Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 50553 

Commodity Parts per million 

*****

Avocado ............................................................................................................................................................................... 1.2 

*****

Canistel ................................................................................................................................................................................ 1.2 

*****

Cattle, meat byproducts ....................................................................................................................................................... 0.02 

Citrus, dried pulp ................................................................................................................................................................. 8.0 

Citrus, oil .............................................................................................................................................................................. 340 

*****

Goat, meat byproducts ........................................................................................................................................................ 0.02 

*****

Horse, meat byproducts ...................................................................................................................................................... 0.02 

*****

Kiwifruit ................................................................................................................................................................................ 1.8 

*****

Lemon .................................................................................................................................................................................. 0.60 

Lime ..................................................................................................................................................................................... 0.60 

*****

Mango .................................................................................................................................................................................. 1.2 

Onion, bulb .......................................................................................................................................................................... 0.60 

Onion, green ........................................................................................................................................................................ 4.0 

Papaya ................................................................................................................................................................................. 1.2 

Parsley, dried leaves ........................................................................................................................................................... 170 

Parsley, leaves .................................................................................................................................................................... 35 

*****

Sapodilla .............................................................................................................................................................................. 1.2 

Sapote, black ....................................................................................................................................................................... 1.2 

Sapote, mamey .................................................................................................................................................................... 1.2 

Sheep, meat byproducts ...................................................................................................................................................... 0.02 

*****

Star apple ............................................................................................................................................................................ 1.2 

Strawberry ............................................................................................................................................................................ 5.0 

Tomatillo .............................................................................................................................................................................. 0.45 

Tomato ................................................................................................................................................................................. 0.45 

Tomato, paste ...................................................................................................................................................................... 1.0 

*****

Vegetable, cucurbit, group 9 ............................................................................................................................................... 0.70 

Vegetable, leaves of root and tuber, group 2 ..................................................................................................................... 10 

Vegetable, root, except sugarbeet, subgroup 1B ................................................................................................................ 0.75 

*****

* * * * * 

[FR Doc. E8–19747 Filed 8–26–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1020; FRL–8378–5] 

Bacillus subtilis GB03; 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 Bacillus subtilis GB03 in or on 

all raw agricultural commodities when 

applied in accordance with good 

agricultural practices. Growth Products 

Ltd. submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting an amendment of the existing 

exemption from the requirement of a 

tolerance to cover use in or on all 

agricultural commodities and remove 

the regulatory text specifying ‘‘when 

applied as a seed treatment.’’ This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus subtilis GB03 in 

or on all raw agricultural commodities. 

DATES: This regulation is effective 

August 27, 2008. Objections and 

requests for hearings must be received 

on or before October 27, 2008, 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–2007–1020. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket identification (ID) number 

where indicated and select the 

‘‘Submit’’ button. Follow the 

instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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. 


sroberts on PROD1PC70 with RULES
50554 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

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? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this ‘‘Federal Register’’ document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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, as 

amended by FQPA, 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–2007–1020 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 October 27, 2008. 

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–2007–1020, 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’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 

2, 2007 (72 FR 62237) (FRL–8153–8), 

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 7F7236) 

by Growth Products Ltd., P.O. Box 1259, 

White Plains, NY 10602. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Bacillus subtilis GB03. This 

notice included a summary of the 

petition prepared by the petitioner 

Growth Products Ltd. One comment was 

received in response to this notice 

expressing opposition to expanding the 

number of toxic poisons and expressing 

dissatisfaction with the level of safety 

EPA provides Americans. Pursuant to 

its authority under the FFDCA, EPA 

conducted a comprehensive assessment 

of Bacillus subtilis GB03, including a 

review of an acute oral toxicity/ 

pathogenicity study in the rat, an acute 

dermal toxicity study in the rabbit, an 

acute pulmonary toxicity/pathogenicity 

study in the rat, an acute intravenous 

toxicity/pathogenicity study in the rat 

and a primary eye irritation study in the 

rabbit. EPA review of these studies 

indicated that the active ingredient was 

not toxic to test animals when 

administered via the oral, dermal, 

intravenous or pulmonary routes of 

exposure. The active ingredient was not 

infective or pathogenic to test animals 

when administered via the oral, 

pulmonary and intravenous routes. 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 dietary exposure to residues 

of Bacillus subtilis GB03 in or on food 

and feed. Thus, under the standard in 

FFDCA section 408(c)2, an exemption 

from the requirement for a tolerance is 

appropriate. 

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 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 50555 

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. 

Toxicological data on the active 

ingredient has been previously accepted 

to support the current exemption from 

the requirement of a tolerance for 

residues (for seed treatment of 

agricultural commodities) and various 

registrations by the manufacturer Bayer 

CropScience (formerly Gustafson LLC). 

Studies on the active ingredient include 

the following: 

An acceptable acute oral toxicity/ 

pathogenicity study performed on rats 

(MRID 41812302) demonstrated the lack 

of mammalian toxicity at high levels of 

exposure to Bacillus subtilis GB03. In 

this study Bacillus subtilis GB03 was 

neither toxic nor infective to rats given 

an oral dose of 1.9 x 108 CFU/animal. 

An acceptable acute dermal toxicity/ 

pathogenicity study on rabbits (MRID 

41812303) showed no abnormalities in 

body weight gain during the study. 

Desquamation, erythema and edema 

were observed in the majority of treated 

rabbits by day 2, with all signs 

diminishing by day 15. No 

abnormalities were noted in the rabbits 

at necropsy. Bacillus subtilis GB03 was 

not considered toxic when a single 2g 

(3.6 x 109 CFU)/animal dose was 

administered dermally. The dermal 

toxicity study resulted in a classification 

of toxicity category III. 

An acceptable acute injection toxicity/ 

pathogenicity study on rats (MRID 

41812305) demonstrated that Bacillus 

subtilis GB03 was not infective, 

pathogenic or toxic for rats when dosed 

intravenously with approximately 1.8 x 

107 CFU of the test material. Although 

the organism was detected in every 

organ tested, a distinct clearance pattern 

was demonstrated. No abnormalities 

were noted during necropsy. Based on 

the submitted data, the test material was 

not infectious, pathogenic or toxic to 

rats. 

An acceptable primary eye irritation in 

rabbits study (MRID 41812306) 

demonstrated that Bacillus subtilis 

GB03 produced a slight to severe ocular 

irritation when a single 0.1 g ocular 

dose was administered. Ocular irritation 

dissipated 7 days post dosing. The 

primary eye irritation study resulted in 

a classification of toxicity category III 

for this strain of B. subtilis. 

An acceptable acute pulmonary 

toxicity/pathogenicity in rats study 

(MRID 41812304) demonstrated that 

Bacillus subtilis GB03 was neither toxic, 

pathogenic nor infective to rats when 

dosed intratracheally with 

approximately 2.84 x 108 CFU of the test 

material. 

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/pathogenicity 

and the ubiquitous nature of the 

microbe support the establishment of an 

exemption from the requirement of a 

tolerance for Bacillus subtilis GB03. 

1. Food. Dietary exposure to the 

microbe is expected to be minimal. The 

risk posed to adults, infants and 

children is minimal because of the low 

acute oral toxicity/pathogenicity 

potential of the microbial pesticide. In 

addition, standard practices of washing, 

peeling, cooking or processing fruits and 

vegetables reduces residues of Bacillus 

subtilis GB03 and further minimizes 

dietary exposure. 

2. Drinking water exposure. Exposure 

to humans from residues of Bacillus 

subtilis GB03 in consumed drinking 

water would be unlikely. The proposed 

and existing use sites of Bacillus subtilis 

do not include direct application to 

aquatic environments. Potential 

exposure to surface water would be 

negligible. The intended use of Bacillus 

subtilis GB03 is treatment of growing 

plants and crops for the purposes of 

disease control. The risk of the 

microorganism passing through the soil 

to ground water is minimal to unlikely. 

Additionally, the bacteria would not 

tolerate the conditions water is 

subjected to in a drinking water 

treatment facility (including: 

chlorination, pH adjustments, and/or 

filtration). If oral exposure should occur 

through drinking water, the Agency 

concludes that such exposure would 

present insignificant risk due to the lack 

of acute oral toxicity/pathogenicity and 

the ubiquitous nature of the microbe. 

B. Other Non-Occupational Exposure 

The use sites for these products 

include residential garden sites, as well 

as agricultural sites. Bacillus subtilis is 

ubiquitous in the environment. Based 

on evaluations of the Tier I acute 

toxicity tests, the Agency believes that 

the potential aggregate non-occupational 

risk derived from dermal and inhalation 

exposure through the application of 

Bacillus subtilis GB03 is well below the 

currently tested microbial safety levels. 

V. Cumulative Effects 

No mechanism of toxicity in 

mammals has been identified for 

Bacillus subtilis GB03. Therefore, no 

cumulative effect with other related 

organisms is anticipated. Because the 

available data demonstrate a low 

toxicity/pathogenicity potential of the 

active ingredient, adverse dietary effects 

are unlikely. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) as 

amended by the Food Quality Protection 

Act (FQPA) of 1996, provides that EPA 

shall assess the available information 

about consumption patterns among 

infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, 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 Unit III, EPA 

concludes that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to the United States 

population, including infants and 

children, to residues of Bacillus subtilis 

GB03. 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 Bacillus subtilis GB03 

demonstrate a low toxicity/ 

pathogenicity potential. Bacillus subtilis 

is not a human pathogen and has not 

been implicated in human disease, but 


sroberts on PROD1PC70 with RULES
50556 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

has been isolated as a rare contaminant 

from human infections. Thus, there are 

no threshold effects of concern and, as 

a result, the provision requiring an 

additional margin of safety does not 

apply. Further, the considerations of 

consumption patterns, special 

susceptibility, and cumulative effects do 

not apply to pesticides without a 

demonstrated significant adverse effect. 

VII. Other Considerations 

A. Endocrine Disruptors 

The Agency has no information to 

suggest that Bacillus subtilis GB03 has 

an effect on the endocrine system. No 

specific tests have been conducted with 

Bacillus subtilis GB03 to determine such 

effects. However, the submitted toxicity/ 

pathogenicity studies in rodents 

indicated that following several routes 

of exposure, the immune system is still 

intact and able to process and clear the 

active ingredient. Bacillus subtilis GB03 

is a ubiquitous organism in the 

environment and there have been no 

reports of the organism affecting 

endocrine systems. Therefore, it is 

unlikely that this organism would have 

estrogenic or endocrine effects and it is 

practically non-toxic to mammals. 

B. Analytical Method 

The Agency proposes to establish an 

exemption from the requirement of a 

tolerance without any numerical 

limitation; therefore, the Agency has 

concluded that an analytical method is 

not required for enforcement purposes 

for Bacillus subtilis GB03. 

C. Codex Maximum Residue Level 

No Codex maximum residue level 

exists for Bacillus subtilis GB03. 

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 Bacillus subtilis GB03 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 above, 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, 

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: August 14, 2008 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention 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. Section 180.1111 is revised to read 

as follows: 

§ 180.1111 Bacillus subtilis GB03; 

exemption from the requirement of a 

tolerance. 

The biofungicide Bacillus subtilis 

GB03 is exempted from the requirement 

of a tolerance in or on all raw 

agricultural commodities when used in 

accordance with good agricultural 

practices. 

[FR Doc. E8–19860 Filed 8–26–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0987; FRL–8376–4] 

Fenbuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of the 

fungicide fenbuconazole, alpha–[2–(4–


sroberts on PROD1PC70 with RULES