38210 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

refunds are not issued for unused 

postage value less than $25.00 

remaining in a PC Postage system. 

[Revise the title of 9.4 as follows:] 

9.4 Value Added Refunds 

* * * * * 

9.4.14 Criteria for Mailing 

A mailing for which a VAR request is 

submitted must meet these criteria: 

* * * 

[Add a new item 9.4.14f as follows:] 

f. Each mailing refund request must 

be for at least $50.00 in postage. 

Customers may not combine multiple 

postage statements on a single Form 

3533 to reach the $50.00 minimum 

threshold. 

* * * * * 

9.5 Priority Mail Express Postage 

Refund 

[Renumber current items 9.5.1 

through 9.5.7 as new items 9.5.4 through 

9.5.11.] 

[Add new items 9.5.1 through 9.5.3 as 

follows:] 

9.5.1 Priority Mail Express Next Day 

and Second Day Delivery 

For Priority Mail Express Next Day 

and Second Day Delivery, the USPS 

refunds the postage for an item not 

available for customer pickup at 

destination or for which delivery to the 

addressee was not attempted, subject to 

the standards for this service, unless the 

delay was caused by one of the 

situations in 9.5.6. 

9.5.2 Priority Mail Express Military 

Service (PMEMS) 

For PMEMS, the USPS refunds 

postage for an item not available for 

customer pickup at the APO/FPO or 

DPO address or for which delivery to 

the addressee was not attempted 

domestically within the times specified 

by the standards for this service, unless 

the item was delayed by Customs; the 

item was destined for an APO/FPO or 

DPO that was closed on the intended 

day of delivery (delivery is attempted 

the next business day); or the delay was 

caused by one of the situations in 9.5.6. 

9.5.3 Priority Mail Express Custom 

Designed 

For Priority Mail Express Custom 

Designed, the USPS refunds the postage 

for an item not available for customer 

pickup at destination or not delivered to 

the addressee within 24 hours of 

mailing, unless the item was mailed 

under a service agreement that provides 

for delivery more than 24 hours after 

scheduled presentation at the point of 

origin or if the delay was caused by one 

of the situations in 9.5.6. 

* * * * * 

9.5.5 Conditions for Refund 

[Revise the second sentence of newly 

renumbered 9.5.6 as follows:] 

* * * Except as provided in 9.5.6, a 

mailer may file for a postage refund only 

if the item was not delivered, delivery 

was not attempted, or if the item was 

not made available for claim by the 

delivery date and time specified at the 

time of mailing. 

* * * * * 

9.5.6 Refunds Not Given 

Postage refunds may not be available 

if delivery was attempted within the 

times required for the specific service, 

or if the guaranteed service was not 

provided due to any of the 

circumstances as follows: 

[Revise 9.5.6 by adding new items a. 

through i. as follows:] 

a. The item was properly detained for 

law enforcement purposes (see 

Administrative Support Manual 274). 

b. The item was delayed due to strike 

or work stoppage. 

c. The item was delayed because of an 

incorrect ZIP Code or address; or 

forwarding or return service was 

provided after the item was made 

available for claim. 

d. The shipment is available for 

delivery, but the addressee made a 

written request that the shipment be 

held for delayed delivery. 

e. The shipment is undeliverable as 

addressed. 

f. If authorized by USPS 

Headquarters, and the delay was caused 

by governmental action beyond the 

control of USPS or air carriers; war, 

insurrection, or civil disturbance; delay 

or cancellation of flights; projected or 

scheduled transportation delays; 

breakdown of a substantial portion of 

USPS transportation network resulting 

from events or factors outside the 

control of USPS; or acts of God. 

g. The shipment contained live 

animals and was delivered or delivery 

was attempted within 3 days of the date 

of mailing. 

h. The Priority Mail Express Next Day 

shipment was mailed December 22 

through December 25 and was delivered 

or delivery was attempted within 2 

business days of the date of mailing. 

i. The postage refund was other than 

for loss, and the Priority Mail Express 

piece was destined to Guam, American 

Samoa, the Commonwealth of the 

Northern Mariana Islands, the Republic 

of the Marshall Islands, or the Federated 

States of Micronesia (see 608.2.4.1 for 

ZIP Codes). 

* * * * * 

We will publish an amendment to 39 

CFR part 111 to reflect these changes. 

Stanley F. Mires, 

Attorney, Legal Policy & Legislative Advice. 

[FR Doc. 2013–15215 Filed 6–25–13; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2010–0279; FRL–9390–6] 

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 section 

5(a)(2) of the Toxic Substances Control 

Act (TSCA) for 17 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Fifteen 

of these chemical substances are subject 

to TSCA section 5(e) consent orders 

issued by EPA. This action would 

require persons who intend to 

manufacture, or process any of these 17 

chemical substances for an activity that 

is designated as a significant new use by 

this proposed rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: This final rule is effective August 

26, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0279, 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. 

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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 38211 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Jim 

Alwood, Chemical Control Division, 

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: TSCAHotline@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 any of the 17 chemical substances 

contained in this final rule. Potentially 

affected entities may include, but are 

not limited to: 

• Manufacturers, 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 17 chemical 

substances which were the subject of 

PMNs. Fifteen of these chemical 

substances are subject to TSCA section 

5(e) consent orders issued by EPA. The 

final SNURs for 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. The final SNURs for the 2 

remaining substances are not subject to 

a consent order under TSCA section 

5(e). In these two cases, EPA has 

determined in the final SNURs that 

these significant new use activities, ‘‘(i) 

are different from those described in the 

premanufacture notice for the 

substance, including any amendments, 

deletions, and additions of activities to 

the premanufacture notice, and (ii) may 

be accompanied by changes in exposure 

or release levels that are significant in 

relation to the health or environmental 

concerns identified’’ for the PMN 

substance. This action requires persons 

who intend to manufacture, or process 

these 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 December 28, 2011 (76 FR 

81447) (FRL–9326–2), EPA proposed 

SNURs for these seventeen chemical 

substances. More information on the 

specific chemical substances subject to 

this final rule can be found in the 

Federal Register documents proposing 

the SNURs. The record for the SNURs 

for these seventeen chemical substances 

was established in the docket under 

docket ID number EPA–HQ–OPPT– 

2010–0279. That docket includes 

information considered by the Agency 

in developing the proposed and final 

rules, including comments on those 

rules. 

EPA received numerous 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 modified final rules for these 

chemical substances as described in 

Unit V. of this document. 

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, 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 chemical substances, EPA 

concluded that for 15 of the 17 chemical 

substances, 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 

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38212 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

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 orders. 

In the other two cases, where the uses 

were not regulated under a TSCA 

section 5(e) consent order, EPA 

determined that one or more of the 

criteria of concern established at 

§ 721.170 were met. For additional 

discussion of the rationale for the 

SNURs on these chemicals, see Units II. 

and V. of the proposed rule. 

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, 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 will 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 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 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. 

V. Response to Comments on Proposed 

SNURs 

Comment 1: One commenter stated 

that the practice of EPA negotiating 

consent orders with the PMN submitter 

first without public comment or input 

has limited the public’s ability to use 

the comment process to change 

requirements for SNURs based on 

consent orders and has contributed to 

SNURs requiring personal protective 

equipment rather than following the 

industrial hygiene hierarchy of controls 

where personal protective equipment is 

the last option selected to control 

exposures. 

EPA Response: EPA issues orders 

under section 5(e) of TSCA in response 

to PMNs submitted under Section 5(a) 

of TSCA. EPA can only negotiate 

consent orders with persons who 

submitted the PMN. Because the 

consent order only restricts the 

activities of the PMN submitter, EPA 

issues a SNUR to extend the same 

requirements to all manufacturers, and 

processors. SNURs are issued either 

using notice and comment rulemaking 

or as direct final rules. Regardless of 

which procedure is used, the public is 

permitted an opportunity to comment. 

In accordance with the procedural rules 

for promulgating SNURs based on 

section 5(e) orders (see 40 CFR 

721.160(b)), such SNURs are generally 

based on and consistent with the 

underlying section 5(e) consent order. 

However, EPA may also designate 

additional activities as significant new 

uses (SNUs). These additional SNUs 

may be in response to public comment. 

For an example, see the response to 

Comment 14. 

Comment 2: A commenter objected to 

the requirement that domestic 

manufacture of certain PMN substances 

is not permitted. The commenter states 

that if it is unacceptable for Americans 

to be exposed to these substances, then 

it is unacceptable for other humans to 

be exposed. Conversely, the commenter 

stated that if these substances can be 

manufactured safely then Americans 

should also have that opportunity. 

EPA Response: The SNUR does not 

prevent domestic manufacture from 

occurring, it only requires notification 

beforehand. Because domestic 

manufacture is not currently anticipated 

and may never occur, EPA does not 

review potential risks associated with 

domestic manufacture when a PMN is 

submitted with an indication that the 

substance will only be imported and not 

domestically manufactured. EPA did 

not review or address potential risks of 

manufacture outside the United States 

because the statutory authority of TSCA 

is not applicable to actions outside the 

United States. If and when a person 

decides to begin domestic manufacture 

of the substance, the SNUN review will 

then permit EPA to assess and address 

potential risks associated with the SNU 

before they occur. 

Comment 3: For the SNUR for the 

chemical substance which was the 

subject of PMN P–04–244, one 

commenter stated that there was no 

need for a production volume limit for 

the SNUR, based on the limited use of 

the PMN substance as a herbicide 

intermediate, minimal toxicity effects, 

and the use of personal protective 

equipment to limit exposures. Another 

commenter, who is subject to the 

consent order, stated that they would 

petition the Agency to eliminate the 

testing requirement in the consent 

order. The second commenter 

recommended that EPA finalize the 

SNUR after the agency takes action on 

the petition. 

EPA Response: The consent order 

requires testing at a specific production 

volume limit, which is the basis for the 

production volume limit of manufacture 

of the PMN substance contained in the 

SNUR at § 721.80(q). After reviewing the 

petition to modify the consent order, 

EPA decided to retain the testing 

requirement in the consent order, 

because the petitioner did not submit 

alternative data that addressed the 

testing requirement in the consent 

order. EPA retained the testing 

requirement in the consent order at a 

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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 38213 

specific production volume limit to 

address EPA’s finding that the available 

information is insufficient to permit a 

reasoned evaluation of the health effects 

of the PMN substance at larger 

production volumes. Thus, the final rule 

will contain the same production 

volume limit for manufacture. If the 

person subject to the consent order 

submits the required testing before 

exceeding the production volume limit, 

that person is permitted to exceed the 

production volume limit without a 

significant new use notification. EPA 

will review the testing results and take 

appropriate action to continue to 

address any potential unreasonable 

risks. Processors of the PMN substance 

are not subject to the production volume 

limit. 

Comment 4: EPA should make it clear 

to PMN submitters of carbon nanotubes 

and other nanomaterials that required 

test methods will be decided on a caseby-case basis and that preference will be 

given to in vitro nanomaterial-specific 

methods. There are several EPA and 

National Academy of Science testing 

strategies that support this approach. In 

addition to problems with extrapolating 

information from animal studies to 

humans for conventional chemicals, 

nanomaterials possess unique physical 

and toxicological properties that render 

animal testing even more problematic. It 

is critical to completely and accurately 

characterize nanomaterials and then 

apply in vitro and in silico methods 

within an integrated test strategy. In the 

event that additional data is requested, 

EPA should require manufacturers to 

use high-throughput methods that have 

been specifically designed for 

nanomaterials in order to reduce 

reliance on animal-based testing. 

EPA Response: EPA identified 

recommended testing in the preamble of 

the proposed SNUR. Any 

manufacturers, or processors who 

intend to conduct testing or submit a 

SNUN are encouraged to contact EPA 

prior to commencing testing to avoid 

duplicative testing, to identify 

alternative testing, and to discuss 

protocols and testing strategies for any 

testing to be conducted. EPA recognizes 

the potential value of high-throughput 

methods, in vitro nanomaterial specific 

methods, and integrated testing 

strategies for nanomaterials. EPA 

continues to evaluate proposed testing 

methods for carbon nanotubes and other 

nanomaterials. In assessing this on a 

case-by-case basis, EPA will continue to 

consider the alternatives identified by 

the commenter. 

Comment 5: The chemical name for 

P–10–476 should include the word 

brominated. 

EPA Response: EPA agrees that 

brominated is part of the chemical name 

and will include the corrected chemical 

name in the final SNUR. 

Comment 6: All data regarding 

environmental and health effects of 

nanomaterials, especially adverse 

effects, should be made publicly 

available. EPA must challenge claims of 

confidential business information (CBI) 

by manufacturers. EPA could disclose 

CBI in connection with a public 

proceeding to determine whether a nano 

product causes unreasonable adverse 

effects on health or the environment, if 

EPA finds such disclosure is necessary 

in the public interest. 

EPA Response: EPA is committed to 

ensuring that CBI claims do not limit 

the public availability of environmental 

and health effects data beyond the 

confidentiality protections provided in 

TSCA Section 14. EPA has well 

established provisions that provide, as 

appropriate, a mechanism to evaluate 

CBI claims to ensure such claims are 

consistent with the statute. Regarding 

the chemical substances that are 

nanomaterials and intended to be 

subject to the proposed SNUR, each 

consent order and SNUR clearly 

articulates the basis for EPA’s findings 

and describes the data used to assess 

health and environmental effects and 

risks. Moreover there were no CBI 

claims for health and safety data in the 

health and safety studies for the 

substances subject to the proposed 

SNUR. 

Comment 7: The proposed regulations 

fail to address a number of concerns 

including addressing the public’s and 

worker’s right to know by not providing 

for mandatory nano-specific ingredient 

and warning labeling requirements. 

EPA Response: The SNURs and the 

consent orders which are the basis for 

the SNURs do not require labeling of 

nano-specific ingredients or nanospecific warnings because (1) the basis 

for the consent orders and SNURs is not 

that they are nanomaterials per se, but 

rather is based on their specific 

properties and potential risks, and (2) 

companies that manufacture, process, 

and use chemical substances that are 

carbon nanotubes and fullerenes already 

clearly identify those chemical 

substances as nanomaterials. 

Comment 8: The requirements for the 

proposed SNURs for P–09–54–57 and 

P–09–142–144 were inconsistent with 

requirements in the consent order. 

Specifically, the proposed SNURs 

required § 721.63(a)(2)(ii), which is full 

body protective clothing, when the 

consent orders required clothing that 

covers any other exposed areas of the 

arms, legs, and torso. In addition, for P– 

09–55, the proposed SNUR includes 

language that respirators must be used 

‘‘with an assigned protection factor 

(APF) of at least 50’’. The consent order 

for P–09–55 does not contain language 

requiring a respirator with an APF of 50. 

EPA Response: Because the use of 

clothing that covers any other exposed 

areas of the arms, legs, and torso, as 

required by the consent orders for the 

PMN substances, is an ongoing use, the 

proposed SNUR requirements have been 

changed in the final rule to be 

consistent with the ongoing use. In the 

final rule, EPA has changed the 

requirements in § 721.63 to require 

clothing that covers any other exposed 

areas of the arms, legs, and torso for 

these SNURS. Because the consent order 

for P–09–54–57 does not require that the 

PMN submitter demonstrate that the 

clothing is impervious, the SNUR has 

been revised accordingly to reflect the 

ongoing use. However, the consent 

order for P–09–142–144 does require 

that the PMN submitter demonstrate 

that the protective clothing is 

impervious. Therefore, EPA will retain 

the language in the final rules for P–09– 

142–144 that imperviousness must be 

demonstrated for the clothing. EPA 

incorrectly included in the proposed 

rule for P–09–55 in § 721.63 the 

language, ‘‘with an assigned protection 

factor (APF) of at least 50’’. EPA 

removed that language for P–09–55 in 

the final rule. 

Comment 9: NIOSH recommends a 

hierarchical approach to reduce worker 

exposure that relies on respiratory 

protection only after other approaches 

have been attempted. The proposed 

rules allow persons who would be 

subject to SNURs for CNT to submit 

data to EPA in support of a New 

Chemical Exposure Limit (NCEL) under 

40 CFR 721.30. The following comments 

pertain primarily to the CNT chemical 

substances in the proposed SNURS. To 

ensure that the PMN substances that are 

CNT are handled in a safe manner, EPA 

may want to add a requirement that 

employers submit information about 

specific workplace exposure controls in 

addition to the supporting evidence of 

airborne exposure data. EPA should also 

consider providing guidance on 

methods to measure process emissions 

and worker exposures, and 

interpretation of those data in making 

risk management decisions. NIOSH has 

published guidance on general 

approaches as well as specific CNT 

information. The basis of any NCEL 

should be compatible with current 

United States government risk 

assessment policies and practices used 

to set occupational exposure limit. 

NIOSH recommends that EPA use the 

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38214 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

NIOSH REL of 1 ug/m3 as an 8 hourtime-weighted average as identified in 

its final CNT bulletin. This would be an 

interim recommendation for controlling 

workplace exposures, until results of 

ongoing research can elucidate which 

physical and chemical characteristics of 

CNT affect their toxicity and until 

improved methods to measure airborne 

exposures are established. 

EPA Response: EPA agrees that a 

hierarchy of controls should be applied 

and that personal protective equipment 

is the last resort to prevent exposures. 

See EPA’s response to comment 14 

describing language it will add to the 

applicable SNURs in this action. EPA’s 

NCELs language in consent orders states 

that preventing exposures is the 

preferred method for protecting 

workers, see: http://www.epa.gov/oppt/

newchems/pubs/consent-pdf/

riskhhncel.pdf. Most PMN and SNUN 

submissions describe engineering 

controls and other steps that will be 

taken to reduce worker exposures. 

However, in many cases these measures 

may not sufficiently reduce exposures 

or may not used by every manufacturer 

or processor. EPA requires personal 

protective equipment for workers who 

are reasonably likely to be exposed in 

order to prevent unreasonable risks. 

However, persons subject to the SNURs 

for carbon nanotubes may submit 

information under 40 CFR 721.30 on 

any alternative exposure controls, 

including a NCEL, to support a 

determination that those exposure 

controls are equivalent to the 

requirements in the SNUR. While EPA 

encourages submission of as much 

information as possible to support that 

determination, EPA does not require 

submission of specific workplace 

exposure controls in addition to 

airborne exposure data. EPA can 

provide information on the approach 

used to measure releases and exposures 

on a case-by-case basis to support a 

determination that those exposure 

controls are equivalent to the 

requirements in the SNUR. Such 

information would take into 

consideration the fact that new chemical 

substances do not have established 

methods of detection. When 

establishing a NCEL or other alternative 

exposure control, EPA will consider all 

available data including United States 

government policies and practices used 

to set occupational exposure limits. 

Because of the uncertainty surrounding 

the NIOSH REL of 1 ug/m3 (as NIOSH 

noted in its final CNT bulletin the REL 

is based on the current analytical limit 

of quantification and may not be 

preventative of all known health effects 

see: http://www.cdc.gov/niosh/docs/

2013–145/pdfs/2013–145.pdf), EPA will 

not adopt the NIOSH REL as a NCEL at 

this time because EPA cannot determine 

that at the REL the potential exposures 

may not present an unreasonable risk. 

EPA will consider the final NIOSH REL 

or other alternative exposure controls 

for CNTs if a submission requesting 

such is made under 40 CFR 721.30. This 

would allow the submitter to send EPA 

data in support of a proposed exposure 

level and to demonstrate a technique to 

comply with that level. EPA would then 

evaluate the proposal and data as 

described in 40 CFR 721.30. See: 

http://www.epa.gov/oppt/newchems/

pubs/consent-pdf/riskhhncel.pdf and 

http://www.epa.gov/oppt/newchems/

pubs/ncelresp.pdf, which, respectively, 

are EPA’s boilerplate TSCA 5(e) consent 

order containing a NCEL and EPA’s 

Response to Comments on NCELs in 

TSCA 5(e) Orders. These two 

documents contain additional 

information on EPA’s approach to 

NCELs and developing techniques to 

comply with those requirements. 

Comment 10: Each CNT SNUR 

includes a statement that this rule does 

not apply ‘‘ . . . to quantities of the 

PMN substance after they have been 

completely reacted (cured); embedded 

or incorporated in a polymer matrix 

. . . that is not intended to undergo 

further processing, except for 

mechanical processing.’’ NIOSH agrees 

with this approach. The wording in 

§ 721.10274 of the proposed rule (page 

81460) differ from that in other sections 

by stating ‘‘. . . or embedded in a 

permanent solid polymer form with a 

concentration of the PMN substance 

equal to or below 30 percent. The other 

sections did not include the ‘‘30 

percent’’ requirement. Please clarify the 

basis for EPA’s determination for this 

particular PMN substance. 

EPA Response: Based on confidential 

information in the PMN, EPA 

determined, that for this PMN 

substance, P–09–0188, there may not be 

an unreasonable risk if the PMN 

substance was contained in a polymer 

form with a concentration of the PMN 

substance equal to or below 30 percent; 

however, EPA is concerned about 

potential risks above a 30 percent 

concentration. Consequently, the 

consent order does not apply when the 

concentration of the PMN substance is 

equal to or below 30 percent in a 

permanent solid polymer form. 

Comment 11: The proposed rules for 

the carbon nanotube chemical 

substances include statements requiring 

PMNs to include 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, and the reasonably 

anticipated manner and methods of 

manufacturing, processing, distribution 

in commerce, and disposal of a 

chemical substance. A change in these 

factors may not necessarily address 

potential risk to workers. 

EPA Response: These comments 

pertain to the four factors identified in 

section 5(a)(2) of TSCA that EPA must 

consider when determining significant 

new uses of a chemical substance. EPA 

must also consider all other relevant 

factors. These factors are not 

requirements for information that must 

be included in PMNs or SNUNs. EPA 

agrees that a change in these factors 

does not necessarily result in a risk to 

human health or the environment. 

Persons who intend to manufacture, or 

process chemical substances for an 

activity that is designated as a 

significant new use by this final rule 

must notify EPA at least 90 days before 

commencing that activity. This required 

significant new use notification would 

provide EPA with the opportunity to 

evaluate the intended new use and to 

prohibit or limit any activity associated 

with the new use. EPA would assess the 

potential risks from those new uses and 

take action to prevent any unreasonable 

risks to human health or the 

environment from activities described 

in the SNUN. 

Comment 12: One commenter stated 

that the proposed SNURs for the carbon 

nanotubes restrict the uses of the PMN 

substances to those specified in the 

consent order and require certain 

dermal and respiratory personal 

protective equipment. Submission of a 

PMN or SNUN will allow EPA to review 

these chemical substances but would 

not address worker safety as the notices 

would not require reporting of 

information relevant to risk assessment. 

There are several uncertainties 

associated with risk assessment of 

nanomaterials including a lack of 

reliable studies, smaller particles may 

have more detrimental and more potent 

effects, and smaller particles may cause 

different or greater exposures to humans 

and the environment. Because of these 

uncertainties, risk assessment of 

nanomaterials will not be adequate. 

EPA Response: Despite the 

uncertainties cited by the commenter, 

EPA believes that its assessment and 

risk management of nanomaterials, 

although sometimes hampered by a lack 

of submitted data, is adequate to 

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identify and prevent potential 

unreasonable risks to human health or 

the environment from manufacturing 

processing, and using nanomaterials 

including risks to workers . EPA has 

consistently limited exposures to and 

releases of nanomaterials that are new 

chemical substances to prevent 

unreasonable risks through the use of 

TSCA section 5(e) orders and SNURs. 

Comment 13: The SNURs for the 

carbon nanotubes should require 

reporting of risk assessment methods 

and findings, including nanoparticle 

dimension and relevant information. 

Personal protective equipment should 

be required as the last step in risk 

management. The SNURs should also 

require some form of engineering and 

administrative controls on top of the 

required personal protective equipment 

with exhaust ventilation systems 

designed, tested, and maintained as per 

the recommendations of the American 

Conference of Governmental Industrial 

Hygienists and requiring ongoing risk 

monitoring. 

EPA Response: If a manufacturer or 

processor wants to engage in one of the 

new uses, the submitter of the SNUN 

must report all test data that are in the 

possession or control of the submitter as 

well as all other data concerning health 

or environmental effects known or 

reasonably ascertainable by the 

submitter, as described in 40 CFR 

720.45 and 40 CFR 721.25. Risk 

assessment methods and findings are 

not specifically required in these 

regulations to be submitted in a SNUN 

and EPA has not required them for other 

SNUNs because they are not statutorily 

required to be submitted for section 5 

notices under TSCA Section 5(d)(1). 

However, pursuant to TSCA Section 

5(d)(1)(B), available information 

relevant to potential hazards and risks 

must be included in a SNUN and could 

include any relevant risk assessment 

findings that have been developed by 

the SNUN submitter. For example, 

SNUN submitters should report any 

available particle size data for carbon 

nanotubes. The SNURs allow for 

specific engineering and administrative 

controls proposed by a submitter under 

40 CFR 721.30, once EPA has evaluated 

those controls. See also the responses to 

comments 9 and 14 for further 

discussion of engineering and 

administrative controls. 

Comment 14: EPA received a similar 

set of comments from 26 public 

submissions. Each of these comments 

generally stated that EPA’s approach to 

exclusively requiring personal 

protective equipment in SNURs to 

prevent worker exposure instead of 

requiring engineering controls is not 

following the best occupational health 

and safety practices. The commenters 

suggest approaches that EPA could 

adopt. Several commenters identified 

the ‘‘hierarchy of controls’’ approach for 

industrial hygiene and workplace safety 

and controls, where elimination, 

substitution, engineering controls, and 

workplace or administrative controls 

should be used before personal 

protective equipment. Several 

commenters stated that persons subject 

to the SNUR should follow the OSHA 

requirements that a hierarchy of 

controls is required before employers 

use personal protective equipment. 

Some commenters suggest that EPA 

should specifically incorporate OSHA 

requirements at 40 CFR 1910.134(a)(1) 

into each SNUR or modify requirements 

in the SNUR at § 721.63 to require a 

hierarchy of controls. Several 

commenters also suggested that EPA 

incorporate into SNURs applicable to 

CNT the recommendations in NIOSH 

Current Intelligence Bulletin for CNT. 

Other commenters noted that a NIOSH 

Progress Toward Safe Nanotechnology 

publication, a 2006 Rand Report 

summarizing a 2005 workshop, EPA’s 

Nanotechnology White Paper, a NIEHS 

report on training workers, ANSI 

standards, and a Safe Work of Australia 

information sheet on use of carbon 

nanotubes either specifically 

recommend a hierarchy of controls or 

recommend an approach using 

engineering controls to prevent 

exposures before using personal 

protective equipment. 

EPA Response: EPA agrees that a 

hierarchy of controls should be applied 

and that personal protective equipment 

should be the last option to prevent 

exposures. EPA’s NCELs language in 

consent orders states that preventing 

exposures is the preferred method for 

protecting workers. See: http:// 

www.epa.gov/oppt/newchems/pubs/ 

consent-pdf/riskhhncel.pdf. Most PMN 

and SNUN submissions describe 

engineering controls and other steps 

that will be taken to reduce worker 

exposures. However, in many cases 

these measures may not sufficiently 

reduce exposures or it may not be 

feasible for every manufacturer or 

processor to use engineering controls. 

EPA requires personal protective 

equipment only for workers who are 

reasonably likely to be exposed in order 

to prevent unreasonable risks. It should 

be noted that OSHA regulations only 

recommend but do not require specific 

engineering controls for existing 

chemical substances even when there 

are available methods for detecting 

those chemical substances and there are 

engineering controls known to prevent 

exposures. For new chemical 

substances, there is often no data on 

detection methods and limited data on 

which engineering controls prevent 

worker exposures in all situations. In 

addition, because new chemical 

substances have not previously been in 

commerce, there are no specific 

applicable exposure limits or protective 

equipment requirements under any 

other statute. In the case of 

nanomaterials, such as carbon 

nanotubes, there is currently even more 

uncertainty associated with detection 

methods and effectiveness of certain 

engineering controls. 

EPA has added language to the 

SNURs in this final action to require 

engineering controls and administrative 

controls where feasible but will not 

change its approach at this time for new 

chemical substances regarding requests 

for alternative control measures as set 

out in 40 CFR 721.30, NCELs 

requirements, or its requirements for 

personal protective equipment. Persons 

who are subject to a SNUR must follow 

any personal protective equipment 

requirements where workers are 

reasonably likely to be exposed. Persons 

subject to SNUR requirements must 

request and demonstrate, as set out in 

40 CFR 721.30, how any alternative 

control methods they propose are 

equivalent to existing SNUR 

requirements. 

Comment 15: EPA also received one 

comment supporting the SNURs and 

another comment discussing efforts of 

the tire industry to incorporate 

nanomaterials into their products. 

EPA response: Neither comment 

contained a substantive comment 

regarding the rule so EPA has no 

response. 

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. Consult 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, or processing of the 

chemical substances for any of the 

significant new uses designated in the 

proposed SNUR after the date of 

publication of the proposed SNUR, must 

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38216 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

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 40 CFR 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 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In the TSCA section 5(e) consent 

orders for 15 of the chemical substances 

regulated under this rule, EPA has 

established restrictions in view of the 

lack of data on the potential health and 

environmental risks that may be posed 

by the significant new uses or increased 

exposure to the chemical substances. 

These restrictions will not be removed 

until EPA determines that the 

unrestricted use will not present an 

unreasonable risk of injury or result in 

significant or substantial exposure or 

environmental release. This 

determination is usually made based on 

the results of the required or 

recommended toxicity tests. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

of the proposed rule lists tests required 

or recommended in each of the section 

5(e) consent orders underlying the 

proposed 5(e) SNURs, and lists tests 

recommended for the substances subject 

to the proposed non-5(e) SNURs. 

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. 

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, 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–2010–0279. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This final rule establishes SNURs for 

several new chemical substances that 

were the subject of PMNs and, in some 

cases, 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 

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. 

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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 38217 

2. The SNUN submitted by any small 

entity would not cost significantly more 

than $8300. 

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 $8300. 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 

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. 

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. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: June 14, 2013. 

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 

* * * * * 

721.10265 ............................... 2070–0012 

721.10266 ............................... 2070–0012 

721.10267 ............................... 2070–0012 

721.10268 ............................... 2070–0012 

721.10269 ............................... 2070–0012 

721.10270 ............................... 2070–0012 

721.10271 ............................... 2070–0012 

721.10272 ............................... 2070–0012 

721.10273 ............................... 2070–0012 

721.10274 ............................... 2070–0012 

721.10275 ............................... 2070–0012 

721.10276 ............................... 2070–0012 

721.10277 ............................... 2070–0012 

721.10278 ............................... 2070–0012 

721.10279 ............................... 2070–0012 

721.10280 ............................... 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). 

■ 2. Add § 721.10265 to subpart E to 

read as follows: 

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38218 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

§ 721.10265 Ethane, 2-bromo-1, 1-difluoro-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethane, 2-bromo-1,1-difluoro-. (PMN P– 

04–244; CAS No. 359–07–9) 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 after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), 

(a)(6)(v), (a)(6)(vi), (b) (concentration set 

at 0.1 percent), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

least 1000 meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified supplied-air respirator 

operated in pressure demand or other 

positive pressure mode and equipped 

with a tight-fitting full facepiece. 

(A) As an alternative to the respiratory 

requirements listed in paragraph 

(a)(2)(i), a manufacturer, 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 0.5 mg/ 

m3 as an 8-hour time-weighted average. 

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. 

(B) [Reserved] 

(ii) Hazard communication program. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e)(concentration 

set at 0.1 percent), (f), (g)(1)(iv), 

(g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii), 

(g)(2)(iii), (g)(2)(iv)(use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.5 mg/ 

m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k)(chemical 

intermediate for a herbicide) and (q). 

(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), (e), (f), (g), (h), 

and (i) are applicable to manufacturers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 3. Add § 721.10266 to subpart E to 

read as follows: 

§ 721.10266 Multi-walled carbon 

nanotubes (generic) (P–08–733 and P–08– 

734). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as multi-walled carbon 

nanotubes (PMNs P–08–733 and P–08– 

734) are 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 

substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that has been reacted (cured); 

embedded, encapsulated or 

incorporated by the polymer binder into 

a permanent solid matrix (does not 

include slurries) that is not intended to 

undergo further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

physical containment, exhaust control 

ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)—certified respirator with an 

assigned protection factor (APF) of at 

least 50 meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (k), and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 4. Add § 721.10267 to subpart E to 

read as follows: 

§ 721.10267 [5,6]Fullerene-C60-Ih. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]Fullerene-C60-Ih (PMN P–09–54; 

CAS No. 99685–96–8) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b),(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10268 to subpart E to 

read as follows: 

§ 721.10268 [5,6]Fullerene-C70–D5h(6). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]Fullerene-C70–D5h(6) (PMN P–09– 

55; CAS No. 115383–22–7) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63 (a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.10269 to subpart E to 

read as follows: 

§ 721.10269 [5,6]Fullerene-C84–D2. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]Fullerene-C84–D2 (PMN P–09–56; 

CAS No. 145809–19–4) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b),(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 7. Add § 721.10270 to subpart E to 

read as follows: 

§ 721.10270 [5,6]Fullerene-C84–D2d. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

[5,6]Fullerene-C84–D2d (PMN P–09–57; 

CAS No. 145809–20–7) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

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38220 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an intermediate 

compound for use in producing 

downstream products that will in turn 

be used in organic electronic devices 

and an additive to improve mechanical 

properties or conductivity; a compound 

used to improve the mechanical 

properties of rubbers, plastics, and 

lubricants; or a compound for use as an 

additive to increase the conductivity of 

materials). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b),(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.10271 to subpart E to 

read as follows: 

§ 721.10271 3′HCyclopropa[1,9][5,6]fullerene-C60-Ih-3′- 

butanoic acid, 3′-phenyl-, methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

3′H-Cyclopropa[1,9][5,6]fullerene-C60- 

Ih-3′-butanoic acid, 3′-phenyl-, methyl 

ester, (PMNs P–09–142 and Chemical A 

in P–09–416, CAS Number 160848–22– 

6) 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 

substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that itself has been reacted (cured); or 

embedded in a permanent solid polymer 

form that is not intended to undergo 

further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(clothing 

which covers any other exposed areas of 

the arms, legs, and torso), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage or other 

characteristics of the device, a 

compound that improves the 

mechanical properties of lubricants and 

plastics, or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 9. Add § 721.10272 to subpart E to 

read as follows: 

§ 721.10272 3′HCyclopropa[8,25][5,6]fullerene-C70–D5h(6)- 

3′-butanoic acid, 3′-phenyl-,methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as 3′H-Cyclopropa[8,25][5,6]fullereneC70–D5h(6)-3′-butanoic acid, 

3′-phenyl-, methyl ester (PMNs P–09– 

143 and Chemical B in P–09–416, CAS 

Number 609771–63–3) 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 substances 

after they have been completely reacted 

(cured); embedded or incorporated into 

a polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2) (clothing 

which covers any other exposed areas of 

the arms, legs, and torso), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage or other 

characteristics of the device, a 

compound that improves the 

mechanical properties of lubricants and 

plastics, or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

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are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 10. Add § 721.10273 to subpart E to 

read as follows: 

§ 721.10273 3′HCyclopropa[7,22][5,6]fullerene-C70–D5h(6)- 

3′-butanoic acid, 3′-phenyl-, methyl ester. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as 3′H-Cyclopropa[7,22][5,6]fullereneC70–D5h(6)-3′-butanoic acid, 

3′-phenyl-,methyl ester (P–09–144 and 

Chemical C in P–09–416, CAS Number 

1051371–21–1) 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 substances after they have been 

completely reacted (cured); embedded 

or incorporated into a polymer matrix 

that itself has been reacted (cured); or 

embedded in a permanent solid polymer 

form that is not intended to undergo 

further processing, except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2) (clothing 

which covers any other exposed areas of 

the arms, legs, and torso), (a)(3), (a)(4), 

(a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N100 

cartridges. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (use as a 

compound used in fabrication and/or 

operation of electronic devices that 

enables or improves the conductivity, 

efficiency, voltage or other 

characteristics of the device, a 

compound that improves the 

mechanical properties of lubricants and 

plastics, or use as an acceptor molecule 

in a polymer coating in an encapsulated 

organic photovoltaic electronic device) 

and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 11. Add § 721.10274 to subpart E to 

read as follows: 

§ 721.10274 Multi-walled carbon 

nanotubes (generic) (P–09–188). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–09–188) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); or embedded in a 

permanent solid polymer form with a 

concentration of the PMN substance 

equal to or below 30 percent that is not 

intended to undergo further processing 

except for mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), and (c). When determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(1) 

and (a)(4), engineering control measures 

(e.g., physical containment, exhaust 

control ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face 

respirator equipped with N–100, P–100, 

or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), (m), (o), and 

(q). 

(iii) Release to Water. Requirements 

as specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 12. Add § 721.10275 to subpart E to 

read as follows: 

§ 721.10275 Multi-walled carbon 

nanotubes (generic) (P–09–0417). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–09–417) 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 it 

has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

physical containment, exhaust control 

ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

assigned protection factor (APF) of at 

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38222 Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 

least 50 meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (plastics 

additive to improve electrical, thermal 

and/or mechanical properties), (m), and 

(o). 

(iii) Release to Water. Requirements 

as specified in § 721.90(b)(1), and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i) and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.10276 to subpart E to 

read as follows: 

§ 721.10276 Multi-walled carbon 

nanotubes (generic) (P–10–39). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–10–39) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer, metal, glass, 

or ceramic form that is not intended to 

undergo further processing except for 

mechanical processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), and (c). When determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(1) 

and (a)(4), engineering control measures 

(e.g., physical containment, exhaust 

control ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

approved protection factor (APF) of at 

least 50 meets the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k), (m), (o), and 

(p)(120,000 kilograms of the aggregate of 

P–10–39 and P–10–40 the substance 

described in § 721.10277). 

(iii) Release to Water. Requirements 

as specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 14. Add § 721.10277 to subpart E to 

read as follows: 

§ 721.10277 Single-walled and multi-walled 

carbon nanotubes (generic) (P–10–40). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as single-walled and multiwalled carbon nanotubes (PMN P–10– 

40) 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 after it has been completely 

reacted (cured); embedded or 

incorporated into a polymer matrix that 

itself has been reacted (cured); 

embedded in a permanent solid 

polymer, metal, glass, or ceramic form 

that is not intended to undergo further 

processing except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), and (c). When determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(1) 

and (a)(4), engineering control measures 

(e.g., physical containment, exhaust 

control ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 50 meet the minimum 

requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N–100, P– 

100, or R–100 filter. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (m), (o), and 

(p)(120,000 kilograms of the aggregate of 

P–10–40 and P–10–39 the substance 

described in § 721.10276). 

(iii) Release to Water. Requirements 

as specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 15. Add § 721.10278 to subpart E to 

read as follows: 

§ 721.10278 4,4′-Bipyridinium, 1- 

(phosphonoalkyl)-1′-substituted-, salt with 

anion (1:2) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 4,4′-Bipyridinium, 1- 

(phosphonoalkyl)-1′-substituted-, salt 

with anion (1:2) (PMN P–10–224) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace: 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3)(applicable 

to gloves only), (a)(4), (a)(6), 

(b)(concentration set at 1.0 percent), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Rules and Regulations 38223 

least 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 facepiece (either half-face or 

full-face) and HEPA filters; or 

(E) NIOSH-certified supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (f), (j), (s)(1000 

kilograms), (v)(1), and (v)(2). 

(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), (e), and (i) are 

applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

The provisions of § 721.1725(b)(1) 

apply to this section. 

■ 16. Add § 721.10279 to subpart E to 

read as follows: 

§ 721.10279 Multi-walled carbon 

nanotubes (generic) (P–10–246). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–10–246) 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 after 

it has been completely reacted (cured); 

embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); embedded in a 

permanent solid polymer form that is 

not intended to undergo further 

processing, except for mechanical 

processing. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), 

(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (a)(4), 

engineering control measures (e.g., 

physical containment, exhaust control 

ventilation, or isolation) or 

administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 50 meet the minimum 

requirements for § 721.63(a)(4): 

(A) NIOSH-certified air-purifying, 

tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, 

or P100 filters; 

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

loose-fitting hood or helmet and high 

efficiency particulate air (HEPA) filters; 

or 

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

tight-fitting facepiece (either half-face or 

full-face) and HEPA filters. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (conductivity 

additive to resins, rubber, and to battery 

electrodes), and (q). 

(iii) Release to water. Requirements as 

specified in § 721.90(b)(1), and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), (e), (i), and (k) 

are applicable to manufacturers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

■ 17. Add § 721.10280 to subpart E to 

read as follows: 

§ 721.10280 Benzene ethenyl-, polymer 

with 1,3-butadiene, brominated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzene ethenyl-, polymer with 1,3- 

butadiene, brominated (PMN P–10–476; 

CAS No. 1195978–93–8)) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (manufacture by 

the method where the average number 

molecular weight is in the range of 1000 

to 10,000 daltons, or where less than 5 

percent of the particles are in the 

respirable range of 10 microns or less 

and the average number molecular 

weight is greater than or equal to 10,000 

daltons). 

(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, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2013–15032 Filed 6–25–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 81 

[EPA–R09–OAR–2013–0007; FRL–9826–4] 

Approval and Promulgation of 

Implementation Plans; Designation of 

Areas for Air Quality Planning 

Purposes; California; South Coast Air 

Basin; Approval of PM10 Maintenance 

Plan and Redesignation to Attainment 

for the PM10 Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is approving, as a 

revision to the California State 

implementation plan (SIP), the State’s 

request to redesignate the Los AngelesSouth Coast Air Basin (South Coast) to 

attainment for the 24-hour particulate 

matter of ten microns or less (PM10) 

national ambient air quality standard 

(NAAQS). EPA is also approving the 

PM10 maintenance plan and the 

associated PM10 motor vehicle 

emissions budgets for use in 

transportation conformity 

determinations necessary for the South 

Coast PM10 area. Finally, EPA is 

approving the attainment year emissions 

inventory. EPA is taking these actions 

because the SIP revision meets the 

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