Document ID: EPA-HQ-OPP-2004-0317-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-20T04:00Z

1
United
States
Prevention,
Pesticides
September
9,
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
Flumetsulam
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
Flumetsulam,"
which
was
approved
on
September
16,
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
flumetsulam
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.

The
Agency
has
evaluated
all
current
registered
uses
of
flumetsulam
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
exposure
to
flumetsulam
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
180.468
for
flumetsulam
used
on
field
corn
(
forage,
stover,
and
grain)
and
soybean
are
now
considered
reassessed
under
section
408(
q)
of
the
FFDCA.
The
tolerances
for
the
four
commodities
has
been
determined
to
remain
at
0.05
ppm.

Flumetsulam
is
a
herbicide
registered
for
use
on
soybeans
and
field
corn
and
belongs
to
the
triazolopyrimidine
chemical
class.
Flumetsulam
can
be
applied
pre­
plant,
pre­
emergence,
or
postemergence
to
control
broadleaf
weeds
and
may
be
applied
alone
or
in
formulation
with
other
active
ingredients.
The
maximum
application
rate
for
flumetsulam
is
0.07
lb
a.
i/
acre
with
a
minimum
preharvest
interval
range
of
70
to
85
days.
The
highest
usage
of
flumetsulam
is
on
corn
and
approximately
12,000
pounds
are
used
annually.
An
additional
new
use
petition
for
dry
beans
has
been
submitted
to
the
Agency.
This
use
has
been
included
in
the
risk
assessment
and
is
awaiting
further
action
by
the
Registration
Division.
3
Flumetsulam
is
in
Toxicity
Category
III
or
IV
for
acute
oral,
dermal,
and
inhalation
exposure
and
for
dermal
and
ocular
irritation,
and
is
not
a
dermal
sensitizer.
There
was
no
indication
of
reproductive,
neurotoxicant,
or
carcinogenic
effects
from
flumetsulam
in
the
reviewed
studies.

There
are
no
studies
that
identify
an
acute
hazard
based
on
toxic
effects
observed
following
a
single
oral
dose.
No
effects
in
the
developmental
toxicity
studies
in
the
rabbit
or
rat
were
attributed
from
a
single
oral
exposure
during
gestation.
Therefore,
a
dose
and
endpoint
are
not
proposed
for
the
general
population
including
infants
and
children
or
females
13­
49
years
of
age.

The
chronic
feeding
study
conducted
with
dogs
supports
the
toxicity
endpoint
for
chronic
dietary
exposure.
The
No
Observed
Adverse
Effect
Level
(
NOAEL)
is
100/
500
mg/
kg/
day
and
the
Lowest
Observed
Adverse
Effect
Level
(
LOAEL)
is
500/
not
identified
mg/
kg/
day.
An
uncertainty
factor
of
100
(
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability)
was
applied
to
the
chronic
toxicity
endpoint.
The
chronic
reference
dose
for
flumetsulam
is
1.0
mg/
kg/
day.
Dietary
risk
assessments
incorporate
both
exposure
and
toxicity
of
a
given
pesticide.
For
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
a
maximum
acceptable
dose.
This
dose
is
referred
to
as
the
population­
adjusted
dose
(
PAD).
The
PAD
is
equivalent
to
the
reference
dose
divided
by
the
special
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor.
The
toxicology
database
for
flumetsulam
is
adequate
for
FQPA
considerations.
Based
on
the
hazard
data,
the
Agency
recommended
that
the
special
FQPA
Safety
Factor
be
reduced
to
1X
because
there
are
low
concerns,
and
no
residential
uncertainties
with
regard
to
pre
and/
or
post­
natal
toxicity.

A
conservative
dietary
(
food
and
water)
risk
assessment
concluded
that
for
all
supported
commodities
(
including
proposed
use
on
dry
bean),
the
chronic
dietary
exposure
estimates
are
below
the
Agency's
level
of
concern
for
all
population
subgroups
at
less
than
1%
of
the
chronic
PAD.
The
Agency
is,
therefore,
not
concerned
with
any
risk
resulting
from
exposure
to
flumetsulam.

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
as
to
flumetsulam
and
any
other
substances
and
flumetsulam
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
flumetsulam
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
4
http://
www.
epa.
gov/
pesticides/
cumulative/.

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

This
document
summarizes
the
Agency's
decision
on
the
tolerance
reassessment
for
flumetsulam.
Please
contact
Mika
J.
Hunter
of
my
staff
with
any
questions
regarding
this
decision.
She
may
be
reached
by
phone
at
(
703)
308­
0041
or
by
e­
mail
at
hunter.
mika@
epa.
gov.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
cc:
Lois
Rossi,
Registration
Divison
Enclosures:
Flumetsulam:
HED
Risk
Assessment
for
the
Tolerance
Reassessment
Eligibility
Document
(
TRED),
dated
August
31,
2004,
Flumetsulam.
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reassessment
Eligibility
Document,
dated
August
31,
2004,
Flumetsulam.
Summary
of
Analytical
Chemistry
and
Residue
Data
for
the
Tolerance
Reassessment
Eligibility
Decision,
dated
August
31,
2004,
Drinking
Water
Assessment
for
Flumetsulam
for
Uses
on
Field
Corn
and
Soybeans,
dated
May
19,
2004.
5