[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: hollis.linda@epamail.epa.gov.
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:
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 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
