[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Notices]
[Pages 63168-63170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31131]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-776; FRL-5753-3]


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 pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by the docket control number PF-776, must 
be received on or before December 26, 1997.

ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), 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 to: <a href="/cdn-cgi/l/email-protection#8ee1fefea384eae1ede5ebfaceebfeefe3efe7e2a0ebfeefa0e9e1f8">opp-
<span class="__cf_email__" data-cfemail="adc9c2cec6c8d9edc8ddccc0ccc4c183c8ddcc83cac2db">[email protected]</span></a>. Follow 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: The Regulatory Action Leader listed in 
the table below:

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                                Telephone Number/E-    Office Location/ 
   Regulatory Action Leader        mail Address            Address      
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Driss Benmhend...............  703-308-9525, e-      5th floor CS#1,    
                                mail:                 2800 Crystal      
                                <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="2f4d4a4142474a414b014b5d465c5c6f4a5f4e42">[email protected]</a>   Drive, Arlington, 
                                ail.epa.gov.          VA 22202          
Michael Mendelsohn...........  703-308-8715, e-      Do.                
                                mail:                                   
                                <a href="/cdn-cgi/l/email-protection#0a676f646e6f6679656264246763616f4a6f7a6b00676b6366246f7a6b246d657c"><span class="__cf_email__" data-cfemail="80ede5eee4e5ecf3efe8eeaeede9ebe5c0e5f0e1">[email protected]</span>
mail.epa.gov</a>.                           
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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.
    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-776] (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#78170808551c171b131d0c381d081915191114561d0819561f170e"><span class="__cf_email__" data-cfemail="721d02025f161d11191706321702131f131b1e5c1702135c151d04">[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 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-776] 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: November 18, 1997.

Janet 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.

1. Engelhard Corporation

PP 7E4908

    EPA has received a pesticide petition (PP 7E4908) from Engelhard 
Corporation, 101 Wood Avenue, Iselin, NJ 08830, proposing pursuant to 
section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 
346a, to amend 40 CFR part 180 by establishing an exemption from the 
requirement of a tolerance for residues of kaolin in or on all food 
commodities. Pursuant to the section 408(d)(2)(A)(i) of the FFDCA, as 
amended, Engelhard Corporation has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition.

A. Proposed Use Practices

    Kaolin is to be used as an aid in control of damage to plants from 
insects, mites, fungi, and bacteria. Kaolin is used at the rates of 
6.25 to 12.4 lbs/acre for row crop vegetables, 25 to 175 lbs/acre for 
tree fruit crops, and 12.5 to 37.5 lbs/acre for small fruit crops. 
Treatment is made prior to leaf or plant emergence and applied to crops 
at 7 to 10 day

[[Page 63169]]

intervals depending on the pest to be controlled. Dosage rates are 
applied with standard spray equipment.

B. Product Identity/Chemistry

    Kaolin is a white, nonporous, nonswelling, natural occuring 
aluminosilicate mineral with the chemical formula 
Al<INF>4</INF>Si<INF>4</INF>O<INF>10</INF>(OH)<INF>8</INF>. Kaolin is 
one of the most highly divided and highly refined naturally occurring 
minerals. Median particle size of commercial products vary between 0.1 
- 10 microns. Kaolin is nonreative. Its hydrophilic surface allows 
kaolin to be easily dispersed in water at neutral pH values of 6-8. 
Common physical properties of kaolin are: platy shape, high brightness 
(80-95), specific gravity 2.58-2.63, refractive index 1.56-1.62, and 
Mohs hardness 2-3.

C. Toxicological Profile

    Acute toxicity. An acute oral toxicity limit test, acute dermal 
toxicity test on the active ingredient and an acute oral toxicity test, 
a primary skin irritation test, and primary eye irritation test on the 
end use product have been submitted. The acute oral limit dose test on 
the active ingredient showed that the single dose Acute Oral 
LD<INF>50</INF> is greater than 5,000 mg/kg of bodyweight of rats. The 
acute dermal toxicity limit test on the active ingredient showed that 
the single dose Acute Dermal LD<INF>50</INF> is greater than 5,000 mg/
kg of bodyweight. The primary skin irritation study on the end use 
product showed that the test substance is classified as slightly 
irritating to the skin. The primary eye irritation study on the end use 
product showed that the test substance is classified as minimally 
irritating and non-irritating to the unrinsed and rinsed eye 
respectively.
    Kaolin is used as an indirect food additive for paper/paper board 
dry food contact, adhesives, polymeric coatings, rubber articles, and 
cellophane. Kaolin is used in pharmaceuticals, tablet diluents, 
poultices, and surgical dusting powders. Kaolin is used as a cosmetic 
in face powders, face masks, and face packs. Kaolin is used in health 
products and toiletries, toothpaste, and antiperspirants. Kaolin can be 
used directly in foods as an anti-caking agent (up to 2.5%). Kaolin has 
GRAS (Generally Recognized as Safe) status under 21 CFR 186.1256 and is 
generally recognized as safe ``As an indirect human food ingredient 
with no limitation other than current good manufacturing practice.''

D. Aggregate Exposure

    1. Dietary exposure. Dietary exposure of kaolin via food or water 
is difficult to estimate due to the use of kaolin in thousands of 
products. Kaolin is an inert mineral naturally occuring in the 
environment, and has no known toxicological effects.
    2. Non-dietary exposure, non-occupational exposure. Increased non-
dietary exposure of kaolin via lawn care, topical insect repellents, 
etc., is not applicable to this application.

E. Cumulative Exposure

    Kaolin has no mode of toxicity and therefore cumulative exposure is 
not applicable. Kaolin is used in thousands of products as well as 
being a naturally occurring part of the environment. Cumulative 
exposure is not possible to calculate nor is it necessary due to the 
non-toxic nature of kaolin.

F. Endocrine Disruptors

    Engelhard Corporation has no information to suggest that kaolin 
will adversely affect the immune or endocrine systems.

G. Safety Considerations

    The lack of toxicity of kaolin is demonstrated by the above 
summary. Based on this information, the aggregate exposure to kaolin 
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 kaolin residues. Exempting kaolin from the requirement of a 
tolerance should be considered safe and pose insignificant risk.

H. Analytical Method

    An analytical method for residues is not needed as this petition 
requests an exemption from the requirement of a tolerance.

I. Existing Tolerances

    Kaolin is exempted from the requirement of a tolerance ``when used 
as an inert ingredient in pesticide formulations applied to growing 
crops or to raw agricultural commodities after harvest.'' (40 CFR 
180.1001).
    The registrant does not know if international tolerance exemptions 
exist.    (Driss Benmhend).

2. Plant Genetic Systems (America) Inc.

PP 7G4921

    EPA has received pesticide petition (PP 7G4921) from Plant Genetic 
Systems (America), Inc., 7200 Hickman Road, Suite 202, Des Moines, IA 
50322, proposing pursuant to section 408(d) of the Federal Food, Drug 
and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing a temporary exemption from the requirement of a tolerance 
for residues of the plant-pesticide Bacillus thuringiensis subsp. 
tolworthi Cry9C and the genetic material necessary for the production 
of this protein in corn for feed use only. The summary of the petition 
published in this notice was proposed by the petitioner. This request 
proposes to amend Experimental Use Permit, 70218-EUP-1, issued to Plant 
Genetic Systems (America), Inc. on February 5, 1997, issued under crop 
destruct conditions.
    Pursuant to the section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Plant Genetic Systems (America) has submitted the following summary of 
information, data and arguments in support of their pesticide petition. 
This summary was prepared by Plant Genetic Systems (America) and EPA 
has not fully evaluated the merits of the petition. The summary may 
have been edited by EPA if the terminology used was unclear, the 
summary contained extraneous material, or the summary was not clear 
that it reflected the conclusion of the petitioner and not necessarily 
EPA.

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. 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 Bacillus thuringiensis 
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 a 
temporary exemption from the requirement of a tolerance.

[[Page 63170]]

C. Mammalian Toxicological Profile

    Bacillus thuringiensis proteins have been used commercially for 
more than 30 years without any evidence for adverse health effects. 
Bacillus thuringiensis 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 thus 
destroying the midgut lining and causing death of the insect. Bacillus 
thuringiensis proteins do not bind or cause these types of effects to 
mammalian gut membranes. 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). 
Although Bacillus thuringiensis 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) (FRL-4971-3).
    The Cry9C protein insecticidal mode-of-action is apparently similar 
to that of the well known Cry1A proteins. In addition to the safe 
history of Bacillus thuringiensis proteins outlined above, several 
other studies were performed to evaluate 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. However, an amino acid sequence homology 
search performed using three different data banks (against 135,867 
sequences) only found homology to other related Bacillus thuringiensis 
proteins. To determine possible short stretch homology, an 8-amino acid 
homology search was also performed. Except with the Bacillus 
thuringiensis proteins, no identical 8-amino acid peptide sequences 
could be detected in the searches. Therefore, it is unlikely that Cry9C 
protein would have significant allergenic potential.
    The Cry9C protein or metabolites of the protein are not expected to 
interact with the immune or endocrine system, since the protein 
sequence does not match any known allergens or hormones. Since 
proteins, in general, are not known to be carcinogenic it is unlikely 
that the Cry9C protein would have carcinogenic properties.
    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 corn for feed use only.

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. Furthermore, no direct 
human dietary exposure to Cry9C protein will occur since this request 
is for animal feed use only.

E. Cumulative Effects

    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 effects 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 US 
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 of the Cry9C protein provides support for our 
request of a temporary 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 corn 
plant materials, are not expected due to the uses of this product for 
animal feed use only.

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 corn for feed use only.  
  (Michael Mendelsohn)

[FR Doc. 97-31131 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F


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