[Federal Register Volume 75, Number 41 (Wednesday, March 3, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3854]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Trichoderma asperellum strain ICC 012; 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 asperellum strain ICC
012 on all food/feed commodities when applied pre-harvest 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 asperellum strain ICC 012.
DATES: This regulation is effective March 3, 2010. Objections and
requests for hearings must be received on or before May 3, 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-2008-0750. 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-
2008-0750 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 May 3, 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-2008-0750, 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-
8386-8), 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 8F7326) 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 asperellum strain ICC 012
(originally classified as Trichoderma harzianum). The docket for this
notice (EPA-HQ-OPP-2008-0750) 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 FIFRA, the Agency conducted a rigorous
assessment of Trichoderma asperellum strain ICC 012 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
sections 408(b)(2)(C) and (D) 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 asperellum strain ICC 012 was isolated from a
suppressive soil in central Italy. Trichoderma asperellum strain ICC
012 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 asperellum strain ICC 012 acts as a pathogen antagonist,
colonizing in soil and roots to compete with plant pathogenic fungi for
space and nutrients. Moreover, Trichoderma asperellum strain ICC 012
also attacks the cell walls of pathogens with enzymes.
Toxicological data on the active ingredient, submitted by the
manufacturer, Isagro, S.p.A., has been accepted to support the current
exemption from the requirement of a tolerance for residues and various
EPA review of these studies indicated that the active ingredient
was not toxic to test animals when administered via the oral, dermal,
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 asperellum strain ICC 012, including all anticipated
dietary exposures and all other exposures for which there is reliable
information. Thus, under the standard in section 408(c)(2) of FFDCA, an
exemption from the requirement for a tolerance is appropriate. Studies
on the active ingredient include the following:
In an acute oral toxicity study Master Record Identification Number
(MRID 47345901), groups of fasted, 6-7 week old rats (5/sex) were given
a single oral dose of Trichoderma asperellum strain ICC 012
(Trichoderma asperellum conidia 4.2 x 109 CFU/g) in 0.9%
NaCl solution at a dose of 2,000 milligrams/kilograms (mg/kg) of body
weight (bw) in a limit test. The animals were then observed for a
period of 14 days. The following Oral lethal dose (LD)50
findings for males, females, and combined were reported: Males > 2,000
mg/kg of bw, females > 2,000 mg/kg of bw, combined > 2,000 mg/kg of bw.
No mortality occurred during the study. Based on the results of this
Trichoderma asperellum strain ICC 012 was not toxic at 2,000 mg/kg of
In an acute intraperitoneal injection toxicity study (MRID
47345902), groups of fasted, 6-7 week old rats (3/sex) were injected
with Trichoderma asperellum strain ICC 012 (Trichoderma asperellum
conidia 4.2 x 109 CFU/g) in 0.9% NaCl solution at a dose of
1 x 108 CFU/g in a limit test. Animals were then observed
for up to 21 days. Control animals were injected with 0.9% NaCl
solution only. Trichoderma asperellum strain ICC 012 is not toxic based
on these results.
In an acute pulmonary toxicity/pathogenicity study (MRID's
47345903, 47345904), groups of fasted, 44-55 day old rats (31/sex) were
exposed by the intratracheal route to Trichoderma asperellum strain ICC
012 (Trichoderma asperellum conidia 4.2 x 109 CFU/g) in a
0.1% solution of Tween 20 in water for injection at a dose of 1 x
108 CFU/animal. Animals were then observed for up to 22
days. Rats in the control group were administered the vehicle only.
Rats in the reference groups were administered inactivated test item.
There were no treatment related clinical signs or changes in bw.
Samples of feces, lungs, lymph nodes, kidneys, brain, liver, spleen,
and blood were taken for the determination of microbial enumeration.
The viable count was 4.2 x 109 CFU/g and the greatest
density was detected in lung tissue. The pulmonary LD50
observed was: Males > 1 x 107 CFU/animal, females > 1 x
107 CFU/animal, combined > 1 x 107 CFU/animal. No
mortalities occurred during the study. Based on these results,
Trichoderma asperellum strain ICC 012 is of low toxicity and is not
infective or pathogenic in the rat.
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 asperellum strain ICC 012.
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 this
pesticide is typically applied to soil, rather than crops. 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 unlikely event that the applied fungus can grow on
edible portions of the treated crop, there is no hazard present in
these residues, as demonstrated by 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
2. Drinking water exposure. Drinking water exposure is expected to
be negligible because Trichoderma asperellum strain ICC 012 is not
applied to water, nor is it expected to proliferate in aquatic
environments because Trichoderma asperellum 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 asperellum in all the anticipated drinking
water exposures because of the lack of acute oral toxicity/
pathogenicity to mammals, as previously described.
B. Other Non-Occupational Exposure
Trichoderma asperellum strain ICC 012 is a naturally occurring
microbe and is ubiquitous in the environment. Trichoderma asperellum
strain ICC 012 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
asperellum strain ICC 012 is not pathogenic to mammals.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires the Agency to consider
the cumulative effect of exposure to Trichoderma asperellum strain ICC
012 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 asperellum strain ICC 012 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
Section 408(b)(2)(C) of FFDCA, as amended by the Food Quality
Protection Act (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, section 408(b)(2)(C) of FFDCA 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
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
infants and children, to residues of Trichoderma asperellum strain ICC
012. 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
asperellum strain ICC 012 demonstrate a low toxicity/pathogenicity
potential. Trichoderma asperellum strain ICC 012 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
asperellum strain ICC 012 has an effect on the endocrine system. No
specific tests have been conducted with Trichoderma asperellum strain
ICC 012 to determine such effects. However, the submitted
toxicity/pathogenicity studies in rodents indicated that following
several routes of exposure, the immune system is still intact and able
to process and clear the active ingredient. Trichoderma asperellum
strain ICC 012 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 Method
The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation; therefore, the Agency
has concluded that an analytical method is not required for enforcement
purposes for Trichoderma asperellum strain ICC 012.
C. Codex Maximum Residue Level
No Codex maximum residue level exists for Trichoderma asperellum.
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 Trichoderma asperellum strain ICC 012 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 an exemption from the requirement of 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 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.
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 Programs.
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 180.1294 is added to subpart D to read as follows:
Sec. 180.1294 Trichoderma asperellum strain ICC 012; exemption from
the requirement of a tolerance.
Trichoderma asperellum strain ICC 012 is exempted from the
requirement of a tolerance in or on all food and feed commodities when
applied pre-harvest and used in accordance with good agricultural
[FR Doc. 2010-3854 Filed 3-2-10; 8:45 am]
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