10494 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. Therefore, 

consistent with this rule, EPA is 

establishing a tolerance on low growing 

berry, except strawberry, subgroup 13– 

07H. EPA concludes it is reasonable to 

establish the tolerance on the newly 

created subgroup, since the individual 

commodities for which tolerances were 

requested are identical to those which 

comprise low growing berry, except 

strawberry, subgroup 13–07H. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of chlorimuron-ethyl, ethyl 

2-[[[[(4-chloro-6-methoxypyrimidin-2yl) 

amino]carbonyl]sulfonyl]benzoate], in 

or on berry, low growing, except 

strawberry, subgroup 13–07H at 0.02 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 24, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.429 is revised to read 

as follows: 

§ 180.429 Chlorimuron ethyl; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

chlorimuron ethyl, ethyl 2-[[[[(4-chloro6-methoxypyrimidin-2yl) 

amino]carbonyl]sulfonyl]benzoate], in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Berry, low growing, except strawberry, subgroup 13–07H ............. 0.02 

Peanut ............................ 0.02 

Soybean .......................... 0.05 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E9–5192 Filed 3–10–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0303; FRL–8400–2] 

Bacillus Mycoides Isolate J; 

Temporary Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the Bacillus mycoides isolate J in or 

on pecans, potatoes, sugar beets, 

tomatoes, and peppers when used in 

accordance with good agricultural 

practices. Montana Microbial Products, 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting to amend the 

existing temporary tolerance exemption. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus mycoides isolate 

J in or on pecans, potatoes, sugar beets, 

tomatoes, and peppers on a time-limited 

basis. The temporary tolerance 

exemption expires on March 31, 2011. 


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Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 10495 

DATES: This regulation is effective 

March 11, 2009. Objections and requests 

for hearings must be received on or 

before May 11, 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–2005–0303. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susanne Cerrelli, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

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 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. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guideline at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm. 

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–2005–0303 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 May 11, 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–2005–0303, 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 June 18, 

2008 (73 FR 34734-34736) (FRL–8366– 

9), 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 8G7320) 

by Montana Microbial Products, 510 

East Kent Ave., Missoula, MT 59801. 

The petition requested that 40 CFR part 

180 be amended by establishing a 

temporary exemption from the 

requirement of a tolerance for residues 

of Bacillus mycoides isolate J. This 

notice included a summary of the 

petition prepared by the petitioner, 

Montana Microbial Products. There 

were no comments received in response 

to the notice of filing. The Agency has 

determined that the change sought by 

Montana Microbial products is actually 

a revision of § 180.1269, rather than an 

amendment of the exemption. The 

exemption for the commodities listed in 

§ 180.1269 expired on December 31, 

2007 and new exemptions for pecans, 

potatoes, tomatoes, and peppers based 

on the petition are being approved for 

a period that does not expire until 

March 31, 2011, based on the petition 

submitted by Montana Microbial 

Products. Therefore, the section is being 

revised to reflect these changes. 

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 


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tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue....’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

An Acute Pulmonary Toxicity/ 

Pathogenicity study (OPPTS 885.3150) 

in rats which were dosed intratracheally 

with Bacillus mycoides isolate J at 1.1 x 

108 cfu/animal, was reviewed and found 

to be supplemental because a clear 

pattern of clearance from all organs was 

not demonstrated during the study’s 35– 

day length. The test substance, however, 

did show a pattern of clearance in some 

organs. Differential heat treatment of 

tissue samples had suggested that most 

of the recovered organisms were spores. 

No treated animals died nor were there 

signs in the animals of toxicity or 

pathogenicity. Given the ubiquitous 

nature of this spore forming bacterium 

which is found on plants, in soil, water, 

air and decomposing plant tissue, along 

with the lack of mortality of the test 

animals and the absence of overt signs 

of toxicity or pathogenicity in the 

animals during the course of this 

pulmonary study, issuance of the 

Experimental Use Permit (EUP) can be 

justified provided there are instructions 

for appropriate respiratory protection 

for the applicators specified on the 

product label. 

The Agency has granted the requests 

for waivers for Acute Oral Toxicity and 

Pathogenicity (OPPTS 885.3050); Acute 

Injection Toxicity and Pathogenicity 

(OPPTS 885.3200); Acute Oral Toxicity 

(OPPTS 870.1100); Acute Dermal 

Toxicity (OPPTS 870.1200); Acute 

Inhalation Toxicity (OPPTS 870.1300) 

mammalian studies for Bacillus 

mycoides isolate ‘‘J’’ for this 

experimental–use permit (82761–EUP– 

2), based on the following submitted 

rationale: 

1. Personnel who worked with BmJ, 

more than 20 people over 8 years, have 

not reported any exposure effects in 

routine use of the experimental product. 

2. Exposure to BmJ will be limited by 

supervision and label mandated 

protective equipment. 

3. B. mycoides is not reported as a 

human pathogen, or as a cause of 

foodborne illness, food spoilage or plant 

diseases and does not persist on plant 

surfaces. Due to the ubiquitous level of 

B. mycoides present in agricultural 

soils, there has been long term human 

exposure to B. mycoides in crops and to 

residual B. mycoides cells or spores in 

food crops. No toxicity, infectivity or 

pathogenicity of B. mycoides in humans 

was reported in numerous searched 

citations. 

4. B. mycoides is readily differentiable 

from other B. cereus group organisms in 

production batches (including Bacillus 

thuringiensis, Bacillus pseudomycoides, 

Bacillus anthracis, Bacillus cereus, and 

Bacillus weihenstephanensis) and well 

defined quality control procedures keep 

contaminants from fermentation 

batches. B. mycoides is a member of the 

closely related group of Bacillus species 

which includes B. anthracis and B. 

cereus strains known to cause food 

poisoning as well as the widely used 

microbial pesticide B. thuringiensis. As 

part of a well recognized screening 

procedure used for quality control of B. 

thuringiensis and B. cereus, similar 

procedures shall be required for B. 

mycoides. 

The Agency has granted the requests 

for waivers for the studies Primary Eye 

Irritation (OPPTS 870.2400) and 

Primary Dermal Irritation (OPPTS 

870.2500). The registrant had provided 

the following rationales for the requests 

with which the EPA agrees: 

1. Personnel who worked with 

Bacillus mycoides isolate J for 2 to 7 

years showed no eye or dermal exposure 

effects. 

2. Eye or dermal exposure to Bacillus 

mycoides isolate J will be limited by 

supervision and protective equipment. 

If eye or dermal exposure did, however, 

occur, the spores will rinse out of the 

eye with water or wash off the skin with 

soap and water because spores are 

hydrophilic. 

3. Bacillus mycoides isolate J is not 

recorded as a human pathogen. Due to 

the ubiquitous presence of Bacillus 

mycoides isolate J in agricultural soils, 

there has been long term human 

exposure to Bacillus mycoides isolate J 

in crops and to residual Bacillus 

mycoides isolate J cells or spores in food 

crops. No toxicity or pathogenicity of 

Bacillus mycoides isolate J in humans 

has been reported in numerous searched 

citations. 

In connection with the requirement 

for reporting Hypersensitivity Incidents 

(OPPTS 885.3400), the Registrant has 

notified the Agency that no recorded or 

reported adverse hypersensitivity 

reaction to Bacillus mycoides isolate J 

has occurred during the period of 2 

years in which the substance has been 

handled in a laboratory setting. 

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 

The proposed EUP is not expected to 

result in increased dietary exposures of 

Bacillus mycoides isolate J to the general 

population. 

1. Food. The experimental program 

will include five crops, pecans, 

potatoes, sugar beets, tomatoes and 

peppers. The quantity of BmJ applied to 

plant foliage, 7.5 x 1011 spores/acre per 

application in typical applications to a 

maximum of 3.75 x 1012 spores per acre 

in pecan trees, is small compared to the 

natural background levels of Bacillus 

mycoides. In agricultural soils B. 

mycoides typically occurs at about 105

spores per gram and the titer of Bacillus 

mycoides isolate J applied to the foliage 

typically declines from 106 spores/cm2

to between 100 and 1,000 spores/cm2

over a 2–week period. In pecans, spores 

applied as foliage spray will also contact 

nutshells, however spores would be 

removed when shells are removed prior 

to any human consumption. In potatoes, 

spores applied to foliage will not 

directly contact tubers. Tubers are 

exposed to natural soil concentrations of 

Bacillus that exceed the quantity of 

Bacillus mycoides isolate J spores 


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applied to potato foliage. Washing, 

peeling, and or cooking will remove or 

destroy any residual spores. Because the 

ordinary consumer encounters only the 

sugar produced from sugar beets, (in 

which the bacterium is not present), an 

increased dietary exposure is not 

foreseen from treated sugar beets. 

Residue of Bacillus mycoides isolate J 

applied to sugar beet foliage is not 

expected to carry through sugar beet 

processing to create a residue in refined 

sugar for human consumption. 

Application of Bacillus mycoides isolate 

J will create minimal residues on sugar 

beet foliage. Cattle fed sugar beet tops 

treated with Bacillus mycoides isolate J 

may have an exposure to a low level of 

Bacillus mycoides isolate J spores. 

Given the natural occurrence of B. 

mycoides, the exposure to applied 

Bacillus mycoides isolate J on sugar beet 

tops is not expected to represent a 

significant increase in natural exposure 

of cattle to B. mycoides. Nor is human 

exposure anticipated of Bacillus 

mycoides isolate J in meat or milk as a 

result of feeding sugar beet tops with 

Bacillus mycoides isolate J residue to 

cattle. 

In tomatoes and peppers, spores 

applied as foliage sprays may leave a 

Bacillus mycoides isolate J spore residue 

on the tomatoes or peppers. From 

persistence studies, discussed in Unit 

III., residues of Bacillus mycoides 

isolate J are expected to decline by more 

than 1,000–fold over a 2–week period. 

Washing harvested fruit will also further 

reduce or eliminate any Bacillus 

mycoides isolate J residue. 

2. Drinking water exposure. There is 

minimal to negligible risk that surface 

water and, thus, drinking water 

exposure would occur with the 

proposed EUP testing. The proposed test 

sites are at least one half mile from the 

nearest surface water. When spray drift 

or accidental application of Bacillus 

mycoides isolate J over surface water 

did occur, the concentration of Bacillus 

mycoides isolate J spores in the water 

had been found to be very low. For 

example an acre dose of Bacillus 

mycoides isolate J, 7.5 x 1011 spores to 

100 square meters of surface water 1 

meter deep, would result in a 

concentration of 750 spores per cc. of 

water as noted in the EPA ecological 

risk assessment for Bacillus mycoides 

isolate J which is based on data 

submitted by Montana Microbial 

Products. 

B. Other Non-Occupational Exposure 

Natural background levels of Bacillus 

mycoides isolate J are reported to 

typically occur at about 105 spores per 

gram in agricultural soils. 

EPA concludes that dermal or 

inhalation exposure to Bacillus 

mycoides isolate J in the general 

population as a result of this EUP is not 

likely to occur, based on information 

submitted in pesticide tolerance petition 

8G7320 indicating that the relevant EUP 

agricultural sites, which will not exceed 

956 acres, are not accessible to 

individuals other than those conducting 

this EUP program. 

V. Cumulative Effects 

Pursuant to section 408(b)(2)(D)(v) of 

FFDCA, EPA has considered available 

information on the cumulative effects of 

such residues and other substances that 

have a common mechanism of toxicity. 

These considerations included the 

cumulative effects on infants and 

children of such residues and other 

substances with a common method of 

toxicity. Because there is no indication 

of mammalian toxicity or pathogenicity 

resulting from Bacillus mycoides isolate 

J, we conclude that there are no 

cumulative effects for this bacterium. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

The Agency has determined that there 

is reasonable certainty that no harm will 

result to the U. S. population from 

exposure to residues of Bacillus 

mycoides isolate J in connection with 

the testing for the proposed EUP 

program. This determination includes 

all anticipated dietary exposures and 

other non-occupational exposures for 

which there is reliable information. Oral 

ingestion of the Bacillus mycoides 

isolate J organism on crops treated 

under the proposed EUP is unlikely 

because: The portion of the pecans, 

potatoes, and sugar cane that is treated 

is not consumed by humans. The 

residues on peppers and tomatoes are 

readily removed by washing with water, 

and the U.S. population is already 

exposed to B. mycoides as a prevalent 

naturally occurring microbe in 

untreated soil. Data submitted in a 

pulmonary toxicity/pathogenicity study 

revealed no signs of overt toxicity or 

pathogenicity in the test animals. The 

results of an extensive literature search, 

which included numerous citations of 

the test organism, yielded no reports of 

its pathogenicity for mammals. There 

will be no access to persons other than 

participants in the program to the test 

sites for the EUP. The participants in the 

EUP program are required to wear 

appropriate respiratory protection. 

Section 408(b)(2)(C) of FFDCA 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, section 

408(b)(2)(C) of FFDCA also provides 

that EPA shall apply an additional 

tenfold margin of safety, also referred to 

as margins of exposure (MOEs), 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 MOE 

will be safe for infants and children. In 

this instance, based on all available 

information, the Agency concludes that 

there is a finding of no toxicity for 

Bacillus mycoides isolates J. Thus, there 

are no threshhold effects of concern to 

infants and children when the microbial 

is used as a fungicide. Accordingly, the 

Agency concludes that the additional 

MOE is not necessary to protect infants 

and children, and that not adding any 

additional MOE will be safe for infants 

and children. 

VII. Other Considerations 

A. Endocrine Disruptors 

The pesticidal active ingredient, 

Bacillus mycoides isolate J is not known 

to exert an influence on the endocrine 

system. 

B. Analytical Method(s) 

Analytical methods for Bacillus 

mycoides isolate J that are sufficient to 

justify the issuance of an Experimental 

Use Permit (EUP) have been submitted 

to the Agency. An enforcement 

analytical method is not required to 

support an exemption from the 

requirement of a tolerance. 

C. Codex Maximum Residue Level 

No codex maximum residue levels 

exist for the microbial Bacillus 

mycoides isolate J. 

VIII. 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 


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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). 

IX. 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: January 14, 2009. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is revised 

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 180.1269 is revised to read 

as follows: 

§ 180.1269 Bacillus mycoides Isolate J: 

exemption from the requirement of a 

tolerance. 

Bacillus mycoides isolate J is 

temporarily exempt from the 

requirement of a tolerance when used as 

a fungicide on pecans, potatoes, sugar 

beets, tomatoes, and peppers in 

accordance with the Experimental Use 

Permit 82761–EUP–2. This temporary 

exemption from the requirement of a 

tolerance expires and is revoked on 

March 31, 2011. 

[FR Doc. E9–5266 Filed 3–10–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0617; FRL–8397–2] 

2-Propenoic acid, polymer with α-[4- 

(ethenyloxy) butyl]-w-hydroxypoly 

(oxy-1,2-ethanediyl) and 1,2- 

propanediol mono-2-propenoate, 

potassium sodium salt; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-Propenoic 

acid, polymer with a-[4-(ethenyloxy) 

butyl]-w-hydroxypoly (oxy-1,2- 

ethanediyl) and 1,2-propanediol mono2-propenoate, potassium sodium salt; 

(CAS Reg. No. 518026–64–7); when 

used as an inert ingredient in a pesticide 

chemical formulation. BASF 

Corporation 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 2- 

propenoic acid, polymer with a-[4- 

(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 1,2-propanediol 

mono-2-propenoate, potassium sodium 

salt on food or feed commodities. 

DATES: This regulation is effective 

March 11, 2009. Objections and requests 

for hearings must be received on or 

before May 11, 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–2008–0617. 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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@epa.gov. 

SUPPLEMENTARY INFORMATION: 


rwilkins on PROD1PC63 with RULES