Page 1 of 19 Docket Number EPA-HQ-OPP-2011-0483 www.regulations.gov



## Emamectin Benzoate Summary Document Registration Review: Initial Docket
June 2011Page 3 of 19 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 su mmarize 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 Dr inking Water Exposur e Assessments for
Emamectin Benzoate . June 23, 2011.

2. Emamectin Benzoate. Human Health Assessme nt 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 Consider ed 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.Page 4 of 19 I. PRELIMINARY WORK PLAN

Introduction

The Food Quality Protection Act (F QPA) of 1996 mandated a regist ration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e 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 belie ves 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 de velop and commit to a final work plan and schedule for the registration review of emamectin benzoate.

Emamectin benzoate is an insecticide and miticid e currently registered for agricultural use on tree nuts and a variety of vegetable crops. Emamectin benzoate also has registered nonagricultural use on ornamental nonb earing 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 subjec t to the reregistration requirements of FIFRA.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting comprehe nsive human health and ecological risk assessments, including an endangered species ri sk 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 regist ration review of emamectin benzoate and a list of the anticipated data requirements.Page 5 of 19 Ecological Risk:

• The most recent ecological risk assessments for emamectin benzoate were conducted in 1998 in support of the first regi stration of this chemical, in 2005 in support of its use on pome fruit, and in 2010 in support of the reques t 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 endpoint s, and any new data submitted and determined to be adequate.

• The Agency has not conducted a risk asse ssment 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 (NM FS) (the Services), as appropriate.

• On January 19, 2011, the Center for Biologi cal Diversity and the Pesticide Action
Network North America filed a lawsuit in th e United States District Court for the Northern District of California against EP A 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 an d 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 followi ng data for use in conducting a complete ecological risk assessment, including an endangered speci es 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 Invert ebrates EPA 600/R99/064Page 6 of 19 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 fo r 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 Sedi ment-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 Phytot oxicity Tier II, Seedling Emergence (with TEP) 1

o Guideline No. 850.4150 – Nontarget Area Phyt otoxicity 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/Plant s (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, s ee the “Guidance for
Commenters” section below.

• Please refer to Registration Review – Preliminar y Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments fo r 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 Con centration (NOAEC), or alternatively, a concentration at which there is a 5% observed inhibition effect (IC 05 ) to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC 25 (concentration at wh ich 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 IC 05 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.Page 7 of 19 Human Health Risk:

• The most recent human health risk assessmen ts were conducted in 2005 in support of the use of emamectin benzoate on pome fruit a nd 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 occupati onal 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 ch anges in toxicological endpoints, doses, and procedures for dermal and i nhalation risk assessment.

• Based on current registered use patterns of emamectin benzoate and the current toxicological points of departure, the Agen cy 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-eva luation 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 re sidential exposures have not been considered in previous assessments nor would they be cons idered at this time. However, residential bystander inhalation exposures resulting from off-site transport (e.g., spray drift or volatilization) may occur as a re sult 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 antici pates conducting a quantitative occupational postapplication inhalation exposure and ri sk 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 th e 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 chemi cal description rather than the individual tolerance level(s).Page 8 of 19 • The toxicity database for emamectin benz oate is complete except for the following studies, which the Agency anticipates requi ring 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 A ssessment 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 th e anticipated human he alth risk assessment
and data needs.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. EPA selected the most sensit ive endpoints for relevant risk assessment scenarios from the existing hazard database in 2 003 and reviewed the data again in 2008 as part of the most recent emamectin benzoate registra tion 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 whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required
determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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. BetweenPage 9 of 19 October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active in gredients and 9 inert ingredients. Emamectin benzoate is not among the group of 58 pesticide active ingredients on th e 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 submi ssion of EDSP screening assays for emamectin
benzoate. For further information on the status of the EDSP, the policies a nd procedures, the list of 67 chemicals, future lists, th e test guidelines and th e Tier 1 screening ba ttery, please visit our
website: http://www.epa.gov/endo/

.

Timeline

The projected timeline for the completion of th e 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 Revi ew Decision and Open Public
Comment Period 2016 – July – Sept.

Close Public Comment Period 2016 – Oct. – Dec. Issue Registration Review Decision a nd 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 commen ts, 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.Page 10 of 19 Trade Irritants

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Environmental Justice

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r 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 Act 3 . In addition, no Total Maximum Daily Loads (TMDLs) have been developed for emamectin benzoate 4 . More information on impaired
water bodies and TMDLs can be found at the Agency’s website 5 . 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 Proc edure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’ s Registration Review Risk Assessment and Management Process 6 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Other Information

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining risk assessments, includ ing any species-specific ecological effects determinations, for emamectin benzoate. The Ag ency is interested in receiving the following
information:

3 http://iaspub.epa.gov/tmdl_waters10/attains _nation_cy.cause_detail_30 3d?p_cause_group_id=885

4 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail ?p_pollutant_group_id=885&p_ pollutant_group_name=PESTIC IDES

5 http://www.epa.gov/owow/tmdl/

6 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htmPage 11 of 19 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, applicati on 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 di stribution of relevant uses/use sites)

3. Use history

4. Median and 90 th percentile reported use rates (lbs ai/acre, lbs ai/1000 sq. ft.) from usage data – national, state and county
5. Application timing (date of firs t application and application intervals) by use – national, state, and county

6. Sub-county use site location data

7. Usage/use information for non-agricultural us es on ornamental nonbear ing trees as a tree injection for borers and in commercial industria l indoor sites as a re ady-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 a i/acre) from usage data – county
b. median and 90 th percentile number of applications – county

c. total pounds per year – county
d. the year the pesticide was last us ed 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 dama ge and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or beneficial insect mortalit ies) not already reported to the Agency

12. Monitoring data

Next Steps

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner and then issue a Fi nal Work Plan for the registration review of emamectin benzoate. The Agency expects to issu e a Final Work Plan for emamectin benzoate in
November 2011.Page 12 of 19 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 re registration; therefore, there is no Reregistration Eligibility Decision (RED) for emamectin benzoate.

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

LLC.

• Currently, there are seven Sec tion 3 registrations for emamec tin benzoate, including two technical products, one manuf acturing 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 (P RD) 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 EP A-HQ-OPP-2011-0483 at www.regulations.gov.

• Emamectin benzoate is currently registered fo r agricultural uses to control insects on a variety of tree nut and vegetable crops.Page 13 of 19 • Registered non-agricultural use sites fo r emamectin benzoate include ornamental nonbearing trees as a tree injection for bor ers to control arthropod pests as well as
commercial industrial indoor sites as a ready-to-u se cockroach bait.

All emamectin benzoate EUPs are Restricted Us e 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 commerci al industrial indoor use.

• Emamectin benzoate formulation types incl ude soluble granular products for use on
various terrestrial food/feed crops, emulsifiable concen trates 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 fo r terrestrial crops include multiple foliar sprays using ground equipment, aircraft, or airblast equipmen t (for orchards).

• Agricultural usage of emamectin benzoate is mainly on apples, broccoli, cabbage, cauliflower, celery, lettuce, pear s, peppers, and tomatoes, and it fluctuates from year to year. According to July 2010 screening leve l estimates of the ag ricultural uses of emamectin benzoate in the U.S., the larg est 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 cr op 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 vol untarily cancelled by the re gistrant 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 rece nt ecological risk assessments regarding the environmental fate, ecological effects and risk s of emamectin benzoate. Please refer to Registration Review – Preliminary Problem Form ulation for the Environmental Fate, Ecological Risk, Endangered Species, and Dr inking Water Exposur e Assessments for Emamectin Benzoate

, dated June 23, 2011, located in docket EP A-HQ-OPP-2011-0483 at www.r egulations.gov, for a
detailed discussion.Page 14 of 19 • The most recent ecological risk assessments for emamectin benzoate were conducted in 1998 in support of the first regi stration of this chemical, in 2005 in support of its use on pome fruit, and in 2010 in support of the reques t for expansion of tree species for the tree injection use to control arthropod pests.

Ecological Effects:

• Based on toxicity data and othe r information gathered to date, the acute risks of concern from the use of emamectin benzoate are primar ily related to direct effects on terrestrial birds, mammals, terrestrial invertebrates (acu te contact basis), fres hwater and saltwater fish, and freshwater and saltwater invertebrates.

• Based on toxicity data and ot her 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 saltwat er 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 h ealth risk assessments conducted for emamectin benzoate registered us es. 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 assessmen ts were conducted in 2005 in support of the use of emamectin benzoate on pome fruit a nd 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 occ upational 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, depend ing on the test substan ce. It is a severe eye irritant, but not a skin irritant . It is not a skin sensitizer.Page 15 of 19 • Emamectin benzoate has been classified as “not likely to be car cinogenic 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 subg roups. Emamectin benzoate was classified as “not likely to be carcinogenic to humans.” Therefor e, a cancer dietary ri sk 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 inhala tion 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 postapplicati on 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 whethe r emamectin benzoate shares a common mechanism of toxicity with other chemical s ubstances. If, in the future, EPA obtains new data suggesting that emamectin benzoate sh ares a common mechanis m of toxicity with other chemical substances, the Agency will revisit the need for a cumulative risk

assessment.Page 16 of 19 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, invo lving exposure to many different pesticides, comprise generic pesticide exposure database s such as the Pestic ide Handlers Exposure Database (PHED) and the Agricultural Reen try 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 relativ e to the ethical standards prevailing at the time the research was conducte d. All applicable re quirements of EPA’s
Rule for the Protection of Hu man Subjects (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to c ontinued reliance on these studies.

Incidents

Ecological Incidents:

• The Agency reviewed the Ecological Incide nt 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 Aggregat e 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 freque ncy of health effects attri buted to emamectin benzoate exposure. The IDS aggregate summaries from January 1, 2002 to February 1, 2011 include two minor cases reported for emamec tin benzoate. There were no incidents reported to the IDS resulting in higher se verity outcomes from January 1, 2002 to February 1, 2011.

• Based on the low frequency and low severity of incident cases repor ted in the OPP IDS, there does not appear to be a concern at this time that would warrant further investigationPage 17 of 19 of emamectin benzoate human health incident s in the preliminary risk assessment phase of registration review. However, the Agen cy 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 A ssessment Scoping Document in Support of Registration Review  ̧ dated June 16, 2011, availabl e in docket EPA-HQ-OPP-2011-0483 at www.regulations.gov. Currently, there ar e no harmonization issues with Canada, CODEX, or Mexico. During registration review, if any Codex MRLs have been established, the Agency anticipates harmoni zing 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 benz oate can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.Page 18 of 19 I II. SUMMARY OF DATA GAPS

A summary of the anticipated data needs for th e 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 A ssociated Contaminants on Survival, Growth, and Reproduction in USEPA 2000 Methods for Measuring the Toxicity and Bioaccumulation of

Sediment-associated Contam inants 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-a ssociated 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 Toxic ity (passerine species) TGAI 12

850.4100 Nontarget Area Phytotoxicity Tier II, Seedling Emergence 7 TEP 12

850.4150 Nontarget Area Phytotoxicity Tier II, Vegetative Vigor 8 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 Con centration (NOAEC), or alternatively, a concentration at which there is a 5% observed inhibition effect (IC 05 ) to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC 25 (concentration at wh ich 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 IC 05 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 [f rom flowers and, if present, extrafloral nectarines]) TEP 24

870.3465 28-Day Inhalation Toxicity TGAI 12

870.7800 Immunotoxicity TGAI 12