1 Docket Number EPA-HQ-OPP-2010-0751 www.regulations.gov



## Methomyl Summary Document Registration Review: Initial Docket September 20103 TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 11

III. Summary of Data Gaps 17

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 Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Methomyl, July 16, 2010.

2. Methomyl : Registration Review Scoping Document for Human Health Assessments, July 13, 2010.

3. Methomyl Screening Level Usag e Analysis (SLUA), October 19, 2009.

4. Methomyl: Review of Human Incidents, May 20, 2010.

All supporting documents for the registration revi ew of methomyl are located in docket EPAHQ-OPP-2010-0751 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN – METHOMYL

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the United States (U.S .) generally must be registered by the Environmental Protection Agen cy (EPA or the Agency), based on scientific data showing that they will not cause unreasonab le 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 a nd as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreas onable 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 re view program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA), and will review each registered pesticide every 15 years to determine wh ether it continues to m eet the FIFRA standard for registration. The Agency will consider benef its information and data as required by FIFRA. The public phase of registration review begins wh en the initial docket is opened for each case. The docket is the Agency’s opportunity to stat e what it knows about the pesticide and what additional risk analyses and data or information it believes ar e 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 methomyl.

Methomyl is an N-methyl carbamate insectic ide currently registered for use on a wide variety of sites including field, vegetable, and orchard crops, and on turf (sod farms only). Methomyl is generally a restrict ed use pesticide [based on percen t active ingredient (a.i.)] and there are currently no homeowner uses. However, certain low percentage a.i. formulations are not designated as restricted use and can be us ed around livestock quarters, commercial premises and refuse containers. Methomyl was first registered in the Un ited States in 1968. A Reregistration Eligibility Decision (RED) was completed in 1998. Methomyl is the primary metabolite of thiodicarb, which is also an insec ticide. The thiodicarb re gistration review docket (EPA-HQ-OPP-2009-0432) opened on December 16, 2009.

Methomyl and thiodicarb are members of the N-methyl carbamate (NMC) class of

chemicals that share a common mechanism of toxi city and inhibit acetylcholinesterase (AChE) by carbamylation of the serine hyd roxyl group located in the activ e site of the enzyme. The “Revised N-Methyl Carbamate Cumulative Risk Assessment” was completed in September 2007

and is available in the do cket at EPA-HQ-OPP-2007-0935.5 Anticipated Risk Assessment and Data Needs

The Agency intends to require data needed to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, and a revised human health risk assessment for all uses of methomyl. Below is a summary of the issu es relevant to the registration review of methomyl and the da ta the Agency anticipates requiring.

Ecological Risk:

 The most recent comprehensive risk assessment for methomyl was conducted in 1998 in support of the Reregistration Elig ibility Decision (RED) document.

 The Agency has conducted several assessments on some endangered species, but has not conducted an ecological risk assessment that supports a complete endangered species determination for methomyl. The ecological risk assessment planned during registration review will allow the Agency to determine whether methomyl’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an asse ssment concludes that a pesticide’s use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the U.S. Fish and Wildlife Service (FWS) and/or National Marine Fish eries Service (NMFS) (the Services), as appropriate.

 The Agency anticipates needing the followi ng data in order to conduct a complete ecological risk assessment, including a co mplete endangered species assessment, for methomyl:

 GDLN 835.2240 – Aqueous photolysis

 GDLN 835.4100 – Aerobic soil metabolism

 GDLN 835.4300 – Aerobic aquatic metabolism

 GDLN 835.4400 – Anaerobic aquatic metabolism

 GDLN 850.2100 – Avian or al toxicity (passerine species)

 GDLN 850.2300 – Avian reproduction study (mallard duck)

 GDLN 850.4100 – Terrestrial plant toxi city: Tier II Seedling Emergence

 GDLN 850.4150 – Terrestrial plant toxi city: Tier II Vegetative Vigor

 GDLN 850.4400 – Aquatic plant growth: vascular plants

 GDLN 850.5400 – Aquatic plant growth : nonvascular plants

Please refer to the “ Registration Review: Preliminary Probl em Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Methomyl,” dated July16, 2010, for a more detailed discus sion of the anticipat ed ecological risk

assessment and data needs.6 Human Health Risk:

 The most recent comprehensive human health risk assessment for methomyl was completed in support of the 1998 RED. A dietary assessment was completed for methomyl as part of the NMC Cu mulative Risk Assessment.

 Since the last human health exposure and risk assessment in support of the 1998 RED the crop use sites and application s cenarios have remained the same with the exception of the cancellation of methomyl use on strawberries, the pending canc ellation of the grape use,

and the restriction on handheld devices.

 A revised dietary risk assessment, may be n eeded to include updated percent crop treated estimates, updated monitoring data, changes in toxicological endpoints, and revised estimated drinking water concentrations.

 The methomyl tolerance expression in 40 CFR 180.253 will be reviewed during registration review to ensure that it appropr iately covers the metabolites and degradates of methomyl and that it specifies the resi dues to be measured for each commodity. Any proposed revisions would be to the chemical description rather than the individual

tolerance levels.

 A residential handler exposure assessment ma y be needed during registration review. Even though there are currently no homeowner uses for methom yl, there is a potential for exposure to baits in public areas. In addi tion, a residential post -application assessment may be needed to support the use of methomyl on sod farms.

 Revised occupational handler and postapplication assessment may be needed based on the most current toxicity pr ofile and Agency policies.

 Due to the rapid onset and recovery of AChE effects from methomyl, an acute aggregate risk assessment is the only appropriate a ggregate assessment that may be needed to support registration review. Th is acute assessment would in corporate any new point of departures or uncertainty f actors identified for methomyl.

 The Agency anticipates requiring the followi ng data in order to conduct a complete human health risk assessment for methomyl:

o GDLN 870.7800 – Immunotoxicity Study

o Non-guideline – Acute Inhalation Study This acute inhalation study wouldprovide AChE data showing the time to peak AChE inhibition as well as the doseresponse of AChE inhibition at the peak inhibition. A study protocol should be provided to the Agency for review before the onset of such study.7  Prior to a final registration review decision for methomyl, th e Agency will determine if there is any new information, such as new hazard or exposure data or information on changes to the use pattern, that would affect the cumulative risk assessment. Should the Agency determine that new information on me thomyl is available that could potentially impact the cumulative risk assessment and resu lt in a risk of concern, the Agency will

revisit the cumulative risk assessment.

 Please refer to the “ Methomyl: Registration Review Sc oping Document for Human Health

Assessments ,” dated July 13, 2010, available in the docke t, for a detailed discussion of the anticipated human health risk assess ment and data needs for methomyl.

Other Anticipated Data Needs:

 GDLN 830.7050 UV/Visible Li ght Absorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requirements) for registration of a pesticide (food and non-food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s id entity/composition and the wavelengths at which the compound may be suscepti ble to photochemical degradation.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar 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 ap proach to making the 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 quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticid e active ingredients and 9 inert ingredients.

This list of chemicals was selected based on th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.

This list should not be construed as a lis t of known or likely endocrine disruptors.

Methomyl is among the group of 58 pesticide active ingredients on the initial list to be screened

under the EDSP. For information on the status of the orders issued under the EDSP for each chemical, please visit our website at http://www.epa.gov/endo/ and click on the "Status of EDSP8 Orders/DCIs" in the Highlights Box. Additiona l information on the EDSP, including the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, can

also be found at this website.

Timeline

The Agency has created the following estimated timeline for the completion of the methomyl registration review.

Registration Review for Methomyl – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2010 – September

Close Public Comment 2010 – November Case Development

Final Work Plan 2011 – February

Issue DCI 2011 – Oct – Dec

Data Submission 2013 – Oct –Dec Open Public Comment Period for Draft Risk Assessments 2015 – April – June

Close Public Comment Period 2015 – July – Sept Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – Oct – Dec

Close Public Comment Period 2016 – Jan - March Registration Review Decision and Begin Post-Decision Follow-up 2016 Total (years) 1 6

1. An assessment of the potential cumulative risk from the NMC class of insecticides may impact this time estimate

.

Guidance for Commenters

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consid er all comments, as well as any additional information or data provided in a timely manner, prior to issuing a fi nal work plan for the methomyl case.

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 of9 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 nature 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 methomyl compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure, compared to the general population.

Water Quality

Methomyl and thiodicarb are not identified as causes for any water bodies listed as impaired under section 303(d) of the Clean Water Act (based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d? p_cause_group_id=88

5 , accessed April 22, 2010). In addition, no Total Maximum Daily Loads (TMDL) have been developed for thiodicarb or methomyl (based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tm dl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES , accessed April 22, 2010). More information on impaired water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for these pesticides. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (see: http://www.epa.gov/oppfead1/cb/ppdc/2006/novem ber06/session1-sop.pdf ), in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Additional 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. The Agency is interested in receiving the following information:

1. Confirmation on the following label information.

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates10 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 . geographical distributio n of relevant uses).

3. Use history.

4. Median and 90 th percentile reported use rates (lb/A, lb 1K 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. Usage/use information for non-agricultural uses.

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

a. maximum reported use rate (lb/ cc) 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

8. Typical application interval (days).

9. State or local use restrictions.

10. Ecological incidents specific to methomyl (non-target plant damage and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or beneficial inse ct mortalities) not already reported to the Agency.

Next Steps

After the 60-day comment period closes, the Ag ency will consider and respond to any comments received in a timely manner and th en expects to issue a Final Work Plan in February of 2011 for methomyl.11 II. FACT SHEET

Background Information

 The registration review case number for methomyl is: 0028.

 Methomyl PC Code: 090301; CAS # 16752-77-5.

 Methomyl was first registered in the United States in 1968.

 A Reregistration Eligibility Deci sion (RED) was completed in 1998.

 Technical registrant: E.I du Pont de Nemours and Company

 There are 9 FIFRA Section 3 product registra tions and 18 Special Local Needs (24c).

 The non-agricultural produc ts are formulated with cis -9-Tricosene that acts as a fly

attractrant.

 Pesticide Re-evaluation Division Co ntact: Yan Donovan (donovan.yan@epa.gov).

 Registration Division Contact: Thom as Harris (harris.thomas@epa.gov)

Use and Usage Information

 Methomyl is registered for use as an insecticide to control a number of pests in agricultural and non-agricultural areas, but it does not have any registered residential uses. Methomyl is used primarily on sweet corn, lettuce, onions, and tomatoes.

 All methomyl agricultural products are designated as a restricted use pesticide due to high acute toxicity to humans

.

 Methomyl has low percentage formulations (le ss than 1% a.i.), used as scatter bait, bait station, and paste formula tions that are not designated as restricted use.

 Based on a Screening Level Usage Analys is conducted by the Agency (USEPA 2009 a ), using data from 2001 to 2007, there is an estimated 800,000 pounds of methomyl used

per year

.

Recent and Pending Actions

 The use of methomyl on strawberries was deleted from labels in October 2007.

 The use of methomyl on grapes is going thr ough the process of being deleted from labels.

 Methomyl was included in the cumulative risk assessment completed for the N-methyl carbamate group of pesticides in September 2007.12 Ecological Risk Assessment Status

The following are key findings from the most rece nt ecological risk assessments regarding the environmental fate, ecological effects and risks of methomyl. Please refer to “Registration Review: Preliminary Problem Formulation for Environmen tal Fate, Ecological Risk, Endangered Species, and Drinking Water Ex posure Assessments for Methomyl,” dated July16, 2010, located in the docket, for a detailed discussion.

Ecological Risks:

 The most recent comprehensive risk assessment was conducted to support the Reregistration Eligibility Decision (RED) document in 1998. In this assessment the Agency determined that acute and chronic ri sk quotients (RQ) excee ded risk levels of concern (LOC) for endangered/threatened bird s (and, thus, reptiles and terrestrial-phase amphibians), mammals, and aquatic vertebra tes (and, thus, aquatic-phase amphibians)

and invertebrates.

 The Agency consulted with the U.S. Fi sh and Wildlife Serv ice (USFWS) in 1989 regarding methomyl impacts on some enda ngered species. As a result, the USFWS issued a formal Biological Opinion (BiOp) that identified reasonable and prudent measures and alternatives to mitigate effects of methomyl use on endangered species. The reasonable and prudent measures and al ternatives noted in the biological opinion were considered in EPA's County Bulletins. While pesticide users were encouraged to follow the measures in the County Bulletins, they were not enforceable under FIFRA. That biological opinion was ba sed on what are now outdated label instructions and use sites for methomyl and the Agency's assessment was based on methodologies that have since been refined. Therefore, the agency will be reassessing the uses of methomyl during registration review and initiating c onsultation as appropriate, to determine ultimately what if any enforceable limitati ons on its use are necessary to ensure protection of federally listed threatened or endangered species and their designated

critical habitat.

 On April 1, 2003, the Agency initiated formal consultation with the National Marine Fisheries Service (NMFS) relative to an effects determination regarding methomyl’s potential effects to 26 Environmentally Sign ificant Units (ESUs) of Pacific salmon and steelhead. In response to the Agency's ef fects determination and consultation, NMFS issued a BiOp in 2009. In the BiOp, NMFS conc luded that the use of methomyl is likely to jeopardize the continued existence of 18 salmonid ESUs and destroy or adversely modify designated critical habitat for 16 ESUs . To achieve the protections sought under the reasonable and prudent alternatives proposed by NMFS, the Agency plans to implement several measures that would be accomplished by changes to pesticide labeling. These include buffers, wind speed re strictions, and soil moisture restrictions.13  On July 20, 2007, the Agency submitted a risk assessment and effects determination to the USFWS for the California red-legged frog ( Rana aurora draytonii ) (CRLF) (and its designated critical habitat) relative to the us e of methomyl in California. A Likely to Adversely Affect (LAA) effects determinati on was made based on the potential for direct effects to both aquatic- and te rrestrial-phase CRLF and the pote ntial for indirect effects to prey taxa (for both aquatic- and terrestr ial-phase CRLF). Additionally, a ‘habitat

modification’ effects determination was made for CRLF designated critical habitat based on the potential for effects to prey items fo r both aquatic- and terrestrial-phase CRLF.

Human Health Risk Assessment Status

The following are key findings from the human h ealth risk assessments conducted for methomyl registered uses. Please refer to the “ Methomyl: Registration Review Scoping Document for Human

Health Assessments ,” dated July 13, 2010, located in the docket for a detailed discussion of the human

health risk assessment status.

Hazard Characterization:

 Methomyl is a member of the N-methyl car bamate (NMC) class of chemicals sharing a

common mode of action with other NMC pesticides that act to inhibit the acetylcholinesterase enzyme (AChE), typically within 30-60 minutes, at low dose levels and across species. Reactivation of the enzyme and therefore recovery of AChE activity occurs within hours for methomyl as is typica l for the NMCs. Acute exposure, therefore, is the main duration of concern for methomyl.

 Methomyl is classified as “not likely” to be a human carcinogen based on carcinogenicity

studies in rats and mice.

Dietary (Food and Drinking Water):

 A dietary assessment was conducted in associ ation with the 1998 RE D. Dietary risk estimates for methomyl were below EPA’s le vel of concern for al l population subgroups.

 In conjunction with the 2007 NMC cumulative assessment, a highly refined acute single chemical dietary risk assessment was conducted using updated estimated environmental concentrations. The results of the analys is indicated that estimated acute dietary exposure and risk exceeded EPA's level of concern. A sensitivity analysis was also

conducted to determine the foods or food forms which contribute the most to the exposure estimates. Methomyl residues in grapes were the most significant source of dietary exposure. When grapes are excluded from the dietary assessment, dietary risk

estimates are below EPA’s level of concern. The use on grapes is being deleted from methomyl labels due to dietary risk c oncerns and will be effective in 2010.14  Tier II drinking water exposure assessment s were completed for methomyl in 2007, 2009, and 2010 to evaluate currently labeled uses. The assessments used data submitted after the 1998 RED, maximum application rates iden tified on product labels, percent cropped area factors, and current aqua tic exposure models. Exposure estimates for use on some crops, such as lettuce, were hi gher than those previously assessed. Additional assessment refinements are necessary to clarify which cu rrently labeled use patterns may result in drinking water exposure that may ex ceed dietary levels of concern.

Residential:

 Three post-application exposure scenarios we re assessed in the 1998 RED. All three scenarios resulted in risks that were below the Agency’s concern.

A ggregate:

 The aggregate risk assessment evaluates the combined risk from dietary exposure (food and water) and any non-occupational (resident ial) uses. An acute aggregate dietary exposure assessment (food plus drinking water) resulted in risks above the Agency’s level of concern for one drinking water scen ario. As mentioned previously, additional refinements are necessary for the labeled use pa tterns that will resu lt in a highly refined water assessment for methomyl.

Occupational:

 All occupational handler e xposures considered in the 1998 RED did not exceed the Agency’s level of concern with varying levels of personal protective equipment ( i.e

., double layer clothing, chemical resistant gloves, dust/mist respirators) and/or engineering controls ( i.e., water soluble bags).

 Past methomyl 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 of Research ( 40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reli ance on these studies.

 Past methomyl risk assessments have also relied in part on a single human study which may have involved intentional exposure tomet homyl. In the course of registration15 review EPA will reconsider these studies, as well as any other research involving intentional exposure of human subjects to methomyl brought to its attention. If EPA decides to rely on any of these studies, EPA will ensure that all applicable regulatory requirements are met, including but not limited to the requirements for EPA ethics review

and Human Studies Review Bo ard review of certain res earch involving intentional exposure of human subjects

Cumulative Risk Characterization (CRA):

 The Food Quality Protection Act (FQPA) require s the Agency to consider the cumulative risks of chemicals sharing a common mechanism of toxicity. Methomyl is a member of the N-methyl carbamate common mechanism group. The most recent cumulative risk assessment for the NMC carbamates was issued for comment on September 26, 2007 and is available at http://www.epa.gov/oppsrrd1/ REDs/nmc_revised_cra.pdf. The cumulative assessment did not result in any mitigation for methomyl.

Incidents

Ecological:

 Preliminary reviews of the Ecological Incide nt Information System (EIIS, version 2.1) and the Avian Incident Monitoring System (AIMS) were conducted on February 17,

2010. A total of 10 incidents associated w ith methomyl use have been reported (8 involving birds and 2 involving fish). The re ported incidents occurred between 1976 and

2006.

 In addition to the incidents r ecorded in EIIS and AIMS, regi strants have reported 7 minor fish and wildlife incidents as of February 17, 2010, all of which occurred between 2000

and 2007.

Human Health:

 Both the OPP Incident Data System (IDS ) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (C DC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) database were consulted for pesticide incident data on the active ingredient methomyl.

 43 cases were reported in IDS from 2002 to 2010. Of these cases, thirteen resulted from single chemical (methomyl) use only. Five of the incidents involved intentional ingestion/misuse of the product. Six incide nts involved agricultural handlers using methomyl: four in seemingly typical ways and two where equipment malfunctioned/leaked. The symptoms most often reported were neurological (27%) followed by gastrointestinal (23%) and ocular (20%).16  60 cases were reported in NIOSH SENSOR fr om 1998 to 2006. Of these cases, 21 were reviewed because methomyl was the only chem ical used in these cases. All of the

reviewed cases were classified as low or moderate severity.

Tolerances and International Harmonization

 A table listing the differences between U.S. tolerances, Canadian, and CODEX MRLs for methomyl is included in the Methomyl : Registration Review Scoping Document for

Human Health Assessments . Mexico has not currently established MRLs for methomyl, but will adopt the U.S. tolerance and\or Codex MRL for its export purposes. Any methomyl tolerances reassessed during the registration review process will be considered for possible harmonization with international MRLs.

 Tolerances are established under 40 CFR §180.253 for residues of the insecticide methomyl, including its metabolites and degradat es, in or on a variety of food and feed

crops.

Data Call-In Status

 In response to the DCI that was issued after completion of the RED, the registrant has submitted multiple studies and waiver reques ts that are currently under review by the Agency. Depending upon the outcome of these reviews, additional data may be required to support registration review.

 860.1300 Nature of the Residue – Plants (Tomato MRID 46387701)

 860.1340 Residue Analytical Method (MRID 45297106)

 860.1380 Storage Stability Bean seed, potato tubers, peanut nutmeat (MRID 45297101) Dry bulb onions (MRID 45297102) Sorghum grain (MRID 45297103)

 860.1500 Crop Field Trials Bermudagrass and Sorghum Forage (Waiver Request) Cotton gin trash (MRID 45297104) Turnip tops (MRID 45297105)

 860.1850 Confined Rotational Crop Study (Waiver Request)

Labels

 Active Section 3 labels for methomyl can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.17 III. Summary of Data Gaps – Methomyl

The table below summarizes all outstanding data needs for methomyl in Section I of this Preliminary Work Plan.

Guideline

Number Data Requirement Test

Material Estimated

Timeframe

(Months)

835.2240 Aqueous photolysis TGAI 24

835.4100 Aerobic Soil Metabolism* TGAI 24

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.2100 Avian Oral Toxicity (passerine species) TGAI 12

850.2300 Avian Reproduction Study (Mallard duck) TGAI 12

850.4100 Terrestrial Plant toxicity: Tier I Seedling Emergence** TGAI 12

850.4150 Terrestrial Plant toxicity: Tier I Vegetative Vigor** TGAI 12

850.4400 Aquatic Plant Growth: Tier II Vascular Plants** TGAI 12

850.5400 Aquatic Plant Growth: Tier II Algae** TGAI 12

Non-GDLN Acute Inhalation Study TGAI 12

870.7800 Immunotoxicity Study TGAI 12 * Foreign Soil Taxonomic Classification. Soil taxonom ic classifications for foreign soils studied in MRID 45473401 are necessary in order to comp are the studied soils to domestic soils representative of me thomyl use sites.

**Registrants may opt to conduct a Tier I study, w ith the understanding that any adverse effects (even if <25%) will necessitate a Tier II study. A Tier II study will enable the Agency to conduct an endangered species asse ssment for nontarget plants.