2

Metconazole Preliminary Work Plan – Table of Contents 

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

ANTICIPATED DATA NEEDS .................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY ................................................................... 5

CHEMICAL FACTS ...................................................................................................................... 6

USE AND USAGE INFORMATION ............................................................................................ 7

RECENT ACTIONS ....................................................................................................................... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE .................................................................................................................................... 10

NEXT STEPS ............................................................................................................................... 11

Appendix – Additional Areas Considered in the Metconazole Registration Review ................... 12 

References:

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

based on the following documents: 

1. Metconazole: Preliminary Problem Formulation for the Environmental Fate, Ecological 

Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the 

Registration Review. He Zhong, Ph.D., and Michael Lowit, Ph.D. December 10, 2015. 

2. Metconazole. Human Health Scoping Document in Support of Registration Review. Barry 

O’Keefe, Nancy Dodd, and Myron Ottley. November 24, 2015. 

3. Metconazole: Revised Tier I (Scoping) Review of Human Incidents and Epidemiology. 

Elizabeth Evans and Shanna Recore. September 15, 2015. 

4. BEAD Chemical Profile (BCP) for Registration Review: Metconazole (125619). Tara 

Chandgoyal, Ph.D., Don Atwood, Ph.D., and Stephen Smearman. December 14, 2015.

5. Metconazole (125619) Screening Level Usage Analysis (SLUA). May 8, 2015.
3

6. Environmental Fate and Effects Division Label Data Report: Metconazole PC Code 

125619. March 18, 2015.

7. Health Effects Division Master Label Report Spreadsheet: Metconazole PC Code 125619. 

March 18, 2015.

These and other supporting documents for the metconazole registration review case may be 

found in the docket EPA-HQ-OPP-2015-0013 at http://www.regulations.gov. 
4

OVERVIEW

The docket for metconazole is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0013). Metconazole is a demethylation 

inhibiting (DMI) fungicide registered for agricultural uses including bushberries, tree nuts, 

almonds, potatoes, sweet potatoes, corn, sugar beets, small grains, sugarcane, canola, cotton, 

peanuts, soybeans, sunflowers and dry beans. Metconazole is also registered for residential use 

on ornamentals and on golf course turf. This Preliminary Work Plan (PWP) document explains 

what EPA's Office of Pesticide Programs knows about metconazole, 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 metconazole. 

 

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 metconazole and what types of new data or 

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

metconazole. 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 metconazole. 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 metconazole. 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. 

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for metconazole. For additional discussion of 

the anticipated data needs, see the Metconazole: Preliminary Problem Formulation for the 

Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure 

Assessments in Support of the Registration Review and Metconazole. Human Health Scoping 

Document in Support of Registration Review. 
5

Table 1: Anticipated Data Needs for the Metconazole Registration Review 

Guideline 

Number1 Study Title

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Anticipated Data Needs for Metconazole

850.2100 Avian oral toxicity (passerine species) TGAI 12 

850.3040 Full field testing for pollinators (Tier III) TEP 24 

850.6100 Environmental Chemistry Method/Independent 

Laboratory Validation water TGAI 12 

870.3465 90-day inhalation (rat) TGAI 24 

Nonguideline Adult honeybee chronic oral toxicity (Tier I) TGAI 12 

Nonguideline Larval honeybee acute oral toxicity (Tier I) TGAI 12 

Nonguideline Larval honeybee chronic oral toxicity (Tier I) TGAI 12 

Nonguideline Residues in Pollen and Nectar (Tier II) TEP 24 

Nonguideline 

Chronic toxicity to benthic invertebrates (whole 

sediment; 3 test species: freshwater Midge 

(Chironomus dilutes); freshwater amphipod 

(Hyalella azteca); and estuarine amphipod 

(Leptocheirus plumulosus)

TGAI 24 

Nonguideline Semi-field testing for pollinators (tunnel and 

feeding studies (Tier II) TEP 24 

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

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 

 

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 
6

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

program is provided on EPA’s website.2

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 metconazole. 

CHEMICAL FACTS 

Table 2 provides a summary of the chemical facts for metconazole. 

Table 2: Chemical Facts for Metconazole

PC code 125619 

Case Number 7049 

CAS Number 125116-23-6 

Year first registered 2007 

Pesticide Type Fungicide 

Chemical class Triazole 

Reregistration Eligibility 

Decision (RED) 

Metconazole was registered after November 1984; therefore, it 

was not subject to reregistration. 

Tolerance Reassessment 

Eligibility Decision (TRED)

Metconazole was registered after November 1984; therefore, it 

was not subject to tolerance reassessment. 

Cumulative group No cumulative risk assessment is required at this time since the 

Agency has not made a determination regarding a common 

mode of action. 

40 CFR Citation Tolerances for metconazole are established in 40 CFR § 

180.617. 

Dual-use Conventional pesticide uses only. 

Non-pesticidal uses No non-pesticidal uses. 

Pesticide Re-evaluation 

Division, Chemical Review 

Manager 

Jordan Page, page.jordan@epa.gov 703.347.0467 

Registration Division, 

Product Manager 

Hope Johnson; johnson.hope@epa.gov, 703.305.5410 

 

2

 http://www2.epa.gov/pesticide-reevaluation 
7

USE AND USAGE INFORMATION 

Table 3 summarizes the use and usage information for metconazole. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Metconazole (125619) in the registration 

review docket for more details. 

Table 3: Metconazole Use and Usage Information

Summary of Use Metconazole is a broad-spectrum triazole fungicide active 

ingredient that works systemically by preventing spore formation 

and inhibiting mycelial growth. Metconazole acts primarily as an 

inhibitor of ergosterol biosynthesis, thereby interfering with 

synthesis of fungal cell membranes and providing systemic seed 

and seedling protection. 

Use Sites Use sites for metconazole are bushberries (including blueberries 

and cranberries), tree nuts, almonds, stone fruits, tuberous and 

corm vegetables (including potatoes and sweet potatoes), corn 

(field, pop, seed, and sweet), sugar beets, barley, oats, rye, wheat, 

triticale, sugarcane, canola, cotton, peanuts, soybeans, sunflowers 

and dry beans and peas. Metconazole is also registered for 

residential use on ornamentals and golf course turf. 

Summary of Usage Average usage (2010-2013) was approximately 210,000 pounds 

of active ingredient applied annually on approximately 5,440,000 

acres. 

Formulation Type(s) Emulsifiable concentrate, flowable concentrate, soluble 

concentrate, water dispersible granule, ready-to-use 

Application Method(s) Applications can be made with ground, aerial, airblast,

chemigation, hand held, or seed treatment equipment. 

Technical Registrant(s) Kureha Corporation 

No. of Registrations 14 Section 3 products3, 3 24(c)s 

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. 

• Certain metconazole labels are unclear with respect to application parameters such as 

maximum number of applications and minimum application interval (see Metconazole: 

Preliminary Problem Formulation for the Environmental Fate, Ecological Risk, 

Endangered Species, and Drinking Water Exposure Assessments in Support of the 

Registration Review, Table 1). Without further information, EPA expects to use 

conservative assumptions to approximate these parameters in order to conduct a 

quantitative risk assessment. However, the Agency will work with registrants to clarify 

information on metconazole product labels. 

 

3

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

(http://oaspub.epa.gov/pestlabl/ppls.home). 
8

• Maximum annual application rates per acre (maximum lb ai/A/year) for labels that refer 

only to per-crop or per-season rates. 

• Use/Usage information for metconazole as an agricultural seed treatment including use 

distribution (e.g., acreage and geographical distribution). 

• Usage/use information for non-agricultural uses. 

• Foreign technical registrants not listed above who supply technical metconazole to the 

US market. 

RECENT ACTIONS 

Tolerances for stone fruit, tree nut, pea and bean (except for soybean), rapeseed and sunflower 

subgroups were established in May 2015. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent human health risk assessment for metconazole was completed in 2014 for 

certain new uses and crop groupings. The most recent ecological and environmental fate risk 

assessment was completed in 2014 for the same purpose. Findings and conclusions from these 

risk assessments are summarized in the Metconazole: Preliminary Problem Formulation for the 

Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure 

Assessments in Support of the 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 

metconazole. For human health, EPA anticipates the need to conduct revised 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. 

Changes to the standard operating procedures or default exposure assumptions could also trigger 

the need for revised assessments. An updated dietary assessment for common triazole 

degradates/metabolites may also be needed. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 
9

Table 4: Anticipated Risk Assessments for the Metconazole 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 The Agency will conduct a comprehensive 

ecological risk assessment including an 

endangered species assessment during 

registration review. 

Incidents Will check 

for updates 

For a discussion of reported ecological incidents 

for metconazole, see page 21 of the Problem 

Formulation. 

Human Health 

Dietary 

Food N New dietary exposure assessment is not 

anticipated to be needed during registration 

review. 

Drinking water Y A new drinking water assessment for 

metconazole may be needed during registration 

review. 

Metconazole may be considered in an updated 

drinking water assessment for the triazole 

degradates common to members of this 

chemical class.

Occupational 

Handlers (mixers, loaders, 

applicators) 

Y A new occupational handler and postapplication assessment will be needed for 

registration review if the inhalation toxicity data

anticipated to be required for registration review 

result in establishment of a new endpoint and 

point of departure for inhalation exposures. 

Post-application Y 

Residential 

Handlers Y A new residential handler assessment may be 

needed if data anticipated to be required during 

registration review result in a new endpoint and 

point of departure for inhalation exposures. 

Post-application Y The need for spray drift and volatilization 

assessments will be determined during 

registration review. 

Other 

Aggregate4 N May be needed if changes to endpoints and 

points of departure for inhalation exposure 

result in changes to the residential risk 

assessment. 
10

Cumulative N There is currently no evidence to indicate that 

members of this chemical class share a common 

mechanism of toxicity, and EPA is not 

following a cumulative risk approach based on a 

common mechanism of toxicity. 

Tolerances N There is no harmonization issue with Codex and 

Canadian 

 MRLs are the same as U.S. tolerances. 

Incidents Will check 

for updates 

For a discussion of reported human incidents for 

metconazole, see page 9 of the Scoping 

Document and Metconazole: Revised Tier I 

(Scoping) Review of Human Incidents and 

Epidemiology. 

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below. 

• Ecological incidents not already reported to the Agency. 

• Water quality monitoring data (see Appendix for further details). 

TIMELINE 

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

registration review in Table 5 below. 

 

4

 Additionally, a dietary assessment for the triazole degradates common to members of this chemical class may be 

needed. 
11

Table 5: Projected Metconazole Registration Review Timeline

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period December 2015 

Close Public Comment February 2016 

Case Development 

Final Work Plan May 2016 

Issue DCI July-September 2016 

Data Submission July-September 2018 

60-day Public Comment Period for Draft Risk 

Assessments5

January-March 2020 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

October-December 2020 

Registration Review Decision and Begin Post-Decision 

Follow-up 

2021 

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 metconazole. 

 

5

 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. 
12

Appendix – Additional Areas Considered in the Metconazole 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: 

Metconazole is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.6

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for metconazole.7 More information on impaired water bodies 

and TMDLs can be found at the Agency’s website.8 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 Process9

 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 metconazole 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.

 

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

7http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

8 http://www.epa.gov/tmdl/

9 http://www2.epa.gov/pesticide-reevaluation/opp-guidance-submission-state-and-tribal-water-quality-monitoringdata
13

ENDANGERED SPECIES: 

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

conducted for metconazole. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of metconazole 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 metconazole, 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), 

metconazole is 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.10 A second list 

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

 

10 http://www2.epa.gov/endocrine-disruption/overview-first-list-chemicals-tier-1-screening-under-endocrinedisruptor 

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

chemicals. 
14

pesticides scheduled for registration review and chemicals found in water. Metconazole does not 

appear on either list. Neither of these lists should be construed as a list of known or likely 

endocrine disruptors. 

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.12

HUMAN STUDIES: 

Occupational and Residential 

Past metconazole 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 Handler Exposure Task Force (AHETF) database, 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://www2.epa.gov/endocrine-disruption