[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]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[PF-747; FRL-5728-4]


Monsanto Company; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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: [email protected].

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:
    [email protected]


    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-

[[Page 34283]]

 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