2

Thiophanate Methyl & Carbendazim 

Preliminary Work Plan – Table of Contents 

OVERVIEW ................................................................................................................................... 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY ................................................................... 7

CHEMICAL FACTS ...................................................................................................................... 7

USE AND USAGE INFORMATION ............................................................................................ 8

RECENT ACTIONS ..................................................................................................................... 11

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW .............................. 11

TIMELINE .................................................................................................................................... 14

NEXT STEPS ............................................................................................................................... 14

Appendix – Additional Areas Considered in the Thiophanate Methyl and Carbendazim 

Registration Review .................................................................................................................. 15 

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents: 

1. Preliminary Problem Formulation for the Environmental Fate, Ecological Risk, 

Endangered Species, and Human Health Drinking Water Exposure Assessments in Support 

of the Registration Review of Thiophanate Methyl and Carbendazim. Montague, Barrett, 

Carleton, Gowda, Erickson, Shamim. March 18, 2014. 

2. Thiophanate-Methyl and Carbendazim (MBC). Human Health Assessment Scoping 

Document in Support of Registration Review. Collantes, Dotson, Hansen, Mottl, Cavinder. 

March 20, 2014. 

3. Thiophanate-methyl and Carbendazim: Tier I Review of Human Incidents. Recore, Evans. 

December 17, 2013. 
3

4. BEAD Chemical Profile for Registration Review: Thiophanate Methyl (102001) and 

Carbendazim (methyl 2-benzimidazol carbamate – MBC)(128872). Yourman, PaisleyJones, Lee. January 23, 2014

5. Thiophanate-methyl (102001) Screening Level Usage Analysis. March 7, 2013.

6. Thiophanate-methyl (102001) EFED Label Data Report. January 7, 2014.

7. Thiophanate-methyl (102001) HED Label Data Report. January 7, 2014. 

8. Carbendazim (128872) AD Label Data Report. August 6, 2013.

9. Carbendazim (128872) EFED Label Data Report. August 6, 2013.

10. Carbendazim (128872) PRD Label Data Report. August 6, 2013. 

These and other supporting documents for the thiophanate methyl and carbendazim registration 

review case may be found in the docket EPA-HQ-OPP-2014-0004 at 

http://www.regulations.gov. 
4

OVERVIEW 

The docket for thiophanate methyl (TM) and carbendazim (MBC) is now open, initiating the first 

public comment period for this registration review (docket number EPA-HQ-OPP-2014-0004). 

This case includes the following active ingredients: TM and MBC. MBC is a pesticide active 

ingredient but is also a metabolite, environmental degradate and the pesticidally active moiety of 

TM. 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, 

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, ornamental grasses for 

landscapes and interiorscapes. MBC is registered for use on non-agricultural 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. This 

Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs 

knows about TM and MBC, highlighting anticipated data and assessment needs, identifying the 

types of information that would be especially useful to the Agency in conducting the review, and 

providing an anticipated timeline for completing the registration review for TM and MBC. 

 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about TM and MBC and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

TM and MBC. The Agency encourages all interested stakeholders to review the PWP and 

Appendix and to provide comments and additional information that will help the Agency’s 

decision-making process for this chemical. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large. 

The Preliminary Work Plan begins by listing the anticipated data needs for TM and MBC. Next, 

it discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for TM and MBC. Finally, the 

Appendix to this document includes identification and discussion of some areas that are 

considered generally in Registration Review along with some additional chemical case-specific 

information. 
5

ANTICIPATED DATA NEEDS 

Table 1 below summarizes anticipated data needs for TM and MBC. For additional discussion 

of the anticipated data needs, see the Preliminary Problem Formulation for the Environmental 

Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure 

Assessments in Support of the Registration Review of Thiophanate Methyl and Carbendazim and 

Thiophanate-Methyl and Carbendazim (MBC). Human Health Assessment Scoping Document in 

Support of Registration Review. 

Table 1: Anticipated Data Needs for TM and MBC Registration Review 

Guideline 

Number1 Study Title1 

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Anticipated Data Needs for TM

835.1230 Batch equilibrium adsorption / desorption2 TGAI 12 

835.2120 Hydrolysis TGAI 12 

835.4100 Aerobic soil metabolism TGAI 24 

835.4200 Aerobic aquatic metabolism TGAI 24 

835.4300 Anaerobic aquatic metabolism TGAI 24 

835.6200 Environmental chemistry methods and associated 

independent laboratory validations for water TGAI 12 

850.4100 Terrestrial plant toxicity, seedling emergence3 TEP 12 

850.4150 Terrestrial plant toxicity, vegetative vigor3 TEP 12 

NonGuideline Honey bee acute oral toxicity (OECD 213) TGAI 12 

NonGuideline Honey bee larval toxicity (OECD 237) TGAI 12 

870.3465 Subchronic inhalation toxicity TGAI 24 

NonGuideline Developmental thyroid assay TGAI 24 

Anticipated Data Needs for MBC

835.1230 Batch equilibrium adsorption / desorption2 TGAI 12 

835.2120 Hydrolysis TGAI 12 

835.4100 Aerobic soil metabolism TGAI 24 

835.4200 Aerobic aquatic metabolism TGAI 24 

 

1

 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/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 2

 An updated review will be conducted of a previously submitted study (MRID 42351001) which includes batch 

equilibrium adsorption /desorption studies for TM, MBC, and other metabolites of TM. Pending the outcome of this 

review, a new study may be required. 

3

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

maximum application rate. 
6

Table 1: Anticipated Data Needs for TM and MBC Registration Review 

Guideline 

Number1 Study Title1 

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

835.4300 Anaerobic aquatic metabolism TGAI 24 

835.6100/ 

835.6200 

Environmental chemistry methods and associated 

independent laboratory validations for soil and 

water 

TGAI 12 

850.4400/ 

850.4500/ 

850.4550 

Aquatic plant toxicity TGAI 12 

870.7800 Immunotoxicity TGAI 12 

875.1200/ 

875.1400 

Occupational handler dermal and inhalation 

exposure applying paint/stain (airless sprayer, low 

pressure handwand and brush/roller) 

TEP 24 

875.1200/ 

875.1400 

Occupational dermal and inhalation for pouring 

liquid and or solid material preservatives 

formulations (paints/stains, slurries) 

TEP 24 

875.1200/ 

875.1400 

Residential handler dermal and inhalation exposure 

applying paint/stain (airless sprayer and 

brush/roller) 

TEP 24 

875.1700 Product use for applying paints/stains TEP 12 

875.1700 Product use information for pouring liquid/solid 

material preservative formulation TEP 12 

875.2300 Indoor surface residue dissipation for plastic toys 

and textiles TEP 24 

875.2700 Product use for material preservation uses (plastic 

toys and textiles) in residential products TEP 12 

NonGuideline Honey bee acute oral toxicity (OECD 213) TGAI 12 

NonGuideline Honey bee larval toxicity (OECD 237) TGAI 12 

NonGuideline Whole sediment chronic toxicity test for aquatic 

invertebrates TGAI 24 

NonGuideline 

Leaching studies are required for the following use 

scenarios: 

a. Exterior painted surfaces/wood 

protective stains/roof coatings 

b. Treated textiles 

TEP 12 

TGAI = technical grade active ingredient; TEP = typical end-use product; 
7

STATUTORY AND REGULATORY AUTHORITY 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.4

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. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase of 

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

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of TM and MBC. 

CHEMICAL FACTS 

Table 2a provides a summary of the chemical facts for TM and Table 2b provides a summary of 

the chemical facts for MBC. 

Table 2a: Chemical Facts for Thiophanate Methyl (TM)

PC code 102001 

Case Number 2680 

CAS Number 23564-05-8 

Year first registered 1973 

Pesticide Type Fungicide 

Chemical class Carbamate 

Reregistration Eligibility 

Decision (RED) 

October 2005 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

October 2005 

Cumulative group Not applicable 

 

4

 http://www.epa.gov/oppsrrd1/registration_review/ 
8

Table 2a: Chemical Facts for Thiophanate Methyl (TM)

40 CFR Citation Tolerances for TM are established in 40 CFR 158.371. 

Dual-use No 

Non-pesticidal uses Not applicable 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Rusty Wasem, wasem.russell@epa.gov, 703-305-6979 

Registration Division, 

Product Manager 

Shaja Joyner, joyner.shaja@epa.gov, 703-308-3194 

Table 2b: Chemical Facts for Carbendazim (MBC)

PC code 128872 

Case Number 2680 

CAS Number 10605-21-7 

Year first registered 1990 

Pesticide Type Fungicide 

Chemical class Carbamate 

Reregistration Eligibility 

Decision (RED) 

October 2005 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

Not applicable 

Cumulative group Not applicable 

40 CFR Citation There are no specific tolerances established for MBC 

Dual-use Yes 

Non-pesticidal uses Not applicable 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Rusty Wasem, wasem.russell@epa.gov, 703-305-6979 

Registration Division, 

Product Manager 

Shaja Joyner, joyner.shaja@epa.gov, 703-308-3194 

Antimicrobials Division, 

Chemical Review 

Manager 

Sandra O’Neill, oneill.sandra@epa.gov, 703-347-0141 

Antimicrobials Division, 

Product Manager 

Marshall Swindell, swindell.marshall@epa.gov, 703-308-6341 

USE AND USAGE INFORMATION 

Table 3a summarizes the use and usage information for TM and Table 3b summarizes the use 

and usage information for MBC. Please see the BEAD Chemical Profile for Registration 

Review: Thiophanate Methyl (102001) and Carbendazim (methyl 2-benzimidazol carbamate – 

MBC)(128872) in the registration review docket for more details. 
9

Table 3a: TM Use and Usage Information

Summary of Use TM is a broad spectrum, systemic benzimidazole fungicide 

registered for use to manage a variety of diseases on various crops 

as well as on turfgrass and ornamental plants. TM is the only 

registered benzimidazole fungicide that can be used on growing 

plants. TM products are registered for use in agricultural, 

residential, commercial, institutional, and industrial areas. 

Use Sites TM registered agricultural use sites include a variety of crops 

including small fruits, nuts, pome fruits, stone fruits, coffee, 

cucurbits, leafy vegetables, root vegetables, seed and pod 

vegetables, grains, forests, commercial treatment of a variety of 

seeds including potato seed pieces and peanuts, greenhouses and 

nurseries (including bulb dip treatment). 

TM registered non-agricultural use sites include lawns and turf, 

uncultivated areas, sod farms, golf courses, athletic and recreational 

fields, ornamental grasses for landscapes and interiorscapes.. It is 

available for use by residential homeowners.

Summary of Usage During 1998-2012, TM agricultural usage averaged approximately 

500,000 pounds of active ingredient (a.i.) annually on 

approximately 900,000 acres of surveyed agricultural crops. The 

average a.i. rate during this time period was 0.6 pounds a.i. per 

acre. Usage on dry beans/peas, green beans, and apples has 

accounted for more than sixty percent of the TM agricultural usage 

during the periods of 2003-2007 and 2008-2012. 

TM usage on non-agricultural use sites, accounted for nearly half of 

TM total usage during the years 2002, 2004, 2006, and 2011. 

Leading non-agricultural use sites include golf courses, lawns and 

horticultural nurseries. 

Formulation Type(s) TM formulations include dust, emulsifiable concentrate, flowable 

concentrate, granular, soluble concentrate, water-dispersible granules, 

wettable powder, and water soluble bags.

Application Method(s) TM may be applied with aerial, chemigation or ground equipment 

(broadcast, band, or soil drench); as a dip treatment for bulbs, corms, 

cut flowers, rose budwood, or nursery stock; and as a seed treatment 

for peanuts and potato pieces. Handheld equipment may be used on 

turf and ornamentals. The majority of the crops are treated with post 

emergent broadcast applications.

Technical Registrant(s) Arysta Lifescience North America LLC, Celsius Property BV 

Amsterdam, Gowan Company, Nippon Soda Company LTD, and 

NuFarm LTD 

No. of Registrations 95 Section 35 and 12 Section 24(c) special local need 

Restricted Use No 

 

5

 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home). 
10

Table 3b: MBC Use and Usage Information

Summary of Use MBC is a broad spectrum, systemic benzimidazole fungicide 

registered for use as a protectant biocide in paints, caulks and other 

building supplies. The only registered conventional pesticide use of 

MBC is a non-agricultural use as an ornamental tree injection. 

Use Sites Registered use sites for carbendazim include surface treatments, 

injection into ornamental trees, and as an industrial biocide additive 

to coatings, paints, stains, stuccos, plasters, sealants, caulks, fillers, 

adhesives, paper, plastics, and textiles. 

Summary of Usage Private market estimates for 2012 state that paints and coating 

application uses were the principal uses for MBC. 

Formulation Type(s) Pressurized liquids, ready-to-use liquids, emulsifiable concentrates, 

and liquid concentrates. 

Application Method(s) Carbendazim may be applied as a tree injection, or as an industrial 

additive in the formulation of coatings, paints, stains, stuccos, 

plasters, sealants~ caulks, fillers, adhesives, paper, plastics, and 

textiles. 

Technical Registrant Troy Chemical Company LTD 

No. of Registrations 15 Section 3 products6

Restricted Use No 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below. 

 The Agency currently does not have certain information about TM and MBC. Obtaining 

the following information may improve future assessments conducted by the Agency 

related to the use of TM and MBC. 

o Non-agricultural Use: TM is used extensively on golf turfgrass. The use may 

vary by region due to disease pressure differences and occurrence of pathogen 

resistance. To assess benefits, it would be helpful to understand use patterns of 

TM where it is commonly included in fungicide application programs and 

where it is not (either due to resistance or lack of susceptible pathogen 

pressure). Usage information broken down by region would indicate where 

TM is considered beneficial. In addition, it would be useful to have 

information on alternative fungicides that might be used in a similar way in a 

turf grass fungicide program. Usage data would be useful for TM on turf and 

horticulture from 2007 to the present, including pounds applied per year. 

o Usage data would be useful for TM on other non-agricultural uncultivated 

areas, and wide area/general outdoor treatments, including total pounds 

applied per year. 

o Antimicrobial usage data for TM, including important use sites, use patterns, 

and total pounds applied per year. 

 

6

 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home). 
11

o Helpful information would include MBC usage data for tree injection, 

including average application rate and number of applications. In addition, 

The Agency has little information about the benefits of MBC relative to other 

paint and building preservatives. To assess the benefits of MBC to the 

industry it would be helpful to have usage data for MBC, including total 

pounds applied per year, important uses where alternatives may not be as 

effective. 

 Confirmation of the following label information: sites of application; formulations; 

application methods and equipment; maximum application rates; frequency of 

application, application intervals, and maximum number of applications per season; and 

geographic limitations on use. 

 Use distribution (e.g., acreage and geographical distribution of relevant use sites). 

 Median and 90th percentile reported use rates (lbs a.i./A) from usage data – national, 

state, and county. 

 Typical application timing (date of first application and application intervals) – national, 

state, and county. 

 Usage/use information for non-agricultural uses. 

 Typical application interval (days). 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical TM or MBC to the 

US market. 

RECENT ACTIONS 

 In 2009, human health risk assessments were conducted for proposed uses of TM on a 

variety of agricultural crops and non-crop land areas. The 2009 occupational assessment 

resulted in handler and post-application exposure risks of concern for multiple crops 

resulting from the use a variety of formulations and application methods, including 

commercial and on-farm seed treatment. However the uses were not granted because 

residential exposure and risk estimates of concern were identified for MBC; any 

additional exposure to MBC from application of TM to crops would have resulted in risks 

of concern. 

 In 2012, in response to the Food and Drug Administration’s (FDA’s) investigation of 

reports that residues of the pesticide MBC are present in orange juice, EPA conducted a 

risk assessment to determine the safety of these residues. The risk assessment shows that 

there is no public health concern from drinking orange juice containing MBC at reported 

levels. This risk assessment can be found here: 

http://www.epa.gov/pesticides/factsheets/chemicals/carbendazim_ra.pdf. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent human health risk assessment for TM and MBC was completed in 2009 for a 

new use request for TM on a variety of agricultural crops and non-crop land areas. The most 

recent ecological and environmental fate risk assessment for TM was completed in 2009 for the 

same new use request. MBC conventional or antimicrobial uses have not previously been 

assessed for ecological risks. As noted previously, the only registered conventional use of MBC 
12

is as a tree injection. Given this application method, it has historically been viewed as a “closed 

system” with minimal likelihood of environmental exposure. Therefore, there are no recent 

ecological risk assessments or drinking water exposure assessments for MBC tree injection uses. 

Findings and conclusions from these risk assessments are summarized in the Preliminary 

Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and 

Human Health Drinking Water Exposure Assessments in Support of the Registration Review of 

Thiophanate Methyl and Carbendazim and Thiophanate-Methyl and Carbendazim (MBC) 

Human Health Assessment Scoping Document in Support of Registration Review. 

During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of TM and 

MBC. For human health, EPA anticipates the need to 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 anticipated to be 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 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 

Table 4: Anticipated Risk Assessments for the Thiophanate Methyl and Carbendazim

Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Y This will be conducted for both TM and MBC. 

Incidents Will check for 

updates 

For a discussion of reported ecological incidents for 

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 
13

Handlers (mixers, loaders, 

applicators) 

Y An updated non-cancer and cancer occupational 

handler exposure assessment for TM will be required 

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 will be required 

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 

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 required 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 plastic 

toys and textiles is anticipated. 

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, new 

residential and dietary exposure estimates will result 

in the need for new aggregate exposure and risk 

assessments. 
14

Cumulative Will consider During registration review, the Agency will determine 

if there is any new information, such as new hazard or 

exposure data or information on changes to the use 

pattern, which would affect the need for a cumulative 

risk assessment for TM and MBC. Should the 

Agency determine that new information on TM and 

MBC is available that could potentially trigger the 

need for a cumulative risk assessment and result in a 

risk of concern, the Agency will revisit the 

cumulative risk assessment. 

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 

updates 

For a discussion of reported human incidents for TM 

and MBC, see page 28 of the Scoping Document and 

the Thiophanate-methyl and Carbendazim: Tier I 

Review of Human Incidents. 

TIMELINE 

EPA has created the following estimated timeline for the completion of the TM and MBC 

registration review in Table 5 below. 

Projected Registration Review Timeline for TM and MBC

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period 2013 - March 

Close Public Comment 2013 - May 

Case Development 

Final Work Plan 2013 - August 

Issue DCI 2014 – April - June 

Data Submission 2016 – April - June 

60-day Public Comment Period for Draft Risk Assessments 2017 – Oct. –Dec. 

Registration Review Decision 

60-day Public Comment Period for Proposed Registration Review 

Decision 

2018 – April - June 

Registration Review Decision and Begin Post-Decision Follow-up 2019 

Total (years) 6 

NEXT STEPS 

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of TM and MBC. 

 
15

Appendix – Additional Areas Considered in the TM and MBC Registration 

Review 

PUBLIC COMMENTS AND FEEDBACK: 

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern 

Water Quality: 

TM and MBC are not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.7

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for TM and MBC.8 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.9 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process10 in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to TM and MBC compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

 

7 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

8

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES 9 http://www.epa.gov/owow/tmdl/

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
16

ENDANGERED SPECIES: 

A risk assessment that supports a complete endangered species determination has not been 

conducted for TM and MBC. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of TM and MBC has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated critical 

habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Service (the Services), as appropriate. 

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for TM, which included 

consideration of MBC, EPA reviewed these data and selected the most sensitive endpoints for 

relevant risk assessment scenarios from the existing hazard database. However, as required by 

FFDCA section 408(p), TM and MBC are subject to the endocrine screening part of the 

Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 201311 and includes some 

pesticides scheduled for registration review and chemicals found in water. For further 

 

11 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 
17

information on the status of the EDSP, the policies and procedures, the lists of chemicals, future 

lists, the test guidelines and the Tier 1 screening battery, please visit our website.12

TM is on List 2. List 2 represents the next set of chemicals for which EPA intends to issue test 

orders/data call-ins in the near future. MBC is not on List 1 or List 2. 

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.13

HUMAN STUDIES: 

Occupational and Residential 

Past TM and MBC risk assessments rely in part on data from studies in which adult human 

subjects were intentionally exposed to a pesticide to determine their dermal and inhalation 

exposure. Many such studies, involving exposure to many different pesticides, comprise generic 

pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED), the 

Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task 

Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide 

generic exposure databases, and has found no clear and convincing evidence that the conduct of 

any of them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies. 

 

12 http://www.epa.gov/endo/ 

13 http://www.epa.gov/endo/