26186 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 

remain within the regulated area may 

request permission from the COTP or 

the designated representative by 

contacting Sector Boston by telephone 

at 617–223–5750 or VHF radio channel 

16. 

Dated: April 22, 2011. 

John N. Healey, 

Captain, U.S. Coast Guard, Captain of the 

Port Boston. 

[FR Doc. 2011–11057 Filed 5–5–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2009–0686; FRL–8865–4] 

RIN 2070–AB27 

Multi-Walled Carbon Nanotubes; 

Significant New Use Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing a significant 

new use rule (SNUR) under section 

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

Act (TSCA) for the chemical substance 

identified generically as multi-walled 

carbon nanotubes (MWCNT) which was 

the subject of premanufacture notice 

(PMN) P–08–199. This action requires 

persons who intend to manufacture, 

import, or process the chemical 

substance for a use that is designated as 

a significant new use by this final rule 

to notify EPA at least 90 days before 

commencing that activity. EPA believes 

that this action is necessary because the 

chemical substance may be hazardous to 

human health. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

that activity before it occurs. 

DATES: This final rule is effective June 

6, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2009–0686. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Jim 

Alwood, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8974; e-mail 

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; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, import, 

process, or use the chemical substance 

which is the subject of this final rule. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, or 

processors of the subject chemical 

substance (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. For 

importers of the chemical substance 

subject to this SNUR, those 

requirements include the SNUR. 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 the chemical 

substance that is the subject of this final 

rule are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

II. Background 

A. What action is the agency taking? 

EPA is finalizing a SNUR under TSCA 

section 5(a)(2) for the chemical 

substance identified generically (due to 

confidentiality claims) as multi-walled 

carbon nanotubes (PMN P–08–199). 

This action requires persons who intend 

to manufacture, import, or process the 

subject chemical substance 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 February 3, 2010 (75 FR 5546) 

(FRL–8796–7), EPA issued a proposed 

SNUR on the chemical substance. On 

July 28, 2010 (75 FR 44198) (FRL–8828– 

3), in order to address public comment 

and add information to the docket, EPA 

reopened the comment period for 30 

days. In response to comments on the 

basis for the SNUR, EPA developed a 

revised summary document entitled 

‘‘Summary of EPA’s Current 

Assessments of Health and 

Environmental Effects of Carbon 

Nanotubes,’’ that specifies EPA’s current 

hazard concerns as supported by 

available information and data. The 

docket for the proposed SNUR on this 

chemical substance is found under 

docket ID number EPA–HQ–OPPT– 

2009–0686. That docket includes 

information considered by the Agency 

in developing this final rule, including 

comments on the rule and the 


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aforementioned summary document. 

More information on the chemical 

substance subject to this final rule can 

be found in the proposed SNUR. 

EPA received several comments on 

the proposed rule. A full discussion of 

EPA’s response to these comments is 

included in Unit V. of this document. 

Taking into consideration these 

comments, EPA is issuing a final rule on 

this chemical substance that: 

1. Retains the proposed workplace 

protection and specific use provisions 

as significant new uses. 

2. Adds exclusions from applicability 

of the SNUR uses identified as ongoing. 

3. Identifies those forms of the subject 

PMN substance which are exempt from 

the provisions of the SNUR. These 

exemptions apply to quantities of the 

PMN substance: 

• After they have been completely 

reacted (cured); 

• Incorporated or embedded 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. 

B. What is the agency’s authority for 

taking this action? 

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

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

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

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

of a chemical substance is a significant 

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

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture, 

import, or process the chemical 

substance for that use. Persons who 

must report are described in § 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the 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. 

Chemical importers are subject to the 

TSCA section 13 (15 U.S.C. 2612) 

import certification requirements 

promulgated in Customs and Border 

Patrol regulations 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. For importers of a 

chemical substance subject to a final 

SNUR those requirements include the 

SNUR. 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 identified in a 

final SNUR 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. 

III. Rationale and Objectives of the Rule 

A. Rationale 

As discussed in the proposed rule, 

EPA identified concerns for lung effects, 

immunotoxicity, and mutagenicity from 

exposure to the PMN substance during 

its review of the chemical substance, 

which was the subject of P–08–199. 

These concerns were based on test data 

on analogous respirable, poorly soluble 

particulates and on other carbon 

nanotubes (CNTs). EPA determined that 

the PMN substance met the decisional 

criteria at § 721.170. 

B. Objectives 

EPA is issuing this final SNUR for a 

specific chemical substance that has 

undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this final rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacture, import, or 

processing 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. 

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-line 

at http://www.epa.gov/opptintr/ 

newchems/pubs/invntory.htm. 

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 authorizes EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the MWCNT 

subject to this final SNUR, EPA 

considered relevant information— 

included in the docket and discussed 

further in Unit V. of this document— 

about the toxicity of the chemical 

substance, 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, and the 

regulations at § 721.170 for issuing a 

SNUR after receipt of a PMN. 

For the MWCNT described in P–08– 

199, EPA believes that certain changes 

from the use scenario described in the 

PMN could result in increased 

exposures. EPA has determined that 

activities being designated as a 

‘‘significant new use’’ in this rule satisfy 

the two requirements stipulated in 

§ 721.170(c)(2), i.e., these significant 

new use activities, ‘‘(i) are different from 

those described in the premanufacture 


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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. 

V. Response to Comments on Proposed 

SNUR on Multi-Walled Carbon 

Nanotubes 

EPA received public comments on the 

proposed SNUR for the MWCNT which 

was the subject of PMN P–08–199. A 

discussion of the comments received 

and the Agency’s responses follows. 

Comment 1: One commenter 

requested that should EPA require 

testing, it should consider highthroughput methods that have been 

specifically designed for nanomaterials 

in order to reduce reliance on animal 

based testing, and so that testing does 

not become an unreasonable or 

unattainable burden for manufacturers 

as not to violate section 605(b) of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.). The commenter also requested 

that, in addition to relying on early 

characterization of nanomaterials using 

in vitro methods as outlined in EPA’s 

Nanomaterial Testing Strategy, EPA 

apply integrated testing strategies (ITS) 

to assess the toxicological risk of 

nanomaterials. 

Response: EPA identified 

recommended testing in the preamble of 

the proposed SNUR. Any 

manufacturers, importers, or processors 

who intend to conduct testing or submit 

a SNUN are encouraged to contact EPA 

to avoid duplicative testing, to identify 

alternative testing, and to discuss 

protocols for any testing to be 

conducted. EPA recognizes the value of 

high-throughput methods for 

nanomaterials. When contacted by a 

manufacturer, importer, or processor 

who intends to conduct testing or 

requiring testing by a SNUN submitter, 

EPA will consider this and other 

alternatives identified by the 

commenter. 

Comment 2: One commenter asked 

EPA to include language in the SNUR 

that clarifies the exempt status of its 

laboratory in particular and research 

laboratories in general to SNUR 

requirements. 

Response: The general SNUR 

requirements of 40 CFR part 721, 

subpart A, apply to this SNUR. The 

requirements in § 721.45(b) exempts a 

person from the notification 

requirements of this SNUR when they 

manufacture, import, or process small 

quantities of the substance subject to the 

SNUR solely for research and 

development in accordance with the 

conditions in § 721.47. 

Comment 3: One commenter 

supported the use of respiratory 

equipment to prevent exposures and 

another commenter supported timely 

issuance of the SNUR. 

Response: EPA is issuing the final 

rule to include respiratory protection 

when workers are reasonably likely to 

be exposed. 

Comment 4: One commenter noted 

that the proposed SNUR for the 

MWCNT, which was the subject of P– 

08–199, did not contain a no-release-towater restriction and that other consent 

orders and SNURs for carbon nanotubes 

do contain a no-release-to-water 

restriction. The commenter stated that 

this difference was inappropriate and 

that it should not be allowed to persist. 

Response: The PMN submitter 

identified a release to water in the PMN 

for this substance and EPA did not act 

to restrict the activity under TSCA 

section 5(e). Because the release to 

water is an ongoing use, EPA is unable 

to issue a SNUR that includes a no 

release to water provision. 

Comment 5: The PMN submitter 

commented that significant new uses 

must not be ongoing and should be 

consistent with the existing uses 

identified in its comments. The PMN 

submitter also outlined its 

understanding of how the rule would 

apply in practice to particular existing 

uses and requested that the Agency 

clarify that understanding. 

Response: After reviewing the PMN 

and the PMN submitter’s outline of how 

the SNUR would apply in practice to its 

existing uses, EPA confirms that the 

significant new uses in this rule are not 

ongoing and that the commenter’s 

outline of how the rule would apply to 

existing uses is correct. However, in its 

March 5, 2010, comments on the 

proposed SNUR, the PMN submitter 

identified specific use(s) other than as 

an additive/filler for polymer 

composites and support media for 

industrial catalysts. The company 

claimed these specific uses as CBI. As 

described in the proposed SNUR, 

persons who begin, after the date of the 

proposed rule, commercial manufacture, 

import, or processing of the MWCNT 

that was the subject of P–08–199 for a 

use preliminarily designated as a 

‘‘significant new use’’ in the proposed 

rule must cease any such activity before 

the effective date of the rule if and when 

finalized. After the final SNUR is 

effective, any person intending to 

manufacture, import, or process the 

substance for a use other than as an 

additive/filler for polymer composites 

and support media for industrial 

catalysts must submit a SNUN (in 

accordance with the requirements of 40 

CFR part 721, subpart A) at least 90 days 

before commencing such use. 

Comment 6: The PMN submitter 

asked EPA to clarify the meaning of uses 

as described in the PMN. The uses 

described in the PMN were additive/ 

filler for polymer composites and 

support media for industrial catalysts. 

The PMN submitter asked whether 

notification would be required for each 

specific polymer composite or for 

different equipment used to 

manufacture or process the PMN 

substance. 

Response: If a manufacturer or 

processor is using the PMN substance as 

either an additive/filler for polymer 

composites, or support media for 

industrial catalysts, they may change 

processes to include new equipment or 

new polymer composites. If there is any 

question as to whether a specific use or 

application is not the use described in 

the PMN, a manufacturer or processor 

may contact EPA or submit a SNUN. 

Comment 7: The PMN submitter 

commented that there should be an 

exemption for bound forms of the PMN 

substance when the SNUR would not 

apply, for example, when the PMN 

substance is embedded or incorporated 

into plastic resin pellets. 

Response: EPA agrees that, consistent 

with other SNURs and consent orders 

for CNTs, (e.g., the MWCNT which was 

the subject of PMN P–08–177), and the 

existing uses of the PMN substance, 

there should be an exemption from the 

final SNUR requirements once the PMN 

substance has been fixed to a substrate 

or encapsulated within a plastic or other 

polymer matrix. The Agency has 

included language in the final SNUR to 

exempt from SNUR requirements 

persons that manufacture, import, or 

process the PMN substance when the 

substance has been incorporated or 

embedded 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. 

Comment 8: The PMN submitter 

asked EPA to specify the identity of the 

PMN substance specifically in relation 

to other MWCNTs, explaining how EPA 

is describing the PMN substance as a 

unique chemical type. 

Response: Because of a lack of 

established nomenclature for CNTs, 

EPA has allowed PMN submitters to 

represent their CNTs using a generic 

name such as carbon nanotube (CNT), 

multi-walled carbon nanotube 

(MWCNT), or single-walled carbon 

nanotube (SWCNT) while submitting a 


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detailed description of the CNT using 

specific structural characteristics. All 

submitters of new chemical notices for 

CNTs, including the submitter for the 

MWCNT described in P–08–199, have 

claimed those specific structural 

characteristics as CBI. EPA is publishing 

the generic chemical name along with 

the PMN number to identify that a 

distinct chemical substance was the 

subject of the PMN without revealing 

the confidential chemical identity of the 

PMN substance. Confidentiality claims 

preclude a more detailed description of 

the identity of this MWCNT. 

Manufacturers may submit a bona fide 

intent to manufacture or import under 

§ 720.25 to determine whether a specific 

CNT is on the TSCA Inventory. 

Comment 9: The PMN submitter 

commented on the document entitled, 

‘‘Material Characterization of Carbon 

Nanotubes for Molecular Identity (MI) 

Determination & Nomenclature’’ (docket 

ID number EPA–HQ–OPPT–2009–0686– 

0015), that identifies a list of chemical 

structural features, chemical particle 

properties, and manufacturing methods 

that may be important for making 

carbon nanotube molecular identity 

determinations and naming them for 

TSCA purposes. The PMN submitter 

stated it was difficult to comment on the 

document, as the record does not 

identify either its particular provenance, 

or how the Agency is using, or plans to 

use it. The commenter also noted that 

many of the features may be impractical 

to observe, measure, or characterize 

with any consistency or statistical 

certainty, and others may be altered 

simply by the act of measuring. The 

commenter stated that several of the 

criteria refer only to properties of a CNT 

material (i.e., a collection of molecules 

rather than a single molecule), then 

asserted that these characteristics may 

be relevant to management 

considerations, but they are not relevant 

to defining molecular identity for TSCA 

purposes. 

Response: EPA does not agree that 

these characteristics are not relevant to 

defining the molecular identity of a 

CNT. As noted in the response to 

‘‘Comment 8,’’ because of a lack of 

established nomenclature for CNTs, 

EPA is currently representing CNTs 

using a generic chemical name along 

with the PMN number to identify them 

as distinct chemical substances. EPA 

included this list of physical features 

that may be important to demonstrate 

that it is considering additional 

characteristics when reviewing and 

identifying CNTs. EPA has used a wide 

variety of characteristics to identify 

chemical substances of unknown or 

variable composition, complex reaction 

products, and biological materials 

(UVCB) for TSCA purposes. As noted by 

the commenter, some of these 

characteristics may not be suitable for 

unambiguously determining molecular 

identity. As EPA learns more about the 

structures of CNTs, it will develop a set 

of characteristics to systematically 

identify CNTs. 

Comment 10: A commenter noted that 

recent signed and draft consent orders 

for other CNTs contain additional 

updated hazard assessment information 

for both health and environmental 

concerns. The commenter suggested this 

language should be referenced in the 

final SNUR so that all of EPA’s concerns 

are described in a similar manner for all 

SNURs pertaining to CNTs. The PMN 

submitter stated that while EPA did 

place data in the public docket 

supporting the finding at 

§ 721.170(b)(3)(ii) from inhalation 

exposure, there is no data in the public 

docket supporting the finding from 

dermal exposures. 

Response: EPA is continually refining 

and adding to its risk assessment and 

risk management approaches, especially 

for new chemical substances such as 

CNTs that have limited available 

hazard, exposure, and fate data. Recent 

consent orders for CNTs cite additional 

data which was not referenced in the 

proposed SNUR for this PMN substance. 

EPA placed in the public docket a 

document entitled, ‘‘Summary of EPA’s 

Current Assessment of Health and 

Environmental Effects of Carbon 

Nanotubes’’ (docket ID number EPA– 

HQ–OPPT–2009–0686–0016), in 

support of the health effects findings 

and significant new use designations 

made in the proposed rule. This 

document identifies those references 

available at the time of assessment of 

the chemical substance in this final rule. 

EPA also reopened the comment period 

on July 28, 2010 (75 FR 44198), to allow 

interested parties to comment on the 

additional information that was the 

basis for the SNUR. 

Comment 11: EPA missed the 270-day 

deadline so it should use the procedure 

and analysis otherwise required by 

5(a)(2) of TSCA. 

Response: A schedule for issuing 

SNURs with various types of 

rulemaking, including proposed rules, 

interim rules, and direct final rules is 

included at § 721.170(e)(1). The 

schedule states that EPA will issue the 

SNUR within 270 days of receipt of the 

notice of commencement under 

§ 720.102 for any substance for which 

the notice of commencement was 

received on or after October 10, 1989. 

The schedule is not mandatory, and 

rulemaking is not contingent on meeting 

this schedule. Although EPA did not 

issue the rule within the time period set 

out in the schedule, the Agency remains 

able to do so by any rulemaking 

procedure compatible with the 

Administrative Procedure Act (APA). 

EPA believes the procedures followed in 

developing this rule are consistent with 

the requirements in TSCA section 

5(a)(2) and the APA. 

Comment 12: The PMN submitter 

expressed concerns with respect to the 

cited inhalation (or simulated 

inhalation) studies. The commenter 

questioned the validity of the studies as 

several of the cited studies exist only as 

abstracts of unpublished presentations. 

The commenter stated there is no 

assessment of the doses involved in 

these studies, or the studies underlying 

the poorly soluble particles chemical 

categories report. The commenter also 

noted a Bayer Material Science study for 

carbon nanotubes and detailed results of 

the inhalation studies that have been 

recently published in the peer-reviewed 

journals, Inhalation Toxicology, 

Toxicological Sciences and Toxicology 

that EPA should take into account in 

connection with the rulemaking. 

Finally, the commenter states that EPA 

does not explain how these studies 

satisfy the regulatory concern criteria on 

which EPA relies. 

Response: EPA has found that the 

substance meets the decisional criteria 

in § 721.170(b)(3)(ii). The decisional 

criteria state that: The substance may 

cause serious chronic effects, serious 

acute effects, or developmentally toxic 

effects under reasonably anticipated 

conditions of exposure because the 

substance is closely analogous, based on 

toxicologically relevant similarities in 

molecular structure and physical 

properties, to another chemical 

substance that has been shown by valid 

test data to cause serious chronic effects, 

serious acute effects, or 

developmentally toxic effects in humans 

or in at least one species of laboratory 

animal at dose levels that could be of 

concern under reasonably anticipated 

conditions of exposure. EPA is not 

required to conduct a quantitative risk 

assessment or establish safe dose levels. 

EPA must only establish that effects 

could occur under reasonably 

anticipated conditions of exposure. The 

papers referenced in the docket, the 

Bayer Material Science study and other 

data cited by the PMN submitter, and 

data that is the basis for the poorly 

soluble respirable particulates category, 

demonstrate the potential chronic 

pulmonary and cardiovascular effects 

(including pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity, and cardiovascular 


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toxicity) of carbon nanotubes, including 

the PMN substance, at various dose 

levels. EPA considered this information 

in the review of the MWCNT described 

in PMN P–08–199, and concluded that 

the specified significant new uses of the 

PMN substance could result in 

inhalation exposures at levels where 

health effects were observed in the 

papers referenced in the docket. All of 

the papers referenced in the docket are 

publicly available peer reviewed 

scientific journals and publications. 

Comment 13: The PMN submitter 

stated that the company supports 

minimizing dermal and inhalation 

exposures to the extent reasonably 

practicable on a voluntary basis, and 

that controls should be used where 

warranted, but they should not be 

required to prevent particular exposures 

for which the Agency has no reasoned 

basis to believe may cause significant 

effects. The commenter asserted that the 

materials in the public docket only 

address the potential direct and indirect 

effects of inhalation exposures. Further, 

in summary, the commenter stated that 

the proposal appears to lack any 

reasoned basis for the particular dermal 

controls proposed in the SNUR and 

does not appear to meet the decisional 

criteria in § 721.170(b)(3)(ii) as the basis 

for establishing controls. The 

commenter stated that one cannot assess 

the basis and extent for the Agency’s 

concern, making it impossible to 

comment on whether the suggested 

controls are reasonably tailored to those 

concerns. 

Response: EPA believes it has 

demonstrated that the subject substance 

meets the decisional criteria in 

§ 721.170(b)(3)(ii), including the 

significant new use of manufacturing, 

importing, or processing of the PMN 

substance without dermal protection 

where workers are reasonably likely to 

be exposed. As noted in the response to 

‘‘Comment 12,’’ EPA has established that 

CNTs, including the PMN substance, 

may cause pulmonary toxicity, fibrosis, 

carcinogenicity, mutagenicity, and 

immunotoxicity, and cardiovascular 

toxicity. The ‘‘Summary of EPA’s 

Current Assessment of Health and 

Environmental Effects of Carbon 

Nanotubes’’ (docket ID number EPA– 

HQ–OPPT–2009–0686–0016) states that 

‘‘absorption is expected to be poor for all 

routes’’ which includes dermal 

exposure. This suggests that some 

dermal absorption could occur. EPA 

considered this information in the 

review of the MWCNT described in 

PMN P–08–199, and concluded that the 

specified significant new uses of the 

PMN substance could also result in 

dermal exposures at levels where health 

effects were observed in the papers 

referenced in the docket. 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

As discussed in the Federal Register 

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

has decided that the intent of TSCA 

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

designating a use as a significant new 

use as of the date of publication of the 

proposed SNUR rather than as of the 

effective date of the final rule. If uses 

begun after publication were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements because a person 

could defeat the SNUR by initiating the 

proposed significant new use before the 

rule became effective, and then argue 

that the use was ongoing before the 

effective date of the final rule. 

Any person who began commercial 

manufacture, import, or processing of 

the MWCNT described in PMN P–08– 

199 for any of the significant new uses 

designated in the proposed SNUR after 

the date of publication of the proposed 

SNUR must stop that activity before the 

effective date of this final rule. Persons 

who ceased those activities will have to 

meet all SNUR notice requirements and 

wait until the end of the notification 

review period, including all extensions, 

before engaging in any activities 

designated as significant new uses. If, 

however, persons who began 

manufacture, import, or processing of 

the chemical substance between the 

date of publication of the proposed 

SNUR and the effective date of this final 

SNUR meet the conditions of advance 

compliance as codified at § 721.45(h), 

those persons would be considered to 

have met the final SNUR requirements 

for those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require the development of any 

particular test data before submission of 

a SNUN. There are two exceptions: 

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 this case, 

EPA recommends persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. 

The recommended testing specified in 

Unit IV. of the proposed rule may not 

be the only means of addressing the 

potential risks of the chemical 

substance. However, SNUNs submitted 

without any test data may increase the 

likelihood that EPA will respond by 

taking action under TSCA section 5(e), 

particularly if satisfactory test results 

have not been obtained from a prior 

PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests prior to submitting a 

SNUN. 

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 substance. 

• Potential benefits of the chemical 

substance. 

• Information on risks posed by the 

chemical substance 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 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 evaluated the potential costs of 

establishing SNUN requirements for 

potential manufacturers, importers, and 

processors of the chemical substance 

subject to this final rule. The Agency’s 

complete Economic Analysis is 

available in the docket under docket ID 

number EPA–HQ–OPPT–2009–0686. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This final rule establishes a SNUR for 

a chemical substance that was the 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 26191 

subject of a PMN. 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 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of this SNUR 

will not have a significant adverse 

economic impact on a substantial 

number of small entities. The rationale 

supporting this conclusion is discussed 

in this unit. The requirement to submit 

a SNUN applies to any person 

(including small or large entities) who 

intends to engage in any activity 

described in the final rule as a 

‘‘significant new use.’’ Because these 

uses are ‘‘new,’’ based on all information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activities. A SNUR 

requires that any person who intends to 

engage in such activity in the future 

must first notify EPA by submitting a 

SNUN. Although some small entities 

may decide to pursue a significant new 

use in the future, EPA cannot presently 

determine how many, if any, there may 

be. However, EPA’s experience to date 

is that, in response to the promulgation 

of over 1,400 SNURs, the Agency 

receives on average only 5 notices per 

year. Of those SNUNs submitted from 

2006–2008, only one appears to be from 

a small entity. In addition, the estimated 

reporting cost for submission of a SNUN 

(see Unit VIII.) is minimal regardless of 

the size of the firm. Therefore, EPA 

believes that the potential economic 

impacts of complying with this SNUR 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register of 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that final SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government 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 affect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This final rule does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This final rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note), does not 

apply to this action. 


jlentini on DSKJ8SOYB1PROD with RULES
26192 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This 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: April 29, 2011. 

Wendy C. Hamnett, 

Director, 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 section in 

numerical order under the undesignated 

center heading ‘‘Significant New Uses of 

Chemical Substances’’ to read as 

follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10183 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.10183 to subpart E to 

read as follows: 

§ 721.10183 Multi-walled carbon 

nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multi-walled carbon 

nanotubes (PMN P–08–199) 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 chemical substance 

after it has been completely reacted 

(cured), incorporated or embedded 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)(ii), (a)(4), (a)(5) 

(National Institute for Occupational 

Safety and Health (NIOSH)-approved 

full-face respirators with N100 

cartridges), (a)(6)(i), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j) (additive/filler 

for polymer composites and support 

media for industrial catalysts). 

(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), and (i) are applicable to 

manufacturers, importers, and 

processors of this chemical substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2011–11127 Filed 5–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2011–0302; FRL–9292–6] 

Revisions to the California State 

Implementation Plan, Northern 

Sonoma County Air Pollution Control 

District (NSCAPCD) and Mendocino 

County Air Quality Management 

District (MCAQMD) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve revisions to the 

Northern Sonoma County Air Pollution 

Control District (NSCAPCD) and 

Mendocino County Air Quality 

Management District (MCAQMD) 

portions of the California State 

Implementation Plan (SIP). Both 

districts are required under Part C of 

title I of the Clean Air Act (CAA) to 

adopt and implement SIP-approved 

Prevention of Significant Deterioration 

(PSD) permit programs. These revisions 

update the definitions used in the 

districts’ PSD permit programs. 

DATES: This rule is effective on July 5, 

2011 without further notice, unless EPA 

receives adverse comments by June 6, 

2011. If we receive such comments, we 

will publish a timely withdrawal in the 

Federal Register to notify the public 

that this direct final rule will not take 

effect. 

ADDRESSES: Submit comments, 

identified by docket number EPA–R09– 

OAR–2011–0302, by one of the 

following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

online instructions. 

2. E-mail: R9airpermits@epa.gov. 

3. Mail or deliver: Gerardo Rios (Air3), U.S. Environmental Protection 

Agency Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901. 

Instructions: All comments will be 

included in the public docket without 

change and may be made available 

online at http://www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Information that 

you consider CBI or otherwise protected 


jlentini on DSKJ8SOYB1PROD with RULES