2

Imazalil and Imazalil Sulfate 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 ..................................................................................................................... 10

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW .............................. 10

TIMELINE .................................................................................................................................... 13

NEXT STEPS ............................................................................................................................... 13

Appendix – Additional Areas Considered in the Imazalil and Imazalil Sulfate Registration 

Review ...................................................................................................................................... 14 

References:

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

based on the following documents: 

1. Registration Review – Preliminary Problem Formulation for Ecological Risk and 

Environmental Fate, Endangered Species, and Drinking Water Assessments for Imazalil 

and Imazalil Sulfate. Christine Hartless, Ph.D., R. David Jones, Ph.D., and Laura Parsons. 

12/05/13. 

2. Imazalil and Imazalil Sulfate: Human Health Assessment Scoping Document in Support of 

Registration Review. Karlyn Middleton, Dennis McNeilly, and Zaida Figueroa. 11/21/13. 

3. Imazalil and Imazalil Sulfate: Tier I Review of Human Incidents. Elizabeth Evans and 

Shanna Recore. July 25, 2013.

4. BEAD Chemical Profile for Registration Review: Imazalil (111901) and Imazalil Sulfate 

(111902). Tara Chandgoyal, Ph. D., Cynthia Doucoure, and Andrew Lee. July 30, 2013.
3

5. Imazalil (111901) Screening Level Usage Analysis (SLUA). January 22, 2013.

6. Imazalil EFED Label Data Report. June 6, 2013.

7. Imazalil HED Label Data Report. June 6, 2013.

These and other supporting documents for the imazalil and imazalil sulfate registration review 

case may be found in the docket EPA-HQ-OPP-2013-0305 at http://www.regulations.gov.
4

OVERVIEW

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

registration review (docket number EPA-HQ-OPP-2013-0305). This case includes the following 

active ingredients: imazalil (PC Code 111901) and imazalil sulfate (PC Code 111902). Imazalil 

is a systemic imidazole fungicide registered for use for control of a variety of fungal pathogens. It 

is used for postharvest treatment of citrus fruits and bananas (imported), seed treatment of barley, 

wheat, and triticale, and ornamental plants in commercial greenhouses. Imazalil also has an 

antimicrobial indoor non-food use: the control of Aspergillus fumigates in egg hatching facilities 

and equipment disinfection. There are no registered residential uses for imazalil. This 

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

knows about imazalil and imazalil sulfate, highlighting anticipated data and assessment needs, 

identifying the types of information that would be especially useful to the Agency in conducting 

the registration review, and providing an anticipated timeline for completing the review for 

imazalil and imazalil sulfate.

 

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 imazalil and imazalil sulfate and what types 

of new data or other information would be helpful for the Agency to receive as it moves toward a 

decision on imazalil. 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 imazalil and imazalil 

sulfate. 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 imazalil. Finally, the Appendix 

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

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

 
5

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for imazalil and imazalil sulfate. For 

additional discussion of the anticipated data needs, see the Registration Review – Preliminary 

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

Drinking Water Assessments for Imazalil and Imazalil Sulfate and Imazalil and Imazalil Sulfate: 

Human Health Assessment Scoping Document in Support of Registration Review. 

Table 1: Anticipated Data Needs for the Imazalil & Imazalil Sulfate Registration Review1

Guideline 

Number2 Study Title Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Imazalil – PC Code 111901 

835.1410 Laboratory Volatility3 TEP 12 

835.4100 Aerobic Soil Metabolism TGAI or 

PAIRA 

24 

835.6100 Terrestrial Field Dissipation TGAI 24 

850.1075 Fish Acute Toxicity Test (saltwater only) TGAI 12 

850.1400 Fish Early-Life Stage Toxicity Test (freshwater) TGAI 12 

850.1730 Fish Bioconcentration Factor TGAI 12 

850.1735 Whole Sediment Chronic Invertebrate Toxicity 

(Freshwater)4

TGAI 24 

850.1740 Whole Sediment Chronic Invertebrate Toxicity 

(Estuarine/marine)5

TGAI 12 

850.2100 Avian Acute Oral Toxicity (passerine species) TGAI 12 

850.3020 Honeybee Acute Contact Toxicity TGAI 12 

850.3100 Earthworm Subchronic Toxicity Test6 TGAI 12 

850.6100 Environmental Chemistry Method and Associated 

Independent Laboratory Validation (soil only) TGAI 12 

870.3465 90-day Inhalation Toxicity - Rat TGAI 24 

875.2100 Dislodgeable Foliar Residue (DFR) Dissipation7 TEP 24 

 

1

 For studies listed in this table that are requested for both imazalil and imazalil sulfate (all studies listed except 

875.2100: Dislodgeable Foliar Residue Dissipation), data may be bridged between imazalil and imazalil sulfate. 

The preferred test material for all studies is imazalil rather than imazalil sulfate. 2

 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 3

 Anticipated to be required as Henry’ Law Constant > 10-6 atm·m3·mol-1 and to support greenhouse use (see 

problem formulation). Study must be performed at a pH above 7. 

4

 Requested freshwater studies are a 42-day study with Hyallela azteca and/or a 56-day study with Chironomus 

dilutus or C. tentans. Both are found in Second Edition EPA/600/R-99/064, Duluth, MN. 5

 Requested estuarine/marine study is a 28-day study conducted with the Amphipod Leptocheirus plumulosa found 

in First Edition, EPA Report 600/R-01/020, March 2001. 

6

 An acute 14-day earthworm (Eisenia foetida) toxicity study identified in the ESFA Pesticide Review for imazalil

(http://www.efsa.europa.eu/en/efsajournal/doc/1526.pdf) may meet this data need if submitted for Agency review. 7

 This study is anticipated to be required for use in conducting risk assessments for workers contacting treated 

ornamental plants in greenhouses. The requested test material is imazalil (PC Code 111901). 
6

Table 1: Anticipated Data Needs for the Imazalil & Imazalil Sulfate Registration Review1

Guideline 

Number2 Study Title Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Nonguideline Honeybee Acute Oral Toxicity TGAI 12 

Imazalil Sulfate – PC Code 111902 

835.1410 Laboratory Volatility8 TEP 12 

835.4100 Aerobic Soil Metabolism TGAI or 

PAIRA 

24 

835.6100 Terrestrial Field Dissipation TGAI 24 

850.1075 Fish Acute Toxicity Test (saltwater only) TGAI 12 

850.1400 Fish Early-Life Stage Toxicity Test (freshwater) TGAI 12 

850.1730 Fish Bioconcentration Factor TGAI 12 

850.1735 Whole Sediment Chronic Invertebrate Toxicity 

(Freshwater)9

TGAI 24 

850.1740 Whole Sediment Chronic Invertebrate Toxicity 

(Estuarine/marine)10

TGAI 12 

850.2100 Avian Acute Oral Toxicity (passerine species) TGAI 12 

850.3020 Honeybee Acute Contact Toxicity TGAI 12 

850.3100 Earthworm Subchronic Toxicity Test11 TGAI 12 

850.6100 Environmental Chemistry Method and Associated 

Independent Laboratory Validation (soil only) TGAI 12 

870.3465 90-day Inhalation Toxicity - Rat TGAI 24 

Nonguideline Honeybee Acute Oral Toxicity TGAI 12 

Outstanding Data Requirements (for Imazalil) from GDCI-111901-2168312

860.1340 Residue Analytical Method (ILV-livestock 

commodities) 13

Residue of 

Concern Past Due 

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

 

 

8

 Anticipated to be required as Henry’ Law Constant > 10-6 atm·m3·mol-1 and to support greenhouse use (see 

problem formulation). Study must be performed at a pH above 7. 

9

 Requested freshwater studies are a 42-day study with Hyallela azteca and/or a 56-day study with Chironomus 

dilutus or C. tentans. Both are found in Second Edition EPA/600/R-99/064, Duluth, MN. 10 Requested estuarine/marine study is a 28-day study conducted with the Amphipod Leptocheirus plumulosa found 

in First Edition, EPA Report 600/R-01/020, March 2001. 

11 An acute 14-day earthworm (Eisenia foetida) toxicity study identified in the ESFA Pesticide Review for imazalil

(http://www.efsa.europa.eu/en/efsajournal/doc/1526.pdf) may meet this data need if submitted for Agency review. 12 The study listed in this section was previously required through a generic data call-in issued in April, 2005 and is 

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

required through the earlier DCI. 13 Only an ILV is anticipated to be required. An adequate residue analytical method is available for determining the 

total toxic residues of imazalil in/on plant commodities but not in livestock commodities. 
7

STATUTORY AND REGULATORY AUTHORITY

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

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

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

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

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

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

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

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

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

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

program is provided on EPA’s website.14

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 imazalil. 

CHEMICAL FACTS

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

Table 2: Chemical Facts for Imazalil and Imazalil Sulfate

PC code Imazalil (PC Code 111901) and imazalil sulfate (PC Code 111902) 

Case Number 2325 

CAS Number Imazalil: 3555-44-0; Imazalil Sulfate: 58594-72-2 

Year first registered Imazalil was first registered by Janssen Pharmaceutica (FIFRA 

Section 3) in 1983. Imazalil sulfate was registered in March, 2004. 

Pesticide Type Systemic fungicide

Chemical class Imidazole 

Reregistration Eligibility 

Decision (RED) 

Imazalil RED completed in September 30, 2003 

Because it was registered after November 1984, imazalil sulfate 

was not subject to reregistration. 

Tolerance Reassessment 

Eligibility Decision 

(TRED) 

Imazalil TRED completed in July 12, 2002 

Because it was registered after November 1984, imazalil sulfate 

was not subject to reregistration. 

 

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

Table 2: Chemical Facts for Imazalil and Imazalil Sulfate

Cumulative group Imazalil and imazalil sulfate are not members of a cumulative 

group and no cumulative risk assessment is planned. 

40 CFR Citation Tolerances for imazalil and imazalil sulfate are established in 40 

CFR § 180.413. 

Dual-use Imazalil is registered for both conventional and antimicrobial 

pesticidal uses. 

Non-pesticidal uses There are no identified non-pesticidal uses of imazalil. 

Pesticide Re-evaluation 

Division, Chemical Review 

Manager 

Margaret Hathaway, hathaway.margaret@epa.gov, (703) 305-5076

Antimicrobials Division, 

Chemical Review Manager 

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

Registration Division, 

Product Manager 

Tony Kish, kish.tony@epa.gov, (703) 308-9443 

USE AND USAGE INFORMATION

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

Profile for Registration Review: Imazalil (111901) and Imazalil Sulfate (111902) in the registration 

review docket for more details.

Table 3: Imazalil and Imazalil Sulfate Use and Usage Information 

Summary of Use A fungicide registered for use in controlling fungal pathogens on 

postharvest citrus fruits and on wheat, barley and triticale; for 

ornamental plants in commercial greenhouses; and in poultry 

hatcheries for the control of Aspergillus fumigatus.

Use Sites Imazalil and imazalil sulfate have registered agricultural, 

commercial and industrial use sites. Used for seed treatments, 

postharvest citrus fruit treatments, sterilization of egg hatcheries, 

and in commercial greenhouses. There are currently no residential 

uses registered for imazalil or imazalil sulfate. 

Summary of Usage EPA has limited usage data for imazalil and imazalil sulfate due to 

its non-agricultural and diffuse types of use patterns. From 2004-

2011, and average of 4000 lbs A.I. was used as a seed treatment for 

spring wheat and 2000 lbs A.I. was used as a seed treatment for 

winter wheat. Data for earlier or more recent years were not 

available. 

Formulation Type(s) Imazalil: liquid ready-to-use, pressurized liquid, emulsifiable 

concentrate, water soluble granule, and in smoke candles. 

Imazalil sulfate: soluble powder, water soluble granule, and a 

flowable concentrate. 

Application Method(s) Imazalil: Applied as a seed treatment using mist-type equipment 
9

Table 3: Imazalil and Imazalil Sulfate Use and Usage Information 

and mechanical slurries; as a postharvest treatment using a foamer, 

spray brush, dips, wash tanks, wax, and drenches; and using 

automatic and handheld foggers in poultry hatcheries as a smoke 

candle treatment in greenhouses for ornamental plants, and to 

disinfect equipment prior to the introduction of eggs. 

Imazalil Sulfate: Applied as a postharvest treatment using dip and 

wash tanks, drenchers, and in aqueous line and storage wax line 

spray applications, as well as in non-recovery spray and water spray 

brush applications. 

Technical Registrant(s) Imazalil: Certis Europe B.V., Janssen Preservation & Material 

Protection (PMP), and Makhteshim Chemical Works Ltd 

Imazalil Sulfate: Janssen Preservation & Material Protection (PMP) 

No. of Registrations Imazalil: 15 Section 3 products15 

Imazalil Sulfate: 3 Section 3 products 

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. 

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

application methods and equipment; maximum application rates; frequency of 

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

geographic limitations on use. 

 Labeling clarification on which combinations of two treatments are included in 

postharvest applications, and confirmation on whether three treatments are ever applied 

on citrus. 

 For egg hatchery uses, information about handler process and potential inhalation risks. 

What type of equipment is used in hatcheries for imazalil application: an automatic or a 

handheld fogger? 

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

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

and county. Information about citrus uses is especially sought. Noting that imazalil is 

not a typical field crop with a specific use in pounds per acre, the Agency also asks for 

confirmation the quantity of imazalil used to treat a given volume of fruit (i.e. volume 

A.I. and dilution factor data). In the case of wax treatments, the Agency seeks 

information on whether the volume A.I. indicated is per treatment or for two wax 

treatments combined, in the case of citrus receiving both a pre- and post-storage 

treatment. 

 Post-treatment residue information, especially about lemons. 

 

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

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

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

state, and county. 

 Usage/use information for non-agricultural uses. 

 Typical application interval (days). 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical imazalil and imazalil 

sulfate to the US market. 

RECENT ACTIONS

The RED for imazalil was completed on September 30, 2003. Imazalil sulfate was first 

registered in 2004. There are no recent approved actions for imazalil or imazalil sulfate. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for imazalil was completed on 

February 7, 2002 in preparation for the imazalil Reregistration Eligibility Decision. The most 

recent ecological and environmental fate risk assessment was completed on April 18, 2001 for 

the same purpose. No ecological or human health risk assessments have been conducted by the 

Agency for imazalil sulfate, and no endangered species assessments have been conducted for 

either imazalil or imazalil sulfate. Findings and conclusions from these risk assessments are 

summarized in the Registration Review – Preliminary Problem Formulation for Ecological Risk 

and Environmental Fate, Endangered Species, and Drinking Water Assessments for Imazalil and 

Imazalil Sulfate and Imazalil and Imazalil Sulfate: Human Health Assessment Scoping Document 

in Support of Registration Review. 

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

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

and imazalil sulfate. For human health, EPA anticipates the need to conduct revised dietary and 

occupational risk assessments during registration review. If toxicological endpoints or points of 

departure are revised based on the data that are anticipated to be required for registration review, 

they will be considered in the new assessments, as well as any changes to the standard operating 

procedures or default exposure assumptions. 

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

EFED Problem Formulation and HED Scoping Document. 

 
11

Table 4: Anticipated Risk Assessments for the Imazalil and Imazalil Sulfate 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 

Yes Assessments are needed for both imazalil and imazalil 

sulfate. 

Incidents Will check for 

updates 

There are no reported ecological incidents for imazalil 

or imazalil sulfate. 

Human Health 

Dietary 

Food Yes HED may need to update the dietary exposure 

estimates with more recent monitoring data for citrus 

commodities than the percent crop treated information 

and monitoring data used in HED’s dietary 

assessment for the 2003 RED. 

Drinking water Yes A new drinking water assessment will be needed to 

incorporate the use of the most current drinking water 

models. At the time of registration review, HED will 

include any updates in the modeled drinking water 

residues in the new dietary exposure assessment. 

Occupational 

Handlers (mixers, loaders, 

applicators) 

Yes Updated occupational handler exposure assessments 

will be required under registration review based on 

revisions to the Agency’s scenario-specific surrogate 

handler exposure data and updated exposure 

assessment methodologies. 

Post-application Yes Chemical-specific data to evaluate post-application 

exposure associated with the greenhouse uses on 

ornamentals are needed to support registration review. 

The information/data will be incorporated into a 

revised post-application exposure and risk assessment 

for occupational workers. 

Residential 

Handlers No There are no registered residential uses for imazalil. 

Post-application No There are no registered residential uses at this time. 

However, residential exposures from off-site transport 

(e.g., spray drift or volatilization) may occur as a 

result of imazalil applications to agricultural fields. 

The Agency may conduct a spray drift assessment and 

examine the need for a volatilization assessment for 

imazalil during Registration Review. 

Other 
12

Aggregate Yes Evaluates the combined risk from dietary and 

residential exposures. During registration review, 

updated aggregate assessments will be needed to 

include any potential updates to exposure from food 

and drinking water, revised regulatory endpoints, 

points of departure (PoDs) and uncertainty 

factors/safety factors (UF/SFs). 

Cumulative No Imazalil is not a member of a cumulative group and 

no cumulative risk assessment is planned. 

Tolerances Yes Tolerances for residues of imazalil and imazalil 

sulfate are established in 40 CFR § 180.413; the 

tolerance expression will be revised to reflect current 

policy. Harmonization may not be possible due to 

differences in residues of concern for enforcement 

purposes. 

Incidents Will check for 

updates 

For a discussion of reported human incidents for 

imazalil and imazalil sulfate, see page 14 of the 

Scoping Document and the Imazalil and Imazalil 

Sulfate: Tier I Review of Human Incidents. 

Guidance for Commenters: Additional ecological information requested for this 

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

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 
13

TIMELINE

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

review in Table 5 below. 

Table 5: Projected Imazalil and Imazalil Sulfate Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period 2013 – December

Close Public Comment 2014 – February

Case Development

Final Work Plan 2014 – May

Issue DCI 2014 July – Sept.

Data Submission 2016 July – Sept.

60-day Public Comment Period for Draft Risk 

Assessments[1]

2018 Jan. - March

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2018 July – Sept.

Registration Review Decision and Begin Post-Decision 

Follow-up

2019

Total (years) 6

NEXT STEPS

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

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

review of imazalil and imazalil sulfate. 

 

 

[1] 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. 
14

Appendix – Additional Areas Considered in the Imazalil and Imazalil Sulfate 

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: 

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

section 303(d) of the Clean Water Act.16 In addition, no Total Maximum Daily Loads (TMDL) 

have been developed for imazalil.17 More information on impaired water bodies and TMDLs 

can be found at the Agency’s website.18 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 

Process19 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 imazalil and imazalil sulfate 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.

 

16 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 17http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES 18 http://www.epa.gov/owow/tmdl/

19 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
15

ENDANGERED SPECIES:

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

conducted for imazalil and imazalil sulfate. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether use of imazalil 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 imazalil, EPA reviewed 

these data and selected the most sensitive endpoints for relevant risk assessment scenarios from 

the existing hazard database. Imazalil sulfate was registered in 2004 on the basis of risk 

assessments previously conducted for imazalil. As required by FFDCA section 408(p), both 

imazalil and imazalil sulfate are subject to the endocrine screening part of the Endocrine 

Disruptor Screening Program (EDSP). 

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

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

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

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

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

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

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

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

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

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

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

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

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

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 
16

of chemicals identified for EDSP screening was published on June 14, 201320 and includes some 

pesticides scheduled for registration review and chemicals found in water. 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.21

HUMAN STUDIES:

Occupational 

Past imazalil 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. 

Imazalil sulfate was registered in 2004 on the basis of assessments previously conducted for 

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

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

Agricultural Reentry Task Force (ARTF) 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. 

 

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

chemicals. 21 http://www.epa.gov/endo/