Docket Number EPA

-HQ

-OPP-2013-0539 www.regulations.gov



# - Dried Fermentation Solids and Solubles of 

# Myrothecium verrucaria FinalWorkPlan (PC Code: 119204) Registration Review

Case Number 6051 September 2014

Approved by:



### Robert McNally, Director 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 Dried Fermen tatio n Solids and Solubles of Myrothecium verrucaria. Thi s FWP follows the Preliminary Work Plan (PWP) posted in the Registration Review docket for Dried Fermentation Solids and So l ub l es of Myrothecium verrucaria (EPA-HQ-OPP-2013-0539). Dried Fermentation Solids and Solubles of Myrothecium verrucaria i s registered for applications to so il in agricultural fie lds and ornamenta l crops to control nematodes that parasitize plants, usually through the roots, thereby reducing the quality and yield of the plants they infest. The EPA is implementing the Registration Review program pursuant to Section 3(g) ofthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pes t icide every 15 years to determine whether it continues to meet the FIFRA standa rd for registration. Changes in science, public po licy , and pesticide u se practices occur over time. The Re gistration 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 s tandard of no unreasonable adverse effects to human health or the env ironm ent. 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 substant iv e comments received, if any, during the public comment period for the PWP concerning anticipated data needs, expected risk assessments, or the estimated timeline id entified 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 Dried Fermentation Solids and Solubles of Myrothecium

verrucaria. Lastly, there is a discussion of next steps. UPDATES SINCE THE PWP WAS ISSUED Over the course of preparing the PWP, EPA became aware that labe l s for some products containing the active ingredient (a.i.), Dried Fermentation Solids and Solubles of Myrothecium verrucaria, may have been inconsistent with mitigation measures needed to limit exposure to aquatic organisms. According to the ecological risk assessment conducted for the original registration in 1996, minimal risk was identified for birds, wild mammals, nontarget plants,

nontarget insects, and honey bees, but th e a.i. was determined to be moderately toxic (LCso = 2.1 mg / L) to rainbow trout in a 96-hour static renewa l study. Data subm itt ed on aquatic invertebra tes were determined to be un acceptable. Ho wever, at that time EPA determined that a concl u sion of minimal risk to all nontarget organisms could be made as long as: 1) batch-level quality control measures were in place to ensure non-viability of the Myrothecium verrucaria fungus and that t he presence of mycotoxins were below a specified lim i t, 2) end - use product la bels contained language prohibiting application to water, 2 and 3) application methods were limited to so il 1 See http: // www.epa.gov / oppsrrdl l registration review ! 2 EN VIRONMENTAL HAZARDS: For terrestrial uses: Do not a pply directly to water , or to areas where surface water is pre se nt or to intertidal areas below the mean high water mark. Do not contaminate water by cleaning of equipment or disposal of equipment washwaters. 2applied spray with incorporation (mechanical means orwatering in) ordrip chemigation to reduce thepotential for the a.i. to move beyond farm fields into surrounding streams,ponds, and other water bodies. The EPA also concluded that, with these mitigations in place, this preparation ofMyrothecium verrucaria should pose no threat to endangered species when used according to label directions. As discussed in the PWP, EPA was able to confirmthe mitigation measures described initems 1 and 2 were in place, but would need to determine whether labels for end-use products containing Dried Fermentation Solids and Solubles ofMyrothecium verrucaria were consistent with restrictions on application methods as described in item 3. Between 2000- 2003, certain labels allowed application by border, flood, basin and furrow chemigation. Since the PWP was issued in September 2013, the registrant, Valent Biosciences, Inc., agreed to restrict chemigation application to only drip chemiga tion, thereby significantly reducing the likelihood offish and other aquatic species being exposed tothepesticide. In2014The EPA accepted label amendments for the three end-use products

- DiteraWP (EPA Reg. No. 73049-37), Ditera ES (73049-43), and DiteraDF (73049-67)

- that revised the Directions for Use sections by deleting all other forms ofchemigation. The current labels comport with the recommendations ofthe original ecological risk assessment, and adverse effects to nontarget organisms are not anticipated due to lowtoxicity, lack of exposure to the applied fungus, or both. Myrothecium verrucaria is a common fungus in the environment, and is found inplant material, cellulosic matter, running and still water, and in various cultivated and non-cultivated soils. Therefore, nontarget organisms in the areas where the end

-use products wouldbe used likely are naturally exposedto this fungus and its secondary compounds. This a.i. is also rendered nonviable, so it will notproliferate inthe environment once applied. Restricting application methods as required onthe current labels is expected toprevent exposure in aquatic environments by limiting the amountpresent onthe soil surface and reducing the potential for movement offthe crop field. Thisconclusion is supported by research on the environmental fate ofliving pollutant microorganisms in and on soil and their inputfrom land into nearby surface waters. While subsurface movement ofmicroorganisms is possible (AbuAshour et al. 1994), surface flow is understood to contribute more to runoffinto nearby surface waters (Jamieson etal. 2002, see also Collins and Rut herford 2004, Hunteretal. 1992). The contribution ofsubsurface flow canbe several orders ofmagnitude lower than contributions from surface flow (e.g., Atwill etal. 2002). Additionally, what is known about movement of microorganisms in to water is dependent on measurement ofviable organisms, and survival in soil is important factor determining thepresence in nearby surface waters (Jamieson etal. 2002, see also Atwill et al. 2002, Collins and Rutherford 2004). Since the a.i. is nonviable, survival and reproduction ofthe a.i. will not occur. Furthermore, common soil microorganisms are expected to degrade secondary compounds (Sudakin 2003), and the killed M verrucaria would be subject to microbial degradation, as well. Based onthe above analysis, the recent amendments to the end-use product labels for this nonviable fungus are expect ed to prevent exposure to aquatic organisms, which was the concern raised in the original risk assessment. In 2014 a search ofthe literature was also performed to ensure that no additional nontarget effects had beenreported thatpreviously had notbeen considered. This search was conducted using multiple databases or collections ofdatabases, including lSI Web ofScience (includes Science CitationIndex Expanded and Current Contents
3Connect), Ag rico la, and ProQue st Envir onme n ta l Science Collection (on l y peer rev iewe d articles searched, databas e includes Aqualine, Aquatic Science and Fisheries A bstracts , Bacterio log y Abstracts, COS Confe r e nc e Papers Index, Eco logy Abstracts, ToxLi n e, and Tox icolo gy Abstracts). The search inclu de d all years available in each da tabase, r a n gi n g from 1960 to the present (2014). Searc h terms included "Myrothecium verrucaria" in com binat ion with each of th e following terms : "b i r d ," "mamma l ," ''fish," "invertebra t e," "plan t ," "insect, " "arthropo d ," "arac hnid ," " reptile ," "a mphibian ," "fres hwa te r ," " marine ," "aquatic," "toxi n ," "pathogen," and " be e . " No reports were found indicating additional effec t s that were not considered in pr evio u s risk assessments. Therefore, previous risk assessmen t conclusions regarding th e lack of anticipated adverse effects to nontarget organisms, includin g federally l isted threatened and endangered species, apply to the c urrent uses of pr oducts containing Dried Fermen tat ion Solids and Solubles of Myrothecium verrucaria . As a r esult of the lab e l r evisions, i t is extreme ly unli ke ly t hat residues ofthe pesticide will move beyond farm fi elds into surroun ding streams, ponds, and other water bodies , and t he risk to aquatic species has b een practically e liminat ed. The EPA does not need to revise i t s ecological ri s k assessment and endangered s pec ies assessment f rom 1996. SUMMARY OF COMMENTS AND THE EPA'S RESPONSES Duri ng the 60-day public comment period o n the Dried Fermentation Solids and So luble s of

My roth eciu m verrucaria PWP, which opened on Septe mb er 25,2013, and closed on Novembe r 25,2013, the EP A r ece i ved one public comment. The commenter, t he FIFRA Endan gered

Species Task Force (FES TF) offered " da ta developed by FESTF, in response to t he Agency's en dang ered spe ci es data requiremen ts to address (federally l is ted en dang ered ] spec ies proximity to Myrothecium ver rucar ia uses." The EPA no tes these da ta in i ts files; ho w e ver, the Agency does no t need to use these data because we no lon ger plan to conduct an en dan ge r e d spec ies assessment. In the PWP , the EPA also solic ited comments on the specific topic s of environmental j us tic e, water quality concerns, and trade irri ta nts , but no comments or i nformation we re received on t hose issues. PLANNED DATA NEEDS The EPA has no anticipated registration review data need s for Dried Ferment atio n Solids and Solubles of Myrothecium ve rrucar ia based on t he EPA's ri sk assessment memoranda and other references associated wi th this pe s ticidal active ingredient. 3 RISK ASSESSMENTS FOR REGISTRATION REVIEW During Registration Re view, the EPA w ill determine whether, pursuant to Section 408(p) ( 4) of the Federal Food, Drug , and Cosme tic Ac t , Dried Fermenta t ion Solids and So lubl es of Myrothecium verrucaria qualifies f o r exe mp t ion from the Endocrine Disruptor Screening P ro g ram (EDSP). The EP A belie ves t hat Dried Fermentation S olid s and Solubles of 3**S~e** Section 1II ("B i l>li9graph/') of the D r ied Fermen t at ion Solids and Solubles of Myrothecium verrucaria PWP. 4Myrothecium verrucaria is likely not anendocrine disrupter; as such, the EPA may exemptit from the EDSP (ifexempted, an order will be issued)
. TIME LINE TheEPAhas created the following estimated timeline for the completion ofthe Registra tion Review for DriedFermentation Solids and SolublesofMyrothecium verrucaria. Registration Review for Dried Fermentation Solids and Solubles ofMyrothecium verrucaria- Projected Registration Review Timeline Activities Estimated MonthlYear Opening the Docket OpenDocket and 60

-day Public Comment Period for Dried September 2013

- Completed Fermentation Solids and Solubles ofMyrothecium verrucaria Close Public CommentPeriod November2013 -Completed Case Development Issue Final Work Plan September 2014- Completed Issue Data Call

-in N/A Data Submission N/A Open 30

-day Public CommentPeriod for DraftRisk Assessments N /A Close Public Comment Period N/A Registration Review Decision Open 60

-day Public Comment Period for Proposed Registration October 2014 Review Final Decision Close Public Comment Period December 2014 Registration ReviewFinal Decision and BeginPost-decision January 2015 Follow-up Total years* 1.5

.. 

### * Th1s schedule IS subject to reviSIOn should unforeseen Issues anse dunngthe Reg1stratwn Rev1ew process. In the

event an issue arises, such as the failure to acquire an EDSP exemption, then an amended FWP will he issued at that time. ThatFWP will identify any newly planned data needs and set forth a new timeline. NEXT STEPS Due to the label revisions the EPA accepted in2014, the Agency does not need to conduct new risk assessments or issue a data call-in. Ifthe EPA issues an order exempting Dried Fermentation Solids and Solubles ofMyrothecium verrucaria from the EDSP, then the Agency will open a 60

- day public commentperiod for theproposed registration review final decision. REFERENCES Abu-Ashour, J. , D. Joy, H
. Lee, H
. Whiteley, S. Zelin. 1994
. Transport ofmicroorganisms through soil. Water, Air, and Soil Pollution 75: 14 1

-152.



### 5Atwill, E . R, L. Hou, B.M. Karle, T. Harter, K.W. Tate, R.A. Dahlgren. 2002. Transport of Cryptosporidium parvum oocysts through vegetated buffer strips and estimated filtration efficiency. Applied and Environmental Microbiology 68: 5517 - 5527 . Collins R., K. Rutherford . 2004. Mode lli ng bacterial water quality in streams draining pastoral land. Water Research 38: 700 - 712. Hun t er , C. , A. McDonald , K. Beven. 1992 . Input of fecal coliform bacteria to an upland stream channel in the Yorkshire Dales. Water Resource Research 28: 1869-1876. J amieson, R., R. Go r don , K. Sharples, G. Stratton , A. Madani. 2002 . Movement and persistence of fecal bacteria in agricultural so il s and subsurface d r ainage water. Canadian Biosystems EI)gineering 44: 6.1 - 6.1 0 . Sudakin, D.L. 2003 . Trichothecenes in the environment: relevance t o human health. T ox i co l ogy Letters 143: 97-107. 6