Document ID: EPA-HQ-OPP-2002-0329-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-12-09T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
August
2,
2002
CERTIFIED
MAIL
Dear
Registrant:

This
is
to
inform
you
that
the
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
tolerance
reassessment
decision
for
Asulam.
This
letter,
signed
on
August
2,
2002,
and
the
attached
 
Overview 
document
serve
as
EPA s
 
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Asulam. 
A
Notice
of
Availability
soliciting
public
comment
for
a
30­
day
period
will
be
published
in
the
Federal
Register
(
FR)
shortly.

FFDCA,
as
amended,
requires
EPA
to
reassess
all
the
tolerances
that
were
in
effect
for
registered
chemicals
on
or
before
the
date
of
the
enactment
of
FQPA
in
August
of
1996
against
the
new
safety
standard
adopted
in
the
FQPA.
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.
The
tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
modification
or
revocation
occurs.
A
reregistration
eligibility
decision
(
RED)
for
asulam
was
completed
in
September
1995
prior
to
FQPA
enactment.
Therefore,
it
needed
to
be
updated
to
reassess
the
tolerances
under
the
FQPA
standard.

The
Agency
has
evaluated
the
dietary
risks
associated
with
asulam
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
asulam
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
tolerances
established
for
residues
of
asulam
are
now
considered
reassessed
as
safe
under
section
408(
q)
of
the
FFDCA.
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
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
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.
EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
review
of
asulam
because
the
Agency
has
not
determined
that
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
in
common
with
asulam.
If
EPA
identifies
other
substances
that
share
a
common
mechanism,
then
a
cumulative
risk
assessment
will
be
conducted
that
includes
asulam
once
EPA s
final
framework
for
conducting
cumulative
risk
assessments
is
available.
Further,
EPA
is
in
the
process
of
developing
criteria
for
characterizing
and
testing
endocrine
disrupting
chemicals
and
plans
to
implement
an
Endocrine
Disruptor
Screening
Program.
Asulam
will
be
reevaluated
at
that
time
and
additional
studies
may
be
required.

The
Agency s
human
health
findings
for
the
pesticide
asulam
were
discussed
in
a
closure
conference
call
on
July
25,
2002,
and
are
summarized
in
the
attached,
 
Overview
of
Asulam
Risk
Assessment. 
The
risk
assessment
and
other
documents
pertaining
to
the
asulam
tolerance
reassessment
decision
are
listed
at
the
end
of
this
document
and
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
in
the
public
docket
for
viewing.

Tolerances
are
established
for
residues
of
asulam
in/
on
raw
agricultural
commodities
as
defined
in
40
CFR
180.180.360.
The
Agency
recommends
that
the
tolerance
expression
be
revised
to
include
all
metabolites
containing
the
sulfanilamide
moiety.
An
adequate
enforcement
method
is
available
for
the
determination
of
combined
residues
of
asulam
and
all
metabolites
containing
the
sulfanilamide
moiety
in/
on
sugarcane.

Additional
data
are
required
at
this
time.
The
registrant
must
submit
label
amendment
requests
for
the
use
of
asulam
on
sugarcane.
The
amendments
must
include
lower
maximum
application
rates
and
longer
PHIs,
and
must
be
region
specific,
as
given
below.
If
the
registrant
request
the
suggested
label
changes,
no
further
sugarcane
field
trial
data
are
required
for
asulam
at
this
time.
No
plantback
restrictions
are
required
on
the
label.

The
Agency
recommends
that
the
registrant
request
label
amendments
specifying
a
maximum
of
two
asulam
applications
per
year
to
sugarcane
at
a
maximum
single
application
rate
of
3.34
lbs.
a.
i./
A,
a
PHI
of
100
days
for
Louisiana,
a
PHI
of
140
days
for
the
remainder
of
the
US
mainland,
and
a
PHI
of
400
days
for
Hawaii.
If
the
registrant
does
not
propose
the
recommended
label
changes,
existing
labels
must
be
supported
by
new
field
trials.

In
addition,
the
following
product
chemistry
data
guidelines
remain
unfulfilled
for
the
technical
sodium
salt:
GLN
830.6317
(
Storage
Stability)
and
830.6320
(
Corrosion
Characteristics).
The
following
tolerances
have
been
reassessed:

 
The
registrant
proposes
for
asulam
residue
in/
on
cane
of
0.05
ppm,
resulting
from
2
applications,
each
3.34
lbs.
a.
i./
Acre,
with
a
100
day
PHI.
The
data
do
not
support
this
tolerance.
For
the
proposed
use
pattern,
the
maximum
residue,
corrected
for
loss
in
storage,
is
0.71
pp.
A
tolerance
of
1.0
ppm
is
appropriate
for
residues
of
asulam
and
the
sulfanilamide­
containing
metabolites
in/
on
sugarcane.
This
replaces
the
current
tolerance
of
0.1
ppm.

 
Based
on
the
highest
average
field
trial
residue
and
the
concentration
factor
from
processing,
a
tolerance
of
30
ppm
is
needed
for
asulam
and
sulfanilamide­
containing
metabolite
residues
in
molassess.

 
The
decrease
in
the
sugarcane
tolerance
for
asulam
and
its
sulfanilamide
containing
metabolites
from
the
reevaluated
15
ppm
to
1
ppm
does
not
alter
the
previous
conclusion
that
residues
of
asulam
and
the
sulfanilamide­
containing
metabolites
are
anticipated
in
ruminant
commodities
from
a
diet
containing
10%
molasses.
Animal
commodity
tolerances
should
be
proposed,
0.05
ppm
for
ruminant
milk
and
meat
and
fat
and
0.2
ppm
for
ruminant
meat
byproducts.
There
are
no
significant
poultry
feed
items;
poultry
commodity
tolerances
are
not
needed.

TOLERANCE
REASSESSMENT
SUMMARY
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment
Tolerances
listed
under
40
CFR
§
180.360
Sugarcane,
cane
0.1
1.0
Tolerances
to
be
Established
Under
40
CFR
§
180.360
Sugarcane,
molasses
­
30
Milk
­
0.05
Cattle,
meat
Cattle,
fat
Goat,
meat
Goat,
fat
Hog,
meat
Hog,
fat
Horse,
meat
Horse,
fat
Sheep,
meat
Sheep,
fat
­.
05
Cattle,
meat
byproducts
Goat,
meat
byproducts
Hog,
meat
byproducts
Horse,
meat
byproducts
Sheep,
meat
byproducts
­.
2
0
0
This
document
also
contains
a
generic
Data
Call­
In
(
DCI)
that
outlines
further
data
requirements
for
this
chemical.
Note
that
registrants
of
asulam
must
respond
to
DCIs
issued
by
the
Agency
within
90
days
of
receipt
of
this
letter.

If
you
have
questions
on
this
document,
please
contact
the
Chemical
Review
Manager,
Demson
Fuller
,
at
(
703)
308­
8062.

Sincerely,

Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Attachments:
List
of
Supporting
Documents
Overview
of
Asulam
Risk
Assessment
Generic
Data
Call­
In
(
DCI)
List
of
Documents
Supporting
the
Asulam
Reassessment
Decision
The
Tolerance
Reassessment
Decision
for
asulam
is
based
on
the
revised
human
health
risk
findings,
disciplinary
chapters,
and
other
supporting
documentation
as
follows:

Asulam.
HED
Human
Health
Assessment
for
the
tolerance
Reassessment
Eligibility
Decision
(
TRED).
Chemical
No.
106901/
02.
No
MRID
#.
DP
Barcode
No.
D276505.
Jose
Morales
(
February
28,
2002)

Asulam
­
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
John
Liccione
(
December
5,
2001)

Asulam
­
Report
of
the
FQPA
Safety
Factor
Committee.
Carol
Christensen
(
February
5,
2002)

Asulam.
Toxicology
Chapter
of
the
RED.
John
Liccione
(
October
12,
2001)

Asulam
(
List
A,
Case
0265,
Chemical
106901/
02).
Tolerance
Reassessment
Eligibility
Decision
Document.
Product
and
Residue
Chemistry
Chapter.
DP
Barcode
D278884.
Jose
Morales
(
December
6,
2001)

Asulam.
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reasssement
Eligibility
Decision
Document
(
TRED),
PC
Codes
106901/
02;
DP
Barcode
D279592.
Jose
Morales
(
December
18,
2001)

Asulam:
Revised
Tier
I
Drinking
Water
EECs
for
Use
in
the
Human
Health
Risk
Assessment.
Jose
Morales
(
January
3,
2002)

Quantitative
Usuage
Analysis
for
Asulam.
Alan
Halvorson
(
July
25,
2001)
Generic
Data
Call­
In
[
place
holder
­­
to
be
generated]