[Federal Register Volume 66, Number 215 (Tuesday, November 6, 2001)]
[Notices]
[Pages 56105-56106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27840]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-211046A; FRL-6808-7]


TSCA Section 21 Petition; Response to Citizen's Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: On August 2, 2001, EPA received a petition under section 21 of 
the Toxic Substances Control Act (TSCA) from the Cystic Fibrosis 
Foundation. The petition requests that EPA initiate a rulemaking under 
TSCA section 6(a)(1)(A) to prohibit the manufacture processing, 
distribution in commerce, use, and improper disposal of Burkholderia 
Cepacia Complex (Bcc), a group of naturally occurring microorganisms in 
order to ``address the significant threat that these microorganisms 
pose to individuals with cystic fibrosis (CF) and other diseases that 
compromise the immune system.'' For the reasons set forth in this 
notice, EPA has denied the petition to initiate rulemaking. However, 
based on EPA's review of Bcc's commercial status, and in light of the 
seriousness of the potential hazard presented to CF patients, EPA 
intends to initiate a rulemaking to issue a Significant New Use Rule 
(SNUR) under TSCA section 5(a)(2).

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) 564-8974; 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-211046A. 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, is available 
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.

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 TSCA 
section 4, 5(a)(2), or 6, or an order under TSCA section 5(e) or 
6(b)(2). 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. 
Pursuant to TSCA section 21(b)(4)(B)(ii), ``if the petitioner 
demonstrates to the satisfaction of the court by a preponderance of 
evidence that ... there is a reasonable basis to conclude that the 
issuance of such [TSCA section 6(a)(1)(A) rule] is necessary to protect 
health or the environment against an unreasonable risk of injury to 
health or the environment'' the court can order EPA to initiate the 
requested action.

B. What Action is Requested Under this TSCA Section 21 Petition?

    On August 2, 2001, EPA received a petition under TSCA section 21 
from the Cystic Fibrosis Foundation. The petition requests that EPA 
initiate rulemaking under TSCA section 6(a)(1)(A) to prohibit the 
manufacture, processing, distribution in commerce, use, and improper 
disposal of Bcc, a group of naturally occurring microorganisms in order 
to ``address the significant threat that these microorganisms pose to 
individuals with CF and other diseases that compromise the immune 
system.''

III. Disposition of Petition

    The petitioners submitted extensive information on the potential 
hazard Bcc microorganisms may present to CF patients. EPA agrees that 
Bcc microorganisms, when encountered in sufficient numbers through an 
appropriate route of exposure by a member of a sensitive population, 
such as a CF patient, have the potential to cause a severe infection, 
resulting in significantly increased rates of mortality. The petition 
claims that Bcc is likely used in products and services

[[Page 56106]]

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 petition claims to document these potential uses. 
However, the petition contains no evidence that Bcc is currently used 
in existing commercial industrial products to which a sensitive 
individual might be exposed.
    In order to gauge the scope of commercial use of Bcc, EPA conducted 
a survey of over 100 firms, associations, and researchers. In sum, EPA 
was able to discover no evidence that Bcc is contained in a commercial 
product currently available for use in the United States. The only 
potential TSCA uses of Bcc for which information is available are field 
demonstration studies of Bcc in the biodegradation of chlorinated 
solvents in groundwater. (See Commercial Uses of Burkholderia Cepacia 
Complex, USEPA, October 2001.) Specifically, one company has injected a 
strain of Bcc into aquifers in New Jersey to demonstrate its ability to 
degrade trichloroethylene and a consulting firm carried out a pilot 
study in Wichita, KS, to verify the effectiveness and overall 
feasibility of using Burkholderia Cepacia PR1301 to degrade 
chlorinated aliphatic hydrocarbons. However, none of these strains is 
currently available in an existing commercial industrial product.
    No companies indicated that Bcc was currently used for the 
degradation of grease (typically in drain cleaners) or for turf 
management (typically in thatch reduction), although researchers and 
firms cautioned that even the companies that produce such products may 
be unaware of the specific presence of Bcc.
    One respondent indicated that lipases harvested from Bcc are used 
in the production of specialty chemicals. One company's web site, lists 
seven lipases derived from Bcc species available for sale under their 
brand names. However, when this company was contacted, it indicated 
that it purchases the lipases from an overseas firm, and does not work 
with Bcc microorganisms; no more information was available.
    Many respondents indicated a knowledge of Bcc and its possible 
applications, but very few had any knowledge that it was actually being 
used. Some contacts indicated that Bcc's known potential for 
opportunistic pathogenicity had led them to discount it for use in 
their products. Thus, the information available to EPA indicates that 
there is no current commercial use of Bcc in the United States, 
although demonstration studies of its effectiveness in degrading 
chlorinated solvents in groundwater have been reported.
    At this time EPA is unable to identify any existing commercial use 
of products containing Bcc, other than demonstration studies. Based on 
this information, EPA finds that issuing a ban of Bcc under TSCA 
6(a)(1)(A) is not the appropriate mechanism under TSCA to prevent an 
unreasonable risk of injury to health. However, based on EPA's review 
of Bcc's commercial status, and in light of the seriousness of the 
potential hazard presented to CF patients, EPA intends to initiate a 
rulemaking to issue a Significant New Use Rule (SNUR) under TSCA 
section 5(a)(2). As the only identified commercial uses of Bcc are 
demonstration studies, the SNUR when issued, would require 
manufacturers, importers, and processors of Bcc to notify EPA at least 
90 days before any use of Bcc, other than such demonstration studies, 
occurs. The notice would provide EPA with an opportunity to evaluate 
the intended new use and associated activities and, if necessary, to 
prohibit or limit that activity before it occurs.

IV. Comments Received

    EPA received no comments in response to the Federal Register notice 
published September 5, 2001 (66 FR 46459) (FRL-6800-5) announcing EPA's 
receipt of this TSCA section 21 petition.

List of Subjects

    Environmental protection, Burkholderia Cepacia Complex (Bcc), 
Cystic fibrosis, Hazardous substances.


    Dated: October 30, 2001.
Stephen L. Johnson,
Assistant Administrator, Office of Pesticides, Prevention and Toxic 
Substances.

[FR Doc. 01-27840 Filed 11-5-01; 8:45 am]
BILLING CODE 6560-50-S