UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 22, 20 15 

SUBJECT: Diphenylamine: Tier I (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 038501 DP Ba rcodc: 0429308 

Decision No.: 509355 

Petition No.: A 

Risk Assessment Type: A 

TXR No.: NA 

M RIO No.: NA 

Registration No.: A 

Regulatory Action: A 

Case No.: A 

CAS No.: 94361-06-5 

40 C FR: NA 

FROM: Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

and 

Ver.Apr.OS 

Shanna Recore, lndustiial Hygienist ~p /1 ,,., I\ 1 1 

Toxicology and Epidemiology Branch ~'-.. 

Health Effect Division (7509P) 

David Mill er, Acting Branch Chief {2Y~ ,;(1.,)."' '-' 

Toxicology and Epidemiology Branch 

THROUGH: 

TO: 

Health Effects Division (7509P) 

Karlyn Middleton, Risk Assessor 

Risk Assessment Branch ll 

Health Effects Division (7509P) 

and 

R. Johnson, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summaiy and Conclusions 

There are no incident cases reported for diphenyla mine in JDS and SENSOR-Pesticides. There 

does not appear to be a concern at this time that would warrant further investigation. The 

Agency will continue to monitor the incident infom1ation and if a concern is triggered, additional 

analysis will be included in the risk assessment. 

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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 formul ation phase ofregistration review. Reports of 

adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are 

largely self-reported and therefore, generall y speaking, ne ither exposure to a pesticide or 

reported symptom (or the connection betv.reen the two) is validated or otherwise confinned. 

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 fmther 

investigate a pa1ticul ar 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 

DP A is a plant growth regulator used post-harvest to control storage scald on apples. This is an 

indoor food end-use chemical. It can be applied by dipping, drenching, or spraying. 1 

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease 

Control and Prevention/National Institute fur Occupational Safety and Health (CDC/N lOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient diphenylamine (pc code: 038501 ). 

The purpose of the database search is to identify potential patterns in the frequency and seve1ity 

of the health effects attributed to diphenylamine exposure. Diphenylamine is not included in the 

AHS, and therefore this study does not provide information for this report. 

Ill. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OP P's IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecti cide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since I 992, 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 anecdotal reports or al1egations only, unless otherwise stated in 

the report. 

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

1 EPA Factsheet, found online at: hllp://www.epa.gov/oppsrrd J/reregistra1ion/REDs/fac1shec1: 22 1 Ofac1.pdf 

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o Main IDS contains incidents resulting in higher severity o utcomes and provides 

more detail with regard to case specifics. This system stores incident data for 

death, major and moderate incidents, and it includes informatio n about the 

location, date and nature of the incident. Mai n 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 pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants onJ y as 

counts in what are aggregate summaries. 

There were no incidents involving diphenylamine reported to either Main or Aggregate IDS, 

from January I, 2010 to May 27, 2015. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2011 , 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, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. The 

state coordinator at each of the 12 respective state Depa11ments 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 infomrntion into the state-based system whi ch 

is sent to NIOSH annually to be aggregated. 

A review of SENSOR-Pesticides 1998-20 11 identifies 2011 identifies no incidents involving 

di phenyl amine. 

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 p1ivate 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 formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The AHS includes in formation on use of 80 different pesticide 

active ingredients commonly used in agri culture. Diphenylamine is not included in the AHS, 

and therefore this study does not provide information for this repo11. 

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IV. CONCLUSION 

There arc no incident cases reported for diphenylamine in IDS and SENSOR-Pesticides. There 

does not appear to be a concern at this time that would warrant further investigation. The 

Agency will continue to monitor the incident infonnation and if a concern is triggered, additional 

analysis will be included in the risk assessment. 

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