[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