[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: docket@epamail.epa.gov. 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
[email protected] Drive, Arlington,
ail.epa.gov. VA 22202
Michael Mendelsohn........... 703-308-8715, e- Do.
mail:
mendelsohn.mike@epa.
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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:
opp-docket@epamail.epa.gov
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
Al4Si4O10(OH)8. 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
LD50 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 LD50 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 LD50 >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
