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[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: [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 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:
    [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 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
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