[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Notices]
[Pages 15686-15690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8396]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-725; FRL-5594-8]
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-725, must
be received on or before May 2, 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-725 (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
[[Page 15687]]
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 (PF-725) 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.
Dated: March 24, 1997.
Janet L. Andersen,
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. AgriPhi Inc.
OPP-300357
EPA issued a notice OPP-300357, (FRL-4906-6), which was published
in the Federal Register of September 7, 1994 (59 FR 46247-46248),
announcing the establishment of a temporary tolerance exemption for
residues of the microbial pesticide bacteriophages isolated from
Xanthomonas campestris subsp. vesicatoria in or on the raw agricultural
commodities, tomatoes and peppers. EPA has received a pesticide
petition from AgriPhi Inc., which proposes, pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), as recently amended
by the Food Quality Protection Act, 21 U.S.C. section 346a, to amend 40
CFR part 180 to reestablish a temporary exemption from the requirement
of a tolerance for residues of the plant pesticide Xanthomonas
campestris pv. vesicatoria in or on the raw agricultural commodities,
tomatoes and peppers.
A. Proposed Use Practices
Recommended application method and rate(s), frequency of
application, and timing of application. AgriPhi Inc., proposes to
conduct testing of 120 gallons of bacteriophages isolated from
Xanthomonas campestris pv. vesicatoria in Brandenton Florida and Ruskin
Florida. Total acreage for both sites will occupy 25 acres. Tests will
be designed to evaluate the effectiveness of the active ingredient for
use in controlling bacterial diseases of tomatoes and peppers conducted
all year long (as needed) for two years. Growing plants of tomato and
pepper and/or the soil around the growing plants will be treated with
bacteriophages as a drench, spray or through chemigation at a
concentration of approximately 10 --8 pfu per ml. Plants will be given
multiple treatments at preplant and postmergence. Upon termination of
the tests the bactericide and container will be boiled for 10 minutes
and disposed of in accordance with local state and federal regulations.
B. Product Identity/Chemistry
The product is a colorless to light brown liquid with no to slight
odor. The liquid is non-corrosive and stable in aqueous solutions (pH 5
to 9) but denature by organic solvents. The liquid has a density of
1.06 g/cc and is stored stably for >1 year @ 4 degrees C but can be
degraded in four days if maintained at room temperature.
1. Identity of the pesticide and corresponding residues. AgriPhi
Inc., believes that no pesticide residues are expected.
2. Magnititude of residue anticipated at the time of harvest and
method used to dermine the residue. AgriPhi Inc., believes that little
concern exists for any residues of phages as they are ubiquitous in
nature, found in soil, water, raw produce, oysters and cheese. Data
from the published scientific literature indicates that bacteriophages
are harmless to mammals, fish and wildlife. Additionally,
bacteriophages are completely biodegradable and so pose not threat to
the environment.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. AgriPhi
Inc., states that phage residue at any level will pose no threat to
human health or the environment, therefore an analytical method for
detecting and measuring residue levels is not needed.
C. Mammalian Toxicological Profile
AgriPhi Inc., requested data waivers for Acute Toxicity/
Pathogenicity, Genotoxicity, Reproductive and Developmental Toxicity,
Subchronic Toxicity and Chronic Toxicity Studies. These data waivers
are supported by data from the published scientific literature which
indicates that bacteriophages are specific for their bacterial host and
present no unique toxicity hazards to humans, fish and wildlife or to
the environment. In addition to the phages effectiveness against there
has been no evidence to suggest non-selective infection. Phages have
been documented as being active against bacteria of many human
diseases. Daily exposure of phages are evident in the human consumption
of raw produce, cheeses and water without any adverse health effects.
AgriPhi Inc., believes that inasmuch as each phage is specific for its
target bacterial plant pathogen, they are nontoxic for growers who
would be applying page mixtures to seed, soil or crops.
D. Aggregate Exposure
1. Dietary exposure. a. Food. AgriPhi Inc., states that humans
are exposed daily to phages in the consumption of raw produce and
cheeses without any adverse effects or detriment to the human
intestinal microflora.
b. Drinking water. AgriPhi Inc., states that phages are naturally
occurring in waters and that there have been no reports of adverse
effects to humans exposed to municipal waters.
2. Non-dietary exposure (lawn care, topical insect repellents,
etc.). AgriPhi Inc., states that the use for this pesticide is
agricultural, therefore, non-dietary exposure pesticide will be minimal
to non-existent.
E. Cumulative Exposure
Exposure through other pesticides and substances with the common
mode of toxicity as this pesticide. AgriPhi, Inc., states that
bacteriophages are nontoxic to humans, fish and wildlife, therefore,
cumulative effects with other pesticides and substances will be minimal
to non-existent.
F. Safety Determination
1. U.S. population. AgriPhi Inc., states that phages are naturally
occurring entities found in soil, water and some foods. AgriPhi Inc.,
believes that because phages present no unique toxicity hazard to
humans, safety factors are not appropriate. Phages have been
[[Page 15688]]
active in the treatment of bacterial human diseases and have been
consumed by humans without any detectable or detrimental adverse human
health effects. Therefore, AgriPhi Inc., believes that there is
reasonable certainty that no harm will result to the U.S. population in
general from consumption of a bacteriophage.
2. Infants and children. AgriPhi Inc., states that data from the
published scientific literature reports that bacteriophages have been
used as a prophylactic treatment for children without any harmful
effects. Bacteriophages found in foods are not likely to occur in
different amounts in foods consumed by children and infants. Therefore,
AgriPhi Inc., concludes that there is a reasonable certainty that no
harm will result to infants and children from aggregate esposure to
residues of bacteriophages.
G. Existing Tolerances
A temporary tolerance was granted for this pesticide in August 1994
and expired in August 1996.
H. International Tolerance
No known international tolerances have been granted for this
pesticide. Therefore, based on the completeness and reliability of the
toxicity data from the published literature and the conservative
exposure assessment, AgriPhi Inc., concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to residues
of the pesticide Bacteriophages of Xanthomonas campestris pv.
vesicatoria including all anticipated dietary exposure and all other
non-occupational exposures.
2. Asgrow Seed Company
PP 6E4670
EPA has received a pesticide petition (PP) 6E4670 from Asgrow Seed
Company. 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 Cucumber Mosaic Virus and the
genetic materail 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. Asgrow 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, 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. Asgrow 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. Asgrow 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. Asgrow 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. However, because the Agency proposes to exempt all plant
virus coat proteins from the requirement of a tolerance, Asgrow
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 proeitn 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
ahve always been a part of both the human and domestic animal food
supply, and Asgrow agrees with EPA's finding that plant viruses are not
known to be harmful to humans (59 FR 60519-60535, November 23, 1994).
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 veterbrates,
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, Asgrow 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. Asgrow 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
Cucumber Mosaic Virus, 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
concumed with no detectable or observed adverse effects to human
health, including children and infants. Given this information, Asgrow
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, Asgrow believes that coat
proteins produced as plant-pesticides would represent a negligible
addition to those existing in drinking water.
2. Non-dietary exposure. Asgrow 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. Asgrow 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.
[[Page 15689]]
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, Asgrow reasonable believes that
consumption of a noninfectious component of the CMV 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 ubiquitious 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 that on adults. Viral coat proteins are not toxic and,
therefore, Asgrow 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 CMV coat protein.
H. International Tolerance
No international tolerance or exemption from tolerance has been
previously granted for CMV coat protein. Asgrow Seed Company concludes
that plant viruses, including CMV 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 Cucumber Mosaic Virus
and the genetic material necessary for its production, including all
anticipated dietary exposures and all other non-occupational exposures.
Accordingly, Asgrow believes that the CMV coat protein qualifies for an
exemption from the requirement of a tolerance in or on all raw
agricultural commodities.
3. Cornell University
PP 7F4813
EPA has received a pesticide petition (PP) 7F4813 from Cornell
University. 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 Papaya Ringspot 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. Cornell University states that
because the inserted genes are under the control of a constitutive
promoter, the coat proteins will be continuously produced by the plant
and not applied externally. In information accompanying the seeds that
are sold or provided to commercial growers, the resistance of the
resulting plants to Papaya ringspot Virus will be described. However,
no special instructions for use will be necessary. Appropriate cultural
practices will be determined by individual growers, as they are for all
other plant varieties.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Cornell
University states that the pesticide is a chimeric virus coat protein
that is produced by the transgenic papaya. The coat protein that is
produced consist of 16 amino acids from the cucumber mosaic virus coat
protein and the coat protein of papaya ringspot virus which consist of
289 amino acids. The molecular weight of the chimeric coat protein is
34,511.
2. Magnitude of residue anticipated at the time of harvest and
method used to determine the residue. Cornell University 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. Cornell University 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. However, because the Agency proposes to exempt all plant
virus coat proteins from the requirement of a tolerance, Cornell
University 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 Cornell University agrees with EPA's finding that plant
viruses are not known to be harmful to humans (59 FR 60519-60535,
November 23, 1994). 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 veterbrates, 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, Cornell University 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. Cornell University 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 Papaya Ringspot Virus, 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, Cornell
Unversity 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
[[Page 15690]]
be in the drinking water. Plant viruses are a natural component of the
environment and are present in soil and water. Consequently, Cornell
University believes that coat proteins produced as plant-pesticides
would represent a negligible addition to those existing in drinking
water.
2. Non-dietary exposure. Cornell University 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. Cornell University 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, Cornell University reasonably believes
that consumption of a noninfectious component of the PRV 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 ubiquitious in
foods, including those foods consumed by infants and children.
Moreover, there is not 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 that on adults. Viral coat proteins are not toxic and,
therefore, Cornell University 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 PRV coat protein.
H. International Tolerance
International tolerance levels for Papaya Ringspot Virus Coat
Protein have not been determined. However, papaya fruit from trees
infected with papaya ringspot virus are consumed by numerous people
throughout the world.
Cornell University concludes that plant viruses, including PRV 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 Papaya Ringspot Virus and the genetic material necessary for
its production, including all anticipated dietary exposures and all
other non-occupational exposures. Accordingly, Cornell University
believes that the PRV coat protein qualifies for an exemption from the
requirement of a tolerance in or on all raw agricultural commodities.
[FR Doc. 97-8396 Filed 4-1-97; 8:45 am]
BILLING CODE 6560-50-F