Docket Number EPA-HQ-OPP-2014-0184 

www.regulations.gov 

Bacillus licheniformis strain SB3086 

Final Work Plan 

(PC Code: 006492) 

Registration Review 

Case Number 6014 

September 2014 · 

Approved by: 

Robert McNally, Direc or 

Biopesticides and Pollution 

Prevention Division 

Date: 
INTRODUCTION 

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

Registration Review of Bacillus licheniformis strain SB3086. This FWP follows the Preliminary 

Work Plan (PWP) posted in the Registration Review docket for B. licheniformis strain SB3086 

(EPA-HQ-OPP-2014-0184). Products containing B. licheniformis strain SB3086 are registered as 

microbial pesticides for use as a fungicide or as an algaecide. As a fungicide, it is intended to 

control dollar spot, anthracnose, and other plant diseases on lawns, conifers, tree seedlings, and 

ornamental turf and plants. As an algaecide, it is intended for direct application to ornamental 

fish ponds and water gardens. 

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

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

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

registration. Changes in science, public policy, and pesticide use practices occur over time. The 

Registration Review program is intended to make sure that, as the ability to assess risk evolves 

and as policies and practices change, all registered pesticides continue to meet the statutory 

standard of no unreasonable adverse effects to human health or the environment. The public 

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

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

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

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

concerning anticipated data needs, expected risk assessments, or the estimated timeline identified 

in the PWP, and a summary of the EPA's responses to those comments. This section is followed 

by the planned data needs, risk assessments expected to be conducted, and the projected 

Registration Review timeline for B. licheniformis strain SB3086. Lastly, there is a discussion of 

next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

Since the PWP was issued in March 2014, there have not been any changes in the registrations of 

the three currently registered products that contain B. licheniformis strain SB3086 as an active 

ingredient. 

SUMMARY OF COMMENTS AND THE EPA'S RESPONSES 

During the 60-day public comment period on the B. licheniformis strain SB3086 PWP, which 

opened on March 28,2014, and closed on May 27,2014, the EPA did not receive any public 

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

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

on those issues. 

1 See http: www.epa.gov opnsrrdl registration revie11' . 

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PLANNED DATA NEEDS 

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 on 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. 

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

In the Registration Review Preliminary Work Plan (PWP) for B. licheniformis strain SB3086, the 

EPA stated that, because no data gaps existed, the need to conduct additional risk assessments 

would not be necessary if no previously unknown effects were identified in a literature search. 

Since the PWP was published, the EPA has conducted this literature search. The search was 

conducted using multiple databases or collections of databases, including lSI Web of Science 

(includes Science Citation Index Expanded and Current Contents Connect), Agricola, and 

ProQuest Environmental Science Collection (only peer reviewed articles searched, database 

includes Aqualine, Aquatic Science and Fisheries Abstracts, Bacteriology Abstracts, COS 

Conference Papers Index, Ecology Abstracts, ToxLine, and Toxicology Abstracts). The search 

included all years available in each database, ranging from 1960 to the present. Search terms 

included "Bacillus licheniformis" in combination with each of the following terms: "bird," 

"mammal," "fish," "invertebrate," "plant," "insect," "arthropo~," "arachnid," "reptile," 

"amphibian," "freshwater," "marine," "aquatic," "toxin," "pathogen," and "bee." No reports 

were found indicating additional effects that were not considered in previous risk assessments. 

On September 17,2014, the EPA conducted a search of EPA's ECOTOX database 

(http://cfuub.epa.gov/ecotow using the terms "Bacillus," "licheniformis," and "Bacillus 

licheniformis," but none of these terms were found in the chemical index. Therefore, conclusions 

from previous risk assessments remain current, and an additional risk assessment is not necessary 

for B. licheniformis strain SB3086. 

In addition, the EPA will determine whether, pursuant to Section 408(p)(4) ofthe Federal Food, 

Drug, and Cosmetic Act, B. licheniformis strain SB3086 qualifies for exemption from the 

Endocrine Disruptor Screening Program (EDSP). The EPA believes that B. licheniformis strain 

SB3086 is likely not an endocrine disruptor; as such, the EPA may exempt it from the EDSP. If · 

it is exempted, then the EPA will issue an order. 

THREATENED AND ENDANGERED SPECIES 

When the EPA conducted an ecological risk assessment for B. licheniformis strain SB3086 in 

2002, the Agency determined that adverse effects to nontarget organisms are not anticipated with 

the labeled uses of products containing this a.i. registered at that time. Data from the registration 

were cited to support the registration of additional products in 2007, which sufficiently addressed 

nontarget concerns for those uses. Because the uses have not been expanded since 2007 and EPA 

is aware of no additional nontarget effects that were not previously considered, the conclusions 

ofthe previous risk assessment are still current. Since the EPA has determined that no adverse 

effects will occur to any nontarget organism as a result of the labeled applications of B. 

licheniformis strain SB3086, effects to federally-listed threatened and endangered species and 

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their designated critical habitats also are not expected. Therefore, a "No Effect" determination is 

made for direct and indirect effects to listed species and their designated critical habitats 

resulting from the uses of B. licheniformis strain SB3086, as labeled. If any additional 

information becomes available, th.en the EPA will consider it. 

TIMELINE 

The EPA has created the following estimated time line for the completion of the Registration 

Review for Bacillus licheniformis strain SB3086 . . 

Registration Review for Bacillus licheniformis strain SB3086- Projected Registration 

Review Timeline 

Activities Estimated MonthlY ear 

Opening the Docket 

Open Docket and 60-day Public Comment Period for Dried March 2014 - Completed 

Fermentation Solids and Solubles of B. licheniformis strain SB3086 

verrucaria 

Close Public Comment Period May 2014 - Completed 

Case Development 

Issue Final Work Plan September 2014-

Completed 

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 December 2014 Review Final Decision 

Close Public Comment Period February 2014 

Registration Review Final Decision and Begin Post-decision 

March 2015 Follow-up 

Total years* 1.00 .. * Th1s schedule IS subJect to rev1s1on should unforeseen 1ssues anse durmg the Reg1stratton Rev1ew process. In the 

event an issue arises, such as the failure to acquire an EDSP exemption, then an amended FWP will be issued at 

that time. That FWP will identify any newly planned data needs and set forth a new timeline. 

NEXT STEPS 

As noted previously, the EPA will determine whether, pursuant to Section 408(p)(4) ofthe 

Federal Food, Drug, and Cosmetic Act, B. licheniformis strain SB3086 qualifies for exemption 

from the EDSP. This determination will inform the Agency's final registration review decision. 

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