Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 76619

revisions if consistent with the Clean 

Air Act. 

SIP requirements applicable to all 

areas are provided in section 110. Part 

D of title I the Clean Air Act specifies 

additional requirements applicable to 

nonattainment areas. Section 110 and 

part D describe the elements of a SIP 

and include, among other things, 

emission inventories, a monitoring 

network, an air quality analysis, 

modeling, attainment demonstrations, 

enforcement mechanisms, and 

regulations which have been adopted by 

the State to attain or maintain NAAQS. 

EPA has adopted regulatory 

requirements which spell out the 

procedures for preparing, adopting and 

submitting SIP’s and SIP revisions; that 

are codified in 40 CFR part 51. 

EPA’s action on each State’s SIP is 

promulgated in 40 CFR part 52. The first 

section in the subpart in 40 CFR part 52 

for each State is generally the 

‘‘Identification of plan’’ section which 

provides chronological development of 

the State SIP. Or if the state has 

undergone the new Incorporation by 

Reference format process (see 62 FR 

27968, May 22, 1997), the identification 

of plan section identifies the Statesubmitted rules and plan elements 

which have been Federally approved. 

The goal of the State-by-State SIP 

compilation is to identify those rules 

under the ‘‘Identification of plan’’

section which are currently Federallyenforceable. In addition, some of the SIP 

compilations may include control 

strategies, such as transportation control 

measures, local ordinances, State 

statutes, and emission inventories, or 

may include regulations provided in 

other sections of the State-specific 

subpart of part 52. Some of the SIP 

compilations may not identify these 

other Federally-enforceable elements. 

The contents of a typical SIP fall into 

three categories: (1) State-adopted 

control measures which consists of 

either rules/regulations or sourcespecific requirements (e.g., orders and 

consent decrees); (2) State-submitted 

‘‘non-regulatory’’ components (e.g., 

attainment plans, rate of progress plans, 

emission inventories, transportation 

control measures, statutes 

demonstrating legal authority, 

monitoring networks, etc.); (3) 

additional requirements promulgated by 

EPA (in the absence of a commensurate 

State provision) to satisfy a mandatory 

section 110 or part D (Clean Air Act) 

requirement. 

What Is Federally-Enforceable 

Enforcement of the state regulation 

before and after it is incorporated into 

the Federally-approved SIP is primarily 

a state responsibility. However, after the 

regulation is Federally approved, EPA is 

authorized to take enforcement action 

against violators. Citizens are also 

offered legal recourse to address 

violations as described in section 304 of 

the Clean Air Act. 

You should note that, when States 

have submitted their most current State 

regulations for inclusion into Federallyenforceable SIPs, EPA will begin its 

review process of submittals as soon as 

possible. Until EPA approves a 

submittal by rulemaking action, Statesubmitted regulations will be Stateenforceable only; therefore, Stateenforceable SIPs may exist which differ 

from Federally-enforceable SIPs. As 

EPA approves these State-submitted 

regulations, the regional offices will 

continue to update the SIP compilations 

to include these applicable 

requirements.

Dated: December 16, 2004. 

Michael O. Leavitt, 

Administrator.

[FR Doc. 04–27993 Filed 12–21–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0175; FRL–7682–6]

Bacillus pumilus GB34; Exemption 

from the Requirement of a Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the microbial 

pesticide Bacillus pumilus GB34 when 

used as a seed treatment in or on all 

food commodities. An exemption is also 

granted for such residues on treated but 

unplanted soybean seeds. Gustafson 

LLC 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), 

to amend and expand an existing 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

pumilus GB34.

DATES: This regulation is effective 

December 22, 2004. Objections and 

requests for hearings must be received 

on or before February 22, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0175. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Anne Ball, Biopesticides and Pollution 

Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8717; e-mail 

address:ball.anne@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:

• Industry (NAICS 111), e.g. crop 

production, vegetable and fruit farming

• Industry (NAICS 112), e.g. animal 

production

• Industry (NAICS 311), e.g. food 

manufacturing

• Industry (NAICS 32532), e.g. 

pesticide and other agricultural 

chemical manufacturing 

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 applicability provisions in 

the NAICS listings which are published 

by the U. S. Census Bureau. If you have 

76620 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 

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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of March 3, 

2004 (69 FR 10037) (FRL –7343–8), EPA 

issued a notice pursuant to section 

408(d)(3) of the FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 1F6344) 

by Gustafson LLC, 1400 Preston Road, 

Suite 400, Plano, TX 75093. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus 

pumilus GB34 when used as a seed 

treatment in or on all food commodities, 

which term for purposes of the tolerance 

exemption that is sought, includes all 

soybean seeds treated prior to planting, 

but not planted, but excludes all other 

non-soybean seeds that are treated, but 

not planted. This request would amend 

and expand an existing exemption from 

the requirement of a tolerance that the 

Agency had granted for residues of 

Bacillus pumilus GB34 when used as a 

seed treatment in or on soybeans, 

including once again, all soybean seeds 

treated prior to planting, but not planted 

and thereafter used as a food 

commodity. This notice included a 

summary of the petition prepared by the 

petitioner Gustafson LLC.

One comment was received in 

response to the notice of filing. The 

comment states that ‘‘the material safety 

data sheet is horrific on this bacillus. It 

is listed as an irritant on Gustafson’s 

own MSDS, with eye irritation, skin and 

lung sensitization, producing 

carcinogen (sic) in rats and scarring of 

lungs, with inhalation dangerous’’. In 

response, it should be clarified that the 

purpose of the Federal Register notice 

of filing upon which comment was 

received is intended to inform the 

public about receipt of a petition for a 

tolerance exemption. Pursuant to the 

FFDCA, as amended by the FQPA, that 

Federal Register notice of filing 

included the company’s interpretation 

of the data they submitted in support of 

the requested tolerance exemption. 

Importantly, however, the FR notice of 

filing is not the final Agency 

determination on the tolerance 

exemption request. Second, EPA has 

now evaluated the potential hazards 

posed by this microbial pesticide 

product in connection with its proposed 

seed treatment use pattern, including 

the toxicity of the cited filler, in the 

proposed seed treatment use pattern 

during the risk assessment undertaken 

in order to make a determination on this 

petition. The results of end product 

testing indicate low toxicity or irritation 

potential (toxicity category III or IV), 

and the active ingredient itself displays 

no infectivity, pathogenicity or toxicity. 

Therefore, use of the product as a seed 

treatment presents negligible concern. 

In addition, a fate study presented by 

the company showed that Bacillus 

pumilus GB34 treated soybean seeds, 

when processed by typical procedures 

for soybeans, had no greater level of 

Bacillus species present than ordinary 

untreated soybeans. This final rule 

includes EPA’s assessment of the 

submitted data and discusses why the 

seed treatment application of this 

microbial agent, and the use as a food 

commodity of Bacillus pumilus GB34 

treated but unplanted soybean seeds 

that are then processed, have a 

reasonable certainty of causing no harm 

considering the expected aggregate 

residues, if any, and the negligible to no 

dietary exposure resulting from these 

applications or uses. 

Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the 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 the 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. 

The Bacillus pumilus species was first 

described by Meyer and Gottheil in 

1901. This naturally occurring species is 

one of the most numerous of the 

Bacillus species found on plant 

surfaces. The strain Bacillus pumilus

GB34 is a naturally occurring soil 

colonizer. The mode of action of the 

strain, an antifungal agent, is to colonize 

the developing root system of the plant 

it is to protect, in this case the 

developing root system of plants of food 

crops including that of the soybean 

plant. The organism Bacillus pumilus

GB34 then suppresses by competition, 

through the formation of a physical 

barrier, the continued formation of 

spores of the fungal diseases such as 

Rhizoctonia and Fusarium. 

Subsequently, Bacillus pumilus GB34 

colonizes the remaining fungal disease 

spores themselves, thereby destroying 

them. On the basis of acute injection 

toxicity/pathogenicity tests on rats, 

Bacillus pumilus GB34 does not appear 

to be toxic, infective, or pathogenic in 

those mammals. 

Toxicity studies in support of this 

tolerance exemption petition are 

summarized below. More detailed 

analyses of these studies may be found 

in the specific Agency reviews of the 

studies. Waivers from certain data 

requirements were requested and 

granted, and these are noted below as 

well. 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 76621

Summarized below are toxicity 

studies relating to the Bacillus pumilus

GB34 Concentrate (end use product), 

which initially were submitted to 

support an application for an 

experimental use permit (EUP) for 

Bacillus pumilus GB34 Concentrate and 

later were bridged to support a section 

3 registration for the microbial product, 

as well as studies pertaining to Bacillus 

pumilus GB34 Technical. All of these 

studies supported the initial, more 

limited tolerance exemption for residues 

of Bacillus pumilus GB34 when used as 

a seed treatment in or on soybeans, 

including all soybean seeds treated prior 

to planting, but not planted and 

thereafter used as a food commodity. 

Additionally, all of these studies 

support the broader tolerance 

exemption considered in this Final Rule 

for residues of Bacillus pumilus GB34 

when used as a seed treatment in or on 

all food commodities, which term, for 

purposes of this tolerance exemption, 

includes all soybeans treated prior to 

planting, but not planted, but excludes 

all other, non-soybean seeds that are 

treated but not planted. In addition to 

these studies, the company presented to 

the Agency a fate study supporting the 

use of soybean seeds, which had been 

treated but not planted, as a food 

commodity. The study demonstrated 

that Bacillus pumilus GB34 treated 

soybean seeds, when processed by 

typical procedures for soybeans, have 

no greater level of Bacillus species 

present than ordinary untreated and 

processed soybeans.

1. Acute oral toxicity—i. Bacillus 

pumilus GB34 Concentrate. (Originally 

submitted to support an application for 

an EUP for Bacillus pumilus GB34 

Concentrate and subsequently bridged 

to support a section 3 registration for the 

microbial product (and its exemption 

from a tolerance.) (OPPTS 870.1100; 

Master Record Identification Number 

(MRID) 452940–01). Five male and five 

female young adult Sprague-Dawley rats 

each received a single 5,000 milligrams/

kilogram (mg/kg) gavage dose of 

Bacillus pumilus GB34 Concentrate, 

previously diluted to a 40% weight/

weight (w/w) solution with distilled 

water at a dosing volume of 1 milliliter 

(mL)/100 grams (g). The rats were 

observed for morbidity/moribundity, 

and behavior changes 1 and 3 hours 

after dosing and at least daily thereafter 

for 14 days. They were weighed on days 

0, 7, and 14. At the end of the study the 

rats were all euthanized and necropsied. 

No morbidity, moribundity, or effects on 

body weight were found following 

treatment of rats with 5,000 mg/kg test 

material. Therefore, the Sprague-Dawley 

rat oral lethal (LD)50 of Bacillus pumilus

GB34 Concentrate for male, female, and 

male and female combined is >5,000 

mg/kg, placing the test material in 

Toxicity Category IV. 

ii. Acute oral toxicity—Bacillus 

pumilus GB34 Technical. (OPPTS 

870.1100; MRID 454335–01 corrected as 

MRID 457225–01). Five male and five 

female Sprague-Dawley rats each 

received a single 5,000 mg/kg gavage 

dose of the Bacillus pumilus GB34 

Technical, previously diluted to a 40% 

w/w solution with distilled water, at a 

dosing volume of 1ml/100g. The rats 

were observed for morbidity, 

moribundity, and behavioral changes 1 

hour and 3 hours after dosing and at 

least daily thereafter for 14 days. They 

were weighed on days 0, 7, and 14. At 

the end of the study, the rats were 

euthanized and necropsied. No 

morbidity, moribundity, or effects on 

body weight were found following 

treatment of rats with 5,000 mg/kg test 

material. Therefore, the Sprague Dawley 

rat oral LD50 of Bacillus pumilus GB34 

Technical for male, female and male 

and female combined is >5,000 mg/kg, 

placing the test material in Toxicity 

Category IV.

2. Acute dermal toxicity—Bacillus 

pumilus GB34 Concentrate and Bacillus 

pumilus GB34 Technical. (OPPTS 

870.1200 and OPPTS 885.3100 (Acute 

dermal Toxicity/Pathogenicity); waiver 

request, no MRID). A waiver from this 

data requirement was requested and 

granted for a seed treatment use. The 

rationale for the waiver is that the rate 

of application of the product is 0.1 

ounce per 100 pounds of seed. The seed 

treatment is to take place in a 

commercial seed treatment facility in 

which there is no exposure to the 

general population. After germination of 

the treated seed, the habit of the 

bacterium is to inhabit the root system 

of the plant. Thus there is expected to 

be minimal, if any, dermal exposure for 

the general population in a seed 

treatment use of the microbial pesticide. 

As stated above , with respect to its use 

as a food commodity, of any soybeans 

treated but not planted, a fate study 

presented by the company demonstrated 

that bacillus pumilus GB3 4 treated 

soybeans seeds, when processed by 

typical procedures for soybeans, had no 

greater level of Bacillus species present 

than ordinary untreated and processed 

soybeans. 

3. Acute inhalation toxicity—Bacillus 

pumilus GB34 Concentrate and Bacillus 

pumilus GB34 Technical. (OPPTS 

870.1300 and OPPTS 885.3150 (Acute 

Pulmonary Toxicity/Pathogenicity); 

waiver request, no MRID). A waiver 

from this data requirement was 

requested and granted for a seed 

treatment use. The use of Bacillus 

pumilus GB34 as a seed treatment will 

take place in a commercial seed 

treatment facility in which there is no 

potential for inhalation exposure by the 

general population. The rate of 

application of the pesticide is 0.1 oz per 

100 lbs of seed. The habit of the 

bacterium is to gravitate to the root 

system of the developing plant. Thus, 

for a seed treatment use of Bacillus 

pumilus GB34 there is expected to be a 

negligible, if any, inhalation exposure. 

In addition, the fate study referred to 

above supports the use of any treated 

but not planted, soybean seeds as a food 

commodity, and the data waiver is 

applicable for that use as well. 

4. Acute oral toxicity/pathogenicity—

Bacillus pumilus GB34 Technical and 

Bacillus pumilus GB34 Concentrate. 

(OPPTS 885.3050). A waiver from this 

data requirement was requested and 

granted for a seed treatment use. The 

rationales include the following:

i. There is expected to be a low rate 

of application (0.1 oz per 100 lbs of 

seed). 

ii. There is expected to be a minimal 

exposure to the general population since 

the seed treatment will take place in a 

commercial seed treating facility with 

mechanical treating equipment.

iii. The results of the toxicity tests 

submitted to date do not indicate that 

this strain is toxic or infective. 

Moreover, the results would suggest that 

the Bacillus pumilus GB34 strain does 

not express the 6,500 molecular weight 

toxin discussed in two papers in the 

literature. In addition, the habit of the 

bacterium to gravitate to the root system 

of the developing plant makes it 

unlikely that any would be present in 

the above ground parts of the mature 

plant, thus minimizing the the potential 

for oral exposure for humans. Finally, 

the fate study referred to above supports 

the use as a food commodity of any 

treated, but not planted, soybean seed 

that have been processed by typical 

procedures for soybeans.

5. Primary eye irritation—i. Bacillus 

pumilus GB34 Concentrate. (Originally 

submitted to support an application for 

an EUP for Bacillus pumilus GB34 

Concentrate and subsequently bridged 

to support a section 3 registration for the 

microbial product and its exemption 

from a tolerance.) (OPPTS 870.2400; 

MRID 452940–02). Three male and three 

female young adult new Zealand whit 

rabbits were used in the experiment. 

Prior to test material instillation, both 

eyes were treated with 2% fluorscein 

and examined under ultraviolet (UV) 

light for ocular abnormalities. The test 

material, 0.1ml (equivalent to 0.05 to 

76622 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 

0.07 g) was instilled into the everted 

lower lid of the right eye and the upper 

and lower lids held closed for one 

second. The contralateral eye acted as 

control. The eyes were examined and 

scored according to the Draize method 

1, 24, 48 and 72 hours after test material 

instillation. The 24 hour examination 

also included a fluorescein staining 

examination.for corneal effects. All 

rabbits survived the study. All rabbits 

developed slight conjunctival irritation 

that cleared within 24 hours after 

treatment. No corneal opacity or iritis 

was noted. Bacillus pumilus GB34 

Concentrate was minimally irritating to 

the eye and is placed in Toxicity 

Category IV.

ii. Bacillus pumilus GB34 Technical. 

(OPPTS 870.2400; MRID 454335–02, 

corrected as 457225–02). Prior to the 

test, three male and three female young 

adult New Zealand white rabbits were, 

treated in both eyes with 2% fluorscein 

and then examined under UV light for 

ocular abnormalities. The test material, 

in the amount of 0.1 mL was instilled 

into the everted lower lid of the right 

eye and the upper and lower lids were 

held closed for 1 second. The 

contralateral eye served as control. The 

eyes were examined and scored 

according to the Draize metnod 1, 24, 48 

and 72 hours after test material 

instillation. The 24 hour examination 

also included a fluorescein staining 

examination for corneal efffects. All 

rabbits developed moderate 

conjunctival irritation that cleared up 

within 72 hours of treatment. No 

corneal opacity or irritis or non-ocular 

effects were noted. The Bacillus 

pumilus GB34 test substance was mildly 

irritating to the eye and is placed in 

Toxicity Category III.

6. Primary Dermal Irritation—i. 

Bacillus pumilus GB34 Concentrate. 

(Originally submitted to support an 

application for an EUP for Bacillus 

pumilus GB34 Concentrate and 

subsequently bridged to support a 

section 3 registration for the microbial 

product and its exemption from a 

tolerance) (OPPTS 870.2500; MRID 

452940–03). Three male and three 

female young adult New Zealand white 

rabbits were received for the study. The 

fur on the dorsal-lumbar area of each 

rabbit was clipped. The rabbits were 

given a single 0.5 g dose of test material 

applied under a 1′′x1′′ 4-ply gauze pad 

on a 6 cm square clipped site. The gauze 

pad is then secured and Elizabethan 

collars were placed on the animals. Four 

hours later these were removed and the 

sites wiped with a moistened towel. The 

application sites were observed for 

dermal irritation 1, 24, 48 and 72 hours 

after patch removal. In addition, the 

rabbits were observed at least daily for 

clinical signs of toxicity during the 72–

hour study period. All rabbits survived 

the study. No dermal irritation was 

observed on any rabbit at any site. Based 

on the study, Bacillus pumilus GB34 

Concentrate is non-irritating to the New 

Zealand white rabbit and is placed in 

Toxicity Category IV. 

ii. Bacillus pumilus GB34 Technical. 

(OPPTS 870.2500; MRID 454335–03 

corrected as MRID 457225–03). Three 

male and three female New Zealand 

white albino rabbits were prepared by 

clipping the doesal area and the trunk. 

Only healthy animals without 

preexisting skin irritation had been 

selected for the test. The test substance 

in the amount of 0.5 g was placed on a 

1 inch x 1 inch, 4-ply gauze pad which 

was applied and secured on each rabbit. 

After 4 hours exposure to the test 

substance, the pads were removed and 

the test site wiped with water and towel 

to remove any residual test substance. 

Individual test sites were scored 

according to the Draize scoring at 

approximately 1, 24, 48, and 72 hours 

after patch removal. The animals were 

observed for signs of gross toxicity and 

behavioral changes at least once daily 

during the test period. All animals 

appeared active and healthy. There were 

no signs of gross toxicity, adverse 

pharmacological effects or abnormal 

behavior. No dermal irritation was 

noted at any test site during the study. 

Under the conditions of the study, the 

Bacillus pumilus GB34 Technical is 

classified as non-irritating to the skin 

and placed in Toxicity Category IV.

7. Acute injection toxicity/

pathogenicity, Bacillus pumilus GB34 

Technical. (originally submitted to 

support an application for an EUP for 

Bacillus pumilus GB34 Technical and 

subsequently bridged to support a 

section 3 registration for the microbial 

product and its exemption from a 

tolerance) (OPPTS 885.3200; MRID 

453416–01). A total of 39 male and 39 

female rats were used in the tests. The 

results showed:

i. Mortality. No deaths were observed 

in any of the dosed or control groups 

prior to scheduled sacrifice.

ii. Body and organ weights. Overall, 

both male and female rats gained weight 

for the duration of the study, 

demonstrating the continued health of 

the animals.

iii. Clinical observation. Overall, both 

male and female rats showed no 

abnormal clinical signs.

iv. Gross necropsy. No significant 

signs of abnormalities were seen except 

for a laceration on the left shoulder of 

a test-substance- treated male rat. An 

enlarged spleen was seen in one testsubstance-treated male rat. 

Based on the results of the acute 

injection toxicity/pathogenicity study, 

the Agency determined that Bacillus 

pumilus GB34 does not appear to be 

toxic, infective or pathogenic in rats 

when dosed at 1x 10 7 cfu/animal. This 

test supports the requirements for both 

the technical grade active ingredient 

(the technical) and the end use product 

(the concentrate). 

A hypersensitivity study, or dermal 

sensitization study is not required for 

registration of this product since, in the 

case of the use of the product as a seed 

treatment, there is not expected to be 

repeated human contact by inhalation or 

dermal routes (routes specified in 

footnote iii of the table in 40 CFR 

158.740 (c)). In the case of the use as a 

food commodity of the treated but not 

planted soybean seeds, a fate study 

presented by the company, as 

mentioned elsewhere in this document, 

showed that Bacillus pumilus GB34 

treated soybean seeds, when processed 

by typical procedures for soybeans, had 

no greater level of Bacillus species 

present than ordinary untreated 

soybeans. Furthermore, there have been 

no reports of incidents of 

hypersensitivity, allergies or other 

adverse effects in connection with the 

production or use of Bacillus pumilus

GB34. Nonetheless, to comply with 

EPA’s requirements under FIFRA 

section 6(a)(2) , any incident of 

hypersensitivity associated with the use 

of this pesticide must be reported. (See 

also 40 CFR 158.690(c)(iv)).

An immune response study is not 

required for registration of or exemption 

from the requirement of a tolerance for 

this product because the Acute I.V., I.C., 

or I.P. injection toxicity/pathogenicity 

study (OPPTS Guidelines 885.3200) 

previously submitted in support of an 

EUP for Bacillus pumilus GB34 and 

subsequently bridged to support a 

section 3 registration and an earlier, 

more limited in scope tolerance 

exemption for this microbial product, 

serves to address the endpoint of 

immune response. This injection study 

examines the normal functioning of the 

immune system when faced with the 

potentially most challenging exposure 

to this microbial pesticide active 

ingredient: direct injection into the 

bloodstream. If the test animal is able to 

withstand and survive the introduction 

of such a large number of microbes, 

bypassing the normal protective barriers 

of the skin, the pulmonary macrophages 

and the gastrointestinal lymphoid 

tissues, then the immune system is 

functioning normally. The normal 

functioning of the immune system 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 76623

implies that it can recognize the 

introduced microbes as foreign and can 

clear them from the blood and other 

exposed organs. After the active 

ingredient, Bacillus pumilus GB34 , was 

intravenously injected into the test 

animals (rats), no deaths, adverse 

clinical signs or significant findings 

upon necropsy were seen 35 days after 

the injection. 

The requirement for Tier II and Tier 

III data was not triggered based on the 

results of Tier I data which had been 

submitted or waived.

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the 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 pumilus GB34 is a naturally 

occurring and ubiquitous 

microorganism. It inhabits the root 

system of plants where it acts as an 

antifungal agent. Review of the available 

toxicology data submitted in support of 

the registration of this active ingredient 

indicate that it is non-toxic and nonpathogenic to animals. In its proposed 

use as a seed treatment, which will take 

place in a commercial seed treating 

facility with mechanical treating 

equipment, it is foreseen that it will not 

contribute to any additional dietary 

exposures over and above those 

exposures that already exist due to the 

fact that the organism is naturally 

occurring and ubiquitous. In connection 

with the proposed use of the treated but 

not planted soybean seeds as a food 

commodity, it has been shown that the 

pesticide Bacillus pumilus GB34 does 

not survive, except for negligible 

amounts, the processing customary for 

soybeans. A fate study presented to EPA 

by the company, as stated above, 

showed that Bacillus pumilus GB34 

treated soybeans, after processing by 

typical procedures for soybeans, had no 

greater level of Bacillus species present 

than ordinary untreated soybeans. These 

uses, thus, are not expected to add in a 

significant measure to the density with 

which this naturally occurring, 

ubiquitous bacterium, which is nontoxic and non-pathogenic to animals, is 

found in soil, water, air and plant tissue.

1. Food. When used as a seed 

treatment in or on all food commodities, 

Bacillus pumilus GB34 migrates to and 

inhabits the roots of the plants. 

Accordingly, it is anticipated that 

negligible to no dietary exposure from 

food will result for humans from such 

uses. Similarly, with respect to the use 

of Bacillus pumilus GB34 as a seed 

treatment on soybean seeds that are not 

planted and thereafter used as a food 

commodity, based on the fate study 

discussed above, it is anticipated that 

negligible to no dietary exposure will 

result for humans from such use. To 

date, there have been no reports of any 

hypersensitivity incidents or reports of 

any known adverse reactions in humans 

resulting from exposure to Bacillus 

pumilus GB34. 

2. Drinking water exposure. There is 

expected to be only insignificant or 

minimal human exposure to the 

organism in drinking water resulting 

from its use in the treatment of seeds or 

from the use as a food commodity of any 

treated, but not planted, soybean seeds 

that are processed using typical 

procedures for soybeans. The treatment 

of seeds is expected to take place in a 

commercial seed treatment facility 

before the farmer plants the seeds in the 

soil. As stated elsewhere in this 

document, the organism is ubiquitous, 

naturally occurring, already found in 

water, among other places, and is nontoxic and non-pathogenic to humans. 

Thus, even if insignificant additional 

amounts were to seep or otherwise find 

their way into the ground water as a 

result of its uses, there is expected to be 

no adverse effect on humans as a result 

of the uses of Bacillus pumilus GB34 

contemplated in this tolerance 

exemption action.

B. Other Non-Occupational Exposure

The possibility for non-dietary 

exposure to residues of this Bacillus 

pumilus GB34 pesticide for the general 

population, including infants and 

children, is unlikely as a result of its use 

as a seed treatment or as a result of the 

use of any treated soybean seed that are 

not planted and thereafter used as a 

food commodity. Since the seed 

treatment is to take place in a 

commercial seed treating facility where 

mechanical treating equipment is used, 

it is not expected that dermal or 

inhalation exposure will occur in the 

general population, including infants 

and children. As stated elsewhere in 

this document, a fate study showed that 

the treated but not planted soybean 

seeds, when processed by typical 

procedures for soybeans, had no greater 

level of Bacillus species present than 

ordinary untreated soybeans. Bacillus 

pumilus GB34 is a ubiquitous, naturallyoccurring bacterium that functions as an 

antifungal agent and already is found in 

soil, water, air and decomposing plant 

tissue. It is not known to be pathogenic, 

infective or toxic to any animal or plant 

species. The bacteria typically occur at 

106 to 107 colony forming units (CFUs) 

per gram of soil. The added soil density 

from the proposed seed treatment use 

rates represents a very small proportion 

of the naturally occurring bacilli in the 

soil or water and therefore is not 

expected to add substantially to nonoccupational dermal or inhalation 

exposure for the general population, 

including infants and children.

V. Cumulative Effects

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, 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.’’ These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. The Agency has 

considered the potential for cumulative 

effects of Bacillus pumilus GB34 and 

other substances in relation to a 

common mechanism of toxicity. Based 

on tests in mammalian systems, Bacillus 

pumilus GB34 does not appear to be 

toxic or pathogenic to humans. The 

product strain belongs to the bacterial 

genus of Bacillus. Bacillus pumilus

Gb34 may have a similar mode of action 

in mammals as Bacillus subtilis that has 

been shown to be non-toxic and nonpathogenic to mammalian species. A 

similar mode of action of Bacillus 

pumilus GB34 and Bacillus subtilis

would not be expected to result in any 

cumulative adverse effect since, in each 

case, intravenous toxicity and 

pathogenicity studies have 

demonstrated the organism to be nontoxic and non-pathogenic. Thus, the 

Agency does not expect any cumulative 

or incremental effects from exposure to 

residues of Bacillus pumilus GB34 when 

used as directed on the label and in 

accordance with good agricultural 

practices.

VI. Determination of Safety for U.S 

Population, Infants and Children 

The Agency has determined that there 

is a reasonable certainty that no harm 

will result to the U. S. population, 

including infants and children, from 

aggregate exposures to residues of 

Bacillus pumilus GB34 as a result of or 

in connection with the uses described in 

this action. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. As discussed previously, 

76624 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 

there is little to no potential for harm 

from this bacterium in its uses via 

dietary exposure since the organism is 

non-toxic and non-pathogenic to 

animals and humans. The Agency has 

arrived at this conclusion based on the 

very low levels of mammalian toxicity 

(no toxicity at the maximum doses 

tested, Toxicity Categories III and IV. 

Moreover, as mentioned above, no nonoccupational inhalation or dermal 

exposure is expected. 

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

that EPA shall apply an additional 10-

fold 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 

(safety) will be safe for infants and 

children. Margins of exposure (safety), 

which are often referred to as 

uncertainty (safety) 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. In this instance, and 

based on all the available information 

reviewed and discussed more fully 

above, the Agency concludes that the 

additional margin of exposure (safety) is 

not necessary to protect infants and 

children and that not adding any 

additional margin of exposure (safety) 

will be safe for infants and children.

VII. Other Considerations

A. Endocrine Disruptors 

EPA is required under FFDCA section 

408(p), as amended by FQPA, to 

develop a screening process to 

determine whether pesticide chemicals 

(and any other substance that may have 

an effect that is cumulative to an effect 

of a pesticide chemical) ‘‘may have an 

effect in humans that is similar to an 

effect produced by a naturally occurring 

estrogen, or other such effects as the 

Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Advisory Committee (EDSTAC), EPA 

determined that there was a scientific 

basis for including, as part of the 

program, the androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone systems. EPA also 

adopted EDSTAC’s recommendation 

that the Program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority to require the 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). When the 

appropriate screening and/or testing 

protocols being considered under the 

Agency’s Endocrine Disruptor Screening 

Program have been determined, Bacillus 

pumilus GB34 may be subjected to 

additional screening and/or testing to 

better characterize any effects related to 

endocrine disruption. At this time, 

however, and based on the weight of 

available data, there is no basis for 

including this organism, since no 

endocrine system-related effects have 

been identified for Bacillus pumilus

GB34.

B. Analytical Method(s) 

The organism, Bacillus pumilus GB34, 

as mentioned above, is a naturally 

occurring soil microorganism which 

inhabits the root system of plants and 

acts as an antifungal agent in that area 

of the plant. The acute oral studies 

discussed above demonstrate that this 

active ingredient is non-toxic and nonpathogenic to animals and humans and 

thus, does not pose a dietary risk to 

humans in its uses. The Agency has 

concluded, therefore, that analytical 

methods are not needed for enforcement 

purposes.

C. Codex Maximum Residue Level 

There are no Codex Maximum Levels 

nor any tolerances or exemptions issued 

for Bacillus pumilus GB34 outside the 

United States.

VIII. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0175 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 February 22, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VIII.A., you should also send a 

copy of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP-2004–0175, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via eVerDate jul<14>2003 14:24 Dec 21, 2004 Jkt 205001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\22DER1.SGM 22DER1
Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Rules and Regulations 76625

mail to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

IX. Statutory and Executive Order 

Reviews

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) of the 

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 rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the tolerance exemption in this 

final rule, do not require the issuance of 

a proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

X. Congressional Review Act 

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 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: December 10, 2004.

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 180.1224 is revised to read 

as follows:

§ 180.1224 Bacillus pumilus GB34; 

exemption from the requirement of a 

tolerance.

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticide Bacillus 

pumilus GB34 when used as a seed 

treatment in or on all food commodities. 

An exemption is also granted for such 

residues on treated but unplanted 

soybean seeds.

[FR Doc. 04–27982 Filed 12–21–04; 8:45 am]

BILLING CODE 6560–50–S