[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Notices]
[Pages 46459-46460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22284]



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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-211046; FRL-6800-5]


TSCA Section 21 Petition; Notice of Receipt

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of a petition submitted by the 
Cystic Fibrosis Foundation under section 21 of the Toxic Substances 
Control Act (TSCA), and requests comments on the petition. The 
Foundation has petitioned EPA to initiate a rulemaking proceeding under 
section 6(a)(1)(A) of TSCA to prohibit the manufacture, processing, 
distribution in commerce, use, and improper disposal of Burkholderia 
cepacia complex (Bcc), a group of naturally occurring microorganisms. 
The Petitioner believes that this action is necessary to ``address the 
significant threat that these microorganisms pose to individuals with 
cystic fibrosis and other diseases that compromise the immune system.'' 
Under section 21 of TSCA, the Agency must respond to the petition by 
October 30, 2001. The Agency does not plan at this time to schedule a 
public hearing for this petition. However, if it is determined that a 
hearing is needed, the Agency will hold a public hearing in the future.

DATES: Comments, identified by docket control number OPPTS-211046, 
should be received on or before September 19, 2001. The Agency will 
accept comments received after that date, but cannot guarantee that 
they will be considered prior to preparing its response to the 
petition.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPPTS-211046 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division, 
Office of Pollution Prevention and Toxics (7401), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: James Alwood, Chemical Control 
Division, (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-1857; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to manufacturers (including importers), 
processors, and users of products that contain living microorganisms 
subject to jurisdiction under TSCA, especially if that entity knows 
that its products contain or may contain Bcc. Since other entities may 
also be interested, the Agency has not attempted to describe all the 
specific entities that may be affected by this action. 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 Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-211046. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, isavailable for 
inspection in the TSCA Nonconfidential Information Center, North East 
Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The 
Center is open from noon to 4 p.m., Monday through Friday, excluding 
legal holidays. The telephone number for the Center is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-211046 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments and data will also be accepted on standard disks in 
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPPTS-211046. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI Information That I Want To Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version

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of the official record without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the actions sought by the 
petitioner, the facts, technical information, supporting rationale 
which the petitioner believes establishes the need for the requested 
action, the potential impacts of the requested action (including 
possible unintended consequences), and any data or information that you 
would like the Agency to consider during the development of its 
response to the petition. You may find the following suggestions 
helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What is a TSCA section 21 petition?

    Section 21 of TSCA allows citizens to petition EPA to initiate a 
proceeding for the issuance, amendment, or repeal of a rule under 
sections 4, 5(a)(2), 6, or an order under section 5(e) or 6(b)(2) of 
TSCA. A TSCA section 21 petition must set forth facts which the 
petitioner believes establish the need for the action requested. EPA is 
required to grant or deny the petition within 90 days of its receipt. 
If EPA grants the petition, the Agency must promptly commence an 
appropriate proceeding. If EPA denies the petition, the Agency must 
publish its reasons for the denial in the Federal Register. Within 60 
days of denial or no action, petitioners may commence a civil action in 
a U.S. district court to compel initiation of the requested rulemaking. 
When reviewing a petition for a new rule, as in this case, the court 
must provide an opportunity for de novo review of the petition. After 
hearing the evidence, the court can order EPA to initiate the requested 
action.

B. What Action is the Agency Taking/Announcing?

    This notice announces receipt by EPA on August 2, 2001, of a 
petition submitted by the Cystic Fibrosis Foundation under section 21 
of TSCA, and requests comments on the petition. The Foundation has 
petitioned EPA to initiate rulemaking proceeding under section 
6(a)(1)(A) of TSCA to prohibit the manufacture, processing, 
distribution in commerce, use, and improper disposal of Bcc. Under 
section 21 of TSCA, the Agency must respond to the petition by October 
30, 2001.
    The petitioner's request for a prohibition under section 6(a)(1)(A) 
of TSCA is based on their assertion that Bcc consists of a number of 
naturally occurring microorganisms which are subject to regulation 
under TSCA as chemical substances and exposure to Bcc resulting from 
its use in a ``wide variety of commercial activities'' poses a deadly 
risk to cystic fibrosis patients and individuals with certain other 
diseases that compromise the immune system. These commercial uses are 
asserted to include ``products and services that involve drain 
cleaning, bioremediation, biomonitoring of hazardous wastes, biomass 
conversion, production of specialty chemicals, oil recovery, wastewater 
treatment, bio-mining, and desulfurization of oil and coal.'' The 
petitioner's request for action under section 6(a)(1)(A) of TSCA is 
based on several points including assertions that Bcc is not necessary 
for such applications, that the manufacturing, and use of Bcc poses an 
unreasonable risk to cystic fibrosis patients, and, despite limitations 
and uncertainties in the understanding of the extent to which Bcc is 
used in various products, that the ``only regulatory action that will 
adequately reduce the risk presented by Bcc is a flat prohibition 
against manufacturing and use.'' EPA has commenced a review of this 
petition. Comments on the petition may be submitted by any of the 
methods identified in Unit I.

List of Subjects

    Environmental protection.


    Dated: August 27, 2001.
William H. Sanders III,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 01-22284 Filed 9-4-01; 8:45 am]
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