[Federal Register Volume 75, Number 37 (Thursday, February 25, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3732]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Trichoderma gamsii strain ICC 080; Exemption from the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Trichoderma gamsii strain ICC 080 on
all food/feed commodities when applied preharvest in accordance with
good agricultural practices. Isagro, S.p.A. submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Trichoderma gamsii strain ICC 080.
DATES: This regulation is effective February 25, 2010. Objections and
requests for hearings must be received on or before April 26, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0749. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8077; e-mail address: email@example.com.
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
B. How Can I Access Electronic Copies of this Document?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2008-0749 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before April 26, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0749, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 12, 2008 (73 FR 66897) (FRL-
8368-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F7327) by Isagro, S.p.A., Via Caldera 21, fabbricato D,
la 3, 20153 Milano, Italy. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of Trichoderma gamsii strain ICC 080 (originally
classified as Trichoderma viride).
The docket (EPA-HQ-OPP-2008-0749) included a summary of the
petition prepared by the petitioner Isagro, S.p.A.. An anonymous
American citizen commented that only zero residue should be allowed and
expressed concern about toxic chemicals found in the bodies of
Americans. Pursuant to its authority under Federal Insecticide
Fungicide, and Rodenticide Act (FIFRA), the Agency conducted a rigorous
assessment of Trichoderma gamsii strain ICC 080 and concluded that it
is not expected to cause any unreasonable adverse effects to human
health or the environment. The Agency is establishing an exemption from
the requirement of a tolerance for this active ingredient, as neither
toxicity nor pathogenicity were observed for this active ingredient in
submitted laboratory studies.
Section 408(c)(2)(A)(i) of 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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA 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. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require 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) of FFDCA 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.
III. 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.
Trichoderma gamsii strain ICC 080 was isolated from a suppressive
soil in Sardinia, Italy. Trichoderma gamsii strain ICC 080 is used for
control of many soil borne fungal plant pathogens [i.e., Pythium
species (spp.), Phytophthora spp., Sclerotinia spp., Sclerotium spp.,
Thielaviopsis basicola, Rhizoctonia spp., Verticillium spp].
Trichoderma gamsii strain ICC 080 acts as a pathogen antagonist,
colonizing in soil and roots to compete with plant pathogenic fungi for
space and nutrients. Moreover, Trichoderma gamsii strain ICC 080 also
attacks the cell walls of pathogens with enzymes.
The Agency has reviewed toxicological data on Trichoderma gamsii
strain ICC 080 that was submitted by the manufacturer, Isagro, S.p.A.
in support of its petition for an exemption from the requirement of a
tolerance for residues of Trichoderma gamsii strain ICC 080.
EPA review of these studies indicated that the active ingredient
was not toxic to test animals when administered via the oral,
intraperitoneal or pulmonary routes of exposure. The active ingredient
was not infective or pathogenic to test animals when administered via
the pulmonary route. This pulmonary clearance is enough evidence to
demonstrate no infectivity. No reports of hypersensitivity have been
recorded from personnel working with this organism. Based on these
data, the Agency has concluded that there is a reasonable certainty
that no harm will result from aggregate exposure to residues of
Trichoderma gamsii strain ICC 080, including all anticipated dietary
exposures and all other exposures for which there is reliable
information. Thus, under the standard in FFDCA section 408(c)(2), an
exemption from the requirement for a tolerance is appropriate.
Studies on the active ingredient include the following.
An acceptable acute oral toxicity study (MRID 47345801)
was performed on rats given a single oral dose of Trichoderma gamsii
(formerly known as Trichoderma viride) strain ICC 080 of (7.5 x
108 CFU/g) in 0.9% NaCl solution at a dose of 2,000
milligrams/kilogram (mg/kg) of body weight in a limit test. The animals
were observed for a period
of up to 14 days. The oral LD50 for males, females, and the
combined test animals were: Males >2,000 mg/kg of body weight, females
>2,000 mg/kg of body weight, combined >2,000 mg/kg of body weight. No
mortalities occurred during the study. Based on the results of this
study, Trichoderma gamsii strain ICC 080 was found to be of low acute
oral toxicity. There were no treatment related clinical signs, changes
in body weight or pathological findings at necropsy.
An acceptable acute intraperitoneal injection toxicity (MRID
47345802) was submitted, in which groups of fasted, 41-48 days
old rats (3/sex) were injected with Trichoderma gamsii strain ICC 080
(at 7.5 x 108 CFU/g) in 0.9% NaCl solution at a dose of 1 x
107 CFU/g. Animals were then observed for up to 21 days.
Control animals (2/sex) were injected with 0.9% NaCl solution only.
Trichoderma gamsii strain ICC 080 is not toxic based on the results of
this study. There were no treatment - related necropsy findings or
changes in body weight. All of the animals treated with the test
material experienced slightly reduced mobility, slight ataxia, slightly
reduced muscle tone, slight dyspnea, mydriasis, and writhing, observed
60 minutes after administration. All of these clinical signs were
completely resolved within 24 hours.
Acceptable acute pulmonary toxicity/pathogenicity studies (MRID
47345803, 47345804) were submitted, in which groups of fasted
43-56 days old rats (31/sex) were exposed by the intratracheal route to
Trichoderma gamsii strain ICC 080 at a dose of 2.5 x 106
CFU/animal. Animals were observed for up to 22 days. Rats in the
control group were administered the vehicle, 0.1% solution of Tween 20
in aqua ad iniectabilia (water for injection) only. Rats in the
reference groups were administered inactivated test item. Samples of
feces, lungs, lymph nodes, kidneys, brain, liver, spleen, and blood
were taken for microbial enumeration in those tissues. None of the
administered Trichoderma gamsii conidia from lung tissue of the animals
appeared in other organ tissue. Conidia could not be detected in blood
samples at any time during the study. Conidia were detected in the
feces up to 21 days post administration. Conidia density in the lung
tissue decreased to 0 within 21 days post administration. This shows a
pattern of clearance and lack of infectivity of Trichoderma gamsii
strain ICC 080. The recorded pulmonary LD50 was greater than
2.5 x 106 CFU/animal in males, females and in the combined
group of test animals. No mortality occurred. Based upon these results,
Trichoderma gamsii strain ICC 080 is of low toxicity, and Trichoderma
gamsii was not infective or pathogenic in the rat. There were no
treatment related clinical signs, changes in body weight, or
pathological changes observed at necropsy.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Dietary exposure to the microbial pesticide is likely to occur.
However the lack of acute oral toxicity, infectivity, and pathogenicity
support the establishment of an exemption from the requirement of a
tolerance for Trichoderma gamsii strain ICC 080.
1. Food. Dietary exposure to the microbe is expected to be minimal.
The product is typically applied to soil and sometimes may be applied
when the crops are growing in the field, resulting in residues on the
crops. The Agency expects residues on food to be minimal because of the
typical way in which this pesticide will be applied to soils. Moreover,
Trichoderma lives in soils and is unlikely to live on the plants
because any spores that do end up on the plant due to application will
likely decrease over time due to weathering, desiccation and
ultraviolet radiation which can kill even quiescent forms of the
fungus. In the remote likelihood that the applied fungus can grow on
edible portions of the treated crop, there is no hazard present in
these residues due to the results of testing which show no toxicity or
pathogenicity in treated animals when dosed with the fungus at orders
of magnitude above any expected exposure to the microbial pesticide.
2. Drinking water exposure. Drinking water exposure is expected to
be negligible because this Trichoderma gamsii is not applied to water,
nor is it expected to proliferate in aquatic environments because
Trichoderma gamsii lives in soil. Moreover, the Agency believes that
Trichoderma within the soil will not likely percolate into water
because of the large size of the fungal spores and the fact that they
adhere to soil particles. Even if oral exposure should occur through
drinking water, the Agency concludes that there is a reasonable
certainty that no harm will result from the exposure to the residues of
Trichoderma gamsii in all the anticipated drinking water exposures
because of the lack of acute oral toxicity/pathogenicity to mammals as
B. Other Non-Occupational Exposure
Trichoderma gamsii strain ICC 080 is a naturally occurring microbe
and is ubiquitous in the environment. Trichoderma gamsii strain ICC 080
will be applied to substrate mixes, ornamental plants, agricultural
fields, turf, and various plants grown in greenhouses. Although some
applications to turf or ornamental plants may be in residential areas,
non-dietary exposure would be expected to be below the Agency's level
of concern because of its low toxicity classification, and because the
lab results indicate Trichoderma gamsii strain ICC 080 is not
pathogenic to mammals.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Trichoderma gamsii strain
ICC 080 and to other substances that have a common mechanism of
toxicity. These considerations include the possible cumulative effects
of such residues on infants and children. Based on tests in mammalian
systems, Trichoderma gamsii strain ICC 080 does not appear to be toxic
to humans via dietary and pulmonary exposure. Therefore, the
requirement to consider cumulative effects does not apply.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) as amended by the FQPA of 1996, provides
that EPA shall assess the available information about consumption
patterns among infants and children, special susceptibility of infants
and children to pesticide chemical residues and the cumulative effects
on infants and children of the residues and other substances with a
common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C)
also provides that EPA shall apply an additional tenfold margin of
safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database unless EPA determines that a different margin of safety will
be safe for infants and children.
Based on the acute toxicity information discussed in this Unit, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to the United States population, including
children, to residues of Trichoderma gamsii strain ICC 080. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because the data available on Trichoderma gamsii strain ICC
080 demonstrate a low toxicity/pathogenicity potential. Trichoderma
gamsii strain ICC 080 is not a human pathogen and has not been
implicated in human disease. Thus, there are no threshold effects of
concern and, as a result, the provision requiring an additional margin
of safety does not apply.
VII. Other Considerations
A. Endocrine Disruptors
The Agency has no information to suggest that Trichoderma gamsii
strain ICC 080 has an effect on the endocrine system. The submitted
acute pulmonary toxicity/pathogenicity study in rodents indicated that
following pulmonary exposure, the immune system is still intact and
able to process and clear the active ingredient. Trichoderma gamsii
strain ICC 080 is a ubiquitous organism in the environment and there
have been no reports of the organism affecting endocrine systems.
Therefore, it is unlikely that this organism would have estrogenic or
endocrine effects and it is practically non-toxic to mammals.
B. Analytical Methods
The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation. Because of the lack of
toxicity, pathogenicity, and infectivity of this organism and the fact
that its use as a pesticide is indistinguishable from what naturally
occurs in the environment, the Agency has concluded that an analytical
method is not required for enforcement purposes for Trichoderma gamsii
strain ICC 080.
C. Codex Maximum Residue Level
No Codex maximum residue level exists for Trichoderma gamsii.
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to residues of the Trichoderma gamsii strain ICC 080 in or on
all food and feed commodities. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion because, as
discussed in Unit III., no toxicity or pathogenicity to mammals has
been observed in test animals.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: February 4, 2010.
Acting Director, Office of Pesticide Program.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1293 is added to subpart D to read as follows:
Sec. 180.1293 Trichoderma gamsii strain ICC 080; exemption from the
requirement of a tolerance.
Trichoderma gamsii strain ICC 080 is exempted from the requirement
of a tolerance in or on all food and feed commodities when applied
preharvest and used in accordance with good agricultural practices.
[FR Doc. 2010-3732 Filed 2-24-10; 8:45 am]
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