[Federal Register: October 16, 2003 (Volume 68, Number 200)]
[Notices]
[Page 59613-59615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc03-73]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0323; FRL-7329-2]
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 by Interregional Research Project Number 4 (IR-4), New Jersey
Agricultural Experiment Station, Technology Center, on behalf of the
Arizona Cotton Research and Protection Council to conditionally
register the pesticide product Aspergillus flavus AF36 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 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)
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[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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. 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 ID number OPP-2003-0323. 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.
Legacy docket for this case is OPP-2003-0048, which was set up in
connection with the Notice of receipt of an application to register the
pesticide product Aspergillus flavus AF36 containing a new active
ingredient not included in any previously registered product pursuant
to the provisions of section 3(c)(4) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended.
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 available
for public inspection in the Public Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal
Mall 2, Arlington, VA (703) 305-5805. 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. Such requests
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
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 Aspergillus flavus AF36, 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 Aspergillus
flavus AF36, 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 these conditional registrations are 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 Registration
EPA issued a notice, published in the Federal Register of March
12, 2003 (68 FR 11841) (FRL-7293-8), which announced that Interregional
Research Project Number 4 (IR-4), New Jersey Agricultural Experiment
Station, Technology Center of New Jersey, 681 U.S. Highway 1
South, North Brunswick, NJ 08902-3390, on behalf of the Arizona Cotton
Research and Protection Council, 3721 East Weir Avenue, Phoenix, AZ
85040-2933, had submitted an application to register the pesticide
product, Aspergillus flavus AF36, antifungal agent (EPA File Symbol
71693-R) containing Aspergillus flavus AF36 at 0.0008%, an active
ingredient not included in any previously registered product.
EPA file symbol 71693-1: Aspergillus flavus AF36, a non aflatoxin-
producing strain of Aspergillus flavus, is conditionally registered for
use on cotton in Arizona and Texas to displace aflatoxin-producing
strains of Aspergillus flavus.
The application was conditionally approved on June 24, 2003 for an
end-use product manufactured by an integrated process:
Aspergillus flavus AF36 is conditionally registered for use on
cotton in Arizona and Texas to reduce aflatoxin-producing colonies of
Aspergillus flavus. The mammalian health effects and ecological effects
data bases support the conditional approval of the pesticide. Soil and
air monitoring studies were provided to demonstrate the efficacy of the
product for the proposed uses in Arizona. Because the pesticide is to
be used to reduce aflatoxin-producing strains of Aspergillus flavus,
with a potential reduction of aflatoxin, a public health hazard, this
pesticide qualifies for an automatic presumptive finding, and its use
is presumed to be in the public interest. Aspergillus flavus AF36 was
used for several years in an experimental use program without
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adverse effects. Conditions of registration include (a) analyses of 5
batches at production, (b) confirmation by high performance liquid
chromatography (HPLC) that the strain does not produce aflatoxin, (c)
polymerase chain reaction (PCR) analyses of the active ingredient to
confirm product identity, and (d) efficacy (product performance) data
to demonstrate the reduction of toxigenic strains by Aspergillus flavus
AF36 in Texas. These data must be submitted within 30 months of the
conditional registration date. Additional data will be required to
support application of the pesticide to cotton in other states or to
other food/feed commodities. An exemption from tolerance for residues
of Aspergillus flavus AF36 on cotton was established in association
with this conditional registration.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: September 25, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 03-26195 Filed 10-15-03; 8:45 am]
BILLING CODE 6560-50-S