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Docket Number EPA-HQ-OPP-2011-0483 

www.regulations.gov

Emamectin Benzoate 

Summary Document 

Registration Review: Initial Docket 

June 2011 

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TABLE OF CONTENTS 

 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 12 

III. Summary of Data Gaps 18 

 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency’s 

current position based on the following documents: 

1. Registration Review – Preliminary Problem Formulation for the Environmental Fate, 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for 

Emamectin Benzoate. June 23, 2011. 

2. Emamectin Benzoate. Human Health Assessment Scoping Document in Support of Registration 

Review. June 16, 2011. 

3. Emamectin Benzoate: Review of Human Incidents. March 1, 2011. 

4. Emamectin Benzoate California Department of Pesticide Regulation Usage Data. July 

14, 2010. 

5. Emamectin Benzoate Screening Level Usage Analysis (SLUA). July 29, 2010. 

6. PRD Appendix A: Food/Feed & Non-Food/Non-Feed Uses Considered in Registration 

Review Work Planning. Emamectin Benzoate. October 26, 2010. 

Supporting documents for the registration review of emamectin benzoate are located in docket 

EPA-HQ-OPP-2011-0483 at www.regulations.gov. 
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I. PRELIMINARY WORK PLAN 

Introduction

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 at: http://www.epa.gov/oppsrrd1/registration_review/ . 

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 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 and commit to a final work plan and 

schedule for the registration review of emamectin benzoate. 

Emamectin benzoate is an insecticide and miticide currently registered for agricultural use on 

tree nuts and a variety of vegetable crops. Emamectin benzoate also has registered nonagricultural use on ornamental nonbearing trees as a tree injection for borers and for commercial 

industrial indoor sites as a ready-to-use cockroach bait. There are currently no residential uses or 

uses expected to result in direct residential exposure. Emamectin benzoate was first registered in 

the U.S. in 1999; therefore, it was not subject to the reregistration requirements of FIFRA. 

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting comprehensive human health and ecological risk 

assessments, including an endangered species risk assessment, for all uses of emamectin 

benzoate. The Agency anticipates needing data for use in conducting these assessments. Below 

is a summary of the issues relevant to the registration review of emamectin benzoate and a list of 

the anticipated data requirements. 
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Ecological Risk: 

• The most recent ecological risk assessments for emamectin benzoate were conducted in 

1998 in support of the first registration of this chemical, in 2005 in support of its use on 

pome fruit, and in 2010 in support of the request for expansion of tree species for the tree 

injection use to control arthropod pests. 

• The Agency anticipates conducting an updated environmental fate and ecological risk 

assessment for emamectin benzoate, including an endangered species assessment, during 

registration review. The new assessment will incorporate the most up-to-date modeling 

methodologies, updated toxicological endpoints, and any new data submitted and 

determined to be adequate. 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for emamectin benzoate. The ecological risk assessment planned 

during registration review will allow the Agency to determine whether emamectin 

benzoate’s use 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 (USFWS) and/or 

National Marine Fisheries Service (NMFS) (the Services), as appropriate. 

• On January 19, 2011, the Center for Biological Diversity and the Pesticide Action 

Network North America filed a lawsuit in the United States District Court for the 

Northern District of California against EPA for allegedly failing to undergo consultation 

with the USFWS and the NMFS regarding the effects of over 350 pesticides, including 

emamectin benzoate, on over 200 endangered and threatened species throughout the U.S. 

(Center for Biological Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.). 

• The environmental fate database for emamectin benzoate is currently considered 

complete; however, data gaps exist in the ecological toxicity database. The Agency 

anticipates needing the following data for use in conducting a complete ecological risk 

assessment, including an endangered species assessment, for emamectin benzoate:

Ecological Toxicity – Aquatic Data

o Non-Guideline Study – Special Study – Chronic Sediment Toxicity 

o Test Method 100.4: Hyalella azteca 42-d Test for Measuring the Effects of 

Sediment Associated Contaminants on Survival, Growth, and Reproduction in 

USEPA 2000 Methods for Measuring the Toxicity and Bioaccumulation of 

Sediment-associated Contaminants with Freshwater Invertebrates EPA 600/R99/064 
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o Test Method 100.5: Life cycle Test for Measuring for Measuring the Effects 

of Sediment-associated Contaminants on Chironomus dilutus (formerly 

known as C. tentans) in USEPA 2000 Methods for Measuring the Toxicity 

and Bioaccumulation of Sediment-associated Contaminants with Freshwater 

Invertebrates EPA 600/R-99/064 

o Leptocheirus plumulosus in USEPA 2001 Method for Assessing the Chronic 

Toxicity of Marine and Estuarine Sediment-associated Contaminants with the 

Amphipod Leptocheirus plumulosus EPA 600/R-01/020 

o Guideline No. 850.1075 – Fish Acute Toxicity Test, Freshwater (bluegill sunfish, 

Lepomis macrochirus) 

Ecological Toxicity – Terrestrial Data

o Guideline No. 850.2100 – Avian Acute Oral Toxicity (passerine species) 

o Guideline No. 850.4100 – Nontarget Area Phytotoxicity Tier II, Seedling Emergence 

(with TEP)1

o Guideline No. 850.4150 – Nontarget Area Phytotoxicity Tier II, Vegetative Vigor 

(with TEP)2

o Non-Guideline Study – Special Study – Acute Oral Honeybee 

o Non-Guideline Study – Special Study – Magnitude of Residues Study: Field Residue 

Analysis of Edible Parts of Trees/Plants (Whole Flowers, Leaves, Fruit, Seeds, 

Pollen, and Nectar [from flowers and, if present, extrafloral nectarines]) 

• The Agency seeks additional information, particularly use and usage information, for use 

in conducting a refined, complete ecological risk assessment, including an endangered 

species assessment for emamectin benzoate. For further details, see the “Guidance for 

Commenters” section below.

• Please refer to Registration Review – Preliminary Problem Formulation for the 

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

Exposure Assessments for Emamectin Benzoate, dated June 23, 2011, located in docket 

EPA-HQ-OPP-2011-0483 at www.regulations.gov, for a more detailed discussion of the 

anticipated ecological risk assessment and data needs.

 

1

 A Tier II study is expected to be required. The DCI expected to be issued will provide that a Tier I plant study 

may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I 

study would necessitate conduct and submission of a Tier II study as well. The purpose of a Tier II study is to 

establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05) to be used in a risk assessment and effects determination for 

endangered or threatened species (listed species), and a definitive IC25 (concentration at which there is a 25% 

observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a 

Tier I study and neither a definitive NOAEC nor a definitive IC05 value is available, then the Agency may have to 

presume in its effects determination, that Emamectin benzoate "may affect" and is “likely to adversely affect” listed 

plant species 

2

 See footntote 1. 
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Human Health Risk: 

• The most recent human health risk assessments were conducted in 2005 in support of the 

use of emamectin benzoate on pome fruit and in 2008 in support of the uses of 

emamectin benzoate on tree nuts and pistachios, as an injection treatment for 

ornamental/nonbearing trees, and an occupational assessment for the use as a cockroach 

bait. 

• During registration review, the endpoints, doses, and safety factors used in the most 

recent human health risk assessments will be revisited based on current policy as well as 

to incorporate any new data received and determined to be adequate. 

• The Agency anticipates conducting updated dietary, aggregate, and occupational 

exposure risk assessments to include any changes in toxicological endpoints, doses, and 

procedures for dermal and inhalation risk assessment. 

• Based on current registered use patterns of emamectin benzoate and the current 

toxicological points of departure, the Agency does not anticipate conducting an updated 

drinking water exposure risk assessment at this time. If, in the future, any new uses are 

requested or if there is any reason for re-evaluation of the points of departure, a revised 

dietary (food + water) risk assessment may be needed. 

• Currently, there are no registered uses for emamectin benzoate that would result in 

residential exposure. As such, risks from residential exposures have not been considered 

in previous assessments nor would they be considered at this time. However, residential 

bystander inhalation exposures resulting from off-site transport (e.g., spray drift or 

volatilization) may occur as a result of applications of emamectin benzoate. The Agency 

is in the process of examining its policies and refining the methods used to complete 

residential exposure assessments. Therefore, the potential need for a bystander inhalation 

risk assessment for emamectin benzoate will be examined during registration review. 

 

• During registration review, the Agency anticipates conducting a quantitative occupational 

postapplication inhalation exposure and risk assessment based on updated doses, 

endpoints, and procedures for inhalation risk assessment. 

• The tolerance expression in 40 CFR §180.505 will be reviewed during registration review 

to ensure that it appropriately covers the metabolites and degradates of emamectin 

benzoate and that it specifies the residues to be measured in each commodity. Any 

proposed revisions likely would be to the chemical description rather than the individual 

tolerance level(s). 
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• The toxicity database for emamectin benzoate is complete except for the following 

studies, which the Agency anticipates requiring for use in conducting an updated human 

health risk assessment: 

Toxicology Data

o Guideline No. 870.3465 – 28-Day Inhalation Toxicity 

o Guideline No. 870.7800 – Immunotoxicity 

• Please refer to Emamectin Benzoate. Human Health Assessment Scoping Document in Support of 

Registration Review ̧ dated June 16, 2011, available in docket EPA-HQ-OPP-2011-0483 at 

www.regulations.gov, for a detailed discussion of the anticipated human health risk assessment 

and data needs. 

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. EPA selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database in 2003 and reviewed the data again in 2008 as part 

of the most recent emamectin benzoate registration decision. However, as required by FFDCA 

section 408(p), emamectin benzoate 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 
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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. Emamectin 

benzoate is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Accordingly, as part of registration review, EPA will issue future 

EDSP orders/data call-ins, requiring the submission of EDSP screening assays for emamectin 

benzoate. For further information on the status of the EDSP, the policies and procedures, the list 

of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

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

Timeline

 

The projected timeline for the completion of the emamectin benzoate registration review is 

presented in Table 1. 

Table 1. Projected Emamectin Benzoate Registration Review Timeline 

Activity Estimated Date 

Opening the Docket 

Open Docket and Open Public Comment Period 2011 – June 

Close Public Comment Period 2011 – August 

Case Development 

Develop Final Work Plan (FWP) 2011 – November 

Issue Data Call-In (DCI) 2012 – July – Sept. 

Data Submission 2014 – July – Sept. 

Develop Preliminary Risk Assessments and Open Public Comment 

Period 

2015 – Jan. – March 

Close Public Comment Period 2016 – April – June 

Registration Review Decision 

Develop Proposed Registration Review Decision and Open Public 

Comment Period 

2016 – July – Sept. 

Close Public Comment Period 2016 – Oct. – Dec. 

Issue Registration Review Decision and Begin Post-Decision Follow-up 2017 

Total (years) 6 

Guidance for Commenters

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency 

will carefully consider all comments, as well as any additional information or data provided in a 

timely manner, prior to issuing a final work plan for the emamectin benzoate case. 
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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. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (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. 

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 emamectin benzoate 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. 

Water Quality 

Emamectin benzoate is not identified as a cause of impairment for any water bodies listed as 

impaired under section 303(d) of the Clean Water Act3

. In addition, no Total Maximum Daily 

Loads (TMDLs) have been developed for emamectin benzoate4

. More information on impaired 

water bodies and TMDLs can be found at the Agency’s website5. 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 Process6

 in order to ensure they can be used quantitatively or 

qualitatively in pesticide risk assessments. 

Other Information 

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining risk assessments, including any species-specific ecological effects 

determinations, for emamectin benzoate. The Agency is interested in receiving the following 

information: 

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 4 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES 5 http://www.epa.gov/owow/tmdl/

6 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
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1. Confirmation on the following label information 

a. sites of application 

b. formulations 

c. application methods and equipment 

d. maximum application rates 

e. frequency of application, application intervals, and maximum number of 

applications per season and per year 

f. geographic limitations on use 

2. Use or potential use distribution (e.g. acreage and geographical distribution of relevant 

uses/use sites) 

3. Use history 

4. Median and 90th percentile reported use rates (lbs ai/acre, lbs ai/1000 sq. ft.) from usage 

data – national, state and county 

5. Application timing (date of first application and application intervals) by use – national, 

state, and county 

6. Sub-county use site location data 

7. Usage/use information for non-agricultural uses on ornamental nonbearing trees as a tree 

injection for borers and in commercial industrial indoor sites as a ready-to-use cockroach 

bait; and information on effective alternatives 

8. Directly acquired county-level usage data (not derived from state level data) 

a. maximum reported use rate (lbs ai/acre) from usage data – county 

b. median and 90th percentile number of applications – county 

c. total pounds per year – county 

d. the year the pesticide was last used in the county/sub-county area 

e. the years in which the pesticide was applied in the county/sub-county area 

9. Typical application interval (days) 

10. State or local use restrictions 

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

mammalian mortalities, and bee or beneficial insect mortalities) not already reported to 

the Agency 

12. Monitoring data 

Next Steps

After the 60-day 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 

emamectin benzoate. The Agency expects to issue a Final Work Plan for emamectin benzoate in 

November 2011. 
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II. FACT SHEET 

Background Information

• Registration Review Case Number: 7607. 

• Pesticide Chemical (PC) Code: 122806. 

• Chemical Abstracts Service (CAS) Numbers: 

o Emamectin: 119791-41-2 (formerly 123997-28-4). 

o Emamectin benzoate: 155569-91-8 (formerly 137512-74-4 and 179607-18-2). 

• Emamectin benzoate was first registered in the U.S. in 1999. 

• Emamectin benzoate was not subject to reregistration; therefore, there is no 

Reregistration Eligibility Decision (RED) for emamectin benzoate. 

• Currently, the technical registrant for emamectin benzoate is Syngenta Crop Protection, 

LLC. 

• Currently, there are seven Section 3 registrations for emamectin benzoate, including two 

technical products, one manufacturing use product (MUP), and five end-use products 

(EUPs). 

• U.S. tolerances for emamectin benzoate currently range from 0.002 ppm to 0.2 ppm [40 

CFR §180.505]. 

• Pesticide Re-evaluation Division (PRD) Contact: Katherine St. Clair 

(stclair.katherine@epa.gov). 

• Registration Division (RD) Contact: Tom Harris (harris.thomas@epa.gov). 

Use and Usage Information

For additional details, please refer to Emamectin Benzoate California Department of Pesticide 

Regulation Usage Data, dated July 14, 2010; Emamectin Benzoate Screening Level Usage 

Analysis (SLUA), dated July 29, 2010; and PRD Appendix A: Food/Feed & Non-Food/Non-Feed 

Uses Considered in Registration Review Work Planning. Emamectin Benzoate (122806)., dated 

October 26, 2010; located in docket EPA-HQ-OPP-2011-0483 at www.regulations.gov. 

• Emamectin benzoate is currently registered for agricultural uses to control insects on a 

variety of tree nut and vegetable crops. 
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• Registered non-agricultural use sites for emamectin benzoate include ornamental 

nonbearing trees as a tree injection for borers to control arthropod pests as well as 

commercial industrial indoor sites as a ready-to-use cockroach bait. 

All emamectin benzoate EUPs are Restricted Use pesticides (for retail sale to and use 

only by certified applicators or persons under their direct supervision, and only for those 

uses covered by the certified applicator’s certification), except for one ready-to-use 

cockroach bait product for commercial industrial indoor use. 

• Emamectin benzoate formulation types include soluble granular products for use on 

various terrestrial food/feed crops, emulsifiable concentrates for use on cotton and 

tobacco and for tree injection, and ready-to-use gels for use as a cockroach bait,. 

• Emamectin benzoate application methods for terrestrial crops include multiple foliar 

sprays using ground equipment, aircraft, or airblast equipment (for orchards). 

• Agricultural usage of emamectin benzoate is mainly on apples, broccoli, cabbage, 

cauliflower, celery, lettuce, pears, peppers, and tomatoes, and it fluctuates from year to 

year. According to July 2010 screening level estimates of the agricultural uses of 

emamectin benzoate in the U.S., the largest agricultural use is on apples, with 

approximately 1,000 pounds of ai used annually in 2010, an average of 10 percent of the 

crop treated, and a maximum of 20 percent of the crop treated. Screening level estimates 

do not include non-agricultural uses.

Recent and Pending Actions

• There were 12 Section 24c Special Local Need (SLN) registrations for emamectin 

benzoate which were voluntarily cancelled by the registrant on March 12, 2010. 

• The Agency approved a request for expansion of the emamectin benzoate tree injection 

use to a variety of trees and pests in 2011. 

Ecological Risk Assessment Status

The following are key findings from the most recent ecological risk assessments regarding the 

environmental fate, ecological effects and risks of emamectin benzoate. Please refer to 

Registration Review – Preliminary Problem Formulation for the Environmental Fate, Ecological 

Risk, Endangered Species, and Drinking Water Exposure Assessments for Emamectin Benzoate, 

dated June 23, 2011, located in docket EPA-HQ-OPP-2011-0483 at www.regulations.gov, for a 

detailed discussion. 
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• The most recent ecological risk assessments for emamectin benzoate were conducted in 

1998 in support of the first registration of this chemical, in 2005 in support of its use on 

pome fruit, and in 2010 in support of the request for expansion of tree species for the tree 

injection use to control arthropod pests. 

Ecological Effects: 

• Based on toxicity data and other information gathered to date, the acute risks of concern 

from the use of emamectin benzoate are primarily related to direct effects on terrestrial 

birds, mammals, terrestrial invertebrates (acute contact basis), freshwater and saltwater 

fish, and freshwater and saltwater invertebrates. 

• Based on toxicity data and other information gathered to date, the chronic risks of 

concern from the use of emamectin benzoate are primarily related to direct effects on 

mammals, freshwater and saltwater fish, and freshwater and saltwater invertebrates. 

• There are potential risks to nonvascular plants from the use of emamectin benzoate. 

Potential risks to listed and non-listed species of non-target terrestrial plants have not 

been quantitatively assessed because there is no acceptable data available to assess risk to 

these taxa. 

Human Health Risk Assessment Status

The following are key findings from the human health risk assessments conducted for emamectin 

benzoate registered uses. Please refer to Emamectin Benzoate. Human Health Assessment 

Scoping Document in Support of Registration Review ̧ dated June 16, 2011, located in docket 

EPA-HQ-OPP-2011-0483 at www.regulations.gov, for a detailed discussion of the human health 

risk assessment status. 

• The most recent human health risk assessments were conducted in 2005 in support of the 

use of emamectin benzoate on pome fruit and in 2008 in support of the uses of 

emamectin benzoate on tree nuts and pistachios, as an injection treatment for 

ornamental/nonbearing trees, and an occupational assessment for the proposed 

commercial use as a cockroach bait. 

Hazard Characterization: 

• The acute toxicity of technical grade emamectin benzoate is low to moderate via the oral, 

dermal, and inhalation routes of exposure, depending on the test substance. It is a severe 

eye irritant, but not a skin irritant. It is not a skin sensitizer. 
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• Emamectin benzoate has been classified as “not likely to be carcinogenic in humans.” 

There is no mutagenicity concern for emamectin benzoate based on the available data. 

Summary of Risks: 

Dietary (Food and Drinking Water)

• Acute and chronic non-cancer dietary (food and drinking water) risk estimates for 

emamectin benzoate were below the Agency’s level of concern for the general U.S. 

population and all population subgroups. Emamectin benzoate was classified as “not 

likely to be carcinogenic to humans.” Therefore, a cancer dietary risk assessment was not 

conducted for emamectin benzoate.

Residential 

• Emamectin benzoate is not registered for use in residential settings and there is currently 

no risk concern for residential exposure. 

Aggregate

• Since a residential risk assessment was not conducted for emamectin benzoate, acute and 

chronic aggregate risks were equivalent to acute and chronic dietary (food and drinking 

water) risks and were below the Agency’s level of concern. 

Occupational

• All occupational handler dermal and inhalation exposures and risks were previously 

assessed based on current Agency policies. All scenarios resulted in dermal and 

inhalation exposure risk estimates below the Agency’s level of concern based on use of 

the personal protective equipment (PPE) required by the product label. 

• All occupational postapplication dermal exposures and risks have been previously 

assessed based on current Agency policies. All scenarios resulted in dermal exposure 

risk estimates below the Agency’s level of concern. 

Cumulative

• The Agency has not determined whether emamectin benzoate shares a common 

mechanism of toxicity with other chemical substances. If, in the future, EPA obtains new 

data suggesting that emamectin benzoate shares a common mechanism of toxicity with 

other chemical substances, the Agency will revisit the need for a cumulative risk 

assessment. 
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Human Studies

• Past emamectin benzoate 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) 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 (40 CFR Part 26) have been satisfied, and 

there is no regulatory barrier to continued reliance on these studies. 

Incidents

Ecological Incidents: 

• The Agency reviewed the Ecological Incident Information System (EIIS), which is 

maintained by the EPA Office of Pesticide Programs (OPP), and the Avian Monitoring 

System (AIMS), which is maintained by the American Bird Conservancy, for ecological 

incident reports associated with the use of emamectin benzoate in the U.S. There were 

no reported ecological incidents associated with the use of emamectin benzoate. A 

review of the OPP Aggregate Incident Report database also yielded no ecological 

incident reports for emamectin benzoate. 

• Although no incidents have been reported to the Agency, the absence of reported 

incidents should not be construed as the absence of incidents. 

Human Health Incidents: 

• The Agency reviewed the OPP Incident Data System (IDS) for human health pesticide 

incident data associated with the use of emamectin benzoate in the U.S. to identify 

potential patterns on the frequency of health effects attributed to emamectin benzoate 

exposure. The IDS aggregate summaries from January 1, 2002 to February 1, 2011 

include two minor cases reported for emamectin benzoate. There were no incidents 

reported to the IDS resulting in higher severity outcomes from January 1, 2002 to 

February 1, 2011. 

• Based on the low frequency and low severity of incident cases reported in the OPP IDS, 

there does not appear to be a concern at this time that would warrant further investigation 
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of emamectin benzoate human health incidents in the preliminary risk assessment phase 

of registration review. However, the Agency anticipates continuing to monitor the 

incident information and including additional analysis in the registration review risk 

assessment if a concern is triggered. 

Tolerances and International Harmonization

• U.S. tolerances for emamectin benzoate are established for residues of emamectin 

benzoate and its metabolites in or on the crop and livestock commodities listed in 40 CFR 

§180.505. 

• A table listing the differences between U.S. tolerances and Canadian, Mexican, and 

CODEX Maximum Residue Limits (MRLs) for emamectin benzoate is included in the

Emamectin Benzoate. Human Health Assessment Scoping Document in Support of 

Registration Review ̧ dated June 16, 2011, available in docket EPA-HQ-OPP-2011-0483 

at www.regulations.gov. Currently, there are no harmonization issues with Canada, 

CODEX, or Mexico. During registration review, if any Codex MRLs have been 

established, the Agency anticipates harmonizing the U.S. tolerances with the Codex 

MRLs when the data warrant harmonization. 

Data Call-Ins

• No DCIs have been issued for emamectin benzoate. 

Labels 

• Active Section 3 labels for emamectin benzoate can be obtained from the Pesticide 

Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home. 
Page 18 of 19 

III. SUMMARY OF DATA GAPS 

A summary of the anticipated data needs for the emamectin benzoate registration review is 

presented in Table 2. 

Table 2. Summary of Anticipated Data Needs for Emamectin Benzoate

Guideline Number Anticipated Data Requirement Test 

Material 

Study 

Duration 

Non-Guideline 

Special Study – Chronic Sediment Toxicity 

Test Method 100.4: Hyalella azteca 42-d Test for Measuring 

the Effects of Sediment Associated Contaminants on 

Survival, Growth, and Reproduction in USEPA 2000 

Methods for Measuring the Toxicity and Bioaccumulation of 

Sediment-associated Contaminants with Freshwater 

Invertebrates EPA 600/R-99/064 

TGAI 24 

Non-Guideline 

Special Study – Chronic Sediment Toxicity 

Test Method 100.5: Life cycle Test for Measuring for 

Measuring the Effects of Sediment-associated Contaminants 

on Chironomus dilutus (formerly known as C. tentans) in 

USEPA 2000 Methods for Measuring the Toxicity and 

Bioaccumulation of Sediment-associated Contaminants with 

Freshwater Invertebrates EPA 600/R-99/064 

TGAI 24 

Non-Guideline 

Special Study – Chronic Sediment Toxicity 

Leptocheirus plumulosus in USEPA 2001 Method for 

Assessing the Chronic Toxicity of Marine and Estuarine 

Sediment-associated Contaminants with the Amphipod 

Leptocheirus plumulosus EPA 600/R-01/020 

TGAI 24 

850.1075 Fish Acute Toxicity Test, Freshwater (bluegill sunfish, 

Lepomis macrochirus) TGAI, TEP 12 

850.2100 Avian Acute Oral Toxicity (passerine species) TGAI 12 

850.4100 Nontarget Area Phytotoxicity Tier II, Seedling Emergence7 TEP 12 

850.4150 Nontarget Area Phytotoxicity Tier II, Vegetative Vigor8 TEP 12 

Non-Guideline Special Study – Acute Oral Honeybee TGAI 12 

 

7

 A Tier II study is expected to be required. The DCI expected to be issued will provide that a Tier I plant study 

may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I 

study would necessitate conduct and submission of a Tier II study as well. The purpose of a Tier II study is to 

establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05) to be used in a risk assessment and effects determination for 

endangered or threatened species (listed species), and a definitive IC25 (concentration at which there is a 25% 

observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a 

Tier I study and neither a definitive NOAEC nor a definitive IC05 value is available, then the Agency may have to 

presume in its effects determination, that Emamectin benzoate "may affect" and is “likely to adversely affect” listed 

plant species. 

8

 See footnote 7. 
Page 19 of 19 

Guideline Number Anticipated Data Requirement Test 

Material

Study 

Duration

Non-Guideline 

Special Study – Magnitude of Residues Study: Field Residue 

Analysis of Edible Parts of Trees/Plants (Whole Flowers, 

Leaves, Fruit, Seeds, Pollen, and Nectar [from flowers and, if 

present, extrafloral nectarines]) 

TEP 24 

870.3465 28-Day Inhalation Toxicity TGAI 12 

870.7800 Immunotoxicity TGAI 12