Docket Number EPA-HQ-OPP-2011-0705 

www.regulations.gov 

Bacillus tlturingiensis 

Final Work Plan 

Registration Review 

Case Number 0247 

Bacillus thuringiensis subsp. galleriae strain SDS-502 - PC Code 006399 

Bacillus thuringiensis subsp. israelensis - PC Code 00640 I 

Bacillus thuringiensis subsp. kurslaki - PC Code 006402 

Bacillus thuringiensis subsp. k11rs1aki strain BMP 123 - PC Code 006407 

Bacillus thuringiensis subsp. kurslaki strain EG237 I - PC Code 006423 

Bacillus thuringiensis subsp. kurslaki strain EG2348 - PC Code 006424 

Bacillus thuringiensis subsp. aizawai strain GC-91 - PC Code 006426 

Bacillus thuringiensis subsp. kurstaki strain EG784 I - PC Code 006453 

Bacillus thuringiensis subsp. kurstaki strain EG7826 - PC Code 006459 

Bacillus thuringiensis subsp. israelensis strain EG22 l 5 - PC Code 006476 

Bacillus thuringiensis subsp. ai::awai strain NB200 - PC Code 006494 

Bacillus thuringiensis subsp. kurstaki strain SA-12 - PC Code 006518 

Bacillus thuringiensis subsp. kurstaki strain SA- I I - PC Code 006519 

Bacillus thuringiensis subsp. israelensis strain BMP 144 - PC Code 006520 

Bacillus rhuringiensis subsp. kursraki strain ABTS-351 - PC Code 006522 

Bacillus th11ringiensis subsp. aizawai strain ABTS-1857 - PC Code 006523 

Bacillus thuringiensis subsp. tenebrionis strain NB- 176 - PC Code 006524 

Bacillus thuringiensis subsp. israelensis strain SUM-62 18 - PC Code 006642 

Bacillus rhuringiensis subsp. kurstaki strain VBTS-2546 - PC Code 006699 

Bacillus thuringiensis subsp. israelensis strain AM 65-52 - PC Code 069162 

Bacillus rh11ringiensis subsp. israelensis strain SA3A - PC Code 0692 10 

(\ ob rt McNally, Director 

Biopesticid es and Pollution 

Prevention Division 

September 2015 

Date: 
2

INTRODUCTION

This is the U.S. Environmental Protection Agency’s (EPA) Final Work Plan (FWP) for the 

Registration Review of Bacillus thuringiensis. This FWP follows the revised Preliminary Work 

Plan (PWP) posted in the Registration Review docket for Bacillus thuringiensis (EPA-HQ-OPP2011-0705) on September 24, 2014. Bacillus thuringiensis is an active ingredient in pesticide 

products that are registered for use on field-, greenhouse-, and water-grown crops; outdoor and 

greenhouse-grown ornamental and nursery crops; seed; forested areas; food and nonfood storage 

containers, buildings, and transport vehicles; and/or standing water to control insects of the 

orders Coleoptera, Lepidoptera, or Diptera.

The EPA is implementing the Registration Review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

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

registration. Changes in science, public policy, and pesticide use practices occur over time. 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 to human health or the environment. The public 

phase of Registration Review begins when the initial docket is opened for each case. Information 

on this program is provided on the EPA’s website.

1

The FWP begins with any updates since the revised PWP was issued. Next, it provides a

summary of substantive comments received, if any, during the public comment period for the

revised PWP concerning anticipated data needs, expected risk assessments, or the estimated 

timeline identified in the revised PWP, and a summary of the EPA’s responses to those 

comments. This section is followed by the planned data needs, risk assessments expected to be 

conducted, and the projected Registration Review timeline for Bacillus thuringiensis. Lastly, 

there is a discussion of next steps.

UPDATES SINCE THE REVISED PWP WAS ISSUED

There are no updates for Bacillus thuringiensis since the revised PWP.

SUMMARY OF COMMENTS AND THE EPA’S RESPONSES

During the 60-day public comment period on the Bacillus thuringiensis revised PWP, which 

opened on September 24, 2014, and closed on November 24, 2014, the EPA received two public 

comments: one from the FIFRA Endangered Species Task Force (FESTF) and one from the 

Center for Biological Diversity (CBD).

The EPA received the FESTF’s comment, which was a letter dated November 20, 2014, through 

www.regulations.gov. The FESTF letter expresses concern about data compensation issues 

related to any future endangered species assessments. The EPA will take note of the information 

provided in the letter while conducting this Registration Review.

 1 See http://www2.epa.gov/pesticide-reevaluation.
3

The CBD’s comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife 

Service and the National Marine Fisheries Service (the Services) on the Registration Review of 

Bacillus thuringiensis in accordance with the Endangered Species Act (ESA). The CBD’s

comments mention various aspects of the risk assessment process, including use of the best 

available data to develop endangered species risk assessments, and evaluation of effects on 

endangered and threatened species and their designated critical habitat. The CBD also expresses 

concern regarding the rigor of the EPA’s preliminary determinations regarding the effects of 

Bacillus thuringiensis on endangered and threatened (listed) species and their designated critical 

habitat for the Bacillus thuringiensis Registration Review.

 

The EPA has reviewed the comments from the CBD on the Registration Review docket opening 

for Bacillus thuringiensis and plans to address many of the concerns raised by the CBD as part of 

the implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations of the April 2013 National Academy of Sciences (NAS) report. The EPA will 

address concerns specific to Bacillus thuringiensis in connection with the development of its 

final Registration Review decision for Bacillus thuringiensis.

In November 2013, the EPA, along with the Services and the U.S. Department of Agriculture 

(USDA), released a summary of their joint Interim Approaches for assessing risks to endangered 

and threatened (listed) species from pesticides. The Interim Approaches were developed jointly 

by the agencies in response to the NAS’ recommendations and reflect a common approach to 

risk assessment shared by the agencies as a way of addressing scientific differences between the 

EPA and the Services. The NAS report2 outlines recommendations on specific scientific and 

technical issues related to the development of pesticide risk assessments that the EPA and the 

Services must conduct in connection with their obligations under the ESA and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 

15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 

Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and 

Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April 

and October 2014, allowing additional opportunities for stakeholders to comment on the Interim 

Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a 

phased, iterative process for developing the Interim Approaches, the agencies will also consider 

public comments on the Interim Approaches in connection with the development of upcoming 

Registration Review decisions. The details of the joint Interim Approaches are contained in the 

white paper “Interim Approaches for National-Level Pesticide Endangered Species Act 

Assessments Based on the Recommendations of the National Academy of Sciences April 2013 

Report,” dated November 1, 2013.3

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

designated critical habitat, the ecological problem formulation supporting this FWP for Bacillus 

thuringiensis does not describe the specific ESA analysis, including effects determinations for 

specific listed species or designated critical habitat, to be conducted during Registration Review.

 2 http://www.nap.edu/catalog.php?record_id=18344 3 http://www.epa.gov/espp/2013/nas.html
4

Once the agencies have fully developed and implemented the scientific methods necessary to 

complete risk assessments for endangered and threatened (listed) species and their designated 

critical habitats, these methods will be applied to subsequent analyses for Bacillus thuringiensis

as part of completing this Registration Review.

In the revised PWP, the EPA also solicited comments on the specific topics of environmental 

justice, water quality concerns, and trade irritants, but no comments or information were received 

on those issues.

PLANNED DATA NEEDS

The table below summarizes the current planned data needs for Bacillus thuringiensis based on 

the EPA’s risk assessment memoranda and other references associated with Bacillus 

thuringiensis.

4 The planned data needs have not changed from what was included in the revised 

PWP.

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

Bacillus thuringiensis subspecies israelensis strain EG2215 (PC Code 006476)

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

885.1200 Manufacturing Process TGAI & MP 8 months

885.1250 Deposition of a Sample in a Nationally Recognized Culture 

Collection TGAI 8 months

885.1300 Discussion of Formation of Unintentional Ingredients TGAI & MP 8 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain BMP 144 (PC Code 006520)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

 4 See Appendix VIII (“Bibliography”) of the Bacillus thuringiensis revised PWP.
5

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain AM 65-52 (PC Code 069162)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain SA3A (PC Code 069210)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months
6

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months

885.4280 Estuarine and Marine Fish/Invertebrate Testing TGAI 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months
7

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

Bacillus thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

Bacillus thuringiensis subspecies kurstaki strain EG7826 (PC Code 006459)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain SA-12 (PC Code 006518)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months
8

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain SA-11 (PC Code 006519)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain ABTS-351 (PC Code 006522)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months
9

Planned Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized 

Guideline 

Number

Study Title Test 

Material

Estimated 

Timeframe

(Months from 

Receipt of DCI)

885.1400 Analysis of Samples TGAI & MP 8 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies aizawai strain NB200 (PC Code 006494)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

Bacillus thuringiensis subspecies aizawai strain ABTS-1857 (PC Code 006523)

830.6317 Storage Stability TGAI & MP 16 months

Bacillus thuringiensis subspecies tenebrionis strain NB-176 (PC Code 006524)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal 

Ions TGAI 8 months

TGAI = technical grade of the active ingredient, MP = manufacturing-use pesticide product, TEP = typical end-use pesticide 

product

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During Registration Review, the EPA will (1) conduct an endangered species assessment for all 

uses of Bacillus thuringiensis; (2) revise/update the product analysis, human health, and 

environmental risk assessments for Bacillus thuringiensis; and (3) determine whether, pursuant 

to Section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act, Bacillus thuringiensis

qualifies for exemption from the Endocrine Disruptor Screening Program (EDSP). The EPA 

believes that Bacillus thuringiensis is likely not an endocrine disruptor; as such, the EPA may 

exempt it from the EDSP (if exempted, an order will be issued).
10

TIMELINE

The EPA has created the following estimated timeline for the completion of the Registration

Review for Bacillus thuringiensis.

Registration Review for Bacillus thuringiensis – Projected Registration Review Timeline

Activities Estimated Month/Year

Opening the Docket

Open Docket and 60-Day Public Comment Period for Bacillus thuringiensis September 2011 – Completed

Close Public Comment Period November 2011 – Completed

Open Docket and 60-Day Public Comment Period for Bacillus thuringiensis

(2nd Time for Revised PWP)

September 2014 – Completed

Close Public Comment Period November 2014 – Completed 

Case Development

Issue Final Work Plan September 2015 – Completed

Issue Data Call-in September 2016

Data Submission January 2018

Open 30-Day Public Comment Period for Draft Risk Assessments July 2019

Close Public Comment Period August 2019

Registration Review Decision

Open 60-Day Public Comment Period for Proposed Registration Review 

Final Decision December 2019

Close Public Comment Period February 2020

Registration Review Final Decision and Begin Post-Decision Follow-Up March 2020

Total (years)* ~8.5

* This schedule is subject to revision should unforeseen issues arise during the Registration Review process. In the event an 

issue arises, such as the failure to acquire an EDSP exemption, an amended FWP will be issued at that time. That FWP will 

identify any newly planned data needs and set forth a new timeline.

NEXT STEPS

As noted previously, the EPA plans to require several product analysis, toxicology, and nontarget 

organism studies for Bacillus thuringiensis through a data call-in, expected to be issued in 

September 2016.