8504 Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 

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). 

XII. 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 19, 2010. 

Meredith F. Laws, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

1,2,3-Propanetriol, homopolymer diisooctadecanoate (CAS Reg. 

No. 63705–03–3) 

Emulsifier 

* * * * * 

[FR Doc. 2010–3859 Filed 2–24–10; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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 


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Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 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 


jlentini on DSKJ8SOYB1PROD with RULES
8506 Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 

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 nonoccupational 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 


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Federal Register / Vol. 75, No. 37 / Thursday, February 25, 2010 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.1293 is added to 

subpart D to read as follows: 

§ 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 


jlentini on DSKJ8SOYB1PROD with RULES