Bacillus licheniformis strain SB3086 

(PC Code: 006492) 

Preliminary Work Plan and Summary Document 

Registration Review: Initial Docket

March 2014 

Case 6014 

 

Approved by: 

 

Robert McNally, Director 

Biopesticides and 

Pollution Prevention Division 

 Date:

 

 

 

 
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TABLE OF CONTENTS

I. PRELIMINARY WORK PLAN ...................................................................................................... 4 

A. Overview .................................................................................................................................................................. 4 

B. Statutory and Regulatory Authority ..................................................................................................................... 4 

C. Background and Regulatory Information ............................................................................................................ 5 

D. Anticipated Data Needs and Risk Assessments .................................................................................................... 7 

E. Risk to Threatened and Endangered Species ..................................................................................................... 10 

F. Endocrine Effects .................................................................................................................................................. 10 

G. Incidents ................................................................................................................................................................ 11 

H. Timeline ................................................................................................................................................................. 11 

I. Guidance for Commenters ................................................................................................................................... 11 

J. Next Steps .............................................................................................................................................................. 13 

II. BIBLIOGRAPHY ........................................................................................................................... 14 

A. Studies Supporting Registration Review of Bacillus licheniformis strain SB3086 ......................................... 14 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda ........................................................... 18 

 
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ACRONYMS AND ABBREVIATIONS 

BPPD The EPA’s Biopesticides and Pollution Prevention Division 

CFR Code of Federal Regulations 

DCI Data Call-In 

EDSP Endocrine Disruptor Screening Program 

EPA U.S. Environmental Protection Agency 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

FWP Final Work Plan 

IDS Incident Data System 

MRID No. Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the 

Office of Pesticide Programs. 

MRL Maximum Residue Limit 

OPP The EPA’s Office of Pesticide Programs 

PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. 

PMRA Health Canada’s Pest Management Regulatory Agency 

PWP Preliminary Work Plan 

TGAI Technical grade of the active ingredient 

TMDL Total Maximum Daily Load 

US United States 
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I. PRELIMINARY WORK PLAN 

A. Overview 

The docket for Bacillus licheniformis strain SB3086 (Case 6014) is now open, thereby initiating the first 

public comment period for this Registration Review case (docket number EPA-HQ-OPP-2014-0184). 

Bacillus licheniformis strain SB3086 is currently registered in two products for use as a biofungicide and 

in one product for use as an algaecide. This Preliminary Work Plan (PWP) explains what the U.S. 

Environmental Protection Agency’s (EPA) Office of Pesticide Programs knows about Bacillus 

licheniformis strain SB3086, highlights its anticipated data and assessment needs, identifies types of 

information that would be especially useful in conducting the review, and provides an anticipated 

timeline for completing the Registration Review process for this biopesticide. 

The Registration Review process was designed to include a public participation component and by 

sharing this information in the docket, EPA intends to inform the public of what it knows about Bacillus 

licheniformis strain SB3086 and what types of new data or other information would be helpful to receive 

as the Agency moves toward a decision on Bacillus licheniformis strain SB3086. The EPA encourages 

all interested stakeholders to review the PWP and to provide comments and additional information that 

will help the EPA’s decision-making process for this microbial pesticide. In addition to general areas on 

which persons may wish to comment, there are some areas identified in the PWP about which the EPA 

specifically seeks comments and information. Interested stakeholders could include the following: 

environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity 

groups; commercial, institutional, residential, and other users of pesticides; or the public at large. 

The PWP begins by describing the statutory and regulatory authorities for Registration Review. Next, it 

provides background on Bacillus licheniformis strain SB3086, including a description of its mode of 

action, the currently registered pesticide product, application rates and methods, use sites, and tolerance 

exemption information. Then, it lists the anticipated data needs, risk assessments, and a projected 

Registration Review timeline for this case. Finally, the PWP provides guidance for commenters, explains 

the next steps EPA will be taking, summarizes background information, and lists supporting studies, risk 

assessments, and other documents available for the Registration Review of Bacillus licheniformis strain 

SB3086. 

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

http://www.regulations.gov (under “SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents,” enter the docket identification number, which is indicated above). 

B. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review program. All 

pesticides distributed or sold in the United States (US) must generally be registered by the EPA, 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 to human 

health or the environment. Changes in science, public policy, and pesticide use practices will occur over 

time. Through the Registration Review program, the EPA periodically reevaluates pesticides to make 
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sure that, as change occurs, products in the marketplace can continue to be used safely. Information on 

this program is provided on the EPA’s website.1

 

 

The EPA is implementing 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 regulations governing 

Registration Review begin at 40 C.F.R. § 155.40. The EPA 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 EPA’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 initial 

comment period, the EPA will develop a Final Work Plan (FWP) and the anticipated schedule for the 

Registration Review of Bacillus licheniformis strain SB3086. 

 C. Background and Regulatory Information 

i. Summary of the Active Ingredient, Usage and the Associated Pesticide Product 

Bacillus licheniformis strain SB3086 is registered as a microbial pesticide for use as a fungicide and as 

an algaecide. Bacillus licheniformis strain SB3086 is the active ingredient in Novozymes Biofungicide 

Green Releaf, a microbial fungicide for use on lawns, conifers, tree seedlings, ornamental turf and 

ornamental plants in outdoor, greenhouse, and nursery sites. This product is intended to control dollar 

spot, anthracnose, and other plant diseases. Bacillus licheniformis is a ubiquitous, saprophytic, common 

soil bacterium that contributes to nutrient cycling and displays antifungal activity. While numbers of B. 

licheniformis in soil are unknown and likely vary from soil to soil, the use of B. licheniformis at current 

label rates is not expected to add substantially to the size of the naturally occurring B. licheniformis

populations. The acute toxicity data performed resulted in an overall classification of Toxicity Category 

IV. (U.S. EPA. Biopesticides Registration Action Document: Bacillus licheniformis strain SB3086 (PC 

Code 006492), February 4, 2003). Further information regarding this product appears in Table 2, below. 

Table I provides a summary of the chemical facts for Bacillus licheniformis strain SB3086. 

Table 1. Chemical Facts for Bacillus licheniformis strain SB3086 

PC code 006492 

Case Number 6014 

CAS Number NA 

Year first registered 2003 

Pesticide Type Fungicide/Algaecide 

Chemical class Microbial 

Reregistration Eligibility 

Decision (RED) 

Not applicable. Because it was registered after November 1984, Bacillus 

licheniformis strain SB3086 was not subject to reregistration. 

Tolerance Reassessment 

Eligibility Decision (TRED) 

Not applicable. There are no food uses for this microbial pesticide. 

Cumulative group Not applicable. Bacillus licheniformis strain SB3086 has not been identified as a 

member of a cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation Not applicable. This microbial pesticide is not approved for use on food crops or 

animal feed; hence, the EPA did not issue a tolerance or an exemption from the 

requirement of a tolerance. 

Non-pesticidal uses B. licheniformis is used in laundry detergent and to make the antibiotic Bacitracin. 

 

1

 See http://www.epa.gov/oppsrrd1/registration_review/. 
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TABLE 2. Information About the Currently Registered Bacillus licheniformis strain SB3086 Pesticide Products 

EPA 

Registration 

Number 

Product Name 

(% Active Ingredient; 

Formulation Type)

Date 

Registered Application Rates Application Methods Use Sites 

70127-2 

Novozymes 

Biofungicide GREENRELEAF 710-140 

(0.14% Bacillus 

licheniformis strain 

SB3086; liquid 

formulation, user adds 

water) 

February 4, 

2003 

On grass and golf 

greens, 20 fl. oz. per 

1,000 square feet; 

on plants, 1.3 – 2.6 

fl. oz.; on home 

lawns, 13 fl. oz. per 

500 square feet. 

Foliar spray or soil 

drench 

Lawns, gardens, 

golf courses, 

greenhouses, 

nurseries, sports 

turf, turf farms, 

and arboretums. 

70127-3 

Novozymes 

Biofungicide 145F 

[Alternative Brand 

Name: EcoGuard-GN] 

(1.26% Bacillus 

licheniformis strain 

SB3086; liquid 

formulation, user adds 

water) 

January 17, 

2007 

On ornamental 

plants and in 

greenhouse, 64 oz. 

per 100 gallons of 

water or 0.5 oz. per 

1 gallon of water 

Soil drench: direct spray 

or chemigation 

Ornamental plants: 

greenhouses, 

nurseries, and 

gardens. 

8709-10 

PondCare Micobioal 

Algae Clean (0.0035% 

Bacillus licheniformis

strain SB3086; liquid 

formulation; user 

applies directly to fish 

ponds or water 

gardens) 

October 25, 

2007 

In ornamental fish 

ponds and water 

gardens; 1 tsp. (5 

ml) for each 50 

gallons or 1⁄4 cup (60 

ml) for each 600 

gallons. 

Direct application to fish 

ponds or water gardens. 

Ornamental fish 

ponds and water 

gardens 

ii. Tolerance Actions

Currently, there are no registered products for food use that contain Bacillus licheniformis strain SB3086 

as an active ingredient. Whether it is used as a fungicide to control plant diseases or as an algaecide to 

control green water algae, this microbial pesticide is not to be used on food crops or animal feed, as 

explicitly stated on product labels. The algaecide product referenced above is labeled for use only in 

ornamental ponds and gardens; hence, the fish and plants in the ponds are not allowed to be used for 

food, and treated plants are not to be fed to livestock or domestic animals. Therefore, the EPA did not 

issue a tolerance or an exemption from the requirement of a tolerance for residues of B. licheniformis

strain SB3086 found on or in food and feed. (EPA, BRAD for Bacillus licheniformis strain SB3086, 

2003.) 

 

 
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D. Anticipated Data Needs and Risk Assessments 

Provided below are tables of the current data requirements for microbial pesticides as set forth in 40 

CFR § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health 

assessment, and nontarget organisms and environmental fate), and descriptions are included regarding 

how the data requirements have been fulfilled or where data have been waived. At this time, no data 

gaps (anticipated data needs) for Bacillus licheniformis strain SB3086 have been identified. The most 

recent comprehensive risk assessment for B. licheniformis strain SB3086 was completed September 20, 

2002, in support of the first registration of B. licheniformis strain SB3086, which occurred on February 

4, 2003. Additional data were submitted by a second registrant for the registration of the algaecide 

product in 2007. Because there are no data gaps for Bacillus licheniformis strain SB3086, the Agency 

does not anticipate the need to conduct a new risk assessment during registration review. Nevertheless, 

the EPA plans to conduct a literature search to update its understanding of the current state of the science 

on this pesticide and will consider the need to conduct a new risk assessment depending on the findings. 

Product Chemistry (40 C.F.R. § 158.2120)

TABLE 3. Summary of Product Chemistry Data for Bacillus licheniformis strain SB3086 

Harmonized 

Guideline 

Number 

Data Requirement 

Has Data 

Requirement 

Been 

Addressed? 

How? 

Source MRID/ Accession Number or Other 

Reference 

885.1100 Product Identity Yes; Study U.S. EPA (2002) 

458202-01 

457771-01 

453021-01 

885.1200 Manufacturing Process Yes; Study U.S. EPA (2002) 458202-01 457771-01 

453021-01

885.1250 

Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection 

Yes; ATTC U.S. EPA (2006) 46827401; 

Deposit No. 55405

885.1300 

Discussion of Formation 

of Unintentional 

Ingredients 

Yes; Study U.S. EPA (2002) 458202-01 

453021-01 

885.1400 Analysis of Samples Yes; Study U.S. EPA (2002) 

458202-01 

457771-01 

453678-01 

453021-01 

885.1500 Certification of Limits Yes; Study U.S. EPA (2002) 

458202-01 

457771-01 

453021-01 

 
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TABLE 4. Summary of Physical and Chemical Characteristics for Bacillus licheniformis strain SB3086 

Harmonized 

Guideline 

Number 

Data Requirement 

Has Data 

Requirement 

Been 

Addressed? 

How? 

Source MRID/ Accession Number or 

Other Reference 

830.6302 Color Yes; Study U.S. EPA (1994) 433370-04 

830.6303 Physical State Yes; Study U.S. EPA (2002) 453021-02 

830.6304 Odor Yes; Study U.S. EPA (2002) 453021-02 

830.6317 Storage Stability Yes; Study U.S. EPA (2002) 453021-02

830.6319 Miscibility Yes; Study U.S. EPA (2002) 453021-02 

830.6320 Corrosion 

Characteristics 

Yes; Study U.S. EPA (2002) 453021-02

830.7000 pH Yes; Study U.S. EPA (2002) 453021-02

830.7100 Viscosity Yes; Study U.S. EPA (2002) 453021-02 

830.7300 Denisty/relative 

density/bulk density Yes; Study U.S. EPA (2002) 453021-02 

Toxicology (40 C.F.R. § 158.2050) 

TABLE 5. Summary of Toxicology Data for Bacillus licheniformis strain SB3086 

Harmonized 

Guideline 

Number 

Data Requirement 

Has Data 

Requirement 

Been Addressed? 

How? 

Source MRID/ Accession Number or 

Other Reference 

885.3050 Acute Oral Toxicity/ 

Pathogenicity Yes, Study U.S. EPA (2002) 456017-01 

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity Yes; Study U.S. EPA (2002) 456017-04 

885.3200 Acute Intravenous 

Toxicity/ Pathogenicity Yes; Study U.S. EPA (2002) 456017-02 

885.3400 Hypersensitivity 

Incidents 

Any future hypersensitivity incidents should be reported per OCSPP Guideline 

885.3400. 

885.3500 Cell Culture Not applicable. 

 870.1100 Acute Oral Toxicity Yes; Study U.S. EPA (2002) 453021-05
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TABLE 5. Summary of Toxicology Data for Bacillus licheniformis strain SB3086 

Harmonized 

Guideline 

Number 

Data Requirement 

Has Data 

Requirement 

Been Addressed? 

How? 

Source MRID/ Accession Number or 

Other Reference 

870.1200 Acute Dermal Toxicity Yes; Study U.S. EPA (2002) 456488-01 

870.1300 Acute Inhalation 

Toxicity Yes; Study U.S. EPA (2002) 456017-03 

870.2400 Acute Eye Irritation Yes; Study U.S. EPA (2002) 456-17-04 

870.2500 Primary Dermal 

Irritation Yes; Study U.S. EPA (2002) 456017-06 

Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060) 

TABLE 6. Summary of Nontarget Organisms Data for Bacillus licheniformis strain SB3086 

Harmonized 

Guideline 

Number 

Data Requirement 

Has Data Requirement 

Been Addressed? 

How? 

Source 

MRID/Accession 

Number or Other 

Reference 

885.4050 Avian Oral Toxicity Yes; Study U.S. EPA (2002) 45302106 

885.4100 Avian Inhalation 

Toxicity/Pathogenicity 

The nature of the microbial pesticide does not indicate potential 

pathogenicity to birds. (EPA BRAD, 2003.) 

885.4150 Wild Mammal Toxicity/ 

Pathogenicity 

Not applicable: No testing expected to be required. Results of the Tier 1 

toxicity tests required by 40 CFR § 158.2140 (Table 5) are adequate and 

appropriate for assessment of hazards. 

885.4200 Freshwater Fish Toxicity/ 

Pathogenicity Yes; Study U.S. EPA (2002) 45302107 45602501

885.4240 Freshwater Invertebrate 

Toxicity/ Pathogenicity Yes; Study U.S. EPA (2002)

45367802 

45602501

885.4280 Estuarine And Marine 

Invertebrate Testing 

Yes; Data waiver based 

on scientific rationale U.S. EPA (2002) None 

885.4300 Nontarget plant 

Testing 

Yes; Data waiver based 

on scientific rationale U.S. EPA (2002) 455771-01 

885.4340 Nontarget insect testing Yes; Data waiver based 

on scientific rationale U.S. EPA (2002) None 

885.4380 Honey bee testing Yes; Study U.S. EPA (2002) 45302108 

 
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E. Risk to Threatened and Endangered Species

Bacillus licheniformis strain SB3086 is a ubiquitous soil bacterium that contributes to nutrient cycling 

and displays antifungal activity. While numbers of B. licheniformis in soil are unknown and likely vary 

from soil to soil, the use of B. licheniformis at current label rates is not expected to add substantially to 

the size of naturally occurring B. licheniformis populations. Data submitted, either as studies or as 

scientific rationale in support of the ecological risk assessment at the time of registration, demonstrated 

that adverse effects to terrestrial and aquatic nontarget organisms are not expected. The EPA anticipates 

no effects to federally-listed threatened or endangered species; however, the EPA plans to conduct a 

literature search to determine whether any additional nontarget effects of Bacillus licheniformis may 

have been reported since they were previously assessed at the time of registration. Based on the data 

submitted to support the registrations and additional findings from the literature, if any, the EPA will 

conduct an assessment and make a determination on potential effects to listed species and designated 

critical habitat during Registration Review. 

F. Endocrine Effects 

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408(p), the 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, the EPA issued test orders/data call-ins for the first group of 

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 2013,2

 and includes some pesticides 

scheduled for registration review and chemicals found in water. Bacillus licheniformis strain SB3086 is 

not among the group of pesticide active ingredients on the lists to be screened under the EDSP. 

The EPA, as part of this Preliminary Work Plan, believes that Bacillus licheniformis strain SB3086 is a 

substance that would not likely produce any effect in humans similar to an effect produced by a 

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

determine in the future whether it can exempt B. licheniformis strain SB3086 from the requirements of 

the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance from the EDSP, 

an order will be issued. 

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

future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

http://www.epa.gov/endo/. 

 

 

2

 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the second list of chemicals. 
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 G. Incidents

From February 1, 2003 through March 1, 2014, the Office of Pesticide Programs’ Incident Data System 

(IDS) and Ecological Incident Information System indicate that there was one report of an adverse 

domestic animal incident for one of the pesticide products containing Bacillus licheniformis strain 

SB3086 as its active ingredient. The incident, which involved Algae Destroyer Advanced, was reported 

by Mars Fishcare in July 2010.The EPA will consider any additional incident data or comments 

submitted in response to this Preliminary Work Plan. 

H. Timeline 

Below is the projected timeline for Registration Review case 6014: Bacillus licheniformis strain 

SB3086. 

Activities Estimated Month/Year 

 Opening the Docket 

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

strain SB3086 

March 2014 

 Close Public Comment Period May 2014 

 Case Development 

 Issue Final Work Plan July 2014 

 Issue Data Call-in N/A 

 Data Submission N/A 

 Open 30-Day Public Comment Period for Draft Risk Assessments N/A 

 Close Public Comment Period N/A 

 Registration Review Decision 

 Open 60-Day Public Comment Period for Proposed Registration Review 

 Decision 

January 2015 

 Close Public Comment Period March 2015 

 Final Decision May 2015 

*Estimated Total (years) 1 year and 2 months 

* This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event that

an issue arises, such as the failure to acquire an EDSP exemption or the need to further analyze ecological risk based on an 

updated literature review, then the EPA would issue an amended Final Work Plan. That Final Work Plan would identify any 

newly anticipated data needs and set forth a new timeline. 

I. Guidance for Commenters

 

The public is invited to comment on the EPA’s Preliminary Work Plan and rationale. The areas below 

highlight topics of special interest to the EPA where comments, information and data, or reference to 

sources of additional information could be of particular use. The EPA 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 this case. 
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i. Environmental Justice 

The 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 EPA seeks information on any groups or segments of the population who, as a result of 

their location, cultural practices, or other factors, may have unusually high exposure to the pesticidal use 

of Bacillus licheniformis strain SB3086 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. 

ii. Water Quality 

 

Bacillus licheniformis strain SB3086 is not identified as a cause of impairment for any water bodies 

listed as impaired under section 303(d) of the Clean Water Act.3 In addition, no Total Maximum Daily 

Loads (TMDLs) have been developed for Bacillus licheniformis strain SB3086.4

 More information on 

impaired water bodies and TMDLs can be found at the EPA’s website.5 The EPA 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 Process6 to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments. 

iii. Trade Irritants 

Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to 

the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize 

tolerance and international Maximum Residue Limits (MRLs) and, if necessary, may modify tolerance 

levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, 

providing as much specificity as possible regarding the nature of the concern. 

Pesticidal food-use is not allowed, as explicitly stated on product labels, and there is no approved 

tolerance or exemption from the requirement of a tolerance for residues of this pesticide found in or on 

food or animal feed. Moreover, there are no known MRLs for Bacillus licheniformis strain SB3086. 

Therefore, the EPA does not anticipate that current uses of Bacillus licheniformis strain SB3086 will 

pose concerns as trade irritants. 

iv. Additional Information 

 

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

refining the risk assessments. The EPA is interested in obtaining the following information regarding 

Bacillus licheniformis strain SB3086: 

 Additional incident data. 

 

3

 Based on information provided at http://www.epa.gov/owow/tmdl/. 4 Based on information provided at http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_search_form. 5 See http://www.epa.gov/owow/tmdl/. 6

 This document can be found at http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm. 
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 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 (e.g., acreage and geographical distribution of relevant use 

sites) 

 Median and 90th percentile reported use rates (lbs active ingredient/1,000 square feet) from 

usage data – national, state, and county 

 Application timing (date of first application and application intervals) – national, state, and 

county 

 Usage/use information for nonagricultural uses 

 Typical application interval (days) 

 State or local use restrictions 

 Monitoring data 

 J. Next Steps 

 

After the 60-day comment period closes, the EPA will review and respond to any comments received in 

a timely manner and then issue a Final Work Plan for case 6014: Bacillus licheniformis strain SB3086. 

 
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II. BIBLIOGRAPHY 

A. Studies Supporting Registration Review of Bacillus licheniformis strain SB3086 

MRID 

Number Citation

5302100 Sybron Chemicals, Inc. (2000) Submission of Product Chemistry and Toxicity Data in 

Support of the Application for Registration of Sybron Biofungicide Green Releaf 710-

140. Transmittal of 8 Studies. 

45302101 Jellinek, Schwartz & Connolly, Inc. (2000) Product Analysis for Sybron Biofungicide 

Green Releaf 710-140. Unpublished study. 67 p. 

45302102 Jellinek, Schwartz and Connolly, Inc. (2000) Product Chemistry: Physical and Chemical 

Properties of Sybron Biofungicide Green Releaf 710-140: Final Report. Unpublished 

study. 5 p. 

45302103 Mega, W. (2000) Acute Toxicity (Limit) Testing of 710-132 Following Acute Oral 

Challenge in Rats: Lab Project Number: 1222 SN1. Unpublished study prepared by IIT 

Research Institute. 29 p. {OPPTS 885.3050} 

45302104 Sullivan, D. (2000) Acute Inhalation Toxicity Study (Limits Test) of 710-132 in Rats: 

Lab Project Number: 1222 SN2. Unpublished study prepared by IIT Research Institute. 

27 p. {OPPTS 885.3150} 

45302105 Mega, W. (2000) Acute Toxicity (Limit) Testing of 710-140 Following Acute Oral 

Challenge in Rats: Lab Project Number: 1222 SN6. Unpublished study prepared by IIT 

Research Institute. 30 p. {OPPTS 885.3050} 

45302106 Gallagher, S.; Grimes, J.; Beavers, J. (2000) 710-132: An Avian Oral Pathogenicity and 

Toxicity Study in the Mallard: Final Report: Lab Project Number: 511-101. Unpublished 

study prepared by Wildlife International, Ltd. 33 p. {OPPTS 885.4050} 

45302107 Drottar, K.; Kruegar, H. (2000) 710-132: A Five Concentration Toxicity and 

Pathogenicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report: Lab 

Project Number: 511A-101. Unpublished study prepared by Wildlife International, Ltd. 

38 p. {OPPTS 885.4200} 

45302108 Maggi, V. (2000) Evaluation of the Dietary Effect(s) of 710-132 on Honey Bee Larvae 

(Apis mellifera L.): Lab Project Number: CAR 106-00. Unpublished study prepared by 

California Agricultural Research, Inc. 49 p. {OPPTS 885.4380} 

45350200 Syborn Chemicals Inc. (2000) Submission of Efficacy and Toxicity Data in Support of 

the Application for Registration of Syborn Biofungicide Green Releaf 710-140. 

Transmittal of 4 Studies. 

45350201 Findlay, J. (2000) Acute Eye Irritation Study of 710-132 in Rabbits: Final Report: Lab 

Project Number: 1222 SN3: 1222. Unpublished study prepared by IIT Research 

Institute. 23 p. {OPPTS 870.2400} 

45350202 Findlay, J. (2000) Acute Dermal Irritation Study of 710-132 in Rabbits: Final Report: 

Lab Project Number: 1222 SN4: 1222. Unpublished study prepared by IIT Research 

Institute. 25 p. {OPPTS 870.2500} 
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45350203 Findlay, J. (2000) Skin Sensitization Study of 710-132 in Guinea Pigs Using the 

Modified Buehler Method: Final Report: Lab Project Number: 1222 SN5. Unpublished 

study prepared by IIT Research Institute. 28 p. {OPPTS 870.2600} 

45350204 Hilaski, R. (2000) An Acute Pulmonary Toxicity/Pathogenicity Study of Bacillus 

licheniformis SB 3086 in Rats: Lab Project Number: 858-001. Unpublished study 

prepared by MPI Research, Inc. 131 p. 

45367800 Sybron Chemicals, Inc. (2001) Submission of Product Chemistry and Toxicity Data in 

Support of the Application for Registration of Sybron Biofungicide Green Releaf 710-

140. Transmittal of 2 Studies. 

45367801 Drahos, D. (2001) Product Analysis for Sybron Biofungicide Green Releaf 710-140 

Support Information to MRID 45302101. Unpublished study prepared by Sybron 

Chemicals, Inc. 8 p. 

45367802 Cherry, D.; Soucek, D.; Hull, M. (2001) Chronic 21-Day Renewal Toxicity Responses 

with Daphnia magna to a Biofungicide from Sybron Chemicals, Inc. Unpublished study 

prepared by Virginia Polytechnic and State University. 135 p. {OPPTS 885.4200} 

45519000 Novozymes Biologicals, Inc. (2001) Submission of Product Chemistry Data in Support 

of the Application for Registration of Novozymes Biofungicide Green Releaf 710-140. 

Transmittal of 1 Study. 

45519001 Novozymes Biologicals, Inc. (2001) Additional Product Chemistry Support Data 

Novozymes Biological Green Releaf 710-140. Unpublished study. 13 p. 

45539000 Novozymes Biologicals, Inc. (2001) Submission of Toxicity, Environmental Fate, 

Product Chemistry, Risk and Exposure Data in Support of the Registration of 

Novozymes Biofungicide Green Releaf 710-140. Transmittal of 3 Studies. 

45539001 Habig, C. (2001) Overview of Toxicity and Pathogenicity Data for Novozymes 

Biofungicide Green Releaf 710-140: Lab Project Number: BACILLUS 

LICHENIFORMIS 01-02. Unpublished study prepared by Novigen Sciences, Inc. 36 p. 

45539002 Messina, J. (2001) Registration Support Document for Novozymes Biofungicide Green 

Releaf 710-140: Lab Project Number: BACILLUS LICHENIFORMIS 0101. 

Unpublished study prepared by Novigen Sciences, Inc. 44 p. 

45539003 Habig, C. (2001) Compilation of Supporting Literature References for Novozymes 

Biofungicide Green Releaf 710-140: Lab Project Number: BACILLUS 

LICHENIFORMIS 01-03. Unpublished study prepared by Novigen Sciences, Inc. 231 p. 

45577100 Novozymes Biologicals, Inc. (2002) Submission of Environmental Fate Data in Support 

of the Application for Registration of Novozymes Biofungicides Green Releaf. 

Transmittal of 1 Study. 

45577101 Messina, J. (2002) Compilation of Ecotoxicology Supporting Literature References for 

Novozymes Biofungicide Green Releaf: Lab Project Number: BACILLUS 

LICHENIFORMIS 01-04. Unpublished study prepared by Novigen Sciences, Inc. 63 p. 
Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 

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45601700 Novigen Sciences, Inc. (2002) Submission of Toxicity Data in Support of the 

Application for Registration of Novozymes Biofungicide Green Releaf. Transmittal of 6 

Studies. 

45601701 Kuhn, J. (2002) Acute Oral Toxicity/Pathogenicity Study in Rats with a Microbial Pest 

Control Agent (MPCA): (Novozymes Biofungicide Green Releaf): Final Report: Lab 

Project Number: 6633-01. Unpublished study prepared by Stillmeadow, Inc. 44 p. 

{OPPTS 885.3050} 

45601702 Kuhn, J. (2002) Acute Injection Toxicity/Pathogenicity Study in Rats with a Microbial 

Pest Control Agent (MPCA): (Novozymes Biofungicide Green Releaf): Final Report: 

Lab Project Number: 6634-01. Unpublished study prepared by Stillmeadow, Inc. 46 p. 

{OPPTS 885.3200} 

45601703 Carter, L. (2001) Acute Inhalation Toxicity Study in Rats: (Novozymes Biofungicide 

Green Releaf): Final Report: Lab Project Number: 6412-01. Unpublished study prepared 

by Stillmeadow, Inc. 21 p. {OPPTS 870.1300} 

45601704 Kuhn, J. (2001) Acute Eye Irritation Study in Rabbits: (Novozymes Biofungicide Green 

Releaf): Final Report: Lab Project Number: 6413-01. Unpublished study prepared by 

Stillmeadow, Inc. 17 p. {OPPTS 870.2400} 

45601705 Kuhn, J. (2001) Acute Dermal Irritation Study in Rabbits: (Novozymes Biofungicide 

Green Releaf): Final Report: Lab Project Number: 6414-01. Unpublished study prepared 

by Stillmeadow, Inc. 13 p. {OPPTS 870.2500} 

45601706 Kuhn, J. (2001) Skin Sensitization Study in Guinea Pigs: (Novozymes Biofungicide 

Green Releaf): Final Report: Lab Project Number: 6415-01. Unpublished study prepared 

by Stillmeadow, Inc. 18 p. {OPPTS 870.2600} 

45602500 Novozymes Biologicals, Inc. (2002) Submission of Environmental Fate Data in Support 

of the Application for Registration of Novozymes Biofungicide Green Releaf. 

Transmittal of 1 Study. 

45602501 Habig, C. (2002) Addendum to: A Five-Concentration Toxicity and Pathogenicity Test 

with the Rainbow Trout (MRID 453020107) and Chronic 21-Day Renewal Toxicity 

Responses with Daphnia magna (MRID 45367802) Conducted with Bacillus 

licheniformis SB3086, Novozymes Biofungicide Green Releaf 710-140. Unpublished 

study prepared by Novigen Sciences, Inc. 9 p. {OPPTS 885.4200} 

45648800 Novozymes Biologicals, Inc. (2002) Submission of Toxicity Data in Support of the 

Registration of Novozymes Biofungicide Green Releaf 710-140. Transmittal of 1 Study. 

45648801 Kuhn, J. (2002) Acute Dermal Toxicity Study in Rabbits: (Novozymes Biofungicide 

Green Releaf) 710-140: Final Report: Lab Project Number: 6797-01. Unpublished study 

prepared by Stillmeadow, Inc. 13 p. {OPPTS 870.1200} 

45777100 Novozymes Biologicals, Inc. (2002) Submission of Product Chemistry Data in Support 

of the Application for Registration of Novozymes Biofungicide Green-Releaf 710-140. 

Transmittal of 1 Study. 

45777101 Drahos, D. (2002) Support Information and Data to Address Product Chemistry Issues 

Identified in EPA Letter Dated September 26, 2002: Novozymes Biofungicide Green 
Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 

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Releaf 710-140: Lab Project Number: WD00418.00-BOTO-0902-0001. Unpublished 

study prepared by Exponent. 165 p. {OPPTS 885.1100, 885.1200, 885.1400, 885.1500, 

885.1800, 830.7000, 830.7100, 830.7300, 830.6317, 830.6320} 

45820200 Novozymes Biologicals, Inc. (2002) Submission of Product Chemistry Data in Support 

of the Application for Registration of Novozymes Biofungicide Green-Releaf 710-140. 

Transmittal of 1 Study. 

45820201 Drahos, D. (2002) Information and Data to Address Product Chemistry Issues Discussed 

in a Teleconference with EPA on December 12 2002 and Listed in EPA's Review Dated 

December 9, 2002: Novozymes Biofungicide Green Releaf: Lab Project Number: 

BACILLUS LICHENIFORMIS STRAIN SB3086: WD00418.000-AOTO-1202-0003. 

Unpublished study prepared by Exponent. 11 p. {OPPTS 885.1200, 885.1400, 885.1500, 

885.1800} 

46827400 Novozymes Biologicals, Inc. (2006) Submission of Product Chemistry Data in Support 

of the Application for Registration for Novozymes BioFungicide 145F. Transmittal of 1 

Study. 

46827401 Turnbough, A.; Semones, S. (2006) Manufacturing Process and Physical Chemical Data: 

Novozymes Biofungicide 145F. Project Number: WD00418/000/B0T0/040, 

SB3086/06/001. Unpublished study prepared by Exponent. 119 p. 

46945700 Aquarium Pharamaceuticals Inc. (2006) Submission of Product Chemistry Data in 

Support of the Application for Registration of Microbial Algae Control. Transmittal of 2 

Studies. 

46945701 Stevens, D. (2006) Product Chemistry: Identity and Composition: Microbial Algae 

Control. Unpublished study prepared by Aquarium Pharmaceuticals Inc. 27 p. 

46945702 Bryant, E. (2006) Product Chemistry: Physical Properties: Microbial Algae Control. 

Unpublished Study Prepared by Novozymes Biologicals, Inc. 8 p. 

46982700 Novozymes Biologicals (2006) Submission of Product Chemistry Data in Support of the 

Application for Registration of Novozymes Biofungicide 145F. Transmittal of 1 Study. 

46982701 Turnbough, A.; Semones, S. (2006) Addendum to Manufacturing Process and Physical 

Chemical Data: Novozymes Biofungicide 145F. Project Number: SB3086/06/02, 

WD00418/000/B0T0/1106/0001. Unpublished study prepared by Exponent. 20 p. 

47058500 Aquarium Pharmaceuticals, Inc. (2007) Submission of Product Chemistry Data in 

Support of the Application for Registration of Microbial Algae Control. Transmittal of 1 

Study. 

47058501 Turnbough, A. (2007) Microbial Algae Control: Product Chemistry: Identity and 

Composition. Unpublished study prepared by Novozymes Biologicals, Inc. 7 p. 

47160200 Aquarium Pharmaceuticals, Inc. (2007) Submission of Product Chemistry Data in 

Support of the Registration of Microbial Algae Clean. Transmittal of 1 Study. 

47160201 Turnbough, A. (2007) Product Chemistry: Identity and Composition: Microbial Algae 

Clean. Unpublished study prepared by Novozymes Biologicals, Inc. 30 p. 
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47310000 Mars Fishcare North America, Inc. (2008) Submission of Product Chemistry Data in 

Support of the Registration of Microbial Algae Clean. Transmittal of 1 Study. 

47310001 Turnbough, A. (2007) Microbial Algae Clean: Product Chemistry: Identity and 

Composition. Unpublished study prepared by Novozymes Biologicals, Inc. 178 p. 

48222000 Bovozymes Biologicals, Inc. (2010) Submission of Product Chemistry Data in Support 

of the Amended Registrations of Novozymes Biofungicide Green Releaf 710-140 and 

Novozymes Biofungicide 145F. Transmittal of 1 Study. 

48222001 Frodyma, M. (2010) Phylogenetic Analysis and Taxonomic Description of Strain DA33. 

Project Number: NOVOZYMES/10/09. Unpublished study prepared by Novozymes 

Biologicals, Inc. 10 p. 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda 

U.S. EPA. 2002. BPPD Review of Product Chemistry Data, and Acute Toxicity/Pathogenicity Submitted 

by Novozymes, for Registration of Biofungicide Green Releaf 710-140, which contains Bacillus 

licheniformis strain SB3086. Memorandum from C. Etsitty to S. Cerelli, dated September 20, 2002. 

U.S. EPA. 2002. BPPD Review of Product Chemistry Data and Manufacturing Process Submitted by 

Aquarium Pharmaceuticals, Inc. for Microbial Algae Clean, which contains Bacillus licheniformis strain 

SB3086 (EPA Registration Number 8709-RN). Memorandum from C. Etsitty to S. Cerrelli, dated 

September 18, 2007. 

U.S. EPA. 2003. Confirmation of Unconditional Registration of the active ingredient Bacillus 

licheniformis strain SB3086 for ornamental turf, conifer, and ornamental plant use to prevent or cure 

many fungal diseases (EPA Registration Number 70127-E). Memorandum from J. Andersen to J. Jones, 

dated January 31, 2003. 

U.S. EPA. 2003. Biopesticides Registration Action Document: Bacillus licheniformis strain SB3086 (PC 

Code 006492), February 4, 2003.