[Federal Register: October 22, 2003 (Volume 68, Number 204)]
[Notices]               
[Page 60371-60375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc03-89]                         

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0317; FRL-7328-4]

 
Bacillus thuringiensis Cry3Bb1; Notice of Filing a Pesticide 
Petition to Establish a Tolerance Exemption 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 identification (ID) number OPP-
2003-0317, must be received on or before November 21, 2003.

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: Mike Mendelsohn, 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 8715; e-mail address: mendelsohn.mike@epa.gov.

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (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

[[Page 60372]]

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-2003-0317. 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's 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 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-2003-0317. 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 opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2003-0317. 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,

[[Page 60373]]

DC 20460-0001, Attention: Docket ID Number OPP-2003-0317.
    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-2003-0317. 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 9, 2003.
 Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    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 the petitioner 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.

I. Monsanto Company

PP 7F4888

    EPA has received a pesticide petition request from Monsanto 
Company, 800 North Lindberg Blvd., St. Louis, Missouri 63167, proposing 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by removing the time limitation for the exemption from the 
requirement of a tolerance for the plant-incorporated protectant 
Bacillus thuringiensis Cry3Bb1 protein and the genetic material 
necessary for its production in corn in or on field corn, sweet corn, 
and popcorn. The tolerance exemption was originally requested under 
pesticide petition number PF 7F4888.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Monsanto Company has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by Monsanto Company 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

    Corn has been genetically transformed to produce variants of the 
Bacillus thuringiensis protein Cry3Bb1. The production of Cry3Bb1 
protein in root tissue protects corn from damage caused by corn 
rootworm larval feeding. Plants producing this protein are derived from 
transformation events that contain the insecticidal gene and the 
genetic material necessary for its expression in corn. Data developed 
with multiple Cry3Bb1 variants and corn transformation events indicate 
that the protein poses no foreseeable risks to nontarget organisms, 
including mammals, birds, fish, beneficial insects and earthworms. 
Cry3Bb1 corn is less toxic than all other currently registered rootworm 
control products. Cry3Bb1 corn provides growers with a highly 
efficacious product for controlling damage caused by corn rootworms 
that is compatible with integrated pest management practices.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The gene 
encoding Cry3Bb1 protein was isolated from Bacillus thuringiensis 
subspecies kumamotoensis and modified before insertion into corn. Data 
characterizing the Cry3Bb1 variant produced in corn have been submitted 
to and reviewed by EPA. Safety studies were conducted with purified 
extracts of Cry3Bb1 produced in a heterologous bacterial fermentation 
system. Data submitted by Monsanto demonstrate that the plant- and 
bacterial-produced proteins are equivalent with respect to 
immunoreactivity, molecular weight, amino acid sequence, level of 
glycosylation, and insecticidal activity. Production of microbial 
Cry3Bb1 was

[[Page 60374]]

needed to obtain sufficient quantities of the protein for use in safety 
testing.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Cry3Bb1 residue data should not be required for 
a human health effects assessment because of the demonstrated lack of 
mammalian toxicity.
    3.  A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. A 
validated method for extraction and direct enzyme linked immunosorbent 
assay (ELISA) analysis of Cry3Bb1 in corn grain has been submitted to 
the Agency.

C. Mammalian Toxicological Profile

    Cry proteins have been used safely and effectively as pest control 
agents in microbial Bacillus thuringiensis formulations for more than 
40 years. The numerous toxicology studies conducted with these 
microbial products show no significant adverse effects, and demonstrate 
that the products are practically nontoxic to mammals. An exemption 
from the requirement of a tolerance has been in place for these 
products since at least 1971 (40 CFR 180.1011).
    Data have been submitted demonstrating the lack of mammalian 
toxicity at high levels of exposure to purified Cry3Bb1 proteins. These 
data demonstrate the safety of the proteins at levels well above 
maximum possible exposure levels that are reasonably anticipated in 
crops. This conclusion is consistent with the Agency position regarding 
toxicity and residue data requirements for the microbial Bacillus 
thuringiensis products from which this plant-incorporated protectant 
was derived (40 CFR 158.740(b)(2)(i)). For microbial products, further 
toxicity testing and residue data are only triggered by significant 
acute effects in studies such as the mouse oral toxicity study, to 
verify the observed effects and clarify the source of these effects 
(i.e., Tier II and Tier III testing).
    Acute oral toxicity studies have been submitted for three Cry3Bb1 
variants. These variants of the wild type Cry3Bb1 protein contain a 
small number of amino acid substitutions (four to seven) to enhance 
insecticidal activity against corn rootworm larvae. The acute oral 
toxicity data submitted support a prediction that Cry3Bb1 protein will 
be nontoxic to humans. Male and female mice (10 per sex per dose level) 
were dosed with 36, 396, or 3,780 milligrams/kilogram bodyweight (mg/kg 
bwt) of Cry3Bb1 protein for one variant. Mice were dosed with 39, 419, 
or 2,980 mg/kg bwt for a second Cry3Bb1 variant. Mice were dosed with 
400, 1,100, or 3,200 mg/kg bwt of Cry3Bb1 for a third Cry3Bb1 variant. 
In one study, two animals in the high dose group died within a day of 
dosing. These animals both had signs of trauma probably due to dose 
administration (i.e., lung perforation or severe discoloration of lung, 
stomach, brain, and small intestinal tissue). No clinical signs were 
observed in the surviving animals and body weight gains were normal 
throughout the 14-day study for the remaining animals. Gross necropsies 
performed at the end of the study indicated no findings of toxicity 
attributed to exposure to the test substance in any of the three 
studies. No other mortality or clinical signs attributed to the test 
substance were noted in any of the studies.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low levels (Sjoblad, R. et al. ``Toxicological 
Considerations for Protein Components of Biological Pesticide 
Products.'' Regulatory Toxicol. Pharmacol. 15:3-9, 1992). Since no 
acute effects were shown to be caused by Cry3Bb1 proteins, even at 
relatively high dose levels, they are not considered toxic. 
Furthermore, amino acid sequence comparisons between the Cry3Bb1 
variants and known toxic proteins available in public databases showed 
no similarities.
    Since Cry3Bb1 variants are proteins, the potential for allergic 
sensitivities was evaluated. Current scientific knowledge suggests that 
common food allergens are present at high concentrations in food, are 
resistant to pepsin digestion, may be resistant to acid or heat, and 
can be glycosylated. Data have been submitted demonstrating that the 
Cry3Bb1 proteins are rapidly degraded by gastric fluid in vitro. In a 
solution of simulated gastric fluid (pH 1.2 U.S. Pharmacopeia), 
complete degradation of detectable Cry3Bb1 protein occurred within 30 
seconds. Insect bioassay data indicate that the protein loses 
insecticidal activity within 2 minutes of incubation in simulated 
gastric fluid. Incubation in simulated intestinal fluid resulted in a 
[sim]59 kDa protein digestion product. Cry3Bb1 protein produced in corn 
is not glycosylated and it is not detectable in grain following baking 
at elevated temperatures.
    An analysis of amino acid sequences of known allergens uncovered no 
evidence of sequence homology with Cry3Bb1, even at the level of eight 
contiguous amino acid residues. The potential for Cry3Bb1 proteins to 
be food allergens is minimal. Regarding toxicity to the immune system, 
the acute oral toxicity data submitted support the prediction that 
Cry3Bb1 proteins will be nontoxic to humans.
    The genetic material encoding the Cry3Bb1 proteins and the 
regulatory regions controlling expression of the nucleotide sequence 
encoding Cry3Bb1 proteins are nucleic acids deoxyribonucleic acid/
ribonucleic acid ((DNA) and (RNA)). DNA and RNA occur in all forms of 
plant and animal life and there is no documented instance of nucleic 
acids being associated with toxic effects when consumed as a component 
of food. Data characterizing the genetic material necessary for the 
production of Cry3Bb1 in corn has been provided to the Agency. No 
mammalian toxicity is anticipated from dietary exposure to the genetic 
material necessary for production of the subject plant-incorporated 
protectant.

D. Aggregate Exposure

    Data have been submitted with which to evaluate aggregate exposure 
levels for consumers to residues of the plant-incorporated protectant.
    1. Dietary exposure. Cry3Bb1 is a plant-incorporated protectant in 
corn, thus dietary exposure is deemed to be the most relevant route for 
assessing human risk.
    i. Food. Oral exposure, at very low levels, may occur from 
ingestion of processed corn products. However, a lack of mammalian 
toxicity and the rapid digestibility of the plant-incorporated 
protectant have been demonstrated.
    ii. Drinking water. Oral exposure from ingestion of drinking water 
is unlikely because the protein is present at low levels within the 
plant and submitted studies demonstrate that Cry3Bb1 is rapidly 
degraded in soil.
    2. Non-dietary exposure. Exposure via skin or inhalation is not 
likely since the plant-incorporated protectant is contained within 
plant cells, which essentially eliminates these exposure routes or 
reduces them to negligible. The use sites for Cry3Bb1 proteins are all 
agricultural for control of insects. Therefore, exposure via 
residential or lawn use to infants and children is not expected.

E. Cumulative Exposure

    Since there is no indication of mammalian toxicity to the plant-
incorporated protectant there will be no opportunity for cumulative 
toxic effects.

F. Safety Determination

    1.  U.S. population. Sufficient data have been submitted for the 
purpose of assessing health risk of Cry3Bb1

[[Page 60375]]

proteins and the genetic materials necessary for their production in 
raw agricultural commodities. The complete absence of toxicity in high 
dose acute oral studies, the lack of sequence homology with known 
protein toxins, rapid digestion in a gastric matrix, and minimal 
allergenicity potential provide a reasonable certainty of no harm for 
the U.S. general population potentially exposed to Cry3Bb1 proteins.
    2. Infants and children. Nondietary exposure to infants and 
children is not anticipated due to the patterns of use for this plant-
incorporated protectant. The submitted data provide no evidence of 
adverse threshold effects for Cry3Bb1 proteins that would warrant 
application of an additional safety factor for the protection of 
infants and children. Furthermore, the provisions for consumption 
patterns, special susceptibility, and cumulative effects do not apply.

G. Effects on the Immune and Endocrine Systems

    The lack of Cry3Bb1 toxicity in high dose acute oral studies and 
its rapid degradation in a mammalian digestive system suggests minimal 
risk for adverse effects on the immune system. This pesticidal active 
ingredient is a protein, derived from sources that are not known to 
exert an influence on the endocrine system.

H. Existing Tolerances

    There is an existing time-limited tolerance exemption for Bacillus 
thuringiensis Cry3Bb1 protein and the genetic material necessary for 
its production in food and feed commodities of field corn, sweet corn 
and popcorn (40 CFR 180.1214). Unless amended, this exemption is 
scheduled to expire on May 1, 2004.

I. International Tolerances

    No Codex maximum residue levels have been established for this 
plant-incorporated protectant at this time.
[FR Doc. 03-26414 Filed 10-21-03; 8:45 am]

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