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 En vironmental Protection Agency's current position based on the following documents:

1. Preliminary Problem Formul ation for the Environmenta l 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-benzimi dazol carbamate – MBC)(128872). Yourman, PaisleyJones, Lee. January 23, 2014

5. Thiophanate-methyl (102001) Scr eening 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 thi ophanate 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 carb endazim (MBC) is now open, initiating the first public comment period for this registration re view (docket number EPA-HQ-OPP-2014-0004). This case includes the following active ingredient s: 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 be nzimidazole 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 regi stered for use on non-agricultural sites for ornamental tree injection and use as an industria l biocide additive to coatings, paints, stains, stuccos, plasters, sealants, caulks, fillers, adhe sives, paper, plastics, and textiles. This Preliminary Work Plan (PWP) document explai ns what EPA's Office of Pesticide Programs knows about TM and MBC, highlig hting anticipated da ta and assessment ne eds, identifying the types of information that would be especially useful to the Agen cy in conducting the review, and providing an anticipated timeline for completi ng the registration review for TM and MBC.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t TM and MBC and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on TM and MBC. The Agency encourages all inte rested stakeholders to review the PWP and Appendix and to provide comments and addition al 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 iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs fo r TM and MBC. Next, it discusses the statutory and re gulatory authority for Registrati on Review. Then the document provides chemical facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration revi ew timeline for TM and MBC. Finally, the Appendix to this document includes identifica tion and discussion of some areas that are considered generally in Registra tion Review along with some a dditional 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 Formula tion 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). Hum an Health Assessment Scoping Document in Support of Registration Review

.

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

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for TM 835.1230 Batch equilibrium adsorption / desorption 2 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 emergence 3 TEP 12 850.4150 Terrestrial plant toxicity, vegetative vigor 3 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 / desorption 2 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/#!documen tDetail;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 conducte d 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

Number 1 Study Title 1 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 de rmal 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 ingredie nt; 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 4

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration 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 docke t 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 specifi c 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 Carbe ndazim (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 va riety 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 regist ered for use in agricultural, residential, commercial, ins titutional, and industrial areas.

Use Sites TM registered agricultural use s ites include a variety of crops including small fruits, nuts, pom e fruits, stone fruits, coffee, cucurbits, leafy vegetables, root vegetables, seed and pod vegetables, grains, forests, commer cial treatment of a variety of seeds including potato seed piece s and peanuts, greenhouses and nurseries (including bulb dip treatment). TM registered non-agricultural us e 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 agricu ltural usage averaged approximately 500,000 pounds of active ingredie nt (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 per cent of the TM ag ricultural usage during the periods of 2003-2007 and 2008-2012. TM usage on non-agricultural use site s, 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 Lifescien ce North America LLC, Celsius Property BV Amsterdam, Gowan Company, Ni ppon Soda Company LTD, and

NuFarm LTD No. of Registrations 95 Section 3 5 and 12 Section 24(c) special local need

Restricted Use No

5 Section 3 product labels can be obtained from th e 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 spectru m, 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 ca rbendazim 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 applie d as a tree injection, or as an industrial
additive in the formulation of co atings, paints, stains, stuccos, plasters, sealants~ caulks, fillers, adhesives, paper, plastics, and
textiles. Technical Registrant Troy Chemical Company LTD No. of Registrations 15 Section 3 products 6

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular 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 ex tensively 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 resist ance or lack of susceptible pathogen pressure). Usage information broken down by region would indicate where
TM is considered beneficial. In a ddition, it would be useful to have
information on alternative f ungicides 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, includi ng important use sites, use patterns, and total pounds applied per year.

6 Section 3 product labels can be obtained from th e 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 M BC 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; maxi mum application rates; frequency of application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

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

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

 Typical application timing (date of first applic ation and application in tervals) – 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 te chnical 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 la nd areas. The 2009 occupational assessment resulted in handler and post-application e xposure risks of concern for multiple crops resulting from the use a variety of formul ations and applicati on 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 Ad ministration’s (FDA’s) investigation of reports that residues of the pesticide MBC ar e present in orange juice, EPA conducted a risk assessment to determine the safety of thes e residues. The risk assessment shows that there is no public health con cern from drinking orange juic e containing MBC at reported
levels. This risk assessment can be found here: http://www.epa.gov/pesticides/factsh eets/chemicals/carbendazim_ra.pdf

.

ANTICIPATED RISK ASSESSMENT S 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 as sessment for TM was completed in 2009 for the same new use request. MBC conventional or an timicrobial uses have not previously been assessed for ecological risks. As noted previous ly, the only registered conventional use of MBC12 is as a tree injection. Given th is application method, it has histori cally been viewed as a “closed system” with minimal likelihood of environmenta l exposure. Therefore, there are no recent ecological risk assessments or drinking water ex posure assessments for M BC tree injection uses. Findings and conclusions from these risk as sessments are summarized in the Preliminary
Problem Formulation for the Environmental Fate, Ecologica l Risk, Endangered Species, and Human Health Drinking Water Exposure Assessme nts in Support of the Re gistration Review of Thiophanate Methyl and Carbendazim and Thiophanate-Methyl and Carbendazim (MBC) Human Health Assessment Scoping Docume nt in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an endangere d species assessment, for all uses of TM and MBC. For human health, EPA anticipates the ne ed to conduct revised dietary, residential, and occupational risk assessments during registration re view. If toxicologica l endpoints or points of departure are revised based on the data that are an ticipated 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 regi stration 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 reporte d 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 c onducted 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. Occupational13 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 pa int 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-cance r and cancer occupational postapplication exposure assessm ents will be required for agricultural, seed treatment, and commercial turf uses.

Based on the Agency's current practices, a quantitative post-applica tion inhalation exposure assessment for TM and MBC use is not expected.

Residential Handlers Y This assessment will incorporate the additional TM and MBC toxicological e ndpoints 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 residentia l dermal and incidental oral postapplication exposure and ri sk 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 toxico logy 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 upda ted 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 co uld 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 Draf t Risk Assessments 2017 – Oct. –Dec. Registration Review Decision 60-day Public Comment Period fo r 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 i ssue a Final Work Plan for the registration
review of TM and MBC.15 

### Appendix – Additional Areas Considere d 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 submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, 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, provi ding as much specificity as possible regarding
the nature of the concern

Water Quality:

TM and MBC are not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 7 In addition, no Tota l 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 Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 10 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to TM a nd 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.htm16 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 specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service
and/or National Marine Fisheries Service (the Se rvices), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive 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 exis ting hazard database. However, as required by FFDCA section 408(p), TM and MBC are subject to the endocrine scre ening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredient s and 9 inert ingredients. A second list
of chemicals identified for EDSP sc reening was published on June 14, 2013 11 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, pleas e 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 ED SP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, 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 pest icide to determine their dermal and inhalation exposure. Many such studies, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pest icide Handlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Databa se, 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 cl ear 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 wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies.

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

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