Document ID: EPA-HQ-OPPT-2012-0182-0051
Agency: epa
Document Type: Rule
Title: Significant New Use Rule on Certain Chemical Substances
Posted Date: 2014-02-04T05:00Z

[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Rules and Regulations]
[Pages 6470-6475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02223]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0182; FRL-9399-1]
RIN 2070-AB27

Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing a significant new use rule (SNUR) under the 
Toxic Substances Control Act (TSCA) for chemical substances identified 
generically as complex strontium aluminate, rare earth doped, which 
were the subject of several premanufacture notices (PMNs). This action 
requires persons who intend to manufacture (including import) or 
process any of the chemical substances for an activity that is 
designated as a significant new use by this final 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: This final rule is effective April 7, 2014.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2012-0182, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

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. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this final rule. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    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

[[Page 6471]]

12.118 through 12.127 and 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 these SNURs 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 final 
rule 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.

II. Background

A. What action is the agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for five 
chemical substances which were the subject of PMNs. The five chemical 
substances are all identified generically as complex strontium 
aluminate, rare earth doped, which were the subject of PMNs P-12-22, P-
12-23, P-12-24, P-12-25, and P-12-26. This SNUR requires persons who 
intend to manufacture or process any 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 issue of April 25, 2012 (77 FR 24613) (FRL-
9345-4), EPA issued a direct final SNUR on these five chemical 
substances in accordance with the procedures at Sec.  721.160(c)(3)(i). 
EPA received notice of intent to submit adverse comments on this SNUR. 
Therefore, as required by Sec.  721.160(c)(3)(ii), in the Federal 
Register issue of June 22, 2012 (77 FR 37609) (FRL-9353-2), EPA 
withdrew the direct final SNUR in a separate document, and subsequently 
proposed a SNUR on the five chemical substances using notice and 
comment procedures in the Federal Register issue of June 22, 2012 (77 
FR 37634) (FRL-9353-3). More information on the specific chemical 
substances subject to this final rule can be found in the Federal 
Register documents announcing the direct final SNUR or the proposed 
SNUR. The docket for the direct final SNUR on these chemical substances 
was established as docket ID number EPA-HQ-OPPT-2012-0182. That docket 
includes information considered by the Agency in developing the direct 
final rule and this final rule, including comments on those rules. EPA 
received several comments on the proposed rule. A full discussion of 
EPA's response to these comments is included in Unit V. Based on these 
comments, this final rule:
    1. Corrects the chemical identity of the PMN substances.
    2. Simplifies the description of the significant new use.

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 or process the chemical 
substance for that use. Persons who must report are described in 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 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 SNUN 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. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for these five chemical 
substances, EPA determined that one or more of the criteria of concern 
established at Sec.  721.170 were met, as discussed in Unit II. and IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this final rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers 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 can ensure that all manufacturers 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 Chemical Substance 
Inventory (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.

IV. 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 requires EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
five chemical

[[Page 6472]]

substances that are the subject of this SNUR, EPA considered relevant 
information about the toxicity of the chemical substances, likely human 
exposures and environmental releases associated with possible uses, and 
the four bulleted TSCA section 5(a)(2) factors listed in this unit.

V. Response to Comments on Proposed SNUR

    A summary and discussion of the comments received on the proposed 
rule and the Agency's response follow.
    Comment 1: The commenter noted that EPA incorrectly identified the 
chemical substances as ``complex strontium aluminum, rare earth doped 
(generic)'' in the proposed rule.
    EPA Response: EPA acknowledges the error and has corrected the 
generic name to read: ``complex strontium aluminate, rare earth doped 
(generic)''.
    Comment 2: The commenter stated the proposed significant new uses 
are ongoing with respect to chemical substances very similar to the PMN 
substances. Activated phosphors, including strontium aluminates similar 
to the PMN substances, have been manufactured, processed, and used in 
the United States for many years.
    EPA Response: Regardless of whether chemical substances similar to 
the PMN substances are currently being used for purposes similar to the 
significant new use proposed, such use is irrelevant to determining 
ongoing use of the PMN substances for this rulemaking.
    Comment 3: The health and safety data on the PMN substances do not 
justify a SNUR.
    EPA Response: EPA believes that these chemicals will act in the 
respiratory tract similarly to other poorly soluble respirable 
particles causing adverse lung effects. The submitter provided no 
health and safety data information on the PMN substance or analogous 
chemical substances. The commenter submitted no data refuting EPA's 
concerns regarding poorly soluble respirable particles, as more than 5% 
of the PMN substances particles are less than 10 microns. The SNUR is 
therefore appropriate.
    Comment 4: The commenter stated that EPA did not properly consider 
the four factors in TSCA section 5(a)(2) to determine that use of a 
chemical substance is a significant new use, and reasonable 
consideration of them shows that a SNUR is not justified for use of the 
PMN substances. The commenter also contended that because chemical 
substances similar to the PMN substances are widely manufactured 
(including imported) and processed in the United States, and because 
worker safety and environmental laws already apply to the PMN 
substances, approval of the PMN substances without imposing a SNUR will 
not increase the magnitude or duration of exposure of human beings or 
the environment to the PMN substances because the scale of current use 
is significantly larger than any potential increase of use without the 
SNUR. The commenter also stated that strontium aluminates and titanium 
dioxide are regulated by the Occupational Safety and Health 
Administration (OSHA) as an inert or nuisance dust with a permissible 
exposure limit (PEL) of 5 milligrams/cubic meter (mg/m\3\) and that the 
level of exposure required for effects would not be a ``reasonably 
anticipated condition of exposure.''
    EPA Response: Among the factors that must be considered under TSCA 
section 5(a)(2) is ``(C) the extent to which a use increases the 
magnitude and duration of exposure of human beings or the environment 
to a chemical substance.'' This factor pertains to the potential 
changes in exposure to a specific chemical substance, not to other, 
possibly related, chemical substances which may have other exposure 
patterns. EPA identified concerns for potential lung overload to 
workers from inhalation exposure to the PMN substance based on 
analogous respirable, poorly soluble particulate chemical substances 
and predicts potential toxicity to workers from inhalation when more 
than 5% of the PMN substances particles are less than 10 microns. The 
fact that similar chemical substances are widely manufactured and 
processed in the United States and that worker safety and environmental 
laws apply to the PMN substance does not affect the potential for 
change in magnitude and duration of exposure to the PMN substances that 
are the subject of the SNUR. The commenter submitted no information to 
alleviate EPA's concern, based on analogy to exposure patterns of other 
respirable, poorly soluble particulates, that the significant new uses 
(manufacture, process or use of the chemical substances where more than 
5% of the particles are less than 10 microns) could increase the 
magnitude and duration of exposure of human beings to respirable 
particles of the PMN substances when greater than 5% of the PMN 
substances particles are less than 10 microns. The OSHA PEL for 
nuisance dust is 5 milligrams/cubic meter (mg/m\3\) respirable fraction 
(OSHA, 29 CFR 1910.1000, Table Z-3). The change in particle size at the 
reasonably anticipated levels of inhalation exposure to the PMN 
substances, which is the PEL of 5 mg/m\3\, could result in potential 
lung effects.
    Comment 5: The commenter stated that activated phosphors, including 
strontium aluminates, have been subject to reporting under TSCA section 
8(e) for many years, and is aware of no TSCA section 8(e) reports, and 
EPA references no such reports in the regulations.gov for this docket. 
The docket does not support that use of the strontium aluminate other 
than as described in the PMNs may cause serious health effects.
    EPA Response: EPA acknowledges that it has not received TSCA 
section 8(e) information for these chemical substances. However, the 
fact that data has not been received does not demonstrate that hazards 
for activated phosphors containing respirable particles do not exist, 
just that none have been reported under TSCA section 8(e). Based on 
analogous respirable and poorly soluble chemical substances, any use of 
the chemical substances other than as described in the PMNs may cause 
serious health effects to workers from inhalation when more than 5% of 
the PMN substances particles are less than 10 microns.
    Comment 6: The commenter stated that EPA identified concerns 
regarding potential lung overload to workers from inhalation exposure 
to the PMN substance based on data for titanium oxide, and that 
apparently based on these concerns, EPA found that changes in exposure 
or release levels for ``any use of the substances other than as 
described in the PMNs may cause serious health effects.'' The commenter 
stated that the PMN substances are not closely analogous to titanium 
oxide, however, and the docket contains no support for the conclusion 
that their use other than as described in the PMNs would involve 
changes in exposure or release levels that are significant in relation 
to the health or environmental concerns in accordance with Sec.  
721.170(c)(2)(ii). The commenter also stated that the data on titanium 
oxide does not justify a SNUR for the PMN substances. Even if titanium 
oxide were closely analogous to the PMN substances, the toxicological 
data on titanium oxide are inconclusive.
    EPA Response: The Agency's concern for the PMN substances is based 
on how these chemical substances will physically act in the respiratory 
tract, not on chemical composition or how they chemically interact with 
the respiratory tract. This concern is for the ability of the chemicals 
to enter the deep lung via inhalation of small particles. The PMN 
substances are

[[Page 6473]]

considered analogous in their physical properties to respirable, poorly 
soluble particulates (RPSP). See ``TSCA New Chemicals Program Chemical 
Categories,'' at http://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf, for a discussion of these concerns. The RPSP 
category identifies that there is potential for lung effects if workers 
are exposed by inhalation to particles less than or equal to 10 microns 
in diameter, based on five different types, or subcategories, of poorly 
soluble particulates. Accordingly, the significant new use in this SNUR 
is based on an increased exposure to particles less than 10 microns 
which may cause lung effects. Each subcategory in the RPSP category 
lists a New Chemicals Exposure Limit based on available information for 
specific compounds. As is described in the RPSP category, EPA will also 
consider the specific toxicity of the metal compound that is a 
respirable poorly soluble particulate. However, no such data was 
provided for the PMN substances. As there is no toxicity data available 
on the PMN substances indicating potential for chemical toxicity, EPA 
is considering only its attributes as a respirable, poorly soluble 
particulate chemical substance. As a result, EPA believes the metal 
oxide titanium dioxide subcategory is the appropriate subcategory based 
on physical-chemical considerations. Adverse lung effects are 
associated with the inhalation of crystalline metal compound 
particulates. Crystalline particles more readily embed in lung alveolar 
sacs than amorphous particles, and are difficult to clear with mucous 
flow or coughing, leading to irritation and clogging of the sacs and 
hampering of carbon dioxide-oxygen exchange in the lungs. EPA considers 
the metal compound titanium dioxide to be a surrogate for most non-
silica, crystalline poorly soluble respirable metal compound 
particulates, such as the PMN substances, that contain this type of 
crystalline structure. This physical analogy with the metallic poorly 
soluble respirable PMN substances is the primary driver in this case. 
There are several studies, cited in the EPA's RPSP category, that 
document lung effects from titanium dioxide exposure, and the RPSP 
category also states that available data are inconclusive for 
carcinogenicity effects from exposure to titanium dioxide. The National 
Institute for Occupational Safety and Health (NIOSH) Current 
Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide 
(http://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf) also cites 
data demonstrating lung effects from exposure to titanium dioxide.
    Comment 7: The definition of the significant new use is ambiguous 
and, as drafted, could be interpreted to impose the proposed SNUR on 
uses described in the PMN, referenced in Sec.  721.10423(a)(2). The 
commenter would like EPA to change the language of the proposed rule to 
make clear that the particle size limitation does not apply to the uses 
of the strontium aluminates described in the PMN.
    EPA Response: Although Sec.  721.10423(a)(2) of the proposed rule 
is correct as written, EPA agrees that the wording in the regulatory 
text for Sec.  721.80(j) can be confusing. Therefore, EPA has 
simplified the wording in the regulatory text to now read ``A 
significant new use of the substance is a use other than manufacture, 
processing, or use where no more than 5 percent of particles are less 
than 10 microns.'' The SNUR would permit any use of the PMN substances 
as long as the particle size limits are being met.

VI. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered 
ongoing rather than new, any person could defeat the SNUR by initiating 
the significant new use before the final rule was issued. Therefore, 
EPA has designated the date of publication of the proposed rule as the 
cutoff date for determining whether the new use is ongoing. See the 
Federal Register notice of April 24, 1990 (55 FR 17376) (FRL-3658-5) 
for a more detailed discussion of the cutoff date for ongoing uses. Any 
person who began commercial manufacture, import, or processing of the 
chemical substances identified generically as complex strontium 
aluminate, rare earth doped, which were the subject of PMNs P-12-22, P-
12-23, P-12-24, P-12-25, and P-12-26 for any of the significant new 
uses, designated in the proposed SNUR after the date of publication of 
the proposed SNUR, must stop that activity before the effective date of 
the final rule. Persons who ceased those activities will have to first 
comply with all applicable SNUR notification requirements, and wait 
until the notice review period, including any extensions, expires, 
before engaging in any activities designated as significant new uses. 
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.

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) 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 40 CFR 
720.50). However, upon review of PMNs and SNUNs, EPA has the authority 
to require appropriate testing. Unit IV. of the proposed rule lists the 
testing recommended by EPA. Specifically, EPA has determined that a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substances. 
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 selection. To 
access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''
    The recommended tests 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.

[[Page 6474]]

VIII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 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.  721.25 and 40 CFR 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 and processors of the chemical 
substances subject to this final rule. EPA's complete economic analysis 
is available in the docket under docket ID number EPA-HQ-OPPT-2012-
0182.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes a SNUR for 5 chemical substances that 
were the subject of PMNs. 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 (PRA)

    According to 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 is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this final 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 does 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 (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUN submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
final rule.
    This final rule is within the scope of the February 18, 2012, 
certification. Based on the Economic Analysis discussed in Unit IX. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300. Therefore, the promulgation of the SNUR 
would not have a significant economic impact on a substantial number of 
small entities.

D. Unfunded Mandates Reform Act (UMRA)

    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 will be impacted by this final rule. 
As such, EPA has determined that this final rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action will 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 final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments, nor does 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 final 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 action 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

[[Page 6475]]

action is not a significant regulatory action under Executive Order 
12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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).

XI. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: January 20, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following section in numerical order under the 
undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
          40 CFR citation                      OMB Control No.
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                               * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
                721.10423                            2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

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

0
4. Add Sec.  721.10423 to subpart E to read as follows:

Sec.  721.10423  Complex strontium aluminate, rare earth doped 
(generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
complex strontium aluminate, rare earth doped (PMNs P-12-22, P-12-23, 
P-12-24, P-12-25, and P-12-26) are 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) Industrial, commercial, and consumer activities. A significant 
new use of the substance is a use other than manufacture, processing, 
or use where no more than 5 percent of particles are less than 10 
microns.
    (ii) [Reserved]
    (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), 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. 2014-02223 Filed 2-3-14; 8:45 am]
BILLING CODE 6560-50-P