Document ID: EPA-HQ-OPP-2004-0335-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-10-18T04:00Z

United
States
Prevention,
Pesticides
July
19,
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
D­
Limonene
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
d­
Limonene,"
which
was
approved
on
July
19,
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.

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
d­
limonene
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.

The
Agency
has
evaluated
all
current
registered
uses
of
d­
limonene
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
exposure
to
dlimonene
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
tolerance
exemptions
at
40
CFR
180.539,
180.910
and
180.930
are
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.

d­
Limonene
occurs
naturally
in
citrus
fruits,
vegetables,
meats
and
spices.
It
is
used
as
both
an
active
and
inert
ingredient
in
various
pesticide
products.
As
an
active
ingredient,
it
is
used
as
an
insecticide,
insect
repellent,
and
animal
(
dog
and
cat)
repellent.
As
a
pesticide
inert
ingredient
is
used
as
a
solvent
or
fragrance.
It
is
also
found
in
consumer
products
such
as
certain
foods,
soaps,
and
perfumes.
FDA
considers
dlimonene
to
be
GRAS
as
a
food
additive
when
used
as
a
synthetic
flavoring
substance
and
adjuvant
(
21CFR
182.60).
As
a
result,
the
Agency
has
made
a
safety
finding
that
d­
limonene
is
safe
as
currently
used
in
pesticide
products.

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
d­
limonene
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
d­
limonene,
EPA
is
assuming
no
common
mechanism
with
other
compounds.
Therefore,
a
cumulative
assessment
was
not
conducted
for
this
TRED.

Based
on
currently
available
data,
d­
limonene
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,
d­
limonene
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

The
current
tolerance
exemptions
for
d­
limonene
at
40
CFR
180.539,
180.910
and
180.930,
are
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.
This
document
summarizes
the
Agency's
decision
on
the
tolerance
reassessment
for
d­
limonene.
Please
contact
Mark
Perry
of
my
staff
with
any
questions
regarding
this
decision.
He
may
be
reached
by
phone
at
(
703)
308­
8024
or
by
e­
mail
at
perry.
mark@
epa.
gov.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Enclosures:
FQPA
Risk
Assessment
for
Tolerance
Reassessment
of
d­
Limonene
(
7/
15/
2004,
OPP
Lower
Toxicity
Pesticide
Chemical
Focus
Group)