Document ID: EPA-HQ-OPP-2010-0053-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Trichoderma virens strain G-41
Posted Date: 2012-02-01T05:00Z

[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Rules and Regulations]
[Pages 4903-4908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2216]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0053; FRL-9333-5]

Trichoderma virens strain G-41; 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 Trichoderma virens strain G-41 in or on 
all food commodities when applied as a fungicide and used in accordance 
with good agricultural practices. BioWorks, Inc., 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 virens strain G-41 under the FFDCA.

DATES: This regulation is effective February 1, 2012. Objections and 
requests for hearings must be received on or before April 2, 2012, 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-2010-0053. 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 Office of Pesticide Programs (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: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; email 
address: kausch.jeannine@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

[[Page 4904]]

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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2010-0053 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 2, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0053, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: 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 March 10, 2010 (75 FR 11171) (FRL-8810-
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 9F7618) by Technology Sciences Group, Inc., on behalf of 
BioWorks, Inc., 100 Rawson Rd., Suite 205, Victor, NY 14564. The 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 
Trichoderma virens strain G-41. This notice referenced a summary of the 
petition prepared by the petitioner, BioWorks, Inc., which is available 
in the docket via http://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    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 exemption 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 EPA 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.

A. Overview of Trichoderma virens strain G-41

    Trichoderma species are common soil hyphomycetes found in all 
climate zones ranging from Antarctica to the tropics (Ref. 1). Since 
1989, several Trichoderma species (e.g., Trichoderma polysporum, 
Trichoderma viride, and Trichoderma harzianum) have been used in 
pesticide products--notably without reported incidents--to control 
various fungal plant pathogens such as Pythium species, Phytophthora 
species, Heterobasidion annosum, and Chondrostereum purpureum. In 
conjunction with the registration of some of these pesticide products, 
EPA established the following exemptions from the requirement of a 
tolerance:
    1. Gliocladium virens strain GL-21 (now recognized as Trichoderma 
virens strain GL-21) (40 CFR 180.1100)--see the Federal Register of 
September 20, 1995 (60 FR 48657) (FRL-4974-1) and October 5, 1995 (60 
FR 52248) (FRL-4974-1).
    2. Trichoderma harzianum Rifai strain T-22 (40 CFR 180.1102)--see 
the Federal Register of April 7, 1999 (64 FR 16856) (FRL-6070-3).
    3. Trichoderma harzianum strain T-39 (40 CFR 180.1201)--see the 
Federal Register of June 22, 2000 (65 FR 38753) (FRL-6383-7).
    4. Trichoderma gamsii strain ICC 080 (40 CFR 180.1293)--see the 
Federal Register of February 25, 2010 (75 FR 8504) (FRL-8799-4).
    5. Trichoderma asperellum strain ICC 012 (40 CFR 180.1294)--see the 
Federal Register of March 3, 2010 (75 FR 9527) (FRL-8800-9).

[[Page 4905]]

    6. Trichoderma hamatum isolate 382 (40 CFR 180.1298)--see the 
Federal Register of July 23, 2010 (75 FR 43072) (FRL-8835-6).
    Specifically, Trichoderma virens, including strain G-41, is a 
naturally occurring fungus that is native to the United States and is 
widely distributed throughout the world, inhabiting forest, 
agricultural, and orchard soils, as well as plant litter (Ref. 2). 
Trichoderma virens strain G-41 was isolated from soil samples taken 
from Aphanomyces-suppressive fields in Livingston County, New York. 
Much like other Trichoderma species, Trichoderma virens strain G-41 
inhibits or kills certain plant-pathogenic fungi (e.g., Rhizoctonia 
species and Fusarium species) through competition for food and space, 
mycoparasitism, antibiosis, and induction of plant defense responses 
(Refs. 1, 2, 3, and 4).

B. Microbial Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the request for an exemption from the requirement of a tolerance for 
residues of Trichoderma virens strain G-41 in or on all food 
commodities have been fulfilled with data submitted or cited by the 
petitioner.
    The petitioner conducted several acute toxicological tests with 
Trichoderma virens strain G-41 or a substance containing Trichoderma 
virens strain G-41. The acute oral toxicity/pathogenicity test 
evaluated the potential toxicity and pathogenicity of the active 
ingredient should dietary exposure occur. The acute dermal toxicity and 
primary dermal irritation tests evaluated the potential for a substance 
containing the active ingredient to cause toxicity or irritation should 
skin exposure occur. The acute inhalation toxicity test evaluated the 
potential for a substance containing the active ingredient to cause 
toxicity should inhalation exposure occur. The results of these studies 
revealed little to no toxicity or irritation attributed to Trichoderma 
virens strain G-41, and all these studies received a Toxicity Category 
IV classification (see 40 CFR 156.62). Moreover, when the skin was 
bypassed as a protective barrier during an acute injection toxicity/
pathogenicity test, Trichoderma virens strain G-41 was not found to be 
toxic, infective, and/or pathogenic via the intraperitoneal route of 
exposure. Finally, the petitioner has reported that no hypersensitivity 
incidents occurred during development and testing of this fungus.
    With its petition, BioWorks, Inc., also cited to toxicological data 
done with a similar, previously registered strain of Trichoderma 
virens, GL-21 (Refs. 1, 3, 4, and 5). Although GL-21 and G-41 are not 
identical, the two strains share many characteristics typical of 
Trichoderma virens (e.g., particular morphological features, production 
of certain enzymes involved in mycoparasitism, and weak growth at the 
temperature of the human body (37[deg]C)), and thus are considered to 
be functionally similar (Ref. 4). Based on these similarities, EPA 
concluded that data on Trichoderma virens strain GL-21 would be 
representative of the toxicological nature of Trichoderma virens strain 
G-41 (Ref. 6). These additional data on Trichoderma virens strain GL-21 
confirmed (i.e., no toxicity observed) and contributed (i.e., no 
pathogenicity anticipated) to the findings of the acute oral toxicity/
pathogenicity study mentioned above and fulfilled the acute pulmonary 
toxicity/pathogenicity data requirement for Trichoderma virens strain 
G-41.
    The overall conclusions from all toxicological information 
submitted and cited by the petitioner are briefly described below, 
while more in-depth synopses of some study results can be found in the 
associated Biopesticides Registration Action Document provided as a 
reference in Unit IX. (Ref. 5).
    1. Acute oral toxicity/pathogenicity--rat (Harmonized Guideline 
885.3050; Master Record Identification Numbers (MRID Nos.) 483438-01 
and 407198-04). The petitioner submitted or cited to data resulting 
from two separate acute oral toxicity/pathogenicity tests, one 
conducted with Trichoderma virens strain G-41 and the other conducted 
with Trichoderma virens strain GL-21. The results of the first study 
demonstrated that Trichoderma virens strain G-41 was not toxic to rats 
when administered by oral gavage in a single dose of 1.5 x 10\8\ 
colony-forming units (cfu)/animal. Although a pattern of clearance was 
established, the sensitivity of detection indicated low recovery of 
Trichoderma virens strain G-41 from tissues and fluids (i.e., 0.5-9%). 
Thus, pathogenicity was not unequivocally assessed. The second study 
demonstrated that Trichoderma virens strain GL-21, a strain that is 
functionally similar to Trichoderma virens strain G-41, was not toxic 
to, infective in, or pathogenic for rats when given a single oral dose 
of 10\8\ cfu/animal and adequately addressed the pathogenicity endpoint 
that could not be fully assessed in the first study. The weight-of-
evidence from the results of these two studies indicates that 
Trichoderma virens strain G-41 is not acutely toxic and/or pathogenic 
through the oral route of exposure.
    2. Acute pulmonary toxicity/pathogenicity--rat (Harmonized 
Guideline 885.3150; MRID Nos. 407198-05 and 408640-02). An acute 
pulmonary toxicity/pathogenicity study demonstrated that Trichoderma 
virens strain GL-21, a functionally similar strain to Trichoderma 
virens strain G-41, was not toxic to, infective in, or pathogenic for 
rats when given a single intratracheal dose of 10\8\ cfu/animal. Given 
the functional similarity of these two strains, EPA concludes that 
Trichoderma virens strain G-41 is also not likely to be toxic, 
infective, and/or pathogenic through the inhalation route. To further 
support this conclusion, an acceptable acute inhalation toxicity study 
(MRID No. 478650-04) resulted in no mortalities and only minor signs of 
toxicity (activity decrease; piloerection) that resolved by day 2 after 
rats were exposed to a test substance containing Trichoderma virens 
strain G-41 at 5.14 milligrams per liter for 4 hours.
    3. Acute injection toxicity/pathogenicity (intraperitoneal)--rat 
(Harmonized Guideline 885.3200; MRID Nos. 478651-02 and 482368-01). An 
acceptable acute injection toxicity/pathogenicity study demonstrated 
that Trichoderma virens strain G-41 was not toxic to rats when 
administered intraperitoneally in a single dose of 10\7\ cfu/animal. 
While clearance was not directly assessed in this study, the lack of 
clinical findings upon necropsy, in combination with the lack of signs 
of toxicity and mortality in the animals during the observation period, 
strongly suggests that Trichoderma virens strain G-41 is also not 
pathogenic by intraperitoneal injection.
    4. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID 
No. 482526-01). The petitioner reported that no hypersensitivity 
incidents, including immediate-type or delayed-type reactions of humans 
and domestic animals, occurred during research, development, or testing 
of Trichoderma virens strain G-41.
    5. Acute dermal toxicity--rat (Harmonized Guideline 870.1200; MRID 
No. 478650-03). An acceptable acute dermal toxicity study demonstrated 
that a test substance containing Trichoderma virens strain G-41 was not 
toxic to rats when dosed at 5,050 milligrams per kilogram (mg/kg) for 
24 hours. The dermal median lethal dose (LD50), which is a 
statistically derived single dose that can be expected to cause death 
in 50% of test animals, was greater than 5,050 mg/kg for male and 
female rats combined (Toxicity Category IV).

[[Page 4906]]

    6. Primary dermal irritation--rabbit (Harmonized Guideline 
870.2500; MRID No. 478650-06). An acceptable primary dermal irritation 
study demonstrated that a test substance containing Trichoderma virens 
strain G-41 was non-irritating to the skin of rabbits (Toxicity 
Category IV).

IV. Aggregate Exposure

    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

    1. Food exposure. All proposed Trichoderma virens strain G-41 
applications are soil directed or soil incorporated because of the 
targeted soilborne pests (e.g., Rhizoctonia species and Fusarium 
species). Based on calculations made in EPA's environmental risk 
assessment for Trichoderma virens strain G-41 (Ref. 7), these 
applications are not expected to significantly increase the populations 
of this fungus above natural levels in the soil. No reports were 
available in the literature describing natural concentrations of 
Trichoderma virens; however, Trichoderma species have been reported in 
various types of soils at concentrations of 10\4\ to 10\6\ colony-
forming units per gram (cfu/g) (Refs. 8 and 9). Based on the maximum 
application rate of the proposed end-use pesticide products containing 
Trichoderma virens strain G-41, the estimated amount of Trichoderma 
virens applied to the soil surface is approximately 6.7 x 10\3\ colony-
forming units per square centimeter (cfu/cm\2\). Assuming a bulk 
density of 1 to 2 grams per cubic centimeter (g/cm\3\), the maximum 
application rate will not result in soil concentrations that are 
substantially greater than concentrations of Trichoderma virens 
naturally found in the soil, and overall increased exposure to 
Trichoderma virens in the terrestrial environment, including on above-
ground plant parts such as food commodities, is not expected. Work by 
Jackson et al. (1991) supports this conclusion given that, after 
Trichoderma virens and three other Trichoderma isolates were 
incorporated into soil, fungal numbers either transiently increased, 
remained stable, or declined (Ref. 10). Should this microbial pesticide 
be present on food, the acute oral toxicity and pathogenicity data 
available for Trichoderma virens strain G-41 and functionally similar 
Trichoderma virens strain GL-21 demonstrated that no toxicity, 
infectivity, and/or pathogenicity is likely to occur with any exposure 
level of Trichoderma virens strain G-41 resulting from application in 
accordance with good agricultural practices (see additional discussion 
in Unit III.B.).
    2. Drinking water exposure. Exposure to residues of Trichoderma 
virens strain G-41 in consumed drinking water is unlikely. The proposed 
use patterns for Trichoderma virens strain G-41 are soil directed and 
soil incorporated, thereby limiting contact with surface water by drift 
and runoff. Furthermore, ground water is not expected to have 
significant exposure to Trichoderma virens strain G-41 since, like 
other Trichoderma species, this fungus would likely be filtered out by 
the particulate nature of many soil types, and be concentrated in upper 
soil horizons (Refs. 11 and 12) near plant roots (Ref. 13). If 
Trichoderma virens strain G-41 were to be transferred to surface or 
ground waters (e.g., through spray drift or runoff) that are intended 
for eventual human consumption and directed to wastewater treatment 
systems or drinking water facilities, it likely would not survive the 
conditions water is subjected to in such systems or facilities, 
including chlorination, pH adjustments, filtration, and occasionally 
high temperatures (Refs. 14 and 15). For instance, Trichoderma virens 
strain G-41 does not grow well at 37 [deg]C (Refs. 3 and 16), and test 
data has shown it to be unstable at elevated temperatures; therefore, 
any heat treatment applied to water containing Trichoderma virens 
strain G-41 would probably render the fungus non-viable. In the remote 
likelihood that this microbial pesticide is present in drinking water 
(e.g., water not subject to treatment systems or facilities), the acute 
oral toxicity and pathogenicity data available for Trichoderma virens 
strain G-41 and functionally similar Trichoderma virens strain GL-21 
demonstrated no toxicity, infectivity, and/or pathogenicity is likely 
to occur with any exposure level of Trichoderma virens strain G-41 
resulting from application in accordance with good agricultural 
practices (see additional discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Given Trichoderma virens' natural occurrence in soil (Ref. 2), non-
occupational exposure to the fungus is likely already occurring. Even 
with the proposed pesticide applications of Trichoderma virens strain 
G-41, it is not likely that there will be a significant increase in 
these exposures due to the relative stability of typical background 
levels in the soil (see calculations and information presented in the 
food exposure section above). If significant non-occupational exposures 
were to occur, such exposures would not exceed EPA's level of concern 
in light of test results that indicated Trichoderma virens strain G-41 
is not toxic (acute pulmonary toxicity/pathogenicity, acute dermal 
toxicity, and acute inhalation toxicity), is non-irritating (primary 
dermal irritation), and is not pathogenic or infective (acute pulmonary 
toxicity/pathogenicity) (see additional discussion in Unit III.B.).

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance exemption, EPA 
consider ``available information concerning the cumulative effects of 
[a particular pesticide's] * * * residues and other substances that 
have a common mechanism of toxicity.''
    There are several Trichoderma species used as active ingredients in 
registered pesticide products. While these different microbial pest 
control agents may produce similar metabolites, the likelihood of 
adverse cumulative effects via a common mechanism of toxicity is not 
anticipated, based on the lack of toxicity/pathogenicity potential of 
the active ingredients used on food and/or labeled for residential uses 
(see Unit III.B., as well as Refs. 17, 18, 19, and 20). For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for United States Population, Infants and 
Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, 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) provides that EPA shall apply an additional 
tenfold (10X) margin of safety for infants and children in the case of 
threshold effects to account for prenatal

[[Page 4907]]

and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the Food Quality Protection Act Safety 
Factor. In applying this provision, EPA either retains the default 
value of 10X or uses a different additional safety factor when reliable 
data available to EPA support the choice of a different factor.
    Based on the acute toxicity and pathogenicity data/information 
discussed in Unit III.B., as well as use of Trichoderma pesticide 
products since 1989 without reported adverse effects to humans, EPA 
concludes that there are no threshold effects of concern to infants, 
children, or adults when Trichoderma virens strain G-41 is used as 
labeled in accordance with good agricultural practices. As a result, 
EPA concludes that no additional margin of exposure (safety) is 
necessary to protect infants and children and that not adding any 
additional margin of exposure (safety) will be safe for infants and 
children.
    Moreover, based on the same data and EPA analysis as presented 
directly above, the Agency is able to conclude that there is a 
reasonable certainty that no harm will result to the U.S. population, 
including infants and children, from aggregate exposure to the residues 
of Trichoderma virens strain G-41 when it is used as labeled and in 
accordance with good agricultural practices as a fungicide. Such 
exposure includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. EPA has arrived at 
this conclusion because, considered collectively, the data and 
information available on Trichoderma virens strain G-41, as well as 
data available on functionally similar Trichoderma virens strain GL-21, 
do not demonstrate toxic, pathogenic, and/or infective potential to 
mammals, including infants and children.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons stated above and because EPA is establishing an exemption 
from the requirement of a tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. In this 
context, EPA considers the international maximum residue limits (MRLs) 
established by the Codex Alimentarius Commission (Codex), as required 
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United 
Nations Food and Agriculture Organization/World Health Organization 
food standards program, and it is recognized as an international food 
safety standards-setting organization in trade agreements to which the 
United States is a party. EPA may establish a tolerance that is 
different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for Trichoderma virens strain 
G-41.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Trichoderma virens strain G-41. 
Therefore, an exemption from the requirement of a tolerance is 
established for residues of Trichoderma virens strain G-41 in or on all 
food commodities when applied as a fungicide and used in accordance 
with good agricultural practices.

IX. References

1. U.S. EPA. 2011a. Review of Product Chemistry, Manufacturing 
Process, Discussion of Formation of Unintentional Ingredients, 
Analysis of Samples, Certification of Limits, Physical and Chemical 
Characteristics, and Acute Toxicity Studies for Section 3 
Registration of an MUP G-41 Technical (EPA Reg. No. 68539-I) and an 
EP BW240 WP (EPA Reg. No. 68539-O). Memorandum from I.S. Barsoum, 
Ph.D. and J.L. Kough, Ph.D. to J. Kausch dated December 20, 2011.
2. Samuels GJ. 1996. Trichoderma; a review of biology and 
systematics of the genus. Mycological Research. 100:923-935.
3. Kenerley CM. 2010. Report on studies conducted comparing two 
strains of Trichoderma virens; GL-21 and G-41. Texas A&M University, 
Department of Plant Pathology and Microbiology. Unpublished report.
4. U.S. EPA and PMRA. 2011a. Data Evaluation Record for Product 
Characterization and Analysis. Prepared by L. Heikkila and I. 
Barsoum, Ph.D. (dated December 6, 2011).
5. U.S. EPA. 2011b. Draft Trichoderma virens strain G-41 
Biopesticides Registration Action Document dated December 8, 2011 
(available as ``Supporting & Related Material'' within docket ID 
number EPA-HQ-OPP-2010-0057).
6. U.S. EPA and PMRA. 2011b. Data Evaluation Record for Acute 
Pulmonary Infectivity and Toxicity--Waiver Request. Prepared by L. 
Heikkila and I. Barsoum, Ph.D. (dated December 6, 2011).
7. U.S. EPA. 2011c. Environmental risk assessment for the FIFRA 
Section 3 registration of Trichoderma virens strain G-41 (PC Code 
176604; EPA File Symbols 68539-I, -O, -RN). Memorandum from S. 
Borges to J. Kausch dated November 14, 2011 (available as 
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2010-0057).
8. Leandro LFS, Guzman T, Ferguson LM, Fernandez GE, Louws FJ. 2007. 
Population dynamics of Trichoderma in fumigated and compost-amended 
soil and on strawberry roots. Applied Soil Ecology. 35:237-246.
9. Liu B, Glenn D, Buckley K. 2008. Trichoderma communities in soils 
from organic, sustainable, and conventional farms, and their 
relation with Southern blight of tomato. Soil Biology and 
Biochemistry. 40:1124-1136.
10. Jackson AM, Whipps JM, Lynch JM. 1991. Production, delivery 
systems, and survival in soil of four fungi with disease biocontrol 
potential. Enzyme and Microbial Technology. 13:636-642.
11. Longa CMO, Savazzini F, Tosi S, Elad Y, Pertot I. 2009. 
Evaluating the survival and environmental fate of the biocontrol 
agent Trichoderma atroviride SC1 in vineyards in northern Italy. 
Journal of Applied Microbiology. 106:1549-1557.
12. Sariah M, Choo CW, Zakaria H, Norihan MS. 2005. Quantification 
and characterization of Trichoderma spp. from different ecosystems. 
Mycopathologia. 159:113-117.
13. United States Patent and Trademark Office. 2010. Control of 
Plant Diseases and Enhancing Plant Growth Using a Combination of a 
Trichoderma virens Species and a Rhizosphere Competent Trichoderma 
harzianum Species (United States Patent Application--US 2010/0028303 
A1). Available from http://www.freepatentsonline.com/20100028303.pdf.
14. Centers for Disease Control and Prevention. 2009. Drinking 
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.
15. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment 
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.
16. Lumsden RD, Walter JF, Baker CP. 1996. Development of 
Gliocladium virens for damping-off disease control. Canadian Journal 
of Plant Pathology. 18:463-468.
17. U.S. EPA. 2008. Trichoderma Species Final Registration Review 
Decision (signed September 11, 2008). Available from http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2006-0245-
0008;oldLink=false.
18. U.S. EPA. 2010a. Trichoderma asperellum strain ICC 012 
Biopesticides Registration Action Document dated March 4, 2010 
(available as ``Supporting & Related Material'' within docket ID 
number EPA-HQ-OPP-2009-1004).

[[Page 4908]]

19. U.S. EPA. 2010b. Trichoderma gamsii strain ICC 080 Biopesticides 
Registration Action Document dated March 4, 2010 (available as 
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2009-1003).
20. U.S. EPA. 2010c. Trichoderma hamatum isolate 382 Biopesticides 
Registration Action Document dated July 13, 2010 (available as 
``Supporting & Related Material'' within docket ID Number EPA-HQ-
OPP-2010-0489).

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to EPA. 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 
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. As a result, this 
action does not 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, EPA 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, EPA 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) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require EPA 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).

XI. 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 United 
States Senate, the United States 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: January 20, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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 180.1310 is added to subpart D to read as follows:

Sec.  180.1310  Trichoderma virens strain G-41; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma virens strain G-41, in or on all food 
commodities, when applied as a fungicide and used in accordance with 
good agricultural practices.

[FR Doc. 2012-2216 Filed 1-31-12; 8:45 am]
BILLING CODE 6560-50-P