UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICA L SAFETY AND POLLUTION PRE V E NTION

MEMORANDUM Date: June 26, 2014 SUBJECT: 4- C hl orophenoxyacetic Acid, and Salts: T ier I Review of Human Incidents PC Code: 0 19401 ,0 1 9402 Decision No.: 4925 1 2 Petition No.: NA Risk Asses s ment Type: NA TXR No.: NA MRID No.: NA DP Barcode: 042 1 138 Reg istration No.: NA Reg ul atory Action: NA Case No.: NA CAS No.: 1 22-88-3, 53404-23 -2 40CFR: NA Ver.Apr.08 FROM: Shanna Recore , Industrial Hygienist 1 

## l 11. , . ,, A () · /"'\ · Toxicology and Epidemiology Branch

## uJ-f'JJ./~**~** Health Effect Division (7509P) 

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# Elizabe**:'~vans,** Environmental Protection

# ~ Toxicology and Epidemiology Branch Health Effects Division (7509P) 

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# -#;{;_ THROUGH: David Miller, Acting Branch Chief 

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# A Toxicology and Epidemiology Branch Health Effec ts Division (7509P) TO: Id eliz Negron-Encarnacion, Risk Assessor Risk Assessment Branch VII Health Effects Division (7509P) and Miguel Zavala, Chemical Review Manager Risk Management & Implementation Branch 3 Pesticide Re-evaluation Di vision (7508P) Summary and Conclusions There does not appear to be a concern at this time that would warrant further investigation, since there were no incidents involving 4

-chlorophenoxyacetic acid (4-CPA), and salts reported to either ID S or SENSOR-Pes ticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.
Page 1 of4Detailed 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 rep orted symptom (or the connection between the two) is validated or otherwi se 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 app li cators. 

### II. BACKGROUND 4-CPA is used in the food industry as a plant growth regulator to restrict root growth during seed germination of mung beans. The product is used by preparing a diluted solution which is added to the water bath to soak the beans. The beans are soaked for several hours, then washed several times to remove the surface residues. The seeds are then germinated indoors for several days. After sprouting, the hulls and roots are discarded
. The sprouted portion of the beans are packaged and sold for human consumption. 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 4-CPA, and salts (pc code : 019401, 0 19402). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to 4

- CPA, and salts exposure. 4

- CPA, and salts are not included in the AHS, and therefore this study does not provide information for this report. 

### III. RESULTS/DISC USSION
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 1 992, OPP has compi led 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 . 1 http: //www.epa .gov/oppsrrd l/ REDs/ 2115red.pdf Page 2 of 4IDS records incidents in one oftwo modules: Main ID S and Aggre gate IDS:
o Main IDS contains incident s resul ting in higher severity outcomes and provides more detail wi th 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 ac tive ingredient (as opposed to pesticide products with multip le active ingredients) are cons idered to provide more certain information about the pote ntial 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 count s in what are aggregate summaries. For the Main IDS, from January 1, 2009 to March 5, 2014, there were 0 incidents reported involving 4-CPA, and salts in the database
. In Aggregate IDS, from January 1, 2009 to March 5, 2014, there were 0 incidents reported involving 4-CPA, and salts in the database. 

### b . S ENSOR- Pesticides The SENSOR-Pesticides database covers 11 states from 1998

- 2010, 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 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, S ENSOR-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 fo ll owup activities such as obtaining medical records to verify symptoms and severity. Using standardized pro t ocol and case definitions derived from poison center reporting, the state SENSOR-Pes ticide coordinator enters the inc ident information into the state-based system which is sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998

- 20 I0 identifies no cases involving 4-CPA, and salts (pc codes : 019401 , 0 19402).


### c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evalua ting the link between pesticide use and various heal th outcomes including cancer . The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings re levant to a particular pesticide going through regis tration review, the Agency will ensure they are considered in the prob lem formulation/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

Page 3 of4active ingredients commonly used in agriculture. 4-CPA, and salts is not included in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION There does not appear to be a concern at this time that would war rant further investigation, since there were no incidents involving 4-CPA, and salts reported to either IDS or SENSOR

Pe sticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

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