[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Rules and Regulations]
[Pages 16856-16860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8637]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300823; FRL-6070-3]
RIN 2070-AB78


Trichoderma harzianum KRL-AG2 (ATCC #20847) or Strain T-22; 
Revision of Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:This regulation establishes an exemption from the requirement 
of a tolerance for residues of the microbial pesticide active 
ingredient Trichoderma harzianum KRL-AG2 (ATCC #20847) also known as 
strain T-22 when applied/used as seed treatments, on cuttings and 
transplants, or as soil

[[Page 16857]]

treatments and certain foliar applications. Bioworks Inc., 122 North 
Genesee Street, Geneva, New York 14456 submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996 requesting an exemption from the 
requirement of a tolerance. This rule allows a revision of the existing 
exemption from tolerances for seed treatments (40 CFR 180. 1102) for 
residues of Trichoderma harzianum KRL-AG2 (ATCC #20847, also known as 
strain T-22) to include additional food commodities. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Trichoderma harzianum KRL-AG2.

DATES: This regulation is effective April 7, 1999. Objections and 
requests for hearings must be received by EPA on or before June 7, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300823], 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-300823], 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: [email protected]. 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-300823]. 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: 9th 
fl., Crystal Mall #2 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-
8097, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 22, 1997 
(62 FR 34390) (FRL-5737-2), EPA issued a notice pursuant to section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), 
as amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 
104-170) announcing the filing of a pesticide tolerance petition by 
Bioworks Inc., 122 North Genesee Street, Geneva, New York 14456. This 
notice included a summary of the petition prepared by the petitioner 
Bioworks, Inc. The petition requested that 40 CFR part 180 be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of Trichoderma harzianum KRL-AG2 (ATCC #20847) in/on all food 
commodities. There were no comments received in response to the notice 
of filing.

I. Risk Assessment and Statutory Findings

    New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a 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(c)(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...'' Additionally, section 408 (b)(2)(D) requires that 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.''
    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.

II. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant 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.
    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 active ingredient in a list of low risk pesticides 
qualifying for reduced restricted entry intervals (REI) depending on 
the exposure and risk posed to workers. The data submitted to support 
the initial registration of this product includes three acute rat 
studies, an acute oral toxicity/pathogenicity study, an acute pulmonary 
toxicity/pathogenicity study and an acute intravenous toxicity study. 
The active ingredient is classified as Toxicity Category IV on the 
basis of those studies. A waiver was granted for the acute dermal 
toxicity studies.
    T. harzianum KRL-AG2 (ATCC #20847) is not known to produce any 
compounds or metabolites of 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. There are no known genotoxic or reproductive effects.

III. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from groundwater or surface water and exposure through

[[Page 16858]]

pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    Trichoderma harzianum is a naturally occurring fungus. This strain 
is a typical member of that species. There is no evidence that it 
presents any risk to animals or humans. This species 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 is 
not likely to result in a sustained increase in the population levels 
of this organism beyond the naturally occurring background levels of 
Trichoderma harzianum.

A. Dietary Exposure

    Dietary exposure is not expected from the use of this microbial 
pesticide as labeled. The microbial pesticide can be removed by 
peeling, washing, cooking and processing. Therefore, risk and exposure 
to humans, infants and children is likely to be minimal.
    1. Food. 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 exemption from the 
requirement of a tolerance for this active ingredient.
    2. Drinking water exposure. The microorganism Trichoderma harzianum 
KRL-AG2 (ATCC #20847) is common in the soil and may be found in aquatic 
habitats. Drinking water is not being screened for Trichoderma 
harzianum KRL-AG2 (ATCC #20847) as a potential indicator of microbial 
contamination. Both percolation through soil and municipal treatment of 
drinking water would reduce the possibility of exposure to Trichoderma 
harzianum KRL-AG2 (ATCC #20847) through drinking water. Therefore, the 
potential of significant transfer to drinking water is minimal to 
nonexistent. However, even if negligible oral exposure should occur 
through drinking water, 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

    Dermal and inhalation exposure and risk to adults, infants and 
children via treated lawns or recreational areas are likely if the 
pesticide is used as labeled. However, the pesticide is a naturally 
occurring microbe and is ubiquitous in the environment. Based on the 
low toxicity potential as evidenced by the data submitted, the 
microbial pesticide active ingredient is likely to pose a minimal to 
nonexistent dermal or inhalation hazard if used as labeled.

IV. Cumulative Effects

    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 several strains of 
Trichoderma spp. registered at this time. While these strains may 
produce similar metabolites, the likelihood of adverse cumulative 
effects via a common mechanism of toxicity is likely to be minimal 
based on the lack of toxicity/pathogenicity potential of the active 
ingredients.

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

    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 KRL-AG2 
(ATCC #20847) is used as labeled. As a result, the provision requiring 
an additional margin of exposure does not apply.

VI. 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 registrant has submitted data and analytical methods to 
identify potential contaminants and to assure that they are within 
regulatory levels. All batches containing potential human pathogens are 
to be destroyed.

C. Codex Maximum Residue Level

    There are no Codex maximum residue levels for this active 
ingredient.

D. Conclusions

    The Agency has concluded that the use of this pesticide will not 
pose any adverse health effects to the U.S. population, infants and 
children, because of the low toxicological profile. As a result, EPA 
establishes an exemption from tolerance requirements pursuant to FFDCA 
section 408(j)(3) for Trichoderma harzianum KRL-AG2 (ATCC #20847) in/on 
all food commodities.

VII. 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)and 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 June 7, 1999, 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). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services

[[Page 16859]]

Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300823] (including any comments and data submitted 
electronically). 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 public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:

    [email protected].

    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit 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 record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

     This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA 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. 3501et 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 any 
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 Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (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 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 officials and other representatives of

[[Page 16860]]

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.

X. 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 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 rule 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: March 24, 1999.

Janet L. Andersen,

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. 321(q), 346(a), and 371.

    2. Section 180.1102 is revised to read as follows:


Sec. 180.1102   Trichoderma harzianum KRL-AG2 (ATCC #20847) strain T-
22; exemption from requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Trichoderma harzianum KRL-AG2 (ATCC 
#20847); also known as strain T-22 when applied in/or on all food 
commodities.

[FR Doc. 99-8637 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-F