## II. ACTION REQUESTED

This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure hum an incident data and th e Agricultural Health Study (AHS) are part of the problem formulati on phase of Registrati on 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 exposur e to a pesticide or reported symptom (or the connectio n between the two) is validate d. 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 particular chemical or product. Observational epidemiology studi es relate the risk of disease, e.g. , cancer, and exposure to an agent such as a pesticide product in th e general population or specific sub-groups like pesticide applicators.

III. BACKGROUND

For this evaluation, the OPP Incide nt Data System (IDS) was utili zed for pesticide incident data on the active ingredient pyrethrins (PC Code 069001) . The purpose of the da tabase search is to identify potential patterns on the frequency and severity of the health effects attributed to pyrethrins exposure. The IDS incl udes reports of alleged human health incidents from various sources, including mandatory Federal Insecticid e, Fungicide and Rode nticide Act (FIFRA) Section 6(a)(2) reports from registrants, othe r federal and state health and environmental agencies and individual consumers. Since 1992, OPP compiles 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 represen t anecdotal reports or allegations only, unless otherwise stated in the report. 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 app licators and their spouse s. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem fo rmulation/scoping phase of the process and, if appropriate, fully reviewed in the risk asse ssment phase of the process. The AHS includes information on use of 50 different pesticide ac tive ingredients commonly used in agriculture.

IV. RESULTS/DISCUSSION

Incidents resulting in higher se verity outcomes reported by regi strants and incidents reported directly to the Agency by non-re gistrants are recorded in an IDS module called the Main IDS module. This system stores incident data fo r death, major and modera te incidents (and some minor or no effects incidents that are reported as unique cases to the Agency), and it includes more details about the location, da te and nature of the incident . Main IDS incidents involving only one pesticide are considered to provide more certain informa tion about the potential effects of exposure from the pesticide. When an incident involves more than one pesticide, it is difficult to determine which effects are attributed to the pesticide being considered. The less severe human incidents (minor, unknown, or no effects outcomes) are repor ted by registrants as counts called aggregate summaries and are recorded in a separate module ca lled Aggregate IDS.

Page 2 of 8

## In Aggregate IDS, which contains exposures classified as minor, unknown, or no effects outcomes, from January 1, 2006 to June 6, 2011, th ere are 4,375 exposures involving pyrethrins resulting in these low severity outcomes (664 of the exposures are clas sified as an unknown/no effects outcome, 3,711 of the exposures are classi fied as resulting in a minor outcome). As discussed, there are relatively fe w details provided on the incident s in the Aggregate IDS module and these incidents are low seve rity; regardless, the relativel y high frequency of exposures (relative to other pesticides in IDS) reporte d involving pyrethrins indi cates high potential for

exposure.

For the Main IDS, from January 1, 2006 to June 6, 2011, there are 13 exposures reported for single chemical only in the databa se (one exposure classified as resulting in a minor outcome and 12 classified as moderate) 1 

## , and 803 additional exposures that involved more than one chemical. During the scoping phase of Registration Review, the higher severity expo sures (those resulting in fatal or major outcomes) are considered in more detail. Additionally, as described above, incidents involving one pesticide ar e typically focused on because th ey are considered to provide more certain information about the potential effect s of the particular pesticide. However, because pyrethrins are usually co-formulated with other active ingredients, and because there is about a 50-fold difference between the frequency of incidents involving pyrethrins alone versus pyrethrins and other chemicals, it is important to attend to the incidents involving multiple chemicals in this case. Subsequently, the higher severity exposures (those resulting in fatal or major outcomes) that involve pyrethrins and othe r chemicals are described in Table 1 (30 major outcomes and one fatality). Similar to the Aggr egate IDS module, the relatively high frequency of exposures indicates a hi gh potential for exposure.

Pyrethrins is not included in the AHS, and theref ore does not provide information for this report.

In general, both the Aggregate and Main IDS modules result in rela tively high frequency of pyrethrins exposures. Although most of these exposures resulted in low severity outcomes, high severity outcomes did occur. Subsequently, based on the frequency of exposures and the potential for exposures to result in high severity outcomes, thes e incident data warrant further analysis in the preliminary risk asse ssment phase of Registration Review. 2

1 

### Note: when conducting the query in IDS, an incident classified as HB was identified, however, upon further review it did not occur in the relevant time period, and therefore is not included in this review.

2 

### Note: during the Reregistration of pyrethrins, EPA requir ed the Pyrethrins Joint Venture (PJV), an industry task force, to institute a product stewards hip program involving a prospective in-d epth follow-up of reported pyrethrins incidents to clarify any possible correlation between pyrethrins product use and adverse health consequences. The product stewardship program also requires outreach to physicians and Poison Control Centers, and provides them with better guidance and diagnostic standards. The prog ram has been initiated; however, the results are not available. During the preliminary risk assessment phase of Registration Review, it will be important to consider this information, as well as a previous Agency review of pyrethrins conducted in 2009 (H http://www.epa.gov/oppsrrd1/reevaluation/pyreth rins-pyrethroids-asthma-allergy-9-18-09.pdf H)



## Page 3 of 8

## Table 1: Main IDS high severity incidents involving pyrethrins and other substances 

## Chemical: Pyrethrins 

## PC code: 069001 Human Incidents

Incident Number Incident Date Product Name Registration Number City State Exposure Type* Incident Description

018339 - 00001 1/1/2007 565 Plus Xlo Pressurized Contact Insecticide 000499-00310 Denver CO HA A 43 year old male used product off and on, and died. Existing conditions included alcoholism, liver failure and HIV positive.

018344 - 00002 1/12/2007 Adams Room Fogger With Sykillstop 011715-00313- 004758 MI HB A female child crawled on floor where product was used one or two weeks ago. She experienced twitching, jerking, body shudders and decreased muscle to ne. Subsequently,

doctor thought it may be a rare viral disease.

018502 - 00013 4/29/2007 Drione 1 Lb 000432-00992 Rexford NY HB A 49 year old male was using a spreader to apply product on lawn, and experienced agonal (abnormal) breathing and cardiac arrest. He was transported to the Emergency Room. He recovered. A third party involved reported the cardiac arrest was related to a cardiac event.

018517 - 00005 3/25/2007 Raid Ant Killer 16-17.5 Oz 004822-00473 Bellevue WA HB A 56 year old female sprayed product on floor, and 10 minutes later slipped on treated area and broke her hip. Recovery (to walk again) is expected to take 6-8 weeks.

018799 - 00016 12/1/2006 Hot Shot Kitchen Bug Killer 009688-00114- 008845 Niagara Falls NY HB A 52 year old female’s landlord uses product in her apartment when food is out. Subsequently, she reports exposure to product via her diet, and has experienced abdominal pain, nausea, an inflamed stomach, a bad taste in her mouth and throat irritation. Both exposure and symptoms have gone on for 7-8

months. She is medicated for hypertension.

018932 - 00006 7/20/2007 Raid Flea Killer Plus Carpet And Room Spray 16 Oz 004822-00273

Centennial CO HB A 58 year old female used both products. Two days later she experienced abdominal pain, blood in

stool and was hospitalized for three days. Then she experienced skin irritation (bite/sting feeling) which persists; a doctor provided topical

steroids and oral antihistamine. Raid Flea Killer 16 Oz 004822-00073 HB

019154 - 00006 10/9/2007 Zodiac Flea & Tick Powder For Dogs, Puppies, Cats & Kittens 002724-00627 IL HB An adult male (18-64 years old) was chronically exposed to product at the workplace. He experienced dry skin, anemia and deterioration of the heart muscle.



## Page 4 of 8

## Chemical: Pyrethrins 

## PC code: 069001 Human Incidents

Incident Number Incident Date Product Name Registration Number City State Incident Description Exposure

Type*

019721 - 00002 8/15/2006 Raid Deep Reach Fogger 004822-00387 Columbus OH HB A 29 year old male was exposed to product when it was activated in his home. Later he began seeing sparks when he closed his eyes, and the next morning he experien ced bloatedness, numbness, and difficulty thinking. He sought medical help, which said he was seriously poisoned and referred him to Emergency Room (ER). He declined to go to the ER. Within a week he could think clearly, although numbness remained and he experienced impotency.

019849 - 00001 5/1/2008 Ultracide Pressurized Igr & Adulticide 000499-00404 NC HB An adult male (18-64 years old) used product at work and was exposed via the dermal and inhalation routes. Soon after exposure a rash on most of his body, that persisted despite treatment from healthcare practitioner. Then he experienced mobility problems and was diagnosed with a mild stroke.

019950 - 00001 6/29/2008 Tat Roach & Ant Killer 000506-00166 Memphis TN HB A 29 year old male used product indoors for several days. Subsequently, he experienced lacrimation, tongue numbness, and paralysis of the left side of his face.

020344 - 00002 11/10/200 8 Ultraguard Flea & Tick Dip For Dogs & Cats Concentrate 002596-00086 GA HB A two year old male ingested gulp of product, and vomited 3-4 times per day for 6-7 days and also experienced diarrhea. Previously he had been diagnosed with a 24-hour stomach flu. Medical treatment was sought, as

the diarrhea and vomiting persisted, and he then begin having difficulty walking.

020416 - 00002 1/1/2008 Garden Safe Brand Houseplant & Garden Insect Spray 067702-00006- 039609 Runnemede NJ HB A 60 year old female has used product for a year and a half (4 bottles in the last year). Over the last 18 months she experienced health problems, including her heart skipping beats and breathing difficulties.

020597 - 00002 1/1/2009 Advanced Care 3 In 1 Carpet Powder 004758-00175- 002596 CO HB A 73 year old female used half the container of product over the last month without vacuuming. She was recently hospitalized with dementia and is unable to walk. She was diagnosed with a neurological disorder.



## Page 5 of 8

## Chemical: Pyrethrins 

## PC code: 069001 Human Incidents

Incident Number Incident Date Product Name Registration Number City State Incident Description Exposure

Type*

020671 - 00006 9/20/2008 Adams Flea And Tick Mist 000270-00343 La Fayette GA HB An adult female used product and noticed odor. The next day the skin

around her nose, cheekbones and throat were red, and she could not speak and had trouble swallowing. She was hospitalized for two weeks,

given IV antibiotics and a feeding tube.

020861 - 00001 10/5/2008 Knock Out Room & Area Fogger/ Zema Igr Total Release Fogger 002382-00184 Black River Falls WI HB A 20-month old male was hospitalized for seizures, chewing face and irritability after application of product in home. Environmental samples confirmed presence of multiple pesticides in his home.

021037 - 00001 7/9/2009 Walgreens Roach & Flea Fogger 000498-00146- 043428 Chicago (Berwyn?) IL HB A 60 year old male used product and his apartment exploded. He was transported to the hospital in an ambulance. He was treated for hearing loss. There was damage to the apartment. The incident included a complaint that the instructions were too small a font size to read.

HB An adult female (wife of adult male described above) was in apartment where product was used. She was transported to hospital in an ambulance and treated for head injuries.

021066 - 00009 7/9/2009 Ultraguard Rid Flea & Tick Shampoo For Dogs Clean Fresh Scent 002596-00022 MO HB A five year old male ingested product (about 45 ounces), and about two weeks later sought medical attention for renal failure. A biopsy of kidneys indicated failure may be due to phosphorus.

021149 - 00001 7/16/2009 Flysect Super-7 Repellent Spray 000270-00300 VA HB A 54 year old female got product (about 1 teaspoon) on hand while transferring product to spray bottle.

She hosed off hand immediately. Shortly thereafter she experienced skin irritation (felt like “thousands of

bugs under her skin”) and swelling. She passed out and vomited. An ambulance transported her to thehospital and was administered an EpiPen en route. At the hospital, her blood pressure was low and she was give IV steroids. Upon discharge, she was instructed to take Zantac 2x/day and Benadryl 3x/day

021542 - 00007 1/1/2009 Zodiac Fleatrol Flea & Tick Spray/Dogs, Cats, Puppies & Kittens 002724-00404 WI HB A 14 year old male developed new seizure activity after product was used on dog (for the past two months). He is on medication that has seizure activity as a possible side effect.



## Page 6 of 8

## Chemical: Pyrethrins 

## PC code: 069001 Human Incidents

Incident Number Incident Date Product Name Registration Number City State Incident Description Exposure

Type*

021605 - 00009 11/30/200 9 Tri-Die Silica 000499-00385 San Diego CA HB An 82 year old male was hospitalized for five days, and experienced skin and sinus problems, and renal failure.

The adjacent rooms in the extended stay hotel he was living in were treated with product 10 days prior to his hospitalization.

022178 - 00009 8/19/2009 Knockout Extra Strength Area Treatment 16 Oz 000499-00404- 002382 Biscoe NC HB An adult female (18-64 years old) used product and inhaled some. Shortly thereafter she felt lousy, and the following day she developed black stools, lethargy, and an odor that persist. About a week after exposure, she was admitted to the hospital and given blood.

022379 - 00011 9/13/2010 Ultraguard Plus Flea & Tick Carpet Powder 2 002724-00777- 002596 OH HB A 43 year old female used product and inhaled some. Shortly thereafter, she developed respiratory distress and

shortness of breath. She was brought to the hospital and put on ventilator, given antibiotics and diagnosed with Acute Respiratory Distress Syndrome. About two weeks after exposure, she had a tracheotomy. She is an asthmatic and smoker.

022469 - 00006 10/21/201 0 Hot Shot Bedbug & Flea Killer 009688-00150- 008845

Lexington KY HB A 22 year old male had seizures 4-10 days after product was used in his home. He has epilepsy. Hot Shot Bedbug And Flea Fogger 001021-01674- 008845 HB

022514 - 00001 10/19/201 0 Ultraguard Plus Flea & Tick Carpet Powder 2 002724-00777- 002596

Boston MA HB A female child (6-12 years old) experienced respiratory issues the day after the product was used in her home. She was hospitalized and almost put on the respirator, but she improved with antibiotics, prednisone and fluids. Ultraguard Plus Flea & Tick Fogger 001021-01623- 002596 HB

022851 - 00004 7/18/2010 Advanced Care 3 In 1 Carpet Powder 002724-00777- 002596 Tiffin OH HB And adult female (18-64 years old) used product in two rooms. The day after she experienced burning eyes, face and throat irritation. Symptoms persisted and worsened over 8 months, and now she has lost weight, and is experiencing joint pain and headaches. She has consulted doctors, and they have ruled out lupus.



## Page 7 of 8

## Page 8 of 8 

## Chemical: Pyrethrins 

## PC code: 069001 Human Incidents

Incident Number Incident Date Product Name Registration Number City State Exposure Type* Incident Description

HB The daughter (13 years old) of the adult female desc ribed above also experienced similar symptoms, in addition to nausea, abdominal pain, numbness in her limbs and twitching of her legs and arm. She was treated

for pink eye for two months before medical professionals realized it was an incorrect diagnosis.

HB The husband (adult male 18-64 years old) of the adult female described above and father of youth female described above experienced diarrhea, joint pain, facial swelling, throat and eye irritation and burning

eyes two months after the product was applied in the home. * Severity Categories H-A Human Fatality Death (if the person died)

H-B Human Major Major (if the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse reproductive effects or in residual disability) H-C Human Moderate 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 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)

H-D Human Minor Minor (if the person alleged or exhibited some symptoms, but they were minimally traumatic; the symptoms resolved rapidly and usually involve skin, eye or respir atory irritation)

H-E Human Unspecified Unspecified (if symptoms are unknown, unspecifi ed or are alleged to be of a delayed or chronic nature tha t may appear in the future)

H Human Undetermined (an undetermined severity) from 40 CFR § 159.184



### **Incidents that are involved in lawsuits and inci dents that occur outside of the U.S. are excluded