Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations 4903 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action, 

determining that the Baltimore Area did 

not attain the 1997 8-hour ozone 

NAAQS by its June 15, 2011 attainment 

date and reclassifying the Baltimore 

Area by operation of law to be a serious 

8-hour ozone nonattainment area for the 

1997 8-hour ozone standard, may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 81 

Air pollution control, National parks, 

Wilderness areas. 

Dated: January 24, 2012. 

W.C. Early, 

Acting Regional Administrator, Region III. 

40 CFR part 81 is amended as follows: 

PART 81—[AMENDED] 

■ 1. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 81.321 the table entitled 

‘‘Maryland—Ozone (8-Hour Standard)’’ 

is amended by revising the entries for 

Baltimore, MD, revising footnote 4, and 

adding a new footnote 5 at the end of 

the table to read as follows: 

§ 81.321 Maryland. 

* * * * * 

MARYLAND—OZONE (8-HOUR STANDARD) 

Designated area 

Designation a Category/classification 

Date1 Type Date1 Type 

Baltimore, MD: 

Anne Arundel County ................................................ ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

City of Baltimore ....................................................... ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

Baltimore County ...................................................... ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

Carroll County ........................................................... ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

Harford County .......................................................... ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

Howard County ......................................................... ................ Nonattainment ........................................ (5) Subpart 2/Serious.4

* * * * * * * 

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is June 15, 2004, unless otherwise noted. 

* * * * * * * 

4Attainment date is June 15, 2013. 

5Effective March 2, 2012. 

* * * * * 

[FR Doc. 2012–2218 Filed 1–31–12; 8:45 am] 

BILLING CODE 6560–50–P 

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 


tkelley on DSK3SPTVN1PROD with RULES
4904 Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations 

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/textidx?&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). 


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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 Aphanomycessuppressive 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°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 × 108 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 108 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 108 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 107

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 delayedtype 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). 


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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 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 

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 104 to 106 colonyforming 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 × 103 colony-forming 

units per square centimeter (cfu/cm2). 

Assuming a bulk density of 1 to 2 grams 

per cubic centimeter (g/cm3), 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 °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), nonoccupational 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 


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Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations 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). 


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4908 Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1310 is added to 

subpart D to read as follows: 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, and 476 

[CMS–1518–CN4] 

RIN 0938–AQ24 

Medicare Program; Hospital Inpatient 

Prospective Payment Systems for 

Acute Care Hospitals and the LongTerm Care Hospital Prospective 

Payment System and Fiscal Year 2012 

Rates; Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correction of final rule. 

SUMMARY: This document corrects 

technical errors that occurred in the 

Addendum of the final rule entitled 

‘‘Medicare Program; Hospital Inpatient 

Prospective Payment Systems for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Fiscal Year 2012 Rates’’ which 

appeared in the August 18, 2011 

Federal Register. 

DATES: Effective Date: This document is 

effective January 31, 2012. 

Applicability Date: The corrections 

noted in this document and posted on 

the CMS Web site are applicable to 

hospital payments and discharges on or 

after October 1, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Brian Slater, (410) 786–4487. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2011–19719 of August 18, 

2011 (76 FR 51476), the final rule 

entitled ‘‘Medicare Program; Hospital 

Inpatient Prospective Payment Systems 

for Acute Care Hospitals and Fiscal Year 

2012 Rates and to the Long-Term Care 

Hospital Prospective Payment System 

and Rate Year 2012 Rates’’ (hereinafter 

referred to as the FY 2012 IPPS/FY 2012 

LTCH PPS final rule) there were a 

number of technical errors in the tables 

included in the Addendum of the final 

rule which are, posted on the CMS Web 

site. In section II. of this correcting 

document, we describe these errors and 

note the tables that will include the 

corrections. We have already made 

changes to our rates, updated PRICER 


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