[Federal Register Volume 63, Number 121 (Wednesday, June 24, 1998)]
[Notices]
[Pages 34390-34392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16778]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-815; FRL-5795-9]
Pesticide Temporary Tolerance Exemption Petition; Notice of
Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the filing of a pesticide petition
proposing the extension of the exemption from the requirement of a
temporary tolerance for residues of Trichodex (Trichoderma harzianum T-
39) in and on all raw agricultural commodities as granted in Pesticide
Petition 6G4622, concomitant with the extension of the Experimental Use
Permit 11678-EUP-1. These extensions are requested to comply with the
Food Quality Protection Act of 1997. The summary of the petition in
this notice was prepared by the petitioner.
DATES: Comments, identified by the docket control number PF-815, must
be received on or before July 24, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7502C), 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. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow 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. 119 at the
Virginia address given above, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus (PM-90) Biopesticides
and Pollution Prevention Division,
[[Page 34391]]
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington DC 20460. Office location and telephone number:
5th floor, CS #1, 2800 Crystal Drive, Arlington, VA 22202, Telephone
number 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-815] (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 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [PF-815] 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: June 15, 1998.
Kathleen D. Knox,
Acting 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.
Makhteshim-Agan of North America Inc.
PP 6G4622
EPA has received a request to extend the pesticide petition (PP
6G4622) 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. section 346a(d), to
amend 40 CFR part 180 by extending the exemption from the requirement
of a temporary tolerance for residues of the biofungicide Trichodex
(Trichoderma harzianum T-39) in and on all raw agricultural
commodities. According to the proposed extension request, 8,120 pounds
(3,683 kg) of the microbial pesticide are to be applied to the sites
previously described in the original Experimental Use Permit which has
been in progress for 2 years.
EPA has determined that the petition contains 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.
As required by section 408 (d) of the FFDCA, as recently amended by
the Food Quality Protection Act, Makhteshim-Agan of North America Inc.
included in the petition a summary of the petition and authorization
for the summary to be published in the Federal Register in a notice of
the receipt of the petition. The summary represents the views of
Makhteshim-Agan of North America Inc.; EPA as mentioned above is in the
process of evaluating the petition. As required by section 408 (d) (3)
EPA is including the summary as part of this notice of filing. EPA may
have made minor edits to the summary for the purpose of clarity.
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, 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 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 resulting from Trichodex
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applications do not pose a hazard to humans, plants and animals. T.
harzianum 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 extension
of the exemption from the requirement of a temporary 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 milligrams/kilograms (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. i. 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 in all RACs.
Submitted studies indicate that residues of Trichodex do not pose a
hazard to humans by route of ingestion.
ii. 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.
2. Non-dietary exposure. Based on label directions for use as a
foliar applied biofungicide, he 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, and, (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
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. 98-16778 Filed 6-23-98; 8:45 am]
BILLING CODE 6560-50-F
