DocketNumberEPA-HQ-OPP

-2014-0184 www.regulations.gov



# Bacillus licheniformis strain SB3086 FinalWorkPlan (PC Code: 006492) Registration Review

Case Number 6014 September2014 ·

Approved by:



### RobertMcNally, 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 th e Registration Review doc ke t 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, F un gic ide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether i t continues to meet the FIFRA standard for registration. Changes in science, public policy, and pesticide use practic es occur over time. The Registration Review program is in tended to make sure that , as th e ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the s tatu tory s tandard of no unreasonable adverse effects to human health or the environment. The public phase of Regi st ra t ion Revie w begins when the ini t ial docket is opened for each case. Information on th is program is provided on th e EPA's website. 1 The FWP begins with any updates since the PWP was issued. Next, it provides a summary of substantive comments rece ived, if any, during the public comment period for the PWP concerning anticipated data needs , expecte d risk assessments, or the es timated timeline iden tifi e d in th e PWP, and a summary of th e 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 i ssued in March 2014, there have not been any changes in the registrations of th e 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 p ublic comment period on the B. licheniformis stra in 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 so licited comments on the specific topic s of environmental justice, water quality concerns, and trade irritants, but no comments or information were recei ved on those i ssues .

1 See http: www . epa.gov opnsrrdl registration revie11' . 2PLANNED DATA NEEDS Atthistime, no datagaps (anticipated dataneeds) for Bacillus licheniformis strain SB3086have been identified. The mostrecentcomprehensive risk assessmentforB. licheniformis strain SB3086 was completed on September20, 2002, in support ofthe first registration of

### B. licheniformis strain SB3086, which occurred onFebruary 4, 2003. Additional data were submitted by a second registrantfor the registration ofthe algaecideproduct in2007. RISKASSESSMENTS FOR REGISTRATION REVIEW Inthe Registration Review Preliminary Work Plan (PWP) forB. licheniformis strain SB3086, the EPA statedthat, because no data gaps existed, the need to conduct additionalrisk assessments wouldnot be necessary ifno previously unknowneffects were identifiedin a literature search. Since the PWP waspublished,the EPAhas conducted this literature search. The searchwas conducted usingmultiple databases orcollections ofdatabases, including lSIWeb ofScience (includes Science Citation Index Expanded and Current Contents Connect), Agricola, and ProQuest Environmental Science Collection (onlypeerreviewed articles searched, database includes Aqualine, Aquatic Science and Fisheries Abstracts, Bacteriology Abstracts, COS ConferencePapers Index, EcologyAbstracts, ToxLine, andToxicology Abstracts). The search included all years available in each database, ranging from 1960 to the present. Searchterms included "Bacillus licheniformis" incombinationwitheach ofthe following terms: "bird," "mammal," "fish," "invertebrate," "plant," "insect,"**"arthropo~,"** "arachnid," "reptile," "amphibian," "freshwater," "marine," "aquatic," "toxin," "pat hogen," and "bee."Noreports were found indicating additional effects that werenotconsidered in previous risk assessments. On September 17,2014, the EPA conducted a searchofEPA'sECOTOX database (http://cfuub.epa.gov/ecotowusing the terms "Bacillus, " "licheniformis," and "Bacillus licheniformis," butnone ofthese terms were found inthe chemical index. Therefore, conclusions from previous risk assessments remain current, and an additional risk assessment is notnecessary for B. licheniformis strain SB3086. In addition, theEPAwill determine whether,pursuantto Section 408(p)(4) oftheFederal Food, Drug, and Cosmetic Act, B. licheniformis strain SB3086 qualifies for exemption from the EndocrineDisruptor ScreeningProgram (EDSP). The EPA believesthat 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 anorder. THREATENED AND ENDANGERED SPECIES WhentheEPA 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 labeleduses ofproducts containing this a.i. registered atthattime. Datafrom the registration were cited to supportthe registration ofadditional productsin2007, which sufficiently addressed nontarget concerns for those uses. Because the uses have notbeen expanded since 2007 and EPA is aware ofno additional nontargeteffectsthat were notpreviously considered, the conclusions oftheprevious risk assessment are still current. Sincethe EPA has determinedthat no adverse effects will occurto anynontarget organismas a result ofthe labeled applications ofB

. licheniformis strain SB3086, effectsto federally-listed threatened and endangered species and
3their 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

resu l ting from the uses of B. licheniformis strain SB3086, as l abe l ed. If any additiona l information becomes availab l e , th . en t h e EPA will consider it. TIMELINE The EP A has created the following estimated time line for the completion of the Registration Rev i ew 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 Pub li c Comment Period for Dried March 2014 - Completed Fermentation Solids and So l ubles of B. licheniformis strain SB3086 verrucaria C l ose Pub li c Comment Period May 2014 - Completed Case Development Issue Final Work Plan September 2014- Completed I ssue Data Call - in N / A Data Submission N / A Open 30-day Public Comment Period for Draft Risk Assessmen t s N / A Close Public Comment Period N / A Registration Review Decision Open 60-day Pub l ic Comment Period for Proposed Registration December 2014 Review Final Decision C l ose Pub li c Comment Period February 2014 Reg i s t ration Review Fina l Decision and Beg i n Post - decision March 2015 Follow-up Tota l years* 1.00 .. * Th1s schedu l e IS subJect to rev1s1on shou l d unforeseen 1ssues anse durmg the Reg1stratton Rev1ew process . In the event an issue arises, such as the failure t o acquire an EDSP exemption, then an amended F WP will be issued at

that time. That FWP will id en t ify any newly planned data needs and set forth a new t i meline. NEXT STEPS As noted previous l y, the EPA will determine whether , pursuant to Section 408(p)(4) ofthe Federa l Food, Drug, and Cosmetic Act, B . licheniformis strain SB3086 qualifies for exemption from the EDSP. This determination will inform the Agency's final regis t ration review decision . 4