Document ID: EPA-HQ-OPPT-2008-0252-0115
Agency: epa
Document Type: Proposed Rule
Title: Proposed Significant New Use Rules on Certain Chemical Substances
Posted Date: 2009-11-06T05:00Z

[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Proposed Rules]               
[Page 57430-57436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no09-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0252; FRL-8436-8]
RIN 2070-AB27

 
Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two 
chemical substances which were the subject of premanufacture notices. 
The two substances are identified generically as multi-walled carbon 
nanotubes (P-08-177) and single-walled carbon nanotubes (P-08-328). 
These substances are subject to TSCA section 5(e) consent orders issued 
by EPA. The consent orders require protective measures to limit 
exposures or otherwise mitigate the potential unreasonable risk. The 
proposed SNURs on these substances are based on and consistent with the 
provisions in the underlying consent orders. The proposed SNURs 
designate as a ``significant new use'' the absence of the protective 
measures required in the corresponding consent orders. This action 
would require persons who intend to manufacture, import, or process 
either of these two substances for an activity that is designated as a 
significant new use by this proposed rule to notify EPA at least 90 
days before commencing that activity. The required notification would 
provide EPA with the opportunity to evaluate the intended use and, if 
necessary, to prohibit or limit that activity before it occurs.

DATES: Comments must be received on or before December 7, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0252, 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

[[Page 57431]]

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-2008-0252. 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-
2008-0252. 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 website 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 general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Jim Alwood, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail 
address: alwood.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this 
proposed rule. Potentially affected entities may include, but are not 
limited to:
     Manufacturers, importers, or processors of one or both 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 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 
and 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 chemicals 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 that is the subject 
of this proposed rule on or after December 7, 2009 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.

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 
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 
then identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.

[[Page 57432]]

    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing significant new use rules (SNURs) under section 
5(a)(2) of TSCA for two chemical substances which were the subject of 
premanufacture notices (PMNs). The two substances are identified 
generically as multi-walled carbon nanotubes (P-08-177) and single-
walled carbon nanotubes (P-08-328). These substances are subject to 
TSCA section 5(e) consent orders issued by EPA, which require 
protective measures to limit exposures or otherwise mitigate the 
potential unreasonable risk. The proposed SNURs on these substances are 
based on and consistent with the provisions in the underlying consent 
orders. The proposed SNURs designate as a ``significant new use'' the 
absence of the protective measures required in the corresponding 
consent orders. These SNURs would require persons who intend to 
manufacture, import, or process either of these two substances for an 
activity that is designated as a significant new use to notify EPA at 
least 90 days before commencing that activity.
    In the Federal Register of June 24, 2009 (74 FR 29982) (FRL-8417-
6), EPA issued direct final SNURs on these two substances in accordance 
with the procedures at Sec.  721.160(c)(3)(i). EPA received a notice of 
intent to submit adverse comments on these SNURs. Therefore, as 
required by Sec.  721.160(c)(3)(ii), in the Federal Register of August 
21, 2009 (74 FR 42177) (FRL-8433-9), EPA withdrew the direct final 
SNURs and is now issuing this proposed rule on the two substances. The 
record for the direct final SNURs on these substances was established 
as docket EPA-HQ-OPPT-2008-0252. That record includes information 
considered by the Agency in developing the direct final rules and the 
notice of intent to submit adverse comments.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use. The mechanism 
for reporting under this requirement is established under Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same notice requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA may take regulatory action under 
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it 
has received the SNUN. If EPA does not take action, EPA is required 
under TSCA section 5(g) to explain in the Federal Register its reasons 
for not taking action.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C. 
1612) import certification requirements promulgated at 19 CFR 12.118 
through 12.127, and 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 final SNUR are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2612 (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 of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
two chemical substances that are the subject of these proposed SNURs, 
EPA considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, and the above four factors listed in 
TSCA section 5(a)(2).

IV. Substances Subject to this Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for two chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name if the specific name is 
claimed as CBI).
     CAS number (if assigned for non-confidential chemical 
identities).
     Basis for the TSCA section 5(e) consent order.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including production limits and other uses designated in this

[[Page 57433]]

proposed rule, may be claimed as CBI. Unit VIII. discusses a procedure 
companies may use to ascertain whether a proposed use constitutes a 
significant new use.
    This proposed rule concerns two PMN substances that are subject to 
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) 
where EPA determined that activities associated with the PMN substances 
may present unreasonable risk to human health. Those consent orders 
require protective measures to limit exposure or otherwise mitigate the 
potential unreasonable risk. The so-called proposed ``5(e) SNURs'' on 
these PMN substances are issued pursuant to Sec.  721.160, and are 
based on and consistent with the provisions in the underlying consent 
orders. The proposed 5(e) SNURs would designate as a ``significant new 
use'' the absence of the protective measures required in the 
corresponding consent orders.
PMN Number P-08-177
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: September 1, 2009 
(amended).
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a property 
modifier in electronic applications and as a property modifier in 
polymer composites. The order was issued under sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous 
respirable, poorly soluble particulates and on other carbon nanotubes 
(CNTs), EPA believes that the PMN substance may cause lung effects. To 
protect against this risk, the consent order requires use of a National 
Institute for Occupational Safety and Health (NIOSH)-approved full-face 
respirator with N-100 cartridges. Based on physical properties of the 
PMN substance, EPA believes it may cause health effects via dermal 
exposure. To protect against this risk, the consent order requires that 
workers wear gloves and protective clothing impervious to the chemical 
substance. The consent order also prohibits any predictable or 
purposeful release of the PMN substance into the waters of the United 
States. The proposed SNUR would designate as a ``significant new use'' 
the absence of these protective measures.
Toxicity concern: There is a concern for lung health effects based on 
data for poorly soluble particulates and for other CNTs, and for lung 
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity study in rats (OPPTS Harmonized Test Guideline 
870.3465 or Organisation for Economic Co-operation and Development 
(OECD) 413 test guideline) with a post exposure observation period of 
up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis; 
and certain material characterization data would help characterize 
possible effects of the PMN substance. In the consent order, the PMN 
submitter has agreed not to exceed a specified production volume or 
production time limit (whichever comes first) without performing these 
tests.
CFR citation: 40 CFR 721.10155.
PMN Number P-08-328
Chemical name: Single-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: September 1, 2009 
(amended).
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a property 
modifier in electronic applications and as a property modifier in 
polymer composites. The order was issued under sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous 
respirable, poorly soluble particulates and on other carbon nanotubes 
(CNTs), EPA believes that the PMN substance may cause health effects. 
To protect against this risk, the consent order requires use of a 
NIOSH-approved full-face respirator with N-100 cartridges. Based on 
physical properties of the PMN substance, EPA believes it may cause 
health effects via dermal exposure. To protect against this risk, the 
consent order requires that workers wear gloves and protective clothing 
impervious to the chemical substance. The consent order also prohibits 
any predictable or purposeful release of the PMN substance into the 
waters of the United States. The proposed SNUR would designate as a 
``significant new use'' the absence of these protective measures.
Toxicity concern: There is a concern for health effects based on data 
for poorly soluble particulates and for other CNTs, and for lung 
irritation based on particle size.
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity study in rats (OPPTS Harmonized Test Guideline 
870.3465 or OECD 413 test guideline) with a post exposure observation 
period of up to 3 months, including BALF analysis; and certain material 
characterization data would help characterize possible effects of the 
PMN substance. In the consent order, the PMN submitter has agreed not 
to exceed a specified production volume or production time limit 
(whichever comes first) without performing these tests.
CFR citation: 40 CFR 721.10156.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for these two chemical 
substances, EPA concluded that regulation was warranted under TSCA 
section 5(e), pending the development of information sufficient to make 
reasoned evaluations of the human health effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The proposed SNUR provisions for these chemical substances 
are consistent with the provisions of the TSCA section 5(e) consent 
orders including the recent modifications to the consent orders. These 
proposed SNURs are issued pursuant to Sec.  721.160.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances that 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA would be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
     EPA would ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the

[[Page 57434]]

chemical substance is listed on the TSCA Inventory. Guidance on how to 
determine if a chemical substance is on the TSCA Inventory is available 
on the Internet at http://www.epa.gov/opptintr/newchems/pubs/
invntory.htm.

VI. 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. The chemical substances subject to this proposed 
rule have undergone premanufacture review and are subject to TSCA 
section 5(e) consent orders. The PMN submitters are prohibited by these 
TSCA section 5(e) consent orders from undertaking activities which EPA 
is proposing as significant new uses. EPA solicits comments on whether 
any of the uses proposed as significant new uses are ongoing.
    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is 
best served by designating a use as a significant new use as of the 
date of publication of the proposed rule rather than as of the 
effective date of the final rule. If uses begun after publication 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 
before 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 before 
the effective date of the rule if and when finalized. To resume their 
activities, these persons would have to comply with all applicable SNUR 
notice requirements and wait until the notice review period, including 
all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this 
proposed SNUR before the effective date. If a person were to meet the 
conditions of advance compliance under Sec.  721.45(h), the person 
would be considered exempt from the requirements of the SNUR.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN, except where the 
chemical substance subject to the SNUR is also subject to a test rule 
under TSCA section 4 (see TSCA section 5(b)). 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 IV. 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. Many OPPTS Harmonized Test Guidelines are now 
available on the Internet. Please go to http://www.epa.gov/oppts and 
select ``Test Methods and Guidelines'' on the left-side navigation 
menu. 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.
    In the TSCA section 5(e) consent orders for the two chemical 
substances regulated under this proposed rule, EPA has established 
production volume limits in view of the lack of data on the potential 
health risks that may be posed by the significant new uses or increased 
exposure to the chemical substances. These limits cannot be exceeded 
unless the PMN submitter first submits the results of toxicity tests 
that would permit a reasoned evaluation of the potential risks posed by 
these chemical substances. Under recent TSCA section 5(e) consent 
orders, each PMN submitter is required to submit each study at least 14 
weeks (earlier TSCA section 5(e) consent orders required submissions at 
least 12 weeks) before reaching the specified production limit. 
Listings of the tests specified in the TSCA section 5(e) consent orders 
are included in Unit IV. The SNURs contain the same production volume 
limits as the TSCA section 5(e) consent orders. Exceeding these 
production limits is defined as a significant new use. Persons who 
intend to exceed the production limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
    The recommended tests may not be the only means of addressing the 
potential risks of the chemical substance. However, SNUNs submitted for 
significant new uses without any test data may increase the likelihood 
that EPA will take action under TSCA section 5(e), particularly if 
satisfactory test results have not been obtained from a prior PMN or 
SNUN submitter. EPA recommends that potential SNUN submitters contact 
EPA early enough so that they will be able to conduct the appropriate 
tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. Procedural Determinations

    By this action, EPA is proposing certain significant new uses which 
have been claimed as CBI subject to Agency confidentiality regulations 
at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final 
determination or other disposition of the confidentiality claim under 
40 CFR part 2 procedures, EPA is required to keep this information 
confidential. EPA promulgated a procedure to deal with the situation 
where a specific significant new use is CBI. This rule cross-references 
Sec.  721.1725(b)(1) and is similar to that in Sec.  721.11 for 
situations where the chemical identity of the chemical substance 
subject to a SNUR is CBI. This procedure is cross-referenced in each 
SNUR that includes specific significant new uses that are CBI.
    Under these procedures a manufacturer, importer, or processor may 
request EPA to determine whether a proposed use would be a significant 
new use under the rule. The manufacturer, importer, or processor must 
show that it has a bona fide intent to manufacture, import, or process 
the chemical substance and must identify the specific use for which it 
intends to manufacture, import, or process the chemical substance. If 
EPA concludes that the person has shown a bona fide intent to 
manufacture, import, or process the chemical substance, EPA will tell 
the person whether the use identified in the bona fide submission would 
be a significant new use under the rule. Since the chemical identities 
of the chemical substances subject to these SNURs are also CBI, 
manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  721.1725(b)(1) with that under 
Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission

[[Page 57435]]

would not be a significant new use, i.e., the use does not meet the 
criteria specified in the rule for a significant new use, that person 
can manufacture, import, or process the chemical substance so long as 
the significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

IX. SNUN Submissions

    As stated in Unit II.C., according to Sec.  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.  
720.50. SNUNs must be mailed to the Environmental Protection Agency, 
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Information must be submitted in the form 
and manner set forth in EPA Form No. 7710-25. This form is available 
from the Environmental Assistance Division (7408M), 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001 (see Sec.  Sec.  721.25 and 
720.40). Forms and information are also available electronically at 
http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

X. 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.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical 
substances that were the subject of PMNs and TSCA section 5(e) consent 
orders. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under 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 would amend the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this proposed rule. This listing 
of the OMB control numbers and their subsequent codification in the CFR 
satisfies the display requirements of PRA and OMB's implementing 
regulations at 5 CFR part 1320. This Information Collection Request 
(ICR) was previously subject to public notice and comment prior to OMB 
approval, and given the technical nature of the table, EPA finds that 
further notice and comment to amend it is unnecessary. As a result, EPA 
finds that there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this 
table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action would not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of these SNURs 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 1,000 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 IX.) is minimal regardless of the size of the firm. Therefore, the 
potential economic impacts of complying with these SNURs are not 
expected to be significant or adversely impact a substantial number of 
small entities. In a SNUR that published in the Federal Register 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) (Public Law 104-4).

[[Page 57436]]

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.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), 
because this action is not expected to affect energy supply, 
distribution, or use and because this action is not a significant 
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: October 26, 2009.
Wendy C. Hamnett,
Acting 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 would continue to read as 
follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

    2. By adding new Sec.  721.10155 to subpart E to read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National 
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100 
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to this section.
    3. By adding new Sec.  721.10156 to subpart E to read as follows:

Sec.  721.10156  Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-08-328) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National 
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100 
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to this section.

[FR Doc. E9-26818 Filed 11-5-09; 8:45 am]

BILLING CODE 6560-50-S