[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Notices]
[Pages 34281-34283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16657]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-747; FRL-5728-4]
Monsanto Company; Pesticide Tolerance Petition Filing
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 the docket control number PF-747, must
be received on or before July 25, 1997.
ADDRESSES: By mail submit written comments to: Information and Records
Integrity Branch, Public Information and Services Divison (7506C),
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: Linda Hollis, Product Manager
(PM) 90, Biopesticides and Pollution Prevention Division, (7501W),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location and telephone number:
Rm. 5th floor, CS1, 2800 Crystal Drive, Arlington, VA., 22202, (703)
308-8733; e-mail: hollis.linda@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemical 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 this petition
contains 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
[[Page 34282]]
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-747] (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''.
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 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (PF-747) and appropriate petition
number. Electronic comments on this proposed rule 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: June 19, 1997.
Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Summary of Petition
Petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summary of the petition
was prepared by the petitioner and represent the views 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.
Monsanto Company
PP 7F4831
EPA has received a pesticide petition (PP 7F4831) from Monsanto
Company of St. Louis Missouri. The petition proposes, pursuant to
section 408 of the Federal Food Drug and Cosmetic Act (FFDCA), 21
U.S.C. 346a, to amend 40 CFR part 180 to establish an exemption from
the requirement of a tolerance for the plant-pesticide Coat Protein of
Potato Virus Y and the genetic material necessary for its production in
or on all raw agricultural commodities.
A. Proposed Use Practices
Recommended application method and rate(s), frequency
ofapplication, and timing of application. Monsanto states that the
plant viral coat protein is produced within tissues of the engineered
plant and is not to be applied externally. Appropriate cultural
practices for growing seed with genetically engineered virus resistance
will be determined by individual growers, such practices are for all
other plant varieties. Accordingly, no special instructions for use
will be necessary.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Monsanto
has determined that the sequence of the engineered viral coat protein
expressed in transformed plants is identical to a viral coat protein
found in nature.
2. Magnitude of residue anticipated at the time of harvest and
method used to determine the residue. Monsanto states that the viral
coat protein is expressed in plant tissues, and therefore, is not a
residue in the same manner as a pesticide applied externally to growing
crop plants. Monsanto does not expect any measurable residue of the
engineered viral coat protein to remain on or in transformed raw
agricultural commodities (RACs).
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. The ELISA
(Enzyme-Linked Immunoabsorbent Assay) test can be used to determine
expression levels of viral coat proteins in transformed plants, fruits
and leaves if the level of expression is high enough for detection. In
Monsanto's assay, the amount of viral coat protein expressed is below
the limit of detection and between 10-100-fold lower than the levels
found in natural infections of potato with PVY. However, because the
Agency proposes to exempt all plant virus coat proteins from the
requirement of a tolerance, Monsanto believes that an analytical method
for detecting and measuring the levels of viral coat proteins in or on
all RACs is not required for enforcement purposes.
C. Mammalian Toxicological Profile
Viral Coat Proteins are substances that viruses produce during a
plant infection to encapsulate and protect their genetic material. When
the genetic material encoding the coat protein for a plant virus is
introduced into a plant's genome, the plant is able to resist
subsequent infections by that same virus as will as strains closely
related to the donor virus. Virus-infected plants currently are and
have always been a part of both the human and domestic animal food
supply, and Monsanto agrees with EPA's finding, published in the
Federal Register of November 23, 1994 (59 FR 60519-60535), that plant
viruses are not known to be harmful to humans. All available data from
the scientific literature indicates that plant viruses are not toxic to
humans or other vertebrates. Additionally, plant viruses are unable to
replicate in mammals or other vertebrates, eliminating the possibility
of human infection. This has been shown by injections of purified whole
virus into laboratory animals to develop antibodies for ELISA tests.
More importantly, however, this tolerance exemption will apply to that
portion of the viral genome coding for the whole coat protein and any
subcomponent of the coat protein expressed in the plant. This component
alone is incapable of forming infectious particles. Because whole
intact plant viruses are not known to cause deleterious human health
effects, Monsanto believes that it is reasonable to assume that a
subunit of these viruses likewise will not cause adverse human health
effects.
D. Aggregate Exposure
1. Dietary exposure.--a. Food. Monsanto believes that the use of
viral coat protein-mediated resistance will not result in any new
dietary exposure to plant viruses. Entire infectious particles of
Potato Virus Y, including the coat protein component, are found in the
fruit, leaves and stems of most plants. Virus-infected food plants are
and have always been a part of the human and domestic animal food
supply. Such food plants and food derived from them have been consumed
with no detectable or observed adverse effects to human health,
including children and infants. Given this information, Monsanto
believes that exposure via the human diet provides a direct and better
method of establishing the lack of toxicity versus animal models of
toxicity.
b. Drinking water. No measurable residues of coat proteins from
engineered plant viruses are expected to be in the drinking water.
Plant viruses are a natural component of the environment and are
present in soil and water. Consequently, Monsanto believes that coat
proteins produced as plant-
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pesticides would represent a negligible addition to those existing in
drinking water.
2. Non-dietary exposure. Monsanto believes that non-dietary
exposure to engineered coat proteins will be minimal to non-existent
because the coat protein is expressed only within the plant tissues.
E. Cumulative Exposure
Exposure through other pesticides and substances with the common
mode of toxicity as this pesticide. Monsanto believes that due to the
lack of toxicity/pathogenicity associated with plant viruses or plant
viral coat proteins, cumulative effects with other pesticides and
substances will be non-existent.
F. Safety Determination
1. U.S. population. There is no known toxicity associated with coat
proteins from plant viruses. Consequently, a safety assessment is not
needed for these proteins. Given the long history of mammalian
consumption of the entire plant virus particle in foods, without any
adverse human health effects, Monsanto reasonable believes that
consumption of a noninfectious component of the PVY plant virus is
safe. There are no known data that indicate aggregate exposure to plant
viral coat proteins under normal conditions will result in harm to any
person.
2. Infants and children. Viral coat proteins are ubiquitous in
foods, including those foods consumed by infants and children.
Moreover, there is no reason to believe that plant viral coat proteins
are likely to occur in different amounts in foods, consumed by children
and infants. Further, there is no scientific evidence that viral coat
proteins used as plant-pesticides would have a different effect on
children than on adults. Viral coat proteins are not toxic and,
therefore, Monsanto believes with reasonable certainty that no harm
will result to infants and children from aggregate exposure to coat
proteins from plant viruses.
G. Existing Tolerances
No tolerance or exemption from tolerance has been previously
granted for PVY coat protein.
H. International Tolerance
No international tolerance or exemption from tolerance has been
previously granted for PVY coat protein. Monsanto Company concludes
that plant viruses, including PVY coat proteins, are not harmful to
humans, and that there is a reasonable certainty that no harm will
result from aggregate exposure to Coat Protein of Potato Virus Y and
the genetic material necessary for its production, including all
anticipated dietary exposures and all other non-occupational exposures.
Accordingly, Monsanto believes that the PVY coat protein qualifies for
an exemption from the requirement of a tolerance in or on all raw
agricultural commodities.
[FR Doc. 97-16657 Filed 6-24-97; 8:45 am]
BILLING CODE 6560-50-F
