Document ID: EPA-HQ-OPP-2004-0334-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-10-18T04:00Z

United
States
Prevention,
Pesticides
April
7,
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
Carbon
Dioxide
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
Carbon
Dioxide,"
which
was
approved
on
April
7,
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
pesticide
chemical
residue
tolerances
or
tolerance
exemptions
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
carbon
dioxide
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.

The
Agency
has
evaluated
all
currently
registered
uses
of
carbon
dioxide
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
exposure
to
carbon
dioxide
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
exemption
at
40
CFR
180.1049
for
carbon
dioxide
when
used
after
harvest
in
modified
atmospheres
for
stored
insect
control
on
food
commodities
is
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.

Carbon
dioxide
is
used
as
a
fumigant
to
control
insects
in
enclosed
indoor
areas
where
grain
or
other
food
and
feed
crops
are
stored.
Taking
into
consideration
available
information
on
carbon
dioxide,
including
its
designation
by
the
US
Food
and
Drug
Administration
as
generally
recognized
as
safe
(
GRAS),
its
expected
use
pattern,
its
safe
history
of
use
as
a
food
additive
and
its
essential
role
in
human
metabolism
and
respiration,
there
is
a
reasonable
certainty
of
no
harm
from
exposure
to
carbon
dioxide
through
its
use
in
pesticides.
As
a
result,
the
Agency,
using
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
carbon
dioxide,
has
made
a
safety
finding
that
carbon
dioxide
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.

Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
carbon
dioxide,
nor
does
carbon
dioxide
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
EPA
has
not
assumed
that
carbon
dioxide
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

The
current
tolerance
exemption
for
carbon
dioxide
at
40
CFR
180.1049,
when
used
after
harvest
in
modified
atmospheres
for
stored
insect
control
on
food
commodities
is
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.
This
document
summarizes
the
Agency's
decision
on
the
tolerance
reassessment
for
carbon
dioxide.
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:
Lower
Risk
Pesticide
Chemical
Focus
Group's
Assessment
for
Carbon
Dioxide
Tolerance
Reassessment
(
4/
1/
2004,
OPP
Lower
Risk
Pesticide
Chemical
Focus
Group)