UNITED STATES ENVIRONMENTAL PROTECTION A G E N CY WAS H ING T ON, D.C

. 20460

OFFICE O F CHEMIC A L S A FE TY A ND P O LLUTION PRE V ENTION

MEMORANDUM

Date: February 4, 2014

SUBJECT: MCPP (Mecoprop) : Tie r I R ev i ew of H um a n Inc i den t s

P C Co d e: 031501.031503,031519,03 1 520,03 1 563,031564, 119046

, 129046 Decis i o n No.: 485917 P etit i o n No.: NA R i sk Assessment Type: NA TXRNo.:NA MRID No.: NA

FROM: DP Barc o de: 0417595

Regis t rat ion No

. : NA Reg ul atory Actio n : NA Case No.: NA CAS No.: 7085-19-0

, 93-65-2 40CFR: NA Ver.Apr.08

Shanna Recore, Industrial H ygienist Toxicology and Epidemiology Branch Health Effec t D ivis i on (7509P) and Elizabeth Evans, Envirorupental Protection Specialist Toxicology and Epidem i ology Branch 

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Hea l th Effects Di vision (7509P) 

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THROUGH: David M ill er, Act i n g Branch Chief 

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Toxicology and Epi d e m iolog y Br anch Healt h Effe ct s Divis i o n ( 7 5 09P )

TO: Seyed T adayon, Risk Assessor Risk Assessment B r anc h V Health Effects Division (7509P) and Kaitlin Keller, Chemical Review Manager Risk Management & Imp l ementation Branch 3 Pesticide R e-evaluation D ivision (7508P)

Summary and Conclusions 

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There are no incidents reported for MCPP as a single chemical only, but there is a high absolute number of incidents reported involving MCPP with another active ingredien t. Alt h o u gh t h e vast majority of these incidents were of l ow seve r ity, some high severity outcomes are repo rt ed in 

### the IDS database. It is important to no te t hat since most of these reported inc i dents invo l ve more

Page 1 of9

### than one active ingredient (i.e. MCPP and another active ingredient), the i nc id e n ts that we re reported were not necessarily attributable to MCP P. Further, while incident infonnation can be

an important source of feedback to the Agency, 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 exposure to a pest icide or reported symptom (or the connection between the two) is valida te d or otherwise confirmed. Typically, causation cannot be determ ine d based on incident data. Neverthe l ess, based on the absolute number of incidents and the few high severity outcomes that are reported, these incident data may warrant further analysis in the preliminary risk assessment phase of Registration Review. Obtaining additional information on current usage data for MCPP would improve future assessments.

Detailed Review



### I. ACTION REQUESTED

This rev iew i s intended to fulfill our requirement to docket summaries of i ncident data that were reported to the Agency, as we ll as to ensure human incident data and the Agricultura l 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 " in cident") 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 othe r wise confirmed. Typically, causation cannot be determined based on incident data. However, incident informa tion can be an imp ortant source of feedback to the Agency: in cidents of severe outcome,

or a suggested pattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemica l or product. Observational epidemiology studies 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.



### II

. BACKGROUND

MCPP-p compounds are plant growth regulators that are part of th e ch l orophenoxys
group of herbicides. MCPP

- p is used in combination with other herbicides for postemergence broadleafweed and brus h control. It 

### is used primarily on turf ( i. e

. lawns and golf courses) and sod farms with smaller quantities used on non-turf areas such as rights-of way.

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 MCPP (PC codes: 03150 l , 

### 031503

, 031519, 031520, 031563, 031564, 119046, 129046). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to MCPP
exposure. MCPP is not included in the AHS, and therefore this study does not prov id e information for this report.



### III. RESULTS/DISCUSSION

Page 2 of9

### Page 3 of 9 a. IDS (Incide nt 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 e nvironmental 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 anecdot al reports or allegations only, unless otherwise stated in the report. It should be noted there were two incident reported as lawsuits to IDS that were not considered in this report.

IDS records incidents in one of two modules: Main IDS and Aggregate I DS:

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 death, major and moderate incidents, and it includes information about the location, date and nature of the 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 pe sticide.

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 M ain IDS, from January 1, 200 9 to Ja nuary 15, 2014

, there were 0 incidents reported for single chemical only in the database. There were 261 incident reported involving more than one chemical. 1 

### Eleven incidents were classified as major severity, 245 incidents were classified as moderate severity and 1 incident was classified as having unknown or no effects. The incident narratives for incidents classified as major severity are included in Append ix 1.

In A ggregate IDS , from January 1, 200 9 to January 15, 2014

, there were 1215 reported incident s involving MCPP

. Twenty eight incidents were classified as unknown or no effects and 1187 incidents were classified as minor severity.

b. SENSOR

- Pesticides

The SENSOR

- Pesticides database covers 11 states from 1998

- 2009, although reporting varies from state to state. Cases of pesticide

- related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Depa rtment of Labor workers’ compensation claims when reported by physicians, reports from State Departments of

1 There were 21 foreign incidents were not reviewed in detail because of the potential differences in the exposure patterns, use practices, and product formulation. These incidents occurred in Canada (13), Germany (5), Ireland (1), England (1) and China (1)

.

### Page 4 of 9

Agriculture, and physician reports to state Departments of Health. Although both occupational and non

- occupational incidents are included in the dat abase, SENSOR

- Pesticides focuses on occupational pesticide incidents, and is of particular value in providing that information. The state coordinator at each of the 11 respective state Departments of Health conducts case follow

up activities such as obtai ning 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 t o NIOSH annually to be aggregated.

A query of SENSOR

- Pesticides 1998

- 2010 identifies 210 cases, stemming from 160 events, involving MCPP (pc codes 031501, 031503, 031519, 031520, 031563, 031564, 119046, and 129046). Eighty nine cases were work

- related; 121 cases were not work

- related or unknown. Three cases were high in severity (one high severity case was a suicide attempt and will be excluded), 36 were moderate in severity, and 171 were low in severity. Reported health effects are included in Table 1. High and moderate case descriptions are provided in Appendix 2 below.

Table 1. SENSOR

- Pesticides 1998

- 2010: Reported Health Effects for MCPP Cases

N=210

Health Effect # of Times Reported Nervous System 110 Respiratory 99

Gastrointestinal 81

Dermal 77

Ocular 29

Cardiovascular 25

Renal 2 * Cases may report multiple health effects



### c. Agricultural 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 . If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem for mulation/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process

. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. MCPP i s not included in t he AHS, and therefore this study does not provide information for this report.

IV. CONCLUSION

### Page 5 of 9

There are no incidents reported for MCPP as a single chemical only, but there is a high absolute number of incidents reported involving MCPP with another active ing redient . Although vast majority of these incidents w ere of low severity, some high severity outcomes are reported in the IDS database. It is important to note that since most of these reported incidents involve more than one active ingredient (i.e. MCPP a nd another active ingredient), the incidents that were reported were not necessarily attributable to MCPP. Further, while incident information can be an important source of feedback to the Agency, reports of adverse health effects allegedly due to a speci fic pesticide exposure ( i.e. , an “incident”) 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. Typically, causation can not be determined based on incident data. Nevertheless, based on the absolute number of incidents and the few high severity outcomes that are reported, these incident data may warrant further analysis in the preliminary risk assessment phase of Registrati on Review. Obtaining additional information on current usage data for MCPP would improve future assessments.

### Page 6 of 9

Appendix 1. Main IDS Major Severity Incidents Descriptions for MCPP.
Human Incident Chemical: MCPP PC Codes: 031501, 031503, 031519, 031520, 031563, 031564, 119046, 129046

Incident Package Report Incident

Date Location Reg Number Product Name Incident Description

020578

- 00003 1/6/2009 MISHAWAKA, IN 000538

-

00282 TURF BUILDER

WITH PLUS 2 WATER SMART An adult female was exposed to product and seems to be sick since then.

Apparently it was a year ago but details are fuzzy.

020813

- 00174 4/15/2009 MONETA, VA 000538

- 00028 TURF BUILDER

WITH PLUS 2 WEED CONTROL A 77 year old male applied the product to his lawn with his bare hands.

He developed slurred speech. He went to ER and was diagnosed with a TIA (mini

- stroke).

020813

- 00176 4/17/2009 KANSAS CITY, MO 000239

-

02640

- 000538 TURF BUILDER

WITH PLUS 2 WEED CONTROL An adult male got the product on his hands while applying it. He

experienced nausea and stomach cramping. He went to ER and was diagnosed with appendicitis.

022933

- 00004 8/4/2010 KY WEED

- B

- GON (NON

- SPECIFIC) An adult female used this product 8 months prior and she got some of it

on her skin. She didn't rinse it off right away because she didn't think it was a big deal. She did rinse it off later that day and then the next day she developed derma l irritation and blisters. She didn't go to the doctor or call us back then because she didn't think it was a big deal and doesn't have health benefits. She said the symptoms started to look better and then they look bad again. Her skin is hard and discolo red now and she still has tiny blisters that itch.

023011

- 00017 5/10/2011 JEFFERSON CITY, MO WEED

- B

- GON (NON

- SPECIFIC) A 60 year old male used the product. Approximately 2 hours after using

the product, he fainted, displayed slurred speech, complained of confusion, malaise and headache. He went the hospital via ambulance.

023301

- 00017 6/4/2011 DE WEED

- B

- GON (NON

- SPECIFIC) An adult male mixed/loaded and applied the product and got it on his

legs. He did not wash it off for at least an hour. His blood work shows decreased kidney function. His doctor took him off of his arthritis medication that he had been on f or 20 years.

023382

- 00153 9/26/2011 STREET, MD 000239

- 02689 WEED B GON

MAX PLUS CRABGRASS KILLER RTU 1.1 GAL An adult woman rode around with product in the car for over a month.

When she reached in to get it, she found it had fallen over and about half had spilled out. She had on occasion smelled chemical and has been treated for severe headaches for over a month. 025017

- 00014 2/1/2013 HARRISBURG, NC UNKNOWN PRODUCT A young female child had a seizure after a post application exposure to

the product. 025238

- 4/25/2013 PA 002217

- VIGORO ULTRA This product was placed in the grass and was not watered down as

### Page 7 of 9

Human Incident Chemical: MCPP PC Codes: 031501, 031503, 031519, 031520, 031563, 031564, 119046, 129046

00001 00884

- 073327 TURF

PHOSPHORUS

FREE WEED & FEED directed in the package. The next day as the homeowner began to water

down the product into the ground; her 2 year old grandson came outside and ran across the grass with no shoes on. Two hou rs rater, her grandson was "chewing on a lotion container" when he dropped it and began to cry. They gave him the lotion container again and he again began to chew on it. Caller states that within one minute he became "lifeless" and "stiff'' and was not br eathing. Caller states that that she checked him for airway obstructions and could not see anything, and started to slap him on the back and he came to, but was still dazed. They rushed him to the ER, where they will be doing a CT scan and keeping him for observation.

025337

- 00013 5/1/2013 UT 000538

- 00282 TURF BUILDER

WITH PLUS 2 WEED CONTROL A 1 year old male got into the product. He walked into the garage, put his

hands in it and threw it up in the air. His mother states she didn't find any in his mouth at the time. She called poison control, who told her to watch for skin irritation. By the next day his fingers started cracking and peeling. She saw a doctor 24 hours after the exposure. The doctor diagnosed the child with burns down his throat. That evening the child vomited. the next day, the child had seizures and went to the ER. The child h as been seen by 3 different doctors since these symptoms started. The latest MD said what she thinks are seizures are rigors. One MD diagnosed him with pneumonia while the other 2 disagreed. Something is seen in lower lobe of one lung on x

- ray. He has some blood in his urine but they don't feel it's a bladder infection. He's been running a high temp of 104 on and off. When asked, he would have had access to the product for less than 30 seconds. There was no evidence in or around his mouth of ingestion. He h as been treated with an antibiotic but she's not seeing much improvement. He has not been admitted to the hospital for further evaluation

025337

- 00020 5/10/2013 MI 000239

- 02682 WEED

- B

- GON

RTU An adult female used the product twice. She describes no specific

exposure during use. The wind was blowing, but caller states she was covered up with long pants and long sleeves. Two days later, she woke up with symptoms of an itchy rash covering her entire body. She has been using oral Benadryl at the recommen ded dosage as well as hydrocortisone cream, but her symptoms persisted. On call back it was stated that she was admitted to the hospital yesterday and diagnosed with cancer. She does not feel that her symptoms had anything to do with product use or exposu re.

### Page 8 of 9

Appendix 2.

SENSOR

- Pesticides 1998

- 2010 MCPP High/Moderate Case Descriptions

N=38
ID Year Severity Case Description
MI00530 2006 High Fertilizer had been stored outside over winter. Roof leak resulted in chemical rx, heat. She was discarding into compactor. NY00561 2002 High Man drinking alcohol all day had a fight with wife and reportedly drank 10 oz of weedkiller.
NY01820 2008 Moderate Medical record indicates that he got some of the product on his hands while working (substance is a powder).
NY01276 2005 Moderate Applying herbicide and accidentally got product in his eye.
NY01201 2005 Moderate Applying weed control product in garden for about 3 hours.
NY00802 2004 Moderate This man did not follow label precautions when he used a handheld granular spreader to treat his lawn.
NY00390 2000 Moderate Man had been applying a granular insecticide and herbicide to a customer's lawn on a hot day.
NY00176 1999 Moderate Subject lives in basement apt and super sprays pesticides around exterior of his windows.
FL01181 2003 Moderate Not provided
MI01161 2007 Moderate Required to mix/load pesticides but not provided with PPE as required by label
TX03209 2000 Moderate Exposed at work, lawn treated previous day, fumes seeped in building via vent.
MI00930 2007 Moderate Trigger got stuck, loosened nozzle to unclog, spray shot out. Got herbicides & fertilizer in eyes, thinks he swallowed 1/4 c.
MI00586 2005 Moderate Pulling hose out of backyard, stood up too fast & fainted (hot day, no history of fai nting). Lay on lawn wet with spray 15

- 20 min.
IA00248 2007 Moderate Not provided
FL03884 2010 Moderate Caller states that he was using speed zone herbicide from 0800

- 1600 with gloves but still was exposed.
FL02603 2008 Moderate Patient was found in yard spraying pesticide.
FL02120 2007 Moderate Child was found eating fertilizer the evening before. Was fine until the next day.
NC00485 2008 Moderate Not provided
TX03229 2000 Moderate Exposed at work, lawn treated previous day, fumes seeped into building via vent.
WA02504 2007 Moderate A 39 y/o female landscaper used a backpack sprayer to apply 2 herbicides to weeds in a lawn. She didn't wear a mask and inhal ed
WA02169 2006 Moderate A 47 y/o female developed respiratory & systemic symptoms after clearing weeds from a lawn. She treated herself. She sought
WA01647 2004 Moderate A 26 y/o male unlicensed applicator applied around an apartment complex. He was not using goggles or a respirator.
WA01176 2003 Moderate She said spray hit side of her truck/smelled spray
WA00719 2001 Moderate 71 y/o male dropped a container of Ortho Weed B Gon he got at a garage sale. He got some on his hand and smelled the chemical
TX06265 2010 Moderate Case had a container of spectracide weed stop for lawns in a case along with more containers of same pesticide. Case asserts that container must have ruptured during transport because when he reached to pick it up, as he grabbed it, that pressure
TX03232 2000 Moderate E xposed at work, lawn treated previous day, fumes seeped into building via vent.

### Page 9 of 9 SENSOR

- Pesticides 1998

- 2010 MCPP High/Moderate Case Descriptions

N=38
ID Year Severity Case Description
OR01383 2006 Moderate Worker was exposed to drift momentarily and then to fumes for three and a half days while product was applied to university c ampus. TX03230 2000 Moderate Exposed at work, lawn treated on the previous day, fumes seeped into building via vent.
TX03203 2000 Moderate
TX03228 2000 Moderate
TX03225 2000 Moderate
TX03223 2000 Moderate
TX03219 2000 Moderate
TX03218 2000 Moderate
TX03213 2000 Moderate
TX03210 2000 Moderate
TX03231 2000 Moderate
WA02516 2007 Moderate A 73 y/o male developed primarily respiratory symptoms with some ocular and neurological involvement after an exposure to an