Document ID: EPA-HQ-OPPT-2009-0686-0019
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Multi-walled Carbon Nanotubes
Posted Date: 2011-05-06T04:00Z

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Rules and Regulations]
[Pages 26186-26192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11127]

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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.

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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: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use 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 Sec.  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 Sec.  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

[[Page 26187]]

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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  721.170(c)(2), i.e., these significant 
new use activities, ``(i) are different from those described in the 
premanufacture

[[Page 26188]]

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 high-throughput 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 Sec.  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 Sec.  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-
to-water 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

[[Page 26189]]

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 Sec.  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 Sec.  
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 Sec.  721.170(e)(1). The schedule states that EPA 
will issue the SNUR within 270 days of receipt of the notice of 
commencement under Sec.  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 Sec.  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

[[Page 26190]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  
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

[[Page 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.

[[Page 26192]]

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]

0
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.

0
2. The table in Sec.  [emsp14]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:

Sec.  [emsp14]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]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  [emsp14]721.10183 to subpart E to read as follows:

Sec.  [emsp14]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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.

[FR Doc. 2011-11127 Filed 5-5-11; 8:45 am]
BILLING CODE 6560-50-P