Docket Number EPA -HQ-OPP- 2014

- 0004 www.regulations.gov



# Thiophanate Methyl & 

# Carbendazim Final Work Plan Registration Review

Case Number 2680
September 2014

Approved By :

**~)_** (..:>



### ~_,(_cr-.(_~~ 

### Richard P

. Keigwin, Jr. , Director Pesticide Re

- evaluation Division

Date <


# L:~~ 

# 2 '<-A.-A-1-VJ 

### Susan Lewi s, Director Antimicrobials Division

Date

### INTRODUCTION This is the Env ironmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the re g i stration review of thiophanate methyl (TM) and carbendazim (M BC ). This work plan ad dres ses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the TM and MBC registration review docket (EPA-HQ-OPP-2014-0004). MBC is both a pestic ide active ingredient and also a m etabo li te, environmental degradate and the pesticidally active moiety ofTM

. Th e two compounds are therefore cons idere d together in this reg i stration review pursuant to 40 CFR Part 155.42(a ). TM is a systemic benzimidazole f un gicide registered for use on a va ri ety of agricultural use sites including ro w, field and orchard crops, g reenhou ses, nurseries , and as a commercial seed and bulb dip treatment. TM non-agricultural use sites include use on turf, which includes sod farms, go lf courses, athletic and recreational fields, and ornamental g rasses for land sca pes and interiorscapes

. MBC is reg istered for use on non agricultural si te s for ornamental tree injection and use as an indus trial biocide additive to coatings, paint s, stains, stuccos, plasters, sealant s, caulks, fillers, adhesives, paper, plastics, and textile s. The Agency i s implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fung icide, and Rodenticide Ac t (FIFRA), and will review each reg i stered pesticide every 15 years to determine whether it continues to meet the FIFRA s tandard for registrati o n. C hanges in science, public policy, and pesticide use practices occur ove r time. The reg istration rev iew pro g r am is intended to make sure that, as the ab ility to assess ri s k evolves and as polici es and practices change, all registered pesticides continue to meet the statutory standard. The publ ic phase of registration review begin s when the initial docket is opened for each ca se. Information on this program is provided on the Agency's web s ite. ' The FWP begins with any updates since the PWP was issued. Next is a summary of substanti ve comments rece ived during the public comment period for the PWP concerning anticipated data needs , expected risk as sessments, or the estimated timeline identified in the PWP , and a summary of the Agency's res ponses to tho se comments. This section is followed by registration review planned data needs , risk assessments expected to be conducted, and the projected registration rev iew time line for TM and MB C. Lastly, there is a discuss ion of ne xt steps. 

### UPDATES SINCE THE PWP WAS ISS UE D During the co mment period , the task force for the technical re gist rants, Thiophanate-Methyl and Carbend az im T as k Force (TM/MBC Task Force) subm itted several comments focused on the anticipated data requirement s listed in the PWP and its supporting documents fro m BEAD , EFED, and HED. Specifically, TMIMBC Task Force has already submitted a batch equilibrium adsorption/desorption study (GLN 835.1230) and an anaerobic aquat ic metab olism stud y (GLN 835.4400) for both TM and MBC. The Agency has found the data for both studies to be acceptable; and , therefore, will not include GLN 835.1230 (batch equilibrium adsorption/desorption study) or GLN 835.4400 (anaerob ic aquatic metabolism study) in the registration rev iew DCI TM and MBC.

1 http: //www . epa.gov/oppsrrd ! / registratio n _review/ 2A correcti on in the registration review timeline has been made since the PWP. T he antic ipated time li ne in th e PWP incorrectly li sted an anticipated issuance of the O CI as Apr il to June 2014 , when 

### it shou ld have been listed as October to December 2014. As a result of this correction, the anticipated registration review timeli ne has been adjusted and is expected to conclude in 2020. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day pub li c comment period on the Thi ophanate Methyl and Carbendazim Preliminary Work Plan , which opened on March 28, 2014 and closed on May 27 , 201 4 , the Agency received comments from eight stakeholders. Comments were submitted by the TMIMBC T ask Force, the FIFRA Endangered Species Task Force (FESTF), the Center for Biological Diversity (CBD), and other organi zat ions and individual stakeholders with agricultural interes ts : Northwes t Horticu ltural Counc i l; Central Vall ey Regional Water Quality Contro l Board; Washington State Pes t Management Resource Service, Washin g ton State University Tri-Cities; U niver sity of Hawaii ; and Arizona Pest Management Center, University of Arizona. The comments do not address the timeline described in the PWP , but those submitted by the TMIMBC Task Force do address the planned ecological and human heal th risk assessments and the data requirements

. In the PWP, EPA als o so licited comments on the specific topics of environmental justice , water quality concerns, and trade irri t ants, and of these topics EPA rece ived one comment on trade irritants from the Northwest Horticultural Council. This secti on does not capture every comment made in respon se to the PWP nor all of the Agency's responses . Summarized below are public comments that resulted in changes to the anticipated registration review data needs , risk assessments, or timeline , or are of a broader regulatory nature

. Pub li c comments and EPA responses in their entir ety are located in th e docket , EPA -H Q -O PP-2014

- 0004. Summarized public comments and Agency responses related to the anticipated ecological risk assess ment or data needs are in the EFED and AD Response to Task Force Comments on Preliminary Problem Formulation Assessment in Support of Regist ration Review ofThiophanate Methyl and Carbendazim (D420909 and 420913) while those relevant to the anticipated human health risk assessment or data needs a re in the Thiophanate-Methyl (I'M)/ Carbendazim (MBC). Respon se to Registrants ' Comments on Registration Review Preliminary Workplan (D420917 and 0420 1 9). Comments s ubmitted by TM/MBC Task Force in EPA
- HQ-OPP
-2014
- 0004
- 0013. 1

. Comment: The TMIMBC Task Force submitted a comm en t reques ting a 30-day extension of the public commentpe riod for the TMIMBC registration revi ew docket

. However , the TM/MB C Task Force then submitted com ments on the registration revi ew ofTMIMBC. Respons e: The Agenc y thanks the TMIMB C Task Force for its co mment. No time extension was granted for the public comment period because the Agency accepted submission of comments by the TM/MB C Task Force on June 10,2014. The Agency responses to these comments can be found in the EFED and AD Response to Task Force Comments on Preliminary Problem Formulation Assessment in Support of Registration Review ofThiophanate Methyl and Carbendazim (0420909 and 420913) and Thiophanate-Methyl (TM)/Carbendazim (M BC ). Response to Registrants ' Comments on Registration Review Preliminary Workplan ( 0 420917 and 042 0919) documents.



### 3Additional Comments subm itted by TM/MBC Task Force. 2. Comment: The Ta sk Force requested confirmation that a 28-day inhalation s tud y is acceptable in lieu of a 90-day inhalation study to fulfill the data requirement based on previous discussions with the EPA. Respons e: EPA concurs that a rat 2 8- day i nha lation toxicity with assessment of thyroid parameters w ill satisfy the guideline requirement for a subchronic inhalation toxicity study and that the study protocol should be submitted for review

. 3. Comment: The Task Force requested that the Agency reserv e the requirement for a developmental thyroid study on TM pending review of the rat exte nded one-gen erati on reproductiv e toxicity study on MBC. Since TM is rapidly metab o lized to MBC, the Task Force propos es that th e MBC study will adequately assess potentia/th yroid toxicity jrom TM and that the requirement for a developmental thyroid study on Tlvfshould be held in reserve pending its review. Respons e: A lthough TM is metabo lized to MBC , it has been shown to affect th e liver and thyro i d. Effects on th e thyroid are observed in se veral species exposed to TM, but the available studies on MBC do not show toxicity to the thyroid. There remain uncertainties regarding the relati ve sensitivity to effects fro m TM during early development because thyroid effects may result i n permanent develop mental effects. T hus , this study is required to support registration review ofTM.
4. Comment: The Task Force requested that the Agency reserve the requirem ent for an immunotoxicity study on MBC pending review of the rat extended one-generation reproductive toxicity study on MBC, which includes evaluation of several parameters relevant to immunotoxicity. Response: The Agency wi ll reserve this requ irement pending review of the extended o n egeneration reproductive toxicity study. Upon consideration of that data, the requirement for an immunotoxici ty study will be determined. 5. Comment: The Task Force has indicated the exposure data requirement to assess occupational and residential handler exposures associated with the use of an airless sprayer, low pressure handwand , and brush/roller,· various pouring /

mi xing activities for liquid and solid material s (paints/s tains and slurries) ; and indoor surface residue dissipation data for plastic toys and textiles will be satisfied through its membership in the American Chemistry Council ' s (ACC) Antimicrobial Exposure Assessment Task Force 11 (AEATF II). For the textiles and toys, the Task Fo rce is reassessing the role of MBC in the textile market, and intends to limit the use of MBC in plastic articles which are not for toys. Pending afinal decision with respect to MBC in textiles andplastics, the Task Force has requested the Agency hold the residue dissipation requirem ent in reserve.

4Response: The Agency considers the proposed use of the AEATF II data to be an acceptable approach to providing the additional occupational and residential exposure information for MBC. With respect to the impregnated toys, no data would be required if these products are removed from the market. Likewise, no data would be required if tex ti les containing MBC are no longer marketed.
6. Comment: The Task Force believes that previously submitted datafor GLN 835.1230, Batch Equilibrium Adsorption ! Des01ption, and GLN 835.4400 (listed incorrectly as 835.4300), Anaerobic Aquatic Metabolism, adequately fu(fills the data requirements for TMIMBC. Response: The Agency has re-examined the data and concurs with the Task Force, no further data are required for GLNs 835.1230 and 835.4400. 7. Comment: The Task Force believes that currently available datafor GLN 835.2120, Hydrolysis, for TMIMBC fulfill this data requirement.
Re sponse : The Agency has reviewed existing hydrolysis data and it does not conclusively confirm that MBC is completely stable at all environmental p H and temperature conditions. The Agency believes environmental exposure assessments can continue for TM and MBC without any additional data. However, from the available data the Agency can only conclude that TM is potentially stable in acidic so ils and waters and MBC is generally stable to hydrolysis in the environment and, in lieu of any addi tional data, will make s uch assumptions in future environmental fate modeling. 8. Comment: The Task Force believes that existing data for GLN 835.4100 , Aerobic Soil Metabolism , for TM I

MBC fulfill this data requirement. The data explains the behavior of both TM and MBC in the environment. Response: The data for TM were tested in a 1976 study (MRID 001 06085) using thin

- layer chromatography (TLC) for analysis of residues over t ime, and t hat, up to the most r ecent assessment these data we r e not identified as inadequate to meet curre nt data requirements. TLC is no longer accepted for quantitative analysis in environmental fate studies su bmitted to the Agency. The Agency reserves the right to assume that results from the TM hydrolys i s studies represent the m?st conservative estimate ofTM aerobic soil degradation rates in acidic and neutral soils and waters. With regards to the 835.4100 studies for MBC, the Agency notes that while the MRID 00106085 studies are inadequate by current standards, the y do appear to show very hi gh stab ili ty of the MBC as a r a pidly formed de gradate of TM

. The Agency can rely on the acceptab le study conduc te d with benomyl (MRID 41255801 ), however, data is only availab le for a s in gle soi l test. Currently under OCSPP guidelines tests in four so ils are required for most pesticides with s ignificant field 

### I outdoor uses. Standard modeling procedure under current EFED guidelines is to multiply the aerobic soil metabolism halflife value by 3x when data from on ly a single test soil are available. Additionally, the Agency will have to determine the mechanism for reliance on data submitted for the support of the registration of a different active ingredient (benomyl, which is now canceled).



### 59. Comment: The Task Force believes that ex isting data for GL N 835.4300 (listed incorrectly 835.4200), Aer o bic Aquatic Metabolism study, is acceptable and fulfills the data requirement for TM Re sponse: The Agency reiterates this study was classified as "supplemental" and additional data are requi red. However, data will only be required in two test systems at least one of which is significantly acidic. An intern a l Agency memorandum dated 3/3/2003 states the following: Attached to this memorandum is the aerobic aquatic metabolism DERs for the 1 62 -4 studies for thiophanate

- methy l and carbendazim. The aerobic aquatic metabolism study of thiophanate methyl (MR ID 45621401) is classified as supplemental. It is scientifically valid, but does not meet the guidelines for an aerob ic aquatic metabolism study because the sed iment phase was anaerobic at the time of treatment and remained anaerobic throughout the study. The aerobic aquatic study ofMBC (M RID 45620001) does not satisfy the guideline requirements for a U.S. EPA Subdivision N, section 162-4, thus it is classified as unacceptable. In the later study, no evidence of redo x potential monitoring data was provided to demon strate that the sedi ment phases were aerobic/anaerobic at the time of treatment. Based on the Pesticides Reregistration Rejection Rate Analysis, redox potentials of the sediment-water system should be monitored during the study. With respec t to 835.4300 studies fo r MBC, given the extremely high persistenc e shown by MBC in all available aerobic soil studies, the Agency remains concerned that MBC may be more stable in some waters than the studies with benomyl applied demonstrate

. The Agency respectfully beli ev es these stud ies should still be required, but is reducing the request to two test sediment water systems with technical MBC applied; at least one of these test systems should be significantly acidic , but the spec ific selection of the sediment water systems will be at the registrant's discretion (but they must be fully characterized as required under OCSPP guidelines). 10. Co mment: The Task Force believes that ex isting data for GLN 850.4 100 , Terrestrial Plant Toxicity, Seedling Emergence , and 850.4150 , Terrestrial Plant Toxicity , Vegetative Vigor satisfy the se data require ments. Howeve r , the Task Force will consider th e co nduct of the studies relative to rate adjustment (if any) on turf · Re spo nse: Seedling Emergence and Ve ge tative Vigor testin g at hi g her rates was requested in the original TM RED based on the labeled rates that exceed the 1.4 lb a i rate that was tested with Topsin M (95% ai test material) (M RID 42123504 Tier I and Tier II test). Onion and soybean emergence were affec ted at this rate. The vegetative vigor study was considered supplemental due to missing informa ti on regarding growth stage of tested plants. 11. Comment: The Task Force has indicated that they have adult ora/test results with the hon eybee from a 2005 study and that they intend to submit this study. Additionally, the Task Force has questioned the need for larval toxicity testing based on low toxicity to adult honeybees in the contact toxicity test.

6Response: The Agency will make every effort to review the adult ho neybee data quickly for determination of acceptability. Wi th regards to the larval toxicity testi n g, the Agency does not agree that th e acute toxicity to adults will necessarily be reflective of the chronic toxicity to developing l arvae. This has been shown to be true for other pe st icides that demonstrated relati ve ly low toxicity to adu lt s, but higher toxicity to the developing larvae. In addition , a recent extensive study on over 200 pesticides found in wax and pollen within hives ofNorth America (Mullin, C.A. eta!, 2010) has shown that thiabendazole, a closely related benzimidazole to thiophanate methyl, was present in concentrations ranging from 1.4 to 5.6 ppb in pollen samp les and from 1.4 to 76 ppb in bee wax samples. MBC was also detected in pollen and wax at conce ntration s ranging from 1.5 to 149 ppb in pollen, and from 2.1 to 133 ppb in bee wax. It wou ld seem likely that the presence of MBC was from crop uses of TM and less likely from tree in jec tion use as MBC. This suggests that larvae will be exposed thi s fami ly of chemical s, but does not provide us with th e toxicity l evels at which this type of exposure will prove hazardous to developin g larvae

. 12. Comment: The Task Force has proposed that testing with an aquatic vascular plant (Lemna sp) and th e more sensitive freshwate r diatom (Navicula pelliculosa) be conducted and all other aquatic plant species testin gfo r MBC as a degradate be held in reserve, until res ults for these two species can be compared to the result s with parent TM Respon se: AD requires testing with both

**L~mna** and green algae. If the ECs o fo r the green algae is less than 1 ppm, then testing with freshwater and marine diatoms and cyanobacteria also is required.
13. Comm e nt: The Task Force has requested that the sediment testing with a marine invertebrate be held in reserve pending results of the freshwater invertebrate test based on the fact that es tuarine mysid chron ic test results with MBC show lower toxicity than that of freshwater organisms. The Task Force proposes that the results from thefreshwater insect larvae sediment test be used to dismiss the need for chronic sedimen t testing with the marine amphipod species

. Response: T he Agency believes that MBC will reach aquatic sed iments in both fres h and marine environments based on current use patterns of TM

. The Agency does not agree with the basis for this request and therefore is asking that both the freshwater and marine tests be conducted , as requested. Th e Agency re commends that a proto co l for the marine test be s ubmitted before commencing the study. Comments su bmitted by Washington State Pest Management Resource Service, Washington State Un ivers ity Tri-Cities in EPA-HQ-OPP-2014-0004-0014. 14. Comment: The Washington State Pest Management Resource Service, Washington State University Tri-Cities provided information on TMIMBC use in Integrated Pest Management (!PM) programs in Alaska, California, Idaho, Montana, Oregon, Utah, and Washington. Th e primary uses ofTMIMBC {n th ese regions are on almond , cherry/peach/nectarine, chickpea, grape , greenhouse, pistachio, pome fruit , potato, and strawberry. The almond use information that was included in this submission was supplied by the Almond Board of California.

7Response: The Agency thanks the Washington State P est Management Resource Service Washington State University Tri-Cities for its comment. This informatio n will be considered dur ing the TM/MBC registration review. Comments su bmitted by Northwest Horticultural Council in EPA
- HQ-OPP-2014-0004
- 0015.
15. Comment: The Northwes t Horticultural Council represents the growe rs and shippers of apples, pears , and che rries from Idaho, Oregon, and Washingt on and provided information on TMIMBC use in these states as well as on trade irritants. Response: The Agency thank s the Northwest Horticultural Council for its comment. This information will be considered during the TM/MBC registratio n review. Comments submitted by Arizona Pest Management Center, University of Arizo na in EPA
HQ
- OPP -2 014 -0004-00 16. 16. Comment: The Arizona Pest Management Center provided information on TMIMBC use in A rizo na. The main uses from 2010 and on have been on onion and beans. Response: The Agency thanks the Arizona Pest M anagement Center for its comment. T hi s information will be considered durin g the TM/MBC registrati on review

. Comments subm itte d by FESTF in EPA-HQ -OPP-20 14-0004-001 7. 17

. Comment: FESTF submitted a comm ent that the TM and MBC technical registrants, Gowan Company , Nipppon Soda Company Ltd., and Nufarm, are members of the FESTF task force and are entilled to rely on data submitted by FESTF. Re s ponse: The Agency thanks FES TF for its comment and will cons ider this information during the TM/MBC registration review. Comments s ub mitted by CBD in EPA
- HQ-O PP -20 14-0004-0018 . 18. Com men t: CB D 's comm ents focus on the E P

A 's duty to consult with the 

### U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review ofTMJMBC in accordance with the Endangered Species Act (E SA}. CBD 's comments mention various aspects of th e risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened species and their designated critica l habitat

. CBD also exp resse s concern regarding the rigor of the Agency's preliminaty determinations regarding the effec ts ofTM IM BC on endangered and threatened (listed) specie s and their designated critical habitat for the TMIMBC registration review.
Re sponse: EPA has reviewed th e comments from CBD on the registration review docket opening for TM/MBC and plans to address many of the concerns raised by CBD as part of the

8implementation plan for assessing the ri sks of pesticides to li sted spec ies based on the recommendations ofthe April2013 National Academy of Sciences (NAS) report. E PA will address concerns specific to TM/MBC in connection with the development of its final registration review decision for this pesticide

.. In November 20 1 3, the EPA, along w ith the Services and the USDA, rele ased a summary of the ir joint Interim Approaches for assessing risks to endangered and threatened ( li sted) species from pes t icides. The Interim Approaches were develop ed jointly by the agencies in respon se to the NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific d i fferences between t he EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Serv ices must conduct in connection wi th thei r obligati ons under the ESA and FIFRA. The joint Interim Approaches were released prior to a stakeholder workshop held on November 15,2013. In add ition, the EPA presented the joint Interim App roaches at the December2013 Pesticide Program Dialogue Committee (PPDC) and State-FI FRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder works hop in April 2014, all owing additional opportunities for stakeholders to comment on the Interim Approaches. Addi t ional works hops are planned to enhance stake holder invo lvement ; the next wor k s hop is scheduled for October 2014. As part of a phased, iterative process for developing the Interim Approaches , the agenc ies w ill alsq consider public comments on the Interim Approaches in connection with the development of upcoming registration revi e w decisions. The details of the joint Interim Approaches are contained in the white paper, Interim Approaches for NationalLevel Pesticide Endang ered Species Act Assessmen ts Based on the R eco mm endatio ns of the National Academy of Sciences April 2013 Report, dated November 1, 2013. Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches t o assess the potential risks ofpesticides to listed species and their des i gnated critical habitat, the ecological problem formulation supporting this Final Work Plan fo r TM/MBC does not describe the specific ESA analysis, inc lud ing effects determinati ons for specifi c listed spec ies or designated critical habitat, to be conducted durin g registration review. In the ecologica l problem formu lat ion document for TMIMBC , EPA described the screeninglevel risk assessment to determine the potential effects ofTMIMBC on all taxa of non - target wild li fe and p lants, whic h will assume that li sted spec ies and their designated critical habitats may be present in the vicinity of the application ofTMIMBC. This sc r eening-level assessment will allow EPA to focus its f uture evalu at ions on the types of spec ie s where the potential fo r effects exists once the sc ien tific me thods being developed by th e agencies have been fully vetted. While the agencies continue to develop a common method for ESA analys is , the planned screening-level risk assessment for the registration review of TM/MBC w ill descr i be the level of ESA analysis completed for this particular registration review case. Once the agenc ies have fully developed and implemented the scientific methods nec essary to co mplete ri sk assessments for e ndangered and thre atened ( li sted) sp ec ies and th eir desi gnated critical habitats, th ese method s will be applied to subsequent analyses for 

### TM!MBC as part of comp leting this registration rev1ew.



### 9Comments submitted by Central Valley Regional Water Quality Control Board in EPAH Q

- 0 PP

-2014-0004-0019. 19. Comment: The Central Valley Regional Water Quality Control Board submilled a comment in support of data requirements and thejoint consideration ofTM!MBC. Re sponse: The Agency thank s the Central Valley Re gional Water Quality Control Board for its comment. Comments submitted by Un iversity of Hawaii in EPA -HQ- OPP -201 4-0004-0020. 20. Comment: The University of Hawaii provided information on TMIMBC use in Hawaii. The use information pertained to turf, landscape ornamentals, and nursery ornamentals. Re sponse: The Agency thanks the Univers ity of Hawaii for its comment. Thi s information will be considered during the TM /MBC regi stration review. PLANNED DATA NEEDS Table 1 below sum mari zes the planned data needs for TM and M B C based on the EFED and AD Response to Task Force Comments on Preliminary Problem Formulation Assessment in Support of R egis t ration Review ofThiophanate Methyl and Carbendazim (0420909 and 420913), and Thiophanate-Methyl (IM)/Carbendazim (MBC). Response to Registrants' Comments on Registration Review Preliminary Workplan (Docket ID No. EPA-OPP-2014-0004) (0420917 and 420919). The table has been updated since the PWP to reflect the data requirements that will be issued under the DCI for registration review.
Table 1: Planned Data Needs for TM and MBC Registration Review Estimated Guideline Study Title2 Timeframe Number2 Test Material (Months from receipt of DCI) Anticipated Data Needs for TM 835.2120 Hydrolysis TGAI 12 835.4100 Aerobic soil metabolism TGAI 24 835.4300 Aerobic aquatic metabolism TGAI 24 835.6200 Environmental che mistry meth ods and associated TGAI 12 independent laboratory validations for water 850.4100 Terrestrial plant toxicity, seedling emergence 3 TEP 12

2 On June 27, 2012 , EPA announced certain revisions in harmonized guid eli ne series 850- Ecological Effects Tests -including renumb ering and other designations or changes for some guideline studies. See "Final Test Guidelin es; OCSPP 850 Series; Notic e of Avail ab ility" 77 FR 38282, June 27,2012. http ://www.regulation s. gov/ # !docum e ntDetai i ;D = EP A-HO -OPPT-2009

-0 154-0028 3 Previously submitted plant toxicity studies were conducted at a lower appl ication rate than the currently labeled maximum application rate.
10T ab le 

### 1 : P la n ned D a t a Need s fo r TM a nd MB C Registratio n Review
Estimated Guideline Study Title2 Timeframe Numbea2 Test Material (Months from receipt of DCI) 850.41 

## so Terrestrial plant toxicity, vegetative vigorl TEP 12

Non- Honey bee acute o ral toxicity (OECD 213) TGA I 12 Guideline

Non

- Honey bee larval toxic ity (OECD 237) T GA I 12 Guidel ine 870

. 3465 Subchronic inh alati on toxic i ty TGA I 24 Non- D evelopme nta l thy ro id assay TGA I 2 4 Gu idel ine Anticipated Data Needs for MBC 835.2120 Hydrolysi s TGA I 12 835.4100 Aerobic s oil metabolism TGA I 24 835.4300 Aerobic aquatic metabolism TGAI 24 835.6 1 00/ Environmental chemistry methods and assoc iated 835

. 62 00 independent labo rat o ry va lid atio n s for soi l and TGA I 12 water 850.4400/ 850.4500/ Aq uat ic plant tox icity TGA l 12 850.4550 870.7800 l mmu n otoxicity TGA 1 12 875.1200 / Dermal and inhalation exposu re applying 875.1400 paint/stain (airless sprayer, low pressure TEP 24 handwand and brush/roller) 875.1200/ Occ up ationa l de rma l and inh alation fo r pouri n g 875

. 140 0 liquid an d or so l id m ate ria l preservati ves TEP 2 4 fo rm u la ti o n s ( p ai nts/s tain s, sl urr ies) 875. 1 700/ Product Use Info rmation (A ntimicrob ia l Uses) TEP 12 875.2700 for applying paints / sta ins 875.2300 Indoor surface residue dissipation for plastic toys TEP 24 a nd textile s Non- Honey bee acute oral toxicity (OECD 213) TGA I 12 Guide line

Non

- H o ney bee larval toxic i ty (O ECD 23 7) TGA I 12 Gu ide line

N o n- Whole sedime nt c hronic t ox ic ity test for a quatic TGA I 24 Gu ide line invertebrates

No n- L eac hi ng study: Exterior p ai nted surfaces/wood TEP 12 Guideline pro tective s tains/ roof coatings

No n- L each ing study : Treated textiles T E P 12 Guide l ine

1 12 On June 27, 20 I 2, EP A announ ced cert ain rev isions in harmon ized gui del ine series 850

- Ecolog ical Effects Tests -includi ng renumbering and other designations or changes for some guidel ine stud ies

. See " Final Test Guidelines ; OCSPP 850 Series ; Notice of Availability " 77 FR 38282, June 27 , 2012. http: //www .regulation s .gov / #! documentDetail; D= EPA-HQ -OPPT

-2 009-0 1 54 -0028 

### RISK ASSESSMENTS FOR REGISTRATION REVIEW During r egistrati on review, the Agency will conduct a com prehe nsive ec ological ri sk assessment, including an endangered species assessment, for all us es ofTM and MBC. For human health, EPA wi ll conduct revised di etary, res identi a l , and occup ational ri sk ass essments during regis trati on review. If toxico log ical endpoints or points of departure are revised based on the data that are req uired for registration review, they w ill be co nsider ed in the new assessments , as well as any changes to the s tandard operating procedures or de fault exposure assumptions

. Tab le 2 below summarizes the planned reg i stration review risk assessments based on the EFED Problem Formu lation and HED Sco ping Document. The planned assessments have not changed from what was included in the PWP. ·

12Table 2: Planned Risk Assessments for the Th i ophanate Methyl and Carbendazim Registration Review Type of Risk Assessment Conduct? Notes Ecological and Environmental Fate Comprehensive ecological 

### y This will be cond ucted for both TM and MBC. (species to be assessed include terre strial and aquatic organisms) , incl uding endangered s pe c ies Inc idents Will check for For a discussion o f reported ecological incidents for updates TM and MBC , s ee page 28 of the Problem Formul ation. Human Health D ietary Food 

### y This will be cond ucted for both TM and MBC. Will include updated percent crop treated estimates , residue monitoring data if available, changes in toxico logical endpoints and uncertainty fac tors, and the revised estimated drinking water concentrations. Drinking water 

### y This will be conducted for both TM and MBC using the most current version of the dietary model along with any potenti a l changes in endpoints and doses for risk assessment. Occ upati o na l Handlers (mixers , loaders, 

### y An updated non- c ancer and cancer occupational applicators) handler exposure assessment for TM will be conducted for reg istered agricultural , seed treatment , and commercial turf (i.e., golf course maintenance) uses. Updated hand ler dermal and inhalation exposure risk assessments for the MBC paint use along with manufacturing preservative uses (liquid and solid pouring) will be c onducted and will incorporate updated toxicolo gical endpoints and updates to the Agency's standard assumptions for condu cting handler exposure assessments, including revised unit exposure data. Post-application 

### y Updated non-can c er and cancer occupational po s tapplication expo s ure assessments will be required for agricultural, seed treatment, and commercial turf uses. Based on the Agency's current practices, a quantitative post-application inhalation exposure assessment for TM and MBC us e is not expected. Residential



### 13Handlers 

### y This assessment will incorporate the additional TM and MB C toxicological endpo int s and uncertainty factors , updated h uman exposure facto rs assumption s (e.g., body weight), and the 2 012 S OPs for Residential Pe sti c ide Expos ure Assessments. Post-application 

### y A revised residential d erm al and incidental oral postapplication exposure and risk assessment (non

- cancer and cancer) for turf w ill be conducted during reg istration review for all formulations of TM pro du cts used on commercial and residential treated turf.
A residential dermal and in c idental oral postapplication expo sure assessment fo r MBC us es in plastic toys an d textile s is antici pate d. Howev e r, no assessment wo uld be completed if these produ cts are removed f rom the market. Other Aggregate 

### y Additional tox icology data on TM and MBC may change th e endpoints selected for ri s k assessment , and could impact the s electi o n of safety and uncertaint y factors. Because of update d scie nc e policies and n e w residentia l and di etary exposure es timates new agg rega t e exposure and risk assessme nts will be conducted. Cumulative Will consider The Agency has not determined whether TM and MBC share a common mechanism of toxicity with other chemical substances. A cumu lative assessment is not needed at this time fo r TM and MBC, but may be required in the future if a cumulative assessment group (CAG) for benzimidazo le fungicides is identified and th e hazard or expos ure data indicate that it is ap propri ate to in cl ud e TM and MBC in that

**group**

**~** To lerances 

### y EPA will re vis it the tolerances and tolerance definitions, and harmonize them w ith the Codex and Canadian M RLs and MRL definitions, when possibl e. Inc ide n ts Will check fo r Fo r a discussion of reported human incident s for TM updates and MBC, see page 28 of the Scoping Document and the Thiophanate-methyl and Carbe nda zim : Tier I R eview of Huma n Incidents.

T I M ELINE
14EPA has created the following est imated timeline for the completion of the TM and MBC registration review in Table 3 below. The projected timeline has been updated due to the PWP incorrectly li sting the issuance of the DCI as April to June 20 1 4 , when it should have been listed as October to December 20 14. As a result of this correction the anticipated registration review timeline has been adjusted and is expected to conclude in 2020. Table 3: Projected Registration Review Timelinc for TM and 

### MBC Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2014- March Close Public Com ment 2014- May Case Development Final Work Plan 2014

- September Issue DCI 2014- Oct.

- Dec. Data Submiss ion 2016

- Oct.

- D ec. 60-day Public Comment Period for Draft Risk Assessments 2018

- April- June Registration Review Decision 60-day Public Comment Period for Propo sed Registration 2019

- Jan.

- Mar. Review Decis io n Re gistration Review Decision and Begin Post-Decision Follow- 2020 up Total (years) 6 NEXT STEPS As noted previously , the Agency plan s to require several env ironmental fate , ecological effects , and human health st udies fo r TM and MBC through a D ata Call-In Notice, expected to be issued in 2014.



### 15