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bacillus subtilis Pesticide Petition Filing 4/99

 

[Federal Register: April 26, 1999 (Volume 64, Number 79)]
[Notices]               
[Page 20295-20297]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap99-89]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-871; FRL-6074-8]

 
Notice of Filing of Pesticide Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing 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-871, must 
be received on or before May 26, 1999.

ADDRESSES: By mail submit written comments to: Information and Records 
Integrity Branch, Public Information and Services Divison (7502C), 
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.

[[Page 20296]]

    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: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 912, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-
8077; e-mail: cerrelli.susanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows proposing the establishment and/or amendment of regulations for 
residues of 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 of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-871] (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-871) and appropriate 
petition number. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries.

List of Subjects

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

    Dated: April 12, 1999,

Janet L. Andersen,

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

Summary of Petition

    The 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 petitioner and represents the views of the 
petitioner. 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.

 AgraQuest,Inc.

PP 8F5032

    EPA has received a pesticide petition 8F5032 from AgraQuest, Inc., 
1105 Kennedy Place, Davis, California 95616, 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 for the microbial pesticide Bacillus 
subtilis QST 713 strain in or on all raw agricultural commodities 
(RAC).
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
AgraQuest, Inc. has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by AgraQuest, Inc. 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.

A. Product Name and Proposed Use Practices

    Serenade<SUP>TM</SUP> WP is being submitted for use as a 
biofungicide on the following crop groupings:
    Curcurbits; Grapes; Hops; Leafy Vegetables (except Brassica); 
Mushrooms; Peanuts; Peppers; Pome Fruits; Potatoes; Stone Fruits; 
Strawberries; Tomatoes; Tree Nuts (almonds and pistachios)

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Serenade<SUP>TM</SUP> contains the QST 713 strain of dried Bacillus 
subtilis as the active ingredient. QST 713 Technical is used to 
formulate Serenade<SUP>TM</SUP> WP.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Since Bacillus subtilis is a ubiquitous 
organism, it is commonly recovered from soil, water and decomposing 
plant residue. It is found at population levels of 10<SUP>+6</SUP> to 
10<SUP>+7</SUP> per gram of # soil (EPA Risk Assessment of Bacillus 
subtilis, February, 1997).
    3.  A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. As 
formulated in Serenade<SUP>TM</SUP> WP, Bacillus subtilis will be 
delivered at 1.0 x 10<SUP>+6</SUP> per gram of Serenade<SUP>TM</SUP> 
WP. Therefore, analysis for the organism from use of 
Serenade<SUP>TM</SUP> WP would not be specific and is therefore, not 
necessary.

C. Mammalian Toxicological Profile

    1. Acute toxicity--i. Serenade<SUP>TM</SUP> WP has been evaluated 
in an Acute Oral study in male and female Sprague-Dawley Crl:CD (SD)BR 
rats. No treatment related effects in body weight (bwt) or body weight 
gain was noted. No clinical signs were noted during the study. Necropsy 
findings were normal for all male and female rats. The results of this 
study indicated that the estimated acute oral LD<INF>50</INF> was 
greater than 5,000 milligram kilogram (mg/kg).
    ii. Serenade<SUP>TM</SUP> WP was evaluated as a single dermal dose 
of 2,000 mg/kg in an acute dermal study in male and female New Zealand 
White rabbits. There was

[[Page 20297]]

no mortality observed during the study. Erythema, edema, necrosis, 
fissuring and/or sloughing of the skin at the application site was 
noted in all animals. All treated animals exhibited increases in bwt. 
There were no visible lesions noted in any animal at terminal necropsy. 
The dermal LD<INF>50</INF> was estimated to be greater than 2,000 mg/
kg.
    iii. Serenade<SUP>TM</SUP> WP was evaluated in a 4-hour, whole 
body, acute inhalation study in male and female Sprague-Dawley rats. 
The maximum concentration (MC) which could be aerosolized was 0.63 
milligrams per liter (mg/L), which gave a median aerodynamic particle 
size of less than 0.4 . No mortality was noted during the study. Some 
of the clinical abnormalities noted in one or more animals were 
transient incidences of salvation, breathing abnormalities, decreased 
activity, wobbly gait, apparent hypothermia, hunched posture, decreased 
defecation, urine stain, decreased food consumption, and dark material 
around the facial area. Bwt loss was noted for three female rats (one 
during the 0-7 day interval, and two during the 7-14 day interval). 
However, this was a slight bwt loss and was not considered to be 
biologically significant. No significant gross findings were observed 
at necropsy. The acute inhalation LC<INF>50</INF> was estimated to be 
greater than 0.63 mg/L.
    iv. Administration of Serenade<SUP>TM</SUP> WP to the eye of New 
Zealand white rabbits, in a Primary Eye Irritation study, resulted in 
irritation of the conjunctivae (redness, chemosis, and/or discharge) in 
all treated animals within 1-hour post-dose. All scores returned to 
normal by 72 hours post-dose. Therefore, Serenade<SUP>TM</SUP> WP is 
considered to be a mild irritant.
    v. In a Primary Dermal Irritation study using New Zealand White 
rabbits, Serenade<SUP>TM</SUP> WP, after a 4-hour exposure, resulted in 
very slight edema and/or very slight erythema. No other dermal signs 
were observed. Therefore, Serenade<SUP>TM</SUP> WP is considered to be 
a very slight irritant after 4-hours of exposure.
    vi. Serenade<SUP>TM</SUP> WP was evaluated in a standard 
Hypersensitivity study (Buehler) in Guinea Pigs, using 
Serenade<SUP>TM</SUP> WP as received (without any dilution). There were 
no signs of systemic toxicity in any dose group, and all animals gained 
weight during the study. Under the conditions of this study, 
Serenade<SUP>TM</SUP> WP elicited a delayed mild contact 
hypersensitivity response in guinea pigs when challenged and 
rechallenged at 100%.
    vii. The active ingredient in Serenade<SUP>TM</SUP> WP, Bacillus 
subtilis, QST 713 strain, has been evaluated in several pathogenicity 
studies (acute oral, intravenous, and intratracheal). In the acute oral 
pathogenicity study there were no deaths noted during the study and 
necropsy findings were normal for all rats. There was no evidence of 
pathogenicity or toxicity related to treatment. In the intravenous 
study in rats, no deaths occurred during the study. There were no 
treatment related effects noted. The organism was found to 
significantly clear the body within 35 days. No evidence of toxicity or 
pathogenicity related to treatment was noted during the course of the 
study. In the intratracheal study in rats, there was no evidence of 
toxicity or pathogenicity related to treatment noted during the course 
of the study.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Due to the ubiquitous nature of the 
organism, the concentrations of the organism that already exists in the 
environment, and the fact that food is already in contact with the 
organism, the likelihood of increased risk to humans or animals from 
the use of Serenade<SUP>TM</SUP> WP is low.
    ii. Drinking water. Similarly, exposure to humans from residues of 
Serenade<SUP>TM</SUP> WP in consuming drinking water would be low. The 
organism is already present in this medium.
    2. Non-dietary exposure. Exposure to Bacillus subtilis in the 
manufacturing plant (fermentation facility) will be minimal due to 
rigorous GMP's and quality controls put in place to minimize 
contamination, cross contamination, and exposure to the workers, and 
also due to protective equipment worn by manufacturing plant workers. 
Therefore, inadvertent releases in the workplace would not be expected 
to increase the risk, especially since high levels of the organism 
already exist in this environment.
    The EPA Risk Assessment of Bacillus subtilis (February, 1997) 
concludes that ``human health and environmental hazards of Bacillus 
subtilis are low'' and ``the number of microorganisms released from the 
fermentation facility is low''.

E. Cumulative Exposure

    Exposure to Bacillus subtilis in the manufacturing plant 
(fermentation facility) will be minimal due to rigorous GMP's and 
quality controls put in place to minimize contamination, cross 
contamination, and exposure to the workers, and also due to protective 
equipment worn by manufacturing plant workers. Therefore, inadvertent 
releases in the workplace would not be expected to increase the risk, 
especially since high levels of the organism already exist in this 
environment. The EPA Risk Assessment of Bacillus subtilis (February, 
1997) concludes that ``human health and environmental hazards of 
Bacillus subtilis are low'' and ``the number of microorganisms released 
from the fermentation facility is low''.

F. Safety Determination

    1. United States population. Bacillus subtilis is not pathogenic 
and pathogenicity data indicate that the organism clears the body 
significantly within 35 days. Therefore, there would be no increased 
risk to humans from the expected use of Serenade<SUP>TM</SUP> WP.
    Serenade<SUP>TM</SUP> WP is produced under strict quality controls. 
The active ingredient is routinely screened for contaminants, including 
human pathogens. Fermentation raw materials are sterilized before use 
to eliminate potential contaminants. Antimicrobial agents are included 
in the formulation to reduce/eliminate any potential contaminants.
    2. Infants and children. Since Bacillus subtilis is ubiquitous, not 
pathogenic, causes no human disease, and is considered to be of low 
risk by the United States EPA, it is unlikely that any harmful effects 
on children or infants would be expected.

G. Effects on the Immune and Endocrine Systems

    Bacillus subtilis is a naturally occurring, non-pathogenic organism 
which has fungicidal properties. There is no indication that this 
organism has ever or will ever produce any adverse effect on the human 
immune or endocrine system. It can be concluded that based upon the 
existing toxicology, which indicates minimal effects, that there would 
be no adverse effects on the immune or endocrine systems from the use 
of Serenade<SUP>TM</SUP>.

H. Existing Tolerances

    Bacillus subtilis GB03 and MBI600 are exempted from the 
requirements of a tolerance in or on all agricultural commodities when 
applied as a seed treatment on seeds used for growing crops in 
accordance with good agricultural practices.
[FR Doc. 99-10391 Filed 4-23-99; 8:45 am]
BILLING CODE 6560-50-F