Document ID: EPA-HQ-OPP-2014-0184-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-12-04T05:00Z

Bacillus licheniformis strain SB3086
                                       
                     Interim Registration Review Decision
                               Case Number 6014
                                       
                                       
                                       
                                       
                                      for
Approved by:	___________________________      					Robert C. McNally, Director
                              Biopesticides and Pollution Prevention Division

                               September 6, 2018
                      Date:			___________________________

                               Table of Contents

I.	Introduction	3
II.	Use and Usage	4
III.	Scientific Assessments	5
A.	Human Health Assessment	5
B.	Environmental Assessment	7
C.	Endocrine Disruptor Screening Program	8
IV.	Interim Registration Review Decision	9
V.	Next Steps and Timeline	9
References	10

I.	Introduction
This document is the Environmental Protection Agency's (EPA or the Agency) Interim Registration Review Decision for Bacillus licheniformis strain SB3086 (Case 6014, PC Code 006492) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, an Interim Registration Review Decision before completing a registration review. Among other things, the interim registration review decision may:  1) require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify data or information required to complete the review; and 4) establish schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on Bacillus licheniformis strain SB3086, additional documents can be found in EPA's public docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov. 
FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to ensure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pesticides to ensure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at www.epa.gov/pesticide-reevaluation. In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g). The Agency will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.
This document is organized into five sections: the Introduction, which includes this summary and a summary of any public comments and the Agency's response; Use and Usage, which describes how and why Bacillus licheniformis strain SB3086 is used and summarizes data on its use; Scientific Assessments, which summarizes the Agency's risk assessments, any revisions, and risk conclusions; Interim Registration Review Decision, which describes the regulatory rationale for the Agency's interim registration review decision; and, last, the Next Steps and Timeline for completion of this registration review case.
Summary of Bacillus licheniformis strain SB3086 Registration Review
Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for Bacillus licheniformis strain SB3086 (Case 6014). The following list highlights significant events that have occurred during the registration review of Bacillus licheniformis strain SB3086. Documentation of these events for Bacillus licheniformis strain SB3086 can be found in the Agency's public docket, EPA-HQ-OPP-2014-0184, available at www.regulations.gov.
 March 28, 2014 - Publication of the Bacillus licheniformis strain SB3086 Preliminary Work Plan (PWP) in the docket for a 60-day public comment period. The comment period closed May 27, 2014. The Agency received no comments.
 September 25, 2014 - Publication of the Bacillus licheniformis strain SB3086 Final Work Plan (FWP) - The FWP confirmed that the most recent exposure and risk assessments still support the registration of pesticide products containing Bacillus licheniformis strain SB3086. It was determined that no additional data were needed for the Bacillus licheniformis strain SB3086 registration review because sufficient information was available to conduct a qualitative risk assessment, supporting a proposed interim registration review decision, pursuant to 40 CFR section 155.53(b).
 May 24, 2018  -  Publication of the Bacillus licheniformis strain SB3086 Proposed Interim Registration Review Decision for a 60-day public comment period. The comment period closed July 23, 2018. One comment was received in support of the decision in response to this publication. 
 September 2018  -  The Agency is now publishing the Bacillus licheniformis strain SB3086 Interim Registration Review Decision.
Additional information on Bacillus licheniformis strain SB3086 can be found in EPA's public docket, EPA-HQ-OPP-2014-0184, available at www.regulations.gov.
II.	Use and Usage
Products containing Bacillus licheniformis strain SB3086 are registered as microbial pesticides for use as fungicides and as algaecides. Bacillus licheniformis strain SB3086 is the active ingredient in Novozymes Biofungicide Green Releaf, a microbial fungicide registered 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 soil bacterium that contributes to nutrient cycling and displays antifungal activity. While numbers of Bacillus licheniformis in soil are unknown and likely vary from soil to soil, the use of Bacillus licheniformis at current label rates is not expected to add substantially to the size of the naturally occurring Bacillus licheniformis populations. The acute toxicity data performed resulted in an overall classification of Toxicity Category IV (U.S. EPA, 2003). Table I provides a summary of the chemical facts for Bacillus licheniformis strain SB3086.
      
    Table 1. Bacillus licheniformis strain SB3086 Use and Usage Information
Summary of Use
Microbial pesticide registered for use as a biofungicide and algaecide
Use Sites
For use on greenhouse plants, turf, golf courses and lawns; algaecide in ornamental fish ponds and water gardens
Summary of Usage
N/A 
Formulation Type
Liquid formulation; user adds water
Application Method
Foliar spray, soil drench, chemigation, direct application to ornamental ponds
Technical Registrants
None. (Registrant for end-use product with highest AI concentration: Novozymes)
No. of Registrations
3 FIFRA Section 3 products
Restricted Use
No

III.	Scientific Assessments
A summary of the Agency's human health, environmental and ecological risk assessments for Bacillus licheniformis strain SB3086 is presented below. The most recent assessments were conducted in September 2002 for the first registration of a pesticide product containing this active ingredient. Additional data were submitted by a second registrant for the registration of the algaecide product in 2007. For the detailed risk assessments, see the Bacillus licheniformis strain SB3086 public docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov.

 Human Health Assessment
 Hazard Characterization and Risk
The toxicological database is considered complete for characterizing hazard and assessing risk from Bacillus licheniformis strain SB3086. No additional studies are anticipated to be needed for registration review. All data requirements, per 40 CFR 158.2050, have been fulfilled for Bacillus licheniformis strain SB3086. Hazard and exposure data, agency risk assessments and other information on this active ingredient were evaluated against standards established by FIFRA and the Agency's regulations and scientific policies. 
All acute toxicity data requirements for Bacillus licheniformis strain SB3086 have been satisfied with guideline studies. Acute oral toxicity, primary eye irritation, acute dermal toxicity, and primary dermal irritation are all Toxicity Category IV. The products are not considered to be dermal sensitizers. Subchronic and chronic toxicity data were not required because survival, replication, infectivity, toxicity, or persistence of the microbial agent was not observed in the test animals treated in the acute oral infectivity test (U.S. EPA, 2003).
Based on existing use patterns and personal protection equipment (PPE) requirements of the active ingredient, exposure is expected to be minimal. When used as a fungicide or algaecide in accordance with their respective labels, Bacillus licheniformis strain SB3086-containing products are not expected to cause unreasonable adverse effects to humans. Therefore, it was determined that there is no need to conduct an additional human health risk assessment at this time.

 Dietary Exposure and Risk Assessment
A quantitative dietary (food and drinking water) exposure and risk assessment was not conducted since Bacillus licheniformis strain SB3086 demonstrated low toxicity at the levels of exposure relative to its anticipated pesticidal use. A qualitative risk assessment was considered adequate. The present use sites for products containing Bacillus licheniformis strain SB3086 do not include food or feed sites; therefore, dietary exposure and risk from the consumption of residues are likely to be minimal to non-existent for the general population including infants and children.
The microorganism Bacillus licheniformis is ubiquitous in the natural environment; and it is not considered to be a risk to drinking water. Accordingly, drinking water is not being screened for Bacillus licheniformis strain SB3086 as a potential indicator of microbial contamination or as a direct pathogenic contaminant. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to Bacillus licheniformis strain SB3086 through drinking water. Altogether, the potential of significant exposure to Bacillus licheniformis strain SB3086 in drinking water is expected to be negligible; and the potential of minimal exposure notwithstanding, there is no significant risk of dietary toxicity relative to pesticidal exposure to Bacillus licheniformis strain SB3086. Therefore, the continued use of Bacillus licheniformis strain SB3086 as a pesticide does not present any dietary concern to the Agency.
Food Tolerances
Currently, there are no registered products for food or feed use that contain Bacillus licheniformis strain SB3086 as an active ingredient. Whether it is used as a fungicide to control plant diseases on turf or ornamentals or as an algaecide to control green water algae, food and feed uses are explicitly prohibited on the labels. Therefore, the EPA did not require a tolerance or an exemption from the requirement of a tolerance for residues of Bacillus licheniformis strain SB3086 found on or in food and feed (U.S. EPA, 2003).

Residential and Occupational Exposure and Risk
In residential and day care settings, children may be exposed to this pesticide on treated lawns, ornamental turf, recreational fields and ornamental plants; however, any exposure is expected to be negligible. Bacillus licheniformis strain SB3086 is a natural soil isolate. The general population, including infants and children, are exposed to Bacillus licheniformis strain SB3086 and other strains of these Bacilli in untreated soils on a regular basis without hazard (U.S. EPA, 2003).

The potential for occupational and residential risk is expected to be minimal based on the evaluations of submitted Tier I acute toxicity tests. For occupational uses, potential risks from regular occupational exposure will be mitigated through the use of appropriate Personal Protective Equipment (PPE). Labels for these EPs currently require the following PPE for applicators/handlers: long sleeve shirt, long pants, shoes, socks, waterproof gloves, protective eyewear, and for exposure in enclosed areas or outdoors, a particulate-filtering NIOSH-approved respirator. No significant residential or occupational exposure is anticipated; no potential cumulative effects have been identified; and there is no concern for aggregate exposure (U.S. EPA, 2003).
 Human Incidents
A search of the Office of Pesticide Programs' (OPP) Incident Data System (IDS) on January 25, 2018, revealed no reported human health incidents associated with the currently registered products containing Bacillus licheniformis strain SB3086 from February 1, 2003 through January 25, 2018. This database contains information dating back to the 1970s and is continuously updated as incidents are reported.
 Environmental Assessment
All ecological data requirements have been fulfilled. Hazard and exposure data on this chemical were evaluated against current standards established by the Agency's scientific policies and regulations. Bacillus licheniformis is a ubiquitous, saprophytic soil microbe that contributes to nutrient cycling and displays antifungal activity. While numbers of Bacillus licheniformis in soil are unknown and likely vary from soil to soil, the numbers of total Bacillus organisms are estimated at 1x10[7] cfu/g soil (U.S. EPA, 1997). The added soil density of Bacillus licheniformis from the proposed use rates would be 0.42% to 1.5% (U.S. EPA, 2003). This represents a very small proportion of the naturally occurring bacilli in the soil and therefore is not expected to add substantially to the effects of the naturally occurring Bacillus populations (U.S. EPA, 2003).

The nontarget toxicity data requirements for Bacillus licheniformis strain SB3086 were fulfilled as follows: Avian Pulmonary/Inhalation, Wild Mammal, Estuarine/Marine Animal, Nontarget Plant, and Nontarget Insect requirements were waived by EPA based on a rationale demonstrating a lack of potential for exposure or toxicity to plants, insects, mammals, estuarine and marine animals, or birds. A guideline study on rainbow trout demonstrated no pathogenicity, and only showed toxicity at 117X the expected environmental concentration. Guideline studies on young mallards and daphnia each demonstrated no evidence of pathogenicity or toxicity of the test substance. Additionally, a guideline study on honey bees demonstrated no evidence of pathogenicity or toxicity of the test substance, indicating that the use of products containing Bacillus licheniformis strain SB3086 is not likely to adversely affect pollinators (U.S. EPA, 2003). 
      
Based on the ecological reviews of the nontarget organisms and environmental fate information, the Agency has determined that unreasonable adverse effects to nontarget organisms or the environment are not likely to result when products containing Bacillus licheniformis strain SB3086 are used in accordance with their respective use directions. In addition, EPA has determined that no adverse effects will occur to bees or other nontarget insects as a result of the labeled applications of Bacillus licheniformis strain SB3086. Therefore, risk to pollinators is not expected as a result of the labeled uses. Environmental scientific reviews for Bacillus licheniformis strain SB3086 are located in the Bacillus licheniformis strain SB3086 registration review docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov. 
Endangered Species Assessment
There is no expectation for any registered use of Bacillus licheniformis strain SB3086 to cause direct or indirect adverse effects to threatened and endangered species. Bacillus licheniformis and other Bacillus species are naturally ubiquitous in the soil environment, and the application of Bacillus licheniformis strain SB3086 is not expected to add substantially to the effects of the naturally occurring Bacillus populations. Acute and subchronic human health toxicity studies have demonstrated no evidence of toxicity or pathogenicity. Nontarget organism studies were either waived based upon the natural occurrence of Bacillus licheniformis in the environment or demonstrated a lack of toxicity or pathogenicity in exposure to nontarget organisms.
      
Consequently, adverse effects to terrestrial and aquatic organisms are expected to be negligible; therefore, the Agency has come to a "No Effect" determination under the Endangered Species Act (ESA) for all listed endangered or threatened species and their designated critical habitat. As a result, the Agency has concluded that consultation with the Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7 (a)(2) is not required. The Agency anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the registration review process that would indicate such an assessment would be needed to inform the Agency's decision. The Endangered Species Assessment can be found in the Registration Review docket (EPA-HQ-OPP-2014-0184).
 Ecological Incidents
A search covering the period from February 1, 2003 through January 25, 2018 of the OPP's Incident Data System (IDS) and Ecological incident information System indicated 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 and involved some pond casualties. There was insufficient information to make a determination as to whether the incident was related to the pesticidal application or whether it was anomalous.

 Endocrine Disruptor Screening Program
As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the Agency 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."
Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The Agency has reviewed all of the assay data received for the List 1 chemicals and the conclusions of those reviews are available in the chemical-specific public dockets. A second list of chemicals identified for EDSP screening was published on June 14, 2013 and includes some pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. Bacillus licheniformis strain SB3086 is not on either list. 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.
In this interim decision, the Agency is making no human health or environmental safety findings associated with the EDSP screening of Bacillus licheniformis strain SB3086. As such, pursuant to Section 408(p)(4), and before completing this Registration Review, EPA will determine whether it can exempt Bacillus 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. 
IV.	Interim Registration Review Decision
In accordance with 40 CFR §155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. Except for the EDSP component of this case, the Agency has made the following Interim Decision: (1) no additional data are required at this time; and (2) no changes to the affected registrations and their labels are needed at this time. In this interim decision, the Agency is making no human health or environmental safety findings associated with the EDSP screening of Bacillus licheniformis strain SB3086. The Agency's final registration review decision for Bacillus licheniformis strain SB3086 will be made following completion of an EDSP FFDCA §408(p) determination.
V.	Next Steps and Timeline
A Federal Register Notice will announce the availability of this Interim Registration Review Decision for Bacillus licheniformis strain SB3086. A final decision on the Bacillus licheniformis strain SB3086 registration review case will occur after an EDSP FFDCA section 408(p) determination has been made.
                                               Activities
                                                           Estimated Month/Year
Opening the Docket/Case Development
Open Docket and 60-Day Public Comment Period 
                                March 28, 2014
Close Public Comment Period
                                 May 27, 2014
Issue Final Work Plan 
                              September 25, 2014
 Proposed Interim and Final Registration Review Decision
                                       
Open 60-Day Public Comment Period for Proposed Interim Registration Review Decision
                                 May 24, 2018
Close Public Comment Period
                                 July 23, 2018
Interim Registration Review Decision
                                September 2018
Final Decision*
                                      TBD
*This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time that will set forth a new timeline and, if applicable, any new data requirements will be included in the amended document and a Data Call-In Notice will be issued.

                                  References
U.S. EPA. 1997. TSCA Final Risk Assessment of Bacillus licheniformis. U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics. February 1997. Available at: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2014-0184.
U.S. EPA, 2003. Biopesticide Registration Action Document: Bacillus licheniformis Strain SB3086 (PC Code 006492). U.S. Environmental Protection Agency Office of Pesticide Programs. April 2003. Available at: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2014-0184.