46678 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–120391–10), room 

5205, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand-delivered to: 

CC:PA:LPD:PR (REG–120391–10), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC 20224. 

Alternatively, taxpayers may submit 

comments electronically via the Federal 

eRulemaking Portal at http:// 

www.regulations.gov (IRS REG–120391– 

10). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the regulations, Karen Levin 

at 202–622–6080; concerning 

submissions of comments, Treena 

Garrett at 202–622–7180 (not toll-free 

numbers). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

The temporary regulations published 

elsewhere in this issue of the Federal 

Register amend § 54.9815–2713T of the 

Miscellaneous Excise Tax Regulations. 

The proposed and temporary 

regulations are being published as part 

of a joint rulemaking with the 

Department of Labor and the 

Department of Health and Human 

Services (the joint rulemaking). The text 

of those temporary regulations also 

serves as the text of these proposed 

regulations. The preamble to the 

temporary regulations explains the 

temporary regulations and these 

proposed regulations. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

has also been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 

to these regulations, and because the 

regulation does not impose a collection 

of information requirement on small 

entities, the Regulatory Flexibility Act 

(5 U.S.C. chapter 6) does not apply. 

Pursuant to section 7805(f) of the 

Internal Revenue Code, this regulation 

has been submitted to the Chief Counsel 

for Advocacy of the Small Business 

Administration for comment on its 

impact on small business. 

Comments and Requests for a Public 

Hearing 

Before these proposed regulations are 

adopted as final regulations, 

consideration will be given to any 

written comments (a signed original and 

eight (8) copies) or electronic comments 

that are submitted timely to the IRS. 

Comments are specifically requested on 

the clarity of the proposed regulations 

and how they may be made easier to 

understand. All comments will be 

available for public inspection and 

copying. A public hearing may be 

scheduled if requested in writing by a 

person that timely submits written 

comments. If a public hearing is 

scheduled, notice of the date, time, and 

place for the hearing will be published 

in the Federal Register. 

Drafting Information 

The principal author of these 

proposed regulations is Karen Levin, 

Office of the Division Counsel/Associate 

Chief Counsel (Tax Exempt and 

Government Entities), IRS. The 

proposed regulations, as well as the 

temporary regulations, have been 

developed in coordination with 

personnel from the U.S. Department of 

Labor and the U.S. Department of 

Health and Human Services. 

List of Subjects in 26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

Proposed Amendments to the 

Regulations 

Accordingly, 26 CFR part 54, as 

proposed to be amended on July 19, 

2010, at 75 FR 41787. is further 

proposed to be amended as follows: 

PART 54—PENSION EXCISE TAXES 

Paragraph 1. The authority citation 

for part 54 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

Par. 2. Section 54.9815–2713, as 

proposed to be added at 75 FR 41788, 

July 19, 2010, is amended by revising 

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

§ 54.9815–2713 Coverage of preventive 

health services. 

(a) * * * 

(1) * * * 

(iv) [The text of proposed § 54.9815– 

2713(a)(1)(iv) is the same as the text of 

§ 54.9815–2713T(a)(1)(iv) published 

elsewhere in this issue of the Federal 

Register]. 

* * * * * 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. 2011–19685 Filed 8–1–11; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2011–0108; FRL–8878–3] 

RIN 2070–AB27 

Tris carbamoyl triazine; Proposed 

Modification of Significant New Uses 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Under section 5(a)(2) of the 

Toxic Substances Control Act (TSCA), 

EPA is proposing to amend the 

significant new use rule (SNUR) for the 

chemical substance identified 

generically as tris carbamoyl triazine, 

which was the subject to 

premanufacture notice (PMN) P–95– 

1098. This action would amend the 

SNUR to allow certain uses without 

requiring a significant new use notice 

(SNUN), and would extend SNUN 

requirements to certain additional uses. 

EPA is proposing this amendment based 

on review of new toxicity test data. 

DATES: Comments must be received on 

or before September 2, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0108, 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 Bldg., 

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

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2011–0108. 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2011–0108. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 


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whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

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

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

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

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

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

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

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

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Tracey 

Klosterman, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–2209; e-mail 

address: klosterman.tracey@epa.gov. 

For general information contact: The 

TSCA–Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: 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 substance 

identified generically as tris carbamoyl 

triazine (PMN P–95–1098). Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, importers, or 

processors of the subject chemical 

substance (NAICS codes 325 and 

324110), e.g., chemical manufacturers 

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 e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

In the Federal Register of August 20, 

1998 (63 FR 44562) (FRL–5788–7), EPA 

published a final SNUR (codified at 

§ 721.9719) for the chemical substance 

identified generically as tris carbamoyl 

triazine (PMN P–95–1098), in 

accordance with the procedures at 

§ 721.160. 

EPA is proposing to amend the 

requirements of the SNUR as detailed in 


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this unit. The modified SNUR would 

require persons who intend to 

manufacture, import, or process the 

chemical substance for an activity 

designated as a significant new use to 

notify EPA at least 90 days before 

commencing that activity. The docket 

established for this proposed SNUR is 

available under docket ID number EPA– 

HQ–OPPT–2011–0108. The docket 

includes information considered by the 

Agency in developing the final rule and 

the modified TSCA section 5(e) consent 

order negotiated with the PMN 

submitter. 

PMN Number P–95–1098 

Chemical name: Tris carbamoyl 

triazine (generic). 

CAS number: Not available. 

Effective date of the TSCA section 5(e) 

consent order: April 25, 1997. 

Effective date of the modified TSCA 

section 5(e) consent order: December 1, 

2010. 

Federal Register publication date and 

reference for the final SNUR: August 20, 

1998 (63 FR 44562). 

Basis for the modified TSCA section 

5(e) consent order: The generic (nonconfidential) use of the PMN substance 

is as a cross linking resin. The original 

TSCA section 5(e) consent order was 

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

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

based on the findings that the chemical 

substance may present an unreasonable 

risk of injury to the environment, that it 

will be produced in substantial 

quantities, and there may be significant 

or substantial human exposure to the 

chemical substance. The original 5(e) 

consent order required establishment of 

a hazard communication program; 

established a maximum manufacture 

and importation volume limit for 

submission of required human health 

testing; and prohibited purposeful or 

predictable releases of the PMN 

substance in concentrations that exceed 

40 parts per billion (ppb) in surface 

waters. The proposed SNUR for this 

chemical substance is based on and 

consistent with the provisions of the 

modified TSCA section 5(e) consent 

order, discussed below. The proposed 

SNUR designates as a ‘‘significant new 

use’’ the absence of the protective 

measures required in the corresponding 

modified consent order. 

Human Health Toxicity Concerns: 

During the initial PMN review process, 

EPA established a no-observable-effect 

level (NOEL) of 15 mg/kg/day and a 

lowest-observable-effect level (LOEL) of 

150 mg/kg/day for systemic effects 

based on the results of a 28-day 

inhalation study in rats on the PMN 

substance, but did not determine that 

the PMN substance may present an 

unreasonable risk to human health as a 

result of expected exposure. However, 

the TSCA section 5(e) consent order 

required the PMN submitter to complete 

and submit a prenatal developmental 

toxicity study at a certain production 

volume limit. This is consistent with the 

exposure-based finding pursuant to 

section 5(e)(1)(A)(ii)(II) of TSCA. The 

PMN submitter completed this study 

and based on the results the Agency 

established a NOEL of 30 mg/kg/day for 

maternal toxicity and 1,000 mg/kg/day 

for fetal toxicity. Using the results from 

both this prenatal developmental study 

and the earlier 28-day study, the Agency 

then reevaluated the predicted 

workplace exposures and determined 

that there may be an unreasonable risk 

of maternal and systemic toxicity 

resulting from unprotected inhalation 

exposure to the PMN substance. 

Ecotoxicity Concerns: In addition, to 

address Agency environmental 

concerns, the PMN submitter completed 

a fish early-life stage toxicity test and a 

daphnid chronic toxicity test on the 

PMN substance. During the initial 

review of the PMN, EPA’s preliminary 

Ecological Structural Activity 

Relationship (EcoSAR) analysis of test 

data on structurally analogous 

substances resulted in a predicted 

toxicity to aquatic organisms at 

concentrations that exceed the 

concentration of concern (COC) of 40 

ppb of the PMN substance in surface 

waters. Based on the results of the 

submitted fish and daphnid tests, fish 

were identified as the most sensitive 

species and a revised COC for aquatic 

toxicity of 66 ppb was established. 

Based on the revised COC, EPA then 

performed environmental modeling 

assessments for the PMN releases to 

surface waters and determined that the 

new COC would not be exceeded under 

expected conditions of manufacture, 

import, processing, distribution in 

commerce, use or disposal of the PMN 

substance. 

The Agency concluded, after 

examining this new information and 

reexamining the test data and other 

information supporting its findings 

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

the original TSCA section 5(e) consent 

order, that the finding that certain 

activities involving the substance may 

present an unreasonable risk of injury to 

the environment is no longer supported. 

The Agency also concluded that certain 

additional activities involving the 

substance may present an unreasonable 

risk of injury to human health, pursuant 

to 5(e)(1)(A)(ii)(I). To conform with 

these findings and to protect against the 

remaining potential risks, the Agency 

has modified the TSCA section 5(e) 

consent order (‘‘modified order’’); these 

modifications became effective on 

December 1, 2010. The modified TSCA 

section 5(e) consent order: 

1. Identifies those forms of the PMN 

substance that are exempt from the 

provisions of the consent order. These 

exemptions apply to quantities of the 

PMN substance after it has been 

completely reacted (cured). 

2. Adds protection in the workplace 

requirements for respiratory protection 

and alternative New Chemical Exposure 

Limit (NCEL) exposure monitoring to 

address the newly-identified potential 

risks from inhalation exposure in the 

workplace. 

3. Revises the hazard communication 

requirements to add the human health 

hazard and exposures and remove the 

environmental hazards and exposures. 

4. Removes all release to water 

requirements. 

5. Revises the recordkeeping 

requirements to reflect the 

aforementioned modified consent order 

requirements. 

The proposed rule would conform to 

the scope of the significant new uses in 

the SNUR to mirror the modified 

consent order. 

Recommended testing: EPA has 

determined that the results of the 90-day 

inhalation toxicity test in rats (OPPTS 

Test Guideline 870.3465) would help 

further characterize the human health 

effects of the PMN substance. The 

modified TSCA section 5(e) consent 

order does not require submission of the 

aforementioned information at any 

specified time or production volume. 

However, the order’s restrictions on 

manufacturing, import, processing, 

distribution in commerce, use and 

disposal of the PMN substance will 

remain in effect until the order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

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 TSCA section 5(a)(2) 

factors, listed in Unit III. of this 

document. Once EPA determines that a 

use of a chemical substance is a 

significant new use, TSCA section 

5(a)(1)(B) and 40 CFR part 721 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 


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use. Persons who must report are 

described in § 721.5. 

EPA may respond to SNUNs by, 

among other things, issuing or 

modifying a TSCA section 5(e) consent 

order and/or amending the SNUR 

promulgated under TSCA section 

5(a)(2). Amendment of the SNUR will 

often be necessary to allow persons 

other than the SNUN submitter to 

engage in the newly authorized use(s), 

because even after a person submits a 

SNUN and the review period expires, 

other persons still must submit a SNUN 

before manufacturing on processing for 

the significant new use. Procedures and 

criteria for modifying or revoking SNUR 

requirements appear at § 721.185. 

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 to 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 chemical 

substance identified generically as Tris 

carbamoyl triazine (PMN P–95–1098), 

EPA considered relevant information 

about the toxicity of the chemical 

substance, likely human exposures and 

environmental releases associated with 

possible uses, taking into consideration 

the four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Rationale for the Proposed Rule 

During review of PMN P–95–1098, the 

chemical substance identified 

generically as tris carbamoyl triazine, 

EPA concluded that regulation was 

warranted under TSCA section 5(e), 

pending the development of information 

sufficient to make reasoned evaluations 

of the health or environmental effects of 

this chemical substance. The basis for 

such findings is outlined in Unit II. of 

this notice and in the Federal Register 

document of August 20, 1998 (63 FR 

44562) (FRL–5788–7). Based on these 

findings, a TSCA section 5(e) consent 

order requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitter. The SNUR 

provisions for this chemical substance 

are consistent with the provisions of the 

original TSCA section 5(e) consent 

order. This SNUR was promulgated 

pursuant to § 721.160. 

After the review of test data submitted 

pursuant to the TSCA section 5(e) 

consent order for P–95–1098 (see Unit 

II.) and consideration of the factors 

included in TSCA section 5(a)(2) (see 

Unit III.), EPA determined that the 

chemical substance may pose an 

unreasonable risk to human health, but 

no longer may present an unreasonable 

risk to the environment. Consequently, 

EPA is proposing this modification to 

the SNUR at § 721.9719 according to 

procedures in §§ 721.160 and 721.185 so 

that SNUR provisions for this chemical 

substance remain consistent with the 

provisions of the TSCA section 5(e) 

consent order, as modified. 

V. Applicability of Proposed Rule to 

Uses Occurring Before Effective Date of 

the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. EPA solicits comments on 

whether any of the uses proposed as 

significant new uses are ongoing. As 

discussed in the Federal Register of 

April 24, 1990 (55 FR 17376), EPA has 

decided that the intent of section 

5(a)(1)(B) of TSCA 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 of the proposed 

rule 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 as of the 

effective date of the final rule. 

Thus, any persons who begin 

commercial manufacture, import, or 

processing activities with the chemical 

substances that are not currently a 

significant new use under the current 

rule but which would be regulated as a 

‘‘significant new use’’ if this proposed 

rule if this rule is finalized, must cease 

any such activity as of the effective date 

of the rule if and when finalized. To 

resume their activities, these persons 

would have to comply with all 

applicable SNUR notice requirements 

and wait until the notice review period, 

including all extensions, expires. 

EPA has promulgated provisions to 

allow persons to comply with this 

SNUR before the effective date. If a 

person were to meet the conditions of 

advance compliance under § 721.45(h), 

the person would be considered to have 

met the requirements of the final SNUR 

for those activities. 

VI. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require the development of any 

particular test data before submission of 

a SNUN. There are two exceptions: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In this case, EPA recommends persons, 

before performing any testing, to consult 

with the Agency pertaining to protocol 

selection. To access the Harmonized 

Test Guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

The modified TSCA section 5(e) 

consent order for the chemical 

substance that would be regulated under 

this proposed rule does not require 

submission of the test at any specified 

time or volume. However, the 

restrictions on manufacture, import, 

processing, distribution in commerce, 

use and disposal of the PMN substance 

would remain in effect until the consent 

order is modified or revoked by EPA 

based on submission of that or other 

relevant information. These restricted 

activities cannot be commenced unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by this chemical 

substance. The test specified in the 

modified TSCA section 5(e) consent 

order is included in Unit II. The 

proposed SNUR would contain the same 

restrictions as the modified TSCA 

section 5(e) consent order. Persons who 

intend to commence non-exempt 

commercial manufacture, import, or 

processing for those activities proposed 

as significant new uses would be 


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required to notify the Agency by 

submitting a SNUN at least 90 days in 

advance of commencement of those 

activities. 

The recommended testing specified in 

Unit II. of this document may not be the 

only means of addressing the potential 

risks of the chemical substance. 

However, SNUNs submitted without 

any test data may increase the 

likelihood that EPA will take action 

under TSCA section 5(e), particularly if 

satisfactory test results have not been 

obtained from a prior PMN or SNUN 

submitter. EPA recommends that 

potential SNUN submitters contact EPA 

early enough so that they will be able 

to conduct the appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substance. 

• Potential benefits of the chemical 

substance. 

• Information on risks posed by the 

chemical substance compared to risks 

posed by potential substitutes. 

VII. SNUN Submissions 

According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 

§ 720.50. SNUNs must be 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. 

VIII. Economic Analysis 

EPA 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. The Agency’s complete 

Economic Analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2011–0108. 

IX. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would modify a 

SNUR for a chemical substance that is 

the subject of a PMN and TSCA section 

5(e) consent order. 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 the 

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 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 rationale 

supporting this conclusion is discussed 

in this unit. 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 rule as a ‘‘significant 

new use.’’ Because these uses are 

‘‘new,’’ based on all information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activities. A SNUR 

requires that any person who intends to 

engage in such activity in the future 

must first notify EPA by submitting a 

SNUN. Although some small entities 

may decide to pursue a significant new 

use in the future, EPA cannot presently 

determine how many, if any, there may 

be. However, EPA’s experience to date 

is that, in response to the promulgation 

of SNURs covering over 1,000 

chemicals, the Agency receives only a 

handful of notices per year. For 

example, the number of SNUNs was 

four in Federal fiscal year 2005, eight in 

FY2006, six in FY2007, eight in FY2008, 

and seven in FY2009. During this fiveyear 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, the potential economic 

impacts of complying with this SNUR 

would not be 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 reason 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, 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 46683 

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: July 22, 2011. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR part 721 is 

proposed to be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

2. Amend § 721.9719 as follows: 

a. Revise the section heading. 

b. Revise paragraphs (a)(1), (a)(2)(i), 

and (a)(2)(ii). 

c. Remove paragraph (a)(2)(iii). 

d. Revise paragraph (b)(1). 

e. Remove paragraph (b)(3). 

The revisions and addition read as 

follows: 

§ 721.9719 Tris carbamoyl triazine. 

(a) * * * 

(1) The chemical substance identified 

generically as tris carbamoyl triazine 

(PMN P–95–1098) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

rule do not apply to quantities of the 

chemical substance after it has been 

completely reacted (cured). 

(2) * * * 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

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

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 5. As an alternative to 

the respiratory requirements listed, a 

manufacturer, importer, or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provisions listed 

in the Toxic Substances Control Act 

(TSCA) section 5(e) consent order for 

this substance. The NCEL is 1.0 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 section 

5(e) consent order. The following 

NIOSH-certified respirators meet the 

requirements for § 721.63(a)(4): 

(A) Air purifying, tight-fitting halfface respirator equipped with the 

appropriate combination cartridges; 

cartridges should be tested and 

approved for the gas/vapor substance 

(i.e., organic vapor, acid gas, or 

substance-specific cartridge) and should 

include a particulate filter (N100 if oil 

aerosols are absent, R100, or P100); 

(B) Air purifying, tight-fitting full-face 

respirator equipped with the 

appropriate combination cartridges, 

cartridges should be tested and 

approved for the gas/vapor substance 

(i.e., organic vapor, acid gas, or 

substance-specific cartridge) and should 

include a particulate filter (N100 if oil 

aerosols are absent, R100, or P100); 

(C) Powered air-purifying respirator 

equipped with loose-fitting hood or 

helmet equipped with a High Efficiency 

Particulate Air (HEPA) filter; powered 

air-purifying respirator equipped with 

tight-fitting facepiece (either half-face or 

full-face) equipped with a High 

Efficiency Particulate Air (HEPA) filter; 

(D) Supplied-air respirator operated in 

pressure demand or continuous flow 

mode and equipped with a hood or 

helmet, or tight-fitting face piece (either 

half-face or full-face). 

(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)(1)(iv), 

(g)(1)(ix), (g)(2)(ii), (g)(2)(iv), and (g)(5). 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

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

applicable to manufacturers, importers, 

and processors of this substance. 

* * * * * 

[FR Doc. 2011–19412 Filed 8–2–11; 8:45 am] 

BILLING CODE 6560–50–P 


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