Docket Number: EPA-HQ-OPP-2010-0278 http://www.regulations.gov



# Methiocarb Summary Document Registration Review: Initial Docket

June 2010

### TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 10

________________________ ______________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency’s current position base d on the following documents:

1. Registration Review Pre liminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Methiocarb (April 6, 2010).

2. Methiocarb. Human Health Assessment Scoping Document in Support of Registration Review (March 17, 2010).

3. Methiocarb: Review of Huma n Incidents (February 25, 2010).

4. Appendix A: Food/Feed & Non-Food/Non-F eed Uses Considered in Registration

Review of Methiocarb. Current as of June 2, 2009 (Report run date July 16, 2009).

Additional supporting documents for methiocarb may be found in the docket EPA-HQOPP-2010-0278 which may be f ound on the Internet at www.regulations.gov

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3I. Preliminary Work Plan

Introduction: The Food Quality Protection Act of 1996 ma ndated a pesticide registration review program. All pesticides distributed or sold in the United States generally must be registered by EPA, 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 ma ke sure that, as the ability to assess risk evolves and as policies and pract ices change, all registered pe sticides 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 progr am, the Agency periodically reevaluates pesticides to make sure that as change o ccurs, 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 determ ine whether it continues to meet the FIFRA standard for registration. The Agency will c onsider benefits information and data as required by FIFRA. The public phase of regi stration 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 ri sk analyses and data or other information it believes are needed to make a registra tion review decision. After reviewing and responding to comments and data received in the docket during th is initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of methiocarb.

Methiocarb is an N-methyl carbamate ins ecticide, acaricide, molluscicide and avian repellent registered for use to control sna ils, slugs, mites and insects on ornamentals, lawns, and non-bearing deciduous and nut trees. There are no food or feed uses for methiocarb. The wettable powder formulations of methiocarb are restricted use pesticides available only to professional appl icators and are applied by broadcast, foliar spray, and soil incorporation to ornamental plants and non-bearing deciduous and nut

trees. One formulation of methiocarb is a general use pesticide sold as solid bait products, which can be used by homeowners and which are sprinkled over ornamental plant and non-bearing tree foliage, or applie d to soil around plants grown in greenhouses, nurseries, or residential gardens. Potentia l metabolites of concern are methiocarb sulfoxide (MSO), methiocarb phenol (MP), and methiocarb sulfoxide phenol (MSOP). Methiocarb is a member of the N-methyl carb amate (NMC) class of chemicals that share a common mechanism of toxicity and inhibi t acetylcholinesterase by carbamylation of the serine hydroxyl group located in the active site of the enzyme. The “Revised NMethyl Carbamate Cumulative Risk Assessment” was completed in September 2007 (available in the doc ket EPA-HQ-OPP-2007-0935).

4Anticipated Risk Assessment and Data Needs: The Agency anticipates conducting comprehe nsive human health and ecological risk assessments, including an endangered species assessment, for all uses of methiocarb and its metabolites of concern. Below is a summary of the issues relevant to the registration review process for methiocarb.

Ecological Risk:

• The most recent comprehensive ecological ri sk assessment for registered uses of methiocarb was conducted in 1994 in support of the Methiocarb RED. Acute levels of concern (LOC) were exceeded for birds, reptiles, mammals, and invertebrates, and chronic risk LOC were exceeded for birds, fish, and aquaticphase amphibians.

• The degradation of methiocarb in soils is not well-defined, and more data are anticipated to be needed on aerobic soil metabolism.

• Data are needed for aerobic and anaerobic aquatic metabolism because use on ‘field grown ornamentals’ is not prec luded by current methiocarb labels, and

therefore must be assumed.

• A fish accumulation data requirement (G uideline 165-4) was previously waived because methiocarb and its degradates were assumed to kill fish before toxic

residues could bioaccumulate. Based on ne w guideline requirements, this study is anticipated to be required as part of the registration review process.

• Toxicity data for methioicarb degrad ates (methiocarb sulfoxide (MSO), methiocarb phenol (MP), methiocarb sulfoxide phenol (MSOP), methiocarb sulfone (MSO 2 ), and methiocarb sulfone phenol (MSO 2 P) are lacking. The residues of concern for exposure and risk as sessment will be reconsidered prior to analysis. In the absence of confirmatory data indicating low toxicity concerns for the major degradates of methiocarb, they will be assumed of equal toxicity as the
parent.

• The Agency has not conducted a risk assessment that supports a complete endangered species determination for methio carb. The ecological risk assessment planned during registration review will a llow the Agency to determine whether methiocarb’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitat. When an

assessment concludes that a pesticide’s use “may affect ” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

• The Agency anticipates needing the followi ng data in order to conduct a complete environmental fate and ecological risk assessment for parent methiocarb and its degradates, including a complete endangered species assessment.

Environmental Effects Studies:

o Guideline 850.1730 - Fish Bioconcentration Study

o Guideline 850.2300 - Avian Reproduction Test (Bobwhite Quail)

o Guideline 850.3030 - Honeybee Toxicity of Residues on Foliage

5o Guideline 850.1075, 850.1025 and 850.1035, 850.1045, or 850.1055 - Estuarine/Marine Fish & Invertebrate Acute Toxicity Tests

o Guideline 850.1300 & 850.1350 - Freshw ater & Estuarine/Marine Invertebrate Life Cycle Toxicity Test

o Guideline 850.1400 - Freshwater & Estu arine/Marine Fish Early Life Stage Toxicity Test

o Guideline 850.4100 & 850.4150 - Terrestrial Plant Toxicity Tests (Tier I)

o Guideline 850.4400 - Aquatic Vasc ular Plant Growth (Tier I)

o Guideline 850.5400 - Aquatic Non-vasular Plant Growth (Tier I)

Environmental Fate Studies: These studies are anticipated to be need ed to provide information on how, or by what mechanism, the pesticide degrades, the rate at which it degrades, where it goes, and what transformation products are formed once the compound is applied

in the environment.

o Guideline 835.4100 - Aerobic soil metabolism study

o Guideline 835.4300 - Aerobic aquatic metabolism study

o Guideline 835.4400 - Anaerobic aquatic metabolism study

o Guideline 835.1230 & 1240 - Leaching and adsorption/desorption (for methiocarb, methiocarb phenol, methiocarb sulfoxide, methiocarb sulfoxide phenol).

o Guideline 835.6100 (Footnote 7) - Environmental chemistry analytical method in soil and independent laboratory validation

o Guideline 835.6200 (Footnote 7) - Environmental chemistry analytical method in water and independent laboratory validation

• Please refer to the Registration Review Preliminar y Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Methiocarb in the methiocarb registration review docket (EPA-HQ-OPP-2010-0278)

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Human Health Risk:

• The most recent dietary and drinking water risk assessments for methiocarb were conducted for the February 1994 Reregist ration Eligibility Decision (RED) for

methiocarb.

• The toxicology database for methiocarb is not considered complete for the purposes of registration review because of data gaps for a comparative ChE study in adults and offspring and an immunotoxicity study.

• A 2-generation reproduction study has been submitted and will be reviewed during registration review.

• Both acute and subchronic neurotoxicity st udies were previously identified as data gaps in the RED. However, informati on about N-methyl carbamate neurotoxicity

is now known from the EPA National Health and Environmental Effects Research Laboratory (NHEERL) studies and from th e carbamate cumulative assessment. Consequently, the Agency anticipat es requiring an acute comparative

6cholinesterase study for methiocarb, but does not anticipate requiring acute and subchronic neurotoxicity studies, or a developmen tal neurotoxicity study.

• A drinking water exposure assessment for groundwater and surface water has not

been conducted and will be incl uded during regi stration review.

• Since there are no food or feed uses for methiocarb, dietary exposure from food is not expected. However, a decision on re sidues of concern in drinking water has not yet been made, and an updated dr inking water assessment, as well as aggregate risk assessment (due to po tential residential exposure), may be conducted to support the regist ration review of methiocarb.

• Both residential handler and residentia l postapplication expos ure are possible and neither has been quantitativel y assessed. Residential ha ndler exposure could occur from application of bait formulation to la wns and (non-food) gardens. Residential postapplication exposure could occur from : 1) contact with commercially grown nursery plants previously treated with me thiocarb; 2) dermal and incidental oral exposure to children from contact with tr eated garden plants; and 3) dermal and incidental oral exposure to children through contact with or ingestion of pellets or granules of the bait treatment. Both residential handler and postapplication exposures will be assessed during registration review.

• The Agency anticipates conducting a re vised occupational handler exposure assessment and a postapplication assessment for methiocarb for all handler exposures, except the egg treatment use pa ttern, to reflect updates in Agency occupational/residential expos ure assessment methodologies.

• The Agency anticipates requiring the fo llowing studies in order to conduct a complete human health assessment:

o Special Study - Comparativ e Cholinesterase Assay

o Guideline 870.7800 - Immunotoxicity

• Prior to a final registration review decision for methiocarb, the Agency will determine if there is any new information, such as new hazard or exposure data or information on changes to the use patt ern, which could affe ct the 2007 Revised

NMC Cumulative Risk Assessment. If s o, the Agency will revisit the cumulative

risk assessment.

• Please refer to the Methiocarb. Human Health Assessment Scoping Document in Support of Registration Review in the methiocarb regi stration review docket (EPA-OPPTS-OPP-2010-0278) for a detailed discussion of previous human

health assessments.

Other Anticipated Data Needs:

• OPPTS GLN 830.7050 UV/Visible Light Absorption – this study is a new data requirement under 40 CFR part 158 (Produc t Chemistry Data Requirements) for registration of a pesticid e (food and non-food uses). The Agency anticipates requiring this study to obtain basi c information a bout the compound’s identity/composition and the wavelengths at which the compound may be susceptible to photochemical degradation.

7Endocrine Disruptor Screening Program (EDSP): As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (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 other such endocrine effects as the Administrator may designate.” The EDSP em ploys a two-tiered approach to making the statutorily required determinations. Tier 1 cons ists of a battery of 11 screening assays to identify the potential of a chemical substan ce to interact with th e estrogen, androgen, or thyroid (E, A, or T) hormona l 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. Ti er 2 testing is designed to identify any adverse endocrine related effects caused by th e substance, and esta blish a quantitative relationship between the dose a nd the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Methiocarb was one of several pest icides removed from the initial list of pesticides to be screened because changes in their use and a pplication methods eliminated the potential for exposure in one or more pathways. Specifically, the remaining agricultural uses for methiocarb are granular applications in nurseries and greenhouses, and current registrations no longer include use on food crops. Although methiocarb is only present in two exposure pathways (water and resident ial), under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Acco rdingly, EPA anticipates issuing future EDSP

orders/data call-ins for all Re gistration Review cases, incl uding those for which EPA has already opened a Registration Review docke t for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Timeline: EPA has created the following estimated timeline for the completion of the methiocarb registration review.

Registration Review for Methiocarb – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – June

Close Public Comment 2010 – August Case Development

8Final Work Plan 2010 – November

Issue DCI 2011 – Jul.-Sept.

Data Submission 2013 – Jul.-Sept. Open Public Comment Period for Preliminary Risk Assessments 2015 – Jan.-Mar.

Close Public Comment Period 2015 – Apr.-Jun. Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – Jul.-Sept.

Close Public Comment Period 2015 – Oct.-Dec. Final Registration Review Deci sion and Begin Post-Decision Follow-up 2016

Total (years) 6

Guidance for Commenters: The public is invited to comme nt on EPA’s preliminary regi stration review work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely ma nner prior to issuing a final work plan for

methiocarb.

Trade Irritants: Through the registration review process, th e 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 Li mits (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.

Since there are no food or feed uses for meth iocarb, there should be no issues regarding

trade irritants.

Water Quality:

Methiocarb is not identified as a cause of impairment 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/attain s_nation_cy.cause_detail_303d?p_cause_grou p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for methiocarb, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant _detail?p_pollutant_gr oup_id=885&p_pollutant_group_name=PESTICIDES . 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 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 A ssessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

9Environmental Justice: EPA seeks to achieve environmental justi ce, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcemen t 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 factor s, may have atypical, unusually high exposure to methiocarb, compared to the general popula tion. Please comment if you are aware of any sub-populations that may have atypical , unusually high exposure compared to the general population.

Additional Information: Stakeholders are also specifically asked to pr ovide information and da ta that will assist the Agency in refining the risk assessment s, including 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 rates e. frequency of application, application interv als, and maximum number of applications per season f. geographic limitations on use

2. Use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crops)

3. Use history

4. Median and 90 th percentile reported use rates (l bs ai/acre) from usage data – national, state, and county

5. Application timing (date of first application and applic ation intervals) by crop – national, state, and county

6. Sub-county crop location data 7. Directly acquired county-level usag e data (not derived from state-level data) a. maximum reported use rate (lbs ai/acre) from usage data – county b. percent crop treated – county

c. median and 90 th percentile number of a pplications – county d. total pounds per year – county e. the year the pesticide was last used in the county/sub-county area f. the years in which the pesticide wa s applied in the county/sub-county area 8. Typical application interval (days)

9. State or local use restrictions

10. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

11. Surface and/or ground water a nd air monitoring data

10Next Steps: After the 60-day public comment period clos es, the Agency will review any comments received in a timely manner and then issue a Final Work Plan for this pesticide.

11II. FACT SHEET

Background Information:

• Methiocarb [4-methylthio-3,5-xylylmethyl carbamate] registration review case

number: 0577

• Methiocarb PC Code: 100501; CAS #: 2032-65-7

• Technical registrant: Gowan.

• Currently, there are 1 technical and 1 manufacturing use pesticide (MUP) products and 5 end-use products. End use pr oducts are restricted use pesticides (RUPs) except for one granular homeowner product.

• First registered in 1972.

• Reregistration Eligibility Decision (RED) published February 1994.

• Pesticide Re-evaluation Division Chemical Review Manager (CRM): Jude

Andreasen: andreasen.jude@epa.gov

• Registration Division Product Contacts: Venus Eagle: eagle.venus@epa.gov

Use & Usage Information: For additional details on label rates and allowed uses, please refer to Appendix A in the methiocarb registration review docket (EPA-OPPTS-OPP-2010-0278).

• Methiocarb is an N-methyl carbamate in secticide, acaricide, molluscicide and avian repellent registered for use to c ontrol snails, slugs, mites and insects on ornamentals, lawns, and non-bearing deci duous and nut trees. There are no food

or feed uses.

• Methiocarb is sold as wettable powder form ulations as restricted use products available only to professional applicator s and applied by broadcast, foliar spray, and soil incorporation to ornamental pl ants and non-beari ng deciduous and nut trees. Methiocarb is also sold as granular bait products, one of which is a general use product for homeowners. Granular products are sprinkled over ornamental plant and non-bearing tree foliage, or applied to soil around plants grown in greenhouses, nurseries, or residential gardens.

• Methiocarb is registered as a bird repe llent for use by the U.S. Department of Agriculture. Common eggs are injected with methiocarb to condition egg predator bird species, such as crows, not to prey upon Federally listed threatened or endangered species, or eggs of other spec ies designated to be in need of special protection.

• National usage figures are not available for methiocarb. Usage in California during the period from 2005 to 2007 was 2,460, 1,788, and 1,766 pounds of the active ingredient respectively.

Recent Actions:

• Methiocarb was included in the cumulative risk assessment completed for the Nmethyl carbamate group of pesticides in September 2007.

• A previously acceptable absorption/de sorption study was reclassified as unacceptable, and several other absorptio n/desorption or leaching studies were

12determined to be not scien tifically valid. These data are currently noted as data gaps (see “Anticipated Risk Asse ssment and Data Needs” above).

Ecological Risk Assessment Status: The following are key findings of the most r ecent methiocarb ecological risk assessment, conducted in support of the 1994 RED. Please refer to the Registration Review: Preliminary Problem Formulation for Envi ronmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposur e Assessments for Methiocarb for a detailed discussion of the ecological risk assessment.

• A national level risk assessment for methiocarb was completed in support of the

1994 Methiocarb RED.

• The primary environmental concerns identi fied in the previous risk assessment were acute risks to birds, mammals, a nd honeybees. Data on risk to terrestrial plants are not available and ar e anticipated to be required.

• Acute LOCs were exceeded for aquatic i nvertebrates, and chronic LOCs were exceeded for fish (as well as aquatic-phase amphibians for which fish serve as surrogates) for all outdoor use sites and fo rmulations. There are no toxicity data available for estuarine/marine fish, estu arine/marine invertebrates, or aquatic plants. Chronic data on methiocarb are only available for fres hwater fish. LC50

values for the most sensitive fish and inve rtebrate species tested are less than 1 mg/L. Data on risk to vascular and non-vascular plants are not currently

available for methiocarb and ar e anticipated to be required.

Human Health Risk Assessment Status: The following are key findings of the most recent methiocarb human health risk assessment, conducted in support of the 1994 RED. Please refer to the Human Health Assessment Scoping Document in Support of Registration Review for methiocarb for a

detailed discussion of the huma n health risk assessment.

Hazard Characterization:

• As with other N-methyl carbamates, the principal toxic effects induced by methiocarb are related to its cholinesterase-inhibiting activity.

• However, the 1994 RED reported that the dermal endpoint (embryonic resorptions and incomplete ossification) was selected from the rabbit dermal developmental toxicity study. Howe ver, there was no assessment of cholinesterase inhibition, which is consid ered the most sensitive endpoint for the N-methyl carbamates.

• Methiocarb studies were nega tive for mutagenicity. No increase in tumors was reported in the rat chronic/carcinogeni city study, and a mouse carcinogenicity study is not anticipated as being need ed because there are no food uses for

methiocarb.

Dietary (Food and Water):

• Since methiocarb is a non-food/non-feed us e pesticide, exposure to methiocarb from consuming treated foods is not expected.

13• A determination of the potential residue s of concern in drinking water was not incorporated into previous risk asse ssments of methiocarb, but the Agency anticipates conducting an assessment for re gistration review that will include available surface water and groundwater monitoring data.

Residential:

• Residential handler exposure from granular application to lawns and gardens, and post application exposure from purchased nur sery plants previously treated with methiocarb were not previously assessed, but the Agency anticipates conducting an assessment for registration review.

Occupational:

• The RED specified risk mitigation measur es for occupational handlers, including additional personal protective equipmen t (PPE) of coveralls and gloves to mitigate handler dermal risks. The RED also specified respirators for all handlers during ventilation activities , and dust masks for mixer/loaders using wettable powders.

• There is potential worker exposure from pos tapplication exposure associated with non-bearing nut and deciduous trees and ornamental plants. Postapplication exposure was not assessed but a quantita tive assessment will be conducted during registration review, which may include data from the already submitted (MRID # 44522702) dislodgeable foliar residue study.

• No occupational exposure assessment is re quired for the egg treatment use, and postapplication exposure is not expected from this use.

Reliance on Human Studies:

• Past methiocarb 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, involv ing exposure to many different pesticides, comprise generic pe sticide exposure databases such as the Outdoor Residential Exposure Task For ce (ORETF) Database and the Pesticide Handlers Exposure Database (PHED). EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and convincing eviden ce 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 c onducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regul atory barrier to continued reliance on

these studies.

• EPA is aware of a previously submitted study involving intent ional exposure of human subjects to methiocarb (MRID 44724302) . In the course of registration review EPA will consider this study, as well as any other research involving intentional exposure of human subjects to methiocarb br ought to its attention. If EPA decides to rely on any of these studi es, EPA will ensure that all applicable regulatory requirements are met, including but not limited to the requirements for

14EPA ethics review and Huma n Studies Review Board revi ew of certain research involving intentional exposur e of human subjects.

Aggregate:

• As there are no food uses for methiocarb, the only potential for dietary exposure is through drinking water. The Agency will need to determine the residues of concern and evaluate the potential aggregat e risks from water and residential uses to support the registration review of methiocarb.

Cumulative Risk Characterization (CRA):

• Methiocarb was assessed as part of th e N-methyl carbamate cumulative risk assessment (CRA), completed in Sept ember 2007. No cumulative risks of

concern for methiocarb were identified in that assessment, and no additional mitigation was specified.

Incident Reports:

Ecological Incidents:

• Preliminary reviews of the Ecological In cident Information System (EIIS) in December 2009 showed no reported wild life or plant incidents involving methiocarb. However, the Agency received a report (not yet entered into the EIIS) from the National Wildlife Health Ce nter for an incident involving the death of 30 bats ( Myotis lucifugus ) in July 2009 in Valley County, ID, which tested positive for carbofuran and methiocarb. The Avian Incident Monitoring System (AIMS) contained one incide nt involving both methiocarb and carbofuran in an intentional misuse resulting in the death of three bald eagles, six chickens, four red-tailed hawks, and one great horned owl.

Human Incidents:

• The Methiocarb Incident Report dated February 25, 2010 is based on two cases reported to the NIOSH/SENSOR from 1998 to 2006. No incidents were reported to the Incident Data System from 2002 to the present. Although the two incidents reported to NIOSH/SENSOR involved a leak/spill, they were in different settings (one of which resulted in a low severity outcome) and are not considered a pattern or trend. The Agency will continue to m onitor the incident information and if a concern is triggered additional analyses will be included in the risk assessment.

Tolerances:

• There are no food or feed uses for methio carb, and there are consequently no U.S.

tolerances.

Data Call-In (DCI) Status:

• DCI’s were issued for methiocarb in 1994 and 1995 requiring a number of human

health and environmental effects studies. Some studies have been submitted and

15reviewed, classified as eith er acceptable, supplemental, or invalid. Other studies are no longer required due to changes in the use pattern. A fish accumulation study was waived because methiocarb and its degradates in aquatic systems were

assumed to kill fish before residues could accumulate to levels of concern in fish tissue. Based on new guideline requiremen ts, this study (fish bi oconcentration) is anticipated to be required as part of the Registration Review process. Invalid or supplemental studies are being required fo r Registration Review, or being held in reserve if nonguideline data are av ailable for a variety of species.

Labels:

There are 7 current Section 3 labels and no Sp ecial Local Need (SLN) labels. Labels can

be obtained from the Pesticide Produ ct Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.

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