56880 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 

§ 36.4408 Submission of proof to the 

Secretary. 

The Secretary may, at any time, 

require submission of such proof of 

costs and other matters as the Secretary 

deems necessary. 

(Authority: 38 U.S.C. 501, 2101(d)) 

(The Office of Management and 

Budget has approved the information 

collection provisions in this section 

under control numbers 2900–0031 and 

2900–0300.) 

§ 36.4409 Delegations of authority. 

(a) Each employee of the Department 

of Veterans Affairs appointed to or 

lawfully filling any of the following 

positions is hereby delegated authority, 

within the limitations and conditions 

prescribed by law, to exercise the 

powers and functions of the Secretary 

with respect to assisting eligible 

individuals in acquiring specially 

adapted housing: 

(1) Under Secretary for Benefits. 

(2) Director, Loan Guaranty Service. 

(3) Deputy Director, Loan Guaranty 

Service. 

(4) Assistant Director, Loan Policy 

and Valuation. 

(5) Chief, Specially Adapted Housing, 

Loan Guaranty Service. 

(6) Director, VA Medical Center. 

(7) Director, VA Regional Office. 

(8) Loan Guaranty Officer. 

(9) Assistant Loan Guaranty Officer. 

(b) Nothing in this section will be 

construed to authorize the 

determination of basic eligibility or 

medical feasibility under § 36.4404(a), 

(b)(1)(i), or (b)(1)(ii) by any employee 

designated in this section, except as 

otherwise authorized. 

(Authority: 38 U.S.C. 501, 512, ch. 21) 

§ 36.4410 Supplementary administrative 

action. 

Subject to statutory limitations and 

conditions prescribed in title 38, U.S.C., 

the Secretary may take such action as 

may be necessary or appropriate to 

relieve undue prejudice to an eligible 

individual or a third party contracting 

or dealing with such eligible individual 

which might otherwise result. 

(Authority: 38 U.S.C. 501, 2101(d)) 

§ 36.4411 Annual adjustments to the 

aggregate amount of assistance available. 

(a) On October 1 of each year, the 

Secretary will increase the aggregate 

amounts of assistance available for 

grants authorized under 38 U.S.C. 

2101(a) and 2101(b). Such increase will 

be equal to the percentage by which the 

Turner Building Cost Index for the most 

recent calendar year exceeds that of the 

next preceding calendar year. 

(b) Notwithstanding paragraph (a) of 

this section, if the Turner Building Cost 

Index for the most recent full calendar 

year is equal to or less than the next 

preceding calendar year, the percentage 

increase will be zero. 

(c) No later than September 30 of each 

year, the Secretary will publish in the 

Federal Register the aggregate amounts 

of assistance available for the upcoming 

fiscal year. 

(Authority: 38 U.S.C. 2102(e)) 

[FR Doc. 2010–23277 Filed 9–16–10; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2008–0252; FRL–8835–5] 

RIN 2070–AB27 

Multi-Walled Carbon Nanotubes and 

Single-Walled Carbon Nanotubes; 

Significant New Use Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing significant new 

use rules (SNURs) under section 5(a)(2) 

of the Toxic Substances Control Act 

(TSCA) for two chemical substances 

which were the subject of 

Premanufacture Notices (PMNs). The 

two chemical substances are identified 

generically as multi-walled carbon 

nanotubes (MWCNT) (PMN P–08–177) 

and single-walled carbon nanotubes 

(SWCNT) (PMN P–08–328). This action 

requires persons who intend to 

manufacture, import, or process either 

of these two chemical substances 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 these chemical 

substances may be hazardous to human 

health and the environment. 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 

October 18, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2008–0252. 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 either of the chemical 

substances contained in this final rule: 

Multi-walled carbon nanotubes 

(MWCNT) (PMN P–08–177) and singlewalled carbon nanotubes (SWCNT) 

(PMN P–08–328). Potentially affected 

entities may include, but are not limited 

to: 

• Manufacturers, importers, or 

processors of one or more 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 


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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 (the corresponding EPA policy 

appears at 40 CFR part 707, subpart B). 

Chemical importers must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA. Importers of 

chemicals subject to these SNURs must 

certify their compliance with the SNUR 

requirements. In addition, any persons 

who export or intend to export a 

chemical substance that is the subject of 

this final rule on or after October 18, 

2010 are subject to the export 

notification provisions of TSCA section 

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

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

II. Background 

A. What Action is the Agency Taking? 

EPA is finalizing SNURs under TSCA 

section 5(a)(2) for two chemical 

substances which were the subject of 

PMNs. The two chemical substances are 

identified generically (due to 

confidentiality claims) as multi-walled 

carbon nanotubes (MWCNT) (PMN P– 

08–177) and single-walled carbon 

nanotubes (SWCNT) (PMN P–08–328). 

This action requires persons who intend 

to manufacture, import, or process 

either of these two chemical substances 

for an activity that is designated as a 

significant new use by this final rule to 

notify EPA at least 90 days before 

commencing that activity. 

Previously, in the Federal Register 

issue of June 24, 2009 (74 FR 29982) 

(FRL–8417–6), EPA issued direct final 

SNURs on these two chemical 

substances (see §§ 721.10155 and 

721.10156). However, EPA received 

notices of intent to submit adverse 

comments on these SNURs. Therefore, 

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

Federal Register issue of August 21, 

2009 (74 FR 42177) (FRL–8433–9), EPA 

withdrew the direct final SNURs on 

these two chemical substances and 

subsequently proposed SNURs using 

notice and comment procedures in the 

Federal Register issue of November 6, 

2009 (74 FR 57430) (FRL–8436–8). More 

information on the specific chemical 

substances subject to this final rule can 

be found in the direct final or proposed 

SNURs. The record for the direct final 

and proposed SNURs on these two 

chemical substances was established in 

the docket under docket ID number 

EPA–HQ–OPPT–2008–0252. That 

docket includes information considered 

by the Agency in developing the direct 

final rule and this final rule including 

comments on those rules. 

EPA received several comments on 

the proposed rule. A full discussion of 

EPA’s response to these comments is 

included in Unit V. of this document. 

Based on these comments, EPA is 

issuing a modified final rule on these 

chemical substances that: 

1. Retains the proposed workplace 

protection, specific use, aggregate 

manufacturing and importation volume 

limitations, and release to water 

provisions. 

2. Provides clarification on the 

exemptions from applicability of the 

SNUR. 

3. Provides additional human health 

and environmental summary 

information to support EPA’s findings 

under § 721.170(b)(4)(ii) and EPA’s 

findings in the proposed rule. 

See the proposed rule for a discussion 

of EPA’s findings and recommended 

testing. 

In response to comments on the 

applicability of the SNURs, EPA 

included in the regulatory text clarifying 

language for those forms of the subject 

PMN substances which are exempt from 

the provisions of the SNURs. These 

exemptions apply to quantities of the 

PMN substances: 

• 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. 

In response to comments on the basis 

for the SNURs, EPA developed revised 

Human Health Effects and 

Environmental Effects Summaries for 

carbon nanotubes (CNTs). See Unit V. of 

this document. These summaries 

specify EPA’s current hazard concerns 

as supported by available information 

and data. See Unit X. of this document 

for a list of those sources. 

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 

(the corresponding EPA policy appears 

at 40 CFR part 707, subpart B). Chemical 

importers must certify that the shipment 

of the chemical substance complies with 

all applicable rules and orders under 

TSCA. For importers of chemical 

substances subject to a final SNUR those 

requirements include the SNUR. 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 


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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 

During review of the PMNs submitted 

for these two chemical substances, EPA 

concluded that regulation was 

warranted under TSCA sections 

5(e)(1)(A)(i) and 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, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. The SNUR 

provisions for these chemical 

substances are consistent with the 

provisions of the TSCA section 5(e) 

consent orders including the recent 

modifications to the consent orders. 

These final SNURs are issued pursuant 

to § 721.160. EPA also finds that, based 

on the environmental effects data, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). See the 

docket under docket ID number EPA– 

HQ–OPPT–2008–0252 for the 

corresponding consent orders. For 

additional discussion of the rationale for 

the SNURs on multi-walled carbon 

nanotubes (MWCNT) (PMN P–08–177) 

and single-walled carbon nanotubes 

(SWCNT) (PMN P–08–328) see Units II. 

and V. of this document. 

B. Objectives 

EPA is issuing these final SNURs for 

specific chemical substances that have 

undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this final rule: 

• EPA will receive notice of any 

person’s intent to manufacture, import, 

or process a listed chemical substance 

for the described significant new use 

before that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing, importing, or 

processing a listed chemical substance 

for the described significant new use. 

• EPA will be able to regulate 

prospective manufacturers, importers, 

or processors of a listed chemical 

substance before the described 

significant new use of that chemical 

substance occurs, provided that 

regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6, or 7. 

• EPA will ensure that all 

manufacturers, importers, and 

processors of the same chemical 

substance that is subject to a TSCA 

section 5(e) consent order are subject to 

similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

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

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 authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the two chemical 

substances that are the subject of these 

final SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four bulleted TSCA section 5(a)(2) 

factors listed in this unit. 

V. Response to Comments on Proposed 

SNURs on Multi-Walled Carbon 

Nanotubes and Single-Walled Carbon 

Nanotubes 

EPA received comments from 

numerous submitters on the proposed 

rules for MWCNTs that are the subject 

of PMN P–08–177 and SWCNTs that are 

the subject of PMN P–08–328. A 

discussion of the comments received 

and the Agency’s responses follows. 

Comment 1: The SNURs did not 

properly identify the chemical identity 

of the substances and the submitter of 

the PMNs did not claim the chemical 

name of the substances as CBI; therefore 

there is no basis for the use of bona fide 

procedures under 40 CFR part 721. 

Further, EPA did not give any objective 

identifying information to identify 

specific substances subject to the 

SNURs. It was requested that EPA 

clarify the particular chemical identity 

of the substances covered by these 

SNURs and how users can tell the 

difference. 

Response: The SNURs for MWCNTs 

and SWCNTs did properly present the 

chemical identity of the PMN 

substances. The SNURs contain the 

same objective identifying information 

as hundreds of previously published 

SNURs where the chemical identity was 

claimed as CBI. EPA published the 

generic 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. Because of a lack of 

established nomenclature for CNTs, 

EPA has allowed PMN submitters to 

represent their CNTs using a name such 

as CNT, MWCNT, or SWCNT while 

submitting a detailed description of the 

CNTs using specific structural 

characteristics. In these instances, the 

PMN submitters claimed those specific 

structural characteristics as CBI. If an 

intended manufacturer, importer, or 

processor of CNTs is unsure of whether 

its CNTs are subject to this or any other 

SNUR, the company can either contact 

EPA or obtain a written determination 

from EPA pursuant to the bona fide 

procedures at § 721.11. 

EPA is using the specific structural 

characteristics, for all CNTs submitted 

as new chemicals substances under 

TSCA, to develop standard 

nomenclature for placing these chemical 

substances on the TSCA Inventory. EPA 

has compiled a generic list of those 

structural characteristics entitled 

‘‘Material Characterization of Carbon 

Nanotubes for Molecular Identity (MI) 

Determination & Nomenclature.’’ A copy 

of this list is available in the docket for 

this SNUR. If EPA develops a more 

specific generic name for these 

materials, that name will be made 

publicly available. 

Comment 2: Reviewing the proposed 

SNUR gives the impression that EPA 

considered that MWCNTs and SWCNTs 

were categories of new substances that 

may present unreasonable risks to 

human health. EPA informally noted 

that the SNURs apply only to the 

specific CNTs in the PMNs. It appears 

that EPA has taken the position that 

some CNTs made by different 

manufacturers are different chemical 

substances for purposes of reporting 

new chemicals under TSCA. EPA 

should clarify ‘‘whether the SNURs are 

intended to apply to the PMN 

substances made by other 

manufacturers.’’ 


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Response: The SNURs and the 

findings in the SNURs apply only to the 

specific CNTs that were the subject of 

PMNs P–08–177 and P–08–328. As 

noted in the public comments to this 

SNUR, EPA has also received and 

reviewed numerous other new chemical 

notices for CNTs. EPA acknowledges 

that CNTs made by different 

manufacturers and processes may be 

considered different chemical 

substances for purposes of reporting 

new chemical substances under TSCA. 

EPA will make this determination on a 

case-by-case basis. The Agency will 

assess and manage the risks of CNTs in 

a similar manner when that assessment 

is based on similar data. EPA may assess 

and manage CNTs differently as new 

data becomes available, especially in 

cases where there are new 

environmental health and safety data for 

specific CNTs. 

Comment 3: Specify how EPA defines 

CNT chemical identities so that 

downstream users can determine when 

processing of CNTs sufficiently change 

them so that a new substance is formed 

that requires new chemical notification 

under TSCA? 

Response: Processing activities that 

causes a chemical reaction, where new 

chemical bonds are formed, could result 

in new chemical substances reportable 

under TSCA. However, processing 

activities that change the physical state 

or physical properties would not result 

in a new chemical substance reportable 

under TSCA. Companies with specific 

questions for specific materials should 

contact the Agency for a Prenotice 

Consultation. See http://www.epa.gov/ 

oppt/newchems/pubs/roster.htm for 

Agency contact information. 

Comment 4: In some instances 

companies may not be able to make the 

certifications required to make a bona 

fide submission and obtain an identity 

determination under § 721.11 for carbon 

nanotubes. 

Response: Companies that 

manufacture, import, or process CNTs 

can identify the specific structural 

characteristics referenced in the 

response to ‘‘Comment 1’’ in order to file 

a bona fide submission. EPA 

recommends that companies that have 

any questions regarding the information 

required or the need for a bona fide 

submission for CNTs contact the 

Agency. See http://www.epa.gov/oppt/ 

newchems/pubs/roster.htm for Agency 

contact information. 

Comment 5: The SNURs did not 

include one of the terms included in the 

consent order which exempts from the 

Order’s requirements quantities of the 

PMN substances that have been 

completely reacted (cured). EPA should 

clarify (1) whether quantities of the 

PMN substances that have been 

completely reacted (cured) are subject to 

the disposal restrictions in the SNURs; 

(2) what other terms of the SNURs are 

applicable once the PMN substances 

have been fixed to a substrate or 

encapsulated within plastic; and (3) 

applicability of the entire SNURs once 

the PMN substances have been 

incorporated into an article. 

Response: EPA agrees that all terms of 

the consent orders should be included 

in the SNURs and has now amended the 

regulatory text to include an exemption 

from SNUR requirements once the PMN 

substance has been completely reacted 

or cured. EPA has also developed new, 

more specific language that addresses 

applicability of the consent orders once 

the PMN substances have been fixed to 

a substrate or encapsulated within a 

plastic or other matrix. The Agency has 

included this new language in the 

regulatory text of the SNURs to exempt 

from SNUR requirements PMN 

substances that have 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. As stated in 

§ 721.45(f), once a chemical substance 

has been incorporated into an article the 

notification requirements of the SNUR 

do not apply. The term ‘‘article’’ is 

defined in 40 CFR 720.3(c). 

Comment 6: The proposed rules do 

not reference highly controlled 

circumstances of use where exposure 

criteria are met. 

Response: The rules do not reference 

exposure criteria or exposure-based 

criteria. The rules establish significant 

new uses that may result in changes of 

the types, forms, magnitude, and 

duration of exposures. A SNUR requires 

notification before any persons 

manufacture or process for a significant 

new use so that EPA can evaluate any 

potential exposures and assess potential 

risks. 

Comment 7: The rules require 

manufacturers and importers to provide 

testing at a specified production 

volume. 

Response: The SNURs require 

notification when a manufacturer or 

importer exceeds a maximum aggregate 

manufacturing and importation volume 

limit. The 90–day inhalation toxicity 

study (Harmonized Test Guideline 

870.3465) is EPA’s recommended 

testing in the proposed SNURs 

preamble. This is the same study 

required in the TSCA section 5(e) 

consent orders for the PMN substances 

before the PMN submitter exceeds the 

specified aggregate maximum 

manufacturing and importation volume. 

Other manufacturers or importers who 

intend to conduct testing or send a 

SNUN if they believe that they will 

exceed that limit, are encouraged to 

contact EPA to avoid duplicative 

testing, to identify alternative testing, 

and to discuss protocols for any testing 

to be conducted. 

Comment 8: Differences in legislation 

could result in different market 

situations for companies in the United 

States and the European Union. 

Emphasis was placed on the utility of 

taking into account the volumes of 

manufacture or importation of a 

substance, the potential hazard and/or 

exposures when proposing requirements 

for generation of information on 

substances. EPA was encouraged to 

ensure convergence of requirements, 

minimize the economic burden on 

industry, and the number of tests on 

vertebrate animals through development 

of tools, especially testing approaches 

and subsequent guidance, under the 

OECD Working Party on Manufactured 

Nanomaterials. 

Response: EPA agrees with these 

comments. When considering testing 

requirements, EPA takes into account all 

of the factors suggested by the 

commenter. However, differences in 

legislation do result in different 

regulatory situations in each 

jurisdiction. EPA is committed to 

addressing all of the issues identified by 

the commenter under the Organization 

for Economic Cooperation and 

Development (OECD) Working Party on 

Manufactured Nanomaterials. EPA 

participates in or chairs each project in 

the OECD Working Party. 

Comment 9: EPA should further 

clarify the meaning of predictable or 

purposeful releases to water. For 

example, a regulated entity may seek to 

comply with this standard by using a 

well-designed filtration system. 

Manufacturers and engineers cannot 

warrant 100% removal. Because there is 

no evidence to believe that trace losses 

in water may cause significant 

environmental harm, the proposed 

standard should allow for small but 

arguably predictable losses associated 

with well designed filtration systems 

without triggering notice obligations. 

Carbon nanotubes occur naturally and 

are produced from many anthropogenic 

sources, making the proposed rule 

impractical and unenforceable (i.e., one 

cannot necessarily distinguish between 

incidental carbon nanotubes found in 

nature and these PMN Substances). 

Adopting a 100% restriction on any 

arguably predictable loss of the PMN 

Substances under such circumstances 


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would impose significant and 

unnecessary costs on the nation’s 

burgeoning nanotechnology industry. 

Response: Purposeful or predictable 

releases to water include any intentional 

or reasonably foreseeable releases to 

water from a waste stream you identify 

as part of a manufacturing process or 

other industrial process. For example, 

when filling out a PMN (EPA Form 

7710–25), submitters are asked to 

identify environmental releases of the 

PMN substance from their 

manufacturing process and other known 

industrial processes. Section 5(d) of 

TSCA, which specifies the required 

content of the PMNs, refers to TSCA 

section 8(a)(2) which specifies a 

standard of requiring information that is 

‘‘known to or reasonably ascertainable 

by’’ the PMN submitter. Any water 

releases of the PMN substance identified 

in the PMN would qualify as purposeful 

or predictable releases. The commenter 

example, a waste stream subject to water 

filtration before release to water, 

qualifies as a purposeful or predictable 

release to water. 

Purposeful or predictable releases to 

water would not include accidents or 

spills. This significant new use 

designation was not intended to prevent 

every single molecule of a subject 

chemical substance from being released 

to surface waters. For the uses identified 

in PMNs P–08–177 and P–08–328, EPA 

did not identify any purposeful or 

predictable releases to water. To prevent 

any potential unreasonable risks, EPA 

prohibited predictable or purposeful 

releases to water as a restriction in the 

consent orders and also designated such 

water releases as significant new uses in 

the SNURs. EPA is willing to consider 

alternatives that establish an acceptable 

level of release to water in these SNURs 

and future CNT submissions when 

information on the toxicity, exposure, 

and fate for that specific CNT is 

available. EPA has included a 

significant new use designation of no 

purposeful or predictable releases to 

water in SNURs for hundreds of PMN 

substances. EPA will continue this 

approach on a case-by-case basis 

depending on the findings in the SNUR 

and the environmental exposures 

identified in the PMN. 

Comment 10: EPA should clarify that 

the term predictable or purposeful 

releases to waters of the United States 

does not prevent disposal of the PMN 

substance as a solid waste. 

Response: General SNUR provisions 

at § 721.3 define the term ‘‘Waters of the 

United States’’ as having the meaning set 

forth in 40 CFR 122.2 which describes 

surface waters of the United States. This 

does not prevent disposal of the PMN 

substances as a solid waste in landfills 

or by incineration. In addition, as stated 

in the response to ‘‘Comment 5,’’ the 

terms of the SNUR do not apply once 

the PMN substance is completely 

reacted or 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. 

Comment 11: EPA should clarify what 

constitutes a dust including if the term 

dust applies only to dry forms and what 

types of exposure to dusts are included. 

Response: The term dust applies to 

any dry solid particle with a size 

ranging from submicroscopic to 

macroscopic. It does not apply to wet 

forms. As stated in the terms of the 

consent orders and SNURs, the standard 

for using the required personal 

protective equipment is to protect 

anyone who is reasonably likely to be 

exposed dermally or by inhalation to the 

PMN substance in the form of a dust. It 

does not matter how the dust is 

generated. 

Comment 12: The Agency did not give 

an adequate basis for the no–release-towater provision. Request the Agency to 

consider establishing a safe level of 

exposure in water utilizing SNUR 

provisions in § 721.90 (b)(2), (b)(3), and 

(b)(4). Another commenter stated that 

EPA should not issue a SNUR before 

there is evidence that the PMN 

substance may present an ‘‘unreasonable 

risk.’’ 

Response: EPA is not required to 

make a ‘‘may present unreasonable risk’’ 

finding in order to issue a SNUR. As 

discussed in Unit IV. of this document, 

TSCA section 5(a)(2) describes the 

factors EPA must consider when issuing 

a SNUR. EPA may issue a SNUR for a 

new chemical substance subject to a 

TSCA section 5(e) consent order as 

described at § 721.160, or for a new 

chemical substance that has completed 

PMN review as described at § 721.170, 

when, respectively, activities other than 

those described in the TSCA section 5(e) 

consent order or the PMN may result in 

significant changes in human exposure 

or environmental release levels and/or 

that concern exists about the chemical 

substance’s health or environmental 

effects. See § 721.170(a). 

The TSCA section 5(e) consent orders 

for these PMN substances, which are the 

bases for these SNURs, do include a 

finding that the PMN substances may 

present an unreasonable risk to human 

health. In addition to referencing 

potential risks to workers exposed by 

inhalation and dermal routes, the 

consent orders also reference potential 

risks to the general population from 

exposures via releases to water, landfill, 

or incineration. While the TSCA New 

Chemicals Program’s Poorly Soluble 

Respirable Particles chemical category 

(see ‘‘Human Health Effects Summary 

for CNTs,’’ in the response to ‘‘Comment 

13’’) does not specifically reference 

these routes of exposure, EPA identified 

a potential unreasonable risk from these 

exposures based on a lack of 

environmental fate and exposure data 

for CNTs to make a reasoned evaluation. 

EPA’s review of the PMNs did not 

identify any predictable or purposeful 

releases to water. To prevent any 

potential unreasonable risks, EPA 

prohibited predictable or purposeful 

releases to water as a restriction in the 

consent orders and also designated such 

water releases as significant new uses in 

the SNURs. EPA is willing to consider 

alternatives that establish an acceptable 

level of release to water in a 

modification to these SNURs and future 

CNT submissions when information on 

the toxicity, exposure, and fate for that 

specific CNT is available. The response 

to ‘‘Comment 13’’ also contains 

information supporting EPA’s 

environmental effects findings and 

terms in the consent orders and SNURs. 

Comment 13: It was noted that more 

recent signed and draft consent orders 

contain additional updated hazard 

assessment information for both health 

and environmental concerns. It was 

suggested this language should be 

referenced in the final SNURs so that all 

of EPA’s concerns are described in a 

similar manner for all SNURs pertaining 

to CNTs. 

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 do cite 

additional data which was not part of 

the basis for the consent orders or 

SNURs for these PMN substances, P– 

08–177 and P–08–328. EPA is 

incorporating this most current language 

in the next two paragraphs as part of 

this preamble to the final rules. This 

language does repeat some of the 

information found in the consent order 

for the PMN substances. EPA has also 

placed, in the reference section of this 

document (Unit X. of this document), 

and in the docket references to publicly 

available data on the health and 

environmental effects of CNTs. These 

data support the findings and significant 

new use designations already made in 

the rule. The environmental effects 

summary is also being used in CNT 

consent orders to support a finding of 


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potential unreasonable risk. EPA also 

finds that, based on the environmental 

effects data, the PMN substances meet 

the concern criteria at 

§ 721.170(b)(4)(ii). 

‘‘Human Health Effects Summary for 

CNTs’’: Absorption is expected to be 

poor via all routes for CNTs based on 

test data for chemicals with similar 

molecular structures and chemicals 

with similar physical/chemical 

properties. Data on other analogous 

substances indicate the potential for 

generation of increased amounts of 

respirable or absorbable particles during 

processing and use of nanoscale 

materials. Further evaluation is needed 

to determine the toxicity of nanoscale 

materials for all routes of exposure. In 

addition, there are concerns for lung 

effects, based on EPA’s Poorly Soluble 

Respirable Particulates chemical 

category. See www.epa.gov/oppt/ 

newchems/pubs/cat02.htm#Respirable. 

Based on test data for analogous 

chemicals, including other CNTs, there 

are concerns for pulmonary toxicity, 

fibrosis, carcinogenicity, mutagenicity, 

and immunotoxicity. There are also data 

suggesting that pulmonary deposition of 

some nanoscale materials, including 

CNTs in the agglomerated form, may 

induce cardiovascular toxicity when 

these nanoscale materials are inhaled. 

The major health concerns are for 

potential pulmonary toxicity, fibrosis, 

and cancer to workers exposed via 

inhalation. Based on the uncertainty of 

the characterization and exposure of 

nanoscale materials in general, there 

may be additional potential for 

translocation across the dermis and 

effects on target organs. 

‘‘Environmental Effects Summary for 

CNTs’’: Toxicity from exposure to CNTs 

has been reported in many aquatic 

species at concentrations that exceed 

estimated solubility limits. Although 

CNTs are not appreciably water soluble 

as manufactured, aqueous suspensions 

can be easily formed by reaction with 

strong acids, ozone, or dispersing 

agents. Recent laboratory research 

shows that CNTs may be combined with 

dissolved organic matter to form stable 

aqueous suspensions. To date, there is 

a lack of available studies on CNTs 

which investigate a broad range of 

production methods, sources, 

purification, functionalization, etc. EPA 

expects that some fraction of the CNTs, 

if released into the environment, will 

eventually become suspended in water. 

Sublethal effects, including respiratory 

stress, ventilation rate, gill mucus 

secretion, gill damage, and aggressive 

behaviors, have been noted for SWCNTs 

in fish at levels as low as 100 parts per 

billion (ppb). Liver cell injuries were 

readily apparent at these exposure 

levels, suggesting the possibility of liver 

tumor formation over longer exposure 

periods. These injuries are notable as 

the effects were seen in cells closest to 

blood vessels, suggesting transport of 

respired or ingested SWCNTs via the 

blood stream. Some effects in the gut 

lumen were also observed at these 

exposure levels. Further studies need to 

be conducted before EPA can establish 

a concentration of concern. Such studies 

must measure actual concentrations of 

CNTs and control for the effects of 

contaminants, solvents, and physical 

factors such as blockage of gills or 

intestines. Before such testing is 

conducted, advanced fate testing may be 

needed to determine the environmental 

behavior. EPA also finds that, based on 

the environmental effects data, the PMN 

substances meet the concern criteria at 

§ 721.170(b)(4)(ii). 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

As discussed in the Federal Register 

issue 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 as of the 

effective date of the final rule. 

Any person who began commercial 

manufacture, import, or processing of 

multi-walled carbon nanotubes (PMN 

P–08–177) or single-walled carbon 

nanotubes (PMN P–08–328) 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 either of these 

chemical substances 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 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, see Unit 

II. of the proposed rule which lists those 

tests, 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. To access the Harmonized 

Test Guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http:// 

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 

In the TSCA section 5(e) consent 

orders for the two chemical substances 

regulated under this final rule, EPA has 

established an aggregate maximum 

manufacturing and importation volume 

limits 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 limits cannot be exceeded unless 

the PMN submitter first submits the 

results of toxicity tests that would 

permit a reasoned evaluation of the 

potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. Listings of 


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the tests specified in the TSCA section 

5(e) consent orders are included in the 

proposed rule for these chemical 

substances. The SNURs contain the 

same volume limits as the TSCA section 

5(e) consent orders. Exceeding these 

production limits is defined as a 

significant new use. Persons who intend 

to exceed this limit must notify the 

Agency by submitting a SNUN at least 

90 days in advance of commencement of 

non-exempt commercial manufacture, 

import, or processing. 

The recommended tests 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. 

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 

As stated in Unit II.C. of this 

document, 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 40 CFR 720.50. SNUNs 

must be submitted to EPA on EPA Form 

No. 7710–25 in accordance with the 

procedures set forth in § 721.25 and 40 

CFR 720.40. This form is available from 

the Environmental Assistance Division 

(7408M), 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. Forms 

and information are also available online 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 substances 

during the development of the direct 

final rule. The Agency’s complete 

Economic Analysis is available in the 

docket under docket ID number EPA– 

HQ–OPPT–2008–0252. 

X. References 

The following is a listing of those 

documents used to prepare the 

preamble to this final rule. A copy of 

this list is available in the docket for 

this final rule under docket ID number 

EPA–HQ–OPPT–2008–0252, which is 

available for inspection as specified 

under ADDRESSES. 

1. Baun A, Hartmann NB, Grieger K, 

and Kusk KO. (2008) Ecotoxicity of 

Engineered Nanoparticles to Aquatic 

Invertebrates: A Brief Review and 

Recommendations for Future Toxicity 

Testing. Ecotoxicology. 17:387–395. 

2. Blaise C, Gagne F, Ferard JF, and 

Eullaffroy P. (2008) Ecotoxicity of 

Selected Nano-Materials to Aquatic 

Organisms. Environmental Toxicology. 

23:591–598. 

3. Bonner JC, et al. (2009) Inhaled 

multi-walled carbon nanotubes 

stimulate a pleural inflammatory 

response in the lung of mice. Society of 

Toxicology. Abstract No. 2205. 

4. Cheng J, Flahaut E, and Cheng SH. 

(2007) Effect of Carbon Nanotubes on 

Developing Zebrafish (Danio rerio) 

Embryos. Environmental Toxicology 

and Chemistry. 26:708–716. 

5. EPA. (2010) Material 

Characterization of Carbon Nanotubes 

for Molecular Identity (MI) 

Determination & Nomenclature. 

Available in the docket under docket ID 

number EPA–HQ–OPPT–2008–0252. 

6. Farre M, Gajda-Schrantz K, 

Kantiani L, and Barcelo D. (2009) 

Ecotoxicity and Analysis of 

Nanomaterials in the Aquatic 

Environment. Analytical and 

Bioanalytical Chemistry. 393:81–95. 

7. Hubbs A, Mercer RR, Coad JE, and 

Batelli LA. (2009) Persistent pulmonary 

inflammation, airway mucous 

metaplasia and migration of multiwalled carbon nanotubes from the lung 

after subchronic exposure. The 

Toxicologist. 108:A2193. 

8. Hyung H, Fortner JD, Hughes JB, 

and Kim JH. (2007) Natural Organic 

Matter Stabilizes Carbon Nanotubes in 

the Aqueous Phase. Environmental 

Science & Technology. 41:179–184. 

9. Klaine SJ, Alvarez PJJ, Batley GE, 

Fernandes TF, Handy RD, Lyon DY, 

Mahendra S, McLaughlin MJ, and Lead 

JR. (2008) Nanomaterials in the 

Environment: Behavior, Fate, 

Bioavailability, and Effects. 

Environmental Toxicology and 

Chemistry. 27:1825–1851. 

10. Lam CW, James JT, McClusky R, 

and Hunter R. (2004) Pulmonary 

Toxicity of Single-Walled Carbon 

Nanotubes in Mice 7 and 90 Days after 

Intratracheal Instillation. Toxicological 

Sciences. 77:126–134. 

11. Landsiedel, et al. (2009) Carbon 

nanotubes tested in 5– and 90–day 

inhalation studies in rats. Society of 

Toxicology. Abstract No. 2194. 

12. Ma-Hock L, Treumann S, Strauss 

V, Brill S, Luizi F, Mertler M, Wiench 

K, Gamer AO, van Ravenzwaay B, and 

Landsiedel R. (2009) Inhalation toxicity 

of multiwall carbon nanotubes in rats 

exposed for 3 months. Toxicological 

Sciences. 112:468–481. 

13. Mitchell LA, Gao J, Wal RV, 

Gigliotti A, Burchiel SW, and McDonald 

JD. (2007) Pulmonary and systemic 

immune response to inhaled 

multiwalled carbon nanotubes. 

Toxicological Sciences. 100:203–214. 

14. Mouchet F, Landois P, 

Sarremejean E, Bernard G, Puech P, 

Pinelli E, Flahaut E, and Gauthier L. 

(2008) Characterisation and in vivo 

ecotoxicity evaluation of double-wall 

carbon nanotubes in larvae of the 

amphibian Xenopus laevis. Aquatic 

Toxicology. 87:127–137. 

15. Muller J, Huaux F, Moreau N, 

Misson P, Heilier J, Delos M, Arras M, 

Fonseca A, Nagy JB, and Lison D. (2005) 

Respiratory toxicity of multi-wall 

carbon nanotubes. Toxicology and 

Applied Pharmacology. 207: 221–231. 

16. Nurkiewicz TR, Porter DW, Hubbs 

AF, Cumpston JL, Chen BT, Frazer DG, 

and Castranova V. (2008) Nanoparticle 

inhalation augments particle-dependent 

systemic microvascular dysfunction. 

Particle and Fibre Toxicology. 5:1. 

Available at http:// 

www.particleandfibretoxicology.com/ 

content/5/1/1. 

17. Petersen EJ, Huang Q, and Weber 

Jr WJ. (2008) Ecological Uptake and 

Depuration of Carbon Nanotubes by 

Lumbriculus variegatus. Environmental 

Health Perspectives. 116:496–500. 

18. Poland CA, Duffin R, Kinloch I, 

Maynard A, Wallace WAH, Seaton A, 

Stone V, Brown S, MacNee W, and 

Donaldson K. (2008) Carbon nanotubes 

introduced into the abdominal cavity of 

mice show asbestos-like pathogenicity 

in a pilot study. Nature 

Nanotechnology. 3:423–428. 

19. Roberts AP, Mount AS, Seda B, 

Souther J, Qiao R, Lin S, Ke PC, Rao 

AM, and Klaine SJ. (2007) In vivo 

Biomodification of Lipid-Coated Carbon 

Nanotubes by Daphnia magna. 

Environmental Science & Technology. 

41:3025–3029. 

20. Schladweiler, et al. (2009) Singlewalled carbon nanotubes induced 

pulmonary and vascular response 

following intratracheal instillation. 

Society of Toxicology. Abstract No. 

2203. 


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21. Shvedova AA, Kisin ER, Mercer 

AR, Murray AR, Johnson VJ, Potapovich 

AI, Tyurina YY, Gorelik O, Arepalli S, 

Schwegler-Berry D, Hubbs AF, Antonini 

J, Evans DE, Ku BK, Ramsey D, Maynard 

A, Kagan VE, Castranova V, and Baron 

P. (2005) Unusual Inflammatory and 

Fibrogenic Pulmonary Responses to 

Single Walled Carbon Nanotubes in 

Mice. American Journal Physiology 

Lung Cellular and Molecular Physiology. 

10:1152–1184. 

22. Shvedova AA, Fabisiak JP, Kisin 

E, Murray AR, Roberts JR, Tyurina YY, 

Antonini JM, Feng WH, Kommineni C, 

Reynolds J, Barchowsky A, Castranova 

V, and Kagan VE. (2008) Sequential 

exposure to carbon nanotubes and 

bacteria enhances pulmonary 

inflammation and infectivity. American 

Journal of Respiratory Cell and 

Molecular Biology. 38:579–590. 

23. Smith CJ, Shaw BJ, and Handy RD. 

(2007) Toxicity of Single Walled Carbon 

Nanotubes to Rainbow Trout, 

(Oncorhynchus mykiss): Respiratory 

Toxicity, Organ Pathologies, and other 

Physiological Effects. Aquatic 

Toxicology. 82:94–109. 

24. Templeton RC, Ferguson PL, 

Washburn KM, Scrivens WA, and 

Chandler GT. (2006) Life-Cycle Effects 

of Single-Walled Carbon Nanotubes 

(SWNTs) on an Estuarine Meiobenthic 

Copepod. Environmental Science & 

Technology. 40:7387–7393. 

25. Warheit DB, Laurence BR, Reed 

KL, Roach DH, Reynolds GAM, and 

Webb TR. (2004) Comparative 

Pulmonary Toxicity Assessment of 

Single-wall Carbon Nanotubes in Rats. 

Toxicological Sciences. 77:117–125. 

26. Wolfarth, MG, et al. (2009) 

Pulmonary toxicity of multi-walled 

carbon nanotubes. Society of 

Toxicology. Abstract No. 2196. 

27. Zhu X, Zhu L, Chen Y, and Tian 

S. (2009) Acute Toxicities of Six 

Manufactured Nanomaterial 

Suspensions to Daphnia magna. Journal 

of Nanoparticle Research. 11:67–75. 

XI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This final rule establishes SNURs for 

two new chemical substances that were 

the subject of PMNs and TSCA section 

5(e) consent orders. 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 these 

SNURs 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 XI. of this document) is 

minimal regardless of the size of the 

firm. Therefore, EPA believes that the 

potential economic impacts of 

complying with these SNURs are not 

expected to be significant or adversely 

impact a substantial number of small 

entities. In a SNUR that published in the 

Federal Register issue 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) (Public 

Law 104–4). 

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 


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56888 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 

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 does not 

significantly or uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

In addition, since this action does not 

involve any technical standards, section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

XII. 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: September 10, 2010. 

Wendy Cleland-Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

■ Therefore, 40 CFR chapter I is 

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 

* * * * * 

721.10155 ............. 2070–0012 

721.10156 ............. 2070–0012 

40 CFR citation OMB control No. 

* * * * * 

* * * * * 

* * * * * 

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 § 721.10155 to subpart E to 

read as follows: 

§ 721.10155 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–08–177) 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)(3), 

(a)(4), (a)(5) (National Institute for 

Occupational Safety and Health 

(NIOSH)-approved air-purifying, 

tightfitting full-face respirator equipped 

with N100 filters), (a)(6)(i), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(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, 

importers, and processors of this 

chemical 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 this section. 


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Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Rules and Regulations 56889 

■ 5. Add § 721.10156 to subpart E to 

read as follows: 

§ 721.10156 Single-walled carbon 

nanotubes (generic). 

(a) Chemical substance and 

significant new uses subject to 

reporting—(1) The chemical substance 

identified generically as single-walled 

carbon nanotubes (PMN P–08–328) 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)(3), 

(a)(4), (a)(5) (National Institute for 

Occupational Safety and Health 

(NIOSH)-approved air-purifying, 

tightfitting full-face respirator equipped 

with N100 filters), (a)(6)(i), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(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, 

importers, and processors of this 

chemical 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 this section. 

[FR Doc. 2010–23321 Filed 9–16–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2010–0569; FRL–9200–6] 

Revisions to the California State 

Implementation Plan, San Diego 

County Air Pollution Control District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve revisions to the San 

Diego County Air Pollution Control 

District (SDCAPCD) portion of the 

California State Implementation Plan 

(SIP). This revision concerns the 

definition of volatile organic compound 

(VOC). We are approving a local rule 

that regulates these emission sources 

under the Clean Air Act as amended in 

1990 (CAA or the Act). 

DATES: This rule is effective on 

November 16, 2010 without further 

notice, unless EPA receives adverse 

comments by October 18, 2010. 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–2010–0569], by one of the 

following methods: 

1. Federal eRulemaking Portal: www.

regulations.gov. Follow the on-line 

instructions. 

2. E-mail: steckel.andrew@epa.gov. 

3. Mail or deliver: Andrew Steckel 

(Air–4), 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 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 

should be clearly identified as such and 

should not be submitted through 

www.vregulations.gov or e-mail. www.

regulations.gov is an ‘‘anonymous 

access’’ system, and EPA will not know 

your identity or contact information 

unless you provide it in the body of 

your comment. If you send e-mail 

directly to EPA, your e-mail address 

will be automatically captured and 

included as part of the public comment. 

If EPA cannot read your comment due 

to technical difficulties and cannot 

contact you for clarification, EPA may 

not be able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: The index to the docket for 

this action is available electronically at 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

either location (e.g., CBI). To inspect the 

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Allen, EPA Region IX, (415) 

947–4120, allen.cynthia@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us,’’ 

and ‘‘our’’ refer to EPA. 

Table of Contents 

I. The State’s Submittal 

A. What rule did the State submit? 

B. Are there other versions of this rule? 

C. What is the purpose of the submitted 

rule revisions? 

II. EPA’s Evaluation and Action 

A. How is EPA evaluating this rule? 

B. Does this rule meet the evaluation 

criteria? 

C. Public Comment and Final Action 

III. Statutory and Executive Order Reviews 

I. The State’s Submittal 

A. What rule did the State submit? 

Table 1 lists the rule we are approving 

with the date that it was adopted by the 

local air agency and submitted by the 

California Air Resources Board (CARB). 

TABLE 1—SUBMITTED RULES

Local agency Rule No. Rule title Adopted Submitted 

SDCAPCD ............................................................ 2 Definitions ............................................................. 06/30/99 05/17/10 


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