UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 O F FICE OF CHEMICAL SAFETY AND P OLL UT I ON PR EVENTION

MEMORANDUM Date: May 8, 2013 SUBJECT: Aluminum Phosphide, Magnesium Phosphide and Phosphine: Review of Human Incidents PCCode:066501,066504 , 066500 Decision No.: 476795 Petit ion No.: NA DP Barcode : 0411384 Reg istration No.: NA Regulatory Action: NA Case No.: NA R isk Assessment Type: NA TXRNo.: NA MRIDNo.:NA CAS No.: 20859

-73

- 8, 12057-74-8,7803

-51-2 40 CFR: NA
FROM: S hanna Recore, Industrial Hygienist
. 

### II (}. /1. 11 T oxico logy and Epidemiology Branch \}LJI\...YU/; Health Effects Division (7509P) and Elizabeth Evans , Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Divi sion (7509P) THROUGH: David 

### J. Miller, Acting B r anch Chief 

# a)J!l/£.. Toxicology and Epidemio logy Branch Health Effects Division (7509P) TO: Thurston Morton, Risk Assessor Risk Assessment Branch IV Health Ef fects Division (7509P) and Dan a Friedman, Chemical Review Manager Risk Management & Implementation Branch 2 Pesticide Re

- evaluation Division (7508P) Summary and Conclusions Yer.Apr.08

For magnesium phosphide and phosphine there is relatively low frequency and severity of incident cases reported both IDS and NIOSH SENSOR

- Pesticides, there does not appear to be a concern at this time that wou ld warrant further investigation. The Agency will continue to
Page 1 of 10monitor the incident information and if a concern is triggered, additional analysis wi ll be inc luded in the risk assessment. Although aluminum phosphide had a low frequency of incidents in IDS, there was one incident that resu lted in two deaths. In NOISH SENSOR-Pestic ides, aluminum phosphide had a moderately high frequency of incidents that were mostly moderate or low in severity. EPA has recently (20 1 0) expanded and clarified the outdoor use restrictions for a ll phosphine products used against burrowing rodents. Considering the new ly requ ired safety measures , the Agency will continue to monitor the incident information and provide an updated review of incidents during regis tration review. The Agricultural Health Study (AHS) is al so a potential source of information assoc iated with hu man health effects associated with certain pesticides. Magnes ium phosphide and phosphine are not included in the AHS
. Aluminum phosphide is included in AHS; however, because fumigant use is rare in the AHS popul ation, there are no studies published that include aluminum phosphide. Therefore AHS does not provide information for this report. Detailed Review I. 

### ACTION REQUESTED This review is i ntended to fu lfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an " i ncident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed
. T ypically, causation cannot be determined based on incident data. However, incident information can be an important source of feedback 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 re late the risk of disease, 

### e.g., cancer, an d exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide app li cators. 

### II. BACKGROUND Aluminum phosphide and magnesium phosphide liberate phosphine gas and are therefore clustered with phosphine for registration review. Phosphine is formulated as a pressurized gas. Aluminum and magnesium phosphide are formulated as impregnated materials, pellets/tablets , and granu les which release phosphine gas upon exposure to atmospheric moisture. Phosphine fumigants are highly toxic pesticides that are restricted to use only by specially trained pesticide applicators. Phosphine is an insec ticide/rodenticide labeled for use on numerous stored raw commodities (i .e . tree nuts, dried fruits, cereal grains), animal feed and feed ingredients, and processed foods (i .e.

Page 2 of 10candy, bakery mixes, crackers, cheese, meat products). Phosphine is also labeled for use on numerous non-food co mmodi ties and other non-food items. These include to bacco, cloth fibers, feathers, hair, wood and wood products, paper, tires , and beehives. Aluminum /magnesi um phosphide pellets/tab lets are used for rodent control, especially burrowing pests. Pellets or tablets are placed into the rodent burrows
. However, these products may not be used in burrows that are within 100 feet of a building that is, or may be, occupied by humans and/or domestic animals. Indoor use of these products is prohibited. 1 For this evaluation, both OPP Inci dent Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIO S H) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR-Pesticides) databases were consulted for pesticide incident data on the active ingredient aluminum phosphide, magnesium phosphide and p ho sphine (PC Codes: 066501, 066504, 066500). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to aluminum phosphide, magnesium phosphide and phosphine exposure. In addition, findings from the AHS were reviewed. The Agricultural He alth Study (AHS) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Magnesium phosphide and phosphine are not included in the AHS. Aluminum phosphide i s included in AHS ; however, because fumigant use is rare in the AHS population, there are no studies published that include aluminum phosphide. Therefore AHS does not provide information for this report.


### III. RESULTS/DISCUSSION a. IDS (Incident Data System) OPP's IDS include s reports of a lleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from reg istrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS conta in s 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 oftwo 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 inc ident data for death , major and moderate incidents, and it includes information about the loca tion, da te and nature of the incident. Main IDS inc idents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are cons idered to provide more certain information about the potential effects of exposure f rom the pesticide.

1 Prior to the new mitigation implemented in 20 I0, pellets or tab lets could not be used within 15ft of a building occupied by humans or domestic animals. Page 3 of 10o 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
. Aluminum Phosphide For the Main IDS , from January 1, 2008 to February 19 ,2013, there were 3 incidents reported for single chemical only in the database. This incident was cl assified as major severity
. These incidents are de scribed further in Table 1. There was 1 additional incident reported invol ving more than one chemical. Overall, there are few incidents involving aluminum phosphide reported to IDS. In Aggregate IDS , from January 1 , 2008 to February 19,2013, there were 6 reported incidents involving aluminum phosphide. The se incidents were classified as minor sever ity. Table 1. Main IDS Major Incidents for the single chemical Aluminum Phosphide Human Incident Chemical: Aluminum Phosohide J PC Code: 066501 Incident Package Reg Exposure Report Incident Date Location Number Product Name Severitv* Incident Descript ion Four year old and 15 month old sisters d ied after the product was misapplied by a PCO within about 7 feet of the family residence (the pellets are not to be used within 15 feet of homes). The parents and siblings were 021602- LAYTON, 072959

- FUM I TOXIN also trea te d for flu -like 00001 2/6/2010 UT 00002 PELLETS HA symp toms. Ten employees experienced nausea, eye irritation and chest discomfort and were transported to area ERs
. They had be en trying to extinguish a fire within a canvas bag that contained 072959- 2200 lbs of pistachios 021605- WASCO , 00002- FUMITOXIN undergoing fumigation with 00005 12 /1 0/2009 CA 005857 PELLETS HC the product. A male worker applying tablets to gopher holes experienced numbness on the left side of his body and became sick to his stomach
. He was taken to the ER, examined and released
. He was wearing g loves during the application and was 022748

- KERM AN, 070506- WEEVIL-CIDE t rained prior to the 00001 l/20/2011 CA 00013 TABLETS HC application. Page 4 of 10Exposu re Severity* H-A H-B H-C Human F atality Human**M~or** Human Moderate Death (ifthe person died) Major (ifthe person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse reproductive effects or in residual disability) Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms; and involved some form oftreatment, even though symptoms were not life threatening and the person returned to his/her pre-exposure state ofhealth with no additional residual disability) Magnesium Phosphide For the Main IDS , from January 1, 2008 to February 19, 20 13, there was 1 incident reported in the database. This inci dent was classified as minor severity. Overall, there are few incident s involving magnesium phosphide repo rted to IDS
. In Aggregate IDS, from Ja nuary 1, 2008 to February 19, 2013, there were no reported inc idents involving magnesium phosphide. Phosphine For the Main IDS, from January 1, 2008 to February 19,2013, there was 1 incident reported in the database . This incident was clas si fi ed as moderate severity. This incident i s described further in Table 2. Overa ll , there are few incidents involving phosphine reported to IDS. In Aggregate IDS, from January 1, 2008 to February 19,2013, there were no reported incidents invo lvi ng phosphine
. Table 2. Main IDS Major Incidents for the single chemical Phosphine Human Incident Chemical: Phosphine 

## I PC Code: 066500 Incident Package Incident Reg Expos ure Report Date Locati on Number Product Name Severity* Incident Description A male working was in a fumigated silo of nut crop and inhaled phosphine gas . He was admitted to the hospital and was observed for signs and symptoms of acute lung injury. An investigation revealed that the proper procedure was not followed because the sign placed on the silo had blown away . The sign shou ld not have been removed until the commodity was completely aerated (contained 0.3 VAPORPH30S ppm or less of phosphine gas). The case 019519 068387- PHOSPHINE was exposed to 15 to 20 ppm of -00026 1 /29/ 2008 CA 00008 FU MIGANT HC phosphine gas . Exposure Severity* Moderate (if the person alleged or exhibited symptoms more pronounced , more prolonged or of a more systemic nature than H-C Human Moderate minor symptoms; and involved some form of treatment, even though symptoms were not life threatening and the person returned to his/her pre-exposure state of health with no additional residual disability) 

### b. SENSOR-Pesticid es Page 5 of 10The SENSOR-Pesticides database covers 1 1 states from 1999

-2009, although reporting varies from state to state. Cases ofpestic ide

-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 phys icians, reports from Sta te Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR

- Pestici des focuses on occupational pesticide incidents, and is ofparticular value in providing that information. A state SENSOR contact specialist attempts to follow

-up with cases and obtains medical records to verify symp toms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions derived from poison center reporting, SENSOR coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician and pat ient into the SENSOR data system. The SENSORPesticides data system i s accessib le to participating states and EPA. Aluminum Ph osphide A query of SENSOR-Pesticides 1998-2009 identifies 75 cases involving aluminium phosphide, stemming from 57 events. Seventy two cases involved a single active ingredient. Ofthese single active ingredient cases, there was one fatality that was resu ltant from a suicide; two high severity cases; 29 moderate sever ity cases and 50 low severity cases. The case detail for the high and moderate severity cases are provided in Table 3. Ofthe 72 single active i ngredient cases, 66 were work-related. Commonly reported symptoms include headache, dizziness, shortness of breath and cough. A breakdown of reported health effects is provided in Table 4
. Multiple exposure events TX02769- In Texas in 2004, 7 warehouse workers were made ill after entering a wareh ouse fumigated with aluminum phosphide (Weevil -C ide pellets) the previous day. The case notes indicate the warehouse was not properly ventil ated and the applicator failed to post warnings at all entrances. Applicator was cited with violations for making an application inconsistent with labeling and failure to provide [warning] s igns.

Tabl e 3. S E NSOR-P e sticide s 1998-2009: Aluminum Phosphide Case Detail High and Moderate S everity Case s Case ID Severity* Year Narrative CA05595 Moderate 1999 Case detail not provided CA06456 Moderate 1998 Case detail not provided CA07330 Moderate 2000 Case detail not provided CA09402 Moderate 2001 Case detail not provided CA09874 Moderate 2002 Case detail not provided CA13812 Moderate 2004 Exposed when he wrapped up tarps that had chemicals on them CA13813 Moderate 2004 Was picking up pallets with his forklift when container burst and spilled aluminum phosphide on him CAI5341 Moderate 2008 Working with a bin of walnuts that had recently been fumigated, not wearing monitoring device , developed symptoms
. Page 6 of 10Table 3. SENSOR-Pesticides 1998-2009: Aluminum Phosphide Case Detail High and Moderate Severity Cases Case ID Severity* Year Narrative CA17730 Moderate 2009 Exposed to aluminum phosphide fumes while eradica ti ng gophers LA02276 Moderate ' 2005 transferring rice from truck to bin, exposed to a luminium phosphide; did not wear mask; no PPE worn or training provided; he lping on a friend's farm OR0 1940 High 2009 Reports to PEST via translation that he app li ed th is pesticide fo r mole extermination (he's not licensed); would drop tab let TX03 315 Moderate 2001 Deputy heard an explosion at a grain coop, saw cloud of smoke and got out of vehicle, smelled strong odor. TX03786 Moderate 2003 Case works in a grainery and puts down phofume fumigat ion pellets every Friday to control rats. Concerned about chronic expos TX03831 Moderate 2001 Case entered warehouse to work after being fumigated the day before. TX03878 High 2004 Case removing pellets from plastic container, placing in 5 gallon barrels
. S tanding over barrels when activated by moisture outside TX03893 Moderate 2004 Case had gloves on, cleaned up the ashes of the chemical , was there between 6:00 and 7:15a.m. TX03897 Moderate 2004 Case came to work at 6 a.m . on June I. Walked inside door, no tape, cleaned room until 8:30, 2 guys helped him take out signs TX04471 Moderate 2005 Fumigating barns w/han ds
. Breathing heavy, opened a bottle (of substance) and inhaled. Working hard for peanut harvest

- no intervention WA01494 Moderate 2004 Patient inhaled fumes WA02288 Moderate 2006 A 75 y/o male was taken to the ER five days post exposure for gastrointestinal, respiratory and neurological symptoms. WA03118 Moderate 2009 Flash Explosion *SENSOR-Pesticides Severity Index Death Hu man Fa tality High L ife threatening, requires treatment >5 days lost work/time Moderate Involves systemic effects 3-5 days lost work/time Minor Symptoms typically resolve without treatment <3 days lost work/time

Table 4. SENSOR-Pesticides 1998-2009: Reported Health Effects for Aluminum Phosphide Cases (N=72)

Health Effect # of Times Reported Dermal I I Ocular 13 Respiratory 50
Page 7 of 10Gastrointestinal 45 Renal 1 Nervous System 56 Cardiovascu lar 20 Misc. 18 * Cases may report mu ltip le health effects Magnesium phosphide A query of SENSOR-Pesticides 1998-2009 identifies 2 cases, stemming from 2 events, involving the single active ingredient magnesium phosphide
. One case occurred in California in 1998 and was moderate in severity; however, no case details were recorded
. The second case occurred in Washington in 2009 and was low in severity. According to the case description, this case was employed by a wholesale coffee company and was exposed as he "unloaded merchandise from a large container that was fumigated over the weekend. There was improper ventil ation when the container was closed because of drizzle. He unloaded materials from the container over a 3 day period and developed fatigue and gastrointestinal health effects
. He sought healthcare." Phosphine A query of SENSOR

-Pesticides from 1998-2009 ide ntifies 22 cases, stemming from 9 events, involving phosphine. Twenty one cases involved a single active ingredient and are further discussed below. Ten cases are moderate in severity and 1 1 are low in severity. All cases are work-related. One event in California in 2007 resulted in 14 case reports. The cas e information for these 14 cases reads "Fumigant was trapped in a room that had not been vent il ated, case exposed when the doors were opened." Case details fo r the 10 moderate severity phosphine cases are provided in Table 5. A summary of symptoms reported is provided in Tab le 6 below. The most commonly reported symptom was headache (n=14).

Tabl e 5. SENSOR-Pesticides 1998-2009: Phosphine Case Detail Moderate Severity Cases 

### Case ID Severity* Year Case Narrative CA 1 3933 Moderate 2004 Exposed to phosphine gas CA15346 Moderate 2007 Fu migant was trapped in a room that had not been ventilated, case exposed when the doors were opened CA15354 Moderate 2007 Fumigant was trapped in a room that had not been ventilated, case exposed when the doors were opened CA15402 Moderate 2007 Fumigant was trapped in a room that had not been ventilated, case exposed when the doors were opened CA15406 Moderate 2007 Fumigant was trapped in a room t h at had not been ventilated, case exposed when the doors were opened CA15713 Modera te 2007 Fumigant was trapped in a room that had not been ventilated, case exposed when the doors were opened CAI5714 Moderate 2007 Fumigant was trapped in a room that had not been ventilated, case exposed when the doors were opened CA15716 Moderate 2007 Fumigant was trapped in a room that had not been ventilated, case exposed when the doors were opened Page 8 of 10studies published that include aluminum phosphide. Therefore AHS does not provide information for this report.


### IV. CONCLUSION In 2010, EPA and the primary manufacturers of aluminum and magnesium phosphide pesticide products worked together to expedite the process of amending product labels to inc lude the expanded use restrictions and reduce the potential for accidental poisonings. The new restrictions apply to all phosphine products for use against burrowing rodents
. The expanded and clarified restrictions for these outdoor use products include prohibition of use in all residential areas and increased buffer zones (for a building that is or may be occupied with people or animals) from 15 to 100 feet. For more information regarding the expanded use restrictions visit: http

### :1l www.epa. govIoppsrrd 1 /reregistration/alphosphide/aluminum- magnsmphos

- fs.html. For magnesium phosphide and phosphine there is relatively low frequency and severity of incident cases reported both IDS and NIOSH SENSOR-Pesticides, 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. Although aluminum phosphide had a low frequency of incidents in IDS, there was one incident that resu lted in two deaths. In NOISH SENSOR-Pesticides, aluminum phosphide had a moderately high frequency of incidents that were mostly moderate or low in severity
. As stated above, EPA has recently (20 1 0) expanded and clarified the outdoor use restrictions for all phosphine products used against burrowing rodents. Considering the new ly required safety measures, the Agency w ill continue to monitor the incident information and provide an updated review of incidents during registration review. The Agricultural Health Study (AHS) is also a potential source of information associated with human health effects associated with certain pesticides. Magnesium phosphide and phosphine are not included in the AHS. Aluminum phosphide is included in AHS; however, because fumigant use is rare 

### in the AHS population, there are no studies published that include aluminum phosphide . Therefore AHS does not provide information for this report.

Page 10 of 10Table 5. SENSOR-Pesticides 1998-2009: Pho sphine Case Detail Moderate Severity Cases 

### Case ID Severity* Year Case Na rrative TX00997 Moderate 1999 Working in a grain elevator when he accidentally inhaled phosphine fumigant. Phosphine pellet was left on the floor. WA02976 Moderate 2009 A 45 y / o male employee of packing company came into contact with fumigant fumes after opening and entering an empty rail car. *SENSOR- Pe sticides Severity Index High Life threatening, requires treatment > 5 days lost work/ti me Moderate Involves systemic effects 3-5 days lost work/time Minor Symptoms typically resolve without treatment <3 days lost work/time High Life
. threatening, require s treatment > 5 days lost work/time

Table 6. SENSOR-Pe st icide s 1998-2009: Repor ted Health Effects for Phosphine Cases N=066500

Health Effect #of Times Reported Dermal 7 Ocular 12 Respiratory 13 Gastrointestinal II Renal 5 Nervous System 17 Cardiovascular 6 Misc. 9 

### * Cases may report multiple health effects



### c. Agric ultural Health Study (AHS) The AHS is a high quality , prospective epidemiology study evaluating potential links between pestic id e use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review , the Agency will en sure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AI-IS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Magnesium phosphide and phosphine are not included in the AHS. Aluminum phosphide is included in AHS; however, because fumigant use is rare in the AHS population, there are no Page 9 of 10