Document ID: EPA-HQ-OPP-2004-0142-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-10-18T04:00Z

1
United
States
Prevention,
Pesticides
August
31,
2004
Environmental
Protection
and
Toxic
Substances
Agency
(
7508C)

Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Trifluralin
2
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
CERTIFIED
MAIL
Dear
Registrant:

This
is
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
EPA
or
the
Agency)
"
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
for
Trifluralin,"
which
was
approved
on
August
31,
2004.
This
document
is
also
known
as
a
Tolerance
Reassessment
Decision,
or
TRED.
A
Notice
of
Availability
of
this
tolerance
reassessment
decision
will
be
published
shortly.
Additionally,
the
Agency
will
be
proposing
to
establish
a
tolerance
for
trifluralin
in
mint
oil.

The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
EPA
to
reassess
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
enactment
of
the
FQPA
on
August
3,
1996.
In
reassessing
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.
Once
a
safety
finding
has
been
made,
the
tolerances
are
considered
reassessed.
Existing
tolerances
and
exemptions
associated
with
trifluralin
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.

The
Agency
has
completed
the
human
health
risk
assessment
for
trifluralin
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
exposure
to
trifluralin
when
considering
dietary
exposure
and
all
other
non­
occupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.
Therefore,
no
mitigation
measures
are
needed,
and
the
current
tolerances
at
40
CFR
180.207
for
residues
of
trifluralin
are
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.
Accordingly,
the
Agency
will
be
proposing
to
establish
a
permanent
tolerance
at
2.0
ppm
for
mint
oil.

Trifluralin
is
used
as
a
pre­
emergence
herbicide
to
control
annual
grasses
and
broadleaf
weeds
on
a
variety
of
food
crops
as
well
as
for
non­
food
uses,
including
residential
use
sites.
Taking
into
consideration
available
information
on
trifluralin
and
its
expected
use
pattern,
there
is
reasonable
certainty
of
no
harm
from
exposure
to
trifluralin
through
its
use
in
pesticides.
Available
data
show
that
residues
of
trifluralin
in
foods
prepared
with
mint
oil
will
not
exceed
the
existing
raw
agricultural
commodity
tolerance.
As
a
result,
the
Agency,
using
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
trifluralin,
has
made
a
safety
finding
that
trifluralin
is
safe
as
currently
used
in
pesticide
products.
3
FQPA
requires
that
EPA
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
Agency
considers
other
substances
because
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect,
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.

The
Agency
has
not
yet
determined
whether
the
chemical
class
which
includes
trifluralin
exhibits
a
common
mechanism
of
toxicity.
Therefore,
the
Agency
defers
any
cumulative
risk
assessment
to
a
later
date.
For
the
purposes
of
tolerance
reassessment
of
trifluralin,
EPA
is
assuming
no
common
mechanism
with
other
compounds.
Therefore,
a
cumulative
assessment
was
not
conducted
for
this
TRED.

Based
on
currently
available
data,
trifluralin
does
not
appear
to
be
an
endocrine
disruptor.
However,
when
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
Program
have
been
developed,
trifluralin
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

Trifluralin
is
classified
as
a
skin
sensitizer.
However,
EPA
has
no
method
of
quantifying
risk
due
to
skin
sensitization
and
remains
concerned
about
dermal
sensitization
reactions
to
adults
and
children
who
are
exposed
to
trifluralin
in
residential
settings.
Therefore,
it
is
recommended
that
all
products
containing
trifluralin
be
labeled
as
"
SENSITIZER"
and
state
that
"
skin
contact
should
be
avoided".

Currently,
there
is
no
tolerance
for
trifluralin
in
or
on
raw
agricultural
commodities
for
mint
oil.
Therefore,
a
permanent
tolerance
of
2.0
ppm
for
mint
oil
will
be
proposed
for
trifluralin
at
40
CFR
180.207
and
is
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.

This
document
summarizes
the
Agency's
decision
on
the
tolerance
reassessment
for
trifluralin
and
the
establishment
of
a
permanent
tolerance
for
mint
oil.
Please
contact
John
W.
Pates,
Jr.
of
my
staff
with
any
questions
regarding
this
decision.
He
may
be
reached
by
phone
at
(
703­
308­
8195)
or
via
e­
mail
at
Pates.
john@
epa.
gov.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Enclosures:
Trifluralin
Risk
Assessment
Overview