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INTRODUCTION

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

the registration review of metiram. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the metiram registration 

review docket (EPA-HQ-OPP-2015-0290). Metiram is a broad-spectrum, fungicide within the 

ethylene bisdithiocarbamate (EBDC) group of fungicides registered for agricultural application 

to apples (foliar) and potatoes (foliar or seed piece). Horticultural uses include a Special Local 

Need use on leatherleaf ferns (nurseries and greenhouses; Florida use only). There are no 

registered residential uses.

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.

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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 metiram. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

860.1200 Directions for Use: Bananas and Grapes and 860.1560 Reasonable Grounds in 

Support of the Petition

The Agency erroneously noted 860.1200 Directions for Use: Bananas and Grapes only and

860.1560 Reasonable Grounds in Support of the Petition: Bananas as data gaps in the PWP. In 

2011, EPA established import tolerances for metiram in or on wine grapes and bananas (EPA–

HQ–OPP–2005–0308; FRL–8869–1) and does not expect to re-evaluate these tolerances during 

registration review. Regarding 860.1200 Directions for Use: Potato, the Agency will pursue 

identified potato use label changes with metiram registrants outside of the data call-in process.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Metiram Preliminary Work Plan, which opened 

on June 24, 2015 and closed on August 24, 2015, the Agency received four public comments.

Comments were submitted by BASF Corporation, the Center for Biological Diversity, the 

FIFRA Endangered Species Task Force (FESTF) and the Northwest Horticultural Society. The 

 1 http://www.epa.gov/oppsrrd1/registration_review/
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comments do not address the timeline described in the PWP, but they do address the planned 

ecological and human health risk assessments and data requirements. In the PWP, EPA also 

solicited comments on the specific topics of environmental justice, water quality concerns, and 

trade irritants, but no comments or information were received on those issues.

This section does not capture every comment made about 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-HQOPP-2015-0290.

Comments submitted by BASF Corporation (BASF) in EPA-HQ-OPP-2015-0290-0013.

1. Comment: BASF commented that the Endangered Species section states "A previous 

endangered species assessment for the California red-legged frog was conducted in 

October 2007", which is not relevant to this assessment as metiram was not part of the 

2007 assessment. BASF also commented that the 1989-1990 ethylene-bisdithiocarbamate (EBDC) Market Basket (MB) survey remains relevant for refining the 

metiram dietary assessment and requests clarification on what specific information the 

EPA requires to justify the continued use of this survey.

Response: The Agency confirms that an endangered species assessment for the California 

red-legged frog was not conducted for metiram and appreciates the BASF comment for 

bringing this error to our attention. For details on what information EPA needs to justify 

the continued use of the existing MB survey, please see the HED Response to Comments 

on the Registration Review Preliminary Work Plan in the metiram registration review 

docket.

Comments submitted by Northwest Horticultural Council in EPA-HQ-OPP-2015-0290-

0014.

2. Comment: The NHC requests that metiram be maintained for use in the tree fruit 

industry, as it is an important tool to prevent apple scab and rusts as part of an 

Integrated Pest Management (IPM) process.

Response: The Agency appreciates the NHC comments, which corroborate the Agency’s 

findings in the BEAD Chemical Profile, on the utility of metiram to the tree fruit 

industry.

Comments submitted by FIFRA Endangered Species Task Force (FESTF) in EPA-HQOPP-2015-0290-0012.

3. Comment: The technical registrant for metiram, as identified on the fact sheet in the 

PWP, is BASF Corporation, which is a FESTF member and is entitled to rely on FESTF 

data.
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Response: EPA appreciates FESTF’s comments and will consider this information during 

registration review.

Comments submitted by the Center for Biological Diversity in EPA-HQ-OPP-2015-0290-

0011.

4. Comment: The Center for Biological Diversity’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 of metiram in accordance with the 

Endangered Species Act (ESA). The CBD 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 (listed) 

species and their designated critical habitat. CBD also expresses concern regarding the 

rigor of the Agency’s preliminary determinations regarding the effects of metiram on 

listed species and their designated critical habitat for the metiram registration review.

Response: EPA has reviewed the comments from CBD on the registration review docket 

opening for metiram and plans to address many of the concerns raised by CBD as part of 

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

recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA 

will address concerns specific to metiram in connection with the development of its final 

registration review decision for metiram. 

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

of their joint Interim Approaches for assessing risks to 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 report2 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 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder 

workshops in April and October 2014, allowing additional opportunities for stakeholders 

to comment on the Interim Approaches. Additional workshops are planned to enhance 

stakeholder involvement. As part of a phased, iterative process for developing the Interim 

Approaches, the agencies will also 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 National-Level Pesticide Endangered Species Act Assessments Based on 

 2 http://www.nap.edu/catalog.php?record_id=18344
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the Recommendations of the National Academy of Sciences April 2013 Report”3, 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 metiram 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 metiram, 

EPA described the screening-level risk assessment to determine the potential effects of 

metiram 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 of metiram. 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 screeninglevel risk assessment for the registration review of metiram 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 listed species and their designated critical habitats, these methods will be 

applied to subsequent analyses for metiram as part of completing this registration review.

PLANNED DATA NEEDS

Table 1 below summarizes planned data needs for metiram and ethylenethiourea (ETU), the 

major degradate of metiram, based on the Registration Review; Problem Formulation for the 

Ecological Risk Assessment and Drinking Water Exposure Assessment to be Conducted for 

Metiram and Metiram: Human Health Risk Assessment Scoping Document in Support of 

Registration Review. The planned data needs have not changed from what was included in the 

PWP, with the exception of the deletion of 860.1200 Directions for Use: Bananas and Grapes 

only and 860.1560 Reasonable Grounds in Support of the Petition: Bananas as explained in the 

Updates section.

Table 1: Planned Data Needs for the Metiram Registration Review

Guideline 

Number4 Study Title Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Planned Data Needs for the Parent Metiram

835.2120 Hydrolysis TGAI 12

 3 http://www.epa.gov/espp/2013/nas.html

4 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
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Table 1: Planned Data Needs for the Metiram Registration Review

Guideline 

Number4 Study Title Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

835.4100 Aerobic soil metabolism TGAI 245

835.4400 Anaerobic aquatic metabolism TGAI 245

850.2100 Avian oral toxicity (passerine) TGAI 12

850.2300 Avian reproduction (bobwhite quail) TGAI 245

850.3020 Honey bee adult acute contact toxicity TGAI 126

850.3030 Honey bee toxicity of residues on foliage TGAI 12

850.3040 Full-Field Testing for Pollinators TEP 24

850.6100 Environmental Chemistry Methods and 

Independent Laboratory Validation for Soil 

and Water

TGAI 12

860.1200 Directions for Use: Potato7 TEP 12

Non-GLN Honey bee adult acute oral toxicity TGAI 126

Non-GLN Honey bee adult chronic oral toxicity TGAI 12

Non-GLN Honey bee larvae chronic oral toxicity TGAI 12

Non-GLN Field trial of residues in pollen and nectar TEP 12

Non-GLN

(OECD Test 

GLN 237)

Honey bee larvae acute oral toxicity TGAI

12

Non-GLN 

(OECD Test 

GLN 75)

Semi-field testing for pollinators TGAI or TEP

24

Non-GLN Residue/Monitoring (Market Basket) Study TEP 36

Planned Data Needs for the Degradate ETU

835.4100 Aerobic soil metabolism Degradate 24

835.4300 Aerobic aquatic metabolism Degradate 24

835.4400 Anaerobic aquatic metabolism Degradate 24

850.6100 Analytical method in soil (ECM/ILV) Degradate 12

Outstanding Data Requirements from GDCI-014601-260818

870.3700 Prenatal developmental toxicity study 

(rabbits) TGAI 12

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

 5 The PWP has the incorrect timeframe listed for these studies. 6 A study to fulfill this requirement is currently under review (MRID 4940301) 7 The Agency will pursue identified potato use label changes with metiram registrants outside of the data call-in 

process.

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The study listed in this section was previously required through a generic data call-in issued in July 2007 and is still 

outstanding. This study will not be included in the Registration Review DCI because it is already required through 

the earlier DCI.
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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 of metiram. 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 and the planned assessments have not 

changed from what was included in the PWP.
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Table 2: Planned Risk Assessments for the Metiram 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 A Total Toxic Residue approach will be taken to 

estimate the aquatic environmental concentrations of 

parent metiram and its degradate, EBIS.

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

metiram, see page 40 of the Problem Formulation.

Human Health

Dietary

Food Y The dietary risk assessment may need to be updated if 

the toxicology endpoints, uncertainty factors, or 

drinking water exposure estimates change.

Drinking water Y

Occupational

Handlers (mixers, loaders, 

applicators)

Y An updated handler and post-application occupational 

risk assessments (cancer and non-cancer) will be 

Post-application Y performed for all currently registered metiram uses.

Residential

Handlers N There are no residential or homeowner uses registered 

for metiram; therefore the Agency does not plan to 

conduct a quantitative assessment for residential 

handlers or residential (non-occupational) postapplication exposure. The Agency plans to conduct a 

spray drift assessment and will evaluate the need for a 

volatilization assessment during registration review.

Post-application Y

Other

Aggregate Y Because there are no homeowner or residential uses, 

an aggregate assessment would consist of food and 

drinking water only. An updated aggregate 

assessment may be needed if the toxicology 

endpoints, uncertainty factors, or drinking water 

exposure estimates change.

Cumulative N Metiram has not been identified as a member of a 

cumulative group that shares a common mechanism 

of toxicity.

Tolerances Y During registration review, the Agency will evaluate 

the need to harmonize tolerances with Canadian 

maximum residue limits and the need to update the 

current tolerance expressions.

Incidents Will check for 

updates

There are currently no incident cases reported for 

metiram. See page 16 of the Scoping Document and 

the Metiram: Tier I (Scoping) Review of Human 

Incidents.
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TIMELINE

EPA has created the following estimated timeline for the completion of the metiram registration

review in Table 3 below. The projected timeline has not changed since the PWP.

Table 3: Projected Metiram Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2015 – June

Close Public Comment 2015 – August

Case Development

Final Work Plan 2015 – December

Issue DCI 2016 January – March

Data Submission 2019 January – March

60-day Public Comment Period for Draft Risk Assessments 2020 July – Sept.

Registration Review Decision

60-day Public Comment Period for Proposed Registration Review 

Decision

2021 April - June

Registration Review Decision and Begin Post-Decision Follow-up 2022

Total (years) 7

NEXT STEPS

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

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

early 2016.