UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: February 20, 2013 SUBJECT: Abamectin: Review ofHuman Incidents
PC Code: 122804 DP Barcode: 0409003 Decision No.: 473543 Petition No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA



### FROM: Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: 65195-55-3, 65195-56-4 40CFR:NA Ver.Apr.08 Shanna Recore, Industrial Hygienist 

# A J /1 • • . Toxicology and Epidemiology Branch**~** Health Effects Division (7509P) and

## ~ Elizabeth Evans, Environmental Protection Specialist

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TO: Health Effects Division (7509P) 

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## 6,6. lot$ David

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.Miller, Acting Branch Chief 

# ;j**~ilL** ?" Toxicology and Epidemiology Branch Health Effects Division (7509P) Nancy Dodd, Risk Assessor Risk Assessment BranchIII Health Effects Division (7509P) and K. Nguyen, Chemical Review Manager Risk Management 

### & Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based onthe relatively low frequency and severity ofincident cases reported for abamectin in both IDS and NIOSH SENSOR-Pesticides, there does not appear to be a concern that would warrant further investigation at this time. It is important to note that there were three incidents that occurred due to allergic reactions to the peanut products in the RAID Ant Baits (004822- 00472 and 004822-00529). The Agency will continue to monitor the incident information, Page 1of6particularly incidents involving allergic reactions to RAID Ant Baits II and III, and ifa concern is triggered, additional analysis will be included in the risk assessment. The Agricultural Health Study (AHS) is also a potential source ofinformation associated with human health effects associated with certainpesticides. Abamectin is not included in the AHS, and therefore this study does not provide information for this report.

Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfill ourrequirementto docket summaries ofincident datathat were reported to the Agency, as well as to ensure human incidentdata and the Agricultural Health Study (AHS) arepart oftheproblem formulation phase ofregistration review. Reports of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e., an "incident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (orthe connectionbetweenthe two) is validated or otherwise confirmed. Typically, causation cannotbe determined based on incident data. However, incident information can be an important source offeedback to the Agency: incidents ofsevere outcome, or a suggested pattern ortrend among less severe incidents, can signal the Agency to further investigate a particular chemical or product. Observational epidemiology studies relate the risk ofdisease, 

### e.g., cancer, and exposure to an agent such as a pesticide productinthe general population or specific sub-groups like pesticide applicators. 

### II. BACKGROUND Abamectin is an insecticide/miticide used to control mites, leafminers, and other insects on various use sites including, butnot limited to, citrus, cotton, grapes, strawberries, corn, soybeans, ornamentals, Christmas trees, and lawns. Abamectin acts as an insecticide by interfering withthe nervous system ofthe insect, causing the insect to become paralyzed. It should be noted that Ivermectin (Abamectin) is also an anti-parasitic drug useful for treatment ofinternal (e.g. lymphatic filariasis, ascariasis, hook worms and cutaneous larvamigrans) and external parasites (e.g. head lice, scabies) inhuman. Itcanbe given orally orby injection (Ottesen and Campbell, 1994). The side effects ofabamectin are related to the depression ofthe nervous system; particularly in children who have not developed a sufficientblood brain barrier. Therefore it is not indicated for children less than 5 years ofage. Therapeutic dose is 150-200 microgram/kg. Ingestion of2.5 -12 grams ofabamectinhas resulted in serious toxicity (Rumack BH Poisindex, 2013). Forthis evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel EventNotification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data onthe active ingredient abamectin (PC Code: 122804). The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to abamectin exposure. Page 2 of6In addition, findings from the AHS were reviewed. The Agricultural Health Study (AHS) is a high quality, prospective epidemiology study evaluating the link betweenpesticide use and various health outcomes including cancer. Abamectin is not included inthe AHS, and therefore this study does notprovide information for this report. 

### III. RESULTS/DISCUSSION a. IDS (IncidentData System) OPP'sIDS includes reports ofalleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide 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 has compiledthese reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevantproductinformationrecorded. Reports submittedto the IDS represent anecdotal reports or allegations only, unless otherwise statedin the report. IDS records incidents in one oftwo modules: Main IDS andAggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail withregard to case specifics. This system stores incident data for death, major and moderate incidents, and itincludes information aboutthe location, date andnature ofthe incident. Main IDS incidents involving only one active it;1gredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information aboutthe potential effects ofexposure from the pesticide. o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reportedbyregistrants only as counts inwhat are aggregate summaries. For the Main IDS, from January 1, 2007 to December 11,2012, there were 25 incidents reported for single chemical only inthe database. There were 11 additional incidents reported involving more than one chemical. All ofthese incidents were classified as moderate severity. Overall, there are few incidents involving abamectinreportedto IDS; however, it is importantto note that there were three incidents that occurred due the cases having allergic reactions to the peanut products inthe RAID AntBaits II and III (004822-00472 004822-00529). These exposures occurred while handling orbeing exposed to products placed in the home (see Table 1for more details). In Aggregate IDS, from January 1, 2007 to December 11,2012, there were 120 reported incidents involving abamectin.

Page 3 of6T bl 1 M . IDS I "d t I I

. All . R ti t RAID A t B "t a e 

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### nc1 enS nvo VID2 Cr2IC eac on o n a1 s Human Incidents Chemical: Abamectin PCCode: 122804 i •.

,If I'**"' Incident** **~,** ,·r ,..,. ' l'i, lpcident Registration Product Incident Pac!(age Report ,, Date Location Number Name Exposure Severity* Description 

### .**~** A 7 year old female had an allergic reaction to the product in RAID the evening. Her DOUBLE mother had CONTROL placed the 019835- 004822- ANT BAITS II product earlier 00032 6/22/2008 GILBERT, AZ 00472 USA HC that day. A 5 year old female had allergic reaction to the peanut RAID ANT butter in the BAITS Ill traps that were 019835- 3/29/2011 004822- USA (NON- set out in her 00032 FRESNO,CA 00529 SPECIFIC HC home. A 30 year old female placed ant baits in her home. She has a peanut allergy and had an RAID ANT allergic reaction BAITS Ill to the bait which 023313- 8/28/2011 NORTH 004822- USA(4 contains 00028 PORT, FL 00529 COUNT) HC derivatives

.

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### b. NIOSH SENSOR The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-relatedillnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLaborworkers' compensation claims when reportedby physicians, reports from State Departments of Agriculture, and physicianreports to state Departments ofHealth. Although both occupational and non-occupational incidents are included inthe database, SENSORfocuses on occupational pesticide incidents, and is ofparticularvalue inproviding that information. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surroundingthe exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting, SENSORcoordinators at State Departments ofHealth enterthe incident interview descriptionprovidedbythe case, medical report, physician and patient into the SENSOR data system. The SENSORdata system is accessible to participating states and EPA. A query ofSENSOR-Pesticides 1998-2009 identifies 147 cases stemming from 43 events. Ofthe 147 cases, 18 involved the single active ingredient abamectin andthe remaining 129 cases involved exposure to multiple active ingredients. 137 cases (93%) were exposed at their workplace. One case was classified as high severity, 19 cases were classified as moderate severity and 127 were classified as low severity. The one high severity case was occupational and occurred in Washington in 2002. This exposure event is described as follows, "A 55 y/o male construction worker developed respiratory and dermal allergic reaction afterhe alleged contact from insecticide." A breakdown ofsymptoms for all abamectin cases reported is provided inthe Table 2 below.

Table 2. SENSOR-Pesticides 1998- 2009: Reported Health Effects for Abamectin Cases* Dermal 30 Ocular 102 Respiratory 94 Gastrointestinal 121 Renal 8 Nervous System 125 Cardiovascular 17 Misc. 15

* Cases mayreport multiple health effects Multiple case events

Page 5 of6In Louisiana in 2003, 58 cases were reported following one work-related event. Inthis event a building was evacuated following an application ofmultiple products. The individuals went to the ERcomplaining ofnausea, upper respiratory irritation and ocularpain. In Californiain 1998, 41 cases were reported following one work-related event involving exposure to multiple pesticideproducts. This event occurred in Fresno County where a crew of field workers became 

### illwhile weeding in a cotton field sprayed withpesticides 2 hours earlier. They were taken to a medical clinic complaining ofsymptoms (including neurological, gastrointestinal, cardiovascular, dermal, and ocular). Violations were recorded pertaining to earlyreentry and 'other misuse.'



### c. AgriculturalHealth Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link betweenpesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered inthe problem formulationlscoping phase ofthe process and, ifappropriate, fully reviewed inthe risk assessmentphase ofthe process. The AHS includes information onuse of50 differentpesticide active ingredients commonly used in agriculture. Abamectin is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based onthe relatively low frequency and severity ofincident cases reported for abamectin in both IDS and NIOSH SENSOR-Pesticides, there does not appearto be a concern that would warrant further investigation at this time. Itis important to note that there were three incidents that occurred due to allergic reactions to the peanutproducts in the RAID AntBaits (004822- 00472 and 004822-00529). The Agency will continue to monitor the incident information, particularly incidents involving allergic reactions to RAID Ant Baits II and III, and ifa concern is triggered, additional analysis will be included in the risk assessment. 

### References: Rumack BH POISINDEX(R) Information System Micromedex, Inc., Englewood, CO, 2013; CCIS Volume 156, edition expires May, 2013. HallAH & Rumack BH (Eds): TOMES(R) Information System Micromedex, Inc., Englewood, CO, 2013; CCIS Volume 156, edition expires May, 2013 (http:/ /toxnet.nlm.nih.gov

### Icgi-bin/sis/search/a?dbs+hsdb:@term+@DOCN0+6941) Ottesen EA, Campbell WC. Review Ivermectin inhuman medicine. Journal of Antimicrobial Chemotherapy. 1994:(34): 195-203. (ftp://ftp

.puce.edu.ec/Facultades/CienciasExactas/PE/Helminths/Ivermectin%20in%20human%2 Omedicine

.pdt)

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