43072 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 

4Attainment date extended to June 15, 2011. 

* * * * * 

[FR Doc. 2010–17969 Filed 7–22–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

EPA–HQ–OPP–2009–0407; FRL–8835–6 

Trichoderma Hamatum Isolate 382; 

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 microbial 

pesticide, Trichoderma hamatum 

isolate 382, in or on all food 

commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. Interregional 

Research Project Number 4 (IR-4) of 

Rutgers University (on behalf of Sellew 

and Associates, LLC) 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 hamatum 

isolate 382 under the FFDCA. 

DATES: This regulation is effective July 

23, 2010. Objections and requests for 

hearings must be received on or before 

September 21, 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–2009–0407. 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: Ann 

Sibold, Biopesticides and Pollution 

Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6502; e-mail address: 

sibold.ann@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 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:// 

www.gpoaccess.gov/ecfr. 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–2009–0407 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 September 21, 2010. 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–2009–0407 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 July 22, 

2009 (74 FR 36200) (FRL–8425–8), 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 7E7188) 

by IR-4, Rutgers University, 500 College 

Road, East, Suite 201W, Princeton, NJ 

08540 (on behalf of Sellew and 

Associates, LLC, 84 Shadybrook Lane, 

Carlisle, MA 01741). The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Trichoderma hamatum 

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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 43073 

isolate 382. This notice referenced a 

summary of the petition prepared by the 

petitioner, IR-4 (on behalf of Sellew and 

Associates, LLC), which is available in 

the docket, http://www.regulations.gov. 

A comment was received on the notice 

of filing. EPA’s response to this 

comment is discussed in Unit VII.C. 

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. 

A. Overview of Trichoderma Hamatum 

Isolate 382. 

Trichoderma hamatum isolate 382 is 

a naturally occurring fungus that is 

found widely in soils, potting media, 

corn grits, and flour, as well as on root 

surfaces of various plants, decaying 

bark, fruits, and vegetables. Indeed, 

Trichoderma hamatum populations 

have been measured at levels between 1 

x 104 and 1 x 108 colony-forming units 

(cfu) per gram dry weight of container 

media alone. As a pesticidal active 

ingredient, Trichoderma hamatum 

isolate 382 will be mixed with or 

applied to soilless potting media or 

compost mainly to induce systemic 

resistance to diseases of roots and 

aboveground plant parts. It may also 

suppress the activity of certain soilborne 

plant pathogens (including Pythium 

species, Phytophthora species, 

Fusarium species, Rhizoctonia solani, 

Sclerotium rolfsii, and Thielaviopsis 

basicola) and protect the foliage of some 

plant species from powdery mildew, 

Botrytis blight, Phytophthora blights, 

and dieback diseases (e.g., 

Botryosphaeria dieback) through 

competition for nutrients and space. No 

relationships are known between the 

Trichoderma genus and any pathogen of 

humans, animals, or plants. Most 

notably, Trichoderma hamatum isolate 

382 is not considered a dermatophyte 

fungus in that it is not classified into 

any of the three genera (Microsporum, 

Epidermophyton, and Trichophyton) 

known to cause skin disease in animals 

and humans. 

In conjunction with Experimental Use 

Permit 69006–EUP–1, which was 

effective from January 1, 1996 until 

January 1, 1998, a temporary exemption 

from the requirement of a tolerance was 

established previously for Trichoderma 

hamatum isolate 382 for use on selected 

ornamentals and vegetable bedding 

plants in or on the raw agricultural 

commodities broccoli, cabbage, 

cauliflower, cucumber, eggplant, 

lettuce, cantaloupe, pepper, tomato, and 

watermelon (61 FR 28580, June 5, 1996, 

FRL–5371–2). This temporary 

exemption expired on March 1, 1998. 

Although there are no currently existing 

tolerances or tolerance exemptions for 

Trichoderma hamatum species, there 

are permanent tolerance exemptions 

established for all food commodities for 

two strains of a closely related 

Trichoderma species: Trichoderma 

harzianum KRL–AG2 (ATCC #20847) 

strain T–22 under 40 CFR 180.1102 (64 

FR 16856, April 7, 1999 FRL–6070–3) 

and Trichoderma harzianum strain T– 

39 under 40 CFR 180.1201 (65 FR 

38753, June 22, 2000, FRL–6383–7). 

The petitioner submitted Tier I 

mammalian toxicology data for the 

active ingredient, Trichoderma 

hamatum isolate 382. EPA has reviewed 

and found these data acceptable to 

support the establishment of a 

permanent exemption from the 

requirement of a tolerance for residues 

of Trichoderma hamatum isolate 382. 

These studies indicate that the active 

ingredient is not toxic, infective, and/or 

pathogenic to rats when administered 

by the oral, pulmonary, or injection 

routes of exposure and is only slightly 

irritating to the skin. Furthermore, even 

with extensive experimental uses in the 

mid- to late-1990s and subsequent 

compilation of data to support potential 

pesticide products, no Trichoderma 

hamatum isolate 382-related 

hypersensitivity incidents have been 

reported to EPA. The overall 

conclusions from these data are 

described in Unit III.B., while more indepth synopses of the study results can 

be found in the risk assessments and 

Biopesticides Registration Action 

Document provided as references in 

Unit III.C. 

B. Microbial Pesticide Toxicology Data 

Requirements 

1. Acute oral toxicity and 

pathogenicity – rat (Harmonized Test 

Guideline 885.3050; Master Record 

Identification Number (MRID No.) 

455836–03). An acceptable acute oral 

and pathogenicity study demonstrated 

that Trichoderma hamatum isolate 382 

was not toxic, infective, and/or 

pathogenic to rats when dosed at up to 

3.9 x 108 cfu/animal (U.S. EPA 2009, 

2010b, 2010c). 

2. Acute pulmonary toxicity and 

pathogenicity – rat (Harmonized Test 

Guideline 885.3150; MRID Nos. 460106– 

02 and 469997–01). An acceptable acute 

pulmonary toxicity and pathogenicity 

study demonstrated that Trichoderma 

hamatum isolate 382 was not toxic, 

infective, and/or pathogenic to rats 

when dosed intratracheally at 1.3 x 107

cfu/animal (U.S. EPA 2009, 2010b, 

2010c). 

3. Acute injection toxicity and 

pathogenicity – rat (Harmonized Test 

Guideline 885.3200; MRID No. 475989– 

08). An acceptable acute injection 

toxicity and pathogenicity study 

demonstrated that Trichoderma 

hamatum isolate 382 was not toxic, 

infective, and/or pathogenic in rats 

when dosed intraperitoneally at 4.0 x 

107 cfu/animal (U.S. EPA 2009, 2010b, 

2010c). 

4. Hypersensitivity incidents 

(Harmonized Test Guideline 885.3400). 

No hypersensitivity incidents involving 

Trichoderma hamatum isolate 382 and 

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43074 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 

occurring during fermentation, 

processing, formulation, or research 

have been reported to the Agency. Any 

future hypersensitivity incidents must 

be reported per 40 CFR 158.2140 (U.S. 

EPA 2010c). 

5. Acute oral toxicity (Harmonized 

Test Guideline 870.1100; MRID No. 

475989–04), acute dermal toxicity 

(Harmonized Test Guideline 870.1200; 

MRID No. 475989–04), and acute 

inhalation toxicity (Harmonized Test 

Guideline 870.1300; MRID No. 475989– 

04). The Agency waived these acute 

toxicity data requirements based on 

Trichoderma hamatum isolate 382’s 

ubiquitous presence in the environment 

(see Unit III.A.) and the absence of 

incidents of hypersensitivity, allergies, 

or other adverse effects, despite varying 

uses of Trichoderma hamatum isolate 

382 since 1996 (e.g., research activities 

performed in accordance with the terms 

of an experimental use permit) (U.S. 

EPA 2009, 2010c). 

6. Primary dermal irritation – rabbit 

(Harmonized Test Guideline 870.2500; 

MRID 475989–05). An acceptable 

primary dermal irritation study 

demonstrated that Trichoderma 

hamatum isolate 382 was slightly 

irritating to the skin of rabbits. The 

study resulted in a classification of 

Toxicity Category IV for this strain of 

Trichoderma hamatum (U.S. EPA 2009, 

2010a, 2010c). 

C. References 

1. U.S. EPA. 2009. Review of Product 

Chemistry, Manufacturing Process, and 

Acute Toxicity Studies of the End Use 

Product (EP) Floraguard (EPA Reg. No. 

74205–G) Containing the Active 

Ingredient (AI) Trichoderma hamatum 

isolate 382 (0.9%). Memorandum from I. 

Barsoum, Ph.D. and J. Kough, Ph.D. to 

A. Sibold dated December 14, 2009 

(available as ‘‘Supporting & Related 

Materials’’ within Docket Number EPA– 

HQ–OPP–2010–0489 at http:// 

www.regulations.gov). 

2. U.S. EPA. 2010a. Review of the 

Registrant’s Response to the 

Deficiencies Found by the Agency in Its 

Review of Product Chemistry, 

Manufacturing Process, and Acute 

Toxicity Studies of the Product 

Trichoderma hamatum isolate 382 (EPA 

Reg. No. 74205–G). Memorandum from 

I. Barsoum, Ph.D. and J. Kough, Ph.D. to 

A. Sibold dated April 27, 2010 

(available as ‘‘Supporting & Related 

Materials’’ within Docket Number EPA– 

HQ–OPP–2010–0489 at http:// 

www.regulations.gov). 

3. U.S. EPA. 2010b. Review of 

Information to Support a Food 

Tolerance Determination for 

Trichoderma hamatum isolate 382 

(ATCC# 20765), the Active Ingredient in 

Floraguard Related to Tolerance Petition 

(7E7188). Memorandum from J. Kough, 

Ph.D. to A. Sibold dated May 18, 2010 

(available as ‘‘Supporting & Related 

Materials’’ within Docket Number EPA– 

HQ–OPP–2010–0489 at http:// 

www.regulations.gov). 

4. U.S. EPA. 2010c. Trichoderma 

hamatum isolate 382 Biopesticides 

Registration Action Document dated 

June 1, 2010 (available as ‘‘Supporting & 

Related Materials’’ within Docket 

Number EPA–HQ–OPP–2010–0489 at 

http://www.regulations.gov). 

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 may occur (more likely 

through food than drinking water), but 

the lack of acute oral toxicity, 

infectivity, and/or pathogenicity, based 

on a toxicology test on rats presented in 

Unit III.B., is just one of several factors 

supporting the establishment of a 

permanent exemption from the 

requirement of a tolerance for residues 

of Trichoderma hamatum isolate 382. 

1. Food. Dietary exposure to the 

microbial active ingredient is expected 

to be minimal. Trichoderma hamatum 

isolate 382 is only intended for directed 

application to or incorporation into 

soilless potting media or compost. 

These application methods are not 

conducive to residue accumulation in 

crops. Moreover, Trichoderma species 

live in soils and are unlikely to persist 

on plants. Any spores that end up on 

plants due to application as a pesticide 

would decrease over time as a result of 

weathering, desiccation, and ultraviolet 

radiation, which can kill even quiescent 

forms of the fungus. In the remote 

likelihood that the applied fungus grew 

on the edible portions of treated crops, 

the results of the toxicology testing 

demonstrated that no toxicity, 

infectivity, and/or pathogenicity in 

treated animals occurred, even when 

dosed with high levels of Trichoderma 

hamatum isolate 382 by the oral route 

of exposure (see additional discussion 

in Unit III.B.). 

2. Drinking water exposure. Drinking 

water exposure is expected to be 

negligible because the microbial 

fungicide will not be applied to water. 

Further, Trichoderma hamatum isolate 

382 is a soil microorganism and would 

not proliferate in aquatic environments. 

Moreover, the Agency believes that 

Trichoderma species within the soil 

will not likely percolate into water due 

to the large size of the fungal spores and 

the fact that they adhere readily to soil 

particles. Even in the unlikely event that 

dietary exposure occurs through 

drinking water, the results of the oral 

toxicology testing, as described in Unit 

III.B., demonstrated that no toxicity, 

infectivity, and/or pathogenicity in 

treated animals occurred. 

B. Other Non-Occupational Exposure 

Trichoderma hamatum isolate 382 is 

a naturally occurring microorganism 

and is ubiquitous in the environment. 

As a pesticidal active ingredient, 

Trichoderma hamatum isolate 382 will 

be applied to or incorporated into 

soilless potting media or compost 

predominantly in greenhouses. 

Although some applications may take 

place in residential areas, there is no 

evidence of any concern for inhalation 

or dermal toxicity at exposure levels 

several orders of magnitude higher than 

would be expected to be encountered by 

a typical residential end user (see Unit 

III.B.). Additionally, as anticipated 

given that there are no recognized 

relationships between the Trichoderma 

genus and any pathogen of humans and 

animals, there have been no reports of 

adverse effects to humans from 

inhalation or dermal exposure to this 

widespread fungus. 

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, 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 has not found Trichoderma 

hamatum isolate 382 to share a common 

mechanism of toxicity with any other 

substances, and Trichoderma hamatum 

isolate 382 does not appear to produce 

a toxic metabolite as its mode against 

the target pests. For the purposes of this 

tolerance exemption action, therefore, 

EPA has assumed that Trichoderma 

hamatum isolate 382 does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 43075 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants, and Children 

FFDCA section 408(b)(2)(C) 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) 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. Margins of exposure (safety), 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

Based on the acute toxicity and 

pathogenicity data discussed in Unit 

III.B., as well as the ubiquity of 

Trichoderma hamatum isolate 382 in 

the environment without reported 

adverse effects to humans, EPA 

concludes that there is a reasonable 

certainty that no harm will result to the 

United States population, including 

infants and children, from aggregate 

exposure to the residues of Trichoderma 

hamatum isolate 382. 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 and information available on 

Trichoderma hamatum isolate 382 do 

not demonstrate toxic, pathogenic, and/ 

or infective potential to mammals. Thus, 

there are no threshold effects of concern 

and, as a result, an additional margin of 

safety is not necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency 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 hamatum isolate 382. 

C. Response to Comments 

One comment, which specifically 

stated that the petition should be 

rejected without full testing for 20 years, 

was received in response to the notice 

of filing. The Agency notes that the data 

requirements do not require 20 years of 

testing, and no current information 

available to EPA suggests the need for 

20 years worth of data to characterize 

the pesticide’s toxicity, infectivity and/ 

or pathogenicity. For the proposed uses 

of the microbial active ingredient (i.e., 

applications to or incorporation into 

soilless potting media or compost), the 

Agency has concluded that there is a 

reasonable certainty that no harm will 

result to the United States population, 

including infants and children, from 

aggregate exposure to the residues of 

Trichoderma hamatum isolate 382. 

Thus, under the standard in FFDCA 

section 408(c)(2), an exemption from the 

requirement of a tolerance for residues 

of Trichoderma hamatum isolate 382 is 

appropriate. 

VIII. Conclusions 

The Agency concludes that there is a 

reasonable certainty that no harm will 

result to the United States population, 

including infants and children, from 

aggregate exposure to residues of 

Trichoderma hamatum isolate 382. 

Therefore, an exemption is established 

for residues of Trichoderma hamatum 

isolate 382 in or on all food 

commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. 

IX. 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 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 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, 

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 

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43076 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Rules and Regulations 

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: July 14, 2010. 

Steven Bradbury, 

Director, 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. Section 180.1298 is added to 

subpart D to read as follows: 

§ 180.1298 Trichoderma hamatum isolate 

382; exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Trichoderma hamatum isolate 382 in 

or on all food commodities when 

applied as a fungicide and used in 

accordance with good agricultural 

practices. 

[FR Doc. 2010–18076 Filed 7–22–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0138; FRL–8825–6] 

2-Propanol, 1,1′,1′′-nitrilotris-; 

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 2-Propanol, 

1,1′,1′′-nitrilotris- (TIPA) (CAS No. 122– 

20–3) when used as an inert ingredient 

for use as a neutralizer on growing crops 

and raw agricultural commodities preand post-harvest. Dow AgroSciences, 

LLC submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting establishment 

of an exemption from the requirement of 

a tolerance. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of TIPA. 

DATES: This regulation is effective July 

23, 2010. Objections and requests for 

hearings must be received on or before 

September 21, 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–2009–0138. 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@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 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 cite at 

http://www.gpoaccess.gov/ecfr. To 

access the harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0138 in the subject line on 

the first page of your submission. All 

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