# 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:Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

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### T ABLE 

### O F 

### C ONTENTS

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 Regi stration Review of Bacillus licheniformis strain SB3086 ......................................... 14 B. U.S. Environmental Protection Ag ency Risk Assessment Memoranda ........................................................... 18Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

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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 numb er 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 StatesBacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

4 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 num ber EPA-HQ-OPP-2014-0184). Bacillus licheniformis strain SB3086 is currently re gistered in two products fo r use as a biofungicide and in one product for use as an algaecide. This Prel iminary 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 an ticipated 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 particip ation component and by sharing this information in the docket, EPA inte nds 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 a dditional 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. Intere sted stakeholders coul d include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultu ral labor or commodity groups; commercial, institutional, residential, and ot her users of pesticides; or the public at large.

The PWP begins by describing the statutory and regul atory authorities for Registration Review. Next, it provides background on Bacillus licheniformis strain SB3086, including a de scription of its mode of action, the currently registered pest icide product, application rates and methods, use sites, and tolerance exemption information. Then, it lists the anticipate d 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 backgr ound 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, Comm ents, 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 (U S) must generally be registered by the EPA, based on scientific data showing that they will not cau se unreasonable risks to human health or the environment when used as directed on the pr oduct 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 statutor y 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 makeBacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

5 sure that, as change occurs, products in the marketpl ace 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 progr am pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will re view 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 wh en 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 a nd data or information it believes are needed to make a Registration Review decision. After reviewing and responding to comments a nd 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 lawn s, conifers, tree seedlings , ornamental turf and ornamental plants in outdoor, greenhouse, and nurser y 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 substant ially to the size of the naturally occurring B. licheniformis populations. The acute toxicity data performed resulted in an overall classificat ion of Toxicity Category IV. (U.S. EPA. Biopesticides Registration Action Document: Bacillus licheniformis strain SB3086 (PC Code 006492), February 4, 2003). Further information rega rding this product appear s 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 re gistered after November 1984, Bacillus licheniformis strain SB3086 was not subject to reregistration. Tolerance Reassessment Eligibility Decision (TRED) Not applicable. There are no food us es for this microbial pesticide.

Cumulative group Not applicable. Bacillus licheniformis strain SB3086 has not been identified as a member of a cumulative group that sh ares 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 issu e 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/oppsrr d1/registration_review/

.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

6 TABLE 2. Information Abou t 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 NovozymesBiofungicide 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 pr oducts for food use that contain Bacillus licheniformis strain SB3086 as an active ingredient. Whether it is used as a fungici de to control plant diseases or as an algaecide to control green water algae, this micr obial 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 pl ants 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 tole rance for residues of B. licheniformis strain SB3086 found on or in f ood and feed. (EPA, BRAD for Bacillus licheniformis strain SB3086, 2003.)Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

7 D. Anticipated Data Needs and Risk Assessments

Provided below are tables of the current data requir ements for microbial pesticides as set forth in 40 CFR § 158, subpart U. They are arraye d by scientific discipline (i.e., product chemistry, human health assessment, and nontarget organisms and environmenta l 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 re gistrant 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 registrati on review. Nevertheless, the EPA plans to conduct a literatu re search to update it s understanding of the curr ent state of the science on this pesticide and will consider the need to co nduct 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 453021-01Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

8 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 sh ould be reported per OCSPP Guideline 885.3400.

885.3500 Cell Culture Not applicable.

870.1100 Acute Oral Toxicity Yes; Study U.S. EPA (2002) 453021-05Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

9 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 Environm ental 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) 45302108Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

10 E. Risk to Threatened and Endangered Species

Bacillus licheniformis strain SB3086 is a ubiquitous soil bacteriu m 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 ex pected to add substantially to the size of naturally occurring B. licheniformis populations. Data submitted, either as studies or as scientific rationale in su pport of the ecological risk assessment at the time of registration, demonstrated that adverse effects to terrestria l and aquatic nontarget organisms are not expected. The EPA anticipates no effects to federally-lis ted threatened or endangered specie s; however, the EPA plans to conduct a literature search to determine whethe r any additional nontarget effects of Bacillus licheniformis may have been reported since they were previously as sessed at the time of regi stration. 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 pot ential effects to listed species and designated critical habitat during Registration Review.

F. Endocrine Effects

As required by the Administrator under the Fede ral Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the EPA has developed the Endocrine Disruptor Screening Pr ogram (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 pestic ide active and other ingredients) ma y have an effect in humans or wildlife similar to an effect produc ed by a “naturally occu rring 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 occurr ing 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 ingr edients and 9 inert ingredients. A second list of chemicals identified for EDSP scr eening 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 ingredient s on the lists to be sc reened under the EDSP.
The EPA, as part of this Pre liminary Work Plan, believes that Bacillus licheniformis strain SB3086 is a substance that would not likely produce any effect in humans sim ilar to an effect produced by a naturally occurring estrogenic substance. As su ch, 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 de termine to exempt this substance from the EDSP, an order will be issued.

For further information on the status of the EDSP, th e policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, pleas e visit our website at http://www.epa.gov/endo/

.

2 See http://www.regulations. gov/#!documentDetail;D=E PA-HQ-OPPT-2009-0477-0074 for the second list of chemicals.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

11 G. Incidents

From February 1, 2003 through March 1, 2014, the Office of Pesticide Programs’ Incident Data System (IDS) and Ecological Incident Info rmation System indicate that ther e 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 exemp tion or the need to further anal yze ecological risk based on an updated literature review, then the EPA would issue an amende d 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 Prel iminary Work Plan and rationale. The areas below highlight topics of special intere st to the EPA where comments, info rmation 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 manne r, prior to issuing a Final Work Plan for this case.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

12 i. Environmental Justice

The EPA seeks to achieve environmental justice, the fair treatment and meani ngful 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, cultu ral practices, or other factor s, 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 atypic al, unusually high exposure compared to the general population.

ii. Water Quality

Bacillus licheniformis strain SB3086 is not identified as a cau se of impairment for any water bodies listed as impaired under secti on 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 Process 6 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

iii. Trade Irritants

Through the Registration Review process, the EPA inte nds to solicit information on trade irritants and, to the extent feasible, take steps toward facilitati ng 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 tole rance 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 da ta that will assist the EPA in refining the risk assessments. The EPA is interest ed in obtaining the followi ng 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_waters 10/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/regist ration_review/water_quality_sop.htm

.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

13  Confirmation on the following label information:

- Sites of application - Formulations - Application methods and equipment - Maximum application rates - Frequency of application, app lication intervals, and maxi mum number of applications - Geographic limitations on use

 Use or potential use distribu tion (e.g., acreage and geographical distribution of relevant use sites)

 Median and 90 th percentile reported use rates (lbs active ingredien t/1,000 square feet) from usage data – national, state, and county

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

 Usage/use information for nonagricultural uses

 Typical applicati on 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.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

14 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 Registrati on 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 Malla rd: Final Report: Lab Projec t Number: 511-101. Unpublished study prepared by Wildlife Intern ational, Ltd. 33 p. {OPPTS 885.4050} 45302107 Drottar, K.; Kruegar, H. (2000) 710-132: A Five Concentration Toxicity and Pathogenicity Test with the Rainbow Tr out (Oncorhynchus mykiss): Final Report: Lab Project Number: 511A-101. Unpublished study pr epared by Wildlife International, Ltd. 38 p. {OPPTS 885.4200} 45302108 Maggi, V. (2000) Evaluation of the Dietar y Effect(s) of 710-132 on Honey Bee Larvae (Apis mellifera L.): Lab Project Number : CAR 106-00. Unpublished study prepared by California Agricultural Resear ch, 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 St udy 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 Irritati on Study of 710-132 in Rabbits: Final Report: Lab Project Number: 1222 SN4: 1222. Unpublis hed study prepared by IIT Research Institute. 25 p. {OPPTS 870.2500}Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

15 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 Pr oject 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 Registrati on of Sybron Biofungicide Green Releaf 710- 140. Transmittal of 2 Studies. 45367801 Drahos, D. (2001) Product Analysis fo r 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 an d State University. 135 p. {OPPTS 885.4200} 45519000 Novozymes Biologicals, Inc. (2001) Submi ssion of Product Chemistry Data in Support of the Application for Registration of N ovozymes Biofungicide Green Releaf 710-140. Transmittal of 1 Study. 45519001 Novozymes Biologicals, Inc. (2001) A dditional Product Chemistry Support Data Novozymes Biological Green Rele af 710-140. Unpublished study. 13 p. 45539000 Novozymes Biologicals, Inc. (2001) Subm ission 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 prepar ed by Novigen Sciences, Inc. 36 p. 45539002 Messina, J. (2001) Registration Support Do cument for Novozymes Biofungicide Green Releaf 710-140: Lab Project Numb er: 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 prepar ed by Novigen Sciences, Inc. 231 p. 45577100 Novozymes Biologicals, Inc. (2002) Submissi on 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 Ecotoxico logy Supporting Literature References for Novozymes Biofungicide Green Rel eaf: Lab Project Number: BACILLUS LICHENIFORMIS 01-04. Unpublished study prepar ed by Novigen Sciences, Inc. 63 p.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

16 45601700 Novigen Sciences, Inc. (2002) Submissi on of Toxicity Data in Support of the Application for Registration of Novozymes Bi ofungicide Green Releaf. Transmittal of 6 Studies. 45601701 Kuhn, J. (2002) Acute Oral Toxicity/Pathogeni city Study in Rats with a Microbial Pest Control Agent (MPCA): (Novozymes Biofungici de 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 Injecti on Toxicity/Pathogenicity Study in Rats with a Microbial Pest Control Agent (MPCA): (Novozymes Biof ungicide Green Rel eaf): Final Report: Lab Project Number: 6634-01. Unpublished stud y prepared by Stillmeadow, Inc. 46 p. {OPPTS 885.3200} 45601703 Carter, L. (2001) Acute I nhalation Toxicity Study in Ra ts: (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 Nu mber: 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) Submissi on 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-Concen tration Toxicity and Pathogenicity Test with the Rainbow Trout (MRID 453020107) an d Chronic 21-Day Renewal Toxicity Responses with Daphnia magna (MRID 45367802) Conducted with Bacillus licheniformis SB3086, Novozymes Biofungi cide Green Releaf 710-140. Unpublished study prepared by Novigen Sciences, Inc. 9 p. {OPPTS 885.4200} 45648800 Novozymes Biologicals, Inc. (2002) Submissi on 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) Submi ssion 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 Septembe r 26, 2002: Novozymes Biofungicide GreenBacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

17 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) Submi ssion 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 LICHENIF ORMIS STRAIN SB30 86: 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) Submi ssion of Product Chemistry Data in Support of the Application for Registration for N ovozymes BioFungicide 145F. Transmittal of 1 Study. 46827401 Turnbough, A.; Semones, S. (2006) Manufacturi ng Process and Physical Chemical Data: Novozymes Biofungicide 145F. Pr oject Number: WD00418/000/B0T0/040, SB3086/06/001. Unpublished study pr epared 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: Phys ical Properties: Micr obial 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 Biofungi cide 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 Cont rol: 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 Microb ial Algae Clean. Transmittal of 1 Study. 47160201 Turnbough, A. (2007) Product Chemistry: Iden tity and Composition: Microbial Algae Clean. Unpublished study prepared by Novozymes Biologicals, Inc. 30 p.Bacillus licheniformis strain SB3086 EPA-HQ-OPP-2014-0184 www.regulations.gov

18 47310000 Mars Fishcare North Americ a, Inc. (2008) Submission of Product Chemistry Data in Support of the Registration of Microb ial Algae Clean. Transmittal of 1 Study. 47310001 Turnbough, A. (2007) Microbial Algae Cl ean: Product Chemistry: Identity and Composition. Unpublished study prepared by Novozymes Biologicals, Inc. 178 p. 48222000 Bovozymes Biologicals, Inc. (2010) Submi ssion of Product Chemistry Data in Support of the Amended Registrations of Novozym es 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. Unpub lished 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 Biofungici de 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 Chemis try Data and Manufacturing Process Submitted by Aquarium Pharmaceuticals, Inc. for Mi crobial Algae Clean, which contains Bacillus licheniformis strain SB3086 (EPA Registration Number 8709-RN). Memorandu m from C. Etsitty to S. Cerrelli, dated September 18, 2007.

U.S. EPA. 2003. Confirmation of Unconditional Re gistration of the active ingredient Bacillus licheniformis strain SB3086 for ornamental turf, conifer, a nd ornamental plant use to prevent or cure many fungal diseases (EPA Registra tion Number 70127-E). Me morandum 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.