[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Notices]
[Pages 49224-49226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24940]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-759; FRL-5739-9]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition (PP 7F4826), submitted by Plant Genetic Systems (America), 
Inc., proposing the establishment of a regulation for an exemption from 
the requirement of a tolerance for residues of plant-pesticides 
Bacillus thuringiensis subsp. tolworthi Cry9C and the genetic material 
necessary for the production of this protein in or on all raw 
agricultural commodities.
DATES: Comments, identified by the docket control number PF-759, must 
be received on or before October 20, 1997.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7506C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132, 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. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Michael Mendelsohn, 
Biopesticides and Pollution Prevention Division (7511W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Rm. CS51B6, 
Westfield Building North Tower, 2800 Crystal Drive, Arlington, VA 
22202, (703) 308-8715; e-mail: <a href="/cdn-cgi/l/email-protection#96fbf3f8f2f3fae5f9fef8b8fbfffdf3d6f3e6f7fbf7fffab8f3e6f7b8f1f9e0"><span class="__cf_email__" data-cfemail="016c646f65646d726e696f2f6c686a64416471606c60686d2f6471602f666e77">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain 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.

[[Page 49225]]

    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-759] (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:
    <a href="/cdn-cgi/l/email-protection#e28d9292cf868d81898796a28792838f838b8ecc879283cc858d94"><span class="__cf_email__" data-cfemail="3c534c4c1158535f5759487c594c5d515d555012594c5d125b534a">[email protected]</span></a>


    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 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [PF-759] and appropriate petition 
number. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

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

    Dated: August 29, 1997.

Janet L. Andersen,

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

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. 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.

Plant Genetic Systems (America), Inc.

PP 7F4826

    EPA has received a pesticide petition (PP 7F4826) from Plant 
Genetic Systems (America), Inc., proposing the establishment of a 
regulation for an exemption from the requirement of a tolerance for 
residues of plant-pesticides Bacillus thuringiensis subsp. tolworthi 
Cry9C and the genetic material necessary for the production of this 
protein in or on all raw agricultural commodities.

A. Bacillus thuringiensis subsp. tolworthi Cry9C protein uses

    Corn plants have been protected from lepidopteran insect pests such 
as European corn borer [Ostrinia nubilalis (Huber)], by expressing a 
Cry9C protein. The Cry9C protein expressed by the corn plants 
corresponds to the insecticidal moiety of the Cry9C crystal protein of 
a Bacillus thuringiensis subsp. tolworthi strain. The Cry9C protein 
poses no foreseeable risks to non-target organisms, including mammals, 
birds and non-target insects. Transgenic corn plants, expressing Cry9C 
protein, represents an excellent addition to growers' options for 
insect control that reduces or eliminates the need for chemical inputs 
and fits well within an integrated pest management program.

B. Product Identity/Chemistry

    The Cry9C gene, was isolated from the B.t. tolworthi strain, 
truncated and modified before it was stably inserted into corn plants. 
The tryptic core of the microbially produced Cry9C delta-endotoxin is 
similar to the Cry9C protein found in event CBH351. The Cry9C protein 
was produced and purified from a bacterial host, for the purposes of 
mammalian toxicity studies. Product analysis that compared the Cry9C 
protein from the two sources included: SDS-PAGE, Western blots, N-
terminal amino acid sequencing, glycosylation tests (for possible post-
translational modifications) and insect bioassays.
    No analytical method is included since this petition requests an 
exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

    Bacillus thuringiensis proteins have insecticidal properties and 
have been used commercially for more than 30 years. This long history 
of safe use is the primary reason that Bt proteins have been chosen as 
the basis for the first insecticidal plants produced by biotechnology. 
Bt mode-of-action can be divided into a series of critical steps: 
ingestion by the insect, specific binding to brush border membrane 
receptors, membrane insertion, and pore formation. Bt proteins do not 
bind or cause any other effects to mammalian gut membranes thereby 
displaying human safety properties. The Cry9C protein mode-of-action is 
apparently similar to that of the well known Cry1A proteins. Although 
Bt strains have been used for decades as sprayable microbial products, 
no confirmed cases of allergic reactions have been documented, despite 
dermal, oral and inhalation exposures. A reference to this is made by 
the EPA in a Federal Register notice, dated August 16, 1995 [60 FR 
42443].
    In addition to the safe history of Bt proteins outlined above, 
several other studies were performed to provide evidence for mammalian 
safety of the Cry9C protein. An acute toxicological study was performed 
with mice, which demonstrated that the Cry9C protein had an 
LD<INF>50</INF> > 6,500 mg/kg. A test for in vitro digestibility under 
simulated gastric conditions showed that the Cry9C protein found in 
bacteria and the protein produced in plants was stable for 4 hours when 
exposed to simulated gastric juice. An amino acid sequence homology 
search performed using three different data banks (against 135,867 
sequences) only found homology to other related Bt proteins. All other 
proteins in the data bank have no major stretches of sequence homology, 
indicating that the sequence homology is not significant. Therefore, no 
homology with any known allergen or protein toxin could be 
demonstrated.
    The Cry9C protein or metabolites of the protein are not expected to 
interact with the immune system, the endocrine system or to have any 
carcinogenic activity since the protein sequence does not match any 
known allergens, hormones or since proteins, in general, are not known 
to be carcinogenic.
    All living organisms contain DNA and there are no examples of 
nucleic acids causing any toxicological effects from dietary 
consumption. The genetic material necessary for the production of the 
Cry9C protein in plants includes the genetic construct that encodes the 
Cry9C protein and all other necessary genetic elements for it's 
expression. These elements include: a promotor, polylinker sequences, 
leader sequences and terminators and none of which are expected to 
cause any toxicological effects.
    Taken together, the data supports the lack of mammalian 
toxicological effects for the plant-pesticide Bacillus thuringiensis 
subsp. tolworthi Cry9C protein and the genetic material necessary for 
the production of this protein in or on all raw plant agricultural 
commodities.

[[Page 49226]]

D. Aggregate Exposure

    Since the Cry9C protein is expressed in plant tissues, dermal or 
inhalation will be negligible to non-existent. Drinking water is 
unlikely to be contaminated with Cry9C protein due to the rapid 
degradation of plant materials in the soil. Processed plant products 
may allow for low levels of exposure to the Cry9C protein, but the lack 
of mammalian toxicity and the lack of sequence homology to known toxins 
or allergens, has already been demonstrated.

E. Cumulative Exposure

    The unique mode-of-action of Bt proteins in general, coupled with 
the lack of mammalian toxicity for the Cry9C protein provides no basis 
for the expectation of cumulative exposure with other compounds.

F. Safety Determination

    Bt microbial pesticides containing Cry proteins have been applied 
for more than 30 years to food and feed crops consumed by the U.S. 
population. There have been no human safety problems attributed to Cry 
proteins. The extensive mammalian toxicity studies performed to support 
the safety of Bacillus thuringiensis - containing pesticides clearly 
demonstrate that the tested isolates are not toxic or pathogenic 
(McClintock, et al., 1995, Pestic. Sci. 45:95-105). The lack of 
mammalian toxicity or allergenic properties of the Cry9C protein 
provides support for our request of an exemption from the requirement 
of a tolerance set forth in this petition. Non-dietary exposure of 
infants, children or the US population in general, to the Cry9C protein 
expressed in plant materials, are not expected due to the uses of this 
product within agricultural settings.

G. Existing Tolerances

    No tolerances or tolerance exemptions have been granted for the 
Bacillus thuringiensis subsp. tolworthi Cry9C and the genetic material 
necessary for the production of this protein in or on all raw 
agricultural commodities.
[FR Doc. 97-24940 Filed 9-18-97; 8:45 am]
BILLING CODE 6560-50-F


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