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



### MEMORANDUM Date: November 12, 2015 

### SUBJECT: Metaldehyde : Tier I (Scoping) Review of Human Incidents and Epidemiology

PC Code : 05300 I DP Barcode: 0430090 Decision No
. : 509276 Petition No.: NA Ri s k Assessment Type: NA TXR No.: NA MRIDNo.: NA Registration No.: NA Regulatory Action: NA Case No.: NA CAS No.: I 08-62-3 40 CFR: NA Ver.Apr.08 Elizabeth Evans , Environmental Protection Specialist /' __.-> Toxicology and Epidemiology Branch 

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### FROM: Health Effects Division (7509P) v 

# J and Shanna Recore, Industrial Hygienist 

### A A Toxicol ogy and Epidemiology Branch 

### ..@ Health Effect Division (7509P)**·**

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### THROUGH: David Miller, Acting Branch Chief Toxicology and Epidemiolo gy Branch Health Effects Division (7509P) 

### TO: Ronnie Bever, Risk Assessor Risk Assessment Branch VI Health Effects Division (7509P) and Leigh Rimmer, Chemical Review Manager Risk Management 

### & Implementation Branch 2 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Based on the severity of incident cases reported for metaldehyde in both IDS and SENSORPesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.
Page 1of6Detailed Review 

### I. ACTION REQUESTED This review is intended to fulfi ll our requirement to docket summaries ofincident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part ofthe problem 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, generall y speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. However, incident information can be an important source offeedback to the Agency: incidents of severe outcome , or a suggested pattern or trend among less severe incidents , can signal the Agency to further investigate a particular 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**~ub groups**  like pesticide applicators. 

### II. BACKGROUND Metaladehyde is a molluscide used to kill snail and slug pests ofvarious food, seed, and ornamental plants. For this evaluation , both the OPP 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 Occupational Risk

-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient metaldehyde (pc code: 053001)
. The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to metaldehyde exposure. Metaldehyde is not included in the AHS, and therefore this study does not provide information for this report
. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports of alleged 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 indi vidua l consumers. Since 1992 , OPP has compiled these reports in IDS
. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for Page 2of6

### death, major and moderate incidents, and it includes information about the location, date and nature ofthe incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential effects of exposure from the pesticide.

o 

### Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries
. For the Main IDS , from January 1 , 2010 to September 24, 2015 , there were 31 incidents reported for the single chemical metaldehyde only in the database. Thirty incidents were classified as moderate severity and one incident was classified as major severity. An 

### adult male was spreading bait on a windy evening
. He thought he inhaled the product dust. The next day he developed nausea, vomiting, sweating and drooling
. He was admitted to the hospital but his health care provider did not think his symptoms were related to the product. There were 13 additional metaldehyde incidents reported to Main IDS involving more than one active ingredient. In Aggregate IDS , from January 1, 2010 to September 24 , 2015 , there were 104 incidents reported involving metaldehyde. These incidents were classified as minor severity. 

### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 states from 1998-2011, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources , including: reports from local Poison Control Centers , state Department of Labor workers ' compensation claims when reported by physicians , reports from State Departments of Agriculture , and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value in providing that information. The state coordinator at each ofthe 12 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides from 1998-2011 identifies a total of 58 cases involving metaldehyde, 47 of which involve a single ai. Ofthe single 

### ai cases, five were classified as moderate in severity and 42 were classified as low in severity. Fifteen cases were work-related and 32 cases were not work-related. Most cases (90%) involved exposure to snail/slug bait granules. Location of Case Exposure • 57% occurred at private residences • 15 % occurred at schools

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### o In Washington State in 20 1 1, five students ages 12-14 were sent to clean up a school greenhouse. The product spilled during clean up and the students reported stomachaches and headaches to the schoo l nurse . • 13% occurred at retail establishments Case Expos ure Route Information• • 66% of cases (n=31) were exposed from inhalation of the product. o Twelve of these inhalation cases resulted from spill of the product, including seven inhalation cases involving spill or leak ofproduct onto retai l employees including cashiers and stockers. o Five inhalation cases occurred at the school greenhouse
. 

### o Fifteen inhalation cases occurred when the case was applying the product; eight of these cases specifically note that w ind " picked up" or "changed direction" during the application. • 40% of cases (n=l 9) were exposed dermally. • 25% of cases (n=12) were exposed from ingestion of the product including 6 homeowner applicators who got product in their mouth from applying while windy. Case Activity at Time ofExposure • 40% of cases were applying the product • 11 % of cases were transporting the product • 17% of cases were at work not involved in appli cation. All eight of these cases were retail establishment employees. See Table 3 for these case descriptions. Symptoms Reported Nausea (n=l 5), respiratory irritation (n= l 7) , headache (n=l4) were among the symptoms report d e Table I. SENSOR

-Pesticides 1998- 20 11 Symptoms reported for metaldehyde cases (n=42) Respiratory 23 Gastrointestinal 23 Nervous System 22 Dermal 15 Ocular 8 Cardiovascular 2 Renal 0 *Cases may report multipl e symptoms.

'.faBle 2. SENSOR-Pesticide5 1998-2011 Moderate Severity Cases involving metaldehyde (pc code 053001) Case ID Year Case Description OROl227 2005 Chi ld was playing in grass and around plants where slug bait had been applied ear lier

' Cases may report multiple exposure routes. Page 4of6A 61 y/o male reported that he got slug & snail product in his eyes. he experienced ocular WA02870 2008 symptoms. He phoned WPC two days after exposure and sought health care the next day. DOH was unable to reach the individual for an interview. but medical records indicate exposure could have contributed to ocular symptoms. A 63 y / o male developed an allergic reaction after applying loose meal bait for slugs in his WA02112 2006 home garden. He sought health care at the ER and later followed up with his private MD. There was no topical testing to confirm that metaldehyde was source ofallergy
. CA l 7020 2009 Bag of s nail bait spilled open**~** er Table 3
. SENSOR-resticides 1998-2011 Retail Worker Cases involving metaldehyde (pc code 05300 1)

- Case ID Year Case Description - ... - A 30 year o ld pregnant female who had asthma was working as a cashier at a retail food center. She described picking up a container ofthe product and dust from it WA02230 2006 came up into her eyes. As she was wearing contacts . she took them out. washed her face. and went to a clinic for an exam. She continued 10 have dry eyes with them bothering her when she was awake. CA l 4761 2007 Stocking shel ves at Walmart pesticide spilled on him
LA02706 2007 Cashier checked out bag of(snail and slug killer). bag leaking and inhaled cloud of dust
TX03978 2004 Case works at Walmart and he was lifting a box
. It broke open and spilled on case's body. He was reorganizing the department A 26 year old female garden shop employee for a retail s tore experienced an WA02117 2006 accidental facial exposure to dust from a slug control product. She sought medical care the same day for mild re spiratory and neurological symptoms. Patient lost to follow

- up. A 25 y / o female cashier at a retail store set down a box ofs lug bait and the dust. from an unobserved tear. puffed up on to her face and into her mouth. She WA02880 2008 experienced pain and irritation immediately and GI problems for two consecutive nights
. She notified co-workers prior to washing off. S he was seen at a clinic the following day
. CA l2348 2003 Case was a 23 year old laborer / stocker who experienced an inhalation exposure at work that was classified as moderate in severity: no further details are provided. CA l4 764 2007 Case was unloading an empty box that had some residue in it, inhaled some residue.

c. Ag ricultural Health Study (AHS) 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 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 in the problem formu lation/scoping phase of the process and , if approp ri ate, fu lly reviewed in the risk assessment phase of the process. The AHS includes information on use of 80 different pesticide active ingredients commo nly used in agriculture
. Metaldehyde is not included in the AHS, and therefore this study does not provide information for this report. Page 5of6

### IV. CONCLUSION Based on the severity of incident cases reported for metaldehyde in both IDS and SENSORPesticides there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident informati on and if a concern is triggered, additional analysis will be included in the risk assessment.

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