Based on the current use profile, exposures can b e expected to occur via the dietary, (food and drinking water) and occupational (h andler and post-application) routes for methomyl. Also, there is a potential for residential ha ndler and post-application

exposure.

As with other NMCs, methomyl causes rapi d acetylcholinesterase (AChE) inhibition, typically within 30-60 minutes, at low dose leve ls and across species. Reactivation of the enzyme and therefore recovery of AChE activ ity occurs within hours for methomyl as is typical for the NMCs. Acute exposure, theref ore, is the main duration of concern for methomyl. Toxicity studies that evaluate AC hE inhibition are available via the oral and dermal route. Methomyl is classified as “not likely” to be a human carcinogen based on carcinogenicity studies in rats and mice. A comparative cholinesterase study (CCA) is available, which evaluates AChE activity at the time of peak effect in both adult and juvenile rats as well as rec overy of AChE activity. Benc hmark dose (BMD) analyses of
the brain and RBC AChE data fr om oral toxicity studies we re updated for methomyl in
2006.

An acute inhalation study with both the time to peak effect as well as dose-response is required for methomyl. In addition, an imm unotoxicity study is re quired for methomyl based on the revised Part 158 guidelines. On ce these studies have been received and reviewed; HED will reevaluate the points of departure and uncertainty factors for the dietary, aggregate, and occupational assessments.

A highly refined acute diet ary risk assessment (F. Fort, D340694, 06/19/2007) was conducted using new estimated environmental co ncentrations (EECs) in conjunction with the NMC CRA. The last drinking water assessment for methomyl was completed by the Environmental Fate and Effects Division (E FED) during this time as well (D. Young, 05/02/2007). Seventeen separate drinking wate r scenarios were modeled. Based on the current knowledge of the mode of action for methomyl (i.e., rapid reactivation of recovery), like other NMCs, chronic dietary risk assessments are not warranted. An updated dietary risk assessment may be required during the registration review process to further revise residues in drinking water and food, percent crop treated information and any revised points of departure (PoD) or uncertainty factors.

The residue chemistry database for methomyl is adequate to support the registration review process with the excep tion of the deficiencies that were noted in the 1998 HED RED chapter (F. Fort, D245742, 05/05/1998). The registrant has submitted multiple studies and waiver reques ts that are currently un der review by HED.

Methomyl is a restricted use pesticide (bas ed on percent active ingredient) and there are currently no homeowner uses for methomyl. However, certain low percentage a.i.
formulations exist that are not de signated as restricted use. Therefore, there is a potential for residential handler and post-application exposure. In addition, a residential postapplication assessment will be required due to the use of methomyl on sod farms

There is a potential for exposure to me thomyl during mixing, loading, and applying activities. However, as stated previously, acute exposure is the dur ation of concern for methomyl. Since the last risk assessment application rates have been reduced and

Page 2 of 25handheld equipm ent was prohibited during ap plication. Occupati onal postapplication exposure can occur via the dermal and/or inhalation route. An updated occupational assessment will be required based on the most cu rrent toxicity data and Agency policies.

Due to the rapid onset and recovery of AChE effects from methomyl, a new acute aggregate risk assessment is the only appr opriate aggregate assessment required to support registration review. Th is acute assessment would in corporate any new PoDs or uncertainty factors identified for methomyl.

As part of the revised NMC CRA, the regist rant voluntarily cancelle d uses of methomyl on grapes, and which will be effective in 2010. Use on strawberry had previously been voluntarily cancelled by the registrant due to overtolerance residues issues. Additionally, mitigation measures in the Methomyl RED al so resulted in a reduction in the maximum seasonal rate for broccoli, cabbage, cauliflo wer, celery, Chinese cabbage, sweet corn, head lettuce, and tomato. Reductions in the maximum single applica tion rates were made for peaches and commercial sod farms.

Prior to a final registration review decision for methomyl, th e Agency will determine if there is any new information, such as new h azard or exposure data or changes to the use pattern, which would affect the NMC cumula tive risk assessment. Should the Agency determine that new information on methomyl is available that could potentially impact
the cumulative risk assessment and result in a risk of concern, the Agency will revisit the
cumulative risk assessment.

Introduction Methomyl is a broad-spectrum carbamate insecticide registered for use on a wide range of field crops, vegetables, fruits, and ornamentals. HED has reviewed the most recent exposure and risk asse ssments (including the N -Methyl carbamate cumulative) for methomyl, as well as toxicity data, exposure and usage databases, and the latest Agency science policy and risk assessment methodolog ies to determine if sufficient data are available and if updates are needed to s upport registration review. Additionally, the Team conducted a screening-leve l literature search for any in formation that would aid in assessing human health risks to methomyl.

Chemical Identity Methomyl [S-methyl N-[(methylcarbamoyl)oxy] thioacetimidate] is a broad-spectrum
carbamate insecticide registered for use on a variety of food and feed crops. Tolerances are established under 40 CFR §180.253 for resi dues of the insecticide methomyl, including its metabolites and degradates, in or on a variety of food and feed crops. Compliance with the tolerance levels specified is to be determined by measuring only the sum of methomyl [S-methyl N-[(methylcarba moyl)oxy] thioacetimidate] and its oxime metabolite (S-methyl N- hydroxythioacetimidate), calculated as the stoichiometric equivalent of methomyl, in or on the commodity. The chemical structure and nomenclature of methomyl and the physic ochemical properties of technical grade methomyl are presented in Tables 1 and 2.

Hazard Identification/Toxicology Methomyl is a member of the N -methyl carbamate (NMC) cumulative risk assessment (CRA) sharing a common mode of action with other NMC pesticides (inhibition of the

Page 3 of 25acety lcholinesterase enzyme (AChE)). The NMCs react differently than the organophosphates (OPs) in that NMCs bind loosely with the enzyme thus allowing reactivation of the enzyme. The acute in hibition of acetylcholinesterase (AChE), therefore, is the main exposure duration of concern. Moreover, a more sophisticated cholinesterase assay methodology has been developed in order to measure enzyme
inhibition before reactivation occurs. As part of the da ta requirements from the 1998 RED as well as the NMC CRA, additional AChE data for methomyl has been submitted to the Agency (Table 3A).

An updated oral benchmark dose (BMD) analysis was performed that utilized all of the appropriate AChE data for the methomyl dietary assessment (F. Fort, D340694, 06/19/2007). This AChE data provides specifi c information for the refinement of the single chemical methomyl assessme nt for registration review.

A 21-day dermal toxicity study that evaluate s cholinesterase at the critical time is available for methomyl. A BMD analysis, howev er, will need to be performed during the registration review process.

Since inhalation exposure is an ticipated based on the use pr ofile, an acute inhalation study is required. This acute inhalation study would provide AChE data showing the time to peak AChE inhibition as well as the dose-response of AChE inhibition at the peak inhibition. A study protocol s hould be provided to the Agency for review before the onset of such study.

Methomyl is classified as “not likely” to be a human carcinogen based on carcinogenicity
studies in rats and mice. This classifica tion is supported by th e lack of mutagenic activity.

A comparative cholinesterase assay is avai lable for methomyl and was included in the NMC CRA. Therefore, the FQPA factor is based on a data-derived approach as
consistent with other NMCs. The current BMD analyses for methomyl are shown in Table 3B. It is important to note that Po Ds and uncertainty factors (UFs) may change during the registration review process when the BMD results and toxicity data are reviewed for methomyl.

An immunotoxicity study is required as a pa rt of new data requirements in the 40 CFR
Part 158 for conventional pesticide registration

. Because the immune system is highly complex, studies not specifically conduc ted to assess immunotoxic endpoints are inadequate to characterize a pesticide’s pot ential immunotoxicity. While data from hematology, lymphoid organ weights, and histopathology in routine chronic or subchronic toxicity studies may offer us eful information on potential immunotoxic effects, these endpoints alone are insufficient to predict immunotoxicity. In the absence of required studies, EPA may use a database uncertainty factor of up to 10X. An immunotoxicity study on methomyl should be conducted (refer to Table 4). Once all data have been received and reviewed, the methom yl registration review team recommends that the points of departure and safety f actors used for risk assessment purposes be reexamined and a new risk assessment done, if necessary.

Page 4 of 25Endocrine Disruption 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, and or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Ti er 2 testing is designed to identify any adverse endocrine related effects caused by th e substance, and esta blish a dose-response 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.

Methomyl is among the group of 58 pesticide acti ve ingredients on the initial list to be screened under the EDSP. The Agency will review the EDSP Tier 1 data and any “other scientifically relevant information” submitted in response to test orders. Based on this review the Agency will determine the need fo r additional testing. For further information on the status of the EDSP, the policies and pro cedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.
Residue Chemistry Methomyl [S-methyl N-[(methylcarbamoyl) oxy] thioacetimidate] is an insecticide registered for use on numerous crops. Methomyl is manufactured by E. I. du Pont de Nemours & Company, Inc., the basic produc er, under the trade name Lannate®. Methomyl formulations registered for use on food/feed crops include soluble concentrate (SC/C or L) formulations. These produc ts may be applied to crop plants as postemergence broadcast applications using ground or aerial equipment.

The existing residue chemistry database for methomyl is adequate for risk assessment purposes with the exceptions noted below. The qualitative nature of the residue(s) of methomyl in plants and animals has been adequately identified/characterized and is understood. The residue of concern in plants and animals is met homyl. Tolerances are established under 40 CFR §180.253 for residues of the insecticide methomyl, including its metabolites and degradates, in or on a va riety of food and feed crops. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of methomyl [S-methyl N-[(methylcarbam oyl)oxy] thioacetimidate] and its oxime metabolite (S-methyl N- hydroxythioacetimidate), calculated as the stoichiometric equivalent of methomyl, in or on the commodity. Adequate methods are available for the enforcement of established tolerances, as currently defined. No tolerances have been
Page 5 of 25estab lished or are currently required for any animal commodities. Adequate analytical
methods exist for data collection and toleran ce enforcement. Adequate storage stability, processed food, and magnitude of the residue in data exist with the exceptions noted
below.

Multiple residue chemistry deficiencies we re outlined in the 1997 residue chemistry chapter (C. Eiden, D303039 and D230187, 02/11/1997) . The registrant subsequently submitted waiver requests as well as multiple studies to fulfill these deficiencies. Depending upon the outcome of these reviews, additional data may be required to support registration review.

 830.7050 U/V Visible Absorption (MRID 45013201)

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

 860.1340 Residue Analytical Method (MRID 45297106)

 860.1380 Storage Stability

o Bean seed, potato tubers, peanut nutmeat (MRID 45297101)

o Dry bulb onions (MRID 45297102)

o Sorghum grain (MRID 45297103)

 860.1500 Crop Field Trials

o Bermudagrass and Sorghum Forage (Waiver Request)

o Cotton gin trash (MRID 45297104)

o Turnip tops (MRID 45297105)

 860.1850 Confined Rotational Crop Study (Waiver Request)

Dietary Exposure and Risks A highly refined acute diet ary risk assessment (F. Fort, D340694, 06/19/2007) was conducted using new estimated environmental co ncentrations (EECs) in conjunction with the NMC CRA. The last drinking water assessments for methomyl were completed by the Environmental Fate and Effects Division (EFED) during this time as well (D. Young, 05/02/2007). Seventeen separate drinking water scenarios were modeled. Based on the current knowledge of the mode of action for methomyl (i.e., rapid reactivation of recovery), like other N -Methyl carbamates, chronic dietary risk assessments are not warranted. An updated dietar y risk assessment may be required during the registration review process to further revise residues in drinking water and f ood, percent crop treated information and any revised points of departure (PoD) or uncertainty factors.

Drinking Water
The Environmental Fate and Effects Divisi on (D. Young, 5/2/07) used Tier-II modeling to generate estimated environmental concentr ations (EECs) in surface water. Seventeen drinking water scenarios were modeled. Only surface water values were used in the assessment as these represent upper bound concen trations that would be expected in drinking water. Specifically, the Pesticid e Root Zone Model and Exposure Analysis Model System (PRZM/EXAMS) Index Reser voir was used to generate surface water EECs for drinking water. The model is used by OPP to estimate pesticide concentrations that may be in surface water due to pesticide use and runoff. The PRZM/EXAMS estimates of potential pesticide levels in surface water incorporat e pesticide-specific properties, simulation of multiple years to re flect climatic variations, and modeling on a crop-specific basis. The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.
Page 6 of 25In the dietary assessm ent, a distribution of estimates of possible concentrations in drinking water were used. Approximately 11000 values were generated based on the methomyl use pattern. The values were ad justed for regional percent crop area (PCA) and represent the complete daily 36 year PRZM EXAMS output distribution with acute concentrations ranging from 2.5 to 99 ppb. Thes e results have been characterized as conservative, though not unreasonable estimates of possible concentrations in drinking water. For the acute assessment, a RDF file was created using these values for the two commodities “Water, direct, all sources” and “Water, indirect, all sources” in the residue
file editor for DEEM-FCID.

Acute Dietary Exposure (Food Only) and Risk The dietary risk analyses were conducted using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 2.03 which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. HED calculated anticipated residues (ARs) for methomyl based on USDA Pesticide Data Program (PDP) and field trial data for multiple commodities. Acute dietary exposure assessments were conducted for the general US population and population subgroups including all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

The results of the 2007 analysis indicated that estimated acute dietary exposure and risk (food only) exceeded HED's level of concern [i.e., <100 % of the acute population adjusted dose (aPAD)] for the population subgroups, children 1 to 2 years old and children 3 to 5 years old, at the 99.9th percentile of exposure. The estimated food only dietary exposure and risk for the general U.S. population at the 99.9 th percentile exposure was 0.001063 or 71% aPAD. For children 1 – 2 years old, the most highly exposed population subgroup, and children 3 to 5 years old, dietary exposure was 0.002234 mg/kg/day or 149% aPAD and 0.001946 mg/kg/day or 130% of the aPAD, respectively.

An analysis was also conducted to determine the foods or food forms which contribute the most to the exposure estimates. For children 1 to 2 years old, residues in grapes were the most significant source of dietary exposure. When grapes are excluded from the dietary assessment, the estimated dietary exposure and risk for the general U.S. population at the
99.9 th percentile exposure was 0.000837 or 56% aPAD. For children 1 to 2 years old, the most highly exposed population subgroup, di etary exposure was 0.001269 mg/kg/day, or
85% aPAD.

Acute Dietary Exposure (Drinking Water Only) and Risk Using the DEEM dietary model, the data indi cate that drinking water acute risks (from surface water sources) are of concern for fourteen of the seventeen drinking water scenarios modeled. Risk estimates ranged from 10 to 264% of the aPAD for children 1-2 years old and 23 to 622% of the aPAD for infants (<1 years old) (see Table 4). These risk estimates areconsidered conservative since the food diaries used by Dietary Exposure Evaluation ModelFood Consumption Intake Database (DEEM-FCID Version 2.03) are based on total daily intake. The estimated risks are overestimates to the extent that food and drinking water are consumed throughout the day, rather than during only one event, and this assessment does not account for recovery of cholinesterase between exposure events. Consequently, HED further refined the acute risk from drinking water by incorporating the time and amounts consumed for each eating occasion from the USDA CSFII food diaries to estimate exposures

Page 7 of 25and risks for each eating occasion throughout the day and factoring in the cholinesteraseinhibition half-life related to methomyl exposure. The resulting estimated risks at the per capita 99.9 th percentile are below the level of concern for all but one drinking water scenario. For infants, the estimated risks at the per capita 99.9 th percentile exceed the level of concern under the Illinois corn scenario (101% - 176% of the aPAD).

Chronic Due to the rapid recovery of AChE activity for methomyl, the acute exposure from methomyl is the main duration of concern.

Conclusions The use on grapes is being deleted from methom yl labels due to diet ary risk concerns and will be effective in 2010. An updated diet ary risk assessment has not been conducted since that time, but will be required during the registration review process to further revise residues in drinking water and food, percent crop treated information and any revised acute oral point of departur e (PoD) or uncertainty factors.

Residential Exposure and Risks Methomyl is a restricted use pesticide (bas ed on percent active ingredient) and there are currently no homeowner uses for methomyl. However, certain low percentage a.i.
formulations exist that are not de signated as restricted use. Therefore, there is a potential for residential handler and post-application exposure. In addition, a residential postapplication assessment will be required due to the use of methomyl on sod farms.

Residential exposure was most r ecently assessed in the Revised N -methyl Carbamate Cumulative Risk Assessment (NMC CRA, 2007). The assessment included only drinking water and dietary assessment for me thomyl as part of the cumulative risk assessment. The last occupati onal/residential human health risk assessment (J. Leahy, D230188, 3/21/1997 and J. Leahy, D237093, 3/25/1998) was completed for the 1998 Registration Eligibility Document.

Residential Handlers There are currently no registered homeowne r uses for methomyl, however, because the methomyl scatter bait, bait station, a nd paste formulations (Reg no. 270-255, 2724-274, 7319-6, and 53871-3) are not desi gnated as restricted use pesticides, these potential handler exposure scenarios should be assess ed for both dermal and inhalation exposure and risk as part of registration review.

Residential Postapplication The three post-applica tion scenarios discussed in the 1998 Occupational and Residential Exposure Assessment (J. Leahy, D230188, 03/21/1997 and J. Leahy, D237093, 03/25/1998) were (1) post-applica tion dermal for “U-pick” peach es, (2) incidental dermal exposure for pelleted baits in public places, a nd (3) ingestion of bait pellets. HED had determined that there is potential for post-ap plication exposure to children who come into contact with pellets in public places through the dermal and incidental oral routes of exposure. The MOEs for post-application dermal “U-pick” did not exceed HED’s level of concern (MOEs > 100). At the time of the assessment, HED concluded that dermal exposure to pelleted baits woul d be less of an exposure than the “U-pick” scenario, and therefore, exposure would be below that wh ich would present a concern. The incidental

Page 8 of 25oral exposure to pelleted baits was not qua ntitatively assessed but HED concluded if proper application m easures are taken, poten tial incidental oral exposure should not present significant risk. Inha lation exposure was not assessed in this previous assessment based on the low vapor pressure of methomyl . However, the need for an inhalation assessment will be re-visited based upon the most current standards, guidance, and policies at the time of registration review.

The most recent labels suggest that methomyl is not to be used inside or around homes or any other places where children are likely to be present and residential use of the product is prohibited. The most curre nt registered labels for meth omyl use on agricultural crops (Reg no. 5742-2, 352-342, and 352-384) also prohibit use of methomyl on any commercial crop turned into a “U-pick”, “pick your own”, or similar operation.

An updated residential post-application exposur e assessment may be necessary due to use of methomyl on sod farms. Application to tu rf grass will likely warrant adult and child post-application dermal and inhalation exposur e assessment along with a child incidental oral (hand-to-mouth) assessment.

Conclusions The three residential po st-application exposure scenarios pr esented previously resulted in risks that did not quantitatively or qualitat ively exceed HED’s level of concern (MOEs > 100). No additional uses have been register ed for residential use since the previous
assessment. Based on the restricted use sites for the scatter bait, bait station, and paste formulations of methomyl a re sidential post-application asse ssment for those particular exposure scenarios may not be necessary, how ever, the application of methomyl on sod farms to turf does warrant a post-application residential exposure a ssessment. In addition, current use patterns will require reassessment of all exposure and risk estimates if additional guidelines, policies, and standard operating procedures change at the time of registration review.

Aggregate Risk Assessment The aggregate risk assessment evaluates the combined risk from dietary exposure (food and water) and any non-occupational (residential) uses. Due to the non-restricted status of certain uses, a new acute aggregate a ssessment will be required combining food, drinking water, and any reside ntial exposures, as appropriate. As noted above, a revised acute aggregate dietary exposure assessment (f ood plus drinking water) resulted in risks
above HED’s level of concern for only the Illinois corn drinking water scenario. Once any
new data have been reviewed and the a ppropriate exposure assessments have been completed, a new aggregate risk assessment will be needed to support the registration review of methomyl.

Aggregate Exposure and Risk (Food plus Drinking Water) An acute aggregate assessment was also conducted combining food and drinking water. Since food alone exceeds HED’s level of concern, the aggregate assessment was performed without grapes, the major food driver. Additi onally, as discussed above, drinking water risks alone without the incorporation of eating occasions also exceeds our level of concern. Therefore, HED refined the aggregate (food plus drinking water) assessment by considering eating occasions. The analyses again showed that the estimated risk at the 99.9 th percentile of exposure exceeds our level of concern for only the Illinois corn drinking water scenario.

Page 9 of 25Risks for this scenario for infants and children were 176 and 116% respectively. Sensitivity analyses showed that drinking water was the major risk driver.

Occupational Exposure and Risks Methomyl is a broad spectrum insecticide used in agricultural and commercial settings on a wide variety of food and non-food sites and on liv estock and foodpreparation/processing premises. Methomyl is formulated as a composition product (92 % active ingredient), a liquid (29 % active i ngredient), a wettable powder (90% active ingredient), a bait station, paste, and scatter bait (1 % active ingredient), and as a granular (5% active ingredient).

For agricultural use sites, me thomyl can be applied with chemigation (overhead and drop irrigation), aerial equipment, groundboom sprayers, standard granular ground broadcast and banded spreaders, granular row planters, airblast sprayers. Handheld equipment is prohibited. The bait station and scatter bait formulations are applied via hand dispersion or directly from the shaker can. The paste formulation is applied via brush. Application rates vary from 0.0025 to 1 lb active ingredie nt per acre depending upon the application
scenario. For bait stations and scatter ba it, the maximum application rate is 0.25 lbs product per 500 ft 2 . Methomyl can be applied to a vari ety of food, feed, and fiber crops, animal facilities, food/feed processing and pr eparation facilities, and commercial sites.

There is a potential for short- and inte rmediate-term exposure to methomyl during mixing, loading, and applying activities. Fifteen exposure scenarios were assessed in the previous human health risk assessment (F. Fort, D245742, 05/05/1998). An additional 3
scenarios were not assessed due to lack of data: dust application, mixing pelleted baits with water to form the paste formulation, and flagging aerial bait applications. All scenarios that were quantitatively assessed did not exceed HED’s level of concern (MOEs > 100) with varying levels of pers onal protective equipment (i.e., double layer clothing, chemical resistant gloves, dust/mist respirators) and/or engineering controls (i.e., water soluble bags).

Post-application exposure and risk was cal culated using a study (MRID No. 410323-01) based on an airblast applicat ion to grapes. The study looked at both foliage and soil dislodgeable residue as well as worker reentry exposure measurements. High and low exposure crops were assessed with a range of tr ansfer coefficients to evaluate potential post-application dermal exposure for workers. Post-application exposures following applications of dusts, baits, and pastes us ing aerial, ground equipment, and paint brushes
were not assessed due to lack of data. Post-application inhala tion exposure was not assessed due to the low vapor pressure of methomyl.

Occupational Handlers Table 4 summarizes the occupational uses (a gricultural and non-agricultural) along with exposure scenarios and application rates for methomyl as determined from the most current labels. As part of the NMC CRA ( 2007) application rates for the following crops were reduced: broccoli, cabbage, cauliflower, celery, Chinese cabbage, corn (sweet), head lettuce, tomato, peaches, and commercial sod farms. However, the maximum application rate on the current product labels is reflected in the range of a pplication rates
that were assessed in the 1998 risk assessmen t. The risks based on the previous risk
assessment do not exceed HED’s level of con cern (MOEs > 100) with varying levels of
Page 10 of 25personal protective equipm ent (PPE) (i.e., double layer clothing, chemical resistant gloves, dust/mist respirators) and/or engineeri ng controls (i.e., water soluble bags). The degree of PPE or engineering controls nece ssary to mitigate exposure may be reduced based on the lowered application rates.

Conclusions Since the last human health exposure and risk assessment (F. Fort, D245742, 05/05/1998) the crop use sites and applicati on scenarios have remained the same with the exception of the cancellation of methomyl use on strawb erries (2007) and grapes (2010) and the
restriction on handheld devices (the belly grinder scenario previously assessed is no longer allowed). The reduction in applica tion rates are reflected in the range of applications that were assessed previously.

An updated exposure and risk assessment may be necessary during registration review to reflect the reduction in applic ation rate and corresponding mitigation measures. Updated assessments may also be necessary to inco rporate the most current unit exposures and potential exposure from the inhalation route. Additionally, any changes in standards, guidelines, and/or policies will need to be considered during registration review.

Occupational Postapplication Occupational postapplication expos ure can occur via the dermal and/or inhalation route. Post-application exposure and risk was cal culated using a study (MRID No. 410323-01) based on an application to grapes at a rate of 0.9 lb ai/acre using an airblast sprayer. The study looked at both foliage and soil dislodge able residue as well as worker reentry exposure measurements. High and low exposur e crops were assessed with a range of transfer coefficients to calculate potentia l post-application dermal exposure and risk estimates for workers. Specific restricted entry intervals (REI) were determined for certain crops and activities for which MOEs do not reach 100 on day zero after treatment.
The most current label establishes the followi ng REIs: grapes = 7 days, peaches = 4 days, apple, cotton, grapefruit, lemon, nectarine, orange, tangelo, tangeri ne = 3 days, and all other worker protection standard (WPS) uses = 48 hours. Because methomyl is an acute toxicity category I for pr imary eye irritation, the minimum of a 48 hour REI is appropriate.

Post-application exposures following applications of dusts, baits, and pastes using aerial, ground equipment, and paint brushes were not assessed due to lack of data.

Conclusions There are many cultural practices which require hand labor that may lead to the exposure of fieldworkers such as harvesting, irriga tion, scouting or weeding. Exposure and risk estimates will need to be updated with the most current transfer coefficient values that will be developed based on the study specific data or data from the Agricultural Reentry
Task Force and as discussed at the 2008 meeting of the FIFR A Scientific Advisory Panel meeting on this issue. Additionally, the inhalation route of exposure will need to be considered contingent upon the most current standards, guidance, a nd policies at the time of registration review.

Public Health and Pesticide Epidemiology Data

Page 11 of 25An updated review of methom yl incident reports was recently prepared by HED (S. Winfield, D376770, 05/20/2010). For this eval uation, both the OPP Incident Data System (IDS) and the Centers for Disease C ontrol and Prevention/National Institute for Occupational Safety and Hea lth (CDC/NIOSH) Sentinel Ev ent Notification System for Occupational Risk-Pesticides (S ENSOR) database were consu lted for pesticide incident data on the active ingredient methomyl.

For IDS 43 cases were reported for methomyl in the United States from 2002 to the present. Of these cases, thirteen were re viewed because in these cases methomyl was used as a single chemical only and therefore these cases provide more certain information about the potential effects of methomyl exposure. Five of the incidents involved intentional ingestion/misuse of the product. Six incidents i nvolved agricultural handlers using methomyl: four in seemingly t ypical ways and two where equipment malfunctioned/leaked (all of these resulted in moderately severe symptoms). The symptoms most often reported were neurolog ical (27%) followed by gastrointestinal (23%) and ocular (20%).

For NIOSH SENSOR from 1998 to 2006, there are 60 cases reported for methomyl in the database. Of these cases, 21 were reviewed because, in these cases, methomyl was used as a single chemical only and had a certainty classification of de finite, probable, or possible, as these cases provide more certain information about the potential effects of methomyl exposure. All of the reviewed cas es were classified as low or moderate severity. The health effects reported include : neurological (81%), gastrointestinal (71%), ocular (24%), respiratory (19 %), cardiovascular (19%), derm al (14%), and genitourinary (5%). Ten cases were exposed in an o ccupational handler se tting, including mixing, loading and applying methomyl. The health effects most often reported for these cases include: neurological (80%) and gastrointestinal (80%).

Tolerance Assessment and International Harmonization

Tolerances are established for residues of the inse cticide methomyl, including its metabolites and degradates, in or on the commodities in Table 7. The Codex
Alimentarius Commission and Canada have established maximum residue limits (MRLs) for methomyl but some are not harmonized with all US tolerances. The Codex MRLs are based on sum of methomyl a nd thiodicarb, expressed as methomyl (methomyl is a metabolite of thiodicarb). MRLs related to methomyl and thiodicarb are combined into a single list. Mexico has not currently esta blished MRLs for meth omyl. Any methomyl tolerances reassessed during the registration review process will be considered for possible harmonization with international MRLs.

Environmental Justice Potential areas of environmental justice concer ns, to the extent possi ble, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898,"Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations," http://www.epa.gov/compliance/resour ces/policies/ej/exec_order_12898.pdf . The Office of Pesticide Programs (OPP) t ypically considers the highest potential exposures from the legal use of a pesticide when conducting human health risk assessments, including, but not limited to, people who obtain drinking water from sources near agricultural areas, the

Page 12 of 25variability of diets within the U.S., and people who m ay be exposed when harvesting crops. Should these high exposures indicat e potential risks of concern, OPP will further
refine the risk assessments to ensure that th e risk estimates are based on the best available
information.

Cumulative Risk Assessment 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.

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, which would aff ect the cumulative risk assessment. Should the Agency determine that new informati on on methomyl is available that could potentially impact the cumulative risk assessm ent and result in a ri sk of concern, the Agency will revisit the cu mulative risk assessment.

Human Studies Methomyl risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pe sticide or other chemical. An oral human study with methomyl was considered to be et hically conducted and sc ientifically valid by the Human Studies Review Board (HSRB) in 2006. Studies such as those from the Pesticide Handlers Exposure Database (PHE D), the Outdoor Residential Exposure Task Force (ORETF), and the Agricultural Reentry Task Force (ARTF) database have been reviewed by the Agency and found on the ba sis of available evidence to have been neither fundamentally unethical nor significantly deficient relative to standards of ethical research conduct prevailing when they were conducted. There is no barrier in EPA's
"Protection of Human Subjects" regulation to reliance on these studies.

Data Requirements HED does not anticipate that addition al residue chemistry, toxicology or occupational/residential exposure data will be required for the methomyl registration review process, with the exception of the following studies listed below:

 Immunotoxicity Study (OPPTS 870.7800) (S ee Table 5A for more details).

 Non-guideline Acute Inhalation Study (See Table 5B for more details).

 Multiple residue chemistry deficiencies were outlined in the 1997 residue chemistry chapter (C. Eiden, D303039 a nd D230187, 02/11/1997). The registrant subsequently submitted waiver requests as well as multiple studies to fulfill these deficiencies. Depending upon outcome of these reviews, additional data may be required to support registration review.

Page 13 of 25Table 1. Methomyl Nomenclature

Compound: Parent Chemical Structure

N O N H CH

3 CH 3

S CH 3 O

Common name Methomyl

IUPAC name S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate

CAS name methyl N-[[(methylamino) carbonyl]oxy]ethanimidothioate

CAS # 16752-77-5

Empirical Formula C 5 H 10 N 2 O 2 S

End-use product/EP Lannate 

Table 2. Physicochemical Properties of Methomyl

Parameter Value Reference

Appearance white, crystalline solid with a slightly sulfurous odor

Melting point/range 78-79°C

Water solubility (g/100 g) 5.8

Organic solvents (g/100 g) methanol: 100
acetone: 72
ethanol: 42 isopropanol: 22
Toluene: 3 Methomyl Product Chemistry Chapter (C. Eiden, D203039 and D230187, 02/11/1997)

Vapor pressure at 25°C 6.65 mPa http://extoxnet.orst. edu/p ips/methomyl.htm

Table 3A: New studies available since the time of the 1998 methomyl RED Study MRID Route AchE Data

Comparative Cholinestera se Assay (CCA) 46646401 oral brain, RBC

Reversibility Study 44472001 oral brain, RBC

Acute Neurotoxicity Study 44487501 oral Brain, RBC

Human RBC AChE Study 44721401 oral RBC

NHEERL NA oral brain, RBC

Subchronic Neurotoxicity Study 44666201 oral brain, RBC

Page 14 of 25Table 3B: Bench Mark Dose Analysis Results for Methomyl 1

Brain RBC Route of Exposure BMD 10 (mg/kg) BMDL 10 (mg/kg) BMD 10 (mg/kg) BMDL 10 (mg/kg)
Oral 2 NA NA 0.04 mg/kg 0.03 mg/kg
Dermal BMD analysis to be performed as part of registration review
Inhalation Inhalation study required as part of registration review

1 Brain ChE data not available since a human study provides only RBC ChE data.

2 The 2007 revised aPAD was based on AChE data of 0.0015 mg/kg/day, based on a RBC PoD of 0.03 mg/kg with 10x intraspecies factor, 1x interspecies factor, and 2x FQPA RBC factor.

Table 4. Summary of Representative Occupation al Use Patterns, Formulations, and Application Rates for Methomyl

Product Formulation Application Equipment Use Sites Maximum Application
Rates

Farnam Die FlyTM (EPA Reg No 270-255) Granular
1% Hand dispersal of
scatter bait and bait
stations Where children are not present, Feed lots, Dairies, Stables, Broiler houses, Hog houses, Livestock barns, Meat and poultry processing

establishments, Beverage plants, Canneries, Food processing establishments, On walkways of caged layer houses. Other
additionalcommercial (nonresidential) use sites

are allowed when using bait stations 0.0025 lb ai/500 sq ft

Golden Marlin RF ® 128 Fly
Killer (EPA Reg No 2724-274) Granular
1% Shaker can and bait
stations Scatter Bait : Certain
commercial agricultural production facilities
where children are not present, feedlots, broiler houses, livestock barns, outside of canneries, beverage plants, meat and poultry processing plants, food processing plants, commercial refuse dumpsters
Bait Stations : secured
4 feet above the ground in stables, outside of milking parlors, kennels, fast food establishments,
restaurants, commissaries,

bakeries, supermarkets, refuse

dumpsters, and

warehouses 0.0025 lb ai/500 sq ft

Lurectron® Scatterbait Gra nular Hand dispersal, bait Scatter bait : Outside 0.0025 lb ai/500 sq ft
Page 15 of 25(EPA Reg No 7319-6) 1% stations, and brush on paste of feed lots, poultry houses, livestock barns, canneries, beverage plants, meat and poultry processing establishments, food

processing plants,
and commercial refuse dumpsters, on walkways in caged layer houses
Bait stations : secured

4 feet above the ground in stables, outside of feed lots,

poultry houses, livestock barns, canneries, beverage

plants, meat and poultry processing establishments, food

processing plants, kennels, and refuse dumpsters, in fenced
areas around
restaurants, supermarkets, and bakeries, and in caged layer houses.
Paste : apply paste on walls, windowsills, and support beamson
the outside of
livestock barns and

poultry houses

Stimukil Fly Bait (EPA Reg No 53871-3) Granular
1% Hand dispersal, bait stations, and brush on paste Bait Station : Do not
use around or inside homes or other places

where children are likely to be present. Hang Fly Bait out of
reach of food producing animals or

pets (at least 4 feet off the ground). Do not place ba it station
in reach of children.

Use around the
outside of broiler houses, kennels, canneries, beverage processing plants, meat and poultry processing plants, food processing plants and refuse dumpsters, associated
with these establishments, and inside of caged layer houses. May also be

used in fenced or
otherwise enclosed
areas inaccessible to 0.0025 lb ai/500 sq ft

Page 16 of 25children, and around
the outside of
restaurants, supermarkets, commissaries, and
bakeries.
Scatter bait : limited solely to the outside
of certain
commercial
establishments where
children will not be present, such as feed lots, poultry houses,

livestock barns, canneries, beverage

plants, meat and poultry processing

establishments,
commercial refuse dumpters, which are fenced or enclosed, and food processing plants.
Paste : apply paste on walls, windowsills, and support beams where flies usually

land such that children, poultry,

cattle, or other
animals cannot come
into contact with the paste.

Methomyl 5G Granules (EPA Reg No 57242-2) Granular
5% Ground equipment
EXCLUDING handheld equipment Corn 0.15 lb ai/A

Dupont Lannate® SP (EPA Reg No 352-342) Water soluable powder in water soluable bags
90% Ground, aerial, and chemigation,
EXCLUDING handheld equipment Alfalfa, Anise, Asparagus, Avocado, Barley, Beans, Beets, Bermudagrass,

Blueberries, Broccoli, Brussels sprouts, Cabbage, Carrot, Cauliflower,

Celery, Chicory, Chinese cabbage, Collards, Corn, Cotton, Cucumber, Eggplant, Endive, Garlic, Grapefruit, Grapes, Horseradish, Leafy green vegetables, Lemon,

Lentils, Lettuce, Melons, Mint, Nectarine, Oats, Onions, Oranges, Peaches, Peanuts, Pears, Peas, Pecans, Peppers, Pomegranates, Potato, Sorghum, Soybeans, Spinach, Sugar beet, Summer 0.9 lb ai/A 1

Page 17 of 25squash, Tangelo, Tangerine, Tobacco, Tomato, Turf, Wheat

DuPont Lannate® LV (EPA Reg No 352-384) Water soluable liquid
29% Ground, aerial, and chemigation,
EXCLUDING handheld equipment Alfalfa, Anise, Apple, Asparagus, Avocado, Barley,

Beans, Beets, Bermudagrass pasture, Blueberries,

Broccoli, Brussels sprouts, Cabbage, Carrot, Cauliflower,

Celery, Chicory, Chinese cabbage, Collards, Corn, Cotton, Cucumber, Eggplant, Endive, Garlic, Grapefruit, Grapes, Horseradish, Leafy green vegetables, Lemon,

Lentils, Lettuce, Melons, Mint, Nectarine, Oats, Onions, Oranges, Peaches, Peanuts, Pears, Peas, Pecans, Peppers, Pomegranates,

Potato, Rye, Sorghum, Soybeans, Spinach, Sugar beets,

Summer squash, Tangelo, Tangerine, Tobacco, Tomato, Turf, Wheat 0.9 lbs ai/A 2

1 Application rate is calculat ed based on the assumption that the ai is 90% of the dry weight of the total product.
2 Application rate is calculated based on the assumption that the water soluble liquid formulation contains 2.4 lbs active ingredient pre gallon.

Page 18 of 25Table 5A: Guideline Number: 870.7800 Study Title: Immunotoxicity on Methomyl

Rationale for Requiring the Data
This is a new data requirement under 40 CFR Part 158 as a part of the data requirements for registration of a pesticide (food and non-food uses).

The Immunotoxicity Test Guideline (OPPTS 870.7800) prescribes functional immunotoxicity testing and is designed to evaluate the potential of a repeated chemical exposure to produce adverse e ffects (i.e., suppression) on the immune system. Immunosuppression is a deficit in the ability of the immune system to respond to a challenge of bacterial or vira l infections such as tuberculosis (TB), Severe Acquired Respiratory Syndrome (SARS), or neoplasia. Because the immune system is highly complex, studi es not specifically conducted to assess immunotoxic endpoints are inadequate to characterize a pest icide’s potential immunotoxicity. While data from he matology, lymphoid organ weights, and histopathology in routine chronic or subc hronic toxicity studie s may offer useful information on potential immunotoxic effect s, these endpoints alone are insufficient to predict immunotoxicity.

Practical Utility of the Data
How will the data be used?

Immunotoxicity studies provi de critical scientific information needed to characterize potential hazar d to the human population on the immune system from pesticide exposure. Since epidemiologic data on the effects of chemical exposures on immune parameters are limited and are in adequate to characterize a pesticide’s potential immunotoxicity in humans, animal studies are used as the most sensitive endpoint for risk assessment. These animal studies can be used to select endpoints
and doses for use in risk assessment of a ll exposure scenarios a nd are considered a primary data source for reliable reference dose calculation. For example, animal
studies have demonstrated that immunotoxicity in rode nts is one of the more sensitive manifestations of TCDD (2 ,3,7,8-tetrachlorodibenzo-p-dioxin) among developmental, reproductive, and endocrino logic toxicities. Additionally, the EPA has established an oral reference dose (R fD) for tributyltin oxide (TBTO) based on observed immunotoxicity in animal studies (IRIS, 1997).

How could the data impact the Agency's future decision-making?

If the immunotoxicity study show s that the test material pos es either a greater or a diminished risk than that given in th e interim decision’s conclusion, the risk assessments for the test material may need to be revised to reflect the magnitude of potential risk derive d from the new data.

If the Agency does not have this data, a 10X database uncertainty factor may be applied for conducting a risk assessment from the available studies.

Page 19 of 25Table 5B.: Non-guideline Study Title: Acute Inhalation Toxicity of Methomyl Rationale for Requiring the Data

This acute inhalation toxicity study evaluates cholinestera se (ChE) inhibition of an N -methyl carbamate (NMC) pesticide at the time of peak inhibition and recovery as well as provides dose-response ChE data. This study is critical for NMCs with a use pattern in which there is potential for inhalation (e.g., pr ofessional applicators, green house, residential use etc) exposure. The study design is critical to the mode of action of the NMCs (i.e., rapid ChE
inhibition and reactiv ation). In this two pa rt study, animals are firs t exposed (nose only/whole body) to a concentration of the test mate rial for 8 hours and ChE activity measured periodically during exposure and post-exposure to ascertain the time of peak RBC and brain ChE inhibition as well as the time required for recovery of ChE activit y. The second part of the study involves exposing the an imals (M&F) to varying concen trations (including controls) for 8 hours with ChE activity measured at the tim e of peak inhibition. Concentrations should be established to determine approximately a 10% ChE inhibition level (RBC and brain) from control animals. A detailed toxicological examination including the histopathology of the respiratory system is not required due to the specific mode of action of the NMCs. This route-specific study would provide ChE data for hazard characterization, dose response assessment, and a dose and endpoint for assessing potential risks via th e inhalation route for methomyl. Practical Utility of the Data

How did the Agency make its re-registration decision without these data? This acute inhalation study provides critical scie ntific information needed to characterize potential hazard (i.e., ChE inhibition) to the human population from methomyl exposure. In the case of methomyl, an acute inhalation study th at provides ChE inhibi tion data is currently unavailable. An oral study that provided ChE data was used in lieu of the acute inhalation study. An additional Uncertainty Factor was not applied to the 1998 inhalation assessment. At that time, it was believed that oral studies would be protective of the inhalation route of exposure. However, based on the current knowle dge of the mode of action for the NMCs, the oral study currently used may underestimate th e amount of ChE inhibition from an acute inhalation exposure. This non-guideline acute inhalation study will characterize hazard and provide specific mode of action (i .e., ChE) data for an inhalation assessment that is protective for registration review.

How will the data be used?

This study will identify hazard (i.e., ChE inhibi tion) following an acute inhalation exposure at the determined time of peak ChE inhibition. Th is ChE data will be used as the point of departure in the single chemical occupational/residential risk assessments, and may result in a lower point of departure.

If the Agency does not have this data, a 10X da tabase uncertainty factor may be applied for conducting a risk assessment from the available studies.

Page 20 of 25

### Methomyl: Maximum Residue Limits (MRL) Table
Table 6. Summary of US and Internationa l Tolerances and Maximum Residue Limits

US Canada Mexico 2 Codex 3

Residue Definition:
40 CFR 180.253 Methomyl (S -methyl N -[(methylcarbamoyl)oxy] thioacetimidate) S-methyl-N- (methylcarbamoyloxy)
thioacetimidate sum of methomyl and thiodicarb, expressed as methomyl.
MRLs related to methomyl and (154)
thiodicarb are
combined into a single list. Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg) Commodity US Canada Mexico 2 Codex

Alfalfa, forage 10 Alfalfa
fodder 20 Alfalfa, hay 10 Apple 1 0.5 0.3 Asparagus 2 2
Avocado 2 Barley, grain 1 2 Barley, hay 10

Barley, straw 10 Straw of cereal grains
10 Bean, dry, seed 0.1(N) 0.05

Bean, forage 10 Bean, fodder
10

Bean, succulent 2 1 (except
broad bean and soya bean) Beet, garden, tops 6 Bermudagrass, forage 10 Bermudagrass, hay 40 Blueberry 6 6.0

Broccoli 3 7 (proposed)

Brussels sprouts 2 7 (proposed)

Cabbage 5 5.0 7 (proposed)

Cabbage, Chinese, bok choy 5 7 (proposed)

Page 21 of 25Table 6. Summary of US and Internationa l Tolerances and Maximum Residue Limits

US Canada Mexico 2 Codex 3

Cabbage, Chinese, napa 5 7 (proposed)

Cauliflower 2 7 (proposed)

Celery 3 0.5 3 (proposed)
Collards 6 Corn, field, forage 10 Corn, field, grain 0.1 0.02 (*) Corn, field, stover 10 Corn, pop, grain 0.1 Corn, pop, stover 10 Corn, sweet, forage 10 Corn, sweet, kernel plus cob
with husks removed 0.1(N)

Corn, sweet, stover 10 Cotton, undelinted seed 0.1(N) 0.2
Cucurbits 0.2(N) 0.1 Dandelion, leaves 6 30
Endive 5 30 Grape 5 4.0 0.3

Grapefruit 2 Citrus fruits
1.0 Citrus fruits
1 Hop, dried cones 1 12
Kale 6 7
Leek 3.0

Lemon 2 Citrus fruits
1.0 Citrus fruits
1 Lentil, seed 0.1

Lettuce 5 2.0 Head, leaf
0.2 Mustard greens 6 7
Nectarine 5 Oat, forage 10 Oat, grain 1 Oat, hay 10

Oat, straw 10 Straw of cereal grains
10 Onion, green 3 Orange, sweet 2 1.0 1 Parsley, leaves 6 30

Page 22 of 25Table 6. Summary of US and Internationa l Tolerances and Maximum Residue Limits

US Canada Mexico 2 Codex 3

Pea 5 Pods and
succulent=im
mature seeds
5 Pear (Regional Registration) 4 Pea, field, vines 10
Peach 5 0.2

Peanut 0.1(N)

Pecan 0.1 Pepper 2 0.7 Peppermint, tops 2 Pomegranate 0.2(N) Rye, forage 10 Rye, grain 1

Rye, straw 10 Straw of cereal grains
10 Sorghum, forage 1 Sorghum, grain 0.2(N) Soybean 0.2(N) Dry, 0.2 Soybean, forage 10 Fodder, 0.2 Spearmint, tops 2 Spinach 6 30 Strawberry 2 1.0
Swiss chard 6 30

Tangerine 2 Citrus fruits
1.0 Citrus fruits
1

Tomato 1 1 Turnip, greens 6 Vegetable, brassica, leafy, group 5 6.0 30 (proposed) Vegetable, fruiting 0.2(N) 0.1 Vegetables, leafy [exc. beet (tops), broccoli, Brussels sprouts, cabbage, cabbage, Chinese, cauliflower, celery, collards, dandelions, endive (escarole), kale, lettuce, mustard greens, parsley, spinach, Swiss chard, turnip, greens (tops), and watercress] 0.2(N) 30 (including
Brassica leafy) (proposed).
See lettuce.

Vegetable, root 0.2(N)

Watercress 6

Wheat, forage 10 Straw and fodder, dry 5

Page 23 of 25Table 6. Summary of US and Internationa l Tolerances and Maximum Residue Limits

US Canada Mexico 2 Codex 3 Wheat, grain 1 2 Wheat, hay 10 Wheat, straw 10 5 MRLs with no US equivalent Beans, except broad bean and soya bean 1

Citrus pulp, Dry 3 Common bean (pods and/or immature seeds) 1

Cotton seed, hulls 0.2 Cotton seed, meal 0.05 Cotton seed oil, Edible 0.04 Edible offal (mammalian) 0.02 (*) Eggs 0.02 (*) Maize oil, edible 0.02 (*) Meat (from mammals other than marine mammals) 0.02 (*)

Milks 0.02 (*) Mint hay 0.5 Onion, bulb 0.2
Plums 1

Potato 0.02 (*) Poultry meat 0.02 (*) Poultry, edible offal 0.02 (*) Rape seed 0.05 Soya bean hulls 1 Soya bean meal 0.2 Soya bean oil, crude 0.2 Soya bean oil, refined 0.2 Straw, fodder (dry) and hay of cereal grains and other grass like plants 10

Wheat bran, unprocessed 3
Wheat flour 0.03 Wheat germ 2

1 There are no U.S. registrations fo r use of methomyl on hop, dri ed cone, as of February 14, 1990.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated comm odity, such as processing of treat ed stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the
CCPR and the CAC.

Page 24 of 25Page 25 of 25 Table 7: HED Memoranda Relevant to Registration Review
Author Barcode/TXR # Date Title

S. Winfield D376770 05/20/2010 Methomyl Incident Report

F. Fort D340694 06/19/2007 Acute, Probabilistic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Reregistration Eligibility Decision.

F. Fort D245742 05/05/1998 The HED Chapter of the Reregistration Eligibility Decision Document (RED) for Methomyl. J. Leahy D237093 03/25/1998 Revised OCCUPATIONAL AND
RESIDENTIAL EXPOSURE
ASSESSMENT
AND RECOMMENDATIONS FOR THE
REREGISTRATION
ELIGIBILITY DECISION DOCUMENT
FOR METHOMYL J. Leahy D230188 02/21/1997 OCCUPATIONAL AND RESIDENTIAL
EXPOSURE ASSESSMENT
AND RECOMMENDATIONS FOR THE
REREGISTRATION
ELIGIBILITY DECISION DOCUMENT
FOR METHOMYL
C. Eiden D303039 and D230187 02/11/1997 Methomyl Residue and Product Chemistry Chapters.