Document ID: EPA-HQ-OPP-2008-0381-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-18T04:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

(7/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: Shanaz
Bacchus, (703) 308-8097.>

 

<>

<TEMPLATE: Company submission>

<Circle One Global, Inc.>

<Pesticide Petition 7F7302>

<	EPA has received a pesticide petition 7F7302 from Circle One Global,
Inc. (Circle One), P.O. Box 28, Shellman, GA 39886-0028, proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.1254 to establish
an amendment/expansion of an existing tolerance exemption for the
microbial pesticide Aspergillus flavus NRRL 21882 for its use on the
food/feed commodity corn.>

<	Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Circle One
has submitted the following summary of information, data, and arguments
in support of their pesticide petition. This summary was prepared by
Circle One and EPA has not fully evaluated the merits of the pesticide
petition. The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material, or the
summary unintentionally made the reader conclude that the findings
reflected EPA’s position and not the position of the petitioner.>

<I. Circle One Petition Summary>

<	Pesticide Petition 7F7302>

<A. Product Name and Proposed Use Practices>

<	Circle One proposes to expand the registration for afla-guard®, which
is formulated with Aspergillus flavus NRRL 21882, to include use on
corn.  The product will be applied aerially at 20 pounds per acre, the
rate currently approved for use on peanuts.  The application to corn
will be once per season at the first sign of corn tasseling.>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. Aspergillus
flavus NRRL 21882 is a naturally-occurring non-aflatoxin-producing
fungal active ingredient that will be used to displace the ubiquitous A.
flavus group of microbes, many of which can produce aflatoxins, which
are potent carcinogens.  The residues resulting from treatment on corn
are Aspergillus flavus NRRL 21882.  The active ingredient is cultured
from spores originally obtained from the U.S. Department of
Agriculture’s (USDA) Agricultural Research Service (ARS) Patent
Culture Collection in Peoria, Illinois.  It is cultured on a selective
isolation medium and can be identified by vegetative compatibility group
(VCG) assays and characterized as non-aflatoxin-producing by standard
thin layer chromatography (TLC) and high performance liquid
chromatography (HPLC) procedures.  Product characterization previously
submitted confirmed the absence of aflatoxins (B1, B2, G1, and G2), and
cyclopiazonic acid (CPA) (see Aspergillus flavus NRRL 21882
Biopesticides Registration Action Document (BRAD), May 24, 2004, pp.
15-16).  Additionally, the manufacturer of the technical grade active
ingredient routinely conducts standard microbiological assays on
Aspergillus flavus NRRL 21882 conidia to assay for potential aflatoxins,
metabolites, CPA, bacterial contaminants, and bacterial pathogens. >

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue.   It is expected that the percent toxic strains
of total A. flavus found in corn grain will be reduced as a result of
treatment with the registered product.  A dilution plating method has
been used to quantify the A. flavus colonization in both corn and
peanuts, as well as the aflatoxin  contamination (J.W. Dorner (2002)
Simultaneous Quantification of Aspergillus flavus/A. parasiticus and
Aflatoxins in Peanuts, J. of AOAC International, 85(4): 911-916).>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. A petition for
exemption from the requirement of tolerance is being submitted with
applications to add the corn use to both the manufacturing-use label for
Aspergillus flavus NRRL 21882 and the end-use label for afla-guard®. 
EPA previously has determined that an exemption from tolerance is
supported when the product is used on peanuts (see 69 FR 39341, June 30,
2004, codified at 40 C.F.R. § 180.1254) and temporarily when used on
corn (see 72 FR 27460, May 16, 2007) in association with an Experimental
Use Permit (EPA File Symbol 75624-EUP-2).  In reaching these
conclusions, EPA noted that Aspergillus flavus NRRL 21882 occurs
naturally in the environment and beneficially displaces toxigenic
strains of naturally-occurring A. flavus.  EPA also noted that there is
no indication of toxicity, infectivity, or pathogenicity in mammalian
acute oral and pulmonary studies using Aspergillus flavus NRRL 21882 as
the test material.  Accordingly, a numerical tolerance and an analytical
method to measure pesticide residues are not needed.>

<C. Mammalian Toxicological Profile>

<	The toxicological profile previously has been summarized and published
in the final rule to create a tolerance exemption for use on peanuts, 69
Fed. Reg. 39341 (Jun. 30, 2004) as well as in the May 24, 2004, BRAD.> 
The pesticide is classified as Toxicity Category IV   on the basis of
acute oral toxicity/pathogenicity tests submitted for the exemption from
tolerance for its use on peanuts.  EPA also noted that there is no
indication of toxicity, infectivity, or pathogenicity in mammalian acute
oral, pulmonary and intravenous studies using Aspergillus flavus NRRL
21882 as the test material.  Aspergillus flavus NRRL 21882 cleared all
tissues examined during those tests (see 69 FR 39341, June 30, 2004). 
Those studies also supported the temporary exemption from tolerance for
corn (see 72 FR 27460, May 16, 2007). 

<D. Aggregate Exposure>

<	1. Dietary exposure. The total dietary exposure consists of the
potential exposure in food and drinking water, which are discussed
below.  Aspergillus flavus NRRL 21882 is neither toxic nor infective as
determined by submitted studies (see May 24, 2004, BRAD).  A tolerance
exemption has been granted for use on peanuts (69 Fed. Reg. 39341, Jun.
30, 2004).  >

<	i. Food. The product is proposed for use for treatment of corn at the
same rate as approved for use on peanuts.  Levels of Aspergillus flavus
NRRL 21882 are not expected to exceed total levels of
naturally-occurring Aspergillus fungi on corn and thus would not
increase dietary exposure.  Aspergillus flavus NRRL 21882 is a
naturally-occurring strain that does not produce aflatoxins, CPA, or
other known intermediates in the aflatoxin biosynthetic pathway, some of
which are toxic.  The use of the product reduces the aflatoxin content
of treated corn when compared with untreated controls, as demonstrated
by efficacy data submitted with the registration amendment application
for afla-guard®.  In the United States, aflatoxin levels in corn are
monitored to verify they do not exceed the regulatory action levels
(limits) set by the U.S. Food and Drug Administration (FDA). >

<	ii. Drinking water. Exposure to Aspergillus flavus NRRL 21882 in
drinking water is not expected to be greater than existing exposures to
A. flavus strains generally.  Potential risks via exposure to drinking
water or runoff are mitigated adequately by, among other things,
percolation through soil.  The product is not applied to crops grown in
water and is not likely to accumulate in drinking water if used as
directed on the label.  Accordingly, exposure by drinking water will not
increase as a result of the proposed use on corn.>

<	2. Non-dietary exposure. The product currently is registered for use
on peanuts only.  EPA has evaluated occupational, residential,
ecological, and environmental exposure with the peanut use.  Based on
these evaluations, the only mitigation required was with respect to the
exposure by pesticide handlers.  To mitigate this exposure, EPA requires
the use of personal protective equipment.  This requirement is triggered
by the properties of the A. flavus species, not the specific registered
strain, which has had no hypersensitivity incidents reported during the
12 years handled by workers in the laboratory and in field trials. 
There are no residential or non-crop uses.  Non-occupational exposure is
not likely to be greater than that which normally exists to the
naturally-occurring A. flavus species.  This issue is discussed in
further detail at 69 FR 39347 and in the May 24, 2004, BRAD.>

<E. Cumulative Effects>

<	Completed toxicology studies indicate that Aspergillus flavus NRRL
21882 is not toxic or pathogenic to humans.  It currently is registered
for use on peanuts only.  Another strain of Aspergillus flavus, A.
flavus AF36, is registered under Section 3(c)(5) for use on cotton.  A.
flavus AF36 is also temporarily exempt from the requirement of a
tolerance on corn in accordance with an EUP (EPA File Symbol
71693-EUP-2).  Other A. flavus strains abound naturally in the
environment.  The displacement of aflatoxin-producing strains of A.
flavus by Aspergillus flavus NRRL 21882 is expected to reduce aflatoxin
contamination in corn, as demonstrated by the efficacy data submitted
with the registration amendment for afla-guard®.  As Aspergillus flavus
NRRL 21882 is naturally occurring, in toxicity Category IV, and
atoxigenic, no cumulative incremental effect from its use on corn is
expected.>

<F. Safety Determination>

<	1. U.S. population. There is a reasonable certainty that no harm will
result to the U.S. population from aggregate exposures to residues of
Aspergillus flavus NRRL 21882 as a result of its use on corn.  EPA has
already concluded that the organism is non-toxic and non-pathogenic to
animals and humans.  The additional exposure to this organism from use
on corn should not increase the overall exposure to A. flavus, and the
use is expected to reduce potential exposure to potent mycotoxins. 
Accordingly, use of the product on corn should not change the conclusion
concerning the safety of the product already reached by EPA in the
context of its use on peanuts.>

<	2. Infants and children. EPA previously has concluded that Aspergillus
flavus NRRL 21882 is non-toxic to mammals, including human infants and
children.  As there are no threshold effects of concern for infants,
children, and adults, no additional margin of safety was added in
EPA’s assessment of the product’s use on peanuts.  As Aspergillus
flavus NRRL 21882 is naturally occurring, in toxicity Category IV, and
atoxigenic, it can be concluded that no additional safety factor is
needed.>

<G. Effects on the Immune and Endocrine Systems>

<	EPA has not required submission of information on the endocrine
effects of the active ingredient, Aspergillus flavus NRRL 21882.  There
is no known metabolite produced by this microorganism that acts as an
endocrine disruptor.  The submitted toxicity/infectivity and/or
pathogenicity studies in the rodent indicate that, following oral and
pulmonary routes of exposure, the immune system is intact and able to
process and clear the active ingredient.  Additionally, based on the low
potential exposure associated with the proposed, single application per
season use, no adverse effects to the endocrine or immune system are
expected.  >

<H. Existing Tolerances>

<	An exemption from the requirement of a tolerance currently exists for
residues of Aspergillus flavus NRRL 21882 in/on peanuts, which is
published in 40 C.F.R. § 180.1254.  There also is a temporary tolerance
exemption for residues of Aspergillus flavus NRRL 21882 in/on corn when
used in accordance with Experimental Use Permit 75624-EUP-2, which will
expire on May 2, 2009.>

<I. International Tolerances>

<	There is no Codex maximum residue level for residues of Aspergillus
flavus NRRL 21882.>

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