25524 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations 

* * * * * 

[FR Doc. E8–9950 Filed 5–6–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0159; FRL–8362–7] 

Bacillus firmus isolate 1582; 

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 Bacillus 

firmus isolate 1582 or Bacillus firmus I1582 on all food/feed commodities 

when applied/used as soil applications 

and seed treatments. AgroGreen 

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 exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus firmus I-1582. 

DATES: This regulation is effective May 

7, 2008. Objections and requests for 

hearings must be received on or before 

July 7, 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–2007–0159. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket 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. 

FOR FURTHER INFORMATION CONTACT: 

Shanaz Bacchus, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8097; e-mail address: 

bacchus.shanaz@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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicable provisions. 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 pilot 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–2007–0159 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 July 7, 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–2007–0159, 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 March 21, 

2007 (72 FR 13277) (FRL–8117–4), 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 6F7111) 

by AgroGreen, Biological Division, 

Minrav Infrastructures (1993) Ltd., 3 

Habossem Str, P.O. Box 153, Ashdod 


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Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations 25525 

77101, Israel. The petition requested 

that 40 CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Bacillus firmus isolate I-1582 when 

used as a soil application or seed 

treatment. This notice included a 

summary of the petition prepared by the 

petitioner RegWest Company, LLC, 

30856 Rocky Road, Greeley, CO 80631–

9375, United States Department of 

Agriculture (USDA) and submitted on 

behalf of AgroGreen. The current 

representative for AgroGreen is SciReg, 

Inc. 12733 Director’s Loop, Woodbridge, 

VA 22192, USA. There were no 

comments received in response to the 

notice of filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

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

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance 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. 

Bacillus firmus isolate 1582 (called B. 

firmus I-1582) (U.S. Patent No. 

6,406,690) is a Microbial Pesticide 

Control Agent (MPCA). It is intended to 

be used as a biological nematode 

suppressant on fruits, vegetables, field 

crops, and on such non-food crops as 

turf, and ornamentals. Further 

information regarding this MPCA can be 

found in the Biopesticide Registration 

Action Document (BRAD) on the 

Biopesticides and Pollution and 

Prevention Division website http:// 

www.epa.gov/pesticides/biopesticides. 

Studies submitted to the agency were 

issued Master Record Identification 

numbers (MRIDs) and then reviewed by 

the Biopesticides and Pollution 

Prevention Division (BPPD). The 

Agency also considered these 

submissions in light of the new 

microbial pesticides data requirements, 

which became final on December 26, 

2007 (72 FR 61002). The following 

summaries of the toxicological profile of 

Bacillus firmus isolate I-1582 are based 

on Agency reviews or Data Evaluation 

Records (DERs) dated March 05, 2008. 

These reviews include the following 

acute toxicity/pathogenicity studies; 

oral, dermal, pulmonary and injection. 

a. Acute oral toxicity/pathogenicity - 

rats (OPPTS 885.3050; MRID 

#46933007; DER 03/05/2008). Nineteen 

male and 19 female Sprague-Dawley rats 

were each treated by a single oral gavage 

dose of 0.1 mL per animal (>108 colony 

forming unit (cfu) animal) of Bacillus 

firmus I-1582 spores. The presented 

data showed no clinical signs and no 

weight loss related to test substance in 

rats. Bacillus firmus I-1582 was detected 

in brain, blood, cecum content, kidneys, 

lungs, lymph nodes, and spleen of the 

treated animals with clearance from the 

blood by day 7 and from all other organs 

by day 14. Necropsy was not conducted. 

Based on the presented/submitted data, 

Bacillus firmus I-1582 does not appear 

to be toxic, infective, and/or pathogenic 

in rats, when dosed orally at >108 cfu/ 

animal. This study was classified as 

‘‘acceptable’’ and the pesticide 

considered Toxicity Category IV for 

acute oral effects. 

b. Acute dermal toxicity/ 

pathogenicity - rabbits (OPPTS 

885.3100; MRID #46933008; DER 03/05/ 

2008). Five male and five female New 

Zealand White rabbits were each treated 

with 5,050 milligrams/kilogram/ 

bodyweight (mg/kg/bwt) Bacillus firmus 

I-1582 spore suspension applied to the 

clipped dorsal trunk in an area of 

approximately 10% of the body surface 

in a dermal occlusion test according to 

standard laboratory procedures. 

Animals were observed for dermal 

irritation 60 minutes after patch 

removal. The test animals were 

observed for mortality and clinical signs 

of toxicity at least three times on the day 

of treatment and once daily thereafter 

for 14 days. The rabbits were euthanized 

on day 14 and necropsies were 

performed. With the exception of one 

female that lost weight during the first 

week, all animals had normal body 

weight gain. All rabbits appeared 

normal during the study and all 

survived the study. Very slight to well 

defined erythema was observed on day 

1 with clearance by day 4. No 

observable abnormalities were noted at 

necropsy. The dermal LD50 for males, 

females, and combined was greater than 

5,050 mg/kg. Thus, Bacillus firmus I1582 is not toxic, infective, or 

pathogenic via the dermal route of 

exposure, and the active ingredient is 

placed in Toxicity Category IV for acute 

dermal effects. 

c. Acute pulmonary toxicity/ 

pathogenicity - rats (OPPTS 885.3150; 

MRID #46933009; DER 03/05/2008). 

Thirty male and 30 female SpragueDawley rats received 0.1 mL per animal 

(>108 cfu/animal) Bacillus firmus I-1582 

by intratracheal instillation. The 

presented data show no adverse 

abnormal clinical signs in rats. No test 

organisms were detected in any sample 

from the control rats. All six animals 

sacrificed on day 3 had significant cfus 

(686 to 30,731 cfu/g) in their lungs. The 

test organism was detected in brain, 

blood, cecum content, kidneys, lungs, 

lymph nodes, and spleen of the treated 

animals. Clearance was observed from 

the blood, kidneys, and liver by day 7 

and from all other organs by day 14. 

Necropsy studies were not conducted. 

Based on the presented/submitted data, 

the test organisms were not toxic, 

infective and/or pathogenic to rats and 

the active ingredient was placed in 

Toxicity Category IV for acute 

pulmonary effects. 

d. Acute inhalation toxicity (OPPTS 

870.1300; MRID # 46933009; DER 03/ 

05/2008). An acute inhalation study was 

not required for this non-volatile active 

ingredient. The Agency also considered 

the acute pulmonary study in Unit III.c., 

the nature of the inert ingredients, the 

label requirements for Personal 

Protective Equipment for workers, and 

the potential low exposure associated 


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with the proposed application methods. 

Based on its non-volatile nature, if the 

pesticide is used as labeled, it will pose 

minimal to non-existent risk to nonoccupationally-exposed populations via 

inhalation. 

e. Acute injection toxicity/ 

pathogenicity - rats (OPPTS 885.3200; 

MRID # 46933010; DER 03/05/2008). 

Twenty six male and 26 female SpragueDawley rats each received a dose of 0.1 

mL per animal (>107 cfu/animal), by 

injection into the tail vein. The 

presented data showed no observable 

clinical signs in treated rats. No test 

organisms were recovered in any 

samples from the control rats. The test 

organism was detected in the blood, 

kidneys, liver, lungs, lymph nodes, and 

spleen of the treated rats. Clearance 

from the brain, blood, kidneys, lymph 

nodes, and spleen was established by 

day 21 after dosing. Clearance from the 

cecum and liver was established by day 

14 after dosing. Necropsy studies 

showed no abnormal findings. Bacillus 

firmus spores did not appear to be toxic, 

infective, and/or pathogenic in rats, 

when dosed at >107 cfu/animal. The 

submission is classified as acceptable. 

f. Cell culture (OPPTS 885.3500). This 

data requirement is only required for 

active ingredients that are viruses and 

not for this type of bacterial pesticide. 

g. Waiver request: Hypersensitivity 

incidents technical-grade active 

ingredient (TGAI) (OPPTS 885.3400; 

DER 03/05/2008). In addition to the 

rationales in Unit III.h., the applicant 

requested that hypersensitivity 

incidents be waived based on there 

being no adverse effects of Bacillus 

firmus or its metabolites to humans or 

mammals in literature searches. The 

request to waive this requirement is not 

granted. As required for all pesticides, 

the Agency requires that 

hypersensitivity incidents, should 

adverse effects occur, must be reported 

to comply with section 6(a)(2) 

40CFR159.152. 

h. Waiver requests for Tiers II and 

Tier III (OPPTS 885.3550); MRID #s 

46933011; 47024806; DER 03/05/2008). 

The registrant requested that the Agency 

waive the requirement for submission of 

data to support Tier II and Tier III 

requirements for the TGAI. 

The following rationales were 

provided to support requests to waive 

submission of the studies 

1. The active ingredient, Bacillus 

firmus strain I-1582, is a naturally 

occurring microorganism. 

2. No reports of adverse effects of 

Bacillus firmus or its metabolites to 

humans or mammals were found in 

literature searches. 

3. The proposed uses of the proposed 

End-use Product (EP) are not expected 

to result in increased exposure or 

adverse effects to humans or mammals. 

4. The bacteria count falls to subeffective levels in the environment 

within 90 days of treatment. 

5. The submitted studies, MRIDs 

46933007, 46933008, 46933009, and 

46933010, did not show pathogenicity 

to animals treated by oral gavage, 

dermal application, pulmonary 

instillation, or intravenous injection. 

6. Bacillus firmus was not found on 

any of eleven lists of pathogens 

searched. 

Based on these acceptable rationales 

and there being no toxicological, 

infectivity or pathogenicity concerns in 

the Tier I mammalian toxicity data 

submitted, the Agency granted the 

request to waive studies required for 

Tier II and Tier III testing. 

i. Waiver requests: EP and 

hypersensitivity incidents (OPPTS 

885.3400; DER 03/05/2008). The 

applicant has submitted rationales to 

waive data for acute oral toxicity/ 

pathogenicity, acute pulmonary 

toxicity/pathogenicity, acute dermal, 

primary eye, hypersensitivity study, 

acute inhalation, and primary dermal, 

primary eye studies. These rationales 

were based on the results of tests for the 

TGAI discussed in the toxicological 

profile in Unit III of this document. In 

addition to the rationales in Unit III.h., 

the applicant reiterated that there were 

no reports of adverse effects of Bacillus 

firmus or its metabolites to humans or 

mammals in literature searches. 

The request to waive toxicity testing 

for the EP was based on acceptable data 

reviews of the TGAI and the nature of 

the inert ingredients which are exempt 

from the requirement of a tolerance. The 

Agency decided to grant the request to 

waive the test for primary eye irritation 

based on the acceptable low acute 

dermal toxicity category IV 

classification of the pesticide. Any 

potential primary eye irritation to this 

low toxcity pesticide can be mitigated 

by goggles or personal protective eye 

equipment. In addition the application 

rate and types of soil application and 

seed treatments indicate minimal to 

non-existent risk via eye exposure. The 

request to waive the requirement for 

hypersensitivity incidents for the EP is 

not granted. As required for all 

pesticides, the Agency requires that 

hypersensitivity incidents, should 

adverse effects occur, must be reported 

to comply with section 6(a)(2) (40 CFR 

159.152). 

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 

1. Food. Dietary exposure to the 

microbial pesticide is likely to occur to 

this ubiquitous microbe. The lack of 

acute oral toxicity/pathogenicity, based 

on the toxicology test in rats, supports 

the exemption from the requirement of 

a tolerance for this active ingredient. 

The pesticide is intended to be applied 

to the soil or to be used as seed 

treatments, mainly for control of 

nematodes. It is not systemic. Thus, 

dietary exposure by direct contact with 

food is not expected. The acute oral 

study described in Unit III indicates that 

the active ingredient is not toxic, 

infective or pathogenic when 

administered to mammals (rats) via the 

oral route. In addition to this acute oral 

study, other toxicology studies 

indicated that the microbe cleared all 

organs within the time allotted for the 

studies. 

There is no direct post-harvest 

treatment of food commodities with 

Bacillus firmus I-1582. Thus, detectable 

residues of Bacillus firmus I-1582 are 

not expected on agricultural crops or 

food commodities as a result of the 

proposed use of this active ingredient. 

All inerts in the proposed EP are exempt 

from the requirement of a tolerance. 

Based on these observations, the Agency 

concluded that dietary exposure to 

Bacillus firmus I-1582 is not expected to 

cause harm to human adults, infants 

and children. 

2. Drinking water exposure. Drinking 

water is not being screened for Bacillus 

firmus I-1582 as a potential indicator of 

microbial contamination. The pesticide 

is not intended for application to 

aquatic agricultural crops. In the 

unlikely event that Bacillus firmus I1582 was transferred to ground water, 

the microbe would not survive the 

conditions of drinking water treatment, 

such as chlorination, pH adjustments, 

and other water processing conditions. 

However, because of the lack of 

mammalian toxicity, even if negligible 

oral exposure should occur through 

drinking water, the Agency concludes 

that such exposure would present no 

risk. 


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Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations 25527 

B. Other Non-Occupational Exposure 

The Agency expects non-occupational 

dermal and inhalation exposure to pose 

no harm if the pesticide is used as 

labeled. The proposed product is anEP 

that is intended to be used 

commercially for seed and soil 

treatments of agricultural crops. Other 

homeowner and residential uses are also 

for soil applications outdoors at very 

low rates. No indoor residential, school, 

or daycare uses are currently permitted 

for this active ingredient. Even if there 

is non-occupational residential, school 

or day care exposure from the proposed 

uses of Bacillus firmus I-1582, the risk 

posed by this low toxicity microbe is 

likely to be minimal. 

1. Dermal exposure. As discussed in 

Unit III. Bacillus firmus I-1582 is not 

toxic, infective, or pathogenic via the 

dermal route of exposure, and the active 

ingredient is placed in Toxicity 

Category IV for acute dermal effects. The 

pesticide is proposed for use as soil and 

seed treatments to agricultural crops. 

For these exposure scenarios, nonoccupational dermal exposure is not 

expected. The potential for nonoccupational exposure exists for 

residential and home and garden use. 

However, low application rates, soil 

applications and the low toxicity 

potential of the active ingredient 

indicate that non-occupational exposure 

through these uses is not likely to cause 

harm to the exposed population if the 

pesticide is used as labeled. 

2. Inhalation exposure. A similar 

rationale supports the Agency’s 

conclusion that non-occupational 

inhalation exposure is not likely to 

cause harm to the exposed population if 

the pesticide is used as labeled. The 

active ingredient is placed in Toxicity 

Category IV on the basis of the acute 

pulmonary study (see Unit III.) and is 

non-volatile. 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the FFDCA 

requires the Agency to consider the 

cumulative effect of exposure to 

Bacillus firmus I-1582 and to other 

substances that have a common 

mechanism of toxicity. These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. Bacillus firmus I1582 is not toxic or pathogenic to 

mammals via several routes of exposure 

(Unit III.) There are no other Bacillus 

firmus strains registered. Consequently, 

no cumulative effects from the residues 

of this product with other related 

microbial pesticides are anticipated. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

See Unit III. for acute toxicological 

evaluations of Bacillus firmus I-1582. 

Further, FFDCA section 408(b)(2)(C) 

provides that EPA shall apply an 

additional tenfold margin of exposure 

(safety) for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure, unless EPA determines 

that a different margin of exposure 

(MOE) (safety) will be safe for infants 

and children. Margins of exposure 

(safety), which often are referred to as 

uncertainty factors, are incorporated 

into EPA risk assessment either directly 

or through the use of a margin of 

exposure analysis or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. Actual exposures to 

adults and children through diet are 

expected to be several orders of 

magnitude less than the doses used in 

the toxicity and pathogenicity tests 

referenced in Unit III. Thus, the Agency 

has determined that an additional 

margin of safety for infants and children 

is unnecessary. 

VII. Other Considerations 

A. Endocrine Immunotoxicity 

EPA is required under section 408(p) 

of the FFDCA, as amended by FQPA, to 

develop a screening program to 

determine whether certain substances 

(including all pesticide active and other 

ingredients) ‘‘may have an effect in 

humans that is similar to an effect 

produced by a naturally-occurring 

estrogen, or other such endocrine effects 

as the Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there was a 

scientific basis for including, as part of 

the program, androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that it include evaluations of potential 

effects in wildlife. 

The Agency has no knowledge of 

Bacillus firmus I-1582 being an 

endocrine disruptor, nor if this microbe 

is related to any class of known 

endocrine disruptors. Consequently, 

endocrine-related concerns did not 

impact the Agency’s safety finding for 

these Bacillus firmus I-1582 strains. 

Additional data specifically on the 

endocrine effects of this microbial 

pesticide are not required at this time. 

When the appropriate screening and/or 

testing protocols being considered 

under the Agency’s Endocrine Disrupter 

Screening Program (EDSP) have been 

developed and implemented, Bacillus 

firmus I-1582 may be subject to 

additional screening and/or testing to 

better characterize effects related to 

endocrine disruption. 

As discussed in this document in Unit 

III. Tier I toxicology data evaluated for 

this active ingredient showed clearance 

in a variety of tissues and did not trigger 

Tier III data requirements for 

immunotoxicity testing. 

B. Analytical Methods 

The acute oral studies discussed in 

Unit III. demonstrate that the active 

ingredient does not pose a dietary risk. 

In addition, the active ingredient is not 

likely to come into contact with the 

treated food commodities. Furthermore, 

the low application rate and nonpersistence on food during applications 

suggests very low exposure potential via 

the dietary route. Since residues are not 

expected on treated commodities, the 

Agency has concluded that an analytical 

method to detect residues of this 

pesticide on treated food commodities 

for enforcement purposes is not needed. 

Nevertheless, the Agency has 

concluded that for analysis of the 

pesticide itself, microbiological and 

biochemical methods exist and are 

acceptable for enforcement purposes for 

product identity of Bacillus firmus I1582. Other appropriate methods are 

required for quality control to assure 

that product characterization, the 

control of human pathogens and other 

unintentional metabolites or ingredients 

are within regulatory limits, and to 

ascertain storage stability and viability 

of the pesticidal active ingredient. 

C. Codex Maximum Residue Level 

There is no Codex maximum residue 

level for residues of Bacillus firmus I1582. 

VIII. Conclusions 

The results of the studies discussed in 

Unit III. meet the safety standards of the 

1996 FQPA. They support an exemption 

from the requirement of a tolerance for 

residues of Bacillus firmus I-1582, on 

treated food or feed commodities. In 

addition, the Agency is of the opinion 

that, if the microbial active ingredient is 

used as allowed, aggregate and 

cumulative exposures are not likely to 

harm the adult human U.S. population, 

children and infants. Therefore, an 

exemption from tolerance is granted for 

residues of Bacillus firmus I-1582 when 

used as soil and seed treatments in/on 

all food/feed commodities in response 

to pesticide petition 6F7111. 


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25528 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations 

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: April 23, 2008. 

Debra Edwards, 

Director, Office of Pesticide Programs 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1282 is added to read 

as follows: 

§ 180.1282 Bacillus firmus I-1582; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established in/on all 

food/feed commodities, for residues of 

Bacillus firmus I-1582 when used as a 

soil application or seed treatment. 

[FR Doc. E8–10121 Filed 5–6–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2004–0306; FRL–8361–4] 

Pyridalyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyridalyl in or 

on vegetables, leafy, except Brassica, 

group 4; Brassica, head and stem, 

subgroup 5A; vegetables, fruiting, group 

8; mustard greens; and turnip greens. 

Valent U.S.A. Corporation and the 

International Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective May 

7, 2008. Objections and requests for 

hearings must be received on or before 

July 7, 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–2004–0306. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket 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. 

FOR FURTHER INFORMATION CONTACT: Olga 

Odiott, Registration Division (7505P), 


jlentini on PROD1PC65 with RULES