Document ID: EPA-HQ-OPP-2005-0262-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

United
States
Prevention,
Pesticides
EPA739­
R­
05­
008
Environmental
Protection
and
Toxic
Substances
September
2005
Agency
(
7510C)

Reregistration
Eligibility
Decision
for
Trichloromelamine
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
(
EPA)
has
completed
its
review
of
the
available
data
on
the
antimicrobial
trichloromelamine.
The
enclosed
Reregistration
Eligibility
Decision
(
RED)
document
was
approved
on
September
23,
2005.

Based
on
its
review,
EPA
is
now
publishing
its
Reregistration
Eligibility
Decision
(
RED)
and
risk
management
decision
for
trichloromelamine
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
assessment
for
trichloromelamine
are
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2005­
0262
at:
http://
www.
epa.
gov/
edockets.

Please
note
that
the
trichloromelamine
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
trichloromelamine
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
trichloromelamine
will
be
eligible
for
reregistration
provided
that
all
the
conditions
identified
in
this
document
are
satisfied.
Sections
IV
and
V
of
this
RED
document
describe
data
requirements
and
necessary
label
amendments.
Instructions
for
registrants
on
submitting
the
revised
labeling
can
be
found
in
the
set
of
instructions
for
product­
specific
data
that
accompanies
this
document.
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
TRICHLOROMELAMINE
List
C
CASE
3144
Approved
By:

Frank
T.
Sanders
Director,
Antimicrobials
Division
September
23,
2005
Attachment
Table
of
Contents
Trichloromelamine
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
Trichloromelamine
Risk
Assessments          ..
5
A.
Human
Health
Risk
Assessment               ...
5
1.
Toxicity
of
Trichloromelamine
             ..
5
2.
FQPA
Safety
Factor                  
8
3.
Population
Adjusted
Dose
(
PAD)            ...
9
a.
Acute
PAD                   
9
b.
Chronic
PAD                 
...
9
4.
Exposure
Assumptions                 
9
5.
Dietary
Risk
Assessment                .
9
a.
Dietary
Risk
from
Food             ..
9
b.
Dietary
Risk
from
Drinking
Water
        ..
11
6.
Residential
Risk
Assessment ...             
11
7.
Aggregate
Risk                    .
11
8.
Occupational
Risk                  ...
12
a.
Occupational
Toxicity              .
12
b.
Occupational
Handler
Exposure          
13
c.
Occupational
Handler
Risk
Summary       ...
13
B.
Environmental
Risk
Assessment               ...
15
1.
Environmental
Fate
and
Transport           ...
15
2.
Ecological
Risk                    .
15
a.
Toxicity
(
Hazard)
Assessment
...          
16
b.
Exposure
and
Risk
               .
16
c.
Risk
to
Listed
Species       .       .
16
IV.
Risk
Management,
Reregistration,
and
Tolerance
Reassessment
Decision 
17
A.
Determination
of
Reregistration
Eligibility           
17
B.
Public
Comments
and
Responses               .
17
C.
Regulatory
Position                     
17
1.
Food
Quality
Protection
Act
Findings          ...
17
a.
"
Risk
Cup"
Determination            .
17
b.
Determination
of
Safety
to
U.
S.
Population     .
18
c.
Determination
of
Safety
to
Infants
and
Children   
18
d.
Endocrine
Disruptor
Effects           ..
18
e.
Cumulative
Risks                .
19
2.
Tolerance
Summary                  
19
a.
Tolerance
Exemption
Currently
Listed
and
Tolerance
Reassessment                
20
b.
Codex
Harmonization              
20
D.
Regulatory
Rationale                    ..
20
1.
Human
Health
Risk
Management            .
20
2.
Environmental
Risk
Management          ..
21
3.
Other
Labeling
Requirements              
21
4.
Listed
Species
Considerations          ..   ..
21
a.
The
Endangered
Species
Act  .         .
21
b.
General
Risk
Mitigation    ...        ..
22
V.
What
Registrants
Need
to
Do                    
23
A.
Manufacturing­
Use
Products                 
25
1.
Additional
Generic
Data
Requirements          
25
2.
Labeling
for
Technical
and
Manufacturing­
Use
Products  ..
25
B.
End­
Use
Products                   ...  
25
1.
Additional
Product­
Specific
Data
Requirements    .........
25
2.
Labeling
for
End­
Use
Products             ..
26
a.
Label
Changes
Summary
Table          .
27
VI.
Appendices                           .
28
A.
Table
of
Use
Patterns
for
Trichloromelamine
         ..
29
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision              
32
C.
Technical
Support
Documents               ..
37
D.
Bibliography
Citations                   
38
E.
Generic
Data
Call­
In                    
43
F.
Product
Specific
Data
Call­
In                ..
44
G.
Batching
of
End­
Use
Products                
45
H.
List
of
All
Registrants
Sent
the
Data
Call­
In          
48
I.
List
of
Available
Forms                   
49
i
Trichloromelamine
Reregistration
Team
Health
Effects
Risk
Assessment
Laura
Bailey
Timothy
Leighton
Timothy
McMahon
Najm
Shamim
Ecological
Risk
Assessment
Genevieve
Angle
Registration
Support
Adam
Heyward
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
human
health
and
environmental
review
for
trichloromelamine
and
is
issuing
its
risk
management
decision.
The
Agency
has
decided
trichloromelamine
is
eligible
for
reregistration
provided
all
measures
outlined
in
this
document
are
implemented.
Trichloromelamine
is
a
sanitizer
and
disinfectant
with
direct
and
indirect
food
uses,
as
well
as
non­
food
uses.
It
is
used
on
hard
surfaces
and
as
a
fruit
and
vegetable
wash.
End­
use
products
are
formulated
as
a
soluble
concentrate
(
in
powder
form).
Trichloromelamine
currently
has
a
tolerance
exemption
as
an
antimicrobial
pesticide
when,
ready
for
use,
the
end­
use
concentration
does
not
exceed
200
ppm
(
40
CFR
180.940(
c))
when
applied
to
food
processing
equipment
and
utensils.

Overall
Risk
Summary
The
Agency's
human
heath
risk
assessment
indicates
no
risks
of
concern.
Acute
and
chronic
dietary
risk
estimates
were
completed
for
the
general
U.
S.
population
and
all
population
subgroups.
All
dietary
risk
estimates
are
below
the
Agency's
level
of
concern.
As
none
of
the
uses
associated
with
trichloromelamine
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,
combined
dermal
and
inhalation
risks
for
handlers
were
assessed.
All
margins
of
exposures
(
MOE)
are
below
the
Agency's
level
of
concern
when
workers
are
wearing
baseline
PPE
(
long­
sleeved
shirt
and
pants,
no
gloves).
In
cases
such
as
this,
where
an
oral
endpoint
is
used
to
evaluate
inhalation
exposures,
an
additional
10x
route­
toroute
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.
The
inhalation
MOE
for
either
washing
mess
kits
or
fruits
and
vegetables
in
military
mess
halls
falls
below
the
MOE
of
1,000.
Therefore,
an
inhalation
study
will
be
required
to
confirm
these
findings.

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
(
assumes
100%
of
fruits/
vegetables
consumed
are
treated
with
trichloromelamine
and
100%
transfer
of
residues
from
treated
food­
contact
surfaces)
was
conducted.
Risk
estimates
for
the
most
highly
exposed
population
subgroup,
children,
are
31.6%
of
the
aPAD
and,
therefore,
were
not
of
concern.

Chronic
dietary
risk
estimates
were
also
made
using
the
same
assumptions.
This
assessment
concludes
that
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
(<
54%
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
trichloromelamine
are
expected
to
impact
either
surface
or
ground
water
resources.
Therefore,
no
drinking
water
assessment
was
performed.

Residential
Risk
A
separate
residential
risk
assessment
was
not
performed,
as
the
assessment
for
occupational
handlers
in
restaurants
is
considered
to
be
a
conservative
and
protective
surrogate
for
residential
uses.
Since
a
higher
application
rate
is
found
on
the
label
used
to
calculate
occupational
risks,
these
values
are
used
to
represent
residential
risks
in
the
aggregate
assessment
and
are
an
overestimate
of
the
residential
exposures
and
risks.
These
values
are
not
being
refined
because
the
assessment
shows
no
risks
of
concern.

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
only,
as
no
residential
exposure
scenario
exists
for
children.
The
ARIs
are
greater
than
1.8
for
males
and
females
and
below
the
Agency's
level
of
concern
(
ARI<
1).
No
mitigation
measures
are
necessary
to
reduce
risks
from
aggregate
exposures.

Occupational
Risk
To
address
occupational
exposure,
combined
dermal
and
inhalation
risks
for
handlers
were
assessed.
All
margins
of
exposures
(
MOE)
are
below
the
Agency's
level
of
concern
when
workers
are
wearing
baseline
PPE
(
long­
sleeved
shirt
and
pants;
no
gloves).
However,
since
the
inhalation
MOE
for
either
washing
mess
kits
or
fruits
and
vegetables
in
military
mess
halls
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.

Environmental
and
Ecological
Risk
The
Agency
conducted
an
environmental
risk
assessment
to
determine
the
potential
impact
of
trichloromelamine
use
on
non­
target
terrestrial
and
aquatic
organisms.
Environmental
exposure
modeling
was
not
conducted
for
trichloromelamine
because
its
limited
use
as
a
food
surface
disinfectant
in
restaurants
and
similar
establishments
is
not
likely
to
result
in
significant
outdoor
exposure.
The
uses
of
trichloromelamine
considered
in
this
RED
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
trichloromelamine.
However,
the
high
toxicity
of
trichloromelamine
to
freshwater
organisms
is
of
concern
in
the
event
of
a
spill
or
misuse
of
the
product.

Regulatory
Decision
The
Agency
has
completed
its
review
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
supported
products
containing
trichloromelamine.
The
Agency
is
issuing
this
RED
for
trichloromelamine,
as
announced
in
a
Notice
of
Availability
published
in
vi
the
Federal
Register.
The
RED
and
supporting
risk
assessment
for
trichloromelamine
are
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2005­
0262
at
http://
www.
epa.
gov/
edockets.
This
RED
document
includes
guidance
and
time
frames
for
making
any
necessary
label
changes
for
products
containing
trichloromelamine.

Summary
of
Mitigation
Measures
The
Agency
has
determined
that
trichloromelamine
is
eligible
for
reregistration
provided
the
label
changes
included
in
Table
12
in
Section
V
of
the
RED
are
implemented.
As
there
are
no
risks
of
concern,
no
mitigation
measures
are
necessary.

Data
Requirements
Additional
confirmatory
data
are
required
to
complete
the
reregistration
of
trichloromelamine.
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
trichloromelamine
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
human
health
and
ecological
risk
assessments
and
the
Reregistration
Eligibility
Decision
(
RED)
for
trichloromelamine.

Trichloromelamine
is
used
as
an
indirect
food­
contact
sanitizer
and
disinfectant
in
or
on:
mess
gear;
food
processing
plants;
eating
establishments;
industrial
and
institutional
food
service
areas;
food
marketing,
storage,
and
distribution
equipment
and
utensils;
food
dispensing
equipment;
soft
custard
equipment;
and
household/
domestic
dwellings.
Trichloromelamine
is
also
used
as
a
direct
food­
contact
sanitizer
in
one
product
as
a
fresh
fruit
and
vegetable
wash.
Trichloromelamine
is
used
as
a
sanitizer
on
non­
food
contact
premises
and
equipment
in
hospitals
and
nursing
homes
(
non­
critical
areas)
and
institutional,
commercial,
and
industrial
settings.

The
Agency
has
concluded
that
the
FQPA
Safety
Factor
for
trichloromelamine
should
be
removed
(
equivalent
to
1X)
based
on:
(
1)
the
developmental
toxicity
studies
both
showed
a
lack
of
effects
in
offspring
up
to
and
including
the
highest
doses
tested
in
both
studies;
(
2)
the
LOAELs
for
both
studies
were
based
on
general
systemic
effects
that
were
not
considered
severe;
(
3)
both
studies
were
well­
designed
and
provided
an
adequate
dose­
response
for
trichloromelamine;
and
(
4)
the
risk
assessment
does
not
underestimate
the
potential
risk
for
infants
and
children.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
the
active
ingredients
trichloromelamine.
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
2
could
lead
to
the
same
adverse
health
effect
that
would
occur
at
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
trichloromelamine
and
any
other
substances.
Trichloromelamine
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
action,
therefore,
EPA
has
not
assumed
that
trichloromelamine
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
trichloromelamine.
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
document
for
trichloromelamine
referenced
in
this
RED.
The
risk
assessments
and
related
addenda
are
not
included
in
this
document,
but
are
available
in
the
Public
Docket
OPP­
2005­
0262
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
trichloromelamine,
and
its
regulatory
history.
Section
III,
Summary
of
Trichloromelamine
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
Trichloromelamine
was
first
registered
in
the
United
States
in
1959
as
an
active
ingredient.
Currently
eight
products
(
six
end­
use
products
and
two
technical­
grade
products)
are
registered
under
Section
3
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
for
use
as
a
disinfectant
and
sanitizer
(
primarily
on
food­
contact
surfaces).

B.
Chemical
Identification
Figure
1.
Molecular
Structure
of
Trichloromelamine
Common
name:
Trichloromelamine
Chemical
name:
1,3,5­
Triazine,
N,
N',
N''­
trichloro­
2,4,6­
triamino­

Chemical
family:
Triazine
Empirical
formula:
C3H3Cl3N6
CAS
Registry
No.:
7673­
09­
8
Case
number:
3144
OPP
Chemical
Code:
077101
Molecular
weight:
229.42
Other
names:
Decco
Salt
No.
5;
1,3,5­
Triazine­
2,4,6­
triamine,
N,
N',
N''­
trichloro­;
2,4,6­
Tris(
chloroamine)
triazine;
Chloromelamine;
Melamine,
N2,
N4,
N6­
trichloro­;
Melamine,
trichloro­;
N,
N',
N''­
Trichloro­
2,4,6­
triamine­
1,3,5­
triazine;
TCM
Basic
manufacturer:
JohnsonDiversey,
Inc.;
H
&
S
Chemical
Co.,
Inc.;
DBK,
Inc.
N
H
Cl
N
N
H
Cl
N
N
H
Cl
N
4
Chemical
properties:
Trichloromelamine
is
in
the
form
of
a
powder
and
is
cream
in
color.
It
has
a
melting
point
above
300
E
C.
The
water
solubility
of
trichloromelamine
is
0.064
g/
100
mL
at
20
E
C.
Trichloromelamine
has
a
vapor
pressure
of
7.1
x
10­
5
mm
Hg
at
25
E
C.

C.
Use
Profile
The
following
is
information
on
the
currently
registered
uses
of
products
that
contain
trichloromelamine
as
an
active
ingredient
and
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
trichloromelamine
eligible
for
reregistration
is
contained
in
Appendix
A.

Type
of
Pesticide:
Algicide,
Disinfectant,
Microbiocide/
Microbiostat
(
slime­
forming
bacteria),
Bacteriocide/
Bacteriostat,
Sanitizer
Summary
of
Use:

Food:
Trichloromelamine
is
used
as
an
indirect
food­
contact
sanitizer
and
disinfectant
in
or
on:
mess
gear
(
used
at
oversees
military
bases);
food
processing
plants;
eating
establishments
(
on
equipment,
utensils,
dishware,
glasses,
surfaces,
tabletops,
countertops,
floors,
walls,
sinks,
and
splashbacks);
industrial
and
institutional
food
service
areas
(
premises
and
equipment);
food
marketing,
storage,
and
distribution
equipment
and
utensils;
food
dispensing
equipment;
soft
custard
equipment;
and
household/
domestic
dwellings
(
food­
contact
surfaces).
Trichloromelamine
is
also
used
as
a
direct
food­
contact
sanitizer
in
one
product
as
a
fresh
fruit
and
vegetable
wash.

Non­
Food:
Trichloromelamine
is
used
as
a
sanitizer
on
non­
food
contact
premises
and
equipment
in
hospitals
and
nursing
homes
(
non­
critical
areas)
and
institutional,
commercial,
and
industrial
settings.

Target
Pests:
Slime­
Forming
Bacteria,
Animal
Pathogenic
Bacteria
(
g­
and
g+
vegetative),
Bacteria
(
causing
rot
or
decay),
Algae
Formulation
Types:
All
end­
use
products
are
powders
and
are
soluble
concentrates.

Method
and
Rates
of
Application:

Equipment:
Applied
to
surfaces
by
immersion,
wiping/
swabbing,
or
spraying
Application
Rates:
The
maximum
labeled
application
rate
for
the
direct
food
use
(
fruit
and
vegetable
wash)
is
0.0345%
a.
i.
in
solution
(
0.115
lbs.
used
daily).
For
indirect
and
non­
food
uses,
the
maximum
labeled
application
rates
are
0.0276%
a.
i.
in
solution
and
0.115
lbs.
used
daily.

Use
Classification:
General
use
5
III.
Summary
of
Trichloromelamine
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
document
listed
in
Appendix
C
was
used
to
formulate
the
safety
finding
and
regulatory
decision
for
trichloromelamine.
While
the
risk
assessment
is
not
included
in
this
document,
it
is
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
2005­
0262.
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
Trichloromelamine
A
brief
overview
of
the
acute
toxicity
studies
and
those
used
for
determining
endpoints
in
the
risk
assessment
are
outlined
below
in
Tables
1­
3.
Further
details
on
the
toxicity
of
trichloromelamine
can
be
found
in
the
"
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
September
15,
2005.
This
document
is
available
on
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.

The
Agency
has
reviewed
all
toxicity
studies
submitted
for
trichloromelamine
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
Trichloromelamine
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
Acute
Toxicity
81­
1
Acute
Oral
43165701
LD50
=
398
mg/
kg
II
81­
2
Acute
Dermal
43159901
LD50
>
2000
mg/
kg
III
81­
3
Acute
Inhalation
43368501
LC50
=
0.4
mg/
L,
males
and
0.780
mg/
L,
females
II
81­
4
Primary
Eye
Irritation
43159902
Severe
conjunctival
irritation
I
81­
5
Primary
Skin
Irritation
43159903
Severe
irritant
II
81­
6
Dermal
Sensitization
43159904
No
sensitization
reactions
for
group
treated
with
0.1%
[
w/
v]
solution
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.
For
the
chronic
dietary
endpoint,
the
uncertainty
factor
(
UF)
of
300
includes
a
10x
interspecies
extrapolation,
10x
intraspecies
variation,
and
3x
extrapolation
6
from
a
subchronic
study
to
a
chronic
endpoint.
The
Agency
chose
the
NOAEL
of
30
mg/
kg/
day
from
the
subchronic
study
in
rats
as
a
conservative
endpoint
for
all
exposure
scenarios.
Residues
of
trichloromelamine
are
likely
to
disappear
quickly
based
on
the
chemistry
of
trichloromelamine,
and
subchronic
and
chronic
exposures
are
likely
to
be
very
low.

Table
2.
Doses
and
Toxicological
Endpoints
Used
in
Exposure
Scenarios
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
Population
including
infants
and
children)
NOAEL
=
30
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
90­
Day
Oral
Rodent
Study
(
MRID
43064301)

LOAEL
=
150
mg/
kg/
day
A
NOAEL
of
30
mg/
kg/
day
was
determined,
based
on
histological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland)
observed
at
the
next
highest
dose
of
150
mg/
kg/
day.

Acute
Dietary
(
Females
13+
years
of
age)
An
appropriate
endpoint
for
this
sub­
population
was
not
identified
in
the
hazard
database
Chronic
Dietary
(
All
populations)
NOAEL
=
30
mg/
kg/
day
UF
=
300
Chronic
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.1
mg/
kg/
day
90­
Day
Oral
Rodent
Study
(
MRID
43064301)

LOAEL
=
150
mg/
kg/
day
A
NOAEL
of
30
mg/
kg/
day
was
determined,
based
on
histological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland)
observed
at
the
next
highest
dose
of
150
mg/
kg/
day.

Short­
Term
Incidental
Oral
(
1­
30
days)
NOAEL=
30
mg/
kg/
day
UF
=
100
Target
MOE
=
100
Occupational
=
NA
See
Chronic
Dietary
Endpoint
Intermediate­
Term
Incidental
Oral
(
1­
6
months)
NOAEL=
30
mg/
kg/
day
UF
=
100
Target
MOE
=
100
Occupational
=
NA
See
Chronic
Dietary
Endpoint
7
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term
and
Intermediate­
Term
Dermal
Exposure
Oral
Study
NOAEL=
30
mg/
kg/
day
UF
=
100
Dermal
Absorption=
100%
Target
MOE
=
100
See
Chronic
Dietary
Endpoint
Short­
Term
and
Intermediate­
Term
Inhalation
Exposure
No
appropriate
route­
specific
study
was
available.
The
oral
endpoint
of
30
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.

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
(
NOAEL/
UF),
MOE
=
margin
of
exposure
General
Toxicity
Observations
Table
3.
Summary
of
General
Toxicity
Data
for
Trichloromelamine
Guideline
No.
Study
Type
MRID
#(
s)
Results
Subchronic
Toxicity
82­
1(
a)
90­
day
Oral
Study
(
Rodent)
43064301
NOAEL
=
30
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day,
based
on
the
observation
of
histological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland).

Developmental
Toxicity
Systemic
Toxicity
NOAEL
<
30
mg/
kg/
day
and
LOAEL
 
30
mg/
kg/
day,
based
on
depressions
in
mean
maternal
body
weights
and
decreased
mean
feed
consumption
values.
43614301
(
Rabbit)

Developmental
toxicity
NOAEL
 
120
mg/
kg/
day
Maternal
NOAEL
<
62.5
mg/
kg/
day
and
LOAEL
 

62.5
mg/
kg/
day,
based
on
clinical
signs
at
several
or
all
dose
levels
(
alopecia,
gasping,
altered
respiration,
salivation,
lethargy,
chromodacryorrhea),
reduction
in
body
weight
gains,
and
statistically
significant
trends
for
decreased
food
consumption
at
all
dose
levels.
83­
3
Developmental
Toxicity
43614302
(
Rat)

Developmental
toxicity
NOAEL
=
500
mg/
kg/
day
8
Guideline
No.
Study
Type
MRID
#(
s)
Results
Mutagenicity
Studies
84­
2(
a)
84­
2(
b)
84­
2(
c)
Gene
Mutation
42148801,
42021801,
42021701
Positive
result
at
25
µ
g/
plate
for
TA98
and
at
50
µ
g/
plate
in
Chinese
hamster
ovary
cells,
both
with
and
without
metabolic
activation.
Negative
result
in
primary
rat
hepatocytes.

Notes:
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level
Melamine
Toxicity
Trichloromelamine
is
expected
to
rapidly
break
down
into
hypochlorous
acid
and
melamine
(
EPA,
1994).
A
number
of
toxicity
studies
have
been
performed
to
characterize
the
hazard
of
melamine.
The
Agency
has
concluded
that
it
is
unlikely
that
melamine
is
a
carcinogenic
hazard
to
humans
from
the
pesticidal
usage
of
a
pesticide
product
(
EPA,
1988).
They
noted
that
"
humans
are
not
likely
to
be
exposed
to
the
high
doses
of
melamine
that
produce
the
urinary
tract
toxicity
that
precedes
and
seems
to
lead
to
the
carcinogenic
response
in
rats"
(
EPA,
1993).
This
conclusion
is
based
on
the
review
of
a
number
of
studies,
including
a
mouse
carcinogenicity
study
in
which
no
evidence
of
tumors
were
found
due
to
exposure
to
melamine
at
the
highest
dose
tested.
In
addition,
the
weight­
of­
evidence
is
not
sufficient
to
reasonably
anticipate
that
melamine
will
cause
serious
or
irreversible
chronic
health
effects
(
EPA,
1983).

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,
trichloromelamine
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
trichloromelamine
based
on:
(
1)
the
developmental
toxicity
studies
both
showed
a
lack
of
effects
in
offspring
up
to
and
including
the
highest
doses
tested
in
both
studies;
(
2)
the
LOAELs
for
both
studies
were
based
on
general
systemic
effects
that
were
not
considered
severe;
(
3)
both
studies
were
well­
designed
and
provided
an
adequate
doseresponse
for
trichloromelamine;
and
(
4)
the
risk
assessment
does
not
underestimate
the
potential
risk
for
infants
and
children.
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.
9
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
trichloromelamine
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
(
0.3
mg/
kg/
day)
modified
by
the
FQPA
safety
factor.
The
acute
reference
dose
was
derived
from
a
90­
day
subchronic
oral
toxicity
study
in
rats
in
which
both
the
NOAEL
(
30
mg/
kg/
day)
and
the
LOAEL
(
150
mg/
kg/
day)
were
determined.
The
trichloromelamine
aPAD
is
0.3
mg/
kg/
day
based
on
a
reference
dose
of
0.3
mg/
kg/
day,
and
incorporating
the
FQPA
safety
factor
of
1X.

b.
Chronic
PAD
Chronic
dietary
risk
for
trichloromelamine
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
(
0.1
mg/
kg/
day)
modified
by
the
FQPA
safety
factor
(
1X).
The
cPAD
was
derived
from
a
90­
day
subchronic
oral
toxicity
study
in
rats
in
which
both
the
NOAEL
(
30
mg/
kg/
day)
and
the
LOAEL
(
150
mg/
kg/
day)
were
determined
based
on
histopathological
lesions.
The
trichloromelamine
cPAD
is
0.1
mg/
kg/
day
based
on
a
reference
dose
of
0.1
mg/
kg/
day,
which
includes
the
incorporation
of
the
FQPA
safety
factor
(
1X)
for
the
overall
U.
S.
population
or
any
population
subgroups.

4.
Exposure
Assumptions
Acute
and
chronic
dietary
exposure
assessments
were
conducted
using
FDA
assumptions
for
the
residues,
migration,
and
surface
area
of
exposure
from
indirect
food­
contact
surfaces.
The
assessment
for
the
fruit
and
vegetable
rinse
was
conducted
using
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
The
CSFII
data
are
based
on
the
reported
food
consumption
by
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
For
exposure
estimates,
mean
consumption
data
are
used
for
adult
male
and
female
populations.
It
is
assumed
that
children
are
not
eating
in
military
mess
halls
overseas.

5.
Dietary
Risk
Assessment
a.
Dietary
Risk
from
Food
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.
10
Screening­
level
dietary
risk
assessments
were
conducted
for
the
direct
and
indirect
food
uses
of
trichloromelamine.
The
estimates
dietary
intake
(
EDI)
for
consumption
of
fruits
and
vegetables
was
based
on
a
mean
consumption
estimate
for
males
and
females
ages
20
and
older
in
military
mess
halls
from
the
CSFII
data
for
both
acute
and
chronic
exposures.
The
dietary
intake
for
fruits
and
vegetables
is
limited
to
subset
of
the
general
population,
specifically
members
of
the
military;
since
this
subpopulation
is
not
representative
of
the
general
population,
the
90th
percentile
was
not
used
to
calculate
dietary
risk.
For
disinfecting
mess
kits,
FDA
worstcase
assumptions
were
used.
The
results
of
the
assessment
for
military
mess
hall
patrons
showed
risks
to
be
6.2%
(
males)
and
7.1%
(
females)
of
the
aPAD
and
18.6%
(
males)
and
21.3%
(
females)
of
the
cPAD
and,
therefore,
are
not
of
concern.

The
indirect
food
uses
in
eating
establishments,
disinfecting
utensils
and
countertops,
were
also
assessed
using
FDA
worst­
case
assumptions.
For
both
assessments,
the
product
with
highest
percent
of
the
active
ingredient
in
solution
(
as
diluted
per
label
instructions)
was
used
to
estimate
the
worst
case
scenario.
However,
two
labels
state
that
additional
quantities
should
be
used
if
the
diluted
solution
falls
below
100
ppm
available
chlorine
and
list
the
amount
of
product
required
to
achieve
200
ppm
available
chlorine.
Although
the
Agency
does
not
believe
that
these
higher
concentrations
will
be
used
often,
as
a
conservative
measure,
they
are
assessed
as
an
acute
exposure.
The
results
of
the
assessment
for
bar
and
restaurant
patrons
showed
risks
to
be
<
32%
of
the
aPAD
and
53.7%
of
the
cPAD
for
children,
the
most
highly
exposed
population
subgroup.
Therefore,
all
risks
are
below
the
Agency's
level
of
concern.

Table
4.
Summary
of
Dietary
Exposure
and
Risk
Population
EDIa
(
mg/
kg/
day)
%
PADb
Military
Fruits/
Vegetables
Mess
Kits
Total
Acute
Chronic
Adult
Males
0.00282
0.0158
0.0186
6.20%
18.6%

Adult
Females
0.00290
0.0184
0.0213
7.10%
21.3%

Restaurant/
Bar
(
Acute)

Food
Utensil
Countertop
Total
Acute
Adult
Males
0.0135
0.00677
0.0203
6.77%

Adult
Females
0.0158
0.0079
0.0237
7.90%

Children
0.0632
0.0316
0.0948
31.6%

Restaurant/
Bar
(
Chronic)

Food
Utensil
Countertop
Total
Chronic
Adult
Males
0.00669
0.00483
0.0115
11.5%

Adult
Females
0.00780
0.00563
0.0134
13.4%

Children
0.0312
0.0225
0.0537
53.7%
EDI=
Estimated
Daily
Intake;
PAD=
Population
Adjusted
Dose
(
acute
or
chronic)
a
EDI=
Intake
(
mg/
person/
day)/
BW
(
adult
male=
70kg,
adult
female=
60kg,
and
child=
15kg)
b
%
PAD
=
EDI/
aPAD
or
cPAD
*
100,
where
aPAD=
0.3
mg/
kg/
day
and
cPAD=
0.1
mg/
kg/
day
11
b.
Dietary
Risk
from
Drinking
Water
None
of
the
uses
associated
with
trichloromelamine
are
expected
to
impact
either
surface
or
ground
water
resources.
Therefore,
no
drinking
water
assessment
was
performed.

6.
Residential
Risk
Assessment
A
separate
residential
risk
assessment
was
not
performed,
as
the
assessment
for
occupational
handlers
in
restaurants
is
considered
to
be
a
conservative
and
protective
surrogate
for
residential
uses.
Since
a
higher
application
rate
is
found
on
the
label
used
to
calculate
occupational
risks,
these
values
are
used
to
represent
residential
risks
in
the
aggregate
assessment
and
are
an
overestimate
of
the
residential
exposures
and
risks.
These
values
are
not
being
refined
because
the
assessment
shows
no
risks
of
concern.

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.
A
short­/
intermediate­
term
aggregate
assessment
was
performed
for
adults
exposed
to
trichloromelamine
based
on
the
following
exposure
scenarios:
dietary
exposure
from
eating
food
that
has
come
into
contact
with
treated
surfaces,
utensils,
and
glassware;
dermal
and
inhalation
exposure
from
opening
and
pouring
of
the
trichloromelamine
product
in
residential
settings;
and
dermal
and
inhalation
exposure
from
wiping
the
countertop
in
residential
settings.
No
aggregate
assessment
was
performed
for
children
as
they
are
not
likely
to
have
non­
dietary
exposures.
Further,
a
long­
term
aggregate
assessment
is
not
necessary,
as
the
residential
exposure
scenarios
associated
with
trichloromelamine
uses
involve
only
short­
and
intermediate­
term
exposures.

Aggregate
MOE
calculations
were
performed
using
the
Aggregate
Risk
Index
(
ARI)
method
(
EPA,
2001).
Generally,
an
ARI
that
is
greater
than
1
does
not
exceed
the
Agency's
risk
concerns.
As
shown
in
Table
5,
no
aggregate
risks
of
concern
were
identified
for
either
males
or
females,
as
the
ARI
value
is
above
1
for
both.
Further
details
on
the
aggregate
risk
assessment
of
trichloromelamine
can
be
found
in
the
"
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
September
15,
2005.
This
document
is
available
on
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.
12
Table
5.
Summary
of
Short­
and
Intermediate­
Term
(
ST/
IT)
Aggregate
Exposure
and
Risk
Calculations
Population
Chronic
Food
Exposure
mg/
kg/
day
(
MOE)
Opening
and
Pouring
Inhalation
Exposure
mg/
kg/
day
(
MOE)
Opening
and
Pouring
Dermal
Exposure
mg/
kg/
day
(
MOE)
Wiping
Inhalation
Exposure
mg/
kg/
day
(
MOE)
Wiping
Dermal
Exposure
mg/
kg/
day
(
MOE)
Aggregate
Risk
Index
Adult
Males
0.0115
(
2610)
1.72x10­
6
(
1.7x107)
3.18x10­
3
(
9400)
1.16x10­
3
(
26,000)
1.20x10­
1
(
250)
1.89
Adult
Females
0.0134
(
2240)
1.72x10­
6
(
1.7x107)
3.18x10­
3
(
9400)
1.16x10­
3
(
26,000)
1.20x10­
1
(
250)
1.83
ARI
=
1/
((
UF1/
MOE1)
+
(
UF2/
MOE2)
+
(
UF3/
MOE3)
+
 ),
where
the
UF
=
300
for
chronic
dietary
exposure
and
100
for
inhalation
and
dermal
exposures.
ARIs
greater
than
1
are
not
of
concern.

8.
Occupational
Risk
Workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
pesticide.
Occupational
handlers
of
trichloromelamine
include
workers
in
military
mess
halls;
restaurants
and
bars;
food
processing
plants;
institutional,
commercial,
and
industrial
sites;
and
hospitals
and
nursing
homes.
In
this
assessment,
it
is
assumed
that
workers
in
military
mess
halls
and
restaurants
represent
the
high­
end
exposure
scenario
for
all
workers
exposed
to
trichloromelamine.
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
trichloromelamine,
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
extrapolation
(
differences
between
humans
and
animals).

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
powder
formulations,
as
all
products
are
in
this
form.
For
more
information
on
the
assumptions
and
calculations
of
potential
risk
of
trichloromelamine
to
workers,
see
the
Occupational
Exposure
Assessment
(
Section
5.1)
in
the
"
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
September
15,
2005.

a.
Occupational
Toxicity
The
toxicological
endpoints
used
in
the
assessment
can
be
found
in
Table
2
above.
13
b.
Occupational
Handler
Exposure
Occupational
handler
risk
estimates
have
been
assessed
for
trichloromelamine
using
surrogate
unit
exposure
data
from
the
Chemical
Manufacturers
Association
(
CMA)
database,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled
(
MRID
42587501).

The
Agency
has
determined
that
there
are
potential
exposures
to
individuals
who
mix,
load,
apply,
and
otherwise
handle
trichloromelamine
during
the
usual
use
patterns
associated
with
the
pesticide's
use.
Based
on
the
use
patterns,
the
following
exposure
scenarios
were
assessed:

(
1)
mixing/
loading
powder
formulations
(
opening
and
pouring
packets
into
water);
(
2)
applying
by
dipping
mess
kits
into
diluted
solution;
(
3)
applying
by
dipping
fruits
and
vegetables
into
diluted
solution;

(
4)
applying
by
dipping
food
utensils
into
diluted
solution;
and
(
5)
applying
by
wiping
countertops
with
diluted
solution.

c.
Occupational
Handler
Risk
Summary
Occupational
Handler
Exposure
Assumptions
Exposure
analyses
were
performed
using
the
surrogate
data
from
the
Chemical
Manufacturers
Association
(
MRID
42587501)
and
the
DERMAL
model
(
U.
S.
EPA,
1997).
A
description
of
these
and
the
calculations
used
are
included
in
the
Occupational
Exposure
Assessment
(
Section
5.1)
in
the
"
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
September
15,
2005.
Both
inhalation
and
dermal
exposures
were
assessed,
and
these
exposures
were
combined
because
the
endpoints
were
based
on
the
same
study.
The
target
MOE
is
100.
Scenarios
with
an
MOE
less
than
100
indicate
a
risk
of
concern.

The
following
assumptions
and
factors
were
used
in
order
to
complete
the
exposure
and
risk
assessments
for
occupational
handlers:

 
It
is
assumed,
for
this
assessment,
that
two
4.77
oz.
packets
are
sufficient
for
the
needs
of
an
individual
worker
in
a
mess
hall
kitchen
per
day,
either
washing
mess
kits
or
washing
fruits
and
vegetables;

 
Labels
for
restaurant
and
bar
use
state
that
additional
quantities
should
be
used
if
the
diluted
solution
falls
below
100
ppm
available
chlorine.
It
is
assumed,
for
this
occupational
assessment,
that
the
available
chlorine
does
not
fall
over
the
course
of
a
day,
and
that
the
standard
label
rate
is
sufficient
for
the
needs
of
one
worker
in
a
restaurant
per
day.
The
maximum
typical
rate
from
any
label
for
this
use
was
the
basis
for
this
assessment;

$
The
surrogate
data
from
the
Chemical
Manufacturers
Association
(
MRID
42587501)
for
`
solid
pour'
scenarios
are
representative
to
model
dermal
and
inhalation
exposure
from
14
opening
the
packet
and
pouring
the
contents,
as
well
as
for
`
wiping'
scenarios
are
representative
of
inhalation
exposure
from
standing
over
the
containers
with
solution
while
washing
mess
kits,
fruits
and
vegetables,
countertops,
and
utensils;

$
To
calculate
the
dermal
exposure
for
a
worker
treating
mess
kits,
fruits,
and
vegetables,
the
DERMAL
model
was
used
(
U.
S.
EPA,
1997);

 
A
body
weight
of
70
kg
was
assumed
because
the
endpoint
is
not
gender
specific;

 
The
inhalation
and
dermal
absorption
rates
are
100%;

 
Baseline
PPE
includes
long
sleeve
shirts,
long
pants
and
no
gloves
or
respirator;
and
 
All
trichloromelamine
products
are
powders
that
are
mixed
with
water
per
labeled
instructions
to
form
a
diluted
solution.

Summary
of
Risk
Estimates
for
Handlers
All
of
the
inhalation
and
dermal
MOEs
are
above
the
target
MOE
of
100
with
baseline
PPE
and,
therefore,
not
of
concern.
No
respiratory
or
dermal
PPE
is
required.
As
a
conservative
measure,
it
is
assumed
that,
because
this
is
potentially
a
small­
scale
process,
one
person
could
mix
the
solution
and
use
it
immediately
after.
The
combined
risks
from
these
exposures
are
below
the
Agency's
level
of
concern.
However,
as
the
inhalation
MOE
for
either
washing
mess
kits
or
fruits
and
vegetables
in
military
mess
halls
falls
below
the
MOE
of
1,000,
when
the
additional
route­
to­
route
extrapolation
uncertainty
factor
is
applied,
an
inhalation
study
would
be
required
to
confirm
these
findings.
The
MOEs
for
handlers
are
summarized
in
Tables
6
and
7.

Table
6.
Occupational
Handler
Risk
Summary
Exposure
Scenario
Use
site
Label
Application
Rate
(
lb
a.
i./
day)
a
Baseline
Dermal
MOE
Baseline
Inhalation
MOE
Mix/
Load
(
Opening
and
Pouring)
Powder
Mess
Kits
&
Fruits/
Vegetables
(
Military
Mess
Halls)

Food
Utensils
&
Hard
Surfaces
(
Commercial/
Institutional)
0.115
0.00292
240
9400
440,000
1.7
x
107
Washing
Mess
Kits
Fruits/
Vegetables
Food
Utensils
(
Comm/
Inst)
0.115
(
0.0276%
a.
i.)

0.115
(
0.0345%
a.
i.)

0.00292
(
0.0117%
a.
i.)
5200
4200
6100
660
660
26,000
Wiping
Commercial/
Institutional
Hard
Surfaces
0.00292
250
26,000
a
For
dermal
calculations
for
washing
mess
kits;
fruits
and
vegetables;
and
food
utensils,
the
weight
fraction
of
active
ingredient
in
the
product
(
after
dilution)
is
used
rather
than
the
pounds
of
a.
i.
used
daily.
15
Table
7.
Combined
Occupational
Handler
Risk
Summary
Exposure
Scenario
Crop
Dermal
MOE
Inhalation
MOE
Aggregate
MOE
Mix/
Load
(
Opening
and
Pouring)
Powder
+
Washing
Mess
Kits
Fruits/
Vegetables
Food
Utensils
230
230
3700
660
660
26,000
170
170
3200
Mix/
Load
(
Opening
and
Pouring)
Powder
+
Wiping
Commercial/
Institutional
Hard
Surfaces
240
26,000
240
B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
is
presented
below.
Trichloromelamine
has
several
registered
use
sites:
fruits
and
vegetables,
eating
establishment
utensils
and
glassware,
and
food
and
non­
food
contact
surfaces.
The
following
risk
characterization
is
intended
to
describe
the
magnitude
of
the
estimated
environmental
risks
for
trichloromelamine
use
sites
and
any
associated
uncertainties.

For
detailed
discussions
of
all
aspects
of
the
environmental
risk
assessment,
see
the
Ecotoxicology
and
Environmental
Risk
Assessment
(
Section
8.0)
in
the
"
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,"
dated
September
15,
2005.

1.
Environmental
Fate
and
Transport
According
to
EPA's
EPI
Suite
database
used
by
OPPTS,
a
linear
model
on
biodegradability
predicts
that
trichlormelamine
has
a
high
probability
of
biodegrading
in
water
within
hours.
The
half­
life
in
air
for
trichloromelamine,
as
determined
through
mediation
of
the
hydroxy
radical
in
the
atmosphere,
is
about
16
days
(
based
on
a
12­
hour
day),
and
it
appears
to
be
moderately
persistent
in
the
atmosphere
(
EPA,
2005).

The
half­
life
of
trichloromelamine
in
soils
has
been
estimated
to
be
about
38
days
and
150
days
in
sediments.
With
an
estimated
Koc
of
150,
it
is
likely
to
be
immobile
and
persistent
in
soils
and
sediments
and
may
not
pose
a
concern
for
groundwater
contamination.
However,
as
trichloromelamine
is
immobile,
it
may
pose
a
concern
for
surface
water
contamination
due
to
soil
erosion.
Because
use
of
trichloromelamine
is
limited
to
use
as
a
food
and
food­
contact
surface
sanitizer
in
restaurants
and
similar
establishments,
and
in
military
mess
halls,
trichloromelamine
is
not
expected
to
enter
the
environment
and
exposure
to
soil
and
water
should
be
minimal.

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.
16
a.
Toxicity
(
Hazard)
Assessment
Information
regarding
the
potential
ecotoxicity
of
trichloromelamine
is
shown
in
Table
8.
In
addition,
although
the
information
currently
available
regarding
melamine,
a
degradate
of
trichloromelamine,
toxicity
is
insufficient
for
a
hazard
assessment,
the
Agency
believes
that
there
is
sufficient
evidence
to
conclude
that
melamine
may
be
chronically
toxic
to
fish
and
invertebrates,
causing
adverse
effects
on
reproduction
and
embryonic
development.
It
was
noted
that
melamine
may
be
more
toxic,
chronically,
than
the
data
reviewed
indicate
(
EPA,
1983).
Based
on
the
structure­
activity­
relationship
(
SAR)
of
melamine
to
meta­
phenylenediamine,
the
96­
hour
EC50
for
melamine
for
green
algae
is
expected
to
be
2.4
mg/
L.
The
LC50
for
daphnids
is
expected
to
be
5.9
mg/
L,
and
the
MATC
is
expected
to
range
between
0.05
and
0.09
mg/
L.

Table
8.
Summary
of
Ecotoxicity
Data
(
Trichloromelamine)

Endpoint
Type
Species
Results
Reference/
MRID#

Acute
Avian
Oral
Bobwhite
quail
(
Colinus
virginianus)
LD50
>
5,000
mg/
kg
NOEC
=
5,000
mg/
kg
42250801
Acute
Avain
Diet
Bobwhite
quail
(
Colinus
virginianus)
LD50
>
2,150
mg/
kg
42280801
Acute
Avain
Diet
Mallard
duck
(
Anas
platyrhynchos)
LC50
>
5,000
mg/
kg
NOEC
=
2,500
mg/
kg
42247401
Acute
Fish
Toxicity
Bluegill
sunfish
(
Lepomis
macrochirus)
LC50
=
4.5
mg/
L
NOEC
=
1.0
mg/
L
41934901
Acute
Fish
Toxicity
Rainbow
Trout
LC50
=
4.0
mg
a.
i./
L
NOEC
=
0.56
mg
a.
i./
L
42010601
Acute
Aquatic
Invertebrate
Toxicity
Daphnia
EC50
=
0.80
mg
ai/
L
NOEC
=
0.32
mg
ai/
L
42020801
b.
Exposure
and
Risk
Environmental
exposure
modeling
was
not
conducted
for
trichloromelamine.
Because
the
use
of
trichloromelamine
is
limited
to
use
as
a
food
surface
disinfectant
in
restaurants
and
similar
establishments,
significant
outdoor
exposure
is
not
likely
to
result.
The
uses
of
trichloromelamine
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur.
However,
the
high
toxicity
of
trichloromelamine
to
freshwater
organisms
is
of
concern
in
the
event
of
a
spill
or
misuse
of
the
product.

c.
Risk
to
Listed
Species
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
trichloromelamine,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.
17
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
trichloromelamine
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
trichloromelamine.

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
trichloromelamine.
Based
on
a
review
of
these
data,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
trichloromelamine
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
trichloromelamine­
containing
products
are
eligible
for
reregistration
provided
that:
(
i)
current
data
gaps
and
confirmatory
data
needs
are
addressed
and
(
ii)
necessary
label
amendments
are
made.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
trichloromelamine
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
trichloromelamine
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.

B.
Public
Comments
and
Responses
Risk
assessments
for
trichloromelamine
were
not
issued
for
public
comment
per
the
Agency's
public
participation
process
because
no
risks
of
concern
were
identified.
To
ensure
that
an
opportunity
is
presented
to
the
public
to
comment
on
the
risk
assessments
and
risk
management
decisions
for
trichloromelamine,
the
Agency
will
implement
a
public
comment
period
on
this
RED
document.

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
trichloromelamine.
The
Agency
has
concluded
that
the
exemption
from
the
requirement
of
a
tolerance
for
trichloromelamine
meets
the
FQPA
safety
standards
and
that
the
risk
from
dietary
exposure
is
within
the
"
risk
cup."
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
other
residential
uses.
The
Agency
has
determined
that
the
human
health
risks
18
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
trichloromelamine.
The
Agency
has
determined
that
the
established
tolerance
exemption
for
trichloromelamine
meets
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
trichloromelamine.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
trichloromelamine.

Dietary
risk
assessments
were
conducted
for
adults
and
children,
with
the
highest
risk
(
31.6%
aPAD
and
53.7%
cPAD
for
children)
being
below
the
Agency's
level
of
concern.
Aggregate
assessments
were
only
conducted
for
adults,
as
no
residential
non­
dietary
exposure
scenarios
existed
for
children.
The
Aggregate
Risk
Index
was
above
1.8
for
both
adult
males
and
females,
which
is
above
the
Agency's
level
of
concern
(
ARI 
1).

c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
established
tolerance
exemption
for
trichloromelamine,
with
amendments
and
changes
as
specified
in
this
document,
meets
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
factors
of
the
toxicity,
use
practices,
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
trichloromelamine
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
trichloromelamine
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
trichloromelamine
based
on:
(
1)
the
developmental
toxicity
studies
both
showed
a
lack
of
effects
in
offspring
up
to
and
including
the
highest
doses
tested
in
both
studies;
(
2)
the
LOAELs
for
both
studies
were
based
on
general
systemic
effects
that
were
not
considered
severe;
(
3)
both
studies
were
well­
designed
and
provided
an
adequate
dose­
response
for
trichloromelamine;
and
(
4)
the
risk
assessment
does
not
underestimate
the
potential
risk
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
19
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,
trichloromelamine
may
be
subject
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

e.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
trichloromelamine.
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
trichloromelamine.
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
A
tolerance
exemption
is
currently
established
for
trichloromelamine
in
the
40CFR
§
180.940(
c)
when
used
in
accordance
with
good
manufacturing
practice
as
an
ingredient
in
an
antimicrobial
pesticide
formulation,
provided
that
the
substance
is
applied
on
a
semi­
permanent
or
permanent
food­
contact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food.
Trichloromelamine
is
currently
exempted
from
the
requirement
of
a
tolerance
when
applied
to
food
processing
equipment
and
utensils,
provided
that,
when
ready
for
use,
the
end­
use
concentration
does
not
exceed
200
ppm
as
total
available
chlorine.
20
Although
there
is
a
use
for
dairy
processing
on
one
of
the
labels
(
Reg.
No.
6198­
3),
no
tolerance
exemption
for
this
use
has
been
established
and
this
registrant
has
expressed
its
intention
to
remove
this
use
from
the
label
(
Landman,
2005).
Any
registrant
wishing
to
maintain
this
use
site
for
trichloromelamine
must
petition
the
Agency
for
an
exemption
from
the
requirement
of
a
tolerance
under
the
40CFR
§
180.940(
b).
If
no
such
petition
is
received
by
the
Agency,
any
reference
on
a
label
to
dairy
processing
facilities
or
dairies
must
be
removed
during
product
reregistration.

a.
Tolerance
Exemption
Currently
Listed
Under
40
CFR
§
180.940
and
Tolerance
Reassessment
Table
9.
Tolerance
Reassessment
Summary
for
Trichloromelamine
Tolerance
Exemption
Listed
Under
40
CFR
§
180.940
(
c)

Use
Site
Current
Limit
(
ppm)
Tolerance
Reassessment
(
ppm)
Correct
Definition/
Comment
Food
processing
equipment
and
utensils
200
(
as
available
chlorine)
200
(
as
available
chlorine)
Trichloromelamine
is
exempted
from
the
requirement
of
a
tolerance
as
an
antimicrobial
pesticide,
provided
that
the
substance
is
applied
on
a
semi­
permanent
or
permanent
foodcontact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food,
when
applied
to
food
processing
equipment
and
utensils,
as
long
as,
when
ready
for
use,
the
end­
use
concentration
does
not
exceed
200
ppm
as
total
available
chlorine.
Based
on
the
evaluation
of
available
data,
the
current
tolerance
of
200
ppm
should
remain.

b.
Codex
Harmonization
Currently
there
are
no
Codex
MRLs
established
for
trichloromelamine.

D.
Regulatory
Rationale
The
Agency
has
determined
that
trichloromelamine
is
eligible
for
reregistration
provided
that
additional
required
data
confirm
this
decision
and
the
necessary
label
amendments
are
made.
Where
labeling
revisions
are
warranted,
specific
language
is
set
forth
in
the
summary
table
of
Section
V
of
this
document.

1.
Human
Health
Risk
Management
As
the
risk
estimates
resulting
from
dietary,
residential,
and
occupational
exposures
are
all
below
the
Agency's
level
of
concern,
no
risk
mitigation
measures
are
required
to
address
human
exposure
to
trichloromelamine.
21
2.
Environmental
Risk
Management
As
the
uses
of
trichloromelamine
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur,
no
risk
mitigation
measures
are
required
to
address
environmental
exposure
to
trichloromelamine.

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
trichloromelamine.
As
there
are
no
mitigation
measures
being
required,
the
only
specific
labeling
statements
(
in
Section
V)
are
precautionary
(
in
case
of
a
spill)
based
on
acute
ecotoxicity
data.

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

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

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
22
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
trichloromelamine,
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
Trichloromelamine
end­
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
trichloromelamine
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.
23
V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
trichloromelamine
is
eligible
for
reregistration
provided
that:
(
i)
additional
data
that
the
Agency
intends
to
require
confirm
this
decision
and
(
ii)
necessary
label
amendments,
set
forth
in
the
Label
Changes
Summary
Table
in
Section
B
below
(
Table
12),
are
made.
The
additional
data
requirements
that
the
Agency
intends
to
obtain
will
include,
among
other
things,
submission
of
the
following:

For
trichloromelamine
technical
grade
active
ingredient
products,
the
registrant
needs
to
submit
the
following
items:

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

1.
completed
response
forms
to
the
GDCI
(
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
GDCI:

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

Please
contact
Jennifer
Slotnick
at
(
703)
305­
0601
with
questions
regarding
generic
reregistration.

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
GDCI/
AD)
Document
Processing
Desk
(
GDCI/
AD)
Jennifer
Slotnick
Jennifer
Slotnick
Office
of
Pesticide
Programs
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
US
EPA
US
EPA
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
S.
Bell
Street
Arlington,
VA
22202
24
For
end­
use
products
containing
the
active
ingredient
trichloromelamine,
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
12
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/
AD)
Document
Processing
Desk
(
PDCI/
AD)
Adam
Heyward
Adam
Heyward
Office
of
Pesticide
Programs
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
US
EPA
US
EPA
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
South
Bell
Street
Arlington,
VA
22202
25
A.
Manufacturing­
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
database
supporting
the
reregistration
of
trichloromelamine
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
trichloromelamine.
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
trichloromelamine.

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
10.
Confirmatory
Data
Requirements
for
Reregistration
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

28­
Day
Inhalation
Toxicity
Study­
Rata
870.3465
82­
4
Dermal
Indoor
Exposure
875.1200,
875.1600
233
Inhalation
Indoor
Exposure
875.1400,
875.1600
234
Descriptions
of
Human
Activity
875.2800
133­
1
aStudy
duration
must
be
at
least
28
days.

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
12,
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
26
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
11
below.

Table
11.
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
40510­
1
65169­
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)

Disinfectant
Fruits
and
vegetables
40510­
1
Special
Studya
NA
NA
Sanitizer
Non­
food
contact
surfaces
(
nonresidual
65169­
1
70627­
28
Sanitizer
Test
for
Hard
Inanimate
Non­
Food
Contact
Surfaces
810.2100
(
l)
91­
2
(
j)

Sanitizer
Previously
cleaned
food­
contact
surfaces
(
nonresidual
6198­
3
8160­
1
65169­
1
70627­
26
70627­
28
AOAC
Germicidal
and
Detergent
Sanitizers
Method
810.2100
(
m)(
2)
91­
2
(
l)(
2)

NA=
Not
Applicable
a
The
registrant
for
this
use
will
need
to
work
with
the
Agency
to
establish
an
acceptable
protocol
for
this
study.

2.
Labeling
for
End­
Use
Products
Labeling
changes
are
necessary
to
protect
the
environment
in
case
of
a
spill.
Specific
language
to
incorporate
these
changes
is
specified
in
Table
12.

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
labeling
changes
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.
27
a.
Label
Changes
Summary
Table
In
order
to
be
eligible
for
reregistration,
amend
all
product
labels
to
incorporate
the
language
in
the
following
table.

Table
12.
Labeling
Changes
Summary
Table
Summary
of
Labeling
Changes
for
Trichloromelamine
Description
Amended
Labeling
Language
Placement
on
Label
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
If
more
than
50
pounds
or
5
gallons
of
product
is
sold
in
one
package:

"
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
Environmental
Hazards
"
This
chemical
is
toxic
to
aquatic
organisms."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
28
VI.
APPENDICES
29
Appendix
A.
Table
of
Use
Patterns
for
Trichloromelamine
Use
Site
Formulation
Method
of
Application
Application
Rate
(
Range)
1
Use
Limitations
Food
handling/
storage
establishments
premises
and
equipment
Immerse
Surfaces
(
Reg.

6198­
3)
0.012%­
0.024%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.

Wipe/
Swab
Surfaces
(
Reg.

8160­
1;
65169­
1;

70627­
28)
0.0117%­
0.0169%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Eating/
Drinking
Establishments
(
Premises
and
Equipment:
Hard
Surfaces)
Powder
(
Soluble
Concentrate)
Spray
Surfaces
(
Reg.
8160­
1)
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Eating/
Drinking
Establishments
(
Utensils,

Dishes,
and
Glassware)
Powder
(
Soluble
Concentrate)

(
Reg.
6198­
3;

65169­
1;
70627­

26)
Immerse
Surfaces
0.0114%­
0.024%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.

Dairy
Processing
Plants
Powder
(
Soluble
Concentrate)

(
Reg.
6198­
3)
Immerse
Surfaces
0.012%­
0.024%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.

Food
Processing
Plants
Powder
(
Soluble
Concentrate)

(
Reg.
6198­
3;

70627­
28)
Immerse
Surfaces;
Wipe
or
Swap
Surfaces
0.012%­
0.024%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

1
Application
rate
is
given
in
terms
of
percent
of
active
ingredient
in
diluted
solution
following
label
directions
for
dilution.
30
Use
Site
Formulation
Method
of
Application
Application
Rate
(
Range)
1
Use
Limitations
Foodservice
Equipment
(
including
soft­
serve,

yogurt,
shake,
and
slush)
Powder
(
Soluble
Concentrate)

(
Reg.
70627­
26)
Immerse
Surfaces
0.0114%­
0.0227%
Never
use
soap
when
prewashing.
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Mess
Gear
Powder
(
Soluble
Concentrate)

(
Reg.
40510­
1)
Immerse
Surfaces
0.0276%
Use
only
when
hot
water
rinse
is
not
available.

Allow
mess
gear
to
air
dry.
Do
not
reuse
solution
after
disinfecting
100
mess
kits.

Fresh
Fruits
and
Vegetables
Powder
(
Soluble
Concentrate)

(
Reg.
40510­
1)
Wash
and
Completely
Immerse
0.0345%
Do
not
cut
or
peel
fruits
or
vegetables
before
disinfecting.
After
immersion,
rinse
with
potable
water.
Solutions
are
not
to
be
reused.

Commercial,
institutional
and
industrial
premises
and
equipment
Wipe
Surfaces
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Commercial
Premises
Powder
(
Soluble
Concentrate)

(
Reg.
8160­
1)
Spray
Surfaces
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Wipe
Surfaces
0.0136­
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Schools
Powder
(
Soluble
Concentrate)

(
Reg.
8160­
1;

70627­
28)
Spray
Surfaces
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Institutional/
Industrial
Food
Service
Areas
Powder
(
Soluble
Concentrate)

(
Reg.
70627­
28)
Wipe
Surfaces
0.0136%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.
31
Use
Site
Formulation
Method
of
Application
Application
Rate
(
Range)
a
Use
Limitations
Residential
and
public
access
premises
Wipe
Surfaces
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Residential
Premises
Powder
(
Soluble
Concentrate)

(
Reg.
8160­
1)
Spray
Surfaces
0.0169%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.

Medical
premises
and
equipment
Nursing
homes
and
hospitals
(
non­
critical
areas)
Powder
(
Soluble
Concentrate)

(
Reg.
70627­
28)
Wipe
Surfaces
0.0136%
Never
towel
dry
sanitized
items.
Do
not
reuse
solution
the
next
day.
32
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
(
trichloromelamine)
covered
by
this
RED.
It
contains
generic
data
requirements
that
apply
to
trichloromelamine
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.
33
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
42385101,
42283401,
421311012
830.1600
830.1620
830.1650
61­
2a
Starting
Materials
and
Manufacturing
Process
All
42385101,
42283401,
42131101
830.1670
61­
2b
Formation
of
Impurities
All
43350301,
42131101
830.1700
62­
1
Preliminary
Analysis
All
43350302,
42131101
830.1750
62­
2
Certification
of
Limits
All
43350302,
42131101
830.1800
62­
3
Analytical
Method
All
43350302,
42131101
830.6302
63­
2
Color
All
42385101,
42131101
830.6303
63­
3
Physical
State
All
42385101,
42131101
830.6304
63­
4
Odor
All
42131101
830.7050
None
UV/
Visible
Absorption
All
Waived3
830.7200
63­
5
Melting
Point
All
42385101,
42131101
830.7220
63­
6
Boiling
Point
All
Not
Applicable
830.7300
63­
7
Density
All
42385101,
42131101
830.7840
830.7860
63­
8
Solubility
All
42385101,
42131101
830.7950
63­
9
Vapor
Pressure
All
Not
Applicable
830.7370
63­
10
Dissociation
Constant
in
Water
All
43350303
2
MRID
42131101
was
also
submitted
to
fulfill
old
guideline
160­
5,
Chemical
Identity.

3
The
study
is
waived
because,
based
on
the
chemical
structure,
it
is
not
likely
to
provide
useful
information
in
the
UV
region.
34
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
Not
Applicable
830.7000
63­
12
pH
All
42385101,
42131101
830.6313
63­
13
Stability
All
43395401,
42131101
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
Not
Applicable
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
42250801
850.2200
71­
2
Avian
Dietary
Toxicity
All
42280801
(
quail),
42247401
(
duck)

850.1075
72­
1
Fish
Acute
Toxicity
­
Freshwater
All
41934901
(
bluegill),
42010601
(
rainbow
trout)

850.1010
72­
2
Acute
Aquatic
Invertebrate
Toxicity
All
42020801
TOXICOLOGY
870.1100
81­
1
Acute
Oral
­
Rat
All
43165701
870.1200
81­
2
Acute
Dermal
­
Rabbit
All
43159901
870.1300
81­
3
Acute
Inhalation
­
Rat
All
43368501
35
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.2400
81­
4
Primary
Eye
Irritation
­
Rabbit
All
43159902
870.2500
81­
5
Primary
Dermal
Irritation
­
Rabbit
All
43159903
870.2600
81­
6
Dermal
Sensitization
All
43159904
870.3100
82­
1a
90­
Day
Feeding­
Rodent
All
43064301
870.3100
82­
1b
90­
Day
Feeding­
Non­
Rodent
All
Waived4
870.3200
82­
2
21/
28­
Day
Dermal
Toxicity
­
Rat
All
Waived5
870.3250
82­
3
90­
day
Dermal
Toxicity
­
Rodent
Waived6
870.3465
82­
4
90­
Day
Inhalation
­
Rat
Data
gap
870.3700
83­
3
Developmental
Toxicity
All
43614302
(
rat),
43614301
(
rabbit)

870.3800
83­
4
Reproduction
and
Fertility
Effects
­
2
Generation
Repro
All
Waived7
83­
1a
Chronic
Feeding
Toxicity
­
Rodent
Waived8
870.4100
83­
1b
Chronic
Feeding
Toxicity
­
Non­
Rodent
(
dog)
Waived7
870.4200
83­
2a
Oncogenicity
­
Rat
Waived7
870.4200
83­
2b
Oncogenicity
­
Mouse
Waived7
870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity
Waived7
870.5265
84­
2
Bacterial
Reverse
Mutation
Assay
All
42148801
(
Structural
Chromosomal
Aberration)

870.5385
84­
2
Micronucleus
Assay
All
Not
Required9
4
The
90­
feeding
study
in
the
rodent
is
sufficient
to
cover
this
guideline.

5
This
study
is
waived
because
the
risks
are
below
the
Agency's
level
of
concern
using
the
conservative
100%
dermal
absorption
factor
and
an
oral
endpoint.

6
This
requirement
was
waived
because
the
registrants
committed
to
submitting
a
90­
day
feeding
study
in
its
place.

7
This
study
is
waived
because
risk
levels
are
acceptable
using
conservative
assumptions.

8
These
studies
are
waived
because
melamine,
a
degradate
of
trichloromelamine,
is
the
chemical
of
concern
for
any
potential
chronic
effects,
as
trichloromelamine
rapidly
breaks
down
into
hypochlorous
acid
and
melamine.

9
Only
one
of
the
2
studies,
870.5385
or
870.5375,
is
necessary.
MRID
42021801
satisfies
this
requirement
under
guideline
870.5375.
36
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.5375
84­
2
Cytogenic
assay
with
human
lymphocytes
All
42021801
870.5550
84­
2
UDS
Assay
All
42021701
870.7485
85­
1
General
Metabolism
Waived10
870.7600
85­
2
Dermal
Absorption
Waived11
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2400
875.2900
133­
3
Dermal
Passive
Dosimetry
All
Waived12
875.2500
875.2900
133­
4
Inhalation
Passive
Dosimetry
All
Waived11
875.1200
875.1600
233
Dermal
Indoor
Exposure
All
Data
Gap
875.1400
875.1600
234
Inhalation
Indoor
Exposure
All
Data
Gap
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
Not
Applicable
10
Metabolism
data
are
not
required
for
the
registered
uses
of
trichloromelamine.
In
addition,
trichloromelamine
rapidly
degrades
to
hypochlorous
acid
and
melamine.
Melamine
is
rapidly
eliminated
in
urine
after
oral
dosing
and
has
been
found
to
be
not
of
toxicological
concern.

11
The
risks
are
below
the
Agency's
level
of
concern
assuming
100%
dermal
absorption.
This
study
is
waived
as
no
refinements
are
needed
to
the
assessment.

12
As
trichloromelamine
breaks
down
rapidly
into
melamine,
the
post­
application
exposure
studies
are
waived.
37
Appendix
C.
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
room
119,
Crystal
Mall
#
2,
1801
Bell
St.,
Arlington,
VA
22202.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
AM
to
4:
00
PM.

The
RED
and
supporting
document,
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
The
RED
technical
support
document
is
the
risk
assessment:

$
Trichloromelamine
Risk
Assessment
for
the
Reregistration
Eligibility
Decision,
PC
Code
077101,
Case
3144,
Antimicrobials
Division,
9/
15/
05.
38
Appendix
D.
Citations
Considered
to
be
Part
of
the
Data
Base
Supporting
the
Reregistration
Decision
(
Bibliography)

1.
MRID
Studies
MRID#
Citation
41934901
Bowman,
J.
(
1986)
Acute
Toxicity
of
Trichloromelamine
to
Bluegill
Sunfish
(
Lepomis
macrochirus):
Lab
Project
Number:
34811.
Unpublished
study
prepared
by
ABC
Labs,
Inc.
17
p.

42010601
Bowman,
J.
(
1986)
Acute
Oral
Toxicity
Trichloromelamine
to
Rainbow
Trout
(
Salmo
gairdneri):
Lab
Project
Number:
34812.
Unpublished
study
prepared
by
Analytical
Bio­
chemistry
Laboratories,
Inc.
17
p.

42020801
Burgess,
D.;
Frazier,
S.;
Schoen,
L.
(
1991)
Acute
Toxicity
Trichloromelamine
to
Daphnia
magna:
Lab
Project
Number:
34813.
Unpublished
study
prepared
by
ABC
Laboratories,
Inc.
15
p.

42021701
Cifone,
M.
(
1986)
Evaluation
of
Trichloromelamine
in
the
Rat
Hepatocyte
Unscheduled
DNA
Synthesis
Assay:
Lab
Project
Number:
20991
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
25
p.

42021801
Ivett,
J.
(
1986)
Clastogenic
Evaluation
of
Trichloromelamine
in
an
In
Vitro
Cytogenic
Assay
Measuring
Chromosomal
Aberration
Freq­
uencies
in
Chinese
Hamster
Ovary
(
CHO)
Cells:
Lab
Project
Number:
20990.
Unpublished
study
prepared
by
Hazelton
Laboratories
America,
Inc.
33
p.

42131101
Leifheit,
B.
(
1990)
Product
Chemistry
for
Trichloromelamine,
Technical
Grade.
Unpublished
study
prepared
by
Drackett
Co.
8
p.

42148801
Jagannath,
D.
(
1987)
Evaluation
of
Trichloromelamine,
(...)
in
Ames
Salmonella/
Microsome
Reverse
Mutation
Assay:
Lab
Project
Number:
20988.
Unpublished
study
prepared
by
Hazleton
Labs.,
America,
Inc.
26
p.

42247401
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
8­
Day
Acute
Dietary
LC50
Study
in
Mallard
Ducklings:
Lab
Project
Number:
88
DC
109.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
26
p.

42250801
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
21­
Day
Acute
Dietary
LD50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
BLAL
88
QD
109.
Unpublished
study
prepared
by
Bio­
Life
Assocs.
31
p.

42280801
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
8­
Day
Acute
Dietary
LC50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
BLAL
88
QC
110.
Unpublished
39
study
prepared
by
Bio­
Life
Associates,
Ltd.
25
p.

42283401
DBK
Incorporated
(
1992)
Trichloromelamine
&
DBK
Food
Contact
Sanitizer:
Product
Chemistry
Data.
Unpublished
study.
35
p.

42385101
Schneder,
D.
(
1992)
Trichloromelamine­­
Efficacy
Data
"
Replacement
Study":
Lab
Project
Number:
TCM­
EFF.
Unpublished
study
prepared
by
H
&
S
Chemical
Co.
Inc.
25
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.

43064301
Michie,
M.
(
1989)
Trichloromelamine­­
90­
Day
Subchronic
Study
in
Rats:
Lab
Project
Number:
75­
51­
0743­
88:
40­
0743­
88.
Unpublished
study
prepared
by
U.
S.
Army
Environmental
Hygiene
Agency.
1177
p.

43159901
Glaza,
S.
(
1994)
Acute
Dermal
Toxicity
Study
in
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102386:
TP3016.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
31
p.

43159902
Glaza,
S.
(
1994)
Primary
Eye
Irritation
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102388:
TP3015.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
26
p.

43159903
Glaza,
S.
(
1994)
Primary
Dermal
Irritation
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102387:
TP3014.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
24
p.

43159904
Glaza,
S.
(
1994)
Dermal
Sensitization
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Guinea
Pigs­­
Closed
Patch
Technique:
Final
Report:
Lab
Project
Number:
HWI
31102389:
TP2008.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
38
p.

43165701
Glaza,
S.
(
1994)
Acute
Oral
Toxicity
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rats:
Final
Report:
Lab
Project
Number:
HWI/
31102385.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
44
p.

43350301
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
61­
3:
Product
Chemistry:
Lab
Project
Number:
TCM­
61­
3.
Unpublished
study
prepared
by
H&
S
Chemical
Co.,
Inc.
5
p.

43350302
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
62­
1,2:
Product
Chemistry:
Lab
Project
Number:
TCM­
62­
1,2.
Unpublished
study
prepared
by
H&
S
Chemical
40
Co.,
Inc.
6
p.

43350303
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
63­
9,
10,
11:
Product
Chemistry:
Lab
Project
Number:
TCM­
63­
9,
10,
11.
Unpublished
study
prepared
by
H&
S
Chemical
Co.,
Inc.
8
p.

43368501
Viau,
A.
(
1994)
An
Evaluation
of
the
Acute
Toxicity
of
Inhaled
Trichloromelamine
Dry
Powder
Formulation
in
the
Albino
Rat:
Lab
Project
Number:
90906.
Unpublished
study
prepared
by
Bio­
Research
Lab.,
Ltd.
190
p.

43395401
Lee,
H.
(
1994)
Physical
and
Chemical
Characteristics
of
Trichloromelamine:
Lab
Project
Number:
7673/
09/
08/
A1:
233A1.
Unpublished
study
prepared
by
S.
C.
Johnson
&
Son,
Inc.
17
p.

43614301
Tyl,
R.;
Marr,
M.;
Myers,
C.
(
1995)
Developmental
Toxicity
Evaluation
of
Trichloromelamine
Administered
by
Gavage
to
New
Zealand
White
Rabbits:
Final
Report:
Lab
Project
Number:
65C­
5742­
300/
400.
Unpublished
study
prepared
by
Research
Triangle
Institute.
215
p.

43614302
Tyl,
R.;
Marr,
M.;
Myers,
C.
(
1995)
Developmental
Toxicity
Evaluation
of
Trichloromelamine
Administered
by
Gavage
to
CD
(
Sprague­
Dawley)
Rats:
Final
Report:
Lab
Project
Number:
65C­
5742­
100/
200.
Unpublished
study
prepared
by
Research
Triangle
Institute.
246
p.

45012316
Walls,
C.;
Watters,
J.
(
1999)
Exposure
and
Risk
Assessments
for
Sodium
Lauryl
Sulfate:
Lab
Project
Number:
99­
02:
99­
01.
Unpublished
study
prepared
by
Novigen
Sciences,
Inc.
153
p.

2.
Website
References
EPA,
2001.
"
General
Principles
for
Performing
Aggregate
Exposure
and
Risk
Assessments."
US
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
November
28,
2001.
http://
www.
epa.
gov/
pesticides/
trac/
science/
aggregate.
pdf.

EPA,
2004a.
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
Appendix
A,
Section
IIB,
pg.
81.
US
Environmental
Protection
Agency.
January
24,
2004.
http://
www.
epa.
gov/
oppfead1/
endanger/
consultation/
ecorisk­
overview.
pdf.

EPA,
2004b.
USEPA/
OPP
Pesticide
Products
Database
Query
­
Updated
Weekly.
US
Environmental
Protection
Agency.
http://
www.
cdpr.
ca.
gov/
docs/
epa/
m2.
htm.
Accessed
July,
2004.

EPA,
2005.
Estimation
Program
Interface
(
EPI)
Suite.
US
Environmental
Protection
Agency.
41
http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuite.
htm.
Accessed
2005.

European
Chemicals
Bureau,
2004.
European
Inventory
of
Existing
Commercial
Substances.
http://
ecb.
jrc.
it/
EINECS#
231­
648­
4.
Accessed
2004.

FDA,
2003.
"
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
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2003.

H&
S
Chemical
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Inc,
2004.
Material
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http://
www.
hschem.
com/
tccmmsds.
html.
Accessed
2004.

USDA,
Agricultural
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Service,
1999.
"
Food
and
Nutrient
Intakes
by
Children
1994­
96,
1998."
ARS
Food
Surveys
Research
Group,
US
Department
of
Agriculture,
available
under
"
Products"
at
http://
www.
barc.
usda.
gov/
bhnrc/
foodsurvey/
home.
htm.
Last
accessed
July
28,
2004.

Wilson
JW,
CW
Enns,
JD
Goldman,
KS
Tippett,
JH
Mickle,
LE
Cleveland,
and
PS
Chahil,
1997.
"
Data
tables:
Combined
results
from
USDA's
1994
and
1995
Continuing
Survey
of
Food
Intakes
by
Individuals
and
1994
and
1995
Diet
and
Health
Knowledge
Survey."
ARS
Food
Surveys
Research
Group,
available
under
"
Releases"
at
http://
www.
barc.
usda.
gov/
bhnrc/
foodsurvey/
home.
htm.
Last
accessed
July
28,
2004.

4.
Supporting
Documents
Environmental
Protection
Agency,
1983.
Meeting
with
FDA
Toxicology
Department
concerning
their
evaluation
of
pituitary
tumor
incidence
in
male
Fischer
344
rats
and
bone
marrow
leukemia
incidence
in
female
F
344
rats
in
the
30­
month
melamine
study
submitted
by
American
Cyanamin
(
1983).
Memorandum
from
Stephanie
April,
Toxicology
Branch,
to
Tim
Gardner,
Registration
Division.
December
14,
1983.

Environmental
Protection
Agency,
1984.
Melamine
Studies.
Memorandum
from
Stephanie
April,
Toxicology
Branch,
to
James
Davis,
Pesticide
and
Toxic
Substances.
May
2,
1984.

Environmental
Protection
Agency,
1988.
Data
waiver
request
for
Trichloromelamine;
EPA
I.
D.
No.
8029­
5;
Proj.
No.
8­
0169A;
Caswell
No.
877.
Memorandum
from
James
Rowe,
Toxicology
Branch,
HED,
to
Quang
Bui,
Section
Head
of
Section
V,
Toxicology
Branch,
HED.
July
6,
1988.

Environmental
Protection
Agency,
1993.
Carcinogenicity
Peer
Review
of
Melamine.
Memorandum
from
Stephen
C.
Dapson,
Senior
Pharmacologist,
HED,
and
Esther
Rinde,
Manager
of
Carcinogenicity
Peer
Review
Committee,
HED,
to
Phil
Hutton,
Insecticide­
Rodenticide
Branch,
Registration
Division.
July
21,
1993.
42
Environmental
Protection
Agency,
1994.
Trichloromelamine:
Review
of
Acute
Toxicity
Studies
Submitted
in
Response
to
DCI.
Memorandum
from
Jess
Rowland,
Toxicologist,
HED,
to
K.
Davis
and
B.
Alder,
Product
Managers,
Reregistration
Division.
July
21,
1994.

Environmental
Protection
Agency,
1997.
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments.
Prepared
for
the
Office
of
Pesticide
Programs,
Health
Effects
Division.
Contract
No.
68
Environmental
Protection
Agency,
2000.
Review
of
the
Proctor
&
Gamble
Submission
for
Registration
of
the
Product,
FIT,
to
Wash
Fruits
and
Vegetables.
Memorandum
from
Robert
Quick,
Chemist,
RASSB,
to
Velma
Noble,
Product
Manager
Team,
RMB
I.
DP
Barcode
D262976.

Environmental
Protection
Agency,
2004.
Residue
Chemistry
Comments
on
the
Trichloromelamine
Preliminary
Risk
Assessment.
Electronic
Correspondence
from
Robert
Quick,
Chemist,
RASSB,
to
L.
Bailey,
Senior
Environmental
Scientist,
Antimicrobial
Division,
Immediate
Office.
August
24,
2004.

Landman,
LC,
2005.
"
Reference
to
use
in
Dairies,
B­
T­
F
Chloromelamine
Sanitizer,
EPA
Reg.
No.
6198­
3."
Correspondence
from
Dr.
L.
Charles
Landman,
National
Chemicals,
Inc.
to
Adam
Heyward,
Antimicrobials
Division.
September
22,
2005.
43
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
trichloromelamine
RED
for
a
list
of
studies
that
the
Agency
plans
to
require.
44
Appendix
F.
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
at
a
later
date.
45
Appendix
G.
Batching
of
Trichloromelamine
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
trichloromelamine
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,
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
completion
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
46
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.

Table
1.
Batches
for
Products
Containing
The
Active
Ingredient
Trichloromelamine
Batch
Registration
Number
Percent
Active
Ingredient
8160­
1
Trichloromelamine
18.0%

65169­
1
Trichloromelamine
18.7%
1
70327­
26
Trichloromelamine
18.2%

No
Batch
Group:
The
following
products
were
not
considered
similar
enough
to
any
of
the
other
products
to
be
placed
in
a
batch.
These
products
are
not
batched.

No
Batch
Group
Registration
Number
Percent
Active
Ingredient
6198­
3
Trichloromelamine
9.5%

40510­
1
Trichloromelamine
Potassium
Iodide
19.3%
28.6%

65146­
1
Trichloromelamine
98.0%

70627­
27
Trichloromelamine
91.0%

70627­
28
Trichloromelamine
18.2%

Please
note
that
while
products
may
have
the
same
percent
active
ingredient
as
another
product,
the
composition
of
their
inert
ingredients
may
vary
greatly.
47
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.
48
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.
49
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
50
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
51
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
52
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.