B. bassiana - Pesticide Petition Filing 6/98
[Federal Register: June 10, 1998 (Volume 63, Number 111)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing of a Pesticide Petition
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the amendment of pesticide petition (PP
5F4483), proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-812, must
be received on or before July 10, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7502C), Information Resources and Services
Division, 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 to: opp-
firstname.lastname@example.org. Follow the instructions under "SUPPLEMENTARY
INFORMATION." No confidential business information should be submitted
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: By mail: Shanaz Bacchus, Biopesticides
and Pollution Prevention Division (7511W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. CS51B6, Westfield
Building North Tower, 2800 Crystal Drive, Arlington, VA 22202, (703)
308-8097; e-mail: email@example.com.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various food
commodities under section 408 of the Federal Food, Drug, and Comestic
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 of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-812] (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:
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 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [PF-812] and appropriate petition number.
Electronic comments on this notice may be filed online at many Federal
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
Dated: May 29, 1998.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Summary of the Petition
Petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summary of the petition
was prepared by the petitioners and represent the views of the
petitioners. EPA is publishing the petition summary verbatim without
editing it 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.
Troy Biosciences, Inc.
EPA has received an amended pesticide petition (PP 5F4483) from
Troy Biosciences, Inc., 2620 North 37th Dr., Phoenix, Arizona 85009,
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish
an exemption from the requirement of a tolerance for the microbial
pesticide Beauvaria bassiana ATCC 74040 in or on all raw agricultural
commodities. The initial notice of filing was published in the Federal
Register of June 15, 1995 (60 FR 31465) (FRL-4955-4). This amended
petition was submitted to comply with the provisions of the 1996 Food
Quality Protection Act (FQPA).
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Troy
Biosciences, Inc. has submitted the following summary of information,
data and arguments in support of their pesticide petition. This summary
was prepared by Troy Biosciences, Inc. and EPA has not fully evaluated
the merits of the petition. The summary may have been edited by EPA if
the terminology used was unclear, the summary contained extraneous
material, or the summary was not clear that it reflected the conclusion
of the petitioner and not necessarily EPA.
A. Product Name and Proposed Use Practices
Beauvaria bassiana ATCC 74040 is the active ingredient in the
technical product Naturalis. End-use products are to be used to treat
all food commodities using standard ground and aerial application
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The active
ingredient, Beauveria bassiana ATCC # 74040 (TBI#1), is a naturally
occurring, soil-borne fungal entomopathogen that is found in soil
environments worldwide. This particular strain was isolated for TBI
from an infected boll weevil collected from the Rio Grande Valley in
Texas. Beauveria bassiana organisms, and particularly the spores, do
not display good viability outside soil environments. They are
extremely sensitive to high ambient temperatures, low humidity and
intense light. Following foliar application to RACs, it is unlikely
spores will survive beyond 3 to 5 days. Data generated under
experimental use permits and data obtained from use of Beauveria
bassiana ATCC # 74040 (TBI#1) on ornamentals and turf demonstrate that
there are no detectable organisms.
2. Magnitude of residue at the time of harvest and method used to
determine the residue-- Plant metabolism. Beauveria bassiana is a well-
known, soil-inhabiting fungal organism. It is not pathogenic to plants,
and will not invade plant tissue. Results of research conducted under
the Experimental Use Permit (EUP) also document that the conidia of
Beauveria bassiana are not viable 96 hours following foliar
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. An
acceptable analytical method exists to determine the viability of
spores on the foliar surface. Troy Biosciences also has developed a
method to enumerate viable spores per unit volume. Additionally, Troy
Biosciences has developed methods and provided data required by EPA on
screens for bacterial contaminants, including human pathogens, and on
beauvericin and aflatoxins, potential metabolites of concern for the
active ingredient. Further, the inert ingredients used in the
formulated product are food grade or meet all other applicable FDA
standards. Finally, all lots of the active ingredient and the
formulated product are monitored as part of Troy Biosciences' rigorous
quality control program.
C. Mammalian Toxicological Profile
Acute toxicity. The acute oral toxicity/pathogenicity of the
technical grade active ingredient (TGAI) in the rat was determined
following a single exposure to 108 colony forming units
(CFU). The organism was not infectious to the rat and total clearance
from the animal was projected to occur in 23 days. In a single 24 hour
dermal exposure of two grams of the technical powder, erythema and
edema were observed in 30% of the animals. These symptoms cleared in 1-
7 days and indicated that the material was a moderate dermal irritant.
These results were classified as Toxicity Category IV. A bovine corneal
opacity and permeability assay was conducted to project the potential
irritancy of the technical powder. The results indicated that the
technical powder might be a slight irritant. The results of a primary
eye irritation study confirmed that the technical powder was a slight
irritant to the eye (Toxicity Category III). A study was conducted in
the rat in which the animals were exposed by intraperitoneal injection
to 107 CFU of the material (MRID 43294201). The animals were
unaffected by the test material during the 29 day observation period.
In a rat intratracheal toxicity study, rats were exposed to
107 CFU per animal. There were small tan nodules in the
lungs of the test animals following exposure. These lesions reversed as
the study progressed and the author opined that they would be totally
reversible if more time were allowed. Total clearance of Beauveria
bassiana occurred within 15 days. There were no effects on survival and
the test material was not found in any tissue outside the lungs. The
organism was not considered toxic or pathogenic in this test animal.
D. Aggregate Exposure
1. Dietary exposure-- Food. Troy Biosciences has requested an
exemption from the requirement for a tolerance, based on the well-
documented instability of the conidia of Beauveria bassiana outside its
natural environment, the soil. Residues should not be present because
Troy Biosciences has requested a waiver of the requirement for a
tolerance, based on the well-documented instability of the conidia of
Beauveria bassiana outside its natural environment, the soil. Residues
should not be present because spores are not viable 96 hours following
2. Drinking water. Use of Naturalis L in agriculture could result
in the entry of the active ingredient into surface waters via drift
from the agricultural application or run-off from treated
foliage during rainfall events. It is unlikely that the organism,
because of its short half-life, would survive more than 1-2 days in
this environment and would be unlikely to contaminate drinking water.
Further, the organism is not a known human pathogen.
3. Non-dietary exposure. The only non-dietary exposures are
expected to be to applicators and other pesticide handlers working with
the product, including those workers involved at the manufacturing
facility. Use of the product according to the directions for use on the
label is not expected to result in any risk of adverse health effects.
Exposure to the active ingredient in the manufacturing process is
minimized by engineering controls. There may also be limited dermal
exposure as a result of the turf use of the product (homes, schools,
other public areas). Adults and children could contact treated foliage;
however, these residues are not pathogenic in humans and the residues
degrade rapidly over time after application.
E. Cumulative Exposure
Beauveria bassiana is a naturally occuring, soil-borne
microorganism which is found throughout the World. Over 400 different
strains have been identified, with concentrations varying from region
to region depending on soil type and climatic conditions. Factors such
as sunlight, temperature and humidity affect the persistence of this
organism in the environment. Data from the past experimental use
program indicate residues of this organism are not present on treated
crops 96 hours after application.
Optimum growth for Beauveria bassiana occurs between 28-32 deg.C,
with no growth occurring at temperatures above 35 deg.C. From a
biological viewpoint the human body does not have the specific surface
factors nor proper temperature to stimulate spore germination and
infection hindering the organism's ability to cause systemic disease.
This is corroborated by additional biological data from animal testing
via oral, intraperitoneal, intratracheal, and dermal exposure. These
studies indicate both a lack of systemic toxicity and non-
pathogenicity. In addition, clearance of the test animals occurs within
a relatively short time (<21 days).
Beauveria bassiana is effective by infecting target insects. In
this respect, it shares a common mode of action with many other
registered biological pesticides, including another strain of Beauveria
bassiana. The lack of infectivity in humans and other non-insect
species, combined with low toxicity indicates that there is likely to
be no appreciable cumulative effect from application of several
pesticides with this mode of action. Moreover, because both products
have similar target pests (whiteflies, aphids and thrips) and the
product labels state that 7 to 9 days at a minimum are needed to
observe control, it is unlikely that both products would be used within
the 96-hour effective period on the foliage. Consequently, there would
be no accumulation of residues.
F. Safety Determination
1. U.S. population. Beauveria bassiana is a ubiquitous soil
microorganism which is susceptible to sunlight, temperature and
humidity. Data generated during the experimental use program (1992-
1994) indicate that, once applied to raw agricultural commodities,
Beauveria bassiana does not persist. Exposure to the general public
from treated foods will be negligible. Biological data previously cited
indicate the organism does not persist in the mammalian body, is not
pathogenic and clearance from the body occurs within 21 days.
Troy Biosciences' Beauveria bassiana and its formulated product,
Naturalis L, are carefully monitored under a rigorous quality control
program. The active ingredient is screened for bacterial contaminants,
including human pathogens, and for the presence of beauvericin and
aflatoxins, metabolites of potential concern. Raw materials used for
the formulated product also are subject to quality control screens and
meet all applicable EPA and FDA quality standards. To further assure
the safety of the formulated product, each batch is monitored and must
meet rigorous quality control standards.
2. Infants and children. Based upon the lack of persistence,
favorable biological data and quality control procedures no adverse
effects would be expected for infants and children. Residues of
Beauveria bassiana would not be present on commodities used for the
production of foods or formulae for infants and children.
G. Effects on the Immune and Endocrine Systems
Beauveria bassiana ATCC # 74040 (TBI#1) is a naturally-occurring,
living, fungal organism that is not pathogenic to humans. It is
unlikely that exposure to this organism would result in an effect on
the human endocrine or immune systems. There are no reports of any
estrogenic or other adverse effects to human population as a result of
the use of Beauveria bassiana in the field. Based on this information,
combined with its low mammalian toxicity, it is concluded that there is
a reasonable certainty that no adverse endocrine effects nor immune
system effects will result from the use of Beauveria bassiana as an
H. Existing Tolerances
No maximum residue level has been established for this organism by
the Codex Alimentarius Commission.
[FR Doc. 98-15325 Filed 6-9-98; 8:45 am]
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