[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Notices]
[Pages 34283-34286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16658]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-742; FRL-5723-2]


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 agricultural commodities.

DATES: Comments, identified by the docket control number PF-742, must 
be received on or before July 25, 1997.

ADDRESSES: By mail submit written comments to: Public Response and 
Program Resources Branch, Field Operations Divison (7505C), 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 pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various raw 
agricultural 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 grantinig of the petition. Additional data may be needed 
before EPA rules on the petition.
    The official record for this notice, as well as the public version, 
has been established for this notice of filing under docket control 
number PF-742 (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:
    [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 control number (insert docket number) and 
appropriate petition number. Electronic comments on this notice may be 
filed online at many Federal Depository Libraries.

    Authority: 21 U.S.C. 346a.

List of Subjects

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


[[Page 34284]]


    Dated: June 19, 1997.

Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summaries of Petitions

    Below summaries of the pesticide petitions are printed. The 
summaries of the petitions were prepared by the petitioners. 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. Monsanto Company

PP 7F4836

    EPA has received a pesticide petition (PP 7F4836) from Monsanto 
Company of St. Louis, Missouri. The petition proposes to amend 40 CFR 
part 180 to establish an exemption from the requirement of a tolerance 
for the plant pesticide Replicase Protein of Potato Leaf Roll Virus 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 of 
application, and timing of application. Monsanto states that the plant 
viral replicase is produced within tissues of the engineered plant and 
is not to be applied externally. Appropriate cultural practices for 
growing potatoes with genetically engineered virus resistance will be 
determined by individual growers, as 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 replicase gene 
transformed into potato plants is identical to a PLRV replicase gene 
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 
replicase 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 replicase 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 PLRV 
replicase protein is produced at a level that is not detectable by 
either ELISA (Enzyme-Linked Immunoabsorbent Assay) or by Western 
analysis. There has been no reason to develop a commercial to detect 
PLRV replicase in naturally infected potatoes, thus, Monsanto believes 
that there is no reason to determine the PLRV replicase content in 
these PLRV-resistant potatoes.

C. Mammalian Toxicological Profile

    Replicase proteins are substances that viruses produce during a 
plant infection to replicate their genetic material. When the genetic 
material encoding the replicase gene 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 are currently, and have always been, 
a part of both the human and domestic animal food supply. Monsanto 
believes that plants containing replicase proteins are not harmful to 
humans or animal that consume these foods. 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 replicase protein. 
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: Food. Monsanto believes that the use of 
replicase protein-mediated resistance will not result in any new 
dietary exposure to plant viruses. Entire infectious particles of 
Potato Leafroll Virus, including the replicase component, are found in 
the tubers, leaves and stems of potato 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.
    2. Drinking water. No measurable residues of replicase 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 the 
replicase protein produced as plant-pesticides would represent a 
negligible addition to those existing in drinking water.
    3. Non-dietary exposure. Monsanto believes that non-dietary 
exposure to engineered replicase proteins will be minimal to non-
existent because the replicase 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 replicase 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 
replicase 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 PLRV plant virus 
is safe. There are no known data that indicate aggregate exposure to 
plant viral replicase proteins under normal conditions will result in 
harm to any person.
    2. Infants and children. Viral replicase proteins are present in 
any food which have replicating virus. Potatoes routinely are infected 
by virus and these potatoes are consumed by infants and children. 
Moreover, there is no reason to believe that plant viral replicase 
proteins are likely to occur in different amounts in foods that are 
consumed by children and infants. Further, there is no scientific 
evidence that viral replicase proteins used as plant-pesticides would 
have a different effect on children than on adults. Viral replicase 
proteins are not toxic and, therefore, Monsanto believes with

[[Page 34285]]

 reasonable certainty that no harm will result to infants and children 
from aggregate exposure to replicase proteins from plant viruses.

G. Existing Tolerances

    No tolerance or exemption from tolerance has been previously 
granted for PLRV replicase.

H. International Tolerance

    No international tolerance or exemption from tolerance has been 
previously granted for PLRV replicase protein. Monsanto Company 
concludes that plant viruses, including PLRV replicase proteins, are 
not harmful to humans, and that there is a reasonable certainty that no 
harm will result from aggregate exposure to Replicase Protein of Potato 
Leafroll Virus and the genetic material necessary for its production, 
including all anticipated dietary exposures and all other non-
occupational exposures. Accordingly, Monsanto believes that the PLRV 
protein qualifies for an exemption from the requirement of a tolerance 
in or on all raw agricultural commodities.

2. Mycogen Corporation

PP 7G4823

    EPA has received a pesticide petition (PP) 7G4823 from Mycogen 
Corporation of San Diego, California. The petition proposes to amend 40 
CFR part 180 by establishing a temporary exemption from the requirement 
of a tolerance for residues of the Cry1F derived delta endotoxin of 
Bacillus thuringiensis encapsulated in killed Pseudomonas fluorescens 
in or on all raw agricultural commodities.

A. Proposed Use Practices

    Recommended application method and rate(s), frequency of 
application, and timing of application. Mycogen Corporation proposes to 
conduct testing under an Experimental Use Permit using 11,365 gallons 
of an end-use formulation containing the Cry1F derived delta endotoxin 
of Bacillus thuringiensis encapsulated in killed Pseudomonas 
fluorescens. The testing will occur during a two-year experimental 
program in Alabama, Arizona, California, Delaware, Florida, Georgia, 
Louisiana, Maryland, Mississippi, New Jersey, New York, North Carolina, 
South Carolina, Texas, Virginia and Puerto Rico. The total acreage for 
all sites over the two-year period will cover 2,740 acres.
    The trials conducted will focus on control of armyworm, looper and 
cutworm pests in vegetable, field crop, legume, turf and ornamental, 
nut crop, stone and pome fruit, small fruit and berry, and herb 
commodities. Weekly and biweekly treatments with 7 and 3 to 4 day 
intervals will be evaluated starting shortly after plant emergence 
through whorl stage and, in selected cases, through harvest. Five rates 
at 0.5, 1, 2, 3, and 4 quarts per acre will be tested. Applications 
will be made using the conventional tractor-mounted spray booms 
operated by cooperating growers. Spray volumes of 25 to 100 GPA and 
pressures of 50 to 250 psi will be targeted.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The Cry1F 
delta endotoxin gene from Bacillus thuringiensis variety aizawai has 
been cloned and expressed in the gram negative bacterium Pseudomonas 
fluorescens. The Pseudomonas fluorescens host bacteria is then killed, 
thereby encapsulating the Cry1F delta endotoxin. The product is a light 
brown liquid with a slight earthy odor. The formulation is stable and 
non-corrosive with a pH of 4.86 and a density of 1.061 g/cm3. The 
viscosity was measured to be 1,379 cps.
    2. Magnitude of residue anticipated at the time of harvest and 
method used to determine the residue. Mycogen expects the residue of 
the Cry1F derived delta endotoxin of Bacillus thuringiensis 
encapsulated in killed Pseudomonas fluorescens will be minimal at time 
of harvest due to the rapid degradation of the killed cells in the 
environment. In situations where treatments are made just prior to 
harvest, Mycogen believes residues on the commodity will not present 
any risk to human or animal health based on the established toxicology 
data and historical safe use of products containing delta endotoxins 
derived from Bacillus thuringiensis encapsulated in killed Pseudomonas 
fluorescens. Mycogen's petition for a temporary exemption from the 
requirement of a tolerance eliminates the need to determine the residue 
at time of harvest.
    3. A statement why an analytical method for detecting and measuring 
the levels of the pesticide residue are not needed. Mycogen states that 
residues of the Cry1F derived delta endotoxin of Bacillus thuringiensis 
encapsulated in killed Pseudomonas fluorescens at any level will not 
pose a threat to human health or to the environment. Mycogen is 
requesting a temporary exemption from the requirement of a tolerance 
for residues on all raw agricultural commodities; therefore, this 
action should prevent the need to quantify residues on food or feed 
commodities.

C. Mammalian Toxicological Profile

    The aizawai strain of Bacillus thuringiensis, which produces the 
Cry1F delta endotoxin, is used commercially in several registered 
pesticide products based on the general tolerance exemption established 
under 40 CFR 180.1011. To confirm the human safety of the Cry1F derived 
delta endotoxin encapsulated in killed Pseudomonas fluorescens, Mycogen 
conducted an acute oral LD50 toxicity study using the 
technical material. The acute oral LD50 was determined to be 
greater than 5,000 mg/kg body weight.
    Extensive toxicology tests have been performed by Mycogen with 
similar encapsulated delta endotoxins derived from Bacillus 
thuringiensis. Mycogen states that no toxic effects were observed for 
any of the organisms tested, including mammals, birds, fish and aquatic 
invertebrates.

D. Aggregate Exposure

    1. Dietary exposure: Food. Mycogen states that any dietary exposure 
to the Cry1F derived delta endotoxin of Bacillus thuringiensis 
encapsulated in killed Pseudomonas fluorescens will not present a risk 
to human or animal health due to the nontoxic properties of the killed 
organism. Dietary exposure is suggested to be minimal as the killed 
cells breakdown in the environment into natural biochemical components.
    2. Drinking water. Mycogen believes the immobility of the cells 
prevents transfer of the killed organism to aquatic habitats, 
groundwater or other drinking water sources.
    3. Non-dietary exposure. The use of the encapsulated Cry1F derived 
delta endotoxin under a controlled Experimental Use Permit will 
mitigate the potential for non-occupational exposure. The product will 
be used only by participants in the experimental program, and 
applications will involve terrestrial food crops on commercial 
agricultural property. The product will not be used on sites involving 
schools, parks or recreation facilities, or any other site not listed 
on the experimental product label.

E. Cumulative Exposure

    Like native strains of Bacillus thuringiensis, the encapsulated 
Cry1F derived delta endotoxin has a highly targeted mode of action on 
specific insect pests. This unique mode of action is a distinguishing 
factor of Bacillus thuringiensis delta endotoxins versus traditional 
chemistries. No cumulative exposure will occur with other pesticides 
and substances as a result of common mode of toxicity. Mycogen

[[Page 34286]]

believes normal use patterns and rapid degradation of the organism will 
not lead to accumulation of the killed cells in the environment.

F. Safety Determination

    1. U.S. population. Toxicology information regarding delta 
endotoxins derived from Bacillus thuringiensis is well established. 
During the widespread use of Bacillus thuringiensis over several 
decades for pest control purposes there has not been any confirmed 
reports indicating toxicity to humans or animals. In the Draft 
Registration Standard for Bacillus thuringiensis, EPA Case No. 0247 
dated December 1986, EPA stated that the delta endotoxin in Bacillus 
thuringiensis ``has no known toxic pathogenic effect in humans or other 
mammals.''
    2. Infants and Children. Mycogen states that the Cry1F derived 
delta endotoxin of Bacillus thuringiensis encapsulated in killed 
Pseudomonas fluorescens is practically non-toxic to humans and presents 
minimal risk to the environment. A determination of safety for infants 
and children can be made based on: (a) the established toxicology 
database demonstrating no mammalian toxicity; (b) the historical safe 
use of similar products using delta endotoxins from Bacillus 
thuringiensis; (c) the lack of persistence and mobility of the killed 
cells in the environment; and (d) the absence of use patterns under the 
Experimental Use Permit which may lead to exposure to infants and 
children.

G. Effects on the Immune and Endocrine Systems

    Mycogen states that the toxicology database on delta endotoxins 
derived from Bacillus thuringiensis demonstrate no toxicity to 
mammalian immune or endocrine systems. Using the encapsulation process 
to effectively kill all cells ensures that no metabolic byproducts are 
produced which could potentially present an adverse effect to the 
immune or endocrine systems. The decomposition of the killed cells in 
the environment and in mammalian metabolic systems will not lead to 
adverse effects to the immune or endocrine systems.

H. Existing Tolerances

    Strains of Bacillus thuringiensis are approved for use on raw 
agricultural commodities under the general tolerance exemption 
established by 40 CFR 180.1011. The gene encoding the Cry1F delta 
endotoxin is derived from Bacillus thuringiensis variety aizawai. 
Several products registered with EPA currently use the aizawai strain 
and are exempt from the requirement of a tolerance.
    The use of other similar delta endotoxins derived from Bacillus 
thuringiensis and encapsulated in killed Pseudomonas fluorescens are 
approved under 40 CFR 180.1107, 180.1108, and 180.1154. The 
encapsulated Cry1F derived delta endotoxin was already previously 
approved on April 29, 1994 under a temporary tolerance exemption from 
Mycogens Petition Number 3G4224.

[FR Doc. 97-16658 Filed 6-24-97; 8:45 am]
BILLING CODE 6560-50-F