[Federal Register: January 22, 2003 (Volume 68, Number 14)]
[Notices]
[Page 3025-3026]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja03-54]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0300; FRL-7282-7]
Pesticide Product Registrations; Conditional Approval
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces Agency approval of an application
submitted SafeScience, Inc., now known as GlycoGenesys, Inc. to
conditionally register the pesticide product BAITS MOTEL Stay Awhile -
Rest ForeverTM containing a new active ingredient not
included in any previously registered products pursuant to the
provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended.
FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail
address: bacchus.shanaz@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS code 111)
[sbull] Animal production (NAICS code 112)
[sbull] Food manufacturing (NAICS code 311)
[sbull] Pesticide manufacturing (NAICS code 32532)
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 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 an official public docket for this
action under docket identification (ID) number OPP-2002-0300. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
In accordance with section 3(c)(2) of FIFRA, a copy of the approved
label, the list of data references, the data and other scientific
information used to support registration, except for material
specifically protected by section 10 of FIFRA, are also available for
public inspection. Requests for data must be made in accordance with
the provisions of the Freedom of Information Act and must be addressed
to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave.,
NW., Washington, DC 20460-0001. The request should: Identify the
product name and registration number and specify the data or
information desired.
A paper copy of the fact sheet, which provides more detail on this
registration, may be obtained from the National Technical Information
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.
2. Electronic access. You may access this Federal Register document
[[Page 3026]]
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Did EPA Conditionally Approve the Application?
A conditional registration may be granted under section 3(c)(7)(C)
of FIFRA for a new active ingredient where certain data are lacking, on
condition that such data are received by the end of the conditional
registration period and do not meet or exceed the risk criteria set
forth in 40 CFR 154.7; that use of the pesticide during the conditional
registration period will not cause unreasonable adverse effects; and
that use of the pesticide is in the public interest. The Agency has
considered the available data on the risks associated with the proposed
use of Beauveria bassiana strain 447, and information on social,
economic, and environmental benefits to be derived from such use.
Specifically, the Agency has considered the nature and its pattern of
use, application methods and rates, and level and extent of potential
exposure. Based on these reviews, the Agency was able to make basic
health and safety determinations which show that use of Beauveria
bassiana strain 447 during the period of conditional registration will
not cause any unreasonable adverse effect on the environment, and that
use of the pesticide is, in the public interest.
Consistent with section 3(c)(7)(C) of FIFRA, the Agency has
determined that this conditional registration is in the public
interest. Use of the pesticides are of significance to the user
community, and appropriate labeling, use directions, and other measures
have been taken to ensure that use of the pesticides will not result in
unreasonable adverse effects to man and the environment.
III. Conditionally Approved Registrations
EPA issued a notice, published in the Federal Register of September
19, 2001 (66 FR 48256) (FRL-6791-1), which announced that SafeScience,
Inc., now known as GlycoGenesys, 31 St. James Ave., 8th Floor, Boston,
MA 02116, had submitted an application to conditionally register the
pesticide product, Healthy Indoors Brand, Ant and Cockroach Bait
Station, now known as BAITS MOTEL Stay Awhile - Rest
ForeverTM, for use as an indoor, non-food use,
microbiological bait for control of fire ants and cockroach (EPA File
Symbol 70464-U), containing Beauveria bassiana strain 447 at 10%, an
active ingredient not included in any previously registered product.
One comment was received in response to the original publication of
the notice of receipt of this application. The comment referred to the
isolation of the microorganism in Brazil and the recognition of the
Brazilian contribution. The applicant, GlycoGenesys, confirmed the
original isolation of the fungus in Brazil. Following approved
importation and release of the fungus in Gainesville, Florida, the
applicant recovered it from release sites in Florida. A biologically
pure culture of a novel isolate, specific for imported fire ants, was
deposited in the American Type Culture Collection and is recognized as
ATCC 20872 (December 29, 1987). Beauveria bassiana strain 447 is the
subject of invention in U.S. registered patents, which names the
commenter as the co-inventor.
On the basis of data submitted to the Agency, the pesticide was
considered acute toxicology Category III for primary eye irritation and
IV for acute oral and pulmonary effects. Certain data requirements were
waived by the Agency based on the low exposure levels associated with
this method of application. Efficacy data support the use of the
pesticide as a bait against ants and fire ants. While the active
ingredient is efficacious against cockroaches as a spray, its efficacy
in the form of a bait needs further study. Because the pesticide is
proposed for control of fire ants, it qualifies for an automatic
presumptive finding, and its use is presumed to be in the public
interest. The conditional registration allows use against ants and fire
ants until the applicant provides analysis of five batches to
demonstrate adequate production Quality Control and Assurance
procedures. Further data are required should the applicant wish to
register the pesticide for control of cockroach and other extensive
agricultural use patterns. The label prohibits use in/on or near food
storage, handling areas, or utensils.
The application was conditionally approved on September 27, 2002
for the end-use product BAITS MOTEL Stay Awhile - Rest
ForeverTM (EPA Registration Number 70464-4) for indoor bait
use on the basis of data submitted to the Agency. The pesticide
contains 10% w/w (1 x 1010 cfu/gram) of the active
ingredient Beauveria bassiana strain 447, a new active ingredient. This
strain of Beauveria bassiana can be distinguished from the other
strains of Beauveria bassiana by isozyme analysis. Like the other
strains, it is also an entomopathogenic fungus, which germinates on the
cuticles of insects, which it kills by secreting enzymes in their soft
tissue .
List of Subjects
Environmental protection, Pesticides and pest.
Dated: December 23, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 03-970 Filed 1-21-03; 8:45 am]
BILLING CODE 6560-50-S