Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81441 

believes that the potential economic 

impacts of complying with this SNUR 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register of 

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

1), the Agency presented its general 

determination that final SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

E. Executive Order 13132 

This action would not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would not significantly nor 

uniquely affect the communities of 

Indian Tribal governments, nor would it 

involve or impose any requirements that 

affect Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this proposed rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This proposed rule 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). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 16, 2011. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

2. Add § 721.5725 to subpart E to read 

as follows: 

§ 721.5725 Phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2,4-dimethyl-6-(1- 

methylpentadecyl)- (PMN P–94–209; 

CAS No. 134701–20–5) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(2)(i) and (a)(3). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–33256 Filed 12–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2010–1075; FRL–9329–4] 

RIN 2070–AB27 

Proposed Significant New Use Rules 

on Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for the chemical substances 

rutile, tin zinc, calcium-doped (CAS No. 

389623–01–2) and rutile, tin zinc, 

sodium-doped (CAS No. 389623–07–8) 

which were the subject of 

premanufacture notices (PMNs P–06–36 

and P–06–37) and TSCA section 5(e) 

consent orders issued by EPA. The 

proposed SNURs on these substances, 

which are based on and consistent with 

the provisions of the underlying consent 

orders, would designate as a significant 

new use the absence of the protective 

measures required in the consent orders. 

This action would require persons who 

intend to manufacture, import, or 

process either of the chemical 

substances for an activity that is 

designated as a significant new use by 

this proposed rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

the activity before it occurs. 

DATES: Comments must be received on 

or before January 27, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

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81442 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

number EPA–HQ–OPPT–2010–1075, 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 Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2010–1075. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2010–1075. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available 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: TSCA– 

Hotline@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 proposed rule. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, or 

processors of one or more subject 

chemical substances (NAICS codes 325 

and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to a final SNUR 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of a proposed or final 

SNUR are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

B. What should i consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

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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 proposing significant new use 

rules (SNURs) under section 5(a)(2) of 

TSCA for two chemical substances 

which were the subject of PMNs and 

TSCA section 5(e) consent orders. The 

two chemical substances are identified 

as rutile, tin zinc, calcium-doped (PMN 

P–06–36; CAS No. 389623–01–2) and 

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

06–37; CAS No. 389623–07–8). The 

proposed SNUR on these substances are 

based on and consistent with the 

provisions in the underlying consent 

orders. The proposed SNURs designate 

as a significant new use the absence of 

the protective measures required in the 

corresponding consent orders. These 

SNURs would require persons who 

intend to manufacture, import, or 

process either of these chemical 

substances for an activity that is 

designated as a significant new use to 

notify EPA at least 90 days before 

commencing that activity. 

In the Federal Register of October 5, 

2011 (76 FR 61566) (FRL–8880–2), EPA 

issued direct final SNURs on these two 

chemical substances in accordance with 

the procedures at § 721.160(c)(3)(i). EPA 

received notice of intent to submit 

adverse comments on these SNURs. 

Therefore, as required by 

§ 721.160(c)(3)(ii), in the Federal 

Register of December 5, 2011 (76 FR 

75794) (FRL–9329–5), EPA withdrew 

the direct final SNURs and is now 

issuing this proposed rule on the two 

chemical substances. The record for the 

direct final SNURs on these substances 

was established as docket EPA–HQ– 

OPPT–2010–1075. That record includes 

information considered by the Agency 

in developing the direct final rule and 

the notice of intent to submit adverse 

comments. 

B. What is the agency’s authority for 

taking this action? 

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

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

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

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

Once EPA determines that a use of a 

chemical substance is a significant new 

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

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture, import, or 

process the chemical substance for that 

use. Persons who must report are 

described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

notice requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorizes EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the two chemical 

substances that are the subject of these 

proposed SNURs, EPA considered 

relevant information about the toxicity 

of the chemical substances, likely 

human exposures and environmental 

releases associated with possible uses, 

taking into consideration the four 

bulleted TSCA section 5(a)(2) factors 

listed in this unit. 

IV. Substances Subject to This Proposed 

Rule 

EPA is proposing to establish 

significant new use and recordkeeping 

requirements for two 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. 

• Chemical Abstracts Service (CAS) 

number. 

• Basis for the TSCA section 5(e) 

consent order. 

• Toxicity concerns. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VII. for more information). 

• CFR citation assigned in the 

regulatory text section of this proposed 

rule. 

This proposed rule concerns two 

PMN substances that are subject to 

‘‘risk-based’’ consent orders under 

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

consent orders require protective 

measures to limit exposures or 

otherwise mitigate the potential 

unreasonable risk. The so-called ‘‘5(e) 

SNURs’’ on these PMN substances are 

promulgated pursuant to § 721.160, and 

are based on and consistent with the 

provisions in the underlying consent 

orders. The 5(e) SNURs designate as a 

‘‘significant new use’’ the absence of the 

protective measures required in the 

corresponding consent orders. 

PMN Numbers P–06–36 and P–06–37 

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

zinc, calcium-doped and (P–06–37) 

Rutile, tin zinc, sodium-doped. 

CAS numbers: (P–06–36) 389623–01– 

2 and (P–06–37) 389623–07–8. 

Effective date of TSCA section 5(e) 

consent order: February 17, 2009. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the 

substances will be used as colorants for 

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polymers and industrial coatings. The 

order was issued under TSCA sections 

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

on a finding that the substances may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the consent order requires: Use of 

personal respiratory equipment, 

including a National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Assigned Protection Factor (APF) of at 

least 10, or compliance with a New 

Chemical Exposure Limit (NCEL) of 1.5 

mg/m3 as an 8-hour time weighted 

average; establishment of a hazard 

communication program; and restricts 

the company from manufacturing the 

PMN substances with a d10 particle size 

less than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller; and 

corresponding recordkeeping. The 

SNUR designates as a ‘‘significant new 

use’’ the absence of these protective 

measures. 

Toxicity concern: Based on structural 

activity relationship analysis derived 

from test data on structurally similar 

respirable, poorly soluble particulates, 

the PMN substances may cause lung 

overload and fibrosis in workers 

exposed to the PMN substances by the 

inhalation route. 

Recommended testing: EPA has 

determined that the following test 

would help characterize the human 

health effects of the PMN substances: A 

90-day inhalation toxicity test (OPPTS 

Test Guideline 870.3465) in rats. The 

testing should include a 60-day recovery 

period to assess the progression or 

regression of any lesions; and include 

special attention to histopathology 

(inflammation and cell proliferation) of 

the lung tissues and to various 

parameters of the bronchoalveolar 

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

enzyme activities, total protein content, 

total cell count, cell differential, and 

cell viability. The order does not require 

submission of the aforementioned 

information at any specified time or 

production volume. However, the 

order’s restrictions on manufacturing, 

import, processing, distribution in 

commerce, use, and disposal of the 

PMN substances will remain in effect 

until the order is modified or revoked 

by EPA based on submission of that or 

other relevant information. 

CFR citations: 40 CFR 721.10230 (P– 

06–36) and 40 CFR 721.10231 (P–06– 

37). 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During review of the PMNs submitted 

for these two chemical substances, EPA 

concluded that regulation was 

warranted under TSCA section 5(e), 

pending the development of information 

sufficient to make reasoned evaluations 

of the human health 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 proposed SNUR provisions for 

these chemical substances are consistent 

with the provisions of the TSCA section 

5(e) consent orders. These proposed 

SNURs are issued pursuant to § 721.160. 

B. Objectives 

EPA is proposing these SNURs for 

specific chemical substances that have 

undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this proposed rule: 

• EPA would 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 would 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 would 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 would 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. Applicability of the Proposed Rule 

to Uses Occurring Before Effective Date 

of the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this proposed rule have 

undergone premanufacture review and 

are subject to TSCA section 5(e) consent 

orders. The PMN submitters are 

prohibited by these TSCA section 5(e) 

consent orders from undertaking 

activities which EPA is proposing as 

significant new uses. EPA solicits 

comments on whether any of the uses 

proposed as significant new uses are 

ongoing. 

As discussed in the Federal Register 

issue of April 24, 1990 (55 FR 17376), 

EPA has decided that the intent of 

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

designating a use as a significant new 

use as of the date of publication of the 

proposed rule rather than as of the 

effective date of the final rule. If uses 

begun after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements because a person 

could defeat the SNUR by initiating the 

significant new use before the rule 

became final, and then argue that the 

use was ongoing before the effective 

date of the final rule. Thus, persons who 

begin commercial manufacture, import, 

or processing activities with the 

chemical substances regulated through 

this proposed SNUR must cease any 

such activity before the effective date of 

the rule, if and when finalized. To 

resume their activities, these persons 

would have to comply with all 

applicable SNUR notice requirements 

and wait until the notice review period, 

including all extensions, expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

proposed 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. 

VII. 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) 

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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81445 

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

describes those tests. Descriptions of 

tests are provided for informational 

purposes. EPA strongly encourages 

persons, before performing any testing, 

to consult with the Agency pertaining to 

protocol selection 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.’’ 

In the TSCA section 5(e) consent 

orders for the two chemical substances 

regulated under this proposed rule, EPA 

has established restrictions in view of 

the lack of data on the potential human 

health risks that may be posed by the 

significant new uses or increased 

exposure to the chemical substances. 

These restrictions will not be removed 

until EPA determines that the 

unrestricted use will not present an 

unreasonable risk of injury or result in 

significant or substantial exposure or 

environmental release. This 

determination is usually made based on 

the results of the required or 

recommended toxicity tests. 

The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 

§ 720.50. SNUNs must be submitted on 

EPA Form No. 7710–25, generated using 

e-PMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in §§ 721.25 and 

720.40. E–PMN software is available 

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

opptintr/newchems. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substances 

during the development of the direct 

final rule. EPA’s complete Economic 

Analysis is available in the docket 

under docket ID number EPA–HQ– 

OPPT–2010–1075. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would establish 

SNURs for two chemical substances that 

were the subject of PMNs and 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 would amend the table 

in 40 CFR part 9 to list the OMB 

approval number for the information 

collection requirements contained in 

this proposed rule. This listing of the 

OMB control numbers and their 

subsequent codification in the CFR 

satisfies the display requirements of 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act, 5 U.S.C. 

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

further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action would not impose any 

burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

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

certifies that promulgation of this SNUR 

would not have a significant adverse 

economic impact on a substantial 

number of small entities. The 

requirement to submit a SNUN applies 

to any person (including small or large 

entities) who intends to engage in any 

activity described in the final rule as a 

‘‘significant new use.’’ Because these 

uses are ‘‘new,’’ based on all 

information currently available to EPA, 

it appears that no small or large entities 

presently engage in such activities. A 

SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. Although some 

small entities may decide to pursue a 

significant new use in the future, EPA 

cannot presently determine how many, 

if any, there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of SNURs covering 

over 1,000 chemicals substances, the 

Agency receives only a handful of 

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81446 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 

SNUNs per year. For example, the 

number of SNUNs was four in Federal 

fiscal year (FY) 2005, eight in FY 2006, 

six in FY 2007, eight in FY 2008, and 

seven in FY 2009. During this 5-year 

period, three small entities submitted a 

SNUN. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit VIII.) is minimal regardless of 

the size of the firm. Therefore, EPA 

believes that the potential economic 

impacts of complying with those SNURs 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register issue 

of June 2, 1997 (62 FR 29684) (FRL– 

5597–1), the Agency presented its 

general determination that final SNURs 

are not expected to have a significant 

economic impact on a substantial 

number of small entities, which was 

provided to the Chief Counsel for 

Advocacy of the Small Business 

Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any affect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

E. Executive Order 13132 

This action would not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would not significantly nor 

uniquely affect the communities of 

Indian Tribal governments, nor would it 

involve or impose any requirements that 

affect Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this proposed rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This proposed rule 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). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 16, 2011. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

2. Add § 721.10230 to subpart E to 

read as follows: 

§ 721.10230 Rutile, tin zinc, calciumdoped. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

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

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

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been incorporated into a polymer, 

glass, dispersion, cementitious matrix, 

or a similar incorporation. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1.0 percent), and (c). The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10 

meet the minimum requirements for 

§ 721.63(a)(5): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

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

loose- fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

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

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

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

(1) As an alternative to the respiratory 

requirements listed in paragraph 

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

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for these substances. 

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

time-weighted-average for both 

chemical substances combined. Persons 

who wish to pursue NCELs as an 

alternative to the § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will receive NCELs 

provisions comparable to those 

contained in the corresponding section 

5(e) consent order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules 81447 

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

1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), 

(g)(2)(iv) (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.5 mg/m3), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (f), (g), (h), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

3. Add § 721.10231 to subpart E to 

read as follows: 

§ 721.10231 Rutile, tin zinc, sodium-doped. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

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

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

to reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance that 

have been incorporated into a polymer, 

glass, dispersion, cementitious matrix, 

or a similar incorporation. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

set at 1.0 percent), and (c). The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of 10 

meet the minimum requirements for 

§ 721.63(a)(5): 

(A) NIOSH-certified air-purifying, 

tight-fitting half-face respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters; 

(B) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

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

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

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

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

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

(1) As an alternative to the respiratory 

requirements listed in paragraph 

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

processor may choose to follow the new 

chemical exposure limit (NCEL) 

provisions listed in the TSCA section 

5(e) consent order for these substances. 

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

time-weighted-average for both 

chemical substances combined. Persons 

who wish to pursue NCELs as an 

alternative to the § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will receive NCELs 

provisions comparable to those 

contained in the corresponding section 

5(e) consent order. 

(2) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), 

(g)(2)(iv) (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.5 mg/m3), 

and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substances with a particle size less 

than 100 nanometers, where d10 

particle size presents the particle size, 

as determined by laser light scattering, 

at which 10 percent by weight of the 

substance measured is smaller). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d), (f), (g), (h), and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–33255 Filed 12–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2010–0279; FRL–9326–2] 

RIN 2070–AB27 

Proposed Significant New Use Rules 

on Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for 17 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Fifteen 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action would 

require persons who intend to 

manufacture, import, or process any of 

these 17 chemical substances for an 

activity that is designated as a 

significant new use by this proposed 

rule to notify EPA at least 90 days before 

commencing that activity. The required 

notification would provide EPA with 

the opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: Comments must be received on 

or before January 27, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0279, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2010–0279. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2010–0279. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

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