[Federal Register Volume 69, Number 245 (Wednesday, December 22, 2004)]
[Rules and Regulations]
[Pages 76619-76625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27982]


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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.

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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 <greek-i>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:<a href="/cdn-cgi/l/email-protection#4e2c2f2222602f20202b0e2b3e2f60292138"><span class="__cf_email__" data-cfemail="dcbebdb0b0f2bdb2b2b99cb9acbdf2bbb3aa">[email protected]</span></a>.

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:
    <bullet> Industry (NAICS 111), e.g. crop production, vegetable and 
fruit farming
    <bullet> Industry (NAICS 112), e.g. animal production
    <bullet> Industry (NAICS 311), e.g. food manufacturing
    <bullet> 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

[[Page 76620]]

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.

[[Page 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)<INF>50</INF> 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 LD<INF>50</INF> 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

[[Page 76622]]

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<gr-thn-eq>x1<gr-thn-eq> 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 test-substance-
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 
<SUP>7</SUP> 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

[[Page 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 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 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 non-pathogenic 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 
non-toxic 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 non-toxic 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, naturally-occurring 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 non-occupational 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 non-
pathogenic 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 non-
toxic 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,

[[Page 76624]]

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 non-occupational 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 non-pathogenic 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 14<SUP>th</SUP> 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 e-

[[Page 76625]]

mail to: <a href="/cdn-cgi/l/email-protection#48273838652c272b232d3c082d3829662f273e"><span class="__cf_email__" data-cfemail="0d627d7d2069626e6668794d687d6c236a627b">[email protected]</span></a>. 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.

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), 346a and 371.

0
2. Section 180.1224 is revised to read as follows:


Sec.  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


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