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[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Proposed Rules]
[Pages 68306-68312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28006]

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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.

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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

[[Page 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 e-
mail. 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 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 Sec.  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 Sec.  
[emsp14]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

[[Page 68308]]

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 Sec.  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 Sec.  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 Sec.  
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.

[[Page 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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)

[[Page 68310]]

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 Sec.  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 Sec.  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 Sec.  
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 Sec.  [emsp14]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 Sec.  [emsp14]720.50. SNUNs must be submitted to EPA, on 
EPA Form No. 7710-25 in accordance with the procedures set forth in 
Sec.  [emsp14]721.25 and Sec.  [emsp14]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

[[Page 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.

[[Page 68312]]

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 Sec.  [emsp14]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:

Sec.  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 Sec.  
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 Sec.  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 Sec.  721.63(a)(3)(ii), thereafter, they must use the 
method described in Sec.  721.63(a)(3)(i).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  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 Sec.  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 Sec.  721.125(a) through (i).
* * * * *
[FR Doc. 2010-28006 Filed 11-4-10; 8:45 am]
BILLING CODE 6560-50-P
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