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Aspergillus flavus - Pesticide Petition Filing 2/99

[Federal Register: February 19, 1999 (Volume 64, Number 33)]
[Notices]
[Page 8358-8360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe99-75]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-858; FRL-6057-3]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the amendment of a pesticide petition
proposing the establishment of regulations for residues of a certain
pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-858, must
be received on or before March 22, 1999.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following
the instructions under "SUPPLEMENTARY INFORMATION." No confidential
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
"Confidential Business Information" (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 119 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, c/o PM 90,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 5th floor CS1 2800 Crystal Drive, Arlington, VA. (703-308-
8097, e-mail: bacchus.shanaz@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received an amendment to a pesticide
petition as follows proposing the establishment and/or amendment of
regulations for residues of a certain pesticide chemical in or on
various food commodities under section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this
petition contains data or information regarding the elements set forth
in section 408(d)(2); however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.
    The official record for this notice, as well as the public version,
has been established for this notice under docket control number [PF-
858] (including comments and data submitted electronically as described
below). A public version of this record, including printed, paper
versions of electronic comments, which does not include any information
claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The official record is
located at the address in ADDRESSES at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov.

    Electronic comments must be submitted as an ASCII File avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in WordPerfect 5.1/6.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket control number [PF-858]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries.

    Dated: February 9, 1999.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of

Pesticide Programs.

Summaries of Petition

    Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and

[[Page 8359]]

represent the views of the petitioners. EPA is publishing the petition
summaries verbatim without editing them in any way. The petition
summary announces the availability of a description of the analytical
methods available to EPA for the detection and measurement of the
pesticide chemical residues or an explanation of why no such method is
needed.

Amended Petition

    EPA has received a request from the Interregional Research Project
Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology
Center of New Jersey, Rutgers University, 681 U.S. Highway #1 South,
North Brunswick, NJ 08902-3390 proposing pursuant to section 408(d) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, to amend 40
CFR part 180 by extending the exemption from the requirement of a
temporary tolerance for residues of the microbial pesticide Aspergillus
flavus (A. Flavus) AF36 in or on the raw agricultural commodity cotton
until December 30, 2001. The request for an extension of the exemption
from temporary tolerance was submitted on behalf of the Southern
Regional Research Center, United States Department of Agriculture,
Agricultural Research Service, 1100 Robert E. Lee Blvd., New Orleans,
LA 70179-0687. These extensions are requested to comply with the Food
Quality Protection Act of 1996 and to extend the use of the
biopesticide to a larger area. Concomitant with this notice of filing,
EPA is issuing a notice of receipt of application for extension
(amendment) of the Experimental use Permit 69224-EUP-1. According to
the proposed amended application for an Experimental Use Permit 69224-
EUP-1, 200,000 pounds (90,719 kg) of the microbial pesticide are to be
applied to a total of 20,000 acres of commercial cotton fields in 5 of
the 15 counties in Arizona. The proposed applications are to be made in
Yuma, LaPaz, Maricopa, Mohave and Pinal Counties.
    EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.
    As required by section 408(d) of the FFDCA, as recently amended by
the Food Quality Protection Act, the Southern Regional Research Center,
United States Department of Agriculture, Agricultural Research Service
prepared a summary of the petition and authorization for the summary to
be published in the Federal Register in a notice of the receipt of the
petition. The summary represents the views of the Southern Regional
Research Center, United States Department of Agriculture, Agricultural
Research Service; EPA, as mentioned above, is in the process of
evaluating the petition. As required by section 408(d)(3) EPA is
including the summary as part of this notice of filing. EPA may have

made minor edits to the summary for the purpose of clarity.

A. Proposed Use Practices

    Aspergillus flavus isolate AF36 is for application to cotton to
reduce the incidence of aflatoxin producing strains of A. flavus and
thereby reduce aflatoxin contamination of cottonseed. When applied just
prior to flowering, A. flavus isolate AF36, which does not produce
aflatoxin, competitively excludes aflatoxin producing A. flavus strains
without increasing A. flavus in the environment in the long term.

Sterile wheat seed colonized with A. flavus strain AF36 is applied at
10 pounds per acre.

B. Product Identity/Chemistry

    1. The pesticide and corresponding residues are identified as A.
flavus isolate AF36.
    2. Aspergillus flavus isolate AF36 is a naturally occurring fungus
isolated from cottonseed produced in the Yuma Valley of Arizona. AF36
has been shown to be naturally and consistently associated with
commercial cotton grown in Arizona. The overall quantity of A. flavus
at time of harvest on cottonseed grown in fields where AF36 has been
applied (i.e. colony forming units per gram of seed) has been shown to
be similar to levels on cottonseed grown in fields where no application
was made. A. flavus is a widespread fungus. It is particularly well
adapted to the hot desert regions of Arizona where it is widespread in
the environment. The communities of A. flavus in the desert and in
agricultural fields are naturally composed of both aflatoxin producing
(toxigenic) and aflatoxin non-producing (atoxigenic) strains. Both
atoxigenic and toxigenic strains have been found on essentially all
plant material and soils in the desert valleys of Arizona. The goal of
applications is to increase the percent of A. flavus that is the AF36
strain and to decrease the percent of A. flavus that produces
aflatoxins.
    3. An extension of the exemption from the requirement of a
tolerance for residues of the microbial pesticide A. flavus AF36 in/on
cotton is being proposed. A. flavus isolate AF36, when applied to the
soil just prior to bloom has been shown to significantly reduce the
levels of aflatoxin in cottonseed at harvest. Aflatoxin levels in
cottonseed products are regulated by the Food and Drug Administration
(FDA). FDA does not allow cottonseed products containing aflatoxin at
20 parts per billion (ppb) or higher to be used in dairy rations. FDA
regulations also do not allow cottonseed products containing aflatoxin
above 300 ppb to be used for feeding beef cattle. All lots of the
active ingredient (A. flavus isolate AF36) and the formulated product
are monitored as part of a rigorous quality control program.Starter
cultures of A. flavus isolate AF36 used in the production of the end-
use product are always screened for aflatoxin production using TLC and
appropriate standards. Quality control standards are zero tolerance for
aflatoxin production in starter cultures. A. flavus AF36 has never been
found to produce aflatoxin. Starter cultures of A. flavus AF36 as well
as end-use products containing this active ingredient are also
identified to isolate by vegetative compatibility analysis. Quality
control standards are zero tolerance for A. flavus not identified as A.
flavus isolate AF36 in the starter cultures and in the formulated
product.

 C. Mammalian Toxicological Profile

    An acute oral toxicity test was performed whereby a single oral
dose of 5,000 milligrams/kilogram (mg/kg) per animal of A. flavus
isolate AF36 colonized wheat seed was administered by gavage to five
male and five female Sprague Dawley rats. The oral LD50 of
A. flavus AF36 was determined to be greater than 5,000 mg/kg rat body
weight. No clinical signs were observed during the 14 day study and no
abnormalities or adverse effects were observed in any of the rats upon
necropsy.
    Genotoxicity, reproductive and developmental toxicity, subchronic
toxicity and chronic toxicity testing were not performed on this
microbial pest control agent. This testing is not warranted, since: (1)
A. flavus AF36 has been worked with at the Southern Regional Research
Center for over 10 years and in commercial fields (1996 to 1998) and in
hand picked field plots (1989 to 1994) without report of any adverse
health effects; (2) A. flavus AF36 is widely distributed in the
environment and its occurrence is natural; and (3) the label will
require applicators and other handlers to wear waterproof gloves, a
dust/mist filtering respirator with the appropriate NIOSH

[[Page 8360]]

approval prefix N-95, P-95, or R-95, coveralls, long sleeved shirt and
long pants, and shoes plus socks so exposure should not be a problem.

D. Aggregate Exposure

    1. Dietary Exposure. Aspergillus flavus isolate AF36 is a naturally
occurring organism, which does not produce aflatoxin and is thus safer
than the A. flavus isolates that produce aflatoxin. Proposed uses and
application rates will not result in increases in the total population
of A. flavus on the mature crop beyond naturally occurring background
levels.
    2. Food. FDA does not allow cottonseed products containing
aflatoxin at 20 ppb or higher to be used in dairy rations. FDA
regulations also do not allow cottonseed products above 300 ppb to be
used for feeding beef cattle. A. flavus isolate AF36, when applied to
the soil just prior to bloom, has been shown to significantly reduce
the levels of aflatoxin in cottonseed at harvest. Furthermore, the
proposed use and application rate will not increase exposure of humans
to A. flavus by dietary means. There is minimal dietary exposure to A.
flavus from cottonseed. There is no mechanism for A. flavus to be
transferred from the seed to cow products and there is no evidence that
the fungus readily contaminates meats or milk. Seed is typically
extracted for oil with hexane and that process kills the fungus.
Furthermore, applications of A. flavus AF36 do not increase the
indigenous populations of A. flavus associated with the harvested crop.
The applications merely alter the composition of the fungal community
associated with the mature crop so that aflatoxin producing strains are
far less frequent. The result is a much lower incidence of aflatoxins
in the crop and in the environment associated with the developing and
mature crop.
    3. Drinking Water. Aspergillus flavus isolate AF36 is a naturally
occurring organism that is already widespread in the environment and is
not considered to be a risk to drinking water. Both percolation through
soil and municipal treatment of drinking water would reduce the
possibility of exposure of A. flavus through the drinking water.
Applications of A. flavus AF36 do not increase the long-term
populations of A. flavus in the environment, and thus are not expected
to influence the relationship of A. flavus to water sources.
Applications merely change the composition of the A. flavus community
so that aflatoxins are less common in the environment.
    4. Non-dietary exposure. The potential for non-occupational, non-
dietary exposure to the general population is not expected to be
significant and is not expected to present any risk of adverse health
effects.

E. Cumulative Exposure

    There are no other registered products containing A. flavus isolate
AF36 or any other isolates (strains) of the microbial active
ingredient. Data submitted show that the fungal metabolite of concern
which is aflatoxin is not produced by A. flavus isolate AF36 in the
crop or in artificial media in the lab. When applied prior to
flowering, A. flavus isolate AF36 has been shown to exclude aflatoxin
producing fungi competitively from the developing crop and to reduce
aflatoxin contamination of cottonseed. Data show that the proposed use
will not result in appreciable increases in the long-term population of
A. flavus on the crop beyond naturally occurring levels. Furthermore,
there is no expectation of cumulative effects with other pesticides.

F. Safety Considerations

    Aspergillus flavus isolate AF36 is a naturally occurring organism.
This isolate has low toxicity as demonstrated by the acute oral
toxicity study in rats. A. flavus is ubiquitous throughout the hot
desert valleys in Arizona. Studies have shown that treatment of cotton
fields just prior to flowering with sterile wheat seed colonized by A.
flavus isolate AF36 at 10 lbs. per acre does not increase the long-term
populations of A. flavus either on the crop at maturity or in the soil
1 year after application. Based on this information, IR-4 is of the
opinion that the aggregate exposure to A. flavus over a lifetime should
not change with application of AF36, and exposure to both aflatoxin
producing A. flavus strains and aflatoxin should decrease. This should
be beneficial to human health. Thus, there is a reasonable certainty
that no harm will result from aggregate exposure to A. flavus isolate
AF36. Extending the exemption of A. flavus isolate AF36 from the
requirement of a temporary tolerance should be considered safe and pose
insignificant risk.

G. Existing Tolerances

     A temporary tolerance exemption on cotton in conjunction with an
Experimental Use Permit for A. flavus isolate AF36 is currently in
effect (61 FR 30235-30236, June 14, 1996).

[FR Doc. 99-4158 Filed 2-18-99; 8:45 am]
BILLING CODE 6560-50-F