6470 Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Rules and Regulations 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.1712 to read as follows: 

§ 165.1712 Safety Zone; Alaska Marine 

Highway System Port Valdez Ferry 

Terminal, Port Valdez; Valdez, AK. 

(a) Location. The following area is a 

safety zone: all navigable waters of Port 

Valdez extending 200 yards in all 

directions from the edges of the Alaska 

Marine Highway System Terminal dock 

located in Port Valdez at 61 °07′26′′ N 

and 146 °21′50′′ W. 

(b) Enforcement period. The rule will 

be enforced whenever there is an Alaska 

Marine Highway System Ferry vessel 

transiting within the area described in 

paragraph (a) of this section and there 

is a Commercial Salmon Fishery Opener 

that includes the navigable waters 

within the safety zone. Each 

enforcement period will be announced 

by a broadcast notice to mariners when 

the Commercial Salmon Fishery Opener 

is announced. 

(c) Definitions. The following 

definitions apply to this section: 

(1) The term ‘‘designated 

representative’’ means any Coast Guard 

commissioned, warrant or petty officer 

of the U. S. Coast Guard who has been 

designated by the Captain of the Port, 

Prince William Sound, to act on his or 

her behalf. 

(2) The term ‘‘official patrol vessel’’ 

may consist of any Coast Guard, Coast 

Guard Auxiliary, state, or local law 

enforcement vessels assigned or 

approved by the COTP, Prince William 

Sound. 

(3) The term ‘AMHS vessel’ means 

any vessel owned or operated by the 

Alaska Marine Highway System, 

including, but not limited to: M/V 

AURORA, M/V CHENEGA, M/V 

COLUMBIA, M/V FAIRWEATHER, M/V 

KENNICOTT, M/V LECONTE, M/V 

LITUYA, M/V MALASPINA, M/V 

MATANUSKA, M/V TAKU and M/V 

TUSTUMENA. 

(d) Regulations. (1) The general 

regulations contained in 33 CFR 165.23, 

as well as the requirements in 

paragraphs (d)(2) through (5) of this 

section, apply. 

(2) No vessels, except for AMHS 

ferries and vessels owned or operated by 

AMHS will be allowed to transit the 

safety zone without the permission of 

the COTP Prince William Sound or the 

designated representative during 

periods of enforcement. 

(3) All persons and vessels shall 

comply with the instructions of the 

COTP or the designated representative. 

Upon being hailed by a U.S. Coast 

Guard vessel or other official patrol 

vessel by siren, radio, flashing light or 

other means, the operator of the hailed 

vessel shall proceed as directed. 

(4) Vessel operators desiring to enter 

or operate within the regulated area may 

contact the COTP or the designated 

representative via VHF channel 16 or 

907–835–7205 (Prince William Sound 

Vessel Traffic Service) to request 

permission to do so. 

(5) The COTP, Prince William Sound 

may be aided by other Federal, state, 

borough and local law enforcement 

officials in the enforcement of this 

regulation. In addition, members of the 

Coast Guard Auxiliary may be present to 

inform vessel operators of this 

regulation. 

Dated: January 9, 2013. 

Benjamin J. Hawkins, 

Commander, U.S. Coast Guard, Captain of 

the Port, Prince William Sound. 

[FR Doc. 2014–02219 Filed 2–3–14; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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 


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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 § 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 § 721.160(c)(3)(i). 

EPA received notice of intent to submit 

adverse comments on this SNUR. 

Therefore, as required by 

§ 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 

§ 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 

§ 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 

§ 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 


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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/m3) 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/m3) 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/ 

m3, 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 

§ 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 


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Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Rules and Regulations 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 

§ 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 

§ 721.10423(a)(2) of the proposed rule is 

correct as written, EPA agrees that the 

wording in the regulatory text for 

§ 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 § 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. 


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6474 Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Rules and Regulations 

VIII. SNUN Submissions 

According to § 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 § 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Rules and Regulations 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] 

■ 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, 300j2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901– 

6992k, 7401–7671q, 7542, 9601–9657, 11023, 

11048. 

■ 2. In § 9.1, add the following section 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 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] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add § 721.10423 to subpart E to 

read as follows: 

§ 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 

§ 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 § 721.185 apply to this 

section. 

[FR Doc. 2014–02223 Filed 2–3–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 424 

[CMS–6046–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs: 

Announcement of New and Extended 

Temporary Moratoria on Enrollment of 

Ambulances and Home Health 

Agencies in Designated Geographic 

Locations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Extension and establishment of 

temporary moratoria. 

SUMMARY: This document announces the 

imposition of temporary moratoria on 

the enrollment of new ambulance 

suppliers and home health agencies in 

designated geographic locations to 

prevent and combat fraud, waste, and 

abuse. 

DATES: Effective January 30, 2014. 

FOR FURTHER INFORMATION CONTACT: 

August Nemec, (410) 786–0612. News 

media representatives must contact 

CMS’ Public Affairs Office at (202) 690– 

6145 or email them at press@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. CMS’ Authority To Impose 

Temporary Enrollment Moratoria 

Under the Patient Protection and 

Affordable Care Act (Pub. L. 111–148), 

as amended by the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152) (collectively known as 

the Affordable Care Act), the Congress 

provided the Secretary with new tools 

and resources to combat fraud, waste, 

and abuse in Medicare, Medicaid, and 

the Children’s Health Insurance 

Program (CHIP). Section 6401(a) of the 

Affordable Care Act added a new 

section 1866(j)(7) to the Social Security 

Act (the Act) to provide the Secretary 

with authority to impose a temporary 

moratorium on the enrollment of new 

Medicare, Medicaid or CHIP providers 

and suppliers, including categories of 

providers and suppliers, if the Secretary 

determines a moratorium is necessary to 

prevent or combat fraud, waste, or abuse 

under these programs. Section 6401(b) 

of the Affordable Care Act added 

specific moratorium language applicable 

to Medicaid at section 1902(kk)(4) of the 

Act, requiring States to comply with any 


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