# . .

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND
POLLUTION PREVENTION



### MEMORANDUM

Date: February 20, 2013

SUBJECT: Soap Salts: Updated Tier I Review ofHwnan Incidents

PCCode:079021,079009,031801

Decision No.: 469863

Petition No.: NA DP Barcode: D405417 Registration No.: NA Regulatory Action: NA

Case No.: NA Risk Assessment Type: NA

TXRNo.:NA

MRIDNo.:NA CAS No.: 10124-65-9

, 68952-95-4, 84776-33-0

40CFR:NA Ver.Apr.08

Shanna Recore, Industrial Hygienist

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# n

A " I\

. d Toxicology and Epidemiology Branch

## ~~ Health Effects Division (7509P) 

# l1 FROM:

THROUGH: David Miller, Acting Branch Chief 

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. 

# J /IL Ao/eP

- ZIJ/3 Toxicology and Epidemiology Branc 'i

Health Effects Division (7509P)

TO: Matt Lloyd, Risk Assessor

Risk Assessment Branch VII

Health Effects Division (7509P)

and

Monica Wait, Chemical Review Manager

Risk Management 

### & Implementation Branch III

Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Soap salts incidents were previously analyzed in 2008 (M. Hawkins and 

### J. Cordova,
10/30/2008, Updated Review of Soap Incident Reports). In this review, no incidents were identified in IDS from 2000 to 2008. Updated incident analyses are included from the Main

and Aggregate Incident Data System (IDS) from January 1, 2007, to September 4, 2012. Additionally, 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) 1998-2008 dataset was analyzed. The results are consistent with the previous analyses. The results are as follows:

Page 1 of7

### Page 2 of 7  For the Main IDS, from January 1, 2007 to September 4, 2012, there were 7 incidents reported for single chemical only in the da tabase and 1 additional incident reported involving more than one chemical. These incidents were classified as moderate severity. These incidents are described in table 1.

 In Aggregate IDS, from January 1, 2007 to September 4, 2012, there were 104 reported incidents involving soap salts. These incidents were classified as minor severity.

 A query of the SENSOR-Pesticides dataset from 1998 to 2008 identified a total of 30 cases involving soap salts. Thirteen of these cases occurr ed at the individual’s place of work. Twenty nine of the cases we re low severity (all SENSOR cases are symptomatic).

 The Agricultural Health Study (AHS) is al so a potential source of information

associated with the human health effect asso ciated with certain pesticides. Soap salts are not included in the AHS, and therefor e this study does not provide information for this report.

In summary, based on the continued low frequency and severity of incident cases reported for soap salts, there does not appear to be a conc ern at this time that would warrant further investigation. The Agency will co ntinue to monitor the incident information and if a concern is triggered, additional analysis will be conducted.

Detailed Review

I. ACTION REQUESTED

Soap salts is a pesticide be ing considered under the FQPA-m andated Registration Review program established to review, on a 15 year cy cle, 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 da ta. In conjunction with a human health 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. This review is intended to provide an update to the prev iously prepared incident repo rt (M. Hawkins and J. Cordova, 10/30/2008, Updated Review of Soap Incident Reports).

II. BACKGROUND

The soap and soap salts registra tion review case is comprised of three active ingredients which are currently associated with active product registrations. These chemicals are (1) ammonium

salts of C 8 

### - C 18 

### saturated and C 18 

### unsaturated fatty acids; (2 ) potassium salts of C 12 

### —C 18 

### saturated fatty acids; and (3) sodium salts of mixed fatty acid esters. Potassium salts are produced by adding potassium hydroxide to fatty aci ds found in animal fats and in plant oils,

### Page 3 of 7 such as palm, coconut, olive, castor, and cottonseed oils. A similar process is used for producing the ammonium and sodium soap salts.

The potassium salts are used as insecticides, herb icides, fungicides and alga ecides in a variety of settings, including food crops and residences. The ammonium salts are used as herbicides and deer and rabbit repellents, also in a wide variety of settings including agricu ltural settings. The

sodium salts are used as a deer re pellent in residential settings only.

For this evaluation, both the OPP IDS and NIOSH SENSOR da tabases were consulted for pesticide incident data on the active ingr edients Soap Salts (PC Codes 079021, 079009, 031801). The purpose of the database search is to identify potential patterns in the frequency and severity

of the health effects attri buted to soap salt exposure.

III. RESULTS/DISCUSSION

a. IDS

OPP’s IDS includes reports of alleged human hea lth incidents from vari ous sources, including mandatory Federal Insecticide, Fungicide and Ro denticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state hea lth and environmental agencies, and individual consumers. Since 1992, OPP has compiled these repor ts 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 m odules: Main IDS and Aggregate IDS.

 Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. 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 incide nts involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about th e potential effects of exposure from the pesticide.

 Aggregate IDS contains inci dents resulting in less seve re human incidents (minor, unknown, or no effects outcomes). These are re ported by registrants only as counts in what are aggregate summaries.

For the Main IDS, from January 1, 2007 to Se ptember 4, 2012, there were 7 incidents reported for single chemical only in the database and 1 ad ditional incident reported involving more than

one chemical. These incidents were classified as moderate severity. These incidents are

described in table 1.

In Aggregate IDS, from January 1, 2007 to Se ptember 4, 2012, there were 104 reported incidents involving soap salts. These incidents were classified as minor severity.

b. NIOSH SENSOR

### Page 4 of 7 The NIOSH SENSOR database covers 11 stat es from 1998-2008, although reporting varies from state to state. Cases of pesticide-related illn esses are ascertained from a variety of sources, including: reports from local Poison Control Ce nters, state Department of Labor workers’ compensation claims when reported by physicia ns, reports from State Departments of Agriculture, and physician reports to state Departments of He alth. Although both occupational and non-occupational incidents ar e included in the database, SENSOR focuses on occupational pesticide incidents, and is of particular value in providing th at information. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized protocol and case definitions, derived from poi son center reporting, SENSOR coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician and patient into the SE NSOR data system. The SENSOR data system is accessible to participating states and EPA.

A query of the SENSOR-Pesticides dataset fr om 1998 to 2008 identified a total of 30 cases involving soap salts. Thirteen of these cases o ccurred at the individual’s place of work and were

therefore coded as work-related. Twenty nine of the cases were low severity (all SENSOR cases are symptomatic). One case was moderate severity due to ocular symptoms; this case involves a woman who got Safer Insect Killing Soap in her eye. Her reported symptoms include: corneal abrasion, eye pain/irritation and or inflammation, and conjunctivitis . The database indicates both patient and physician reported these symptoms . In summary, 11 cases reported ocular symptoms, 7 cases reported dermal symptoms, 7 cases reported GI symptoms, 9 cases reported respiratory symptoms, 13 cases reported ner vous/sensory symptoms, and 2 cases reported cardiovascular symptoms.

c. AHS

The AHS is a high quality, prospective epidemio logy study evaluating the link between pesticide use and various health outcomes including can cer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findi ngs relevant to a particular pesticide going through registration review, the Agen cy will ensure they are fully reviewed in the risk assessment phase of the process. The AHS includes info rmation on use of 50 different pesticide active ingredients co mmonly used in agriculture.

Soap salts are not included in the AHS, and th erefore this study does not provide information for this report.

IV. CONCLUSION

Updated incident analyses of the Main and Aggregate Incident Data System (IDS) from January 1, 2007, to September 4, 2012 and are c onsistent with the previous analyses. Additionally, a query of NIOSH SE NSOR was analyzed. The results are consistent with the previous analyses.

Based on the continued low frequency and severity of incident cases reported for soap salts, there does not appear to be a concern at this time that would warrant furt her investigation. The

### Page 5 of 7 Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted.Page 6 of 7Table 1: Main IDS Incidents involving Soap SaltsHuman IncidentsChemical: Soap SaltsPC Code: 079021, 079009, 031801IncidentPackageReportIncidentDateLocationRegistrationNumberProduct NameExposureSeverity*Incident Description018675 -00001 6/3/2007 DEER PARK, NY067702-00011-036909GARDEN SAFE BRANDINSECTICIDAL SOAPMULTI-PURPOSEINSECT KILLER CONCENHCA 76 year old female applied the product to herlettuce and vegetable garden. The product goton her hands and toes. She was wearingpants during the application. Two days afterexposure, she experienced irritation, pain,inflammation and a caustic alkalis alkaline burnon her right leg where she had existingpsoriasis. She consulted her MD, who irrigatedand washed the affected area.019033 -00019 9/28/2007 WHITE FISH, MT067702-00012-0721552-IN-1 MOSS & ALGAEKILLER READY-TOSPRAYHCA 57 year old male used the product. Six hourslater he was experiencing shortness of breathwhich resolved with the use of his asthmainhaler. 12 hours later he felt nauseous andlethargic. Three daysafter the exposure hewent to his MD. Four day after his exposure hewas feeling fine.020065 -00003 6/25/2008PATCHOGUE,NY062719-00515M-PEDEINSECTICIDE/FUNGICIDEHCA 41 year old female was outside while herneighbor was applying the product. Sheexperienced a cough and throat irritation.020877 -00371 5/6/2009 CUTBANK, MT067702-00021-000239ECOSENSE BRANDINSECTICIDAL SOAPHCA 63 year old female got the product in hereyes while using it. She experienced burningand redness in her eyes.021181 -00015 8/19/2009MANHATTANBEACH, CA067702-00013-039609GARDEN SAFE BRANDINSECTICIDAL SOAPMULT-PURPOSE INSECTKILLERHCAn 83 year female used the product. Sheexperienced high pulse, high blood pressureand metallic taste in her mouth.021191 -00011 1/1/2009 WA067702-00021-000239ECOSENSE BRANDINSECTICIDAL SOAPHCA 48 year old male ate tomatoes that had beentreated with the product. He experienced a rashon his thighs, chest and arms. He went to hisMD and was diagnosed with poison ivy.Page 7 of 7IncidentPackageReportIncidentDateLocationRegistrationNumberProduct NameExposureSeverity*Incident Description023011 -00145 5/8/2011 BALTIMORE, MD067702-00021-000239ECOSENSEINSECTICIDAL SOAPHCThe case uses the product. Case's MD calledfrom the emergency room. Case was in ER forunspecified reasons. Case has an iodineallergy and the MD was wondering if there isiodine in this product.* Severity CategoriesH-A Human Fatality Death (if the person died)H-B Human Major Major (if the person alleged orexhibited symptoms which may have been lifethreatening, or resulted in adverse reproductive effects or in residual disability)H-C Human Moderate Moderate (if the person allegedor exhibited symptoms more pronounced, more prolongedor of a more systemic nature than minor symptoms; and involved some form of treatment,even though symptoms were not life threatening and the person returned to his/her preexposure state of health withno additional residual disability)H-D Human Minor Minor (if the person alleged or exhibited some symptoms, but they were minimallytraumatic; the symptoms resolved rapidly and usually involve skin, eye or respiratoryirritation)H-E Human Unspecified Unspecified (if symptoms are unknown, unspecified or are alleged to be of a delayed orchronic nature that mayappear in the future)H Human Undetermined (an undetermined severity)from 40 CFR § 159.184