
[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Notices]               
[Page 64946-64947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc08-71]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2004-0122; FRL-8386-6]

 
Toxic Substances Control Act Inventory Status of Carbon Nanotubes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document gives notice of the Toxic Substances Control Act 
(TSCA) requirements potentially applicable to carbon nanotubes (CNTs). 
EPA generally considers CNTs to be chemical substances distinct from 
graphite or other allotropes of carbon listed on the TSCA Inventory. 
Many CNTs may therefore be new chemicals under TSCA section 5. 
Manufacturers or importers of CNTs not on the TSCA Inventory must 
submit a premanufacture notice (PMN) (or applicable exemption) under 
TSCA section 5 where required under 40 CFR part 720 or part 723. In 
order to determine the TSCA Inventory status of a CNT, a manufacturer 
may submit to EPA a bona fide intent to manufacture or import under 40 
CFR 720.25.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: James Alwood, Chemical Control 
Division (7405M), Office 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.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use CNTs that are chemical substances subject to 
the jurisdiction of TSCA. Potentially affected entities may include, 
but are not limited to:
     Chemical manufacturers (NAICS code 325), e.g., persons 
manufacturing, importing, processing, or using chemicals for commercial 
purposes.
     Petroleum and coal product industries (NAICS code 324), 
e.g., persons manufacturing, importing, processing, or using chemicals 
for commercial purposes.
    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. 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.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPPT-2004-0122. 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, will be publicly 
available only in hard copy. Publicly available docket materials are 
available electronically 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 Federal 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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access 
information about the TSCA program on-line at http://www.epa.gov/oppt.

[[Page 64947]]

II. Background

    Pursuant to TSCA section 5(a)(1), any person manufacturing 
(including importing) a new chemical substance must file with EPA a PMN 
(or applicable exemption) at least 90 days prior to manufacture, unless 
the substance is excluded from PMN reporting. See 40 CFR part 720 
regarding when reporting is required.
    CNTs are considered chemical substances subject to the jurisdiction 
of TSCA unless and to the extent they are within the classes of 
materials specified in TSCA section 3(2)(B) as outside the jurisdiction 
of TSCA, such as pesticides, foods, drugs, and cosmetics. For example, 
nanoscale materials used in drugs are subject to the jurisdiction of 
the U.S. Food and Drug Administration.
    EPA has taken steps to inform manufacturers that CNTs may require 
notification under TSCA section 5. EPA has made numerous public 
statements and responses to written inquiries indicating that CNTs are 
not necessarily identical to graphite or other allotropes of carbon. 
Manufacturers have been encouraged to submit a bona fide intent to 
manufacture or import, to submit a notice under TSCA section 5 (where 
required), or contact the Agency with additional questions. On July 12, 
2007 (72 FR 38081) (FRL-8139-9) and January 28, 2008 (73 FR 4861) (FRL-
8344-5), EPA issued Federal Register notices which reference a paper, 
TSCA Inventory Status of Nanoscale Substances--General Approach. EPA 
stated in that document that CNTs might not have the same molecular 
identity as non-nanoscale allotropes of carbon. EPA has received and is 
reviewing several PMNs for CNTs as new chemical substances.
    Despite these efforts, current pre-notice inquiries to the Agency 
and questions in public forums still indicate a lack of clarity on this 
issue. Some of the misunderstanding may be the result of an EPA 
communication to a chemical manufacturer a number of years ago 
pertaining to a substance the Agency now considers to be a carbon 
nanotube material. EPA's initial response, which was specific to that 
inquiry and based upon the information presented at the time, was that 
the material was already on the TSCA Inventory. EPA has since notified 
that manufacturer that a PMN is required for that carbon nanotube 
material. Nonetheless, the Agency understands that the earlier 
communication may have been misunderstood by some companies as a 
possible indication that all CNTs may be equivalent to other allotropes 
of carbon for purposes of the TSCA Inventory.
    This document is intended to give notice of the potential TSCA 
requirements applicable to CNTs. If a particular CNT is not on the TSCA 
Inventory, anyone who intends to manufacture or import that CNT is 
required to submit a PMN (or applicable exemption) under TSCA section 5 
at least 90 days before commencing manufacture. Manufacturers may 
submit a bona fide intent to manufacture or import under 40 CFR 720.25 
to determine whether a specific CNT is on the TSCA Inventory. Companies 
may also contact the Agency with specific questions. EPA strongly 
recommends that persons who currently manufacture CNTs for commercial 
purposes determine whether their CNTs are on the TSCA Inventory and in 
compliance with the TSCA section 5 requirements.
    EPA continues to enforce TSCA consistent with its other priorities. 
Some time after March 1, 2009, EPA anticipates focusing its compliance 
monitoring efforts to determine if companies are complying with TSCA 
section 5 requirements for carbon nanotubes.
    If you have further questions regarding notification requirements 
for CNTs, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

List of Subjects

    Environmental protection, Carbon nanotubes, Chemicals, hazardous 
substances, Nanoscale materials.


    Dated: October 27, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-26026 Filed 10-30-08; 8:45 am]

BILLING CODE 6560-50-S
