Document ID: EPA-HQ-OPP-2008-0749-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Trichoderma gamsii strain (ICC 080)
Posted Date: 2010-02-25T05:00Z

[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Rules and Regulations]               
[Page 8504-8507]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe10-20]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0749; FRL-8799-4]

 
Trichoderma gamsii strain ICC 080; 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 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) 
305-5805.

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: cerrelli.susanne@epa.gov.

SUPPLEMENTARY INFORMATION:

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 
CONTACT.

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

[[Page 8505]]

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

[[Page 8506]]

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 
previously described.

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 
infants and

[[Page 8507]]

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.

VIII. Conclusions

    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 
note).

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 
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: February 4, 2010.
Steven Bradbury,
Acting Director, Office of Pesticide Program.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
0
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]
BILLING CODE 6560-50-S