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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 mancozeb. This work plan addresses public comments received 

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

review docket (EPA-HQ-OPP-2015-0291). Mancozeb is an ethylenebis dithiocarbamate (EBDC) 

non-systemic fungicide with protective action on contact. Mancozeb and other EBDC fungicides, 

maneb (no registered uses) and metiram, have a common metabolite/degradate, ethylenethiourea 

(ETU). Mancozeb’s specific mode of action (MOA) is unknown and it is classified by the code 

M3 (multi-site action) by the Fungicide Resistance Action Committee (FRAC1). Mancozeb is 

currently registered for foliar application and seed treatment on over 30 agricultural crops. Nonagricultural uses include ornamental plants in nurseries and greenhouses, home gardens, sod 

farms, and golf courses. Mancozeb is considered an important fungicide in many areas of 

agriculture, including its significant role in pest management, resistance management, and the 

U.S. fungicide market.

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

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on mancozeb since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

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

opened on June 24, 2015 and closed on August 24, 2015, the Agency received five public 

comments. Comments were submitted by the FIFRA Endangered Species Task Force, the 

Center for Biological Diversity, the Physicians Committee for Responsible Medicine, the 

Mancozeb Task Force, and the Northwest Horticultural Council. The comments do not address 

 1 Fungicide Resistance Action Committee (http://www.frac.info/index.htm) classification available at 

http://www.frac.info/publication/anhang/2014%20FRAC%20Code%20List.pdf (accessed January, 2015). 2 http://www2.epa.gov/pesticide-reevaluation
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the timeline described in the PWP, but they do address the planned ecological risk assessment

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

environmental justice, water quality concerns, and trade irritants; one comment from the 

Northwestern Horticultural Council was received concerning trade irritants and is included 

below.

Summarized below are public comments that resulted in changes to the anticipated registration 

review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public 

comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP-2015-

0291. Summarized public comments and Agency responses related to the anticipated ecological

risk assessment or data needs are in the Review of Public Response to Mancozeb Problem 

Formulation and Mancozeb: HED Response to Comments on the Registration Review 

Preliminary Work Plan.

Comments submitted by the Center for Biological Diversity in EPA-HQ-OPP-2015-0291-

0012.

1. Comment: The Center for Biological Diversity’s (CBD) 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 mancozeb in accordance with the Endangered 

Species Act (ESA). CBD mentions various aspects of the risk assessment process, including 

use of the best available data to develop endangered species risk assessments, and evaluation 

of effects on endangered and threatened species and their designated critical habitat. CBD 

also expressed concern regarding the rigor of the Agency’s preliminary determinations 

regarding the effects of mancozeb on endangered and threatened (listed) species and their 

designated critical habitat for the mancozeb registration review.

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

opening for mancozeb 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 mancozeb in connection with the development of its final 

registration review decision for mancozeb.

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 

report3 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 

 3 http://www.nap.edu/catalog.php?record_id=18344
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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 the 

Recommendations of the National Academy of Sciences April 2013 Report”4, 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 mancozeb 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 mancozeb, 

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

mancozeb 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 

mancozeb. This screening-level assessment will allow EPA to focus its future evaluations on 

the types of species where the potential for effects exists once the scientific methods being 

developed by the agencies have been fully vetted. While the agencies continue to develop a 

common method for ESA analysis, the planned screening-level risk assessment for the 

registration review of mancozeb 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 

mancozeb as part of completing this registration review.

Comments submitted by the FIFRA Endangered Species Task Force, L.L.C. in EPA-HQOPP-2015-0291-0013.

2. Comment: The technical registrant for mancozeb, as identified on the fact sheet included in 

the PWP, is Cheminova, Inc., which has recently been acquired by FMC Corporation, and 

Dow AgroSciences, which are FESTF members and entitled to rely on FESTF data.

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

the registration review of mancozeb.

 4 http://www.epa.gov/espp/2013/nas.html
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Comments submitted by the Physicians Committee for Responsible Medicine in EPA-HQOPP-2015-0291-0014.

3. Comment: The Physicians Committee for Responsible Medicine (PCRM) recommended that 

the OECD Test Guideline 223 for the Avian Acute Oral Toxicity Test be used as the protocol 

instead of EPA Guideline 850.2100 in the interest of reducing the numbers of animals used 

by up to 61%. PCRM also referred the registrant to the “Guidance for Classifying Studies 

Conducted Using the OECD Test Guideline 223 (TG223) (Acute Avian Oral Sequential Dose 

Study)” available on the Agency’s website.

Response: For studies with bobwhite quail and mallard, the Agency will accept testing under 

OECD Guideline 223. The Agency however recommends against the use of OECD 223 for 

passerine species studies, as this guideline has not been tested or validated for passerines.

4. Comment: PCRM cited data to fulfill the Agency’s needs without additional avian dietary 

toxicity testing under the requirement 850.2200.

Response: The data cited are from a secondary source (summary document). The document 

provides only the toxicity values, and does not provide the detailed information necessary to 

allow validation of the data. The Agency thanks PCRM for their comment.

Comments submitted by the Mancozeb Task Force in EPA-HQ-OPP-2015-0291-0015.

5. Comment: The Mancozeb Task Force submitted comments asking the Agency to reconsider 

the need for the pollinator studies identified in the Preliminary Work Plan. The Task Force 

cited data from an acute contact study on bees with mancozeb conducted by the University of 

California-Riverside in which little toxicity is observed.

Response: The Agency thanks the Mancozeb Task Force for their comment. EPA’s 

determination is that acute toxicity testing with adult bees does not necessarily reflect 

potential toxicity to developing larvae or chronic toxicity to adult bees. In order to conduct a 

Tier I assessment of pollinator risk, chronic effects to adults and larval bees are considered. 

The registrant may wish to consult the Office of Pesticide Programs Guidance for Assessing 

Pesticide Risks to Bees implemented June 23, 2014 regarding determination for testing needs 

and assessment of exposure potential currently used by the Agency.

6. Comment: The Mancozeb Task Force submitted comments regarding the anticipated data 

needs, specifically concerning the Residue/Monitoring (market basket) study. They mention 

that a previously compiled market basket survey was conducted for EPA from 1989-1990. 

The Mancozeb Task Force believes that the results gleaned from that survey continue to be 

viable and useable for Agency dietary risk assessment purposes.

Response: The Agency thanks the Mancozeb Task Force for their comment. The Mancozeb 

Task Force however is asked to provide specific information demonstrating the relevancy of 

the 1989-1990 market basket survey for use in current assessments. Given the age of the 

survey, any changes in application techniques, typical rates, handling, storage, and 

transportation could result in incurring different residue levels in food today than those 
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reported in the older survey. To allow for the continued use of the market basket survey, 

specific data must be submitted to illustrate that the survey results remain representative of 

present EBDC usage. This would include providing comparisons (across time) of typical 

rates, EBDC usage totals, application techniques/timing, percent crop treated data, 

commercial practices (handling, storage and transportation), and the capabilities of analytical 

methods to detect residues. In the event that the continued use of the market basket survey 

cannot be justified, the Agency will rely on residue data from available controlled studies 

(field trial and processing studies), which will likely result in significantly greater risk 

estimates, until a new survey can be provided.

Comments submitted by the Northwestern Horticultural Council (NHC) in EPA-HQ-OPP2015-0291-0016.

7. Comment: Indonesia and Russia, who are among the top export markets for U.S. tree fruits, 

do not have a maximum residue limits (MRL) for mancozeb residues in apples (Indonesia) 

and pears (Russia). These countries are top export markets for Northwest growers; therefore, 

we request that EPA work with its counterpart agencies to open access to these markets.

Response: During registration review, the Agency will work to minimize trade irritants and 

harmonize US tolerances with MRLs with its trading partners, to the extent feasible (and 

consistent with domestic law). To facilitate this, the Agency works with the United States 

Department of Agriculture Foreign Agricultural Service and the United States Trade 

Representative to identify potential trade irritants. EPA is currently working with some of the 

countries identified by Northwest Horticultural Council to assist with the development of 

science-based MRLs.
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PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for mancozeb based on the Registration 

Review – Problem Formulation for the Ecological Risk Assessment and Drinking Water 

Exposure Assessment to be Conducted for Mancozeb and Mancozeb: Human Health Risk 

Assessment Scoping Document in Support of Registration Review, Review of Public Response to 

Mancozeb Problem Formulation and Mancozeb: HED Response to Comments on the 

Registration Review Preliminary Work Plan. The planned data needs have not changed from 

what was included in the PWP.

Table 1: Planned Data Needs for the Mancozeb Registration Review

Guideline 

Number5 Study Title5

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Planned Data Needs for the Parent Mancozeb

835.2120 Hydrolysis TGAI 12

835.4400 Anaerobic aquatic metabolism TGAI 24

850.2100 Avian acute oral toxicity (passerine species and 

upland game or waterfowl species) TGAI 12

850.2200 Avian dietary toxicity (upland game and 

waterfowl species) TGAI 12

850.3040 Field testing for pollinators TEP 24

850.4100 Terrestrial plant toxicity, seedling emergence TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor TEP 12

850.4400 Aquatic plant growth (using Lemna spp.) TGAI 12

850.4500 Algal toxicity (Freshwater and marine diatom) TGAI 12

850.4550 Cyanobacteria toxicity TGAI 12

850.6100

Environmental chemistry methods and associated 

independent laboratory validations for soil and 

water

TGAI 12

860.1480 Ruminant feeding study TGAI 24

860.1500 Crop field trials (tobacco, safflower seed or 

propagation stock treatment data) TEP 24

860.1520 Processing studies (wheat, barley, oats, potatoes) TEP 24

860.1850 Confined rotational crop study TEP 24

NonGuideline Honey bee adult acute oral toxicity TGAI 12

NonGuideline Honey bee adult chronic oral toxicity TGAI 12

 5 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 Mancozeb Registration Review

Guideline 

Number5 Study Title5

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

NonGuideline Honey bee larval acute oral toxicity TGAI 12

NonGuideline Honey bee larval chronic oral toxicity TGAI 12

NonGuideline Semi-field testing for pollinators TEP or TGAI 24

NonGuideline Field trial of residues in pollen and nectar TEP 24

NonGuideline Residue/Monitoring (market basket) study TEP 36

Planned Data Needs for the ETU Degradate

835.4100 Aerobic soil metabolism Degradate 24

835.4300 Aerobic aquatic metabolism Degradate 24

835.4400 Anaerobic aquatic metabolism Degradate 24

850.6100 Environmental chemistry methods and associated 

independent laboratory validations for soil Degradate 24

Outstanding Data Requirements from Mancozeb GDCI-014504-26952

860.1340 Enforcement analytical method (mancozeb and

ETU in meat and milk)6 TGAI Past due

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

RISK ASSESSMENTS FOR REGISTRATION REVIEW

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

including an endangered species and pollinator assessment, for all uses of mancozeb. For human 

health, EPA will conduct revised dietary, residential, aggregate, 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.

 6 Submitted methods were deemed suitable with several revisions. EPA required submission of the revised methods, 

which have not been received to date.
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Table 2: Planned Risk Assessments for the Mancozeb 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 

Incidents Will check for 

updates

For a discussion of reported ecological incidents for 

mancozeb, see page 42 of the Problem Formulation.

Human Health

Dietary

Food Y The Agency is requiring additional 

residue/monitoring data to support the mancozeb 

dietary assessment. Until adequate updated market 

basket data are submitted, the Agency will rely on 

data from available controlled studies (e.g., field trial 

data, processing studies), which will likely result in 

significantly greater risk estimates than determined in 

the most recent assessment. ETU is the drinking water 

residue of concern. The planned environmental fate 

data needs identified for mancozeb parent and ETU in 

Table 1 are expected to be used to determine the 

estimated drinking water concentrations for ETU.

Drinking water Y

Occupational

Handlers (mixers, loaders, 

applicators)

Y EPA plans on conducting a comprehensive

quantitative handler and post-application occupational 

risk assessments (cancer and non-cancer), using the 

Agency’s updated exposure assessment methodology.

Post-application Y

Residential

Handlers Y EPA expects to revise the residential assessment only 

if endpoints, methodologies or use patterns change.

Post-application Y

Other

Aggregate Y Evaluates the combined risk from dietary and 

residential exposures. The Agency may conduct a 

revised aggregate assessment if there are significant 

changes to estimated residues in food or drinking 

water.
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Cumulative N Mancozeb has not been identified as a member of a 

cumulative group that shares a common mechanism 

of toxicity. However, mancozeb does produce a toxic 

metabolite, ETU, which is produced by other EBDC 

compounds. Risks from combined exposures to ETU 

from all EBDC compounds will be addressed in a 

separate ETU aggregate risk assessment.

Tolerances Y

Incidents Will check for 

updates

For a discussion of reported human incidents for 

mancozeb, see page 18 of the Scoping Document and 

the Mancozeb: Tier I (Scoping) Review of Human 

Incidents. EPA plans to conduct a Tier II assessment 

of the human health effects of mancozeb, given the 

number of epidemiological findings. This Tier II 

assessment will integrate the epidemiological 

findings, including information from the Agricultural 

Health Study, with the available experimental 

toxicological data.

EPA also plans to review the findings presented by a 

Reach the Decision Makers group7 in a May 29, 2014 

meeting with the Agency. A summary of the meeting 

and the submitted paper entitled, “An Updated Look 

at Mancozeb: Concerns about Farmworker 

Reproductive Health”, can be found in the mancozeb 

public docket. This paper contains a systematic 

identification, evaluation, and integration of in vitro, 

in vivo, and epidemiology studies regarding the 

potential developmental and reproductive toxicity of 

mancozeb.

TIMELINE

EPA has created the following estimated timeline for the completion of the mancozeb

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

Table 3: Registration Review for Mancozeb – Projected 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

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The Reach the Decision Makers Fellowship program is a training fellowship administered through the University of 

California at San Francisco’s Program on Reproductive Health and the Environment.
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Issue DCI 2016 Jan. - March

Data Submission 2019 Jan. - March

60-day Public Comment Period for Draft Risk 

Assessments8

2020 July – Sept.

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2021 April - June

Registration Review Decision and Begin PostDecision Follow-up2022

Total (years) 7

NEXT STEPS

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

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

early 2016. 

 8 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.