Document ID: EPA-HQ-OPP-2005-0181-0022
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

United
States
Prevention,
Pesticides
EPA738­
R­
05­
001
Environmental
Protection
and
Toxic
Substances
January
2005
Agency
(
7508C)

Reregistration
Eligibility
Decision
for
Para­
Tertiary­
Amylphenol,
Potassium
Sodium
Salt
(
Case
3016)
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
CERTIFIED
MAIL
Dear
Registrant:

This
is
to
inform
you
that
the
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
review
of
the
available
data
and
public
comments
received
related
to
the
preliminary
risk
assessments
for
the
antimicrobial,
Para­
Tertiaryamylphenol
(
4­
t­
amylphenol).
The
enclosed
Reregistration
Eligibility
Decision
(
RED)
document
was
approved
on
September
30,
2005.
Public
comments
and
additional
data
received
were
considered
in
this
decision.

Based
on
its
review,
EPA
is
now
publishing
its
Reregistration
Eligibility
Decision
(
RED)
and
risk
management
decision
for
4­
t­
amylphenol
and
its
associated
human
health
and
environmental
risks.
A
Notice
of
Availability
will
be
published
in
the
Federal
Register
announcing
the
publication
of
the
RED.

The
RED
and
supporting
risk
assessments
for
4­
t­
amylphenol
are
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2005­
0181
at:
http://
www.
epa.
gov/
edockets.

The
4­
t­
amylphenol
RED
was
developed
through
EPA's
public
participation
process,
published
in
the
Federal
Register
on
July
20,
2005,
which
provides
opportunities
for
public
involvement
in
the
Agency's
pesticide
tolerance
reassessment
and
reregistration
programs.
Developed
in
partnership
with
USDA
and
with
input
from
EPA's
advisory
committees
and
others,
the
public
participation
process
encourages
robust
public
involvement
starting
early
and
continuing
throughout
the
pesticide
risk
assessment
and
risk
mitigation
decision
making
process.
The
public
participation
process
encompasses
full,
modified,
and
streamlined
versions
that
enable
the
Agency
to
tailor
the
level
of
review
to
the
level
of
refinement
of
the
risk
assessments,
as
well
as
to
the
amount
of
use,
risk,
public
concern,
and
complexity
associated
with
each
pesticide.
Using
the
public
participation
process,
EPA
is
attaining
its
strong
commitment
to
both
involve
the
public
and
meet
statutory
deadlines.

Please
note
that
the
4­
t­
amylphenol
risk
assessment
and
the
attached
RED
document
concern
only
this
particular
pesticide.
This
RED
presents
the
Agency's
conclusions
on
the
dietary,
drinking
water,
occupational
and
ecological
risks
posed
by
exposure
to
4­
t­
amylphenol
alone.
This
document
also
contains
both
generic
and
product­
specific
data
that
the
Agency
intends
to
require
in
Data
Call­
Ins
(
DCIs).
Note
that
DCIs,
with
all
pertinent
instructions,
will
be
sent
to
registrants
at
a
later
date.
Additionally,
for
product­
specific
DCIs,
the
first
set
of
required
responses
will
be
due
90
days
from
the
receipt
of
the
DCI
letter.
The
second
set
of
required
responses
will
be
due
eight
months
from
the
receipt
of
the
DCI
letter.

As
part
of
the
RED,
the
Agency
has
determined
that
4­
t­
amylphenol
will
be
eligible
for
reregistration
provided
that
all
the
conditions
identified
in
this
document
are
satisfied,
including
implementation
of
the
risk
mitigation
measures
outlined
in
Section
IV
of
the
document.
Sections
IV
and
V
of
this
RED
document
describe
labeling
amendments
for
end­
use
products
and
data
requirements
necessary
to
implement
these
mitigation
measures.
Instructions
for
registrants
on
submitting
the
revised
labeling
can
be
found
in
the
set
of
instructions
for
product­
specific
data
that
accompanies
this
document.

Should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
outlined
in
this
document,
the
Agency
will
continue
to
have
concerns
about
the
risks
posed
by
4­
t­
amylphenol.
Where
the
Agency
has
identified
any
unreasonable
adverse
effect
to
human
health
and
the
environment,
the
Agency
may
at
any
time
initiate
appropriate
regulatory
action
to
address
this
concern.
At
that
time,
any
affected
person(
s)
may
challenge
the
Agency's
action.

If
you
have
questions
on
this
document
or
the
label
changes
necessary
for
reregistration,
please
contact
the
Chemical
Review
Manager,
Killian
Swift,
at
(
703)
308­
6346.
For
questions
about
product
reregistration
and/
or
the
Product
DCI
that
accompanies
this
document,
please
contact
Adam
Heyward
at
(
703)
308­
6422.

Sincerely,

Frank
Sanders,
Director
Antimicrobials
Division
(
7510C)
REREGISTRATION
ELIGIBILITY
DECISION
for
Para­
tertiary­
amylphenol
List
C
CASE
3016
Approved
By:

Frank
Sanders
Director,
Antimicrobials
Division
Date:
September
30,
2005
Attachment
ix
Table
of
Contents
Glossary
of
Terms
and
Abbreviations                 ..
xvi
4­
t­
amylphenol
Reregistration
Team                  .
xiv
Executive
Summary                        ....
xv
I.
Introduction                           ..
1
II.
Chemical
Overview                       .
..
3
A.
Regulatory
History                    ..
3
B.
Chemical
Identification
                  ..
3
C.
Use
Profile                        ...
4
III.
Summary
of
4­
t­
amylphenol
Risk
Assessments            .
6
A.
Human
Health
Risk
Assessment               
6
1.
Toxicity
of
4­
t­
amylphenol              .
6
2.
FQPA
Safety
                     
8
3.
Population
Adjusted
Dose
(
PAD)            ...
9
a.
Acute
PAD                   
9
b.
Chronic
PAD                 
9
4.
Exposure
Assumptions                 
10
5.
Dietary
(
Food)
Risk
Assessment             .
10
a.
Acute
Dietary
Risk               ..
10
b.
Chronic
(
Non­
Cancer)
Dietary
Risk        ..
10
c.
Dietary
Risks
from
Drinking
Water        ..
11
6.
Residential
Exposure...                 
11
a.
Toxicity                    .
12
b.
Residential
Handler ...             ..
13
i.
Exposure
Scenarios,
Data
and
Assumptions  ..
13
ii.
Residential
Handler
Risk
Estimates     ..
14
c.
Residential
Post­
application
 .          .
14
i.
Exposure
Scenarios,
Data
and
Assumptions  ..
14
ii.
Residential
Post­
Application
Risk
Estimates .
15
7.
Aggregate
Risk                    
16
a.
Short
and
Intermediate
Term
Aggregate
Risk
....  ..
17
b.
Long
Term
Aggregate
Risk           ..
18
8.
Occupational
Risk                  ...
18
a.
Occupational
Toxicity              .
19
b.
Occupational
Handler
Exposure          
19
c.
Occupational
Handler
Risk
Summary       ...
19
d.
Occupational
Post­
Application
Risk
Summary    
21
e.
Human
Incident
Data              ..
21
B.
Environmental
Risk
Assessment               ..
21
x
1.
Environmental
Fate
and
Transport           ...
21
2.
Ecological
Risk                    
22
3.
Endocrine
Effects
in
Fish                
23
4.
Listed
Species
Consideration
              .
24
a.
The
Endangered
Species
Act  .         .
24
b.
General
Risk
Mitigation ..           
25
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision 
26
A.
Determination
of
Reregistration
Eligibility           
26
B.
Public
Comments
and
Responses               .
26
C.
Regulatory
Position                     
27
1.
Food
Quality
Protection
Act
Considerations       ...
27
a.
"
Risk
Cup"
Determination            .
27
b.
Determination
of
Safety
to
U.
S.
Population     .
27
c.
Determination
of
Safety
to
Infants
and
Children   
28
d.
Endocrine
Disruptor
Effects           ..
28
e.
Cumulative
Risks                .
29
2.
Tolerance
Summary                 
29
a.
Tolerances
Currently
Listed
and
Tolerance
Reassessment                
29
b.
Codex
Harmonization              
30
D.
Regulatory
Rationale                    ..
30
1.
Human
Health
Risk
Management            .
30
a.
Dietary
(
Food)
Risk
Mitigation          .
30
b.
Drinking
Water
Risk
Mitigation         ..
30
c.
Residential
Risk
Mitigation            
30
d.
Occupational
Risk
Mitigation           
31
i.
Handler
Exposure             .
31
ii.
Post­
Application
Risk
Mitigation      .
31
2.
Environmental
Risk
Management          ..
31
3.
Other
Labeling
Requirements              
31
4.
Threatened
and
Endangered
Species
Considerations    ..
32
a.
The
Endangered
Species
Program         .
32
b.
General
Risk
Mitigation            ..
32
V.
What
Registrants
Need
to
Do                   ..
34
A.
Manufacturing
Use­
Products                 
36
1.
Additional
Generic
Data
Requirements         ..
36
2.
Labeling
for
Technical
and
Manufacturing­
Use
Products  ..
38
B.
End­
Use
Products                    ..
38
1.
Additional
Product
Specific
Data
Requirements    ..........
38
2.
Labeling
for
End­
Use
Products             ..
38
a.
Label
Changes
Summary
Table          .
39
xi
VI.
Appendices                           .
41
A.
Table
of
Use
Patterns
for
4­
t­
amylphenol            
43
B.
Table
of
Generic
Data
Requirements
and
Studies
Use
to
Make
the
Reregistration
Decision                 .
68
C.
Technical
Support
Documents                
73
D.
Bibliography
Citations                   .
74
E.
Generic
Data
Call­
In                    .
79
F.
Product
Specific
Data
Call­
In                 
80
G.
Batching
of
End­
Use
Products                .
81
H.
List
of
All
Registrants
Sent
the
Data
Call­
In          ..
83
I.
List
of
Available
Forms                   ..
84
xii
Glossary
of
Terms
and
Abbreviations
a.
i.
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
APHIS
Animal
and
Plant
Health
Inspection
Service
ARTF
Agricultural
Re­
entry
Task
Force
BCF
Bioconcentration
Factor
CDC
Centers
for
Disease
Control
CDPR
California
Department
of
Pesticide
Regulation
CFR
Code
of
Federal
Regulations
ChEI
Cholinesterase
Inhibition
CMBS
Carbamate
Market
Basket
Survey
cPAD
Chronic
Population
Adjusted
Dose
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
CWS
Community
Water
System
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DL
Double
layer
clothing
{
i.
e.,
coveralls
over
SL}
DWLOC
Drinking
Water
Level
of
Comparison
EC
Emulsifiable
Concentrate
Formulation
EDSP
Endocrine
Disruptor
Screening
Program
EDSTAC
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
EEC
Estimated
Environmental
Concentration.
The
estimated
pesticide
concentration
in
an
environment,
such
as
a
terrestrial
ecosystem.
EP
End­
Use
Product
EPA
U.
S.
Environmental
Protection
Agency
EXAMS
Tier
II
Surface
Water
Computer
Model
FDA
Food
and
Drug
Administration
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FOB
Functional
Observation
Battery
FQPA
Food
Quality
Protection
Act
FR
Federal
Register
GL
With
gloves
GPS
Global
Positioning
System
HIARC
Hazard
Identification
Assessment
Review
Committee
IDFS
Incident
Data
System
IGR
Insect
Growth
Regulator
IPM
Integrated
Pest
Management
RED
Reregistration
Eligibility
Decision
LADD
Lifetime
Average
Daily
Dose
LC50
Median
Lethal
Concentration.
Statistically
derived
concentration
of
a
substance
expected
to
cause
death
in
50%
of
test
animals,
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LCO
Lawn
Care
Operator
LD50
Median
Lethal
Dose.
Statistically
derived
single
dose
causing
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation),
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LOAEC
Lowest
Observed
Adverse
Effect
Concentration
LOAEL
Lowest
Observed
Adverse
Effect
Level
LOC
Level
of
Concern
LOEC
Lowest
Observed
Effect
Concentration
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
xiii
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MRL
Maximum
Residue
Level
N/
A
Not
Applicable
NASS
National
Agricultural
Statistical
Service
NAWQA
USGS
National
Water
Quality
Assessment
NG
No
Gloves
NMFS
National
Marine
Fisheries
Service
NOAEC
No
Observed
Adverse
Effect
Concentration
NOAEL
No
Observed
Adverse
Effect
Level
NPIC
National
Pesticide
Information
Center
NR
No
respirator
OP
Organophosphorus
OPP
EPA
Office
of
Pesticide
Programs
ORETF
Outdoor
Residential
Exposure
Task
Force
PAD
Population
Adjusted
Dose
PCA
Percent
Crop
Area
PDCI
Product
Specific
Data
Call­
In
PDP
USDA
Pesticide
Data
Program
PF10
Protections
factor
10
respirator
PF5
Protection
factor
5
respirator
PHED
Pesticide
Handler's
Exposure
Data
PHI
Pre­
harvest
Interval
Ppb
Parts
per
Billion
PCCs
Poison
Control
Centers
PPE
Personal
Protective
Equipment
PRZM
Pesticide
Root
Zone
Model
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RPA
Reasonable
and
Prudent
Alternatives
RPM
Reasonable
and
Prudent
Measures
RQ
Risk
Quotient
RTU
(
Ready­
to­
use)
RUP
Restricted
Use
Pesticide
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SL
Single
layer
clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24C
of
FIFRA)
STORET
Storage
and
Retrieval
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TRAC
Tolerance
Reassessment
Advisory
Committee
TTRS
Transferable
Turf
Residues
UF
Uncertainty
Factor
USDA
United
States
Department
of
Agriculture
USFWS
United
States
Fish
and
Wildlife
Service
USGS
United
States
Geological
Survey
WPS
Worker
Protection
Standard
xiv
4Para­
Tertiary­
Amylphenol
Reregistration
Team
Office
of
Pesticide
Programs
Environmental
Fate
and
Effects
Risk
Assessment
Srinivas
Gowda
David
Bays
Health
Effects
Risk
Assessment
Jonathan
Chen
Timothy
Leighton
Tim
McMahon
Siroos
Mostaghimi
Myron
Ottley
Bob
Quick
Najm
Shamim
Deborah
Smegal
Cassi
Walls
Registration
Support
Adam
Heyward
Risk
Management
Ben
Chambliss
Killian
Swift
ShaRon
Carlisle
xv
Executive
Summary
The
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
review
of
public
comments
on
the
human
health
and
environmental
risk
assessments
for
para­
tertiary­
amylphenol
(
4­
t­
amylphenol)
and
its
potassium
and
sodium
salt
and
is
issuing
its
risk
management
decision.
The
Agency
has
determined
4­
t­
amylphenol
and
its
potassium
and
sodium
salts
are
eligible
for
reregistration
provided
all
measures
outlined
in
this
document
are
implemented.
4­
t­
Amylphenol
is
a
member
of
the
phenolic
class
of
antimicrobials.
4­
t­
Amylphenol
is
an
active
ingredient
in
disinfectant,
food­
contact
sanitizer
and
deodorizer
products
used
in
agricultural,
food
handling,
commercial,
institutional,
industrial,
residential,
public
access,
and
medical
settings,
primarily
on
hard,
non­
porous
surfaces.
The
majority
of
the
products
are
virucidal,
fungicidal,
tuberculocidal
or
bactericidal.
Examples
of
registered
uses
for
4­
t­
amylphenol
include
application
to
hard
surfaces
(
e.
g.,
walls,
floors,
tables,
fixtures),
textiles
(
e.
g.,
clothing,
diapers,
mattresses,
bedding),
carpets,
medical
instruments,
and
agricultural
equipment.
Additionally,
there
are
registered
uses
for
fogging
in
occupational
settings
and
air
deodorization
in
both
occupational
and
residential
settings.

Overall
Risk
Summary
The
Agency's
human
heath
risk
assessment
indicates
no
risks
of
concern
for
dietary
or
drinking
water
exposures.
An
acute
dietary
risk
estimate
was
completed
for
females
13­
49
years
old,
the
only
population
subgroup
with
an
acute
toxicity
endpoint,
and
is
below
the
Agency's
level
of
concern.
Chronic
dietary
risk
estimates
were
provided
for
the
general
U.
S.
population
and
all
population
subgroups.
All
chronic
dietary
risk
estimates
are
below
the
Agency's
level
of
concern.

4­
t­
Amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters
based
on
its
use
patterns
and
fate
characteristics.
Thus,
a
drinking
water
assessment
was
not
conducted.
Therefore,
no
risk
mitigation
measures
are
required
to
address
4­
t­
amylphenol
exposure
from
drinking
water.

Residential
risks
from
handler
and
post­
application
exposure
were
calculated
for
shortand
intermediate­
term
dermal,
inhalation
and
incidental
oral
exposures.
All
exposure
and
risk
estimates
for
residential
handler
scenarios
are
below
the
Agency's
level
of
concern.
Risks
of
concern
have
been
identified
for
several
post­
application
exposure
scenarios
including
children's
dermal
exposure
to
treated
clothing
and
treated
diapers
and
children's
incidental
oral
exposure
to
treated
clothing.
The
Agency
believes
that
adding
clear
instructions
for
washing
and
rinsing
textile
items
will
result
in
the
adequate
removal
of
residues
from
the
treated
items
and
address
the
Agency's
concerns
for
this
scenario.
The
MOE
for
dermal
exposure
to
children
to
treated
surfaces
in
daycare
centers
slightly
exceeds
the
Agency's
level
of
concern
(
MOE
=
940
with
a
target
MOE
of
1,000).
However,
the
Agency
believes
actual
exposure
from
this
pathway
to
not
exceed
its
level
of
concern
when
taking
into
account
the
conservative
nature
of
the
risk
estimate
which
is
likely
to
overestimate
potential
exposures.
xvi
Aggregate
short
and
intermediate
term
risk
assessments
were
conducted
for
this
chemical
that
includes
incidental
oral
and
inhalation
risks
only.
Dermal
risks
are
not
included
in
the
aggregate
risk
estimates
because
they
have
a
different
toxicity
endpoint.
The
aggregate
oral
and
inhalation
risks
are
not
of
concern
for
adults,
as
the
total
aggregate
MOE
is
greater
than
the
target
of
3,000.
For
children,
the
aggregate
risk
estimates
are
also
above
the
target
MOE
of
3,000
and
thus
are
not
of
concern.
However,
incidental
oral
exposures
to
treated
textiles
are
not
included
in
the
aggregate
assessment
because
the
oral
MOE
is
already
of
concern.

For
the
occupational
handler
dermal
and
inhalation
risk
assessment,
the
short­
and
intermediate­
term
risks
calculated
at
baseline
exposure
(
no
gloves
and
no
respirators)
were
above
target
MOEs
for
all
scenarios.
For
most
of
the
occupational
scenarios,
postapplication
dermal
exposure
is
not
expected
to
occur
or
is
expected
to
be
negligible
based
on
the
application
rates
and
chemical
properties
of
the
chemical.
Postapplication/
bystander
inhalation
exposures,
however,
were
assessed
for
entry
into
a
building
after
a
fogging
application.
The
representative
building
selected
was
a
poultry
barn.
The
calculated
inhalation
MOEs
were
above
the
target
MOE
of
300
for
all
fogging
postapplication
scenarios
with
the
exception
of
the
scenario
for
8­
hr
exposure
to
the
product
with
a
2­
hr
reentry
interval
(
MOE
=
86).

There
is
a
concern
about
the
possibility
of
endocrine
disruption
in
fish,
since
4­
tamylphenol
is
considered
an
ecoestrogen.
However,
since
this
chemical
is
restricted
to
indoor
uses
only,
the
possibility
for
exposure
to
fish
to
4­
t­
amylphenol
would
be
limited.
The
limited
exposure
resulting
from
indoor
uses
of
4­
t­
amylphenol
and
its
salts
is
not
anticipated
to
cause
adverse
effects
to
terrestrial
or
aquatic
organisms.

Dietary
Exposure
Risk
An
acute
dietary
risk
assessment
was
conducted
for
4­
t­
amylphenol
indirect
food
uses.
Dietary
risk
estimates
are
provided
for
females
13­
49
years
old,
the
only
population
subgroup
for
which
an
endpoint
was
selected.
The
result
of
this
assessment
showed
the
risk
estimate
to
be
2.7%
of
the
aPAD
and
therefore
is
not
of
concern
A
chronic
dietary
risk
assessment
was
conducted
for
4­
t­
amylphenol
food
uses.
The
risk
analysis
assumes
daily
exposure
from
the
hard
surface
disinfection
of
counter
tops.
The
result
of
this
assessment
showed
the
risk
estimates
to
be
<
42%
of
the
cPAD
and
therefore
are
not
of
concern.

Drinking
Water
Risk
4­
t­
Amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters
based
on
its
use
patterns
and
fate
characteristics.
There
are
no
currently
registered
outdoor
uses
of
4­
t­
amylphenol
and
its
salts.
Further,
the
estimated
value
for
biodegradation
indicates
it
may
biodegrade
linearly
within
days
in
the
aquatic
environment,
although
ultimate
biodegradation
(
mineralization)
may
take
months.
It
also
is
volatile
based
on
its
vapor
pressure
of
0.00116
mmHg,
and
has
a
moderate
to
slight
mobility
in
soils
based
on
its
estimated
Koc
value
of
3799.
The
sodium
and
potassium
salts
of
4­
t­
amylphenol
also
are
slightly
to
moderately
mobile
in
xvii
soils,
and
are
estimated
to
biodegrade
within
days
to
weeks.
Because
of
the
possibility
of
biodegradation
in
water
and
soils
and
the
lack
of
outdoor
uses,
4­
t­
amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters.
Thus,
a
drinking
water
assessment
was
not
conducted.

Residential
Handler
Risk
For
residential
handlers
that
handle
products
containing
4­
t­
amylphenol
and
its
salts,
short­
term,
and
intermediate­
term
MOEs
were
above
the
target
MOEs
(
i.
e.,
 
>
1,000
for
dermal
and
>
3,000
for
inhalation)
for
all
scenarios
evaluated
and
thus,
do
not
exceed
the
Agency's
level
of
concern.

Residential
Post­
Application
Risk
Risks
of
concern
have
been
identified
for
several
post­
application
exposure
scenarios
including
children's
dermal
exposure
to
treated
clothing
and
treated
diapers
and
children's
incidental
oral
exposure
to
treated
clothing.
The
Agency
believes
that
adding
clear
instructions
for
washing
and
rinsing
textile
items
will
result
in
the
adequate
removal
of
residues
from
the
treated
items
and
address
the
Agency's
concerns
for
this
scenario.
The
MOE
for
dermal
exposure
to
children
to
treated
surfaces
in
daycare
centers
slightly
exceeds
the
Agency's
level
of
concern
(
MOE
=
940
with
a
target
MOE
of
1,000).
However,
the
Agency
believes
actual
exposure
from
this
pathway
to
not
exceed
its
level
of
concern
when
taking
into
account
the
conservative
nature
of
the
risk
estimate
which
is
likely
to
overestimate
potential
exposures.

Aggregate
Risk
Short­
and
intermediate­
term
aggregate
risks
are
considered
together
because
the
exposure
and
toxicity
endpoints
are
identical
for
incidental
oral
and
inhalation
residential
exposures
for
both
durations.
For
children,
the
short­
and
intermediate­
term
aggregate
assessment
includes
average
dietary
exposure
(
food)
and
estimated
incidental
oral
exposures
to
children
from
residential
uses
such
as
hard
surface
disinfection.
In
addition,
inhalation
exposure
from
post­
application
of
an
air
deodorizer
use
was
aggregated
with
the
oral
exposures
since
the
toxicity
endpoint
is
the
same.
For
adults,
the
aggregate
assessment
includes
dietary
(
oral)
and
residential
inhalation
exposures
from
wiping
a
hard
surface
disinfectant,
in
addition
to
post
application
inhalation
exposure
from
the
air
deodorizer.

Aggregate
oral
and
inhalation
risks
are
not
of
concern
for
adults,
as
the
total
aggregate
MOE
is
greater
than
the
target
of
3,000.
For
children,
the
aggregate
risk
estimates
are
also
above
the
target
MOE
of
3,000
and
thus
are
not
of
concern.
As
noted
previously,
incidental
oral
exposures
to
treated
textiles
are
not
included
in
the
aggregate
assessment
because
the
oral
MOE
is
already
of
concern.

A
dermal
aggregate
assessment
was
not
conducted
because
the
toxicity
effects
for
the
dermal
exposure
route
are
not
the
same
as
the
oral/
inhalation
exposure
route.
However,
short
xviii
and
intermediate
dermal
risks
are
already
of
concern
for
residents
for
the
treated
textile
and
diaper
use.

Occupational
Risk
To
assess
the
handler
risks,
the
Agency
used
surrogate
unit
exposure
data
from
both
the
proprietary
Chemical
Manufacturers
(
CMA)
antimicrobial
exposure
study
and
the
Pesticide
Handlers
Exposure
Database
(
PHED).
For
the
occupational
handler
dermal
and
inhalation
risk
assessment,
the
short­
and
intermediate­
term
risks
calculated
at
baseline
exposure
(
no
gloves
and
no
respirators)
were
above
target
MOEs
for
all
scenarios
(
i.
e.,
dermal
MOEs
>
100
and
inhalation
MOEs
were
>
300).
Note,
however,
that
high
pressure
spray
application
method
in
the
agricultural
use
site
category
was
assessed
using
gloved
data.

For
most
of
the
occupational
scenarios,
post­
application
dermal
exposure
is
not
expected
to
occur
and
it
is
expected
to
be
negligible
based
on
the
application
rates
and
chemical
properties
of
the
chemical.
However,
post­
application/
bystander
inhalation
exposures
were
assessed
for
entry
into
a
building
after
fogging
application.
The
representative
building
selected
was
a
poultry
barn.
The
Agency
used
MCCEM
(
Multi­
Chamber
Concentration
and
Exposure
Model)
to
estimate
post­
application/
bystander
exposures.
The
calculated
inhalation
MOEs
were
above
the
target
MOE
of
300
for
all
fogging
post­
application
scenarios
with
the
exception
of
the
scenario
for
8­
hour
exposure
to
the
product
with
a
2­
hour
re­
entry
interval
(
MOE
=
86).

The
Agency
does
not
believe
that
any
mitigation
is
necessary
to
address
the
postapplication
scenario
with
a
2­
hr
reentry
interval
at
this
time.
The
risk
estimate
was
calculated
using
the
Agency's
standard
assumptions
for
air
exchange
rates.
The
Agency
believes
that
in
the
case
of
animal
barns
and
facilities
this
assumption
in
very
conservative
given
the
relatively
high
air
exchange
rates
for
such
facilities.

Ecological
Risk
There
is
a
concern
about
the
possibility
of
endocrine
disruption
in
fish,
since
4­
tamylphenol
is
considered
an
ecoestrogen.
This
was
documented
in
several
studies
on
carp
(
Cyprimus
carpio).
However,
since
this
chemical
is
restricted
to
indoor
uses
only,
the
possibility
for
exposure
to
fish
to
4­
t­
amylphenol
would
be
limited.
The
limited
exposure
resulting
from
indoor
uses
of
4­
t­
amylphenol
and
its
salts
is
not
anticipated
to
cause
adverse
effects
to
terrestrial
or
aquatic
organisms.

Regulatory
Decision
The
Agency
has
completed
its
review
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
supported
products
containing
4­
t­
amylphenol.
The
Agency
is
issuing
this
RED
for
4­
t­
amylphenol,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
This
RED
document
includes
guidance
and
time
frames
for
making
any
necessary
label
changes
for
products
containing
4­
t­
amylphenol.
xix
Summary
of
Mitigation
Measures
The
Agency
has
determined
that
4­
t­
amylphenol
and
its
salts
(
potassium
and
sodium)
are
eligible
for
reregistration
provided
the
mitigation
measures
described
in
this
document
and
the
label
changes
included
in
Table
13
in
Section
V
of
the
RED
are
implemented.

Residential
Risk
Mitigation
To
reduce
residential
exposure,
the
Agency
has
determined
that
the
following
mitigation
and
label
changes
for
specific
scenarios
are
appropriate
and
required
for
reregistration
eligibility:

­
Delete
all
diaper
uses
­
Delete
all
use
on
non­
laundered
textiles\
items
including
mattresses,
helmets,
headgear,
headphones,
facegear,
and
mouthpieces.
­
All
labels
with
laundered
textile
uses
must
have
directions
that
indicate
that
items
must
be
treated
prior
to
washing
and
rinsing.
1
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
and
amended
again
by
the
Pesticide
Registration
Improvement
Act
of
2003
to
set
time
frames
for
the
issuance
of
Reregistration
Eligibility
Decisions.
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
by
the
U.
S.
Environmental
Protection
Agency
(
EPA
or
the
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
hazards
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
of
1996
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
tolerance
reassessment.
The
Agency
has
decided
that,
for
those
chemicals
that
have
tolerances
and
are
undergoing
reregistration,
the
tolerance
reassessment
will
be
initiated
through
this
reregistration
process.
The
Act
also
requires
that
by
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
date
of
the
enactment
of
the
FQPA.
FQPA
also
amends
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
consideration
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.
This
document
presents
the
Agency's
revised
human
health
and
ecological
risk
assessments;
and
the
Reregistration
Eligibility
Decision
(
RED)
for
4­
tertiary­
amylphenol
(
4­
t­
amylphenol),
and
salts
(
potassium
and
sodium).

4­
t­
Amylphenol
and
salts
are
active
ingredients
in
disinfectant
and
food­
contact
sanitizer
products
used
in
agricultural,
food
handling,
commercial/
institutional/
industrial,
residential,
public
access,
and
medical
settings
 
primarily
on
hard,
non­
porous
surfaces.
The
majority
of
the
products
are
virucidal,
fungicidal,
bactericidal,
pseudomonacidal,
or
staphylocidal.
Examples
of
registered
uses
for
4­
t­
amylphenol
and
salts
include
application
to
hard
surfaces
(
e.
g.,
walls,
floors,
tables,
and
fixtures),
textiles
(
e.
g.,
clothing,
diapers,
mattresses,
and
bedding),
carpets,
medical
instruments,
and
agricultural
equipment.
Additionally,
there
are
registered
uses
for
fogging
in
occupational
settings
and
air
deodorization
in
both
occupational
and
residential
settings.
Concentrations
of
4­
t­
amylphenol
and
salts
in
products
range
from
0.0027%
to
10%.
The
products
are
formulated
as
soluble
concentrates,
ready­
to­
use
liquid
solutions,
pressurized
sprays,
and
impregnated
wipes.

The
Agency
has
concluded
that
the
hazard
based
FQPA
safety
factor
should
be
retained
at
10X.
The
toxicology
data
base
is
not
complete
with
respect
to
assessing
the
increased
susceptibility
to
infants
and
children
as
required
by
FQPA
for
4­
t­
amylphenol.
The
rat
prenatal
developmental
study
showed
no
quantitative
evidence
of
increased
susceptibility
(
i.
e.,
developmental
NOAELs
/
LOAELs
were
higher
than
those
for
maternal
effects).
However,
there
was
qualitative
evidence
of
increased
susceptibility
as
the
fetal
effects
(
i.
e.,
skeletal
abnormalities,
decreased
body
weight
gain)
were
considered
to
be
more
severe
than
maternal
toxicity
(
reversible
clinical
signs).
In
addition,
there
is
an
absence
of
developmental
toxicity
data
in
the
rabbit,
and
an
absence
of
reproductive
toxicity
data.
Furthermore,
studies
in
the
open
2
literature
suggest
that
4­
t­
amylphenol
may
be
an
endocrine
disruptor.
It
increased
non­
pregnant
uterine
weight
in
rats
and
was
associated
with
elevated
blood
levels
of
billirubin
in
children
exposed
to
4­
t­
amylphenol
and
other
phenols
in
disinfectants.
These
studies,
while
not
indicative,
are
suggestive
of
a
basis
for
increased
concern
for
reproductive
and/
or
developmental
effects
due
to
exposure
to
4­
t­
amylphenol.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
the
active
ingredients
4­
t­
amyphenol
and
its
salts
(
potassium
and
sodium).
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
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.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
lowlevel
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
that
would
occur
at
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
4­
t­
amyphenol
and
its
salts
(
potassium
and
sodium)
and
any
other
substances.
4­
t­
Amyphenol
and
it
salts
(
potassium
and
sodium)
do
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
action,
therefore,
EPA
has
not
assumed
that
4­
t­
amyphenol
and
it
salts
(
potassium
and
sodium)
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
.

This
document
presents
the
Agency's
decision
regarding
the
reregistration
eligibility
of
the
registered
uses
of
4­
t­
amyphenol
and
its
salts
(
potassium
and
sodium).
In
an
effort
to
simplify
the
RED,
the
information
presented
herein
is
summarized
from
more
detailed
information
which
can
be
found
in
the
technical
supporting
documents
for
4­
t­
amylphenol
and
salts
referenced
in
this
RED.
The
revised
risk
assessments
and
related
addenda
are
not
included
in
this
document,
but
are
available
in
the
Public
Docket
at
http://
www.
epa.
gov/
edocket
(
OPP­
2005­
0181)

This
document
consists
of
six
sections.
Section
I
is
the
introduction.
Section
II
provides
a
chemical
overview,
a
profile
of
the
use
and
usage
of
4­
t­
amylphenol
and
its
salt
(
potassium
and
sodium),
and
its
regulatory
history.
Section
III,
Summary
of
4­
t­
amylphenol
and
salts
Risk
Assessment,
gives
an
overview
of
the
human
health
and
environmental
assessments,
based
on
the
data
available
to
the
Agency.
Section
IV,
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision,
presents
the
reregistration
eligibility
and
risk
management
decisions.
Section
V,
What
Registrants
Need
to
Do,
summarizes
the
necessary
label
changes
based
on
the
risk
mitigation
measures
outlined
in
Section
IV.
Finally,
the
Appendices
list
all
use
patterns
eligible
for
reregistration,
bibliographic
information,
related
documents
and
how
to
access
them,
and
Data
Call­
In
(
DCI)
information.
3
II.
Chemical
Overview
A.
Regulatory
History
4­
t­
Amyphenol
and
its
salts
(
potassium
and
sodium)
have
been
registered
for
use
since
1962.
Currently,
there
are
35
products
containing
4­
t­
amyphenol
(
one
technical
product
and
34
end­
use­
products)
registered
under
Section
3
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).

B.
Chemical
Identification
1.
Para­
Tertiary­
Amylphenol
&
its
Potassium
and
Sodium
Salts
OH
C
CH3
CH3
C
H
H
CH3
O
­
Na
+
CH
3
CH
3
CH
3
P
aratertiaryam
yl
P
h
enol,
S
o
dium
S
a
lt
O
­
K
+
CH
3
CH
3
CH
3
P
aratert
iaryam
yl
P
hn
eo
l,
P
o
tass
ium
S
a
lt
Common
name:
Para­
Tertiary
amylphenol
Chemical
name:
4­
tertiary­
amylphenol,
and
salts
Chemical
Family:
Antimicrobial
Disinfectant
4
Empirical
formula:
C5H11C6H4OH
(
064101)
C5H11C6H4Na+
(
064111)

C5H11C6H4K+
(
064112)

CAS
Registry
No.:
064101:
80­
46­
6
(
4­
t­
amylphenol)
064111:
53404­
18­
5
(
sodium
salt)
064112:
31366­
95­
7
(
potassium
salt)

Case
number:
3016
OPP
Chemical
Code:
064101,
064111,
064112
Molecular
weight:
164.25
(
064111)

Trade
name:
Nipacide
PTAP
Basic
manufacturer:
Clariant
Corporation
Technical
4­
t­
amylphenol
is
a
white
solid.
4­
t­
Amylphenol
has
a
melting
point
of
95
E
C.
The
water
solubility
of
4­
t­
amylphenol
is
113.4
ppm.
4­
t­
Amylphenol
has
a
vapor
pressure
of
1.16
x
10­
3
mm
Hg
at
25o
C.

Sodium
4­
tert­
amylphenate
is
also
a
solid
with
an
estimated
melting
point
of
205
E
C,
water
solubility
of
4,595
ppm
and
an
estimated
vapor
pressure
of
7.7
x10­
10
at
25oC.
Potassium
4­
tert­
amylphenate
is
also
a
sold
with
an
estimated
melting
point
of
206
E
C,
water
solubility
of
3,811
ppm
and
an
estimated
vapor
pressure
of
7.7
x10­
10
at
25oC.

C.
Use
Profile
The
following
is
information
on
the
currently
registered
uses
of
4­
t­
amylphenol
and
salts
products
and
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
eligible
for
reregistration
is
contained
in
Occupational
and
Residential
Exposure
Assessment
for
this
RED.

Type
of
Pesticide:
Antimicrobial
Summary
of
Use:

Food:
4­
tert­
amylphenol
and
its
salts
are
applied
to
the
following
use
sites,
which
may
result
in
indirect
food
contact:
commercial
egg
washing,
handling,
hatchery,
and
processing
facilities;
milking
equipment;
and
mushroom
houses.

Non­
Food:
Farm
and
agricultural
equipment
and
structures/
premises;
beverage
processing
plants;
eating
establishment
surfaces,
equipment,
and
utensils;
5
food
storage
and
distribution
equipment
and
utensils;
and
food
dispensing
equipment.

Residential:
Air
deodorizer
in
residential
premises,
hard
surface
disinfection,
textiles,
and
carpets.

Target
Pests:
Viruses,
fungi,
tuberculocidal
microbes,
bacteria,
pseudomonacidal
microbes,
and
staphylocidal
microbes.

Formulation
Types:
Soluble
concentrates,
ready­
to­
use
liquid
solutions,
pressurized
sprays,
and
impregnated
wipes
Method
and
Rates
of
Application:

Equipment:
Mops,
wipes,
trigger­
pump
sprayer,
aerosol.

Application
Rates:
Concentrations
of
4­
t­
amylphenol
and
salts
products
range
from
0.0027%
to
10%.

Timing:
Most
labeling
indicates
product
needs
to
remain
on
surface
for
at
least
a
10
second
contact
time
before
it
is
removed
using
a
potable
water
rinse.
6
III.
Summary
of
4­
Tert­
Amylphenol
Risk
Assessments
The
purpose
of
this
summary
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
these
risk
assessments,
and
to
help
the
reader
better
understand
the
conclusions
reached
in
the
assessments.
The
human
health
and
ecological
risk
assessment
documents
and
supporting
information
listed
in
Appendix
C
were
used
to
formulate
the
safety
finding
and
regulatory
decision
for
4­
t­
amylphenol.
While
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
from
the
OPP
Public
Docket
and
may
also
be
accessed
on
the
Agency's
website
at
http://
epa.
gov/
dockets.
Hard
copies
of
these
documents
may
be
found
in
the
OPP
public
docket
under
docket
number
OPP­
2004­
0220.
The
OPP
public
docket
is
located
in
Room
119,
Crystal
Mall
II,
1801
Bell
Street,
Arlington,
VA,
and
is
open
Monday
through
Friday,
excluding
Federal
holidays,
from
8:
30
a.
m.
to
4:
00
p.
m.

A.
Human
Health
Risk
Assessment
1.
Toxicity
of
4­
tertiary­
amylphenol
A
brief
overview
of
the
toxicity
studies
used
for
determining
the
dietary
endpoints
in
the
risk
assessments
are
outlined
in
Table
2.
Further
details
on
the
toxicity
of
4­
t­
amylphenol
can
be
found
in
the
"
Toxicology
Science
Chapter
for
Reregistration
Eligibility
Decision
Document",
September
2005;
and
"
4­
t­
amylphenol
Report
of
the
Antimicrobial
Division's
Toxicology
Endpoint
Selection
Committee
(
ADTC)",
July
2005.
These
documents
are
available
on
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.
(
OPP­
2005­
0181)

The
Agency
has
reviewed
all
toxicity
studies
submitted
for
4­
t­
amylphenol
and
has
determined
that
the
toxicological
database
is
sufficient
for
reregistration.
Major
features
of
the
toxicology
profile
are
presented
below.
The
toxicology
database
for
4­
t­
amylphenol,
in
terms
of
guideline
studies,
is
largely
incomplete.
4­
t­
amylphenol
appears
to
be
a
primary
dermal
and
eye
irritant
(
Category
I),
and
it
may
be
in
Category
III
for
acute
oral
dermal
studies,
according
to
data
from
the
open
literature,
and
two
registrant
submitted
studies.
However,
four
acceptable
guideline
acute
studies
are
not
available,
and
the
literature
data
protocols
were
inadequate.

Table
1.
Acute
Toxicity
of
4­
t­
amylphenol
Technical
Guideline
No./
Study
Type
MRID
Number
Results
Toxicity
Category
870.1100
Acute
Oral
Toxicity
46616601
LD50
>
2000
mg/
kg
III
870.1200
Acute
Dermal
Toxicity
Not
available;
required
870.1300
Acute
Inhalation
Toxicity
Not
available;
required
870.2400
Acute
Eye
Irritation
Not
available;
required
870.2500
Acute
Dermal
Irritation
46616602
Corrosive
I
870.2600
Skin
Sensitization
Not
available;
required
7
The
doses
and
toxicological
endpoints
selected
for
the
dietary
exposure
scenarios
are
summarized
in
Table
2
below.

Table
2.
Toxicological
Endpoints
for
4­
t­
amylphenol
and
salts
(
Dietary)
Exposure
Scenario
Dose
for
Risk
Assessment
and
Uncertainty
Factor
Special
FQPA
Safety
Factor
and
Population
Adjusted
Dose
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
50
years
of
age)
NOAEL
=
200
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.67
mg/
kg/
day
FQPA
SF
=
10x
aPAD
=
acute
RfD
FQPA
SF
=
0.6
mg/
kg/
day
Developmental
Toxicity
Study
in
Rats
LOAEL
=
500
mg/
kg/
day
based
on
skeletal
effects
and
decreased
fetal
body
weight.

Chronic
Dietary
(
All
populations)
NOAEL=
50
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.17
mg/
kg/
day
FQPA
SF
=
10x
cPAD
=
chronic
RfD
FQPA
SF
=
0.17
mg/
kg/
day
Developmental
toxicity
study
in
the
rat.
LOAEL
=
200
mg/
kg/
day
based
on
clinical
signs
of
toxicity,
decreased
body
weight
and
body
weight
gain,
and
decreased
food
consumption.

UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose,
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
N/
A
=
Not
Applicable
In
short­
term
studies,
4­
t­
amylphenol
produced
clinical
signs
along
with
decreased
food
consumption
and
body
weight
in
a
developmental
toxicity
study,
but
not
systemic
effects
in
a
13­
week
dermal
study.
The
structural
abnormalities
and
developmental
delays
that
occurred
in
the
developmental
study
occurred
at
higher
dose
levels
than
the
maternal
effects,
suggesting
that
increased
quantitative
susceptibility
concerns
are
not
warranted.
However,
the
minimal
maternal
effects
(
reversible
clinical
signs)
seen
in
the
presence
of
developmental
effects
increases
concern
for
qualitative
susceptibility.

Available
data
suggest
that
4­
t­
amylphenol
has
endocrine
disrupter
capabilities
(
uterotrophic
and
estrogenic
effects)
and
increased
billirubin
production
in
babies.
When
taken
with
the
lack
of
available
developmental
and
reproductive
toxicity
data,
concerns
for
FQPA
issues
are
heightened.

General
Toxicity
Observations
Dietary
The
acute
RfD
is
0.67
mg/
kg/
day
for
females
(
13­
50
years),
based
on
adverse
developmental
effects
(
skeletal
effects
and
decreased
fetal
body
weight)
at
500
mg/
kg/
day
in
a
rat
developmental
study.
The
chronic
RfD
is
0.17
mg/
kg/
day
based
on
clinical
signs
of
toxicity
and
decreased
body
weight
and
food
consumption
at
200
mg/
kg/
day
in
a
rat
developmental
study.
An
uncertainty
factor
of
300
(
10X
for
interspecies
extrapolation,
10X
for
intraspecies
variability,
and
3X
for
database
uncertainties)
was
applied
to
the
NOAEL
to
obtain
the
acute
and
chronic
RfDs.
A
database
uncertainty
factor
of
3x
is
applied
to
non­
occupational
risk
assessments
for
4­
t­
amylphenol,
due
to
the
number
and
significance
of
the
data
gaps
including
lack
of
repeated
oral
toxicity
studies.
An
additional
Food
Quality
Protection
Factor
(
FQPA)
safety
factor
is
applied,
which
is
discussed
below.
8
Incidental
Oral
The
short­
and
intermediate­
term
incidental
oral
NOAEL
is
50
mg/
kg/
day
from
a
rat
oral
developmental
toxicity
study
that
noted
clinical
signs,
decreases
in
body
weight
and
body
weight
gain,
coupled
with
decreased
food
consumption
at
200
mg/
kg/
day.
The
target
margin
of
exposure
(
MOE)
is
3,000
(
includes
10X
FQPA
factor).

Short­
and
Intermediate­
term
Dermal
The
short­
and
intermediate­
term
dermal
NOAEL
is
25
mg/
kg/
day,
which
is
based
on
the
lack
of
systemic
effects
identified
up
to
and
including
a
dose
of
25
mg/
kg/
day
in
a
rat
subchronic
dermal
toxicity
study.
Uncertainty
factors
or
"
target"
margins
of
exposure
(
MOE)
for
4­
tamylphenol
dermal
exposures
are
100
for
occupational
scenarios
and
1,000
for
residential
scenario
(
includes
10X
FQPA
factor).

Short­,
Intermediate­
and
Long­
term
Inhalation
The
short­,
intermediate­
and
long­
term
inhalation
NOAEL
is
50
mg/
kg/
day
from
a
rat
oral
developmental
toxicity
study
that
noted
clinical
signs,
decreases
in
body
weight
and
body
weight
gain,
coupled
with
decreased
food
consumption
at
200
mg/
kg/
day.
In
the
absence
of
data,
it
was
conservatively
assumed
that
inhalation
absorption
is
equivalent
to
oral
absorption
(
i.
e.,
100%).
For
inhalation
exposures,
the
uncertainty
factors
are
300
for
occupational
scenarios
and
3,000
for
residential
scenarios
(
includes
10X
FQPA
factor).
An
additional
3X
database
uncertainty
factor
was
applied
due
to
the
absence
of
inhalation
toxicity
data,
and
studies
that
address
the
sensitivity
of
infants
and
children.
The
3,000
MOE
represents
the
maximum
uncertainty
that
can
be
applied
under
Agency
guidelines
and
applies
to
residential
exposures.

Carcinogenicity
Classification
There
are
no
lifetime
carcinogenicity
studies
available
for
4­
t­
amylphenol.

Mutagenicity
Potential
The
data
base
for
mutagenicity
is
considered
adequate
based
on
EPA's
1991
mutagenic
guidelines
and
indicates
that
4­
t­
amylphenol
is
not
mutagenic
or
genotoxic.

Endocrine
Disruption
Potential
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
4­
t­
Amylphenol
has
properties
that
could
indicate
Endocrine
Disrupting
Chemical
(
EDC)
properties
given
that
available
data
suggest
that
4­
t­
Amylphenol
has
endocrine
disruptor
capabilities
(
uterotrophic
and
estrogenic
effects)
and
increased
billirubin
production
in
babies.

2.
FQPA
Safety
Factor
The
FQPA
Safety
Factor
(
as
required
by
the
Food
Quality
Protection
Act
of
1996)
is
intended
to
provide
an
additional
10­
fold
safety
factor
(
10X),
to
protect
for
special
sensitivity
in
infants
and
children
to
specific
pesticide
residues
in
food,
drinking
water,
or
residential
exposures,
or
to
compensate
for
an
incomplete
database.
The
FQPA
Safety
Factor
has
been
9
retained
(
i.
e.,
remains
10X)
for
4­
t­
amylphenol
based
on
the
limited
database,
qualitative
evidence
of
sensitivity
in
the
developmental
toxicity
study,
and
the
suggestive
evidence
in
the
open
literature
of
possible
endocrine
effects.

The
toxicology
data
base
is
not
complete
with
respect
to
assessing
that
increased
susceptibility
to
infants
and
children
as
required
by
FQPA
for
4­
t­
Amylphenol.
The
rat
prenatal
developmental
study
showed
no
quantitative
evidence
of
increased
susceptibility
(
i.
e.,
developmental
NOAELs/
LOAELs
were
higher
than
those
for
maternal
effects).
However,
there
was
qualitative
evidence
of
increased
susceptibility
[
i.
e.,
fetal
effects
(
skeletal
abnormalities,
decreased
body
weight
gain)
were
considered
to
be
more
severe
than
the
maternal
toxicity
(
reversible
clinical
signs)
observed
at
the
same
dose
level].
In
addition,
there
is
an
absence
of
developmental
toxicity
data
in
the
rabbit
and
an
absence
of
reproductive
toxicity
data.

3.
Population
Adjusted
Dose
(
PAD)

Dietary
risk
is
characterized
in
terms
of
the
Population
Adjusted
Dose
(
PAD),
which
reflects
the
reference
dose
(
RfD),
either
acute
or
chronic,
that
has
been
adjusted
to
account
for
the
FQPA
Safety
Factor
(
SF).
This
calculation
is
performed
for
each
population
subgroup.
A
risk
estimate
that
is
less
than
100%
of
the
acute
or
chronic
PAD
is
not
of
concern.

a.
Acute
PAD
Acute
dietary
risk
for
4­
t­
amylphenol
is
assessed
by
comparing
acute
dietary
exposure
estimates
(
in
mg/
kg/
day)
to
the
acute
Population
Adjusted
Dose
(
aPAD).
Acute
dietary
risk
is
expressed
as
a
percent
of
the
aPAD.
The
aPAD
is
the
acute
reference
dose
(
0.67
mg/
kg/
day)
modified
by
the
FQPA
safety
factor.
The
acute
reference
dose
was
derived
from
a
developmental
toxicity
study
in
rats
in
which
both
the
NOAEL
(
200
mg/
kg/
day)
and
the
LOAEL
(
500
mg/
kg/
day)
were
determined.
Acute
dietary
exposure
was
estimated
only
for
females
ages
13­
49
because
available
studies
did
not
show
a
toxicity
endpoint
attributable
to
a
single
exposure
for
the
general
population.
The
4­
t­
amylphenol
aPAD
is
0.067
mg/
kg/
day
based
on
a
reference
dose
of
0.6
mg/
kg/
day,
and
incorporating
the
FQPA
safety
factor
of
10X.

b.
Chronic
PAD
Chronic
dietary
risk
for
4­
t­
Amylphenol
is
assessed
by
comparing
chronic
dietary
exposure
estimates
(
in
mg/
kg/
day)
to
the
chronic
Population
Adjusted
Dose
(
cPAD).
Chronic
dietary
risk
is
expressed
as
a
percent
of
the
cPAD.
The
cPAD
is
the
chronic
reference
dose
(
0.17
mg/
kg/
day)
modified
by
the
FQPA
safety
factor.
The
cPAD
was
derived
from
a
developmental
toxicity
study
in
rats
in
which
both
the
NOAEL
(
50
mg/
kg/
day)
and
the
LOAEL
(
200
mg/
kg/
day)
were
determined.
The
4­
t­
amylphenol
cPAD
is
0.017
mg/
kg/
day
based
on
a
reference
dose
of
0.17
mg/
kg/
day,
which
includes
the
incorporation
of
the
FQPA
safety
factor
(
10X)
for
the
overall
U.
S.
population
or
any
population
subgroups.
10
4.
Exposure
Assumptions
The
use
of
antimicrobial
chemicals
on
food
or
feed
contact
surfaces,
agricultural
commodities,
in
animal
premises
and
poultry
premises
including
hatcheries
and
application
to
food­
grade
eggs
may
result
in
pesticide
residues
in
human
food.
The
Agency
must
determine
the
risk
to
human
health
that
may
occur
from
exposure
to
these
chemicals.

Refrigerators,
counter
tops,
sinks
and
stoves
are
use
sites
on
registered
labels.
These
surfaces
that
have
been
treated
with
the
4­
t­
amylphenol
products
may
bear
small
residues
of
the
4­
t­
amylphenol
products
after
rinsing
with
potable
water;
i.
e.,
rinsing
with
potable
water
may
not
remove
all
residues
deposited
on
the
treated
surfaces
from
the
proposed
uses.
Residues
from
treated
surfaces
can
migrate
to
food
coming
into
contact
with
the
treated
and
rinsed
surfaces
and
can
be
ingested
by
humans.

In
the
absence
of
residue
data
for
4­
t­
amylphenol
on
treated
food
contact
surfaces,
the
Agency
estimated
residue
levels
that
may
occur
in
food
using
the
highest
application
rate
for
food
contact
surfaces.
To
estimate
the
Estimated
Daily
Intake
(
EDI),
the
Agency
has
used
an
FDA
model.
The
maximum
ingredient
percentage
for
4­
t­
amylphenol
in
food
handling
establishments
from
the
various
labeled
ready­
to­
use
products
is
0.054
%
a.
i
(
540
ppm).
The
Agency
assumed
that
food
can
contact
2000
cm2
of
treated
surfaces,
and
that
10%
of
the
pesticide
migrates
to
food
based
on
the
Agency
Residential
SOPs.
The
use
of
the
10%
transfer
rate
instead
of
the
use
of
a
100%
transfer
rate
that
is
used
in
the
FDA
Sanitizer
Solution
Guidelines
requires
the
submission
of
confirmatory
data
to
establish
the
reliability
of
the
use
of
the10%
transfer
rate.
These
daily
estimates
were
conservatively
used
to
assess
both
acute
and
chronic
dietary.

5.
Dietary
(
Food)
Risk
Assessment
Generally,
a
dietary
risk
estimate
that
is
less
than
100%
of
the
acute
or
chronic
PAD
does
not
exceed
the
Agency's
risk
concerns.
A
summary
of
acute
and
chronic
risk
estimates
are
shown
in
Table
3.

a.
Acute
Dietary
Risk
An
acute
dietary
risk
assessment
was
conducted
for
4­
t­
amylphenol
food
uses.
Dietary
risk
estimates
are
provided
for
females
13­
49
years
old,
the
only
population
subgroup
for
which
an
endpoint
was
selected.
The
result
of
this
assessment
showed
the
risk
estimate
to
be
2.7%
of
the
aPAD
and
therefore
is
not
of
concern
b.
Chronic
(
Non­
cancer)
Dietary
Risk
A
chronic
dietary
risk
assessment
was
conducted
for
4­
t­
amylphenol
food
uses.
The
risk
analysis
assumes
daily
exposure
from
the
hard
surface
disinfection
of
counter
tops.
The
result
of
this
assessment
showed
the
risk
estimates
to
be
<
42%
of
the
cPAD
and
therefore
are
not
of
11
concern.
However,
since
the
Agency
assumed
10%
of
the
residues
are
transferred
to
foods
it
is
requiring
confirmatory
data
for
this
transfer
rate
because
100%
residue
transfer
indicates
risks
of
concern.

Table
3:
Acute
and
Chronic
Dietary
Exposure
and
Risk
Acute
Dietary
Chronic
Dietary
Population
Subgroup
Dietary
Exposure
(
mg/
kg/
day)
a
%
aPAD
b
Dietary
Exposure
(
mg/
kg/
day)
a
%
cPAD
b
adult
male
0.0015
NA
0.0015
9
females
(
13­
50
years)
0.0018
2.7
0.0018
10.6
infants/
children
0.0072
NA
0.0072
42
NA=
not
applicable
b.
Dietary
Risk
from
Drinking
Water
4­
t­
Amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters
based
on
its
use
patterns
and
fate
characteristics.
There
are
no
currently
registered
outdoor
uses
of
4­
t­
amylphenol
and
its
salts.
Further,
the
estimated
value
for
biodegradation
indicates
it
may
biodegrade
linearly
within
days
in
the
aquatic
environment,
although
ultimate
biodegradation
(
mineralization)
may
take
months.
It
also
is
volatile
based
on
its
vapor
pressure
of
0.00116
mmHg,
and
has
a
moderate
to
slight
mobility
in
soils
based
on
its
estimated
Koc
value
of
3799.
The
sodium
and
potassium
salts
of
4­
t­
amylphenol
also
are
slightly
to
moderately
mobile
in
soils,
and
are
estimated
to
biodegrade
within
days
to
weeks.
Because
of
the
possibility
of
biodegradation
in
water
and
soils
and
the
lack
of
outdoor
uses,
4­
t­
amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters.
Thus,
a
drinking
water
assessment
was
not
conducted.

6.
Residential
Exposure
Residential
exposure
assessment
considers
all
potential
pesticide
exposure,
other
than
exposure
due
to
residues
in
food
or
in
drinking
water.
Exposure
may
occur
during
and
after
application
as
a
hard
surface
disinfectant
(
e.
g.,
walls,
floors,
tables,
fixtures),
to
textiles
(
e.
g.,
clothing,
diapers,
mattresses,
bedding)
and
to
carpets.
Each
route
of
exposure
(
oral,
dermal,
inhalation)
is
assessed,
where
appropriate,
and
risk
is
expressed
as
a
Margin
of
Exposure
(
MOE),
which
is
the
ratio
of
estimated
exposure
to
an
appropriate
NOAEL.
Based
on
its
use
patterns,
4­
t­
amylphenol
has
been
assessed
for
the
residential
mixing/
loading/
applicator
(
or
"
handler")
exposure
for
applications
by
homeowners
mopping,
wiping
and
spraying
hard
surfaces.
For
post­
application
exposure,
4­
t­
amylphenol
has
been
assessed
for
adults
and
children
contacting
treated
hard
surfaces/
floors,
wearing
treated
clothing,
wearing
treated
diapers
(
children),
mouthing
treated
textiles
(
children)
and
bystander
inhalation
exposure.
12
a.
Toxicity
The
toxicological
endpoints
and
associated
uncertainty
factors
used
for
assessing
the
nondietary
risks
for
4­
t­
amylphenol
are
listed
in
Table
4.

A
MOE
greater
than
or
equal
to
3,000
is
considered
adequately
protective
for
the
residential
exposure
assessment
for
the
incidental
oral
and
inhalation
routes
of
exposure.
The
MOE
of
3,000
includes
10x
for
interspecies
extrapolation,
10x
for
intraspecies
variation,
3x
for
database
uncertainty
and
the
10x
FQPA
factor.
For
the
dermal
route
of
exposure,
a
MOE
greater
than
or
equal
to
1,000
is
considered
adequately
protective
for
the
residential
exposure
assessment.
The
MOE
of
1,000
includes
10x
for
interspecies
extrapolation,
10x
for
intraspecies
variation
and
the
10x
FQPA
factor.

Table
4:
Toxicity
Endpoints
Selected
for
Assessing
Occupational
and
Residential
Risk
for
4­
t­
Amylphenol
Exposure
Scenario
Dose
Used
in
Risk
Assessment
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Incidental
Oral,
Short­
and
Intermediate­
Term
Maternal
Oral
NOAEL
=
50
mg/
kg/
day
Residential
LOC
for
MOE
=
3000
Occupational
=
NA
Developmental
toxicity
study
in
the
rat
LOAEL
=
200
mg/
kg/
day
based
on
clinical
signs
of
toxicity,
decreased
body
weight
and
body
weight
gain,
and
decreased
food
consumption
Short­,
and
Intermediate
­
Term
Dermal
Dermal
NOAEL
=
25
mg/
kg/
day
for
systemic
effects
Residential
LOC
for
MOE
=
1000
Occupational
=
100
Subchronic
dermal
toxicity
study
in
Rats
Systemic
LOAEL
=
not
identified.
No
systemic
effects
identified
up
to
and
including
25
mg/
kg/
day
(
HDT).

Dermal
LOAEL=
10
mg/
kg/
day
for
dermal
effects
and
irritation.
Dermal
NOAEL=
2.5
mg/
kg/
day
Short­,
Intermediate­,
and
Long­
Term
Inhalation
Oral
NOAEL
=
50
mg/
kg/
day
Residential
LOC
for
MOE
=
3000
Occupational
=
300
Developmental
toxicity
study
in
the
rat
LOAEL
=
200
mg/
kg/
day
based
on
clinical
signs
of
toxicity,
decreased
body
weight
and
body
weight
gain,
and
decreased
food
consumption.

Cancer
No
cancer
data
available
for
4­
t­
amylphenol
HDT=
Highest
dose
tested
13
b.
Residential
Handler
i.
Exposure
Scenarios,
Data
and
Assumptions
Residential
exposure
may
occur
during
application
of
4­
t­
amylphenol
as
a
hard
surface
disinfectant
(
e.
g.,
walls,
floors,
tables,
fixtures),
to
textiles
(
e.
g.,
clothing,
diapers,
mattresses,
bedding)
and
to
carpets.
A
number
of
assumptions,
or
estimates,
such
as
adult
body
weight
and
area
treated
per
application,
are
made
by
the
Agency
for
residential
risk
assessment.
Also,
note
that
residential
handlers
are
sometimes
addressed
somewhat
differently
than
occupational
handlers
in
that
homeowners
are
assumed
to
complete
all
elements
of
an
application
(
mix/
load/
apply)
without
the
use
of
personal
protective
equipment.

The
quantitative
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
these
scenarios:

(
1)
mopping
hard
surfaces,
(
2)
wiping
hard
surfaces,
(
3)
using
trigger
pump
equipment
to
treat
hard
surfaces
and/
or
textiles,
and
(
4)
application
to
air
using
an
aerosol
spray
can
4­
t­
Amylphenol
products
are
widely
used
disinfectants
and
have
a
large
number
of
use
patterns
that
are
difficult
to
completely
capture
in
this
assessment.
As
such,
the
Agency
has
selected
representative
scenarios
for
each
use
site
that
are
believed
to
be
representative
of
the
vast
majority
of
4­
t­
amylphenol
uses,
based
on
end­
use
product
application
methods
and
use
amounts.

Surrogate
data
are
available
for
mopping,
wiping,
trigger
pump
spray
and
aerosol
can
application
methods.
Dermal
and
inhalation
exposures
were
assessed
for
mopping
and
wiping
using
proprietary
Chemical
Manufacturers
Association
(
CMA)
data
(
CMA
1992,
USEPA
1999).
These
data
are
based
on
individuals
mopping
floors
and
receiving
exposure
via
contact
with
the
mop
or
with
the
bucket,
or
using
a
finger
pump
sprayer
to
apply
the
product
and
then
wipe
the
surfaces
with
a
paper
towel.
Dermal
and
inhalation
exposures
were
assessed
for
trigger
pump
spray
and
aerosol
application
methods
using
PHED
Version
1.1
values
found
in
the
Residential
Exposure
SOPs
(
U.
S.
EPA,
1997a,
2001).
The
surrogate
exposure
data
in
PHED
are
based
on
test
subjects
applying
an
aerosol
insecticide
to
baseboards
in
kitchens.
The
dermal
and
inhalation
exposures
from
these
techniques
have
been
normalized
by
the
amount
of
active
ingredient
handled
and
reported
as
unit
exposures
(
UE)
expressed
as
mg/
lb
ai
handled.

In
addition,
product
label
maximum
application
rates,
related
use
information,
and
Agency
standard
values
were
used
to
assess
residential
handler
exposures.
For
example,
it
was
assumed
that
one
gallon
of
diluted
solution
is
used
for
mopping
floors,
while
0.5
liters
(
0.13
gallons)
are
used
in
the
wiping
and
trigger
pump
spray
scenario.
For
aerosol
can
spray,
it
was
assumed
that
one
16
oz
can
of
product
is
used
in
a
day.
The
residential
handler
scenarios
are
assumed
to
be
of
short­
and
intermediate­
term
duration
(
1­
30
days
and
1­
6
months)
14
ii.
Residential
Handler
Risk
Estimates
Based
on
toxicological
criteria
and
potential
for
exposure,
the
Agency
has
conducted
dermal
and
inhalation
exposure
assessments.
As
noted
previously,
MOEs
greater
than
or
equal
to
3,000
for
the
inhalation
route
of
exposure
and
1,000
for
dermal
exposure
are
considered
adequately
protective
for
the
residential
exposure
assessment.

A
summary
of
the
residential
handler
exposures
and
risk
are
presented
on
Table
5.
For
residential
handlers
that
handle
products
containing
4­
t­
amylphenol
and
its
salts,
short­
term,
and
intermediate­
term
MOEs
were
above
the
target
MOEs
(
i.
e.,
 
>
1000
for
dermal
and
>
3000
for
inhalation)
for
all
scenarios
evaluated
and
thus,
do
not
exceed
the
Agency's
level
of
concern.

Table
5:
Estimates
of
Exposures
and
Risks
to
Residential
Handlers
of
4­
t­
Amylphenol
(
Short­
and
Intermediate­
Duration)

Scenario
Dermal
Dose
(
mg/
kg/
day)
Inhalation
Dose
(
mg/
kg/
day)
Dermal
MOE
(
Target
MOE>
1000)
Inhalation
MOE
(
Target
MOE>
3000)

(
1)
Mopping
0.00128
4.25x10­
5
20,000
1,200,000
(
2)
Wiping
0.00666
1.56x10­
4
3,800
320,000
(
3)
Trigger
Pump
Spray
0.00198
2.16x10­
5
13,000
2,300,000
(
4)
Aerosol
Spray
0.00233
2.54x10­
5
11,000
2,000,000
c.
Residential
Post­
Application
i.
Exposure
Scenarios,
Data
and
Assumptions
Residential
postapplication
exposures
result
when
bystanders
(
adults
and
children)
come
in
contact
with
4­
t­
amylphenol
in
areas
where
pesticide
end­
use
products
have
recently
been
applied
(
e.
g.,
treated
hard
surfaces/
floors),
or
when
children
incidentally
ingest
the
pesticide
residues
through
mouthing
the
treated
end
products/
treated
articles
(
i.
e.,
hand­
to­
mouth
or
object­
to­
mouth
contact).

For
the
purposes
of
this
screening
level
assessment,
postapplication
scenarios
have
been
developed
that
encompass
multiple
products,
but
still
represent
a
high
end
exposure
scenario
for
all
products
represented.
Representative
postapplication
scenarios
assessed
include:

°
contacting
treated
hard
surfaces/
floors
(
dermal
and
incidental
oral
exposure
to
children),
°
wearing
treated
clothing
(
dermal
exposure
to
adults
and
children),
°
wearing
diapers
treated
with
a
trigger­
pump
spray
(
dermal
exposure
to
children),
°
mouthing
treated
textiles
such
as
clothing
and
blankets
(
incidental
oral
exposure
to
children),
and
15
°
postapplication/
bystander
inhalation
exposures
from
use
of
disinfecting/
deodorizing
products
(
vapor
exposure
to
adults
and
children).

Typically,
most
products
used
in
a
residential
setting
result
in
exposures
occurring
over
a
short­
term
time
duration
(
1
 
30
days).
If
the
products
are
used
on
a
routine
basis
(
i.
e.,
once
a
week)
and
the
active
ingredient
has
a
long
indoor
half­
life,
exposures
may
occur
over
an
intermediate­
term
time
duration
(
30
days
 
6
months).
At
this
time,
the
Agency
does
not
have
residue
dissipation
data
or
reliable
use
pattern
data,
including
the
frequency
and
duration
of
use
of
antimicrobial
products
in
the
residential
setting.
Even
though
the
Agency
does
not
believe
that
the
use
patterns
of
many
residential
products
result
in
intermediate­
term
exposure,
they
are
assessed
to
provide
an
upper
bound
estimate
of
exposure.
The
Agency
does
believe,
however,
that
intermediate­
term
exposure
to
children
may
occur
in
day
care
centers
where
disinfecting
products
are
used
more
frequently.

A
number
of
conservative
assumptions
were
used
in
assessing
postapplication
risks
including
maximum
application
rate
from
the
label.
In
addition
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
the
Draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000,
2001)
and
the
AD
Draft
Residential
SOP
use
table.
In
certain
cases,
no
standard
values
were
available
for
some
scenarios.
Assumptions
for
these
scenarios
were
based
on
AD
estimates
and
could
be
further
refined
from
input
from
affected
sectors.
In
the
absence
of
data,
for
both
the
textile
and
diaper
scenarios,
it
was
assumed
that
either
100%
or
5%
of
4­
t­
amylphenol
could
transfer
and
be
available
for
dermal
contact.
The
Agency
will
require
data
to
confirm
the
actual
transfer
factor
of
4­
t­
amylphenol.

No
postapplication
air
concentration
data
have
been
submitted
for
4­
t­
amylphenol
to
determine
potential
vapor
inhalation
risk.
Therefore,
the
Multi­
Chamber
Concentration
and
Exposure
Model
(
MCCEM
v1.2)
was
used
to
present
a
screening­
level
estimate
of
the
potential
inhalation
risk
to
adults
and
children
for
the
air
deodorizer
use.
MCCEM
estimates
average
and
peak
indoor
air
concentrations
of
chemicals
released
from
products
or
materials
in
houses,
apartments,
townhouses,
or
other
residences.
The
data
libraries
in
MCCEM
contain
information
about
residential
settings.
MCCEM
estimates
inhalation
exposures
to
chemicals,
calculated
as
single
day
doses,
chronic
average
daily
doses,
or
lifetime
average
daily
doses.
All
dose
estimates
are
potential
doses;
they
do
not
account
for
actual
absorption
into
the
body.

ii.
Residential
Post­
Application
Risk
Estimates
Based
on
toxicological
criteria
and
potential
for
exposure,
the
Agency
has
conducted
dermal,
incidental
oral
and
inhalation
exposure
assessments.
As
noted
previously,
MOEs
greater
than
or
equal
to
3,000
for
incidental
oral
and
inhalation
exposure
and
1,000
for
dermal
exposure
are
considered
adequately
protective
for
the
residential
exposure
assessment.
A
summary
of
the
residential
post­
application
exposures
and
risk
are
presented
on
Table
6.

The
child
short­
and
intermediate­
term
dermal
MOEs
for
contact
following
hard
surface
disinfection
is
above
the
target
MOE
of
1,000
for
residential
settings
and
slightly
below
the
MOE
for
daycare
centers.
The
short­
and
intermediate­
term
MOEs
for
dermal
contact
with
16
treated
clothing
is
of
concern
for
young
children
(
MOEs
are
<
1
assuming
a
100%
transfer
factor;
MOE=
17
assuming
a
5%
transfer
factor).
For
adults,
the
dermal
MOE
is
below
the
target
MOE
of
1,000
using
a
100%
transfer
factor
(
MOE
=
140)
and
above
the
MOE
using
the
5%
transfer
factor.
The
dermal
MOE
for
children
wearing
treated
diapers
is
only
of
concern
(
MOE=
59)
using
a
transfer
factor
of
100%,
but
it
not
of
concern
when
using
a
transfer
factor
of
5%.
In
addition,
it
should
be
noted
that
4­
t­
amylphenol
caused
dermal
irritant
effects
following
repeated
dermal
exposure,
and
may
also
be
a
potential
dermal
sensitizer.

The
short­
and
intermediate­
term
incidental
oral
MOEs
following
hard
surface
disinfection
are
above
the
target
MOE
of
3,000
for
residential
settings
and
daycare
centers,
and
thus
are
not
of
concern.
However,
the
oral
MOE
for
children
mouthing
treated
textiles
exceeds
the
Agency's
level
of
concern
(
MOE=
650
compared
to
target
MOE>
3,000).

For
both
adults
and
children,
the
calculated
inhalation
MOEs
are
greater
than
the
target
MOE
of
3,000
for
inhalation
exposures
following
use
of
an
air
deodorizer,
and
thus
are
not
of
concern.

Table
6:
Summary
of
Short­
and
Intermediate­
Term
Residential
Post­
Application
Exposures
and
Risks
Scenario
Dose
(
mg/
kg/
day)
MOE
(
Target
MOE>
1000
dermal;
>
3000
oral
and
inhalation)
Dermal
Exposure
Residential
Setting
0.0067
3,700
Hard
surface
Disinfection
Daycare
center
0.0267
940
Adults
0.0092
(
5%
transfer)
0.185
(
100%
transfer)
2,700
140
Treated
clothing
Children
1.45
(
5%
transfer)
28.9
(
100%
transfer)
17
<
1
Treated
Diapers
Children
0.0212
(
5%
transfer)
0.424
(
100%
transfer)
1,200
59
Incidental
Oral
Exposure
Residential
Setting
0.000817
61,000
Hard
surface
Disinfection
Daycare
center
0.00155
32,000
Treated
clothing
Children
650
Inhalation
Exposure
Adults
0.00186
27,000
Air
Deodorizer
Children
0.00666
7,500
7.
Aggregate
Risk
The
Food
Quality
Protection
Act
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
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure.
Since
no
drinking
water
estimates
17
were
developed
for
4­
t­
amylphenol,
aggregate
assessments
include
exposure
to
food
and
as
a
result
of
residential
uses
only.

Typically,
aggregate
risk
assessments
are
conducted
for
acute
(
1
day),
short­
term
(
1­
30
days),
intermediate­
term
(
1­
6
months)
and
chronic
(
6
months
to
lifetime)
exposures.
However,
acute
and
chronic
aggregate
assessments
were
not
conducted
because
there
are
no
significant
impacts
to
drinking
water
sources,
nor
are
there
long­
term
residential
uses.
Thus,
only
short­
and
intermediate­
term
aggregate
assessments
were
conducted.
Oral
and
inhalation
exposure
and
risk
estimates
were
combined
for
the
aggregate
risk
assessment
because
these
endpoints
are
based
on
the
same
toxicity
study
(
oral
developmental
study)
and
effects
of
concern
(
clinical
signs
and
changes
in
body
weight
and
food
consumption).
Dermal
exposures
were
not
aggregated
with
the
oral
or
inhalation
exposures
due
to
different
toxicological
endpoints
for
oral
(
clinical
signs
and
body
weight
changes),
and
dermal
(
no
systemic
effects
at
the
highest
dose
tested).

a.
Short­
and
Intermediate­
Term
Aggregate
Risk
Aggregate
short­
and
intermediate­
term
risk
assessments
are
designed
to
provide
estimates
of
risk
likely
to
result
from
exposures
to
the
pesticide
or
pesticide
residues
in
food,
water,
and
from
residential
(
or
other
non­
occupation)
pesticide
uses.
Short­
and
intermediateterm
aggregate
risks
are
considered
together
because
the
exposure
and
toxicity
endpoints
are
identical
for
incidental
oral
and
inhalation
residential
exposures
for
both
durations.
For
children,
the
short­
and
intermediate­
term
aggregate
assessment
includes
average
dietary
exposure
(
food)
and
estimated
incidental
oral
exposures
to
children
from
residential
uses
such
as
hard
surface
disinfection.
In
addition,
inhalation
exposure
from
postapplication
of
an
air
deodorizer
use
was
aggregated
with
the
oral
exposures
since
the
toxicity
endpoint
is
the
same.
For
adults,
the
aggregate
assessment
includes
dietary
(
oral)
and
residential
inhalation
exposures
from
wiping
a
hard
surface
disinfectant,
in
addition
to
post
application
inhalation
exposure
from
the
air
deodorizer.

The
results
of
the
aggregate
short­
and
intermediate­
term
risk
assessments
are
presented
in
Table
7.
The
aggregate
oral
and
inhalation
risks
are
not
of
concern
for
adults,
as
the
total
aggregate
MOE
is
greater
than
the
target
of
3,000.
For
children,
the
aggregate
risk
estimates
are
also
above
the
target
MOE
of
3,000
and
thus
are
not
of
concern.
As
noted
previously,
incidental
oral
exposures
to
treated
textiles
are
not
included
in
the
aggregate
assessment
because
the
oral
MOE
is
already
of
concern.

A
dermal
aggregate
assessment
was
not
conducted
because
the
toxicity
effects
for
the
dermal
exposure
route
are
not
the
same
as
the
oral/
inhalation
exposure
route.
However,
as
shown
previously
on
Table
6,
short­
and
intermediate
dermal
risks
are
already
of
concern
for
residents
for
the
treated
textile
and
diaper
use.
18
Table
7.
Summary
of
Short­
and
Intermediate­
Term
Aggregate
Risk
Estimates
Exposure
Scenario
Dose
(
mg/
kg/
day)
Total
MOE
(
b)
(
Target
MOE>
3000
Oral
Exposure
Dietary
Exposure
Hard
Surface
Disinfection
 
Daycare
Center
Child
0.0072
0.00155
Adult
0.0018(
a)
NA
Child
6940
(
c)
32,000
Adult
28,000
(
c)
NA
Inhalation
Exposure
Handler
of
hard
surface
Disinfectant
 
wiping
NA
0.000156
NA
320,000
Air
Deodorizer
0.00666
0.00186
7,500
27,000
Total
Aggregate
Dose
&
MOE
0.0154
0.00316
3,240
13,000
NA:
Not
Applicable.
(
a):
Chronic
Dietary
Exposure
for
Females
(
13­
50
years).
(
b):
MOE
=
NOAEL
(
mg/
kg/
day)
/
potential
dose
rate
(
mg/
kg/
day)
[
Where
short­
&
intermediate­
term
oral
NOAEL
=
50.
(
c):
Risk
estimates
are
equivalent
to
percent
of
the
PAD
of
42%
for
child
and
10.6%
for
adults.

b.
Long­
Term
Aggregate
Risk
A
long­
term
(
or
chronic)
aggregate
assessment
was
not
undertaken
because
the
only
long­
term
residential
use
(
diaper
use)
results
in
dermal
exposure,
which
has
a
different
toxicological
effect
than
the
chronic
dietary
oral
exposure.

8.
Occupational
Exposure
and
Risk
Workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
pesticide,
or
re­
entering
treated
sites.
Occupational
handlers
of
4­
t­
amylphenol
include
workers
in
a
variety
of
occupational
settings.
Additionally,
postapplication
exposures
are
likely
to
occur
in
these
settings.
The
representative
scenarios
selected
for
assessment
were
evaluated
using
maximum
application
rates
as
recommended
on
the
product
labels
for
4­
t­
amylphenol.

Occupational
risk
is
assessed
for
exposure
at
the
time
of
application
(
termed
"
handler"
exposure)
and
is
assessed
for
exposure
following
application,
or
post­
application
exposure.
Application
parameters
are
generally
defined
by
the
physical
nature
of
the
formulation
(
e.
g.,
formula
and
packaging),
by
the
equipment
required
to
deliver
the
chemical
to
the
use
site,
and
by
the
application
rate
required
to
achieve
an
efficacious
dose.

Occupational
risk
for
all
of
these
potentially
exposed
populations
is
measured
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(
NOAEL)
from
toxicological
studies.
In
the
case
of
4­
tamylphenol
MOEs
greater
than
100
for
dermal
exposures
and
300
for
inhalation
exposures
are
not
of
concern
to
the
Agency.
For
workers
entering
a
treated
site,
MOEs
are
calculated
for
each
day
after
application
to
determine
the
minimum
length
of
time
required
before
workers
can
safely
re­
enter.
19
For
more
information
on
the
assumptions
and
calculations
of
4­
t­
amylphenol
`
s
potential
risk
to
workers,
see
the
Occupational
Exposure
Assessment
(
Section
8.0)
in
the
"
AD
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document"(
Revised),"
dated
September,
2005.
3
a.
Occupational
Toxicity
Table
4
provides
a
listing
of
the
toxicological
endpoints
used
in
the
occupational
risk
assessment
for
4­
t­
amylphenol.

b.
Occupational
Handler
Exposure
Potential
occupational
handler
exposure
can
occur
at
various
use
sites,
including
agricultural
premises,
food
handling,
commercial/
institutional/
industrial
premises,
and
medical
premises.
MOEs
are:
>
100
for
dermal
exposure
and;
>
300
for
inhalation
exposure.
Only
the
high
pressure
spray
in
the
agricultural
use
scenario
was
evaluated
using
gloved
data.

The
Agency
has
determined
that
there
is
potential
for
dermal
and
inhalation
worker
exposure
to
4­
t­
amylphenol
at
various
use
sites
including
agricultural
premises,
food
handling,
commercial/
institutional/
industrial
premises,
and
medical
premises.
To
assess
handler
risks,
the
Agency
used
surrogate
unit
exposure
data
from
both
proprietary
Chemical
Manufacturers
(
CMA)
antimicrobial
exposure
study
and
the
Pesticide
Handlers
Exposure
Database
(
PHED).

c.
Occupational
Handler
Risk
Summary
For
the
occupational
handler
dermal
and
inhalation
risk
assessment,
the
short­
and
intermediate­
term
risks
calculated
at
baseline
exposure
(
no
gloves
and
no
respirators)
were
above
target
MOEs
for
all
scenarios
(
i.
e.,
dermal
MOEs
were
>
100
and
inhalation
MOEs
were
>
300).
Note,
however,
that
the
high
pressure
spray
application
method
in
the
agricultural
use
site
category
was
assessed
using
gloved
data.
A
summary
of
the
results
of
the
occupational
handler
assessment
is
provided
in
Table
8.
20
Table
8:
Short­,
Intermediate­
Term
Risks
for
Occupational
Handlers
MOE
Exposure
Scenario
Method
of
Application
Application
Rate
(
lb
ai/
gallon)
Quantity
Handled/
Treated
per
day
(
gallons)
Baseline
Dermal
(
a)
(
Target
MOE>
100)
PPE
Gloves
Dermal
(
b)
(
Target
MOE>
100)
Baseline
Inhalation
(
Target
MOE>
300)
Agricultural
Premises
and
Equipment
Low
Pressure
Handwand
10
270
No
Data
150,000
High
Pressure
Handwand
40
No
Data
5,100
210,000
Mopping
2
3,600
No
Data
220,000
Wiping
0.26
690
No
Data
59,000
Application
to
hard
surfaces
Trigger
Pump
Spray
0.0034
0.26
10,000
24,000
3,000,000
Fogger
Liquid
Pour
of
soluble
concentrate
0.163
lb
ai/
gal/
6,000
ft2
15,000
ft2
120
No
Data
4,500
Food
Handling
Low
Pressure
Handwand
2
1,800
No
Data
1,000,000
Mopping
2
4,900
No
Data
290,000
Wiping
0.26
940
No
Data
80,000
Application
to
indoor
hard
surfaces
Trigger
Pump
Spray
0.0025
0.26
7,300
17,000
2,100,000
Commercial/
Institutional
Premises
Low
Pressure
Handwand
2
920
No
Data
510,000
Mopping
2
2,400
No
Data
150,000
Wiping
0.26
470
No
Data
40,000
Application
to
indoor
hard
surfaces
Trigger
Pump
Spray
0.005
0.26
7,100
17,000
2,100,000
Air
Deodorization
Aerosol
Spray
0.074%
ai
by
weight
3
16
oz
cans
4,100
9,700
1.200,000
Medical
Premises
and
Equipment
Low
Pressure
Handwand
2
920
No
Data
510,000
Mopping
45
110
No
Data
6,500
Wiping
0.26
470
No
Data
40,000
Application
to
indoor
hard
surfaces
Trigger
Pump
Spray
0.005
0.26
7,100
17,000
2,100,000
Air
Deodorization
Aerosol
Spray
0.074%
ai
by
weight
3
16
oz
cans
4,100
9,700
1,200,000
(
a)
Baseline
Dermal:
Long­
sleeve
shirt,
long
pants,
no
gloves.
(
b)
PPE
Dermal
with
gloves:
baseline
dermal
plus
chemical­
resistant
gloves.
21
d.
Occupational
Post­
application
Risk
Summary
For
most
of
the
occupational
scenarios,
postapplication
dermal
exposure
is
not
expected
to
occur
or
is
expected
to
be
negligible
based
on
the
application
rates
and
chemical
properties
of
the
chemical.
Postapplication/
bystander
inhalation
exposures,
however,
were
assessed
for
entry
into
a
building
after
a
fogging
application.
The
representative
building
selected
was
a
poultry
barn.
The
Agency
used
the
MCCEM
(
Multi­
Chamber
Concentration
and
Exposure
Model)
to
estimate
postapplication/
bystander
exposures.
The
calculated
inhalation
MOEs
were
above
the
target
MOE
of
300
for
all
fogging
postapplication
scenarios
with
the
exception
of
the
scenario
for
8­
hr
exposure
to
the
product
with
a
2­
hr
reentry
interval
(
MOE
=
86).

The
Agency
does
not
believe
that
any
mitigation
is
necessary
to
address
the
postapplication
scenario
with
a
2­
hr
reentry
interval
at
this
time.
The
risk
estimate
was
calculated
using
the
Agency's
standard
assumptions
for
air
exchange
rates.
The
Agency
believes
that
in
the
case
of
animal
barns
and
facilities
this
assumption
in
very
conservative
given
the
relatively
high
air
exchange
rates
for
such
facilities.

e.
Human
Incident
Data
There
are
some
reported
incidents
associated
with
exposure
to
end­
use
products
containing
4­
t­
amylphenol.
Dermal,
ocular
and
inhalation
are
the
primary
routes
of
exposure.
Most
of
the
incidents
are
related
to
irritation
reaction.
The
most
common
symptoms
reported
for
cases
of
inhalation
exposure
were
respiratory
irritation/
burning,
irritation
to
mouth/
throat/
nose,
coughing/
choking,
shortness
of
breath,
dizziness,
flu­
like
symptoms,
and
headache.
Eye
pains,
burning
of
eyes,
conjunctivivitis,
blurring
vision,
and
acute
inflammation
have
been
reported
in
ocular
incidents.
Neurological
effects,
such
as
dizziness,
headache
and
blurred
vision
also
have
been
reported.

B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
is
presented
below.
The
following
risk
characterization
is
intended
to
describe
the
magnitude
of
the
estimated
environmental
risks
for
4­
t­
amylphenol
use
sites
and
any
associated
uncertainties.
A
detailed
ecological
hazard
and
environmental
risk
assessment
for
4­
t­
amylphenol
and
its
salts
is
presented
in
"
Ecological
Hazard
and
Environmental
Risk
Assessment
for
4­
tert­
amylphenol
and
salts
to
be
included
in
the
RED",
September
2005.
A
brief
summary
is
presented
below.

1.
Environmental
Fate
and
Transport
The
environmental
fate
assessment
for
4­
t­
amylphenol
and
its
potassium
and
sodium
salts
is
based
on
US
EPA
=

s
Estimation
Programs
Interface
(
EPI)
Suite.
EPI
Suite
provides
estimations
of
physical/
chemical
properties
and
environmental
fate
properties.

4­
t­
Amylphenol
may
be
bioaccumlative
(
log
KOW
3.91)
and
is
likely
to
pose
a
concern
for
aquatic
organisms.
It
is
expected
to
have
moderate
to
slight
mobility
in
soils
based
upon
the
estimated
Koc
value
of
3799.
Estimated
value
for
biodegradation
probability
indicates
that
it
22
may
biodegrade
linearly
within
days
in
aquatic
medium.
However,
ultimate
biodegradation
(
mineralization)
may
take
months.
It
is
volatile
and
may
vaporize
into
the
atmosphere.
The
estimated
half
life
in
the
air
for
4­
t­
amylphenol
is
about
three
hours
which
indicates
that
it
is
not
persistent
in
air.
Because
of
the
possibility
of
biodegradation
in
water
and
soils,
it
is
not
likely
to
contaminate
surface
and
ground
waters.

4­
t­
Amylphenol,
potassium
salt,
is
not
likely
to
be
bioaccumlative
(
log
KOW
1.23)
and
may
not
pose
a
concern
for
bioconcentration
in
aquatic
organisms.
It
may
be
expected
to
have
moderate
to
slight
mobility
in
soils
as
its
estimated
Koc
value
is
3799.
Estimated
probability
of
biodegradation
of
4­
t­
amylphenol,
potassium
salt,
in
soils
and
water
indicates
that
it
is
likely
to
biodegrade
within
days
to
weeks.
Therefore,
it
may
be
unlikely
that
soil
and
water
contamination
would
take
place.
It
has
low
volatility
and
its
estimated
half
life
in
air
is
about
4.68
hours
and
is
not
likely
to
be
persistent
in
air.

4­
t­
Amylphenol,
sodium
salt,
is
not
likely
to
be
bioaccumlative
(
log
KOW
is
1.23)
and
may
not
pose
a
concern
for
bioconcentration
in
aquatic
organisms.
It
may
be
expected
to
have
moderate
to
slight
mobility
in
soils
as
its
estimated
Koc
value
is
the
same
as
the
parent
molecule,
4­
t­
amylphenol.
Probability
for
sodium
4­
t­
amylphenate
biodegradation
is
the
same
as
the
parent
molecule,
4­
t­
amylphenol.
Hence,
it
is
not
likely
to
persist
in
soils
and
water,
and
surface
and
ground
water
contamination
is
not
likely
to
occur.
It
has
low
volatility
and
its
estimated
half
life
in
air
is
about
4.68
hours
and
is
not
likely
to
be
persistent
in
air.

2.
Ecological
Risk
Guideline
ecological
effects
data
has
not
submitted
for
4­
t­
amylphenol.
The
only
data
that
was
available
was
found
in
the
peer­
reviewed
literature.
None
of
these
studies
met
current
guideline
requirements
and
therefore,
could
not
be
used
in
a
risk
assessment.
There
is
a
concern
about
the
possibility
of
endocrine
disruption
in
fish,
since
4­
t­
amylphenol
is
considered
an
ecoestrogen.
This
was
documented
in
several
studies
on
carp
(
Cyprimus
carpio).
However,
since
this
chemical
is
restricted
to
indoor
uses
only,
the
possibility
for
exposure
to
fish
to
4­
tamylphenol
would
be
limited.
The
limited
exposure
resulting
from
indoor
uses
of
4­
tamylphenol
and
its
salts
is
not
anticipated
to
cause
adverse
effects
to
terrestrial
or
aquatic
organisms.

The
acute
toxicity
data
for
4­
t­
amylphenol
are
summarized
on
Table
9.
As
shown
in
Table
9,
acute
toxicity
for
freshwater
fish
ranged
from
2.50
mg/
L
to
16
mg/
L
in
the
fathead
minnow.
The
first
study
was
conducted
using
criteria
similar
to
OPP/
OPPTS
guidelines
and
would
have
more
weight
than
the
second
study
which
did
not
provide
any
information
on
how
the
study
was
conducted.
Therefore,
the
data
indicates
that
4­
t­
amylphenol
is
moderately
toxic
to
coldwater
species,
such
as
the
fathead
minnow.
The
fathead
minnow
is
considered
to
be
less
sensitive
than
the
bluegill.
Also
shown
in
Table
9,
acute
toxicity
to
shrimp
was
LC50
=
1.7
mg/
L.
This
indicated
that
4­
t­
amylphenol
was
moderately
toxic
to
shrimp.
The
study
does
not
meet
current
guideline
requirements.
23
Table
9.
Acute
Toxicity
of
4­
t­
amylphenol
and
salts
Organism
Results
­
LC50
(
mg/
L)
(
95%
Confidence
Limit)
Toxicity
Category
Comments
Reference
Freshwater
Fish
Fathead
minnow
(
Pimephales
promelas)
2.50
(
1.87
­
3.34)
moderatel
y
toxic
­
96h
test
duration;
­
flow­
through
bioassay
­
caused
necrosis
in
fish
Holcombe,
G
W
et
al.
1984
Environ
Pollut
ser
A
Ecol
Biol
35:
367­
81
Fathead
minnow
(
Pimephales
promelas)
16
Slightly
toxic
­
No
information
available
on
the
test
parameters
Russon,
C
L
et
al.
1997
Environ.
Toxicol.
Chem
16:
948
Marine/
Estuarine
Invertebrates
Shrimp
(
Crangon
septemspinosa)
96h
LC50
=
1.7
mg/
L
Moderatel
y
toxic
­
96h
test
duration;
­
aerated
gently
and
changed
at
49
hours
McLeese,
D
W
1981
Chemosphere
10(
7):
723
3.
Endocrine
Effects
in
Fish
As
mentioned
above,
potential
endocrine
effects
for
4­
t­
amylphenol
have
been
identified.
Examples
of
the
impacts
of
4­
t­
amylphenol
affecting
the
reproductive
processes
of
carp
have
been
reported
in
the
peer­
reported
literature.
Since
the
use
pattern
for
this
chemical
is
restricted
to
indoor
uses,
exposure
to
fish,
such
as
carp,
should
be
limited.
Therefore,
no
additional
testing
for
endocrine
disruption
effects
on
fish
is
necessary.
24
Table
10:
Examples
of
4­
t­
amylphenol
Affecting
the
Endocrine
System
in
Fish
Organism
Results
Toxicity
Category
Comments
Reference
Male
common
carp
(
Cyprinus
carpio)
caused
formation
of
oviducts
in
male
fish
and
reduced
the
number
of
primordial
germ
cells
in
gonads
identified
as
an
ecoestrogen
­
test
concentration
0.14
mg/
L
­
exposed
embryos
and
fingerlings
at
various
ages
Gimeno
et
al.
1997
Environ
Sci
Technol
31(
10):
2884­
2890.

Male
common
carp
(
Cyprinus
carpio)
30­
day
EC50
for
oviduct
formation
=
63
ug/
L
NOEC
for
oviduct
formation
=
<
36
ug/
L
primordial
germ
cells
lower
in
treated
fish
NOEC
for
vitellogenin
induction
=
90­
256
ug/
L
identified
as
causing
endocrine
disruption
effects
­
120
male
carp
tested
­
nominal
concentrations
of
100,
320,
&
1000
ug/
L
were
tested
­
160
day
test
duration
­
intermittent
flow
through
system
Gimeno,
S.
et
al.
1998a
Aquatic
Toxicology
(
Amsterdam)
43:
77­
92.

Cultured
hepatocytes
from
geneticallyuniform
all
male,
F1­
hybrid
progenies
of
common
carp
(
Cyprinus
capio)
vitellogenin
induction
in
carp
hepatocytes
with
LOEC
ranging
from
5­
50
uM,
cytotoxic
at
100uM
identified
as
causing
endocrine
disruption
effects
­
six
month
old
hepatocytes
with
fully
mature
testes
containing
mature
sperm
Smeets,
J.
M.
et
al.
1999.
Toxicol.
Sci.
50(
2):
206­
213.

Male
common
carp
(
Cyprinus
carpio)
elevated
levels
of
vitellogenin,
inhibition
of
spermatogenesis,
disappearance
of
spermatozoa
and
spermatogenic
cysts,
reduced
diameter
of
seminiferous
lobules,
reduced
spermatocrit
values
and
early
appearance
of
ovotestes
LOAEL=
0.032
mg/
L
identified
as
causing
endocrine
disruption
effects
and
no
mortality
or
growth
effects
­
3
month
test
duration
­
nominal
concentrations
of
32,
100,
320
and
1000
ug/
L
were
tested
Gimeno
et
al.
1998b
Aquatic
Toxicology
(
Amsterdam)
43:
93­
109.

4.
Listed
Species
Consideration
a.
The
Endangered
Species
Act
Section
7
of
the
Endangered
Species
Act,
16
U.
S.
C.
Section
1536(
a)(
2),
requires
all
federal
agencies
to
consult
with
the
National
Marine
Fisheries
Service
(
NMFS)
for
marine
and
anadromous
listed
species,
or
the
United
States
Fish
and
Wildlife
Services
(
FWS)
for
listed
wildlife
and
freshwater
organisms,
if
they
are
proposing
an
"
action"
that
may
affect
listed
species
or
their
designated
habitat.
Each
federal
agency
is
required
under
the
Act
to
insure
that
any
action
they
authorize,
fund,
or
carry
out
is
not
likely
to
jeopardize
the
continued
existence
of
a
25
listed
species
or
result
in
the
destruction
or
adverse
modification
of
designated
critical
habitat.
To
jeopardize
the
continued
existence
of
a
listed
species
means
"
to
engage
in
an
action
that
reasonably
would
be
expected,
directly
or
indirectly,
to
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
the
species."
50
C.
F.
R.
§
402.02.

To
facilitate
compliance
with
the
requirements
of
the
Endangered
Species
Act
subsection
(
a)(
2)
the
Environmental
Protection
Agency,
Office
of
Pesticide
Programs
has
established
procedures
to
evaluate
whether
a
proposed
registration
action
may
directly
or
indirectly
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
any
listed
species
(
U.
S.
EPA
2004).
After
the
Agency's
screening­
level
risk
assessment
is
performed,
if
any
of
the
Agency's
Listed
Species
LOC
Criteria
are
exceeded
for
either
direct
or
indirect
effects,
a
determination
is
made
to
identify
if
any
listed
or
candidate
species
may
co­
occur
in
the
area
of
the
proposed
pesticide
use.
If
determined
that
listed
or
candidate
species
may
be
present
in
the
proposed
use
areas,
further
biological
assessment
is
undertaken.
The
extent
to
which
listed
species
may
be
at
risk
then
determines
the
need
for
the
development
of
a
more
comprehensive
consultation
package
as
required
by
the
Endangered
Species
Act.

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
1/
23/
04,
Appendix
A,
Section
IIB,
pg.
81).
Chemicals
in
these
categories
therefore
do
not
undergo
a
full
screening­
level
risk
assessment,
and
are
considered
to
fall
under
a
"
no
effect"
determination.
Due
to
the
low
likelihood
of
exposure
form
the
indoor
uses
of
4­
t­
amylphenol
,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.

b.
General
Risk
Mitigation
4­
t­
Amylphenol
end­
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
4­
tamylphenol
specific
to
federally
listed
species,
the
Agency
needs
to
address
potential
risks
from
other
end­
use
products.
Therefore,
the
Agency
requires
that
users
adopt
all
listed
species
risk
mitigation
measures
for
all
active
ingredients
in
the
product.
If
a
product
contains
multiple
active
ingredients
with
conflicting
listed
species
risk
mitigation
measures,
the
more
stringent
measure(
s)
should
be
adopted.
26
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision
A.
Determination
of
Reregistration
Eligibility
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submission
of
relevant
data
concerning
an
active
ingredient,
whether
or
not
products
containing
the
active
ingredient
are
eligible
for
reregistration.
The
Agency
has
previously
identified
and
required
the
submission
of
the
generic
(
i.
e.,
active
ingredient­
specific)
data
required
to
support
reregistration
of
products
containing
4­
t­
amylphenol
and
its
salts
(
potassium
and
sodium)
as
active
ingredients.
The
Agency
has
completed
its
review
of
these
generic
data,
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
supported
products
containing
4­
t­
amylphenol
and
salts,

The
Agency
has
completed
its
assessment
of
the
dietary,
occupational,
drinking
water
and
ecological
risks
associated
with
the
use
of
pesticide
products
containing
the
active
ingredients
4­
t­
amylphenol.
Based
on
a
review
of
these
data
and
on
public
comments
on
the
Agency's
assessments
for
the
active
ingredients
4­
t­
amylphenol
and
its
salts
(
potassium
and
sodium),
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
to
make
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
products
containing
4­
t­
amylphenol
and
its
salts
are
eligible
for
reregistration
provided
that:
(
i)
current
data
gaps
and
confirmatory
data
needs
are
addressed;
(
ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted;
and
(
iii)
label
amendments
are
made
to
reflect
these
measures.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
4­
t­
amylphenol
and
salts
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
determination
of
reregistration
eligibility
of
4­
t­
amylphenol
and
salts,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.
Data
gaps
are
identified
as
generic
data
requirements
that
have
not
been
satisfied
with
acceptable
data.

Based
on
its
evaluation
of
4­
t­
amylphenol
and
salts,
the
Agency
has
determined
that
4­
tamylphenol
and
salts
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA.
Accordingly,
should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
the
use
of
4­
t­
amylphenol
and
salts.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
4­
t­
amylphenol
and
salts
(
potassium
and
sodium)
will
be
substantially
mitigated
for
the
purposes
of
this
determination.

B.
Public
Comments
and
Responses
Through
the
Agency's
public
participation
process,
EPA
worked
with
stakeholders
and
the
public
to
reach
the
regulatory
decisions
for
4­
t­
amylphenol.
During
the
public
comment
period
on
the
risk
assessments,
which
closed
on
September
19,
2005,
the
Agency
received
comments
from
the
Clariant
Corporation
regarding
risk
assessment
assumptions
and
endocrine
disruption
potential
and
from
a
private
citizen
concerned
about
the
diaper
use
of
this
chemical.
These
comments
in
their
entirety
are
available
in
the
public
docket,
http://
docket.
epa.
gov/
edkpub/
index.
jsp,
(
OPP­
2005­
0181).
27
C.
Regulatory
Position
1.
Food
Quality
Protection
Act
(
FQPA)
Considerations
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
4­
t­
amylphenol.
The
Agency
has
concluded
that
the
tolerance
exemption
for
4­
tamylphenol
meets
the
FQPA
safety
standards
and
that
the
risk
from
dietary
(
food
sources
only)
exposure
is
within
the
"
risk
cup."
An
aggregate
assessment
was
conducted
for
exposures
through
food,
drinking
water
and
residential
exposure.
The
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels
provided
that
the
mitigation
contained
in
this
document
is
implemented.
In
reaching
this
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
aggregate
exposure
from
food,
water
and
residential
exposures.

b.
Determination
of
Safety
to
U.
S.
Population
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
4­
t­
amylphenol
and
its
salts
(
potassium
and
salts).
The
Agency
has
determined
that
the
established
tolerance
exemption
for
4­
t­
amylphenol
and
its
salts
with
amendments
and
changes
as
specified
in
this
document,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)
(
2)
(
D)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
no
harm
will
result
to
the
general
population
or
any
subgroup
from
the
reregistered,
labeled
uses
of
4­
t­
amylphenol
and
salts.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
4­
t­
amylphenol
and
its
salts.
Both
the
acute
dietary
(
food
alone)
and
chronic
dietary
risks
from
4­
t­
amylphenol
are
not
of
concern.
4­
t­
Amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters
based
on
its
use
patterns
and
fate
characteristics.
Thus,
a
drinking
water
assessment
was
not
conducted.

Short­
and
intermediate­
term
aggregate
risk
assessments
were
conducted
for
4­
tamylphenol
The
aggregate
oral
and
inhalation
risks
are
not
of
concern
for
adults,
as
the
total
aggregate
MOE
is
greater
than
the
target
of
3,000.
For
children,
the
aggregate
risk
estimates
are
also
above
the
target
MOE
of
3,000
and
thus
are
not
of
concern.
As
noted
previously,
incidental
oral
exposures
to
treated
textiles
are
not
included
in
the
aggregate
assessment
because
the
oral
MOE
is
already
of
concern.

A
dermal
aggregate
assessment
was
not
conducted
because
the
toxicity
effects
for
the
dermal
exposure
route
are
not
the
same
as
the
oral/
inhalation
exposure
route.
However,
as
shown
previously
on
Table
6,
short­
and
intermediate
dermal
risks
are
already
of
concern
for
the
treated
textile
and
diaper
uses.
28
c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
established
tolerance
exemption
for
4­
t­
amylphenol,
with
amendments
and
changes
as
specified
in
this
document,
meets
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
factors
of
the
toxicity,
use
practices,
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
4­
t­
amylphenol
residues
in
this
population
subgroup.

A
Special
FQPA
Safety
Factor
is
necessary
to
protect
the
safety
of
infants
and
children.
In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
4­
t­
amylphenol
residues,
the
Agency
considered
the
completeness
of
the
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
other
information.
The
FQPA
Safety
Factor
has
been
retained
(
i.
e.,
remains
10X)
for
4­
t­
amylphenol
based
on
a
lack
of
guideline
studies,
qualitative
evidence
of
sensitivity
in
the
developmental
toxicity
study,
and
the
suggestive
evidence
in
the
open
literature
of
possible
endocrine
effects.

The
toxicology
data
base
is
not
complete
with
respect
to
assessing
that
increased
susceptibility
to
infants
and
children
as
required
by
FQPA
for
4­
t­
amylphenol.
The
rat
prenatal
developmental
study
showed
no
quantitative
evidence
of
increased
susceptibility
(
i.
e.,
developmental
NOAELs/
LOAELs
were
higher
than
those
for
maternal
effects).
However,
there
was
qualitative
evidence
of
increased
susceptibility
(
i.
e.,
fetal
effects
(
skeletal
abnormalities,
decreased
body
weight
gain)
were
considered
to
be
more
severe
than
the
maternal
toxicity
(
reversible
clinical
signs)
observed
at
the
same
dose
level).
In
addition,
there
is
an
absence
of
developmental
toxicity
data
in
the
rabbit
and
an
absence
of
reproductive
toxicity
data.

d.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
EPA
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
29
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EDSP
have
been
developed,
4­
t­
amylphenol
may
be
subject
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

e.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
4­
tamylphenol
and
salts.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
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."
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
4­
t­
amylphenol.
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/.

2.
Tolerance
Summary
4­
t­
amylphenol
(
also
known
as
phenol,
4­
1,1­
dimethylpropyl)
(
CAS
No.
80­
46­
6)
has
a
tolerance
exception
in
40CFR
180.940
(
c)
as
a
food­
contact
sanitizer
for
use
in
food­
processing
equipment
and
utensils
with
a
not
to
exceed
limit
of
80
ppm.

a.
Tolerances
Currently
Listed
Under
40
CFR
§
180.940(
c)
and
Tolerance
Reassessment
Table
11.
Tolerance
Reassessment
Summary
for
4­
t­
amylphenol
Tolerance
Exemption
Listed
Under
40
CFR
§
180.940
(
c)

Use
Site
Current
Limit
(
ppm)
Tolerance
Reassessment
(
ppm)
Correct
Definition/
Comment
Food
processing
equipment
and
utensils
80
540
When
ready
for
use,
the
end­
use
concentration
is
not
to
exceed
540
ppm.

b.
Codex
Harmonization
Currently
there
are
no
Codex
MRLs
established
for
4­
t­
amylphenol.
30
D.
Regulatory
Rationale
The
Agency
has
determined
that
4­
t­
amylphenol
is
eligible
for
reregistration
provided
that
additional
required
data
confirm
this
decision
and
that
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
label
amendments
are
made
to
reflect
these
measures.

The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
4­
t­
amylphenol.
Where
labeling
revisions
are
warranted,
specific
language
is
set
forth
in
the
summary
tables
of
Section
V
of
this
document.

1.
Human
Health
Risk
Management
a.
Dietary
(
Food)
Risk
Mitigation
For
all
supported
uses,
the
acute
and
chronic
dietary
exposure
estimates
are
below
the
Agency's
level
of
concern.
Therefore,
no
risk
mitigation
measures
are
required
to
address
exposure
to
4­
t­
amylphenol
residues
in
food.
Residue
data
are
required
to
confirm
the
10%
transfer
assumption
used
in
the
risk
assessment.

b.
Drinking
Water
Risk
Mitigation
4­
t­
Amylphenol
and
its
salts
are
not
likely
to
contaminate
surface
and
ground
waters
based
on
its
use
patterns
and
fate
characteristics.
Thus,
a
drinking
water
assessment
was
not
conducted.
Therefore,
no
risk
mitigation
measures
are
required
to
address
4­
t­
amylphenol
exposure
from
drinking
water.

c.
Residential
Risk
Mitigation
Residential
risks
from
handler
and
post­
application
exposure
were
calculated
for
shortand
intermediate­
term
dermal,
inhalation
and
incidental
oral
exposures.
All
exposure
and
risk
estimates
for
residential
handler
scenarios
are
below
the
Agency's
level
of
concern.
Therefore,
no
risk
mitigation
measures
are
required
for
these
handler
scenarios.

Risks
of
concern
have
been
identified
for
several
post­
application
exposure
scenarios
including
children's
dermal
exposure
to
treated
clothing
and
treated
diapers
and
children's
incidental
oral
exposure
to
treated
clothing.
The
Agency
believes
that
adding
clear
instructions
for
washing
and
rinsing
textile
items
will
result
in
the
adequate
removal
of
residues
from
the
treated
items
and
address
the
Agency's
concerns
for
this
scenario.
The
MOE
for
dermal
exposure
to
children
to
treated
surfaces
in
daycare
centers
slightly
exceeds
the
Agency's
level
of
concern
(
MOE
=
940
with
a
target
MOE
of
1,000).
However,
the
Agency
believes
actual
exposure
from
this
pathway
to
not
exceed
its
level
of
concern
when
taking
into
account
the
conservative
nature
of
the
risk
estimate
which
is
likely
to
overestimate
potential
exposures.
31
In
summary,
to
reduce
residential
exposure,
the
Agency
has
determined
that
the
following
mitigation
and
label
changes
for
specific
scenarios
are
appropriate
and
required
for
reregistration
eligibility:

­
Delete
all
diaper
uses
­
Delete
all
use
on
non­
laundered
textiles\
items
including
mattresses,
helmets,
headgear,
headphones,
face
gear,
and
mouthpieces.
­
All
labels
with
laundered
textile
uses
must
have
directions
that
indicate
that
items
must
be
treated
prior
to
washing
and
rinsing.

d.
Occupational
Risk
Mitigation
i.
Handler
Exposure
Occupational
risks
from
handler
and
applicator
exposures
were
calculated
for
short­
term
and
intermediate­
term
dermal
and
inhalation
exposures.
All
exposure
and
risk
estimates
for
occupational
handler
scenarios
are
below
the
Agency's
level
of
concern.
Therefore,
no
risk
mitigation
measures
are
required
for
these
handler
scenarios.

ii.
Post­
Application
Risk
Mitigation
Post­
application
exposure
to
re­
entry
workers
is
possible
because
4­
t­
amylphenol
can
be
applied
as
a
fogging
application
to
animal
buildings.
The
Agency
used
the
MCCEM
(
Multi­
Chamber
Concentration
and
Exposure
Model)
to
estimate
postapplication/
bystander
exposures.
The
calculated
inhalation
MOEs
were
above
the
target
MOE
of
300
for
all
fogging
postapplication
scenarios
with
the
exception
of
the
scenario
for
8­
hr
exposure
to
the
product
with
a
2­
hr
reentry
interval
(
MOE
=
86).

The
Agency
does
not
believe
that
any
mitigation
is
necessary
to
address
the
postapplication
scenario
with
a
2­
hr
reentry
interval
at
this
time.
The
risk
estimate
was
calculated
using
the
Agency's
standard
assumptions
for
air
exchange
rates.
The
Agency
believes
that
in
the
case
of
animal
barns
and
facilities
this
assumption
is
very
conservative
given
the
relatively
high
air
exchange
rates
for
such
facilities.

2.
Environmental
Risk
Management
As
the
uses
of
4­
t­
amylphenol
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur,
no
risk
mitigation
measures
are
required
to
address
environmental
exposure
to
4­
t­
amylphenol.

3.
Other
Labeling
Requirements
In
order
to
be
eligible
for
reregistration,
various
use
and
safety
information
will
be
included
in
the
labeling
of
all
end­
use
products
containing
4­
t­
amylphenol.
For
the
specific
labeling
statements
and
a
list
of
outstanding
data,
refer
to
Section
V
of
this
RED
document.
32
4.
Listed
Species
Considerations
a.
The
Endangered
Species
Act
Section
7
of
the
Endangered
Species
Act,
16
U.
S.
C.
Section
1536(
a)(
2),
requires
all
federal
agencies
to
consult
with
the
National
Marine
Fisheries
Service
(
NMFS)
for
marine
and
anadromous
listed
species,
or
the
United
States
Fish
and
Wildlife
Services
(
FWS)
for
listed
wildlife
and
freshwater
organisms,
if
they
are
proposing
an
"
action"
that
may
affect
listed
species
or
their
designated
habitat.
Each
federal
agency
is
required
under
the
Act
to
insure
that
any
action
they
authorize,
fund,
or
carry
out
is
not
likely
to
jeopardize
the
continued
existence
of
a
listed
species
or
result
in
the
destruction
or
adverse
modification
of
designated
critical
habitat.
To
jeopardize
the
continued
existence
of
a
listed
species
means
"
to
engage
in
an
action
that
reasonably
would
be
expected,
directly
or
indirectly,
to
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
the
species."
50
C.
F.
R.
§
402.02.

To
facilitate
compliance
with
the
requirements
of
the
Endangered
Species
Act
subsection
(
a)(
2)
the
Environmental
Protection
Agency,
Office
of
Pesticide
Programs
has
established
procedures
to
evaluate
whether
a
proposed
registration
action
may
directly
or
indirectly
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
any
listed
species
(
U.
S.
EPA
2004).
After
the
Agency's
screening­
level
risk
assessment
is
performed,
if
any
of
the
Agency's
Listed
Species
LOC
Criteria
are
exceeded
for
either
direct
or
indirect
effects,
a
determination
is
made
to
identify
if
any
listed
or
candidate
species
may
co­
occur
in
the
area
of
the
proposed
pesticide
use.
If
determined
that
listed
or
candidate
species
may
be
present
in
the
proposed
use
areas,
further
biological
assessment
is
undertaken.
The
extent
to
which
listed
species
may
be
at
risk
then
determines
the
need
for
the
development
of
a
more
comprehensive
consultation
package
as
required
by
the
Endangered
Species
Act.

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
1/
23/
04,
Appendix
A,
Section
IIB,
pg.
81).
Chemicals
in
these
categories
therefore
do
not
undergo
a
full
screening­
level
risk
assessment,
and
are
considered
to
fall
under
a
"
no
effect"
determination.
Due
to
the
low
likelihood
of
exposure
of
4­
t­
amylphenol,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.

b.
General
Risk
Mitigation
4­
t­
Amylphenol
end
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
4­
tamylphenol
specific
to
federally
listed
threatened
and
endangered
species,
the
Agency
needs
to
address
potential
risks
from
other
end­
use
products.
Therefore,
the
Agency
requires
that
users
adopt
all
threatened
and
endangered
species
risk
mitigation
measures
for
all
active
ingredients
in
33
the
product.
If
a
product
contains
multiple
active
ingredients
with
conflicting
threatened
and
endangered
species
risk
mitigation
measures,
the
more
stringent
measure(
s)
should
be
adopted.
34
V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
4­
t­
amylphenol
is
eligible
for
reregistration
provided
that:
(
i)
additional
data
that
the
Agency
intends
to
require
confirm
this
decision;
and
(
ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
(
iii)
label
amendments
are
made
to
reflect
these
measures.
To
implement
the
risk
mitigation
measures,
the
registrants
must
amend
their
product
labeling
to
incorporate
the
label
statements
set
forth
in
the
Label
Changes
Summary
Table
in
Section
B
below
(
Table
13).
The
additional
data
requirements
that
the
Agency
intends
to
obtain
will
include,
among
other
things,
submission
of
the
following:

For
4­
t­
amylphenol
technical
grade
active
ingredient
products,
the
registrant
needs
to
submit
the
following
items:

Within
90
days
from
receipt
of
the
generic
data
call
in
(
DCI):

1.
completed
response
forms
to
the
generic
DCI
(
i.
e.,
DCI
response
form
and
requirements
status
and
registrant's
response
form);
and
2.
submit
any
time
extension
and/
or
waiver
requests
with
a
full
written
justification.

Within
the
time
limit
specified
in
the
generic
DCI:

1.
cite
any
existing
generic
data
which
address
data
requirements
or
submit
new
generic
data
responding
to
the
DCI.

Please
contact
Killian
Swift
at
(
703)
308­
6346
with
questions
regarding
generic
reregistration.

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
DCI/
SRRD)
Document
Processing
Desk
(
DCI/
SRRD)
Killian
Swift
Killian
Swift
US
EPA
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
S.
Bell
Street
Arlington,
VA
22202
35
For
end
use
products
containing
the
active
ingredient
4­
t­
amylphenol,
the
registrant
needs
to
submit
the
following
items
for
each
product.

Within
90
days
from
the
receipt
of
the
product­
specific
data
call­
in
(
PDCI):

1.
completed
response
forms
to
the
PDCI
(
i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
2.
submit
any
time
extension
or
waiver
requests
with
a
full
written
justification.

Within
eight
months
from
the
receipt
of
the
PDCI:

1.
two
copies
of
the
confidential
statement
of
formula
(
EPA
Form
8570­
4);

2.
a
completed
original
application
for
reregistration
(
EPA
Form
8570­
1).
Indicate
on
the
form
that
it
is
an
"
application
for
reregistration";

3.
five
copies
of
the
draft
label
incorporating
all
label
amendments
outlined
in
Table
13
of
this
document;

4.
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);
and
5.
if
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(
EPA
Form
8570­
32);
and
6.
the
product­
specific
data
responding
to
the
PDCI.

Please
contact
Adam
Heyward
at
(
703)
308­
6422
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
(
PDCI/
PRB)
Document
Processing
Desk
(
PDCI/
PRB)
Adam
Heyward
Adam
Heyward
US
EPA
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
South
Bell
Street
Arlington,
VA
22202
36
A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
4­
t­
amylphenol
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
following
additional
data
requirements
have
been
identified
by
the
Agency
as
confirmatory
and
included
in
the
generic
DCI
for
this
RED.

The
Agency
has
established
an
interim
two­
tiered
system
for
toxicology
testing
requirements.
Tier
I
toxicology
data
requirements
would
apply
to
all
indirect
food
additives
that
result
in
residue
concentrations
ranging
from
0­
200ppb
which
applies
to
4­
t
amylphenol.
The
requirements
would
consist
of
an
acute
toxicity
testing
battery,
subchronic
toxicity
studies
in
the
rodent,
a
developmental
toxicity
study
in
the
rat,
and
a
mutagenicity
testing
battery.
The
developmental
toxicity
study
in
the
rat,
mutagenicity
testing
battery,
the
acute
oral
toxicity
and
the
acute
dermal
irritation
data
requirements
has
been
fulfilled
for
4­
t
amylphenol.
The
Agency
also
conducts
a
literature
search
and
can
also
conduct
a
Structural
Activity
Relationship
analysis
(
SAR)
if
appropriate.
The
Agency
also
will
hold
in
reserve
a
two­
generation
reproduction
toxicity
study
in
the
rat
and
a
subchronic
toxicity
studies
in
a
non­
rodent
which
would
become
data
requirements
if
warranted
by
the
Agency's
evaluation
of
the
Tier
1
data.
A
2­
generation
reproduction
study
and
a
subchronic
toxicity
study
in
a
non­
rodent
are
being
held
in
reserve
for
4­
t
amylphenol.

Tier
II
studies
would
be
triggered
by
the
presence
of
significant
(
i.
e.
>
200ppb)
residues
in
food
or
evidence
of
significant
toxicity
from
the
Tier
I
data
set,
which
may
include
developmental
/
reproductive,
or
other
systemic
toxicity
such
as
presence
of
neoplastic
growth
or
significant
target
organ
toxicity.
In
such
cases,
chronic
toxicity
and
carcinogenicity
testing
would
be
required.

As
mentioned
earlier,
the
Agency
assumed
that
food
can
contact
2000
cm2
of
treated
surfaces,
and
that
10%
of
the
pesticide
migrates
to
food
based
on
the
Agency
Residential
SOPs
in
its
dietary
risk
assessment.
The
use
of
the
10%
transfer
rate
instead
of
the
use
of
a
100%
transfer
rate
that
is
used
in
the
FDA
Sanitizer
Solution
Guidelines
requires
the
submission
of
confirmatory
data
to
establish
the
reliability
of
the
use
of
the10%
transfer
rate.

The
Agency
is
also
holding
in
reserve
a
developmental
toxicity
study
in
rabbits
based
on
the
potential
endocrine
disruption
effects
of
this
chemical.
The
need
for
this
study
will
be
determined
following
the
Agency's
review
of
the
90­
day
oral
study
in
rodents.

The
risk
assessment
noted
deficiencies
in
the
surrogate
dermal
and
inhalation
exposure
data
available
from
the
Chemical
Manufacturers
Association
(
CMA)
data
base.
Therefore,
the
Agency
is
requiring
confirmatory
data
to
support
the
uses
assessed
with
the
CMA
exposure
data
within
this
risk
assessment.
The
risk
assessment
also
noted
that
many
of
the
use
parameters
37
(
e.
g.,
amount
handled
and
duration
of
use)
were
based
on
professional
judgments.
Therefore,
descriptions
of
human
activities
associated
with
the
uses
assessed
are
required
as
confirmatory.

A
28­
day
rat
inhalation
study
for
hazard
considerations
because
4­
t­
amylphenol
is
an
air
deodorizer
was
considered,
however,
the
Agency
does
not
believe
this
study
is
necessary
because
the
MOEs
are
sufficiently
high
for
this
use,
and
thus
not
of
concern.
In
addition,
the
Agency
believes
the
repeat
dermal
toxicity
study
with
end
use
formulation
product,
and
confirmatory
residue
migration
data
are
not
necessary
because
the
diaper
and
textile
use
are
no
longer
eligible
for
registration.

Table
12.
Confirmatory
Data
Requirements
for
Reregistration
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

90­
day
Oral
Subchronic
in
Rats
(
including
neurotoxicity
and
endocrine
endpoints)
870­
3100
82­
1
Acute
Dermal
Toxicity
870.1200
81­
2
Acute
Inhalation
Toxicity
870.1300
81­
3
Acute
Eye
Irritation
870.2400
81­
4
Skin
Sensitization
870.2600
81­
6
Dermal
Indoor
Exposure
875.1200,
875.1600
233
and
236
Inhalation
Indoor
Exposure
875.1400,
875.1600
234
and
236
Descriptions
of
Human
Activity
875.2800
133­
1
Avian
acute
oral
toxicity
850.2100
71­
1
Freshwater
fish
acute
toxicity
850.1075
72­
1
Freshwater
invertebrate
acute
toxicity
850.1010
72­
2
Dietary­
Residues
in
Food
from
Treating
Countertops
with
4­
t
amylphenol
(
FDA
Wipe
Study
Methodology)
(
FDA,
2003a
and
2003b)
Non­
Guideline
Non­
Guideline
Studies
Held
in
Reserve
2­
Generation
Reproduction
870.3800
83­
4
90­
day
Oral
Subchronic
in
Non­
Rodents
870­
3150
82­
1
Developmental
Toxicity
in
Rabbits
870.3700b
83­
3b
38
2.
Labeling
for
Technical
and
Manufacturing
Use
Products
To
ensure
compliance
with
FIFRA,
technical
and
manufacturing
use
product
(
MP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices
and
applicable
policies.
The
Technical
and
MP
labeling
should
bear
the
labeling
contained
in
Table
13
,
Label
Changes
Summary
Table.

B.
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.

A
product­
specific
data
call­
in,
outlining
specific
data
requirements,
will
follow
this
RED.

2.
Labeling
for
End­
Use
Products
Labeling
changes
are
necessary
to
implement
measures
outlined
in
Section
IV
above.
Specific
language
to
incorporate
these
changes
is
specified
in
Table
13.

Registrants
may
generally
distribute
and
sell
products
bearing
old
labels/
labeling
for
26
months
from
the
date
of
the
issuance
of
this
Reregistration
Eligibility
Decision
document.
Persons
other
than
the
registrant
may
generally
distribute
or
sell
such
products
for
52
months
from
the
approval
of
labels
reflecting
the
mitigation
described
in
this
RED.
However,
existing
stocks
time
frames
will
be
established
case­
by­
case,
depending
on
the
number
of
products
involved,
the
number
of
label
changes,
and
other
factors.
Refer
to
"
Existing
Stocks
of
Pesticide
Products;
Statement
of
Policy,"
Federal
Register,
Volume
56,
No.
123,
June
26,
1991.
39
a.
Label
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measures
outlined
in
Section
IV.
The
following
table
describes
how
language
on
the
labels
should
be
amended.

Table
13.
Labeling
Changes
Summary
Table
Summary
of
Labeling
Changes
for
4­
t­
Amylphenol
and
its
Salts
Description
Amended
Labeling
Language
Placement
on
Label
Delete
use
on
diapers
Use
Directions
Delete
all
use
on
nonlaundered
textiles\
items
including
mattresses,
helmets,

headgear,
headphones,

facegear,
and
mouthpieces.
Use
Directions
Laundry
Use
Clarify
language
to
ensure
use
requires
washing
and
rinsing
prior
to
wearing
clothing
Use
Directions
40
41
VI.
APPENDICES
42
43
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
4­
T­
Amylphenol
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
(
1)
Agricultural
premises
and
equipment
Soluble
concentrate:

Reg.
211­
36
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Use
as
a
premises
spray,
do
not
apply
to
the
crop,
compost,
or
casing.

Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Mushroom
houses­
empty
premises/
equipment
Soluble
concentrate:

Reg.
1043­
26
Reg.
211­
25
Reg.
65020­
7
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hard,
non
porous,
non
food
contact
surfaces
Soluble
concentrate:

Reg.
211­
36
Reg.
49403­
6
Reg.
1043­
118
Reg.
11725­
9
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
44
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
minutes
allow
to
air
dry
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Soluble
concentrate:

Reg.
211­
36
Reg.
49403­
6
Reg.
1043­
118
Reg.
66171­
1
Reg.
11725­
9
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
**
Shoe
bath
sanitizer
containing
one
inch
of
freshly
made
disinfectant
should
be
placed
at
all
entrances
Do
not
use
in
milking
stalls.
Milking
parlors,
or
milk
houses.
Do
not
apply
to
crop,
soil
or
growing
media
in
which
a
crop
grows
or
will
be
growing
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Agricultural/
farm
equipment/
shoe
baths
Agricultural/
farm
equipment/
shoe
baths
(
continued)
Soluble
concentrate:

Reg.
11725­
8
Reg.
1043­
91
Reg.
11725­
7
Reg.
1043­
26
Reg.
211­
25
Fogger
(
wet
misting)
½
oz
per
gallon
of
water
1:
256
dilution
Set
the
automatic
timer
on
the
fogger
for
6
minutes
for
1000cu.
ft
and
leave
the
room.
Allow
at
least
2
hours
before
entering
a
room
that
has
been
fogged
Treated
food
contact
surfaces
must
be
thoroughly
rinsed
with
potable
water
prior
to
use.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)
45
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
66171­
1
Reg.
11725­
7
Reg.
1043­
26
Reg.
211­
25
Reg.
65020­
7
Reg.
3862­
180
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
**
Shoe
bath
sanitizer
containing
one
inch
of
freshly
made
disinfectant
should
be
placed
at
all
entrances
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

(
2)
Food
handling/
storage
establishments
premises
and
equipment
Hard,
non
porous,
non
food
contact
surfaces
Hard,
non
porous,
non
food
contact
surfaces
(
continued)
Ready
to
use
solution:

Reg.
1270­
237
Reg.
1008­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
46
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
1043­
92
Reg.
1043­
91
Reg.
11725­
7
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Ready
to
use
solution:

Reg.
10088­
105
Reg.
1270­
237
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Meat
processing
plant
premises
(
nonfood)
Soluble
concentrate:

Reg.
11725­
7
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
47
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Ready
to
use
solution:

Reg.
10088­
105
Reg.
1270­
237
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Poultry
processing
plant
premises
(
nonfood)

Poultry
processing
plant
premises
(
nonfood)

(
continued)
Soluble
concentrate:

Reg.
49403­
23
Reg.
211­
25
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Processing/
handling
equipment
(
nonfood)
Ready
to
use
solution:

Reg.
10088­
105
Reg.
1270­
237
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
48
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
11725­
7
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

(
3)
Commercial,
institutional
and
industrial
premises
and
equipment
Institutional
premises
Ready­
to­

usesolution

Reg.
104319,

Reg.
44446­
67
Reg.
10088­
105
Reg.
1270­
237
Reg.
7405­
51
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
49
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Institutional
premises
(
continued)
Soluble
concentrate:

Reg.
11725­
8
Reg.
1043­
91
Fogger
(
wet
misting)
½
oz
per
gallon
of
water
1:
256
dilution
Set
the
automatic
timer
on
the
fogger
for
6
minutes
for
1000cu.
ft
and
leave
the
room.
Allow
at
least
2
hours
before
entering
a
room
that
has
been
fogged
Treated
food
contact
surfaces
must
be
thoroughly
rinsed
with
potable
water
prior
to
use.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)

Hard,
non
porous,
non
food
contact
surfaces
Soluble
concentrate:

Reg.
66171­
1
Reg.
117258
Reg.
1043­
91
Reg,
1043­
92
Reg.
66171­
2
Reg.
211­
25
Reg.
3862­
180
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
50
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
211­
36,

Reg.
1043­
115
Reg.
1043­
87
Reg.
2212­
5
Reg.
49403­
6
Reg.
1043­
118
Reg.
11725­
9
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Ready­
to­

usesolution
Reg.
1043­
19
Reg.
44446­
67
Reg.
10088­
105
Reg.
1270­
237
Reg.
7405­
51
Reg.
55195­
3
Reg.
3862­
104
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
51
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Hard,
non
porous,
non
food
contact
surfaces
(
continued)
Soluble
concentrate:

Reg.
11725­
8
Reg.
1043­
91
Fogger
(
wet
misting)
½
oz
per
gallon
of
water
1:
256
dilution
Set
the
automatic
timer
on
the
fogger
for
6
minutes
for
1000cu.
ft
and
leave
the
room.
Allow
at
least
2
hours
before
entering
a
room
that
has
been
fogged
Treated
food
contact
surfaces
must
be
thoroughly
rinsed
with
potable
water
prior
to
use.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)

Bedside
and
office
furniture
Soluble
concentrate:

Reg.
66171­
1,

Reg.
11725­
8,

Reg.
1043­
92
Reg.
1043­
91,

Reg.
66171­
2,

Reg.
211­
25
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
52
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
211­
36
Reg.
1043­
115
Reg.
1043­
87
Reg.
2212­
5
Reg.
49403­
6
Reg.
1043­
118
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Impregnated
material.:

Reg.
55195­
4
Wipe
Thoroughly
wet
precleaned
surface
with
a
wipe
and
allow
to
air
dry
Do
not
reuse
wipes
Bedside
and
office
furniture
(
continued)
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67,

Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Trash
carts
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
53
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Reg.
10088­
105
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Telephones
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Waste
cans
and
laundry
hampers
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Sinks
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
54
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Reg.
10088­
105
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Soluble
concentrate:

Reg.
70263­
7
Hot
water
extraction
1
oz
per
gallon
of
water
Inject
and
extract
as
you
would
with
other
extraction
cleaners
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Soluble
concentrate:

Reg.
70263­
7
Spin
bonnet
cleaning
(
spray)
4
oz
per
gallon
of
water
Spray
on
at
a
rate
of
200­

300
square
feet
per
gallon,

scrub
with
rotary
floor
machine
equipped
with
bonnet
or
pad
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Carpet
cleaning
Soluble
concentrate:

Reg.
70263­
7
Immersion
Mix
2
oz
per
gallon
of
water
in
a
cleaning
tank.

Immerse
rug
in
cleaning
solution.
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

(
4)
Residential
and
public
access
premises
Household/
domestic
dwelling
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
4444667
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
55
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Reg.
10088­
105
Reg.
1008­
104
Reg.
1270­
237
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Soluble
concentrate:

Reg.
70263­
7
Hot
water
extraction
1
oz
per
gallon
of
water
Inject
and
extract
as
you
would
with
other
extraction
cleaners
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Soluble
concentrate:

Reg.
70263­
7
Spin
bonnet
cleaning
(
spray)
4
oz
per
gallon
of
water
Spray
on
at
a
rate
of
200­

300
square
feet
per
gallon,

scrub
with
rotary
floor
machine
equipped
with
bonnet
or
pad
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Carpet
cleaning
Carpet
cleaning
(
continued)
Soluble
concentrate:

Reg.
70263­
7
Immersion
Mix
2
oz
per
gallon
of
water
in
a
cleaning
tank.

Immerse
rug
in
cleaning
solution.
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Hard,
non
porous,
non
food
contact
surfaces
Ready­
to­

usesolution

Reg.
1043­
19,

Reg.
44446­
67
Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
56
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Reg.
1008­
104
Reg.
1270­
237
Reg.
3862­
104
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Soluble
concentrate:

Reg.
303­
225
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Animals
kennels/
sleeping
quarters
(
commercial)
Soluble
concentrate:

Reg.
66171­
2
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

(
5)
Medical
premises
and
equipment
57
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Reg.
10088­
105
Reg.
1270237
Reg.
10807­
177
Reg.
10807­
178
Reg.
3862­
104
Reg.
706­
69
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Soluble
concentrate:

Reg.
211­
25
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hospital
non
critical
items(
bedpans/
furniture
Soluble
concentrate:

Reg.
675­
21
Mop,
cloth,

sponge
or
hand
trigger
sprayer
40cc
per
2
gallons
of
water
1:
200
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
58
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Hospital
non
critical
items(
bedpans/
furniture
(
continued)
Soluble
concentrate:

Reg.
211­
36
Reg.
49403­
6
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hospital
semi
critical
items
Soluble
concentrate:

Reg.
211­
36
Reg.
49403­
6
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
**
Prior
to
sterilization
or
high
level
decontamination
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
59
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
1043­
114
Immersion
2
oz
per
gallon
of
water
1:
64
dilution
Soak
for
a
minimum
of
20
minutes
to
achieve
interim
instrument
decontamination
**
Prior
to
sterilization
or
high
level
decontamination
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)

Hospital
critical
items
(
surgical
instruments/
pacemakers)
Soluble
concentrate:

Reg.
675­
21
Immersion
5oz
per
2
gallons
of
water
2:
100
dilution
Soak
for
15
minutes
to
achieve
interim
instrument
decontamination,
then
immerse
in
70%
alcohol
for
one
minute
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)
60
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Hospital
critical
items
(
surgical
instruments/
pacemakers)

(
continued)
Soluble
concentrate:

Reg.
2212­
170
Ultra
sonic
cleaning
system
1
oz
per
gallon
of
water
1:
128
dilution
Fill
the
basket
with
pre
cleaned
instruments,
place
cover
on
machine
and
run
cycle
for
10
minutes
**
Prior
to
sterilization
or
high
level
decontamination
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hospital/
medical
institutions
premises
(
human/
veterinary)
Ready
to
use
solution:

Reg.
7405­
51,

Reg.
3862­
104
Reg.
706­
69
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
61
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
11725­
8
Fogger
(
wet
misting)
½
oz
per
gallon
of
water
1:
256
dilution
Set
the
automatic
timer
on
the
fogger
for
6
minutes
for
1000cu.
ft
and
leave
the
room.
Allow
at
least
2
hours
before
entering
a
room
that
has
been
fogged
Treated
food
contact
surfaces
must
be
thoroughly
rinsed
with
potable
water
prior
to
use.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)

Soluble
concentrate:

Reg.
66171­
1
Reg.
1043­
92
Reg.
11725­
8
Reg.
66171­
2
Reg.
49403­
23
Reg.
211­
25
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hospital/
medical
institutions
premises
(
human/
veterinary)

(
continued)
Soluble
concentrate:

Reg.
211­
36
Reg.
1043­
87
Reg.
1043­
115
Reg.
49403­
6
Reg.
1043­
118
Reg.
11725­
9
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
62
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Impregnated
material:.

Reg.
55195­
4
Wipe
Thoroughly
wet
precleaned
surface
with
a
wipe
and
allow
to
air
dry
Do
not
reuse
wipes
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Reg.
1008­
105
Reg.
12702­
37
Reg.
10807­
177
Reg.
10807­
178
Reg.
7405­
51
Reg.
55195­
3
Reg.
3862­
104
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Hard,
non
porous,
non
food
contact
surfaces
Soluble
concentrate:

Reg.
11725­
8
Reg.
66171­
2
Reg.
211­
25
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
63
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
11725­
8
Fogger
(
wet
misting)
½
oz
per
gallon
of
water
1:
256
dilution
Set
the
automatic
timer
on
the
fogger
for
6
minutes
for
1000cu.
ft
and
leave
the
room.
Allow
at
least
2
hours
before
entering
a
room
that
has
been
fogged
Treated
food
contact
surfaces
must
be
thoroughly
rinsed
with
potable
water
prior
to
use.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/
water)

Impregnated
material:

Reg.
55195­
4
Wipe
Thoroughly
wet
precleaned
surface
with
a
wipe
and
allow
to
air
dry
Do
not
reuse
wipes
Soluble
concentrate:

Reg.
211­
36
Reg.
1043­
87
Reg.
1043­
115
Reg.
49403­
6
Reg.
1043­
118
Reg.
11725­
9
Mop,
cloth,

sponge
or
hand
trigger
sprayer
1
oz
per
gallon
of
water
1:
128
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Household
sickrooms
premises/
contents/
utensils
Ready­
to­

usesolution

Reg.
1043­
19
Reg.
44446­
67
Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
64
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Reg.
3862­
104
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Morgues/
mortuaries/
autop
sy/
embalming
equipment
Ready
to
use
solution:

Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Morgues/
mortuaries/
autop
sy/
embalming
room
premises
Ready
to
use
solution
:

Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)
65
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Ready
to
use
solution:

Reg.
10088­
105
Spray
To
disinfect:
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Barber/
beauty
shop
instruments
and
equipment
Soluble
concentrate:

Reg.
66171­
1
Immersion
1/
2
oz
per
gallon
of
water
1:
256
dilution
Thoroughly
wet
for
10
minutes
allow
to
air
dry
Following
application
as
a
spray,
do
not
enter
or
allow
others
to
enter
the
treated
area
until
sprays
have
dries.
Do
not
apply
in
a
way
that
will
contact
workers
or
any
other
persons,

either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
the
application.
Do
not
contaminate
other
materials
(
including
foods/
drinks/
feeds/

water)

Carpet
cleaning
Soluble
concentrate:

Reg.
70263­
7
Hot
water
extraction
1
oz
per
gallon
of
water
Inject
and
extract
as
you
would
with
other
extraction
cleaners
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.
66
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Soluble
concentrate:

Reg.
70263­
7
Spin
bonnet
cleaning
(
spray)
4
oz
per
gallon
of
water
Spray
on
at
a
rate
of
200­

300
square
feet
per
gallon,

scrub
with
rotary
floor
machine
equipped
with
bonnet
or
pad
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.

Carpet
cleaning
(
continued)
Soluble
concentrate:

Reg.
70263­
7
Immersion
Mix
2
oz
per
gallon
of
water
in
a
cleaning
tank.

Immerse
rug
in
cleaning
solution.
Test
fibers
for
colorfastness
before
use.
Apply
diluted
cleaner
to
inconspicuous
area,
and
rub
with
a
white
cloth.
If
color
transfers
to
cloth
or
changes,
a
water
based
cleaning
system
should
not
be
used.
67
68
APPENDIX
B:
Para­
Tertiary
Amylphenol
Case
3016
Appendix
B
lists
the
generic
(
not
product
specific)
data
requirements
which
support
the
re­
registration
of
Para­
tertiary
Amylphenol.
These
requirements
apply
to
Para­
Tertiary
Amylphenol
in
all
products,
including
data
requirements
for
which
a
technical
grade
active
ingredient
is
the
test
substance.
The
data
table
is
organized
in
the
following
formats:

1.
Data
Requirement
(
Columns
1
and
2).
The
data
requirements
are
listed
by
Guideline
Number.
The
first
column
lists
the
new
Part
158
Guideline
numbers,
and
the
second
column
lists
the
old
Part
158
Guideline
numbers.
Each
Guideline
Number
has
an
associated
test
protocol
set
forth
in
the
Pesticide
Assessment
Guidance,
which
are
available
on
the
EPA
website.

2.
Guideline
Description
(
Column
3).
Identifies
the
guideline
type.

3.
Use
Pattern
(
Column
4).
This
column
indicates
the
standard
Antimicrobial
Division
use
patterns
categories
for
which
the
generic
(
not
product
specific)
data
requirements
apply.
The
number
designations
are
used
in
Appendix
B.

(
1)
Agricultural
premises
and
equipment
(
2)
Food
handling/
storage
establishments
premises
and
equipment
(
3)
Commercial,
institutional
and
industrial
premises
and
equipment
(
4)
Residential
and
public
access
premises
(
5)
Medical
premises
and
equipment
(
6)
Human
water
systems
(
7)
Materials
preservatives
(
8)
Industrial
processes
and
water
systems
(
9)
Antifouling
coatings
(
10)
Wood
preservatives
(
11)
Swimming
pools
(
12)
Aquatic
areas
3.
Bibliographic
Citation
(
Column
5).
If
the
Agency
has
data
in
its
files
to
support
a
specific
generic
Guideline
requirement,
this
column
will
identity
each
study
by
a
"
Master
Record
Identification
(
MRID)
number.
The
listed
studies
are
considered
"
valid"
and
acceptable
for
satisfying
the
Guideline
requirement.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
each
study.
69
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
PRODUCT
CHEMISTRY
830.1550
61­
1
Product
Identity
and
Composition
All
Data
Gap
830.1600
830.1620
830.1650
61­
2a
Starting
Materials
and
Manufacturing
Process
All
Data
Gap
830.1670
61­
2b
Formation
of
Impurities
All
Data
Gap
830.1700
62­
1
Preliminary
Analysis
All
Data
Gap
830.1750
62­
2
Certification
of
Limits
All
Data
Gap
830.1800
62­
3
Analytical
Method
All
Data
Gap
830.6302
63­
2
Color
All
Data
Gap
830.6303
63­
3
Physical
State
All
Data
Gap
830.6304
63­
4
Odor
All
Not
Applicable
830.7050
None
UV/
Visible
Absorption
All
Data
Gap
830.7200
63­
5
Melting
Point
All
Data
Gap
830.7220
63­
6
Boiling
Point
All
Not
Applicable
830.7300
63­
7
Density
All
Data
Gap
830.7840
830.7860
63­
8
Solubility
All
Data
Gap
830.7950
63­
9
Vapor
Pressure
All
Data
Gap
830.7370
63­
10
Dissociation
Constant
in
Water
All
Not
Applicable
70
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
830.7550
830.7560
830.7570
63­
11
Partition
Coefficient
(
Octanol/
Water)
All
Data
Gap
830.7000
63­
12
pH
All
Data
Gap
830.6313
63­
13
Stability
All
Data
Gap
830.6314
63­
14
Oxidizing/
Reducing
Action
All
Not
Applicable
830.6315
63­
15
Flammability
All
Data
Gap
830.6316
63­
16
Explodability
All
Not
Applicable
830.6317
63­
17
Storage
Stability
All
Data
Gap
830.7100
63­
18
Viscosity
All
Not
Applicable
830.6319
63­
19
Miscibility
All
Data
Gap
830.6320
63­
20
Corrosion
Characteristics
All
Not
Applicable
830.6321
63­
21
Dielectric
breakdown
voltage
All
Not
Applicable
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
Test
(
Quail/
Duck)
All
Data
Gap
850.1075
72­
1
Fish
Acute
Toxicity
 
Freshwater
(
Rainbow
Trout)
All
Data
Gap
850.1010
72­
2
Acute
Aquatic
Invertebrate
Toxicity
All
Data
Gap
TOXICOLOGY
870.1100
81­
1
Acute
Oral
­
Rat
All
46616601
870.1200
81­
2
Acute
Dermal
­
Rabbit
All
Data
Gap
870.1300
81­
3
Acute
Inhalation
­
Rat
All
Data
Gap
870.2400
81­
4
Primary
Eye
Irritation
­
Rabbit
All
Data
Gap
870.2500
81­
5
Primary
Dermal
Irritation
­
Rabbit
All
46616602
71
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.2600
81­
6
Dermal
Sensitization
All
Data
Gap
870.3100
82­
1a
90­
Day
Feeding­
Rodent,
with
modifications
(
See
RED)
All
Data
Gap
870.3200
82­
2
21/
28­
Day
Dermal
Toxicity
­
Rat
All
Not
Applicable
870.3250
82­
3
90­
day
Dermal
Toxicity
­
Rodent
All
42470301
870.3465
82­
4
28/
90­
Day
Inhalation
­
Rat
All
waived
870.3700
83­
3
Developmental
Toxicity
­
Rat
All
Data
Gap
870.3700a
83­
3a
Prenatal
Developmental
in
Rodents
All
41920002,
41920001,
42026801
870.5265
84­
2
Bacterial
Reverse
Mutation
Assay
All
41438401,
41572701,
41728801
870.5300
84­
2
Detection
of
gene
mutations
in
somatic
cells
(
CHO)
All
41572701
870.5385
84­
2
Micronucleus
Assay
All
41710801
Reserved
Studies
870.3150
82­
1b
90­
Day
Oral
Subchronic
in
Non­
Rodent
Data
Gap,
Reserved
Study
870.3700b
83­
3b
Developmental
Toxicity
­
Rabbit
Data
Gap,
Reserved
Study
870.3800
83­
4
Reproduction
and
Fertility
Effects
­
2
Generation
Repro
Data
Gap,
Reserved
Study
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2800
133­
1
Descriptions
of
Human
Activity
All
Data
Gap
875.1200
875.1600
233/
236
Dermal
Indoor
Exposure
All
Data
Gap
875.1400
875.1600
234/
236
Inhalation
Indoor
Exposure
All
Data
Gap
72
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
All
Required
OTHER
DATA
REQUIREMENTS
FDA
Guideline
identified
here
FDA
Guideline
identified
here
Dietary­
Residues
in
Food
from
Treating
hard
non­
porous
surfaces
with
4­
t­
Amylphenol
(
conducted
according
to
FDA
guideline
entitled
"
Recommendations
for
Chemistry
Data
for
Indirect
Food
Additive
Petitions.")
All
Required
73
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
Bell
St.,
Arlington,
VA
22202.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
AM
to
4:
00
PM.

The
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
April
28,
2004.
Sixty
days
later
the
first
public
comment
period
closed.
The
EPA
then
considered
comments
and
revised
the
risk
assessments.

All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
site:
http://
www.
epa.
gov/
edockets
These
documents
include:

1.
4­
t­
Amylphenol:
Report
of
the
Antimicrobials
Divisions's
Toxicology
Endpoint
Selection
Committee
(
ADTC),
July
2005
2.
Toxicology
Science
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
From
M.
Ottley
to
K.
Swift,
July
2005
D316279
3.
Occupational
and
Residential
Exposure
Assessment
for
t­
Tert­
Amylphenol
and
Salts.
S.
Mostaghimi
.
May
2005.
D316290
4
Product
Chemistry
of
Para­
Tertiary­
Amylphenol,
para­
tertiary­
amylphenol,
sodium
salt
and
para­
tertiary­
amylphenol,
potassium
salt.
From
A.
N.
Shamim
to
T.
McMahon.
D316275
5
Environmental
Fate
Assessment
of
4­
tert­
Amylphenol
and
its
Potassium
and
Sodium
salts
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
From
S.
Gowda,
Microbiologist
to
M.
Hartman.
May
2005,
D316277
6
Ecological
Hazard
and
Environmental
Risk
Assessment
for
4­
tert­
amylphenol
and
salts
to
be
included
in
the
RED.
D.
Bays
to
A.
Heyward
and
K.
Swift.
July
2005,
D316278
7
Incident
Reports
Associated
with
4­
tert­
amylphenol.
J.
Chen.
May
2005,
D3162
8
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision.
R.
Quick.
July
2005.
D316295.
74
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
4­
tamylphenol
Reregistration
Decision
(
Bibliography)

GUIDE
TO
APPENDIX
D
1.
CONTENTS
OF
BIBLIOGRAPHY.
This
bibliography
contains
citations
of
all
studies
considered
relevant
by
EPA
in
arriving
at
the
positions
and
conclusions
stated
elsewhere
in
the
4­
t­
amylphenol
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.
Selections
from
other
sources
including
the
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
as
a
single
study.

3.
IDENTIFICATION
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
sixdigit
"
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
to
be
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
material
submitted
to
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
75
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.

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.

BIBRA,
Working
Group
(
1990):
Para­
tertiary­
Amylphenol.
Toxicity
Profile
BIBRA
Toxicology
International.
3pp.

MRID
No.
41710801
Edwards,
C.
N.
1990.
Assessment
of
Clastogenic
Action
on
Bone
Marrow
Erthrocytes
in
the
Micronucleus
Test.
Prepared
by
Life
Science
Research
Ltd.,
Suffolk,
UK.
Study
No.
90/
NLL033.0533.
Submitted
by
Nipa
Laboratories,
Inc.
Wilmington,
DE.
76
MRID
No.
41438401
May,
K.
1990.
Nipacide
PTAP
(
para­
tertiary
amylphenol):
Assessment
of
Mutagenic
Potential
in
Histidine
Auxotrophs
of
Salmonella
typhimurium.
Prepared
by
Life
Science
Research
Ltd.,
Suffolk,
UK.
Study
No.
90/
0109.
Submitted
by
Nipa
Laboratories,
Inc.
Wilmington,
DE.

MRID
No.
41572701
Lloyd,
J.
M.
1990.
Investigation
of
Mutagenic
Activity
in
the
TK+/
­
Mouse
Lymphoma
Cell
Mutation
System.
Prepared
by
Life
Science
Research
Ltd.,
Suffolk,
UK.
Study
No.
90/
NLL034/
0395.
Submitted
by
Nipa
Laboratories,
Inc.,
Wilmington,
DE.

MRID
No.
41920002
Siglin,
J.
C.
1991.
Nipacide
PTAP,
Teratology
Study
in
Rats.
Prepared
by
Springborn
Laboratories,
Inc.
Spencerville,
OH.
Study
No.
3227.3.
Submitted
by
Nipa
Laboratories,
Inc.,
Wilmington,
DE.

MRID
No.
46616601
Tufnell,
P.
P.
1992.
Phenol,
4­(
1,1­
dimethylpropyl):
Acute
Oral
Toxicity
Test
in
the
Rat.
Prepared
by
Safepharm
Laboratories
Ltd.,
Derby
U.
K.,
Laboratory
Test
No.
47/
2097.
Submitted
by
Sandoz
Chemicals
Ltd.

MRID
No.
46616602
Tufnell,
P.
P.
1992.
Phenol,
4­(
1,1­
dimethylpropyl):
Acute
Dermal
Irritation
Test
in
the
Rabbit.
Prepared
by
Safepharm
Laboratories
Ltd.,
Derby
U.
K.,
Laboratory
Test
No.
47/
2098.
Submitted
by
Sandoz
Chemicals
Ltd.

Gimeno
S.,
Komen,
H.,
Venderbosch,
P.
W.
and
Bowner,
T.
(
1997)
Disruption
of
sexual
differentiation
in
genetic
male
carp
(
Cyprinus
carpio)
exposed
to
an
alkylphenol
during
different
life
stages.
Enviro
Sci.
Technol.
31(
10):
2884­
2890.

Gimeno
S.,
Komen
H.,
Venderbosch,
P.
W.
and
Bowner,
T.
(
1998a):
Feminisation
of
young
males
of
the
common
carp,
Cyprinus
carpio,
exposed
to
4­
ter­
pentyphenol
during
sexual
differentiation.
Aquatic
Toxicology
(
Amsterdam)
43:
77­
92.

Gimeno,
S.
Komen,
H.
Jobling
S.,
Sumpter,
J.
and
Bowner,
T.
(
1998b):
Demasculinisation
of
sexually
mature
male
carp,
Cyprinus
carpio,
exposed
to
4­
tert­
amylphenol
during
Spermatogenesis.
Aquatic
Toxicology
(
Amsterdam)
43:
93­
109.

Hazard
Substances
Databank
(
HSDB).
A
Database
of
the
National
Library
of
Medicine's
TOXNET
System.

Helwig,
D.
(
2003)
Personal
Communication
between
D.
Helwig
(
Johnson
Dirersey,
Inc.)
and
K.
Riley
(
Versar,
Inc.,
November
11,
2003.
77
Holcombe,
G.
W.,
Phipps,
G.
L.,
Knuth,
M.
L.
and
Felhabert,
T.
(
1984):
The
acute
toxicity
of
selected
substituted
phenols,
benzenes
and
benzoic
acid
ester
to
fathead
minnows
Pimephales
promelas.
Environ.
Pollut.
Ser.
A.
Ecol.
Biol.
35(
4):
367­
381.

McLeese,
D.
W.
(
1981).
Lethality
and
accumulation
of
alkylphenols
in
aquatic
fauna.
Chemosphere
10(
7):
723.

Routledge,
E.
J.
Sumpter,
J.
P.
(
1997)
Structural
features
of
alkylphenolic
chemicals
associated
with
estrogenic
activity.
J.
Biol.
Chem.
272(
6):
3280­
3288.

Russon,
C.
L.,
Bradbury,
S.
P.,
Broderius
S.
J.,
Hammermeister,
R.
A.
and
Drummond,
R.
A.
(
1997)
[
no
title
given]
environ.
Toxicol.
Chem.
16:
948.

Smeets,
J.
M.,
Van,
H.
I.,
Giesey,
J.
P.,
Seinen,
W.,
and
van
den,
B.
M.
(
1999).\

Soto,
et.
al.(
1995).
The
E­
SCREEN
assay
tool
to
identify
estrogens:
An
update
on
estrogenic
environmental
pollutants.
Environ.
Health
Perspect.
103
(
Suppl.
7):
113­
122.

Stevenson,
C.
J.
(
1984):
Environmentally
induced
vitililigo
(
leukoderma)
from
depigmenting
agents
and
chemicals.
J.
Toxicol.
Cutaneous
Ocul.
Toxicol.
3(
3):
299­
308.

USEPA.
1997.
Exposure
Factors
Handbook.
Volume
I­
II.
Office
of
Research
and
Development.
Washington,
D.
C.
EPA/
600/
P­
995/
002
Fa.

EPA,
1997.
"
Exposure
Factors
Handbook,
Volume
III:
Activity
Factors."
EPA/
600/
P­
95/
002Fe
August
1997.

USEPA.
1998.
PHED
Surrogate
Exposure
Guide.
Estimates
of
Worker
Exposure
from
the
Pesticide
Handler
Exposure
Database
Version
1.1.
Washington,
DC:
U.
S.
Environmental
Protection
Agency.

USEPA.
1999.
Evaluation
of
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study.
Memorandum
from
Siroos
Mostaghimi,
Ph.
D.,
USEPA,
to
Julie
Fairfax,
USEPA.
Dated
November
4,
1999.
DP
Barcode
D247642.

EPA,
1999.
"
Available
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide."

U.
S.
Environmental
Protection
Agency
(
EPA)
2001.
Residential
SOPs
Policy
Update
12,
EPA
Office
of
Pesticide
Programs
 
Human
Health
Division.
Dated
April
5,
2000.

U.
S.
Environmental
Protection
Agency
(
EPA).
2002.
ECOTOX
User
Guide:
ECOTOXicology
Database
System.
Version
3.0.
Available:
http://
www.
epa.
gov/
ecotox/
78
USEPA.
2005.
Product
Chemistry
of
Para­
Tertiary­
Amylphenol
(
PC
Code
064101),
Para­
Tertiary­
Amylphenol,
Sodium
Salt
(
PC
Code
064112),
and
Para­
Tertiary­
Amylphenol,
Potassium
Salt
(
PC
Code
064111).
Memorandum
from
A.
Najm
Shamim,
Ph.
D.,

USEPA.
2005.
the
Estimation
Programs
Interface
(
EPI)
Suite.
Windows­
based
suite
of
physical/
chemical
properties
and
environmental
estimation
models
developed
by
the
US
EPA's
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPTS)
and
Syracuse
Research
Institute
(
SRC)
http://
www.
epa.
gov/
oppintr/
exposure/
docs/
EPISuitedl.
htm
USEPA's
Estimation
of
P/
Chem
Properties
Program,
EPS
Suite.

FDA,
2003a.
"
Guidance
For
Industry:
Preparation
of
Food
Contact
Notifications
and
Food
Additive
Petitions
for
Food
Contact
Substances:
Chemistry
Recommendations.
Final
Guidance."

FDA,
2003b.
"
Sanitizing
Solutions:
Chemistry
Guidelines
for
Food
Additive
Petitions."
January,
1993.
http://
www.
cfasan.
fda.
gov/~
dms/
opa­
cg3a.
html.
Last
accessed
June
9,
2003.

Whatman,
2005.
Whatman
Absorbent
Sinks.
http://
www.
whatman.
com/
products/?
pageID=
7.32.42,
Accessed
March
2005.

Wysowski,
D.
K.
et.
al.
(
1978)
Epidemic
neonatal
Hyperbilirubinemia
and
use
of
phenolic
disinfectant
detergent.
Pediatrics
61:
165­
170.

Yamasaki,
K.
et.,
al.
(
1978).
Immature
rat
uterotrophic
assay
of
18
chemicals
and
Hershberger
assay
of
30
chemicals.
Toxicology
183:
93­
115.

Zeiger,
E.,
Anderson
B.,
Haworth,
S.,
Lawlor,
T.
and
Mortelmans,
K.
(
198):
Salmonella
mutagenicity
tests.
4.
results
from
testing
of
300
chemicals.
Environ.
Mol.
Mutagen
11:
1­
158.
79
Appendix
E.
Generic
Data
Call­
In
The
Agency
intends
to
issue
a
Generic
Data
Call­
In
at
a
later
date.
See
Chapter
V
of
the
RED
for
a
list
of
studies
that
the
Agency
plans
to
require
for
4­
t­
amylphenol.
80
Appendix
F.
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
at
a
later
date.
81
Appendix
G.
Batching
of
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
4­
t­
amylphenol
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.
Not
with­
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
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
82
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.

The
batching
information
will
be
provided
with
the
product­
specific
DCI
83
Appendix
H.
List
of
All
Registrants
To
Be
Sent
the
Generic
Data
Call­
In
Clariant
Corporation
84
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@
epamail.
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
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
(
in
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
in
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
in
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
in
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
85
Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/.

Dear
Registrant:

For
your
convenience,
we
have
assembled
an
online
registration
kit
that
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
the
Acrobat
reader.)

Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices.

3.
Pesticide
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
86
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'
Web
Site
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.
Please
note
that
EPA
is
currently
in
the
process
of
updating
this
booklet
to
reflect
the
changes
in
the
registration
program
resulting
from
the
passage
of
the
FQPA
and
the
reorganization
of
the
Office
of
Pesticide
Programs.
We
anticipate
that
this
publication
will
become
available
during
the
Fall
of
1998.

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
Web
site.

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
Web
site:
http://
npic.
orst.
edu
.
87
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:

Date
of
receipt
EPA
identifying
number
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
CAS
number
if
one
has
been
assigned.