Document ID: EPA-HQ-OPP-2005-0524-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-12-30T05:00Z

Reregistration
Eligibility
Decision
For
Erioglaucine
and
Tartrazine
(
Aquashade
*)

Case
No.
4010
2
Reregistration
Eligibility
Decision
(
RED)
Document
for
Erioglaucine
and
Tartrazine
(
Aquashade*)

Approved
by:
__________________
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
September
23,
2005
3
Erioglaucine
and
Tartrazine
Reregistration
Eligibility
Decision
Team
Office
of
Pesticide
Programs
Health
Effects
Risk
Assessment
Cathy
Eiden
Danette
Drew
Kim
Morgan
Wade
Britton
Environmental
Fate
and
Effects
Risk
Assessment
Dan
Rieder
Silvia
Termes
Jim
Goodyear
Stephanie
Syslo
Registration
Support
Tracy
White
Joanne
Miller
Risk
Management
Kendra
Tyler
Laura
Parsons
Bonnie
Adler
4
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
EEC
Estimated
Environmental
Concentration
EPA
Environmental
Protection
Agency
EPI­
Suite
Estimation
Programs
Interface
Suite
TM
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
5
Fg/
g
Micrograms
Per
Gram
Fg/
L
Micrograms
Per
Liter
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
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
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
6
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
submitted
data
to
the
EPA.
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
the
pesticide;
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
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
and
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA)
to
require
reassessment
of
all
existing
tolerances
for
pesticides
in
food.
FQPA
also
requires
that
by
August
3,
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
enactment
of
the
FQPA,
which
was
August
2,
1996.
FQPA
also
amends
the
FFDCA
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
The
existing
exemption
from
tolerance
for
erioglaucine
has
been
reassessed.

This
document
presents
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
EPA
or
the
Agency)
decision
regarding
the
reregistration
eligibility
of
the
registered
uses
of
the
aquatic
algaecide/
herbicide
Aquashade*
and
other
related
end­
use
products
containing
the
dyes
erioglaucine
and
tartrazine
as
active
ingredients.
The
Agency's
reregistration
eligibility
determination
is
based
on
its
review
of
required
data
and
published
scientific
literature.
The
Agency
has
found
that
currently
registered
uses
of
erioglaucine/
tartrazine
are
eligible
for
reregistration.

Use
Profile
The
dyes
erioglaucine
(
Acid
Blue
9
or
FD&
C
Blue
No.
1)
and
tartrazine
(
Acid
Yellow
23
or
FD&
C
Yellow
No.
5),
when
combined,
act
as
an
aquatic
algaecide/
herbicide.
This
aquatic
herbicide,
commonly
referred
to
by
the
trade
name
Aquashade*,
will
be
referred
to
as
erioglaucine/
tartrazine
or
"
the
dyes"
throughout
the
rest
of
the
document.
The
mixture
of
erioglaucine
and
tartrazine
control
the
wavelength
range
of
the
sunlight
spectrum
required
for
photosynthesis,
thereby
inhibiting
growth
of
filamentous
algae
and
submerged
aquatic
vegetation.
It
can
be
used
in
natural
or
manmade
ponds,
lakes,
fountains,
fish
farms,
and
fish
hatcheries,
and
may
be
applied
by
both
professional
applicators
and
homeowners.
Application
is
recommended
early
in
the
growing
season
while
growth
is
on
the
bottom
of
the
water
body,
or
later
in
the
season
after
the
killing
7
and/
or
removal
of
any
existing
growth.
There
are
4
registered
end­
use
products
containing
the
combination
of
erioglaucine
and
tartrazine;
each
product
has
a
different
ratio
of
the
dyes,
but
in
all
the
product
formulations
the
percent
of
erioglaucine
is
higher
than
tartrazine.

Human
Health
Risk
Assessment
Reference:
"
Aquashade:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED);"
W.
Britton;
9/
13/
05.

Toxicology
This
risk
assessment
takes
a
weight
of
the
evidence
approach
and
considers
available
data
from
a
variety
of
sources,
including
the
Food
and
Drug
Administration
(
FDA)
and
the
Joint
Expert
Committee
on
Food
Additives
of
the
Food
and
Agriculture
Organization/
World
Health
Organization
(
JECFA).
This
information
is
sufficient
to
evaluate
the
toxicity
of
erioglaucine/
tartrazine
and
related
compounds.
Both
erioglaucine
and
tartrazine
are
listed
as
safe
for
general
use
as
food,
drug,
and
cosmetic
color
additives
by
the
Food
and
Drug
Administration
(
FDA).
The
Agency
is
not
aware
of
any
adverse
effects
associated
with
exposure
resulting
from
the
FDA­
approved
uses
of
either
tartrazine
or
erioglaucine.
Based
on
the
information
available
from
these
sources,
the
available
toxicity
database
is
complete
and
there
are
no
data
gaps.

Erioglaucine
and
tartrazine
both
have
very
low
toxicity
potentials.
A
definitive
target
organ
has
not
been
identified
and
clinical
signs
of
toxicity
were
not
observed
in
any
study
performed
using
these
dyes.
Both
are
rapidly
metabolized
and
excreted
in
rats,
rabbits,
and
dogs.
Erioglaucine
is
poorly
absorbed;
this
is
not
the
case
for
tartrazine
which
can
be
found
in
bile.
However,
generally
the
parent
compounds
are
excreted
unchanged
mainly
in
feces
with
a
small
amount
excreted
by
the
urine.
Systemic
toxicity
was
observed
in
one
study
in
the
toxicity
database
and
was
limited
to
a
decrease
in
mean
body
weight
following
long­
term
dietary
exposure
to
high
doses
in
rats.
There
were
no
adverse
effects
observed
in
mice
or
dogs.
All
NOAELs
were
reported
to
be
greater
than
or
equal
to
500
mg/
kg/
day
with
the
exception
of
a
non­
guideline
21­
day
dermal
study
in
rats.
The
NOAEL
for
this
study
was
5
mg/
kg/
day
which
was
the
highest
dose
tested.

The
various
end­
use
products
each
have
a
different
ratio
of
the
two
dyes.
A
product
containing
68%
erioglaucine
and
4.5%
tartrazine
was
tested
for
acute
toxicity.
The
product
has
low
acute
oral
toxicity
with
no
deaths
occurring
near
the
limit
dose
(
category
IV).
It
has
a
moderate
acute
dermal
toxicity
(
category
III).
There
were
no
clinical
signs
of
systemic
toxicity
in
the
acute
oral
and
dermal
studies.
Based
on
the
use
pattern,
an
acute
inhalation
study
is
not
required.
The
product
caused
slight
eye
irritation
(
category
III).
It
was
negative
for
dermal
irritation
(
category
IV),
but
it
was
determined
to
be
a
dermal
sensitizer.

Based
on
the
lack
of
evidence
of
pre­
and/
or
post­
natal
susceptibility
following
exposure
to
tartrazine
or
erioglaucine,
and
considering
the
lack
of
residual
uncertainties
and
the
8
low
level
of
concern
for
pre­
and/
or
post­
natal
toxicity
and
exposure,
no
special
FQPA
safety
factor
is
needed.
The
special
FQPA
safety
factor
was
reduced
to
1X.

There
was
no
evidence
of
neurotoxicity
in
any
study,
and
no
evidence
of
carcinogenicity
was
observed
in
carcinogenicity
studies
in
mice
and
rats
with
erioglaucine
(
Borzelleca
and
Hallagan,
1988a,
1988b)
or
tartrazine
(
Borzelleca
et
al,
1990).

An
acute
reference
dose
(
aRfD)
was
not
established
since
no
appropriate
endpoint
could
be
attributed
to
a
single
exposure
available
from
oral
studies,
including
the
developmental
toxicity
studies.
A
chronic
reference
dose
(
cRfD)
of
5
mg/
kg/
day
was
established
for
erioglaucine/
tartrazine
based
on
a
NOAEL
of
500
mg/
kg/
day
in
a
chronic
oral
toxicity
study
in
dogs
(
tartrazine)
and
a
combined
chronic
oral
toxicity/
carcinogenicity
study
in
rates
(
erioglaucine),
done
by
FDA.
The
NOAEL
of
500
mg/
kg/
day
was
used
as
the
dermal
and
inhalation
exposure
endpoint
for
residential
and
occupational
risk
assessments
as
well.
The
default
assumption
of
100%
absorption
was
used
for
both
dermal
and
inhalation
assessments.
Please
refer
to
the
human
health
risk
assessment
for
a
complete
listing
of
studies
and
endpoints.

Dietary
Risk
from
Food
Based
on
the
consideration
of
anticipated
exposure
scenarios
and
risk,
a
dietary
food
exposure
assessment
was
not
conducted.
Although
water
treated
with
the
dyes
may
potentially
be
used
for
irrigation
of
food
crops
and
livestock
watering
and
the
dyes
are
registered
for
use
in
fish
farms
and
hatcheries,
the
Agency
has
not
quantitatively
assessed
exposures
and
risks
from
food
sources
for
several
reasons:
(
1)
Erioglaucine/
tartrazine
are
used
primarily
in
ornamental
and/
or
recreational
lakes
and
ponds
with
very
little
treated
water
expected
to
be
used
for
agricultural
purposes.
(
2)
Erioglaucine
and
tartrazine
are
highly
water
soluble
compounds
and
are
not
likely
to
accumulate
in
livestock
or
fish
tissues.
(
3)
Any
residues
of
erioglaucine
and
tartrazine
occurring
in
foods
from
the
use
of
the
dyes
as
an
aquatic
algaecide/
herbicide
would
be
negligible
compared
to
residues
in
food
from
the
common
use
of
these
dyes
as
food
coloring
additives,
which
are
listed
as
safe
for
general
use
as
food,
drug
and
cosmetic
color
additives
by
the
FDA.
(
4)
The
most
significant
route
of
exposure
to
erioglaucine
and
tartrazine
from
the
use
of
the
products
is
residential
exposure,
including
residential
handler
and
postapplication
(
swimming)
exposure.
The
Agency
believes
that
the
conservative
residential
exposure
and
risk
estimates
discussed
below
are
more
than
adequate
to
cover
any
food
exposures
that
could
potentially
occur
from
the
use
of
the
combination
of
dyes
as
an
aquatic
algaecide/
herbicide.

Dietary
Risk
from
Drinking
Water
Since
the
dyes
are
directly
applied
by
hand
to
contained
water
bodies
with
little
or
no
outflow
and
because
none
of
the
treated
water
bodies
serve
as
a
source
of
drinking
water,
9
drinking
water
exposure
is
not
expected
and
therefore
a
drinking
water
assessment
was
not
conducted.

Residential
Risk
Reference:
Aquashade:
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
09/
13/
05)

Aquatic
herbicide
products
containing
erioglaucine/
tartrazine
are
labeled
for
consumer
use
to
control
aquatic
algae
and
weeds
in
ponds
and
lakes.
The
anticipated
use
patterns
and
current
labeling
indicate
several
residential
handler
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
to
make
dye
applications.
Residents
or
consumers
applying
erioglaucine/
tartrazine
products
to
ponds
or
lakes
may
be
exposed
for
short­
term
(
1
to
30
days)
duration
through
skin
contact
or
by
inhalation.
All
residential
handler
scenarios
assessed
(
dermal
and
inhalation)
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Residential
short­
term
dermal
MOEs
range
from
1,930
(
Liquids
for
Pouring
Applications)
to
16,000
(
Liquids
for
LCO
Handgun),
and
short­
term
inhalation
MOEs
range
from
550,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
6,600,000
(
Liquids
for
Pouring
Applications).

Postapplication
exposures
to
children
and
adults
that
contact
erioglaucine/
tartrazinetreated
swimming
ponds
are
anticipated.
To
address
the
risk
of
such
exposures,
a
screening
tool
called
the
Swimmer
Exposure
Assessment
Model
(
SWIMODEL)
was
applied.
The
SWIMODEL
uses
well­
accepted
screening
exposure
assessment
equations
to
calculate
the
total
worst­
case
exposure
for
swimmers
expressed
as
a
mass­
based
intake
value
(
mg/
event).
Postapplication
residential
exposure
durations
are
expected
to
be
short­
and
intermediate­
term
(
1
to
6
months)
in
duration.
All
residential
postapplication
scenarios
assessed
(
dermal,
ingestion,
aural,
buccal/
sublingual,
and
nasal/
orbital
routes
of
exposure)
resulted
in
estimated
combined
MOEs
well
above
100
(>
4900)
and,
therefore,
are
not
of
concern.

To
better
quantify
residential
erioglaucine/
tartrazine
hazard,
results
from
residential
handler
and
residential
postapplication
(
i.
e.,
swimmer)
risk
assessments
were
aggregated.
Aggregate
calculations
of
residential
exposure
were
performed
using
worst­
case
MOEs
resulting
from
each
assessment.
The
residential
aggregated
exposure
resulted
in
an
estimated
MOE
of
1400
and,
therefore,
is
not
a
risk
of
concern.

Aggregate
Risk
In
accordance
with
the
FQPA,
EPA
must
consider
and
aggregate
pesticide
exposures
and
risks
from
three
major
sources:
drinking
water,
food
and
residential
exposures.
Since
the
dyes
are
applied
to
contained
water
bodies
with
little
or
no
outflow,
and
none
of
the
treated
water
bodies
serves
as
a
source
of
drinking
water,
no
drinking
water
exposure
is
expected.
Also,
no
quantitative
dietary
assessment
was
deemed
necessary
for
reasons
listed
above.
The
most
significant
route
of
exposure
to
erioglaucine
and
tartrazine
is
10
residential
exposure,
including
residential
handler
and
postapplication
(
swimming)
exposure.
Estimated
exposures
(
combined)
for
residential
handlers
and
swimmers
were
well
below
the
Agency's
level
of
concern.
Therefore,
the
Agency
finds
no
risk
concerns
due
to
aggregate
exposures
to
erioglaucine
and
tartrazine.

Cancer
Risk
A
cancer
risk
assessment
was
not
conducted
because
there
was
no
evidence
of
carcinogenicity
in
the
toxicology
studies
submitted
for
the
dyes.

Cumulative
Risk
Characterization/
Assessment
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
erioglaucine
and
tartrazine
and
any
other
substances,
and
the
dyes
do
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
assumed
that
the
dyes
do
not
share
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/.

Occupational
Risk
The
Agency
determined
that
the
potential
for
occupational
exposure
from
erioglaucine/
tartrazine
exists
in
a
variety
of
occupational
environments.
The
anticipated
use
patterns
and
current
labeling
indicate
several
occupational
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
for
application
of
the
dyes.
These
include
the
handling
of
erioglaucine/
tartrazine
during
mixing,
loading,
and
applying
processes
(
i.
e.
mixer/
loaders,
and
mixer/
loader/
applicators).
As
a
result,
a
risk
assessment
has
been
completed
for
the
occupational
handler
scenario.
Short­
term
(
1
to
30
days)
and
intermediate­
term
exposures
(
1
to
6
months)
may
occur;
however,
longterm
exposures
(
greater
than
6
months)
are
not
expected.

The
calculated
occupational
handler
exposures
for
all
scenarios
resulted
in
estimated
MOEs
greater
than
100
and,
therefore,
are
not
of
concern.
Short­
and
intermediate­
term
MOEs
do
not
differ
because
they
share
the
same
toxicological
endpoint.
Short­
and
intermediate­
term
dermal
MOEs
range
from
410
(
Liquids
for
Pouring
Applications)
to
4,300
(
Liquids
for
Garden
Hose­
End
Sprayer).
Short­
and
intermediate­
term
inhalation
MOEs
range
from
120,000
(
Liquids
for
Garden
Hose
End
Sprayer)
to
1,600,000
(
Liquids
for
Pouring
Applications).
A
summary
of
the
short­
and
intermediate­
term
risks
(
dermal
and
inhalation)
for
each
exposure
scenario
can
be
found
in
the
occupational
and
residential
exposure
chapter
referenced
above.
11
Environmental
Risk
Assessment
Reference:
"
Ecological
Risk
Assessment
for
the
Re­
registration
of
Tartrazine
("
Acid
Yellow
23")
and
Erioglaucine
("
Acid
Blue
9")
Dyes
in
the
End­
use
Products
Aquashade,
Admiral,
and
Algae
Blocker;"
James
Goodyear
and
Silvia
Termes;
09/
10/
05.

The
Agency
has
conducted
an
environmental
assessment
of
erioglaucine/
tartrazine
for
the
purpose
of
making
a
reregistration
eligibility
decision.
The
Agency
evaluated
environmental
fate
and
effects
studies
submitted
for
erioglaucine
and
tartrazine.
Published
literature
on
effects
were
obtained
by
EPA's
Office
of
Research
and
Development
through
their
literature
search
conducted
as
part
of
the
ECOTOX
program.
The
Agency
has
determined
that
the
data
are
adequate
to
support
a
reregistration
decision.

More
in
depth
details
of
the
ecotoxicity
and
environmental
fate
used
to
develop
the
risk
assessment
and
to
support
the
requirements
are
provided
in
the
environmental
risk
assessment
referenced
above.

Environmental
Fate
and
Transport
Properties
No
environmental
fate
data
were
required
for
either
dye
based
on
the
use
pattern
and
toxicity
studies.
The
environmental
fate
information
in
this
assessment
is
qualitative,
based
mostly
on
data
from
the
open
literature
on
structurally
related
dyes.
However,
structure­
activity
relationship
estimates
do
not
adequately
estimate
physical
and
chemical
properties
of
salts,
particularly
those
of
large
anions
such
as
in
Acid
Blue
9
and
Acid
Yellow
23.

Unlike
the
uses
on
food,
drugs,
and
cosmetics,
the
dyes
are
exposed
to
an
open
aquatic
environment
when
used
as
herbicides.
Because
the
concentrated
products
are
added
directly
to
a
water
body,
the
dyes
(
which
do
not
react
chemically
with
each
other)
become
diluted
in
the
treated
water.
Neither
runoff
nor
spray
drift
are
routes
of
exposure
because
a
specified
amount
of
product
is
directly
applied
to
the
water
body.
End­
product
labeling
recommends
target
concentrations
of
a
product
at
either
"
1
ppm
or
2
ppm",
depending
on
the
weed
to
be
controlled.
To
attain
these
target
concentrations,
the
labels
specify
the
volume
of
product
to
be
added
per
volume
of
water
to
be
treated.
For
this
assessment,
these
maximum
target
concentrations
were
assumed
to
be
maintained
after
treatment
and
no
degradation
was
assumed
The
major
route
of
dissipation
of
the
dyes
in
an
aquatic
environment
is
likely
indirect
photolysis,
which
depends
on
the
nature
and
concentration
of
natural
photosensitizers
as
well
as
on
the
geographical
location
and
season
when
the
products
are
used.
Biotransformation
under
anaerobic
conditions
may
also
contribute
to
the
dissipation
of
each
dye.
The
specific
chemical
nature
of
photoproducts
and
metabolites
is
not
known.
12
The
dyes
are
predominantly
associated
with
the
water
column
and
have
no
potential
to
volatilize
from
water.
Although
the
dyes
are
not
applied
to
soils,
data
indicate
they
would
be
unlikely
to
volatilize
from
soils.
Acid
Blue
9
and
Acid
Yellow
23
do
not
have
the
potential
to
bioaccumulate
in
fish.

Ecological
Risk
Assessment
To
estimate
potential
ecological
risk,
EPA
usually
integrates
the
results
of
exposure
and
ecological
ecotoxicity
using
the
risk
quotient
method.
RQs
are
then
compared
to
levels
of
concern
(
LOCs),
which
represent
the
threshold
of
potentially
significant
risk
in
the
environment.
Generally,
the
higher
the
RQ
is
above
the
LOC,
the
higher
the
risks.
The
ecotoxicity
studies
submitted
for
the
dyes
included
an
avian
oral,
two
avian
dietary,
two
fish
acute
toxicity,
and
an
aquatic
invertebrate
acute
toxicity.
All
studies
indicated
very
low
toxicity.
All
of
the
ecological
toxicity
studies
were
conducted
with
the
Aquashade*
end­
use
product
containing
23.63%
Acid
Blue
9
and
2.39%
Acid
Yellow
23
as
the
test
substance,
whereas
the
mammalian
toxicity
study
was
conducted
with
the
Admiral
WSP
end­
use
product
which
contains
49.72%
Acid
Blue
9
and
3.27%
Acid
Yellow
23.

1.
Risk
to
Aquatic
Animals
Review
of
aquatic
toxicity
studies
on
bluegill
fish,
rainbow
trout,
and
daphnia
studies
showed
erioglaucine/
tartrazine
to
be
"
slightly
toxic"
to
aquatic
animals
and
aquatic
invertebrate.
The
calculated
RQs
were
less
than
0.01,
and
no
risks
of
concern
were
observed
for
any
aquatic
animal.

2.
Risk
to
Terrestrial
Animals
The
avian
oral
acute
toxicity
studies
for
both
the
bobwhite
quail
and
the
mallard
duck
found
LD50s
and
NOAELs
greater
than
or
equal
to
5,620
ppm.
The
dyes
are
considered
to
be
practically
nontoxic
to
birds.
Two
rat
studies
reviewed
for
the
human
health
risk
assessment
showed
that
the
dyes
are
practically
non­
toxic
to
mammals.
Since
the
dyes
are
applied
directly
applied
to
water,
there
are
unlikely
to
be
any
pesticide
residues
on
terrestrial
food
items,
which
forms
the
basis
of
EPA's
standard
terrestrial
animal
risk
assessment.
Therefore,
acute
RQs
for
birds
and
mammals
exposed
to
the
dyes
via
consumption
of
contaminated
water
were
calculated
for
each
of
three
body
weight
classes
using
the
daily
exposure
value
expressed
as
milligrams
of
erioglaucine/
tartrazine
and
the
toxicity
value
expressed
in
terms
of
milligrams
of
the
dye
combination.
RQs
are
below
all
levels
of
concern
with
RQs
less
than
0.01
and
the
dyes
are
not
expected
to
harm
terrestrial
animals
that
drink
treated
water,
or
harm
freshwater
animals
and
invertebrates
dwelling
in
treated,
confined
water
bodies.

3.
Risk
to
aquatic
plants
The
combination
of
erioglaucine/
tartrazine
in
water
bodies
kills
non­
target
plants
by
depriving
them
of
light
necessary
for
photosynthesis.
Because
submerged
aquatic
plants
are
the
target
species
and
it
is
assumed
that
all
submerged
plants
will
be
killed,
no
aquatic
13
plant
studies
were
required.
Because
the
dyes
are
only
applied
to
contained
ponds
with
little
or
no
outflow,
and
since
the
runoff
water
is
generally
not
used
for
irrigation,
it
is
not
expected
to
come
into
contact
with
non­
target
aquatic
organisms
outside
of
the
target
pond.
All
submerged
plants
in
a
treated
pond
are
considered
to
be
targets;
therefore,
RQs
were
not
calculated
for
aquatic
plants.

4.
Risk
to
terrestrial
plants
Terrestrial
plants
growing
in
dry­
land
and
semi­
aquatic
environments
are
not
exposed
because
the
products
containing
erioglaucine/
tartrazine
are
applied
to
confined
water
bodies
with
little
or
no
outflow.
Therefore,
a
terrestrial
plant
risk
characterization
was
not
performed.

5.
Endangered
Species
Based
on
EPA's
screening
level
assessment,
erioglaucine/
tartrazine
will
have
no
effect
on
endangered
species
of
aquatic
animals,
terrestrial
animals,
or
terrestrial
plants.
The
Agency
concludes
that
the
only
potential
risks
are
direct
effects
to
aquatic
plants
that
may
be
present
in
treated
ponds
and
lakes,
and
indirect
effects
to
aquatic
or
terrestrial
animals
that
depend
on
the
vegetation
in
the
treated
water
bodies.

The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
(
ESA)
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
that
may
affect
any
particular
species,
EPA
uses
basic
toxicity
and
exposure
data
developed
for
the
REDs
and
considers
it
in
relation
to
individual
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species,
as
part
of
a
refined
species­
specific
analysis.
When
conducted
this
speciesspecific
analysis
will
take
into
consideration
any
regulatory
changes
recommended
in
this
RED
that
are
being
implemented
at
that
time.

Following
this
future
species­
specific
analysis,
a
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
or
its
critical
habitat
may
result
in:
limitations
on
the
use
of
herbicide
products
containing
erioglaucine/
tartrazine,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.
If
the
Agency
determines
the
use
of
erioglaucine/
tartrazine
"
may
affect"
listed
species
or
their
designated
critical
habitat,
EPA
will
employ
the
provisions
in
the
Services
regulations
(
50
CFR
Part
402).
EPA
is
not
requiring
specific
label
language
at
the
present
time
relative
to
threatened
and
endangered
species.
If,
in
the
future,
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.
14
Tolerance
Reassessment
The
Agency
has
determined
that
the
existing
exemption
from
a
tolerance
for
erioglaucine
is
adequate
and
is
considered
reassessed.
However,
the
Agency
will
propose
to
establish
an
additional
tolerance
exemption
for
the
FD&
C
Yellow
No.
5
dye
tartrazine.

Active
ingredient
Current
Tolerance
Tolerance
Reassessment
Comment
Tolerance
Exemption
Listed
Under
40
CFR
§
180.1074:

F.
D.&
C.
Blue
No.
1
F.
D&
C.
Yellow
No.
5
Exempted
from
the
requirement
of
a
tolerance
when
used
as
an
aquatic
plant
control
agent.

No
current
exemptions
Exempted
from
the
requirement
of
a
tolerance
when
used
as
an
aquatic
plant
control
agent.

Proposed
to
add
Exemption
from
the
requirement
of
a
tolerance
when
used
as
an
aquatic
plant
control
agent.
In
1982,
based
on
Aquashade's
low
toxicity
profile,
EPA
waived
residue
chemistry
data
requirements
and
established
an
exemption
from
the
requirement
of
a
tolerance
for
erioglaucine
(
F.
D&
C.
Blue
No.
1)
when
used
as
an
aquatic
plant
control
agent.

What
Registrants
Need
to
Do
The
Agency
has
determined
that
the
dye
combination
of
erioglaucine/
tartrazine
is
eligible
for
reregistration.
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
Notices
(
DCIs)
requiring
product
specific
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
request
time
extension
and/
or
waiver
requests
with
a
full
written
justification.
For
product
specific
data,
the
registrant
will
have
8
months
to
submit
data
and
amended
labels.

Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
the
dyes
for
the
eligible
uses
has
been
reviewed
and
determined
to
be
complete.
No
additional
data
are
required.

2.
Labeling
for
Manufacturing­
Use
Products
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.
15
End­
Use
Products
1.
Additional
Product­
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
product­
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
registrant
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.
The
Agency
intends
to
issue
a
separate
product­
specific
data
call­
in
(
PDCI),
outlining
specific
data
requirements.

2.
Labeling
for
End­
Use
Products
Currently,
there
are
no
required
labeling
changes
for
erioglaucine/
tartrazine.
16
Appendices
Appendix
A.
Food/
Feed
Use
Patterns
Subject
to
Reregistration
for
Aquashade
(
Case)

Site
Application
Timing
Application
Type
Application
Equipment
Maximum
Single
Application
Rate
(
lb
a.
i./
A)
Maximum
Number
of
Applications
Per
Year
Maximum
Yearly
Rate
(
lb
a.
i./
A)
Min.
App
Interval
(
days)
Use
Directions
and
Limitations
Commercial
Fishery
Water
Systems
Do
not
apply
directly
to
water
except
as
specified
on
the
product
label.

Do
not
contaminate
water
intended
for
irrigation
or
domestic
purposes.

Do
not
contaminate
water,
food,
or
feed
by
storage
or
disposal.

Preemergence
Water
treatment
Package
applicator
0.68365
lb
A­
ft
NS
NS
AN
When
needed
Water
treatment
Measuring
container/
Not
on
label/
Product
container/
Squeeze
applicator
(
L)
0.004165
lb
1K
gal
0.6897
lb
A­
ft
NS
NS
AN
Lakes/
Ponds/
Reservoirs
(
with
Human
or
Wildlife
Use)
Do
not
apply
directly
to
water
except
as
specified
on
the
product
label.

Do
not
contaminate
water
intended
for
irrigation
or
domestic
purposes.

Do
not
contaminate
water,
food,
or
feed
by
storage
or
disposal.

Preemergence
Water
treatment
Package
applicator
0.68365
lb
A­
ft
NS
NS
AN
When
needed
Water
treatment
Measuring
container/
Not
on
label/
Product
container/
Squeeze
applicator
(
L)
0.004165
lb
K
gal
0.6897
lb
A­
ft
NS
NS
AN
Appendix
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
GUIDE
TO
APPENDIX
B
Appendix
B
contains
a
listing
of
data
requirements
which
support
the
reregistration
for
active
ingredients
within
the
case
dicamba
covered
by
this
RED.
In
contains
generic
data
requirements
that
apply
dicamba
in
all
products,
including
data
requirements
for
which
a
"
typical
formulation"
is
the
test
substance.

The
data
table
is
organized
in
the
following
formats:

1.
Data
requirement
(
Column
1).
The
data
requirements
are
listed
in
the
order
in
which
they
appear
in
40
CFR
158.
The
reference
numbers
accompanying
each
test
refer
to
the
test
protocols
set
in
the
Pesticide
Assessment
Guidance,
which
is
available
from
the
National
Technical
Information
Service,
5285
Port
Royal
Road,
Springfield,
VA
22161.
(
703)
487­
4650.

2.
Use
Pattern
(
Column
2).
This
column
indicates
the
use
patterns
for
which
the
data
requirements
apply.
The
following
letter
designations
are
used
for
the
given
use
patterns.

A.
Terrestrial
food
B.
Terrestrial
feed
C.
Terrestrial
non­
food
D.
Aquatic
food
E.
Aquatic
non­
food
outdoor
F.
Aquatic
non­
food
industrial
G.
Aquatic
non­
food
residential
H.
Greenhouse
food
I.
Greenhouse
non­
food
J.
Forestry
K.
Residential
L.
Indoor
food
M.
Indoor
non­
food
N.
Indoor
medical
O.
Indoor
residential
3.
Bibliographic
Citation
(
Column
3).
If
the
Agency
has
acceptable
data
in
its
files,
this
column
lists
the
identifying
number
of
each
study.
This
normally
is
the
Master
Record
Identification
(
MRID)
number,
but
may
be
a
"
GS"
number
is
no
MRID
number
has
been
assigned.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
the
study.
19
Appendix
B.
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Dicamba
New
Guideline
Number
Old
Guideline
Number
Description
Use
Patterns
Citations
PRODUCT
CHEMISTRY
63­
0
Reports
of
multiple
physical/
chemical
characteristics
D,
E,
G
43503401,
43503402
ECOLOGICAL
EFFECTS
850.2100
71­
1A
Avian
Acute
Oral
Toxicity
D,
E,
G
4336701
71­
1B
Avian
Acute
Oral
­
Duck
D,
E,
G
4336702
850.2200
71­
2A
Avian
Dietary
Toxicity
 
Quail
D,
E,
G
43503403
850.2200
71­
2B
Avian
Dietary
Toxicity
 
Duck
D,
E,
G
43503404
850.2300
71­
4A
Avian
Reproduction
­
Quail
D,
E,
G
1
850.2300
71­
4B
Avian
Reproduction
 
Duck
D,
E,
G
1
71.3
Acute
Wild
Mammal
Toxicity­
Rat
D,
E,
G
45281101
850.1075
72­
1A
Fish
Toxicity
Bluegill
D,
E,
G
43297502
850.1075
72­
1C
Freshwater
Fish
Toxicity
Rainbow
Trout
D,
E,
G
43297501
850.1075
72­
1D
Freshwater
Fish
Toxicity
Rainbow
Trout
 
TEP
D,
E,
G
850.1010
72­
2A
Freshwater
Invertebrate
Toxicity
D,
E,
G
43297503
850.5400
122­
2
Aquatic
Plant
Growth
D,
E,
G
TOXICOLOGY
870.1100
81­
1
Acute
Oral
Toxicity
­
Rat
D,
E,
G
45281101
870.1200
81­
2
Acute
Dermal
Toxicity
 
Rabbit/
Rat
D,
E,
G
45144401
870.2400
81­
4
Primary
Eye
Irritation
­
Rabbit
D,
E,
G
44902902
870.2500
81­
5
Primary
Skin
Irritation
D,
E,
G
45086102
870.2600
81­
6
Dermal
Sensitization
D,
E,
G
44902904
870.3100
82­
1A
Subchronic
Oral
Toxicity:
90­
Day
Study
Rodent
D,
E,
G
Satisfied
2
870.3150
82­
1B
Subchronic
Oral
Toxicity:
90­
Day
Study
Non­
rodent
D,
E,
G
Satisfied
2
870.3200
82­
2
21­
Day
Dermal
 
Rabbit/
Rat
D,
E,
G
43410101
870.3700
83­
3A
Developmental
Toxicity
 
Rat
D,
E,
G
43408101
870.3700
83­
3B
Developmental
Toxicity
 
Rabbit
D,
E,
G
Satisfied2
870.3800
83­
4
2­
Generation
Reproduction
 
Rat
D,
E,
G
43410901
870.4100
83­
1A
Chronic
Feeding
Toxicity
 
Rat
D,
E,
G
Satisfied2
870.4100
83­
1B
Chronic
Feeding
Toxicity
­
Nonrodent
D,
E,
G
Satisfied2
870.4200a
83­
2A
Oncogenicity
Rat
D,
E,
G
Satisfied2
870.4200
83­
2B
Carcinogenicity
Mice
D,
E,
G
Satisfied2
870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity:
Rats
D,
E,
G
Satisfied2
870.5100
84­
2
Bacterial
Reverse
Gene
Mutation
D,
E,
G
Satisfied2
870.7485
85­
1
General
Metabolism
D,
E,
G
Satisfied2
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
D,
E,
G
Waived3
835.2240
161­
2
Photodegradation
­
Water
D,
E,
G
Waived3
835.4400
162­
3
Anaerobic
Aquatic
Metabolism
D,
E,
G
Waived3
835.4300
162­
4
Aerobic
Aquatic
Metabolism
D,
E,
G
Waived3
835.1240
163­
1
Leaching/
Adsorption/
Desorption
D,
E,
G
Waived3
835.1410
163­
2
Laboratory
Volatilization
D,
E,
G
Waived3
20
New
Guideline
Number
Old
Guideline
Number
Description
Use
Patterns
Citations
None
165­
4
Bioaccumulation
in
Fish
D,
E,
G
Waived3
1.
Aquashade*
is
acutely
non­
toxic
to
birds.
Long­
term
exposures
are
unlikely
and
chronic
risks
are
not
expected;
therefore,
no
avian
reproduction
data
are
required.

2.
Information
from
open
literature
are
included
to
supplement
the
submitted
studies.
No
additional
data
are
required.

3.
All
Environmental
Fate
Data
Requirements
were
placed
under
"
reserved"
in
1993,
depending
on
the
results
of
the
required
ecological
toxicity
studies.
Because
the
risk
assessment
did
not
identify
risks
to
fish,
aquatic
invertebrates,
or
mammals,
the
environmental
fate
studies
may
be
waived.
21
Appendix
C.
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
119,
Crystal
Mall
2,
1801
S.
Bell
Street,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
AM
to
4:
30
PM.

The
nitrapyrin
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
October
27,
2004.
Sixty
days
later,
the
comment
period
closed.
The
Agency
considered
the
comments
and
added
the
formal
"
Response
to
Comments"
documents
to
the
docket.
All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
website:

http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.

These
documents
include:

HED
Documents:

Aquashade:
Revised
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document.
(
Wade
Britton
and
Kim
Morgan.
9/
27/
2005)

Aquashade:
Revised
Occupational
and
Residential
Exposure
Assessment
ad
Recommendations
for
the
Reregistration
Eligibility
Decision
Document.
(
Wade
Britton.
9/
27/
2005)

EFED
Documents:

Ecological
Risk
Assessment.
Reregistration:
"
Acid
Blue
9"
(
Erioglaucine)
and
"
Acid
Yellow
we"
(
Tartrazine)
Dyes
Used
Together
in
the
End­
Use
Products
Aquashade,
Aquashade
OA,
Admiral
Liquid,
Admiral
WSP
and
Pond
Care
Algae
Blocker
for
Control
of
Algal
Growth
and
Other
Undesirable
Aquatic
Plants
22
Appendix
D.
Citations
Considered
to
be
Part
of
the
Database
Supporting
the
Reregistration
Eligibility
Decision
(
Bibliography)

GUIDE
TO
APPENDIX
D
1.
CONTENTS
OF
BIBLIOGRAPHY.
This
bibliography
contains
citations
of
all
studies
considered
relevant
by
EPA
in
arriving
at
positions
and
conclusions
stated
elsewhere
in
the
Reregistration
Eligibility
Document.
Primary
sources
for
studies
in
this
bibliography
have
been
the
body
of
data
submitted
to
EPA
and
its
predecessor
agencies
in
support
of
past
regulatory
decisions.
Selection
from
other
sources,
including
published
literature,
in
those
instances
where
they
have
been
considered,
are
included.

2.
UNITS
OF
ENTRY.
The
unit
of
entry
in
this
bibliography
is
called
a
"
study."
In
the
case
of
published
materials,
this
corresponds
closely
to
an
article.
In
the
case
of
unpublished
materials
submitted
to
the
Agency,
the
Agency
has
sought
to
identify
documents
at
a
level
parallel
to
the
published
article
from
within
the
typically
larger
volumes
in
which
they
were
submitted.
The
resulting
"
studies"
generally
have
a
distinct
title
(
or
at
least
a
single
subject),
can
stand
alone
for
purposes
of
review,
and
can
be
described
with
a
conventional
bibliographic
citation.
The
Agency
has
also
attempted
to
unite
basic
documents
and
commentaries
upon
them,
treating
them
a
s
single
studies.

3.
IDENIFICATION
OF
ENTRIES.
The
entries
in
this
bibliography
are
sorted
numerically
by
Master
Record
Identifier,
or
"
MRID"
number.
This
number
is
unique
to
the
citation,
and
should
be
used
whenever
a
specific
reference
is
required.
It
is
not
related
to
the
six­
digit
"
Accession
Number",
which
has
been
used
to
identify
volumes
of
submitted
studies
(
see
paragraph
4(
d)(
4)
below
for
further
explanation).
In
a
few
cases,
entries
added
to
the
bibliography
late
in
the
review
may
be
preceded
by
a
nine
character
temporary
identifier.
These
entries
are
listed
after
all
MRID
entries.
This
temporary
identifying
number
is
also
used
whenever
specific
reference
is
needed.

4.
FORM
OF
ENTRY.
In
addition
to
the
Master
Record
Identifier
(
MRID),
each
entry
consists
of
a
citation
containing
standard
elements
followed,
in
the
case
of
EPA,
by
a
description
of
the
earliest
known
submission.
Bibliographic
conventions
used
reflect
the
standard
of
the
American
National
Standards
Institute
(
ANSI),
expanded
to
provide
for
certain
special
needs.

a.
Author.
Whenever
the
author
could
confidently
be
identified,
the
Agency
has
chosen
to
show
a
personal
author.
When
no
individual
was
identified,
the
Agency
has
shown
an
identifiable
laboratory
or
testing
facility
as
the
author.
When
no
author
or
laboratory
could
be
identified,
the
Agency
has
shown
the
first
submitter
as
the
author.
23
b.
Document
date.
The
date
of
the
study
is
taken
directly
from
the
document.
When
the
date
is
followed
by
a
question
mark,
the
bibliographer
has
deduced
the
date
from
the
evidence
contained
in
the
document.
When
the
date
appears
as
(
1999),
the
Agency
was
unable
to
determine
or
estimate
the
date
of
the
document.

c.
Title.
In
some
cases,
it
has
been
necessary
for
the
Agency
bibliographers
to
create
or
enhance
a
document
title.
Any
such
editorial
insertions
are
contained
between
square
brackets.

d.
Trailing
parentheses.
For
studies
submitted
to
the
Agency
in
the
past,
the
trailing
parentheses
include
(
in
addition
to
any
self­
explanatory
text)
the
following
elements
describing
the
earliest
known
submission:

(
1)
Submission
date.
The
date
of
the
earliest
known
submission
appears
immediately
following
the
word
"
received."

(
2)
Administrative
number.
The
next
element
immediately
following
the
word
"
under"
is
the
registration
number,
experimental
use
permit
number,
petition
number,
or
other
administrative
number
associated
with
the
earliest
known
submission.

(
3)
Submitter.
The
third
element
is
the
submitter.
When
authorship
is
defaulted
to
the
submitter,
this
element
is
omitted.

(
4)
Volume
Identification
(
Accession
Numbers).
The
final
element
in
the
trailing
parentheses
identifies
the
EPA
accession
number
of
the
volume
in
which
the
original
submission
of
the
study
appears.
The
six­
digit
accession
number
follows
the
symbol
"
CDL,"
which
stands
for
"
Company
Data
Library."
This
accession
number
is
in
turn
followed
by
an
alphabetic
suffix,
which
shows
the
relative
position
of
the
study
within
the
volume.
24
Open
Literature
Books
Lynch,
D.
G.
"
Estimating
the
Properties
of
Synthetic
Organic
Dyes",
in
Handbook
of
Property
Estimation
Methods
for
Chemicals­
Environmental
Health
Sciences,
Edited
by
Robert
S.
Boethling
and
Donald
Mackay.
Published
by
Lewis
Publishers,
Boca
Raton,
FL;
Pages
447­
467.
And
pertinent
references
therein.

Marmion,
D,
M.
Handbook
of
U.
S.
Colorants­
Food,
Drugs,
and
Medical
Devices,
Third
Edition.,
1991.
Published
by
John
Wiley
and
Sons,
New
York
Helz,
G.
R.,
Zepp,
R.
G.,
and
Crosby,
D.
G,
Editors.
1994.
Aquatic
and
surface
photochemistry.
Lewis
Publishers,
Boca
Raton,
Florida.

Journal
Articles
Jank.
M.,
Köser,
H.,
Lücking,
F.,
Martienssen,
M.,
and
Wittchen,
S.
1998,
"
Decolorization
and
Degradation
of
Erioglaucine
(
Acid
Blue
9)
Dye
in
Wastewater,"
Environmental
Technology,
v.
19(
7),
pp.
741­
747.

Weber,
E.
J.
and
Adams,
R.
L.
1995.
"
Chemical
and
Sediment­
Mediated
Reduction
of
the
Azo
Dye
Disperse
Blue
79,"
Environ.
Sci.
Technol.
v.
29,
pp.
1163­
1170.

Baughman,
G.
L.
1995.
"
Fate
of
azo
dyes
in
aquatic
systems.
Part
3:
The
role
of
suspended
sediments
in
adsorption
and
reaction
of
acid
and
direct
dyes,"
Dyes
and
Pigments,
v.
27,
pp.
197­
210.

Brown,
D.
and
Laboureur,
P.
1983,
"
The
Degradation
of
Dyestuffs:
Part
I­
Primary
biodegradation
under
anaerobic
conditions,"
Chemosphere,
v.
122,
pp.
397­
404.

Baran,
W.,
Makowski,
A.,
Wardas,
W.
2003.
"
The
influence
of
FeCl3
on
the
photocatalytic
degradation
of
dissolved
azo
dyes
in
aqueous
TiO2
suspensions,"
Chemosphere,
v.
53,
pp
82­
95.

Tai,
W.
T.,
Chang,
C.
Y,
Ing,
C.
H.,
and
Chang,
C.
F.
2004.
"
Adsorption
of
acid
dyes
from
aqueous
solutions
on
activated
bleaching
earth,"
J.
Colloid
and
Interface
Science,
vol.
275,
pp
72­
78.

Mon,
J.,
Flury,
M.,
and
Harsh,
J.
B.
2005
."
Sorption
of
four
triarylmethane
dyes
in
a
sandy
soil
determined
by
batch
and
column
experiments,"
Geoderma.
in
press.

Mon,
J.,
Flury.
M.,
and
Harsh.
2005
"
A
quantitative
structure­
activity
relationship
(
OSAR)
analysis
of
triarylmethane
dye
tracers,"
Journal
of
Hydrology,
in
press.
25
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A
96­
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the
Rainbow
Trout
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A
96­
Hour
Static
Acute
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the
Bluegill
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Final
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196A/
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43297503
Graves,
W.;
Swigert,
J.
(
1994)
Aquashade:
A
48­
Hour
Static
Acute
Toxicity
Test
with
the
Cladoceran
(
Daphnia
magna):
Final
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Lab
Project
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196A/
109.
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International
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38
p.

43336701
Campbell,
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Beavers,
J.
(
1994)
Aquashade:
An
Acute
Oral
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Northern
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Lab
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196/
103A.
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24
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43336702
Campbell,
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Beavers,
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1994)
Aquashade:
An
Acute
Oral
Toxicity
Study
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the
Mallard:
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196/
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23
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Acid
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9­­
The
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C
Blue
#
1
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Lab
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106
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43503401
Ellison,
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1994)
Physical
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Shade
Blue
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Physical
State,
Odor,
Boiling
Point,
Specific
Gravity,
Solubility,
Vapor
Pressure,
pH
and
Stability:
Lab
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140­
11:
2398:
DTI
2398.
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by
Case
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Labs,
Inc.
19
p.

43503403
Campbell,
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Beavers,
J.
(
1994)
Aquashade:
A
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LC50
Study
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Northern
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Lab
Project
Number:
196­
101.
Unpublished
study
prepared
by
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Ltd.
36
p.

43503404
Campbell,
S.;
Beavers,
J.
(
1994)
Aquashade:
A
Dietary
LC50
Study
With
the
Mallard:
Lab
Project
Number:
196­
102.
Unpublished
study
prepared
by
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Ltd.
35
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44902902
Fitzgerald,
G.
(
1992)
Primary
Eye
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Lake
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II:
(
in
Rabbits):
Lab
Project
Number:
92G­
0511.
Unpublished
study
prepared
by
Toxikon
Corporation.
22
p.

44902904
Fitzgerald,
G.
(
1992)
Buehler
Sensitization
Test:
Lake
Colorant
II:
(
in
Guinea
Pigs):
Lab
Project
Number:
92G­
0512.
Unpublished
study
prepared
by
Toxikon
Corporation.
23
p.

45086102
Tay,
C.
(
2000)
Acute
Dermal
Irritation
(
in
Rabbits):
Admiral
WSP:
Final
Report:
Lab
Project
Number:
00­
0661­
G2.
Unpublished
study
prepared
by
Toxikon
Corp.
19
p.
{
OPPTS
870.2500}

45144401
Cerven,
D.
(
2000)
Acute
Dermal
Toxicity
in
Rabbits/
LD50
in
Rabbits:
Admiral
WSP:
Lab
Project
Number:
1100:
MB
00­
8314.02.
Unpublished
study
prepared
by
MB
Research
Labs.
14
p.
{
OPPTS
870.1200}

45281101
Graver,
K.
(
2000)
Acute
Oral
Toxicity/
LD
50
in
Rats:
Admiral
WSP:
Lab
Project
26
Number:
MB
00­
8731.01:
1000.
Unpublished
study
prepared
by
MB
Research
Laboratories.
13
p.
{
OPPTS
870.1100}

Bibliography
PC
Code:
110302
43297501
Graves,
W.;
Swigert,
J.
(
1994)
Aquashade:
A
96­
Hour
Static
Acute
Toxicity
Test
with
the
Rainbow
Trout
(
Oncorhynchus
mykiss):
Final
Report:
Lab
Project
Number:
196A/
107A.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
39
p.

43297502
Graves,
W.;
Swigert,
J.
(
1994)
Aquashade:
A
96­
Hour
Static
Acute
Toxicity
Test
with
the
Bluegill
(
Lepomis
macrochirus):
Final
Report:
Lab
Project
Number:
196A/
108.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
38
p.

43297503
Graves,
W.;
Swigert,
J.
(
1994)
Aquashade:
A
48­
Hour
Static
Acute
Toxicity
Test
with
the
Cladoceran
(
Daphnia
magna):
Final
Report:
Lab
Project
Number:
196A/
109.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
38
p.

43336701
Campbell,
S.;
Beavers,
J.
(
1994)
Aquashade:
An
Acute
Oral
Toxicity
Study
with
the
Northern
Bobwhite:
Lab
Project
Number:
196/
103A.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
24
p.

43336702
Campbell,
S.;
Beavers,
J.
(
1994)
Aquashade:
An
Acute
Oral
Toxicity
Study
with
the
Mallard:
Lab
Project
Number:
196/
104.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
23
p.

43408101
Smith,
J.
(
1972)
Acid
Yellow
23­­
Rat
Teratology
Study:
Lab
Project
Numbers:
71R­
719A;
71R­
721A.
Unpublished
study
prepared
by
Bio­
dynamics,
Inc.
142
p.

43410901
Smith,
J.
(
1973)
Acid
Yellow
23:
Three
Generation
Reproduction
Study
of
FD&
C
Yellow
5:
Lab
Project
Number:
71R/
735.
Unpublished
study
prepared
by
Bio­
dynamics
Inc.
212
p.

43503402
Ellison,
F.
(
1994)
Physical
and
Chemical
Characteristics
of
Aqua
Shade
Yellow
23:
Color,
Physical
State,
Odor,
Boiling
Point,
Specific
Gravity,
Solubility,
Vapor
Pressure,
pH
and
Stability:
Lab
Project
Number:
140­
13:
2398:
DTI
2398.
Unpublished
study
prepared
by
Case
Consulting
Labs,
Inc.
20
p.

43503403
Campbell,
S.;
Beavers,
J.
(
1994)
Aquashade:
A
Dietary
LC50
Study
With
the
Northern
Bobwhite:
Lab
Project
Number:
196­
101.
Unpublished
study
prepared
by
Wildlife
Int'l,
Ltd.
36
p.

43503404
Campbell,
S.;
Beavers,
J.
(
1994)
Aquashade:
A
Dietary
LC50
Study
With
the
Mallard:
Lab
Project
Number:
196­
102.
Unpublished
study
prepared
by
Wildlife
Int'l,
Ltd.
35
p.

44902902
Fitzgerald,
G.
(
1992)
Primary
Eye
Irritation
Study:
Lake
Colorant
II:
(
in
Rabbits):
Lab
Project
Number:
92G­
0511.
Unpublished
study
prepared
by
Toxikon
Corporation.
22
p.

44902904
Fitzgerald,
G.
(
1992)
Buehler
Sensitization
Test:
Lake
Colorant
II:
(
in
Guinea
Pigs):
Lab
Project
Number:
92G­
0512.
Unpublished
study
prepared
by
Toxikon
Corporation.
23
p.

45086102
Tay,
C.
(
2000)
Acute
Dermal
Irritation
(
in
Rabbits):
Admiral
WSP:
Final
Report:
Lab
Project
Number:
00­
0661­
G2.
Unpublished
study
prepared
by
Toxikon
Corp.
19
p.
{
OPPTS
870.2500}

45144401
Cerven,
D.
(
2000)
Acute
Dermal
Toxicity
in
Rabbits/
LD50
in
Rabbits:
Admiral
WSP:
Lab
Project
Number:
1100:
MB
00­
8314.02.
Unpublished
study
prepared
by
MB
Research
Labs.
14
p.
{
OPPTS
870.1200}
27
45281101
Graver,
K.
(
2000)
Acute
Oral
Toxicity/
LD
50
in
Rats:
Admiral
WSP:
Lab
Project
Number:
MB
00­
8731.01:
1000.
Unpublished
study
prepared
by
MB
Research
Laboratories.
13
p.
{
OPPTS
870.1100}
28
Appendix
E.
Generic
Data
Call­
In
The
Generic
Data
Call­
In
will
be
posted
at
a
later
date.
29
Appendix
F.
Product
Specific
Data
Call­
In
Please
insert
Product
Specific
Data
Call­
In
here.
Appendix
G
EPA'S
BATCHING
OF
AQUASHADE
PRODUCTS
FOR
MEETING
ACUTE
TOXICITY
DATA
REQUIREMENTS
FOR
REREGISTRATION
In
an
effort
to
reduce
the
time,
resources
and
number
of
animals
needed
to
fulfill
the
acute
toxicity
data
requirements
for
reregistration
of
products
containing
AQUASHADE
as
the
active
ingredient,
the
Agency
has
batched
products
which
can
be
considered
similar
for
purposes
of
acute
toxicity.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
identity,
percent
composition
and
biological
activity),
type
of
formulation
(
e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular,
etc.),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling,
etc.).
Note
that
the
Agency
is
not
describing
batched
products
as
"
substantially
similar"
since
some
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.

Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Notwith­
standing
the
batching
process,
the
Agency
reserves
the
right
to
require,
at
any
time,
acute
toxicity
data
for
an
individual
product
should
the
need
arise.

Registrants
of
products
within
a
batch
may
choose
to
cooperatively
generate,
submit
or
cite
a
single
battery
of
six
acute
toxicological
studies
to
represent
all
the
products
within
that
batch.
It
is
the
registrants'
option
to
participate
in
the
process
with
all
other
registrants,
only
some
of
the
other
registrants,
or
only
their
own
products
within
a
batch,
or
to
generate
all
the
required
acute
toxicological
studies
for
each
of
their
own
products.
If
a
registrant
chooses
to
generate
the
data
for
a
batch,
he/
she
must
use
one
of
the
products
within
the
batch
as
the
test
material.
If
a
registrant
chooses
to
rely
upon
previously
submitted
acute
toxicity
data,
he/
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards
(
see
acceptance
criteria
attached),
the
formulation
tested
is
considered
by
EPA
to
be
similar
for
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material
by
EPA
Registration
Number.
If
more
than
one
confidential
statement
of
formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
which
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"
Data
Call­
In
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"
Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
A
registrant
who
wishes
to
participate
in
a
batch
must
decide
whether
he/
she
will
provide
31
the
data
or
depend
on
someone
else
to
do
so.
If
a
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
select
one
of
the
following
options:
Developing
Data
(
Option
1),
Submitting
an
Existing
Study
(
Option
4),
Upgrading
an
Existing
Study
(
Option
5)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
Cost
Sharing
(
Option
2),
Offers
to
Cost
Share
(
Option
3)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
does
not
want
to
participate
in
a
batch,
the
choices
are
Options
1,
4,
5
or
6.
However,
a
registrant
should
know
that
choosing
not
to
participate
in
a
batch
does
not
preclude
other
registrants
in
the
batch
from
citing
his/
her
studies
and
offering
to
cost
share
(
Option
3)
those
studies.

Four
products
were
found
which
contain
Aquashade
as
the
active
ingredient.
These
products
have
been
placed
in
a
no
batch
group
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.

Batching
Instructions:

No
Batch:
Each
product
in
this
Batch
should
generate
their
own
data.

NOTE:
The
technical
acute
toxicity
values
included
in
this
document
are
for
informational
purposes
only.
The
data
supporting
these
values
may
or
may
not
meet
the
current
acceptance
criteria.

No
Batch
EPA
Reg.
No.
Percent
Active
Ingredient
33068­
1
Acid
Blue
#
9:
23.63
Acid
Yellow
#
23:
2.39
33068­
2
Acid
Blue
#
9:
2.36
Acid
Yellow
#
23:
0.24
67064­
1
Acid
Blue
#
9:
49.72
Acid
Yellow
#
23:
3.27
67064­
2
Acid
Blue
#
9:
15.31
Acid
Yellow
#
23:
1.00
32
Appendix
H.
List
of
Registrants
sent
this
DCI.

Aquashade
W175
N11163
Stonewood
Dr.
Ste
234
Germantown,
Wi
53022
33
Appendix
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:

http://
www.
epa.
gov/
opprd001/
forms/

Pesticide
Registration
Forms
(
These
forms
are
in
PDF
format
and
require
the
Acrobat
reader)

Instructions
1.
Print
out
and
complete
the
forms.
(
Note:
Form
numbers
that
are
bolded
can
be
filled
out
on
your
computer
then
printed.)

2.
The
completed
form(
s)
should
be
submitted
in
hardcopy
in
accord
with
the
existing
policy.

3.
Mail
the
forms,
along
with
any
additional
documents
necessary
to
comply
with
EPA
regulations
covering
your
request,
to
the
address
below
for
the
Document
Processing
Desk.

DO
NOT
fax
or
e­
mail
any
form
containing
'
Confidential
Business
Information'
or
'
Sensitive
Information.'

If
you
have
any
problems
accessing
these
forms,
please
contact
Nicole
Williams
at
(
703)
308­
5551
or
by
e­
mail
at
williams.
nicole@
epa.
gov.

The
following
Agency
Pesticide
Registration
Forms
are
currently
available
via
the
internet:
at
the
following
locations:

8570­
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
forms/
8570­
1.
pdf
8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570­
5.
pdf
8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570­
17.
pdf
8570­
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf
8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570­
27.
pdf
34
8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570­
28.
pdf
8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570­
30.
pdf
8570­
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/

Dear
Registrant:

For
your
convenience,
we
have
assembled
an
online
registration
kit
which
contains
the
following
pertinent
forms
and
information
needed
to
register
a
pesticide
product
with
the
U.
S.
Environmental
Protection
Agency's
Office
of
Pesticide
Programs
(
OPP):

1.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
as
Amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

2.
Pesticide
Registration
(
PR)
Notices
a.
83­
3
Label
Improvement
Program
 
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
Through
Irrigation
Systems
(
Chemigation)
e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
Acrobat
reader.)
35
Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
NoticesPesticide
Product
Registration
Application
Forms
(
These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
EPA
Form
No.
8570­
1,
Application
for
Pesticide
Registration/
Amendment
b.
EPA
Form
No.
8570­
4,
Confidential
Statement
of
Formula
c.
EPA
Form
No.
8570­
27,
Formulator's
Exemption
Statement
d.
EPA
Form
No.
8570­
34,
Certification
with
Respect
to
Citations
of
Data
e.
EPA
Form
No.
8570­
35,
Data
Matrix
4.
General
Pesticide
Information
(
Some
of
these
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
Registration
Division
Personnel
Contact
List
b.
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
Contacts
c.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(
PDF
format)
e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(
PDF
format)
f.
40
CFR
Part
158,
Data
Requirements
for
Registration
(
PDF
format)
g..
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(
November
27,
1985)

Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:

1.
The
Office
of
Pesticide
Programs'
website.

2.
The
booklet
"
General
Information
on
Applying
for
Registration
of
Pesticides
in
the
United
States",
PB92­
221811,
available
through
the
National
Technical
Information
Service
(
NTIS)
at
the
following
address:

National
Technical
Information
Service
(
NTIS)
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(
703)
605­
6000.

3.
The
National
Pesticide
Information
Retrieval
System
(
NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(
765)
494­
6614
or
through
their
website.

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
website:
ace.
orst.
edu/
info/
nptn.
36
The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self­
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

1.
Date
of
receipt;
2.
EPA
identifying
number;
and
3.
Product
Manager
assignment.

Other
identifying
information
may
be
included
by
the
applicant
to
link
the
acknowledgment
of
receipt
to
the
specific
application
submitted.
EPA
will
stamp
the
date
of
receipt
and
provide
the
EPA
identifying
file
symbol
or
petition
number
for
the
new
submission.
The
identifying
number
should
be
used
whenever
you
contact
the
Agency
concerning
an
application
for
registration,
experimental
use
permit,
or
tolerance
petition.

To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(
including
"
blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
chemical
abstract
system
(
CAS)
number
if
one
has
been
assigned.

Documents
Associated
with
this
RED
The
following
documents
are
part
of
the
Administrative
Record
for
this
RED
document
and
may
be
included
in
the
EPA's
Office
of
Pesticide
Programs
Public
Docket.
Copies
of
these
documents
are
not
available
electronically,
but
may
be
obtained
by
contacting
the
person
listed
on
the
respective
Chemical
Status
Sheet.

1.
Health
Effects
Division
and
Environmental
Fate
and
Effects
Division
Science
Chapters,
which
include
the
complete
risk
assessments
and
supporting
documents.
2.
Detailed
Label
Usage
Information
System
(
LUIS)
Report.