[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Rules and Regulations]
[Pages 15958-15963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7638]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0328; FRL-7286-9]


Bacillus pumilus GB 34; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Bacillus pumilus GB 34 when used as 
a seed treatment in or on soybeans and soybeans after harvest. 
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), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Bacillus pumilus GB 34.

DATES: This regulation is effective April 2, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0328, 
must be received on or before June 2, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY 
INFORMATION.

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: [email protected].

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:
    [sbull] Industry (NAICS 111), e.g., crop production
    [sbull] Industry (NAICS 112), e.g., animal production
    [sbull] Industry (NAICS 311), e.g., food manufacturing
    [sbull] Industry (NAICS 32532, e.g., pesticide 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. 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 Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0328. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search'' 
then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of December 31, 2001 (66 FR 67522) (FRL-
6813-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a(e), as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 1F6344) by Gustafson LLC, 
1400 Preston Road, Suite 400, Plano, TX 75093. This notice included a 
summary of the petition prepared by the petitioner Gustafson LLC. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of B. Pumilus GB 34.

III. Risk Assessment

    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 tolerance 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. Section 408(b)(2)(C) of the FFDCA 
requires 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''

[[Page 15959]]

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.

IV. 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 Bacillus sp. found on plant surfaces. The strain Bacillus 
pumilus GB 34 is a naturally occurring soil colonizer. The mode of 
action of the strain, an anti fungal agent, is to colonize the 
developing root system of the plant it is to protect, in this case the 
developing root system of the soybean plant. The organism Bacillus 
pumilus GB 34 then suppresses by competition, by the formation of a 
physical barrier, the continued formation of spores of the fungal 
diseases such as Rhizoctonia and Fusarium. Subsequently GB 34 colonizes 
the remaining fungal disease spores themselves, thereby destroying 
them. On the basis of Acute injection toxicity/Pathogenicity tests on 
rats, Bacillus pumilus GB 34 does not appear to be toxic, infective, 
and/or pathogenic in those mammals.
    Toxicity studies submitted in support of this tolerance petition 
are summarized below. More detailed analyses of these studies may be 
found in the specific Agency reviews of the studies. Waivers requested 
and granted are, as well, noted.
    Toxicity studies relating to the GB 34 Concentrate (End Use 
Product) and GB 34 Technical (Technical Grade Active Ingredient) are as 
follows:
    1. Acute oral toxicity--i. GB 34 Concentrate. (Submitted to 
determine the adequacy of data to support an EUP, GB 34 Concentrate, 
and here, bridged to support a section 3 registration of the microbial 
product) (OPPTS 870.1100; OPP 152.30; 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 GB 34 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 behavioral 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 euthanized by CO2 
inhalation 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 dose 
(LD)50 of GB 34 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--GB 34 Technical. (OPPTS 870.1100; OPP 
152.30; 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 GB 34 Technical, previously diluted to a 40% w/w solution 
with distilled water, at a dosing volume of 1 mL/100 g. The rats were 
observed for morbidity, moribundity, and behavioral 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 
euthanized by CO2 inhalation 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 LD 50 of GB 34 Technical for male, female, and male 
and female combined is >5000 mg/kg, placing the test material in 
Toxicity Category IV.
    2. Acute dermal toxicity--GB 34 Concentrate and GB 34 Technical. 
((OPPTS 870.1200 and OPPTS 885. 3100 (Acute dermal toxicity/ 
Pathogenicity); OPP 152.31; waiver request, no MRID)). A waiver 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 
(oz.) per 100 pounds (lbs.) 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. There is expected to be minimal, if any, dermal exposure for the 
general population in a seed treatment use of the microbial pesticide.
    3. Acute inhalation toxicity--GB 34 Concentrate and GB 34 
Technical. ((OPPTS 870.1300 and OPPTS 885. 3150 (Acute pulmonary 
toxicity/ Pathogenicity); OPP 152.32; waiver request, no MRID)). A 
waiver was requested and granted for a seed treatment use. The use of 
GB 34 is to be limited to that of a seed treatment which is to take 
place in a commercial seed treatment facility in which there is no 
potential inhalation exposure to 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. For a seed treatment use of GB 34 there will most likely be a 
negligible, if any inhalation exposure.
    4. Acute oral toxicity/Pathgenicity--GB 34 Technical and GB 34 
Concentrate. (OPPTS 885.3050). A waiver was requested and granted for a 
seed treatment use. The rationales such as are the minimal increase of 
human oral exposure expected due to the low rate of application (0.1 
oz. per 100 lbs. of seed), the minimal exposure to the general 
population since the seed treatment will take place in a commercial 
seed treating facility with mechanical treating equipment, and the 
results of the toxicity tests submitted to date (see item 1.ii.) which 
do not indicate that this strain is toxic or infective. Moreover the 
results would suggest that the GB 34 strain does not express the 6,500 
molecular weight toxin discussed in two papers. See item 7 below. 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 minimizingthe potential 
for oral exposure for humans.
    5. Primary eye irritation--i. GB 34 Concentrate. ((Submitted to 
determine the adequacy of data to support an EUP, GB 34 Concentrate, 
and here, bridged to support a section 3 registration of the microbial 
product) (OPPTS 870.2400; OPP 152.35; MRID 452940-02)). Three male and 
three female young adult New Zealand white rabbits were used in the 
experiment. Prior to test material instillation, both eyes were treated 
with 2% fluorescein and examined under ultraviolet (UV) light for 
ocular abnormalities. The test material, 0.1 mL (equivalent to 0.05-
0.07 g), was instilled into the everted lower lid of the right eye and 
the upper and lower lids held closed for 1 second. The contralateral 
eye served as control. The eyes were examined and scored acording to 
the

[[Page 15960]]

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 48 
hours of treatment. No corneal opacity or iritis were noted. GB 34 
Concentrate was minimally irritating to the eye and is placed in 
Toxicity Category IV.
    ii. Primary eye irritation--GB 34 Technical. (OPPTS 870.2400; OPP 
152.35; MRID 454335-02, corrected as 457225-02). Three male and three 
female young adult New Zealand white rabbits were, prior to test, 
treated in both eyes with 2% fluorescein 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 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 developed 
moderate conjunctival irritation that cleared up within 72 hours of 
treatment. No corneal opacity or iritis or non-ocular effects were 
noted. The GB technical test substance was mildly irritating to the eye 
and is placed in Toxicity Category III.
    6. Primary dermal irritation--i. GB 34 Concentrate. (Submitted to 
determine the adequacy of data to support an EUP for GB 34 Concentrate, 
and here, bridged to support a section 3 registration of the microbial 
product) (OPPTS 870.2500; OPP 152.34; MRID 452940-03). Three male and 
three female young adult New Zealand white rabbits were received for 
the study. The fur on the dorso-lumbar area of each rabbit was clipped. 
The rabbits were given a single 0.5 g dose of test material applied 
under a under a 1 inch x 1 inch 4-ply gauze pad on a 6 cm2 
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 GB 34 Concentrate is non-irritating to the New 
Zealand white rabbit and is placed in Toxicity Category IV.
    ii. Primary dermal irritation--GB 34 Technical. (OPPTS 870.2500; 
OPP 152.34; MRID 454335-03 corrected as MRID 457225-03). Three male and 
three female New Zealand albino rabbits were prepared by clipping the 
dorsal 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 sites gently 
wiped with water and towel to remove any residual test substance. 
Individual dose sites were scored according to the Draize scoring 
system 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 pharmacologic effects or abnormal behavior. No dermal 
irritation was noted at any test site during the study. Under the 
conditions of the study, the GB 34 Technical is classified as non-
irritating to the skin and placed in Toxicity Category IV.
    7. Acute injection toxicity/Pathogenicity--GB 34 Technical. 
(Submitted to determine the adequacy of data to support an EUP for GB 
34, and here, bridged to support a section 3 registration of the 
microbial product) (OPPTS 885.3200; OPP 152.33; 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 test substance 
treated male rat on day
    The conclusion in the Data Evaluation report was that Bacillus 
pumilus GB 34 does not appear to be toxic, infective, and/or pathogenic 
in rats, when dosed at 1 x 107 cfu/animal. This test 
supports the requirements for both the TGAI (the technical) and the end 
use product (the concentrate).
    A hypersensitivity study, or dermal sensitization study (OPP 
152.36) is not required for registration of this product since the 
routes of use will not result ``in repeated human contact by inhalation 
or dermal routes'' as specified in footnote iii of the table in 40 CFR 
158.740(c). Use of the product is limited to that of a seed treatment 
which takes place in a commercial facility using mechanical seed 
treatment equipment.
    An Immune response study is not required for registration of this 
product because the Acute I.V., I. C., or I. P. Injection toxicity/
Pathogenicity study, (OPPTS guideline 885.3200/OPP 153.33) submitted to 
determine the adequacy of data to support an EUP for GB 34, and here 
bridged support a section 3 registration of the 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 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 GB 
34 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. (See item 7).
    The requirement for Tier II and Tier III data was not triggered 
because of the results of Tier I data which had been submitted or 
waived.

V. Aggregate Exposures

    Section 408(b)(2)(D)(vi) of the FFDCA directs EPA to consider 
available information concerning aggregate exposures to consumers (and 
major identifiable subgroups of consumers) from the pesticide residue 
in food and all other non-occupational 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 GB 34 is a naturally occurring soil microorganism 
which

[[Page 15961]]

inhabits the root system of plants and acts as an antifungal agent. 
Review of the available toxicology data submitted in support of 
registration indicate that it is non-toxic and non-pathogenic to 
animals and humans. In its proposed use as a soybean seed treatment, it 
is not foreseen to contribute any or more than a negligible amount of 
dietary exposure.
    1. Food. The product is used only as a seed treatment and the 
organism inhabits the roots of the plants, in this case the soybean 
plant roots. The use of products which contain B. pumilus GB 34 is not 
anticipated to result in more than negligible, if any, any dietary 
exposure from food for humans. To date there have been no reports of 
any hypersensitivity incidents or reports of any known adverse 
reactions in humans resulting from exposure to B. pumilus GB 34.
    2. Drinking water exposure. There is expected to be only 
insignificant or minimal human exposure to the organism in drinking 
water from its use in the treatment of seeds, its only use proposed. 
The treatment of seeds is expected to take place in a commercial seed 
treatment facility. The farmer then plants the seeds in the soil. Since 
the organism is non-toxic and non-pathogenic to humans, even if small 
amounts would seep into the ground water, there is expected to be no 
adverse effect on humans.

B. Other Non-Occupational Exposure

    The possibility for non-dietary exposure to residues of this B. 
pumilus pesticide for the general population, including infants and 
children, is unlikely because the only proposed use site is in an 
agricultural setting, as a treatment on soybean seeds. 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 to residues will occur in the general 
population, including infants and children. Bacillus pumilus GB 34 is a 
ubiqutous bacterium commonly found in soil, water, air and decomposing 
plant tissue and which acts as an antifungal agent. The bacteria 
typically occur at 106 to 107 colony forming units (CFU's) per gram of 
soil. It is not known to be pathogenic or toxic to any animal or plant 
species. The added soil density from the proposed seed treatment use 
rates represents a very small proportion of the naturally occurring 
bacilli in the soil and therefore is not expected to add substantially 
to the effects of the naturally occurring Bacillus.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to 
considered the cumulative effect of exposure to B. pumilus GB 34 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. B. pumilus does not appear to be toxic or 
pathogenic to humans. Thus, there is no indication that the bacteria we 
consider here share any common mechanisms of toxicity (metabolic 
mechanisms) with other substances.

VII. Determination of Safety for U.S. Population, Infants and Children

    There is reasonable certainty that no harm will result from 
aggregate exposures to residues of B. pumilus GB 34, in its use as a 
seed treatment, to the U. S. population, including infants and 
children. This includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. As discussed 
previously, there is probably no potential for harm, from this 
bacterium in its use as a seed treatment 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 no inhalation or dermal exposure is 
expected. FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional ten-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 data base unless EPA 
determines that a different margin of exposure (safety) will be safe 
for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, based on 
all the available information, the Agency concludes that the bacterium, 
B. pumilus GB34, is non-toxic to mammals, including infants and 
children. Because there are no threshold effects of concern, the 
provision requiring an additional margin of safety does not apply. As a 
result, EPA has not used a margin of exposure (safety) approach to 
assess the safety of B. pumilus GB 34.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under FFDCA section 408(p) to develop a screening 
process to determine whether pesticide chemicals (and any other 
substance that may have an effect that is cummulative 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 such other 
endocrine effects effect 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, the androgen-
and thyroid hormone systems, in addition to the estrogen hormone 
system. 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, B. pumilus GB 34 may be subjected to additional 
screening and/or testing to better characterize any effects related to 
endocrine disruption. Based on the weight of the evidence of available 
data, no endocrine system-related effects have been identified for B. 
pumilus GB 34.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation. Accordingly, the 
Agency has concluded that analytical methods are not needed for 
enforcement purposes related to B. pumilus GB 34.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels nor any tolerances or 
exemptions issued for B. pumilus GB 34 outside the United States.

IX. 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

[[Page 15962]]

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-2002-0328 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before June 2, 
2003.
    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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgment of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of FFDCA section 408(m).'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2002-0328, 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 Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. 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).

X. 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 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

[[Page 15963]]

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.

XI. Congressonial 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: March 12, 2003.
James Jones,
Acting Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1224 is added to subpart D to read as follows:


Sec.  180.1224  Bacillus pumilus GB 34; 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 GB 34 when used as 
a seed treatment in or on soybeans and soybeans after harvest.
[FR Doc. 03-7638 Filed 4-1-03; 8:45 am]
BILLING CODE 6560-50-S