Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15865 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because New 

Jersey’s State Implementation Plans are 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by June 8, 2009. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

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 may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: February 12, 2009. 

George Pavlou, 

Acting Regional Administrator, Region 2. 

■ Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart FF—New Jersey 

■ 2. Section 52.1582 is amended by 

adding new paragraph (l) to read as 

follows: 

§ 52.1582 Control strategy and 

regulations: Ozone. 

* * * * * 

(l) Attainment determination. EPA 

has determined that the PhiladelphiaWilmington-Trenton severe 1-hour 

ozone nonattainment area attained the 

1-hour ozone NAAQS by the applicable 

attainment date of November 15, 2005. 

In New Jersey, this area includes the 

counties of Burlington, Camden, 

Cumberland, Gloucester, Mercer, and 

Salem. EPA also has determined that the 

Philadelphia-Wilmington-Trenton 

severe 1-hour ozone nonattainment area 

is not subject to the imposition of the 

section 185 penalty fees. In addition, the 

requirements of section 172(c)(9) 

(contingency measures) do not apply to 

the area. 

[FR Doc. E9–7683 Filed 4–7–09; 8:45 am] 

BILLING CODE 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0762; FRL–8408–7] 

Bacillus subtilis MBI 600; 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 

biofungicide, Bacillus subtilis MBI 600, 

in or on all food commodities, including 

residues resulting from post-harvest 

uses, when applied/used in accordance 

with good agricultural practices. Becker 

Underwood, Inc. submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

amendment to expand the existing 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

subtilis MBI 600 in or on all food 

commodities. 

DATES: This regulation is effective April 

8, 2009. Objections and requests for 

hearings must be received on or before 

June 8, 2009, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0762. 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: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@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 


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15866 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 

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 electronically 

available documents 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, 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–2008–0762 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 June 8, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0762, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of November 

14, 2008 (73 FR 67512) (FRL–8388–3), 

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 8F7368) 

by Becker Underwood, Inc., 801 Dayton 

Ave., P. O. Box 667, Ames, IA 50010. 

The petition requested that 40 CFR 

180.1128 be amended by expanding the 

existing exemption from the 

requirement of a tolerance for the 

biofungicide Bacillus subtilis MBI 600 

to cover residues in or on all food 

commodities, including residues 

resulting from post-harvest uses. The 

notice included a summary of the 

petition prepared by the petitioner 

Becker Underwood, Inc. 

Previously, on June 8, 1994 (59 FR 

29543) (FRL–4865–8), EPA issued a 

final rule granting an exemption from 

the requirement of a tolerance for 

residues of Bacillus subtilis MBI 600 in 

or on all raw agricultural commodities 

when applied as a seed treatment on 

seeds used for growing agricultural 

crops. In submitting this current 

petition (i.e., 8F7368), Becker 

Underwood, Inc. is relying on the data 

previously submitted by another 

company, Gustafson, Inc., in support of 

the existing tolerance exemption for 

Bacillus subtilis MBI 600. These data 

were previously summarized by EPA in 

the June 8, 1994, final rule. On July 18, 

2002, EPA issued a Tolerance 

Reassessment Decision in which it 

found that the existing tolerance 

exemption for Bacillus subtilis MBI 600 

continues to meet the FQPA safety 

standard. This determination in 2002 

was based on EPA’s review of the data 

on which Becker Underwood, Inc., is 

now relying in connection with this 

action. 

There was one comment received in 

response to the notice of filing. The 

commenter expressed dissatisfaction 

with the level of safety EPA provides to 

Americans. Pursuant to its authority 

under the FFDCA, EPA conducted a 

comprehensive assessment of Bacillus 

subtilis MBI 600, including a review of 

studies addressing acute oral, 

pulmonary and intravenous injection 

toxicity/pathogenicity; acute dermal 

toxicity; primary eye irritation: and skin 

sensitization. EPA review of these 

studies indicated that the active 

ingredient is not toxic to test animals 

when administered via the oral, 

pulmonary, intravenous or dermal 

routes of exposure. In addition, the 

active ingredient was not infective or 

pathogenic to test animals when 

administered via the oral, pulmonary or 

intravenous routes. Moreover, no 

reports of hypersensitivity have been 

recorded in 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 MBI 600 in or on all 

food commodities, including residues 

resulting from post-harvest uses. Thus, 

under the standard in FFDCA section 

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

requirement of 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 


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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. 

Toxicological data on the active 

ingredient were previously submitted to 

support the existing exemption from the 

requirement of a tolerance for residues 

of Bacillus subtilis MBI 600 resulting 

from its use in the treatment of seeds 

used for growing agricultural crops, and 

to support various pesticide product 

registrations held by the petitioner. The 

previously submitted studies on the 

active ingredient include the following: 

An acceptable acute oral toxicity/ 

pathogenicity study performed in rats 

(MRID 419074–02) demonstrated the 

lack of mammalian toxicity at high 

levels of exposure to Bacillus subtilis 

MBI 600. In this study, Bacillus subtilis 

MBI 600 was not toxic, infective nor 

pathogenic to rats given an oral dose of 

2 x 108 colony forming units (CFU) per 

animal. The study resulted in a 

classification of Toxicity Category IV for 

this strain of Bacillus subtilis. 

An acceptable acute pulmonary 

toxicity/pathogenicity study in rats 

(MRID 419074–04) demonstrated that 

Bacillus subtilis MBI 600 was neither 

toxic, pathogenic nor infective to rats 

dosed intratracheally with 3.4 x 108

CFU of the test material. The study 

resulted in a classification of Toxicity 

Category IV for this strain of Bacillus 

subtilis. 

An acceptable acute intravenous 

injection toxicity/pathogenicity study in 

rats (MRID 419074–05) demonstrated 

that Bacillus subtilis MBI 600 was 

neither toxic, pathogenic nor infective 

to rats dosed intravenously with 

approximately 4 x 107 CFU of the test 

material. Although the microbe was 

detected in every organ tested, the test 

material displayed a distinct pattern of 

clearance. The study resulted in a 

classification of Toxicity Category IV for 

this strain of Bacillus subtilis. 

An acceptable acute dermal toxicity 

study in rabbits (MRID 419074–03) 

demonstrated that Bacillus subtilis MBI 

600 was not toxic to rabbits when a 

single 5 x 1010 dose was administered 

dermally. The study resulted in a 

classification of Toxicity Category IV for 

this strain of Bacillus subtilis. 

An acceptable primary eye irritation 

study in rabbits (MRID 419074–06) 

demonstrated that Bacillus subtilis MBI 

600 produced a slight ocular irritation 

when a single 0.1 gram ocular dose was 

administered. Ocular irritation 

dissipated by day 4. The study resulted 

in a classification of Toxicity Category 

IV for this strain of Bacillus subtilis. 

A supplemental skin sensitization test 

resulted in an overall moderate reaction 

in guinea pigs 24 to 78 hours posttreatment. However, an acceptable 

dermal sensitization study, conducted 

with an end use formulation, 

demonstrated no irritation 2 weeks after 

sensitization and treatment using 400 

milligrams of test material. As a result, 

the product was determined to not be a 

dermal sensitizer. Furthermore, in the 

nearly 15 years since its initial 

registration as an active ingredient, 

there have been no hypersensitivity 

reports associated with Bacillus subtilis 

MBI 600 pesticide products. 

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 

Bacillus subtilis MBI 600 is 

ubiquitous in the environment, 

especially in soils and agricultural 

environments (indeed, strain MBI 600 of 

Bacillus subtilis is a naturally-occurring 

isolate of the genus Bacillus, originally 

isolated from faba beans grown at 

Nottingham University School of 

Agriculture in the United Kingdom). As 

a result, dietary exposure to background 

levels of the naturally occurring microbe 

likely is already occurring and likely 

will continue to occur. Because of its 

ubiquitous presence in the environment, 

the Agency expects there to be no 

increase in exposure to Bacillus subtilis 

MBI 600 resulting from the existing and 

proposed pesticidal uses when 

compared to existing exposure to 

background levels of Bacillus subtilis 

MBI 600. 

1. Food. As discussed above, dietary 

exposure to the naturally occurring 

microbe likely is already occurring and 

likely will continue to occur. Notably, 

similar Bacillus subtilis strains are used 

internationally in the production of food 

grade products and in fermented foods 

in Japan and Thailand. Reports in the 

literature implicating Bacillus subtilis 

(as distinguished from the specific 

strain, Bacillus subtilis MBI 600, at issue 

in this action) in food-borne illness do 

not describe any pathogen or toxin 

production, but rather simple spoilage 

from Bacillus subtilis growth in dough. 

Such low-quality dough would not be 

suitable for bread production by 

commercial bakeries and so the Agency 

considers this particular food exposure 

scenario to be unlikely and the risk to 

be negligible. The risk posed to adults, 

infants and children from food-related 

exposures to Bacillus subtilis MBI 600 is 

minimal due to the demonstrated lack of 

acute oral toxicity/pathogenicity 

associated with the microbial pesticide. 

Based on the evaluation of the 

submitted data, there are no dietary 

risks that exceed the Agency’s level of 

concern. 

2. Drinking water exposure. Because 

Bacillus subtilis MBI 600 is ubiquitous 

in the environment, exposure to the 

microbe through drinking water may 

already be occurring and likely will 

continue to occur. While the proposed 

and existing use sites do not include 

direct application to aquatic 

environments, the intended use of 

Bacillus subtilis MBI 600 is treatment of 

growing crops or seed for the control of 

plant disease. If such uses were to result 

in pesticide spray drift or runoff that 

were to reach surface or ground waters, 

there is the potential for human 

exposure to Bacillus subtilis MBI 600 

residues, albeit greatly diluted, in 

drinking water. Municipal drinking 

water treatment processes and deep 

water wells, however, would both 

further reduce any such residues. More 

importantly, even if oral exposure to 

this ubiquitous microbe should occur 

through drinking water, due to its 

demonstrated lack of acute oral toxicity/ 

pathogenicity, the Agency concludes 

that there is a reasonable certainty that 

no harm will result from such exposure. 

B. Other Non-Occupational Exposure 

The pesticide uses of Bacillus subtilis 

MBI 600, both those currently allowed 

and the additional ones being 

established by this rule, are limited to 

commercial agricultural and 

horticultural settings. There are no 

residential uses. Nonetheless, because 

Bacillus subtilis MBI 600 is naturally 

occurring and ubiquitous in the 

environment, the potential for nondietary, non-occupational exposure to 


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its residues for the general population, 

including infants and children, is likely 

since populations have probably been 

previously exposed (and likely will 

continue to be exposed) to background 

levels of the microbe. However, neither 

such common human exposures to 

Bacillus subtilis MBI 600 naturally 

present in soils, waters and plants, nor 

exposures associated with similar 

Bacillus subtilis strains used 

internationally in producing food-grade 

products and fermented foods, have 

resulted in reports of disease or other 

effects. Finally, while the literature 

includes accounts of Bacillus subtilis 

infections in humans (which 

consistently are reported only in 

otherwise-compromised individuals), 

those reports are most notable for their 

rare and exceptional nature. 

EPA’s evaluation of the required highdose Tier I acute toxicity and 

pathogenicity tests resulted in the 

assignment of Toxicity Category IV 

(least toxic), and determinations of not 

infective and not pathogenic, for all 

exposure routes. No toxicological end 

points of concern were identified. There 

are no dietary endpoints that exceed the 

Agency’s Level of Concern (LOC). 

Therefore, the Agency has determined 

that any additional exposure to the 

microbe resulting from residues 

attributable to Bacillus subtilis MBI 600 

pesticide use will not result in 

additional aggregate non-occupational 

risk from dermal and inhalation 

exposures. This conclusion, based 

solely on non-occupational exposures, 

is consistent with EPA’s determination 

that no occupational risks exceed the 

Agency’s LOC, meaning that even 

regular occupational exposures 

associated with this active ingredient 

pose negligible risk. 

V. Cumulative Effects 

No mechanism of toxicity in 

mammals has been identified for 

Bacillus subtilis MBI 600. Therefore, no 

cumulative effect with other related 

organisms is anticipated. Because the 

available data demonstrate a lack of 

toxicity/pathogenicity potential for 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 

(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 to the 

United States population, including 

infants and children, from aggregate 

exposure to residues of Bacillus subtilis 

MBI 600. 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 MBI 600 

demonstrate a lack of toxicity/ 

pathogenicity potential. Thus, there are 

no threshold effects of concern and, as 

a result, the Agency has concluded that 

the additional tenfold margin of safety 

for infants and children is unnecessary 

in this instance. Further, the need to 

consider consumption patterns, special 

susceptibility, and cumulative effects 

does not arise when dealing with 

pesticides with no demonstrated 

significant adverse effects. 

VII. Other Considerations 

A. Endocrine Disruptors 

Bacillus subtilis MBI 600 is a 

ubiquitous organism in the environment 

that is non-toxic to mammals. To date, 

there is no evidence to suggest that 

Bacillus subtilis MBI 600 affects the 

immune system, functions in a manner 

similar to any known hormone, or that 

it acts as an endocrine disruptor. 

Indeed, the submitted toxicity/ 

pathogenicity studies in rodents 

indicate that, following several routes of 

exposure, the immune system is intact 

and able to process and clear the active 

ingredient. Therefore, it is unlikely that 

this organism will have estrogenic or 

endocrine effects. 

B. Analytical Method 

The Agency is establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus subtilis 

MBI 600 in or on all food commodities, 

including residues resulting from postharvest uses, for the reasons stated 

above. Therefore, the Agency has 

concluded that an analytical method is 

not required for enforcement purposes 

for detecting Bacillus subtilis MBI 600 

residues resulting from its use as a 

pesticide. 

C. Codex Maximum Residue Level 

No Codex maximum residue level 

(MRL) exists for Bacillus subtilis MBI 

600. 

VIII. Conclusions 

Based on the toxicity information for 

Bacillus subtilis MBI 600 that was 

previously submitted and reviewed, 

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 

Bacillus subtilis MBI 600 under 

reasonably foreseeable circumstances 

when used as a microbial pesticide in 

accordance with its label and good 

agricultural practices. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. As a result, 

pursuant to FFDCA sections 408(c) and 

(d) EPA is establishing an exemption 

from the requirement of a tolerance for 

residues of the biofungicide Bacillus 

subtilis MBI 600 in or on all food 

commodities, including residues 

resulting from post-harvest uses, when 

applied or used in accordance with 

good agricultural practices. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 


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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15869 

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: March 20, 2009. 

Janet L. Andersen, 

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 180.1128 is revised to read 

as follows: 

§ 180.1128 Bacillus subtilis MBI 600; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the biofungicide Bacillus subtilis MBI 

600 in or on all food commodities, 

including residues resulting from postharvest uses, when applied or used in 

accordance with good agricultural 

practices. 

[FR Doc. E9–7172 Filed 4–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0167; FRL–8407–8] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

thiamethoxam and its metabolite CGA322704 in or on citrus fruits, citrus 

pulp, tree nuts, almond hulls, and 

pistachios. Syngenta Crop Protection, 

Inc., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective April 

8, 2009. Objections and requests for 

hearings must be received on or before 

June 8, 2009, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0167. 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: Julie 

Chao, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8735; e-mail address: 

chao.julie@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 those engaged in the 

following activities: 

• 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 to provide 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 electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 


rwilkins on PROD1PC63 with RULES