[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Notices]
[Pages 44689-44692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22375]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-756; FRL-5737-2]
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 food commodities.
DATES: Comments, identified by the docket control number PF-756, must
be received on or before September 22, 1997.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7506C), Information Resources and Services
Division, 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: Shanaz Bacchus (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) 308-8097;
e-mail: bacchus.shanaz@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 food
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 granting of
the petition. Additional data may be needed before EPA rules on the
petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-756] (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 number [PF-756] and appropriate petition
number. Electronic comments on this notice may be filed online at many
Federal Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: August 17, 1997.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. 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. BioWorks, Inc.
PP 6F4650
EPA has received a pesticide petition from Bioworks, Inc., 122
North Genesee Street, Geneva, New York 14456, proposing pursuant to
section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
section 346a(d), to amend 40 CFR Part 180 to establish an exemption
from the requirement of a tolerance for Trichoderma harzianum Rifai
strain KRL-AG2 in or on all raw agricultural commodities, except
mushrooms.
[[Page 44690]]
A. Residue Chemistry
1. Plant metabolism. The active ingredient is Trichoderma harzianum
Rifai strain KRL-AG2 (a.k.a. T-22), a strain of a naturally occurring
soil microorganism. This organism controls plant diseases mechanically
and is not absorbed or otherwise incorporated into the plant. It has no
affect on plant metabolism. This organism controls plant disease by
competing with plant pathogens for root and foliar surfaces for the
establishment of fungal colonies. Trichoderma harzianum Rifai strain
KRL-AG2 also controls plant pathogens by the mechanism of
mycoparasitism.
2. Analytical method. BioWorks has not proposed an analytical
method for assessing residues because this organism is naturally
occuring, non-toxic and present in a wide variety of habitats,
including water. Because there is a natural background population of
this organism it would be impossible to distinguish between natural and
introduced microbial populations and to establish and enforce any
tolerance for this organism. Trichoderma harzianum (T-22) does not have
adverse affects on the environment, animals or humans. This organism
does not persist when applied to foliage or fruit. Ordinary
environmental conditions cause rapidly declining population levels of
the microbe soon after application to above-ground plant parts.
3. Magnitude of residues. The only residue expected at harvest is
the background level of Trichoderma harzianum (T-22) currently present
on agricultural commodities. Any Trichoderma harzianum (T-22), either
naturally occurring or applied, remaining at harvest will be removed or
rendered nonviable by the usual processing of the food or feed.
B. Toxicological profile
1. Acute toxicity. Strain T-22 was determined to be non-toxic
during the initial Tier I toxicological tests. This pesticide is
currently registered for seed treatments for which an exemption from
tolerance exists for certain raw agricultural commodities (40 CFR
180.1102). In PR Notice 95-3, June 7, 1995 the Agency included this
fungus in a list of low risk pesticides qualifying for reduced
restricted entry intervals.
a. Acute oral toxicity/pathogenicity. Ingestion of this product
produced no apparent signs of toxicity, pathogenicity, or infection
following a 21-day test period in both female and male rats. The active
ingredient is classified as toxicity category IV for oral toxicity.
b. Acute pulmonary toxicity/pathogenicity. A high concentration
test article given by intratracheal injection to male and female rats
produced no apparent signs of toxicity or pathogenicity. The active
ingredient is classified as toxicity category IV for pulmonary
toxicity.
c. Primary dermal and eye irritation. EPA granted a waiver for the
acute dermal toxicity studies in a letter dated June 28, 1990. The
active ingredient is classified as toxicity category III for dermal
exposure.
d. Acute intravenous toxicity. A high concentration test article
was given by intravenous injection to male and female rats. Not
apparent signs of toxicity or pathogenicity were observed.
e. Hypersensitivity incidents reported. No incidents of
hypersensitivity in humans have been reported during the production and
handling of this active ingredient.
f. Immune response. This organism is non-toxic and naturally
occurring. There is no evidence of any negative impact on the immune
systems of humans.
g. Tissue culture. All available literature indicates that the use
of this organism as a pesticide is safe for humans.
Based on the results of the Tier I tests there was no indication
that subchronic or chronic studies were required.
2. Metabolite toxicology. Strain T-22 produces no known metabolites
of any environmental or health concern. This organism controls plant
disease by competing with plant pathogens for root and foliar surfaces
for the establishment of fungal colonies and by mycoparasitism.
C. Aggregate Exposure
1. Dietary exposure. Trichoderma harzianum (T-22) is a non-toxic,
naturally occurring fungi. There is no evidence that it presents any
risk to animals or humans. It is present in many different types of
environments worldwide. Because of its ubiquitous nature all humans and
animals have some natural exposure to the organism. Proposed
application methods, uses, and application rates will not result in a
sustained increase in the population levels of this organism beyond the
naturally occurring background levels of Trichoderma harzianum (T-22).
2. Food. Use of strain T-22 as a pesticide will result in little or
no residue on food and feed and is highly unlikely to increase exposure
of humans to Trichoderma harzianum (T-22) fungi by dietary means.
3. Drinking water. Trichoderma harzianum strains are commonly found
in water worldwide. Their presence in drinking water does not present a
risk to animals or humans because the fungus is non-toxic and consumed
in low concentrations. It is highly unlikely that use of strain T-22 as
a pesticide will increase the concentration of this organism in the
water supply beyond the already existing background levels of naturally
occurring populations.
4. Non-dietary exposure. The only non-dietary exposure expected is
to applicators. However, exposure to this organism resulting from its
application according to label directions is not expected to present
any risk of adverse health effects.
D. Cumulative Effects
Because this organism controls disease by mechanical, not chemical
means, and the organism itself is non-toxic there will be no cumulative
exposure created by other pesticides acting with the same mode of
toxicity. In addition, no cumulative adverse health effects are
expected from long-term exposure to this organism.
E. Safty Determination
1. U.S. population. Strain T-22 is a strain of naturally occurring
non-toxic organism. Use of this organism as a pesticide product will
result in little or no residues on food or feed. Since people are
already exposed to this organism in nature, the incremental exposure
from its use as a pesticide product is expected to be negligible.
2. Infants and children. Any differences in infants and children's
dietary habits or exposure patterns to this organism do not correlate
with an increased risk of harm to children. There is no information
suggesting differential sensitivity of infants and children to this
natural organism. Infants and children are currently exposed to this
organism in the natural environment and no data suggest that the use of
this organism as a pesticide will harm children.
F. Internal Tolerances
There are no international tolerances or tolerance exemptions for
this biocontrol fungus.
2. Makhteshim-Agan of North America Inc.
PP 7F4812
EPA received a pesticide petition (PP 7F4812) from Makhteshim-Agan
of North America Inc., 551 Fifth Avenue, Suite 1100, New York, NY
10176, proposing pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing an exemption from the requirement of a tolerance for
residues of the biofungicide Trichodex
[[Page 44691]]
(Trichoderma harzianum T-39) in or on all raw agricultural commodities.
A. Proposed Use Practices
Recommended application method and rate(s), frequency of
application, and timing of application. Trichodex may be applied with
conventional spray equipment for control of Botrytis (gray mold) on
fruit and vegetable crops. The rate of application is two to four
pounds of Trichodex per acre in sufficient gallonage to insure adequate
coverage. The frequency and timing of application vary with the crop
being treated. For example, one to four applications are made to wine
grapes in a rotational program with conventional chemical fungicides,
while four to six applications may be applied to wine grapes when the
product is used alone. Table grapes are treated with one to three
applications during pre-bloom to fruit set. Treatments on strawberry
may include up to eight applications (once per week) throughout the
growing season from pre-bloom to harvest.
B. Product Identity/ Chemistry
1. Identity of the pesticide and corresponding residues. The active
ingredient is Trichoderma harzianum T-39, a fungus which occurs
naturally in the environment worldwide, including in the U.S. The
strain of T. harzianum used in Trichodex has been designated as ``T-
39.'' This strain has been characterized by colony and structural
morphology, RFLP mapping and classified by intraspecific DNA primers.
The strain is typical of T. harzianum and does not express
characteristics of plant pathogenic strains. The organism does not
persist in the environment and relies on repeated application to
achieve plant protection. The organism degrades in the environment to
natural organic constituents.
2. Magnitude of residue anticipated at the time of harvest and
method used to determine the residue. Makhteshim-Agan of North America
has requested waivers for these data requirements. The waiver requests
were based on the known low toxicity of Trichodex, the natural
occurrence of T. harzianum T-39 in the environment, the non-toxic mode
of action, the submitted data and information available in the open
literature.
3. Statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed.
Makhteshim-Agan of North America has not proposed an analytical method,
because residues of T. harzianum T-39 resulting from Trichodex
applications do not pose a hazard to humans, plants and animals. T.
harzianum T-39 from naturally occurring strains is commonly found in
the environment and can be reasonably expected to exist whether or not
Trichodex has been applied to the growing crop.
C. Mammalian Toxicological Profile
Provide the following or rationale for waiver request.
1. Acute toxicity. The health effects data submitted in the
Makhteshim-Agan of North America Inc. petition and all other relevant
material have been fully evaluated by the EPA in their approval of an
Experimental Use Permit for large scale field evaluation of Trichodex.
The mammalian toxicological data considered in support of the exemption
from the requirement of a tolerance for Trichodex include: an acute
oral toxicity study in rats, a primary eye irritation study in rabbits
and an acute inhalation study in rats. All three studies were assigned
Toxicity Category III. The submitted acute dermal toxicity study in
rabbits, primary dermal irritation study in rabbits, and a dermal
sensitization study in guinea pigs were assigned Toxicity Category IV.
The results of these studies indicated that Trichodex has an acute
oral LD50 greater than 500 mg/kg body weight in rats, an
acute dermal LD50 greater than 1,150-1,570 mg/kg body weight
in rabbits. Trichodex caused reversible eye irritation with complete
clearance after 7 days. No dermal irritation in rabbits was observed,
however, the product was found to be a delayed contact dermal
sensitizer in guinea pigs (based on the modified Beuhler Assay). The
acute pulmonary toxicity/ pathogenicity study in the rat showed no
evidence of pathogenicity or Trichodex reproduction in the tissues
examined. Although the study was of insufficient duration to achieve
complete clearance in the lung, the study demonstrated clearance in
brain, blood, lymph nodes, kidney, liver, spleen, and caecum. Toxicity
Category III was assigned to pulmonary exposure mitigated by label
instructions indicating personal protective equipment for applicators.
2. Genotoxicity, reproductive and developmental toxicity,
subchronic toxicity, and chronic toxicity. The T-39 strain of T.
harzianum, the active ingredient in Trichodex, does not produce fungal
metabolites as its primary mode of action against target plant
pathogens. Submitted studies using the Ames Test and Mouse Micronucleus
test show no indication of genotoxic or reproductive effects.
D. Aggregate Exposure
1. Dietary exposure-- a. Food. Trichodex is based on a naturally
occurring organism normally found in the environment. For the purposes
of assessing the potential dietary exposure under this exemption, it
should be considered that T. harzianum may be present on all RACs.
Submitted studies indicate that residues of Trichodex do not pose a
hazard to humans by route of ingestion.
b. Drinking water. Based on the available studies presented for use
in the assessment of environmental risk, it is not anticipated that
drinking water will provide a route of exposure to residues of
Trichodex. The anticipated use pattern for Trichodex does not include
use in or on waterways. Even though Trichodex can be washed off treated
plants by rain and during processing of crops by water, it degrades in
an aqueous environment into organic constituents by normal biological,
physical, and chemical processes.
c. Non-dietary exposure. Based on label directions for use as a
foliar applied biofungicide. The only non-dietary exposure is to
applicators of the product. However, exposure to Trichodex resulting
from its proper application according to label directions for the use
of personal protective equipment is not expected to present any risk of
adverse health effects.
E. Cumulative Exposure
Other than a possible allergic reaction to spores present in the
product following repeated exposure, no cumulative adverse health
effects are expected from long-term exposure to Trichodex. Risk of
dermal sensitization is addressed on the label which specifies proper
personal protective equipment to minimize exposure.
Exposure through other pesticides and substances with a common mode
of toxicity with this pesticide. Consideration of a common mechanism of
toxicity is not appropriate for several reasons:
(1) Trichodex has a non-toxic mode of action.
(2) Only a small number of pesticidal products containing T.
harzianum as an active ingredient are currently registered.
(3) The species is ubiquitous in nature.
(4) The active ingredient has been demonstrated to be non-toxic in
submitted acute studies.
F. Safety Determination
1. U.S. population in general. Trichodex is based on a naturally
[[Page 44692]]
occurring organism normally found in the environment and on crop
plants. The low toxicity of the subject active ingredients is
demonstrated by the data summarized above. Based on this information,
it has been determined that aggregate exposure to Trichodex over a
lifetime will not pose appreciable risks to human health and there is a
reasonable certainty that no harm will result from Trichodex residues.
Since people are exposed to T. harzianum from natural sources, the
incremental exposure from its use in pesticide products is expected to
be negligible.
2. Infants and children. It has been determined that the toxicity
and exposure data are sufficiently complete to adequately address the
potential for additional sensitivity of infants and children to
residues of Trichodex. It is concluded that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to Trichodex residues.
G. Existing Tolerances
1. Existing tolerances or tolerance exemptions. A temporary
tolerance exemption in conjunction with an Experimental Use Permit for
Trichodex is currently in effect. EPA has also promulgated permanent
exemptions from the requirement for a tolerance for strains of T.
harzianum other than T-39.
2. International tolerances or tolerance exemptions. No maximum
residue level has been established for Trichodex by the Codex
Alimentarius Commission. Exemptions from the requirement of a tolerance
have been granted for Trichodex in all international registrations.
[FR Doc. 97-22375 Filed 8-21-97; 8:45 am]
BILLING CODE 6560-50-F
