# II. ACTION REQUESTED

This review is intended to fulfill our requirement to docket summaries of incident data that were

reported to the Agency, as well as to ensure hum an incident data, and th e Agricultural Health

Study are part of the problem formulation phase of registration review. Repor ts of adverse health

effects allegedly due to a specific pesticide exposure ( i.e. , an “incident”) are largely self-reported

and therefore, generally speaking, neither exposur e to a pesticide or reported symptom (or the

connection between the two) is validated. Typically, causation cannot be determined based on

incident data. However, incident information can be an important feedback loop to the Agency –

incidents of severe outcome, or a suggested pattern or trend among le ss severe incidents can

signal the Agency to further i nvestigate a particul ar chemical or product. Observational

epidemiology studies relate the risk of disease, e.g. , cancer, and exposure to an agent such as a

pesticide product in the general population or specific sub-groups like pesticide applicators.

III. BACKGROUND

For this evaluation, both the O PP Incident Data System (IDS) and the Centers for Disease

Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH)

Sentinel Event Notification System for Occupati onal Risk-Pesticides (SENSOR) database were

consulted for pesticide incident data on the active ingredient meth omyl. Additionally, the

Agency is looking to include findings from the Agricultural Health Stud y (AHS), beginning with

the problem formulation phase of registration review. The purpose of the database searches is to

identify potential patterns on the ex tent and severity of the health effects attributed to methomyl

exposure. The IDS includes reports of alleged human health incidents from various sources,

including mandatory Federal Insecticide, Fungici de and Rodenticide Act (FIFRA) Section 6 (a)

(2) reports from registrants, other federal and state health and environmental agencies and

individual consumers. Since 1992, OPP compiles th ese reports in IDS. IDS contains reports

from across the U.S. and most incidents have a ll relevant product inform ation recorded. Reports

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in

the report. The NIOSH SENSOR database covers 12 states from 1998-2006, although reporting

varies from state to state (the database in cludes a total of 10,659 cas es). Pesticide-related

incidents are collected from Depa rtment of Labor workers’ comp ensation claims when reported

by physicians, reports from State Departments of Agriculture, from poison control centers and

from State Departments of Health based on repo rts by physicians suspecting pesticide exposure.

Although both occupational and non-occupational in cidents are included in the database,

SENSOR focuses on occupational pes ticide incidents, and is of particular value in providing that

information. A state SENSOR contact speciali st does follow-up with workers and obtains

medical records to verify symptoms, circumst ances surrounding the e xposure, severity, and

outcome. Using standardized protocol and case definitions, derived from poison center

reporting, SENSOR coordinators at State Departments of Health enter the incide nt interview

description provided by the worker , medical report, physician and pa tient into the SENSOR data

system, accessible to participating states and EPA. The AHS is a high quality, prospective

epidemiology study evaluating the link between pesticide use and various health outcomes

including cancer. The AHS includes private a nd commercial pesticide applicators and their

spouses. If there are AHS findings relevant to a particular pesticid e going through registration

review, th e Agency will ensure they are considered in the prob lem formulation/scoping phase of

# the process and, if appropriate, fu lly reviewed in the risk assessmen t phase of the process. The

AHS includes information on the use of 50 differe nt pesticide active ingredients commonly used

in agriculture.

IV. RESULTS/DISCUSSION

For IDS we identified 43 cases reported for me thomyl in the United States from 2002 to the

present. Of these cases, thirteen were reviewed because in these cases methomyl was used as a

single chemical only and theref ore these cases provide more certain information about the

potential effects of methomyl exposure. Fi ve of the incidents involved intentional

ingestion/misuse of the product (two of which i nvolved more than one person; and one of which

resulted in a fatality, and the rest resulting in ma jor or moderate severe symptoms). Six incidents

involved agricultural handlers using methomyl: four in seemingly typical ways and two where

equipment malfunctioned/leaked (a ll of these resulted in moderately severe symptoms). The

symptoms most often reported was neurological (27%) followed by gastrointestinal (23%) and

ocular (20%). Proportions relate to the total number of symptoms, not the total number of cases,

i.e ., an individual may report multiple symptoms to the database. See the table below for further

details.

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 certa inty classification of definite, probable, or possible, as these

cases provide more certain information about the pot ential effects of methomyl exposure. All of

the reviewed cases were classified as low or mo derate severity. The health effects reported

include: neurological (81%), gastrointestinal (71%), ocular (24%), respiratory (19%),

cardiovascular (19%), dermal (14%), and genito urinary (5%). Proportions relate to the total

number of symptoms, not th e total number of cases, i.e ., an individual may report multiple

symptoms to the database. Ten cases were expose d in an occupational handler setting, including

mixing, loading and applying methomyl. The health effects most often reported for these cases

include: neurological (80%) and ga strointestinal (80%). One case of occupational postapplication

exposure involved a 62 year old male who entered a field that had been treated the previous

night. He experienced dermal and neurological symptoms. Two of these cases were bystander

exposure to methomyl. Both cases experienced respiratory, neurological and gastrointestinal

symptoms. One case experienced dermal symptoms in addition to the ones previously stated. In

eight cases the details are unknown.

Methomyl is not included in the AHS, and th erefore not considered in this report.

Although there were not many cases, some of the cas es involved moderate and severe effects.

Subsequently, human incident data may warrant further analysis for the risk assessment and/or

risk management of methomyl. The Agency will continue to monitor the incident information

and if a concern is triggered, additional analysis will be included in the risk assessment.IDS ReportChemical: MethomylHuman IncidentsIncidentNumberIncidentDateProduct NameRegistrationNumberCityStateExposureType*Incident Description01305000104-Jun-02LANNATE(UNSPECIFIED)MARTINEZCAHCAdult (18-64 years old) male was exposed to theproduct while spraying crops at work. Hedeveloped nausea, blurred vision, headache andtremors. He was admitted to the hospital fortreatment.01319900110-Jul-02DUPONT LANNATELV INSECTICIDE00035200384GREENVILLENCHCAdult (18-64 years old) male inhaled a significantamount of product accidentally when tubingdisconnected from the sprayer. Within 1-2 hourshe developed sweating, abdominal cramping,agitation, pupils-miosis, vomiting, muscleweakness and drowsiness. He sought treatmentfrom the hospital. According to the nurse, hisblood cholinesterase level was 18.7 (normal 9-19),normal anion gap, no acidosis, and patient wasnot intubated.01321300124-Jul-02DUPONT LANNATESP INSECTICIDE00035200342TURLOCKCAHCAdult (18-64 years old) male accidentally inhaledthe product when it was being loaded into aduster. He became clammy, very sweaty, vomitedseveral times, had constricted pupils, and wasjaundiced looking. He was admitted to thehospital until 1 am thatnight and was discharged.01408100108-May-03DUPONT LANNATELV INSECTICIDE00035200384ATHENSTXHCAdult (18-64 years old) male was exposed to thediluted product when the back sprayer leaked.Product got on his hands, middle back, back oflegs; within ten minutes he showered. Butdeveloped rash, hives, welts and abdominal pain.01430100107-Jul-03DUPONT LANNATELV INSECTICIDE00035200384MILBERKYHCA 67-year old male used an open tractor to spraythe product for 12 hours a day for two days. Onthe evening of second dayhe developed diarrhea,and excessive sweating. The next day hesuffered from nausea, headache, weakness,tremors, constricted pupils, rapid shallowbreathing and chest pain. He was admitted to thehospital for treatment.01524800105-Jun-04DUPONT LANNATELV INSECTICIDE00035200384ALICETXHCA 25-year old male was mixing product 2 hrs. ago;when he returned inside & noticed his left pupilremained pinpoint. No dizziness, headache orother symptoms.01794600106-Oct-06METHOMYLUNSPECIFIED ENDUSE PRODUCTKIRKLANDWAHAA 55-year old male died and a 40-year old Femalebecame blind for 48 hrs. after drinking the productmixed with Jagermeister. Female patient sufferedstroke (in the optical area), and recovered 60% ofher vision.01813900123-Nov-06LANNATEUNSPECIFIED ENDUSE PRODUCTOCEANSIDECAHBAdult (18-64 years old) male ingested the productpossibly bought in Mexico. He developedrespiratory arrest; admitted to the hospital,became stable but still in coma.02085800101-Aug-06DUPONT LANNATELVINSECTICIDE/NEMATICIDE00035200384SAVANNAHNYHBAdult (18-64) year old, Male was exposed to theproduct when he was fillinghis truck with dieselfuel near the location where the aerial applicatorwas loading the product. He developedrespiratory symptoms; pursuing lawsuit againstaerial applicator.02089101120-May-09METONATE 90 PS(MEXICANPRODUCT:METONATE C WASWRONG)CHINOCAHBA 17-year old female allegedly ingested ateaspoonful of product, she developed vomitingand was admitted to the hospital.02107200122-Jul-09DUPONT LANNATEUNSPECIFIED ENDUSE PRODUCTTHOMASVILLEGAHCA 50-year old male, agricultural inspector walkedthrough the fields treated with product. He hadthree episodes of syncope. Second one whiledriving, passed out and got into a ditch. Thirdepisode of syncope was in the ER, his heart ratewent down to 30's.02116000101-Aug-09GOLDEN MALRINFLY BAIT-NONDUPONT PRODUCTTOLEDOOHHBA 69-year old female intentionally ingested 1tablespoon of product. Developed cholinergicsigns and symptoms and was intubated. Laterbecame stable, alert and oriented.02133400101-Aug-09METHOMYLLENEXAKSHERestaurant workers, charged with poisoningpeople by mixing the product into salsa.Customers developed nausea, abdominal cramps,weakness, sweating and discomfort.* Severity CategoriesHHumanH-AHuman FatalityH-BHuman MajorH-CHuman ModerateH-DHuman MinorH-EHuman Unspecified