Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24613 

interfering with its special function as a 

naval ship: Annex I, paragraph 3(a), 

pertaining to the horizontal distance 

between the forward and after masthead 

lights; and Annex I, paragraph 2(k) as 

described in Rule 30 (a)(i), pertaining to 

the vertical separation between anchor 

lights. The DAJAG (Admiralty and 

Maritime Law) has also certified that the 

lights involved are located in closest 

possible compliance with the applicable 

72 COLREGS requirements. 

Moreover, it has been determined, in 

accordance with 32 CFR parts 296 and 

701, that publication of this amendment 

for public comment prior to adoption is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on technical findings that the 

placement of lights on this vessel in a 

manner differently from that prescribed 

herein will adversely affect the vessel’s 

ability to perform its military functions. 

List of Subjects in 32 CFR Part 706 

Marine safety, Navigation (water), and 

Vessels. 

For the reasons set forth in the 

preamble, amend part 706 of title 32 of 

the CFR as follows: 

PART 706—CERTIFICATIONS AND 

EXEMPTIONS UNDER THE 

INTERNATIONAL REGULATIONS FOR 

PREVENTING COLLISIONS AT SEA, 

1972 

■ 1. The authority citation for part 706 

continues to read: 

Authority: 33 U.S.C. 1605. 

■ 2. Section 706.2 is amended as 

follows: 

■ A. In Table Three by adding, in alpha 

numerical order, by vessel number, an 

entry for USS ASHLAND (LSD 48); and 

■ B. In Table Five by revising the entry 

for USS ASHLAND (LSD 48). 

§ 706.2 Certifications of the Secretary of 

the Navy under Executive Order 11964 and 

33 U.S.C. 1605. 

* * * * * 

TABLE THREE

Vessel Number 

Masthead lights 

arc of visibility; 

rule 21(a) 

Side lights arc of 

visibility; rule 

21(b) 

Stern light arc of 

visibility; rule 

21(c) 

Side lights distance inboard of 

ship’s sides in 

meters 3(b) 

Annex 1 

Stern light, distance forward of 

stern in meters; 

Rule 21(c) 

Forward anchor 

light, height 

above hull in meters; 2(k) Annex 

1 

Anchor 

lights relation-ship of 

aft light to 

forward light 

in meters 

2(k) Annex 

1 

*******

USS ASHLAND ... LSD 48 ... ............................ ............................ ............................ ............................ ............................ ............................ 2.60 below. 

*******

* * * * * 

TABLE FIVE

Vessel Number 

Masthead lights not 

over all other lights and 

obstructions. Annex 

I,sec. 2(f) 

Forward masthead light 

not in forward quarter of 

ship. Annex I, sec. 3(a) 

After masthead light 

less than 

1/2 ship’s 

length aft 

of forward 

masthead 

light. Annex 

I, sec. 3(a) 

Percentage 

horizontal 

separation 

attained 

*******

USS ASHLAND ............. LSD 48 .......... ....................................... ....................................... X 63.6 

*******

Approved: April 16, 2012. 

C.J. Spain, 

Deputy Assistant Judge Advocate, General 

(Admiralty and Maritime Law), Acting. 

Dated: April 18, 2012. 

J.M. Beal, 

Lieutenant Commander, Judge Advocate 

General’s Corps, U.S. Navy, Federal Register 

Liaison Officer. 

[FR Doc. 2012–9928 Filed 4–24–12; 8:45 am] 

BILLING CODE 3810–FF–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2012–0182; FRL–9345–4] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

the Toxic Substances Control Act 

(TSCA) for 23 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Nine of 

these chemical substances are subject to 

TSCA consent orders issued by EPA. 

This action requires persons who intend 

to manufacture, import, or process any 

of these 23 chemical substances for an 

activity that is designated as a 

significant new use by this rule to notify 

EPA at least 90 days before commencing 

that activity. The required notification 


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24614 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

will provide EPA with the opportunity 

to evaluate the intended use and, if 

necessary, to prohibit or limit that 

activity before it occurs. 

DATES: This rule is effective on June 25, 

2012. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on May 9, 2012. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before May 25, 2012 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION). 

For additional information on related 

reporting requirement dates, see Units 

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

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0182, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave. NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2012–0182. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2012–0182. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

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

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

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

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substances 

contained in this rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 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 these SNURs 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of this rule are subject 

to the export notification provisions of 

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

(see § 721.20), and must comply with 

the export notification requirements in 

40 CFR part 707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 


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Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24615 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture, import, or processing 

of a chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

issue of April 24, 1990 (55 FR 17376) 

(April 24, 1990 SNUR). Consult that 

preamble for further information on the 

objectives, rationale, and procedures for 

SNURs and on the basis for significant 

new use designations, including 

provisions for developing test data. 

B. What is the agency’s authority for 

taking this action? 

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

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

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

Once EPA determines that a use of a 

chemical substance is a significant new 

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

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture, import, or 

process the chemical substance for that 

use. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA 

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

5(h)(5), and the regulations at 40 CFR 

part 720. Once EPA receives a SNUN, 

EPA may take regulatory action under 

TSCA section 5(e), 5(f), 6, or 7 to control 

the activities for which it has received 

the SNUN. If EPA does not take action, 

EPA is required under TSCA section 

5(g) to explain in the Federal Register 

its reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 23 chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Substances Subject to This Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

23 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

number (if assigned for non-confidential 

chemical identities). 

• Basis for the TSCA section 5(e) 

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

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

SNURs without TSCA section 5(e) 

consent orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture and 

importation volume) and other uses 

designated in this rule, may be claimed 

as CBI. Unit IX. discusses a procedure 

companies may use to ascertain whether 

a proposed use constitutes a significant 

new use. 

This rule includes nine PMN 

substances (P–07–537, P–07–706, P–10– 

135, P–10–358, P–11–264, P–11–561, 

P–11–567, P–11–568, and P–11–569) 

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

orders under TSCA section 

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

that activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment. Those consent orders 

require protective measures to limit 

exposures or otherwise mitigate the 

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

substances are promulgated pursuant to 

§ 721.160, and are based on and 

consistent with the provisions in the 

underlying consent orders. The 5(e) 

SNURs designate as a ‘‘significant new 

use’’ the absence of the protective 


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24616 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

measures required in the corresponding 

consent orders. 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) consent order usually 

requires, among other things, that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL) that is 

established by EPA to provide adequate 

protection to human health. In addition 

to the actual NCEL concentration, the 

comprehensive NCELs provisions in 

TSCA section 5(e) consent orders, 

which are modeled after Occupational 

Safety and Health Administration 

(OSHA) Permissible Exposure Limits 

(PELs) provisions, include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. 

However, no comparable NCEL 

provisions currently exist in 40 CFR 

part 721, subpart B, for SNURs. 

Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. EPA expects that 

persons whose § 721.30 requests to use 

the NCELs approach for SNURs are 

approved by EPA will be required to 

comply with NCELs provisions that are 

comparable to those contained in the 

corresponding TSCA section 5(e) 

consent order for the same chemical 

substance. 

This rule also includes SNURs on 14 

PMN substances (P–05–714, P–11–128, 

P–11–338, P–11–481, P–11–594, P–11– 

654, P–12–22, P–12–23, P–12–24, P–12– 

25, P–12–26, P–12–33, P–12–51, and 

P–12–52) that are not subject to consent 

orders under TSCA section 5(e). In these 

cases, for a variety of reasons, EPA did 

not find that the use scenario described 

in the PMN triggered the determinations 

set forth under TSCA section 5(e). 

However, EPA does believe that certain 

changes from the use scenario described 

in the PMN could result in increased 

exposures or releases, thereby 

constituting a ‘‘significant new use.’’ 

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

promulgated pursuant to § 721.170. EPA 

has determined that every activity 

designated as a ‘‘significant new use’’ in 

all non-5(e) SNURs issued under 

§ 721.170 satisfies the two requirements 

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

significant new use activities, ‘‘(i) are 

different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. 

PMN Number P–05–714 

Chemical name: Polyether ester acid 

compound with a polyamine amide 

(generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an 

additive for industrial paints, industrial 

coatings, and architectural coatings. 

Based on test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur if releases 

of the PMN substance to surface water, 

from uses other than described in the 

PMN, exceed the releases expected from 

the use described in the PMN. For the 

use described in the PMN, significant 

environmental releases are not 

expected. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

described in the PMN may cause 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(i). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity mitigated by humic acid 

test (Office of Pollution Prevention, 

Pesticides and Toxic Substances 

(OPPTS) Test Guideline 850.1085) 

would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10410. 

PMN Number P–07–537 

Chemical name: Alkanenitrile, 

bis(cyanoalkyl)amino (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: June 19, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be as a chemical 

intermediate. Based on test data on the 

PMN substance, EPA identified 

concerns for neurotoxicity to workers 

from dermal and inhalation exposures. 

The NCEL is 70 microgram/cubic meter 

(mg/m3) as an 8-hour time-weighted 

average. In addition, based on ecological 

structure-activity relationship (EcoSAR) 

analysis of test data on structurally 

similar aliphatic amines, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 700 parts 

per billion (ppb). The consent order was 

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

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

that this substance may present an 

unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of personal protective 

equipment including impervious gloves 

(when there is potential dermal 

exposure) and either a National Institute 

for Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 5, or compliance with a NCEL of 

70 mg/m3 as an 8-hour time-weighted 

average (when there is potential 

inhalation exposure). 

2. Establishment and use of a hazard 

communication program. 

3. Manufacture and use of the PMN 

substance only as a site-limited 

intermediate. 

4. Submission of certain human 

health testing prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

5. Disposal of the PMN substance only 

by incineration or landfill. 

6. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a 

neurotoxicity study in rodents 

(Organisation for Economic Cooperation and Development (OECD) 

Test Guideline 424); a fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1085); and a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the human health and 

environmental effects of the PMN 

substance. The PMN submitter has 

agreed not to exceed the confidential 

production volume limit specified in 

the consent order without performing 

the neurotoxicity test. The consent order 

does not require the submission of the 

fish and daphnid testing at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacture, import, processing, 

distribution in commerce, use, and 

disposal of the PMN will remain in 

effect until the consent order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10411. 


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Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24617 

PMN Number P–07–706 

Chemical name: Phosphonic acid 

ester (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: April 8, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a chemical intermediate. 

Based on test data on the PMN 

substance and an analogous chemical, 

EPA identified concerns for 

oncogenicity, mutagenicity, 

reproductive/developmental toxicity, 

skin irritation, and sensitization to 

workers from dermal and inhalation 

exposures. The NCEL is 1.0 milligram 

(mg)/m3 as an 8-hour time-weighted 

average. The consent order was issued 

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

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

this substance may present an 

unreasonable risk of injury to human 

health. To protect against this risk, the 

consent order requires: 

1. Use of personal protective 

equipment including dermal protection 

(when there is potential dermal 

exposure) and a NIOSH-certified 

respirator with an assigned protection 

factor (APF) of at least 15, or 

compliance with a NCEL of 1.0 mg/m3

as an 8-hour time-weighted average 

(when there is potential inhalation 

exposure). 

2. Establishment and use of a hazard 

communication program. 

3. Submission of certain human 

health testing prior to exceeding the 

confidential production volume limit 

specified in the consent order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 422) and a mammalian 

erythrocyte micronucleus test (OECD 

Test Guideline 474) would help 

characterize possible human health 

risks of the PMN substance. The PMN 

submitter has agreed not to exceed the 

confidential production volume limit 

specified in the consent order without 

performing these tests. The consent 

order does not require the submission of 

a genetic toxicology: rodent dominant 

lethal assay test (OECD Test Guideline 

478) at any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10412. 

PMN Number P–10–135 

Chemical name: Fluorinated dialkyl 

ketone (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: October 21, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a heat transfer fluid. Based on 

test data on the PMN substance and 

analogs, EPA identified concerns for 

oncogenicity and liver effects from 

dermal and inhalation exposures. The 

consent order was issued under TSCA 

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

based on a finding that this substance 

may present an unreasonable risk of 

injury to human health. To protect 

against this risk, the consent order 

prohibits exceedance of the confidential 

annual production volume limit 

specified in the consent order. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of this protective 

measure. 

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) and a reproduction/ 

developmental toxicity screening test 

(OECD Test Guideline 421, with 

modifications) would help characterize 

the human health effects of the PMN 

substance. The consent order does not 

require the submission of this testing at 

any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10413. 

PMN Number P–10–358 

Chemical name: Iron(1+), chloro[rel1,5-dimethyl (1R,2S,4R,5S)- 9,9- 

dihydroxy-3-methyl-2,4-di(2-pyridinyl- 

.kappa.N)-7-[(2-pyridinyl- 

.kappa.N)methyl]-3,7- 

diazabicyclo[3.3.1]nonane-1,5- 

dicarboxylate-.kappa.N3,.kappa.N7]-, 

chloride (1:1), (OC-6–63)-. 

CAS number: 478945–46–9. 

Effective date of TSCA section 5(e) 

consent order: February 7, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a coatings additive at 

concentrations not to exceed 1.0 

percent. Based on test data on the PMN 

substance, EPA identified concerns for 

systemic toxicity, neurotoxicity, dermal 

sensitization, acute toxicity and 

immunotoxicity from dermal exposure. 

The consent order was issued under 

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

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

this substance may present an 

unreasonable risk of injury to human 

health. To protect against these risks, 

the consent order requires: 

1. Use of personal protective 

equipment including dermal protection 

(when there is potential dermal 

exposure). 

2. Establishment and use of a hazard 

communication program. 

3. Use of the PMN substance only as 

described in the PMN. 

4. That annual manufacture and 

importation volume not exceed the 

confidential limit specified in the 

consent order. 

5. No manufacture, processing, or use 

of the PMN substance in the form of a 

powder or a solid. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of an acute 

oral toxicity test (OPPTS Test Guideline 

870.1100) in rabbits would help 

characterize the human health effects of 

the substance. The consent order does 

not require submission of the testing at 

any specified time or production 

volume. However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10414. 

PMN Number P–11–128 

Chemical name: 3H-indolium, 2-[2-[3- 

[2-(1,3-dihydro-1,3,3-trimethyl-2Hindol-2-ylidene)ethylidene]-2-[(1- 

phenyl-1H-tetrazol-5-yl)thio]-1- 

cyclohexen-1-yl]ethenyl]-1,3, 3- 

trimethyl-, chloride (1:1). 

CAS number: 440102–72–7. 

Basis for action: The PMN states that 

the substance will be used as a dye used 

in the manufacture of imaging media/ 

products. Based on EcoSAR analysis of 

test data on cationic dyes, EPA predicts 

toxicity to aquatic organisms may occur 

as a result of releases of the PMN 

substance to surface water from 

manufacture or import in quantities 

greater than the 10,000 kilograms (kg) 

per year production volume stated in 

the PMN. At the annual production 

volume of 10,000 kg stated in the PMN, 


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there were no significant environmental 

concerns. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

exceeding an annual manufacturing and 

importation volume of 10,000 kg may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test, 

tiers I and II (OPPTS Test Guideline 

850.5400) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10415. 

PMN Number P–11–264 

Chemical name: Brominated 

polyphenyl ether (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: November 22, 2011. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the PMN 

substance will be as a flame retardant. 

EPA expects that brominated 

dibenzodioxins (BDD) and 

dibenzofurans (BDF) may be generated 

during manufacture of the PMN 

substance and may be potential 

decomposition products of the PMN 

substance in the environment. Human 

health concerns from exposure to BDD 

and BDF include cancer, reproductive 

and developmental toxicity, and 

immunotoxicity. EPA expects the PMN 

to be highly persistent in the 

environment and that it may be 

bioavailable based on data on related 

substances. EPA also has environmental 

concerns based on the high degree of 

bromination of the PMN substance and 

the potential presence of BDD/BDF 

impurities that may form during 

manufacturing and may be 

decomposition products in the 

environment. Current knowledge of the 

ecotoxicity of BDD and BDF indicate 

adverse effects may occur in the parts 

per trillion range in rainbow trout 

embryos and juveniles. The consent 

order was issued under TSCA sections 

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

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

this substance and potential impurities 

and degradants may present an 

unreasonable risk of injury to human 

health and the environment, the 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance. To protect against these risks 

the consent order requires: 

1. No exceedance of the maximum 

levels of BDD and BDF in the PMN 

substance as specified in the consent 

order. 

2. Manufacture of the PMN substance 

only at the site specified in the PMN 

and only using the process described in 

the PMN unless the dioxin/furan testing 

required in the consent order is 

conducted and the test results submitted 

to EPA within 16 months of 

commencement of manufacture at the 

additional site or process. 

3. The molecular weight of the 

manufactured PMN substance be equal 

to or greater than the weight reported in 

the PMN. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of the 

following tests would help characterize 

the possible health and environmental 

effects of the PMN substance, its 

impurities and its degradation products. 

The consent order contains two 

(confidential) production limits. The 

PMN submitter has agreed not to exceed 

the first production limit without 

performing an anaerobic aquatic 

metabolism test (OPPTS Test Guideline 

835.4400) and an amphibian 

metamorphosis assay (OECD Test 

Guideline 231). The PMN submitter has 

also agreed not to exceed a second 

production limit without performing a 

dietary exposure bioaccumulation fish 

test (OECD Test Guideline 305, draft 

dated October 14, 2011) and a test of the 

PMN substance for BDD and BDF 

content by high-resolution gas 

chromatography/high-resolution mass 

spectrometry (HRGC/HRMS) (EPA Test 

Method 8290A). EPA has also 

determined that the following tests 

would help characterize the 

environmental effects of the PMN 

substance. The consent order does not 

require the submission of the following 

information at any specified time or 

production volume: A fish early-life 

stage toxicity test (OPPTS Test 

Guideline 850.1400), a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300), and an algal toxicity, tiers I 

and II test (OPPTS Test Guideline 

850.5400). However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10416. 

PMN Number P–11–338 

Chemical name: Biphenyl alkyl 

morpholino ketone (generic). 

CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as a photo 

initiator. Based on EcoSAR analysis of 

test data on analogous aliphatic amines, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 ppb of the PMN substance 

in surface waters. As described in the 

PMN, the substance is not released to 

surface waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a ready 

biodegradability test (OPPTS Test 

Guideline 835.3110); a fish acute 

toxicity test, freshwater and marine 

(OPPTS Test Guideline 850.1075); an 

aquatic invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test, tiers I and II test (OPPTS 

Test Guideline 850.5400) would help 

characterize the environmental effects of 

the PMN substance. EPA also 

recommends that the special 

considerations for conducting laboratory 

studies (OPPTS Test Guideline 

850.1000) be followed to facilitate 

solubility in the test media, because of 

the PMN’s low water solubility. 

CFR citation: 40 CFR 721.10417. 

PMN Number P–11–481 

Chemical name: 1,2- 

Cyclohexanedicarboxylic acid, 1-butyl 

2-(phenylmethyl) ester. 

CAS number: 1200806–67–2. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an additive for polymers. 

Based on EcoSAR analysis of test data 

on analogous esters, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

2 ppb. Therefore, EPA has not 

determined that the proposed 


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manufacture, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

2 ppb may cause significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test (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 721.10418. 

PMN Number P–11–561 

Chemical name: Tetrafluoroethylene 

chlorotrifluoroethylene copolymer 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: January 27, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substance will be used as a polymer 

used in automotive fuel hoses. Based on 

EPA analysis of the potential content of 

the polymer, EPA is concerned that 

some long-chain perfluorinated 

substances could be present and if 

degraded, especially under thermal 

conditions, could be released into the 

environment. EPA has concerns that the 

PMN substance and its thermal 

degradation products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic to 

humans, wild mammals, and birds. 

These concerns are based on data on 

analog chemicals, including 

perfluorooctanoic acid (PFOA) and 

other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product in 

humans and wildlife. The consent order 

was issued under TSCA sections 

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

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

this substance may present an 

unreasonable risk of injury to human 

health and the environment, the 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance and its potential degradation 

products. To protect against this 

exposure and risk, the consent order 

requires the PMN substance be 

manufactured, processed, distributed in 

commerce, and used only as a polymer 

in automotive fuel hoses and the 

submitter has agreed to analyze, report, 

and limit specific fluorinated impurities 

of the PMN substance where the carbon 

chain meets or exceeds a specified 

length. The SNUR designates as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the consent order 

would help characterize possible effects 

of the substances and their degradation 

products. The consent order does not 

require submission of the testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMN will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10419. 

PMN Numbers P–11–567, P–11–568, 

and P–11–569 

Chemical name: Fluoropolymers 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

consent order: January 27, 2012. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of the PMN 

substances will be in the manufacture of 

elastomer containing materials (P–11– 

567 and P–11–569), and a component of 

film, wire, and cable (P–11–568). Based 

on SAR analysis of test data on 

analogous high molecular weight 

polymers, EPA identified concerns for 

lung effects through lung overload if 

respirable particles of the intact PMN 

substances are inhaled. In addition, EPA 

has concerns for the formation of 

potential incineration or other 

decomposition products from the PMN 

substances. These perfluorinated 

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, suggesting that, 

under some conditions, the PMN 

substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic to people, wild mammals, and 

birds. These concerns are based on data 

on analog chemicals, including PFOA 

and other perfluorinated carboxylates, 

which include the presumed 

environmental degradant of the PMN 

substance. There is pharmacokinetic 

and toxicological data in animals on 

PFOA, as well as epidemiological and 

blood monitoring data in humans. 

Toxicity studies on PFOA indicate 

developmental, reproductive, and 

systemic toxicity in various species, as 

well as cancer. These factors, taken 

together, raise concerns for potential 

adverse chronic effects from the 

presumed degradation product in 

humans and wildlife. The consent order 

was issued under TSCA sections 

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

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

this substance may present an 

unreasonable risk of injury to human 

health and the environment, the 

substance may be produced in 

substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substance and its potential degradation 

products. To protect against these risks, 

the consent order requires the submitter 

has agreed to analyze, report, and limit 

specific fluorinated impurities of the 

PMN substances where the carbon chain 

meets or exceeds a specified length and 

risk notification. The SNUR designates 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Recommended testing: EPA has 

determined that the results of certain 

fate and physical/chemical property 

testing identified in the consent order 

would help characterize possible effects 

of the substances and their degradation 

products. The consent order does not 

require submission of the testing at any 

specified time or production volume. 

However, the consent order’s 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use, and disposal of the PMNs will 

remain in effect until the consent order 

is modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10420. 

PMN Number P–11–594 

Chemical name: 

Mercaptoalkoxysilane (generic). 


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CAS number: Not available. 

Basis for action: The PMN states that 

the substance will be used as an epoxy 

catalyst. Based on EcoSAR analysis of 

test data on analogous alkoxysilanes, 

esters, and phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 ppb of 

the PMN substance in surface waters. As 

described in the PMN, the substance 

will not be released to water. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in surface water 

concentrations exceeding 2 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); and 

an algal toxicity test, tiers I and II 

(OPPTS Test Guideline 850.5400) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10421. 

PMN Number P–11–654 

Chemical name: Phenol, 2-[[[3-(1Himidazol-1- 

yl)propyl]imino]phenylmethyl]-5- 

(octyloxy)-. 

CAS number: 1332716–20–7. 

Basis for action: The PMN states that 

the substance will be used as an epoxy 

catalyst. Based on EcoSAR analysis of 

test data on analogous Schiff bases and 

phenols, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. As 

described in the PMN, the substance 

will not be released to water. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

resulting in surface water 

concentrations exceeding 1 ppb may 

cause significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test, 

tiers I and II (OPPTS Test Guideline 

850.5400) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10422. 

PMN Numbers: P–12–22, P–12–23, P– 

12–24, P–12–25, and P–12–26 

Chemical names: Complex strontium 

aluminum, rare earth doped (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the PMN substances will be used as dye 

used in the manufacture of imaging 

media/products. Based on analogous 

respirable and poorly soluble 

substances, in particular, titanium 

dioxide, EPA identified concerns for 

potential lung overload to workers from 

inhalation exposure to the PMN 

substances. Specifically, the Agency 

predicts potential toxicity to workers 

from inhalation when more than 5% of 

the PMN substances particles are less 

than 10 microns. For the uses described 

in the PMNs, significant worker 

exposure is unlikely, when no more 

than 5% of particles are less than 10 

microns. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances other than as 

described in the PMNs may cause 

serious health effects. Based on this 

information, the PMN substances meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10423. 

PMN Number P–12–33 

Chemical name: Benzoic acid, 4-(1,1- 

dimethylethyl)-, methyl. 

CAS number: 26537–19–9. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate in the manufacture of an 

imaging product. Based on submitted 

test data on p-tert-butyl benzoic acid, 

EPA identified concerns for 

neurotoxicity; reproductive toxicity 

(male); and adverse effects to the liver, 

kidney, and lung. In addition, based on 

data on benzoic acid, EPA identified 

concerns for developmental toxicity and 

hypersensitivity. These concerns are for 

effects to workers from inhalation and 

dermal exposures to the PMN substance. 

For the chemical intermediate use 

described in the PMN, significant 

worker exposure is unlikely, as dermal 

and inhalation exposures are not 

expected. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, use 

of the substance other than as an 

intermediate may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that a combined repeated 

dose toxicity with the reproduction/ 

developmental toxicity screening test 

(OPPTS Test Guideline 870.3650) would 

help characterize the human health 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10424. 

PMN Numbers: P–12–51 and P–12–52 

Chemical names: Substituted 

alkylamides (generic). 

CAS numbers: Not available. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as polymer foam 

additives. Based on test data on 

analogous chemical substances and 

information on the Material Safety Data 

Sheet (MSDS), the Agency identified 

concerns for irritation to all exposed 

tissues, solvent irritation, and solvent 

neurotoxicity to workers from dermal 

exposure to the PMN substances. For 

the use described in the PMNs, 

significant worker exposure is unlikely, 

as dermal exposure is not expected. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, use of the 

substances other than as described in 

the PMNs may cause serious health 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity with 

the reproduction/developmental 

toxicity screening test (OPPTS Test 

Guideline 870.3650); a bacterial reverse 

mutation test (OPPTS Test Guideline 

870.5100); and a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395) would help 

characterize the human health effects of 

the PMN substances. 

CFR citation: 40 CFR 721.10425. 

V. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that for 9 of the 23 chemical substances, 

regulation was warranted under TSCA 

section 5(e), pending the development 


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of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders. These SNURs are 

promulgated pursuant to § 721.160 (see 

Unit II.). 

In the other 14 cases, where the uses 

are not regulated under a TSCA section 

5(e) consent order, EPA determined that 

one or more of the criteria of concern 

established at § 721.170 were met, as 

discussed in Unit IV. 

B. Objectives 

EPA is issuing these SNURs for 

specific chemical substances which 

have undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

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

• EPA will ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

existingchemicals/pubs/tscainventory/ 

index.html. 

VI. Direct Final Procedures 

EPA is issuing these SNURs as a 

direct final rule, as described in 

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

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

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

of this rule is June 25, 2012 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before May 25, 2012. 

If EPA receives written adverse or 

critical comments, or notice of intent to 

submit adverse or critical comments, on 

one or more of these SNURs before May 

25, 2012, EPA will withdraw the 

relevant sections of this direct final rule 

before its effective date. EPA will then 

issue a proposed SNUR for the chemical 

substance(s) on which adverse or 

critical comments were received, 

providing a 30-day period for public 

comment. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, must 

identify the chemical substance and the 

new use to which it applies. EPA will 

not withdraw a SNUR for a chemical 

substance not identified in the 

comment. 

VII. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Rule 

Significant new use designations for a 

chemical substance are legally 

established as of the date of publication 

of this direct final rule April 25, 2012. 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule have undergone 

premanufacture review. TSCA section 

5(e) consent orders have been issued for 

9 chemical substances and the PMN 

submitters are prohibited by the TSCA 

section 5(e) consent orders from 

undertaking activities which EPA is 

designating as significant new uses. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. For chemical 

substances for which an NOC has not 

been submitted at this time, EPA 

concludes that the uses are not ongoing. 

However, EPA recognizes that prior to 

the effective date of the rule, when 

chemical substances identified in this 

SNUR are added to the TSCA Inventory, 

other persons may engage in a 

significant new use as defined in this 

rule before the effective date of the rule. 

However, 19 of the 23 chemical 

substances contained in this rule have 

CBI chemical identities, and since EPA 

has received a limited number of postPMN bona fide submissions (per 40 CFR 

720.25 and § 721.11), the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

rule are ongoing. 

As discussed in the April 24, 1990 

SNUR, EPA has decided that the intent 

of TSCA section 5(a)(1)(B) is best served 

by designating a use as a significant new 

use as of the date of publication of this 

direct final rule rather than as of the 

effective date of the rule. If uses begun 

after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements because a person 

could defeat the SNUR by initiating the 

significant new use before the rule 

became effective, and then argue that 

the use was ongoing before the effective 

date of the rule. Persons who begin 

commercial manufacture, import, or 

processing of the chemical substances 

regulated through this SNUR will have 

to cease any such activity before the 

effective date of this rule. To resume 

their activities, these persons would 

have to comply with all applicable 

SNUR notice requirements and wait 

until the notice review period, 

including any extensions expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person meets the conditions of advance 

compliance under § 721.45(h), the 

person is considered exempt from the 

requirements of the SNUR. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

describes those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 


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24622 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection and test reporting. To access 

the harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 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. To access 

EPA Method 8290A, please go to 

http://www.epa.gov/osw/hazard/ 

testmethods/sw846/pdfs/8290a.pdf. 

In the TSCA section 5(e) consent 

orders for several of the chemical 

substances regulated under this rule, 

EPA has established production volume 

limits in view of the lack of data on the 

potential health and environmental 

risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Listings of the tests 

specified in the TSCA section 5(e) 

consent orders are included in Unit IV. 

The SNURs contain the same 

production limits as the TSCA section 

5(e) consent orders. Exceeding these 

production limits is defined as a 

significant new use. Persons who intend 

to exceed the production limit must 

notify the Agency by submitting a 

SNUN at least 90 days in advance of 

commencement of non-exempt 

commercial manufacture, import, or 

processing. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at § 721.1725(b)(1). 

Under these procedures a 

manufacturer, importer, or processor 

may request EPA to determine whether 

a proposed use would be a significant 

new use under the rule. The 

manufacturer, importer, or processor 

must show that it has a bona fide intent 

to manufacture, import, or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture, import, or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture, import, or 

process the chemical substance, EPA 

will tell the person whether the use 

identified in the bona fide submission 

would be a significant new use under 

the rule. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers, importers, and 

processors can combine the bona fide 

submission under the procedure in 

§ 721.1725(b)(1) with that under 

§ 721.11 into a single step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture, 

import, or process the chemical 

substance so long as the significant new 

use trigger is not met. In the case of a 

production volume trigger, this means 

that the aggregate annual production 

volume does not exceed that identified 

in the bona fide submission to EPA. 

Because of confidentiality concerns, 

EPA does not typically disclose the 

actual production volume that 

constitutes the use trigger. Thus, if the 

person later intends to exceed that 

volume, a new bona fide submission 

would be necessary to determine 

whether that higher volume would be a 

significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in § 721.25 and 40 

CFR 720.40. e-PMN software is available 

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

opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

subject to this rule. EPA’s complete 

economic analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2012–0182. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

B. Paperwork Reduction Act 

According to the Paperwork 

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

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under 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 


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Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24623 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act, 5 U.S.C. 

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

further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act 

On February 18, 2012, EPA certified 

pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

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

a SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUN submitted by any small 

entity would not cost significantly more 

than $8300. 

A copy of that certification is 

available in the docket for this rule. 

This rule is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. Therefore, the 

promulgation of the SNUR would not 

have a significant economic impact on 

a substantial number of small entities. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

rule. As such, EPA has determined that 

this rule does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

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

104–4). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

With Indian Tribal Governments’’ (65 

FR 67249, November 9, 2000), do not 

apply to this rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions To Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act, 5 U.S.C. 801 et seq., EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: April 19, 2012. 

Ward Penberthy, 

Acting Director, Chemical Control Division, 

Office of Pollution Prevention and Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 


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24624 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR Citation OMB Control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10410 ............................. 2070–0012 

721.10411 ............................. 2070–0012 

721.10412 ............................. 2070–0012 

721.10413 ............................. 2070–0012 

721.10414 ............................. 2070–0012 

721.10415 ............................. 2070–0012 

721.10416 ............................. 2070–0012 

721.10417 ............................. 2070–0012 

721.10418 ............................. 2070–0012 

721.10419 ............................. 2070–0012 

721.10420 ............................. 2070–0012 

721.10421 ............................. 2070–0012 

721.10422 ............................. 2070–0012 

721.10423 ............................. 2070–0012 

721.10424 ............................. 2070–0012 

721.10425 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10410 to subpart E to 

read as follows: 

§ 721.10410 Polyether ester acid 

compound with a polyamine amide 

(generic) (P–05–714). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyether ester acid 

compound with a polyamine amide 

(PMN P–05–714) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (additive for 

industrial paints, industrial coatings, 

and architectural coatings). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10411 to subpart E to 

read as follows: 

§ 721.10411 Alkanenitrile, 

bis(cyanoalkyl)amino (generic) (P–07–537). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanenitrile, 

bis(cyanoalkyl)amino (PMN P–07–537) 

is subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after it has been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

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

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

percent), and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirator with an assigned protection 

factor (APF) of at least 5 meets the 

minimum requirements for 

§ 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 loose- fitting 

hood or helmet and high efficiency 

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

respirator equipped with a tight-fitting 

facepiece (full-face) and HEPA filters; or 

NIOSH-certified supplied-air respirator 

operated in pressure demand or 

continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (full-face) and HEPA filters. 

(A) As an alternative to the respiratory 

requirements listed in paragraph 

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

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for this substance. 

The NCEL is 70 microgram/cubic meter 

(mg/m3) as an 8-hour time-weighted 

average. Persons who wish to pursue 

NCELs as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. Persons whose 

§ 721.30 requests to use the NCELs 

approach are approved by EPA will 

receive NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) consent order. 

(B) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), 

(g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), 

(g)(2)(iii), (g)(2)(iv) (use respiratory 

protection, or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 70 mg/ 

m3), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 

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

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h) and (q). 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1), (a)(2), (b)(1), 

(b)(2), (c)(1), and (c)(2). 

(v) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (k) are applicable 

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 6. Add § 721.10412 to subpart E to 

read as follows: 

§ 721.10412 Phosphonic acid ester 

(generic) (P–07–706). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phosphonic acid ester 

(PMN P–07–706) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after it has been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2), (a)(3), (a)(4), (a)(5), 

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

(a)(6)(v), (a)(6)(vi), (b) (concentration set 

at 0.1 percent) and (c). The following 

National Institute for Occupational 

Safety and Health (NIOSH)-approved 

respirators with an assigned protection 


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Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24625 

factor (APF) of 15 meet the minimum 

requirements for § 721.63 (a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with the 

appropriate gas/vapor cartridges 

(organic vapor, acid gas, or substancespecific); NIOSH-certified powered airpurifying respirator equipped with a 

loose-fitting hood or helmet and the 

appropriate gas/vapor cartridges 

(organic vapor, acid gas, or substancespecific); NIOSH-certified powered airpurifying respirator with a tight-fitting 

facepiece (full-face) and equipped with 

the appropriate gas/vapor cartridges 

(organic vapor, acid gas, or substancespecific); NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (full-face); or NIOSH-certified 

supplied-air respirator operated in 

pressure demand or continuous flow 

mode and equipped with a loose-fitting 

hood or helmet or a tight-fitting 

facepiece (full-face) if no cartridge 

service life testing is available. 

(A) As an alternative to the respiratory 

requirements listed in paragraph 

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

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for this substance. 

The NCEL is 1.0 millgram/cubic meter 

(mg/m3) as an 8-hour time-weightedaverage. Persons who wish to pursue 

NCELs as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. Persons whose 

§ 721.30 requests to use the NCELs 

approach are approved by EPA will 

receive NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) consent order. 

(B) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

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

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

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

(use respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 1.0 mg/m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.10413 to subpart E to 

read as follows: 

§ 721.10413 Fluorinated dialkyl ketone 

(generic) (P–10–135). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorinated dialkyl ketone 

(PMN P–10–135) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(t). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.10414 to subpart E to 

read as follows: 

§ 721.10414 Polycyclic polyamine diester 

organometallic compound (generic) (P–10– 

358). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

iron(1+), chloro[rel-1,5-dimethyl 

(1R,2S,4R,5S)-9,9-dihydroxy-3-methyl2,4-di(2-pyridinyl-.kappa.N)-7-[(2- 

pyridinyl-.kappa.N)methyl]-3,7- 

diazabicyclo[3.3.1]nonane-1,5- 

dicarboxylate-.kappa.N3,.kappa.N7]-, 

chloride (1:1), (OC–6–63)-(PMN P–10– 

358, CAS No. 478945–46–9) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after it has been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2), (a)(3), (a)(6)(i), 

(a)(6)(ii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), (b) 

(concentration set at 1.0 percent), and 

(c). 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set at 1.0 percent), 

(g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), 

(g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), and 

(g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j), (t), (v)(1), (v)(2), 

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 9. Add § 721.10415 to subpart E to 

read as follows: 

§ 721.10415 3H-indolium, 2-[2-[3-[2-(1,3- 

dihydro-1,3,3-trimethyl-2H-indol-2- 

ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol5-yl)thio]-1-cyclohexen-1-yl]ethenyl]-1, 3, 3- 

trimethyl-, chloride (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3H-indolium, 2-[2-[3-[2-(1,3-dihydro1,3,3-trimethyl-2H-indol-2- 

ylidene)ethylidene]-2-[(1-phenyl-1Htetrazol-5-yl)thio]-1-cyclohexen-1- 

yl]ethenyl]-1, 3, 3-trimethyl-, chloride 

(1:1) (PMN P–11–128, CAS No. 440102– 

72–7) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(s) (10,000 kilogram 

(kg)). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance, 

(2) Limitations or revocation of 

certain notification requirements. The 


srobinson on DSK4SPTVN1PROD with RULES
24626 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 721.10416 to subpart E to 

read as follows: 

§ 721.10416 Brominated polyphenyl ether 

(generic) (P–11–264). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as brominated polyphenyl 

ether (PMN P–11–264) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substance after it has been completely 

reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (manufacture of 

the substance at a molecular weight 

greater than or equal to that described 

in PMN P–11–264), § 721.80 (k) 

(manufacture at the facility described in 

PMN P–11–264 or by the process 

described in PMN P–11–264 (changes in 

manufacturing processes include, but 

are not limited to, changes in feedstock, 

reaction conditions, and/or product 

isolation and purification) unless the 

brominated dibenzodioxin (BDD)/ 

brominated dibenzofuran (BDF) testing 

(EPA Test Method 8290A) required in 

the consent order is conducted at the 

new facility or for the new 

manufacturing method and the test 

results submitted to EPA within 16 

months of changing the manufacturing 

process or commencement of 

manufacture at a different facility; 

manufacture of the substance where 

levels of the fifteen BDD/BDF congeners 

are detected at or below the Levels of 

Quantification (LOQs) published in 

EPA’s Dioxin test rule (40 CFR 766.27)). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 721.10417 to subpart E to 

read as follows: 

§ 721.10417 Biphenyl alkyl morpholino 

ketone (generic) (P–11–338). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as biphenyl alkyl 

morpholino ketone (PMN P–11–338) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.10418 to subpart E to 

read as follows: 

§ 721.10418 1,2-Cyclohexanedicarboxylic 

acid, 1-butyl 2-(phenylmethyl) ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance is identified 

as 1,2-cyclohexanedicarboxylic acid, 1- 

butyl 2-(phenylmethyl) ester (PMN P– 

11–481, CAS No. 1200806–67–2) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.10419 to subpart E to 

read as follows: 

§ 721.10419 Tetrafluoroethylene 

chlorotrifluoroethylene copolymer (generic) 

(P–11–561). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tetrafluoroethylene 

chlorotrifluoroethylene copolymer 

(PMN P–11–561) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after it has been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture, 

processing, distribution in commerce, 

and use of PMN P–11–561 substance 

only as a polymer in automotive fuel 

hoses; analysis and reporting and 

limitations of maximum impurity levels 

of certain fluorinated impurities). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 14. Add § 721.10420 to subpart E to 

read as follows: 

§ 721.10420 Fluoropolymers (generic) 

(P–11–567, P–11–568, and P–11–569). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fluoropolymers (PMNs 

P–11–567, P–11–568, and P–11–569) are 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the PMN 

substances after it has been completely 

reacted (cured). These PMN substances, 

which have been molded into final 

articles and which are recycled into 

non-virgin raw material are again 

subject to the requirements of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of this substance is 

any manner or method of manufacture, 

import, or processing associated with 

any use of this substance without 

providing risk notification as follows: 

(A) If as a result of the test data 

required under the TSCA section 5(e) 

consent order for this substance, the 

employer becomes aware that this 

substance may present a risk of injury 

to human health, the employer must 

incorporate this new information, and 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 24627 

any information on methods for 

protecting against such risk, into a 

Material Safety Data Sheet (MSDS) as 

described in § 721.72(c) within 90 days 

from the time the employer becomes 

aware of the new information. If this 

substance is not being manufactured, 

imported, processed, or used in the 

employer’s workplace, the employer 

must add the new information to a 

MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive this substance 

from the employer are provided a MSDS 

as described in § 721.72(c) containing 

the information required under 

paragraph (a)(2)(i)(A) of this section 

within 90 days from the time the 

employer becomes aware of the new 

information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 15. Add § 721.10421 to subpart E to 

read as follows: 

§ 721.10421 Mercaptoalkoxysilane 

(generic) (P–11–594). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as mercaptoalkoxysilane 

(PMN P–11–594) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10422 to subpart E to 

read as follows: 

§ 721.10422 Phenol, 2-[[[3-(1H-imidazol-1- 

yl)propyl]imino]phenylmethyl]-5-(octyloxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-[[[3-(1H-imidazol-1- 

yl)propyl]imino]phenylmethyl]-5- 

(octyloxy)- (PMN P–11–654, CAS No. 

1332716–20–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10423 to subpart E to 

read as follows: 

§ 721.10423 Complex strontium aluminum, 

rare earth doped (generic) (P–12–22, P–12– 

23, P–12–24, P–12–25, and P–12–26). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as complex strontium 

aluminum, rare earth doped (PMNs 

P–12–22, P–12–23, P–12–24, P–12–25, 

and P–12–26) are subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (manufacture, 

processing, or use where no more than 

5% of particles are less than 10 

microns). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.10424 to subpart E to 

read as follows: 

§ 721.10424 Benzoic acid, 4-(1,1- 

dimethylethyl)-, methyl. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzoic acid, 4-(1,1-dimethylethyl)-, 

methyl (PMN P–12–33, CAS No. 26537– 

19–9) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 19. Add § 721.10425 to subpart E to 

read as follows: 

§ 721.10425 Substituted alkylamides 

(generic) (P–12–51 and P–12–52). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as substituted alkylamides 

(PMNs P–12–51 and P–12–52) are 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 


srobinson on DSK4SPTVN1PROD with RULES
24628 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Rules and Regulations 

1Title XXXIII of the Public Health Service Act is 

codified at 42 U.S.C. 300mm to 300mm–61. Those 

portions of the Zadroga Act found in Titles II and 

III of Public Law 111–347 do not pertain to the 

World Trade Center Health Program and are 

codified elsewhere. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

[FR Doc. 2012–9965 Filed 4–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2011–0010] 

42 CFR Part 88 

RIN 0920–AA45 

World Trade Center Health Program 

Requirements for the Addition of New 

WTC-Related Health Conditions 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: Title I of the James Zadroga 

9/11 Health and Compensation Act of 

2010 amended the Public Health Service 

Act (PHS Act) to establish the World 

Trade Center (WTC) Health Program. 

Sections 3311, 3312, and 3321 of Title 

XXXIII of the PHS Act require that the 

WTC Program Administrator develop 

regulations to implement portions of the 

WTC Health Program established within 

the Department of Health and Human 

Services (HHS). The WTC Health 

Program, which is administered by the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH), within the Centers for Disease 

Control and Prevention (CDC), provides 

medical monitoring and treatment to 

eligible firefighters and related 

personnel, law enforcement officers, 

and rescue, recovery and cleanup 

workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City, Shanksville, PA, and at 

the Pentagon, and to eligible survivors 

of the New York City attacks. This final 

rule establishes the processes by which 

the WTC Program Administrator may 

add a new condition to the list of WTCrelated health conditions through 

rulemaking, including a process for 

considering petitions by interested 

parties to add a new condition. 

DATES: This final rule is effective May 

25, 2012. 

FOR FURTHER INFORMATION CONTACT: Roy 

M. Fleming, Sc.D., Senior Science 

Advisor, World Trade Center Health 

Program, Office of the Director, National 

Institute for Occupational Safety and 

Health, 1600 Clifton Road NE., MS–E74, 

Atlanta, GA 30329; telephone 866–426– 

3673 (this is a toll-free number). 

Information requests may also be 

submitted by email to 

wtcpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

preamble is organized as follows: 

I. Public Participation 

II. Background 

A. WTC Health Program Statutory 

Authority 

B. Addition of New Health Conditions for 

Coverage in the WTC Health Program 

III. Summary of the Final Rule and Response 

to Comments 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

V. Final Rule 

I. Public Participation 

HHS received comments from six 

individuals and organizations on the 

notice of proposed rulemaking 

published in the Federal Register on 

July 1, 2011 (76 FR 38938). One 

anonymous commenter expressed anger 

about the WTC Health Program’s cost to 

American taxpayers; another individual 

asked that leukemia and other blood 

cancers be added to the list of WTCrelated health conditions; and a 

physician experienced with treating 

WTC-related health conditions 

requested that a mental disorder be 

added to the list of WTC-related health 

conditions. Those comments are outside 

the scope of this rulemaking and could 

not be considered. HHS received 

substantive comments from the New 

York State Laborers’ Health & Safety 

Trust Fund, the Communication 

Workers of America, and the WTC 

Health Program Survivor Steering 

Committee. Those comments are 

described and addressed below. 

II. Background 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within HHS. HHS 

issued an interim final rule on July 1, 

2011 (76 FR 38914), which codified the 

Program in 42 CFR Part 88. Sections 

88.1 through 88.16 were included in 

that rulemaking; this final rule 

establishing § 88.17 was developed in a 

separate rulemaking. 

The WTC Health Program provides 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers (including those who 

are Federal employees) who responded 

to the September 11, 2001, terrorist 

attacks, and to eligible survivors of the 

New York City attacks. The WTC Health 

Program will expand to include eligible 

firefighters and related personnel, law 

enforcement officers, and rescue, 

recovery and cleanup workers who 

responded to the September 11, 2001, 

terrorist attacks at the Pentagon and 

Shanksville, PA. The WTC Program 

Administrator has gathered information 

that may serve as a basis for such 

enrollment, and is working to develop 

eligibility criteria for these responder 

groups. 

All references to the WTC Program 

Administrator in this notice mean the 

NIOSH Director or his or her designee. 

Title XXXIII of the PHS Act 

authorizes the WTC Program 

Administrator to establish a process by 

which health conditions, including 

cancer, may be considered for addition 

to the list of WTC-related health 

conditions. This final rule establishes 

this process. 

B. Addition of New Health Conditions 

for Coverage in the WTC Health 

Program 

The list of WTC-related health 

conditions defined in sections 3312 and 

3322 of Title XXXIII of the PHS Act may 

be amended in the future to add other 

conditions for which exposure to 

airborne toxins, any other hazard, or any 

other adverse condition resulting from 

the September 11, 2001, terrorist 

attacks, based on an examination by a 

medical professional with experience in 

treating or diagnosing the health 

conditions included in the applicable 

list of WTC-related health conditions, is 

substantially likely to be a significant 

factor in aggravating, contributing to, or 

causing the illness or condition (Title 

XXXIII, Sec. 3312(a)(1)(A)(i)). 

Procedures for the addition of a new 

condition are established in this final 

rule. The addition of a new condition 


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