Document ID: EPA-HQ-OPP-2005-0231-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-09T04:00Z

United
States
Prevention,
Pesticides
OPP­
2005­
0231
Environmental
Protection
And
Toxic
Substances
July
27,
2006
Agency
(
7508P)

_________________________________________________________________

Reregistration
Eligibility
Decision
for
Metaldehyde
List
A
Case
No.
0576
Page
2
of
53
Reregistration
Eligibility
Decision
(
RED)
Document
For
Metaldehyde
Approved
by:
/
s/
.
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
July
27,
2006__
.
Page
3
of
53
TABLE
OF
CONTENTS
Metaldehyde
Reregistration
Eligibility
Decision
Team...............................................
5
Glossary
of
Terms
and
Abbreviations..........................................................................
6
I.
Introduction
.........................................................................................................
8
II.
Chemical
Overview............................................................................................
10
III.
Summary
of
the
Metaldehyde
Science
Assessments
.........................................
11
A.
Human
Health
Risk
Assessment
.....................................................................
12
1.
Acute
Toxicity
..............................................................................................
12
2.
FQPA
Safety
Factor.....................................................................................
12
3.
Endpoint
Selection
.......................................................................................
13
4.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water.....................
15
a)
Drinking
Water
Concentrations..............................................................
15
b)
Food
+
Water
Exposures
.........................................................................
15
c)
Acute
Dietary
(
Food
and
Drinking
Water)
Risk
....................................
15
d)
Chronic
Dietary
(
Food
and
Drinking
Water)
Risk.................................
16
5.
Residential
Exposure
and
Risk....................................................................
16
a)
Residential
Handlers................................................................................
16
b)
Residential
Post­
Application
Exposure
and
Risk
...................................
17
6.
Aggregate
Exposure
and
Risk.....................................................................
18
a)
Acute
Aggregate
Risk
..............................................................................
18
b)
Short­
Term
Aggregate
Risk
....................................................................
18
c)
Chronic
Aggregate
Risk
..........................................................................
18
7.
Cumulative
Risk
..........................................................................................
19
8.
Risk
to
Domestic
Animals
from
Ingestion
of
Metaldehyde
Granules
in
Residential
Settings
.............................................................................................
19
9.
Occupational
Risk
Assessment....................................................................
20
a)
Handler
exposures
...................................................................................
20
b)
Handler
risks............................................................................................
21
c)
Occupational
post­
application
risks
........................................................
21
B.
Environmental
Risk
Assessment
.....................................................................
21
1.
Environmental
Fate
and
Transport
............................................................
21
2.
Ecological
Risk.............................................................................................
21
a)
Risk
to
Aquatic
Organisms......................................................................
22
(
1)
Toxicity
to
Fish
and
Aquatic
Invertebrates.....................................
22
(
2)
Exposures
of
Aquatic
Organisms
to
Metaldehyde..........................
23
(
3)
Fish
and
Aquatic
Invertebrate
Risk
Estimates
...............................
24
(
4)
Risks
to
Aquatic
Plants
....................................................................
24
b)
Terrestrial
Risk........................................................................................
24
(
1)
Toxicity
to
Terrestrial
Wildlife........................................................
24
(
2)
Other
Terrestrial
Wildlife................................................................
25
(
3)
Terrestrial
Plants
.............................................................................
25
(
4)
Potential
Exposures
for
Terrestrial
Wildlife...................................
26
(
5)
Terrestrial
Risk
Estimates
...............................................................
27
c)
Endangered
Species
.................................................................................
28
Page
4
of
53
C.
Alternatives
Assessment
and
Related
Information
........................................
29
IV.
Reregistration
Decision......................................................................................
31
A.
Risks
of
Concern
and
Risk
Mitigation............................................................
31
1.
Dietary..........................................................................................................
31
2.
Residential....................................................................................................
31
3.
Aggregate
.....................................................................................................
31
4.
Occupational
................................................................................................
31
5.
General
Concerns
........................................................................................
32
6.
Domestic
Animals
........................................................................................
32
7.
Environmental
.............................................................................................
35
8.
Other
Measures
Addressing
Both
Domestic
Animal
and
Ecological
Risks36
B.
Tolerance
Considerations................................................................................
37
C.
Eligibility
Decision...........................................................................................
38
V.
What
Registrants
Need
to
Do
............................................................................
38
A.
Submissions
for
Technical­
Grade
Active
Ingredient
Products......................
38
1.
Within
90
Days
of
Receipt
of
the
Generic
DCI...............................................
38
2.
Within
Other
Generic
DCI
Deadlines.........................................................
38
B.
Submissions
for
End­
Use
Products
Containing
Metaldehyde
.......................
39
1.
Within
90
Days.............................................................................................
39
2.
Within
Product
DCI
Deadlines
...................................................................
39
C.
Manufacturing­
Use
Products 
Data
Requirements
......................................
40
D.
Labeling
...........................................................................................................
41
Page
5
of
53
Metaldehyde
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs:

Biological
and
Economic
Analysis
Division
Donald
Atwood
Biological
Analysis
Branch
Alan
Halvorson
Economic
Analysis
Branch
Environmental
Fate
and
Effects
Risk
Assessment
Colleen
Flaherty,
Pamela
Hurley,
Environmental
Risk
Branch
3
Lucy
Shanaman
Health
Effects
Risk
Assessment
Jeff
Dawson,
Felecia
Fort,
Reregistration
Branch
1
Matt
Lloyd,
Linda
Taylor
Jerry
Blondell
Retired
Registration
Divsion
Shaja
Brothers
Minor
Use,
Inerts
&
Emergency
Response
Branch
Dani
Daniels,
Venus
Eagle
Insecticide/
Rodenticide
Branch
Dan
Kenny
formerly
of
Insecticide/
Rodenticide
Branch
Risk
Management
Jill
Bloom,
Dirk
Helder
Reregistration
Branch
2
Office
of
General
Counsel:

Robert
Wing
U.
S.
Department
of
Agriculture:

Wilfred
Burr
Page
6
of
53
Glossary
of
Terms
and
Abbreviations
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
BCF
Bioconcentration
Factor
CFR
Code
of
Federal
Regulations
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EDWC
Estimated
Drinking
Water
Concentration
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EUP
End­
Use
Product
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLN
Guideline
Number
HAFT
Highest
Average
Field
Trial
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
µ
g/
g
Micrograms
Per
Gram
µ
g/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
Page
7
of
53
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MUP
Manufacturing­
Use
Product
NA
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
NOAEC
No
Observed
Adverse
Effect
Concentration
NOAEL
No
Observed
Adverse
Effect
Level
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SAP
Science
Advisory
Panel
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TGAI
Technical
Grade
Active
Ingredient
TRR
Total
Radioactive
Residue
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UF
Uncertainty
Factor
UV
Ultraviolet
WPS
Worker
Protection
Standard
Page
8
of
53
I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
data
submitted
to
the
Environmental
Protection
Agency.
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
risks
arising
from
the
currently
registered
uses
of
metaldehyde,
to
determine
the
need
for
additional
data
on
health
and
environmental
effects,
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
was
signed
into
law.
This
Act
amends
FFDCA
to
require
reassessment
of
all
tolerances
in
effect
on
the
day
before
it
was
enacted.
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
among
infants
and
children,
and
the
cumulative
effects
of
pesticides
that
have
a
common
mechanism
of
toxicity.
When
the
Agency
determines
that
aggregate
risks
are
not
of
concern
and
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure,
the
tolerances
are
considered
reassessed.
EPA
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
tolerance
reassessment
will
be
accomplished
through
the
reregistration
process.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
metaldehyde.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
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
metaldehyde,
and
metaldehyde
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
Therefore,
for
the
purposes
of
reregistration,
EPA
has
not
assumed
that
metaldehyde
shares
a
common
mechanism
of
toxicity
with
other
compounds.
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
of
toxicity
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

Metaldehyde
is
a
molluscicide
used
to
control
snails
and
slugs
on
a
wide
variety
of
sites,
including
turf,
ornamentals,
berries,
citrus,
and
vegetables.
Data
on
the
usage
of
metaldehyde
on
nonagricultural
sites
are
limited,
but
usage
is
likely
less
than
50,000
pounds
of
active
ingredient
per
year
(
lbs
ai/
year).
About
11,000
lbs
ai/
year
is
used
on
Page
9
of
53
citrus
and
about
7,000
lbs
ai/
year
is
used
on
artichokes.
About
90%
of
metaldehyde
is
used
in
the
Pacific
Northwest,
California,
and
Hawaii.

Metaldehyde
was
first
registered
in
1967.
The
sole
technical
grade
metaldehyde
registration
in
the
U.
S.
is
held
by
Lonza,
Inc.
Lonza
maintains
an
agreement
with
enduse
product
formulators
that
stipulates
consistency
in
formulation
and
labeling.
The
enduse
product
formulators
are
OrCal,
Corry's,
and
Amvac,
and
there
are
additional
subregistrants
that
do
not
independently
formulate
metaldehyde
products,
including
The
Scotts
Company
LLC.

Metaldehyde
products
currently
bear
labeling
for
a
large
number
of
uses.
The
Agency
allowed
registration
of
these
uses
at
a
time
when
a
determination
had
been
made
that
metaldehyde
was
not
taken
up
into
plants
and
so
tolerances
were
not
needed.
The
Agency
has
since
determined
that
residues
of
metaldehyde
are
present
in
plants
and
that
tolerances
are
needed
to
account
for
residues
in
food
and
feed
crops.
Lonza
is
currently
supporting
a
subset
of
the
uses
on
metaldehyde
product
labels
through
the
development
of
residue
and
other
data;
this
subset
comprises
all
the
uses
the
Agency
has
evaluated
for
reregistration.
The
uses
evaluated
by
the
Agency
for
reregistration
are:
turf,
dichondra,
ornamentals,
citrus,
lettuce,
cole
crops
and
other
leafy
greens,
tomato,
strawberry,
berries
(
including
blackberry,
blueberry,
currant,
elderberry,
gooseberry,
and
raspberries),
artichoke,
and
grass
grown
for
seed.

This
document
presents
EPA's
decision
regarding
the
reregistration
eligibility
of
the
registered
uses
of
metaldehyde.
The
Agency
has
conducted
human
health
and
ecological
risk
assessments
based
on
its
review
of
the
database
supporting
the
uses
of
metaldehyde.
This
document
summarizes
these
risk
assessments
and
describes
the
mitigation
measures
needed
to
address
risks
identified
during
the
reregistration
process.
As
a
result
of
this
review,
the
Agency
has
determined
that
the
following
uses
of
metaldehyde
are
eligible
for
reregistration
under
FIFRA,
provided
that
the
risk
mitigation
measures
detailed
in
this
document
are
adopted
and
the
data
requirements
set
forth
in
this
document
are
fulfilled:
ornamentals,
citrus,
lettuce,
cole
crops
and
other
leafy
greens,
tomato,
strawberry,
berries
(
including
blackberry,
blueberry,
currant,
elderberry,
gooseberry,
and
raspberries),
artichoke,
and
grass
grown
for
seed.
All
other
uses
currently
on
metaldehyde
product
labels
are
not
eligible
for
reregistration
and
must
be
deleted
from
product
labels.
The
Agency
has
determined
that
a
set
of
risk
mitigation
measures
must
be
implemented,
via
labeling
or
reformulation,
to
address
the
risks
associated
with
the
uses
of
metaldehdye
that
are
eligible
for
reregistration.
These
measures
focus
on
risk
reduction
for
domestic
animals
and
wildlife.
In
addition,
the
Agency
is
requiring
that
certain
data
be
submitted
in
support
of
the
continued
registration
of
metaldehyde.
The
Agency
is
releasing
its
reregistration
eligibility
decision
for
metaldehyde
with
a
60­
day
public
comment
period
to
solicit
input
on
a
number
of
mitigation
measures.
Once
an
Endangered
Species
assessment
is
completed
for
metaldehyde,
further
changes
to
metaldehyde
registrations
may
be
necessary,
as
explained
in
Section
III
of
this
document.

The
Agency
has
also
reassessed
the
lone
existing
tolerance
for
metaldehyde.
The
current
tolerance
expression
for
metaldehyde
residues
is
adequate.
A
tolerance
of
"
zero"
Page
10
of
53
previously
was
established
for
residues
of
metaldehyde
on
strawberries
[
40
CFR
§
180.523(
a)].
Residue
data
submitted
since
that
time
are
adequate
to
support
a
tolerance
of
6.25
ppm
for
residues
in/
on
strawberry.
This
metaldehyde
tolerance
is
considered
reassessed.

The
IR­
4
program
of
the
U.
S.
Department
of
Agriculture,
which
develops
residue
data
for
minor
and
specialty
crops,
has
done
research
on
a
number
of
additional
new
uses
for
metaldehyde.
At
the
current
time,
residue
data
for
the
use
of
metaldehyde
on
prickly
pear
cactus
and
watercress
are
in
development.
While
these
uses
were
included
in
the
health
effects
and
environmental
risk
assessments
for
metaldehyde,
decisions
on
their
registration
will
not
be
made
in
this
reregistration
eligibility
decision.

II.
Chemical
Overview
 
Chemical
Structure:

O
O
O
O
CH3
CH3
H3C
H3C
 
Common
Name:
Metaldehyde
 
Chemical
Name:
2,4,6,8­
tetramethyl­
1,3,5,7­
tetraoxacyclooctane
 
CAS
Registry
Numbers:
108­
62­
3
 
PC
Code:
053001
 
Common
Trade
Names:
Snail­
N­
Slug
Beater,
Bug­
Geta
Snail
&
Slug
Pellets,
Slugit,
Deadline,
Slug
&
Snail
Death,
Slug­
Fest,
Metarex
 
Basic
Manufacturer:
Lonza
Inc.
 
Use
Sites
Uses
currently
listed
on
product
labels
include
turf,
ornamentals,
citrus,
cole
crops,
lettuce,
tomato,
strawberry,
blueberry,
caneberries,
artichokes,
seed
crops,
alfalfa,
apples,
asparagus,
avocado,
beans,
celery,
cereal
grains,
clover,
cherries,
corn,
dryland
taro,
fallow
land,
garlic,
ginseng,
grapes,
legumes,
lumberyards,
mint,
papaya,
peaches,
potato,
pumpkin,
seed
crops,
and
watermelon.
 
Mode
of
Action:
Active
ingredient
is
ingested
or
absorbed;
disrupting
mucous
membranes
and
dehydrating
snails
&
slugs
Page
11
of
53
 
Formulations:
granules,
pellets,
minipellets,
meal,
paste,
viscous
liquid
 
Methods
of
Application:
Dry
materials
may
be
scattered
or
shaken
directly
from
the
container;
applied
with
a
whirly­
bird
spreader,
fertilizer
spreader,
or
tractor­
drawn
spreader;
or
broadcast
by
air.
Concentrates
may
be
diluted
and
applied
via
hose­
on
application
or
sprinkler
can.
Liquids
and
pastes
may
be
squeezed
directly
from
bottle.
 
Use
Rates:
Some
labels
do
not
provide
clear
use
instructions.
Application
rates
on
current
labels
may
be
as
high
as
21
lb/
A,
or
0.15
lb
ai/
1000
square
feet,
or
2
oz./
100
square
feet.

Usage
of
metaldehyde
on
agricultural
sites
is
summarized
in
Table
1.
Sites
in
boldface
type
are
among
those
assessed
for
this
RED.

Table
1.
Screening
Level
Estimates
of
Agricultural
Usage,
as
of
April
2005
Use
Site
Pounds
active
ingredient
Percent
crop
treated
Maximum
percent
crop
treated
Seed
Crops
20,000
5
­­
Lemons
8,000
10
25
Artichokes
7,000
25
40
Oranges
3,000
<
1
5
Strawberries
2,000
5
5
Grapes
2,000
<
1
<
2.5
Watermelon
1,000
<
1
<
2.5
Avocado
1,000
<
1
<
2.5
Blackberries
5
­­
Blueberries
10
­­
Cauliflower
<
1
<
2.5
Celery
<
1
<
2.5
Peaches
<
1
<
2.5
Peppers
<
1
<
2.5
Raspberries
<
1
­­
Sweet
corn
<
500
each
<
1
<
2.5
III.
Summary
of
the
Metaldehyde
Science
Assessments
The
following
is
a
summary
of
EPA's
human
health,
domestic
animal,
and
ecological
risk
findings
and
conclusions
for
metaldehyde
as
presented
in
the
risk
assessments
and
supporting
documents
developed
by
the
Agency.
The
risk
assessments
and
related
supporting
documents
are
available
in
the
public
docket
at
www.
regulations.
gov
.
To
find
the
correct
docket
and
documents
associated
with
it,
select
the
Advanced
Search
function,
and
then
select
Docket
Search.
Enter
the
Docket
Number
OPP­
2005­
0231
in
the
Docket
ID
field
and
submit.
Click
on
the
Docket
ID
link,
Page
12
of
53
and
icons
for
viewing
and
downloading
the
supporting
documents
will
appear.
Your
computer's
"
pop­
up
blocker"
function
must
be
turned
off
for
you
to
view
or
download
documents
in
the
docket.

This
section
also
summarizes
the
alternatives
and
benefits
information
the
Agency
has
developed
for
consideration
in
the
metaldehyde
reregistration
decision.
The
alternatives
assessment
is
also
available
in
the
public
docket
at
www.
regulations.
gov
.

The
purpose
of
this
section
is
to
help
the
reader
better
understand
the
risk
management
decisions
reached
by
the
Agency.

A.
Human
Health
Risk
Assessment
The
complete
metaldehyde
human
health
risk
assessment
is
found
in
the
document
"
Metaldehyde:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document,"
dated
April
3,
2006,
and
can
be
accessed
via
www.
regulations.
gov
as
described
above.

The
Agency's
assessment
utilizes
submitted
and
other
data
to
evaluate
the
toxicology,
product
and
residue
chemistry,
dietary
exposure,
and
occupational
and
residential
exposure
associated
with
metaldehyde.
The
Agency
has
determined
that
these
data
are
adequate
to
support
a
reregistration
decision.

1.
Acute
Toxicity
Acute
toxicity
data
for
on
metaldehyde
are
summarized
in
Table
2.

Table
2.
Acute
Toxicity
Profile
Guideline
No.
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
oral
[
rat]
00131435
LD50
=
283
mg/
kg
II
870.1200
Acute
dermal
[
rat]
00131434
LD50
=
>
5000
mg/
kg
III
870.1300
Acute
inhalation
[
rat]
00131429
LC50
=
314
mg/
L/
4
hrs
IV
870.2400
Acute
eye
irritation
[
rabbit]
42068801
mild
irritant
III
870.2500
Acute
dermal
irritation
[
rabbit]
00131971
not
an
irritant
IV
2.
FQPA
Safety
Factor
FQPA
directs
EPA,
in
setting
pesticide
tolerances,
to
use
an
additional
tenfold
(
10X)
margin
of
safety
to
take
into
account
potential
pre­
and
postnatal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
FQPA
authorizes
EPA
to
modify
this
tenfold
safety
factor
only
if
reliable
data
demonstrate
that
the
resulting
level
of
exposure
will
be
safe
for
infants
and
children.
EPA
has
determined
that
the
FQPA
safety
factor
must
be
retained
for
metaldehyde
to
account
for
database
uncertainties.
Page
13
of
53
Neurological
effects
are
suggested
by
clinical
signs
observed
in
studies
in
dogs
and
rats
exposed
to
metaldehyde,
including
ataxia,
twitching,
tremors,
and
hindlimb
paralysis.
Developmental
toxicity
and
2­
generation
reproduction
studies
in
rats
and
rabbits
do
not
demonstrate
an
increased
sensitivity
or
susceptibility
in
developing
fetuses.
Based
on
the
observation
of
clinical
signs
indicating
neurotoxicity
in
several
studies,
the
Agency
is
requiring
a
developmental
neurotoxicity
study
for
metaldehyde.
Because
data
on
potential
neurotoxic
effects
on
the
developing
fetus
are
outstanding,
the
Agency
is
retaining
the
10X
safety
factor
for
assessment
of
dietary,
residential,
and
aggregate
risks.

3.
Endpoint
Selection
Table
3
shows
endpoints
used
in
the
metadehyde
human
health
risk
assessment.

Table
3.
Toxicology
Endpoint
Selection
Exposure
Scenario
NOAEL
Uncertainty
Factors;
Level
of
Concern
Study
type;
Test
species;
Toxic
Effects
(
MRID#)

Acute
Dietary
(
All
populations)
75
mg/
kg/
day
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total);
aPAD
=
0.075
mg/
kg/
day
Developmental
toxicity;
rats;
LOAEL
=
150
mg/
kg/
day
(
mortality,
ataxia,
tremors,
twitching,
rapid
respiration,
decreased
weight
gain,
 
s)
(
MRID
41656001)

Chronic
Dietary
(
All
populations)
10
mg/
kg/
day
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total)
cPAD
=
0.01
mg/
kg/
day
Chronic
oral
toxicity;
dogs;
LOAEL
=
30
mg/
kg/
day
(
mortality,
atrophy
of
the
testes
and
prostate)
(
MRID
46378401)

Residential
Short­
Term
Incidental
Oral
(
duration
of
exposure:
1­
30
days)
30
mg/
kg/
day
Chronic
oral
toxicity
;
dogs;
LOAEL
=
90
mg/
kg/
day
(
clinical
signs
beginning
Week
1)
(
MRID
46378401)

Residential
Intermediate­
Term
Incidental
Oral
(
duration
of
exposure:
1­
6
months)
10
mg/
kg/
day
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total
)
MOE
=
1000
Chronic
oral
toxicity;
dogs;
LOAEL
=
30
mg/
kg/
day
(
mortality,
atrophy
of
testes
and
prostate)
(
MRID
46378401)

Short­
Term
Inhalation
(
duration
of
exposure
1
­
30
days)
30
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
Residential
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total
)
MOE
=
1000
Chronic
oral
toxicity;
dogs;
LOAEL
=
90
mg/
kg/
day
(
clinical
signs
beginning
Week
1)
(
MRID
46378401)
Page
14
of
53
Exposure
Scenario
NOAEL
Uncertainty
Factors;
Level
of
Concern
Study
type;
Test
species;
Toxic
Effects
(
MRID#)
Occupational
10X
interspecies,
10X
intraspecies
(
100X
total)
MOE
=
100
Residential
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total
)
MOE
=
1000
Intermediate­
Term
Inhalation
(
duration
of
exposure
1
­
6
months)
10
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

Occupational
10X
interspecies,
10X
intraspecies
(
100X
total)
MOE
=
100
Residential
10X
interspecies,
10X
intraspecies,
10X
FQPA
(
1000X
total
)
MOE
=
1000
Long­
Term
Inhalation
(
duration
of
exposure
>
6
months)
10
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)

Occupational
10X
interspecies,
10X
intraspecies
(
100X
total)
MOE
=
100
Chronic
oral
toxicity;
dogs;
LOAEL
=
30
mg/
kg/
day
(
mortality,
atrophy
of
the
testes
and
prostate)
(
MRID
46378401)

Dermal
No
toxicological
endpoint
of
concern
is
identified
for
dermal
exposures
Cancer
Weight
of
evidence
is
suggestive
of
carcinogenic
potential.

NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic),
MOE
=
margin
of
exposure
Because
the
Agency
could
not
identify
an
endpoint
for
dermal
exposures,
it
did
not
conduct
an
assessment
of
the
risk
associated
with
dermal
exposures
in
any
exposure
scenario
(
residential,
occupational).
As
a
matter
of
policy,
the
Agency
does
not
quantify
pesticide
cancer
risks
when
the
evidence
for
carcinogenicity
is
"
suggestive."
In
the
case
of
metaldehyde,
incidence
of
benign
liver
tumors
was
increased
in
both
sexes
of
the
mouse.
Although
the
increased
incidence
of
benign
liver
tumors
in
female
rats
relative
to
controls
was
statistically
significant,
it
was
just
slightly
higher
than
the
upper
end
of
the
range
for
historical
controls
at
the
testing
facility.
No
tumors
were
found
in
male
rats
in
the
same
study.
The
mutagenicity
data
for
metaldehyde
are
deficient
and
new
data
are
required,
but
examination
of
the
old
data
suggests
that
metaldehyde
is
not
a
mutagen.
Page
15
of
53
4.
Dietary
Exposure
and
Risk
from
Food
and
Drinking
Water
The
dietary
risk
assessment
is
a
function
of
both
exposure
and
toxicity.
In
the
case
of
metaldehydye,
dietary
risk
is
expressed
as
a
percentage
of
a
level
of
concern.
The
level
of
concern
is
the
dose
predicted
to
result
in
no
unreasonable
adverse
health
effects
to
any
human
population
subgroup,
including
sensitive
members
of
such
population
subgroups.
This
level
of
concern
is
referred
to
as
the
population
adjusted
dose
(
PAD).
Risk
estimates
less
than
100%
of
the
PAD
are
below
EPA's
level
of
concern.
The
acute
PAD
(
aPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
on
any
given
day
with
no
adverse
health
effect
expected.
The
chronic
PAD
(
cPAD)
is
the
highest
predicted
dose
to
which
a
person
could
be
exposed
over
the
course
of
a
lifetime
with
no
adverse
health
effects
expected.

a)
Drinking
Water
Concentrations
Drinking
water
concentrations
of
metaldehyde
were
estimated
for
both
surface
water
and
groundwater.
Scenarios
are
modeled
by
the
Agency
for
reasonable
worst­
case
exposures.
The
drinking
water
assessment
is
detailed
in
the
document
entitled
"
Second
Amended
Tier
II
Estimated
Drinking
Water
Concentrations
(
Surface
and
Ground
Water)
of
the
Molluscicide
Metaldehyde,"
December
12,
2005,
posted
to
the
metaldehyde
docket
at
www.
regulations.
gov.
For
surface
water,
estimated
drinking
water
concentrations
(
EDWCs)
were
generated
from
a
Tier
II
PRZM­
EXAMS
­
Index
Reservoir
model
based
on
the
use
of
metaldehyde
on
cole
crops
and
leafy
vegetables
in
Florida
and
California.
For
groundwater,
EDWCs
were
generated
from
a
Tier
I
SCI­
GROW
analysis,
based
on
use
of
metaldehyde
on
ornamental
plants.
Estimated
drinking
water
concentrations
for
metaldehyde
are
provided
in
Table
4;
values
in
bold
were
used
in
the
dietary
assessment.

Table
4.
EDWCs
for
Metaldehyde
Source
Scenario
Acute
EDWC
Chronic
EDWC
Cole
crops,
FL
110
ppb
8.4
ppb
Surface
water
Leafy
vegetables,
CA
94.8
ppb
55.8
ppb
Groundwater
Ornamentals
62.5
ppb
b)
Food
+
Water
Exposures
An
unrefined
Tier
1
acute
dietary
exposure
assessment
was
conducted
for
all
supported
metaldehyde
food
uses
based
on
upper­
bound
pesticide
residue
inputs
(
e.
g.,
assuming
100%
of
registered
crops
are
treated
with
metaldehyde
and
that
residues
are
present
at
tolerance
levels).
For
Tier
1
analyses,
EPA
presents
results
at
the
95th
percentile
of
exposure,
which
provides
a
high­
end
estimate
of
risk
that
is
protective
of
human
health.
Dietary
risk
estimates
are
calculated
for
exposures
to
the
general
U.
S.
population
and
subpopulations
from
food
and
both
surface
water
and
ground
water
together.

c)
Acute
Dietary
(
Food
and
Drinking
Water)
Risk
Page
16
of
53
For
the
general
population
and
all
subpopulations,
acute
dietary
risk
estimates
are
below
100%
of
the
aPAD.
Dietary
risk
estimates
for
the
general
population
and
the
most
highly
exposed
subpopulation
are
shown
in
Table
5
below.

d)
Chronic
Dietary
(
Food
and
Drinking
Water)
Risk
For
the
general
population
and
all
subpopulations,
chronic
dietary
risk
estimates
are
below
100%
of
the
cPAD.
Dietary
risk
estimates
for
the
general
population
and
the
most
highly
exposed
subpopulation
are
shown
in
Table
5.

Table
5.
Summary
of
Food
+
Water
Dietary
Risk
Estimates
for
Metaldehyde
Acute
Risk;
Food
+
Chronic
Risk;
Food
+
Population
Surface
Water
Groundwater
Surface
Water
Groundwater
General
12%
aPAD
14%
aPAD
29%
cPAD
35%
cPAD
Children
1­
2
years
old
26%
a
PAD
29%
aPAD
59%
cPAD
69%
cPAD
5.
Residential
Exposure
and
Risk
Residents
can
be
exposed
to
metaldehyde
used
on
lawns,
and
ornamental,
vegetable,
and
fruit
plants
as
a
result
of
both
application
and
post­
application
activities,
on
a
short
­
term
exposure
basis.
Non­
cancer
risks
are
calculated
by
the
margin
of
exposure
(
MOE)
approach
which
relies
on
the
ratio
of
the
dose
from
a
toxicological
endpoint
selected
for
risk
assessment
to
the
predicted
exposure.
Risk
estimates
are
compared
to
levels
of
concern
which
reflect
the
endpoint
and
all
relevant
uncertainty
factors.
In
this
case,
MOEs
of
greater
than
1000
do
not
represent
risks
of
concern.
Since
no
dermal
endpoint
of
concern
has
been
identified
for
metaldehyde,
dermal
risks
were
not
estimated.
Intermediate­
and
long­
term
exposures
are
not
expected
for
residential
handlers
because
of
the
sporadic
nature
of
applications
by
homeowners.

a)
Residential
Handlers
Metaldehyde
is
available
in
residential­
use
products
s
in
the
following
formulations:
liquid
concentrate,
ready­
to­
use
liquid/
paste,
and
ready­
to­
use
granules/
pellets/
minipellets/
meal
baits.
Most
of
the
residential
consumer
products
are
formulated
as
granular
baits.
Methods
of
application
include
hose­
end
sprayers,
triggerpump
sprayers,
low
pressure
handwand
sprayers,
sprinkler
cans,
belly
grinders,
push­
type
spreaders,
and
applying
ready­
to­
use
products
by
hand.
The
Agency
assessed
eight
residential
handler
short­
term
exposure
scenarios,
representing
a
range
of
possible
exposures.
MOEs
for
all
of
the
residential
handler
scenarios
assessed
are
greater
than
the
target
MOE
of
1000,
ranging
from
56,000
to
6,000,000.
The
high
MOEs
result
in
part
from
application
methods
that
do
not
create
small
droplets
(
of
respirable
size),
the
low
volatility
of
metaldehyde,
and
dilution
by
ambient
air.
The
Agency
has
determined
that
risks
to
residential
handlers
of
metaldehyde
are
not
of
concern.
Page
17
of
53
b)
Residential
Post­
Application
Exposure
and
Risk
Individuals
potentially
can
be
exposed
to
metaldehyde
after
application
when
they
do
yard
or
garden
work
or
play
within
treated
areas.
No
dermal
endpoint
has
been
identified
for
metaldehyde,
and
significant
residential
post­
application
inhalation
exposures
are
not
anticipated
for
metaldehyde,
because
of
its
limited
volatility
and
dilution
by
ambient
air.
The
Agency
did
assess
the
potential
post­
application
risk
for
toddlers
who
play
on
treated
turf
and
may
be
exposed
through
hand­
to­
mouth
activities,
object­
to­
mouth
activities,
and
ingestion
of
treated
soil.
Short­
term
MOEs
from
these
oral
exposures
are
greater
than
1000,
with
an
MOE
for
exposure
by
all
three
routes
together
of
1600
on
the
day
of
application.
These
MOEs
do
not
represent
risks
of
concern.

The
Agency
also
assessed
risks
associated
with
the
direct
ingestion
of
metaldehyde
granular
materials
by
toddlers.
MOEs
for
ingestion
of
two
different
formulation
types
are
estimated
to
be
well
below
the
target
MOE
of
1000,
at
188
and
50.
The
Agency
also
determined
that
very
low
numbers
of
granules
could
result
in
exposures
at
the
level
of
concern,
depending
on
the
size
of
the
granules
(
estimated
at
2
to
15
granules
for
the
two
formulations).
A
review
of
data
from
the
American
Association
of
Poison
Control
Centers
(
AAPCC)
shows
that
a
total
of
1648
poisoning
incidents
in
children
were
recorded
for
metaldehyde
in
the
years
1993
through
2003.
The
most
recent
year
for
which
data
are
available
from
the
AAPCC
is
2004,
when
244
accidental
exposures
to
metaldehyde
were
reported,
with
105
incidents
occuring
in
children
younger
than
6
years
old.
None
of
the
reported
incidents
were
associated
with
life­
threatening
conditions.
Twenty­
nine
incidents
were
associated
with
minor
symptoms
that
resolved
quickly,
and
three
were
associated
with
more
pronounced
symptoms
that
had
no
residual
ill
effect.

Beginning
in
2001,
a
bittering
agent,
denatonium
benzoate,
was
added
to
metaldehyde
home
and
garden
products
at
a
rate
of
30
ppm.
In
late
2003,
the
concentration
of
denatonium
benzoate
was
increased
to
300
ppm.
Denatonium
benzoate
is
used
in
rodenticides
and
appears
to
be
effective
in
deterring
ingestion
by
children
at
a
concentration
of
300
ppm.
As
discussed
below,
the
evidence
for
its
effectiveness
in
dogs
is
less
conclusive.
Because
consumer
product
may
remain
on
store
shelves
and
in
the
hands
of
consumers
for
a
year
or
more,
the
industry
believes
that
metaldehyde
products
containing
the
higher
level
of
denatonium
benzoate
are
beginning
to
dominate
the
market
this
year,
so
that
the
impact
of
the
new
formulation
would
not
be
evident
in
data
from
2004.

Given
the
movement
of
product
with
the
higher
concentration
of
denatonium
benzoate
into
the
consumer
market,
the
Agency
believes
that
ingestion
by
toddlers
of
metaldehyde
granules
is
unlikely,
and
that
if
ingestion
occurs,
the
bitter
taste
would
cause
a
toddler
to
spit
out
the
material
quickly,
thus
limiting
exposure.
Home
and
garden
products
containing
metaldehyde
already
are
labeled
to
require
that
users
keep
children
out
of
areas
where
the
product
is
stored
or
used,
but
the
Agency
believes
that
it
is
nevertheless
prudent
to
require
that
this
labeling
be
enhanced
for
visibility
and
content.
Page
18
of
53
The
Agency
will
continue
to
monitor
poisoning
data
as
the
new
mitigation
comes
into
effect.

6.
Aggregate
Exposure
and
Risk
The
FQPA
amendments
to
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA,
Section
408(
b)(
2)(
A)(
ii))
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposure
and
other
exposures
for
which
there
is
reliable
information."
In
response
to
this
requirement,
the
Agency
conducts
aggregate
risk
assessments
to
account
for
all
potential
non­
occupational
exposures
when
developing
its
reregistration
decisions.

a)
Acute
Aggregate
Risk
Only
food
and
water
exposures
to
metaldehyde
are
aggregated
for
this
acute
assessment.
This
assessment
is
described
above
and
summarized
in
Table
5.

b)
Short­
Term
Aggregate
Risk
Dietary
(
food
+
water)
exposures
and
post­
application
incidental
oral
exposures
are
aggregated
for
short­
term
exposures
to
metaldehyde.
The
dietary
risk
component
is
summarized
in
Table
5.
Incidental
oral
exposures
may
result
from
children
playing
on
treated
turf
and
ingesting
soil
or
inserting
their
hands
in
their
mouths
while
playing
or
after
playing
on
treated
turf.
Since
these
activities
may
occur
simultaneously,
the
combined
MOE
is
used
in
the
aggregate
assessment.
Adult
residential
exposures
are
estimated
to
be
greatest
for
handlers;
these
adult
exposures
are
aggregated
with
dietary
exposures.
The
target
MOE
for
all
short­
term
aggregate
risks
is
1000
for
all
scenarios.
All
aggregate
MOEs
for
short­
term
exposure
to
metaldehyde
are
1200
or
greater,
and
so
are
not
of
concern.
Short­
term
aggregate
exposures
and
risk
estimates
are
shown
in
Table
6.

Table
6.
Short­
term
Aggregate
Risk
Estimates
for
Metaldehyde
Exposure,
mg/
kg/
day
Aggregate
MOE
Population
Residential
Food
+
Water
Residential
+
Food
+
Water
Surface
water
source
for
drinking
water
Children
0.019
0.0059
1200
Adults
0.00054
0.0029
8700
Groundwater
source
for
drinking
water
Children
0.019
0.0069
1200
Adults
0.00054
0.0035
7400
c)
Chronic
Aggregate
Risk
Only
food
and
water
exposures
to
metaldehyde
are
aggregated
for
this
chronic
assessment,
because
there
are
no
long­
term
residential
exposures
expected
for
Page
19
of
53
metaldehyde.
This
chronic
dietary
(
food
+
water)
assessment
is
described
above
and
summarized
in
Table
5.

7.
Cumulative
Risk
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
metaldehyde
and
any
other
substances,
and
metaldehyde
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
reregistration
eligibility
and
tolerance
action,
EPA
has
not
assumed
that
metaldehyde
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/
.

8.
Risk
to
Domestic
Animals
from
Ingestion
of
Metaldehyde
Granules
in
Residential
Settings
Information
from
several
sources
indicates
that
there
are
a
considerable
number
of
poisonings
of
domestic
animals,
especially
dogs,
resulting
from
ingestion
of
metaldehyde,
typically
after
such
materials
are
used
around
the
home,
but
occasionally
when
pets
eat
granules
after
tearing
into
or
opening
product
containers.

For
the
years
2000­
2004,
NPIC,
a
toll­
free
telephone
service
that
provides
pesticide
information
without
treatment
advice
to
the
general
public
and
medical
and
veterinary
professionals,
collected
data
from
reports
of
104
cases
(
probable
exposure
to
metaldehyde)
and
156
cases
(
possible
exposure)
involving
274
animals.
Most
of
the
metaldehyde
incidents
reported
to
NPIC
were
dogs
(
92%).
All
but
one
of
the
remaining
incidents
was
reported
for
cats.
The
number
of
probable
cases
increased
yearly
from
8
in
2000
to
43
in
2004.
Numbers
of
possible
cases
held
steady
in
2000­
2003
but
increased
in
2004.
Most
cases
involved
animals
exposed
via
ingestion
after
metaldehyde
applications
to
yards
and
gardens.
Granular
and
bait
formulations
were
most
commonly
ingested.
For
cases
in
which
the
outcome
was
reported,
seventeen
animals
in
the
probable
and
five
in
the
possible
categories
died,
while
10
animals
in
the
both
categories
combined
recovered.
NPIC
refers
callers
reporting
animals
in
need
of
immediate
veterinary
care
to
the
ASPCA's
Animal
Poison
Control
Center
(
APCC).

The
APCC
maintains
a
24­
hour
emergency
hotline
for
animal
poisoning
incidents,
similar
to
the
services
provided
by
human
poison
control
centers.
A
representative
of
the
APCC,
in
private
communications
with
the
Agency,
has
indicated
that
the
APCC
receives
incident
reports
of
"
possible"
to
"
observed"
exposure
certainty
for
metaldehyde
on
an
annual
basis
in
greater
numbers
than
NPIC
does
for
its
analogous
probable
and
possible
exposure
categories.
In
the
two­
year
period
2004
through
2005,
APCC
handled
almost
500
cases
(
an
average
of
250
cases/
year
for
APCC
vs.
65/
year
for
Page
20
of
53
NPIC).
The
greater
number
of
calls
received
by
the
APCC
likely
is
attributable
to
several
factors,
including
referral
of
NPIC
callers
to
APCC,
contracting
by
a
subset
of
metaldehyde
manufacturers
directly
to
APCC
for
responding
to
incidents
associated
with
their
products
and
greater
name
recognition
for
the
APCC
among
callers
not
obtaining
telephone
numbers
from
product
labels.
The
APCC
further
advised
the
Agency
that
it
considers
metaldehyde
calls
as
"
immediate
interrupts,"
warranting
termination
of
data
collection
followed
by
immediate
referral
to
veterinarians,
because
of
the
imminent
hazard
to
the
exposed
animal.

Lonza,
the
registrant
of
technical
grade
metaldehyde,
maintains
a
set
of
"
Minimum
Quality
Requirements"
(
MQRs)
with
its
formulators
of
home
and
garden
products.
One
of
the
MQRs
requires
formulators
to
incorporate
denatonium
benzoate,
a
bittering
agent,
into
their
residential
metaldehyde
products,
for
the
purpose
of
making
the
products
unpalatable
to
children
and
domestic
animals
that
might
otherwise
be
attracted
to
and
ingest
the
granules.
Lonza
originally
required
the
incorporation
of
30
ppm
of
denatonium
benzoate
into
these
products.
In
late
2003,
the
rate
was
increased
to
300
ppm.
Denatonium
benzoate
is
a
proven
aversion
agent
for
children
and
is
used
in
rodenticides.
The
Agency
has
reviewed
data
that
Lonza
believes
supports
the
efficacy
of
denatonium
benzoate
in
preventing
ingestion
of
metaldehyde
granules
by
dogs,
but
is
unable
to
determine
the
efficacy
because
of
limitations
in
study
design.
Although
denatonium
benzoate
appears
to
be
an
effective
aversion
agent
for
children,
dogs
are
likely
to
be
less
sensitive
to
the
taste,
or
at
least
less
selective
in
what
they
eat,
than
children.

9.
Occupational
Risk
Assessment
a)
Handler
exposures
Occupational
handlers
of
metaldehyde
may
be
exposed
during
mixing
(
for
products
which
are
diluted
before
application),
loading,
or
applying
metaldehyde
products,
or
through
a
combination
of
these
activities.
Other
workers
may
be
exposed
to
metaldehyde
when
entering
areas
where
metaldehyde
previously
has
been
applied.

The
Agency
believes
that
occupational
handlers
may
be
exposed
to
metaldehyde
on
a
short­
term
(
up
to
30
days)
or
intermediate­
term
(
30
days
to
several
months)
basis.
The
Agency's
occupational
handler
risk
assessment
is
based
on
16
different
scenarios
defined
by
different
handling
tasks
(
e.
g.,
mixer/
loader,
applicator)
and
application
methods
(
e.
g.,
liquids
via
airblast,
granulars
via
tractor­
drawn
spreader).
In
the
absence
of
a
dermal
toxicity
endpoint,
only
inhalation
exposures
are
assessed.
The
Agency
assessed
each
of
the
16
scenarios
for
increasing
levels
of
inhalation
protection
from
baseline
PPE
(
handlers
wearing
long­
sleeve
shirts,
long
pants,
shoes,
socks,
and
no
resprirator)
to
Engineering
Controls
(
a
closed
tractor
cab
or
closed
loading
system).
Page
21
of
53
b)
Handler
risks
For
all
short­
and
intermediate­
term
occupational
handler
scenarios,
risks
are
not
of
concern
even
at
the
baseline
level
of
personal
protection,
without
a
respirator
(
i.
e.,
all
MOEs
are
greater
than
the
target
MOE
of
100).
The
lowest
MOE
at
baseline,
790,
is
associated
with
mixing
and
loading
liquid
concentrates
to
support
application
via
chemigation;
most
scenarios
are
associated
with
MOEs
in
the
thousands.

c)
Occupational
post­
application
risks
Occupational
post­
application
exposures
were
not
assessed
for
metaldehyde
because
no
dermal
hazard
was
identified
and
inhalation
exposures
are
assumed
to
be
negligible
in
outdoor
post­
application
scenarios
due
to
metaldehyde's
low
vapor
pressure
and
dilution
in
outdoor
air.
Post­
application
inhalation
exposures
for
indoor
spaces
(
i.
e.,
greenhouses)
are
also
assumed
to
be
minimal
because
the
Worker
Protection
Standard
for
Agricultural
Pesticides
requires
that
greenhouses
be
well­
ventilated
following
pesticide
application.
The
current
restricted
entry
intervals
(
REIs)
specified
on
various
metaldehyde
labels
range
from
12
to
24
hours.
The
results
of
this
assessment
do
not
impact
the
current
REIs.

B.
Environmental
Risk
Assessment
The
complete
metaldehyde
environmental
risk
assessment
is
found
in
the
document
"
Level
1
Screening
Ecological
Risk
Assessment
for
the
Reregistration
of
Metaldehyde,"
March
30,
2006,
and
can
be
accessed
via
www.
regulations.
gov
as
described
above.

1.
Environmental
Fate
and
Transport
Metaldehyde
is
highly
mobile
in
soils,
and
is
generally
stable
to
abiotic
degradation
mechanisms
such
as
hydrolysis
and
photolysis.
Metaldehyde
is
primarily
dissipated
from
soils
through
biodegradation
under
aerobic
conditions,
with
a
half­
life
of
approximately
2
months.
Under
anaerobic
conditions,
the
half­
life
of
metaldehyde
is
much
higher
(>
200
days).
Its
low
vapor
pressure
and
Henry's
Law
constant
indicate
that
volatilization
from
soils
and
water
surfaces
will
not
be
an
important
transport
process.
In
addition,
the
results
of
a
laboratory
volatility
study
suggest
that
volatilization
losses
from
soil
surfaces
will
be
minor.

Acetaldehyde
is
the
primary
degradation
product
of
metaldehyde.
Acetaldehyde
is
a
relatively
short­
lived
metabolite
in
the
environment,
and
is
readily
oxidized
to
acetic
acid
and
ultimately
to
carbon
dioxide
and
water.

2.
Ecological
Risk
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
to
estimated
environmental
concentrations
(
EECs)
modeled
from
environmental
fate
Page
22
of
53
characteristics
and
pesticide
use
parameters.
To
evaluate
the
potential
risk
to
non­
target
organisms
from
the
use
of
metaldehyde
products,
the
Agency
calculates
a
Risk
Quotient
(
RQ),
which
is
the
ratio
of
the
EEC
to
the
most
sensitive
toxicity
endpoint
values,
such
as
the
median
lethal
dose
(
LD50)
or
the
median
lethal
concentration
(
LC50).
These
RQs
are
then
compared
to
Levels
of
Concern
(
LOCs)
established
by
the
Agency
for
interpreting
potential
risk
to
non­
target
organisms
and
the
need
for
regulatory
action.
When
the
RQ
exceeds
the
LOC
for
a
particular
category,
the
Agency
presumes
a
risk
of
concern.
These
risks
of
concern
may
be
addressed
by
further
refinements
of
the
risk
assessment
or
mitigation
measures.
The
Agency
further
considers
levels
of
uncertainty
in
the
assessment
and
any
reported
incidents
to
non­
target
terrestrial
or
aquatic
organisms
in
the
field
(
e.
g.,
fish
or
bird
kills)
when
characterizing
risk.

Table
7.
EPA's
Levels
of
Concern
and
Associated
Risk
Presumptions
IF...
THEN
the
Agency
presumes...

Mammals
and
Birds
The
acute
RQ
>
LOC
of
0.5
Acute
risk
to
Federally­
listed
and
non­
listed
species
The
acute
RQ
>
LOC
of
0.1
Acute
risk
to
Federally­
listed
species
The
chronic
RQ
>
LOC
of
1
Chronic
risk
to
Federally­
listed
and
non­
listed
species
Fish
and
Aquatic
Invertebrates
The
acute
RQ
>
LOC
of
0.5
Acute
risk
to
Federally­
listed
and
non­
listed
species
The
acute
RQ
>
LOC
of
0.05
Acute
risks
to
Federally­
listed
species
The
chronic
RQ
>
LOC
of
1
Chronic
risk
to
Federally­
listed
and
non­
listed
species
Terrestrial
and
Aquatic
Plants
The
acute
RQ
>
LOC
of
1
Acute
risk
to
Federally­
listed
and
non­
listed
species
a)
Risk
to
Aquatic
Organisms
(
1)
Toxicity
to
Fish
and
Aquatic
Invertebrates
The
results
of
acute
toxicity
studies
with
a
surrogate
freshwater
fish
(
rainbow
trout)
show
that
metaldehyde
is
slightly
toxic
to
freshwater
fish
on
an
acute
basis.
No
acute
toxicity
data
with
estuarine/
marine
fish
are
available
for
metaldehyde.

In
an
acute
toxicity
study
for
a
freshwater
invertebrate
(
Daphnia
magna),
no
treatment­
related
effects
were
observed
at
the
highest
concentration
of
metaldehyde
tested.
No
acute
toxicity
data
with
estuarine/
marine
invertebrates
are
available
for
metaldehyde.

No
chronic
toxicity
data
are
available
for
metaldehyde
in
freshwater
fish
and
invertebrates.
No
toxicity
data
are
available
for
acute
or
chronic
exposures
to
estuarine/
marine
fish
or
invertebrates,
or
aquatic
plants.
No
data
on
toxicity
of
Page
23
of
53
metaldehyde
to
non­
target,
aquatic
mollusks
are
available.
Toxicity
data
for
aquatic
organisms
exposed
to
metaldehyde
are
summarized
in
Table
8.

Table
8.
Metaldehyde
Toxicity
Values
(
mg
ai/
L)
for
Aquatic
Organisms
Exposure
Scenario
Species
Exposure
Duration
Acute
LC/
EC50
or
Chronic
NOAEC
Reference
(
Classification)
Freshwater
Fish
Acute
Rainbow
trout
96
hours
LC50
=
69
mg
ai/
L
MRID
42044004
(
Supplemental)

Chronic
No
data
acceptable
for
quantitative
risk
assessment
are
available
Freshwater
Invertebrates
Acute
Water
flea
48
hours
LC50
>
77.66
mg
ai/
L
MRID
42044005
(
Supplemental)

Chronic
No
data
acceptable
for
quantitative
risk
assessment
are
available
Estuarine/
Marine
Fish
Acute
Chronic
No
data
acceptable
for
quantitative
risk
assessment
are
available
Estuarine/
Marine
Invertebrates
Acute
Chronic
No
data
acceptable
for
quantitative
risk
assessment
are
available
Aquatic
Plants
Acute
Chronic
No
data
previously
required
(
2)
Exposures
of
Aquatic
Organisms
to
Metaldehyde
Exposure
to
aquatic
organisms
is
assumed
to
occur
through
direct
contact
with
contaminated
surface
water.
The
estimated
environmental
concentrations
(
EECs)
of
metaldehyde
to
which
aquatic
organisms
can
be
exposed
are
generated
using
the
Tier
1
model
GENEEC2
(
Generic
Estimated
Environmental
Concentration).
Maximum
application
rates
and
use
patterns
for
citrus,
brassica
(
cole
crops),
leafy
vegetables
(
lettuce),
strawberries,
berries,
artichokes,
turf,
and
ornamentals
are
inputs
to
the
model.
The
GENEEC2
model
uses
soil/
water
partition
coefficients
and
degradation
kinetic
data
to
estimate
run­
off
from
a
theoretical
ten
hectare
field
into
a
1­
hectare
by
2­
meter
deep
"
standard"
pond.
This
Tier
I
model
uses
conservative
inputs
such
as
maximum
application
rates
and
maximum
number
of
applications
from
product
labels,
resulting
in
conservative
exposure
estimates.
EECs
represent
the
one­
in­
ten
year
concentrations
so
Page
24
of
53
that
actual
environmental
concentrations
are
only
expected
to
exceed
the
GENEECgenerated
values
once
in
ten
years.
Peak
EECs
used
in
the
acute
risk
assessment
for
aquatic
wildlife
are
shown
in
Table
9
below.

(
3)
Fish
and
Aquatic
Invertebrate
Risk
Estimates
Acceptable
toxicity
studies
on
metaldehyde
are
only
available
for
acute
exposure
to
freshwater
fish
and
invertebrates.
RQs
were
not
calculated
for
freshwater
invertebrates
since
no
mortalities
were
observed
at
the
highest
dose
tested
in
Daphnia.
Acute
RQs
for
freshwater
fish
are
summarized
in
Table
9.
No
acceptable
toxicity
data
are
available
to
assess
acute
risks
to
marine/
estuarine
fish
and
invertebrates,
chronic
risks
to
freshwater
fish
and
risks
to
marine/
estuarine
fish,
invertebrates,
and
aquatic
plants.

Since
no
toxicity
information
is
available
for
degradates
of
metaldehyde,
RQs
were
derived
only
for
the
parent
compound.

Table
9.
Acute
RQs
for
Freshwater
Fish
Exposed
to
Metaldehyde
Use
Site
Peak
EEC
(
µ
g
ai./
L)
Acute
RQ
(
EEC/
LC50)

Artichokes
238
0.003
Berries
185
0.003
Brassica
(
cole
crops)
189
0.003
Citrus
271
0.004
Strawberries
145
0.002
Grass
grown
for
seed
292
0.004
Dichondra
/
Turf
422
0.006
Ornamentals
1480
0.021
Acute
RQs
for
freshwater
fish
are
below
the
acute
risk
LOC
(
0.5)
and
the
acute
risk
LOC
for
endangered
species
(
0.05)
for
each
of
the
use
sites
modeled.

(
4)
Risks
to
Aquatic
Plants
No
toxicity
data
are
available
to
assess
risk
to
aquatic
plants.
No
adverse
ecological
incidents
have
been
reported
with
regard
to
metaldehyde
and
aquatic
plants.
The
Agency
is
requiring
toxicity
data
for
aquatic
plants.

b)
Terrestrial
Risk
(
1)
Toxicity
to
Terrestrial
Wildlife
Available
data
on
the
acute
toxicity
for
terrestrial
animals
indicate
that
metaldehyde
is
moderately
toxic
to
mammals
and
slightly
to
moderately
toxic
to
birds
on
an
acute
exposure
basis.
Acute
toxicity
data
for
the
rat
are
selected
as
the
basis
of
the
mammalian
wildlife
risk
assessment.
The
endpoint
for
Japanese
quail
was
selected
as
the
basis
of
the
avian
acute
risk
assessment.
Page
25
of
53
For
the
chronic
assessments,
parental
systemic
toxicity
and
toxicity
to
offspring
are
identified
as
the
endpoint
for
mammalian
wildlife.
For
birds,
the
chronic
endpoint
is
based
on
reproductive
effects
(
reductions
in
the
ratios
of
number
hatched
to
eggs
laid,
to
eggs
set,
and
to
live
embryos;
and
reduction
in
the
ratio
of
hatchling
survival
to
eggs
set),
as
observed
in
a
study
conducted
with
mallard
ducks.

Endpoints
selected
for
the
terrestrial
assessment
are
shown
in
bold
in
Table
10.

Table
10.
Metaldehyde
Toxicity
Values
for
Terrestrial
Organisms
Exposure
Scenario
Species
Study
Type
Toxicity
Value
MRID#

Mammals
Acute
Dose­
based
Rat
Single
oral
dose
LD50(
 
)
=
398
mg/
kg
00131435
Chronic
Rat
reproduction
NOAEC
=
1000
mg/
kg
diet
NOAEL
=
65
mg/
kg
bwt/
day
42823101
Birds
Acute
Dose­
based
Japanese
quail
Single
oral
dose
LD50
=
181
mg./
kg
41553201
(
Supplemental)

Acute
Dietary­
based
Peking
duck
5­
day
dietary
LC50
=
2,668
mg./
kg
41553204
(
Supplemental)

Chronic
Dietary­
based
Mallard
duck
reproduction
NOAEC
<
49
mg/
kg
diet
42867902
(
Supplemental)

(
2)
Other
Terrestrial
Wildlife
Predictably,
toxic
effects
have
been
observed
in
clinical
studies
of
snails
and
slugs,
and
have
also
been
observed
in
the
carabid
beetle.
Toxicity
to
earthworms
appears
to
be
low.
None
of
these
studies
provide
sufficient
data
for
a
quantitative
risk
analysis
for
other
terrestrial
animals.

(
3)
Terrestrial
Plants
There
are
no
toxicity
data
available
for
assessing
risks
to
terrestrial
plants.
Metaldehyde
is
used
to
protect
a
wide
variety
of
plant
types.
No
adverse
ecological
incidents
gave
been
reported
with
regard
to
metaldehyde
and
terrestrial
plants.
The
Agency
is
requiring
toxicity
data
for
terrestrial
plants.
Page
26
of
53
(
4)
Potential
Exposures
for
Terrestrial
Wildlife
The
Agency
assessed
potential
exposures
to
terrestrial
wildlife
from
the
granular
applications
to
all
the
supported
uses
of
metaldehyde
using
the
T­
REX
model.
Input
parameters
to
the
model
are
summarized
in
Table
11.

Table
11.
Input
Parameters
for
Terrestrial
EECs
from
Granular
Applications
Input
Variable
Parameter
Value
Source
Maximum
application
rate
Artichokes:
0.8
lb
ai/
acre
Berries:
0.8
lb
ai/
acre
Cole
crops:
1.0
lb
ai/
acre
Citrus
crops:
1.0
lb
ai/
acre
Grass
grown
for
seed:
1.6
lb
ai/
A
Strawberries:
1.0
lb
ai/
acre
Dichondra/
turf:
1.0
lb
ai/
acre
Ornamentals:
3.5
lb
ai/
acre
Registrant
commitment
Maximum
number
of
applications
per
year
Artichokes:
7
Berries:
5
Cole
crops:
4
Citrus
crops:
6
Grass
grown
for
seed:
4
Strawberries:
3
Dichondra/
turf:
12
Ornamentals:
12
Registrant
commitment
Minimum
application
interval
Artichokes:
18
days
Berries:
14
days
Cole
crops:
14
days
Citrus
crops:
14
days
Grass
grown
for
seed:
21
days
Strawberries:
14
days
Dichondra/
turf:
21
days
Ornamentals:
21
days
Product
Labels
Foliar
half­
life
35
days
T­
REX
Default
%
ai
100%
T­
REX
Guidance
Application
method:
broadcast
Product
Label
Inputs
for
the
LD50/
ft2
Method
for
Granular
Applications
to
Soil
Formulation
type:
granular
Product
Label
Exposure
estimates
are
based
on
the
assumption
that
100%
of
the
applied
granules
will
be
present
on
the
surface
of
the
soil.
A
summary
of
acute
EECs
generated
by
T­
REX
for
granular
applications
of
metaldehyde
is
presented
in
Table
12.
The
Agency
currently
has
no
standard
methodology
for
assessing
chronic
exposures
to
terrestrial
organisms
from
granular
applications.
Page
27
of
53
Table
12.
Terrestrial
EECs
for
Granular
Applications
Use
Site
EEC
(
mg
ai./
ft2)
Artichokes
8
Berries
8
Cole
crops
10
Citrus
crops
10
Grass
grown
for
seed
17
Strawberries
10
Dichondra/
Turf
10.4
Ornamental
Plants
36.4
(
5)
Terrestrial
Risk
Estimates
Acute
RQs
for
granular
broadcast
applications
of
metaldehyde
are
derived
by
dividing
the
acute
LD50
values
for
birds
and
mammals
by
the
application
rate
expressed
in
terms
of
mg
ai/
ft2.
These
RQs
are
shown
in
Table
13.

Table
13.
Acute
RQs
for
Birds
and
Mammals
Birds
Mammals
Use
Site
Body
Weight
Acute
RQ
(
LD50/
ft2)
Body
Weight
Acute
RQ
(
LD50/
ft2)
20
g
3.05*
*
15
g
0.66
*

100
g
0.48**
35
g
0.35
**
Artichokes
1000
g
0.03
1000
g
0.03
20
g
3.05*
15
g
0.66
*

100
g
0.48**
35
g
0.35
**
Berries
1000
g
0.03
1000
g
0.03
20
g
3.81*
15
g
0.82
*

100
g
0.6*
35
g
0.44
**
Cole
crops
1000
g
0.04
1000
g
0.04
20
g
3.81*
15
g
0.82
*

100
g
0.6*
35
g
0.44**
Citrus
1000
g
0.04
1000
g
0.04
20
g
6.09*
15
g
1.32*

100
g
0.96**
35
g
0.7**
Grass
grown
for
seed
1000
g
0.07
1000
g
0.06
20
g
3.81*
15
g
0.82
*

100
g
0.6*
35
g
0.44
**
Strawberries
1000
g
0.04
1000
g
0.04
Page
28
of
53
Birds
Mammals
Use
Site
Body
Weight
Acute
RQ
(
LD50/
ft2)
Body
Weight
Acute
RQ
(
LD50/
ft2)
20
g
3.81*
15
g
0.82*

100
g
0.6*
35
g
0.44**
Dichondra/
Turf
1000
g
0.04
1000
g
0.04
20
g
13.33*
15
g
2.89*

100
g
2.09*
35
g
1.53*
Ornamentals
1000
g
0.15**
1000
g
0.12**

*
RQs
exceed
the
acute
risk
LOC
for
birds
and
mammals
and
for
endangered
species
("
the
acute
risk
LOC,"
RQ
>
0.5)
**
RQs
exceed
the
acute
risk
LOC
for
endangered
species
(
RQ
>
0.1)

Results
of
this
screening
level
analysis
indicate
that
small­
and
medium­
sized
birds
and
mammals
may
be
at
acute
risk
from
exposure
to
granular
applications.
For
all
use
sites,
the
acute
RQs
for
the
smallest
birds
exceed
the
acute
risk
LOC.
For
all
use
sites
except
artichokes
and
berries,
acute
RQs
for
the
medium­
sized
birds
exceed
the
acute
risk
LOC;
for
artichokes
and
berries,
they
exceed
the
acute
risk
LOC
for
endangered
species.
For
ornamentals,
the
acute
risk
LOC
for
endangered
species
is
exceeded
for
the
largest
birds.

For
all
use
sites,
acute
RQs
for
the
smallest
mammals
exceed
the
acute
risk
LOC.
For
medium­
sized
mammals,
the
acute
risk
LOC
for
endangered
species
is
exceeded
for
all
sites;
for
ornamentals,
the
acute
risk
LOC
is
also
exceeded.
The
RQ
for
the
largest
mammals
associated
with
applications
to
ornamentals
exceeds
the
acute
risk
LOC
for
endangered
species.

The
Agency
does
not
have
standard
procedures
for
estimating
chronic
risk
to
terrestrial
wildlife
from
exposure
to
granular
formulations.
Thus,
chronic
risks
to
birds
and
mammals
from
granular
applications
of
metaldehyde
are
not
assessed.

c)
Endangered
Species
Risk
quotients
for
metaldehyde,
derived
from
a
screening
level
analysis,
indicate
a
potential
for
acute
risks
to
endangered
(
listed)
terrestrial
species
associated
with
granular
applications
to
the
modeled
use
sites,
as
noted
below:

Birds
(
also
representing
potential
risks
to
reptiles
and
terrestrial­
phase
amphibians)
 
Acute
RQs
exceed
the
LOC
for
listed
species
for
small­
and
medium­
sized
birds
in
artichokes,
berries,
cole
crops,
citrus,
grass
grown
for
seed,
strawberries,
and
dichondra/
turf
 
Acute
RQs
exceed
the
LOC
for
listed
species
of
all
sizes
of
birds
in
ornamentals
Page
29
of
53
Mammals
 
Acute
RQs
exceed
the
LOC
for
listed
species
for
small­
and
medium­
sized
mammals
in
artichokes,
berries,
cole
crops,
citrus,
grass
grown
for
seed,
strawberries,
and
dichondra/
turf
 
Acute
RQs
exceed
the
LOC
for
listed
species
of
all
sizes
of
birds
in
ornamentals
Chronic
risks
were
not
assessed
for
terrestrial
wildlife
because
the
Agency
lacks
a
methodology
for
assessing
chronic
exposures
associated
with
direct
ingestion
of
granules,
so
chronic
risks
to
endangered
birds
and
mammals
cannot
be
ruled
out.
In
addition,
toxicity
information
for
metaldehyde
is
lacking
on
acute
and
chronic
effects
on
marine/
estuarine
fish
and
invertebrates
(
including
mollusks),
chronic
effects
on
freshwater
fish
and
invertebrates,
and
aquatic
and
terrestrial
plant
toxicity.
Risks
to
these
taxa
cannot
be
precluded,
and
there
is
a
potential
for
direct
effects
to
Federally­
listed
species
in
these
taxa.
Furthermore,
potential
indirect
effects
to
any
species
dependent
upon
species
that
experience
effects
from
the
use
of
metaldehyde
can
not
be
precluded
based
on
the
screening
level
ecological
risk
assessment
conducted
for
this
RED.
These
findings
are
based
solely
on
EPA's
screening
level
assessment
and
do
not
constitute
"
may
affect"
findings
under
the
Endangered
Species
Act.

To
address
concerns
about
risks
to
endangered
species
from
pesticide
use,
the
Agency
has
developed
the
Endangered
Species
Protection
Program
(
ESPP).
The
assessments
of
risk
for
aquatic
and
terrestrial
wildlife
described
in
this
RED
serve
as
a
screening
tool
to
determine
the
need
for
any
species­
specific
assessments
for
listed
species,
in
accordance
with
the
ESPP.
Such
assessments
would
refine
the
screening
level
assessment
by
taking
into
account
such
factors
as
the
geographic
areas
of
pesticide
use
in
relation
to
the
listed
species
and
the
habits
and
habitat
requirements
of
the
listed
species.
If
the
Agency's
species­
specific
assessments
result
in
the
need
to
modify
the
use
of
the
pesticide
in
specific
geographic
areas,
those
changes
will
be
undertaken
through
the
process
described
in
the
Agency
Federal
Register
Notice
(
54
FR
27984)
on
implementation
of
the
ESPP.

C.
Alternatives
Assessment
and
Related
Information
The
Agency
solicited
information
about
critical
uses
and
alternatives
from
the
public
and
from
the
Regional
IPM
Centers
and
their
field
and
academic
contacts
through
the
USDA's
Office
of
Pest
Management
Policy.
Additional
information
was
gleaned
from
the
IPM
Centers'
Crop
Profiles
(
located
at
www.
ipmcenters.
org/
CropProfiles/
).

Comments
were
received
on
the
critical
need
for
metaldehyde
in
some
of
the
agricultural
and
commercial
crops
assessed
for
this
RED
(
especially
strawberries,
caneberries,
citrus,
and
production
ornamentals)
and
in
some
of
the
crops
currently
on
product
labels
but
not
supported
by
the
registrant.
Respondents
also
reported
on
alternatives
to
metaldehyde
that
are
used
and
may
be
efficacious
for
various
use
sites 
iron
phosphate
for
home
lawns
and
parks,
and
for
production
ornamentals
in
the
North
Central
States,
and
copper
bands
or
sprays
for
citrus.
Page
30
of
53
Respondents
also
mentioned
cultural
controls
that
provide
adequate
or
supplemental
controls
in
certain
circumstances,
particularly
for
residential
and
public
land
use.
Cultural
controls
include
hand­
picking,
removal
of
plant
debris
that
can
shelter
slugs
and
snails,
and
watering
in
the
morning
rather
than
in
the
evening
(
snails
and
slugs
favor
damp
conditions
and
feed
at
night).
Ironically,
no­
till
agriculture
can
reduce
some
pesticide
inputs
(
i.
e.,
herbicides),
but
can
favor
development
of
economically
damaging
slug
and
snail
populations
in
plant
debris
on
the
ground.
For
strawberries
and
artichokes,
which
can
be
grown
as
either
annuals
or
perennials,
annual
culture
tends
to
reduce
snail
and
slug
populations
relative
to
perennial
culture
so
that
fewer
or
no
applications
of
metaldehyde
may
be
needed.

The
Agency
conducted
an
assessment
of
alternatives
for
metaldehyde.
The
resulting
document,
entitled
"
Metaldehyde
Alternatives
Assessment,"
July
18,
2006
is
accessible
via
the
docket
at
www.
regulations.
gov.
In
summary,
the
Agency
found
that
metaldehyde
is
the
dominant
molluscicide
for
control
of
snails
and
slugs
in
both
agricultural
crops
and
the
residential/
ornamental
environment.
Methiocarb
is
a
Restricted
Use
carbamate
pesticide
and
is
registered
only
for
a
subset
of
the
sites
where
metaldehyde
and
iron
phosphate
can
be
used:
turf,
and
greenhouse
and
nursery
ornamentals.
Methiocarb
has
limited
usage
except
in
greenhouse
ornamentals.
Iron
phosphate,
a
Reduced
Risk
pesticide,
is
a
newer
registration
also
with
limited
usage.

Data
on
the
relative
efficacy
of
metaldehyde
and
iron
phosphate
for
most
use
sites
are
not
available;
however,
the
consensus
of
numerous
publications
is
that
efficacy
of
iron
phosphate
is
variable
in
agricultural
and
production
horticulture.
Data
suggest
iron
phosphate
generally
is
somewhat
less
effective
than
metaldehyde,
but
may
be
used
more
effectively
under
high
moisture
conditions.
In
contrast,
information
received
from
Oregon
indicates
that
iron
phosphate
does
not
hold
up
well
under
wet
conditions
in
Oregon,
suggesting
that
local
environmental
conditions
may
have
a
large
influence
on
effectiveness.
Growers
may
be
reluctant
to
use
iron
phosphate
because
they
consider
it
to
be
new
and
untested,
and
because
it
is
more
expensive
($
1.55/
lb
vs.
$
1.25
for
metaldehyde).
In
addition,
non­
chemical
measures
are
typically
considered
to
be
either
too
expensive
or
too
labor
intensive
for
wide­
scale
use
in
agriculture.

The
Agency
believes
that
for
residential
use,
iron
phosphate
and
non­
chemical
control
measures
may
both
be
acceptable
alternatives
to
metaldehyde.
Some
ornamentals
growers
favor
the
use
of
iron
phosphate
because
metaldehyde
granules
tend
to
become
moldy;
moldy
granules
are
unsightly
in
pots
and
on
soil
surfaces
and
stick
to
the
shoes
of
customers
as
they
walk
around
greenhouses
and
retail
nurseries.

In
addition,
the
Agency
believes
that
programs
relying
on
the
integration
of
different
methods
of
slug
and
snail
control
(
use
of
metaldehyde
and
iron
phosphate
and
cultural
methods)
can
allow
a
reduction
in
the
number
of
times
metaldehyde
is
applied.
Experts
representing
specific
grower
groups
have
informed
the
Agency
that
the
use
parameters
supported
by
Lonza,
which
are
the
basis
of
the
Agency's
risk
assessments,
overstate
what
is
needed
for
economical
control
of
control
slugs
and
snails
in
some
use
sites.
These
experts
have
provided
use
site­
specific
information
on
reduced
application
Page
31
of
53
rates
and
numbers
of
applications
which
provide
adequate
control.
Lonza
itself
has
indicated
that
numbers
of
applications
can
also
be
reduced
for
other
uses
sites
relative
to
the
parameters
it
initially
cited.

The
Agency
has
considered
this
information
in
its
development
of
the
risk
mitigation
plan
for
metaldehyde.

IV.
Reregistration
Decision
A.
Risks
of
Concern
and
Risk
Mitigation
1.
Dietary
There
are
no
dietary
risks
of
concern
for
metaldehyde.

2.
Residential
There
are
no
residential
risks
of
concern.
MOEs
for
post­
application
risk
to
toddlers
are
above
the
target
MOE
of
1000;
the
MOE
for
combined
risk
from
postapplication
exposures
is
1600.
The
Agency
expects
that
the
requirement
for
formulating
metaldehyde
home
and
garden
products
with
a
bittering
agent
(
as
described
below)
is
effective
in
deterring
direct
ingestion
of
granules
by
children.
At
the
same
time,
the
Agency
believes
it
is
prudent
to
require
label
language
on
best
practices
that
provides
residential
users
with
information
on
how
to
reduce
exposures
to
children.
Labeling
requirements
for
metaldehyde
products
are
detailed
in
Table
16.

3.
Aggregate
Aggregated
risks
from
dietary
and
residential
exposures
are
below
levels
of
concern.
Aggregate
risk
estimates
for
toddlers
are
the
highest
of
the
aggregate
exposures,
with
an
MOE
of
1200.
As
noted
above,
the
Agency
is
requiring
labeling
to
address
potential
post­
application
exposures
to
children.

4.
Occupational
None
of
the
occupational
scenarios
assessed
by
the
Agency
posed
risks
of
concern,
even
at
the
baseline
level
(
handlers
wearing
long­
sleeved
shirts,
long
pants,
shoes,
and
socks,
without
respirators
or
gloves).
Current
labels
typically
require
handlers
to
wear
long­
sleeved
shirts,
long
pants,
waterproof
gloves
(
preferably
chemicallyresistant
and
shoes
and
socks.
Additional
PPE
may
be
required
based
on
product
label
reviews.

Occupational
post­
application
exposures
were
not
assessed,
but
are
not
expected
to
pose
risks
of
concern.
REIs
for
metaldehyde
products
may
be
revised
based
on
product
label
reviews.
Page
32
of
53
5.
General
Concerns
All
end­
use
product
labels
must
be
amended
such
that
they
are
consistent
with
only
those
uses
determined
to
be
eligible
for
reregistration.
All
other
uses
must
be
deleted
from
all
labels.

6.
Domestic
Animals
Based
on
the
number
of
poisoning
incidents
involving
ingestion
of
metaldehyde
products
by
domestic
animals
(
primarily
dogs)
after
application
in
residential
settings,
and
incident
information
suggesting
that
dogs
also
may
ingest
metaldehyde
granules
after
opening
product
packaging,
risks
to
domestic
animals
are
of
concern.

The
Agency
is
implementing
a
performance­
based
mitigation
program
for
residential
uses
of
metaldehyde.
The
Agency
believes
that
this
mitigation
program
will
bring
risks
below
levels
of
concern.
Nevertheless,
the
Agency
will
require
registrants
to
evaluate
the
program
and
submit
confirmatory
data
regarding
its
effectiveness
in
reducing
numbers
of
domestic
animal
incidents
and
lethal
poisoning
incidents.
If
the
data
indicate
that
the
risk
mitigation
program
is
not
effective
in
reducing
the
numbers
and/
or
severity
of
poisoning
incidents
among
domestic
animals,
the
Agency
may
require
additional
mitigation
or
the
termination
of
metaldehyde
registrations
for
non­
agricultural
uses.

The
Agency
is
specifying
a
number
of
label
requirements
to
address
the
risks
to
domestic
animals.
The
required
label
language
is
detailed
in
Table
16.
In
summary,
labels
must
be
revised
to
include
the
following
elements:

Labels
for
residential­
use
products
must
prominently
display
language
advising
users
that:

 
dogs
and
other
domestic
animals
are
attracted
to
metaldehyde
products,
both
in
the
package
and
when
applied
 
metaldehyde
ingestion
or
other
exposures
to
metaldehyde
can
be
lethal
to
domestic
animals
 
domestic
animals
must
be
excluded
from
treated
areas
during
and
after
application,
and
until
applied
material
is
no
longer
visible
 
application
of
metaldehyde
granules
is
prohibited
unless
domestic
animals
can
be
excluded
from
the
treated
areas
after
application
and
until
the
material
is
no
longer
visible.
 
metaldehyde
products
must
be
kept
out
of
the
reach
of
domestic
animals
and
children.
 
dogs
have
been
known
to
ingest
metaldehyde
after
opening
or
tearing
packaging,
and
that
resulting
exposures
can
be
fatal
These
statements
must
be
accompanied
by
a
graphic
that
depicts
the
prohibition
for
allowing
children
and
domestic
animals
access
to
treated
areas
(
e.
g.,
the
words
Page
33
of
53
"
Children
and
Pets"
within
a
red
circle
with
a
red
bar
running
diagonally
through
the
circle).
Labels
of
residential
use
metaldehyde
products
already
bear
graphic
images
of
this
nature
that
instruct
the
user
as
to
how
pellets
should
be
placed
(
stylized
plants
with
granules
distributed
improperly
are
shown
within
a
red
circle
with
a
diagonal
red
bar).
The
formulators
of
metaldehyde
have
commented
that
they
believe
a
"
Children
and
Pets"
graphic
of
this
nature
could
be
misleading
to
consumers.
The
Agency
is
evaluating
precedents
for
this
type
of
graphic
in
other
consumer
products,
and
is
specifically
seeking
public
input
in
the
comment
period
after
the
RED
becomes
available
on
how
the
directions
to
exclude
children
and
domestic
animals
from
treated
areas
may
be
enhanced
via
product
labeling.

In
addition,
labels
for
all
residential­
use
products:

 
must
prominently
display
directions
for
users
in
the
case
of
domestic
animal
exposures,
providing
the
information
hotline
number
and
instructing
users
or
pet
owners
to
contact
their
veterinarians
as
soon
as
possible
after
exposure
occurs.

 
must
note
that
broadcast
and
foliar
applications
are
prohibited.

 
must
note
that
applications
to
turf
and
dichondra
are
prohibited.

 
will
allow
application
only
to
non­
turf
areas
directly
surrounding
plants
(
on
soil
or
mulch)
listed
on
product
labels.

 
will
allow
use
only
as
a
barrier
around
gardens
or
individual
plants,
with
application
prohibited
within
one
foot
of
vegetable
plants
or
fruit­
bearing
plants
for
which
metaldehyde
use
is
not
allowed.

 
will
allow
application
for
ornamentals,
and
garden
vegetable
and
fruit­
bearing
plants
only
as
a
barrier
treatment.
The
only
allowable
home
garden
use
sites
for
metaldehyde
are
ornamentals,
cole
crops
and
other
leafy
greens
(
cabbage,
broccoli,
Brussels
sprouts,
cauliflower,
kale,
collard
greens,
etc.),
lettuce,
tomato,
citrus,
strawberry,
blueberries,
and
caneberries
(
e.
g.,
raspberries,
blackberries)
and
other
berries.

 
must
be
amended
to
provide
application
directions
in
user­
friendly
terms,
for
example,
"
Apply
pellets
as
a
barrier
around
plants
by
distributing
pellets
evenly
in
a
line
at
a
rate
of
X
tablespoons
per
X
linear
foot."
The
application
rates
described
in
this
way
must
not
represent
use
at
an
application
rate
greater
than
the
1.0
lb
ai/
A/
application
for
ornamentals.
Applications
for
ornamentals
are
limited
to
6/
year,
at
an
interval
not
less
than
21
days
between
applications.
Application
rates
and
other
application
parameters
for
other
uses
are
as
described
below.

The
technical
registrant
of
metaldehyde,
Lonza,
has
committed
to
expediting
submission
of
residential­
use
products
revised
to
reflect
these
requirements.
Page
34
of
53
The
following
formulation
requirements
must
be
implemented
for
residential­
use
products
containing
metaldehyde:

 
Formulation
of
metaldehyde
in
combination
with
carbaryl
is
prohibited
unless
the
product
is
formulated
to
provide
a
single
application
rate
that
does
not
exceed
the
maximum
allowable
rate
for
either
active
ingredient.

 
All
residential
use
products
containing
metaldehyde
must
be
formulated
with
denatonium
benzoate,
or
another
bittering
agent
approved
by
the
Agency,
at
sufficient
concentration
to
deter
ingestion
by
domestic
animals.
The
bittering
agent
will
also
serve
as
a
deterrent
for
ingestion
by
children.

In
addition,
labels
for
metaldehyde­
carbaryl
combination
products
must
bear
language
advising
users
that
such
products
must
not
be
applied
unless
both
snails
or
slugs
and
target
pests
for
carbaryl
are
present.
Since
metaldehyde
products
will
no
longer
be
permitted
on
turf,
the
utility
of
these
combination
products
may
be
limited
in
the
future.

Furthermore,
the
registrants
are
required
to
submit
data
demonstrating
the
effectiveness
of
the
bittering
agent
incorporated
into
the
residential­
use
metaldehyde
products,
at
the
concentration
used
in
those
formulations.
Lonza
has
indicated
that
it
is
evaluating
a
new
agent,
which
is
composed
of
the
original
bittering
agent,
denatonium
benzoate,
plus
an
olfactory
agent.
The
Agency
is
requiring
palatability
data
for
denatonium
benzoate
and
any
new
bittering
agent
the
registrants
wish
to
employ,
to
confirm
the
effectiveness
of
such
an
approach
in
deterring
ingestion
by
domestic
animals.
If
the
data
indicate
that
the
aversion
agent
used
in
metaldehyde
formulations
(
at
the
concentration
used
in
those
formulations)
is
not
efficacious
in
deterring
ingestion
by
domestic
animals,
the
Agency
may
require
additional
testing
and
implementation
of
additional
mitigation
measures.

The
registrants
are
also
required
to
implement
a
common
reporting
system
for
domestic
animal
poisoning
incidents
associated
with
all
metaldehyde
products,
and
are
required
to
submit
quarterly
reports
on
incidents
reported
for
the
time
period.
The
registrants
are
required
to
submit
a
protocol
for
the
reporting
program
to
EPA
for
review
prior
to
implementing
the
program.
The
Agency's
analysis
of
trends
in
the
numbers
and
severity
of
poisoning
incidents
associated
with
metaldehyde,
or
other
relevant
information,
will
be
the
basis
of
decisions
on
additional
requirements
for
risk
mitigation.

The
registrants
are
also
required
to
submit
data
on
the
efficacy
of
metaldehyde
products
formulated
with
non­
food­
based
inerts
and
bulking
agents.
If
the
Agency
finds
that
products
formulated
with
these
materials
are
efficacious
in
controlling
the
target
pests,
the
registrants
will
be
required
to
reformulate
accordingly.
Page
35
of
53
7.
Environmental
The
Agency
has
assessed
risks
to
nontarget
wildlife
associated
with
the
residential
and
agricultural
uses
of
metaldehyde.

Based
on
a
screening
level
assessment,
the
Agency
has
concluded
that
acute
RQs
for
birds
and
mammals
exceed
LOCs
for
acute
risk
and
acute
endangered
species
risk
for
all
uses
of
metaldehyde
for
most
size
ranges
of
animals.
Incident
data
for
domestic
animals
and
wildlife
are
supportive
of
the
potential
for
risks
of
concern
in
mammalian
wildlife.
Metaldehyde
itself,
and
the
food­
based
materials
the
pesticide
is
formulated
with,
are
reported
to
be
attractive
to
animals.
In
contrast
to
the
conservative
nature
of
the
Agency's
screening
level
exposure
assessment,
preferential
selection
of
metaldehyde
granules
as
a
food
source
would
suggest
that
risks
to
non­
target
wildlife
may
be
underestimated.

Metaldehyde
is
slightly
toxic
to
freshwater
fish
on
an
acute
basis.
RQs
for
freshwater
fish
do
not
exceed
LOCs
as
assessed.
Testing
of
a
representative
freshwater
invertebrate
did
not
result
in
mortality
even
at
the
highest
dose
tested.
There
are
significant
data
gaps
for
chronic
toxicity
to
freshwater
animals
and
for
acute
and
chronic
toxicity
to
estuarine/
marine
animals.
There
are
no
data
to
allow
an
assessment
of
the
risks
metaldehyde
use
poses
to
non­
target
aquatic
mollusks,
but
because
the
pesticide
is
an
effective
molluscicide,
it
is
reasonable
to
assume
that
there
may
be
risks
associated
with
exposures
to
non­
target
aquatic
mollusks.

The
Agency
is
specifying
a
number
of
risk
mitigation
measures
to
target
risks
to
wildlife.
Required
label
language
is
detailed
in
Table
16.

 
Labels
must
allow
use
only
on
the
following
sites
(
maximum
application
rate/
application,
maximum
number
of
applications/
season,
minimum
retreatment
interval):

Citrus:
1.0
lb
ai/
A,
6
applications,
14
days
Cole
crops
and
other
leafy
greens:
1.0
lb
ai/
A,
3
applications,
14
days
Lettuce:
1.0
lb
ai/
A,
3
applications,
14
days
Tomato:
1.0
lb
ai/
A,
3
applications,
14
days
Strawberry
(
when
grown
as
perennials
only):
1.0
lb
ai/
A,
3
applications,
14
days
Blueberries:
0.8
lb
ai/
A,
2
applications,
14
days
Caneberries
and
other
berries:
0.8
lb
ai/
A,
3
applications,
14
days
Grass
grown
for
seed:
0.8
lb
ai/
A,
4
applications,
21
days
Artichokes
(
when
grown
as
perennials):
1.0
lb
ai/
A,
6
applications,
18
days
Artichokes
(
when
grown
as
annuals):
1.0
lb
ai/
A,
2
applications,
18
days
Ornamentals:
1.0
lb
ai/
A,
6
applications,
21
days
Applications
to
turf
and
dichondra
are
prohibited.
The
mandated
application
rate
for
ornamentals
is
lower
than
the
rate
assessed
for
this
RED
(
3.5
lbs
ai
vs.
1
lb
ai),
as
it
is
for
grass
grown
as
seed
(
1.6
lbs
ai
vs.
0.8
lb
ai).
Numbers
of
applications
are
reduced
Page
36
of
53
relative
to
what
was
assessed
in
the
RED
for
lettuce,
cole
crops
and
other
leafy
greens,
tomato,
strawberries
grown
as
perennials,
caneberries
and
other
berries,
artichokes,
and
ornamentals.
Reductions
in
maximum
application
rates
and
numbers
of
repeat
applications
reduce
opportunities
for
exposure
to
domestic
animals
and
wildlife,
and
promote
the
use
of
alternate
methods
of
slug
and
snail
control.
Retreatment
intervals
are
as
proposed
by
Lonza
and
assessed
by
the
Agency,
and
have
not
changed
as
a
result
of
the
risk
assessments.

 
For
strawberries
grown
as
annuals,
pest
populations
are
expected
to
be
much
lower
than
in
strawberries
grown
as
perennials.
The
use
of
metaldehyde
on
annual
strawberries
must
be
deleted
from
product
labels.
The
Agency
is
soliciting
public
comment
on
this
prohibition
of
use
on
strawberries
grown
as
annuals,
will
consider
any
documentary
evidence
of
grower
need
for
metaldehyde
on
this
crop.

 
Certain
cultural
practices
may
reduce
damage
from
snails
and
slugs,
and
may
make
metaldehyde
applications
more
effective.
Labels
of
residential
use
products
must
provide
summary
information
about
cultural
controls
(
e.
g.,
remove
leaf
litter
and
debris;
during
daylight
hours,
look
for
and
remove
slugs
and
snails
in
leaf
litter,
mulch,
or
other
protected
areas
adjacent
to
plants
they
feed
on;
water
or
irrigate
in
the
morning,
when
possible).

It
should
be
noted
that
the
Agency
believes
that
a
bittering
agent
likely
would
not
be
effective
in
preventing
ingestion
of
metaldehyde
by
terrestrial
wildlife
species
because
of
the
great
diversity
of
potentially
exposed
species
and
differences
in
how
they
perceive
taste.
The
Agency
believes
that
these
mitigation
measures
discussed
in
this
section
will
reduce
potential
environmental
exposures
to
metaldeyhyde,
for
both
aquatic
and
terrestrial
organisms.
The
Agency
is
requiring
additional
ecotoxicity
data
to
reduce
the
uncertainty
in
the
ecological
risk
assessment.

8.
Other
Measures
Addressing
Both
Domestic
Animal
and
Ecological
Risks
Based
on
the
similarity
in
size
of
some
pet
foods/
wildlife
forage
items
and
the
larger
pellet
sizes
of
metaldehyde,
and
evidence
suggesting
that
animals
may
mistake
the
pellets
for
food,
the
formulators
of
metaldehyde
products
will
be
prohibited
from
formulating
granular
materials
at
a
rate
of
fewer
than
35
pellets
per
gram.

Based
on
evidence
that
brightly
colored
granules
may
be
less
attractive
to
animals,
formulators
must
incorporate
a
coloring
agent
into
their
granular
formulations.
Many
metaldehyde
products
already
are
formulated
with
a
blue
color.
It
has
been
suggested
that
the
blue
color
may
attract
children
who
could
mistake
the
pellets
for
candy.
Empirical
or
other
evidence
relating
to
the
potential
for
reducing
animal
exposures
with
the
colored
pellets
is
limited.
In
addition,
the
formulators
of
metaldehyde
have
indicated
that
the
use
of
colored
pellets
could
affect
the
marketability
of
some
kinds
of
produce
if
the
blue
color
splashes
or
bleeds
onto
plant
parts,
while
other
sources
have
indicated
that
color
transfer
is
not
and
should
not
be
a
problem
for
soil­
applied
baits.
The
Page
37
of
53
Agency
is
specifically
seeking
public
input
on
this
issue
in
the
comment
period
after
the
RED
becomes
available.

The
Agency
believes
that
the
risk
mitigation
measures
required
by
the
RED
will
be
effective
in
reducing
risks
below
levels
of
concern.
The
Agency
is
requiring
certain
confirmatory
data
to
support
the
adequacy
of
those
measures,
and
may
require
additional
mitigation
measures
and
testing.

The
registrants
are
required
to
submit
data
on
the
efficacy
of
metaldehyde
products
formulated
with
non­
food­
based
inerts
and
bulking
agents.
If
the
Agency
finds
that
products
formulated
with
these
materials
are
efficacious
in
controlling
the
target
pests,
the
registrants
will
be
required
to
reformulate
accordingly.

B.
Tolerance
Considerations
The
Agency
has
reassessed
the
one
existing
tolerance
for
metaldehyde,
and
found
a
reasonable
certainty
of
no
harm
to
the
U.
S.
population
and
all
population
subgroups
from
the
use
of
metaldehyde.
The
Agency
also
has
identified
new
tolerances
that
are
needed
for
metaldehyde.
The
existing
tolerance
is
a
tolerance
exemption
of
0
ppm
on
strawberry.
Both
the
tolerance
exemption
and
the
lack
of
other
tolerances
for
metaldehyde
are
attributable
to
past
belief
by
the
Agency
that
residues
of
metaldehyde
would
not
be
taken
up
by
plants.
The
tolerance
reassessment
and
tolerances
needed
to
support
uses
of
metaldehyde
are
shown
in
Table
14.

Table
14.
Tolerance
Summary
for
Metaldehyde
Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)

Tolerance
Listed
Under
40
CFR
§
180.523(
a)

Strawberry
0
6.25
Tolerances
Needed
under
40
CFR
180.523(
a)

Artichoke,
globe
None
0.0625
Berry,
group
13
None
0.15
Fruit,
citrus,
group
10
None
0.26
Prickly
pear
cactus
None
0.0625
Vegetable,
brassica,
leafy,
group
5
(
cole
crops)
None
2.5
Lettuce
None
1.73
Vegetable,
fruiting,
group
8
(
Tomato)
None
0.24
The
use
of
metaldehyde
on
grass
grown
for
seed
necessitates
development
of
residue
data
and
establishment
of
a
tolerance
for
metaldehyde,
because
screenings
from
Page
38
of
53
seed
cleaning
and
grass
hay
from
the
treated
fields
may
be
used
as
animal
feed.
These
data,
in
development
by
IR­
4,
are
expected
to
be
submitted
to
the
Agency
in
the
future,
at
which
time
the
appropriate
tolerance
level
can
be
identified.

C.
Eligibility
Decision
Metaldehyde
products
are
currently
labeled
for
many
uses
which
are
not
being
supported
by
the
technical
registrant.
Only
those
uses
that
are
supported
by
the
registrant
through
development
of
required
data
have
been
assessed
for
this
reregistration
decision.
The
uses
of
metaldehyde
that
are
being
supported
are:
turf/
dichondra,
ornamentals,
citrus,
lettuce,
cole
crops
and
other
leafy
greens,
tomato,
strawberry,
berries
(
including
blackberry,
blueberry,
currant,
elderberry,
gooseberry,
raspberries),
and
grass
grown
for
seed,
and
artichoke.
With
the
exception
of
the
use
on
turf
and
dichondra,
these
uses
of
metaldehyde
are
eligible
for
reregistration,
provided
that
the
risk
mitigation
measures
required
by
this
RED
are
implemented,
and
the
data
submitted
pursuant
to
the
requirements
identified
in
this
RED
are
confirmatory.

The
IR­
4
program
of
the
U.
S.
Department
of
Agriculture,
which
develops
residue
data
for
minor
and
specialty
crops,
has
done
research
on
a
number
of
additional
uses
for
metaldehyde.
At
the
current
time,
residue
data
for
the
use
of
metaldehyde
on
prickly
pear
cactus
and
watercress
are
in
development.
While
these
uses
were
included
in
the
health
effects
and
environmental
risk
assessments
for
metaldehyde,
decisions
on
their
registration
have
not
been
made
for
this
RED.

V.
What
Registrants
Need
to
Do
A.
Submissions
for
Technical­
Grade
Active
Ingredient
Products
1.
Within
90
Days
of
Receipt
of
the
Generic
DCI
For
each
metaldehyde
technical
grade
active
ingredient
product,
the
registrant
needs
to
submit
the
following
items
within
90
days
of
receiving
the
Generic
DCI:

 
completed
response
forms
to
the
generic
DCI
(
i.
e.,
DCI
response
form
and
requirements
status
and
registrant's
response
form);
and
 
submit
any
time
extension
and/
or
waiver
requests
with
a
full
written
justification
2.
Within
Other
Generic
DCI
Deadlines
Within
the
time
limit
specified
in
the
generic
DCI,
the
registrant
must
cite
any
existing
generic
data
or
submit
new
generic
data
in
response
to
the
DCI.
Please
contact
Jill
Bloom
at
(
703)
308­
8019
with
questions
regarding
generic
reregistration.
Page
39
of
53
By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
Document
Processing
Desk
(
DCI/
SRRD)
(
DCI/
SRRD)
Jill
Bloom
Jill
Bloom
Office
of
Pesticide
Programs
(
7508P)
US
EPA
(
7508P)
4th
Floor,
One
Potomac
Yard
1200
Pennsylvania
Ave.,
NW.
2777
S.
Crystal
Dr.
Washington,
DC
20460
Arlington,
VA
22202
B.
Submissions
for
End­
Use
Products
Containing
Metaldehyde
1.
Within
90
Days
Within
90
days
from
the
receipt
of
the
product­
specific
data
call­
in
(
PDCI),
the
registrant
must
submit,
for
each
product:

 
completed
response
forms
to
the
PDCI
(
i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
 
any
time
extension
or
waiver
requests
with
a
full
written
justification.

2.
Within
Product
DCI
Deadlines
Within
eight
months
from
the
receipt
of
the
PDCI,
the
registrant
must
submit:

 
two
copies
of
the
confidential
statement
of
formula
(
EPA
Form
8570­
4);
 
a
completed
original
application
for
reregistration
(
EPA
Form
8570­
1).
Indicate
on
the
form
that
it
is
an
"
application
for
reregistration";
 
five
copies
of
the
draft
label
incorporating
all
label
amendments
outlined
in
Table
47
of
this
document;
 
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);
and
 
if
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(
EPA
Form
8570­
32);
and
 
the
product­
specific
data
responding
to
the
PDCI.

Please
contact
Bonnie
Adler
at
(
703)
308­
8523
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed
as
follows:

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
Document
Processing
Desk
(
PDCI/
PRB)
(
PDCI/
PRB)
Bonnie
Adler
Bonnie
Adler
OPP
(
7508P)
US
EPA
(
7508P)
4th
Floor,
One
Potomac
Yard
1200
Pennsylvania
Ave.,
NW.
2777
S.
Crystal
Drive.
Washington,
DC
20460
Arlington,
VA
22202
Page
40
of
53
C.
Manufacturing­
Use
Products 
Data
Requirements
The
Agency
has
determined
that
additional
generic
data
are
needed
to
confirm
this
reregistration
eligibility
decision.
These
data
are
summarized
in
Table
15,
and
cited
in
the
Generic
DCI
for
metaldehyde.

Table
15.
Generic
Data
Requirements
for
Metaldehyde
Guideline
or
Special
Study
Name
or
Description
OPPTS
Guideline
No.

Developmental
neurotoxicity
study
(
rat)
870.6300
90
day
inhalation
toxicity
study
(
rat)
1
870.3465
Mutagenicity
battery
870.5000
series
Field
trials2
860.1500
Reference
standard
for
metaldehyde3
860.1650
Field
accumulation
in
rotational
crop
860.1900
Turf
dissipation
study
(
TTR)
4
875.2100
Aerobic
Soil
Metabolism5
835.4100
Anaerobic
Aquatic
Metabolism
835.4400
Aerobic
Aquatic
Metabolism
835.4300
Terrestrial
Field
Dissipation6
835.6100
Bivalve
Acute
(
Embryo
Larval)
EC50
850.1055
Estuarine/
Marine
Fish
LC50
850.1075
Estuarine/
Marine
Mollusk
Shell
Deposition
EC50
850.1025
Estuarine/
Marine
Mysid
Shrimp
EC50
850.1035
Freshwater
Fish
Early
Life­
Stage
850.1400
Daphnid
Chronic
Life­
Cycle
850.1300
Estuarine/
Marine
Invertebrate
Life­
Cycle7
850.1350
Freshwater
Fish
Full
Life­
Cycle7
850.1500
Seedling
Emergence
(
Tier
I)
850.4100
1
The
Agency
will
consider
registrant
submission
of
a
waiver
request
for
this
data
requirement
supported
by
discussion
of
the
volatility
of
metaldehyde
and
potential
for
occupational
inhalation
exposure,
or
other
supporting
information.
2
Confirmatory
field
trial
data
are
required
on
leafy
lettuce
(
2
tests)
to
support
permanent
tolerances
on
the
leafy
vegetable
crop
group
3
Reference
Standard
must
be
submitted
to
the
National
Pesticide
Standards
Repository
4
Confirmatory
data
required
to
support
intermediate­
term
exposure
estimates
5
Weight­
of­
evidence
of
laboratory
and
field
data
suggests
that
there
is
uncertainty
with
relying
on
a
single
aerobic
soil
metabolism
test
system.
The
submission
of
additional
aerobic
soil
metabolism
data
is
required
in
order
to
minimize
this
uncertainty.
6
Soil
samples
were
not
tested
at
lower
depths
for
metaldehyde.
Study
design
must
allow
the
Agency
to
distinguish
between
metaldehyde
residues
in
upper
soil
layer
and
undissolved
pellets.
7
Requirement
reserved
pending
review
of
related
data
Page
41
of
53
Guideline
or
Special
Study
Name
or
Description
OPPTS
Guideline
No.

Vegetative
Vigor
(
Tier
I)
850.4150
Aquatic
Plant
Toxicity
(
Tier
I)
850.4400
Incident
reporting
program8
NA
Palatability
of
materials
incorporating
bittering
agent8
NA
Efficacy
of
products
utilizing
non­
food
based
inerts8
NA
D.
Labeling
To
ensure
compliance
with
FIFRA,
manufacturing­
use
product
(
MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices,
and
applicable
policies.
Furthermore,
all
MUP
labels
must
be
amended
to
incorporate
the
risk
mitigation
measures
outlined
in
this
RED.
Table
16
details
how
language
on
the
labels
must
be
amended.
MUP
labeling
revised
in
this
manner
must
be
submitted
within
90
days
of
receipt
of
the
generic
DCI
issued
pursuant
to
this
RED.

In
order
to
be
eligible
for
reregistration,
labeling
for
all
end­
use
products
containing
metaldehyde
must
be
amended
to
incorporate
the
risk
mitigation
measures
outlined
in
this
RED.
Table
16
details
how
language
on
the
labels
must
be
amended.
End­
use
product
labeling
revised
in
this
manner
must
be
submitted
within
eight
months
from
the
receipt
of
the
PDCI
issued
pursuant
to
this
RED
8
Protocols
required
in
advance
of
study
initiation
Page
42
of
53
Table
47.
Labeling
Changes
for
Products
Containing
Metaldehyde
Description
Amended
Labeling
Language
Placement
on
Label
Manufacturing­
Use
Products
For
all
Manufacturing­
Use
Products
"
This
product
may
be
formulated
into
a
molluscicide
for
the
following
use(
s)

only:
artichokes,
blueberries,
caneberries
(
bingleberry,
black
raspberry,

blackberry,
boysenberry,
dewberry,
lowberry,
marionberry,
olallieberry,
red
raspberry,
youngberry)
and
other
berries
(
currant,
elderberry,
gooseberry,

huckleberry,
loganberry,
lingonberry,
juneberry,
salal),
citrus,
lettuce,
cole
crops
and
other
leafy
greens
(
broccoli,
Brussels
sprouts,
cabbage,
cauliflower,

cavalo,
broccolo,
collards,
kale,
kohlrabi,
mizuna,
mustard
greens,
spinach,

rape
greens),
grass
grown
for
seed,
ornamentals,
tomato,
and
strawberry
(
grown
as
perennials
only)."

"
This
product
may
not
be
formulated
into
end­
use
products
for
use
on
turf
(
except
grass
grown
for
seed),
dichondra
lawns,
or
strawberries
grown
as
annuals."

"
This
product
may
not
be
formulated
into
end­
use
granular
or
pelletized
products
unless
those
products
are
formulated
to
incorporate
a
bright
blue
coloring
agent."

"
This
product
may
not
be
formulated
into
end­
use
granular
or
pelletized
products
unless
those
products
are
formulated
to
contain
more
than
35
pellets
per
gram."

"
This
product
may
not
be
formulated
into
end­
use
granular
or
pelletized
products
with
directions
permitting
use
at
residential
sites
(
i.
e.,
in
yards
or
gardens,
around
homes,
apartments,
schools,
athletic
fields,
playgrounds,
parks,

etc.)
unless
such
products
contain
denatonium
benzoate
at
300
ppm
or
another
Directions
for
Use
Page
43
of
53
Description
Amended
Labeling
Language
Placement
on
Label
bittering
agent
approved
by
the
Agency.
The
bittering
agent
must
be
of
sufficient
concentration
to
deter
ingestion
by
children
and
domestic
animals."

"
This
product
may
not
be
formulated
into
end­
use
products
with
directions
permitting
use
at
residential
sites
(
i.
e.,
in
yards
or
gardens,
around
homes,

apartments,
schools,
daycare
facilities,
athletic
fields,
playgrounds,
parks,

recreation
areas,
etc.)
unless
the
labels
of
such
products
contain
a
graphic
that
depicts
the
prohibition
on
allowing
children
and
domestic
animals
access
to
treated
areas
and
specific
warnings
designed
to
reduce
the
numbers
of
incidents
involving
children
and
domestic
animals."

One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"
This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.

EPA
submission
requirements
regarding
support
of
such
use(
s)."

"
This
product
may
be
used
to
formulate
products
for
any
additional
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
"
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,

estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollution
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."
Precautionary
Statements
End
Use
Products
Intended
for
Agricultural
Use
Page
44
of
53
Description
Amended
Labeling
Language
Placement
on
Label
Domestic
Animal
Precautionary
Statements
"
This
product
can
be
fatal
to
children
and
dogs
(
and
other
domestic
animals)

when
ingested.
Children
and
dogs
may
be
attracted
to
the
product.
Application
of
this
product
is
prohibited
unless
children
and
domestic
animals
can
be
excluded
from
the
treated
area
from
the
start
of
the
application
until
applied
material
is
no
longer
visible."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED9
"
Mixers,
loaders,
applicators,
and
other
handlers
must
wear:

long­
sleeved
shirts
and
long
pants,
and
shoes
plus
socks."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
User
Safety
Requirements
"
Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry."

"
Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
9
PPE
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.
The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.
Page
45
of
53
Description
Amended
Labeling
Language
Placement
on
Label
User
Safety
Recommendations
"
User
Safety
Recommendations"

"
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet."

"
Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.
Then
wash
thoroughly
and
put
on
clean
clothing."

"
Users
should
remove
PPE
immediately
after
handling
this
product.

Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(
Must
be
placed
in
a
box.)

Environmental
Hazard
Statement
"
This
pesticide
is
toxic
to
fish
and
aquatic
invertebrates.
Do
not
apply
directly
to
water,
to
areas
where
surface
water
is
present,
or
to
intertidal
areas
below
the
mean
high
water
mark
except
as
noted
on
appropriate
labels.
Drift
and
runoff
may
be
hazardous
to
aquatic
organisms
in
water
adjacent
to
treated
areas.
Do
not
contaminate
water
when
disposing
of
equipment
wash
waters
or
rinsate.

This
pesticide
is
toxic
to
birds
and
mammals.
Granules
on
soil
surface
may
be
hazardous
to
terrestrial
wildlife.
Cover
or
collect
any
such
materials
spilled
during
loading."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Poisoning
Hotline
"
Seek
medical
care
as
soon
as
possible
after
exposure.
Have
the
product
container
or
label
with
you
when
you
call
a
poison
control
center
or
doctor
or
when
going
for
treatment.
For
information
on
this
pesticide
product
(
including
health
concerns,
medical
emergencies,
or
pesticide
incidents),
call
the
National
Pesticide
Information
Center
at
1­
800­
858­
7378.

"
For
incidents
involving
animals,
seek
veterinary
care
as
soon
as
possible
after
exposure.
Have
the
product
container
or
label
with
you
when
you
call
a
poison
Precautionary
Statements,
under
"
First
Aid"
:

Poisoning
Hotline
Page
46
of
53
Description
Amended
Labeling
Language
Placement
on
Label
control
center
or
veterinarian
or
when
taking
an
exposed
animal
for
treatment.

For
treatment
advice
and
other
information
about
exposures
of
animals
to
this
pesticide,
call
[
registrant
enters
name
of
reporting
service]
at
[
registrant
enters
appropriate
toll­
free
telephone
number].

Restricted­
Entry
Interval
for
products
with
directions
for
use
within
scope
of
the
Worker
Protection
Standard
for
Agricultural
Pesticides
(
WPS)
"
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(
REI)
of
12
hours.
Exception:
if
the
product
is
soil­
injected
or
soil­
incorporated,
the
Worker
Protection
Standard,
under
certain
circumstances,

allows
workers
to
enter
the
treated
areas
without
restriction
if
there
will
be
no
contact
with
anything
that
has
been
treated."
Directions
for
Use,

Under
Agricultural
Use
Requirements
Box
Early
Entry
Personal
Protective
Equipment
for
products
with
directions
for
use
within
the
scope
of
the
WPS
"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil,
or
water,
is:

*
coveralls,

*
shoes
plus
socks
*
chemical­
resistant
gloves
made
of
any
waterproof
material"
Direction
for
Use
Agricultural
Use
Requirements
box
General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application.
"
Direction
for
Use
Immediately
above
the
Agricultural
Use
Requirements
box
Other
Application
Restrictions
"
This
product
is
intended
solely
for
use
on
agricultural
crops
grown
for
commercial
or
research
purposes.
This
product
may
not
be
applied
to
residential
sites
(
i.
e.,
in
yards
or
gardens,
around
homes,
apartments,
schools,

athletic
fields,
playgrounds,
parks,
etc.)."

"
Broadcast
or
foliar
applications
of
this
product
are
prohibited."
Directions
for
Use
Crop
Specific
Directions
for
End­
use
product
labels
must
be
amended
to
contain
directions
for
use
only
on
Directions
for
Use
Page
47
of
53
Description
Amended
Labeling
Language
Placement
on
Label
Use
the
following
crop­
and
use­
sites
and
only
with
the
maximum
application
rate,

maximum
number
of
applications
per
growing
season,
and
minimum
retreatment
intervals
as
listed
below.
All
other
crop­
and
use­
sites
must
be
removed
from
end­
use
product
labels.

Artichokes:

­
When
grown
as
a
perennial,
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
18
days.

­
When
grown
as
an
annual,
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
2
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
18
days.

Blueberries:
the
maximum
application
rate
is
0.8
lb
ai/
A
per
application.
A
maximum
of
2
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Caneberries
(
bingleberry,
black
raspberry,
blackberry,
boysenberry,
dewberry,

lowberry,
marionberry,
olallieberry,
red
raspberry,
youngberry)
and
Other
Berries
(
currant,
elderberry,
gooseberry,
huckleberry,
loganberry,
lingonberry,

juneberry,
salal):
the
maximum
application
rate
is
0.8
lb
ai/
A
per
application.

A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Citrus:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Lettuce,
Cole
Crops,
And
Other
Leafy
Greens:
(
broccoli,
Brussels
sprouts,
associated
with
the
specific
crop­
or
usesite
Page
48
of
53
Description
Amended
Labeling
Language
Placement
on
Label
cabbage,
cauliflower,
cavalo,
broccolo,
collards,
kale,
kohlrabi,
mizuna,

mustard
greens,
spinach,
rape
greens):
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Grass
grown
for
seed:
the
maximum
application
rate
is
0.8
lb
ai/
A
per
application.
A
maximum
of
4
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
21
days.
Applications
to
turfgrass
(
other
than
grass
grown
for
seed)
are
prohibited.

Ornamentals:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
21
days.

Tomatoes:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Strawberries
(
grown
as
perennials
only):
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.
Applications
to
strawberries
grown
as
annuals
are
prohibited.

Storage
Restrictions
"
This
product
can
be
fatal
to
children
and
dogs
(
and
other
domestic
animals)
if
ingested.
Dogs
have
been
known
to
ingest
metaldehyde
after
opening
or
tearing
packaging.
Store
this
product
in
its
original
packaging,
in
a
cool,
secure
location,
and
out
of
reach
of
children
and
pets.
Do
not
store
in
any
location
where
children
and
domestic
animals
can
access
the
packaging
or
the
product."
Storage
and
Disposal
Products
Intended
for
Use
at
Residential
Sites
Page
49
of
53
Description
Amended
Labeling
Language
Placement
on
Label
Precautionary
Statement
and
Graphic
Depiction
for
Products
Intended
for
Use
at
Residential
Sites
The
label
of
any
end­
use
product
with
directions
for
use
at
residential
sites
(
i.
e.,

in
yards
or
gardens,
around
homes,
apartments,
schools,
daycare
facilities,

athletic
fields,
playgrounds,
parks,
recreation
areas,
etc.)
must
contain
a
graphic
that
depicts
the
prohibition
on
allowing
children
and
domestic
animals
access
to
treated
areas.
For
example,
the
symbol
may
be
a
red
circle
with
the
words
"
Children"
and
"
Pets"
within
the
circle
and
with
a
red
bar
running
diagonally
through
it.

The
following
specific
warning
statements
must
be
added
to
the
label
in
close
association
to
the
above
graphic:

"
Keep
out
of
reach
of
children
and
domestic
animals.
This
pesticide
may
be
fatal
to
children
and
dogs
(
and
other
domestic
animals)
when
ingested.

Exclude
children
and
pets
from
treated
areas
until
the
applied
product
is
no
longer
visible.
For
additional
precautionary
measures,
see
"
Directions
for
Use"

and
"
Storage
and
Disposal."
Front
panel
Precautionary
Language
"
IMPORTANT:
This
product
may
be
fatal
to
children
and
dogs
(
and
other
domestic
animals)
if
ingested.
Keep
out
of
reach
of
children
and
domestic
animals.
Children
and
dogs
may
be
attracted
to
metaldehyde
products.
and
their
packaging.
Keep
children
and
dogs
(
and
other
domestic
animals)
out
of
treated
areas
from
the
start
of
application
until
the
applied
product
is
no
longer
visible."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
Poisoning
Hotline
"
Seek
medical
care
as
soon
as
possible
after
exposure.
Have
the
product
container
or
label
with
you
when
you
call
a
poison
control
center
or
doctor
or
when
going
for
treatment.
For
information
on
this
pesticide
product
(
including
health
concerns,
medical
emergencies,
or
pesticide
incidents),
call
the
National
Pesticide
Information
Center
at
1­
800­
858­
7378.

"
For
incidents
involving
animals,
seek
veterinary
care
as
soon
as
possible
after
Precautionary
Statements,
under
"
First
Aid"
:

Poisoning
Hotline
Page
50
of
53
Description
Amended
Labeling
Language
Placement
on
Label
exposure.
Have
the
product
container
or
label
with
you
when
you
call
a
poison
control
center
or
veterinarian
or
when
taking
an
exposed
animal
for
treatment.

For
treatment
advice
and
other
information
about
exposures
of
animals
to
this
pesticide,
call
[
registrant
enters
name
of
reporting
service]
at
[
registrant
enters
appropriate
toll­
free
telephone
number].

Environmental
Hazard
Statement
for
Residential
Use
Products
"
This
product
is
toxic
to
fish
and
aquatic
invertebrates.
Do
not
apply
product
near
water
or
storm
drains.
Do
not
apply
if
heavy
rain
is
expected.
Apply
this
product
only
around
gardens
and
ornamental
plants.

For
granular
or
pelletized
product,
add:

"
This
pesticide
is
toxic
to
birds
and
mammals.
Sweep
up
or
collect
and
remove
any
product
that
lands
on
the
driveway,
sidewalk,
or
other
hard
surface
on
which
it
is
spilled."
Precautionary
Statements
General
Application
Restrictions
"
Do
not
apply
this
product
in
a
way
that
will
contact
other
persons
or
pets
either
directly
or
through
drift.
Keep
people
and
pets
out
of
the
area
during
application."
Directions
for
Use
under
General
Precautions
and
Restrictions
Other
Application
Restrictions
"
This
pesticide
may
be
fatal
to
children,
and
dogs,
and
other
domestic
animals
if
ingested.
Dogs
and
other
domestic
animals
are
attracted
to
metaldehyde
products,
both
in
the
package
and
when
applied.
Children
may
also
be
attracted
to
these
products.
Children
and
dogs
(
and
other
domestic
animals)

must
be
kept
out
of
treated
areas
from
the
start
of
application
until
the
applied
product
is
no
longer
visible."

"
Application
of
this
metaldehyde
product
is
prohibited
unless
children
and
dogs
(
and
other
domestic
animals)
can
be
excluded
from
the
treated
areas
from
the
start
of
application
until
the
applied
product
is
no
longer
visible."
Page
51
of
53
Description
Amended
Labeling
Language
Placement
on
Label
"
Applications
to
turf
and
dichondra
are
prohibited.
Application
is
permitted
only
to
non­
turf
areas
(
i.
e.,
on
soil
or
mulch)
directly
surrounding
plants
listed
for
use
on
the
label."

"
Broadcast
and
foliar
applications
of
this
product
are
prohibited.
Application
is
permitted
only
as
a
barrier
around
gardens
or
individual
plants.
Application
is
prohibited
within
one
foot
of
vegetable
plants
or
fruit­
bearing
plants
not
listed
on
this
label."

"
Certain
cultural
practices
may
reduce
damage
from
snails
and
slugs,
and
may
make
metaldehyde
applications
more
effective.
Examples
of
cultural
methods
to
reduce
snail
and
slug
populations
include:

­­
removing
leaf
litter
and
debris
to
eliminate
places
for
slugs
and
snails
to
hide
during
the
day;

­­
looking
for
and
removing
slugs
and
snails
during
daylight
hours
in
leaf
litter,

mulch,
or
other
protected
areas
adjacent
to
plants
they
feed
on;

­­
watering
in
the
morning
rather
than
the
evening
to
reduce
humidity
during
the
night
when
snails
and
slugs
are
active."

Crop­
and
Use­
Site
Specific
Directions
for
Use
NOTE:
Application
rates
must
be
provided
in
userfriendly
terms,
for
example,

"
Apply
pellets
as
a
barrier
around
plants
by
distributing
pellets
evenly
in
a
line
at
a
rate
of
X
tablespoons
per
X
linear
foot."
End­
use
product
labels
must
be
amended
to
contain
directions
for
use
only
on
the
following
crop­
and
use­
sites
and
only
with
the
maximum
application
rate,

maximum
number
of
applications
per
growing
season,
and
minimum
retreatment
intervals
as
listed
below.
All
other
crop­
and
use­
sites
must
be
removed
from
end­
use
product
labels.

Artichokes:

­
When
grown
as
a
perennial,
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
18
days.

­
When
grown
as
an
annual,
the
maximum
application
rate
is
1.0
lb
ai/
A
per
Directions
for
Use
associated
with
the
specific
crop­
or
usesite
Page
52
of
53
Description
Amended
Labeling
Language
Placement
on
Label
application.
A
maximum
of
2
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
18
days.

Blueberries:
the
maximum
application
rate
is
0.8
lb
ai/
A
per
application.
A
maximum
of
2
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Caneberries
(
bingleberry,
black
raspberry,
blackberry,
boysenberry,
dewberry,

lowberry,
marionberry,
olallieberry,
red
raspberry,
youngberry)
and
Other
Berries
(
currant,
elderberry,
gooseberry,
huckleberry,
loganberry,
lingonberry,

juneberry,
salal):
the
maximum
application
rate
is
0.8
lb
ai/
A
per
application.

A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Citrus:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Lettuce,
Cole
Crops,
And
Other
Leafy
Greens
(
broccoli,
Brussels
sprouts,

cabbage,
cauliflower,
cavalo,
broccolo,
collards,
kale,
kohlrabi,
mizuna,

mustard
greens,
spinach,
rape
greens):
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Ornamentals:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
6
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
21
days.

Tomatoes:
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
Page
53
of
53
Description
Amended
Labeling
Language
Placement
on
Label
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.

Strawberries
(
grown
as
perennials
only)
the
maximum
application
rate
is
1.0
lb
ai/
A
per
application.
A
maximum
of
3
applications
are
permitted
per
growing
season
at
a
minimum
of
retreatment
interval
of
14
days.
Applications
to
strawberries
grown
as
annuals
are
prohibited.

Storage
Restrictions
"
This
product
can
be
fatal
to
children
and
dogs
(
and
other
domestic
animals)
if
ingested.
Dogs
have
been
known
to
ingest
metaldehyde
after
opening
or
tearing
packaging.
Store
this
product
in
its
original
packaging,
in
a
cool,
secure
location,
and
out
of
reach
of
children
and
pets.
Do
not
store
in
any
location
where
children
or
domestic
animals
can
access
the
packaging
or
the
product."
Storage
and
Disposal