[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Notices]
[Pages 31771-31773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15325]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-812; FRL-5793-4]


Notice of Filing of a Pesticide Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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-
[email protected]. Follow 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: 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 protected].

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:
    [email protected]


    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 
Depository Libraries.

[[Page 31772]]

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: May 29, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

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.

PP 5F4483

    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 
equipment.

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 
applications.
    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 
application.
    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

[[Page 31773]]

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 
insecticide.

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]
BILLING CODE 6560-50-F