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TABLE OF CONTENTS

A. Introduction ................................................................................................................... 6

B. Background and Regulatory Information ....................................................................... 6

1. Registered Products ............................................................................................... 6

2. Exemption from the Requirement of Tolerance ...................................................... 8

C. Anticipated Data Needs and Risk Assessment ............................................................. 8

1. Product Analysis (40 CFR 158.2120) ..................................................................... 8

2. Human Health Toxicity (40 CFR 158.2140) ............................................................ 9

3. Environmental Fate & Ecotoxicity (40 CFR 158.2150) ......................................... 10

4. Risk to Threatened and Endangered Species ....................................................... 11

5. Endocrine Disruptor Screening Program .............................................................. 12

6. Incidents ............................................................................................................... 12

7. Summary of Data Gaps ........................................................................................ 13

D. Timeline....................................................................................................................... 13

E. Guidance for Commenters .......................................................................................... 14

F. Environmental Justice .................................................................................................. 14

G. Water Quality .............................................................................................................. 14

H. Trade Irritants .............................................................................................................. 14

I. Additional Information ................................................................................................... 15

J. Next Steps ................................................................................................................... 15

BIBLIOGRAPHY ..................................................................................................................... 16

APPENDIX A: Federal Register Notices Related to the Tolerance Exemption ....................... 20

List of Tables 

Table 1. Crosswalk of Original vs. Current Registration Numbers ............................................ 7

Table 2. Pesticide Products Containing Bacillus cereus strain BP01 ........................................ 7

Table 3. Summary of Product Analysis Data for Bacillus cereus strain BP01 ........................... 9

Table 4. Summary of Toxicology Data for Bacillus cereus strain BP01 ................................... 10

Table 5. Ecological Toxicity Data for Bacillus cereus strain BP01 ............................................ 11

Table 6. Summary of Data Gaps for Bacillus cereus strain BP01 ........................................... 13

Table 7. Projected Timeline for the Registration Review of Case 6053 .................................. 13

 
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ACRONYMS 

Acronym Extension 

μg microgram 

a.i. Active ingredient 

ATTC American Type Tissue Collection 

B. cereus Bacillus cereus

CFR Code of Federal Regulations 

CFU Colony forming units 

DCI Data Call-in 

EDSP Endocrine Disruptor Screening Program 

EP End-use product 

EPA U.S. Environmental Protection Agency or, the Agency 

EPA Reg. No. EPA Registration Number: a two-part number assigned by EPA to identify each 

pesticide product registration. 

ETE Emetic Toxin 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act of 1996 

FR Federal Register 

g gram 

HBL Hemolytic enterotoxin 

IDS Incident Data System 

L liter 

LD50 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, inhalation). 

mg/kg bw Milligrams per kilogram of body weight 

mg/L Milligrams per liter (approximately equivalent to ppm) 

mL Milliliter 

MP Manufacturing-use product 

MPCA Microbial pesticide control agent 

MRID Master Record IDentification (number): EPA's system of recording and tracking 

studies submitted to the Office of Pesticide Programs. 

MRL Maximum residue limits 

Nhe Nonhemolytic enterotoxin 

NPIC National Pesticides Information Center 

OPP EPA’s Office of Pesticide Programs 

OPPTS Office of Prevention, Pesticides and Toxic Substances; now the Office of Chemical 

Safety and Pollution Prevention (OCSPP) 

PC Code Pesticide Chemical Code: a six-digit number assigned by OPP to identify pesticide 

chemicals. 

TMDL Total maximum daily loads 

 
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BACILLUS CEREUS REGISTRATION REVIEW TEAM

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch 

HUMAN HEALTH

Primary Review: Kathleen Martin; MSES, MPA

Secondary Review: John Kough, Ph.D.

 

ENVIRONMENTAL EFFECTS

Primary Review: Kathleen Martin

Secondary Review: Shannon Borges 

RISK MANAGEMENT

Sheryl Reilly, Ph.D., Chief, Microbial Pesticides Branch

 

OFFICE OF GENERAL COUNCIL

Philip Ross, Esq.

 
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PRELIMINARY WORK PLAN

 A. Introduction

 The Food Quality Protection Act (FQPA) of 1996 mandated the continuous review of 

existing pesticides. All pesticides distributed or sold in the United States must generally be 

registered by the U.S. Environmental Protection Agency (EPA or the Agency), based on 

scientific data showing that they will not cause unreasonable risks to human health or the 

environment when used as directed on the product labeling. The Registration Review program 

is intended to make sure that, as the ability to assess risk evolves and as policies and 

practices change, all registered pesticides continue to meet the statutory standard of no 

unreasonable adverse effects. Changes in science, public policy, and pesticide use practices 

will occur over time. Through the Registration Review program, the Agency periodically 

reevaluates pesticides to make sure that as change occurs, products in the marketplace can 

continue to be used safely. Information on this program is provided at: 

http://www.epa.gov/oppsrrd1/registration_review/. 

 The Agency has begun to implement the Registration Review program pursuant to 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each 

registered pesticide every 15 years to determine whether it continues to meet the FIFRA 

standard for registration. The Agency will consider benefits information and data as required 

by FIFRA. The public phase of Registration Review begins when the initial docket is opened 

for each case. The docket is the Agency’s opportunity to state what it knows about the 

pesticide and what additional risk analyses and data or information it believes are needed to 

make a Registration Review decision. After reviewing and responding to comments and data 

received in the docket during this comment period, the Agency will develop and commit to a 

final work plan and schedule for the Registration Review. 

 This Registration Review Summary Document evaluates the microbial pest control 

agent (MPCA) Bacillus cereus strain BP01 (PC Code 129802; ATTC® Number: 55675). 

Further information about this case, including background and supporting documents, is 

available at regulations.gov; under “Keyword” enter the docket number, which is 

EPA-HQ-OPP-2011-0493. 

 B. Background and Regulatory Information

 1. Registered Products

 Bacillus cereus (or B. cereus) strain BP01 is a plant regulator that is used mainly on 

cotton, but is also registered for use on a number of field and row crops including field corn, 

soybean, rice, peanut, cauliflower, and melons; it is applied aerially. EPA has registered seven 

products containing B. cereus strain BP01 as an active ingredient—one manufacturing-use 

product (MP) and six end-use products (EP). These products were first registered to MicroFlo 

Company; later, the registrations were transferred to Arysta Lifescience North America, LLC. 

Table 1 provides a crosswalk between the original and current EPA Registration Numbers (EPA 

Reg. No.). 

 

 
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Table 1. Crosswalk of Original vs. Current Registration Numbers 

 and Product Names 

a

The Registration Notice (EPA 1997g) for this product refers to it as “Mepichlor/BP01 4-2.”

 The first two products registered were the MP (Bacillus cereus, strain BP01 

Technical; EPA Reg. No. 66330-274) and an EP (Pix® Plus® Plant Regulator; EPA Reg. 

No. 66330-351). EPA registered (EPA 1997f) Bacillus Cereus BP01 Technical 

unconditionally but with a term that has been satisfied (SRA 1997b). Pix® Plus® Plant 

Regulator was also registered unconditionally (EPA 1997g; no terms); it contains 

mepiquat chloride (another plant growth regulator) as a second active ingredient. 

 Between 1998 and 2010, the Agency registered five more products containing 

B. cereus strain BP01 as an active ingredient (EPA 1998b,c; 1999a; 2000b; 2010a). 

Three of these products (MepPlusTM Concentrate, MepPlusTM Pill, and ARY 0494-006; 

EPA Reg. Nos. 66330-280, -285, and -393, respectively) contain mepiquat chloride as a 

second active ingredient.1 One product (BP01 1.7; EPA Reg. No. 66330-282) contains 

B. cereus strain BP01 as the single active ingredient and another product (PGRIV®/BP01 Foliar; EPA Reg. No. 66330-291) contains gibberellic acid as a second active 

ingredient.2

 Provided in Table 2 is a summary of the seven registered products; the 

table includes the percent B. cereus strain BP01 in each product and the products’ 

registered use sites. 

Table 2. Pesticide Products Containing Bacillus cereus strain BP01 

 as an Active Ingredient 

EPA 

REG. NO

PRODUCT

NAME

% ACTIVE INGREDIENT (a..i.) REGISTERED

USE SITES

REGISTRATION 

B. CEREUS 2 NOTICE ND A.I. 

Products containing only B. cereus strain BP01

66330-274 Bacillus Cereus, 

BP01 Technical 

10.9 NA Manufacturing-use 

product 

EPA 1997f 

66330-282 BP01 1.7 1.7 NA Cotton and soybean EPA 1998c 

Products containing B. cereus strain BP01 and the active ingredient mepiquat chloride

66330-351 Pix® Plus® Plant 

Regulator 

0.0058 4.2 Cotton EPA 1997g 

66330-280 MepPlusTM 

Concentrate 

0.032 23.5 Cotton EPA 1998b 

66330-285 MepPlusTM Pill 0.11 95.8 Cotton EPA 1999a 

 

1

MepPlusTM Concentrate was registered unconditionally (1998b); MepPlusTM Pill and ARY 0494-006 were registered with 

conditions (1999a, 2010a). 

2

EPA registered both unconditionally (EPA 1998c, 2000b). 

EPA REG. NO. PRODUCT NAME

FIRST 

Original Current REGISTERED

51036-282 66330-274 Bacillus Cereus, BP01 Technical 1997 

51036-283 66330-351 Pix® Plus® Plant Regulatora 1997 

51036-299 66330-280 MepPlusTM Concentrate 1998 

51036-301 66330-282 BP01 1.7 1998 

51036-306 66330-285 MepPlusTM Pill 1999 

51036-325 66330-291 PGR-IV®/BP01 Foliar 2000 

NA 66330-393 ARY 0494-006 2010 
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EPA 

REG. NO

PRODUCT

NAME

% ACTIVE INGREDIENT (a..i.) REGISTERED

USE SITES

REGISTRATION 

B. CEREUS 2 NOTICE ND A.I. 

66330-393 ARY 0494-006 1.13 90 Cotton EPA 2010a 

Products containing B. cereus strain BP01 and the active ingredient gibberellic acid 

66330-291 PGR-IV®/BP01 

Foliar 

0.1 0.225 Row and vegetable crops 

(these include: field corn, 

soybean, rice, peanut, 

cauliflower and melons) 

EPA 2000b 

 2. Exemption from the Requirement of Tolerance

 Cotton is considered a food-use because cottonseed oil is used for cooking and 

cottonseed meal is used as animal feed. In a Final Rule published on August 4, 1997 

(62 FR 41874), EPA established an exemption from the requirement of tolerance for 

residues of the microbial plant regulator B. cereus strain BP01 in or on cottonseed ; it 

was codified at 40 CFR 180.1181. In 2001, the registrant sought to amend the 

tolerance exemption to include all raw agricultural commodities, not just cotton. In a 

Final Rule (67 FR 70012; November 20, 2002), EPA expanded the original tolerance 

exemption to read: 

§180.1181 Bacillus cereus strain BP01; exemption from the requirement of 

a tolerance. An exemption from the requirement of a tolerance for 

residues of the Bacillus cereus strain BP01 in or on all raw agricultural 

commodities when applied/used in accordance with label directions.” 

Appendix A provides a list of Federal Register notices regarding the exemption from 

tolerance for residues of B. cereus strain BP01. 

C. Anticipated Data Needs and Risk Assessment

 Provided below are summaries and tables of the current data requirements for microbial 

pesticides. They are arrayed by scientific discipline, and describe how the requirements have 

been satisfied, as well as any data gaps that have been identified. 

 1. Product Analysis (40 CFR 158.2120) 

B. cereus is an aerobic and facultatively anaerobic, spore-forming, gram-positive 

bacillus (LA DPH 2004) that causes two forms of foodborne illness. The emetic form is 

characterized by nausea and vomiting and abdominal cramps; it has a one- to six-hour 

incubation period. The diarrheal form manifests as abdominal cramps and diarrhea (the 

diarrhea may be a small volume or profuse and watery); it has an eight- to sixteen-hour 

incubation period. The emetic syndrome is caused by a preformed heat-stable emetic 

toxin (ETE). The diarrhea syndrome is caused by in vivo production of two heat-labile 

enterotoxins3

—nonhemolytic enterotoxin (Nhe) and/or hemolytic enterotoxin (HBL). 

(Todar 2008). Because these toxins may cause acute illness in humans, EPA intends to 

require an updated manufacturing process along with a new ‘discussion of formation of 

unintentional ingredients.’ Provided in Table 3 is a summary of the Product Analysis 

requirements for B. cereus strain BP01 and how they have been met. 

 

3

An enterotoxin is a substance that is released by a microorganism in to the intestine. 
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Table 3. Summary of Product Analysis Data for Bacillus cereus strain BP01 

40 CFR 158.2120 

DATA REQUIREMENT

(OPPTS GUIDELINE) 

MRID HOW IT HAS BEEN ADDRESSED

(EPA REVIEW, CONCLUSIONS, COMMENTS)

Product Chemistry and Composition

Product Identity (885.1100) 441773-01; 

452680-01 

EPA 1997a,c 

Manufacturing process 

(885.1200) 

441773-01 Because human health toxins endemic to B. cereus may 

contaminate production batches, EPA is requiring an updated 

manufacturing process. 

DATA GAP

Deposition of a sample in a 

nationally recognized culture 

collection (885.1200) 

441773-01 A sample of B. cereus strain BP01 was deposited in the American Type 

Tissue Collection as ATTC 55675. EPA 1997a 

Discussion of formation of 

unintentional ingredients 

(885.1300) 

441773-01 Because of concern regarding B. cereus toxins, EPA intends to require 

an updated discussion of unintentional ingredients. 

DATA GAP

Analysis and Certified Limits 

Analysis of samples (885.1400) 441773-02 All parts of this requirement have been satisfied. 

EPA 1997a,c; EPA 2002a 

Certification of limits (885.1500) 441773-02 EPA 1997a 

Physical and Chemical Characteristics

Color (830.6302) 441773-03 light yellowish-brown. EPA 1997a 

Physical state (830.6303) 441773-03 powdery flakes. EPA 1997a 

Odor (830.6304) 441773-03 earthy, musty. EPA 1997a 

pH (830.7000) 441773-03 5.23 @ 21◦C in a 5% aqueous suspension. EPA 1997a 

Bulk density (830.7300) 441773-03 0.224 g/mL. EPA 1997a 

Corrosion characteristics 

(830.6320) 

441773-04 In testing using a high density polyethylene (HDPE), study investigators 

demonstrated that B. cereus strain BP01 is not corrosive to this type of 

container. EPA 1997a 

Storage stability (830.6317) Waived (EPA 1997h) 

Stability to normal and elevated 

temperatures, metals and metal 

ions (830.6313) 

Waived (EPA 1997h) 

Miscibility (830.6319) Only required for emulsifiable liquid forms of microbial pesticides.a B. cereus strain 

BP01 technical is a solid. 

Viscosity (830.7100) Only required for liquid forms of microbial pesticides. B. cereus strain BP01 technical 

is a solid.b

a

40 CFR 158.2120, test note 2. 

b

40 CFR 158.2120, test note 4.

2. Human Health Toxicity (40 CFR 158.2140) 

 EPA did not identify any gaps regarding human health toxicity. Table 4 provides 

brief summaries of the submitted data and shows the data gaps. 

 
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 Table 4. Summary of Toxicology Data for Bacillus cereus strain BP01 

40 CFR 158.2120 

DATA REQUIREMENT

(OPPTS GUIDELINE) 

MRID HOW IT HAS BEEN ADDRESSED

(EPA REVIEW, CONCLUSIONS, COMMENTS) 

Acute oral toxicity/ 

pathogenicity 

(885.3050) 

441773-06 B. cereus strain BP01 is not toxic, pathogenic or infective when a 1X 108

CFUa

 dose was administered orally. A distinct clearance pattern was 

observed throughout the study. EPA 1997a,c 

 ACCEPTABLE STUDY

Acute pulmonary toxicity/ 

pathogenicity 

(885.3150) 

441773-08 B. cereus BP01 was not toxic or pathogenic when a 7 to 9.33 X 107 CFU 

dose was administered intratracheally. A distinct clearance pattern was 

observed throughout the study. EPA 1997a,c 

ACCEPTABLE STUDY

Acute injection toxicity/ 

pathogenicity— 

intravenous 

(885.3200) 

441773-09 B. cereus BP01 was not toxic when a 2 X 107 CFU dose was administered 

intravenously; however, clearance data was not submitted. Because the oral 

and intratracheal toxicity/pathogenicity studies demonstrated distinct 

clearance patterns, EPA did not require that this study be repeated. 

EPA 1997a,c 

SUPPLEMENTAL STUDY

Hypersensitivity incidents 

(885.3400) 

NOTE: Hypersensitivity incidents must be reported if they occur.b Such incidents include 

“immediate type and delayed-type reactions of humans or domestic animals....”

Cell culture (885.3500) NA. This study is only required for products whose active ingredient is a virus.c

 B. cereus

is a bacterium. 

Acute oral toxicity 

(870.1100) 

441773-05 In rats, LD50 >5,000 mg/kg bw. EPA 1997a,c 

ACCEPTABLE STUDY

Acute dermal toxicity 

(870.1200) 

441773-07 A single, 2 g dose of B. cereus strain BP01 applied to the skin of rabbits. 

LD50>2,000 mg/kg bw. EPA 1997a,c 

ACCEPTABLE STUDY

Acute inhalation toxicity 

(870.1300)

Required when the product consists of, or under conditions of use would result in, an 

inhalable material (e.g., gas, volatile substances, or aerosol particulate). EPA does not 

expect that products containing B. cereus strain BP01 will result in an inhalable material. 

Acute eye irritation 

(870.2400) 

441773-10 B. cereus strain BP01 was considered practically non-irritating when a 0.1g 

ocular dose was administered to rabbits; ocular irritation was no longer 

present by day 3. EPA 1997a,c 

ACCEPTABLE STUDY

Primary dermal irritation 

(870.2500)

441773-07 A single, 2g dose of B. cereus strain BP01 applied to the skin of rabbits 

produced a produced a slight- to well-defined irritation at 72 hours post 

dosing. By day 14, all signs of signs of irritation resolved. EPA 1997a,c 

 ACCEPTABLE STUDY

a

CFU=colony forming unit 

b

40 CFR 158.2140, test note 3. 

c

40 CFR 158.2140, test note 6. 

3. Environmental Fate & Ecotoxicity (40 CFR 158.2150) 

 Table 5 (below) provides summaries of the ecotoxicity data and data gaps. EPA 

deemed the submitted avian oral toxicity study invalid/supplemental because the actual 

dose of test substance administered was unknown (EPA 1997b); however, based on the 

lack of toxicological findings, the reviewer was able to conclude that B. cereus strain 

BP01 was practically nontoxic to bobwhite quail, adding that the study did not need to 

be repeated. EPA did not require that the study be repeated. 
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 In 1997, when EPA assessed the ecological risks posed by products containing 

B. cereus strain BP01, use of such products was limited to cotton. In its 1997 ecological 

review (EPA 1997b), Agency scientists pointed out that for use sites beyond cotton, 

toxicity to freshwater fish and nontarget insects would need to be addressed, either 

through the submission of data or adequate waivers. In 2002, the tolerance exemption 

was expanded to include a number of crops including soybean, field corn, and melons 

(62 FR 41874). Because the Agency is concerned about potential effects to freshwater 

fish and nontarget insects, we intend to require these data. 

Table 5. Ecological Toxicity Data for Bacillus cereus strain BP01 

40 CFR 158.2120 

DATA REQUIREMENT

(OPPTS GUIDELINE) 

MRID HOW IT HAS BEEN ADDRESSED

(EPA REVIEW, CONCLUSIONS, COMMENTS) 

Avian oral toxicity (885.4050) 441773-12 Bobwhite Quail. When administered to bobwhite quail for five days at a dose 

of 4.44 X 107

 CFU/g day, practically nontoxic to test animals. EPA 1997b. 

 SUPPLEMENTAL STUDY

Avian inhalation toxicity/ 

pathogenicity (885.4100) 

Data required when the nature of the microbial pesticide and/or its toxins indicates 

potential pathogenicity to birds.a EPA does not expect B. cereus strain BP01 to be a 

potential avian pathogen. 

Wild mammal toxicity/ 

pathogenicity (885.4150) 

Required on a case-by-case basis....b EPA expects that this study will not be needed. 

Freshwater fish toxicity/ 

pathogenicity (885.4200) 

EPA expects to require these data (EPA 1997b). 

DATA GAP

Freshwater invertebrate 

toxicity/ pathogenicity 

(885.4240) 

441773-14 Daphnia magna. B. cereus strain BP01 was toxic to daphnids at 

concentrations ranging from 3.9 X 107

 to 6.7 X 108 CFU/L. In addition, 

attenuated B. cereus strain BP01 and the sterile filtrate of B. cereus strain 

BP01 was toxic to daphnids at 50 mg/L. EPA 1997b 

ACCEPTABLE STUDY

Estuarine/Marine fish testing 

Estuarine & marine 

invertebrate testing 

(885.4280) 

EPA expects to require these data for products with aerial application. 

DATA GAP

Nontarget plant testing 

(885.4300) 

Required if the microbial pesticide is taxonomically related to a known plant pathogen.c

Nontarget insect testing 

(885.4340) 

EPA expects to require these data (EPA 1997b). 

DATA GAP

Honey bee testing (885.4380) 453823-02 Honey bees were exposed to B. cereus strain BP01 (topical application) at 

doses ranging from 13 to 100 μg/bee. At the highest dose tested (i.e., 100 

μg/bee) no significant adverse effects were seen. The acute LD50 is >100 

μg/bee. EPA 2002b 

ACCEPTABLE STUDY

a

40 CFR 158.2150, test note 3. 

b

40 CFR 158.2150, test note 4. 

c

40 CFR 158.2150, test note 7.

4. Risk to Threatened and Endangered Species 

EPA has not conducted a risk assessment that supports a complete endangered 

species determination for B. cereus strain BP01. The ecological risk assessment 

planned during Registration Review will allow the Agency to determine whether use of 
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B. cereus strain BP01 will have “no effect”4

 or “may affect”4 federally-listed threatened or 

endangered species (listed species) or their designated critical habitat. When an 

assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife 

Service and/or National Marine Fisheries Service (the Services), as appropriate. 

 Based on the specific use patterns and data gaps in ecological data, the Agency 

anticipates the need for new data. In addition, because this active ingredient has 

products that are registered for outdoor-use, the Agency is required to consider any 

effects on nontarget species, particularly those with endangered and threatened status. 

5. Endocrine Effects 

 As required by the Administrator under the Federal Food, Drug, and Cosmetic 

Act (FFDCA) section 408(p), EPA has developed the Endocrine Disruptor Screening 

Program (EDSP) and has begun to implement the screening program that is to be used 

to test all pesticides in order 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.” 

 FFDCA section 408(p)(4), authorizes the Administrator, by order, to exempt from 

the requirements of the Estrogenic Substances Screening Program a biologic 

substance or other substance if a determination is made that the substance is not 

anticipated to produce any effect in humans similar to an effect produced by a naturally 

occurring estrogenic substance. 

 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 

nine inert ingredients. B. cereus strain BP01, an MPCA that is endemic to soil, is not 

among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. 

 The Agency, as part of this final work plan, believes that B. cereus strain BP01, 

the active ingredient involved in this Registration Review case, likely is a substance that 

is anticipated not to produce any effect in humans similar to an effect produced by a 

naturally occurring estrogenic substance. As such, pursuant to Section 408(p)(4), EPA 

may exempt B. cereus strain BP01 from the requirements of the Section 408(p) EDSP. 

 For further information on the status of the EDSP, the policies and procedures, 

the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, 

please visit our website: http://www.epa.gov/endo/. 

 6. Incidents 

 The National Pesticides Information Center (NPIC) database reported no 

incidents associated with products containing B. cereus strain BP01. The Office of 

 

4

In assessing ecological risk EPA makes an “effects determination.” The effects determination may conclude that the 

pesticide’s use will have: “no effect" on a listed species, "may affect but is not likely to adversely affect" a listed species, or is 

"likely to adversely affect" a listed species. http://www.epa.gov/espp/litstatus/eseffects.htm 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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Pesticide Programs’ (OPP) Incident Data System (IDS) shows one report of adverse 

human, domestic animal, or environmental incidents for products containing B. cereus

strain BP01. Using the classification system described at 40 CFR 159.184(c)(5), the 

incident is considered to be “H-C” and “D-B.” An incident classified as “H-C” is one 

where “the person alleged or exhibited symptoms more pronounced, more prolonged or 

of a more systemic nature than minor symptoms.” A “D-B” incident is one where an 

“animal exhibited or was alleged to have exhibited symptoms which may have been lifethreatening or resulted in residual disability.” The Agency will consider any incident data 

or comments submitted to this docket in response to this preliminary work plan. 

7. Summary of Data Gaps 

 Table 6 summarizes the data gaps for B. cereus strain BP01, case 6053. 

Table 6. Summary of Data Gaps for Bacillus cereus strain BP01 

PRODUCT ANALYSIS

(40 CFR 158.2120)

HUMAN HEALTH TOXICITY

(40 CFR 158.2140) 

ECOLOGICAL TOXICITY

(40 CFR 158.2150) 

Product Chemistry and Composition

 Manufacturing process; and 

 Discussion of unintentional ingredients 

No Data Gaps Freshwater fish toxicity/pathogenicity

Estuarine/marine fish testing 

Estuarine & marine invertebrate testing

Nontarget insect testing 

D. Timeline

 The projected timeline for case 6053—Bacillus cereus strain BP01—Registration 

Review is listed in Table 7, below.

 Table 7. Projected Timeline for the Registration Review of Case 6053

ACTIVITY ESTIMATED

MONTH AND YEAR

 Phase 1: Open the Public Docket

Open Comment Period for Docket June 30, 2011 

Close Comment Period August 30, 2011 

 Phase 2: Case Development

Develop Final Work Plan January 2012 

Issue Data Call-in (DCI) January 2013 

Data Submission January 2015 

Open Public Comment Period for Preliminary Risk Assessments July 2016 

Close Public Comment Period October 2016 

 Phase 3: Registration Review Decision

Open Comment Period for Proposed Registration Review Decision January 2017 

Close Comment Period April 2017 

Final Decision and Begin Post-Decision Followup 2017 

Estimated Total (years) 6 
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E. Guidance for Commenters

 The public is invited to comment on EPA’s preliminary Registration Review work plan 

and rationale. The Agency will consider all comments as well as any additional information or 

data provided in a timely manner prior to issuing a final work plan for the case. 

 

F. 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, in the 

development, implementation, and enforcement of environmental laws, regulations, and 

policies. To help address potential environmental justice issues, the Agency seeks information 

on any groups or segments of the population who, as a result of their location, cultural 

practices, or other factors, may have atypical, unusually high exposure to B. cereus strain 

BP01, compared to the general population. Please comment if you are aware of any 

subpopulations that may have atypical, unusually high exposure compared to the general 

population. 

 G. Water Quality 

B. cereus strain BP01 is not identified as a cause of impairment for any water bodies 

listed as impaired under section 303(d) of the Clean Water Act.5

 In addition, no Total Maximum 

Daily Loads (TMDL) have been developed for B. cereus strain BP01.6 More information on 

impaired water bodies and TMDL’s can be found at: http://www.epa.gov/owow/tmdl/. The 

Agency invites submission of water quality data for this pesticide. To the extent possible, data 

should conform to the quality standards in Appendix A of the Office of Pesticide Program’s 

(OPP) Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process7 to 

ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

H. Trade Irritants

 Through the Registration Review process, the Agency intends to solicit information on 

trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. 

Growers and other stakeholders are asked to comment on any trade irritant issues resulting 

from lack of Maximum Residue Limits (MRL’s) or disparities between United States tolerances 

and MRL’s in key export markets, providing as much specificity as possible regarding the 

nature of the concern. 

 Residues of B. cereus strain BP01 are exempt from the requirement of tolerance and 

there are no known MRL’s (FAO and WHO 2010). Therefore, the Agency does not anticipate 

that current uses of B. cereus strain BP01 will pose concerns as trade irritants. 

 

 

5

Based on information provided at: http://www.epa.gov/owow/tmdl/. 6

Based on information provided at: http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_search_form. 7

This document can be found at: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm. 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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page 15 

I. Additional Information

 Stakeholders are also specifically asked to provide information and data that will assist 

the Agency in refining the risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in obtaining the following information regarding the 

use of B. cereus strain BP01: 

 Confirmation on the following label information: 

- Sites of application 

- Formulations 

- Application methods and equipment 

- Maximum application rates 

- Frequency of application, application intervals, and maximum number of 

applications 

- Geographic limitations on use

 Use or potential use distribution 

 Use history 

 Usage/use information for nonagricultural uses (e.g., materials preservation) 

Typical application interval 

 State or local use restrictions 

 Monitoring data 

J. Next Steps 

 After the 60-day comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a final work plan for case 6053: 

Bacillus cereus strain BP01. 

 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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page 16 

BIBLIOGRAPHY 

Submitted Studies 

441773-00 Micro Flo Company. 1996. Submission of Product Chemistry and Toxicology Data in 

Support of the Application for Registration and Petition for Exemption from Tolerance 

Requirements for Bacillus cereus strain BP01. Transmittal of 17 Studies. December 11, 

1996. 

441773-01 Bowman, L. 1996. Product Identity and Disclosure of Ingredients, Manufacturing 

Process, Discussion of Formation of Impurities: (Bacillus cereus Strain BP01). 

Unpublished study prepared by Chr Hansen BioSystems. 31 p. December 11, 1996. 

441773-02 Bowman, L. 1996. Analysis of Samples, Certification of Limits, and Analytical Methods: 

(Bacillus cereus Strain BP01): Lab Project Number: AG 0205A: MC-004: MC-008. 

Unpublished study prepared by Chr Hansen BioSystems. 46 p. December 11, 1996. 

441773-03 Stenzel, J.; Markley, B. 1996. Product Chemistry Testing of Bacillus cereus Strain 

BP01: Color, Physical State, Odor, Bulk Density, and pH: Amended (Final) Report: Lab 

Project Number: 147C-110: 147/092795/MUP-MPCA.FIFA/CHP104. Unpublished 

study prepared by Wildlife International Ltd. 34 p. December 11, 1996. 

441773-04 Stenzel, J.; Markley, B. 1996. Product Chemistry Testing of Bacillus cereus Strain 

BP01: Corrosion Characteristics: Amended (Final) Report: Lab Project Number: 

147C-109: 147/092795/MUP-MPCA.FIFB/CHP104. Unpublished study prepared by 

Wildlife International Ltd. 29 p. December 11, 1996. 

441773-05 Johnson, W. 1996. Acute Oral Toxicity Study of Bacillus cereus Strain BP01 in Rats 

(Limit Test): Amended Final Report: Lab Project Number: L08594: L08594SN7. 

Unpublished study prepared by IIT Research Institute. 23 p. December 11, 1996. 

441773-06 Sherwood, R. 1996. Toxicity/Pathogenicity Testing of Bacillus cereus Strain BP01 

Following Acute Oral Challenge in Rats: Amended Final Report: Lab Project Number: 

L08594: L08594 SN2. Unpublished study prepared by IIT Research Institute. 73 p. 

December 11, 1996. 

441773-07 Johnson, W. 1996. Acute Dermal Toxicity/Irritation Study of Bacillus cereus Strain 

BP01 in Rabbits: Amended Final Report: Lab Project Number: L08594: L08594SN5. 

Unpublished study prepared by IIT Research Institute. 28 p. December 11, 1996. 

441773-08 Sherwood, R. 1996. Toxicity/Pathogenicity Testing of Bacillus cereus Strain BP01 

Following Acute Intratracheal Challenge in Rats: Amended Final Report: Lab Project 

Number: L08594: L08594SN3. Unpublished study prepared by IIT Research Institute. 

210 p. December 11, 1996. 

441773-09 Sherwood, R. 1996. Toxicity Testing of Bacillus cereus Strain BP01 Following Acute 

Intravenous Challenge in Rats: Amended Final Report: Lab Project Number: L08594: 

L08594SN4. Unpublished study prepared by IIT Research Institute. 27 p. December 

11, 1996. 

441773-10 Johnson, W. 1996. Primary Eye Irritation Study of Bacillus cereus Strain BP01 in 

Rabbits: Amended Final Report: Lab Project Number: L08594: L08594SN6. 

Unpublished study prepared by IIT Research Institute. 25 p. December 11, 1996. 

441773-11 Mega, W. 1996. Sensitivity of Detection of Bacillus cereus Strain BP01 for 

Toxicity/Pathogenicity Testing in Rats: Amended Final Report: Lab Project Number: 

L08594: L08594 SN1. Unpublished study prepared by IIT Research Institute. 36 p. 

December 11, 1996. 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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441773-12 Foster, J.; Beavers, J. 1996. Bacillus cereus Strain BP01: An Avian Oral Pathogenicity 

and Toxicity Study in the Northern Bobwhite: (Final Report): Lab Project Number: 378-

102. Unpublished study prepared by Wildlife International Ltd. 28 p. December 11, 

1996. 

441773-13 Drottar, K.; Swigert, J. 1996. Bacillus cereus Strain BP01: A 21-Day Life-Cycle Toxicity 

and Pathogenicity Test with the Cladoceran (Daphnia magna): Final Report: Lab 

Project Number: 378A-101A. Unpublished study prepared by Wildlife International Ltd. 

38 p. December 11, 1996. 

441773-14 Collins, M. 1996. Bacillus cereus Strain BP01—Toxicity to Daphnids (Daphnia magna) 

During a 21-Day Static-Renewal Test: Amended Final Report: Lab Project Number: 

96-11-6760: 13633.1096.6100.264. Unpublished study prepared by Springborn Labs, 

Inc. 91 p. December 11, 1996. 

441773-15 Crosby, K. 1996. Effect of Bacillus cereus Strain BP01 on Soybean Seedling 

Emergence, Plant Growth, and Phytotoxicity: (Amended Report): Lab Project Number: 

6677-95-0282-BE-001: 6677-95-0282-BE-000. Unpublished study prepared by Ricerca, 

Inc. 51 p. December 11, 1996. 

441773-16 Sherwood, R. 1996. Testing of Bacillus cereus Strain BP01 for Bacillus cereus

Enterotoxin Production: Final Report: Lab Project Number: L08617: L08617 SN1. 

Unpublished study prepared by IIT Research Institute. 19 p. December 11, 1996. 

441773-17 Geno, P.; Wall, C. 1996. Determination of Hemolysis Activity of BP01: Final Report: 

Lab Project Number: 01-6666-029. Unpublished study prepared by Southwest 

Research Institute. 5 p. December 11, 1996. 

443318-01 Young, C.; Lethbridge, G.; Shaw, L.; et al. 1995. Survival of inoculated Bacillus cereus

spores and vegetative cells in non-planted and rhizosphere soil. Soil Biol. Biochem. 

27(8): 1017-1026. July 22, 1997. 

443318-03 West, A.; Burges, H.; Dixon, T.; et al. 1985. Survival of bacillus thuringiensis and 

bacillus cereus spore inocula in soil: Effects of pH, moisture, nutrient availability, and 

indigenous microorganisms. Soil Biol. Biochem. 17(5): 657-665. July 22, 1997. 

443318-04 West, A.; Burges, H. 1985. Persistence of bacillus thuringiensis and bacillus cereus in 

soil supplemented with grass or manure. Plant and Soil 83: 389-398. July 22, 1997. 

443318-05 West, A.; Burges, H.; Dixon, T.; et al. 1985. Effect of incubation in non-sterilised and 

autoclaved arable soil on survival of bacillus thuringiensis and bacillus cereus spore 

inocula. New Zealand Journal of Agricultural Research 28: 559-566. July 22, 1997. 

443318-06 Hagen, C.; Hawrylewicz, E.; Anderson, B. et al. 19??. Ability of Microorganisms to 

Establish Ecological Niches in Different Soils and Environments. Chapter 38 in 

Developments in Industrial Microbiology. July 22, 1997. 

452680-00 Micro Flo Company. 2000. Submission of Product Chemistry Data in Support of the 

Registration of Bacillus Cereus Strain BP01 Technical. Transmittal of 1 Study. 

November 17, 2000. 

452680-01 Smith, F. 2000. Product Identity and Composition, Description of Beginning Materials, 

and Description of Production Process: (Bacillus cereus Strain BP01 Technical). 

Unpublished study prepared by Micro Flo Company. 98 p. (OPPTS 830.1550, 

830.1600, 830.1620). November 17, 2000 

453823-00 Micro Flo Company. 2001. Submission of Toxicity Data in Support of the Petition for 

Tolerance of Bacillus cereus strain BP01 in/on Cottonseed. Transmittal of 2 Studies. 

April 17, 2001. 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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453823-01 Gaskins, M. 1998. Determination of Emetic Toxin from Cultures of Bacillus cereus: 

MTT Assay for Cellular Cytotoxicity: Final Report: Lab Project Number: 980608. 

Unpublished study prepared by Micro Flo Company. 18 p. April 17, 2001. 

453823-02 Hoxter, K.; Porch, J.; Krueger, H. 1999. Bacillus cereus BP01: An Acute Contact 

Toxicity Study with the Honey Bee: Lab Project Number: 378-103A. Unpublished study 

prepared by Wildlife International Ltd. 22 p. (OPPTS 850.3020). April 17, 2001.

EPA Reviews

U.S. EPA. 1997a. Memorandum from Cindy Schaffer, Microbiologist to James Boland, 

Regulatory Action Leader. BPPD Review of Data Submitted by Micro Flo Company for the 

Registration of Mepichlor/BP01 4-2; and the Applicability of a Tolerance Exemption for this 

chemical/microbial mixture (containing the active ingredients: Mepiquat chloride and Bacillus 

cereus strain BP01).... U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. June 11, 1997. 

U.S. EPA. 1997b. Memorandum from Julie Fry Heminway to Phil Hutton. Review of non-target 

studies in support of registration of Bacillus cereus (BP01) technical (EPA File Symbol 51036-

EIE) and the end-use product Mepichlor/BP014-2, (EPA File Symbol # 51036-EIG); DP 

BARCODE 0233600; ... ; MRID No's 44173-12,44173-13, 44173-14,44173-15,44173-16. U.S. 

Environmental Protection Agency. Office of Pesticide Programs. Biopesticides and Pollution 

Prevention Division. June 19, 1997. 

U.S. EPA. 1997c. Memorandum from Cindy Schaffer to James Boland. BPPD Review of 

Additional Data Submitted by Micro Flo Company for the Registration of Mepichlor/BP01 4-2 

(containing the active ingredients: Mepiquat chloride and Bacillus cereus strain BP01) 

(Chemical No.: 119802). U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. July 21, 1997. 

U.S. EPA. 1997h. Registration Eligibility Document. Bacillus cereus strain BP01. U.S. 

Environmental Protection Agency. Office of Pesticide Programs. Biopesticides and Pollution 

Prevention Division. July 1997. 

U.S. EPA. 2000a. Memorandum from Paul Zubkoff to Diana Horne. PGR-IV BP Foliar File 

Symbol 50136-GEL; MRID 449273-01. U.S. Environmental Protection Agency. Office of 

Pesticide Programs. Biopesticides and Pollution Prevention Division. April 4, 2000. 

U.S. EPA. 2002a. Memorandum from Carl Etsitty to Robyn Rose. BPPD Review the Emetic 

Toxin Absence Submitted by Micro Flo Company, lnc., for Bacillus cereus strain BP01 

(Submission No.: S599536; DP Barcode: D277357; MRID 453823-01). U.S. Environmental 

Protection Agency. Office of Pesticide Programs. Biopesticides and Pollution Prevention 

Division. September 19, 2002. 

U.S. EPA. 2002b. Data Evaluation Report (DER). Honey Bee Acute Contact Toxicity (OPPTS 

850.3020). MRID 453823-02. Primary Review by Anthony Armstrong and Patricia Reno, Oak 

Ridge National Laboratory and Susanne Cerrelli, U.S. EPA. Secondary Review by Zigfridas 

Vaitusis, U.S. EPA. U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. October 17, 2002. 

Registration Notices 

U.S. EPA. 1997f. Notice of Pesticide Registration. Bacillus cereus BP01. EPA Reg. No. 

51036-282. U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. July 30, 1997. NOTE: This is now EPA Reg. 

No. 66330-274. 
Bacillus cereus strain BP01 EPA-HQ-OPP-2011-0493 

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U.S. EPA. 1997g. Notice of Pesticide Registration. Mepichlor/BP01 4-2. EPA Reg. No. 

51036-283. U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. July 30, 1997. Note: This is now EPA Reg. 

No. 66330-351. 

U.S. EPA. 1998b. Notice of Pesticide Registration. MepPlusTM Concentrate. EPA Reg. No. 

51036-299. U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. April 17, 1998. NOTE: This is now EPA Reg. 

No. 66330-280. 

U.S. EPA. 1998c. Notice of Pesticide Registration. Bacillus cereus BP01 1.7. EPA Reg. No. 

51036-301. U.S. Environmental Protection Agency. Office of Pesticide Programs. 

Biopesticides and Pollution Prevention Division. May 12, 1998. NOTE: This is now EPA Reg. 

No. 66330-282. 

U.S. EPA. 1999a. Notice of Pesticide Registration. MepPlus Pill. EPA Reg. No. 51036-306. 

U.S. Environmental Protection Agency. Office of Pesticide Programs. Biopesticides and 

Pollution Prevention Division. January 20, 1999. NOTE: This is now EPA Reg. No. 66330-285. 

U.S. EPA. 2000b. Notice of Pesticide Registration. PGR-IV/BP Foliar. EPA Reg. No. 51036-

325. U.S. Environmental Protection Agency. Office of Pesticide Programs. Biopesticides and 

Pollution Prevention Division. October 5, 2000. NOTE: This is now EPA Reg. No. 66330-291. 

U.S. EPA. 2010a. Notice of Pesticide Registration. ARY 0494-006. EPA Reg. No. 66330-393. 

U.S. Environmental Protection Agency. Office of Pesticide Programs. Biopesticides and 

Pollution Prevention Division. March 18, 2010. 

 

Other Information 

FAO and WHO. 2010. Codex Alimentarius. United Nations Food and Agriculture Organization 

& World Health Organization. Information retrieved on June 9, 2011. 

http://www.codexalimentarius.net/mrls/pestdes/jsp/pest_q-e.jsp 

LA DPH. 2004. Infectious Disease Control Manual: Bacillus Cereus Toxi-Infection. Louisiana 

Department of Health and Hospitals. Louisiana Office of Public Health. Infectious Disease 

Epidemiology Section. Information retrieved on June 15, 2011. 

http://www.dhh.louisiana.gov/offices/miscdocs/docs-249/Manual/BacillusCereusManual.pdf 

SRA. 1997b. Letter from Frederick T. Smith, Regulatory Scientist SRA International, Inc. to 

James Boland, Regulatory Action Leader U.S. EPA Office of Pesticide Program. "Bacillus 

cereus BP01 Technical (Reg. No. 51036-282), September 19, 1997. 

Todar, Kenneth. 2008. Todar’s Online Textbook of Bacteriology. University of Wisconsin. 

Information retrieved on June 8, 2011. http://www.textbookofbacteriology.net/B.cereus.html. 

 
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APPENDIX A: Federal Register Notices Related to the Tolerance Exemption 

Table A-1. Federal Register Notices for Bacillus cereus strain Exemptions from the 

Requirement of Tolerance 

Federal Register 

Citation What Was Published 

62 FR 12999 

March 19, 1997 

A Notice of Receipt to register two products containing the new active ingredient 

B. cereus strain BP01: Micro Flo Company’s 51036-EIE and -EIG. 

Note: these were later transferred to Arysta Lifescience North America, with the 

registrations becoming 66330-274 and -351, respectively. 

62 FR 34277 

June 25, 1997 

A Notice of Filing of Micro Flo Company ‘s pesticide petition (PP 7F4801) 

proposing the establishment of an exemption from the requirement of a tolerance 

for residues of B. cereus BP01. 

62 FR 41874 

August 4, 1997 

The Final Rule establishing an exemption from tolerance for residues of the 

microbial plant regulator Bacillus cereus strain BP01 in or on cottonseed; it was 

codified at 40 CFR 180.1181 and read: 

“§180.1181 Bacillus cereus strain BP01;exemption from the requirement of a 

tolerance. An exemption from the requirement of a tolerance is established for 

residues of the microbial plant regulator Bacillus cereus strain BPO1 in or on 

cottonseed.” 

66 FR 58481 

November 21, 2001 

A Notice of Filing regarding Micro Flo’s petition (PP 1F6324) to amend the 

tolerance exemption at 40 CFR 180.1181 to include all raw agricultural 

commodities, not just cotton. 

67 FR 70012 

November 20, 2002 

The Final Rule expanding the original tolerance exemption; It reads: “§180.1181 

Bacillus cereus strain BP01; exemption from the requirement of a tolerance. An 

exemption from the requirement of a tolerance for residues of the Bacillus cereus

strain BP01 in or on all raw agricultural commodities when applied/used in 

accordance with label directions.”