Document ID: EPA-HQ-OPPT-2010-1075-0071
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2011-12-28T05:00Z

[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81441-81447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33255]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2010-1075; FRL-9329-4]
RIN 2070-AB27

Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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 the 
chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623-01-
2) and rutile, tin zinc, sodium-doped (CAS No. 389623-07-8) which were 
the subject of premanufacture notices (PMNs P-06-36 and P-06-37) and 
TSCA section 5(e) consent orders issued by EPA. The proposed SNURs on 
these substances, which are based on and consistent with the provisions 
of the underlying consent orders, would designate as a significant new 
use the absence of the protective measures required in the consent 
orders. This action would require persons who intend to manufacture, 
import, or process either of the chemical substances for an activity 
that is designated as a significant new use by this proposed rule to 
notify EPA at least 90 days before commencing that activity. The 
required notification would provide EPA with the opportunity to 
evaluate the intended use and, if necessary, to prohibit or limit the 
activity before it occurs.

DATES: Comments must be received on or before January 27, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID)

[[Page 81442]]

number EPA-HQ-OPPT-2010-1075, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2010-1075. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-1075. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this 
proposed rule. Potentially affected entities may include, but are not 
limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 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 a proposed or final SNUR 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 email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.

[[Page 81443]]

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

II. Background

A. What action is the agency taking?

    EPA is proposing significant new use rules (SNURs) under section 
5(a)(2) of TSCA for two chemical substances which were the subject of 
PMNs and TSCA section 5(e) consent orders. The two chemical substances 
are identified as rutile, tin zinc, calcium-doped (PMN P-06-36; CAS No. 
389623-01-2) and rutile, tin zinc, sodium-doped (PMN P-06-37; CAS No. 
389623-07-8). The proposed SNUR on these substances are based on and 
consistent with the provisions in the underlying consent orders. The 
proposed SNURs designate as a significant new use the absence of the 
protective measures required in the corresponding consent orders. These 
SNURs would require persons who intend to manufacture, import, or 
process either of these chemical substances for an activity that is 
designated as a significant new use to notify EPA at least 90 days 
before commencing that activity.
    In the Federal Register of October 5, 2011 (76 FR 61566) (FRL-8880-
2), EPA issued direct final SNURs on these two chemical substances in 
accordance with the procedures at Sec.  721.160(c)(3)(i). EPA received 
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 
December 5, 2011 (76 FR 75794) (FRL-9329-5), EPA withdrew the direct 
final SNURs and is now issuing this proposed rule on the two chemical 
substances. The record for the direct final SNURs on these substances 
was established as docket EPA-HQ-OPPT-2010-1075. That record includes 
information considered by the Agency in developing the direct final 
rule and the notice of intent to submit adverse comments.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture, import, or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  [emsp14]721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply 
with the same notice requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA may take regulatory action under 
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it 
has received the SNUN. If EPA does not take action, EPA is required 
under TSCA section 5(g) to explain in the Federal Register its reasons 
for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
two chemical substances that are the subject of these proposed SNURs, 
EPA considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, taking into consideration the four 
bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for two chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name.
     Chemical Abstracts Service (CAS) number.
     Basis for the TSCA section 5(e) consent order.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    This proposed rule concerns two PMN substances that are subject to 
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I). 
Those consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNURs'' on these PMN substances are promulgated pursuant to 
Sec.  721.160, and are based on and consistent with the provisions in 
the underlying consent orders. The 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.

PMN Numbers P-06-36 and P-06-37

    Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-
06-37) Rutile, tin zinc, sodium-doped.
    CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.
    Effective date of TSCA section 5(e) consent order: February 17, 
2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
substances will be used as colorants for

[[Page 81444]]

polymers and industrial coatings. The order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that 
the substances may present an unreasonable risk of injury to human 
health. To protect against these risks, the consent order requires: Use 
of personal respiratory equipment, including a National Institute for 
Occupational Safety and Health (NIOSH)-certified respirator with an 
Assigned Protection Factor (APF) of at least 10, or compliance with a 
New Chemical Exposure Limit (NCEL) of 1.5 mg/m\3\ as an 8-hour time 
weighted average; establishment of a hazard communication program; and 
restricts the company from manufacturing the PMN substances with a d10 
particle size less than 100 nanometers, where d10 particle size 
presents the particle size, as determined by laser light scattering, at 
which 10 percent by weight of the substance measured is smaller; and 
corresponding recordkeeping. The SNUR designates as a ``significant new 
use'' the absence of these protective measures.
    Toxicity concern: Based on structural activity relationship 
analysis derived from test data on structurally similar respirable, 
poorly soluble particulates, the PMN substances may cause lung overload 
and fibrosis in workers exposed to the PMN substances by the inhalation 
route.
    Recommended testing: EPA has determined that the following test 
would help characterize the human health effects of the PMN substances: 
A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in 
rats. The testing should include a 60-day recovery period to assess the 
progression or regression of any lesions; and include special attention 
to histopathology (inflammation and cell proliferation) of the lung 
tissues and to various parameters of the bronchoalveolar lavage fluid 
(BALF), e.g., marker enzyme activities, total protein content, total 
cell count, cell differential, and cell viability. The order does not 
require submission of the aforementioned information at any specified 
time or production volume. However, the order's restrictions on 
manufacturing, import, processing, distribution in commerce, use, and 
disposal of the PMN substances will remain in effect until the order is 
modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citations: 40 CFR 721.10230 (P-06-36) and 40 CFR 721.10231 (P-
06-37).

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for these two chemical 
substances, EPA concluded that regulation was warranted under TSCA 
section 5(e), pending the development of information sufficient to make 
reasoned evaluations of the human health effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The proposed SNUR provisions for these chemical substances 
are consistent with the provisions of the TSCA section 5(e) consent 
orders. These proposed SNURs are issued pursuant to 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 chemical substance is listed on the TSCA Inventory. Guidance on how 
to determine if a chemical substance is on the TSCA Inventory is 
available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed Rule to Uses Occurring Before 
Effective Date of the Final Rule

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this proposed 
rule have undergone premanufacture review and are subject to TSCA 
section 5(e) consent orders. The PMN submitters are prohibited by these 
TSCA section 5(e) consent orders from undertaking activities which EPA 
is proposing as significant new uses. EPA solicits comments on whether 
any of the uses proposed as significant new uses are ongoing.
    As discussed in the Federal Register issue of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is 
best served by designating a use as a significant new use as of the 
date of publication of the proposed rule rather than as of the 
effective date of the final rule. If uses begun after publication were 
considered ongoing rather than new, it would be difficult for EPA to 
establish SNUR notice requirements because a person could defeat the 
SNUR by initiating the significant new use before the rule became 
final, and then argue that the use was ongoing before the effective 
date of the final rule. Thus, persons who begin commercial manufacture, 
import, or processing activities with the chemical substances regulated 
through this proposed SNUR must cease any such activity before the 
effective date of the rule, if and when finalized. To resume their 
activities, these persons would have to comply with all applicable SNUR 
notice requirements and wait until the notice review period, including 
all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this 
proposed SNUR before the effective date. If a person meets the 
conditions of advance compliance under Sec.  721.45(h), the person is 
considered exempt from the requirements of the SNUR.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4)

[[Page 81445]]

listing covering the chemical substance, persons are required only to 
submit test data in their possession or control and to describe any 
other data known to or reasonably ascertainable by them (see 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. describes those tests. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection and test reporting. To access the harmonized test 
guidelines referenced in this document electronically, please go to 
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
    In the TSCA section 5(e) consent orders for the two chemical 
substances regulated under this proposed rule, EPA has established 
restrictions in view of the lack of data on the potential human health 
risks that may be posed by the significant new uses or increased 
exposure to the chemical substances. These restrictions will not be 
removed until EPA determines that the unrestricted use will not present 
an unreasonable risk of injury or result in significant or substantial 
exposure or environmental release. This determination is usually made 
based on the results of the required or recommended toxicity tests.
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 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 
submitted on EPA Form No. 7710-25, generated using e-PMN software, and 
submitted to the Agency in accordance with the procedures set forth in 
Sec. Sec.  721.25 and 720.40. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances during the development of the direct final 
rule. EPA's complete Economic Analysis is available in the docket under 
docket ID number EPA-HQ-OPPT-2010-1075.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act

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

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR would not have a significant adverse economic impact on a 
substantial number of small entities. The requirement to submit a SNUN 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the final rule as a 
``significant new use.'' Because these uses are ``new,'' based on all 
information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. A SNUR requires 
that any person who intends to engage in such activity in the future 
must first notify EPA by submitting a SNUN. Although some small 
entities may decide to pursue a significant new use in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
SNURs covering over 1,000 chemicals substances, the Agency receives 
only a handful of

[[Page 81446]]

SNUNs per year. For example, the number of SNUNs was four in Federal 
fiscal year (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY 
2008, and seven in FY 2009. During this 5-year period, three small 
entities submitted a SNUN. In addition, the estimated reporting cost 
for submission of a SNUN (see Unit VIII.) is minimal regardless of the 
size of the firm. Therefore, EPA believes that the potential economic 
impacts of complying with those SNURs are not expected to be 
significant or adversely impact a substantial number of small entities. 
In a SNUR that published in the Federal Register issue of June 2, 1997 
(62 FR 29684) (FRL-5597-1), the Agency presented its general 
determination that final SNURs are not expected to have a significant 
economic impact on a substantial number of small entities, which was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any affect on small governments subject to the requirements of 
sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 
1995 (UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action would not have a substantial direct effect on States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act

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

J. Executive Order 12898

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

List of Subjects in 40 CFR Part 721

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

    Dated: December 16, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as 
follows:

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

    2. Add Sec.  [emsp14]721.10230 to subpart E to read as follows:

Sec.  721.10230  Rutile, tin zinc, calcium-doped.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as rutile, tin zinc, 
calcium-doped (PMN P-06-36; CAS No. 389623-01-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this rule do not 
apply to quantities of the PMN substance that have been incorporated 
into a polymer, glass, dispersion, cementitious matrix, or a similar 
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of 10 meet the minimum requirements for Sec.  
721.63(a)(5):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose- fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose 
to follow the new chemical exposure limit (NCEL) provisions listed in 
the TSCA section 5(e) consent order for these substances. The NCEL is 
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical 
substances combined. Persons who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. Persons whose Sec.  721.30 requests to use the NCELs 
approach are approved by EPA will receive NCELs provisions comparable 
to those contained in the corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72

[[Page 81447]]

(a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the substances with a 
particle size less than 100 nanometers, where d10 particle size 
presents the particle size, as determined by laser light scattering, at 
which 10 percent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    3. Add Sec.  [emsp14]721.10231 to subpart E to read as follows:

Sec.  721.10231  Rutile, tin zinc, sodium-doped.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as rutile, tin zinc, 
sodium-doped (PMN P-06-37; CAS No. 389623-07-8) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this rule do not apply to 
quantities of the PMN substance that have been incorporated into a 
polymer, glass, dispersion, cementitious matrix, or a similar 
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(5), (a)(6)(i), (b) (concentration set at 1.0 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of 10 meet the minimum requirements for Sec.  
721.63(a)(5):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose 
to follow the new chemical exposure limit (NCEL) provisions listed in 
the TSCA section 5(e) consent order for these substances. The NCEL is 
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical 
substances combined. Persons who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. Persons whose Sec.  721.30 requests to use the NCELs 
approach are approved by EPA will receive NCELs provisions comparable 
to those contained in the corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 
percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 1.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the substances with a 
particle size less than 100 nanometers, where d10 particle size 
presents the particle size, as determined by laser light scattering, at 
which 10 percent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2011-33255 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P