Document ID: EPA-HQ-OPP-2008-0750-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Trichoderma Asperellum Strain (ICC 012)
Posted Date: 2010-03-03T05:00Z

[Federal Register: March 3, 2010 (Volume 75, Number 41)]
[Rules and Regulations]               
[Page 9527-9530]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr10-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0750; FRL-8800-9]

 
Trichoderma asperellum strain ICC 012; 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 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) 
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 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

[[Page 9528]]

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 
registrations.
    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 
study,

[[Page 9529]]

Trichoderma asperellum strain ICC 012 was not toxic at 2,000 mg/kg of 
bw.
    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 
pesticide.
    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 
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 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

[[Page 9530]]

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.

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 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 
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 Programs.

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 180.1294 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 
practices.

[FR Doc. 2010-3854 Filed 3-2-10; 8:45 am]
BILLING CODE 6560-50-S