Document ID: EPA-HQ-OPP-2003-0294-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-19T05:00Z

United
States
Prevention,
Pesticides
September
24,
2003
Environmental
Protection
and
Toxic
Substances
Agency
(
7508C)

Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Lactofen
1
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
Lactofen,"
which
was
approved
on
September
24,
2003.
This
document
is
also
known
as
a
Tolerance
Reassessment
Decision,
or
TRED.
A
Notice
of
Availability
of
this
tolerance
reassessment
decision
and
an
announcement
of
a
30­
day
public
comment
period
will
be
published
in
the
Federal
Register
shortly.

Regulatory
Determination
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
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
Existing
tolerances
associated
with
lactofen
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.
Ecological
and
occupational
assessments
were
originally
conducted
when
lactofen
was
first
registered.
Therefore,
no
further
ecological
or
occupational
assessments
are
being
conducted
as
part
of
this
TRED.

The
Agency
has
evaluated
the
dietary
risk
associated
with
all
currently
registered
uses
of
lactofen
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
lactofen
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
two
(
2)
tolerances
established
for
residues
of
lactofen
in/
on
raw
agricultural
commodities
are
now
considered
reassessed
as
safe
under
section
408(
q)
of
the
FFDCA.

As
part
of
the
TRED,
the
Agency
also
considered
petitions
for
establishment
of
new
food
uses
and
associated
tolerances
of
lactofen
on
cotton
and
peanuts.
To
evaluate
the
tolerance
petition
and
determine
if
new
tolerances
should
be
established,
EPA
considered
all
of
the
criteria
described
above
to
2
ensure
that
the
FQPA
safety
standard
was
met.
For
the
proposed
new
food
uses
of
lactofen
on
cotton
and
peanuts,
the
Agency
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
lactofen.
However,
because
the
TRED
pertains
only
to
the
existing
tolerances,
the
establishment
of
the
new
food
uses
and
associated
tolerances
is
outside
the
scope
of
this
TRED
and
will
be
determined
by
a
separate
decision.

The
Agency's
human
health
findings
for
the
pesticide
lactofen
are
summarized
in
the
enclosed
chemical
overview
of
the
risk
assessments.
For
further
details,
please
refer
to
the
enclosed
list
of
risk
assessments
and
other
technical
documents
pertaining
to
the
lactofen
TRED,
which
are
available
on
the
Internet
at
http://
www.
epa.
gov/
e­
dockets
and
in
the
public
docket
for
viewing.

FQPA
Assessment
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.

Lactofen
belongs
to
the
diphenyl
ether
class
of
chemicals.
The
Agency
has
not
yet
determined
whether
lactofen
and
the
other
diphenyl
ether
herbicides
exhibit
a
common
mechanism
of
toxicity.
Therefore,
the
Agency
defers
any
cumulative
risk
assessment
to
a
later
date.
For
the
purposes
of
tolerance
reassessment
for
lactofen,
EPA
is
assuming
no
common
mechanism
with
other
compounds.
Therefore,
a
cumulative
assessment
was
not
conducted
for
this
TRED.
However,
because
lactofen
is
expected
to
degrade
to
acifluorfen
in
the
environment,
EPA
did
consider
the
contribution
of
acifluorfen
from
use
of
sodium
acifluorfen
as
an
herbicide
and
as
an
environmental
degradate
of
lactofen
in
the
aggregate
assessment.

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

Tolerance
Summary
Tolerances
for
lactofen
in
or
on
raw
agricultural
commodities
for
plants
are
currently
established
for
the
combined
residues
of
lactofen
and
its
associated
metabolites
containing
the
diphenyl
ether
linkage,
but
will
be
revised
to
include
only
lactofen
per
se.
The
two
existing
tolerances
for
lactofen
have
been
reassessed
and
will
be
lowered
from
0.05
ppm
to
0.01
ppm.
There
are
currently
no
tolerances
for
lactofen
in
processed
commodities
or
animal
commodities,
and
the
available
residue
data
indicate
that
tolerances
for
these
commodities
are
not
necessary.
No
maximum
residue
limits
(
MRLs)
for
lactofen
have
been
established
or
proposed
by
Codex.
Therefore,
there
are
no
international
compatibility
issues
with
respect
to
U.
S.
tolerances.
A
summary
of
the
lactofen
tolerance
reassessment
and
recommended
modifications
in
commodity
definitions
are
presented
in
Table
1.
3
Table
1.
Tolerance
Reassessment
Summary
for
Lactofen.

Commodity
Established
Tolerance
(
ppm)
a
Reassessed
Tolerance
(
ppm)
b
Comment
[
Correct
Commodity
Definition]

Tolerances
listed
under
40
CFR
§
180.432(
a):

Beans,
snap
0.05
0.01
Beans,
snap,
succulent
(
excluding
Limas)

Soybean
0.05
0.01
Soybean,
seed
a
Expressed
in
terms
of
lactofen
and
its
metabolites
containing
the
diphenyl
ether
linkage
b
Expressed
in
terms
of
lactofen
per
se
As
previously
mentioned,
the
Agency
has
considered
petitions
for
new
food
uses
on
cotton
and
peanuts
in
the
TRED,
but
the
decision
to
establish
new
tolerances
will
be
made
separately
by
the
Agency.
The
residue
chemistry
data
for
cotton
and
peanuts
has
been
reviewed
and
included
in
the
dietary
risk
assessment
for
this
TRED.

Uses
Subject
to
TRED
and
Label
Amendments
The
food
and
feed
uses
and
associated
use
patterns
subject
to
this
TRED
are
listed
in
Table
2.
The
lactofen
labels
must
conform
with
the
use
patterns
and
use
limitations
listed
in
Table
2,
which
follows.
Table
2
does
not
include
the
forestry
use,
as
this
use
is
not
expected
to
impact
the
dietary
exposure
of
any
population
subgroup
and,
therefore,
is
not
included
in
this
assessment.

Additional
Generic
Data
Requirements
As
mentioned
in
the
attached
Overview
of
Lactofen
FQPA
Risk
Assessment
for
Tolerance
Reassessment,
several
confirmatory
data
requirements
have
been
identified
for
lactofen.
These
are
listed
in
Table
3
and
will
be
included
in
a
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
section
3(
c)(
2)(
B)
data
call
in
(
DCI)
to
be
sent
under
separate
cover.
These
data
are
not
expected
to
change
the
regulatory
conclusions
for
lactofen
described
in
this
document.
4
This
document
summarizes
the
Agency's
decision
on
the
tolerance
reassessment
for
lactofen.
Please
contact
Christina
Scheltema
of
my
staff
with
any
questions
regarding
this
decision.
She
may
be
reached
by
phone
at
(
703)
308­
2201
or
by
e­
mail
at
scheltema.
christina@
epa.
gov.

Sincerely,

Betty
Shackleford,
Acting
Director
Special
Review
and
Reregistration
Division
Enclosures:
Technical
Support
Documents
for
the
Lactofen
TRED
Overview
of
Lactofen
FQPA
Risk
Assessment
for
Tolerance
Reassessment
5
Table
2.
Food/
Feed
Use
Patterns
Subject
to
Tolerance
Reassessment
for
Lactofen
(
PC
Code
128888).

Application
Timing
Application
Type
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Max.
Single
Application
Rate
(
lb
ai/
A)
Max.
#

Apps./
season
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
Cotton
(
Non­
Food
Use)

Postemergence
directed
ground
applications
to
plants
at
least
6
inches
in
height
Ground
equipment
2
lb/
gal
EC
[
59639­
34]
0.4
2
None
A
70­
day
PHI
is
specified.

A
12­
hour
REI
is
specified.

Applications
may
include
crop
oil
concentrate
at
up
to
2
pt/
A
or
a
non­
ionic
surfactant
at
2
pt/
100
gal
of
spray
solution.

For
banded
applications,
the
application
rate
and
broadcast
volume
should
be
reduced
in
proportion
to
the
area
treated.

Do
not
apply
through
any
type
of
irrigation
system.

Do
not
graze
animals
on
forage
or
stubble
or
utilize
hay
or
straw
for
animal
feed
or
bedding.

Soybeans
Broadcast
and
banded,
pre­
and
postemergence
applications
Ground
or
aerial
equipment
2
lb/
gal
EC
[
59639­
34]
0.3
­
preemergence
0.2
­
postemergence
2
None
A
12­
hour
REI
is
specified.

Do
not
apply
within
45
days
of
harvest
or
after
growth
stage
R6
(
full
seed);
90­
day
PHI
is
specified
in
NY.

Do
not
graze
animals
on
forage
or
stubble
or
utilize
hay
or
straw
for
animal
feed
or
bedding.

Do
not
apply
more
than
0.3
lb
ai/
A
preemergence
per
season
and
more
than
a
total
of
0.4
lb
ai/
A/
season
(
0.2
lb
ai/
A/
season
in
NY)

Do
not
apply
through
any
type
of
irrigation
system.

Minimum
application
volumes
of
5
and
10
gal/
A
are
specified
for
aerial
and
ground
applications,
respectively.

For
banded
applications,
the
application
rate
and
broadcast
volume
should
be
reduced
in
proportion
to
the
area
treated.

Applications
may
include
0.125­
2%
(
v/
v)
of
a
crop
oil
concentrate
or
0.25%
of
a
non­
ionic
surfactant.
Application
Timing
Application
Type
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Max.
Single
Application
Rate
(
lb
ai/
A)
Max.
#

Apps./
season
Minimum
Retreatment
Interval
(
Days)
Use
Limitations
6
Soybeans
(
continued)

Postemergence
broadcast
or
banded
applications
Ground
equipment
2.4
lb/
gal
EC
[
59639­
92]
0.13
2
None
A
60­
day
PHI
is
specified.

Do
not
graze
animals
on
forage
or
stubble
or
utilize
hay
or
straw
for
animal
feed
or
bedding.

A
minimum
application
volume
of
15
gal/
A
is
specified.

Applications
may
include
1­
2
pts./
A
of
crop
oil
concentrate
or
methylated
seed
oil.

Do
not
apply
by
air.

Do
not
rotate
to
crops
other
than
soybeans
or
field
corn
within
30
days
of
the
last
application.
Do
not
rotate
to
small
grains
for
at
least
120
days
after
the
last
application.

Snap
beans
(
in
OR
and
TN
only)

Preemergence
broadcast
application
within
48
hours
of
planting.

Ground
equipment
2
lb/
gal
EC
[
59639­
34]
0.22
­
OR
0.25
­
TN
1
Not
Applicable
Restricted
to
use
in
OR
and
TN.

A
55­
day
PHI
is
specified.

Apply
no
later
than
48
hours
after
planting.

Do
not
apply
to
soils
with
high
sand
contents
(
sandy
loams,
loamy
sands,
and
gravelly
sandy
loams)
7
Table
3.
Confirmatory
Data
Requirements
for
Lactofen
OPPTS
Guideline
Number
Guideline
Name
Compound(
s)
Which
Must
be
Tested
Comment/
Rationale
870.3700
Prenatal
developmental
toxicity
study
in
rabbits
Technical
Data
gap
860.1850
Confined
Rotational
Crop
Study
Pure
active
ingredient
radiolabeled
Required
because
confined
rotational
crop
study
in
root
crops
indicated
minimal
uptake
of
radioactivity
in
carrots
and
radishes
planted
after
lactofen
application.

830.7050
UV/
Visible
Absorption
Technical
(
76%
ai)
EPA
Reg.
No.
59639­
94
Formulation
Intermediate
(
60%
ai)
EPA
Reg.
No.
59639­
70
New
Guideline
Requirement
8
Technical
Support
Documents
for
the
Lactofen
TRED
1.
Michael
Metzger
(
USEPA/
OPPTS/
OPP/
HED).
Lactofen.
Revisions
to
HED
Tolerance
Reassessment
Risk
Assessment.
August
12,
2003.

2.
Christine
Olinger
(
USEPA/
OPPTS/
OPP/
HED).
Lactofen:
Preliminary
Human
Health
Risk
Assessment
for
Tolerance
Reassessment
Incorporating
Revised
Cancer
Unit
Risks.
October
12,
2000.

3.
Robert
Fricke
(
USEPA/
OPPTS/
OPP/
HED).
Lactofen:
Report
of
the
Mechanism
of
Toxicity
Assessment
Review
Committee.
March
12,
2001.

4.
(
USEPA/
OPPTS/
OPP/
HED).
Cancer
Assessment
Document:
Evaluation
of
Carcinogenic
Potential
of
Lactofen
(
Second
Review).
Cancer
Assessment
Review
Committee.
May
21,
2002.

5.
James
Wolf
(
USEPA/
OPPTS/
OPP/
EFED).
Drinking
Water
Exposure
Assessment
for
Lactofen
Updated
for
Prospective
Ground
Water
(
PGW)
Monitoring
Study.
January
21,
2003.

6.
James
Wolf
(
USEPA/
OPPTS/
OPP/
EFED).
EFED
Review
of
Lactofen
Small
Scale
Prospective
Ground
Water
Monitoring
Study
166­
1.
February
26,
2003.

7.
Kit
Farwell
(
USEPA/
OPPTS/
OPP/
HED).
Sodium
Acifluorfen.
Revision
to
the
HED
Chapter
for
the
Reregistration
Eligibility
Document.
July
14,
2003.

8.
Elizabeth
Mendez
(
USEPA/
OPPTS/
OPP/
HED).
Lactofen:
Toxicology
Evaluation.
March
2,
2000.

9.
Brenda
Tarplee
(
USEPA/
OPPTS/
OPP/
EFED).
Lactofen
­
Report
of
the
FQPA
Safety
Factor
Committee.
March
25,
2000
10.
George
Keitt.
(
USEPA/
OPPTS/
OPP/
BEAD).
RED
Use
Profile
Report
for
Lactofen.
April
7,
1998.