42990 Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 

Approved: July 11, 2012. 

C.J. Spain, 

Acting Deputy Assistant Judge Advocate, 

General (Admiralty and Maritime Law). 

Dated: July 13, 2012. 

D.G. Zimmerman, 

Lieutenant Commander, Alternate Judge 

Advocate General’s Corps, U.S. Navy, Federal 

Register Liaison Officer. 

[FR Doc. 2012–17874 Filed 7–20–12; 8:45 am] 

BILLING CODE 3810–FF–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2010–1075; FRL–9354–2] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing significant 

new use rules (SNURs) under 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 a 

TSCA consent order issued by EPA. 

This action requires 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 final rule to 

notify EPA at least 90 days before 

commencing that activity. EPA believes 

that this action is necessary because 

new uses of the chemical substances 

may be hazardous to human health. 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 August 

22, 2012. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2010–1075. 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., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket 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: Jim 

Alwood, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8974; email address: 

alwood.jim@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, import, 

process, or use either of the chemical 

substances contained in this final rule. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, or 

processors of the 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 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to a final SNUR 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of this 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 SNURs under TSCA 

section 5(a)(2) for two chemical 

substances which were the subject of 

PMNs and a TSCA section 5(e) consent 

order. The two chemical substances are 

identified as rutile, tin zinc, calciumdoped (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 final SNURs on 

these substances are based on and 

consistent with the provisions in the 

underlying consent order. The final 

SNURs designate as a significant new 

use manufacture (including import) or 

processing in the absence of the 

protective measures required in the 

corresponding consent order. This 

action requires persons who intend to 

manufacture, import, or process either 

of these two 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. 

Previously, in the Federal Register 

issue of October 5, 2011 (76 FR 61566) 

(FRL–8880–2), EPA issued direct final 

SNURs on these two chemical 

substances (see §§ 721.10230 and 

721.10231). However, EPA received 

notices of intent to submit adverse 

comments on these SNURs. Therefore, 

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Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 42991 

as required by § 721.160(c)(3)(ii), in the 

Federal Register issue of December 5, 

2011 (76 FR 75794) (FRL–9329–5), EPA 

withdrew the direct final SNURs on 

these two chemical substances and 

subsequently proposed SNURs using 

notice and comment procedures in the 

Federal Register issue of December 28, 

2011 (76 FR 81441) (FRL–9329–4). More 

information on the specific chemical 

substances subject to this final rule can 

be found in the Federal Register 

documents announcing the direct final 

SNURs or the proposed SNURs. The 

record for the SNURs on these two 

chemical substances was established in 

the docket under docket ID number 

EPA–HQ–OPPT–2010–1075. 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. of this document. 

Based on these comments, EPA is 

issuing a modified final rule on these 

chemical substances that: 

1. Revises the protection in the 

workplace and hazard communication 

provisions. 

2. Retains the industrial, commercial, 

and consumer activities provisions. 

In response to the comments, EPA is 

including in the regulatory text the 

following modifications: 

• Revision to the protection in the 

workplace provision in paragraph 

(a)(2)(i)(1) to reflect a New Chemical 

Exposure Limit (NCEL) of 2.4 mg/m3. 

• Revision to the hazard 

communication provision in paragraph 

(a)(2)(ii) to reflect an NCEL of 2.4 mg/ 

m3. 

B. What is the agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture, 

import, or process the chemical 

substance for that use. 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 final rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear at 

40 CFR part 700. According to 

§ 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. Rationale and Objectives of the 

Final 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)(1)(A)(ii)(I), pending the 

development of information sufficient to 

make reasoned evaluations of the 

human health effects of the chemical 

substances. Based on these findings, a 

TSCA section 5(e) consent order 

requiring the use of appropriate 

exposure controls was negotiated with 

the PMN submitter. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent order. These final SNURs are 

issued pursuant to § 721.160. See the 

docket under docket ID number EPA– 

HQ–OPPT–2010–1075 for the 

corresponding consent order. For 

additional discussion of the rationale for 

the SNURs on these chemicals, see 

Units II. and V. of this document. 

B. Objectives 

EPA is issuing these final 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 final rule: 

• EPA will 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 will 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 will 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 will 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. 

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 authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the two chemical 

substances that are the subject of these 

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. 

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42992 Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 

V. Response to Comments on Proposed 

SNURs 

EPA received comments from 

numerous submitters on the proposed 

rules for 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). 

A summary and discussion of the 

comments received and the Agency’s 

responses follow. 

Comment 1: In the proposed SNUR, 

EPA clarified that it considers 

nanomaterials to include substances 

with a particle size less than 100 

nanometers (nm) 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. The 

commenter supports this approach 

based on the need for a threshold since 

solid particulate material will contain a 

distribution of particle sizes. The 10 

percent threshold strikes a reasonable 

balance between being adequately 

protective of human health and 

recognizing practical limitations 

associated with analytical methods 

available for quantifying materials at or 

below such a threshold. The commenter 

supports using the weight-based 

threshold, as methods and 

instrumentation for performing weightbased particle size measurements are 

more widely available than techniques 

for performing measurements based on 

particle number. There are other 

important elements that should be 

included in any definition of a 

nanomaterial including recognizing that 

aggregates and agglomerates are not the 

same as the primary particles of which 

they are comprised and that many 

agglomerates may not disagglomerate 

readily in any medium. 

EPA Response: In the proposed rule, 

EPA did not attempt to clarify what it 

considers to be a definition of a 

nanomaterial, although particle size of 

less than 100 nm is often used to 

describe such chemical substances. 

Based on information contained in the 

PMNs, EPA believes that the PMN 

submitter is not manufacturing or 

processing the PMN substances with a 

d10 particle size less than 100 nm. EPA 

also believes it is possible that these 

chemical substances could be 

manufactured or processed with a d10 

particle size less than 100 nm. EPA 

proposed a new use in the SNURs for 

these two PMN substances to require 

notification if those chemical substances 

were manufactured or processed with a 

d10 particle size less than 100 nm. 

Upon notification of this new use, EPA 

would review the properties and assess 

any potential risks that were different 

from the chemical substances as 

reported in the PMNs. While EPA 

believes that the threshold and method 

used to measure particle size for these 

PMN substances is appropriate and 

protective of human health, EPA will 

consider different thresholds and 

methods in other TSCA actions, 

depending on the chemical substances 

being measured and available scientific 

knowledge and technology. 

Comment 2: The PMN substances are 

not nanoscale substances and any 

concerns or regulatory requirements 

derived from concerns related to 

nanoscale materials are not pertinent to 

the PMN substances. 

EPA Response: As described in the 

consent order, the basis for EPA’s 

concerns for the PMNs is not whether 

the substances constitute nanoscale 

materials but rather the fact that they 

qualify under the new chemicals 

category for respirable, poorly soluble 

particulates, under the subcategory of 

titanium dioxide (see http://www.epa.

gov/oppt/newchems/pubs/chemcat.

htm). The category document identifies 

that there is potential for respirability if 

workers handle material containing any 

particles less than or equal to 10 

microns in diameter. Based on 

information in the PMNs, workers are 

likely to be exposed to particles less 

than or equal to 10 microns in diameter. 

In addition, based on information 

contained in the PMNs, EPA believes 

that manufacturers and processors could 

use these chemical substances at 

particle sizes less than 100 nm. 

Accordingly, EPA has proposed new 

uses that would enable EPA to review 

any manufacture or processing of the 

PMN substance without the use of 

appropriate respiratory protective 

equipment or engineering controls, or at 

particle sizes less than 100 nm. The 

purpose of these notifications (i.e., 

SNUNs) is to allow EPA to review any 

new properties and assess any potential 

risks presented by the new use. 

Comment 3: EPA’s risk assessment 

stated there is no exposure expected to 

the PMN substances, according to the 

human health effects summary in the 

consent order. EPA determined that 

there can be no risk warranting 

regulation under the proposed rule, 

because of the statement that no 

absorption of the PMNs is expected via 

any route of exposure if the PMN 

substances are produced via the 

calcination method. The PMN 

substances can only be manufactured 

using the calcining process and there is 

no known alternative industrial process 

for making chemical substances such as 

the PMN substances. Based on review of 

EPA’s risk assessment in the 5(e) 

consent order and the extensive 

experience of the Color Pigment 

Manufacturers Association (CPMA) 

members with similar products, there is 

no substantiation of potential risk in the 

record for the proposed rule or the 

necessity for any regulation of the PMN 

substances. 

EPA Response: The human health 

effects summary, contained in Unit IV. 

(‘‘EPA’s Assessment of the Risk’’) of the 

consent order does not address potential 

exposures to the PMN substances; 

workplace inhalation exposures are 

addressed in a separate exposure 

summary of the same Unit IV. The 

health effects summary does state, 

however, that if the PMN substances are 

calcined then EPA does not expect the 

PMN substances to be absorbed by any 

route of exposure. In addition, the 

health effects summary identifies 

concerns for potential lung effects from 

exposure to the PMN substances, 

according to the chemical category for 

respirable, poorly soluble particulates 

under the subcategory of titanium 

dioxide (see http://www.epa.gov/oppt/

newchems/pubs/chemcat.htm). There is 

concern for the potential lung effects 

when workers handle material 

containing particles less than or equal to 

10 microns in diameter. Based on 

information in the PMNs, workers are 

likely to be exposed to particles less 

than or equal to 10 microns in diameter. 

The concern for lung effects is not 

mitigated by calcination; the concern is 

independent of potential for absorption. 

In fact, because these insoluble particles 

are not absorbed, they remain in the 

lung longer than other particles, causing 

further inflammation and lung effects. 

As mentioned earlier in this response, 

the exposure summary in the consent 

order identifies potential inhalation to 

workers. Based on the potential hazard 

and exposure to workers, EPA 

concluded that the PMN substances may 

present an unreasonable risk of lung 

effects to exposed workers. The 

commenter did not provide any specific 

information regarding CPMA’s extensive 

experience with similar products to 

refute EPA’s risk finding for the PMN 

substances. 

Comment 4: EPA should clarify that 

the PMN substances are not salts. It is 

incorrect for EPA to characterize these 

chemical substances as salts. EPA’s 

health risk analysis based on structural 

analogs does not demonstrate a risk 

warranting regulation because the 

regulated substances do not exhibit the 

properties of the constituent metals and 

do not represent an unregulated dust 

exposure. Titanium dioxide is not an 

analog surrogate for the PMN 

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Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 42993 

substances. EPA’s assessment should 

evaluate the risk of the finished crystal 

form of the PMN substances. 

EPA Response: EPA is not 

characterizing the PMN substances as 

salts or as the constituent metals, and 

the structural analogy in the consent 

order was not based on analogy to salts 

or constituent metals. EPA’s structural 

activity relationship (SAR) analysis was 

based on the category of respirable, 

poorly soluble particulates that cause 

lung effects as a result of inhaling 

particles (see http://www.epa.gov/oppt/

newchems/pubs/chemcat.htm). 

Titanium dioxide was chosen as the 

subcategory based on its physical 

characteristics as a poorly soluble 

particulate, and not any chemicallymediated toxicological properties. The 

risk assessment, as described in the 

response to comment 3, is consistent 

with the Agency’s concerns that 

potential exposure to particles of the 

finished crystal form of the PMN 

substances may cause an unreasonable 

risk of lung effects. 

Comment 5: EPA relied on a 

recommended exposure level (REL) 

from the draft National Institute for 

Occupational Safety and Health 

(NIOSH) Current Intelligence Bulletin: 

Occupational Exposure to Titanium 

Dioxide as the source of the proposed 

NCEL of 1.5 mg/m3. Since the final 

NIOSH intelligence bulletin set a higher 

REL of 2.4 mg/m3, EPA should revise its 

risk assessment to incorporate this new 

information. 

EPA Response: EPA agrees that using 

the REL of 2.4 mg/m3 for titanium 

dioxide, from the final NIOSH bulletin, 

would be more appropriate. This 

document is located in the docket under 

docket ID number EPA–HQ–OPPT– 

2010–1075. In fact, paragraph (b)(2) of 

the NCEL of the consent order for the 

PMN substances contains an automatic 

sunset clause stating that the NCEL in 

the consent order would automatically 

and immediately be changed to the final 

REL for titanium dioxide issued by 

NIOSH. Accordingly, EPA will issue the 

final SNURs with a NCEL of 2.4 mg/m3, 

based on the final NIOSH REL for 

titanium dioxide. However, because 

EPA estimates that there are potential 

exposures greater than 2.4 mg/m3, EPA 

continues to find a potential risk of 

concern for the PMN substances. 

Comment 6: These chemical 

substances are subject to existing 

Occupational Safety and Health 

Administration (OSHA) Permissible 

Exposure Levels (PELs) for inorganic tin 

compounds. Given the existing 

applicable OSHA PELs, the proposed 

SNURs are duplicative and unnecessary 

regulation. The NCELs provisions in the 

section 5(e) order states that the NCEL 

and respirator requirements are 

automatically nullified if OSHA 

promulgates a PEL for the same 

substance. There is a separate OSHA 

standard, applicable to all inert dust 

particles, of 5 mg/m3. There is no need 

for EPA to require the development of 

additional and different regulatory 

monitoring techniques for the PMN 

substances because there are already 

analytical monitoring techniques 

developed for inorganic tin compounds 

and inert dust particles. 

EPA Response: While the OSHA PEL 

for inorganic tin compounds would be 

applicable to the inorganic tin contained 

in the PMN substances, it does not 

apply to the PMN substances 

themselves. Based on information 

submitted in the PMNs, EPA considers 

the substances to be mixed metal oxide 

compounds. Previous comments made 

the argument that the constituent metals 

are not bioavailable and there should 

not be concern for exposure to 

bioavailable metals from the PMN 

substances. EPA agreed that it is not 

characterizing the PMN substances as 

metals and the basis of its risk 

assessment is not the constituent metals 

contained in the PMN substances. See 

EPA’s response to comment 4. 

Therefore, the OSHA PEL for inorganic 

tin does not adequately address 

potential risks from the PMN 

substances. While there is an OSHA 

inert dust standard of 5 mg/m3, EPA 

finds there is still a potential risk for 

lung effects from exposures less than 5 

mg/m3 for the PMN substances. 

Paragraph (b)(2) of the NCEL of the 

consent order for the PMN substances 

does state, that if OSHA promulgates a 

PEL specifically applicable to the PMN 

substances then the respirator 

requirements and NCEL become null 

and void. This paragraph (b)(2) also 

states that the requirements of the 

consent order are not negated by any 

pre-existing OSHA PEL, such as the PEL 

for inorganic tin compounds cited by 

the commenters. Because OSHA has not 

promulgated a PEL specifically 

applicable to the PMN substances, the 

respirator requirements and NCEL 

requirements in the consent order for 

the PMN substances remain in effect. 

Neither the PMN submitter nor 

commenters have supplied any 

information on whether existing 

monitoring techniques used for 

inorganic tin compounds would be 

appropriate for use with the PMN 

substances. EPA has issued the consent 

order and will issue the final SNURs 

with the NCEL provisions to allow for 

review of any monitoring techniques for 

the PMN substances that would be used 

to demonstrate compliance with the 

exposure limits. 

Comment 7: The costs and economic 

impacts of the rule are underestimated 

significantly. Customers may not use the 

PMN substances because of compliance 

costs. Manufacturers of the PMN 

substances will incur costs as a result of 

complying with the SNUR 

requirements, and costs associated with 

submitting a SNUN, including 

submitting toxicological testing prior to 

manufacture or import of the PMN 

substances for a significant new use. 

EPA Response: The economic 

assessment developed by EPA for this 

rule estimates and discusses the 

potential costs identified by the 

commenter. The commenter did not 

supply any additional information 

disputing EPA’s specific cost estimates 

or conclusions. Therefore, EPA will not 

change any of its cost estimates or 

conclusions. Contrary to the 

commenter’s assertions, the SNURs do 

not require testing, and submission of a 

SNUN does not require submission of 

toxicological testing. The preamble to 

the proposed SNURs did recommend 

testing that could address potential risks 

EPA has identified for the PMN 

substances, and states that SNUN 

submitters can submit any other data to 

address potential risks. Anyone 

submitting a SNUN is strongly 

encouraged to submit information 

addressing potential risks, but specific 

testing is not required. 

Comment 8: EPA’s economic 

assumptions pursuant to the Regulatory 

Flexibility Act do not reflect the current 

market. Nearly identical structural 

analogs of the PMN substances already 

on the TSCA Inventory are produced by 

companies in the United States and 

abroad. The PMN substances are 

produced abroad and imported in 

finished articles. 

EPA Response: The commenter did 

not supply any information on present 

or future significant new uses by small 

or large entities of the substances 

subject to the SNURs. Therefore, the 

basis for EPA’s finding under the 

Regulatory Flexibility Act, that the 

promulgation of the SNURs will not 

have a significant adverse economic 

impact on a substantial number of small 

entities, will remain unchanged in the 

final rule. 

Comment 9: The rule would prevent 

U.S. manufacturers from manufacturing 

and using the PMN substances in 

finished products while the rule would 

not prevent the use of the PMN 

substances outside the United States. 

Foreign manufacturers of finished 

products containing the PMN 

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42994 Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 

substances will be able to use the PMN 

substances and import them as part of 

articles exempt from TSCA reporting. 

EPA Response: TSCA primarily 

addresses risks within the United States. 

The consent order and the SNURs do 

not prevent United States manufacturers 

from manufacturing and using the PMN 

substances in finished products. In fact, 

the consent order negotiated with the 

PMN submitter allows manufacture, 

subject to certain restrictions. Those 

restrictions are reflected in the SNURs. 

The SNURs exempt all manufacturers 

and processors from significant new use 

reporting once the PMN substances have 

been incorporated into a polymer, glass, 

dispersion, cementitious matrix, or a 

similar incorporation. This includes 

articles imported into the United States. 

For these uses, no significant exposures 

are expected. The consent order and the 

SNURs would only be applicable in the 

United States to manufacturers or 

processors of the PMN substances in 

particulate form. EPA issued the 

consent order and is issuing the SNURs 

to address potential worker exposures 

associated with manufacture and 

processing of the PMN substances that 

could result in a risk of lung effects. 

Comment 10: There are economic and 

environmental benefits identified in the 

PMN submissions for these chemical 

substances. Specifically, the PMN 

substances are intended to replace 

pigments containing heavy metals such 

as lead and cadmium, which are 

associated with risks to human health 

and the environment. 

EPA Response: While EPA agrees that 

it would be beneficial to replace 

pigments that contain lead and 

cadmium, EPA found that the potential 

unreasonable risks associated with the 

PMN substances warranted issuing a 

consent order and SNUR. 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376), EPA 

has decided that the intent of TSCA 

section 5(a)(1)(B) is best served by 

designating a use as a significant new 

use as of the date of publication of the 

proposed rule rather than as of the 

effective date of the final rule. If uses 

begun after publication 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 effective, and then argue that 

the use was ongoing before the effective 

date of the final rule. 

Any person who began commercial 

manufacture, import, or processing of 

the specific chemical substances for any 

of the significant new uses designated in 

the proposed rule after the date of 

publication of the proposed rule must 

stop that activity before the effective 

date of this final rule. Persons who 

ceased those activities will have to meet 

all applicable SNUR notice 

requirements and wait until the notice 

review period, including any 

extensions, before engaging in any 

activities designated as significant new 

uses. 

EPA has promulgated provisions to 

allow persons to comply with these 

SNURs before the effective date. 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 this 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 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

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. 

EPA has determined that a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) in rats would help 

characterize the human health effects of 

the PMN substances. To access this 

guideline, please to go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ This test may 

not be the only means of addressing the 

potential risks of the chemical 

substances. 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 § 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 

§ 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 

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 final rule establishes SNURs for 

two new chemical substances that were 

the subject of PMNs and a TSCA section 

5(e) consent order. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act 

According to the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

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Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 42995 

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 

On February 18, 2012, EPA certified 

pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (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 rule. 

This 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 

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 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 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 

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). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. 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 final rule 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. 

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42996 Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: July 16, 2012. 

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, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. The table in § 9.1 is amended by 

adding the following sections 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 

* * * * * 

721.10230 ................. 2070–0012 

721.10231 ................. 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 § 721.10230 to subpart E to 

read as follows: 

§ 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 

§ 721.63(a)(4), (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 

§ 721.63(a)(4): 

(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 airpurifying respirator equipped with a 

loose- fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting face-piece (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 

face-piece (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 this substance. 

The NCEL is 2.4 mg/m3 as an 8-hour 

time-weighted-average for this 

substance (PMN P–06–36; CAS No. 

389623–01–2) and the substance 

referred to in 40 CFR 721.10231 (PMN 

P–06–37; CAS No. 389623–07–8) 

combined. Persons who wish to pursue 

NCELs as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. Persons whose 

§ 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 

§ 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 2.4 mg/m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substance 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 

§ 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 § 721.185 apply to this 

section. 

■ 5. Add § 721.10231 to subpart E to 

read as follows: 

§ 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 

§ 721.63(a)(4), (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 

§ 721.63(a)(4): 

(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 airpurifying respirator equipped with a 

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

(D) NIOSH-certified powered airpurifying respirator equipped with a 

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Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Rules and Regulations 42997 

tight-fitting face-piece (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 

face-piece (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 this substance. 

The NCEL is 2.4 mg/m3 as an 8-hour 

time-weighted-average for this 

substance (PMN P–06–37; CAS No. 

389623–07–8) and the substance 

referred to in 40 CFR 721.10230 (PMN 

P–06–36; CAS No. 389623–01–2) 

combined. Persons who wish to pursue 

NCELs as an alternative to the § 721.63 

respirator requirements may request to 

do so under § 721.30. Persons whose 

§ 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 

§ 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 2.4 mg/m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (manufacture of 

the substance 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 

§ 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 § 721.185 apply to this 

section. 

[FR Doc. 2012–17895 Filed 7–20–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2011–0353; FRL–9699–5] 

Approval and Promulgation of 

Implementation Plans; Tennessee; 

110(a)(1) and (2) Infrastructure 

Requirements for the 1997 8-Hour 

Ozone National Ambient Air Quality 

Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is taking final action to 

approve in part, and conditionally 

approve in part, the State 

Implementation Plan (SIP) submission, 

submitted by the State of Tennessee, 

through the Tennessee Department of 

Environment and Conservation (TDEC), 

to demonstrate that the State meets the 

requirements of sections 110(a)(1) and 

(2) of the Clean Air Act (CAA or Act) for 

the 1997 8-hour ozone national ambient 

air quality standards (NAAQS). Section 

110(a) of the CAA requires that each 

state adopt and submit a SIP for the 

implementation, maintenance, and 

enforcement of each NAAQS 

promulgated by EPA, which is 

commonly referred to as an 

‘‘infrastructure’’ SIP. TDEC certified that 

the Tennessee SIP contains provisions 

that ensure the 1997 8-hour ozone 

NAAQS are implemented, enforced, and 

maintained in Tennessee (hereafter 

referred to as ‘‘infrastructure 

submission’’). With the exception of 

sub-element 110(a)(2)(E)(ii), which 

pertains to the requirements of section 

128(a)(1) of the CAA, Tennessee’s 

infrastructure submission, provided to 

EPA on December 14, 2007, addresses 

all the required infrastructure elements 

for the 1997 8-hour ozone NAAQS. 

DATES: Effective Date: This rule will be 

effective August 22, 2012. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2011–0353. All documents in the docket 

are listed on the www.regulations.gov 

Web site. Although listed in the index, 

some information is not publicly 

available, i.e., Confidential Business 

Information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the Regulatory Development Section, 

Air Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Nacosta C. Ward, Regulatory 

Development Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. The 

telephone number is (404) 562–9140. 

Ms. Ward can be reached via electronic 

mail at ward.nacosta@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. This Action 

III. Final Action 

IV. Statutory and Executive Order Reviews 

I. Background 

Upon promulgation of a new or 

revised NAAQS, sections 110(a)(1) and 

(2) of the CAA require states to address 

basic SIP requirements, including 

emissions inventories, monitoring, and 

modeling to assure attainment and 

maintenance for that new NAAQS. 

Section 110(a) of the CAA requires 

states to submit SIPs to provide for the 

implementation, maintenance, and 

enforcement of a new or revised 

NAAQS within three years following 

the promulgation of such NAAQS, or 

within such shorter period as EPA may 

prescribe. Section 110(a) imposes the 

obligation upon states to make a SIP 

submission to EPA for a new or revised 

NAAQS, but the contents of that 

submission may vary depending upon 

the facts and circumstances. In 

particular, the data and analytical tools 

available at the time the state develops 

and submits the SIP for a new or revised 

NAAQS affects the content of the 

submission. The contents of such SIP 

submissions may also vary depending 

upon what provisions the state’s 

existing SIP already contains. In the 

case of the 1997 8-hour ozone NAAQS, 

states typically have met the basic 

program elements required in section 

110(a)(2) through earlier SIP 

submissions in connection with 

previous ozone NAAQS. 

More specifically, section 110(a)(1) 

provides the procedural and timing 

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