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 Lewis, Director 

Antimicrobials Division 

Date 
INTRODUCTION 

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

the registration review of thiophanate methyl (TM) and carbendazim (MBC). This work plan 

addresses 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 pesticide active ingredient and also a metabolite, environmental degradate and the pesticidally 

active moiety ofTM. The two compounds are therefore considered together in this registration 

review pursuant to 40 CFR Part 155.42(a). TM is a systemic benzimidazole fungicide registered 

for use on a variety of agricultural use sites including row, field and orchard crops, greenhouses, 

nurseries, and as a commercial seed and bulb dip treatment. TM non-agricultural use sites 

include use on turf, which includes sod farms, golf courses, athletic and recreational fields, and 

ornamental grasses for landscapes and interiorscapes. MBC is registered for use on nonagricultural sites for ornamental tree injection and use as an industrial biocide additive to 

coatings, paints, stains, stuccos, plasters, sealants, caulks, fillers, adhesives, paper, plastics, and 

textiles. 

The Agency 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. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency's website. ' 

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received 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 Agency's responses to those comments. This section is followed by registration 

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

registration review timeline for TM and MBC. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

During the comment period, the task force for the technical registrants, Thiophanate-Methyl and 

Carbendazim Task Force (TM/MBC Task Force) submitted several comments focused on the 

anticipated data requirements listed in the PWP and its supporting documents from BEAD, 

EFED, and HED. Specifically, TMIMBC Task Force has already submitted a batch equilibrium 

adsorption/desorption study (GLN 835.1230) and an anaerobic aquatic metabolism study (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 (anaerobic aquatic metabolism study) in the 

registration review DCI TM and MBC. 

1 http://www.epa.gov/oppsrrd !/registration _review/ 

2 
A correction in the registration review timeline has been made since the PWP. The anticipated 

timeline in the PWP incorrectly listed an anticipated issuance of the OCI as April to June 2014, 

when it should have been listed as October to December 2014. As a result of this correction, the 

anticipated registration review timeline has been adjusted and is expected to conclude in 2020. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period on the Thiophanate Methyl and Carbendazim 

Preliminary Work Plan, which opened on March 28, 2014 and closed on May 27, 2014, the 

Agency received comments from eight stakeholders. Comments were submitted by the 

TMIMBC Task Force, the FIFRA Endangered Species Task Force (FESTF), the Center for 

Biological Diversity (CBD), and other organizations and individual stakeholders with 

agricultural interests: Northwest Horticultural Council; Central Valley Regional Water Quality 

Control Board; Washington State Pest Management Resource Service, Washington State 

University Tri-Cities; University 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 health risk 

assessments and the data requirements. In the PWP, EPA also solicited comments on the specific 

topics of environmental justice, water quality concerns, and trade irritants, and of these topics 

EPA received one comment on trade irritants from the Northwest Horticultural Council. 

This section does not capture every comment made in response 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. Public comments and EPA responses in their entirety are located in the docket, 

EPA-HQ-OPP-2014-0004. Summarized public comments and Agency responses related to the 

anticipated ecological risk assessment or data needs are in the EFED and AD Response to Task 

Force Comments on Preliminary Problem Formulation Assessment in Support of Registration 

Review ofThiophanate Methyl and Carbendazim (D420909 and 420913) while those relevant to 

the anticipated human health risk assessment or data needs are in the Thiophanate-Methyl (I'M)/ 

Carbendazim (MBC). Response to Registrants' Comments on Registration Review Preliminary 

Workplan (D420917 and 042019). 

Comments submitted by TM/MBC Task Force in EPA-HQ-OPP-2014-0004-0013. 

1. Comment: The TMIMBC Task Force submitted a comment requesting a 30-day extension of 

the public comment period for the TMIMBC registration review docket. However, the TM/MBC 

Task Force then submitted comments on the registration review ofTMIMBC. 

Response: The Agency thanks the TMIMBC Task Force for its comment. No time extension 

was granted for the public comment period because the Agency accepted submission of 

comments by the TM/MBC 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 (MBC). 

Response to Registrants' Comments on Registration Review Preliminary Workplan (0 420917 

and 0420919) documents. 

3 
Additional Comments submitted by TM/MBC Task Force. 

2. Comment: The Task Force requested confirmation that a 28-day inhalation study is 

acceptable in lieu of a 90-day inhalation study to fulfill the data requirement based on previous 

discussions with the EPA. 

Response: EPA concurs that a rat 28-day inhalation toxicity with assessment of thyroid 

parameters will 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 reserve the requirement for a 

developmental thyroid study on TM pending review of the rat extended one-generation 

reproductive toxicity study on MBC. Since TM is rapidly metabolized to MBC, the Task Force 

proposes that the MBC study will adequately assess potentia/thyroid toxicity jrom TM and that 

the requirement for a developmental thyroid study on Tlvf should be held in reserve pending its 

review. 

Response: Although TM is metabolized to MBC, it has been shown to affect the liver and 

thyroid. Effects on the thyroid are observed in several species exposed to TM, but the available 

studies on MBC do not show toxicity to the thyroid. There remain uncertainties regarding the 

relative sensitivity to effects from TM during early development because thyroid effects may 

result in permanent developmental effects. Thus, this study is required to support registration 

review ofTM. 

4. Comment: The Task Force requested that the Agency reserve the requirement 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 will reserve this requirement pending review of the extended onegeneration reproductive toxicity study. Upon consideration of that data, the requirement for an 

immunotoxicity 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/mixing activities for liquid and solid 

materials (paints/stains 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 Force 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 a final decision with respect to MBC 

in textiles and plastics, the Task Force has requested the Agency hold the residue dissipation 

requirement in reserve. 

4 
Response: The Agency considers the proposed use of the AEA TF 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 textiles containing MBC are no longer 

marketed. 

6. Comment: The Task Force believes that previously submitted data for 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. 

Response: The Agency has reviewed existing hydrolysis data and it does not conclusively 

confirm that MBC is completely stable at all environmental pH 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 soils and waters and MBC is generally stable to hydrolysis in the 

environment and, in lieu of any additional data, will make such assumptions in future 

environmental fate modeling. 

8. Comment: The Task Force believes that existing data for GLN 835.4100, Aerobic Soil 

Metabolism, for TMIMBC 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 time, and that, up to the most recent 

assessment these data were not identified as inadequate to meet current data requirements. TLC 

is no longer accepted for quantitative analysis in environmental fate studies submitted to the 

Agency. The Agency reserves the right to assume that results from the TM hydrolysis 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, they do appear to show very high stability of the 

MBC as a rapidly formed de gradate of TM. The Agency can rely on the acceptable study 

conducted with benomyl (MRID 41255801 ), however, data is only available for a single soil test. 

Currently under OCSPP guidelines tests in four soils are required for most pesticides with 

significant 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 only 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). 

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9. Comment: The Task Force believes that existing data for GLN 835.4300 (listed incorrectly 

835.4200), Aerobic Aquatic Metabolism study, is acceptable and fulfills the data requirement for 

TM 

Response: The Agency reiterates this study was classified as "supplemental" and additional data 

are required. However, data will only be required in two test systems at least one of which is 

significantly acidic. An internal Agency memorandum dated 3/3/2003 states the following: 

Attached to this memorandum is the aerobic aquatic metabolism DERs for the 162-4 studies for 

thiophanate-methyl and carbendazim. The aerobic aquatic metabolism study of thiophanate 

methyl (MRID 45621401) is classified as supplemental. It is scientifically valid, but does not 

meet the guidelines for an aerobic aquatic metabolism study because the sediment phase was 

anaerobic at the time of treatment and remained anaerobic throughout the study. The aerobic 

aquatic study ofMBC (MRID 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 redox potential monitoring data was provided to demonstrate that the sediment 

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 respect to 835.4300 studies for MBC, given the extremely high persistence 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 

believes these studies 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 specific 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. Comment: The Task Force believes that existing data for GLN 850.4100, Terrestrial Plant 

Toxicity, Seedling Emergence, and 850.4150, Terrestrial Plant Toxicity, Vegetative Vigor satisfy 

these data requirements. However, the Task Force will consider the conduct of the studies 

relative to rate adjustment (if any) on turf · 

Response: Seedling Emergence and Vegetative Vigor testing at higher rates was requested in 

the original TM RED based on the labeled rates that exceed the 1.4 lb ai rate that was tested with 

Topsin M (95% ai test material) (MRID 42123504 Tier I and Tier II test). Onion and soybean 

emergence were affected at this rate. The vegetative vigor study was considered supplemental 

due to missing information regarding growth stage of tested plants. 

11. Comment: The Task Force has indicated that they have adult ora/test results with the 

honeybee 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. 

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Response: The Agency will make every effort to review the adult honeybee data quickly for 

determination of acceptability. With regards to the larval toxicity testing, the Agency does not 

agree that the acute toxicity to adults will necessarily be reflective of the chronic toxicity to 

developing larvae. This has been shown to be true for other pesticides that demonstrated 

relatively low toxicity to adults, 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 samples and from 1.4 to 76 ppb in bee wax samples. MBC was also detected in pollen 

and wax at concentrations ranging from 1.5 to 149 ppb in pollen, and from 2.1 to 133 ppb in bee 

wax. It would seem likely that the presence of MBC was from crop uses of TM and less likely 

from tree injection use as MBC. This suggests that larvae will be exposed this fami ly of 

chemicals, but does not provide us with the toxicity levels at which this type of exposure will 

prove hazardous to developing larvae. 

12. Comment: The Task Force has proposed that testing with an aquatic vascular plant (Lemna 

sp) and the more sensitive freshwater diatom (Navicula pelliculosa) be conducted and all other 

aquatic plant species testingfor MBC as a degradate be held in reserve, until results for these 

two species can be compared to the results with parent TM 

Response: AD requires testing with both L~mna and green algae. If the ECso for the green algae 

is less than 1 ppm, then testing with freshwater and marine diatoms and cyanobacteria also is 

required. 

13. Comment: 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 estuarine mysid chronic test results with MBC show lower toxicity than that of 

freshwater organisms. The Task Force proposes that the results from the freshwater insect 

larvae sediment test be used to dismiss the need for chronic sediment testing with the marine 

amphipod species. 

Response: The Agency believes that MBC will reach aquatic sediments in both fresh 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. The Agency recommends that a protocol for the marine test be 

submitted before commencing the study. 

Comments submitted by Washington State Pest Management Resource Service, 

Washington State University 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. The 

primary uses ofTMIMBC {n these 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. 

7 
Response: The Agency thanks the Washington State Pest Management Resource Service 

Washington State University Tri-Cities for its comment. This information will be considered 

during the TM/MBC registration review. 

Comments submitted by Northwest Horticultural Council in EPA-HQ-OPP-2014-0004-

0015. 

15. Comment: The Northwest Horticultural Council represents the growers and shippers of 

apples, pears, and cherries from Idaho, Oregon, and Washington and provided information on 

TMIMBC use in these states as well as on trade irritants. 

Response: The Agency thanks the Northwest Horticultural Council for its comment. This 

information will be considered during the TM/MBC registration review. 

Comments submitted by Arizona Pest Management Center, University of Arizona in EPAHQ-OPP-2014-0004-0016. 

16. Comment: The Arizona Pest Management Center provided information on TMIMBC use in 

Arizona. The main uses from 2010 and on have been on onion and beans. 

Response: The Agency thanks the Arizona Pest Management Center for its comment. This 

information will be considered during the TM/MBC registration review. 

Comments submitted by FESTF in EPA-HQ-OPP-2014-0004-0017. 

17. Comment: FESTF submitted a comment 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. 

Response: The Agency thanks FESTF for its comment and will consider this information during 

the TM/MBC registration review. 

Comments submitted by CBD in EPA-HQ-OPP-2014-0004-0018. 

18. Comment: CBD 's comments focus on the EPA '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 (ESA}. CBD 's comments 

mention various aspects of the 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 critical habitat. CBD also expresses concern regarding 

the rigor of the Agency's preliminaty determinations regarding the effects ofTMIMBC on 

endangered and threatened (listed) species and their designated critical habitat for the TMIMBC 

registration review. 

Response: EPA has reviewed the 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 

8 
implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations ofthe April2013 National Academy of Sciences (NAS) report. EPA will 

address concerns specific to TM/MBC in connection with the development of its final 

registration review decision for this pesticide .. 

In November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to endangered and threatened (listed) species 

from pesticides. The Interim Approaches were developed jointly by the agencies in response to 

the NAS recommendations and reflect a common approach to risk assessment shared by the 

agencies as a way of addressing scientific differences between the 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 Services must conduct in connection 

with their obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on November 

15,2013. In addition, the EPA presented the joint Interim Approaches at the December2013 

Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and 

Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder workshop in April 

2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. 

Additional workshops are planned to enhance stakeholder involvement; the next workshop is 

scheduled for October 2014. As part of a phased, iterative process for developing the Interim 

Approaches, the agencies will alsq consider public comments on the Interim Approaches in 

connection with the development of upcoming registration review decisions. The details of the 

joint Interim Approaches are contained in the white paper, Interim Approaches for NationalLevel Pesticide Endangered Species Act Assessments Based on the Recommendations 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 to assess the potential risks of pesticides to listed species and their 

designated critical habitat, the ecological problem formulation supporting this Final Work Plan 

for TM/MBC does not describe the specific ESA analysis, including effects determinations for 

specific listed species or designated critical habitat, to be conducted during registration review. 

In the ecological problem formulation document for TMIMBC, EPA described the screeninglevel risk assessment to determine the potential effects ofTMIMBC on all taxa of non-target 

wildlife and plants, which will assume that listed species and their designated critical habitats 

may be present in the vicinity of the application ofTMIMBC. This screening-level assessment 

will allow EPA to focus its future evaluations on the types of species where the potential for 

effects exists once the scientific methods being developed by the agencies have been fully vetted. 

While the agencies continue to develop a common method for ESA analysis, the planned 

screening-level risk assessment for the registration review of TM/MBC will describe the level of 

ESA analysis completed for this particular registration review case. Once the agencies have fully 

developed and implemented the scientific methods necessary to complete risk assessments for 

endangered and threatened (listed) species and their designated critical habitats, these methods 

will be applied to subsequent analyses for TM!MBC as part of completing this registration 

rev1ew. 

9 
Comments 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 the joint consideration ofTM!MBC. 

Response: The Agency thanks the Central Valley Regional Water Quality Control Board for its 

comment. 

Comments submitted by University of Hawaii in EPA-HQ-OPP-2014-0004-0020. 

20. Comment: The University of Hawaii provided information on TMIMBC use in Hawaii. The 

use information pertained to turf, landscape ornamentals, and nursery ornamentals. 

Response: The Agency thanks the University of Hawaii for its comment. This information will 

be considered during the TM/MBC registration review. 

PLANNED DATA NEEDS 

Table 1 below summarizes the planned data needs for TM and MBC based on 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 (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 chemistry methods and associated TGAI 12 independent laboratory validations for water 

850.4100 Terrestrial plant toxicity, seedling emergence3 TEP 12 

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850- Ecological Effects Tests 

-including renumbering and other designations or changes for some guideline studies. See "Final Test Guidelines; 

OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27,2012. 

http ://www.regulations.gov/#!documentDetaii;D=EPA-HO-OPPT-2009-0 154-0028 

3 Previously submitted plant toxicity studies were conducted at a lower application rate than the currently labeled 

maximum application rate. 

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T able 1: P la n ned Da ta Need s for TM a nd MBC Registration Review 

Estimated 

Guideline 

Study Title2 Timeframe 

Numbea2 Test Material (Months from 

receipt of DC I) 

850.41 so Terrestrial plant toxicity, vegetative vigorl TEP 12 

Non- Honey bee acute oral toxicity (OECD 213) TGAI 12 Guideline 

Non- Honey bee larval toxicity (OECD 237) TGAI 12 Guideline 

870.3465 Subchronic inhalation toxicity TGAI 24 

Non- Developmental thyroid assay TGA I 24 Guideline 

Anticipated Data Needs for MBC 

835.2120 Hydrolysis TGAI 12 

835.4100 Aerobic soil metabolism TGAI 24 

835.4300 Aerobic aquatic metabolism TGAI 24 

835.6 100/ Environmental chemistry methods and associated 

835.6200 independent laboratory validations for soil and TGAI 12 

water 

850.4400/ 

850.4500/ Aquatic plant toxicity TGAl 12 

850.4550 

870.7800 lmmunotoxicity TGA1 12 

875.1200/ Dermal and inhalation exposure applying 

875.1400 paint/stain (airless sprayer, low pressure TEP 24 

handwand and brush/roller) 

875.1200/ Occupational dermal and inhalation for pouring 

875.1400 liquid and or solid material preservatives TEP 24 

formulations (paints/stains, slurries) 

875. 1700/ Product Use Information (Antimicrobial Uses) TEP 12 875.2700 for applying paints/stains 

875.2300 Indoor surface residue dissipation for plastic toys TEP 24 

and textiles 

Non- Honey bee acute oral toxicity (OECD 213) TGAI 12 Guideline 

Non- Honey bee larval toxicity (OECD 23 7) TGAI 12 Gu ideline 

Non- Whole sediment chronic toxicity test for aquatic TGAI 24 Gu ideline invertebrates 

Non- Leachi ng study: Exterior painted surfaces/wood TEP 12 Guideline protective stains/roof coatings 

Non- Leaching study: Treated textiles TEP 12 Guideline 

11 
2 On June 27, 20 I 2, EPA announced certain revisions in harmonized guideline series 850 - Ecological Effects Tests 

-including renumbering and other designations or changes for some guideline studies. See "Final Test Guidelines; 

OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 2012. 

http://www .regulations.gov/#! documentDetail; D=EPA-HQ-OPPT -2009-0 154-0028 

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses ofTM and MBC. For human health, 

EPA will conduct revised dietary, residential, and occupational risk assessments during 

registration review. If toxicological endpoints or points of departure are revised based on the 

data that are required for registration review, they will be considered in the new assessments, as 

well as any changes to the standard operating procedures or default exposure assumptions. 

Table 2 below summarizes the planned registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document. The planned assessments have not changed 

from what was included in the PWP. · 

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Table 2: Planned Risk Assessments for the Thiophanate Methyl and Carbendazim Registration 

Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological y This will be conducted for both TM and MBC. 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Incidents Will check for For a discussion of reported ecological incidents for 

updates TM and MBC, see page 28 of the Problem 

Formulation. 

Human Health 

Dietary 

Food y This will be conducted for both TM and MBC. Will 

include updated percent crop treated estimates, 

residue monitoring data if available, changes in 

toxicological endpoints and uncertainty factors, 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 potential changes in endpoints and doses for 

risk assessment. 

Occupational 

Handlers (mixers, loaders, y An updated non-cancer and cancer occupational 

applicators) handler exposure assessment for TM will be 

conducted for registered agricultural, seed treatment, 

and commercial turf (i.e., golf course maintenance) 

uses. 

Updated handler dermal and inhalation exposure risk 

assessments for the MBC paint use along with 

manufacturing preservative uses (liquid and solid 

pouring) will be conducted and will incorporate 

updated toxicological endpoints and updates to the 

Agency's standard assumptions for conducting 

handler exposure assessments, including revised unit 

exposure data. 

Post-application y Updated non-cancer and cancer occupational postapplication exposure 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 use is not expected. 

Residential 

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Handlers y This assessment will incorporate the additional TM 

and MBC toxicological endpoints and uncertainty 

factors, updated human exposure factors assumptions 

(e.g., body weight), and the 2012 SOPs for 

Residential Pesticide Exposure Assessments. 

Post-application y A revised residential dermal and incidental oral postapplication exposure and risk assessment (non-cancer 

and cancer) for turf will be conducted during 

registration review for all formulations of TM 

products used on commercial and residential treated 

turf. 

A residential dermal and incidental oral postapplication exposure assessment for MBC uses in 

plastic toys and textiles is anticipated. However, no 

assessment would be completed if these products are 

removed from the market. 

Other 

Aggregate y Additional toxicology data on TM and MBC may 

change the endpoints selected for risk assessment, and 

could impact the selection of safety and uncertainty 

factors. Because of updated science policies and new 

residential and dietary exposure estimates new 

aggregate exposure and risk assessments 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 cumulative assessment 

is not needed at this time for TM and MBC, but may 

be required in the future if a cumulative assessment 

group (CAG) for benzimidazole fungicides is 

identified and the hazard or exposure data indicate 

that it is appropriate to include TM and MBC in that 

group~ 

Tolerances y EPA will revisit the tolerances and tolerance 

definitions, and harmonize them with the Codex and 

Canadian MRLs and MRL definitions, when possible. 

Incidents Will check for For a discussion of reported human incidents for TM 

updates and MBC, see page 28 of the Scoping Document and 

the Thiophanate-methyl and Carbendazim: Tier I 

Review of Human Incidents. 

TIM ELINE 

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EPA has created the following estimated 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 listing the issuance of the DCI as April to June 2014, 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 Comment 2014- May 

Case Development 

Final Work Plan 2014 - September 

Issue DCI 2014- Oct. - Dec. 

Data Submission 2016 - Oct. - Dec. 

60-day Public Comment Period for Draft Risk Assessments 2018 - April- June 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration 2019 - Jan. - Mar. 

Review Decision 

Registration Review Decision and Begin Post-Decision Follow- 2020 

up 

Total (years) 6 

NEXT STEPS 

As noted previously, the Agency plans to require several environmental fate, ecological effects, 

and human health studies for TM and MBC through a Data Call-In Notice, expected to be issued 

in 2014. 

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