[Federal Register Volume 67, Number 204 (Tuesday, October 22, 2002)]
[Notices]
[Pages 64881-64885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26844]



[[Page 64881]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0263; FRL-7275-7]


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 
Bacillus subtilis var. amyloliquefaciens strain FZB24 in or on various 
food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0263, must be 
received on or before November 21, 2002.

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: Robyn Rose, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9581; 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:
     Industry (NACIS 111, 112, 311, 32532), e.g., crop production, 
animal production, food manufacturing, pesticide manufacturing.
     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-2002-0263. 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 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 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. 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 in 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

[[Page 64882]]

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.
    2. EPA Dockets--i. 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-2002-0263. 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-2002-0263. 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), Office of Pesticide Programs (OPP), 
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2002-0263.
    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-2002-0263. 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 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:October 7, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

 PP 2F06453

     The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by Taensa, 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.
     EPA has received a pesticide petition 2F06453 from Taensa, Inc., 
26 Sherman Ct, P.O. Box 764, Fairfield, CT 06430, 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 var. amyloliquefaciens strain FZB24. Pursuant to section 
408(d)(2)(A)(i) of the FFDCA, as amended, Taensa, Inc. has submitted 
the following summary of information, data, and arguments in support of 
their pesticide petition. This summary was prepared by Taensa, Inc. EPA 
has not fully evaluated the merits of the

[[Page 64883]]

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

     TAEGRO\TM\ is currently registered with EPA for use on ornamentals 
in greenhouses and indoors (EPA Registration Number 72098-5). 
TAEGRO\TM\ Technical (EPA Registration Number 72098-6) is also 
registered with EPA. Registration of TAEGRO\TM\ is being proposed for 
the following sites (including those previously registered): Herbs and 
spices; ornamentals; shrubs, shade and forest trees; tree, vine, bush 
and other crops; turf; and vegetables.
    Methods of application of TAEGRO\TM\ will include seed treatment, 
incorporation into growth substrate as a dry powder or as an aqueous 
suspension, drenching, spraying, dipping (roots or cuttings), spraying, 
chemigation, and hydroponic use. As a plant strengthening agent, 
TAEGRO\TM\ increases yield of many crops, improves flowering and plant 
quality, stimulates resistance of plants to disease, plant disease 
suppressant and can be used with fungicides. Directions for use of 
TAEGRO\TM\ are as follows:
     Apply TAEGRO\TM\ as early as possible in the life cycle of the 
plant to enhance growth and disease resistance. TAEGRO\TM\ should be 
applied to plants every few weeks for up to three to four applications 
as needed. For best results, apply TAEGRO\TM\ to seedlings or to newly 
rooted cuttings.
    1. Transplants, including plugs. TAEGRO\TM\ may be applied to 
transplants by dipping or by drenching, making sure the root system is 
thoroughly soaked. For dipping, follow the instructions for ``Cutting 
and Root Dips'' before planting transplants into soil medium. For 
drenching, first plant the transplants into soil medium and then follow 
instructions for ``Drenching.''
    2. Drenching. Apply TAEGRO\TM\ to seedlings or to newly rooted 
cuttings. Drench plants with the TAEGRO\TM\ suspension making sure the 
root system is thoroughly soaked. Allowing TAEGRO\TM\ to work into the 
root zone.
     Apply TAEGRO\TM\ as follows:
    [sbull] Per 100 gallons of water - by weight use 75 grams or 2.6 
ounces; by volume use 3.5 fluid ounces of TAEGRO\TM\.
    [sbull] Per 1 gallon of water 5 grams - by weight use 0.75 gram; by 
volume use 0.2 teaspoon of TAEGRO\TM\.
    3. Cutting and root dips. Stir suspension for several minutes to 
ensure complete mixture and to eliminate clumps. Place rootstock in the 
suspension for 5 to 10 minutes allowing time for TAEGRO\TM\ to 
penetrate the root zone. Ornamentals should receive at least one 
follow-up drench treatment 2 to 3 weeks following initial treatment.
    Apply TAEGRO\TM\ as follows:
    [sbull] Per 10 gallons of water - by weight, use 40 grams; by 
volume, 1.8 fluid ounces of TAEGRO\TM\.
    [sbull] Per 1 gallon of water - by weight, use 4 grams; by volume, 
use 1 teaspoon of TAEGRO\TM\.
    [sbull] Per 1 Liter of water - by weight, use 1 gram of TAEGRO\TM\.
    4. Turf. As an overhead spray, mix 75 grams of TAEGRO\TM\ in 100 
gallons of water. Before applying, stir product for several minutes to 
ensure complete suspension. Apply solution with a conventional sprayer 
using at least 50 gallons of water per acre. Water-in TAEGRO\TM\ 
immediately after application with a minimum of 1/10 inch of water. For 
best results, make two or three applications spaced 1 week apart.
    5. Row crops. Mix 75 grams of TAEGRO\TM\ in 100 gallons of water. 
Before applying, stir product for several minutes to ensure complete 
suspension. At time of (or just following) planting, apply as a spray 
over furrow. Water-in TAEGRO\TM\ immediately after application with a 
minimum of 1/10 inch of water. For best results, make two or three 
applications spaced 1 week apart.
    6. Hydroponics. Prepare a stock solution by adding 1 gram of 
TAEGRO\TM\, for every 50 feet of irrigation tubing, in 1 gallon of 
water. Stir product for several minutes to ensure complete suspension. 
Add solution to circulating water system and allow to go through three 
to five watering cycles before clearing the system. For best results, 
make two or three applications spaced 1 week apart.
    7. Seed treatments. Prior to planting, mix 4 grams of TAEGRO\TM\ in 
1 liter of water (or 3 teaspoons per gallon of water). Stir solution 
for several minutes to ensure complete suspension. Pour seeds into 
solution and allow to soak for 10 to 30 minutes. For very small seeds, 
soaking seedlings in plug trays after germination might be easier.
    8. Tubers, bulbs and corms. Mix 4 grams of TAEGRO\TM\ in 1 liter of 
water (or 3 teaspoons per gallon of water). Stir solution for several 
minutes to ensure complete suspension. Dip tubers (or bulbs, etc.) for 
10 to 30 minutes before planting. For best results, make two or three 
applications spaced 1 week apart.
    9. Soil incorporation. Mix TAEGRO\TM\ into soil or soilless growing 
media at a rate of 250 grams per cubic yard. Thoroughly mix media, 
using mechanical mixing equipment, to ensure a uniform distribution of 
product. Incorporated into soil, TAEGRO\TM\ can be raked into growing 
beds prior to planting.
    10. Mushrooms. Mix TAEGRO\TM\ into spawn medium at a rate of 10 
grams per cubic foot. Thoroughly mix, using mechanical mixing 
equipment, to ensure a uniform distribution of product.
    11. Interiorscapes. Before application, thoroughly moisten root 
zone with water. Mix 1 gram of TAEGRO\TM\ per 1 liter of water (or 3/4 
teaspoon per gallon of water). Stir solution for several minutes to 
ensure complete suspension. Drench solution onto root zone to ensure 
coverage to all roots. TAEGRO\TM\ performs best when applied to 
seedlings or young plants. For best results, make two or three 
applications spaced 1 week apart.
    12. Orchids and ferns. For potted orchids and ferns, follow 
directions for drenching. For orchids and ferns with exposed roots, 
prepare 4 grams of TAEGRO\TM\ in 1 liter of water (or 3 teaspoons per 
gallon of water). Pour solution into spray container (or squirt bottle) 
and spray roots to point of drip. TAEGRO\TM\ performs best when applied 
to seedlings or young plants. For best results, make two or three 
applications spaced 1 week apart.

B. Product Identity/Chemistry

    1. Identity of pesticide and corresponding residues. The active 
ingredient in TAEGRO\TM\ is Bacillus subtilis var. amyloliquefaciens 
strain FZB24. The mechanism by which Bacillus subtilis var. 
amyloliquefaciens strain FZB24 acts as a plant strengthening agent, 
increases yield of many crops, improves flowering and plant quality, 
stimulates resistance of plants to disease, plant disease suppressant 
appears to be primarily via secondary exudates. Suppression of plant 
disease by Bacillus subtilis var. amyloliquefaciens strain FZB24 may 
also be competitive. Bacillus subtilis var. amyloliquefaciens strain 
FZB24 is not known to produce toxins or antibiotics. Further, Bacillus 
subtilis var. amyloliquefaciens strain FZB24 is a naturally occurring 
microorganism. Bacillus subtilis var. amyloliquefaciens is widespread 
in the environment and occurs in most arable soils of the world.

[[Page 64884]]

    2. Magnitude of residue anticipated at the time of harvest and 
method used to determine the residue. No residues of Bacillus subtilis 
var. amyloliquefaciens strain FZB24 are anticipated in treated crops at 
harvest. Subdivision M - Series 153A-3(a) indicates that ``if Tier I 
toxicology tests indicate no toxic or other harmful properties, then no 
residue data would be indicated.'' Studies with Bacillus subtilis var. 
amyloliquefaciens strain FZB24 demonstrated low mammalian toxicity. No 
pathogenicity or infectivity was observed in any of the tests conducted 
with Bacillus subtilis var. amyloliquefaciens strain FZB24. Further, 
Bacillus subtilis var. amyloliquefaciens strain FZB24 is a naturally 
occurring microorganism. Bacillus subtilis var. amyloliquefaciens is 
widespread in the environment.
    3. Statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. 
Subdivision M - Series 153A-3(a) indicates that `` if Tier I toxicology 
tests indicate no toxic or other harmful properties, then no residue 
data would be indicated and thus a recommendation for an exemption from 
the requirement of a tolerance can be made.'' Studies with Bacillus 
subtilis var. amyloliquefaciens strain FZB24 demonstrated low mammalian 
toxicity. No pathogenicity or infectivity was observed in any of the 
tests conducted with Bacillus subtilis var. amyloliquefaciens strain 
FZB24. Further, Bacillus subtilis var. amyloliquefaciens strain FZB24 
is a naturally occurring microorganism. Bacillus subtilis var. 
amyloliquefaciens is widespread in the environment.

C. Mammalian Toxicological Profile

     Taensa, Inc. conducted the required toxicology studies to support 
its petition for an exemption from the requirement of tolerance and 
associated registrations of Bacillus subtilis var. amyloliquefaciens 
strain FZB24. The studies conducted indicate a low mammalian toxicity 
for Bacillus subtilis var. amyloliquefaciens strain FZB24. No 
pathogenicity or infectivity was observed in any of the tests conducted 
with Bacillus subtilis var. amyloliquefaciens strain FZB24. With the 
exception of an inhalation study for the end-use product (TAEGRO\TM\), 
which is being submitted in support of this application, all toxicology 
data generated by Taensa have been reviewed by EPA's Biopesticides and 
Pollution Prevention Division (BPPD).
     Toxicology data in support of the exemption from the requirement 
of a tolerance for Bacillus subtilis var. amyloliquefaciens strain 
FZB24 included studies with spores (technical) and with the formulated 
product (water dispersible powder) as follows:
    1. Acute toxicity and/or pathogenicity--a. Bacillus subtilis var. 
amyloliquefaciens strain FZB24 Spores (Technical):
    [sbull] Acute oral toxicity/pathogenicity in rats - ``does not 
appear to be toxic and/or pathogenic when dosed at 1.3 x 108 
cfu.'' BPPD Review December 20, 1999.
    [sbull] Acute dermal toxicity/pathogenicity in rabbits - ``The 
severity of irritation persisted 72 h, and slight irritation persisted 
for 10 d, and all resolved by day 11. No deaths observed. The acute 
lethal dose (LD50) is greater than 2,000 mg/kg. . .Dermal 
irritation = Toxicity II; Dermal Toxicity = Toxicity III.'' BPPD Review 
December 20, 1999.
    [sbull] Acute pulmonary toxicity/pathogenicity in rats - ``does not 
appear to be toxic and/or pathogenic in rats, when dosed at 1.3 x 
108 cfu/animal. No total clearance is seen form the lungs of 
treated test animals showed a distinct pattern of clearance from 
kidney, liver, and spleen.'' BPPD Review December 20, 1999.
    [sbull] Acute intravenous toxicity/pathogenicity in rats - ``does 
not appear to be toxic and/or pathogenic in rats, when dosed at 1.7 x 
108 cfu/animal.'' BPPD Review December 20, 1999.
    [sbull] Primary eye irritation - ``showed no signs of persistent 
irritation into day 21, when dosed at 4.7 x 1010 cfu/right 
eye/animal.'' BPPD Review December 20, 1999 - The initial review 
indicated Toxicity Category I, but was amended to Toxicity Category II 
(BPPD Review March 7, 2000).
    [sbull] Hypersensitivity testing - ``Based on the submitted data 
does not appear to be a sensitizer when dosed at 3.6 x 1010 
cfu.'' BPPD Review December 20, 1999.
    [sbull] Hypersensitivity incident reporting - ``No recorded or 
reported hypersensitivity reaction based on handling MCPA in lab 
control setting, equating to 55 person years.'' BPPD Review December 
20, 1999.
    [sbull] Potential health effects - ``Based on information given, 
there are no apparent negative effects - cited literature on B. 
Subtilis indicate and/or support the development as a biological 
control.'' BPPD Review December 20, 1999.
    [sbull] Growth parameters - ``is shown to grow at all tested 
temperatures (e.g., 30, 34, 37, and 50 oC). The enumeration 
shows a low 4.2 x 1011 cfu/g at 37 oC to a high 
6.0 x 1011 cfu/g at 34 oC.'' BPPD Review December 
20, 1999.
    b. Bacillus subtilis var. amyloliquefaciens strain FZB24 WDG 
(formulation):
    [sbull] Acute oral LD50 toxicity in rats - ``Toxic/limit 
dose greater than 2.8 g/kg body weight (6.7 x 1010 cfu/kg) 
Toxicity Category III.'' BPPD Review December 20, 1999.
    [sbull] Acute dermal LD50 toxicity in rats - ``The 
severity of irritation persisted >72 h, but resolved by day 11. No 
deaths observed. The acute dose (LD50) is greater than 2,000 
mg/kg Dermal irritation = Toxicity Category II; Dermal Toxicity = 
Toxicity Category III.'' BPPD Review December 20, 1999.
    [sbull] Acute inhalation LC50 toxicity in rats 
(formulation) - ``an acute inhalation medium lethal concentration 
(LC50) in male and female rats is greater than 0.93 mg/L 
Toxicity Category II.'' IIT Research Institute (Document 2 of this 
submission)
    [sbull] Primary eye irritation ``no corneal opacity, and no signs 
of irritation by day 7, when dosed at 3.6 x 1010 cfu/right 
eye/animal Toxicity Category III.'' BPPD Review December 20, 1999.
    c. The inert ingredients contained in the Bacillus subtilis var. 
amyloliquefaciens strain FZB24 formulation, TAEGRO\TM\ are all minimal 
risk (List 4).
    2. Genotoxicity. Subdivision M Guidelines do not require the 
conduct of genotoxicity studies to support the registration of a 
microbial pest control agent, such as Bacillus subtilis var. 
amyloliquefaciens strain FZB24.
    3. Reproductive and developmental toxicity. Subdivision M 
Guidelines do not require the conduct of reproductive and developmental 
toxicity studies to support the registration of a microbial pest 
control agent, such as Bacillus subtilis var. amyloliquefaciens strain 
FZB24.
    4. Subchronic toxicity. Subdivision M Guidelines do not require the 
conduct of subchronic toxicity studies to support the registration of a 
microbial pest control agent, such as Bacillus subtilis var. 
amyloliquefaciens strain FZB24.
    5. Chronic toxicity. Subdivision M Guidelines do not require the 
conduct of chronic toxicity studies to support the registration of a 
microbial pest control agent, such as Bacillus subtilis var. 
amyloliquefaciens strain FZB24.
     According to Taensa, Inc., sufficient data exist to assess the 
hazards of Bacillus subtilis var. amyloliquefaciens strain FZB24 and to 
make a determination on aggregate exposure, consistent with section 
408(c)(2), for the exemptions from the requirement of a tolerance. The 
exposures, including dietary exposure, and risks associated with 
establishing the requested

[[Page 64885]]

exemption from the requirement of a tolerance follows.

D. Aggregate Exposure

     Bacillus subtilis var. amyloliquefaciens is naturally occurring 
and widespread in the environment. The low toxicity and non-
pathogenicity/infectivity of Bacillus subtilis var. amyloliquefaciens 
strain FZB24 is demonstrated by the data summarized herein. The product 
will be applied as a seed treatment and via incorporation, drenching, 
spraying, dipping, chemigation and hydroponics.
    1. Dietary exposure--a. Food. It is not anticipated that residues 
of Bacillus subtilis var. amyloliquefaciens strain FZB24 will occur in 
treated raw agricultural commodities.
    b. Drinking water. It is not anticipated that residues of Bacillus 
subtilis var. amyloliquefaciens strain FZB24 will occur in drinking 
water.
    2. Non-dietary exposure. The potential for non-occupational, non-
dietary exposure to the general population is not expected to be 
significant.

E. Cumulative Exposure

     There is no anticipated potential for cumulative effects of 
Bacillus subtilis var. amyloliquefaciens strain FZB24 and other 
substances that have a common mode of action.

F. Safety Determination

    1. U.S. population. Bacillus subtilis var. amyloliquefaciens strain 
FZB24 is a naturally occurring microorganism. Bacillus subtilis var. 
amyloliquefaciens is widespread in the environment. The low toxicity of 
Bacillus subtilis var. amyloliquefaciens strain FZB24 is demonstrated 
by the data summarized above. Based on this information, the aggregate 
exposure to Bacillus subtilis var. amyloliquefaciens strain FZB24 over 
a lifetime should not pose appreciable risks to human health. There is 
a reasonable certainty that no harm will result from aggregate exposure 
to Bacillus subtilis var. amyloliquefaciens strain FZB24 residues. 
Exempting Bacillus subtilis var. amyloliquefaciens strain FZB24 from 
the requirement of a tolerance should be considered safe and pose 
insignificant risk.
    2. Infants and children. The toxicity and exposure data are 
sufficiently complete to adequately address the potential for 
additional sensitivity of infants and children to residues of Bacillus 
subtilis var. amyloliquefaciens strain FZB24. There is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to Bacillus subtilis var. amyloliquefaciens strain 
FZB24 residues.

G. Effects on the Immune and Endocrine Systems

     No specific tests have been conducted with Bacillus subtilis var. 
amyloliquefaciens strain FZB24 to determine whether it may have an 
effect in humans that is similar to an effect produced by a naturally 
occurring estrogen or other endocrine effects. However, it is not 
likely that Bacillus subtilis var. amyloliquefaciens strain FZB24 would 
have estrogen or endocrine effects because:
    [sbull] It is a naturally occurring microorganism. Bacillus 
subtilis is widespread in the environment
    [sbull] It has demonstrated low mammalian toxicity. No 
pathogenicity or infectivity was observed in any of the tests conducted 
with Bacillus subtilis var. amyloliquefaciens strain FZB24
     The mechanism by which Bacillus subtilis var. amyloliquefaciens 
strain FZB24 controls diseases appears to be via exudates Bacillus 
subtilis var. amyloliquefaciens strain FZB24 does not produce toxins or 
antibiotics.

H. Existing Tolerances

     No tolerances or exemptions from the requirement of tolerance have 
been established or applied for domestically or internationally other 
that subject petition.

I. International Tolerances

     No maximum residue levels have been established for Bacillus 
subtilis var. amyloliquefaciens strain FZB24 by codex Alimentarius 
Commission.
[FR Doc. 02-26844 Filed 10-21-02; 8:45 am]
BILLING CODE 6560-50-S