UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND PO LLU TION PREV E NT I ON

MEMORANDUM Date: February 2, 20 1 5 SUBJECT: Iron Salts : Tier I Review of Human Incidents for Draft Risk Assessment

PC Code: 034902,050507 Decision No.: 499562 Petition No.: NA Risk Assessment Type: NA TXRNo. : NA MRID No.: NA DP Barcode : 0425357 Registration No. : NA Regulatory Action: NA Case No.: NA CAS No.: 10028-22-5 , 17375-4 1

- 6 40CFR: NA Yer
. Apr.08 FROM: Shanna Recore, Industrial Hygienist

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# n .. " f\. n Toxicology and Epidemiology Branch

### ~**~** Health Effects Division (7509P) and 

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# JfJt Elizabeth Evans , Environmental Protection Speciali sW

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/ v Toxicology and Epidem iology Branch ' • 

## v ', Health Effects Division (7509P) THROUGH: David J. Miller, Acting Branch Chief ·'

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# #$. 62-/eJ '-OI.f Toxicology and Epidemiology

# Branc~**1** Health Effects Division (7509P) TO: Matthew Lloyd, Risk Assessor Ri sk Assessment Branch VII Health Effec ts Divis ion (7509P) and Katherine St. Clair, Chemical Review Manager Risk Management & I mplementation Branch 2 Pesticide Re-evaluation D ivision (7508P) Summary and Conclusions TEB has been asked to review the incidents in ID S and NIOSH SENSOR-Pes ticides and review the findings in the AHS for the iron salts preliminary risk assessment. Based on the low frequency and mostly low severity of inc ident cases reported for iron salts in both IDS and NIOSH SENSOR

- Pesticides, there does not appear to be a concern at this time that would

Page I of6warrant further investigation. The Agency will continue to monitor the incident info rmation and 

### if a concern is triggered , additional analysis will be conducted. The Agricultural Health Study (AHS ) i s also a potential source of information associated w ith human health effects associated with certain pesticides. Iron salts are not included in the AHS, and therefore this study does not provide information for this report. Detailed Review 

### I. ACTION REQUESTED Iron salt s are being considered under the FQPA-mandated Reg istration Review program established to review, on a 15 year cycle , pesticides for which a Re-registration Eligibility Decision has been made. One component of the Agency 's Registration Review Program is consideration of human incident data. In conjunction with a human heal th risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/pesticide products. Reports of adverse health effec ts allegedly due to a specific pesticide exposure (i

. e., an "incident") are largely self-reported and therefore, generally s peaking, 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 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 particul ar chemical or product. Observational epidemiol ogy stu dies 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. 

### II. BACKGROUND Iron salts are registered for use as herbicides to control moss on lawns , turf , ornamental herb aceous plants, woody s hrubs and v ines. For thi s evaluation, both OPP Incident Data System (IDS) and the Centers for Di sease Control and Prevention/National Institute for Occupational Safety and Health (CDC!NIOSH) Sentinel Event Notificati on System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredi ent iron salts (PC Codes: 034902, 050507). The purpose of the database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to iron salts exposure. In addition, findings from the Agricultural Health Study (A HS ) were rev iewed. The AHS is a hi gh quality , prospective ep idemiolog y st udy evaluatin g the link between pe s ticide use and various healt h outcomes including cancer. Iron salts is not included in the AHS, and therefore this study does not provide information for this report.

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### III. RESULTS/DISCUSSION a. IDS (Incident Data System) OPP ' s IDS includes reports of alleged human health incidents from various sources, including mandatory Feder al 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 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 ID S and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case sp ecific. This system stores incident data for death , major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents involving only one pesticide are cons idered 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 January 28,2015 , there were 3 incident reported for single chemica l only in the database involving iron salts. These incidents were classified as moderate severi ty (Table 1). There were no additional in cidents reported involving more than one chemical. In Aggregate IDS , fro m January 1, 2010 to January 20, 2015, there were 18 reported incidents involving iron salts. These incidents were class ified as minor severity. Overall, there are few incid ents involving iron salts reported to ID S.

Page 3 of6d Table 1. Mo erate Iron at nc1 ents m am rom S 1 I . d . M
. ID S 

### f J an u ary , to 1 20 l 0 J anuary 20 20 1 5 

### ' Human I nc id ents I Chemi cal: Iron Salt s 

### 1 PC Code : 034902

. 050507 Incident P ac kag e Inc ident P C R e port Date Location Reg Number P r oduct Name Code I n ci de nt Description An 86 year old male app li ed the product to his lawn. His g love broke hal fway through th e application

. He finished broadcasting the product. Afterwards he took a s hower and changed clothes

. For the next se veral days he experie n ced loss of appetite, chills , and s hak ing. H e saw the MD wh o presc rib e d TURF medicine for a UT I w hich did not BU ILDER he lp. He has a history of heart 02236 1 - ROCHESTER, WITH MOSS bypass/heart condition and 00009 8/ 30 /2 010 NY 000538-00223 CONTROL 050507 hypertension. A 76 year old male spread the pro duct with a hand spreader. Later that night he had irregular TURF heart beat and went to the ER. BUILDER They observed him and sent him 022762- WITH MOSS home. H is symptoms have 00001 1 / 30 /201 1 WA 000538

-00223 CONTRO L 050507 resolved. An adult male applied this product LILLY to h is lawn. He used a rotary MILLER applicator but he could tas te th e MOSS OUT dus t so he switched to a drop PLUS feeder. A couple days later he 025759- FERTILIZER experienced blisters, eryth e m a, 00001 7/2 5/2013 WA 000802-00543 20-2-5 20 LB 050507 pruritu s, and peeling skin

. 

### b

. SENSOR-Pesticides T he SENSOR-P esticides database covers 12 states from 1998-2011 , a lthou gh reporting varies from state to sta te. Cases of pesticide-related illnes ses are ascertained from a variety of sources , including: reports from local Poison Control Centers, state Department of Lab or workers ' compensation claims when reported by phys ic ian s, reports from State D epartments of Ag r iculture , and physician reports to sta te Departments of Health. Although b o th occupational and non-occupational inc idents are included in the database , SENSOR focuses o n occ upati onal pesticide in c id e nts, and is of particular valu e in providing that information. A state SENSOR contact specialist attempts to follow

- up with cases and obta i ns medical records to verify symptoms, circumstances s urrounding the exposure , severity, and outcome. Using standard ized protocol and case definitions d erive d from poison center reporting , SENSO R coordinato rs at State Departments of Heal th enter the incident interv iew desc ri ption p r ovi ded by the case , medical report , physician and patient into the SENSOR data system. T he SENSOR data system i s access ibl e to participating states and EPA.

Page 4 of6A review of SENSOR

- Pesticides from 1998-2011 identifies a total of 33 single active ingredient (ai) cases involv ing iron salts (pc codes 034902 and 050507), stemming from 33 separate events. Thirty one of these cases were reported from Washington State

. Thirty of the cases were not work-related. Twenty
- six of these 33 cases were applying or mixing/loading the product. Most cases invo lved the applicator (mainly homeowner applicators) applying the moss product to their lawn and having ocul ar exposure from spray, sp ill , or splash. One case was high in severity, four cases were moderate in severity, and 28 cases were low in severity . Ocular symptoms were the most frequently reported symptoms (n=25); 23 of the 25 cases with ocular symptoms reported eye pa in/irritation/inflammation. The reported effect are reported in Tab le 2.

Tab le 2. SENSOR

- Pesticides 1998-2011 Reported Hea lth Effects for Iron Salt Cases (N=33)

He a lth E ffect # ofT imes Rep orted Ocular 25 Respiratory 9 Nervous System 6 Dermal 5 Gastrointestinal 3 Cardiovascu l ar 3 Renal 0 

### * Cases mav report multiple health effects The one hi g h severity case is the most recently reported case in the SENSOR database, it occurred in Washington in 2010. The case was mixing/loading two products: L ill y/Mi ll er MossOUT (Reg No 802-509) and 30-Seconds (Reg. No 87429-1). The case description states,
He had used 213 of th e 30-secproduct already and had some MossOUT concentrate mixed with some water in a hand sprinkler container. He decided to miv: them. He added 30-sec then a cloud puffed up in his nose on his skin. " He then exper ienced shortness of breath and coughing. The case also reports preexisting health conditions including: coronary artery disease, hypertension, dyslipidemia, and hypothyroidism

. Thi s case has a "prevention code" that is "mixing of incompatible products." This high severity case also includes a prevention narrative. Th e case stated in his interview with SENSOR that "you can't prevent 

### if people won't read the label" (he didn't read until afteJ). "But 

### if they put a skull and crossbones to get your attention, that might have helped." In ve1y fine print , 30 seconds label cautioned against mixing with other household chemicals

. He mixed 2 moss killing products together

. 30 seconds label recommends wearingprotective clothing to protect c/othingfrom bleaching. Moss out label cautions to wear safety glasses. The case descriptions for the moderate cases are listed in Table 3

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Page 5 of6Table 3. SENS OR-Pest ic id es 1998-2011 Moderate Severity Iron Salt Case Descriptions Case 10 Case Description WA01719 A 46 y / o male was helping his ne ighbor treat his pro perty to control moss. He "acc id en tally got some chemical in his eye". · WA01407 An 83 y / o male appl ied a moss cont r ol product with a ho se end applicator. While unloosening the container it dropped from his WAOlllS Gas was generated when two compo und s were mixed NY01695 While applying product , she b e lieves that she inhaled the granul es. No s kin exposure , case states th at she was weari ng long sleeves and pants.
c . Agricultural Health Study (AHS) The AHS is a hi g h quality , prospective e pidemiolo gy study evalu ating the link between pe sticide use and various health outcomes including cancer. The AHS includ es private and commercial pesticide applicators and the ir spouses. If there are AHS fi nd in gs relevant to a particular pes ticide going through re gistration revi ew, the Agency will ensure they are cons idered in the problem formul ation/scopin g phase of the process and, if appropriate , fully reviewed in the risk assessment phase of the process. The AHS include s information o n use of 50 different pe sticide act ive ingredi ents co mmonl y used in agriculture. Iron salts are not included in the AHS , and therefore this study do es not provide info rm ati o n for th is report. IV. CONCLUSION Base d on th e low frequency a nd mostly low severity of incident cases reported for iron salts in both ID S and NIOSH SENSOR-Pesticides, there do es not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor th e incident in formation and if a concern i s triggered, additional analys is w ill be co nducted

.

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