UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C . 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM Date: July 23, 201 4 SUBJECT: Napthalene Acet ic Ac id : Tier I Review of Human Incidents PC Code : 056007 Decision No.: 493410 Petition No.: NA Risk Assessment Type: N A T XRNo.: NA MRIDNo.: NA DP Barcode: Q421705 Regis tration No. : NA Regulatory Action : NA Case No.: NA CAS No
. : 61-31-4 40CFR: NA
FROM: 

# t . Elizabeth Evans, Environmental Protection Specialist 

# UJ1 Toxicology and Epidemiology Branch Healt h Effects Division (7509P) and Ver

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Shanna Recore, Indust r ial Hygieni st 

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_ _**r~** . 11 To xico logy and Epidemiology Branch**~~~** Health Effect Division (7509P) T H ROUGH: David M ill er, Acting B ranch C hi ef /)

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## Br**~** He alth Effects D ivis ion (7509 P) TO: Thurs ton Morton , R i sk Assessor Risk Assessment Bran ch IV Health Effect s Division (7509P) and Christ ina Scheltema, Chemical Review Manager Risk Management & Implementation B ranch 3 Pesticide Re-evaluation Division (7508P) Summary and Conclusions There does not appear to be a co n cern at this time that would warrant further investigation, since there are no inci dents involving napthalene acetic acid reported to IDS and SENSOR-Pesticides.

Page 1 of4The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment. Detailed 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 du e 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 s u ggested 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 Napthalene acetic acid is used primarily for apples and pears. Apples and pears represent approximately 95% of the total active ingredient used annually with all other registered use sites accounting fo r the remaining 5% of use. Approximately 20,000 lbs of the naphthalene acetate active ingredients are applied annually in the United States. 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 napthalene acetic acid (pc code: 056007). The purpose of the database search is to identify potential patterns in the frequency and severi ty ofthe health effects attributed to napthalene acetic acid exposure. Nap thal ene acetic acid 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 ID S include s reports of all eged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodentic ide 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
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### of 4submitted 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 provides more detail with regard to case s pecifics. 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 w ith multiple active ingredients) are considered to provide more certain information about the potential 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 counts in what are aggregate summaries. For the Main IDS, from January 1, 2006 to May 28,2014, there were 0 incidents reported involving napthalene acetic acid in the database. In Aggregate IDS, from January I, 2009 to May 28, 2014, there were 0 incident reported involving napthalene acetic acid in the database. b. SENSOR-Pesticides The SENSOR-Pesticide s database covers I 1 states f rom 1998-20 I 0, although reporting varies from state to s tate. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, s tate Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to sta te Departments of He alth. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is of part icular value in providing that information. T he state coordinator at each of the 11 res p ectiv e state Departments of Health conducts case followup activities such as obtaining medical records to veri fy symptoms and severity. Usi ng 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 i s sent to NIOSH annually to be aggregated. A query of SENSOR-Pesticides 1998-20 10 identifies no cases involving naptha 1ene acetic acid (pc code 056007).
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 pr ivate and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem fonnulation/scoping phase of the process and, if appropriate, fully reviewed in the risk Page 3 of 4assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture
. Napthalene acetic acid is not included in the AHS, and therefore this study does not pro vide information for this report. 

### IV. CONCLUSION There does not appear to be a concern at this time that would warrant further inve stiga tion , since there were no reported incidents involving napthalene acetic acid reported to ID S and SENSORPesticides. T he 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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