensate (generic). 

(a) * * * (1) The chemical substance 

identified generically as a phenol— 

biphenyl polymer condensate (PMN P– 

00–1220 and S–07–2) is subject to 

reporting under this section for the 

significant new use described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Release to water. Requirements as 

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

(N = 5). 

* * * * * 

■ 10. Amend § 721.8145 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 


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Federal Register / Vol. 80, No. 68 / Thursday, April 9, 2015 / Proposed Rules 19049 

§ 721.8145 Propane,1,1,1,2,2,3,3- 

heptafluoro-3-methoxy-. 

(a) * * * (1) The chemical substance 

identified as propane,1,1,1,2,2,3,3- 

heptafluoro-3-methoxy- (PMN P–01– 

320; SNUN S–04–2; and SNUN 11–1; 

CAS No. 375–03–1) is subject to 

reporting under this section for the 

significant new use described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use is any use of the chemical substance 

other than as a heating transfer fluid, 

refrigerant, flush cleaning, foam 

blowing, deposition coatings, histology 

baths, vapor degreasing, and industrial 

and commercial aerosol spray cleaning. 

* * * * * 

■ 11. Amend § 721.9501 by revising 

paragraph (a)(1) to read as follows: 

§ 721.9501 Silane, triethoxy[3- 

oxiranylmethoxy)propyl]-. 

(a) * * * (1) The chemical substance 

identified as silane, triethoxy[3- 

oxiranylmethoxy)propyl]- (PMN P–01– 

781; CAS No. 2602–34–8) is subject to 

reporting under this section for the 

significant new use described in 

paragraph (a)(2) of this section. 

* * * * * 

■ 12. Amend § 721.9502 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.9502 Siloxanes and silicones, 

aminoalkyl, fluorooctyl, hydroxy-terminated 

salt (generic). 

(a) * * * (1) The chemical substance 

identified generically as siloxanes and 

silicones, aminoalkyl, fluorooctyl, 

hydroxy-terminated salt (PMN P–00– 

1132 and SNUN S–11–5) is subject to 

reporting under this section for the 

significant new use described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(y)(1). A significant 

new use is any use of the chemical 

substance other than in graffiti systems, 

as surface treatment and additive for 

coatings, adhesives, sealants, paste, 

insulation and textiles for porous, nonporous, ceramic, metal, glass, plastic, 

wood and leather surfaces or a surface 

treatment agent for inorganic filler 

particles. 

* * * * * 

■ 13. Amend § 721.9595 as follows: 

■ a. Revise the section heading. 

■ b. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.9595 Benzenesulfonic acid, mono 

C-10–16 -alkyl derivs., compounds with 2- 

propen-1-amine and Alkyl benzene sulfonic 

acids and alkyl sulfates, amine salts. 

(a) * * * (1) The chemical substances 

identified as benzenesulfonic acid, 

mono C-10–16 -alkyl derivs., compds. 

with 2-propen-1-amine (PMN P–97–296 

and SNUN S–03–10; CAS No. 195008– 

77–6) and the chemical substances 

identified generically as alkyl benzene 

sulfonic acids and alkyl sulfates, amine 

salts (PMNs P–97–297/298/299 and 

SNUNs S–03–11/12/13) are subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Release to water. Requirements as 

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

(c)(4) N = 30. 

* * * * * 

■ 14. Amend § 721.9675 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraphs (a)(2)(i) and 

(a)(2)(ii). 

■ c. Revise paragraph (b)(1). 

The revisions read as follows: 

§ 721.9675 Titanate [Ti6O13 (2-)], 

dipotassium. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

titanate [Ti6O13 (2-)], dipotassium (PMN 

P–90–0226; SNUNs P–96–1408, S–08–6, 

S–09–4, and S–13–49; CAS No. 12056– 

51–8)) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f) and (l). In 

addition, a significant new use of the 

substance is importation of the chemical 

substance if: 

(A) Manufactured by other than the 

method described in premanufacture 

notice P–90–226 and significant new 

use notices P–96–1408, S–08–6, S–09–4, 

and S–13–49. 

(B) Manufactured producing 

respirable, acicular fibers with an 

average aspect ratio of greater than 5. 

The average aspect ratio is defined as 

the ratio of average length to average 

diameter. 

(ii) [Reserved] 

(b) * * * 

(1) Recordkeeping. The following 

recordkeeping requirements are 

applicable to manufacturers and 

processors of this substance as specified 

in § 721.125(a), (b), (c) and (i). 

* * * * * 

■ 15. Amend § 721.9892 as follows: 

■ a. Revise the section heading. 

■ b. Revise paragraph (a)(1). 

■ c. Revise paragraph (a)(2)(iii). 

The revisions read as follows: 

§ 721.9892 1,3-Dimethyl-2-imidazolidinone. 

(a) * * * (1) The chemical substance 

identified as 1,3-Dimethyl-2- 

imidazolidinone (PMN P–93–1649, 

SNUN S–04–3 and S–11–3; CAS No. 

80–73–9) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) * * * 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). A significant 

new use is non-industrial use other than 

the commercial uses described in the S– 

04–3 and S–11–3. 

* * * * * 

■ 16. Amend § 721.10008 as follows: 

■ a. Revise paragraph (a)(2)(ii). 

■ b. Remove paragraph (a)(2)(iii). 

■ c. Revise paragraph (b)(1). 

■ b. Remove paragraph (b)(3). 

The revisions read as follows: 

§ 721.10008 Manganese strontium oxide 

(MnSrO3). 

(a) * * * 

(2) * * * 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture, 

processing, or use of the PMN substance 

if the particle size is less than 10 

microns). 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (f), (g), (h), and (i) 

are applicable to manufacturers and 

processors of this substance. 

* * * * * 

■ 17. Amend § 721.10182 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.10182 1-Propene, 2,3,3,3-tetrafluoro-. 

(a) * * * 

(1) The chemical substance identified 

as 1-propene, 2,3,3,3-tetrafluoro- (PMN 

P–07–601 and SNUN S–14–11; CAS No. 

754–12–1) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. A significant new 

use is: 

(A) Use other than as a refrigerant: In 

motor vehicle air conditioning systems 

in new passenger cars and vehicles (i.e., 

as defined in 40 CFR 82.32(c) and (d)), 

in stationary refrigeration, or in 

stationary air conditioning. 


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19050 Federal Register / Vol. 80, No. 68 / Thursday, April 9, 2015 / Proposed Rules 

(B) Section 721.80(m) (commercial 

use other than: In passenger cars and 

vehicles in which the original charging 

of motor vehicle air conditioning 

systems with the PMN substance was 

done by the motor vehicle original 

equipment manufacturer (OEM), in 

stationary refrigeration, or in stationary 

air conditioning). 

(C) Section 721.80(o) (use in 

consumer products other than products 

used to recharge the motor vehicle air 

conditioning systems in passenger cars 

and vehicles in which the original 

charging of motor vehicle air 

conditioning systems with the PMN 

substance was done by the motor 

vehicle OEM). 

* * * * * 

■ 18. Amend § 721.10283 as follows: 

■ a. Revise paragraph (a)(2)(i). 

■ b. Revise paragraph (a)(2)(ii). 

■ c. Revise paragraph (a)(2)(iii). 

■ d. Remove paragraph (a)(2)(iv). 

■ e. Revise paragraph (b)(1). 

The revisions read as follows: 

§ 721.10283 Poly[oxy(methyl-1,2- 

ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, 

C12–13-branched and linear alkyl ethers, 

sodium salts. 

(a) * * * 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(l). 

(ii) Disposal. Requirements as 

specified in § 721.85. A significant new 

of the substances is any method of 

disposal of a waste stream containing 

the PMN substances other than by 

incineration or by injection into a Class 

I or II waste disposal well. 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(2)(ii), (b)(2)(ii), 

and (c)(2)(ii). 

(ii) Disposal. Requirements as 

specified in § 721.85. A significant new 

of the substances is any method of 

disposal of a waste stream containing 

the PMN substances other than by 

incineration or by injection into a Class 

I or II waste disposal well. 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(2)(ii), (b)(2)(ii), 

and (c)(2)(ii). 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

* * * * * 

■ 19. Amend § 721.10284 as follows: 

■ a. Revise paragraph (a)(2)(i). 

■ b. Revise paragraph (a)(2)(ii). 

■ c. Revise paragraph (a)(2)(iii). 

■ d. Remove paragraph (a)(2)(iv). 

■ e. Revise paragraph (b)(1). 

The revisions read as follows: 

§ 721.10284 Poly[oxy(methyl-1,2- 

ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, 

C14–15-branched and linear alkyl ethers, 

sodium salts. 

(a) * * * 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(l). 

(ii) Disposal. Requirements as 

specified in § 721.85. A significant new 

of the substances is any method of 

disposal of a waste stream containing 

the PMN substances other than by 

incineration or by injection into a Class 

I or II waste disposal well. 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(2)(ii), (b)(2)(ii), 

and (c)(2)(ii). 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

* * * * * 

■ 20. Amend § 721.10515 as follows: 

■ a. Revise paragraph (a)(1). 

■ b. Revise paragraph (a)(2)(i). 

The revisions read as follows: 

§ 721.10515 Partially fluorinated alcohol 

substituted glycols (generic). 

(a) * * * 

(1) The chemical substances 

identified generically as partially 

fluorinated alcohol substituted glycols 

(PMNs P–10–58, P–10–59, P–10–60, and 

P–10–184) are subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) * * * 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the PMN substances according to the 

chemical synthesis and composition 

sections of the TSCA section 5(e) 

consent order, including analysis, 

reporting, and limitations of maximum 

impurity levels of certain fluorinated 

impurities; manufacture and import of 

P–10–60/P–10–184 other than when the 

mean number of moles of the ethoxy 

group is between 3 and 11 or the 

average number molecular weight is 

between 496 and 848 daltons based on 

the amounts of raw materials charged to 

the reactor; manufacture and import of 

P–10–58 and P–10–59 only as 

intermediates for the manufacture of P– 

10–60), and (q). 

* * * * * 

[FR Doc. 2015–08090 Filed 4–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R2–ES–2014–0008; 

4500030113] 

RIN 1018–BA32 

Endangered and Threatened Wildlife 

and Plants; 4(d) Rule for the 

Georgetown Salamander 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Revised proposed rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, are amending our 

proposed rule under authority of section 

4(d) of the Endangered Species Act of 

1973, as amended (Act), that provides 

measures that are necessary and 

advisable to provide for the 

conservation of the Georgetown 

salamander (Eurycea naufragia), a 

species that occurs in Texas. We are 

seeking public comments on this 

revised proposed rule. We also 

announce the availability of a draft 

environmental assessment of this 

revised proposed rule. 

DATES: We will consider comments 

received or postmarked on or before 

May 11, 2015. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see Public 

Comments, below) must be received by 

11:59 p.m. Eastern Time on the closing 

date. 

ADDRESSES: Document availability: You 

may obtain copies of the original 

proposed rule, this revised proposed 

rule, and the draft environmental 

assessment at http://

www.regulations.gov at Docket No. 

FWS–R2–ES–2014–0008, or by mail 

from the Austin Ecological Services 

Field Office (see FOR FURTHER

INFORMATION CONTACT). 

Written comments: You may submit 

comments on this revised proposed rule 

by one of the following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: http://

www.regulations.gov. In the Search box, 

enter FWS–R2–ES–2014–0008, which is 

the docket number for this rulemaking. 

Then click on the Search button. When 

you have located the correct document, 

you may submit a comment by clicking 

on ‘‘Comment Now!’’ 

(2) By hard copy: Submit by U.S. mail 

or hand-delivery to: Public Comments 

Processing, Attn: FWS–R2–ES–2014– 

0008; Division of Policy, Performance, 

and Management Programs; U.S. Fish 

and Wildlife Service, MS: BPHC; 5275 


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