68306 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 

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. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. 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 either 

electronically in http:// 

www.regulations.gov or in hard copy at 

the USEPA Docket Center, Public 

Reading Room, Room 3334, EPA West 

Building, 1301 Constitution Ave., NW., 

Washington, DC. The Public Reading 

Room is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Public Reading Room is (202) 

566–1744, and the telephone number for 

the EPA Docket Center is (202) 566– 

2426. 

FOR FURTHER INFORMATION CONTACT: 

Janet Goodwin, USEPA Office of Water 

by phone at (202) 566–1060 or by e-mail 

at goodwin.janet@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

Regulated Entities 

Entities potentially regulated by this 

action include: 

Category Examples of regulated entities 

North American industry classification 

system (NAICS) 

code 

Industry .................. Construction activities required to obtain 236 NPDES permit coverage and performing the following 

activities: Construction of buildings, including building, developing and general contracting. 

236 

Heavy and civil engineering construction, including land subdivision. 237 

EPA does not intend the preceding 

table to be exhaustive, but provides it as 

a guide for readers regarding entities 

likely to be regulated by this action. 

This table lists the types of entities that 

EPA is now aware could potentially be 

regulated by this action. Other types of 

entities not listed in the table could also 

be regulated. To determine whether 

your facility is regulated by this action, 

you should carefully examine the 

applicability criteria in 40 CFR 450.10 

(74 FR 62995) and the definition of 

‘‘storm water discharges associated with 

industrial activity’’ and ‘‘storm water 

discharges associated with small 

construction activity’’ in existing EPA 

regulations at 40 CFR 122.26(b)(14)(x) 

and 122.26(b)(15), respectively. If you 

have questions regarding the 

applicability of this action to a 

particular site, consult the person listed 

for technical information in the 

preceding FOR FURTHER INFORMATION

CONTACT section. 

II. Discussion of Direct Final 

Rulemaking 

EPA is proposing to stay the 

provisions of 40 CFR 450.22(a) and (b) 

that contain the numeric limitation and 

associated monitoring requirements for 

the Construction and Development 

Point Source category. This stay is 

necessary to reconsider the record 

underlying the calculation of the 280 

NTU numeric limitation. After the 

numeric limitation was promulgated, 

and based on EPA’s examination of the 

dataset underlying the 280 NTU limit, 

EPA concluded that it improperly 

interpreted the data and, as a result, the 

calculations in the existing 

administrative record are no longer 

adequate to support the 280 NTU 

effluent limitation. EPA intends to 

expeditiously conduct a separate 

rulemaking to correct the numeric 

effluent limitation. Until the new 

rulemaking is effective, it is proposed 

that the stay will remain in place. EPA 

expects to complete a notice and 

comment rulemaking to correct the data 

error by May 30, 2011 so that the 

revised numeric limitation will be 

effective by June 29, 2011. An effective 

date of June 29, 2011 for the corrected 

numeric limit will enable EPA to 

incorporate the revised numeric limit 

and associated monitoring requirements 

in EPA’s Construction General Permit. 

In the ‘‘Rules and Regulations’’ section of 

today’s Federal Register, we are issuing 

this stay as a direct final rule without 

prior proposal because we view this stay 

as noncontroversial and anticipate no 

adverse comment. We have described 

the justification for the stay in the direct 

final rule. If EPA receives no adverse 

comment on either of these two actions, 

the Agency will not take further action 

on this proposed rule. If EPA receives 

adverse comment on either of these two 

actions, the Agency will publish a 

timely withdrawal of the direct final 

rule in the Federal Register. We would 

then address all public comments in a 

subsequent final rule based on this 

proposed rule. We will not institute a 

second comment period on this action. 

Any parties interested in commenting 

must do so at this time. 

For the various statutes and Executive 

Orders that require findings for each 

rulemaking, EPA incorporates the 

findings from the direct final 

rulemaking into this companion notice 

for the purpose of providing public 

notice and opportunity for comment. 

List of Subjects in 40 CFR Part 450 

Environmental protection, 

Construction industry, Land 

development, Erosion, Sediment, 

Stormwater, Water pollution control. 

Dated: November 1, 2010. 

Lisa P. Jackson, 

Administrator. 

[FR Doc. 2010–28034 Filed 11–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2009–0669; FRL–8849–7] 

RIN 2070–AB27 

Modification of Significant New Uses 

of 2-Propen-1-one, 1-(4-morpholinyl)- 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is proposing to 

amend the significant new use rule 

(SNUR) for 2–Propen-1-one, 1-(4- 

morpholinyl)- (CAS No. 5117–12–4) to 

allow certain uses without requiring a 

significant new use notice (SNUN). EPA 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 68307 

is proposing this amendment based on 

review of new toxicity test data and 

receipt of a SNUN for this chemical 

substance. The proposed amended 

SNUR would continue to require a 

SNUN for new uses that may involve 

significant changes in human exposure. 

DATES: Comments must be received on 

or before December 6, 2010. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2009–0669, 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–2009–0669. 

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– 

2009–0669. 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 

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: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use 2-Propen-1-one, 1-(4- 

morpholinyl)- (CAS No. 5117–12–4). 

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 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 this proposed rule 

on or after December 6, 2010 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 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

68308 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 

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? 

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

Substances Control Act (TSCA), EPA is 

proposing to modify the significant new 

use and recordkeeping requirements at 

§ 721.5185, for the chemical substance 

2-Propen-1-one, 1-(4-morpholinyl)- 

(CAS No. 5117–12–4). In this unit, EPA 

provides a brief description for the 

chemical substance, including the 

Premanufacture Notice (PMN) number, 

chemical name, CAS number, basis for 

modification of the TSCA section 5(e) 

consent order, and the CFR citation. 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. 

In the Federal Register of January 5, 

2000 (65 FR 354) (FRL–6055–2), EPA 

issued a direct final SNUR for this 

chemical substance in accordance with 

the procedures at § 721.160. The record 

established for this proposed SNUR is 

available in the docket under docket ID 

number EPA–HQ–OPPT–2009–0669. 

That record includes all information 

considered by the Agency in developing 

the direct final rule, the modified TSCA 

section 5(e) consent order negotiated 

with the PMN submitter, and review of 

a SNUN (S–08–07) submitted in 2008 by 

a person other than the PMN submitter. 

PMN Number P–95–169 

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

morpholinyl)-. 

CAS number: 5117–12–4. 

Effective date of modified TSCA 

section 5(e) consent order: May 9, 2006. 

Federal Register publication date and 

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

Basis for modified TSCA section 5(e) 

consent order and SNUR: The PMN 

substance will be used as a diluent for 

ultraviolet (UV) and electron beam (EB) 

curable resin for coatings, inks, and 

curable adhesives. The consent order 

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

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

finding that the chemical substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Agency 

issued a TSCA 5(e) consent order which 

became effective on November 27, 1998. 

The order required the use of dermal 

personal protective equipment 

(including gloves demonstrated to be 

impervious) and respiratory personal 

protective equipment (including a 

National Institute of Occupational 

Safety and Health (NIOSH)-approved 

respirator); required establishment of a 

hazard communication program; 

prohibited domestic manufacturing; 

prohibited processing and use activities 

in non-enclosed processes; established 

maximum importation volume limits for 

submission of required testing; 

established waste disposal practices 

(including restrictions for no release to 

surface waters and requirement of 

disposal only in a RCRA hazardous 

waste landfill); and prohibited use of 

the chemical substance involving an 

application method that generates a 

vapor, mist, or aerosol. The proposed 

SNUR for this chemical substance is 

based on and consistent with the 

provisions of the modified consent 

order. The proposed SNUR designates 

as a ‘‘significant new use’’ the absence of 

the protective measures required in the 

corresponding consent order. 

Toxicity concern: Under the terms of 

the TSCA section 5(e) consent order, the 

PMN submitter completed the following 

tiered studies: An in vivo mouse 

micronucleus test, a 90-day oral toxicity 

study in rats, and a reproductive 

toxicity screening study in rats. The 

results of the micronucleus test were 

negative. Based on the results of the 90- 

day study, the Agency established a no 

observed adverse effect level (NOAEL) 

of 20 mg/kg/day for neurotoxicity. 

Further, based on the results of the 

reproductive toxicity screening study, a 

NOAEL of 75 mg/kg/day (highest dose 

tested) was established for reproductive 

effects. From these data, the Agency 

calculated Margins of Exposure (MOEs) 

for predicted workplace exposures. 

Based on these new data, concerns 

remain for possible effects to the liver, 

testes, kidney, and blood from dermal 

exposure. However, EPA no longer has 

substantial human health concerns for 

mutagenicity and neurotoxicity. In 

addition, Agency concerns for 

carcinogenicity by inhalation were 

reduced, but were further mitigated by 

retaining the original consent order 

prohibition of industrial processing and 

use in a non-enclosed process and any 

use application methods that generate a 

vapor, mist, or aerosol form of the PMN 

substance. 

In addition, to address Agency 

environmental concerns, a re-review of 

the environmental toxicity profile for 

the PMN substance was conducted. The 

results of this evaluation indicated a 

low concern for chronic aquatic toxicity. 

Therefore, EPA could no longer make a 

‘‘may present unreasonable risk’’ finding 

for releases of the PMN substance to 

surface waters. As a result of the 

aforementioned review, EPA issued a 

modified TSCA section 5(e) consent 

order which became effective on May 9, 

2006. The modified order removed 

requirements for respiratory protection, 

waived further required trigger testing 

for mutagenicity and cancer (i.e., 

required by a set production volume or 

time), removed the restriction on 

domestic manufacture, and removed 

waste disposal restrictions (i.e., no 

longer prohibiting releases to surface 

waters or limiting disposal to 

incineration or landfill). Pursuant to 

§ 721.185(a)(5), the Agency has 

examined new information and 

reexamined the test data and other 

information supporting its finding 

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

and has concluded that a rational basis 

no longer exists to support findings that 

certain activities involving the 

substance may present an unreasonable 

risk of injury to human health and the 

environment required under section 

5(e)(1)(A) of TSCA. Therefore, the 

Agency is proposing to modify the 

SNUR based on and consistent with the 

provisions in the underlying modified 

consent order. To protect against the 

remaining potential risks, the modified 

consent order: 

• Requires the use of dermal personal 

protective equipment (including gloves 

demonstrated to be impervious). 

• Requires establishment of a hazard 

communication program. 

• Prohibits processing and use 

activities in non-enclosed processes. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 68309 

• Prohibits the use of the chemical 

substance involving an application 

method that generates a vapor, mist, or 

aerosol. 

The proposed modified SNUR 

designates as a ‘‘significant new use’’ the 

absence of these protective measures. In 

addition, EPA has included, in the 

proposed regulatory text, clarifying 

language for those forms of the PMN 

substance which are exempt from the 

provisions of the proposed SNUR. These 

exemptions apply to quantities of the 

PMN substance after it has been 

completely reacted (cured). 

On June 27, 2008, the Agency 

received a SNUN (S–08–07) for the 

subject chemical substance. The 

significant new use identified in the 

notice was release to water for the 

generic (non-confidential) use of 

‘‘contained use in energy production’’. 

The 90-day review period for the SNUN 

expired on October 2, 2008 with the 

Agency not taking action on the 

‘‘significant new use’’ of release of the 

substance to water. The proposed 

modified SNUR would similarly no 

longer include release to water as a 

significant new use, along with the 

other changes noted. 

Recommended testing: EPA has 

determined that the results of the 

combined repeated dose toxicity with 

the reproductive/developmental toxicity 

screening test (OPPTS Test Guideline 

870.3650 or Organisation for Economic 

Co-operation and Development (OECD) 

Test Guideline 422) would help further 

characterize the human health effects of 

the PMN substance. The modified 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. 

CFR citation: 40 CFR 721.5185. 

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 those listed in TSCA section 

5(a)(2) (see 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 SNUN to EPA at least 90 

days before they manufacture, import, 

or process the chemical substance for 

that use. The mechanism for reporting 

under this requirement is established 

under § 721.5. 

Section 5(a)(1) of TSCA (15 U.S.C. 

2604(a)(1)) and its implementing 

regulations at 40 CFR parts 720 and 721 

require that any person intending to 

manufacture a new chemical substance, 

or to manufacture or process any 

chemical substance for a significant new 

use, must give EPA 90-days advance 

written notice in the form of a PMN or 

SNUN, respectively. 

Upon reviewing those notices, if EPA 

makes certain determinations regarding 

potential exposures and risks that may 

be presented by the activities associated 

with the chemical, EPA may regulate 

the chemical by issuing an order under 

TSCA section 5(e) and/or a significant 

new use rule (SNUR) under TSCA 

section 5(a)(2) and 40 CFR part 721. The 

TSCA section 5(e) order governs only 

the entity who submitted the PMN 

whereas the section 5(a)(2) SNUR 

applies to all manufacturers and 

processors of the chemical substance. 

EPA may respond to SNUNs by 

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 companies 

other than the SNUN submitter to 

engage in the newly authorized use(s), 

because even after a manufacturer 

submits a SNUN and the review period 

expires, processors of the same 

substance still must submit a SNUN 

before engaging in the significant new 

use. Provisions regarding EPA’s 

authority to modify or revoke SNUR 

requirements appear at § 721.185. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the proposed rule, recordkeeping 

requirements, and exemptions to 

reporting requirements. Provisions 

relating to user fees appear at 40 CFR 

part 700. According to § 721.1(c), 

persons subject to this SNUR 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 sections 5(b) and 5(d)(1), the 

exemptions authorized by TSCA 

sections 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. 

Chemical importers are subject to the 

TSCA section 13 (15 U.S.C. 2612) 

import certification requirements 

codified at 19 CFR 12.118 through 

12.127; see also 19 CFR 127.28 (the 

corresponding EPA policy appears at 40 

CFR part 707, subpart B). Chemical 

importers must certify that the shipment 

of the chemical substance complies with 

all applicable rules and orders under 

TSCA. Importers of chemical substances 

subject to a final SNUR must certify 

their compliance with the SNUR 

requirements. In addition, any persons 

who export or intend to export a 

chemical substance identified in a 

proposed 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. 

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 authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the chemical 

substance that is the subject of this 

proposed rule, EPA considered relevant 

information about the toxicity of the 

chemical substance, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

IV. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

During the review of test data 

submitted under the TSCA section 5(e) 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

68310 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 

consent order for 2-Propen-1-one, 1-(4- 

morpholinyl)-, EPA determined that the 

chemical substance still met one or 

more of the criteria of concern 

established at § 721.160. (see Unit II.) 

B. Objectives 

EPA is proposing this SNUR 

modification for the specific chemical 

substance 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 chemical substance 

that is the subject of a TSCA section 5(e) 

consent order are subject to similar 

requirements. 

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, 

persons who begin commercial 

manufacture, import, or processing 

activities with the chemical substances 

that would be regulated as a ‘‘significant 

new use’’ through this proposed rule, 

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 cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit II. 

lists 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. To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

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

American Society for Testing and 

Materials (ASTM) standards are 

available at http://www.astm.org/ 

Standard/index.shtml. 

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 test data 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 

required to notify the Agency by 

submitting a SNUN at least 90 days in 

advance of commencement of those 

activities. 

The recommended tests may not be 

the only means of addressing the 

potential risks of the chemical 

substance. However, SNUN submission 

for a significant new use without any 

test data may increase the likelihood 

that EPA will take action under TSCA 

section 5(e). 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 

As stated in Unit II.C., 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 to EPA, on EPA Form No. 

7710–25 in accordance with the 

procedures set forth in § 721.25 and 

§ 720.40. This form is available from 

the Environmental Assistance Division 

(7408M), 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. Forms 

and information are also available 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 68311 

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

opptintr/newchems/pubs/ 

pmnforms.htm. 

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 

public docket under docket ID number 

EPA–HQ–OPPT–2009–0669. 

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 over 1,400 SNURs, the Agency 

receives on average only 5 notices per 

year. Of those SNUNs submitted from 

2006–2008, only one appears to be from 

a small entity. 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 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 or 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. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

68312 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 

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 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: November 1, 2010. 

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. Amend § 721.5185 as follows: 

a. Revise the section heading. 

b. Revise paragraphs (a)(1) and 

(a)(2)(i). 

c. Add paragraph (a)(2)(ii). 

d. Revise paragraph (a)(2)(iii). 

e. Remove paragraphs (a)(2)(iv), 

(a)(2)(v), and (a)(2)(vi). 

f. Revise paragraph (b)(1). 

The revisions and addition read as 

follows: 

§ 721.5185 2-Propen-1-one, 1-(4- 

morpholinyl)-. 

(a) * * * 

(1) The chemical substance identified 

as 2-Propen-1-one, 1-(4-morpholinyl)- 

(PMN P–95–169; CAS No. 5117–12–4) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) * * * 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

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

(a)(3)(ii), (a)(4), (a)(6)(v), (b) 

(concentration set at 1.0 percent), and 

(c). Safety 4/4H EVOH/PE laminate, 

Ansell Edmont Neoprene number 865, 

and Solvex Nitrile Rubber number 275 

gloves have been tested in accordance 

with the American Society for Testing 

Materials (ASTM) F739 method and 

found by EPA to satisfy the consent 

orders and § 721.63(a)(2)(i) requirements 

for dermal protection to 100 percent 

PMN substance. Gloves and other 

dermal protection may not be used for 

a time period longer than they are 

actually tested and must be replaced at 

the end of each work shift. For 

additional dermal protection materials, 

a company must submit all test data to 

the Agency and must receive written 

Agency approval for each type of 

material tested prior to use of that 

material as worker dermal protection. 

However, for the purposes of 

determining the imperviousness of 

gloves, up to 1 year after the 

commencement of commercial 

manufacture or import, the employer 

may use the method described in 

§ 721.63(a)(3)(ii), thereafter, they must 

use the method described in 

§ 721.63(a)(3)(i). 

(ii) Hazard communication program. 

Requirements as specified in § 721.72 

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

1.0 percent), (f), (g)(1)(iv), (g)(1)(vi), 

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

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(a), (c), and (y)(1). 

(b) * * * 

(1) Recordkeeping. The following 

recordkeeping requirements are 

applicable to manufacturers, importers, 

and processors of this chemical 

substance as specified in § 721.125(a) 

through (i). 

* * * * * 

[FR Doc. 2010–28006 Filed 11–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Parts 523, 534, and 535 

[Docket No. NHTSA–2010–0079] 

Notice of Availability of a Draft 

Environmental Impact Statement 

(DEIS) for New Medium- and HeavyDuty Fuel Efficiency Improvement 

Program 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Notice of availability of a Draft 

Environmental Impact Statement (DEIS). 

SUMMARY: NHTSA has prepared a DEIS 

to disclose and analyze the potential 

environmental impacts of the agency’s 

newly proposed fuel consumption 

standards for commercial medium- and 

heavy-duty on-highway vehicles and 

work trucks (‘‘HD vehicles’’), which 

NHTSA recently proposed pursuant to 

the Energy Independence and Security 

Act of 2007. NHTSA invites Federal, 

State, and local agencies, Indian tribes, 

and the public to submit written 

comments on the DEIS using the 

instructions set forth in this notice. To 

facilitate review of the DEIS, NHTSA 

has posted the DEIS on its Web site 

(http://www.nhtsa.gov/fuel-economy) 

and placed it in the agency’s docket, 

identified by the docket number at the 

beginning of this notice. NHTSA will 

consider all public comments received 

on the DEIS in preparing final NEPA 

documents to support final fuel 

consumption standards, which NHTSA 

plans to issue next year. 

DATES: To ensure that NHTSA has the 

opportunity to consider comments on 

the DEIS, NHTSA must receive written 

comments by January 3, 2011. NHTSA 

will try to consider comments received 

after that date to the extent the NEPA 

and rulemaking schedules allow, but 

NHTSA cannot ensure that it will be 

able to do so. 

FOR FURTHER INFORMATION CONTACT: 

Questions concerning the DEIS should 

be addressed to Ms. Angel Jackson, 

Telephone: 1–202–366–0154, Fuel 

Economy Division, Office of 

International Vehicle, Fuel Economy 

and Consumer Standards, National 

Highway Traffic Safety Administration, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590. E-mail: 

nhtsa.nepa@dot.gov. Information about 

the HD vehicle rulemaking and the 

NEPA process is also available at 

http://www.nhtsa.gov/fuel-economy. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS