[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