FILE NAME:  biopetit.wpt   (1/1/2005) (xml)

Number: P4

ATTENTION: 

All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

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

(1/1/2005)

EPA Biopesticides and Pollution Prevention Division contact: Shanaz
Bacchus, 703-308-8097, bacchus.shanaz@epa.gov

TEMPLATE:

Jabb of the Carolinas

PP 5F6960

	EPA has received a pesticide petition, PP 5F6960, from the consultant,
Sarah E. Hinz-Bridger,SHB Scientific Enterprises, P.O. Box 321,
Chandler, AZ 85244-0321 on behalf of Jabb of the Carolinas , P.O. Box
310, Pine Level, NC 27568, 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  to establish an exemption from the requirement of
a tolerance in/on all food commodities for the  microbial pesticide
Beauveria bassiana HF 23

	Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Jabb of
the Carolinas has submitted the following summary of information, data,
and arguments in support of their pesticide petition.  This summary was
prepared by Jabb of the Carolinas 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.   Jabb of the Carolinas  Petition Summary

   	PP 5F6960

A.  Product name and Proposed Use Practices

	Beauveria bassiana HF23 will be used as a biological insecticide for
the control of houseflies in the manure pits of high rise chicken
facilities.  The active ingredient enters and colonizes the insect body.

B.  Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues.    Bieauveria
bassiana HF23  will be applied to the manure pits in high rise chicken
houses. The fungal spores enter and colonize the insect body, which
kills the insect. A study which analyzes the ability of Beauveria
bassiana HF23 to survive in chicken manure is included in TGAI Volume 12
of the registration submission.  As can be noted from the study, average
conidia viability for all the four groups was greater than 94% (9.4 x
10E8 cfu/square foot) for the one-hour post treatment samples and
decreased over time to less than 7% (7.0 x 10E7 cfu/square foot) at Day
35 and less than 2% (2.0 x 10E7 cfu/square foot) at day 56, the final
sample date.  Additionally, Beauveria bassiana HF23 has been tested for
its ability to proliferate at 37◦C by Dr. Ellen Jo Baron at Stanford
University.  As can be noted, this isolate did not show the ability to
grow at 37◦C and so residues would not be expected on any agricultural
commodities.

	2. Magnitude of residue at the time of harvest and method used to
determine the residue.   The magnitude of residue at the time of a
potential harvest will be minimal due to the inability of the Beauveria
bassiana HF23 to survive in the manure for long periods of time as
discussed above.

	3. A statement of why an analytical method for detecting and measuring
the levels of the pesticide residue are not needed.   Residues of the
pesticide are not expected to remain on treated food and feed
commodities when chicken manure treated with Beauveria bassiana HF23 is
applied as fertilizer to agricultural crops.  The fungal active
ingredient occurs naturally in the environment and is ubiquitous.  The
toxicology studies indicate no harm to human health via oral exposure
(including drinking water) as discussed below. Consequently, an
analytical method is not required to monitor residues of Beauveria
bassiana HF23 in/on treated food/feed commodities.

C.  Mammalian Toxicological Profile

    The active ingredient Beauveria bassiana HF23 and the proposed end
use product balEnce have been evaluated for toxicity through oral,
dermal, pulmonary and eye routes of exposure.  The results of the
studies have indicated Toxicity Category IV, which pose no significant
human health risks.

Acute Oral Toxicity (Technical) 

The test organism was detected in the feces of treated animals collected
on the day of dosing, but not in fecal samples collected on Day 3 and 7.
The test organism was not detected in the cecum contents, blood, or in
any of the tissue samples of treated animals at any of the time periods.
 The organism was not detected in the feces, tissues, blood or cecum
contents in the room and shelf control animals at any time during the
study.  All animals survived for the duration of the study.  No abnormal
clinical findings considered treatment-related and no effect on body
weight was noted in any animal.  

Based on the results of this study, clearance of the test organism from
feces was established on Day 7 following a single oral dose in rats.  In
addition, the test organism was not toxic, infective or pathogenic to
rats when administered as a single dose by the oral route.

Acute Dermal Toxicity in Rabbits (Technical)

 Each of the animals received 2 g/kg of the test organism on the
application site.  A porous gauze patch was used to maintain the test
material in contact with the skin.  The patch was secured in place with
Johnson and Johnson hypoallergenic tape.  In order to further secure the
patch, bandaging was wrapped around the trunk of the animal and taped in
place.  Collars were affixed to each animal for 24 hours to prevent
access to the test site.  Exposure duration was 24 hours.   After
exposure, the bandaging and the collar were removed from each animal and
the skin was gently wiped with disposable paper towels wetted with tap
water to remove any remaining test material.

Beauveria bassiana HF23 produced no adverse reactions on the skin of any
of the treated animals.

Acute Intraperitoneal Toxicity/Pathogenicity Testing in Rats (Technical)

The objective of this study is to evaluate the potential toxicity and
pathogenicity of Beauveria bassiana HF23 when administered to rats in a
single dose by intraperitoneal injection.

The test organism was administered to six male and six female rats by
intraperitoneal injection at a dose volume of 1 mL per animal.  The dose
preparation contained 3.97 x 108 cfu/mL by the hemacytometer method and
2.80 X 107 cfu/mL by the dilution plate count method.  In addition, room
controls (Group 1, rats housed in a room separate from the treated rats)
of two males and two females were placed on study.  These animals were
not dosed. 

Animals were observed for viability once each morning and afternoon
throughout the 21-day study.  In addition, each animal was observed for
clinical signs at 1, 2.5 and 4 hr following dosing and daily thereafter
for the duration of the study.  Body weights were measured once pretest,
once weekly throughout the study and at terminal sacrifice.  Animals
were subjected to a gross necropsy at termination.  

All animals survived and gained weight over the duration of the study. 
Sporadic decreased feces were observed in one room control (Group 1)
female and in one male and six females among the treated (Group 2)
animals.  A subcutaneous mass was observed in one male and one female in
the treated group. The test organism was not recovered from these
masses.  No signs of infectivity or pathogenicity were observed during
the gross necropsies.    

The test organism, B. bassiana HF23, was not toxic or pathogenic to rats
when administered in a single dose by the intraperitoneal route.  

Primary Eye Irritation in Rabbits (Technical)

A single dose of 0.07 of the test organism was applied to the eye of
each rabbit.  Eyes were observed at approximately 1, 24, 48 and 72 hours
after ocular instillation of the organism.

Instillation of Beauveria bassiana HF23 into the eye of three rabbits
produced chemosis and discharge up to 48 hr, and redness up to 72 hr.  
Although some of these effects were moderately severe, all of the eyes
were completely normal by 7 days.

Acute Eye Irritation in Rabbits (EP, balEnce):

A single dose of 0.1 mL of the test organism was applied to the eye of
each rabbit.  Eyes were observed at approximately 1, 24, 48 and 72 hours
after ocular instillation of the organism.

Instillation of Beauveria bassiana End-use Product into the eye of three
rabbits produced mild redness up to 48 hr after treatment.  Discharge
was observed in one animal at 1 hr.   All of the treated eyes were
completely normal by 72 hr after treatment.

For the active ingredient, no pathogenic effects were observed in the
acute oral, acute dermal, acute pulmonary toxicology, acute injection or
eye irritation studies.

A waiver is being requested for the acute oral, acute pulmonary and
injection studies on the finished product based on the fact that there
was no toxicity or pathogenicity in the active ingredient pulmonary and
injection studies.  The inerts, used in the formulation, are included
List 4A or 4B and are not expected to have any adverse acute oral and
pulmonary effects effects on human adults, children and infants.  
Dermal toxicity/pathogenicity and eye irritation was not observed in the
finished product studies.

Acute Avian Oral Toxicity:

Chickens were used for the study instead of bobwhite quails.

No mortalities or adverse effects were observed, therefore, both LD50
and ID50 were estimated by >0.91 g/kg body weight.  The No Observed
Adverse Effects Level (NOAEL) was determined to be >0.91 g/kg body
weight. The target dose tested, >0.91g/kg body weight, was based on the
purity test of the substance and the maximum hazard dose level according
to OPPTS Guideline 885.4050.  

D.  Aggregate Exposure						

	1. Dietary exposure.

	i. Food.   Dietary exposure from use of Beauveria bassiana HF23, as
proposed, is minimal.  Beauveria bassiana HF23 is applied to the manure
pits and is not applied directly to growing crops.  Manure used as
fertilizer will have a minimal residue as can be determined by the
inability of Beauveria bassiana HF23 to survive in chicken manure by the
time it is applied to the fields.  Residues of Beauveria bassiana HF23
are not expected on agricultural commodities.

	ii. Drinking water.  Similarly, exposure to humans from residues of
Beauveria bassiana HF23 in consumed drinking water would be unlikely. 
Beauveria bassiana HF23 is a naturally occurring soil microorganism
found in soil types world-wide.  While spores of Beauveria bassiana HF23
may be found in aquatic environments, possibly because they are washed
in from surrounding terrestrial habitats, they are not known to grow or
thrive in aquatic environments.

	2. Non-dietary exposure.   The potential for non-dietary exposure to
the general population, including infants and children, is unlikely as
the proposed use site is in an enclosed environment.  In addition, the
pesticide is to be applied to agricultural fields, such that minimal
exposure is expected to the general population, including infants and
children.  However, non-dietary exposures would not be expected to pose
any quantifiable risk due to a lack of residues of toxicological
concern.

Personal Protective Equipment (PPE) mitigates the potential for exposure
to applicators and handlers of the proposed product, when used in the
chicken facility.

E.  Cumulative Exposure  

It is not expected that, when used as proposed, Beauveria bassiana HF23
would result in residues that would remain on agricultural commodities. 
While other strains of Beauveria bassiana are registered, they are not
registered for this particular use.  Thus, cumulative exposure to
Beauveria bassiana HF23 is not expected from this particular application
method.

F.  Safety Determination 								

	1. U.S. population. Beauveria bassiana HF23 is not pathogenic or
infective to mammals. There has only been 1 report of human infectivity
(deep tissue) by a Beauveria tenella.  The infected individual was
receiving immunosuppressive therapy at the time.

	Beauveria bassiana HF23 is applied to the manure pits in a chicken
facility.  It is not applied to growing crops directly.  Residues of
Beauveria bassiana HF23 are  not expected on agricultural commodities,
and therefore, exposure to the general US population, based on the
proposed use, is not anticipated.

	2. Infants and children.   As mentioned above, residues of Beauveria
bassiana HF23 are not expected on  food and feed commodities.  There is
a reasonable certainty of no harm for infants and children from exposure
to Beauveria bassiana HF23 from the proposed uses.

Effects on the Immune and Endocrine Systems

³

¸

¹

Ò

ë

/No effects on the immune and endocrine systems are expected from
exposure to Beauveria bassiana HF 23.

H.  Existing Tolerances

Exemptions from tolerances exist for Beauveria bassiana ATCC 74040 and
Beauveria bassiana GHA.

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