Document ID: EPA-HQ-OPP-2004-0305-0026
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

United
States
Prevention,
Pesticides
EPA739­
R­
05­
003
Environmental
Protection
and
Toxic
Substances
September
2005
Agency
(
7510C)

Reregistration
Eligibility
Decision
for
PHMB
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
poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB).
The
Reregistration
Eligibility
Decision
(
RED)
was
approved
in
the
form
of
a
decision
memorandum
which
summarized
the
regulatory
decision
for
PHMB
on
September
30,
2004.
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
PHMB
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
PHMB
are
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2004­
0305
at:
http://
www.
epa.
gov/
edockets.

The
PHMB
RED
was
developed
through
EPA's
public
participation
process,
published
in
the
Federal
Register
on
September
10,
2004,
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
PHMB
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
PHMB
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
PHMB
will
be
eligible
for
reregistration
provided
that
all
the
conditions
identified
in
this
document
are
satisfied,
including
implementation
of
the
risk
mitigation
measure
outlined
in
Section
IV
of
the
document.
Sections
IV
and
V
of
this
RED
document
describe
the
labeling
amendments
for
end­
use
products
and
data
requirements
necessary
to
implement
this
mitigation
measure.
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
PHMB.
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
relevant
to
this
reregistration
decision,
please
contact
the
Chemical
Review
Manager,
Jennifer
Slotnick,
at
(
703)
305­
0601.
For
questions
about
product
reregistration
and/
or
the
Product
DCI
that
accompanies
this
document,
please
contact
Adam
Heyward
at
(
703)
308­
6422.

Sincerely,

Frank
T.
Sanders
Director,
Antimicrobials
Division
REREGISTRATION
ELIGIBILITY
DECISION
for
PHMB
List
C
CASE
3122
Approved
By:

Frank
T.
Sanders
Director,
Antimicrobials
Division
September
29,
2005
Attachment
Table
of
Contents
PHMB
Reregistration
Team                   ...  
i
Glossary
of
Terms
and
Abbreviations              ...   
ii
Executive
Summary                      .  ....
iv
I.
Introduction                           ..
1
II.
Chemical
Overview                       .
...
3
A.
Regulatory
History                    ..
...
3
B.
Chemical
Identification
                  ...
3
C.
Use
Profile                        ...
4
III.
Summary
of
PHMB
Risk
Assessments               ...
7
A.
Human
Health
Risk
Assessment               ...
7
1.
Toxicity
of
PHMB
                  ...
7
2.
FQPA
Safety
Factor                  
10
3.
Population
Adjusted
Dose
(
PAD)            ...
10
a.
Acute
PAD                   
10
b.
Chronic
PAD                  
11
4.
Exposure
Assumptions                 
11
5.
Dietary
Risk
Assessment                .
11
a.
Dietary
Risk
from
Food             ..
11
b.
Dietary
Risk
from
Drinking
Water
        ..
12
6.
Residential
Risk
Assessment ...             
12
a.
Residential
Toxicity        ..   ..   .
12
b.
Residential
Handlers           ..
 .. ..
13
i.
Exposure
Assessment .
          .
13
ii.
Risk
Assessment       .  .    .
14
b.
Residential
Post­
Application ..          
14
i.
Exposure
Assessment .
          .
14
ii.
Risk
Assessment       .  .    .
15
7.
Aggregate
Risk                    .
16
a.
Short­
and
Intermediate­
Term
Aggregate
Risk   ...
16
b.
Chronic
Aggregate
Risk
           ... ..
18
8.
Occupational
Risk                  ...
18
a.
Occupational
Toxicity              .
19
b.
Occupational
Handler
Exposure          
19
c.
Occupational
Handler
Risk
Summary       ...
20
9.
Human
Incident
Data        ...        ...
20
B.
Environmental
Risk
Assessment               ..
21
1.
Environmental
Fate
and
Transport           ...
21
2.
Ecological
Risk                    .
21
a.
Toxicity
(
Hazard)
Assessment
...          
22
b.
Exposure
and
Risk
               .
22
c.
Risk
to
Listed
Species       .       .
23
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision 
24
A.
Determination
of
Reregistration
Eligibility           .
24
B.
Public
Comments
and
Responses               ..
24
C.
Regulatory
Position                     
26
1.
Food
Quality
Protection
Act
Findings          ...
26
a.
"
Risk
Cup"
Determination            .
26
b.
Determination
of
Safety
to
U.
S.
Population     ..
26
c.
Determination
of
Safety
to
Infants
and
Children   .
27
d.
Endocrine
Disruptor
Effects           ..
27
e.
Cumulative
Risks                .
28
2.
Tolerance
Summary                  
28
D.
Regulatory
Rationale                    ..
28
1.
Human
Health
Risk
Management            .
28
a.
Dietary
(
Food)
Risk
Mitigation          ..
28
b.
Drinking
Water
Risk
Mitigation          
28
c.
Residential
Risk
Mitigation            
29
i.
Handler
Risk
Mitigation
          .
29
ii.
Post­
Application
Risk
Mitigation  .    .
29
d.
Occupational
Risk
Mitigation           
29
i.
Handler
Risk
Mitigation
          .
29
ii.
Post­
Application
Risk
Mitigation .     .
29
2.
Environmental
Risk
Management          ... ..
29
3.
Other
Labeling
Requirements              
29
4.
Listed
Species
Considerations          ..   ..
29
a.
The
Endangered
Species
Act  .         .
29
b.
General
Risk
Mitigation    ...        ..
30
V.
What
Registrants
Need
to
Do                    
31
A.
Manufacturing­
Use
Products                 
33
1.
Additional
Generic
Data
Requirements          
33
2.
Labeling
for
Technical
and
Manufacturing­
Use
Products  ..
34
B.
End­
Use
Products                   ...  
34
1.
Additional
Product­
Specific
Data
Requirements    .........
34
2.
Labeling
for
End­
Use
Products             ..
34
a.
Label
Changes
Summary
Table          .
35
VI.
Appendices                           .
39
A.
Table
of
Use
Patterns
for
PHMB
               .
40
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision              ...
59
C.
Technical
Support
Documents                ..
65
D.
Bibliography
Citations                   ...
67
E.
Generic
Data
Call­
In                    ..
74
F.
Product
Specific
Data
Call­
In                 
75
G.
Batching
of
End­
Use
Products                ..
76
H.
List
of
All
Registrants
Sent
the
Data
Call­
In          ...
80
I.
List
of
Available
Forms                   ...
81
i
PHMB
Reregistration
Team
Health
Effects
Risk
Assessment
Jonathan
Chen
Timothy
Leighton
Tim
McMahon
Najm
Shamim
Cassi
Walls
Ecological
Risk
Assessment
Kathryn
Montague
Environmental
Fate
Risk
Assessment
Najm
Shamim
Registration
Support
Adam
Heyward
Lisa
McKelvin
Risk
Management
Jennifer
Slotnick
Ben
Chambliss
ii
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
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
MRL
Maximum
Residue
Level
iii
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
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
iv
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
PHMB
and
is
issuing
its
risk
management
decision.
The
Agency
has
decided
PHMB
is
eligible
for
reregistration
provided
all
measures
outlined
in
this
document
are
implemented.
PHMB
is
used
as
a
fungicide,
algicide,
and
sanitizer
in
swimming
pools;
preservative
for
cut
flowers;
materials
preservative;
bacteriostat
in
industrial
processes
and
water
systems;
and
hard
surface
disinfectant
(
food
and
non­
food
contact
surfaces).
End­
use
products
are
formulated
as
soluble
concentrates,
as
solids,
as
ready­
to­
use
solutions,
and
in
water­
soluble
packaging.
The
product
with
the
impregnated
wipe
formulation
was
cancelled
in
July
2005.

Overall
Risk
Summary
The
Agency's
human
heath
risk
assessment
indicates
only
one
risk
of
concern
for
occupational
handlers.
An
acute
dietary
risk
estimate
was
completed
for
females
13­
50
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.
As
none
of
the
uses
associated
with
PHMB
are
expected
to
impact
either
surface
or
ground
water
resources,
no
drinking
water
assessment
was
performed.
When
considering
aggregate
risk
from
dietary
and
residential
exposures,
risk
estimates
are
below
the
Agency's
level
of
concern.

To
address
occupational
exposure,
dermal
and
inhalation
risks
were
assessed
for
handlers.
Scenarios
involving
pour
liquid
for
drilling
muds
and
workover
fluids
showed
a
risk
above
the
Agency's
level
of
concern.
In
order
to
achieve
MOEs
above
the
target
level,
these
scenarios
must
use
mitigation
measures
such
as
metering
pump
systems.
In
addition,
since
the
inhalation
MOE
for
this
scenario
falls
below
the
MOE
of
1,000,
when
the
additional
route­
toroute
extrapolation
uncertainty
factor
is
applied,
an
inhalation
study
will
be
required
to
confirm
these
findings.

An
environmental
risk
assessment
was
also
conducted
for
PHMB.
Due
to
limited
potential
for
environmental
exposure,
environmental
risks
are
below
the
Agency's
level
of
concern.

Dietary
Risk
Acute
and
chronic
dietary
(
food)
risks
are
below
EPA's
level
of
concern
for
the
general
U.
S.
population
and
all
population
subgroups.
A
screening­
level
acute
dietary
risk
assessment
was
conducted
for
PHMB
food
uses.
Risk
estimates
are
provided
for
females
13­
50
years
old,
the
only
population
subgroup
with
an
acute
toxicity
endpoint
of
concern.
Risk
estimates
for
the
use
with
the
highest
exposures
were
9%
of
the
aPAD
and,
therefore,
were
not
of
concern.

The
chronic
dietary
risk
assessment
concludes
that
for
all
included
use
sites,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
for
the
general
U.
S.
population
(<
10%
of
the
cPAD)
and
all
population
subgroups
(
37%
of
the
cPAD
for
children).
Risks,
therefore,
are
not
of
concern
and
no
mitigation
measures
are
necessary.
v
Drinking
Water
Risk
None
of
the
uses
associated
with
PHMB
are
expected
to
impact
either
surface
or
ground
water
resources.
Therefore,
no
drinking
water
assessment
was
performed.

Residential
Risk
Residential
handler
and
post­
application
exposure
scenarios
were
assessed
using
surrogate
exposure
data,
maximum
label
rates,
and
standard
assumptions.
All
margins
of
exposure
(
MOEs)
from
dermal
and
inhalation
exposure
for
residential
handlers
are
above
the
target
MOE
of
100
and,
therefore,
not
of
concern.
For
post­
application
dermal
and
incidental
ingestion
(
oral)
exposures,
MOEs
were
below
the
Agency's
level
of
concern.
No
residential
risk
mitigation
is
necessary.

Aggregate
Risk
The
aggregate
risk
assessment
integrates
the
assessments
conducted
for
dietary
and
residential
exposure.
Using
the
Aggregate
Risk
Index
(
ARI)
method,
aggregate
calculations
were
performed
for
adults
and
children.
The
ARIs
are
greater
than
1.2
for
children
and
5.4
for
adults.
These
risks
are
below
the
Agency's
level
of
concern
(
ARI<
1),
and
no
mitigation
measures
are
necessary
to
reduce
risks
from
aggregate
exposures.

Occupational
Risk
To
address
occupational
exposure,
dermal
and
inhalation
risks
were
assessed
for
handlers.
Only
one
scenario
for
occupational
handlers
showed
a
risk
above
the
Agency's
level
of
concern.
The
dermal
MOE
of
74
for
scenarios
involving
pour
liquid
for
drilling
muds
and
workover
fluids
is
below
the
target
MOE
of
100
and,
therefore,
is
of
concern.
In
order
to
achieve
MOEs
above
the
target
level
(
i.
e.,
greater
than
100),
scenarios
involving
drilling
muds
and
workover
fluids
must
use
mitigation
measures
such
as
metering
pump
systems.
In
addition,
since
the
inhalation
MOE
for
this
scenario
falls
below
the
MOE
of
1,000,
when
the
additional
route­
to­
route
extrapolation
uncertainty
factor
is
applied,
an
inhalation
study
will
be
required
to
confirm
these
findings.
At
this
time,
EPA
does
not
foresee
post­
application
exposures
for
the
occupational
uses
of
PHMB.

Ecological
Risk
The
Agency
conducted
an
environmental
risk
assessment
to
determine
the
potential
impact
of
PHMB
use
on
non­
target
terrestrial
and
aquatic
organisms.
Environmental
exposure
modeling
was
not
conducted
for
PHMB
because
its
uses
are
not
likely
to
result
in
significant
outdoor
exposure.
The
uses
of
PHMB
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur.
The
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
PHMB.
However,
the
high
toxicity
of
PHMB
to
fish
and
aquatic
invertebrates
is
of
concern
in
the
event
of
a
spill
or
misuse
of
the
product.
vi
Regulatory
Decision
The
Agency
has
completed
its
review
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
supported
products
containing
PHMB.
The
Agency
is
issuing
this
RED
for
PHMB,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
The
RED
and
supporting
risk
assessment
for
PHMB
are
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2004­
0305
at
http://
www.
epa.
gov/
edockets.
This
RED
document
includes
guidance
and
time
frames
for
making
any
necessary
label
changes
for
products
containing
PHMB.

Summary
of
Mitigation
Measures
The
Agency
has
determined
that
PHMB
is
eligible
for
reregistration
provided
the
mitigation
measure
described
in
this
document
and
the
label
changes
included
in
Table
12
in
Section
V
of
the
RED
are
implemented.

Occupational
Risk
EPA
determined
that
the
greatest
potential
for
exposure
appears
to
be
the
inhalation
and
dermal
occupational
scenarios
involving
pour
liquid
for
drilling
muds
and
workover
fluids.
Using
an
open
pour
scenario,
these
risks
are
of
concern
to
the
Agency.
In
order
for
risks
to
drop
below
the
Agency's
level
of
concern,
scenarios
involving
drilling
muds
and
workover
fluids
must
use
mitigation
measures
such
as
metering
pump
systems.

Data
Requirements
Additional
confirmatory
data
is
required
to
complete
the
reregistration
of
PHMB.
A
complete
list
of
data
gaps
is
presented
Section
V
and
Appendix
B
(
Table
of
Generic
Data
Requirements).
In
addition,
product­
specific
data
is
required
for
all
products
containing
PHMB
as
described
in
Section
V
of
this
document.
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
poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB).

PHMB
is
an
antimicrobial
used
in
several
types
of
applications,
including
as
a
fungicide,
algicide,
and
sanitizer
in
swimming
pools;
preservative
for
cut
flowers;
materials
preservative;
bacteriostat
in
industrial
processes
and
water
systems;
and
hard
surface
disinfectant.
The
registrant
for
PHMB
has
indicated
that
about
95
percent
of
the
use
of
this
chemical
is
for
pools
and
spas.
The
hard
surface
disinfectant
use
may
be
on
food
and
non­
food
contact
surfaces
in
or
on
agricultural
premises
and
equipment;
commercial,
industrial,
and
institutional
premises
and
equipment;
residential
contents
and
premises;
and
medical
premises
and
equipment.

The
Agency
has
concluded
that
the
FQPA
Safety
Factor
for
PHMB
should
be
removed
(
equivalent
to
1X)
based
on:
(
1)
there
is
no
concern
for
developmental
neurotoxicity
resulting
from
exposure
to
PHMB
because
there
is
no
evidence
PHMB
will
induce
neurotoxic
effects;
(
2)
there
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
the
fetus
following
in
utero
exposure
in
the
prenatal
developmental
toxicity
studies
or
to
the
offspring
when
adults
are
exposed
in
the
two­
generation
reproductive
study;
and
(
3)
the
risk
assessment
does
not
underestimate
the
potential
exposure
for
infants
and
children.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
the
active
ingredients
PHMB.
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
that
would
occur
at
a
higher
level
of
exposure
to
any
of
the
substances
2
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
PHMB
and
any
other
substances.
PHMB
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
action,
therefore,
EPA
has
not
assumed
that
PHMB
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
PHMB.
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
PHMB
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.

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
PHMB,
and
its
regulatory
history.
Section
III,
Summary
of
PHMB
Risk
Assessments,
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
PHMB
was
first
registered
in
the
United
States
in
1982
as
an
active
ingredient.
Currently,
there
are
17
products
containing
PHMB
(
two
technical
products
and
15
end­
use
products)
registered
under
Section
3
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
for
use
as
algaecides,
bacteriocides/
bacteriostats,
fungicides/
fungistats,
microbicides/
microbiostats,
disinfectants,
regulators,
and
sanitizers.

B.
Chemical
Identification
Technical
PHMB
X
­
((
CH2)
3
­
NH
­
C
­
NH
­
C
­
NH
­
(
CH2)
3)
n
­
X
  
  
NH
NH
.
HCl
where
X
=
HCl.
NH2
­
(
CH2)
3
OR
X
=
­
(
CH2)
3
­
NH
­
C
­
NH
­
CN
  
NH
OR
X
=
­
(
CH2)
3
­
NH
­
C
­
NH2
.
HCl
  
NH
Figure
1.
Molecular
Structure
of
PHMB
Common
name:
Poly(
hexamethylenebiguanide)
hydrochloride
Chemical
name:
Poly(
iminoimidocarbonyliminoimidocarbonyliminohexamethylene
hydrochloride
Chemical
family:
Guanidine
Empirical
formula:
C8
H17
N5
HCl
CAS
Registry
No.:
32289­
58­
0
Case
number:
3122
OPP
Chemical
Code:
111801
4
Molecular
weight:
219.5
Other
names:
PHMB,
Vantocil
1B,
Baquacil,
Baquacil
SB,
Cosmoquil
CQ
Basic
manufacturers:
Arch
Chemicals,
Inc.
Mareva,
Inc.

Chemical
properties:
PHMB
is
a
very
faint
yellow,
mobile
liquid.
Since
PHMB
is
a
liquid,
it
has
no
melting
point.
It
has
a
boiling
point
of
100.20C,
and
decomposition
begins
at
205
­
2100C.
PHMB
has
a
specific
gravity
of
1.04
at
20oC.

C.
Use
Profile
The
following
is
information
on
the
uses
of
PHMB
products,
currently
registered
as
of
September
30,
20041,
and
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
PHMB
eligible
for
reregistration
is
contained
in
Appendix
A.

Type
of
Pesticide:
Algicide,
bacteriostat/
bacteriocide,
fungistat/
fungicide,
microbiostat/
microbiocide,
disinfectant,
regulator,
and
sanitizer
Summary
of
Use:

Food:
Hard
surface
disinfectant
uses
on
kitchen
countertops,
high
chairs,
refrigerators,
and
microwave
ovens
are
indirect
food
uses,
as
there
surfaces
have
the
potential
to
come
into
contact
with
food.

Public
Health:
Hard
surface
disinfectant:
For
use
in
residential,
healthcare,
industrial
and
institutional
settings
such
as
hospitals,
nursing
homes,
day
care
centers,
nurseries,
hotels,
schools,
airplanes,
boats,
buses,
campers,
cars,
railroad
trains,
taxicabs,
campgrounds,
restaurants,
animal
laboratories,
veterinary
offices,
kennels,
dental
offices,
health
clubs,
farm
and
livestock
premises
and
mushroom
house
premises.
May
be
used
on
hard,
non­
porous
surfaces
such
as
tables,
countertops,
stovetops,
sinks,
cabinets,
refrigerators,
microwave
ovens,
high
chairs,
tubs,
floors,
glazed
tiles,
urinals,
diaper
pails
and
other
bathroom
surfaces,
garbage
cans,
walls,
floors,
stainless
steel
surfaces,
kennel
runs,
pet
areas,
sealed
stones,
glazed
ceramics,
playground
equipment,
picnic
tables
and
the
coils
of
air
conditioning
units.

Aquatic
non­
food
residential
sanitizer:
For
use
in
swimming
pool,
spa
and
hot
tub
water
systems.

1
The
impregnated
wipe
disinfectant,
EPA
Reg.
No.
50096­
1,
was
cancelled
in
July
2005.
Its
exclusion
in
the
risk
assessment
would
not
change
the
risk
levels
of
concern;
therefore,
the
document
was
not
revised
to
remove
it.
5
Other
Non­
food:
Terrestrial
non­
food
microbiostat
and
preservative:
For
use
on
ornamental
flowering
plants
(
cuttings
or
stored).

Indoor
non­
food
materials
preservative:
For
use
in
the
preservation
of
electrocoat
resins
in
addition
to
aqueous
industrial
chemicals
such
as
reagents,
oil­
in­
water
emulsions,
water­
in­
oil
emulsions,
cellulose
solutions,
silicone
emulsions
and
silicone
dispersions,
aqueous
mineral
slurries
such
as
calcium
carbonate
and
titanium
dioxide
as
well
as
polymer
latices
such
as
polyvinyl
acetate
and
polyvinyl
alcohol.

For
the
preservation
of
textiles
and
cellulosic
materials
such
as
carpet,
curtains,
mops,
dishcloths,
wipes,
sponges,
tissues
and
non­
food
contact
paper
products.

For
the
preservation
of
leather,
fresh
animal
hides
and
skins
prior
to
or
during
processing.

For
the
control
of
microorganisms
in
aqueous
adhesives
such
as
animal
glues,
latex
adhesives
and
other
synthetic
and
protein
based
glues.

Terrestrial
non­
food
bacteriostat:
For
the
control
of
microorganisms
and
bacteria
in
drilling
muds
and
packer
fluids
in
addition
to
workover
fluids.

Indoor
non­
food
bacteriostat:
For
the
control
of
microorganisms
and
bacteria
in
oil
field
injection
water
and
tunnel
pasteurization
water.

Target
Pests:
Slime­
forming
bacteria,
deterioration/
spoilage
bacteria,
animal
pathogenic
bacteria
(
G­
and
G+
vegetative),
pseudomonas
spp,
animal
pathogenic
fungi,
mold/
mildew,
algae.

Formulation
Types:
Soluble
concentrate/
solid,
impregnated
wipes,
ready­
to­
use
solution,
and
water­
soluble
packaging.

Method
and
Rates
of
Application:

Equipment:
The
end­
use
products
are
added
during
the
manufacturing
process
of
treated
articles
and
materials.
Poly(
hexamethylenebiguanide)
hydrochloride
formulations
are
added
directly
to
water
in
swimming
pools,
spas,
and
cut
flower
applications,
as
well
as
in
oil
field
injection
waters
and
workover
fluids.
Impregnated
wipes
are
dampened
with
water
prior
to
use.

Application
Rates:
For
details
about
specific
use
sites
for
PHMB,
refer
to
Appendix
A.
6
 
Use
1
to
50
lbs.
of
end
use
formulation
to
10,000
lbs.
of
product
to
produce
a
100
to
5000
ppm
solution
for
the
preservation
of
reagents,
oil­
in­
water
emulsions,
water­
in­
oil
emulsions,
cellulose
solutions,
silicone
emulsions
and
silicone
dispersions.
 
Use
5
to
50
lbs.
of
end
use
formulation
to
10,000
lbs.
of
product
to
produce
a
500
to
5000
ppm
solution
for
the
preservation
of
aqueous
mineral
slurries
such
as
calcium
carbonate
and
titanium
dioxide,
as
well
as
polymer
latices,
such
as
polyvinyl
acetate
and
polyvinyl
alcohol,
and
adhesives,
such
as
animal
glues,
latex
adhesives
and
other
synthetic
and
protein
based
glues.
 
Use
1
to
30
lbs.
of
end
use
formulation
to
10,000
lbs.
of
product
to
produce
a
100
to
3000
ppm
solution
for
the
preservation
of
leather
and
fresh
animal
hides
and
skins
prior
to
or
during
processing.
 
Use
13
fl.
oz.
to
1
gal.
of
end
use
formulation
to
1000
gals.
of
water
for
the
preservation
of
tunnel
pasteurization
waters.
 
For
non­
porous
surface
disinfection,
spray
end
use
product
on
surface
until
wet.
Surface
must
remain
wet
for
10
minutes
before
wiping
dry.
Rinse
food­
contact
surfaces
with
potable
water
prior
to
reuse.
 
For
sanitizing
pool
water,
use
enough
end­
use
product
to
give
a
concentration
of
50
ppm
PHMB
(
58­
64
oz.
per
10,000
gals.)
for
freshly
filled
pools.
To
maintain
or
raise
level
of
end
use
product
add
at
a
rate
of
one
pint
per
10,000
gals.
of
water.
For
pool
water
sanitizer
tablets,
add
one
tablet
per
approximately
5500
gals.
of
water.

Use
Classification:
General
use.
7
III.
Summary
of
PHMB
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
PHMB.
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
PHMB
A
brief
overview
of
the
toxicity
studies
used
for
determining
endpoints
in
the
risk
assessments
are
outlined
below
in
Table
1.
Further
details
on
the
toxicity
of
PHMB
can
be
found
in
the
"
PHMB
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document,"
dated
January
18,
2005;
"
Poly(
hexamethylenebiguanide)
Hydrochloride
(
PHMB)
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
February
14,
2005;
and
"
PHMB
­
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee,"
dated
April
9,
2003.
These
documents
are
available
on
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.

The
Agency
has
reviewed
all
toxicity
studies
submitted
for
PHMB
and
has
determined
that
the
toxicological
database
is
sufficient
for
reregistration.
The
studies
have
been
submitted
to
support
guideline
requirements.
Major
features
of
the
toxicology
profile
are
presented
below.

Table
1.
Summary
of
Acute
Toxicity
Data
for
PHMB
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
Acute
Toxicity
00030330
LD50
=
2747
mg/
kg
44940701
LD50
=
1831mg/
kg
(
M)
LD50
=
1617mg/
kg
(
F)
870.1100
Acute
Oral
45916505
LD50
=
1049mg/
kg
(
F)
III
00065124
LD50
>
2.0
ml/
kg
44940702
LD50
>
2000mg/
kg
III
870.1200
Acute
Dermal
45916506
LD50
>
5000mg/
kg
IV
870.1300
Acute
Inhalation
44970403
LC50
=
1.76mg/
L
III
8
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
45916508
Corrosive
I
870.2400
Primary
Eye
Irritation
00046789
00065120
44963902
Moderate
irritant
II
00046789
00065120
Moderate
irritant
II
870.2500
Primary
Skin
Irritation
44949704
45916509
Slight
irritant
IV
42674201
Moderate
sensitizer
870.2600
Dermal
Sensitization
44940705
Mild
sensitizer
NA
Notes:
LC
=
Lethal
Concentration;
LD
=
Lethal
Dose;
NA
=
Not
Applicable
The
doses
and
toxicological
endpoints
selected
for
various
exposure
scenarios
are
summarized
in
Table
2
below.

Table
2.
Dietary
Toxicological
Endpoints
for
PHMB
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
50
years
of
age)
NOAEL
=
20
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.2
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.2
mg/
kg/
day
Rabbit
Developmental
Study
(
MRID
42865901)

LOAEL
=
40
mg/
kg/
day
based
on
reduced
number
of
litters
and
skeletal
abnormalities.

Acute
Dietary
(
General
population
including
infants
and
children)
No
Appropriate
single
dose
effects
can
be
selected
for
general
population
Chronic
Dietary
(
All
populations)
NOAEL=
20
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.2
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.2
mg/
kg/
day
Rabbit
Developmental
Study
(
MRID
42865901)
LOAEL
=
40
mg/
kg/
day
Based
on
the
increased
mortality,
reduced
food
consumption,
and
clinical
toxicity;

Mouse
Developmental
Study
(
Report
No.
CTL/
P/
335,
1977
(
cited
in
Report
No.
003810,
1978.
Section
C­
9))
LOAEL
=
40
mg/
kg/
day;
Based
on
reduced
body
weight
gain;
and
Rat
Developmental
Study
(
Report
No.
CTL/
P/
1262,
1976
(
cited
in
Report
No.
003810,
1978.
Section
C­
11))
LOAEL
=
50
mg/
kg/
day
Based
on
reduced
food
consumption.
9
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
Oral,
dermal,
inhalation)
The
HED
Cancer
Assessment
Review
Committee
(
CARC)
classified
PHMB
as
"
Suggestive
Evidence
of
Carcinogenicity,
but
not
sufficient
to
Assess
Human
Carcinogenic
Potential"
by
the
oral
and
dermal
routes.
Quantification
of
human
cancer
risk
is
not
required.

Notes:
UF
=
uncertainty
factor,
FQPA
SF
=
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
General
Toxicity
Observations
Dietary
The
acute
RfD
is
0.2
mg/
kg/
day
for
females
(
13­
50
years),
based
on
adverse
developmental
effects
(
reduced
number
of
litters
and
skeletal
abnormalities)
at
40
mg/
kg/
day
in
a
rabbit
developmental
study.
The
chronic
RfD
is
0.2
mg/
kg/
day
based
on
increased
mortality,
reduced
food
consumption,
and
clinical
toxicity
at
40
mg/
kg/
day
in
a
rabbit
developmental
study;
reduced
body
weight
gain
in
a
mouse
developmental
study
at
40
mg/
kg/
day;
and
reduced
food
consumption
in
a
rat
developmental
study
at
50
mg/
kg/
day.
An
uncertainty
factor
of
100
(
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability)
was
applied
to
the
NOAEL
to
obtain
the
acute
and
chronic
RfDs.

Incidental
Oral
The
short­
and
intermediate­
term
incidental
oral
NOAEL
is
20
mg/
kg/
day
from
the
rabbit,
mouse,
and
rat
developmental
toxicity
studies
that
noted
increased
mortality,
reduced
food
consumption,
clinical
toxicity,
and/
or
reduced
body
weight
gain.
The
target
margin
of
exposure
(
MOE)
is
100.

Short­,
Intermediate­,
and
Long­
term
Dermal
The
short­,
intermediate­,
and
long­
term
dermal
NOAEL
is
150
mg/
kg/
day,
which
is
based
on
decreased
body
weight
and
liver
tumors
identified
at
a
dose
of
750
mg/
kg/
day
in
an
80­
week
dermal
painting
study
in
mice.
The
uncertainty
factor
or
"
target"
MOE
for
PHMB
dermal
exposures
are
100
for
occupational
and
residential
scenarios.

Short­
and
Intermediate­
term
Inhalation
The
short­
and
intermediate­
term
inhalation
NOAEL
is
20
mg/
kg/
day
based
on
the
oral
endpoint.
In
the
absence
of
route­
specific
data,
it
was
conservatively
assumed
that
inhalation
absorption
is
equivalent
to
oral
absorption
(
i.
e.,
100%).
For
inhalation
exposures,
the
uncertainty
factor
is
100
for
occupational
and
residential
scenarios.
An
additional
10x
route­
to­
route
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.

Carcinogenicity
Classification
The
Agency
classified
PHMB
as
"
Suggestive
Evidence
of
Carcinogenicity,
but
not
sufficient
to
Assess
Human
Carcinogenic
Potential"
by
the
oral
and
dermal
routes.
Quantification
of
human
cancer
risk
is
not
required.
10
Mutagenicity
Potential
The
data
base
for
mutagenicity
is
considered
adequate
based
on
EPA's
mutagenic
guidelines
and
indicates
that
PHMB
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."
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disrupting
Screening
Program
(
EDSP)
have
been
developed,
PHMB
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

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
removed
(
i.
e.,
reduced
to
1X)
for
PHMB
based
on:
(
1)
a
lack
of
evidence
that
PHMB
will
induce
neurotoxic
effects,
(
2)
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
the
fetus
following
in
utero
exposure
in
the
prenatal
developmental
toxicity
studies,
and
(
3)
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
the
offspring
when
adults
are
exposed
in
the
two­
generation
reproductive
study.
The
FQPA
Safety
Factor
assumes
that
the
exposure
databases
(
food,
drinking
water,
and
residential)
are
complete
and
that
the
risk
assessment
does
not
underestimate
the
potential
risk
for
infants
and
children.
These
criteria
have
been
met
for
PHMB.
Based
on
the
analysis
of
submitted
developmental
toxicity
studies,
the
Agency
determined
that
no
special
FQPA
Safety
Factor
was
needed
since
there
were
no
residual
uncertainties
for
pre­
and/
or
postnatal
toxicity.

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
PHMB
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
(
0.2
mg/
kg/
day)
modified
by
the
FQPA
safety
factor.
The
acute
reference
dose
was
derived
from
a
developmental
toxicity
study
in
rabbits
in
which
both
the
NOAEL
(
20
mg/
kg/
day)
and
the
LOAEL
(
40
mg/
kg/
day)
were
determined.
Acute
dietary
exposure
was
estimated
only
for
females
ages
13­
50
because
available
studies
did
not
show
a
toxicity
endpoint
attributable
to
a
single
exposure
for
the
general
11
population.
The
PHMB
aPAD
is
0.2
mg/
kg/
day
based
on
a
reference
dose
of
0.2
mg/
kg/
day,
and
the
FQPA
safety
factor
of
1X.

b.
Chronic
PAD
Chronic
dietary
risk
for
PHMB
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
(
0.2
mg/
kg/
day)
modified
by
the
FQPA
safety
factor.
The
cPAD
was
derived
from
developmental
studies
in
rats,
rabbits,
and
mice,
in
which
both
the
NOAELs
(
20
mg/
kg/
day)
and
the
LOAELs
(
40
mg/
kg/
day
in
rats
and
rabbits
and
50
mg/
kg/
day
in
mice)
were
determined.
The
PHMB
cPAD
is
0.2
mg/
kg/
day
based
on
a
reference
dose
of
0.2
mg/
kg/
day,
which
incorporates
the
FQPA
safety
factor
(
1X)
for
the
overall
U.
S.
population
or
any
population
subgroups.

4.
Exposure
Assumptions
Acute
and
chronic
dietary
exposure
assessments
from
PHMB
use
as
a
disinfectant
on
indirect
food­
contact
surfaces
were
conducted
using
an
equation
that
considers
application
rates,
surface
area,
pesticide
migration
fraction,
and
body
weight.
This
approach
differs
from
the
FDA
approach.
However,
in
assessing
dietary
exposures
from
PHMB
in
latex
adhesives,
a
number
of
assumptions
were
made
based
on
the
FDA
guidelines
(
FDA,
2003b)
for
the
migration
level,
consumption
factor,
total
food
intake,
and
amount
of
packaging
required
for
food.
As
a
conservative
assumption,
it
is
assumed
that
latex
adhesive
represents
10%
of
the
packaging.
Also,
it
is
assumed
that
paper
used
in
food
packaging
weighs
50
mg/
in2.

5.
Dietary
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
4.
Based
on
a
review
of
product
labels
containing
PHMB,
four
uses
have
been
identified
as
having
the
potential
to
cause
indirect
dietary
exposure
due
to
indirect
food
contact:
1.
Tunnel
Pasteurization
2.
Disinfectant
on
Countertops
(
representative
of
food­
contact
hard
surfaces)
3.
Latex
Adhesives
on
Food
Packaging
4.
Disinfectant
Cloths
Although
tunnel
pasteurization
has
the
potential
for
causing
indirect
dietary
exposure
to
PHMB,
an
Estimated
Daily
Intake
(
EDI)
has
not
been
calculated
for
this
use
because
the
bottles
or
cans
are
already
sealed,
and
the
possibility
of
infiltration
of
this
product
from
tunnel
pasteurization
water
into
the
food
appears
to
be
minimal.

a.
Dietary
Risk
from
Food
A
screening­
level
acute
dietary
risk
assessment
was
conducted
for
three
of
the
four
PHMB
food
uses,
excluding
tunnel
pasteurization.
Acute
dietary
risk
estimates
are
provided
for
females
13­
49
years
old,
the
only
population
subgroup
for
which
an
endpoint
was
selected.
The
results
showed
risk
estimates
to
be
<
10%
of
the
aPAD
for
each
use
site
and
therefore
were
not
of
concern.
The
chronic
dietary
assessment
concluded
that
for
all
included
uses,
the
chronic
risk
12
estimates
are
below
the
Agency's
level
of
concern
for
the
general
U.
S.
population
(<
10%
of
the
cPAD)
and
all
population
subgroups
(<
40%
of
the
cPAD
for
children,
the
most
highly
exposed
subgroup).
Because
the
exposure
associated
with
latex
adhesives
is
several
orders
of
magnitude
less
than
the
exposure
associated
with
the
countertop
disinfectant
use,
the
combined
dietary
exposure
amounts
are,
for
all
practical
purposes,
the
same
as
the
exposure
to
the
countertop
disinfectant,
with
the
liquid
disinfectant
as
a
worst­
case
scenario.

Table
3.
Summary
of
Dietary
Exposure
and
Risk
for
PHMB
Acute
Dietary
Chronic
Dietary
Population
Subgroup
Dietary
Exposure
(
mg/
kg/
day)
a
%
aPAD
b
Dietary
Exposure
(
mg/
kg/
day)
a
%
cPAD
b
Liquid
Disinfectant
Adult
Male
0.016
­­
0.016
8
Adult
Female
0.018
9
0.018
9
Child
0.074
­­
0.074
37
Wipe
Disinfectant
Adult
Male
0.0045
­­
0.0045
2
Adult
Female
0.0053
3
0.0053
3
Child
0.021
­­
0.021
11
Latex
Adhesive
Adult
Male
7.4x10­
10
­­
7.4x10­
10
5.69x10­
7
Adult
Female
8.6x10­
10
4.3x10­
7
8.6x10­
10
6.62x10­
7
Child
3.4x10­
10
­­
3.4x10­
10
2.62x10­
6
a
acute
and
chronic
exposure
analysis
based
on
daily
consumption
associated
with
use
of
a
liquid
disinfectant
on
counter
tops
and
exposure
to
food
packages
using
treated
latex
adhesive.
b
%
PAD
=
dietary
exposure
(
mg/
kg/
day)
/
aPAD
or
cPAD,
where
aPAD=
0.2
mg/
kg/
day
(
for
adult
females
only)
and
cPAD=
0.2
mg/
kg/
day
(
for
all
populations)

b.
Dietary
Risk
from
Drinking
Water
None
of
the
uses
associated
with
PHMB
are
expected
to
impact
either
surface
or
ground
water
resources.
Therefore,
no
drinking
water
assessment
was
performed.

6.
Residential
Risk
Assessment
a.
Residential
Toxicity
The
toxicological
endpoints
and
associated
uncertainty
factors
used
for
assessing
the
nondietary
residential
risks
for
PHMB
are
listed
in
Table
4.
13
Table
4.
Residential
Toxicological
Endpoints
for
PHMB
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term
Incidental
Oral
(
1­
30
days)
NOAEL=
20
mg/
kg/
day
UF
=
100
Residential
LOC
for
MOE
=
100
Occupational
=
NA
Rabbit
Developmental
Study
(
MRID
42865901)
LOAEL
=
40
mg/
kg/
day
Based
on
the
increased
mortality,
reduced
food
consumption,
and
clinical
toxicity;

Mouse
Developmental
Study
(
Report
No.
CTL/
P/
335,
1977
(
cited
in
Report
No.
003810,
1978.
Section
C­
9))
LOAEL
=
40
mg/
kg/
day;
Based
on
reduced
body
weight
gain;
and
Rat
Developmental
Study
(
Report
No.
CTL/
P/
1262,
1976
(
cited
in
Report
No.
003810,
1978.
Section
C­
11))
LOAEL
=
50
mg/
kg/
day
Based
on
reduced
food
consumption.

Intermediate­
Term
Incidental
Oral
(
1­
6
months)
NOAEL=
20
mg/
kg/
day
UF
=
100
Residential
LOC
for
MOE
=
100
Occupational
=
NA
See
Short­
Term
Incidental
Oral
Endpoint
Short­
Term,
Intermediate­
Term,
and
Long­
Term
Dermal
Exposure
Dermal
(
or
oral)
study
NOAEL=
150
mg/
kg/
day
UF
=
100
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
100
80­
Week
Dermal
Painting
Study
(
MRIDs
00066475
and
00104796)
LOAEL
=
750
mg/
kg/
day
based
on
decreased
body
weight
and
liver
tumors.

Short­
Term
and
Intermediate­
Term
Inhalation
Exposure
No
appropriate
route­
specific
study
was
available.
The
oral
endpoint
of
20
mg/
kg
with
a
Margin
of
Exposure
of
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
is
used.
An
additional
10x
route­
to­
route
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.

Cancer
(
Oral,
dermal,
inhalation)
The
HED
Cancer
Assessment
Review
Committee
(
CARC)
classified
PHMB
as
"
Suggestive
Evidence
of
Carcinogenicity,
but
not
sufficient
to
Assess
Human
Carcinogenic
Potential"
by
the
oral
and
dermal
routes.
Quantification
of
human
cancer
risk
is
not
required.

Notes:
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
LOC
=
level
of
concern,
MOE
=
margin
of
exposure
b.
Residential
Handlers
i.
Exposure
Assessment
Based
on
the
use
patterns
of
PHMB,
EPA
has
identified
the
four
major
exposure
scenarios
for
residential
handlers
including:
°
Open
pouring
for
swimming
pools/
spas;
°
Spraying
(
aerosol
and/
or
trigger
pump
sprays)
disinfectants;
°
Mopping
with
disinfectants;
and
14
°
Wiping
with
disinfectants.

Using
surrogate
unit
exposure
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Chemical
Manufacturers
Association
(
CMA)
database,
maximum
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
to
residential
handlers
were
assessed.
PHMB
is
assessed
using
a
typical
residential
swimming
pool
capacity
of
20,000
gallons.
For
mopping,
it
is
assumed
that
a
1­
gallon
bucket
of
solution
is
used
by
a
homeowner
to
mop
the
floor.

ii.
Risk
Assessment
All
of
the
inhalation
and
dermal
MOEs
for
residential
handlers
are
above
the
target
MOE
of
100
and,
therefore,
not
of
concern.
In
addition,
the
inhalation
MOEs
for
each
use
are
above
the
MOE
of
1,000,
when
the
additional
route­
to­
route
extrapolation
uncertainty
factor
is
applied.
An
inhalation
study
is
not
being
required
for
the
residential
uses
at
this
time.
The
MOEs
for
handlers
are
summarized
in
Tables
5.

Table
5.
Residential
Handler
Risk
Summary
Exposure
Scenario
Use
site
Label
Application
Rate
(
lb
a.
i./
day)
Baseline
Dermal
MOE
Baseline
Inhalation
MOE
Open
Pouring
Residential
Pool
2.2
35,000
180,000
Spraying
Household
Premises
(
hard
surfaces)
0.006
8,000
180,000
Mopping
Household
Floors
(
hard
surfaces)
0.023
6,400
26,000
Wiping
Household
Premises
(
hard
surfaces)
0.006
610
3,400
c.
Residential
Post­
Application
i.
Exposure
Assessment
Based
on
the
use
patterns,
EPA
has
identified
residential
post­
application
exposure
scenarios
for
the
swimming
pool/
spa
use
along
with
the
hard
surface
cleaners.
The
exposure
scenarios
(
and
assumptions
used
in
the
assessment)
that
are
considered
representative
of
the
high­
end
exposures
associated
with
PHMB
include:

°
Dermal
exposure
and
ingestion
of
PHMB
via
swimming
in
treated
pools
for
adults
and
children,
both
competitive
and
non­
competitive.
The
SWIMODEL
3.0
default
values
and
chemical­
specific
values
(
MRIDs
44051301
and
44046301)
were
used
in
the
calculations
for
the
assessment.
Exposure
time
for
non­
competitive
swimmers
is
based
on
data
provided
in
EPA's
Exposure
Factors
Handbook
(
1997)
whereas
competitive
swimmer
exposure
time
data
are
based
on
the
Agency's
review
of
the
American
Chemistry
Council
(
ACC)
study
"
An
Analysis
of
the
Training
Patterns
and
Practices
of
Competitive
Swimmers"
(
ACC,
2002).

°
Dermal
contact
and
incidental
ingestion
(
i.
e.,
hand­
to­
mouth
residue
transfer)
resulting
15
from
toddlers
crawling
on
treated
floors
after
mopping.
While
other
hard
surfaces
may
be
treated
(
e.
g.,
wiping
counter
tops/
sinks),
it
is
believed
that
the
floor
represents
the
high
end
exposure
scenario
for
children's
contact.
Residential
SOP
assumptions
are
used
for
this
assessment.
Toddlers
(
3
years
old)
are
used
to
represent
the
1
to
6
year
old
age
group
and
are
assumed
to
weigh
15
kg,
the
median
for
male
and
female
toddlers
(
USEPA,
2000b).
A
body
surface
area
of
0.657
m2
has
been
assumed,
which
is
the
median
value.
It
was
also
assumed
that
the
diluted
treatment
solution
is
applied
at
a
rate
of
1000
sq.
ft.
per
gallon,
as
this
was
not
provided
on
the
label.
As
a
conservative
measure,
it
has
been
assumed
that
25%
of
the
mop
solution
remains
after
the
final
mop.
The
Residential
SOPs
estimate
of
10%
of
the
amount
on
the
floor/
hard
surface
available
for
dermal
transfer
is
used.

ii.
Risk
Assessment
The
residential
post­
application
risk
assessment
identifies
short­
term
(
1­
30
days)
and
intermediate­
term
(
1­
6
month)
exposure
doses
based
on
the
reported
toxicology
endpoints
for
PHMB.
Because
of
the
shorter
exposure
durations
of
these
toxicological
endpoints,
conservative
event­
based
exposure
assumptions
are
used
to
calculate
upper
bound
daily
dose
estimates.
Doses
are
not
amortized
over
a
lifetime.
Additionally,
since
the
permeability
constant
provides
estimates
of
an
internal
dose
from
the
dermal
route
of
exposure,
the
oral
toxicity
endpoint
rather
than
the
dermal
toxicity
endpoint
is
used
to
assess
the
risks
from
the
dermal
swimming
route.

Table
6
presents
the
estimated
doses
from
the
dermal
and
ingestion
routes
of
exposure
and
the
corresponding
MOEs
based
on
the
oral
endpoint
for
the
swimming
scenarios
for
each
age
group.
The
calculated
results
for
short­,
intermediate­,
and
long­
term
exposures
and
risks
indicate
that
the
risks
from
the
dermal
and
ingestion
routes
of
exposure
are
not
of
concern
(
MOE>
100)
for
the
post­
application
scenarios
developed
in
this
assessment.

Table
6.
Residential
Post­
Application
Risk
Summary
Use
Type
Scenario
Description
Dermal
Dose
(
mg/
kg/
day)
Incidental
Ingestion
Dose
(
mg/
kg/
day)
Dermal
MOEa
Inhalation
MOEa
Adult
Competitive
4.06E­
5
0.0056
490,000
3600
Adult
Non­
Competitive
6.76E­
5
0.019
300,000
1100
Child
(
7­
10
yrs)
Competitive
1.80E­
5
0.017
1,100,000
1200
Child
(
7­
10
yrs)
Non­
Competitive
9.01E­
5
0.087
220,000
230
Child
(
11­
14
yrs)
Competitive
3.08E­
5
0.011
650,000
1800
Swimming
Pool
Child
(
11­
14
yrs)
Non­
Competitive
4.62E­
5
0.033
430,000
620
Floors
Child,
Short­
Term
Duration
150
0.031
600
660
Floors
Child,
Intermediate­
Term
Duration
150
0.014
600
1,400
aMOE
=
NOAEL
(
mg/
kg/
day)/
Dose
(
mg/
kg/
day).
The
same
oral
NOAEL
is
used
for
dermal
and
ingestion
risks.
Target
MOE
=
100;
NA
=
Not
Applicable
16
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.

In
the
case
of
PHMB,
a
cancer
aggregate
assessment
is
not
needed,
as
the
chemical
has
been
classified
by
the
Agency's
Cancer
Assessment
Review
Committee
as
having
"
Suggestive
Evidence
of
Carcinogenicity,
but
Not
Sufficient
to
Assess
Human
Carcinogenic
Potential."
For
the
non­
cancer
aggregate
assessment,
there
is
no
need
for
an
acute
and
chronic
dietary
aggregate
assessment,
as
the
uses
of
PHMB
have
been
determined
to
have
no
impact
on
surface
or
ground
water
and
the
dietary
risk
calculations
estimated
will
characterize
the
total
dietary
risk
of
PHMB.
In
the
case
of
short­,
intermediate­,
and
long­
term
aggregate
assessments,
the
following
exposure
scenarios
were
aggregated
for
adults
exposed
to
PHMB:
dietary
exposure,
dermal
and
inhalation
exposure
from
liquid
pouring
of
PHMB
swimming
pool
product,
and
dermal
and
incidental
oral
exposure
from
swimming.
Aggregate
exposures
for
children
and
toddlers
included
food
exposure
and
dermal
and
incidental
oral
exposure
from
swimming.
Cleaning
activities
were
not
included
in
the
aggregate
assessment
as
these
activities
were
not
felt
to
reasonably
occur
together
with
the
other
exposure
scenarios.
As
about
95%
of
PHMB
is
used
in
swimming
pool
products,
it
is
unlikely
that
residential
users
will
be
using
PHMB
both
to
sanitize
their
swimming
pools
and
clean
their
homes.

a.
Short­
and
Intermediate­
Term
Aggregate
Risk
The
Agency
has
concluded
that,
although
an
oral
toxicity
study
was
selected
for
dietary,
inhalation,
and
incidental
oral
risk
assessments
and
a
dermal
toxicity
study
was
selected
for
dermal
risk
assessments,
the
non­
cancer
effects
occurring
by
the
oral
and
dermal
routes
were
similar
and
that
these
exposures
should
be
aggregated.
The
report
describing
this
decision
can
be
found
in
OPP­
2004­
0305
at
http://
www.
epa.
gov/
edockets.
Inhalation
exposures
are
currently
included
in
the
aggregate
assessment
based
on
the
use
of
the
oral
endpoint.
Aggregate
MOE
calculations
for
adults
and
children
were
performed
using
the
Aggregate
Risk
Index
method
(
USEPA,
2001a).
As
shown
in
Table
7,
no
aggregate
risks
of
concern
were
identified
for
either
adults
or
children.
17
Table
7.
Short­
and
Intermediate­
Term
Aggregate
Risks
Population
Subgroup
Chronic
Food
Exp
mg/
kg/
day/

(
MOE)
ST/
IT
Incidental
Oral
Swimming
Exposure
(
mg/
kg/
day)

(
MOE)
ST/
IT
Dermal
Swimming
Exposure
(
mg/
kg/
day)

(
MOE)
Liquid
Pouring
Dermal
Exposure
(
mg/
kg/
day)

(
MOE)
Liquid
Pouring
Inhalation
Exposure
(
mg/
kg/
day)

(
MOE)
Aggregate
Risk
Index
0.0056
(
comp.)

(
3600)
0.000044
(
comp.)

(
450000)
9.0
Males
0.016/

(
1250)
0.019
(
non­
comp.)

(
1100)
0.000015
(
non­
comp.)

(
1,300000)
0.00424
(
35,000)
0.000113
(
180,000)
5.7
0.0056
(
comp.)

(
3600)
0.000044
(
comp.)

(
450000)
8.2
Females
13­

50
years
0.018/

(
1111)
0.019
(
non­
comp.)

(
1100)
0.000015
(
non­
comp.)

(
1,300000)
0.00491
(
31,000)
0.000131
(
153,000)
5.4
0.017
(
comp.)

(
1200)
0.000018
(
comp.)

(
1,100,000)
2.2
Children
7­

10
years
0.074/

(
270)
0.087
(
non­
comp.)

(
230)
0.00009
(
non­
comp.)

(
220000)
N/
A
N/
A
1.2
0.011
(
comp.)

(
1800)
0.00003
(
comp.)

(
650000)
2.3
Children
11­

14
years
0.074
(
270)
0.033
(
non­
comp.)

(
620)
0.000046
(
non­
comp.)

(
430000)
N/
A
N/
A
1.9
MOE
=
NOEL
(
mg/
kg/
day)/
Dose(
mg/
kg/
day).
Oral
NOAEL
is
20
mg/
kg/
day
for
short­
and
intermediate­
term.
Dermal
NOAEL
is
150
mg/
kg/
day
for
short­
and
intermediateterm
Inhalation
NOAEL
is
20
mg/
kg/
day
for
short­
term.
The
target
Margins
of
Exposure
for
all
exposures
are
100.

Aggregation
was
performed
using
the
Aggregate
Risk
Index
method.
ARI
=
1/
((
UF1/
MOE1)
+
(
UF2/
MOE2)
+
(
UF3/
MOE3)
+
 ).
ARIs
greater
than
1
are
not
of
concern.
18
b.
Chronic
Aggregate
Risk
A
long­
term
aggregate
risk
assessment
was
not
performed
in
this
assessment.
None
of
the
residential
exposure
scenarios
are
considered
to
be
long­
term
and
were,
therefore,
not
aggregated
with
the
chronic
dietary
exposure.

8.
Occupational
Risk
Workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
pesticide,
or
re­
entering
treated
sites
(
post­
application
exposure).
Occupational
handlers
of
PHMB
include
workers
pouring
or
pumping
PHMB
preservatives
into
vats
or
tanks
for
several
uses
(
materials
preservatives,
tunnel
pasteurization,
and
industrial
processes
and
water
systems);
pouring
PHMB
products
into
swimming
pools
and
spas;
and
spraying,
wiping,
and
moping
PHMB
disinfectants
on
medical
premises
and
equipment.
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
PHMB,
MOEs
greater
than
100
are
not
of
concern
to
the
Agency.
This
MOE
includes
the
standard
safety
factors
of
10X
for
intraspecies
variability
(
i.
e.
differences
among
humans)
and
10X
for
interspecies
variability
(
differences
between
humans
and
animals).
An
additional
10x
route­
to­
route
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.
At
this
time,
EPA
does
not
foresee
postapplication
exposures
for
the
occupational
uses
of
PHMB.

Occupational
risk
is
assessed
for
exposure
at
the
time
of
application
(
termed
"
handler"
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
risks
were
assessed
for
exposures
from
pouring
liquid
formulations,
as
well
as
spraying,
wiping,
and
mopping
applications.

For
more
information
on
the
assumptions
and
calculations
of
potential
risk
of
PHMB
to
workers,
see
the
Occupational
Exposure
Assessment
(
Section
7.0)
in
the
"
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
February
14,
2005
and
the
"
PHMB
Occupational/
Residential
Exposure
Assessment,"
dated
February
3,
2005.
19
a.
Occupational
Toxicity
The
toxicological
endpoints
used
in
the
assessment
can
be
found
in
Table
8
below.

Table
8.
Occupational
Toxicological
Endpoints
for
PHMB
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term,
Intermediate­
Term,
and
Long­
Term
Dermal
Exposure
Dermal
(
or
oral)
study
NOAEL=
150
mg/
kg/
day
UF
=
100
Residential
LOC
for
MOE
=
100
Occupational
LOC
for
MOE
=
100
80­
Week
Dermal
Painting
Study
(
MRIDs
00066475
and
00104796)
LOAEL
=
750
mg/
kg/
day
based
on
decreased
body
weight
and
liver
tumors.

Short­
Term
and
Intermediate­
Term
Inhalation
Exposure
No
appropriate
route­
specific
study
was
available.
The
oral
endpoint
of
20
mg/
kg
with
a
Margin
of
Exposure
of
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
is
used.
An
additional
10x
route­
to­
route
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.

Cancer
(
Oral,
dermal,
inhalation)
The
HED
Cancer
Assessment
Review
Committee
(
CARC)
classified
PHMB
as
"
Suggestive
Evidence
of
Carcinogenicity,
but
not
sufficient
to
Assess
Human
Carcinogenic
Potential"
by
the
oral
and
dermal
routes.
Quantification
of
human
cancer
risk
is
not
required.

Notes:
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
LOC
=
level
of
concern,
MOE
=
margin
of
exposure
b.
Occupational
Handler
Exposure
Inhalation
and
dermal
exposures
to
PHMB
were
addressed
for
occupational
populations
using
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
(
USEPA,
1997c),
the
Chemical
Manufacturers
Association
(
MRID
42587501),
and
several
studies
which
relate
to
the
use
patterns
of
PHMB.
Using
surrogate
dermal
and
inhalation
unit
exposure
data,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
and
risks
to
handlers
were
assessed.
A
description
of
the
surrogate
data
and
calculations
used
are
included
in
the
Occupational
Exposure
Assessment
(
Section
7.0)
in
the
"
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
February
14,
2005
and
the
"
PHMB
Occupational/
Residential
Exposure
Assessment,"
dated
February
3,
2005.

The
Agency
has
determined
that
there
are
potential
exposures
to
individuals
who
mix,
load,
apply,
and
otherwise
handle
PHMB
during
the
usual
use
patterns
associated
with
the
pesticide's
use.
Based
on
the
use
patterns,
the
exposure
scenarios
in
Table
9
were
assessed.
20
Table
9.
PHMB
Handler
Scenarios
Category
Scenario
Material
Preservatives
Pouring
PHMB
industrial
preservative
into
vats
or
tanks
of
slurry
containing
leather
processing
fluids,
silicones,
adhesives,
mineral
slurries,
textiles,
etc.

Food
Handling/
Storage
Establishments
Premises
and
Equipment
Pouring
PHMB
preservative
into
vats
or
tanks
for
tunnel
pasteurization.

Industrial
Processes
and
Water
Systems
Pouring
or
pumping
PHMB
preservative
into
vats
or
tanks
for
preservation
of
oil
well
injection
fluids,
mud
packer
solutions,
and
workover
solutions.

Swimming
Pools
Pouring
PHMB
preservatives
into
pools
or
spas
by
commercial
treaters.

Medical
Premises
and
Equipment
PHMB
is
used
in
a
spray,
wipe
and
mop
to
sterilize
surfaces
as
a
hospital
cleaner
disinfectant
and
medical
equipment.
Disinfectants
are
applied
by
spray,
mopping
and
wiping.

c.
Occupational
Handler
Risk
Summary
The
occupational
handler
risk
assessment
included
both
inhalation
and
dermal
exposures.
The
target
MOE
for
both
is
100.
Scenarios
with
an
MOE
less
than
100
indicate
a
risk
of
concern.
After
performing
the
exposure
assessment,
EPA
determined
that
the
greatest
potential
for
exposure
appears
to
be
the
inhalation
and
dermal
occupational
scenarios
involving
pour
liquid
for
drilling
muds
and
workover
fluids,
based
on
application
rates
of
1,052
lbs.
of
active
ingredient
per
day
(
dermal
MOE
=
74
and
inhalation
MOE
=
370,
target
MOEs
of
100).
In
order
to
achieve
MOEs
above
the
target
level
(
i.
e.,
greater
than
100),
scenarios
involving
drilling
muds
and
workover
fluids
must
use
mitigation
measures
such
as
metering
pump
systems.
Calculated
MOEs
using
the
pump
liquid
scenario
(
i.
e.,
dermal
MOE=
1,600
and
inhalation
MOE
3,300)
are
greater
than
the
target
MOE.
As
the
mitigation
measure
brings
the
inhalation
MOE
above
1,000
(
which
includes
the
additional
10x
route­
to­
route
extrapolation),
no
confirmatory
inhalation
toxicity
study
is
needed.

Dermal
and
inhalation
MOEs
for
the
commercial
exposure
scenarios
involving
commercial
pool
operators
pouring
PHMB
liquid
into
multiple
residential
swimming
pools
and
spas
are
greater
than
the
target
MOE
and,
therefore,
are
not
of
concern.
The
commercial
handlers
for
the
medical
premises
uses
did
not
trigger
risks
of
concern
for
the
spray/
mop/
wipe
applications.

9.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
the
National
Poison
Control
Centers
(
PCC),
the
Agency's
Office
of
Pesticide
Program's
Incident
Data
System
(
IDS),
California
Department
of
Pesticide
Regulation,
and
the
National
Pesticide
Telecommunications
Network
(
NPTN).
Incident
reports
were
only
found
in
IDS
and
PCC.
Those
found
in
PCC
were
also
in
IDS.
Therefore,
all
incidents
are
reported
as
found
in
IDS.

A
total
of
118
individual
incident
cases
submitted
to
the
EPA
Office
of
Pesticide
Programs
involving
use
of
PHMB­
containing
swimming
pool
products
were
reviewed
to
determine
the
effects
of
exposure
to
PHMB.
All
of
the
incident
reports
reviewed
were
for
residential
use
of
the
products
by
consumers.
In
17
(
14%)
out
of
the
118
individual
incident
21
cases
reviewed,
it
was
determined
that
the
exposure
effects
were
the
result
of
not
using
the
product
as
intended
by
the
manufacturer.
They
included
not
following
the
instructions
on
the
label,
accidental
ingestion
of
the
product,
or
splashing
the
concentrated
product
onto
the
skin
or
into
the
eyes.

The
reported
routes
for
exposure
of
the
118
incident
cases
were
dermal
(
58%),
ocular
(
30%),
ingestion
(
9%),
inhalation
(
7%),
and
unknown
(<
1%).
In
some
cases
more
than
one
route
of
exposure
applied
for
an
individual
incident
case
(
e.
g.,
both
dermal
and
ocular
exposure).
The
most
common
symptoms
reported
for
each
exposure
route
are
as
follows:
°
Dermal
exposure:
skin
irritation/
burning,
rash,
hives/
welts,
itching,
skin
discoloration/
redness,
allergic
reaction,
and
blistering
°
Ocular
exposure:
eye
irritation/
burning,
eye
pain,
loss
of
vision,
swelling
of
eyes,
and
allergic
reactions.
°
Ingestion/
oral
exposure:
vomiting/
nausea/
abdominal
pain,
irritation
to
the
mouth/
throat,
respiratory
irritation
including
coughing/
choking,
and
diarrhea
°
Inhalation
exposure:
respiratory
irritation
and
coughing/
choking
B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
is
presented
below.
PHMB
has
several
registered
use
sites:
swimming
pools,
cut
flowers,
materials
preservatives,
industrial
processes
and
water
systems,
and
hard
surfaces.
The
following
risk
characterization
is
intended
to
describe
the
magnitude
of
the
estimated
environmental
risks
for
PHMB
use
sites
and
any
associated
uncertainties.

For
detailed
discussions
of
all
aspects
of
the
environmental
risk
assessment,
see
the
Environmental
Risk
Assessment
(
Section
8.0)
in
the
"
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
February
14,
2005,
the
"
Environmental
Fate
Assessment
of
PHMB
for
the
Reregistration
Eligibility
Decision
(
RED),"
dated
August
18,
2004,
and
the
"
Ecological
Hazard
and
Environmental
Risk
Assessment:
Poly(
hexamethlenebiguanide)
hydrochloride
(
PHMB),"
dated
August
4,
2004.

1.
Environmental
Fate
and
Transport
PHMB
is
stable
hydrolytically
in
the
environment
and
has
a
half­
life
of
more
than
thirty
days.
This
may
be
of
environmental
concern
for
surface
water
contamination,
in
the
event
of
exposure
to
surface
water.
Studies
for
other
fate
processes
are
not
required
by
and
have
not
been
submitted
to
the
Agency.

2.
Ecological
Risk
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
estimated
environmental
concentrations
based
on
environmental
fate
characteristics
and
pesticide
use
data.
22
a.
Toxicity
(
Hazard)
Assessment
PHMB
demonstrates
low
toxicity
to
birds
and
mammals
and
high
toxicity
to
freshwater
aquatic
organisms.
All
submitted
ecological
toxicity
studies
were
conducted
with
a
20%
a.
i.
solution
of
PHMB,
which
is
the
technical
formulation,
and
values
were
adjusted
to
100%
a.
i.
to
classify
the
studies
according
to
relative
toxicity.
Submission
of
data
regarding
toxicity
to
marine/
estuarine
organisms,
plants,
or
chronic
effects
was
not
required
for
the
indoor
uses
of
PHMB.
Limited
additional
data
was
found
using
EPA's
ECOTOX
database.
A
summary
of
submitted
data
is
provided
in
the
table
below.

Table
10.
Summary
of
Submitted
Acute
Ecological
Effects
Toxicity
Data
for
PHMB
Species
LD50/
LC50
NOAEL/
NOAEC
Toxicity
category
(
based
on
100%
AI)

Birds
Northern
bobwhite
(
Colinus
virginianus)
LC50
>
5620
(>
1124
ppm
ai)
NOEC
5620
ppm
(
1124
ppm
ai)
Slightly
toxic
Mallard
duck
(
Anas
platyrhynchos)
LC50
>
5620
(>
1124
ppm
ai)
NOEC
5620
(
1124
ppm
ai)
Slightly
toxic
Mallard
(
Anas
platyrhynchos)
LD50
>
2510
(>
502
mg
ai/
kg)
NOEL
=
2510
(
502
mg
ai/
kg)
Slightly
toxic
Mammals
Laboratory
rat
(
Rattus
norvegicus)
LD50
=
2747
mg/
kg
N/
A
Freshwater
Fish
Rainbow
trout
(
Oncorhynchus
mykiss)
96­
hr.
LC50
=
0.02545
ppm
ai
NOEC
=
0.0098
ppm
ai
Very
highly
toxic
Bluegill
sunfish
(
Lepomis
macrochirus)
96­
hr.
LC50
=
0.57
(
0.114
ppm
ai);
NOEC
=
0.17
(
0.034
ppm
ai)
Highly
toxic
Freshwater
Invertebrate
Waterflea
(
Daphnia
magna)
48­
hr.
EC50
=
0.18(
0.12
­
0.30)
(
0.036
ppm
ai)
NOEC
=
0.7
(
0.14
ppm
ai)
Highly
toxic
N/
A
=
not
available
NOAEC=
No­
observable
adverse
effect
concentration
b.
Exposure
and
Risk
Environmental
exposure
modeling
was
not
conducted
for
PHMB.
The
only
use
pattern
likely
to
result
in
significant
outdoor
exposure
is
the
oil
recovery
use;
however,
there
is
a
label
statement
prohibiting
use
over
or
near
marine/
estuarine
(
e.
g.,
offshore)
oil
fields.
The
uses
of
23
PHMB
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur.
Facilities
using
PHMB
for
indoor
industrial
applications
are
required
to
have
NPDES
permits
before
discharging
effluents
into
receiving
waters.

c.
Risk
to
Listed
Species
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
PHMB,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and,
therefore,
makes
a
"
No
Effect"
determination
for
this
chemical.
24
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
PHMB
as
an
active
ingredient.
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
PHMB.

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
ingredient
PHMB.
Based
on
a
review
of
these
data
and
on
public
comments
on
the
Agency's
assessments
for
the
active
ingredient
PHMB,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
PHMB
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
PHMB­
containing
products
are
eligible
for
reregistration
provided
that:
(
i)
current
data
gaps
and
confirmatory
data
needs
are
addressed;
(
ii)
the
risk
mitigation
measure
outlined
in
this
document
is
adopted;
and
(
iii)
label
amendments
are
made
to
reflect
this
measure.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
PHMB
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
PHMB
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
PHMB,
the
Agency
has
determined
that
PHMB
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA.
Accordingly,
should
a
registrant
fail
to
implement
the
risk
mitigation
measure
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
the
use
of
PHMB.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
PHMB
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
decision
for
PHMB.
During
the
public
comment
period
on
the
risk
assessments,
which
closed
on
September
27,
2004,
the
Agency
received
numerous
comments
that
addressed
human
health
and
ecological
concerns
from
one
of
the
technical
registrants
(
Arch
Chemicals,
Inc.);
state
and
local
regulatory
agencies
(
California
Regional
Water
Quality
Control
Board
and
San
Francisco
Department
of
the
Environment);
an
environmental
group
(
Natural
Resources
Defense
Council
[
NRDC]);
water
advocacy
groups
(
Sanitation
Districts
of
Los
Angeles
County
and
California
Stormwater
Quality
Association);
and
one
private
citizen.
Comments
were
received
on
the
following
topics:
25
°
Toxicology
and
Mode
of
Action
of
PHMB
and
Endpoints
Chosen;
°
Ecological
Risks
of
PHMB;
°
Exposure
to
PHMB;
°
Occupational
and
Residential
Exposure
to
and
Risk
from
PHMB;
°
Dietary
Exposure
and
Risk
Assessment;
°
Efficacy
of
PHMB
as
a
Swimming
Pool
Sanitizer;
and
°
Abbreviated
Length
of
Public
Comment
Period.

These
comments
have
been
addressed
and
the
assessments
refined,
as
appropriate,
by
the
Agency.
Response
to
Comments
documents
addressing
these
comments,
and
those
received
by
the
registrants
during
Phase
I
of
the
RED
process,
are
available
in
the
public
docket
at
http://
www.
epa.
gov/
edockets
(
OPP­
2004­
0305).

Comments
that
were
received
comments
from
the
California
Regional
Water
Quality
Control
Board,
San
Francisco
Department
of
the
Environment,
Sanitation
Districts
of
Los
Angeles
County,
and
California
Stormwater
Quality
Association
on
the
possible
release
of
PHMB
to
surface
waters
are
being
addressed
in
the
RED
as
follows:

Comment:
Two
governmental
and
two
advocacy
groups
submitted
comments
in
late
September
2004
stating
the
following
(
exact
language
differed
slightly
among
comments):
Despite
uses
that
will
inevitably
discharge
PHMB
to
surface
waters,
the
U.
S.
EPA
re­
registration
risk
assessment
does
not
estimate
surface
water
concentrations.
U.
S.
EPA
incorrectly
assumes
that
environmental
exposure
to
PHMB
will
not
occur.
Whether
discharged
to
a
storm
drain
or
a
wastewater
treatment
plant,
PHMB
will
flow
to
surface
water.
It
provides
no
chronic
toxicity
data
for
aquatic
organisms
and
presents
no
estimates
of
PHMB's
environmental
fate.
The
risk
assessment
provides
no
scientific
basis
for
evaluating
PHMB
risks
to
aquatic
organisms.
These
risks
must
be
assessed
prior
to
reregistration.

Response:
For
certain
use
categories,
such
as
indoor
sanitizers
or
contained
outdoor
uses,
such
as
swimming
pools,
the
environmental
exposure
will
be
limited
in
most
cases,
due
either
to
treatment
of
wastewaters
discharged
through
municipal
sewers
and/
or
Federal
or
Local
restrictions
on
how
wastewaters
are
to
be
handled.
For
such
uses,
environmental
modeling
is
not
currently
performed,
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
currently
undergo
a
full
screening­
level
risk
assessment
and
are
considered
to
fall
under
a
"
no
effect"
determination.
The
indoor
uses
of
PHMB,
as
well
as
the
swimming
pool
use,
fall
into
this
category.

While
unauthorized
discharges
into
storm
sewers,
into
surrounding
waters,
or
onto
the
ground
could
occur,
this
would
be
considered
a
misuse
of
the
pesticide.
Illegal
uses,
or
"
misuses,"
of
pesticides
are
not
considered
in
Office
of
Pesticide
26
Program
risk
assessments;
the
assessments
are
based
on
the
correct,
labeled
use
of
the
pesticide
products.
In
addition,
AD
recognizes
the
possibility
of
some
of
these
pesticides
entering
into
US
waterways,
which
may
pose
exposure
and
hazard
concerns.
We
are
in
the
process
of
developing
and
validating
various
modeling
programs,
which
will
help
us
to
ascertain
that
pesticides
entering
into
U.
S.
water
ways,
as
well
as
into
the
municipal
waste
treatment
plants,
are
not
at
levels
of
concern.

As
stated
in
the
40CFR
§
158,
the
Agency
requires
a
standard
set
of
environmental
fate
and
aquatic
toxicity
studies
to
be
submitted
for
indoor
uses,
including
hydrolysis,
acute
avian
oral
toxicity,
acute
freshwater
fish
toxicity,
and
acute
freshwater
invertebrate
toxicity.
These
data
requirements
have
been
fulfilled
for
PHMB,
and
the
database
is
considered
adequate
for
the
purposes
of
this
risk
assessment.

Due
to
the
abbreviated
nature
of
the
comment
period
held
on
the
risk
assessments
in
2004,
the
Agency
is
providing
a
60­
day
public
comment
period
on
this
RED.
While
all
comments
are
welcome,
those
with
specific
data
or
information
bearing
on
the
risk
assessments
are
most
useful.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
PHMB.
The
Agency
has
concluded
that
the
risk
from
dietary
exposure
is
within
the
"
risk
cup."
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
residential
uses.
Dietary
exposure
from
drinking
water
was
not
assessed,
as
the
uses
of
PHMB
have
been
determined
to
have
no
impact
on
surface
or
ground
water.
The
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
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
and
residential
uses.

b.
Determination
of
Safety
to
U.
S.
Population
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
PHMB.
The
Agency
has
determined
that
food
uses
of
PHMB,
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
use
of
PHMB.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
PHMB.

Dietary
risk
assessments
were
conducted
for
adults
and
children,
with
the
highest
risk
(
9%
aPAD
for
adult
females
and
37%
cPAD
for
children)
being
below
the
Agency's
level
of
concern.
Aggregate
assessments
from
dietary
and
residential
exposures
were
also
conducted.
27
The
Aggregate
Risk
Index
was
1.2
for
children
ages
7­
10
years,
the
subpopulation
with
the
greatest
risk,
which
is
above
the
Agency's
level
of
concern
(
ARI 
1).

c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
currently
registered
uses
of
PHMB,
with
changes
as
specified
in
this
document,
meet
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
susceptibility
to
the
toxic
effects
of
PHMB
residues
in
this
population
subgroup.

No
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
PHMB
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
removed
(
i.
e.,
reduced
to
1X)
for
PHMB
based
on:
(
1)
there
is
no
concern
for
developmental
neurotoxicity
resulting
from
exposure
to
PHMB
because
there
is
no
evidence
PHMB
will
induce
neurotoxic
effects;
(
2)
there
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
the
fetus
following
in
utero
exposure
in
the
prenatal
developmental
toxicity
studies
or
to
the
offspring
when
adults
are
exposed
in
the
twogeneration
reproductive
study;
and
(
3)
the
risk
assessment
does
not
underestimate
the
potential
exposure
for
infants
and
children.

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).

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EDSP
have
been
developed,
PHMB
may
be
subject
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
28
e.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
PHMB.
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
PHMB.
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
There
are
no
tolerances
or
exemptions
from
the
requirement
of
a
tolerance
established
for
residues
of
PHMB.

D.
Regulatory
Rationale
The
Agency
has
determined
that
PHMB
is
eligible
for
reregistration
provided
that
additional
required
data
confirm
this
decision,
the
risk
mitigation
measure
outlined
in
this
document
are
adopted,
and
label
amendments
are
made
to
reflect
this
measure.

The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
PHMB.
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
The
acute
and
chronic
dietary
risks
from
PHMB
residues
on
food,
estimated
using
conservative
measures,
are
below
the
Agency's
level
of
concern.
Therefore,
no
mitigation
measures
are
necessary
at
this
time.

b.
Drinking
Water
Risk
Mitigation
As
none
of
the
uses
associated
with
PHMB
are
expected
to
impact
either
surface
or
ground
water
resources,
no
drinking
water
mitigation
measures
are
necessary
at
this
time.
29
c.
Residential
Risk
Mitigation
i.
Handler
Risk
Mitigation
Residential
handler
risks
were
considered
for
pouring
PHMB
into
a
single
swimming
pool,
spraying
an
all­
purpose
cleaner,
mopping
floors
with
an
all­
purpose
cleaner,
and
wiping
hard
surfaces
with
an
all­
purpose
cleaner.
No
mitigation
measures
are
needed
at
this
time
for
these
uses,
as
none
present
a
risk
of
concern.

ii.
Post­
Application
Risk
Mitigation
High­
end
exposures
were
assessed
for
residential
exposure
after
application
of
PHMB
products
in
swimming
pools
and
spas,
as
well
as
on
hard
surfaces.
All
risks
were
below
the
Agency's
level
of
concern,
and
no
mitigation
measures
are
presently
required.

d.
Occupational
Risk
Mitigation
i.
Handler
Risk
Mitigation
EPA
determined
that
the
greatest
potential
for
exposure
appears
to
be
the
inhalation
and
dermal
occupational
scenarios
involving
pour
liquid
for
drilling
muds
and
workover
fluids.
Using
an
open
pour
scenario,
these
risks
are
of
concern
to
the
Agency.
In
order
for
risks
to
drop
below
the
Agency's
level
of
concern,
scenarios
involving
drilling
muds
and
workover
fluids
must
use
mitigation
measures
such
as
metering
pump
systems.

ii.
Post­
Application
Risk
Mitigation
At
this
time,
EPA
does
not
foresee
post­
application
exposures
for
the
occupational
uses
of
PHMB;
therefore,
no
mitigation
measures
are
necessary.

2.
Environmental
Risk
Management
As
the
Agency
considers
the
uses
of
PHMB
assessed
in
this
RED
to
be
unlikely
to
result
in
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms,
no
environmental
risk
mitigation
is
required.

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
PHMB.
For
the
specific
labeling
statements
and
a
list
of
outstanding
data,
refer
to
Section
V
of
this
RED
document.

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
30
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
and
low
toxicity
of
PHMB,
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
PHMB
end­
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
PHMB
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.
31
V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
PHMB
is
eligible
for
reregistration
provided
that:
(
i)
additional
data
that
the
Agency
intends
to
require
confirm
this
decision;
(
ii)
the
risk
mitigation
measure
outlined
in
this
document
is
adopted;
and
(
iii)
label
amendments
are
made
to
reflect
this
measure.
To
implement
the
risk
mitigation
measure,
the
registrants
must
amend
their
product
labeling
to
incorporate
the
label
statement
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
PHMB
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
Jennifer
Slotnick
at
(
703)
305­
0601
with
questions
regarding
generic
reregistration.

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
DCI/
SRRD)
Document
Processing
Desk
(
DCI/
SRRD)
Jennifer
Slotnick
Jennifer
Slotnick
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
32
For
end­
use
products
containing
the
active
ingredient
PHMB,
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
23
of
this
document;

4.
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);

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
33
A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
PHMB
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
PHMB.
The
requirements
would
consist
of
an
acute
toxicity
testing
battery,
subchronic
toxicity
study
in
the
rodent,
a
developmental
toxicity
study
in
the
rat,
and
a
mutagenicity
testing
battery.
Each
of
these
data
requirements
has
been
fulfilled
for
PHMB.
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
study
in
a
non­
rodent
which
would
become
data
requirements
if
the
Agency's
evaluation
of
the
Tier
1
data
warranted.
A
2­
generation
reproduction
study
and
a
subchronic
toxicity
study
in
a
non­
rodent
species
are
available
for
PHMB.

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.

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
(
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.

Table
11.
Confirmatory
Data
Requirements
for
Reregistration
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Dermal
Indoor
Exposure
875.1200,
875.1600
233,
236
Inhalation
Indoor
Exposure
875.1400,
875.1600
234,
236
Descriptions
of
Human
Activity
875.2800
133­
1
Dietary­
Residues
in
Food
from
Treating
Countertops
with
PHMB
(
FDA
Wipe
Study
Methodology)
(
FDA,
2003a
and
2003b)
Non­
Guideline
Non­
Guideline
34
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
be
sent
to
registrants
at
a
later
date.
The
efficacy
studies
the
Agency
intends
to
call­
in
are
listed
in
Table
12
below.

Table
12.
Efficacy
Data
Requirements
for
Reregistration
Claim
Use
Pattern
EPA
Reg.
Nos.
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Disinfectant
Hard
inanimate
surfaces
71661­
1
AOAC
Use
Dilution
Test
(
Hard
water
and
organic
soil)
or
AOAC
Germicidal
Spray
Test
or
AOAC
Hard
Surface
Carrier
Test
(
Distilled
water
only)
810.2100
(
c),
(
d),
(
e)
91­
2
(
b),
(
c),
(
d)

Sanitizer
Non­
food
contact
surfaces
(
nonresidual
5813­
75
Sanitizer
Test
for
Hard
Inanimate
Non­
Food
Contact
Surfaces
810.2100
(
l)
91­
2
(
j)

Sanitizer
Swimming
Pools/
Spas
1258­
1263
1258­
1265
1258­
1275
7124­
105
69461­
1
71864­
2
81002­
2
AOAC
Method
for
Water
Disinfectants
for
Swimming
Pools
810.2700
(
d)
91­
8
(
c)

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.
35
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.

a.
Label
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
risk
mitigation
measure
outlined
in
Section
IV.
The
following
table
describes
how
language
on
the
labels
should
be
amended.
36
Table
13.
Labeling
Changes
Summary
Table
Description
Amended
Labeling
Language
Placement
on
Label
For
all
Manufacturing
Use
Products
"
Only
for
formulation
into
algicides,
bacteriostats/
bacteriocides,
fungistats/
fungicides,

microbiostats/
microbiocides,
disinfectants,
regulators,
and
sanitizers
for
the
following
uses:

hard
surfaces
(
food­
contact
and
non
food­
contact);
swimming
pools
and
spas;
cut
ornamental
plants;
materials
preservatives;
drilling
muds,
packer
fluids,
and
workover
fluids;
oil
field
injection
water;
and
tunnel
pasteurization
water."
Directions
for
Use
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
"
This
product
is
toxic
to
fish
and
aquatic
invertebrates.
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollution
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."
Precautionary
Statements
End
Use
Products
Intended
for
Occupational
Use
PPE
Requirements1
"
Wear
goggles
or
face
shield
when
handling
concentrate."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
Engineering
Controls
for
Formulations
Used
in
Drilling
Muds
and
Workover
Fluids
"
Scenarios
involving
drilling
muds
and
workover
fluids
must
use
metering
pump
systems."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
(
Immediately
Following
User
Safety
Requirements.)
37
User
Safety
Recommendations
"
User
Safety
Recommendations
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet.

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

Users
should
remove
PPE
immediately
after
handling
this
product.
Wash
the
outside
of
gloves
before
removing*.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."
Precautionary
Statements
under:

Hazards
to
Humans
and
Domestic
Animals
(
Immediately
Following
Engineering
Controls
(
Must
be
placed
in
a
box.)

Environmental
Hazards
­
for
Labels
with
Oil
Recovery
Uses
"
Not
for
use
in
oil
recovery
systems
which
employ
holding
ponds
for
spent
liquids.
Do
not
apply
in,
over,
or
near
marine
and/
or
estuarine
oil
fields."
Directions
for
Use
End
Use
Products
Intended
for
Residential
Use
PPE
Requirements1
"
Wear
goggles
or
face
shield
when
handling
concentrate."
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
Application
Restrictions­
For
Products
Used
in
Swimming
Pools/
Spas
"
Do
not
use
with
chlorine­
or
bromine­
based
pool
products."
Directions
for
Use
under
General
Precautions
and
Restrictions
Application
Restrictions­
For
Products
Used
on
Food­
Contact
Surfaces
"
Rinse
food­
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,

or
utensils."
Directions
for
Use
under
General
Precautions
and
Restrictions
38
Application
Restrictions­
For
Products
Used
in
Animal/
Pet
Areas
"
Remove
animals
and
feeds.
Remove
litter,
droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.
Rinse
all
food­
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces."
Directions
for
Use
under
General
Precautions
and
Restrictions
Application
Restrictions­
For
Products
Used
in
Mushroom
Houses
"
Do
not
apply
directly
to
the
mushroom
crop,
compost,
or
casing.
Rinse
treated
surfaces
with
potable
water
before
they
contact
the
crop,
compost,
or
casing."
Directions
for
Use
under
General
Precautions
and
Restrictions
Entry
Restrictions­
For
Products
Used
in
Animal/
Pet
Areas,

Veterinary
Offices,
and
Pet
Kennels
"
Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment."
Directions
for
use
under
General
Precautions
and
Restrictions
1
PPE
that
is
established
on
the
basis
of
Acute
Toxicity
of
the
end­
use
product
must
be
compared
to
the
active
ingredient
PPE
in
this
document.
The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93­
7.
39
VI.
APPENDICES
40
Appendix
A.
Table
of
Use
Patterns
for
PHMB
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Agricultural
premises
and
equipment
Hog
Barns/
Houses/
Parlors/

Pens
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Farm
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Farrowing
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

1
Application
rate
is
given
in
terms
of
end­
use
product,
not
active
ingredient.
41
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Livestock
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Livestock
Feeding
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Livestock
Premises
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.
42
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Livestock
Watering
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Mushroom
House
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Do
not
apply
directly
to
the
mushroom
crop,

compost,
or
casing.
Rinse
treated
surfaces
with
potable
water
before
they
contact
the
crop,

compost,
or
casing.

Poultry
Feeding
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Poultry
House
Premises
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.
43
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Poultry
Watering
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
all
animals/
feed.
Remove
all
litter
and
manure.
Empty
feeding/
watering
appliances.

Ventilate
buildings,
vehicles,
and
other
enclosed
spaces.
Do
not
house
animals
or
employ
equipment
until
treatment
has
been
absorbed,
set,

or
dried.
Thoroughly
scrub
all
feeding/
watering
appliances
with
soap
or
detergent
and
rinse
with
potable
water
before
reuse.

Food
handling/
storage
establishments
premises
and
equipment
Tunnel
Pasteurization/
Cooling
(
Bottle/
Can
Wash)
Water
Aqueous
Solution
(
Reg.
1258­

1253)
100­
1,000
ppm
Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Eating
Establishments
(
Non­
Food
Contact
Surfaces,
Premises,
Food­

Contact
Surfaces)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Commercial,
institutional
and
industrial
premises
and
equipment
Commercial
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Commercial
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
44
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Commercial
Transportation
Facilities
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Industrial
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Industrial
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Institutional
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Institutional
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Athletic
Facilities
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Barber
and
Beauty
Shop
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Aircraft
(
NonFeed/
Food)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
45
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Buses
(
Nonfeed/
Nonfood)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Railroad
Trains
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Ships
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Trucks
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Animal
Cages
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Animal
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.
46
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Animal
Feeding/
Watering
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Catteries
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Horse
Stables
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Research
Animal
Facilities
(
Enclosed
Premise
Treatment)/

Animal
Laboratories
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.
47
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Veterinary
Hospital
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Zoo
Premises
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Laundry
Premises
(
Commercial)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Urinals
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Coils/
Drain
Pans
(
Air
Conditioning/

Refrigeration
Equipment
and
Heat
Pumps)

(
Commercial/

Institutional/
Industrial)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Playground
Equipment
(
Institutional)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
48
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Residential
and
public
access
premises
Automobiles
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Boat
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Pet
Kennels
(
Enclosed
Premise
Treatment)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Pet
Sleeping
Quarters
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.

Pet
Areas
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Remove
animals
and
feeds.
Remove
litter,

droppings,
and
manure
from
all
floors
and
other
surfaces.
Empty
all
feeding/
watering
appliances.

Rinse
all
food
contact
surfaces
with
potable
water
prior
to
reuse.
Ventilate
buildings/
closed
spaces.

Wait
for
treatment
to
have
dried
to
house
animals
or
employ
equipment.
49
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Campers
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Garbage
Containers
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Laundry
Premises
(
Residential)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Sinks
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Stovetops
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.

Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Residential
Food­
Contact
Surfaces
(
Microwave
Ovens/
Refrigerators/

High
Chairs/
Tables)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
50
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Bathroom
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Whirlpool
Bath
Surfaces
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Diaper
Pails
Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Domestic
Dwellings
(
House
Trailer)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Household
Contents
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Household
Contents
(
Nursery)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
51
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Ready­
to­
Use
Solution
(
Mopping
System)

(
Reg.
5813­
75)
24
fl.
oz.
lasts
about
2­
3
months
under
"
normal
use" 
mop
has
trigger
to
dispense
solution
Household
Floors
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Household
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Mobile
Homes
(
Indoor)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Coils/
Drain
Pans
(
Air
Conditioning/

Refrigeration
Equipment
and
Heat
Pumps)

(
Residential)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
52
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Powder
(
Water
Soluble
Packaging)

(
Reg.
72992­
2;

72992­
8)
10g
per
2.6
quarts
of
water
0.17
oz
(
5g)
per
pint
(
½
qt)
of
water
2
Ornamental
Flowering
Plants
(
Cut)
Soluble
Concentrate
(
Reg.
72992­
3;

72992­
7)
10,000
­
15,000
ppm
solution
3
Furniture
(
Outdoor)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Campgrounds
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Playground
Equipment
(
Residential)
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

2Although
the
application
rate
of
product
is
different,
the
application
rate
of
active
ingredient
(
as
calculated
by
multiplying
the
product
application
rate
by
the
concentration
of
active
ingredient
in
the
product)
is
approximately
0.96g
PHMB
per
quart
of
water.

3The
application
rate
for
both
products
is
900
ppm
of
active
ingredient
due
to
differences
in
the
concentration
of
the
active
ingredient
in
the
product
formulations.
53
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Medical
premises
and
equipment
Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Hospital
Materials
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Impregnated
Wipe
(
Reg.
50096­
1)
1
wipe
lasts
20
uses
Hospital
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Human
Nursery
Equipment
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Human
Nursery
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.
54
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Nursing
Home
Premises
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Dental
Offices
Ready­
to­
Use
Solution
(
Reg.
71661­
1)
Thoroughly
wet
(
saturate)
all
surfaces
for
10
minutes.
Rinse
food
contact
surfaces
with
potable
water
prior
to
reuse.
Do
not
use
on
glasses,
dishes,
or
utensils.

Materials
preservatives
Adhesives/
Glues
(
Aqueous­
Based)

(
Indirect
Food
Contact)
Aqueous
Solution
(
Reg.
1258­

1253)
500­
5,000
ppm
Aqueous
Industrial
Chemicals
(
Reagents/

Oilin
Water
Emulsions/
Water­
in­
Oil
Emulsions/
Textile
Spin
Finish
Lubricants/
Wash
Water/
Cellulose
Solutions
Aqueous
Solution
(
Reg.
1258­

1253)
100­
5,000
ppm
55
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Cellulosic
Materials
Aqueous
Solution
(
Apply
by
padding,

spraying,

soaking,
or
exhaustion)

(
Reg.
1258­

1253)
0.025­
2%
on
dry
weight
of
substrate
Industrial
Electrocoats
(
Resins
and
Deposition
Systems)
Aqueous
Solution
(
Reg.
1258­

1253)
1,000­
5,000
ppm
Household
Consumer
Products
Aqueous
Solution
(
Reg.
1258­

1253)
250­
2,500
ppm
Leather
Products
and
Hides/
Skins
(
Fresh
Animal)
Aqueous
Solution
(
Reg.
1258­

1253)
15
fl
oz.­
3
gal
[
1.0­
2.6
lbs
product
per
1,000
lbs
hides/
skins]
Use
prior
to
or
during
processing
Polymer
Latices
(
Aqueous­
Based)
(
i.
e.

Polyvinyl
Acetate/
Alcohol)
Aqueous
Solution
(
Reg.
1258­

1253)
500­
5,000
ppm
56
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Silicone
Emulsions/
Dispersions
Aqueous
Solution
(
Reg.
1258­

1253)
100­
5,000
ppm
Slurries
(
Aqueous)

(
Indirect
Food
Contact)
Aqueous
Solution
(
Reg.
1258­

1253)
500­
5,000
ppm
Textiles
Aqueous
Solution
(
Apply
by
padding,

spraying,

soaking,
or
exhaustion)

(
Reg.
1258­

1253)
0.025­
2%
on
dry
weight
of
substrate
(
8)
Industrial
processes
and
water
systems
Leather
Processing
Liquors/
Solutions
Aqueous
Solution
(
Reg.
1258­

1253)
100­
3,000
ppm
57
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Oil
Recovery
Drilling
Muds/
Packer
Fluids
Aqueous
Solution
(
Reg.
1258­

1253)
3,000
ppm
Not
for
use
in
oil
recovery
systems
which
employ
holding
ponds
for
spent
liquids.
Do
not
apply
in,

over,
or
near
marine
and/
or
estuarine
oil
fields.

Workover
Fluids
Aqueous
Solution
(
Reg.
1258­

1253)
3,000
ppm
Not
for
use
in
oil
recovery
systems
which
employ
holding
ponds
for
spent
liquids.
Do
not
apply
in,

over,
or
near
marine
and/
or
estuarine
oil
fields.

95
ppm
Slug
47
ppm
Weekly
Secondary
Oil
Recovery
Injection
Water
Aqueous
Solution
(
Reg.
1258­

1253)
4­
20
ppm
Continuous
Not
for
use
in
oil
recovery
systems
which
employ
holding
ponds
for
spent
liquids.
Do
not
apply
in,

over,
or
near
marine
and/
or
estuarine
oil
fields.

Apply
slug
treatment
to
a
point
where
system
will
be
uniformly
mixed.
Weekly
follows
slug
treatment
when
microbial
control
is
evident.

Before
continuous
treatment,
apply
a
slug
treatment.

Swimming
pools
Swimming
Pool
Water
Systems
Ready­
to­
Use
Solution
(
Reg.
1258­

1263;
1258­

1265;
7124­
105;

69461­
1;
71864­

2;
81002­
2)
Maintain
Concentration
of
30­
50
ppm
Weekly/
As
Necessary
Cannot
use
with
chlorine
or
bromine
based
pool
products.
58
Use
Site
Formulation
Application
Rate
(
Range)
1
No.
of
Applications
Use
Limitations
Tablets
(
Soluble
Concentrate)

(
Reg.
1258­

1275)
Maintain
Concentration
of
6­
10
ppm
Weekly/
As
Necessary
Cannot
use
with
chlorine
or
bromine
based
pool
products.

Hot
Tubs/
Spas
(
Water
Treatment)
Ready­
to­
Use
Solution
(
Reg.
1258­

1263;
1258­

1265;
69461­
1;

71864­
2)
Maintain
Concentration
of
30­
50
ppm
Weekly/
As
Necessary
Cannot
use
with
chlorine
or
bromine
based
pool
products.
59
Appendix
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
Guide
to
Appendix
B
Appendix
B
contains
listing
of
data
requirements
which
support
the
reregistration
for
active
ingredients
within
case
#
3144
(
PHMB)
covered
by
this
RED.
It
contains
generic
data
requirements
that
apply
to
PHMB
in
all
products,
including
data
requirements
for
which
a
"
typical
formulation"
is
the
test
substance.

The
data
table
is
organized
in
the
following
formats:

1.
Data
Requirement
(
Column
1).
The
data
requirements
are
listed
in
the
order
in
which
they
appear
in
40
CFR
part
158.

The
reference
numbers
accompanying
each
test
refer
to
the
test
protocols
set
in
the
Pesticide
Assessment
Guidance,
which
are
available
from
the
National
technical
Information
Service,
5285
Port
Royal
Road,
Springfield,
VA
22161
(
703)
487­
4650.

2.
Use
Pattern
(
Column
4).
This
column
indicates
the
use
patterns
for
which
the
data
requirements
apply.
The
following
letter
designations
are
used
for
the
given
use
patterns.

(
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
acceptable
data
in
its
files,
this
column
list
the
identify
number
of
each
study.
This
normally
is
the
Master
Record
Identification
(
MRID)
number,
but
may
be
a
"
GS"
number
if
no
MRID
number
has
been
assigned.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
the
study.
60
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
41965401,
42728901
830.1600
830.1620
830.1650
61­
2a
Starting
Materials
and
Manufacturing
Process
All
41894001,
41930701
830.1670
61­
2b
Formation
of
Impurities
All
41965401,
42728903
830.1700
62­
1
Preliminary
Analysis
All
41965401
830.1750
62­
2
Certification
of
Limits
All
42728902,
41965401
830.1800
62­
3
Analytical
Method
All
42728902,
41965401
830.6302
63­
2
Color
All
41966401
830.6303
63­
3
Physical
State
All
41966401
830.6304
63­
4
Odor
All
41966401
830.7050
None
UV/
Visible
Absorption
All
Waived1
830.7200
63­
5
Melting
Point
All
41966401
830.7220
63­
6
Boiling
Point
All
41966401
830.7300
63­
7
Density
All
41966401
830.7840
830.7860
63­
8
Solubility
All
41966401
830.7950
63­
9
Vapor
Pressure
All
41966401
830.7370
63­
10
Dissociation
Constant
in
Water
All
41966401
1
Study
waived
because
the
chemical
structure
shows
that
it
will
not
absorb
in
the
UV
spectral
region.
61
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
41687001
830.7000
63­
12
pH
All
41966401
830.6313
63­
13
Stability
All
42728902
830.6314
63­
14
Oxidizing/
Reducing
Action
All
Not
Applicable
830.6315
63­
15
Flammability
All
Not
Applicable
830.6316
63­
16
Explodability
All
Not
Applicable
830.6317
63­
17
Storage
Stability
All
42728902
830.7100
63­
18
Viscosity
All
Not
Applicable
830.6319
63­
19
Miscibility
All
Not
Applicable
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
All
27491
(
93191001)

850.2200
71­
2
Avian
Dietary
Toxicity
All
41382
(
93191002)

850.1075
72­
1
Fish
Acute
Toxicity
­
Freshwater
All
ACC
234289
(
MRID
77928
and
77929),
43949001
850.1010
72­
2
Acute
Aquatic
Invertebrate
Toxicity
All
ACC
234289
(
MRID
77929)

850.1075
72­
3a
Acute
Estuarine/
Marine
Toxicity
­
Fish
8
Waived2
2
Label
precludes
use
in,
over,
or
near
marine
and/
or
estuarine
environments.
Therefore,
Guidelines
850.1075
and
850.1025
are
waived.
62
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
72­
3b
Acute
Estuarine/
Marine
Toxicity
­
Invertebrate
(
Mollusk)
8
Waived2
850.1025
72­
3c
Estuarine/
Marine
Toxicity
­
Invertebrate
(
Shrimp)
8
Waived2
TOXICOLOGY
870.1100
81­
1
Acute
Oral
­
Rat
All
30330
(
93191005),
44940701,

45916505
870.1200
81­
2
Acute
Dermal
­
Rabbit
All
65124,
44940702,
45916506
870.1300
81­
3
Acute
Inhalation
­
Rat
All
44970403
870.2400
81­
4
Primary
Eye
Irritation
­
Rabbit
All
46789,
65120,
44963902,
45916508
870.2500
81­
5
Primary
Dermal
Irritation
­
Rabbit
All
46789,
65120,
44949704,
45916509
870.2600
81­
6
Dermal
Sensitization
All
42674201,
44940705
82­
1a
90­
Day
Feeding­
Rodent
All
Waived3
870.3100
82­
1b
90­
Day
Feeding­
Non­
Rodent
All
53461
870.3200
82­
2
21/
28­
Day
Dermal
Toxicity
­
Rat
All
43047701
870.3250
82­
3
90­
day
Dermal
Toxicity
­
Rodent
All
Waived4
870.3465
82­
4
90­
Day
Inhalation
­
Rat
All
Data
gap
870.3700
83­
3
Developmental
Toxicity
All
65131
(
rodent),
429921015
(
rodent),
42865901
(
non­
rodent)

870.3800
83­
4
Reproduction
and
Fertility
Effects
­
2
Generation
Repro
All
43617401
3
Study
waived
because
Guideline
83­
1a
(
Chronic
Toxicity­
Rodent)
satisfies
this
data
requirement.

4
Study
waived
because
80­
week
dermal
cancer
study
in
mice
submitted
under
Guideline
83­
2b
satisfies
requirement.

5
MRID
42992101
is
an
upgrade
to
the
original
study,
MRID
65131.
63
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
83­
1a
Chronic
Feeding
Toxicity
­
Rodent
2,3,4,5,7,11
44059301,
44042801
870.4100
83­
1b
Chronic
Feeding
Toxicity
­
Non­
Rodent
(
dog)
2,3,4,5,7,11
43620501
83­
2a
Oncogenicity
­
Rat
11
44059301,
44042801
870.4200
83­
2b
Oncogenicity
­
Mouse
11
44074201(
oral),
93191028
(
dermal),

66475(
dermal),
104796
(
dermal)

870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity
11
44059301
870.5265
84­
2
Bacterial
Reverse
Mutation
Assay
All
41687004
870.5385
84­
2
Micronucleus
Assay
All
41096901,
41404503
870.5375
84­
2
Cytogenic
assay
with
human
lymphocytes
All
41404501,
42149905
870.5550
84­
2
UDS
Assay
All
41404502,
42149903
870.7485
85­
1
General
Metabolism
2,3,4,5,7,11
43599901,
43567001,
77926,
86363
870.7600
85­
2
Dermal
Absorption
11
Waived6
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2800
133­
1
Description
of
Human
Activity
All
Data
Gap
875.2400
875.2900
133­
3
Dermal
Passive
Dosimetry
11
44051301
875.2500
875.2900
133­
4
Inhalation
Passive
Dosimetry
11
44051301
875.1200
875.1600
233
Dermal
Indoor
Exposure
All
Data
Gap
875.1400
875.1600
234
Inhalation
Indoor
Exposure
All
Data
Gap
6
Study
waived
because
80­
week
dermal
cancer
study
submitted
under
Guideline
83­
2b
in
mice
satisfies
requirement.
64
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
All
43622301
OTHER
DATA
REQUIREMENTS
Non­
Guideline
Non­
Guideline
Dietary­
Residues
in
Food
from
Treating
Countertops
with
PHMB
(
FDA
Wipe
Study
Methodology7)
2,3,4,5
Data
Gap
7
FDA,
2003a.
"
Guidance
For
Industry:
Preparation
of
Food
Contact
Notifications
and
Food
Additive
Petitions
for
Food
Contact
Substances:
Chemistry
Recommendations.
Final
Guidance."
US
Food
and
Drug
Administration.
April,
2003.
http://
www.
cfsan.
fda.
gov/~
dms/
opa2pmnc.
html.

FDA,
2003b.
"
Sanitizing
Solutions:
Chemistry
Guidelines
for
Food
Additive
Petitions."
US
Food
and
Drug
Administration.
January,
1993.

http://
www.
cfsan.
fda.
gov/~
dms/
opa­
cg3a.
html.
65
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
Street,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4
pm.

The
docket
initially
contained
the
August
26,
2004
preliminary
risk
assessment
and
the
related
documents.
EPA
then
considered
comments
on
these
risk
assessments
(
which
are
posted
to
the
e­
docket)
and
revised
the
risk
assessments.
The
revised
risk
assessments
will
be
posted
in
the
docket
at
the
same
time
as
the
RED.

All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
sites:

http://
www.
epa.
gov/
pesticides/
antimicrobials
http://
www.
epa.
gov/
edockets
These
documents
include:

 
Poly(
hexamethylenebiguanide)
hydrochloride
Preliminary
Risk
Assessment;
Notice
of
Availability,
9/
10/
04.
 
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB)
Summary,
8/
30/
04.
 
Overview
of
the
PHMB
Preliminary
Risk
Assessment,
8/
24/
04.

Preliminary
Risk
Assessment
and
Supporting
Science
Documents:
 
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Preliminary
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
26/
04.
 
Product
Chemistry
Science
Chapter
on
PHMB
(
20%
Formulations
of
Vantocil
P
and
Vantocil
IB).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
4/
04,
A.
Najm
Shamim,
Ph.
D.
 
PHMB
­
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee,
TXR
No.
0051756,
Health
Effects
Division,
4/
9/
03,
Jonathan
Chen,
Ph.
D.
 
Cancer
Assessment
Document:
Evaluation
of
the
Carcinogenic
Potential
of
PHMB,
PC
Code
111801,
Case
3122,
TXR
No.
0052040,
Health
Effects
Division,
7/
16/
03,
Jessica
Kidwell,
Executive
Secretary,
Cancer
Assessment
Review
Committee.
 
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
26/
04,
Jonathan
Chen,
Ph.
D.
and
Timothy
F.
McMahon,
Ph.
D.
 
PHMB
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision.
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
26/
04,
A.
Najm
Shamim,
Ph.
D.
 
PHMB
Occupational/
Residential
Exposure
Assessment.
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
19/
04,
Timothy
Leighton,
Ph.
D.
 
Health
Effects
of
PHMB
in
Humans.
PC
Code
111801,
Case
3122,
Antimicrobials
66
Division,
8/
4/
04,
Jonathan
Chen,
Ph.
D.
 
Environmental
Fate
Assessment
of
PHMB
for
the
Reregistration
Eligibility
Decision
(
RED).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
18/
04,
A.
Najm
Shamim,
Ph.
D.
 
Ecological
Hazard
and
Environmental
Risk
Assessment:
Poly(
hexamethlenebiguanide)
hydrochloride
(
PHMB).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
4/
04,
Kathryn
Montague,
M.
S.

Revised
Risk
Assessment
and
Supporting
Science
Documents
(
RED
Supporting
Documents):
 
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
2/
14/
05.
 
Product
Chemistry
Science
Chapter
on
PHMB
(
20%
Formulations
of
Vantocil
P
and
Vantocil
IB).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
4/
04,
A.
Najm
Shamim,
Ph.
D.

 
PHMB
­
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee,
TXR
No.
0051756,
Health
Effects
Division,
4/
9/
03,
Jonathan
Chen,
Ph.
D.
 
Cancer
Assessment
Document:
Evaluation
of
the
Carcinogenic
Potential
of
PHMB,
PC
Code
111801,
Case
3122,
TXR
No.
0052040,
Health
Effects
Division,
7/
16/
03,
Jessica
Kidwell,
Executive
Secretary,
Cancer
Assessment
Review
Committee.
 
Poly(
hexamethylenebiguanide)
hydrochloride
(
PHMB):
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
1/
18/
05,
Jonathan
Chen,
Ph.
D.
and
Timothy
F.
McMahon,
Ph.
D.
 
PHMB
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision.
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
1/
18/
05,
A.
Najm
Shamim,
Ph.
D.
 
PHMB
Occupational/
Residential
Exposure
Assessment.
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
2/
3/
05,
Timothy
Leighton,
Ph.
D.
and
Cassi
Walls,
Ph.
D.
 
Health
Effects
of
PHMB
in
Humans.
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
4/
04,
Jonathan
Chen,
Ph.
D.
 
Environmental
Fate
Assessment
of
PHMB
for
the
Reregistration
Eligibility
Decision
(
RED).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
8/
18/
04,
A.
Najm
Shamim,
Ph.
D.
 
Ecological
Hazard
and
Environmental
Risk
Assessment:
Poly(
hexamethlenebiguanide)
hydrochloride
(
PHMB).
PC
Code
111801,
Case
3122,
Antimicrobials
Division,
11/
18/
05,
Kathryn
Montague,
M.
S.
67
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Decision
(
Bibliography)

1.
MRID
Studies
MRID#
Citation
27491
Beavers,
J.
B.;
Fink,
R.;
Brown,
R.
(
1979)
Final
Report:
Acute
Oral
LD50­­
Mallard
Duck:
Project
No.
123­
131.
(
Unpublished
study
received
Feb
14,
1980
under
10182­
19;
prepared
by
Wildlife
International,
Ltd.
in
cooperation
with
Washington
State
College,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
241792­
A)

30330
Jackson,
S.
J.
(
1979)
Acute
Oral
and
Dermal
Toxicity:
Report
No.
CTL/
T/
1361:
Vantocil/
P.
(
Unpublished
study
received
Feb
14,
1980
under
10182­
19;
prepared
by
Imperial
Chemical
Industries,
Ltd.,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
241790­
A)

41382
Beavers,
J.
B.;
Fink,
R.;
Brown,
R.
(
1979)
Final
Report:
Eight­
Day
Dietary
LC50­
­
Bobwhite
Quail:
Project
No.
123­
129.
(
Unpublished
study
received
Feb
14,
1980
under
10182­
19;
prepared
by
Wildlife
International,
Ltd.
in
cooperation
with
Washington
State
College,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
241792­
C)

45698
Brown,
D.;
Maddock,
B.
G.
(
1980)
Determination
of
the
Acute
Toxicity
of
Vantocil
P
to
Rainbow
Trout
(~
Salmo
gairdneri~):
BL/
B/
2031.
(
Unpublished
study
received
Aug
21,
1980
under
10182­
19;
prepared
by
Imperial
Chemical
Industries,
Ltd.,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
243099­
B)

46789
Imperial
Chemical
Industries,
Limited
(
1966)
Antibacterial
9073:
Toxicological
Properties:
Report
No.
TR/
558.
(
Unpublished
study
received
Feb
6,
1969
under
0H2556;
CDL:
221701­
I)

53460
Griffiths,
D.;
Hayes,
M.
J.;
McElligott,
T.
F.
(
1966)
Ninety­
Day
Oral
Toxicity
of
Antibacterial
9073­­
Albino
Rats:
Report
No.
IHR/
199.
(
Unpublished
study
received
Feb
6,
1969
under
0H2556;
submitted
by
Imperial
Chemical
Industries,
Ltd.,
London,
England;
CDL:
2217101­
J)

53461
Griffiths,
D.;
Hayes,
M.
J.;
McElligott,
T.
F.
(
1966)
Ninety­
Day
Oral
Toxicity
of
Antibacterial
9073­­
Beagle
Dogs:
Report
No.
IHR/
202.
(
Unpublished
study
received
Feb
6,
1969
under
0H2556;
submitted
by
Imperial
Chemical
Industries,
Ltd.,
London,
England;
CDL:
221701­
K)
68
65120
Conning,
D.
N.
(
1966)
Antibacterial
9073:
Toxicological
Properties:
Report
No.
TR/
558.
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
prepared
by
Imperial
Chemical
Industries
Ltd.,
England,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233267­
B)

65124
Trueman,
R.
W.;
Eaton,
D.
(
1977)
Baquacil
SB:
Acute
Dermal
Toxicity
and
Skin
Irritation
Effects:
Report
No.
CTL/
T/
1057.
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
prepared
by
Imperial
Chemical
Industries
Ltd.,
England,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233267­
F)

65131
Hodge,
M.
C.
E.;
Palmer,
S.
(
1976)
Baquacil
SB:
A
Teratology
Study
in
the
Rat
by
Dietary
Administration:
Report
No.
CTL/
P/
262.
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233267­
M;
233268)

66475
Clapp,
M.
J.
L.;
Iswaran,
T.
J.;
Major,
P.
(
1977)
Polyhexamethylene
Biguanide:
80
Week
Skin
Painting
Study
in
Mice:
Report
No.
CTL/
P/
331
(
Amended).
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233269­
A)

77926
Bratt,
H.
(
1977)
Vantocil
IB:
Absorption
and
Excretion
Studies
in
the
Rat:
Report
No.
CTL/
P/
163B.
Interim
rept.
(
Unpublished
study
received
May
30,
1978
under
10182­
19;
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
234289­
B)

77928
Hill,
R.
W.;
Maddock,
B.
G.;
Hart,
B.
(
1975)
Vantocil:
Determination
of
the
Acute
Toxicity
to
Rainbow
Trout
of
Vantocil
1B
in
Freshwater:
BL/
B/
1631.
(
Unpublished
study
received
May
30,
1978
under
ACC#
234289;
prepared
by
Imperial
Chemical
Industries,
Ltd.,
England,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
234289­
D)

77929
Buccafusco,
R.
J.;
LeBlanc,
G.
A.
(
1977)
Acute
Toxicity
of
Vantocil^(
R)
I
IB,
Mix
No.
1857,
to
Bluegill
(~
Lepomis
macrochirus~)
and
the
Water
Flea
(~
Daphnia
magna~).
(
Unpublished
study
received
May
30,
1978
under
ACC#
234289;
prepared
by
EG
&
G,
Bionomics,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
234289­
E)

86362
Trutter,
J.
A.;
Patterson,
D.
R.
(
1977)
26­
week
Toxicity
Study
in
Dogs:
20%
P.
H.
M.
B.
Final
rept.
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
prepared
by
Hazleton
Laboratories
America,
Inc.,
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233270­
A)

86363
Bratt,
H.
(
1975)
Vantocil
IB:
Absorption
and
Excretion
Studies
in
the
Rat:
Report
No.
CTL/
P/
163B.
Interim
rept.
(
Unpublished
study
received
Mar
10,
1978
under
10182­
EX­
11;
submitted
by
ICI
Americas,
Inc.,
Wilmington,
Del.;
CDL:
233270­
B)
69
104796
ICI
Americas,
Inc.
(
1975)
Polyhexamethylene
Biguanide:
80
Week
Skin
Painting
Study
in
Mice:
Appendix
B:
Pathology
Individual
Animal
Data:
Report
No.
CTL/
P/
331.
(
Unpublished
study
received
Sep
27,
1978
under
10182­
EX­
11;
CDL:
235604­
A)

41096901
Randall,
V.;
Beck,
S.
(
1989)
Vantocil
IB:
An
Evaluation
in
the
Mouse
Micronucleus
Test:
Report
No.
CTL/
P/
2436.
Unpublished
study
prepared
by
ICI
Ltd.,
Central
Toxicology
Laboratory.
37
p.

41404501
Howard,
C.
(
1989)
Vantocil
IB:
An
Evaluation
in
the
in
vitro
Cytogenetic
Assay
in
Human
Lymphocytes:
Lab
Project
ID:
CTL/
P/
2582.
Unpublished
study
prepared
by
ICI
Central
Toxicology
Laboratory.
28
p.

41404503
Randall,
V.;
Beck,
S.
(
1989)
Vantocil
IB:
An
Evaluation
in
the
Mouse
Micronucleus
Test­­
Addendum:
Lab
Project
ID:
CTL/
P/
2436.
Unpublished
study
prepared
by
ICI
Central
Toxicology
Laboratory.
7
p.

41687004
Callander,
R.
(
1989)
Vantocil
IB:
An
Evaluation
in
the
Salmonella
Mutation
Assay:
Lab
Project
Number:
CTL/
P/
2406.
Unpublished
study
prepared
by
ICI
Central
Toxicology
Laboratory.
39
p.

42587501
Popendorf,
W.;
Selim,
M.;
Kross,
B.
(
1992)
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study:
Second
Replacement
to
MRID
41761201:
Lab
Project
Number:
Q626.
Unpublished
study
prepared
by
The
University
of
Iowa.
316
p.

42674201
Duerden,
L.
(
1993)
Polyhexamethylene
Biguanide:
Skin
Sensitisation
to
the
Guinea
Pig
of
a
20%
Aqueous
Solution:
Lab
Project
Number:
CTL/
P/
3889:
GG5741:
GG5694.
Unpublished
study
prepared
by
ZENECA
Central
Toxicology
Lab.
27
p.

42865901
Brammer,
A.
(
1993)
Polyhexamethylene
Biguanide:
Developmental
Toxicity
Study
in
the
Rabbit:
Lab
Project
Number:
CTL/
P/
3997:
RB0614.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
352
p.

43567001
Lythgoe,
R.;
Howard,
E.;
Prescott,
E.
(
1995)
PHMB:
Absorption,
Distribution,
Metabolism
and
Excretion
Following
Single
Oral
Dosing
(
20mg/
kg)
in
the
Rat:
Lab
Project
Number:
CTL/
P/
4537:
UR0360.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
82
p.

43599901
Lythgoe,
R.;
Howard,
E.
(
1995)
PHMB:
Bioavailability
Following
Dietary
Administration
in
the
Rat:
Lab
Project
Number:
CTL/
P/
4595:
UR0468.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
41
p.
70
43617401
Milburn,
G.
(
1995)
Polyhexamethylene
Biguanide:
Multigeneration
Study
in
the
Rat:
Lab
Project
Number:
CTL/
P/
4455:
RR0621/
F0:
RR0621/
F1.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
1985
p.

43620501
Horner,
S.
(
1995)
Polyhexamethylene
Biguanide:
1
Year
Dietary
Toxicity
Study
in
Dogs:
Lab
Project
Number:
CTL/
P/
4488:
PD0947.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
542
p.

43622301
Evans,
K.;
Beaumont,
G.;
Williams,
D.
(
1995)
PHMB
Hydrolysis
Study
for
EPA
Registration:
Project
302:
Lab
Project
Number:
RD012064B.
Unpublished
study
prepared
by
Zeneca
Specialties.
33
p.

43949001
Penwell,
A.;
Roberts,
G.
(
1995)
PHMB:
Acute
Toxicity
to
Rainbow
Trout
Oncorhynchus
mykiss:
Lab
Project
Number:
BL5506/
B:
X839/
B.
Unpublished
study
prepared
by
Zeneca
Ltd.
30
p.

44042801
Busey,
W.
(
1996)
Polyhexamethylene
Biguanide
(
PHMB):
Two
Year
Feeding
Study
in
Rats:
Pathology
Working
Group
Peer
Review
of
Proliferative
Vascular
Lesions
in
Male
and
Female
Rats:
Lab
Project
Number:
PR0936:
CTL/
C/
3172:
Y00156/
008.
Unpublished
study
prepared
by
Experimental
Pathology
Labs.,
Inc.
67
p.
{
Relates
to
L0000061}.

44046301
Dugard,
P.;
Mawdsley,
S.
(
1982)
(
Carbon
14)­
Polyhexamethylene
Biguanide
(
PHMB):
Absorption
Through
Human
Epidermis
and
Rat
Skin
in
vitro:
Lab
Project
Number:
CTL/
R/
579.
Unpublished
study
prepared
by
Imperial
Chemical
Industries
Ltd.,
Central
Toxicology
Lab.
36
p.

44051301
Burt,
M.
(
1996)
Assessment
of
Worker
and
Postapplicator
Exposure
to
PHMB
Used
in
Pools
and
Spas:
Lab
Project
Number:
JCS/
1.
Unpublished
study
prepared
by
Zeneca
Specialties.
41
p.

44059301
Horner,
S.
(
1996)
Polyhexamethylene
Biguanide:
Two
Year
Feeding
Study
in
Rats:
Lab
Project
Number:
CTL/
P/
4663:
PR0936.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
3015
p.
Relates
to
L0000061.

44074201
Milburn,
G.
(
1996)
Polyhexamethylene
Biguanide:
Two
Year
Oncogenic
Study
in
Mice:
Lab
Project
Number:
CTL/
P/
4649:
PM0937.
Unpublished
study
prepared
by
Zeneca
Central
Toxicology
Lab.
2348
p.

45187701
Backhouse,
B.
(
2000)
Health
Risk
Assessment
for
PHMB
in
100%
Cotton
Textile
Applications­
Systemic
Toxicity
by
an
Infant
Sucking
a
Textile
(
Initially
Unwashed,
Subsequently
Washed):
Lab
Project
Number:
SENS10D.
Unpublished
study
prepared
by
Avecia
Limited.
7
p.
71
45710801
Piccirillo,
V.
(
2002)
Evaluation
of
the
Weight­
of­
Evidence
for
the
Carcinogenic
Potential
of
PHMB:
Lab
Project
Number:
VJP
7172­
02­
1.
Unpublished
study
prepared
by
Avecia,
Inc.
11
p.

45710802
Mann,
P.
(
2002)
Polyhexamethylene
Biguanide
(
PHMB):
2
Year
Oncogenic
Study
in
Mice:
Lab
Project
Number:
PM0937:
698­
001.
Unpublished
study
prepared
by
Experimental
Pathology
Laboratories,
Inc.
63
p.
{
OPPTS
870.4300}

45710803
Freemantle,
M.
(
2002)
Polyhexamethylene
Biguanide
(
PHMB):
Two­
Year
Oncogenic
Study
in
Mice:
Statistical
Analysis
of
the
Results
from
the
Pathology
Working
Group
Peer
Review
of
Vascular
Lesions
in
Male
and
Female
Mice:
Lab
Project
Number:
AP­
7.
Unpublished
study
prepared
by
Syngenta
Central
Toxicology
Laboratory.
17
p.

45710804
Brown,
E.
(
2002)
Historical
Control
Data
for
Occurrence
of
Hemangiosarcoma
(
Angiosarcoma)
in
C57BL/
10J/
CD­
1
A1pk
Mice:
Lab
Project
Number:
AP­
1.
Unpublished
study
prepared
by
Syngenta
Central
Toxicology
Laboratory.
7
p.

45710805
Brown,
E.
(
2002)
Exceedance
of
the
Maximum
Tolerated
Dose
at
the
Highest
Tested
Dose
of
PHMB
in
Mice:
Lab
Project
Number:
AP­
2.
Unpublished
study
prepared
by
ChemReg
International,
LLC.
5
p.

45710807
Brown,
E.
(
2002)
Potential
Carcinogenicity
from
Dermal
Applications
of
PHMB:
Lab
Project
Number:
AP­
4.
Unpublished
study
prepared
by
ChemReg
International,
LLC.
10
p.

45710808
Brown,
E.
(
2002)
Historical
Control
Data
for
Occurrence
of
Hemangiosarcoma
(
Angiosarcoma)
in
A1pk:
ApfSD
Wistar
Rats:
Lab
Project
Number:
AP­
5.
Unpublished
study
prepared
by
Syngenta
Central
Toxicology
Laboratory.
8
p.

93191001
Burt,
M.
(
1990)
ICI
Americas
Inc.
Phase
3
Summary
of
MRID
00027491.
Acute
Oral
LD50
­
Mallard
Duck,
Baquacil
Mix
#
5889,
Final
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123­
131.
Prepared
by
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10
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93191002
Burt,
M.
(
1990)
ICI
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Summary
of
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00041382.
Eight
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LC50
­
Bobwhite
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Baquacil
Mix
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5889,
Final
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123­
129.
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by
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Ltd.
11
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93191004
Adams,
D.
(
1990)
ICI
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MRID
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P:
Determination
of
the
Acute
Toxicity
to
Rainbow
Trout
Salmo
gairdneri:
Report
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BL­
B­
2031;
Study
No.
G184­
B.
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14
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2.
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ACC).
2002.
An
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the
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Brunsman,
L.
L.
2002.
PHMB
Qualitative
Risk
Assessment
Based
On
1977
SPF
Alderley
Park
Mouse
Dermal
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1996
C57B1/
10JfCD­
1/
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Dykstra,
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Chemical
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68­
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McMahon,
T.
1995.
Polyhexamethylene
Biguanide
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PHMB,
Baquacil):
Review
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by
the
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011380.

McMahon,
T.
1997.
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IB
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Review
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Mutagenicity
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D240678.

Megosh,
LC,
Hu,
J,
Geroge
K,
O'Brien
TG.
2002.
Genetic
control
of
polyamine­
dependent
susceptibility
to
skin
carcinogenesis.
Genomics
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505­
512.

Milovic
V,
Turchanowa
L.
2003.
Polyamines
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colon
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383.

Pletcher,
J.
M.
2002.
Memorandum
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Pathology
Working
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Peer
Review
of
Proliferative
Vascular
Lesions
in
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and
Female
Mice.
October
28,
2002.
TXR
No.
0052033.

Pletcher,
J.
M.
2003.
Memorandum
on
Pathology
Working
Group
Peer
Review
of
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Vascular
Lesions
in
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and
Female
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16,
2003.
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W6­
0030.
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July
1997.

US
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1997b.
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Environmental
Assessment,
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of
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and
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EPA.
1997c.
Surrogate
Exposure
Guide:
Estimates
of
Worker
Exposure
from
the
Pesticide
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Exposure
Database,
Version
1.1.
May
1997.

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2000.
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(
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Assessments.
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of
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Effects
Division.
April
2000.

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EPA
2001b.
Review
of
a
Health
Risk
Assessment
for
PHMB
(
Vantocil
IB)
used
on
100%
Cotton
Textile
Application
­
Systemic
Toxicity
by
an
Infant
Sucking
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Memorandum
for
Siroos
Mostaghimi,
Ph.
D.
to
Adam
Heyward.
January
3,
2001.

Versar.
2003.
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(
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Version
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the
US
EPA
Antimicrobials
Division.
November
2003.

3.
Website
References
FDA,
2003a.
"
Guidance
For
Industry:
Preparation
of
Food
Contact
Notifications
and
Food
Additive
Petitions
for
Food
Contact
Substances:
Chemistry
Recommendations.
Final
Guidance."
US
Food
and
Drug
Administration.
April,
2003.
http://
www.
cfsan.
fda.
gov/~
dms/
opa2pmnc.
html.
Last
accessed
June
9,
2003.

FDA,
2003b.
"
Sanitizing
Solutions:
Chemistry
Guidelines
for
Food
Additive
Petitions."
US
Food
and
Drug
Administration.
January,
1993.
http://
www.
cfsan.
fda.
gov/~
dms/
opacg3a
html.
Last
accessed
June
9,
2003.

USEPA,
1999.
"
Available
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide."
US
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
June
21,
1999.
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf.
Last
accessed
June
9,
2003.

USEPA,
2001a.
"
General
Principles
for
Performing
Aggregate
Exposure
and
Risk
Assessments."
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Protection
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Office
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Pesticide
Programs.
November
28,
2001.
http://
www.
epa.
gov/
pesticides/
trac/
science/
aggregate.
pdf.

USEPA,
2004.
Overview
of
the
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Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
Appendix
A,
Section
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pg.
81.
US
Environmental
Protection
Agency.
January
24,
2004.
http://
www.
epa.
gov/
oppfead1/
endanger/
consultation/
ecorisk­
overview.
pdf.
74
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
PHMB
RED
for
a
list
of
studies
that
the
Agency
plans
to
require.
75
Appendix
F.
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
at
a
later
date.
76
Appendix
G.
Batching
of
PHMB
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
PHMB
as
an
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),
and
labeling
(
e.
g.,
signal
word,
use
classification,
precautionary
labeling).
Note
that
the
Agency
is
not
describing
batched
products
as
"
substantially
similar,"
since
they
may
not
have
similar
use
patterns.

Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Notwithstanding
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
partial
list
of
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.
The
Agency
must
approve
any
new
or
canceled
formulations
(
that
were
presented
to
the
Agency
after
the
publication
of
the
RED)
before
data
derived
from
them
can
be
used
to
cover
other
products
in
a
batch.
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
77
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.

If
a
registrant
would
like
to
have
the
batching
status
of
a
product
reconsidered,
he/
she
must
submit
detailed
information
on
the
product,
including
a
detailed
rationale
for
the
inclusion
of
the
product
into
a
batch.
An
MSDS
for
each
"
inert"
ingredient
should
be
included
where
possible.
A
current
version
of
the
Confidential
Statement
of
Formula
(
CSF)
is
to
be
included
in
the
submission.
However,
registrants
and
manufacturers
should
realize
that
the
more
unusual
their
formulation
is,
the
less
likely
it
is
to
be
able
to
batch
that
product.

Seventeen
products
were
found
which
contain
PHMB
as
an
active
ingredient.
These
products
have
been
placed
into
three
batches
and
a
"
No
Batch"
category
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.
The
following
bridging
strategies
may
be
employed:

°
Batch
3:
 
For
eye
irritation
and
skin
sensitization
data,
Registration
Numbers
72992­
2
and
72992­
8
may
only
cite
their
own
studies
or
those
of
72992­
2.
 
For
eye
irritation
and
skin
sensitization
data,
Reg.
No.
72992­
3
and
72992­
7
may
cite
each
other's
studies
but
not
72992­
2
or
72992­
8
studies.
 
For
all
other
studies,
each
product
must
cite
its
own
data
or
data
from
Reg.
No.
72992­
2.

°
No
Batch:
Each
product
in
this
batch
should
generate
its
own
data
(
or
cite
its
own
pre­
existing
data
if
it
exists
and
meets
current
Agency
standards).

Table:
PHMB
Batching,
Case
3122
Batch
EPA
Reg.
No.
Active
Ingredients
1258­
1275
PHMB
96.3%

BATCH
1
1258­
1277
PHMB
96.3%

1258­
1252
PHMB
20%

1258­
1253
PHMB
20%

1258­
1263
PHMB
20%

7124­
105
PHMB
20%

69461­
1
PHMB
20%

71864­
2
PHMB
20%
BATCH
2
81002­
2
PHMB
20%
78
72992­
2
PHMB
0.25%

Bronopol*
0.26%

*
CASRN
52­
51­
7,
EPA
code
216400
72992­
3
PHMB
0.09%

Bronopol*
0.09%

*
CASRN
52­
51­
7,
EPA
code
216400
72992­
7
PHMB
0.061%

Bronopol*
0.06%

*
CASRN
52­
51­
7,
EPA
code
216400
BATCH
3
As
indicated
in
the
above
introductory
comments,
the
four
products
listed
here
are
batched
together
with
the
following
limitations:

1.
For
eye
irritation
and
skin
sensitization
data,
Registration
Numbers
72992­
2
and
72992­
8
may
only
cite
their
own
studies
or
those
of
72992­
2.

2.
For
eye
irritation
and
skin
sensitization
data,
Reg.
No.
72992­
3
and
72992­
7
may
cite
each
other s
studies
but
not
72992­
2
or
72992­
8
studies.

3.
For
all
other
studies,
each
product
must
cite
its
own
data
or
data
from
Reg.
No.

72992­
2.
72992­
8
PHMB
0.1%

Bronopol*
0.104%

*
CASRN
52­
51­
7,
EPA
code
216400
1258­
1265
PHMB
20%

5813­
75
PHMB
0.1%

50096­
1
PHMB
3.17%

ADBAC*
7.11%

*
Alkyl
(
50%
C14,
40%
C12,
10%
C16)

dimethyl
benzyl
ammonium
chloride,

CASRN
68424­
85­
1,
EPA
code
069105
NO
BATCH
Each
product
in
this
batch
should
generate
its
own
data
(
or
cite
its
own
pre­
existing
data
if
it
exists
and
meets
current
Agency
standards).

71661­
1
PHMB
0.56%

Silver
0.0095
Please
note
that
while
products
may
have
the
same
percent
active
ingredient
as
another
product,
the
composition
of
their
inert
ingredients
may
vary
greatly.
79
MINIMUM
ACUTE
TOXICITY
ACCEPTANCE
CRITERIA
1
Does
the
study
report
clearly
identify
the
test
material?
That
is,
is
the
test
material
identified
by
EPA
Registration
Number,
product
name,
or,
is
the
product
listed
as
technical
grade?

2
Does
the
report
state
that
the
study
was
conducted
in
concurrence
with
the
(
1984)
40
CFR
§
160.12?

3
Is
the
test
species
identified?

4
Are
the
test
animals
the
proper
weight?
(
Rats
approximately
200­
300
grams,
rabbits
approximately
2.0
­
3.0
kg.)

5
Acute
oral,
dermal
and
inhalation
toxicity:
Did
the
observation
period
last
for
14
days,
or,
until
the
test
subjects
appeared
normal?

6
Primary
eye
irritation:
Did
the
observation
period
continue
for
21
days,
or,
until
all
irritation
subsided?
Studies
displaying
excessive
irritation
(
toxicity
category
I)
may
be
stopped
before
21
days.

7
Primary
skin
irritation:
Did
the
observation
period
continue
for
14
days,
or,
until
all
irritation
subsided?
Studies
displaying
excessive
irritation
(
toxicity
category
I)
may
be
stopped
before
14
days.

8
Acute
inhalation
toxicity:
Were
the
test
subjects
exposed
to
the
material
for
at
least
4
hours
(
if
there
was
no
mortality
during
the
exposure)?

9
Acute
inhalation
toxicity:
Was
particle
size
determined
at
least
twice
during
the
exposure?
Was
the
MMAD
between
1
and
4
microns
(
micrometers)?

10
Acute
inhalation
toxicity:
Was
the
particle
concentration
determined
at
least
twice
during
the
study?

Studies
that
do
not
meet
each
(
1­
10)
of
the
criteria
listed
above
will
be
rejected.
Please
be
informed
that
EPA's
guidelines
change
from
year
to
year.
A
study
that
was
accepted
25
or
more
years
ago
may
not
be
currently
acceptable.

Please
refer
to
the
following
documents
for
more
information.
1.
Health
Effects
Test
Guidelines,
Series
870,
EPA
712­
C­
98­
189,
August
1998.

2.
Conduct
of
Acute
Toxicity
Studies,
EPA
737­
R­
97­
002,
September
1997.
80
Appendix
H.
List
of
All
Registrants
Sent
the
Data
Call­
In
A
list
of
registrants
sent
the
data
call­
in
will
be
posted
at
a
later
date.
81
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
82
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
83
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:
ace.
orst.
edu/
info/
nptn.

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
84
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.