### Docket Number E P A-HQ-OPP-2011-0705 

### www.regulations.gov



# Bacillus tlturingiensis
Final Work Plan

Registration Review

Case Number 0247

Bacillus thuringiensis s ub sp

. 

### galleriae s train SDS-502

- PC Code 006399


### Bacillus thuringiensis subsp. 

### israelensis

- PC Co de 00640 I



### Bacillus thuringiensis subsp. 

### kurslaki

- P C Code 006402


### Bacillus thuringiensis subsp. 

### k11rs1aki s train BMP 1 23

- P C Code 006407


### Bacillus thurin giensis subsp. 

### kurslaki s train EG237 I

- PC Code 006423


### Bacillus thuringiensis subsp. 

### kurslaki s tr ain EG2348

- PC Code 006424


### Bacillus thuringiensis subsp. 

### aizawai s train 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 s ubsp. 

### israelensis strain EG22 l 5

- PC Code 006476



### Bacillus thuringiensis subsp. 

### ai::awai strai n N B 200

- PC Code 006494


### Bacillus thuringiensis s ubsp. 

### kurstaki s train SA-12

- PC Code 006518 

### Bacillus thurin giensis s ubsp. 

### kurstaki stra in SA- I I

- PC Code 006519


### Bacillus thuringiensis subsp. 

### isra elensis s tr ain BMP 144

- PC Code 006520


### Bacillus rhuringi e nsis subsp. 

### kursraki strain ABTS-351

- PC Code 006522


### Bacillus th11ringiensis subsp. 

### aizawai s t ra in ABTS-1857

- PC Code 006523


### Bacillus thuringi e nsis subsp

. 

### tenebrionis s train NB- 1 76

- PC Code 006524


### Bacillus thuringiensis s ub s p

. 

### israelensis stra in SUM-62 1 8

- PC Code 006642


### Ba c illus rhuringiensis s ubsp. 

### ku r s taki stra i n VBTS-2546

- PC Code 006699


### Bacillus thurin giensis s ub sp. 

### israelensis s tr a in AM 65-52

- P C Code 069162


### Baci llu s rh11rin giensis s ub s p. 

### israelensis strain SA3A

- PC Code 0692 10

### (\**ob rt**  

## McNally, D i rector**Biop est** **icid es**  

## and Po ll ution Prevention Div i s ion 

# September 2015

Da te:

## 2 I NTRODUCTION

This is the U.S. Environm ental Protection Agency’s (EPA ) Final Work Plan (FWP) for the
R egistration R eview of Bacillus thuringiensis

. This FWP follows the revised Preliminary Work Plan (PWP) posted in the R egistration R evie w docket for Bacillus thuringiensis (EPA

- HQ

- OPP

201 1

- 0 705 ) 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 or namental 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 R egistration R eview program pursuant to Section 3(g) of the Federal Insecticide, Fungici de, 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 sc ience, public policy, and pesticide use practices occur over time. The
R egistration R eview 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 sta tutory standard of no unreasonable adverse effects to human health or the environment . The public phase of R egistration R eview begins when the initial docket is opened for each case. Informatio n 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 th e estimated timeline identified in the revised PWP

, and a summary of the EPA’s response s to th o se
comments

. This section is followed by the planned data needs, risk assessments expected to be conducted , and the projected R egistration R eview timeline for Ba cillus 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 (C BD ).

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 R egistration R eview 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

co ncern 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 R egistration R eview.

The EPA has reviewed the comments from the CBD on the R egistration R eview 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 li sted 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 R egistration R eview decision for Bacillu s 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 NA S report 2 

## 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 Resear ch 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 stakehol der 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 detai ls 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 suppo rting this FWP for Bacillus thuringiensis does not describe the specific ESA analysis, including effects determinations for specific listed species or designated cr itical habitat, to be conducted during R egistration R eview.

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 dev eloped 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 p art of completing this R egistration R eview.

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.

PL ANNED 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 as sociated 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 R egistration R eview, the EPA will (1) conduct an endangered species assessment for all uses of Bacillus thuringiensis ; (2) re vise/update the product analysis, human health, and environmental risk assessment s for Bacillus thuringiensis ; and (3) determine whether , pursuant to Se ction 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, t he 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 R egistration
R eview for Bacillus thuringiensis

.

Registration Review for Bacillus thuringiensis

– Projected Registration Review Timeline

Activities Estimated Month/Year Opening the Docket Open Docket and 60

- D ay 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 (2 nd 

## Time for Revised PWP) September 2014

– Completed



## Close Public Comment Period November 2014

– Completed 

## Case Development
Issue Final Work Plan September 2015

– Completed


## Issue D ata Call

- in September 2016 

## Data Submission January 2018 

## Open 30

- D ay Public Comment Period for Draft Risk Assessments July 2019 

## Close Public Comment Period August 2019 

## Registration Review Decision Open 60

- D ay Public Comment Period for Proposed Registration Review Final D ecision December 2019



## Close Public C omment P eriod February 2020 

## Registration Review Final D ecision and Begin P ost

- D ecision F ollow

- U p March 2020 

## Total ( years ) *

~ 8.5 * This schedule is subject to revision should unforeseen issues arise during the Registration R eview 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 F WP 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 s tudies for Bacillus thuringiensis through a data call

- in, expected to be issued in September 2016

.