bacillus subtilis Pesticide Petition Filing 4/99
[Federal Register: April 26, 1999 (Volume 64, Number 79)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing of Pesticide Petition
AGENCY: Environmental Protection Agency (EPA).
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.
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: firstname.lastname@example.org.
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:
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
Dated: April 12, 1999,
Janet L. Andersen,
Director, Biopesticide and Pollution Prevention Division, Office of
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.
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
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
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
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/
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
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