[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)

[[Page 59614]]

    [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

[[Page 59615]]

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