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Trichoderma harzianum (T-22G, F-Stop) - Revision of Tolerance Exemption 8/98

[Federal Register: September 16, 1998 (Volume 63, Number 179)]
[Rules and Regulations]
[Page 49466-49469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se98-16]

[[Page 49466]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300698; FRL 6022-1]
RIN 2070-AB78

Trichoderma Harzianum Strain T-39; Exemption from the Requirement
of a Temporary Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a
temporary tolerance for residues of the Trichoderma harzianum strain T-
39 in/on strawberry, table grape and wine grape when applied/used as
ground or foliar applications in accordance with the provisions of
experimental use permit 11678-EUP-1. Makhteshim-Agan of North America,
Inc. submitted an amended petition PP 6G4622 to EPA under the Federal
Food, Drug, and Cosmetic Act as amended by the Food Quality Protection
Act of 1996 (Pub. L. 104-170) requesting an exemption from the
requirement of a temporary tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of
Trichoderma harzianum strain T-39.

DATES: This regulation is effective September 16, 1998. Objections and
requests for hearings must be received by EPA on or before November 16,
1998.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300698], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled "Tolerance Petition Fees" and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk identified
by the docket control number, [OPP-300698], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300698]. No Confidential Business Information
(CBI) should be submitted through e-mail. Copies of electronic
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW, Washington, DC
20460. Office location, telephone number and e-mail address: Rm.
902W34, CM#2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 308-
8097; e-mail: bacchus.shanaz@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 24, 1998,
(63 FR 34390) (FRL 5795-9), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide tolerance petition by Makhteshim-
Agan of North America Inc., 551 Fifth Ave., Suite 1100, New York, NY
10176. This notice included a summary of the petition prepared by the
petitioner and this summary contained conclusions and arguments to
support its conclusion that the petition complied with the Food Quality
Protection Act (FQPA) of 1996.
    The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a temporary tolerance
for residues of the microbial antifungal agent Trichoderma harzianum
strain T-39 in or on all food/feed commodities. The data which were
evaluated for the Experimental Use Permit (EUP) granted in May of 1996
are sufficient to support the exemption from the requirement of a
temporary tolerance in/on table grape, wine grape and strawberry. There
were no comments received in response to the notice of filing. This

exemption from the requirement of a tolerance will expire on November
30, 2000.

I. Risk Assessment and Statutory Findings

    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement of a temporary tolerance (the legal
limit for a pesticide chemical residue in or on a food) only if EPA
determines that the tolerance is "safe." Section 408(b)(2)(A)(ii)
defines "safe" to mean that "there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information." This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to "ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue..." EPA performs a number of analyses to determine the risks
from aggregate exposure to pesticide residues. First, EPA determines
the toxicity of pesticides. Second, EPA examines exposure to the
pesticide through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings.

A. Proposed Use

    The rates, frequency and timing of the applications vary. The
pesticide is to be applied by ground equipment as a foliar spray.
Application rates are 2 to 4 pounds per acre per application from pre-
bloom to harvest. 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. Strawberry may be treated with one to eight
applications once per week throughout the growing season from pre-bloom
to harvest.

B. Product Chemistry

    The data submitted for product identity of the active ingredient,
Trichoderma harzianum strain T-39, and end use product, Trichodex, are
acceptable for the limited use proposed for this EUP. The active
ingredient, Trichoderma harzianum, is a naturally-occurring fungus
which can be found in the US and in the environment worldwide. The
microbial pesticide

[[Page 49467]]

contains dried solids and solubles resulting from the fermentation of
Trichoderma harzianum isolate T-39, containing T-39 fungus propagules
as either conidia or mycelia. Published literature characterize
Trichoderma harzianum strain T-39 by colony and structural morphology,
and by intraspecific DNA primers. Additional data are likely to be
required for more extensive use patterns.

II. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
relevant available scientific data and other information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Results of the following studies support the lack of toxicity/
pathogenicity of the Technical Grade Active Ingredient (TGAI),
Trichoderma harzianum: acute oral, acute dermal, and the primary dermal
irritation. The microbial pesticide was classified acute Toxicity
Category III for these health effects.
    The two acute eye irritation studies indicate a potential for the
TGAI to cause severe eye irritation, placing the Technical Grade Active
Ingredient in acute Toxicity Category I. However, another eye
irritation study in which the test material was the End-use Product
(EP), Trichodex, indicates the EP is mildly irritating or in the acute
Toxicity Category III. This categorization is acceptable for labeling
of the EP.
    While the acute pulmonary study indicated that the TGAI Trichoderma
harzianum did not replicate in the rat body, the reported data did not
demonstrate a clear clearance pattern from the lungs. Based on this
study and because the predominant inert ingredient is a known
inhalation hazard, the microbial was classified as an acute Toxicity
Category II pesticide for acute inhalation effects.

III. Aggregate Exposures and Risk

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures of consumers and
major identifiable subgroups of consumers from the pesticide residue in
food and all other non-occupational exposures, including drinking water
from groundwater or surface water and exposure through pesticide use in
gardens, lawns, or buildings (residential and other indoor uses).

A. Dietary Exposure and Risk

    Dietary exposure to the microbial pesticide is likely to occur. The
lack of acute oral toxicity/pathogenicity, and the ubiquitous nature of
the microbial, support the establishment of an exemption from the
requirement of a temporary tolerance for this active ingredient.
    1. Food. The microbial pesticide can be easily removed from foods
by washing, peeling, cooking and processing. For this EUP, strawberry,
wine grape and table grape are to be treated in small areas in seven
states AZ, CA. FL, NY, OH, OR, and WA. Consequently, dietary exposure
to the microbial and the risk posed by ingestion of foods treated with
the microbial pesticide, are likely to be minimal for adults, infants
and children by the oral route.
    2. Drinking water exposure. Oral exposure, at very low levels, may
occur from ingestion of drinking water. However, the experimental
permit allows use of this pesticide on a small area in one state on
three crops, thus limiting potential exposure to drinking water. Even
if negligible exposure should occur, the Agency concludes that such
exposure would present no risk due to the lack of toxicity and the
ubiquitous nature of the microbe.

B. Other Non-Occupational Exposure

    The experimental use sites for Trichoderma harzianum strain T-39
are strawberry, wine grape and table grape for control of Botrytis by
displacement. Therefore, exposure and risk to adults, infants and
children via treated lawns or recreational areas are not likely if the
pesticide is used as labeled.
    1. Dermal exposure. The experimental use permit allows limited use
of the pesticide in small areas in seven states. Workers are most
likely to be dermally exposed during treatment of strawberry, wine
grape and table grape. Because the pesticide is placed in Acute
Toxicity Category III for dermal effects and the experimental use of
the pesticide is limited, the exposure and risk to workers is likely to
be minimal. Appropriate Personal Protective Equipment have been
recommended by the Agency to mitigate against potential dermal exposure
to pesticide handlers.
    2. Inhalation exposure. The pesticide is considered an Acute
Toxicity Category II microbial pesticide on the basis of inhalation
studies. Adequate Personal Protective Equipment, including a dust-mist
filtering respirator with NIOSH/MSHA prefix TC-21C, or equivalent, such
as N-95, R-95 or P-95 respirator, and a Restricted-Entry Interval of 12
hours are required to mitigate against potential exposure and risk
posed by the use of the pesticide during the experimental field trials.

IV. Cumulative Exposure to Substances with Common Mechanisms of
Toxicity

    Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
"available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a
common mechanism of toxicity." There are other species and strains of
Trichoderma registered. As discussed under Product Chemistry, the
Agency has received information to distinguish strain T-39 from other
registered strains. It is not clear to the Agency whether the
registered strains share a common mechanism of toxicity, or any
mechanism of toxicity with strain T-39.

V. Safety Factors

    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (safety) for infants and children in the
case of threshold effects to account for pre-and-post-natal toxicity
and the completeness of the database unless EPA determines that a
different margin of exposure (safety) will be safe for infants and
children. In this instance, EPA believes there are reliable data to
support the conclusion that there are no threshold effects of concern
to infants, children and adults when Trichoderma harzianum strain T-39
is used as labeled. As a result, the provision requiring an additional
margin of exposure does not apply.

VI. Infants and Children

    The pesticide is to be applied to strawberry, wine grape and table
grape to small areas in seven states as previously described. Because
of this limited use pattern, and its low toxicity/pathogenicity, there
is minimal potential for exposure and risk to infants and children.

VII. Determination of Safety for U.S. Population, Infants and
Children

    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to Trichoderma harzianum strain T-39 from the limited use
pattern of this experimental use permit. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information.

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VIII. Other Considerations

A. Endocrine Disruptors

    EPA does not have any information regarding endocrine effects of
this microbial pesticide at this time. The Agency is not requiring
information on the endocrine effects of this pesticide at this time;
and Congress allowed 3 years after August 3, 1996, for the Agency to
implement a screening and testing program with respect to endocrine
effects.

B. Analytical Method(s)

    The Agency is requiring standard microbial assays and analytical
methods to identify the active ingredient and potential contaminants.

C. Environmental Effects

    This final rule also extends the Experimental Use Permit associated
with the exemption from the requirement of a temporary tolerance. Data
and information have been provided to support the extension of the EUP.
The application of this pesticide to the experimental fields is not
likely to have adverse effects on avian species, fish and honey bee.
These data include two 14-day acute oral avian studies in the mallard
duck and bobwhite quail, a 96-hour study for freshwater fish, and a
honeybee study. While the studies were not adequate for a section 3(c)
2(b) registration, they are adequate for the limited EUP. Additional
data are required for more extensive use patterns.

IX. Conclusions

    The Agency has concluded that the experimental use of this
pesticide will not pose any adverse health effects to the U.S.
population, infants and children, nor to the environment because of the
low toxicological profile and the limited use patterns discussed above
for this EUP. As a result, EPA establishes an exemption from temporary
tolerance requirements pursuant to FFDCA section 408(j)(3) for
Trichoderma harzianum strain T-39 in/on strawberry, table grape and
wine grape. This exemption from the requirement of a temporary
tolerance expires November 30, 2000. This rule also concurrently
extends the Experimental Use Permit to November 30, 2000.

X. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process
for persons to "object" to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) as
was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
    Any person may, by November 16, 1998, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the "ADDRESSES" section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issues(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information 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.

XI. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public
version, as described above, will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in "ADDRESSES" at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov

    Electronic objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of
objections and hearing requests in electronic form must be identified
by the docket contol number (OPP-300698). No CBI should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.

XII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes an exemption from the requirement of a
temporary tolerance requirement under FFDCA section 408(d) in response
to a petition submitted to the Agency. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require and prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629), February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from

[[Page 49469]]

Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997).

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments. If the mandate is unfunded, EPA must
provide to the Office of Management and Budget (OMB) a description of
the extent of EPA's prior consultation with representatives of affected
State, local and tribal governments, the nature of their concerns,
copies of any written communications from the governments, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 12875 requires EPA to develop an effective process
permitting elected officials and other representatives of State, local
and tribal governments "to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates."
    Today's rule does not create an unfunded federal mandate on State,
local or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments "to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities."
    Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
    In additions, since tolerance exemptions that are established on
the basis of a petition under section 408(d) of the FFDCA, such as the
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

XIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This is not a
"major rule" as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 26, 1998.

Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180 -- [AMENDED]

    1. The authority citation for part 180 continues to read as
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1201, is added to subpart D to read as follows:

Sec. 180.1201  Trichoderma harzianum strain T-39; exemption from the
requirement of a temporary tolerance.

    Trichoderma harzianum strain T-39 is exempted from the requirement
of a temporary tolerance in/on table grapes, wine grapes and
strawberries treated in accordance with the Experimental Use Permit
11678-EUP-1. This exemption from the requirement of a tolerance will
expire on November 30, 2000.

[FR Doc. 98-24839 Filed 9-15-98; 8:45 am]
BILLING CODE 6560-50-F