Document ID: EPA-HQ-OPP-2002-0180-0020
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-12-09T05:00Z

1
United
States
Prevention,
Pesticides
November
2002
Environmental
Protection
and
Toxic
Substances
EPA
738­
F­
02­
015
Agency
(
7508C)

Chlorpropham
TRED
Facts
EPA
has
assessed
the
risks
of
chlorpropham
and
completed
a
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
known
as
a
TRED)
for
this
pesticide.
Provided
that
risk
mitigation
measures
are
adopted,
as
outlined
in
the
TRED,
individual
and
aggregated
risks
are
within
acceptable
levels.

The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
EPA
to
review
all
the
tolerances
(
legal
limits
for
residues
in
food)
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
the
FQPA.
In
reviewing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
The
tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
EPA
completed
a
chlorpropham
reregistration
eligibility
decision
(
RED)
prior
to
FQPA
of
1996
enactment;
therefore,
tolerances
needed
to
be
reassessed
to
meet
the
FQPA
standard.

The
Agency
has
evaluated
the
dietary
(
food
and
drinking
water)
risk
associated
with
chlorpropham
and
has
determined
that
provided
the
Special
Local
Need
registration
(
SLN)
for
Easter
lily
bulb
use
is
amended
to
reduce
the
maximum
rate
of
application
as
agreed
upon
by
stakeholders,
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
chlorpropham
when
considering
dietary
exposure
and
all
non­
occupational
sources
of
pesticide
exposure.
Therefore,
with
the
implementation
of
this
mitigation
measure,
fifteen
(
15)
tolerances
established
for
residues
of
chlorpropham
in/
on
raw
agricultural
commodities
are
now
considered
reassessed
as
safe
under
section
408(
q)
of
the
FFDCA.

Uses
°
Chlorpropham
is
a
herbicide
primarily
registered
for
use
on
post­
harvest
potatoes
for
sprout
control.
There
are
four
SLN
registrations
for
use
of
Easter
lilies
(
on
approximately
150
acres
annually
in
Oregon
and
California);
gingko
trees
in
the
District
of
Columbia;
and
post­
harvest
potatoes
stored
in
high
humidity
conditions
in
the
state
of
Maine,
which
requires
a
higher
application
rate.

°
Approximately
445,600
pounds
of
chlorpropham
active
ingredient
(
a.
i.)
are
used
annually.
2
Health
Effects
°
Parent
chlorpropham
has
been
classified
by
the
Agency
as
a
"
Group
E"
human
carcinogen
(
no
evidence
of
carcinogenicity).
However,
some
chlorpropham
is
metabolized
to
3­
chloroaniline
(
3­
CA)
on
potatoes
and
some
anilines
are
known
carcinogens.
The
Agency
does
not
have
data
on
3­
CA
necessary
to
conduct
a
carcinogenicity
assessment,
but
does
have
data
for
4­
chloroaniline
(
4­
CA),
which
is
structurally
similar,
but
not
expected
to
be
formed
in
the
breakdown
of
chlorpropham
in
potatoes.
The
cancer
potency
factor
(
or
Q
1*)
for
4­
CA
was
used
as
a
surrogate
to
assess
the
potential
cancer
risk
from
3­
CA
and
is
expected
to
overestimate
potential
cancer
risk.

°
There
is
no
evidence
of
endocrine
disruption
from
exposure
to
chlorpropham.

Dietary
(
Food
and
Drinking
Water)
Risks
°
Acute
and
chronic
(
non­
cancer
and
cancer)
dietary
exposures
from
eating
food
crops
treated
with
chlorpropham
are
not
of
concern
for
the
entire
U.
S.
population
and
all
subgroups
that
were
assessed.

°
Acute
and
chronic
(
non­
cancer)
exposure
through
surface
and
ground
water
sources
of
drinking
water
is
negligible,
and
not
of
concern
to
the
Agency.
However,
there
are
risks
of
concern
from
chronic
(
cancer)
exposure
to
chlorpropham
from
ground
water
sources
of
drinking
water
from
the
limited
Easter
lily
bulb
use.
These
risks
are
addressed
through
the
mitigation
measures
described
below.

Occupational
and
Ecological
Risks
°
Occupational
and
ecological
risk
have
not
been
assessed.
Occupational
and
ecological
risk
management
decisions
were
made
as
part
of
the
1996
chlorpropham
registration
eligibility
decision
(
RED).
No
new
data
has
been
received
to
warrant
reconsideration
of
these
risks.

Risk
Mitigation/
Label
Amendments
In
completing
this
TRED,
the
Agency
has
identified
certain
label
amendments
which
need
to
be
implemented
to
mitigate
risks
of
concern
and
ensure
consistency
among
the
labels.

°
To
mitigate
chronic
(
cancer)
food
and
drinking
water
risks
of
concern
from
Easter
lily
bulb
use,
product
labels
need
to
be
amended
to
reduce
the
maximum
application
rate
from
3.99
lb
a.
i.
per
acre
to
2.0
lb
a.
i.
per
acre.

°
For
aerosol
ready­
to­
use
(
RTU)
products
used
on
stored
potatoes,
the
labels
which
specify
a
maximum
application
rate
of
165%
of
the
typical
rate
(
0.017
lbs
a.
i.
per
1000
lbs
of
potatoes),
need
to
clearly
state
a
total
seasonal
rate
of
0.028
lb
a.
i.
per
1000
pounds
of
potatoes.
For
the
same
product
labels
which
specify
a
maximum
application
rate
of
145%
of
the
typical
rate,
3
product
labels
need
to
clearly
state
a
total
seasonal
rate
that
does
not
exceed
0.025
lbs
a.
i.
per
1000
pounds
of
potatoes.

°
For
Emulsifiable
Concentrate
(
EC)
products,
a
maximum
seasonal
rate
of
0.0104
lb
a.
i.
per
1000
pounds
of
potatoes
needs
to
be
specified.

°
For
entry
into
enclosed
treatment
/
storage
areas
after
application
of
products
heated
above
250
°
F,
handlers
must
wear
a
respirator
with
either
an
organic­
vapor
removing
cartridge
with
a
prefilter
approved
for
pesticides,
or
a
canister
approved
for
pesticides.

Tolerance
Reassessment
Decisions
A
total
of
fifteen
(
15)
tolerances
for
chlorpropham
have
been
reassessed.
Thirteen
(
13)
tolerances
are
to
raised,
one
(
1)
tolerance
is
to
be
lowered,
and
one
(
1)
tolerance
is
to
be
revoked.
In
addition,
nine
(
9)
new
tolerances
are
to
be
established
for
residues
in/
on
raw
agricultural
commodities
under
section
408(
q)
of
the
FFDCA.

Availably
of
Supporting
Documents
A
Notice
of
Availability
of
the
chlorpropham
TRED
and
other
supporting
documents,
including
the
risk
assessments
and
response
to
comments,
has
bee
published
in
the
Federal
Register
on
September
18,
2002
(
67
FR
58795).
A
copy
of
the
TRED
and
all
supporting
documents
will
also
be
available
on
the
Agency's
website
at:
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP­
2002­
0180,
an
electronic
version
of
which
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Additionally,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
OPP
docket
facility.
Once
in
the
system,
select
"
search,"
then
key
in
the
appropriate
docket
ID
number.