[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Notices]
[Pages 25092-25095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10102]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0105; FRL-7354-4]


Bacillus pumilus Strain QST 2808; Notice of Filing a Pesticide 
Petition to Establish a Tolerance for a Certain Pesticide Chemical in 
or on Food

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 docket ID number OPP-2004-0105, must be 
received on or before June 4, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8077; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer.
     Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturer (NAICS 311)
     Pesticide manufacturer (NAICS 32532)
     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0105. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although, not all docket materials may be 
available electronically, you may still access any of the publicly 
available

[[Page 25093]]

docket materials through the docket facility identified in Unit I.B.1. 
Once in the system, select ``search,'' then key in the appropriate 
docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0105. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0105. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0105.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2004-0105. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior

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notice. If you have any questions about CBI or the procedures for 
claiming CBI, please consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a 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 FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: April 27, 2004.
Phil Hutton,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summary of Petition

     The petitioner's summary of the pesticide petition is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petition was prepared by AgraQuest, Inc. and represents the view of the 
petitioner. 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 4F6826

    EPA has received a pesticide petition (PP 4F6826) from AgraQuest, 
Inc., 1530 Drew Ave., Davis, CA 95616, proposing pursuant to section 
408(d) of FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing a tolerance for residues of SonataTM ASO, which 
contains the QST 2808 strain of Bacillus pumilus, to control various 
plant diseases such as downy mildew, powdery mildew, Phytophthera, 
Sclerotinia, Cercospora, and/or rust on the following vegetable crop 
groups: Brassica, bulb, cucurbits, fruiting, leafy, legume, and root 
and tuber; on the following fruit crop groups: pome and stone; on the 
grain, cereal, group; and the following individual crops: grape, 
grasses grown for seed, hop, mint, peanuts, strawberry, sweet corn, 
tobacco, field grown roses, and certain trees. The product is applied 
as a foliar spray alone, in alternating spray programs, or in tank 
mixes with other registered crop protection products, up to and 
including the day of harvest. SonataTM ASO may be applied 
with spray equipment commonly used for making ground or aerial 
applications. Thorough coverage is essential for optimum disease 
control.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
SonataTM ASO contains the QST 2808 strain of Bacillus 
pumilus as the active ingredient. Bacillus pumilus strain QST 2808 is a 
ubiquitous, naturally occurring, non-pathogenic microorganism. It is 
commonly recovered from water, soil, air, and decomposing plant 
residue. Bacillus pumilus produces proteases and other enzymes that 
enable it to degrade a variety of natural substrates and contribute to 
nutrient recycling. Bacillus pumilus prevents spore germination by 
formation of a physical barrier and subsequently colonizes fungal 
spores. QST 2808 Technical is used to formulate SonataTM 
ASO. SonataTM ASO is applied at a rate of 0.5 to 2 gallons 
per acre, except for the treatment of sudden oak death syndrome where 
the rate range is 1 to 5 gallons per acre.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. AgraQuest, Inc. is submitting a petition 
requesting that EPA establish an exemption from the requirement of a 
tolerance for the QST strain of Bacillus pumilus, therefore, this 
section is not applicable.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. 
AgraQuest, Inc. is submitting a petition requesting that EPA establish 
an exemption from the requirement of a tolerance for the QST strain of 
Bacillus pumilus, therefore, an analytical method for residues is not 
applicable.

C. Mammalian Toxicological Profile

     The active ingredient Bacillus pumilus strain QST 2808 has been 
evaluated for toxicity through oral, dermal, pulmonary, intravenous and 
eye routes of exposure. The results of the studies have indicated there 
are no significant human health risks. The acute oral toxicity/
pathogenicity LD50 in rats was greater than 4.1 x 
109colony forming units/grams (cfu/g). The acute dermal 
lethal dose (LD)50 in rats was greater than 2,000 
milligrams/kilogram (mg/kg) (Toxicity Category III). The acute 
pulmonary toxicity/pathogenicity LD50 in rats was greater 
than 1.6 x 108 cfu per animal. The acute intravenous 
toxicity/pathogenicity LD50 in rats was greater than 1.6 x 
108 cfu per animal. No pathogenic or infective effects were 
observed in the studies.
     Slight eye irritation in rabbits was observed at a dose of 0.1 
milliliter (mL) (Toxicity Category IV) and minimal skin irritation in 
rabbits was observed at a dose of 0.5 mL (Toxicity Category IV). The 
dermal sensitization study with QST 2808 Technical in Guinea pigs 
showed that it is not a sensitizer. Since its discovery, no incidents 
of hypersensitivity have been reported by researchers, manufacturers or 
users of Bacillus pumilus strain QST 2808.
     Acute toxicology studies for the end-use product, 
SonataTM AS, showed a toxicity profile similar to that of 
the technical material. The acute oral toxicity LD50 in rats 
was greater than 5,000 mg/kg (Toxicity Category IV). The acute dermal 
toxicity LD50 in rats was greater than 5,000 mg/kg (Toxicity 
Category IV). The acute inhalation toxicity LD50 in rats was 
greater than 1.06 milligrams/per liter (mg/L) (Toxicity Category III). 
In the acute eye irritation study with rabbits, SonataTM AS 
was classified as a nonirritant by both the EPA and EU classification 
systems (Toxicity Category IV) at a dose of 0.1 mL. In the acute dermal 
irritation study with rabbits, SonataTM AS was

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classified as a mild or slight irritant by the EPA classification 
system (Toxicity Category IV) and as a nonirritant by the EU 
classification system at a dose of 0.5 mL. The dermal sensitization 
study in Guinea pigs showed that it is not a sensitizer. No incidents 
of hypersensitivity have been reported by researchers, manufacturers, 
or users of SonataTM AS or Sonata ASO. The intentionally 
added inert ingredients together comprise less than 3% of the 
SonataTM AS or Sonata ASO formulations. Their individual 
amounts range from 0.1% to 0.9%. Obviously, any specific toxicological 
property of any or all of these inert ingredients had no effect upon 
the overall toxicity of SonataTM AS compared with that of 
the QST 2808 Technical. Sonata ASO is simply an all-organic formulation 
version of SonataTM AS. The inert ingredients in Sonata ASO 
are all from EPA's list 4 and thus are considered even more benign than 
those in Sonata AS. Therefore, the registration data requirements for 
Sonata ASO will be fulfilled by bridging to the toxicity study results 
for SonataTM AS, per the Data Matrix submitted with the 
registration application for Sonata ASO. Copies of the Material Safety 
Data Sheets for the added inert ingredients for SonataTM AS 
were provided in MRID No. 45257201, and for Sonata ASO in MRID No. 
46029501.

D. Aggregate Exposure

     Sonata ASO is proposed for use to control various plant diseases 
on agricultural crops.
    1. Dietary exposure. Dietary exposure is not expected from the use 
of this microbial pesticide as proposed. The lack of acute oral 
toxicity/pathogenicity and the ubiquitous nature of the organism 
support the exemption from the requirement of a tolerance for this 
active ingredient.
    i. Food. Dietary exposure from use of Bacillus pumilus strain QST 
2808, as proposed, is minimal. Residues of Bacillus pumilus strain QST 
2808 are not expected on agricultural commodities. In a study conducted 
to determine the longevity of Bacillus pumilus residues on pepper leaf 
surfaces under field conditions, the results showed that the number of 
colony forming units of Bacillus pumilus decreased significantly over 
time in the first 5 days. In addition, the microbial pesticide can be 
removed from food by peeling, washing, cooking, and processing.
    ii. Drinking water. Exposure to humans from residues of Bacillus 
pumilus strain QST 2808 in consumed drinking water would be unlikely. 
Bacillus pumilus strain QST 2808 is a naturally occurring microorganism 
known to exist in terrestrial habitats. Although, it may be found in 
water, it is not known to 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 sites are agricultural settings. In addition, 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 products, when used in agricultural settings.

E. Cumulative Exposure

     There is no indication of mammalian toxicity of Bacillus pumilus 
and no information to indicate that toxic effects would be cumulative. 
Therefore, consideration of a common mode of action is not appropriate. 
In addition, it is not expected that, when used as proposed, Sonata ASO 
would result in residues that would remain in human food items.

F. Safety Determination

    1. U.S. population. Bacillus pumilus strain QST 2808 is not 
pathogenic or infective to mammals. There have been no reports of 
toxins associated with the organism, and acute toxicity/pathogenicity 
studies have shown that Bacillus pumilus strain QST 2808 is non-toxic, 
non-pathogenic, and non-irritating. Residues of Bacillus pumilus strain 
QST 2808 are not expected on agricultural commodities, and therefore, 
exposure to the general U.S. population, from the proposed uses, is not 
anticipated.
    2. Infants and children. As mentioned above, residues of Bacillus 
pumilus strain QST 2808 are not expected on agricultural commodities. 
There is a reasonable certainty of no harm for infants and children 
from exposure to Bacillus pumilus strain QST 2808 from the proposed 
uses.

G. Effects on the Immune and Endocrine Systems

     Bacillus pumilus strain QST 2808 is a naturally occurring, non-
pathogenic microorganism. There is no evidence to suggest that Bacillus 
pumilus strain QST 2808 functions in a manner similar to any known 
hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

     On June 18, 2003, EPA granted a temporary exemption from the 
requirement of a tolerance for Bacillus pumilus strain QST 2808 in or 
on all agricultural commodities in conjunction with the issuance of an 
Experimental Use Permit for SonataTM AS (EPA Reg. No. 69592-
EUP-1). This exemption will expire June 30, 2006.

I. International Tolerances

     There is no Codex alimentarius commission maximum residue level 
for Bacillus pumilus strain QST 2808.
[FR Doc. 04-10102 Filed 5-4-04; 8:45 am]
BILLING CODE 6560-50-S