Bacillus pumilus strain GHA 180
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT
Bacillus pumilus strain GHA 180
Pesticide Chemical (PC) Code: 016485
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
March 12, 2012
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Biopesticides Registration Action Document
TABLE OF CONTENTS
I. EXECUTIVE SUMMARY 4
II. ACTIVE INGREDIENT OVERVIEW 5
III. REGULATORY BACKGROUND 5
A. Applications for Pesticide Registration 5
B. Food Tolerance Exemption 6
IV. RISK ASSESSMENT 6
A. Product Analysis Assessment (40 CFR § 158.2120) 6
B. Human Health Assessment (40 CFR § 158.2140) 6
C. Environmental Assessment (40 CFR § 158.2150) 12
V. ENVIRONMENTAL JUSTICE 12
VI. RISK MANAGEMENT DECISION 13
VII. ACTIONS REQUIRED BY THE REGISTRANT 14
VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 15
A. Studies Submitted to Support the Bacillus pumilus GHA180 Pesticide Product Registrations 16
B. Environmental Protection Agency Risk Assessment Memoranda 18
C. Other References 18
APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 20
APPENDIX B. PESTICIDE PRODUCTS 27
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM
Office of Pesticide Programs (OPP)
Biopesticides and Pollution Prevention Division
Microbial Pesticides Branch
Science Reviews
Joel V. Gagliardi, Ph.D., Microbial Ecologist Product Analysis, Human Health
John L. Kough, Ph.D. Product Analysis, Human Health
Gail Tomimatsu, Ph.D. Environmental Effects
Regulations
Sheryl K. Reilly, Ph.D.
Alan Reynolds
Susanne Cerrelli
Chief, Microbial Pesticides Branch
Team Leader, Microbial Pesticides Branch
Regulatory Action Leader
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I. EXECUTIVE SUMMARY
Bacillus pumilus strain GHA180 is a new microbial active ingredient discovered in an apple tree
rhizosphere in Mexico. This active ingredient is a bacterium that produces metabolites that
suppress the fungal plant pathogens Pythium ultimum, Fusarium oxysporum, Rhizoctonia solani
and Alternaria spp. This bacterium colonizes plant roots, forming a biofilm.
Premier Horticulture Ltd. has proposed to register three end-use pesticide products (EPs):
• GHA 180 Biological Fungicide, an aqueous suspension, to incorporate into peat moss or
growing media or as a soil drench in greenhouses and enclosed nurseries to suppress
plant pathogens that attack root systems. (Contains 0.37 % Bacillus pumilus strain
GHA180, a minimum of 1 x 109 viable spores/ml)
• Pro-Mix GHA180 and Pro-Mix Tandem. Both Pro-Mix products are a series of
growing media formulations that contain Bacillus pumilus strain GHA180 to suppress
plant pathogens that attack root systems. (Both Pro-Mix products contain Bacillus
pumilus strain GHA180 at 0.001%, with a minimum of 5 x 104 viable spores per a gram
of media.)
Pro-Mix GHA180 and Pro-Mix Tandem are each formulated into eight different custom blended
growing mixes: BX, HP, TA, FPX, MPX, PGX, VFT and BRK Blends. There arel6 different
blended growing mixes in total.
Environmental Protection Agency (EPA) scientists have reviewed product analysis, toxicology,
and nontarget organism data and information (40 Code of Federal Regulations (CFR) §§
158.2120, 158.2140, and 158.2150, respectively) submitted to support the registration of the
three proposed Bacillus pumilus strain GHA 180 products. Overall, these data and information
are adequate for risk assessment purposes, fulfill current data requirements, and allow for
registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA).
Acceptable guideline studies to support the proposed use of these products fulfilled product
analysis data requirements for Bacillus pumilus strain GHA 180, including product chemistry
and composition, analysis of samples, and physical and chemical characteristics.
Adequate mammalian toxicology data and information were submitted to support Bacillus
pumilus strain GHA 180 pesticide products.
EPA has concluded that there is a reasonable certainty that no harm will result to the United
States population, including infants and children, from aggregate exposure to residues of Bacillus
pumilus strain GHA 180. No dietary risks are expected from use of Bacillus pumilus strain GHA
180 as an active ingredient in pesticide products.
The proposed use sites for Bacillus pumilus strain GHA180 are limited to greenhouse and
contained nurseries. It was determined that the use sites for Bacillus pumilus strain GHA180 on
the proposed labels would not result in significant nontarget species exposure and did not trigger
the nontarget and environmental fate date requirements under 40 CFR § 158.2150,
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Biopesticides Registration Action Document
On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for
the public to participate in major registration decisions before they occur. Under this policy, EPA
provides a public comment period prior to making a registration decision for the following types
of applications: new active ingredients; first food uses; first outdoor uses; first residential uses; or
any other registration actions for which EPA believes there may be significant public interest.
Consistent with the policy of making registration actions more transparent, the proposed
registration and first food use of pesticide products containing the new active ingredient, Bacillus
pumilus strain GHA 180, were subject to a 30-day comment period. During this comment
period, no comments were received. The registrations of this new active ingredient includes the
first food use for Bacillus pumilus strain GHA 180. The Agency's risk assessments and
conclusions that the standards for registration under FIFRA section 3(c)(5) have been met for the
proposed active ingredient, Bacillus pumilus strain GHA 180 and are provided in this
Biopesticide Registration Action Document (BRAD).
II. ACTIVE INGREDIENT OVERVIEW
Biological Name:
Culture Deposit:
Bacillus pumilus strain GHA 180
International Depository Authority of Canada, under the reference
number ID AC No. 260707-01
OPP Chemical Code: 016485
Type of Pesticide: Microbial Pesticide - Fungicide
See Appendix B for specific information (e.g.,
use sites, application rates, methods of application,
formulation types, and target pests) regarding
the registered pesticide products containing this
active ingredient.
III. REGULATORY BACKGROUND
A. Applications for Pesticide Registration
On February 14, 2010, Premier Horticulture, (address: 1, avenue Premier, Riviere-du-Loup,
Quebec, Canada G5R6C1) submitted applications to register three end-use products, GHA 180
Biological Fungicide (EPA File Symbol 74267-E), Pro-Mix GHA 180(EPAFile Symbol 74267-
G) and Pro-Mix Tandem (EPA File Symbol 74267-U) under FIFRA section 3. At that time
Premier Horticulture applied to register GHA 180 Biological Fungicide (EPA File Symbol
74267-E) also as a manufacturing product. On November 24, 2010, EPA announced receipt of
these applications to register pesticide products containing a new active ingredient (75 Federal
Register (FR) 71698) and opened a 30-day public comment period pursuant to the provisions of
FIFRA section 3(c)(4). No comments were received following this publication.
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B. Food Tolerance Exemption
Concurrent with its registration applications and under Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(d), Premier Horticulture submitted a petition to establish an exemption
from the requirement of a tolerance for Bacillus pumilus GHA180 (Pesticide Petition (PP)
0F7698). In the Federal Register of September 30, 2010 (75 FR 60452). EPA announced that
Premier Horticulture proposed to establish an exemption from the requirement of a tolerance for
residues of the fungicide, Bacillus pumilus GHA180 in or on all agricultural commodities and
water systems when applied as described in the draft label and opened a 30-day comment period.
No comments were received following this publication.
IV. RISK ASSESSMENT
In the Federal Register of October 26, 2007, EPA issued a Final Rule on the data requirements to
support registration of microbial pesticides and updated the definition for microbial pesticides
(72 FR 61002). The rule became effective on December 26, 2007. The data and information
evaluated for this BRAD were considered in light of these requirements.
The classifications for each data submission are assigned by EPA science reviewers and indicate
the usefulness of the information contained in the documents for risk assessment. A rating of
"acceptable" indicates the study is scientifically sound and is useful for risk assessment. A
"supplemental" rating indicates the data provide some information that can be useful for risk
assessment. The studies may have certain aspects determined not to be scientifically acceptable
("supplemental: upgradeable"). If a study is rated as "supplemental: upgradeable," EPA always
provides an indication of what is lacking or what can be provided to change the rating to
"acceptable." If there is simply a "supplemental" rating, the reviewer often will state that the
study is not required by 40 CFR Part 158. Both "acceptable" and "supplemental" studies may be
used in the risk assessment process as appropriate. An "unacceptable" rating indicates that new
data need to be submitted.
For the acute toxicity data requirements, Toxicity Categories are assigned based on the
hazard(s) identified from studies and/or other information submitted to EPA in support of a
pesticide registration. The active ingredient or particular product is classified as Toxicity
Category I, II, III, or IV, where Toxicity Category I indicates the highest toxicity and Toxicity
Category IV indicates the lowest toxicity.
A. Product Analysis Assessment (40 CFR § 158.2120)
Bacillus pumilus strain GHA180 is a new microbial active ingredient discovered in an apple tree
rhizosphere in Mexico. This bacterium produces metabolites that suppress the fungal plant
pathogens Pythium ultimum, Fusarium oxysporum, Rhizoctonia solani and Alternaria spp. and
colonizes plant roots, forming a biofilm. All product analysis data requirements for Bacillus
pumilus strain GHA180 were fulfilled to support current use sites. Refer to Tables 1, 2, 3, 4, 5,
and 6 in Appendix A for a brief summary of the data requirements, including both generic and
product-specific information.
B. Human Health Assessment (40 CFR § 158.2140)
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1. Toxicity
All toxicology data requirements for Bacillus pumilus strain GHA180 were fulfilled. Acceptable
Tier I mammalian toxicology data and information support registration of the Bacillus pumilus
strain GHA180 pesticide products. Furthermore, Tier II and Tier III studies were not required for
Bacillus pumilus strain GHA180 because of the lack of acute toxicity/pathogenicity in the Tier I
studies.
For a comprehensive summary of the generic toxicology data requirements described in sections
IV(B)(l)(a) and IV(B)(l)(b), as well as additional product-specific data submitted to support the
individual registrations, refer to Table 7 in Appendix A.
a. Acute Toxicity/Pathogenicity - Tier I
Acute Oral Toxicity/Pathogenicity (Office of Chemical Safety and Pollution Prevention (OCSPP)
Guideline 885.3050; and Acute Pulmonary Toxicity/Pathogenicity (OCSPP Guideline
885.3150;Master Record Identification Number (MRID No 48005019.):
Waiver rationale for acute oral and pulmonary toxicity/pathogenicity data requirements were
submitted by Premier Horticulture Ltd, based on the acute injection toxicity and pathogenicity
study and the oral, dermal and inhalation acute toxicity study results discussed below. All of
those tests showed no evidence of infectivity, pathogenicity, toxicity, or other adverse effects.
EPA determined that in light of these results, adverse effects from exposure to Bacillus pumilus
GHA180 are not expected, and waived the acute oral toxicity/pathogenicity and acute pulmonary
toxicity/pathogenicity data requirements for this active ingredient.
Acute Injection Toxicity/Pathogenicity (OCSPP Guideline 885.3200; MRID No. 48005025):
Thirty young adult rats (15/sex) were injected intravenously with Bacillus pumilus GHA180
TGAI (1.4xl010- 6.0xl010 CFU/mL) at a dose of 6.8><107 CFU/animal. Two control groups
(5/sex/treatment) were treated with inactivated Bacillus pumilus GHA180 TGAI, and saline.The
animals were observed for up to 21 days. Bacterial cell counts were made on the blood, liver,
kidney, spleen, lungs, mandibular lymph node, brain, and cecum contents of the rats given live
bacteria on study days 0, 7, 14 and 21, and on day 21 for the control groups. All animals gained
weight and appeared normal during the study, and no visible abnormalities were noted at
necropsy. The test organism completely cleared from the blood, kidneys, mandibular lymph
nodes and cecum contents of the animals by day 14, and it showed a pattern of clearance but had
not completely cleared from the liver and spleen by day 21. No Bacillus pumilus GHA180 was
detected in the tissues/organs of the animals treated with the inactivated test material or the
untreated control group. Bacillus pumilus GHA180 was not toxic, infective or pathogenic to rats
when dosed intravenously at 6.8xlO7 CFU/animal. This study was classified as Acceptable.
Hypersensitivity Incidents (OCSPP Guideline 885.3400):
No hypersensitivity incidents, including immediate-type or delayed-type reactions of humans
and domestic animals during research, development, or testing of Bacillus pumilus GHA180
were reported by the applicant. Any future hypersensitivity incidents must be reported per
OCSPP Guideline 885.3400.
Cell Culture (OCSPP Guideline 885.3500):
This study was not required because Bacillus pumilus strain GHA180 is not a virus (refer to test
note #4 of 40 CFR § 158.2140(d)).
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Acute Oral Toxicity (OCSPP Guideline 870.1100; MRID No. 48005020):
Using the up and down method, 3 fasted young adult female rats were given a single oral gavage
dose of Bacillus pumilus GHA180 TGAI (1.4 xlO10 - 6.0><1010CFU/mL) at a concentration of
5000 mg/kg body weight (bw), and observed for 14 days. All animals gained weight and
appeared normal throughout the study. No visible abnormalities were found at necropsy. The
LD50 > 5000 mg/kg bw. This study was classified as Acceptable; EPA Toxicity Category IV.
Acute Dermal Toxicity (OCSPP Guideline 870.1200; MRID 48005021):
Ten young adult rats (5/sex) were exposed to 5050 mg/kg of Bacillus pumilus GHA180 TGAI (1.4x 1010 -
6.Ox 1010 CFU/mL) for 24 hours on a clipped area of skin (-10% of the body surface area), and observed
for 14 days. One female died on day 1; at necropsy, mottled lungs and a deformed liver were noted but
not attributed to the test substance. All other animals gained weight and appeared normal during the study.
No dermal irritation resulted from exposure to the test material, and observable abnormalities were not
found at necropsy. The LD50 was > 5050 mg/kg bw. This study was classified as Acceptable; EPA
Toxicity Category IV.
Acute Inhalation Toxicity (OCSPP Guideline 870.1300; MRID 48005022):
Groups of young adult rats (5/sex/group) were exposed nose-only to Bacillus pumilus GHA180 TGAI
(1.4xl010 - 6.0xl010 CFU/mL) aerosol for 4 hours at a concentration of 2.18 mg/L, then observed for 14
days. All animals gained weight and appeared normal throughout the study. No abnormalities were
observed at necropsy. The LC50 >2.18 mg/L. This study was classified as Acceptable; EPA Toxicity
Category IV.
Acute Eye Irritation (OCSPP Guideline 870.2400; MRID 48005023):
Three New Zealand White rabbits (2 male, 1 female) were exposed to 0.1 mL of undiluted
Bacillus pumilus GHA180 TGAI (1.4xl010 - 6.0xl010 CFU/mL; instilled into the conjunctival
sac of the right eye) and observed for eye irritation at 1, 24, 48, and 72 hours after exposure.
Corneal opacitiy was observed in 1 male at 1 hour post exposure, which cleared by 48 hours. No
iritis or conjunctival irritation was noted in any animal throughout the study. The maximum
average score was 17.3 at 1 hour after exposure. Bacillus pumilus GHA180 TGAI was mildly
irritating to the eye. This study was classified as Acceptable; EPA Toxicity Category III.
Primary Dermal Irritation (OCSPP Guideline 870.2500; MRID 480050-24):
The skin of 3 rabbits (1 male, 2 female) were exposed to 0.5 mL (under a patch) of Bacillus
pumilus GHA180 TGAI (1.4x 1010 - 6.Ox 1010 CFU/mL) for 4 hours on an approximately 2.5x2.5
cm area of the body surface. The animals were observed at 1, 24, 48, and 72 hours after patch
removal. Very slight erythema was noted on 1 animal at 1 hour after patch removal; this cleared
by 24 hours. No other rabbit exhibited skin irritation during the study. The primary irritation
index was 0.1. This study was classified as Acceptable; EPA Toxicity Category IV.
b. Acute Toxicology and Subchronic Toxicity/Pathogenicity - Tier II;
Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and
Infectivity/Pathogenicity Analysis — Tier III
Tier II and Tier III studies were not required for Bacillus pumilus GHA 180 based on the lack of
acute toxicity/pathogenicity in the Tier I studies.
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c. Endocrine Disruptors
As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor
Screening Program (EDSP) to determine whether certain substances (including pesticide active
and other ingredients) may have an effect in humans or wildlife similar to an effect produced by
a "naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate." The EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a
chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal
systems. Chemicals that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA
will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2
testing is designed to identify any adverse endocrine-related effects caused by the substance, and
establish a quantitative relationship between the dose and the E, A, or T effect.
Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first
group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients.
This list of chemicals was selected based on the potential for human exposure through pathways
such as food and water, residential activity, and certain post-application agricultural scenarios.
This list should not be construed as a list of known or likely endocrine disruptors.
Bacillus pumilus GHA 180 is not among the group of 58 pesticide active ingredients on the
initial list to be screened under the EDSP. Under FFDCA section 408(p), EPA must screen all
pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for
all pesticide active ingredients.
For further information on the status of the EDSP, the policies and procedures, the list of 67
chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:
http://www. epa.gov/endo/.
2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement
for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA
determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to
mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures and all other exposures for
which there is reliable information." This includes exposure through drinking water and in
residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B)
of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a
tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA,
which require EPA to give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to "ensure that there is a reasonable
certainty that no harm will result to infants and children from aggregate exposure to the pesticide
chemical residue..." Additionally, section 408(b)(2)(D) of FFDCA requires that EPA 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
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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.
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data
and other relevant information, 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.
Based on the acute toxicity/pathogenicity data and information discussed previously and
presented in Table 7 in Appendix A. the data required for a FQPA risk assessment for Bacillus
pumilus strain GHA 180 have been fulfilled. Hence, EPA determined that the exemption is
"safe".
a. Aggregate Exposure
In examining aggregate exposure, section 408 of FFDCA directs EPA to consider
available information concerning exposures from the pesticide residue in food and all other
nonoccupational exposures, including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor
uses).
Dietary Exposure and Risk Characterization: Bacillus spp. including Bacillus pumilus are
commonly found in agricultural settings (i.e. soils) and are present on fresh produce of all kinds
with no known adverse effects. The Manual of Clinical Microbiology (9th edition) mentions that
dried food such as spices, milk powder and grains often contain large amounts of Bacillus
spores. Bacillus pumilus has been described as a natural, halotolerant component of fermented
fish sauce and in cocoa bean fermentations (Doyle et. al, 1997). Bacillus pumilus strain GHA180
is not known to produce any mammalian toxins, and no foodborne disease outbreaks associated
with Bacillus pumilus strain GHA180 or foodborne toxin production from Bacillus pumilus
strain GHA180 have been reported. Based on extensive testing of Bacillus pumilus strain
GHA180 TGAI, no toxicity, infectivity, pathogenicity or other adverse effects from dietary
exposure to Bacillus pumilus strain GHA180 are expected. Even if oral exposure should occur by
ingesting harvested fruit vegetables, and/ or tobacco, EPA concludes that there is a reasonable
certainty that no harm will result from exposure to such residues because of the lack of toxicity,
infectivity, and or pathogenicity in the previously described toxicological studies (see section
IV(B)(l)(a) and Table 7 in Appendix A).
Drinking Water Risk Characterization: Since Bacillus pumilus is naturally present in soils,
exposure to Bacillus pumilus from surface and possibly groundwater can be expected. No
adverse effects are expected or have been reported from exposure to Bacillus pumilus through
drinking water. According to the World Health Organization, Bacillus species are often detected
in drinking water even after going through acceptable water treatment processes, largely because
the spores are resistant to these disinfection processes (World Health Organization, 2011).
Should this microbial pesticide be present in drinking water, no adverse effects are expected
from exposure to Bacillus pumilus GHA180 through drinking water, based on the results of
toxicity studies described in section (B)(1)(a) and Table 7 in Appendix A.
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Non-occupational. Residential Risk Characterization: The use sites for these products include
greenhouse and contained nurseries. As stated previously, Bacillus pumilus is naturally present in
many habitats. Based on the studies and other information submitted to satisfy data requirements
for registration of the end-use pesticide products containing the active ingredient Bacillus
pumilus strain GHA180, no toxicity, infectivity, pathogenicity or other adverse effects from
non-occupational exposure are expected (see section IV(B)(l)(a), above, and Table 7 in
Appendix A).
b. Cumulative Effects from Substances with a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify,
or revoke a tolerance exemption, EPA consider "available information concerning the
cumulative effects of [a particular pesticide's] residues and other substances that have a common
mechanism of toxicity."
EPA has not found Bacillus pumilus strain GHA180 to share a common mechanism of toxicity
with any other substance, and Bacillus pumilus strain GHA180 does not appear to produce a
toxic metabolite as its mode of action against target pests. Therefore, for the purposes of this
tolerance action, EPA has assumed that Bacillus pumilus strain GHA180 does not have a
common mechanism of toxicity with other substances. For information on EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at
http: ic ii'ic. eya. sov/vesticides/cumulative.
c. Determination of Safety for the U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility of infants and children to
pesticide chemical residues, and the cumulative effects on infants and children of the residues
and other substances with a common mechanism of toxicity. In addition, FFDCA section
408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of 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 safety will be safe for infants and children. This additional margin of safety is
commonly referred to as the FQPA Safety Factor. In applying this provision, EPA either retains
the default value of 10X or uses a different additional safety factor when reliable data available
to EPA support the choice of a different factor.
Based on the acute toxicity and pathogenicity data summarized in section IV(B)(l)(a) and Table
7 in Appendix A. EPA concludes that there is a reasonable certainty that no harm will result to
the U.S. population, including infants and children, from aggregate exposure to the residues of
Bacillus pumilus strain GHA180. This includes all anticipated dietary exposures and all other
exposures for which there is reliable information. EPA has arrived at this conclusion because the
data and information available on Bacillus pumilus strain GHA180 does not demonstrate toxic,
pathogenic, and/or infective potential to mammals. Because there are no threshold effects of
concern, the provision requiring an additional margin of safety does not apply.
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3. Occupational Exposure and Risk Characterization
Handler exposure to Bacillus pumilus strain GHA180 is not expected to pose any undue risk.
Appropriate personal protective equipment and precautionary statements are required on
pesticide product labels to mitigate any potential risks to pesticide handlers due to prolonged or
numerous exposures. Handlers applying Bacillus pumilus strain GHA180 liquid end-use
products in agricultural settings must wear a long-sleeved shirt, long pants, socks, shoes,
waterproof gloves, and a dust/mist filtering respirator meeting NIOSH standards of at least N-95,
R-95, or P-95. Additional PPE, other than the standard described above, may be required on a
product-specific basis.
4. Human Health Risk Characterization
EPA considered human exposure to Bacillus pumilus strain in light of the standard for
registration in FIFRA and the relevant safety factors in FFDCA. A determination has been made
that no unreasonable adverse effects to the U.S. population in general, and to infants and children
in particular, will result when Bacillus pumilus strain GHA180 pesticide products are used in
accordance with EPA-approved labeling.
C. Environmental Assessment (40 CFR § 158.2150)
The Agency has performed an environmental risk assessment for the proposed uses of Bacillus
pumilus strain GHA180. The proposed use sites for Bacillus pumilus strain GHA180 were
limited to greenhouse and contained nurseries. EPA determined that these use sites for Bacillus
pumilus strain GHA180 would not result in significant nontarget species exposure and did not
trigger the nontarget and environmental fate date requirements under 40 CFR § 158.2150 .
Further testing of nontarget organisms at higher tier levels (i.e., Tiers II, III, and IV) is not
required for the current uses and application methods.
For a comprehensive summary of the generic data requirements described in sections IV(C)(1),
refer to Table 8 in Appendix A.
1. Threatened and Endangered Species Assessment
A "No Effect" determination is also made for direct and indirect effects to listed species and their
designated critical habitats from proposed uses of Bacillus pumilus strain GHA180 as labeled.
The exposure of nontarget organisms to Bacillus pumilus strain GHA180 is not expected to
increase the amount of Bacillus pumilus above levels that are found naturally in the environment
because the use of products containing this active ingredient are limited to green house and
enclosed nurseries. Further testing of nontarget organisms at higher tier levels is not required.
Based on the data, literature citations, and data waiver rationale provided by the applicant, BPPD
has determined that adverse effects to nontarget organisms are not anticipated from the proposed
uses of Bacillus pumilus strain GHA180.
V. ENVIRONMENTAL JUSTICE
EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of
all people regardless of race, color, national origin, or income—with respect to the development,
implementation, and enforcement of environmental laws, regulations, and policies. Fair
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treatment means that no group of people, including racial, ethnic, or socioeconomic groups,
should bear a disproportionate share of the negative environmental consequences resulting from
industrial, municipal, and commercial operations or the execution of federal, state, local, and
tribal environmental programs and policies. Meaningful involvement means that (1) potentially
affected community residents have an appropriate opportunity to participate in decisions about a
proposed activity that will affect their environment and/or health; (2) the public's contribution
can influence the regulatory agency's decision; (3) the concerns of all participants involved will
be considered in the decision-making process; and (4) the decision-makers seek out and facilitate
the involvement of those potentially affected. EPA has this goal for all communities and persons
across the United States.
EPA sought information on any groups or segments of the population who, as a result their
location, cultural practices, or other factors, may have atypical, unusually high exposure to
Bacillus pumilus strain GHA180 compared to the general population. No public comments were
received on this particular matter.
For additional information regarding environmental justice issues, please visit EPA's web site at
http://www.epa.sov/compliance/environmentaliustice/index.html.
VI. RISK MANAGEMENT DECISION
Section 3(c)(5) of FIFRA permits for the registration of a pesticide provided that all the
following determinations are made:
(1) Its composition is such as to warrant the proposed claims for it;
(2) Its labeling and other material required to be submitted comply with the
requirements of FIFRA;
(3) It will perform its intended function without unreasonable adverse effects on
the environment; AND
(4) When used in accordance with widespread and commonly recognized
practice, it will not generally cause unreasonable adverse effects on the
environment.
To satisfy criterion 1, the Bacillus pumilus strain GHA180 pesticide products have well-known
properties. EPA has no knowledge that would contradict the claims made on the GHA 180
Biological Fungicide, Pro-Mix 'GHA180', and Pro-Mix Tandem EP labels. These products are
not expected to cause unreasonable adverse effects on the environment when used according to
label instructions. Criterion 2 is satisfied by the current product labels, as well as the data and
information presented in this document. It is believed that the Bacillus pumilus strain GHA180 1
will not cause any unreasonable adverse effects on the environment, and the GHA 180
Biological Fungicide, Pro-Mix 'GHA180', and Pro-Mix Tandem EPs (end-use products), in
particular, are likely to protect against fungal pests as claimed, thereby satisfying criterion 3.
Criterion 4 is satisfied in that the Bacillus pumilus strain GHA180 pesticide products are not
expected to cause unreasonable adverse effects when used according to label instructions.
Therefore, the GHA 180 Biological Fungicide, Pro-Mix 'GHA180', and Pro-Mix Tandem (all
containing Bacillus pumilus strain GHA180 as a new active ingredient) are eligible for
registration under FIFRA section 3(c)(5) for labeled uses. If the applicant proposes uses that are
more extensive in the future (e.g., outdoor or aquatic applications), EPA will likely require that
additional data be submitted in conjunction with a registration amendment request.
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VII. ACTIONS REQUIRED BY THE REGISTRANT
A. Final Printed Labeling
Before releasing pesticide products containing Bacillus pumilus strain GHA180 for shipment, the
registrant is required to provide appropriate final printed labeling to EPA.
B. Reporting of Adverse Effects and Hypersensitivity Incidents
Notwithstanding the information stated in the previous sections, it should be clearly understood
that certain, specific data are required to be reported to EPA as a requirement for maintaining the
federal registration for a pesticide product. A brief summary of these types of data are described
below.
Reports of all incidents of adverse effects to the environment must be submitted to EPA under
the provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of hypersensitivity
(including both suspected and confirmed incidents) must be reported to EPA under the
provisions of 40 CFR § 158.2140(d).
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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS
ASAE
BPPD
BRAD
bw
CFR
cfu
cfu/kg
cfu/mL
cP
DSMZ
EDSP
EP
EPA
FFDCA
FIFRA
FQPA
FR
g/mL
LC50
LD
50
mg/kg
mg/L
MP
MRIDNo.
NIOSH
NRRL
OCSPP
OPP
PC Code
PP
PPE
ppm
TGAI
ULV
American Society of Agricultural Engineers
Biopesticides and Pollution Prevention Division
Biopesticides Registration Action Document
body weight of animal
Code of Federal Regulations
colony-forming unit(s)
colony-forming units per kilogram
colony-forming units per milliliter
centipoise
Deutsche Sammlung von Mikroorganismen und Zellkulturen (the German Strain
Collection for Microorganisms)
Endocrine Disruptor Screening Program
end-use product
Environmental Protection Agency (the "Agency")
Federal Food, Drug, and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
Food Quality Protection Act
Federal Register
gram per milliliter
median lethal concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water,
air, or feed (e.g., mg/L, mg/kg, or ppm).
median lethal dose. A statistically derived single dose that can be expected
to cause death in 50% of the test animals when administered by the route
indicated (oral, dermal, or inhalation). It is expressed as a weight of
substance per unit weight of animal (e.g., mg/kg).
milligrams per kilogram
milligrams per liter
manufacturing-use product
Master Record Identification Number
National Institute for Occupational Safety and Health
Northern Regional Research Laboratory
Office of Chemical Safety and Pollution Prevention
Office of Pesticide Programs
Pesticide Chemical Code
Pesticide Petition
personal protective equipment
parts per million
technical grade of the active ingredient
ultra low volume
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IX. BIBLIOGRAPHY
A. Studies Submitted to Support the Bacillus pumilus GHA180 Pesticide Product Registrations
MRID Citation Reference
48005000 Premier Horticulture (2010) Submission of Product Chemistry and Toxicity Data
in Support of the Application for Registration of GHA 180, Pro-Mix GHA 180,
and Pro-Mix Tandem and the Petition for Tolerance of Bacillus pumilus GHA
180. Transmittal of 25 Studies.
48005001 Libman, G. (2009) Product Chemistry for (Bacillus pumilus GHA 180).
Unpublished study prepared by Premier Tech, Ltd. 33 p.
48005002 Libman, G. (2009) Product Chemistry for PRO-MIX 'BX' Tandem. Project
Number: PHL/LA/WI/137E3/USA. Unpublished study prepared by Premier Tech,
Ltd. 77 p.
48005003 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'BX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 89 p.
48005004 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'HP' Blend.
Unpublished study prepared by Premier Tech, Ltd. 80 p.
48005005 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'TA' Blend.
Unpublished study prepared by Premier Tech, Ltd. 92 p.
48005006 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'FPX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 90 p.
48005007 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'MPX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 80 p.
48005008 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'PGX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 92 p.
48005009 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'VFT' Blend.
Unpublished study prepared by Premier Tech, Ltd. 92 p.
48005010 Libman, G. (2010) Product Chemistry for Pro-Mix GHA 180 'BRK' Blend.
Unpublished study prepared by GNL Consultation Services and Premier Tech,
Ltd. 80 p.
48005011 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'BX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 126 p.
48005012 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'HP' Blend.
Unpublished study prepared by Premier Tech, Ltd. 118 p.
48005013 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'TA' Blend.
Unpublished study prepared by Premier Tech, Ltd. 94 p.
48005014 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'FPX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 92 p.
48005015 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'MPX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 82 p.
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48005016 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'PGX' Blend.
Unpublished study prepared by Premier Tech, Ltd. 94 p.
48005017 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'VFT' Blend.
Unpublished study prepared by Premier Tech, Ltd. 94 p.
48005018 Libman, G. (2010) Product Chemistry for Pro-Mix Tandem 'BRK' Blend.
Unpublished study prepared by Premier Tech, Ltd. 77 p.
48005019 Libman, G. (2010) Waiver Request for Microbial Pesticide Data Requirements:
Bacillus pumilus GHA 180 and Formulated Products. Unpublished study prepared
by Premier Horticulture. 35 p.
48005020 Kuhn, J. (2009) Acute Oral Toxicity Study (UDP) in Rats: Bacillus Pumilus
GHA-180 TGAI: Amended Final Report. Project Number: 11547/08. Unpublished
study prepared by Stillmeadow, Inc. 12 p.
48005021 Kuhn, J. (2010) Acute Dermal Toxicity Study in Rats: Bacillus pumilus GHA-180
TGAI: Amended Final Report. Project Number: 11548/08. Unpublished study
prepared by Stillmeadow, Inc. 15 p.
48005022 Carter, L. (2009) Acute Inhalation Toxicity Study in Rats: Bacillus pumilus GHA-
180 TGAI: Amended Final Report. Project Number: 11549/08. Unpublished study
prepared by Stillmeadow, Inc. 19 p.
48005023 Kuhn, J. (2009) Acute Eye Irritation Study in Rabbits: Bacillus pumilus GHA-180
TGAI: Amended Final Report. Proj ect Number: 11550/08. Unpublished study
prepared by Stillmeadow, Inc. 18 p.
48005024 Kuhn, J. (2009) Acute Dermal Irritation Study in Rabbits: Bacillus pumilus GHA-
180 TGAI: Amended Final Report. Proj ect Number: 11551/08. Unpublished study
prepared by Stillmeadow, Inc. 13 p.
48005025 Monds, K. (2009) Acute Intravenous Toxicity/Pathogenicity Study in Rats with a
Microbial Pest Control Agent (MPCA): Bacillus pumilus GHA-180 TGAI:
Amended Final Report. Project Number: 11552/08. Unpublished study prepared
by Stillmeadow, Inc. 21 p.
48391500 Premier Horticulture, Inc. (2011) Submission of Product Chemistry Data in
Support of the Applications for Registration of GHA 180 Biological Fungicide,
Pro-Mix GHA 180 and Pro-Mix Tandem. Transmittal of 1 Study.
48391501 Libman, G. (2011) Addendum to Product Process Bacillus pumilus GHA 180 and
Formulated Products: Addendum to MRID 48005001. Unpublished study
prepared by: GNL Consultation Services and Premier Horticulture, Inc. 12 p.
48537300 Premier Horticulture, Inc. (2011) Submission of Product Chemistry Data in
Support of the Application for Registration of Pro-Mix GHA 180, GHA 180
Biological Fungicide and Pro-Mix Tandem. Transmittal of 2 Studies.
Libman, G. (2011) Clarification about Storage Stability Data of Promix GHA 180 a i
Promix Tandem. Unpublished study prepared by Premier Horticulture, Ltd. 8 p.
48537302
.48537303 Libman, G. (2011) Microbiological Analyses: Certificates of Analysis for GHA
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Bacillus pumilus strain GHA180
Biopesticides Registration Action Document
Page 18 of 27
180. Project Number: STIS/10109. Unpublished study prepared by Premier
Horticulture, Ltd. 8 p.
48559501 Libman, G. (2011) 16S rRNA Gene Sequence and DN A Fingerprinting of the
GHA 180 Bacterial Strain. Project Number: 1104081623E. Unpublished study
prepared by GNL Consultation Services and Premier Horticulture, Inc. 32p.
48559502 Libman, G. (2011) Product Chemistry for (Bacillus pumilus GHA180). Project
Number: PHL/LA/WI/128E2. Unpublished study prepared by GNL Consultation
Services. 3 lp.
B. Environmental Protection Agency Risk Assessment Memoranda
U.S. EPA. 201 la. Bacillus pumilus strain GHA180. Memorandum from Joel V. Gagliardi,
Ph.D., and J. L. Kough, Ph.D., to S. Cerrelli dated March 22, 2011
U.S. EPA. 201 lb. Bacillus pumilus strain GHA180. Review of deficiency responses.
Memorandum from Joel V. Gagliardi, Ph.D., and J. L. Kough, Ph.D., to S. Cerrelli dated
October 20, 2011.
C. Other References
Aunpad. R. and K. Na-Bangchang. 2007. Pumilicin 4, a novel bacteriocin with anti-MRSA and
anti-VRE activity produced by newly isolated bacteria Bacillus pumilus strain WAPB4. Curr.
Microbiol. 55(4):308-13.
Babana, A.H., H. Bathily, F. Samake, K. Maiga, D. Traore and A. Dicko. 2011.
Microbiological Control of Bacterial Soft Rot Caused by Bacillus pumilus Od23 on Potato.
British Microbiology Research Journal 1(3): 41-48.
Baneriee C.. C.I. Bustamante. R. Wharton. E. Tallev and J.C. Wade. 1988. us Bacillus
infections in patients with cancer. Arch. Intern. Med. 148(8): 1769-74.
Bathily, H., A.H. Babana and F. Samake. 2010. Bacillus pumilus, a new pathogen on potato
tubers in storage in Mali. African Journal of Microbiology Research 4(20):2067-2071.
Bentur H.N., A.M. Dalzell and F. A. Riordan. 2007. Central venous catheter infection with
Bacillus pumilus in an i mmunocompetent child: a case report. Ann. Clin. Microbiol.
Antimicrob. 6(1): 12.
Bottone, E.J. and R.W. Peluso. 2003. Production by Bacillus pumilus (MSH) of an antifungal
compound that is active against Mucoraceae and Aspergillus species: preliminary report. J.
Med. Microbiol. 52:69-74.
Doyle, M.P., L.R. Beuchat and T.J. Montville. 1997. Food Microbiology: Fundamentals and
Frontiers. American Society for microbiology, Washington, D.C.
-------
Bacillus pumilus strain GHA180
Biopesticides Registration Action Document
Page 19 of 27
Farhat II.. E. Chachaty, S. Antoun. G. Nitenberg and JR. Zahar. 2008. Two cases of Bacillus
infection and immunodepression. Med. Mai. Infect. 38(ll):612-4.
Font, M.I., D.D.M. Bassimba, M.C. Cebrian, L.M. Molina and C. Jorda. 2009. First report
of Bacillus pumilus on Phaseolus vulgaris in Spain. New Disease Reports 19:54.
From, (.. V. Hormazabal and P.E. Granum. 2007. Food poisoning associated with pumilacidin-
producing Bacillus pumilus in rice. Int. J. Food Microbiol. 1 15(3 ):3 19-24.
From C.. R. Pukall. P. Schumann. V. Hormazabal and P.E. Granum. 2005. Toxin-producing
ability among Bacillus spp. outside the Bacillus cereus group. Appl. Environ. Microbiol.
71(3):1178-83.
Galal, A. A., A. A. El-Bana and J. Janse. 2006. Bacillus pumilus, A New Pathogen
on Mango Plants. Egyptian Journal of Phytopathology. 34(l):17-29.
Kramer, J.H. and R.J. Gilbert. 1989. Bacillus cereus and other Bacillus species, p. 21-70. In
M.P. Doyle (ed.), Foodborne Pathogens. Marcel Dekker, Inc., New York.
Meyer, A. and O. Gottheil.1901. In: Gottheil, O. Botanische beschreibung einiger
bodenbakterien. Zentralbl. Bakteriol. Parasitenkd. Infektionskr. Hyg. Abt. II 7:680-691.
Murray, P.R, et al., Manual of Clinical Microbiology. Washington, D. C.: ASM Press; 9th
edition, 2007.
Naruse N.. O. Tenmyo. S. Kobaru. H. Kamei. T. Miyaki. M. Konishi and T. Oki. 1990.
Pumilacidin, a complex of new antiviral antibiotics. Production, isolation, chemical properties,
structure and biological activity. J. Antibiot. (Tokyo) 43(3):267-80.
Ozkocaman V.. T. Ozcelik. R. Ali, F. Ozkalemkas. A. Ozkan. C. Ozakin. H. Akalin. A.
Ursavas. F. Coskun. B. Ener and A. Tunali. 2007. Bacillus spp. among hospitalized patients
with haematological malignancies: clinical features, epidemics and outcomes. Int. J. Food
Microbiol. 115(3):319-24.
Saleh, O.I., P.-I. Huang and J.-S. Huang. 1997. Bacillus pumilus, the cause of bacterial blotch
of immature balady peach in Egypt. Journal of Phytopathology 145:44
Skerman, V.B.D., V. McGowan and P.H.A. Sneath (eds.). 1980. Approved lists of bacterial
names. Int. J. Syst. Bacteriol. 30:225-420.
TenaD.. J. A. Martinez-Torres. M.T. Perez-Pomata. J.A. Saez-Nieto. V. Rubio and J. Bisquert.
2007. Cutaneous infection due to Bacillus pumilus. report of 3 cases. Clin. Infect.
Pis. 44(4):40-2.
World Health Organization, Guidelines for Drinking-water Quality.(2011) Fourth Edition.
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APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS
(40 CFR PART 158 - SUBPART V)
TABLE 1. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/ GHA180
(40 CFR § 158.2120)
OCSPP
Guideline
Number
Data Requirement
Results
MRU) No.
TGAI
GHA 180 (EP)
885.1100
Product Identity
Submitted data fulfill the
requirement for product
identity.
Submitted data fulfill the
requirement for product
identity.
48005001
48559501
885.1200
Manufacturing Process
Submitted data fulfill the requirement for manufacturing
process.
48005001
48391501
Not applicable
Deposition of a Sample
in a Nationally
Recognized Culture
Collection
Bacillus pumilus strain
GHA180 is on deposit at the
International Depository
Authority of Canada, ID AC
No. 260707-01
Not applicable
48005001
885.1300
Discussion of Formation
of Unintentional
Ingredients
Submitted data fulfill the requirement for discussion of
formation of unintentional ingredients
48005001
885.1400
Analysis of Samples
Submitted data fulfill the requirement for analysis of
samples
48005001
48537303
885.1500
Certification of Limits
Not applicable
Limits listed on the
confidential statement of
formula are
adequate/acceptable
CSFs dated
July 12, 2011
Additional Studies
830 .1800
Enforcement Analytical
Method
Not applicable
Submitted data fulfill the
requirement for an
enforcement analytical
method
48005001
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TABLE 2. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient ((TGAI)/ GHA180
Biological Fungicide (EP) (40 CFR § 158.2120)
OCSPP
Guideline
Number
Data Requirement
Results
MRU) No.
TGAI
GHA 180 Biological Fungicide
(EP)
830.6302
Color
Amber
48005001
48559502
830.6303
Physical State
Liquid
48005001
48559502
830.6304
Odor
Musty
48005001
48559502
830.6313
Stability to Normal and
Elevated
Temperatures, Metals,
and Metal Ions
Vegetative cells expected to denature at >50°C.
48005001
48559502
830.6317
Storage Stability
Stable for at least one year; storage conditions not defined.
48005001
830.6319
Miscibility
Not required per OCSPP 830.1000(e)(2), the product is not an
emulsifiable liquid.
830.6320
Corrosion
Characteristics
No corrosion observed during the storage stability testing
48005001
830.7000
pH
6-7.
48005001
48559502
830.7100
Viscosity
Not applicable
2-5 mPa.s at 20 °C
48005001
830.7300
Density/Relative
Density/Bulk Density
(Specific Gravity)
62.30 lbs/ft.
48005001
48559502
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TABLE 3. Product Analysis Data Requirements for the End-Use Product (EP), Pro-Mix GHA180 (40 CFR §
158.2120)
OCSPP Guideline
Data Requirement
Results
MRU) No.
Number
885.1100
Product Identity
Submitted data fulfill the requirement for
product identity.
48005003-
48005010
885.1200
Manufacturing Process
Submitted data fulfill the requirement for
manufacturing process.
48005003-
48005010
48391501
Not applicable
Deposition of a Sample in a
Nationally Recognized
Culture Collection
Not applicable
Not applicable
885.1300
Discussion of Formation of
Submitted data fulfill the requirement for
48005003-
Unintentional Ingredients
discussion of formation of unintentional
ingredients for the current use sites. .
48005010
885.1400
Analysis of Samples
Submitted data fulfill the requirement for
analysis of samples
48005003-
48005010
885.1500
Certification of Limits
Limits listed on the confidential statement
of formula are adequate/acceptable
48005003-
48005010
CSFs dated
1/7/11
Additional Studies
830.1800
Enforcement Analytical
Method
An analytical method is not required for
enforcement purposes since the Agency is
establishing an exemption from the requirement
of a tolerance without any numerical limitation.
48005003-
48005010
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TABLE 4. Product Analysis Data Requirements for the End-Use Product (EP), Pro-Mix Tandem (40 CFR §
158.2120)
OCSPP Guideline
Number
Data Requirement
Results
MRU) No.
885.1100
Product Identity
Submitted data fulfill the requirement for
product identity.
48005011-
48005018
885.1200
Manufacturing Process
Submitted data fulfill the requirement for
manufacturing process.
48005011-
48005018
48391501
Not applicable
Deposition of a Sample in a
Nationally Recognized
Culture Collection
Not applicable
Not applicable
885.1300
Discussion of Formation of
Unintentional Ingredients
Submitted data fulfill the requirement for
discussion of formation of unintentional
ingredients for the current use sites.
48005011-
48005018
885.1400
Analysis of Samples
Storage stability was shown up to two
years in peat growing mixes stored
outdoors with temperature variations from
-30 to +30°C
48005011-
48005018
885.1500
Certification of Limits
Limits listed on the confidential statement
of formula are adequate/acceptable
48005011-
48005018
CSFs dated
1/7/11
830.1800
Enforcement Analytical
Method
An analytical method is not required for
enforcement purposes since the Agency is
establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
TABLE 5. Physical and Chemical Characteristics for the End-Use Product (EP), Pro-Mix Tandem
(40 CFR § 158.2120)
OCSPP Guideline
Number
Data Requirement
Results
MRU) No.
830.6317
Storage Stability
Storage stability was shown up to two
years in peat growing mixes stored
outdoors with temperature variations
from-30 to +30°C.
48005011-
48005018
48537302
830.6319
Miscibility
Not applicable, the product is not an
emulsifiable liquid.
830.6320
Corrosion Characteristics
Not Required. The peat based soil mixes
were not considered corrosive material
830.7100
Viscosity
Not applicable, the product is a solid
830.7300*
Density/Relative Density/Bulk
Density (Specific Gravity)
8-10 lbs/ft3
CSFs dated
1/7/11
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TABLE 6. Physical and Chemical Characteristics for the End-Use Product (EP), Pro-Mix GHA 180
(40 CFR § 158.2120)
OCSPP Guideline Number
Data Requirement
Results
MRU) No.
830.6317
Storage Stability
Storage stability was shown up to two
years in peat growing mixes stored
outdoors with temperature variations
from-30 to +30°C.
48005003-
48005010
48537302
830.6319
Miscibility
Not applicable, the product is not an
emulsifiable liquid.
830.6320
Corrosion Characteristics
Not Required. The peat based soil mixes
were not considered corrosive material
830.7100
Viscosity
Not applicable, the product is a solid
830.7300*
Density/Relative Density/Bulk
Density (Specific Gravity)
8-10 lbs/ft3
CSFs dated
1/7/11
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TABLE 7. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/ and for the
End-Use Products (EP), GHA 180 Biological Fungicide, Pro-Mix GHA 180 Pro-Mix Tandem (40 CFR § 158.2140)
OCSPP
Guideline
Number
Data
Requirement
TGAI
GHA 180
Biological
Fungicide
(EP)
Pro-Mix
GHA 180
(EP)
Pro-Mix
GHA 180
Tandem
(EP)
mrii)
No.
885.3050
Acute Oral
Toxicity/
Pathogenicity
No evidence of infectivity, pathogenicity or toxicity were
noted in the Acute Injection study or in any of the
submitted acute studies listed below. Exposures through
Not
applicable
Not
applicable
Not
applicable
48005019
885.3150
Acute
Pulmonary
Toxicity/
Pathogenicity
the pulmonary or oral routes are not expected to produce
adverse effects based on existing test and product
characterization information.
Not
applicable
Not
applicable
Not
applicable
885.3200
Acute
Injection
Toxicity/
Pathogenicity
15 male and 15 female rats were injected with
TGAI (1.4xl010 - 6.0xl010 CFU/mL) at a dose of 6.8xl07
CFU/animal and observed up to 21 days. All animals
survived, gained weight, and appeared normal during the
study. No observable abnormalities were noted in any
animal at necropsy. The test organism completely cleared
from the blood, kidneys, mandibular lymph nodes and
cecum contents of the animals by day 14, and showed a
pattern of clearance but had not completely cleared from
the liver and spleen by day 21. No test organism was
detected in the tissues/organs of the animals treated with
the inactivated test material or the untreated control group.
Classification: Acceptable - not toxic, infective or
pathogenic to rats when
dosed by IV at 6.8* 107 CFU/animal.
Not
applicable
Not
applicable
Not
applicable
48005025
885.3500
Cell Culture
Not applicable
Not
applicable
Not
applicable
Not
applicable
870.1100
Acute Oral
Toxicity
Oral LD50 was >5000 mg/kg bw.
Classification: Acceptable
TOXICITY CATEGORY IV
Data on
TGAI supports these EPs
48005020
870.1200
Acute Dermal
Toxicity
The LD50 was >5050 mg/kg bw.
Classification: Acceptable
TOXICITY CATEGORY IV
Data on
TGAI supports these EPs
48005021
870.1300
Acute
Inhalation
Toxicity
The LC5q Combined was >2.18mg/L.
Classification: Acceptable
TOXICITY CATEGORY IV
Data on
TGAI supports these EPs
48005022
870.2400
Acute Eye
Irritation
Two male and one female rabbits were treated with 0.1 mL
test material No iritis or positive conjunctival irritation was
noted on any rabbit throughout the study. The maximum
average score was 17.3 at one hour after test material
instillation. Bacillus pumilus GHA180 TGAI was mildly
irritating to the eye. Classification: Acceptable
TOXICITY CATEGORY III
Data on
TGAI supports these EPs
48005023
870.2500
Primary
Dermal
Irritation
One male and two female rabbits were dermally exposed to (
Bacillus pumilus GHA 180 TGAI
(1.4xl010 - 6.0* 1010 CFU/mL) Very slight erythema was
noted on one animal one hour after patch removal with
clearance by 24 hours. No dermal irritation was noted on
any other rabbit during the study. The primary irritation
index was 0.1.
CLASSIFICATION: Acceptable
TOXICITY CATEGORY IV
Data on
TGAI supports these EPs
48005024
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Bacillus pumilus strain GHA 180
Biopesticides Registration Action Document
Page 26 of 27
TABLE 8. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of
the Active Ingredient (TGAI), Bacillus pumilus train GHA180 . (40 CFR § 158.2150)
OCSPP Guideline
Number
Data Requirement
Results
mrii)
No.
Tier I
885.4050
Avian Oral Toxicity
Not required per 40 CFR § 158.2150.
48005019
885.4100
Avian Inhalation
Toxicity/Pathogenicity
The current label use patterns for
greenhouse and nursery use would not
885.4150
Wild Mammal
Toxicity/Pathogenicity
result in significant nontarget species
exposure.
885.4200
Freshwater Fish
Toxicity/Pathogenicity
885.4240
Freshwater
InvertebrateToxicity/Pathogenicity
885.4280
Estuarine/Marine Fish and
Invertebrate Testing
885.4300
Nontarget Plant Testing
885.4340
Nontarget Insect Testing
885.4380
Honey Bee Testing
Tiers II, III, and IV
Not required for Bacillus pumilus strain GHA180 based on the current uses and application methods.
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Bacillus pumilus strain GHA 180
Biopesticides Registration Action Document
Page 27 of 27
APPENDIX B. PESTICIDE PRODUCTS
EPA File
Symbol
Registration
Name
Growing
Medium
Blends
Percentage
Active
Ingredient
Formulation
Type
Use Site(s)
Method(s)
of
Application
Application
Rate
Target Pest
74267-E
GHA 180
Biological
Fungicide
Not
applicable
0.37%
End-use
Product
Greenhouses
And Enclosed
Nurseries
Growing
media of
Ornamentals
and vegetable
transplants
Incorporatio
n Into Peat
Moss Or
Growing
Media Soil
Drench
As directed
on label
Pythium,
Fusarium
and
Rhizoctonia
74267-G
Pro-Mix
GHA 180
BX, HP, TA,
FPX, MPX,
PGX, WT
orBRK
0.001%
End-use
Product
Horticultural
and
agricultural
plants
Tobacco
germinating
seeds
Plant in
Growing
Medium
Not
applicable,
pre-mixed
potting mix
Pythium,
Fusarium
Rhizoctonia
Alternaria
Aspergillus
74267-U
Pro-Mix
Tandem
BX, HP, TA,
FPX, MPX,
PGX, WT
orBRK
0.001%
End-use
Product
Horticultural
and
agricultural
plants
Tobacco
germinating
seeds
Plant in
Growing
Medium
Not
applicable,
pre-mixed
potting mix
Pythium,
Fusarium
Rhizoctonia
Alternaria
Aspergillus
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