UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFF I CE OF CHEMICAL SAFETY AND POLLUTION PRE V ENTION

MEMORANDUM Date: January 7 , 2014 SUBJECT: M CPB ([4-(2-methyl -4-chlorophenoxy) butyric acid]) and Salts: Tier I Review of Human Incidents PC Co de: 019201 , 019202 Decis i on No.: 483037 Petiti on No.: NA Ri s k Assessment Type: NA TXRNo.: NA MRID No. : NA DP Barcode: 04 16737 Reg ist ratio n No.: NA Reg ul atory Actio n : NA Case No.: NA CAS No. : 94-81-5 , 6062-26-6 40CFR: NA
FROM: Shanna Recore , Industrial Hygienist Toxicology and Epidemiology Branch Healt h Effect Division (7509 P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

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## :1.0 4 THROUGH : D avid Miller, Acting Branch C hie 

## vtJt/1/4::/t L Toxicology and E pidemiolo gy Branch Health Effects Divi sion (7509P) TO: Donna D avis, Ri sk Assessor Risk Assessment Branch IV Health Effects Division ( 75 09 P) and K. Nguyen, Chemical Review Manager Ri sk Management & Implementa tio n Branch 1 Pe s ticide Re-evaluation Division (7508 P) Summary and Conclusions Ver.Apr.08

Based on the low frequency and severity of incident cases rep orted for MCPB [4-(2

-methyl -4- chlorophenoxy) butyric acid] and salts, there does not appear to be a concern at thi s time th at would warrant further investigation

. The Agency will continue to monitor the incident

Page 1 of4information and if a concern is triggered, additional analysis will be included in the risk assessment. Detai led Review I. 

### 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 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 ' ' 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 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 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 MCPB is a phenoxy herbicide produced as a sodium salt and an acid. MCPB is registered for use on pea crops before flowering, for post-emergence control of broadleaf annual and perennial weeds including Canadian thistle, buttercup , mustard , purslane , ragweed , common lambsquarters, pigweed , smartweed, sowthistle , and morning glory. 1 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 MCPB and salts (PC codes: 019201 , 019202). The purpose ofthe database search is to identify potential patterns in the frequency and severity of the health effects attributed to MCPB and salts exposure. MCPB and salts is not included in the AHS , and therefore this study does not provide information for this report. 

### III. RESULTS/DISCUSSION
a. IDS (Incident 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 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

1 Excerpt from MCPB Factsheet, found online at: http: //www.epa.gov/opp srrd 1 / REDs/ fucts heets/mcpb f s. htm Page 2 of4pesticide going through regi stration review, the Agency will ensure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase ofthe process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture

. MCPB and salts is not included in the AHS, and therefore this study does not provide information for this report.


### IV. CONCLUSION Based on the low frequency and severity of incident cases reported for MCPB and salts in both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time tha t would warrant further investigation. The Agency will continue to monitor the incident info rmation and if a concern is triggered, additional analysis will be included in the risk assessment.

Page 4 of4submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provide s 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 ofthe 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 potentia l effects of exposure from the pesticide.

o Aggregate IDS contains incidents resulting i n 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 , 2008 to September 11 , 2013, there were no incidents reported in the database involving MCPB and salts. In Aggregate IDS , from January 1, 2008 to September 11, 2013, there was one reported incident involving MCPB and salts.


### b. SENSOR-Pesticides The SENSOR-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-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 physicians, reports from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is of particular value in providing that information. The state coordinator at each ofthe 11 respective state Departments of Health conducts case followup activities such as obtaining 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 inf ormation into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-2009 finds no cases involving MCPB and salts.



### 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
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