U N ITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460 OFFICE OF CHEMIC A L SAFETY AND POLLUTIO N PREVENTIO N

MEMORANDUM Da t e: November 20, 2014 SUBJECT: Forc hlo rfenuron: Tier I Review of Human Inci dent s

PC Co d e: 1288 1 9 DP B arco d e : 0424027 Decis ion No. : 494704 Petitio n No.: NA Risk Assess m e n t Type: NA TXR No.: NA M R ID No. : NA FROM: Reg i str atio n No.: NA R eg u lat o r y A cti o n : NA Case N o .: NA CAS No.: 68 1 5 7

- 60-8 40CF R : NA Ver.Apr.08 Shanna Recore, In dustrial Hygienist 

### 11 • . _ '{}_, 1111 , p Toxi co logy and Epidemi o logy Branch**~~** Healt h Effect D ivisio n (7 509P)**~** and

### ~· L:
_ Elizabeth Evans, Environmental Protection S p ecialist**~**
THROUGH:

TO: Tox icology and Epidemiology Branch Health Effects D ivision (7509P) 

# f)

- - l 

# .1/**~** 

# z u-AN , -uJ 

### tf David Miller, Acti n g B ranch Chief 

# J//ff!'U Toxi cology an d Ep idemiology Branch Health Effects Di visi o n (7509P) Alexandra LaMay, Ri sk Assessor Risk Assessment Branch VII Health Effects Division (7509P) and Wilhelmena Livingston, Chemical Review Manager Risk Management & Imp lementation Branch 4 Pesticide Re-eval u ati on Di visio n (7508P) Summary and Co n clusions Because there were no incident cases reported for forchlorfenuron in eit h er IDS or S ENSORPesticides , there does not appear to be a co n cern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

P age 1 of 4Detailed Review 

### I. ACTION REQUESTED This review is intended to fu lfill 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 re g ist ration 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. Typ ically, causation cannot be determined based on incident data. However, incident information can b e an important source of feedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among les s severe incidents, can signal the Agency to further investi gate 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 Forchlorfenuron is a plant growth regulator registered for use on grapes , bushberries, b lu eberries, and kiwi almond, sweet cherry, fig, pear, pistachio, and plums/prunes. Forchlorfenuron is a phenyl urea compound. Forchlorfenuron is a cytokinin, which improves fruit size, fru it set , cluster weight and cold storage in grapes and kiwifru its
. Forchlorfenuron acts synergistically with natural auxins to promote plant cell division and lateral growth. This plant growth regulator causes an increase in berry or fruit size, including varieties not tol erant to gibberellic acid. 1 For thi s evaluation, both the OPP Incident Da ta 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 forchlorfenuron (pc code: 128819). The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to forchlorfenuron exposure. Forchlorfenuron is not included in the AHS, and therefore this study does not provide information fo r this report. 

### III. RESULTSIDISCUSSION
a . IDS (Incident Data System) OPP's IDS includes reports of alleged human health incidents from various sources, including manda to ry 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 rele vant 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 / pesticides/c hem

_ search!reg

_ actions/registration!fs

_ PC-128819
_0 I-Sep-04
. pdf

Page 2 of4IDS 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 specifics. Thi s system stores incident data for death, major and moderate incidents, and it includes informa tion about the location, date and nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with mul tiple active ingredients) are considered to provide more certain information about th e 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 Januar y 1, 2009 to August 12, 2014, there were 0 incidents reported involving forchlorfenuron. In Aggregate IDS, from January 1, 2009 to August 12, 2014, there were 0 incidents reported invol v ing forchlorfenuron. b. SENSOR- Pesticides The SENSOR-Pesticides database covers 11 states from 1998 -20 10 , although reporting varies f rom state to state . Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, s tate Department of Labo r 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 p roviding that information. The state coordinator at each of the 

### 11 resp ective state Departments of Health conducts case followup activities such as obta inin g medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordi nator enters the incident information into the state-based system which is se nt to NIOSH annuall y to be aggregated. A query of SENSO R-Pes ticide s fro m 1998-2010 identifies no cases involving forchlorfenuron (pc code 128819).
c. Agricu ltural Health Study (AHS) The AHS is a high quali ty, prospective epidemiolo gy 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 rele vant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem form ulation/scop ing phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 80 different pesticide

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

### IV. CONCLUSION Because there were no incident cases reported for forchlorfenuron in either IDS o r SENSORPesticides, there does not appear to be a concern at this time that would warrant further investigation. 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 4 of 4