Document ID: EPA-HQ-OPP-2013-0749-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-03-28T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

                                                  

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

Date:   November 122013

SUBJECT:	Aminopyralid: Tier I Review of Human Incidents

PC Code: 005100, 005219,B)05209

Decision No.:482282

Petition No.: NA

Risk Assessment Type: NA

TXRNo.:NA MRIDNo.: NA

DP Barcode: 04 1 5939

Registration No.:NA Regulatory Action: NA Case No.: NA

CAS No.: 1501 1 4-71 -9, 566191-87-5

40 CFR: NA

Ver.Apr.08

FROM:

                                    

Shanna Recore, Industrial  Hygienist 	!D, "

Toxicology  and Epidemiology Branch

Health Effect Division (7509P)

and

JJ.  n	0,."" nl?

Elizabeth  Evans, Environmental Protection Specialist

Toxicology  and Epidemiology Branch

Health Effects Division (7509P) 	/)

THROUGH:  David Miller, Acting Branch Chie Toxicology  and Epidemiology
Branch Health Effects Division (7509P)

11

/ O/IJ

TO:	Douglas Dotson, Risk Assessor Risk Assessment Branch II Health
Effects Division (7509P)

and

Katie Weyrauch, Chemical  Review Manager

Risk Management  & Implementation Branch 5

Pesticide Re-evaluation Division (7508P) Sum   mary and Conclusions

Based on the low frequency  and severity of incident -cases reported for
aminopyralid, 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.

                                     

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 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

Aminopyralid is a new pyridine carboxylic acid herbicide intended for
use in rangeland, permanent grass pastures, non-cropland  areas
(rights-of-way, roadsides and non-irrigation ditch banks), natural areas
(wildlife management areas, natural recreation areas, campgrounds,
trailheads, and trails), and grazed areas in and around these sites, as
well as wheat. Aminopyralid provides systemic postemergence 
broad-spectrum  control of a number of key noxious and inyasive annual,
biennial and perennial weed species, as well as agronomic broadleaf
weeds. Aminopyralid can also provide residual weed control activity
controlling re-infestations and

reducing the need for re-treatment depending on the rate applied and the
target weeds. 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
Aminopyralid (PC codes: 005100,

00519, 005209).  The purpose of the database search is to identify
potential patterns in the frequency and severity of the health effects
attributed to Aminopyralid exposure.  Aminopyralid 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
Aminopyralid  Factsheet, found online at:

 htt p://www.epa. gov/oppOOOO 1 /chem  search/reg  act i ons/reg istrati
on!fs  PC-005 l 00  1 0-Aug-05.pd f

                                        

submitted  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 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 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 only as

counts in what are aggregate summaries.

For the Main IDS, from January 1, 2008 to September  11,2013, there were
3 incidents reported for single chemical only in the database.  There
were 11 additional incidents reported involving more than one chemical?
There was one fatality that was determined  to be not due to pesticides.
3

The other incidents reported were classified as moderate severity. 
Overall, there are few incidents in volving aminopyralid  reported to
IDS.

In Aggregate IDS, from January 1, 2008 to September 11, 2013, there were
35 reported incidents involving aminopyralid.

b.  SENSOR-Pesticides

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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 11 respective state
Departments of Health conducts case follow

                                                     2 There was a lso
one incident that occurred  in Brazil.   Foreign incidents are not
reviewed  in detail because of the potential differences  in the
exposure  patterns, use practices, and product  formulation.

3 An adult male was alone while applying Milestone from an all terrain
vehicle (ATV).  While attempting a turn on a hill, the ATV rolled on top
of him and pinned him . The Sheriff -Coroner Postmortem  Examination 
stated the cause of death to be Mechanical  Asphyxia and pesticides were
not involved.

A query of SENSOR-Pesticides 1998-2009 finds two cases involving
aminopyralid. Both cases involved multiple active ingredients.  Both
cases were low in severity.

One case is described as follows:  A 54 year old male walked from his
car to his home, he smelled pesticide and saw his neighbor spraying
herbicide with a tractor and boom approximately  400 feet away.  As an
asthmatic  he was concerned for himself and family. WSDA was contacted
and provided pesticide information on what was sprayed, but did not
investigate as resident  wanted to communicate with applicator. Resident
developed  upper respiratory irritation, but did not seek medical care.

The second case is described as "Exposed while mixing and helping to
apply herbicides, unknown how exposed."  This case reported dermal,
respiratory, nervous system and gastrointestinal  symptoms  but was low
in severity.

c.   Agricultural Health Study (AHS)

The AHS is a high quality, prospective epidemiology  study evaluating
the li nk 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

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 assessment  phase of the
process. The AHS includes information on use of 50 different pesticide
active ingredients commonly  used in agriculture.  Aminopyralid  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
aminopyralid  in both 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 information and if a
concern is triggered, additional  anal ysis will be included in the risk
assessment.