Document ID: EPA-HQ-OPP-2005-0250-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

United
States
Prevention,
Pesticides
EPA739­
R­
05­
002
Environmental
Protection
and
Toxic
Substances
September
2005
Agency
(
7508C)

Reregistration
Eligibility
Decision
For
Triethylene
Glycol
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
triethylene
glycol.
The
Reregistration
Eligibility
Decision
(
RED)
was
approved
in
the
form
of
a
decision
memorandum
which
summarized
the
regulatory
decision
for
triethylene
glycol
on
September
30,
2003.

Based
on
the
Agency's
review,
the
Reregistration
Eligibility
Decision
(
RED)
and
risk
management
decision
with
its
associated
human
health
and
environmental
risk
assessments
are
now
being
published.
A
Notice
of
Availability
will
be
published
in
the
Federal
Register
announcing
the
publication
of
the
RED.

The
RED
and
supporting
documents
for
triethylene
glycol
will
be
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2005­
0250
at:
http://
www.
epa.
gov/
edockets.

Please
note
that
the
attached
RED
document
pertains
only
to
triethylene
glycol
and
presents
the
Agency's
conclusions
on
the
dietary,
drinking
water,
occupational
and
ecological
risks
posed
by
exposure
to
triethylene
glycol
alone.
This
document
also
contains
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.
Currently,
there
are
no
generic
data
requirements.
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
triethylene
glycol
is
eligible
for
reregistration.
Sections
IV
and
V
of
this
RED
document
describe
product­
specific
data
requirements.
If
you
have
questions
on
this
document
or
the
label
changes
relevant
to
this
reregistration
decision,
please
contact
the
Chemical
Review
Manager,
Heather
Garvie,
at
(
703)
308­
0034.
For
questions
about
product
reregistration
and/
or
the
Product
DCI
that
accompanies
this
document,
please
contact
Marshall
Swindell
at
(
703)
308­
6341.

Sincerely,

Frank
T.
Sanders
Director,
Antimicrobials
Division
REREGISTRATION
ELIGIBILITY
DECISION
for
Triethylene
Glycol
List
C
CASE
3146
Approved
By:

Frank
T.
Sanders
Director,
Antimicrobials
Division
September
26,
2005
TABLE
OF
CONTENTS
Triethylene
Glycol
Reregistration
Team                      ...
i
Glossary
of
Terms
and
Abbreviations
                       
ii
Executive
Summary                              .
1
I.
Introduction                               
 ..
3
II.
Chemical
Overview                             .
5
A.
Regulatory
History                          .
5
B.
Chemical
Identification                        ..
5
C.
Use
Profile                             ..
6
III.
Summary
of
Triethylene
Glycol
Assessment                   ..
8
A.
Human
Health
Assessment                    .............
8
1.
Toxicity
of
TEG                        ...
8
2.
FQPA
Safety
Factor                     .. ...
9
3.
Population
Adjusted
Dose
(
PAD)
                  
9
4.
Dietary
and
Residential
Exposure                  
9
5.
Aggregate
Exposure                    ..  .
10
6.
Occupational
Exposure                    . .
10
7.
Human
Incident
Data                      .
10
B.
Environmental
Assessment                       
10
1.
Environmental
Fate
and
Transport                 ..
10
2.
Ecological
Risk                        ..
11
a.
Toxicity
(
Hazard)
Assessment               ....
11
b.
Risk
to
Listed
Species                   .
12
IV.
Risk
Management,
Reregistration
and
Tolerance
Reassessment
Decision       ..
13
A.
Determination
of
Reregistration
Eligibility               . .
13
B.
Comments
and
Responses                       .
13
C.
Regulatory
Position                          
13
1.
Food
Quality
Protection
Act
Findings                
13
a.
"
Risk
Cup"
Determination                 ..
13
b.
Determination
of
Safety
to
U.
S.
Population           
14
c.
Determination
of
Safety
to
Infants
and
Children        ....
14
d.
Endocrine
Disruptor
Effects                 
14
e.
Cumulative
Risks                    ....
15
2.
Tolerance
Summary                       
15
a.
Codex
Harmonization                   .
16
D.
Regulatory
Rationale                       .. .
16
1.
Listed
Species
Considerations         .......................................
16
a.
The
Endangered
Species
Act                ..
16
b.
General
Risk
Mitigation                  .
17
V.
What
Registrants
Need
to
Do                        .....
18
A.
Manufacturing­
Use
Products                    ... ..
19
1.
Additional
Generic
Data
Requirements             
 .....
19
B.
End­
Use
Products                         ......
19
1.
Additional
Product­
Specific
and
Efficacy
Data
Requirements     ......
19
VI.
Appendices                               ....
20
A.
Table
of
Use
Patterns
Eligible
for
Reregistration              ..
21
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision                 
       ..
42
C.
Technical
Support
Documents                      
49
D.
Bibliography
Citations                         
50
E.
Generic
Data
Call­
In                          
54
F.
Product
Specific
Data
Call­
In                      .
55
G.
Batching
of
End­
Use
Products                      
56
H.
List
of
All
Registrants
Sent
the
Data
Call­
In                .
59
I.
List
of
Available
Forms                        ..
60
i
Triethylene
Glycol
Reregistration
Team
Health
Effects
Risk
Assessment
Michelle
Centra
Tim
McMahon
Najm
Shamim
Timothy
Leighton
Jonathan
Chen
Environmental
Fate
and
Ecological
Risk
Assessment
Kathryn
Montague
Najm
Shamim
Use
and
Usage
Analysis
Heather
Garvie
Registration
Support
Marshall
Swindell
Risk
Management
Heather
Garvie
Ben
Chambliss
ii
GLOSSARY
OF
TERMS
AND
ABBREVIATIONS
AE
Acid
Equivalent
a.
i.
Active
Ingredient
AGDCI
Agricultural
Data
Call­
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
ARC
Anticipated
Residue
Contribution
BCF
Bioconcentration
Factor
CAS
Chemical
Abstracts
Service
CI
Cation
CNS
Central
Nervous
System
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CFR
Code
of
Federal
Regulations
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DRES
Dietary
Risk
Evaluation
System
DWEL
Drinking
Water
Equivalent
Level
(
DWEL)
The
DWEL
represents
a
medium
specific
(
i.
e.,
drinking
water)
lifetime
exposure
at
which
adverse,
noncarcinogenic
health
effects
are
not
anticipated
to
occur.
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
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
FAO
Food
and
Agriculture
Organization
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLC
Gas
Liquid
Chromatography
GLN
Guideline
Number
GM
Geometric
Mean
GRAS
Generally
Recognized
as
Safe
as
Designated
by
FDA
HA
Health
Advisory
(
HA).
The
HA
values
are
used
as
informal
guidance
to
municipalities
and
other
organizations
when
emergency
spills
or
contamination
situations
occur.
HAFT
Highest
Average
Field
Trial
HDT
Highest
Dose
Tested
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LEL
Lowest
Effect
Level
LOC
Level
of
Concern
iii
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
MCLG
Maximum
Contaminant
Level
Goal
(
MCLG)
The
MCLG
is
used
by
the
Agency
to
regulate
contaminants
in
drinking
water
under
the
Safe
Drinking
Water
Act.
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
MPI
Maximum
Permissible
Intake
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
NA
Not
Applicable
N/
A
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NOEC
No
Observable
Effect
Concentration
NOEL
No
Observed
Effect
Level
NOAEL
No
Observed
Adverse
Effect
Level
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
Pa
pascal,
the
pressure
exerted
by
a
force
of
one
newton
acting
on
an
area
of
one
square
meter.
PAD
Population
Adjusted
Dose
PADI
Provisional
Acceptable
Daily
Intake
PAG
Pesticide
Assessment
Guideline
PAM
Pesticide
Analytical
Method
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRN
Pesticide
Registration
Notice
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
RS
Registration
Standard
RUP
Restricted
Use
Pesticide
SAP
Science
Advisory
Panel
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TC
Toxic
Concentration.
The
concentration
at
which
a
substance
produces
a
toxic
effect.
iv
TD
Toxic
Dose.
The
dose
at
which
a
substance
produces
a
toxic
effect.
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TLC
Thin
Layer
Chromatography
TMRC
Theoretical
Maximum
Residue
Contribution
torr
A
unit
of
pressure
needed
to
support
a
column
of
mercury
1
mm
high
under
standard
conditions.
TRR
Total
Radioactive
Residue
UF
Uncertainty
Factor
Fg/
g
Micrograms
Per
Gram
Fg/
L
Micrograms
Per
Liter
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UV
Ultraviolet
WHO
World
Health
Organization
WP
Wettable
Powder
WPS
Worker
Protection
Standard
1
EXECUTIVE
SUMMARY
The
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
human
health
and
environmental
review
for
triethylene
glycol
and
is
issuing
its
risk
management
decision.
The
Agency
has
decided
that
triethylene
glycol
is
eligible
for
reregistration.
This
Reregistration
Eligibility
Decision
(
RED)
addresses
the
use
of
triethylene
glycol
as
a
bacteriostat
(
against
odor­
causing
bacteria)
for
air
sanitization
and
deodorization.
In
combination
with
other
active
ingredients,
it
is
used
as
a
fungicide,
virucide
and
miticide
for
disinfection
of
hard,
non­
porous
surfaces
and
as
an
insecticide
(
against
lice)
by
direct
application
to
caged
birds
and
to
the
cage.
For
these
uses,
triethylene
glycol
is
formulated
primarily
as
a
pressurized
liquid.
This
document
also
addresses
the
exposures
from
the
use
of
this
pesticide
as
an
inert
ingredient.
As
an
inert
ingredient,
triethylene
glycol
facilitates
delivery
of
formulated
pesticide
chemical
products
that
are
used
as
herbicides,
fungicides,
insecticides,
growth
regulators
and
attractants
on
a
wide
variety
of
agricultural
commodities.
This
RED
reassesses
the
exemption
from
the
requirement
for
a
tolerance
for
these
uses.
This
tolerance
exemption
is
listed
in
40
CFR
180.920
(
69
FR
23124,
Apr.
28,
2004).

In
addition
to
the
above,
triethylene
glycol
is
approved
by
the
Food
and
Drug
Administration
(
FDA)
as
a
preservative
for
food
packaging
adhesives
as
listed
in
21
CFR
175.105.
Currently,
however,
there
are
no
EPA
registered
products
for
this
use.
Triethylene
glycol
also
has
an
indirect
food
additive
regulation
[
21
CFR
177.1200
(
4/
1/
04)]
for
its
use
as
a
plasticizer
in
cellophane.
This
use
is
regulated
by
the
Food
and
Drug
Administration
(
FDA).

Overall
Risk
Summary
Hazard
Profile/
Human
Health
Risk
Based
on
a
review
of
the
available
toxicology
data,
the
Agency
has
concluded
that
triethylene
glycol
is
of
very
low
toxicity
by
the
oral,
dermal,
and
inhalation
routes
of
exposure.
The
toxicology
database
is
adequate
to
characterize
the
hazard
of
triethylene
glycol,
and
no
data
gaps
have
been
identified.
There
are
no
indications
of
special
sensitivity
of
infants
or
children
resulting
from
exposure
to
triethylene
glycol.
Therefore,
the
FQPA
Safety
Factor
has
been
removed
(
i.
e.,
reduced
to
1X)
for
triethylene
glycol.
The
Agency
has
not
identified
toxicological
endpoints
of
concern
for
the
active
and
the
inert
uses
of
triethylene
glycol.
Therefore,
a
quantitative
human
health
risk
assessment
was
not
conducted
for
this
RED
document.
The
Agency
has
no
risk
concerns
for
triethylene
glycol
with
respect
to
human
exposure.

Environmental
Risk
The
Agency
has
relied
on
open
literature
data
that
characterizes
the
fate
properties
of
triethylene
glycol.
The
results
of
these
studies
indicate
that
triethylene
glycol
is
miscible
in
water,
mobile
in
soils
and
stable
to
abiotic
degradation
hydrolysis
and
soil
and
aquatic
photolysis.
Biodegradation
is
expected
to
proceed
rapidly
in
surface
waters.
2
Ecological
effects
data
were
previously
waived
due
to
the
use
of
triethylene
glycol
as
an
indoor
microbiocide,
its
high
volatility,
and
known
low
toxicity
(
it
is
a
preferred
solvent
for
aquatic
organism
toxicity
tests).
Data
obtained
from
published
studies
provide
additional
confirmation
of
the
low
toxicity
of
the
compound
to
fish
and
aquatic
invertebrates.
The
Agency
has
no
risk
concerns
for
triethylene
glycol
with
respect
to
non­
target
organisms.
The
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
TEG.

Regulatory
Decision
The
Agency
has
completed
its
review
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
supported
products
containing
triethylene
glycol.

Summary
of
Mitigation
Measures
The
Agency
has
determined
that
triethylene
glycol
is
eligible
for
reregistration.
Since
no
risks
of
concern
were
identified,
no
specific
mitigation
measures
are
needed
for
triethylene
glycol.

Data
Requirements
No
additional
confirmatory
data
is
required
to
complete
the
reregistration
of
triethylene
glycol.
However,
product
specific
data
is
required
for
all
products
containing
triethylene
glycol
as
described
in
Section
V
of
this
document.
3
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
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
the
pesticide
meets
the
Ano
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
a
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
the
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
review
and
the
Reregistration
Eligibility
Decision
for
triethylene
glycol.

Triethylene
glycol
is
used
as
a
bacteriostat
(
against
odor­
causing
bacteria)
for
air
sanitization
and
deodorization.
In
combination
with
other
active
ingredients,
it
is
used
as
a
fungicide,
virucide
and
miticide
for
disinfection
of
hard,
non­
pourous
surfaces
and
as
an
insecticide
(
against
lice)
by
direct
application
to
caged
birds
and
bird
cages.
This
document
also
addresses
the
exposures
and
risks
from
the
use
of
this
pesticide
as
an
inert
ingredient.
As
an
inert
ingredient,
triethylene
glycol
facilitates
delivery
of
formulated
pesticide
chemical
products
that
are
used
as
herbicides,
fungicides,
insecticides,
growth
regulators
and
attractants
on
a
wide
variety
of
agricultural
commodities.

The
Agency
has
concluded
that
the
FQPA
Safety
Factor
for
triethylene
glycol
should
be
removed
(
equivalent
to
1X)
because
there
is
no
pre­
or
post­
natal
evidence
of
increased
susceptibility
for
infants
and
children
following
exposure
to
triethylene
glycol.

The
review
summarized
in
this
document
concern
only
potential
exposures
from
the
use
of
the
active
ingredient
triethylene
glycol
and
its
use
as
an
inert
ingredient.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
toxic
mechanism
could
lead
to
the
same
adverse
health
effect
that
would
occur
at
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Unlike
other
pesticides
for
which
EPA
has
4
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
triethylene
glycol
and
any
other
substances.
Triethylene
glycol
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
action,
therefore,
EPA
has
not
assumed
that
triethylene
glycol
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
the
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
triethylene
glycol.
In
an
effort
to
simplify
the
RED,
the
information
presented
herein
is
summarized
from
more
detailed
information
which
can
be
found
in
the
technical
supporting
documents
for
triethylene
glycol
referenced
in
this
RED.
Related
documents
are
available
in
the
Public
Docket
at
http://
www.
epa.
gov/
edocket.

This
document
consists
of
six
sections.
Section
I
is
the
introduction.
Section
II
provides
a
chemical
overview,
a
profile
of
the
use
and
usage
of
triethylene
glycol,
and
its
regulatory
history.
Section
III
gives
an
overview
of
the
revised
human
health
and
environmental
assessments
based
on
the
data
available
to
the
Agency.
Section
IV
presents
the
reregistration
eligibility
and
risk
management
decisions.
Section
V
summarizes
procedures
for
the
product­
specific
data
call­
in
(
PDCI).
Finally,
the
Appendices
contain
all
use
patterns
eligible
for
reregistration,
bibliographic
information,
generic
data
requirements
and
studies
used
to
make
the
reregistration
decision,
related
documents
and
how
to
access
them,
and
Data
Call­
In
(
DCI)
information.
5
II.
CHEMICAL
OVEVIEW
A.
Regulatory
History
Triethylene
glycol
was
first
registered
in
1947
for
use
in
hospitals
as
an
air
disinfectant.
At
one
point,
there
were
approximately
105
pesticide
chemical
companies
having
active
triethylene
glycol
registrations.
Many
of
these
registrations
were
canceled
over
the
years
and
more
recently,
the
majority
of
the
remaining
producers
of
triethylene
glycol
formulated
pesticide
products
are
being
represented
by
a
consortium
called
the
CSPA
(
Consumer
Specialty
Products
Association)
Glycols
Joint
Venture.
The
member
companies
currently
represented
by
this
consortium
are:
Amrep,
Inc.,
Chase
Products
Co.,
Medo
Industries,
Inc.,
S.
C.
Johnson
&
Son,
Waterbury
Companies,
Inc.,
Speer
Products,
Inc.
and
Quest
Chemical
Corporation.

B.
Chemical
Identification
Triethylene
Glycol:

$
Common
Name:
Triethylene
Glycol
$
Chemical
Name:
Triethylene
Glycol
$
Chemical
family:
None
$
Case
number:
3146
$
CAS
registry
number:
112­
27­
6
$
OPP
chemical
code:
083501
$
Empirical
formula:
C6H14O4
$
Molecular
weight:
150.20
g/
mol
$
Trade
and
other
names:
TEG
$
Manufacturers:
CSPA
Glycols
Joint
Venture
companies
(
S.
C.
Johnson
&
Son,
Inc.,
Waterbury
Companies,
Inc,
Amrep,
Inc.,
Speer
Products,
Inc.,
Quest
Chemical
Corporation,
Medo
Industries,
Inc.

$
Specific
Gravity:
1.1274
$
Solubility:
Highly
miscible
in
water
6
Soluble
in
alcohol,
benzene,
toluene,
sparingly
soluble
in
ether
and
insoluble
in
petroleum
ether
$
Boiling
Point:
285
o
C,
(
at
760
mm
Hg)
165
o
C
at
14
mm
Hg.

$
Melting
Point:
­
5
o
C
(­
7
o
C)
1
$
Vapor
Pressure:
<
0.01
mm
Hg
at
20
o
C
(
0.00132
mm
Hg
at
25
o
C)
1
$
Structure:
OH­
CH2­
CH2­
O­
CH2­
CH2­
O­
CH2­
CH2­
OH
C.
Use
Profile
The
following
is
information
on
the
currently
registered
uses
of
triethylene
glycol
products
and
an
overview
of
use
sites
and
application
methods.
A
detailed
table
of
the
uses
of
triethylene
glycol
eligible
for
reregistration
is
contained
in
Appendix
A.

Type
of
Pesticide:
Bacteriostat
Summary
of
Use
Sites:

Indoor
Non­
Food:
Triethylene
glycol
is
used
on
the
following
use
sites:
air
treatment
(
eating
establishments,
hospital,
commercial,
institutional,
household,
bathroom,
transportational
facilities);
medical
premises
and
equipment,
commercial,
institutional
and
industrial
premises
and
equipment;
laundry
equipment;
hard
non­
porous
surface
treatments
(
bathroom
facilities);
automobiles;
air
conditioning
filters;
bird
(
caged)
animal
treatment;
pet
bird
cages;
environmental
inanimate
hard
surfaces;
garbage
containers/
storage
Target
Pests:
Odor­
causing
bacteria
Inert
Uses:
As
an
inert
ingredient,
triethylene
glycol
facilitates
delivery
of
formulated
pesticide
chemical
products
that
are
used
as
herbicides,
fungicides,
insecticides,
growth
regulators
and
attractants
on
various
commodities.

Formulation
Types:
Pressurized
liquid
Method
and
Rates
of
Application
Equipment:
A
wall
mounted
dispensing
unit
may
be
needed,
depending
on
the
type
of
application.
Otherwise,
the
sanitizer
is
sprayed
manually.
7
Method
and
Rate:
For
a
wall
mounted
unit,
the
number
of
times
the
product
is
dispensed
depends
on
the
size
of
the
room
and
should
be
used
in
accordance
with
the
label
directions.

If
the
product
is
dispensed
from
a
metered
dose
aerosol
can
or
from
a
hand
held
unit,
as
the
amount
dispensed
will
depend
on
the
valve
size
utilized.

For
an
air
sanitizer
in
a
continuous
action
aerosol
can,
a
one
second
spray
is
used
for
a
9
2
x
9
x
7
room.

Typically,
an
air
sanitizer
that
is
used
manually
is
pointed
toward
the
center
of
the
room
(
12
x
12
x
9)
and
sprayed
for
ten
seconds.

Use
Classification:
General
use.
8
III.
SUMMARY
OF
TRIETHYLENE
GLYCOL
ASSESSMENT
A.
Human
Health
Assessment
1.
Toxicity
of
TEG
A
brief
overview
of
the
toxicity
of
triethylene
glycol
is
presented
below.
Further
details
on
the
toxicity
of
triethylene
glycol
can
be
found
in
the
supporting
documentation
for
this
RED.
The
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
memorandum,
the
toxicology
chapter
for
the
RED
and
other
supporting
documentation
are
available
on
the
Agency's
website
in
the
EPA
Docket
at
http://
www.
epa.
gov/
edockets.

The
toxicological
database
for
triethylene
glycol
is
currently
comprised
of
published
and
unpublished
studies
either
submitted
to
the
Agency
or
obtained
directly
from
the
open
literature.
Although
the
available
studies
do
not
meet
the
requirements
of
the
Agency=
s
OPPTS
harmonized
test
guidelines
published
in
1998,
it
was
determined
that
these
studies
contain
useful
information
that
is
adequate
for
hazard
characterization
of
triethylene
glycol.
These
acceptable
non­
guideline
studies
include
acute,
subchronic,
chronic,
developmental,
and
reproductive
toxicity,
carcinogenicity,
mutagenicity,
metabolism/
pharmacokinetics
and
dermal
absorption
studies.
Therefore,
the
Agency
has
determined
that
the
toxicological
database
is
complete
and
sufficient
for
reregistration.

Major
features
of
the
toxicology
profile
are
presented
below.
Triethylene
glycol
is
shown
to
be
of
low
toxicity,
with
the
exception
of
a
dermal
irritation
study
which
was
Toxicity
Category
III
due
to
slight
irritation.

Table
1.
Acute
Toxicity
of
Triethylene
Glycol
Technical
Guideline
No./
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
Oral
Toxicity
42814404
&
open
literature
LD50
=
15,000
 
22,000
mg/
kg
IV
870.1200
Acute
Dermal
Toxicity
__
Waived
__

870.1300
Acute
Inhalation
Toxicity
OTS:
527779­
2
LC50
>
5.2
mg/
L
IV
870.2400
Acute
Eye
Irritation
42814404
Mild
eye
irritation
IV
870.2500
Acute
Dermal
Irritation
42814404
Slight
irritation
III
870.2600
Skin
Sensitization
Open
literature
Non­
sensitizer
 

General
Toxicity
Observations
Upon
reviewing
the
available
toxicity
information,
the
Agency
has
concluded
that
there
are
no
endpoints
of
concern
for
oral,
dermal,
or
inhalation
exposure
to
triethylene
glycol.
This
conclusion
is
based
on
the
results
of
toxicity
testing
of
triethylene
glycol
in
which
dose
levels
near
or
above
testing
limits
(
as
established
in
the
OPPTS
870
series
harmonized
test
guidelines)
were
employed
in
experimental
animal
studies
and
no
significant
toxicity
observed.
9
Carcinogenicity
Classification
A
review
of
the
available
data
has
shown
triethylene
glycol
to
be
negative
for
carcinogenicity
in
studies
conducted
up
to
the
testing
limit
doses
established
by
the
Agency;
therefore,
no
carcinogenic
analysis
is
required.

Mutagenicity
Potential
Triethylene
glycol
was
tested
for
mutagenic
or
genotoxic
potential
and
found
to
be
negative
in
a
battery
of
studies:
a
bacterial
gene
mutation
assay
using
Salmonella
typhimurium,
and
in
vitro
Chinese
hamster
ovary
(
CHO)
mutation
assay,
an
in
vitro
Chinese
hamster
ovary
(
CHO)
chromosomal
aberration
assay
and
an
in
vitro
sister
chromatid
exchange
assay.

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
triethylene
glycol
because
there
is
no
pre­
or
post­
natal
evidence
for
increased
susceptibility
following
exposure.
Further,
the
Agency
has
concluded
that
there
are
no
endpoints
of
concern
for
oral,
dermal,
or
inhalation
exposure
to
triethylene
glycol
based
on
the
low
toxicity
observed
in
studies
conducted
near
or
above
testing
limit
doses
as
established
in
the
OPPTS
870
series
harmonized
test
guidelines.
Therefore,
a
quantitative
risk
assessment
was
not
conducted
for
triethylene
glycol.

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.
Since
toxicological
endpoints
for
risk
assessment
were
not
identified
based
on
the
available
data,
RfD's
and
PAD's
have
not
been
calculated
for
triethylene
glycol.

4.
Dietary
and
Residential
Exposure
Dietary
exposure
(
food
and
drinking
water)
could
potentially
occur
from
the
use
of
triethylene
glycol
as
a
preservative
in
food
packaging
adhesives
and
from
its
use
as
an
inert
ingredient
in
agricultural
pesticide
formulations.
Residential
exposure
could
also
potentially
occur
as
a
result
of
the
use
of
triethylene
glycol
in
and
around
the
home
as
a
sanitizer,
disinfectant
and
bird
treatment.
However,
risk
estimates
have
not
been
calculated
for
potential
exposures
to
triethylene
glycol
on
food,
in
drinking
water,
or
as
a
result
of
use
in
residential
settings
because
there
are
no
toxicological
endpoints
of
concern
according
to
a
review
of
the
available
toxicity
data.

5.
Aggregate
Exposure
10
The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA,
Section
408(
b)(
2)(
A)(
ii))
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide
and
other
non­
occupational
sources
of
exposure.

Since
toxicological
endpoints
for
risk
assessment
were
not
identified
based
on
the
available
data,
an
aggregate
risk
assessment
was
not
conducted
for
triethylene
glycol.

6.
Occupational
Exposure
The
occupational
exposure
assessment
for
triethylene
glycol
addresses
potential
exposures
and
risks
to
humans
who
may
be
exposed
in
Aoccupational
settings".
An
occupational
and
risk
assessment
is
required
for
an
active
ingredient
if:
1)
certain
toxicological
criteria
are
triggered;
and
2)
there
is
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
triethylene
glycol,
there
is
potential
for
exposure,
however,
there
are
no
toxicological
endpoints
of
concern,
according
to
a
review
of
the
available
toxicity.

7.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
the
1993­
1996
National
Poison
Control
Centers
(
PCC),
the
Agency's
Office
of
Pesticide
Program's
Incident
Data
System
(
IDS),
the
California
Department
of
Pesticide
Regulation,
and
the
National
Pesticide
Telecommunications
Network
(
NPTN).
Although
there
are
incidences
that
have
been
reported
associated
with
TEG
in
the
searched
database,
there
is
no
one
reported
incident
involving
TEG
as
a
single
chemical
exposure.
Either
no
effects
or
minor
effects
are
involved
in
these
reported
incidences.
The
other
ingredients
in
combination
with
TEG
may
be
the
reasons
for
the
symptoms
that
have
been
reported.

B.
Environmental
Assessment
A
summary
of
the
Agency's
environmental
review
is
presented
below.
For
detailed
discussions
of
all
aspects
of
the
environmental
review,
see
the
Product
Chemistry,
Environmental
Fate
and
Toxicology
chapters
available
on
the
Agency's
website
in
the
EPA
Docket
at:
http://
www/
epa.
gov/
edockets.

1.
Environmental
Fate
and
Transport
Triethylene
glycol
is
an
aliphatic
trihydroxy
chemical
and
does
not
contain
any
hydrolyzable
hydrogen.
For
this
reason,
the
Agency
granted
a
waiver
from
the
aquatic
hydrolysis
study.
For
the
reregistration
process,
however,
the
Agency
has
reviewed
available
open
literature
data
and
conducted
the
environmental
fate
assessment
of
triethylene
glycol.
Based
on
a
review
of
the
open
literature,
triethylene
glycol
is
miscible
in
water,
mobile
in
soils
and
11
stable
to
abiotic
hydrolytic
degradation
as
well
as
soil
and
aquatic
photolysis.
A
number
of
River
Dye­
away
tests
(
complete
mineralization
between
7
and
11
days)
have
shown
that
triethylene
glycol
degrades
in
soils
in
days
(
primary
degradation)
to
weeks
(
complete
mineralization).
In
addition,
sludge
innoculum
studies
indicate
that
triethylene
glycol
undergoes
ready
biodegradation.
The
use
of
sludge
innoculum
data
as
a
surrogate
for
terrestrial
soil
metabolism
is
subject
to
considerable
uncertainty
because
sludge
innoculums
tend
to
be
acclimated
to
the
introduction
of
organic
substances
more
so
than
soils
and
the
biomass
on
a
per
volume
basis
tends
to
be
greater.

2.
Ecological
Risk
a.
Toxicity
(
Hazard)
Assessment
As
a
result
of
the
Phase
IV
review
of
triethylene
glycol
for
reregistration
under
FIFRA,
ecological
effects
data
requirements
were
waived
due
to
its
intended
use
as
an
indoor
microbiocide,
its
high
volatility,
and
known
low
toxicity
(
it
is
a
preferred
solvent
for
aquatic
organism
toxicity
tests).
Data
obtained
from
published
studies
provide
additional
confirmation
of
the
low
toxicity
of
the
compound
to
fish
and
aquatic
invertebrates
(
Table
2).
As
mentioned
earlier
in
this
document,
no
toxicological
endpoints
were
selected
for
risk
assessment
based
on
the
available
mammalian
database.

Table
2.
Ecotoxicity
of
Triethylene
Glycol
Species
Percent
Active
Ingredient
Test
Type
Toxicity
Reference
Mysid
(
Mysidopsis
bahia)
99.9
96­
hour
static
acute
LC50
=
11,000
ppm
MRID
#
40228401
(
Mayer,
1986)

Sheepshead
minnow
(
Cyprinodon
variegatus)
99.9
96­
hour
static
acute
LC50
=
48,000
ppm
MRID
#
40228401
(
Mayer,
1986)

Bluegill
sunfish
(
Lepomis
macrochirus)
unknown
96
hour
static
acute
LC50
>
10,000
ppm
Verschuren,
1983
Menidia
beryllina
unknown
96
hour
static
LC50
>
10,000
ppm
Verschuren,
1983
Fathead
minnow
(
Pimephales
promelas)
unknown
96
hour
flowthrough
LC
50
59,900
­
77,400
ppm
Geiger
et
al.,
1988
12
Adverse
effects
to
nontarget
organisms
are
not
anticipated
from
the
indoor
use
of
triethylene
glycol
due
to
the
low
likelihood
of
exposure.
The
very
low
toxicity
of
the
compound
to
aquatic
organisms,
as
indicated
by
the
high
LC50
values
in
the
table
above,
further
supports
the
unlikelihood
of
adverse
effects
to
fish
and
aquatic
invertebrates.

b.
Risk
to
Listed
Species
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
triethylene
glycol,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.
13
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
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
to
support
reregistration
of
products
containing
triethylene
glycol.
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
triethylene
glycol.

The
Agency
has
completed
its
assessment
of
the
dietary,
drinking
water,
residential,
ecological
and
occupational
risks
associated
with
the
use
of
pesticide
products
containing
the
active
ingredient
triethylene
glycol.
Based
on
a
review
of
these
data,
the
Agency
has
sufficient
information
on
the
human
health
and
ecological
effects
of
triethylene
glycol
to
make
a
decision
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
triethylene
glycol
containing
products
are
eligible
for
reregistration.
Appendix
A
summarizes
the
uses
of
triethylene
glycol
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
triethylene
glycol,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.

B.
Comments
and
Responses
Supporting
documents
for
triethylene
glycol
were
not
issued
for
public
comment
per
the
Agency's
public
participation
process
because
no
toxicological
endpoints
were
identified
and,
as
such,
a
quantitative
risk
assessment
was
not
conducted.
To
ensure
that
opportunity
is
presented
to
the
public
to
comment
on
the
risk
management
decisions
and
supporting
documents
for
triethylene
glycol,
the
Agency
will
implement
a
public
comment
period
on
this
RED
document.

C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
A
Risk
Cup
@

Determination
Upon
reviewing
the
available
toxicity
information,
the
Agency
has
concluded
that
there
are
no
endpoints
of
concern
for
oral,
dermal,
or
inhalation
exposure
to
triethylene
glycol.
This
conclusion
is
based
on
the
results
of
toxicity
testing
of
triethylene
glycol
in
which
dose
levels
near
or
above
testing
limits
(
as
established
in
the
OPPTS
870
series
harmonized
test
guidelines)
were
employed
in
experimental
animal
studies
and
no
significant
toxicity
observed.
The
Agency
has
concluded
that
the
exemption
from
the
requirement
for
a
tolerance
is
appropriate
and
is
considered
reassessed
as
required
by
FQPA.
An
aggregate
assessment
was
not
conducted
for
exposures
through
food,
drinking
water
and
residential
exposure
since
toxicological
endpoints
for
14
risk
assessment
were
not
identified
based
on
the
available
data.
In
reaching
this
determination,
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
aggregate
exposure.

b.
Determination
of
Safety
to
U.
S.
Population
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
has
concluded
that
there
are
no
endpoints
of
concern
for
oral,
dermal,
or
inhalation
exposure
to
triethylene
glycol.
This
conclusion
is
based
on
the
results
of
toxicity
testing
of
triethylene
glycol
in
which
dose
levels
near
or
above
testing
limits
(
as
established
in
the
OPPTS
870
series
harmonized
test
guidelines)
were
employed
in
experimental
animal
studies
and
no
significant
toxicity
observed.
The
Agency
has
determined
that
the
established
exemption
from
the
requirement
for
a
tolerance
for
triethylene
glycol
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
triethylene
glycol.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices
and
exposure
scenarios,
and
the
environmental
behavior
of
triethylene
glycol.

Because
no
toxicological
endpoints
were
identified
for
triethylene
glycol,
the
Agency
has
determined
that
exposure
to
it
does
not
result
in
human
health
effects
of
concern.
Therefore
a
quantitative
risk
assessment
was
not
necessary
for
this
pesticide.

c.
Determination
of
Safety
to
Infants
and
Children
EPA
has
determined
that
the
established
exemption
from
a
requirement
for
a
tolerance
for
triethylene
glycol,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
factors
of
the
toxicity,
use
practices,
and
environmental
behavior
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
triethylene
glycol
residues
in
this
population
subgroup.

In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
triethylene
glycol
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
triethylene
glycol
because
there
is
no
pre­
or
post­
natal
evidence
for
increased
susceptibility
following
exposure.

d.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
15
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,
triethylene
glycol
may
be
subject
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

e.
Cumulative
Risks
Any
risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
triethylene
glycol.
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
triethylene
glycol.
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
The
tolerance
exemption
for
residues
of
triethylene
glycol
per
se
is
established
under
40
CFR
180.920
(
69
FR
23124,
Apr.
28,
2004).

Tolerance
Exemptions
The
following
tolerance
exemption
for
triethylene
glycol
is
listed
in
40
CFR
180.920
(
7/
1/
04):

Triethylene
glycol
is
exempted
from
the
requirement
of
a
tolerance
when
used
as
an
inert
(
or
occasionally
active)
ingredient
in
pesticide
formulations
applied
to
growing
crops
only
as
a
deactivator.

In
addition
to
the
above,
triethylene
glycol
is
approved
by
the
Food
and
Drug
Administration
as
a
preservative
for
food
packaging
adhesives
as
listed
in
21
CFR
175.105.
16
Triethylene
glycol
also
has
an
indirect
food
additive
regulation
(
21
CFR
177.1200)
for
its
use
as
a
plasticizer
in
cellophane.
However,
this
use
is
regulated
solely
by
the
Food
and
Drug
Administration
(
FDA).
a.
Codex
Harmonization
Currently
there
are
no
Codex
MRLs
established
for
triethylene
glycol.

D.
Regulatory
Rationale
The
Agency
has
determined
triethylene
glycol
is
eligible
for
reregistration.
Based
on
the
available
data,
the
Agency
has
concluded
that
triethylene
glycol
exhibits
low
toxicity
and
exposures
to
triethylene
glycol
used
as
both
an
active
or
inert
ingredient
do
not
present
risks
of
concern
to
the
Agency.
Therefore,
no
mitigation
measures
are
necessary
at
this
time.

1.
Listed
Species
Considerations
a.
The
Endangered
Species
Act
Section
7
of
the
Endangered
Species
Act,
16
U.
S.
C.
Section
1536(
a)(
2),
requires
all
federal
agencies
to
consult
with
the
National
Marine
Fisheries
Service
(
NMFS)
for
marine
and
anadromous
listed
species,
or
the
United
States
Fish
and
Wildlife
Services
(
FWS)
for
listed
wildlife
and
freshwater
organisms,
if
they
are
proposing
an
"
action"
that
may
affect
listed
species
or
their
designated
habitat.
Each
federal
agency
is
required
under
the
Act
to
insure
that
any
action
they
authorize,
fund,
or
carry
out
is
not
likely
to
jeopardize
the
continued
existence
of
a
listed
species
or
result
in
the
destruction
or
adverse
modification
of
designated
critical
habitat.
To
jeopardize
the
continued
existence
of
a
listed
species
means
"
to
engage
in
an
action
that
reasonably
would
be
expected,
directly
or
indirectly,
to
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
the
species."
50
C.
F.
R.
§
402.02.

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

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
17
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
triethylene
glycol,
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
Triethylene
glycol
end­
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
triethylene
glycol
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.
18
V.
WHAT
REGISTRANTS
NEED
TO
DO
The
Agency
has
determined
that
triethylene
glycol
is
eligible
for
reregistration.
No
additional
generic
data
are
required
at
this
time
to
support
this
decision.

For
end
use
products
containing
the
active
ingredient
triethylene
glycol,
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.
a
completed
form
certifying
compliance
with
data
compensation
requirements
(
EPA
Form
8570­
34);

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

Please
contact
Marshall
Swindell
at
(
703)
308­
6341
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed
as
follows:

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
PDCI/
PRB)
Document
Processing
Desk
(
PDCI/
PRB)
Marshall
Swindell
Marshall
Swindell
US
EPA
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
South
Bell
Street
Arlington,
VA
22202
19
A.
Manufacturing­
Use
Products
There
are
no
currently
registered
triethylene
glycol
manufacturing­
use
products.

1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
triethylene
glycol
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
Therefore
at
this
time,
there
are
no
generic
data
requirements.

B.
End­
Use
Products
1.
Additional
Product­
Specific
and
Efficacy
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.
Registrants
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.

The
Agency
considers
the
terms
"
sanitizer"
and
"
sanitization"
to
be
public
health
claims,
regardless
of
the
use
site
or
whether
the
specific
organisms
for
which
the
product
is
efficacious
against
are
identified
or
not.
This
policy
was
reiterated
in
the
proposed
Part
152/
156
Antimicrobial
Registration
Requirements,
64
FR
50672­
50730,
September
17,
1999.
Upon
finalization
of
this
proposed
rulemaking,
efficacy
data
will
be
required
to
support
the
continued
use
of
the
term
"
air
sanitizer"
on
the
product
label.

Until
the
proposed
Product
Performance
Guidelines
for
proposed
Part
152/
15
are
finalized,
testing
requirements
are
being
deferred
for
products
of
this
type.
Currently,
efficacy
requirements
are
satisfied
by
the
chemical
formula
statement
showing
appropriate
glycol
content.
For
products
containing
at
least
5%
glycols
(
triethylene,
dipropylene,
and/
or
propylene
glycols),
quantitative
chemical
determinations
must
be
performed,
using
an
air
sampling
device,
to
show
the
concentration
of
glycol
vapor
achieved
with
the
product
in
an
enclosed
experimental
room
or
chamber
when
used
as
directed.

A
product­
specific
data
call­
in,
outlining
specific
data
requirements,
will
be
issued
shortly.
In
the
interim,
no
additional
public
health
claims
can
be
made
unless
supported
by
the
appropriate
efficacy
data.
20
VI.
APPENDICES
21
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
Use
Categories:

(
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
Use
Site
Formulation
Application
Rate
(
Range)
No.
of
Applications
Use
Limitations
1.
Agricultural
Premises
and
Equipment
­
no
registered
uses
for
this
pattern
2.
Food
Handling/
Storage
Establishments
Premises
and
Equipment
Air
Treatment
(
Eating
Establishments)
1.
10807­
43
­

pressurized
liquid
­
automatic
dispenser
1.
7
ounce
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
1.
information
not
given
on
label
1.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
22
2.
10807­
37
&

10807­
24
­
pressurized
liquid
­
manual
spray
2.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
2.
spray
several
times
per
day
2.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
3.
Commercial,
Institutional
and
Industrial
Premises
and
Equipment
Commercial
Premises
&

equipment
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes;
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Shower
Room
Premises
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes;
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
1.
9444­
136­

pressurized
liquid
­
automatic
dispenser
1.
metered
valve
actuates
every
fifteen
minutes
­
7
ounce
product
treats
a
room
up
to
30
X
20
X
10
1.
information
not
given
on
label
1.
do
not
contaminate
water,
food
or
feed
by
storage
or
disposal
Air
Treatment
(
Unspecified)
2.
4822­
293­

pressurized
liquid
­
manual
spray
2.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9)
2.
information
not
given
on
label
2.
avoid
contact
with
food
and
food
utensils
23
Laundry
Equipment
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
1.
10807­
43­

pressurized
liquid
­
automatic
dispenser
1.
7
ounces
of
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
1.
information
not
given
on
label
1.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
2.
9444­
19­

pressurized
liquid
­
automatic
intermittent
aerosol
dispenser
2.
6.2
ounces
treats
6,000
cubic
feet
of
closed
air
space.
2.
sprayed
at
intervals
2.
do
not
contaminate
water,
food
or
feed
Air
Treatment
(
Locker
Room)
3.
10807­
37
&

10807­
24­
pressurized
liquid
­
manual
spray
3.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
3.
spray
several
times
per
day
3.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
24
Locker
Room
Premises
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
1.
51838­
1
­

ready
to
use
solutionautomatic
dispenser
operation
1.
7
ounce
product
for
each
6,000
cubic
feet
of
closed
air
space
1.
product
sprayed
at
intervals
1.
avoid
contamination
of
food
2.
51838­
1­

pressurized
liquid
­
for
manual
operation
2.
fill
average
size
room
with
mist
(
approximately
15
sprays)
2.
repeat
application
several
times
daily
2.
avoid
contamination
of
food
3.
10807­
37
&

10807­
24­
pressurized
liquid­
manual
spray
3.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
3.
spray
several
times
per
day
3.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
Air
Treatment
(
Institutional)
4.
4822­
293­

pressurized
liquid
­
manual
spray
4.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9)
4.
information
not
given
on
label
4.
avoid
contact
with
food
and
food
utensils
25
5.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
continuous
action
aerosol
can
5.
one
second
spray
for
a
9.5
X
9
X
7
room
5.
information
not
given
on
label
5.
do
not
position
near
heat
or
electrical
sources;

do
not
spray
directly
onto
surfaces;
in
case
of
contact
with
surfaces,

wipe
immediately
with
damp
cloth.

6.
44446­
20­

pressurized
liquid
­
manual
spray
6.
spray
for
three
seconds
6.
information
not
given
on
label
6.
wash
hands
before
eating,
drinking,

chewing
gum,
using
tobacco,

or
using
the
toilet
26
7.
4822­
531­

wall
mounted
unit
in
metered
dose
aerosol
can
or
pressurized
liquid
­
hand
held
unit
7.
using
a
120
µ
l
valve
with
.22
ounces
of
product:

­
1
time
for
2.5
X
2.5
X
7
room
­
2
times
for
4
X
3
X
7
room
­
3
times
for
4.5
X
4
X
7
room
­
4
times
for
5
X
5
X
7
room
using
a
185
µ
l
valve­

­
1
time
for
3
X
3
X
7
room
­
2
times
for
4.5
X
4
X
7
room
­
3
times
for
a
5.5
X
5
X
7
room
4
times
for
a
6
X
6
X
7
room
7.
information
not
given
on
label
7.
do
not
position
near
heat
or
electrical
sources;

do
not
spray
directly
onto
surfaces;
in
case
of
contact
with
surfaces,

wipe
immediately
with
damp
cloth.

8.
10807­
43­

pressurized
liquid
­
automatic
dispenser
8.
7
ounce
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
8.
information
not
given
on
label
8.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
27
1.
51838­
1­

ready
to
use
solution
­
for
automatic
dispenser
operation
1.
7
ounce
product
for
each
6,000
cubic
feet
of
closed
air
space
1.
product
sprayed
at
intervals
1.
avoid
contamination
of
food
2.
51838­
1­

ready
to
use
solution
­
for
manual
operation
2.
fill
average
size
room
with
mist
(
approximately
15
sprays)
2.
repeat
application
several
times
daily
2.
avoid
contamination
of
food
3.
10807­
43
­

pressurized
liquidautomatic
dispenser
3.
7
ounce
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
3.
information
not
given
on
label
3.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
Air
Treatment
(
Commercial)
4.
10807­
37
&

10807­
24­
pressurized
liquid
­
manual
spray
4.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
4.
spray
several
times
per
day
4.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
28
5.
9444­
19
­

Pressurized
liquid
­
automatic
intermittent
aerosol
dispenser
5.
6.2
ounces
of
product
treats
6,000
cubic
feet
of
closed
air
space.
5.
sprayed
at
intervals
5.
do
not
contaminate
water,
food
or
feed
6.
4822­
293
­

pressurized
liquid
­
manual
spray
6.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9)
6.
information
not
given
on
label
6.
avoid
contact
with
food
and
food
utensils
7.
44446­
20­

pressurized
liquid
­
manual
spray
7.
spray
for
three
seconds
7.
information
not
given
on
label
7.
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
8.
51838­
2
­

pressurized
liquid
­
automatic
dispenser
8.
spray
for
one
second
toward
center
of
average
size
room
(
10
X
14
X
8)
8.
repeat
application
several
times
daily
8.
spray
away
from
drapes,
walls,
plastic,

vinyl,
painted
or
varnished
surfaces
1.
51838­
1­

ready
to
use
solution
­
for
automatic
dispenser
1.
7
ounces
of
product
for
each
6,000
cubic
feet
of
closed
air
space
1.
product
sprayed
at
intervals
1.
avoid
contamination
of
food
Air
Treatment
(
Transp
Facilities)
2.
4822­
293­

pressurized
liquid
­
manual
spray
2.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9
2.
information
not
given
on
label
2.
avoid
contact
with
food
and
food
utensils
29
3.
10807­
37
&

10807­
24
­
pressurized
liquid
­
manual
spray
3.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
3.
spray
several
times
per
day
3.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
4.
51838­
1­

ready
to
use
solution
­
for
manual
operation
4.
fill
average
size
room
with
mist
(
approximately
15
sprays)
4.
repeat
application
several
times
daily
4.
avoid
contamination
of
food
1.
51838­
1­

ready
to
use
solution
­
automatic
dispenser
1.
7
ounces
of
product
for
each
6,
000
cubic
feet
of
closed
air
space
1.
product
sprayed
at
intervals
1.
avoid
contamination
of
food
2.
51838­
1­

ready
to
use
solution
­
for
manual
operation
2.
fill
average
size
room
with
mist
(
approximately
15
sprays)
2.
repeat
application
several
times
daily
2.
avoid
contamination
of
food
Air
Treatment
(
Industrial)
3.
10807­
37
&

10807­
24­
pressurized
liquid
­
manual
spray
3.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
3.
spray
several
times
per
day
3.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
30
4.
10807­
43­

pressurized
liquid
­
automatic
dispenser
4.
7
ounces
of
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
4.
information
not
given
on
label
4.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
4.
Residential
and
Public
Access
Premises
1.
9444­
136­

pressurized
liquid
­
automatic
dispenser
1.
metered
valve
actuates
every
fifteen
minutes
­
7
ounce
product
treats
a
room
up
to
30
X
20
X
10
1.
information
not
given
on
label
1.
do
not
contaminate
water,
food
or
feed
by
storage
or
disposal
Air
Treatment
(
Unspecified)
2.
4822­
293­

pressurized
liquid
­
manual
spray
2.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9)
2.
information
not
given
on
label
2.
avoid
contact
with
food
and
food
utensils
Household
(
Premises
&
Contents)
44446­
20­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
31
Air
treatments
(
commercial/
household)
4822­
531­
pressurized
liquid
­
wall
mounted
unit
in
metered
dose
aerosol
can
or
hand
held
unit
using
a
120
µ
l
valve
with
.22
ounces
of
product:

­
1
time
for
2.5
X
2.5
X
7
room
­
2
times
for
4
X
3
X
7
room
­
3
times
for
4.5
X
4
X
7
room
­
4
times
for
5
X
5
X
7
room
using
a
185
µ
l
valve­

­
1
time
for
3
X
3
X
7
room
­
2
times
for
4.5
X
4
X
7
room
­
3
times
for
a
5.5
X
5
X
7
room
4
times
for
a
6
X
6
X
7
room
information
not
given
on
label
do
not
position
near
heat
or
electrical
sources;
do
not
spray
directly
onto
surfaces;
in
case
of
contact
with
surfaces,

wipe
immediately
with
damp
cloth.

Laundry
Equipment
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toile
Automobiles
44446­
20
­
pressurized
liquid
­
manual
spray
spray
into
air
conditioning
system
and
spray
for
four
to
six
seconds
information
not
given
on
label
shut
off
air
conditioner
after
applying
the
product;
wash
hands
before
eating,
drinking,

chewing
gum,
using
tobacco,
or
using
the
toilet
32
Shower
Room
Premises
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Hard
Nonporous
Surface
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Environmental
Inanimate
Hard
Surfaces
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Garbage
Storage
Premises
&

Containers
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Bathroom
Premises
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
33
1.
10807­
43­

pressurized
liquid
­
automatic
dispenser
1.
7
ounces
of
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
1.
information
not
given
on
label
1.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
2.
9444­
19­

pressurized
liquid
­
automatic
intermittent
aerosol
dispenser
2.
6.2
ounce
of
product
treats
6,000
cubic
feet
of
closed
air
space.
2.
sprayed
at
intervals
2.
do
not
contaminate
water,
food
or
feed
3.
44446­
20­

pressurized
liquid
­
manual
spray
3.
spray
for
three
seconds
3.
information
not
given
on
label
3.
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
Air
Treatment
(
Bathroom)
4.
10807­
37­

pressurized
liquid
­
manual
spray
4.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
4.
spray
several
times
per
day
4.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
34
5.
51838­
1­

pressurized
liquid
­
manual
operation
5.
fill
average
size
room
with
mist
(
approximately
15
sprays)
5.
repeat
application
several
times
daily
5.
avoid
contamination
of
food
6.
4822­
293
­

pressurized
liquid
­
manual
spray
6.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9
6.
information
not
given
on
label
6.
avoid
contact
with
food
and
food
utensils
7.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
continuous
action
aerosol
can
7.
one
second
spray
for
a
9.5
X
9
X
7
room
7.
information
not
given
on
label
7.
information
not
given
on
label
8.
10807­
24
­

pressurized
liquid­
manual
spray
8.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
8.
spray
several
times
per
day
8.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
35
9.
4822­
531­

wall
mounted
unit
in
metered
dose
aerosol
can
or
pressurized
liquid
­
hand
held
unit
9.
using
a
120
µ
l
valve
with
.22
ounces
of
product:

­
1
time
for
2.5
X
2.5
X
7
room
­
2
times
for
4
X
3
X
7
room
­
3
times
for
4.5
X
4
X
7
room
­
4
times
for
5
X
5
X
7
room
using
a
185
µ
l
valve­

­
1
time
for
3
X
3
X
7
room
­
2
times
for
4.5
X
4
X
7
room
­
3
times
for
a
5.5
X
5
X
7
room
4
times
for
a
6
X
6
X
7
room
9.
information
not
given
on
label
9.
information
not
given
on
label
Locker
Room
Premises
44446­
20
­
pressurized
liquid
­
manual
spray
spray
surface
until
completely
wet
and
allow
to
remain
wet
for
10
minutes
or
for
air
sanitization
spray
for
three
seconds
information
not
given
on
label
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
36
1.
10807­
43­

pressurized
liquid
­
automatic
dispenser
1.
7
ounces
of
product
contains
3400
controlled
sprays
that
will
last
for
30
days
when
used
on
a
24
hour
basis
or
60
days
if
used
12
hours
per
day
when
set
to
dispense
every
15
minutes
(
room
size
not
specified)
1.
information
not
given
on
label
1.
do
not
use
in
nurseries
or
rooms
where
infants,
ill
or
aged
patients
are
confined;

food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
2.
9444­
19­

pressurized
liquid
­
automatic
intermittent
aerosol
dispenser
2.
6.2
ounces
treats
6,000
cubic
feet
of
closed
air
space.
2.
sprayed
at
intervals
2.
do
not
contaminate
water,
food
or
feed
Air
Treatment
(
Locker
Room)
3.
10807­
37
&

10807­
24­
pressurized
liquid
­
manual
spray
3.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
3.
spray
several
times
per
day
3.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
Birds
(
Caged)
(
Animal
Treatment)
11715­
20
­
pressurized
liquid­
manual
spray
spray
lightly
with
one
burst
of
2
or
3
seconds
no
more
than
2
times
per
week
information
not
given
on
label
37
Pet
Bird
Cages
(
Enclosed
Premise
Treatment)
11715­
20
­
pressurized
liquid­
manual
spray
thoroughly
spray
perches
and
cage
regular
intervals
information
not
given
on
label
Air
Treatment
(
Pet
Kennels
&

Enclosed
Premise
Treatment)
1.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
metered
dose
aerosol
can
or
hand
held
unit
1.
using
a
120
µ
l
valve
with
.22
ounces
of
product:

­
1
time
for
2.5
X
2.5
X
7
room
­
2
times
for
4
X
3
X
7
room
­
3
times
for
4.5
X
4
X
7
room
­
4
times
for
5
X
5
X
7
room
using
a
185
µ
l
valve­

­
1
time
for
3
X
3
X
7
room
­
2
times
for
4.5
X
4
X
7
room
­
3
times
for
a
5.5
X
5
X
7
room
4
times
for
a
6
X
6
X
7
room
1.
information
not
given
on
label
1.
do
not
position
near
heat
or
electrical
sources;

do
not
spray
directly
onto
surfaces;
in
case
of
contact
with
surfaces,

wipe
immediately
with
damp
cloth.
38
2.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
continuous
action
aerosol
can
2.
one
second
spray
for
a
9.5
X
9
X
7
room
2.
information
not
given
on
label
2.
information
not
given
on
label
3.
4822­
293­

pressurized
liquid
­
manual
spray
3.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9
3.
information
not
given
on
label
3.
avoid
contact
with
food
and
food
utensils
39
5.
Medical
premises
and
equipment
1.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
metered
dose
aerosol
can
or
hand
held
unit
1.
using
a
120
µ
l
valve
with
.22
ounces
of
product:

­
1
time
for
2.5
X
2.5
X
7
room
­
2
times
for
4
X
3
X
7
room
­
3
times
for
4.5
X
4
X
7
room
­
4
times
for
5
X
5
X
7
room
using
a
185
µ
l
valve­

­
1
time
for
3
X
3
X
7
room
­
2
times
for
4.5
X
4
X
7
room
­
3
times
for
a
5.5
X
5
X
7
room
4
times
for
a
6
X
6
X
7
room
1.
information
not
given
on
label
1.
do
not
position
near
heat
or
electrical
sources;

do
not
spray
directly
onto
surfaces;
in
case
of
contact
with
surfaces,

wipe
immediately
with
damp
cloth.

Air
treatments
(
sickroom)
2.
4822­
531­

pressurized
liquid
­
wall
mounted
unit
in
continuous
action
aerosol
can
2.
one
second
spray
for
a
9.5
X
9
X
7
room
2.
information
not
given
on
label
2.
information
not
given
on
label
40
1.
51838­
2
­

pressurized
liquid­
manual
spray
1.
spray
for
one
second
toward
center
of
average
size
room
(
10
X
14
X
8)
1.
repeat
application
several
times
daily
1.
spray
away
from
drapes,
walls,
plastic,

vinyl,
painted
or
varnished
surfaces
2.
51838­
1­

ready
to
use
solution
­
automatic
dispenser
2.
7
ounces
of
product
for
each
6,
000
cubic
feet
of
closed
air
space
2.
product
sprayed
at
intervals
2.
avoid
contamination
of
food
3.
51838­
1­

ready
to
use
solution
­
for
manual
operation
3.
fill
average
size
room
with
mist
(
approximately
15
sprays)
3.
repeat
application
several
times
daily
3.
avoid
contamination
of
food
4.
10807­
37
&

10807­
24
­
pressurized
liquid
­
manual
spray
4.
spray
the
room
until
a
light
fog
forms
­
spray
6
to
8
seconds
in
an
average
room
(
10
X
10)
4.
spray
several
times
per
day
4.
food,
food
contact
surfaces
and
utensils
should
be
protected
from
exposure
to
the
spray
or
rinsed
with
potable
water
before
use
Air
treatment
(
hospital)
5.
4822­
293
­

pressurized
liquid
­
manual
spray
5.
spray
upward
in
center
of
room
for
10
seconds
in
average
room
of
12
X
12
X
9
5.
information
not
given
on
label
5.
avoid
contact
with
food
and
food
utensils
6.
44446­
20­

pressurized
liquid
­
manual
spray
6.
spray
for
three
seconds
6.
information
not
given
on
label
6.
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet
41
7.
9444­
19
­

pressurized
liquid
­
automatic
intermittent
aerosol
dispenser
7.
6.2
ounces
of
product
treats
6,000
cubic
feet
of
closed
air
space
7.
sprayed
at
intervals
7.
do
not
contaminate
water,
food
or
feed
Hospital
(
Premises
and
Materials)
44446­
20­
pressurized
liquid
­
manual
spray
decontamination
against
HIV­
1
of
surfaces/
objects
soiled
with
blood/
body
fluids
­
1800
ppm
of
active
quaternary
water
for
a
contact
time
of
10
minutes
at
room
temperature
­
use
a
10
minute
contact
time
for
disinfection
against
all
other
bacteria
and
fungi
claimed
information
not
given
on
label
dispose
of
infectious
materials
according
to
federal,
state
and
local
regulations
42
Appendix
B:
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
Guide
To
Appendix
B
Appendix
B
lists
the
generic
(
not
product
specific)
data
requirements
which
support
the
re­
registration
of
Triethylene
Glycol
(
TEG).

These
requirements
apply
to
TEG
in
all
products,
including
data
requirements
for
which
a
technical
grade
active
ingredient
is
the
test
substance.
The
data
table
is
organized
in
the
following
formats:

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

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

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

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

and
acceptable
for
satisfying
the
Guideline
requirement.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
each
study.
43
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
TECHNICAL
GRADE
ACTIVE
INGREDIENT
(
TGAI)
CHEMISTRY
830.1550
61­
1
Product
Identity
and
Composition
2,3,4,5
42814401
and
42211801
830.1600
830.1620
830.1650
61­
2A
Starting
Materials
and
Manufacturing
Process
2,3,4,5
42814401
830.1670
61­
2B
Formation
of
Impurities
2,3,4,5
42814401
830.1700
62­
1
Preliminary
Analysis
2,3,4,5
42814402
830.1750
62­
2
Certification
of
Limits
2,3,4,5
42814402
830.1800
62­
3
Analytical
Method
2,3,4,5
42814402
830.6302
63­
2
Color
2,3,4,5
42814403
and
42211801
830.6303
63­
3
Physical
State
2,3,4,5
42814403
and
42211801
830.6304
63­
4
Odor
2,3,4,5
42814403
and
42211801
830.7200
63­
5
Melting
Point
2,3,4,5
not
required
830.7220
63­
6
Boiling
Point
2,3,4,5
42814403
830.7300
63­
7
Density
2,3,4,5
42814403
44
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
830.7840
830.7860
63­
8
Solubility
2,3,4,5
42814403
830.7950
63­
9
Vapor
Pressure
2,3,4,5
42814403
830.7370
63­
10
Dissociation
Constant
in
Water
2,3,4,5
waived
830.7550
830.7560
830.7570
63­
11
Partition
Coefficient
(
Octanol/
Water)
2,3,4,5
42814403
830.7000
63­
12
pH
2,3,4,5
42814401;
42211801;

42814403
830.6313
63­
13
Stability
2,3,4,5
42814401;
42211801;

42814403
830.6314
63­
14
Oxidizing/
Reducing
Action
2,3,4,5
42814403
830.6315
63­
15
Flammability
2,3,4,5
42814403
830.6316
63­
16
Explodability
2,3,4,5
42814403
830.6317
63­
17
Storage
Stability
2,3,4,5
42814403
830.7100
63­
18
Viscosity
2,3,4,5
42814403
830.6319
63­
19
Miscibility
2,3,4,5
42814403
830.6320
63­
20
Corrosion
Characteristics
2,3,4,5
42814403
45
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
830.6321
63­
21
Dielectric
breakdown
voltage
2,3,4,5
42814403
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
Test
­
Quail/
duck
All
waived
due
to
high
volatility
and
low
toxicity
850.1075
72­
1
C
Fish
Acute
Toxicity
­
Rainbow
Trout
All
waived
due
to
high
volatility
and
low
toxicity
850.1075
72­
1
C
Fish
Acute
Toxicity
­
Fathead
Minnow
All
waived
due
to
high
volatility
and
low
toxicity
850.1010
72­
2A
Acute
Aquatic
Invertebrate
Toxicity
All
waived
due
to
high
volatility
and
low
toxicity
46
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
nonguideline
nonguideline
Other
published
literature/
extraneous
submissions:

1.
Mysid
(
Mysidopsis
bahia)­
96­
hour
static
acute;
toxicity
LC50
=
11,000
ppm
2.
Sheepshead
minnow
(
Cyprinodon
variegatus)
­
96­
hour
static
acute;
toxicity
LC50
=
48,000
ppm
3.
Bluegill
sunfish
(
Lepomis
macrochirus)
­
96
hour
static
acute;
toxicity
LC50
>
10,000
ppm
4.
Menidia
beryllina
­
96
hour
static;
toxicity
LC50
>

10,000
ppm
5.
Fathead
minnow
(
Pimephales
promelas)
­
96
hour
flowthrough
toxicity
­
LC
50
59,900
­
77,400
ppm
n/
a
The
below
list
not
required
for
current
uses;
available
in
open
literature:

1.
40228401
2.
40228401
3.
Open
Literature
4.
Open
Literature
5.
Open
Literature
TOXICOLOGY
870.1100
81­
1
Acute
Oral
­
Rat
2,3,4,5
42814404
&
Open
Literature
870.1200
81­
2
Acute
Dermal
­
Rabbit
2,3,4,5
waived
870.1300
81­
3
Acute
Inhalation
 
Rat
2,3,4,5
OTS
527779­
2
(
Nachreiner,
D.
J.,
1991)
47
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.2400
81­
4
Acute
Eye
Irritation
­
Rabbit
2,3,4,5
42814404
870.2500
81­
5
Acute
Skin
Irritation
­
Rabbit
2,3,4,5
42814404
870.2600
81­
6
Dermal
Sensitization
2,3,4,5
42814404
&
Open
Literature
870.3100
82­
1a
90­
Day
Oral
Subchronic
­
Rat
2,3,4,5
Open
Literature
&
OTS
0527779­
1
(
Union
Carbide,
1989
and
Union
Carbide,
1990)

870.3250
82­
3*
21­
Day
Subchronic
Dermal
2,3,4,5
42814404
&
Open
Literature
870.3465
82­
4*
90­
Day
Subchronic
Inhalation
2,3,4,5
OTS
0537563­
1
(
Norris,
J.

and
W.
Kintigh,
1994
&

Sun,
J.
and
W.
Kintigh,

1993)

870.4100
83­
1a
Chronic
Toxicity
­
rat
2,3,4,5
satisfied
by
guideline
870.4300
870.4100
83­
1b
Chronic
Toxicity
­
non­
rodent
2,3,4,5
42814404
&
Open
Literature
870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity
­
rat
2,3,4,5
42814404
&
Open
Literature
48
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.3700
83­
3a
Prenatal
Developmental
Toxicity
­
Rat
2,3,4,5
42814404
&
OTS
7527779­
4
(
Union
Carbide,
1991)

870.3700
83­
3b
Prenatal
Developmental
Toxicity
­
Rabbit
2,3,4,5
42814404
870.3800
83­
4**
Reproduction
and
fertility
effects
­
Rat
2,3,4,5
42814404
&
Open
Literature
870.5100
84­
2
Bacterial
Reverse
Mutation
Test
2,3,4,5
OTS
50527779­
1
870.5300
84­
2
In
Vitro
Mammalian
Cell
Gene
Aberration
Test
2,3,4,5
OTS
50527779­
1
870.5375
84­
2
In
Vitro
Mammalian
Chromosome
Aberration
Test
2,3,4,5
OTS
50527779­
1
870.5900
84­
2
In
Vitro
Sister
Chromatid
Exchange
2,3,4,5
OTS
50527779­
1
870.7485
85­
1
Metabolism
and
Pharmocokinetics
2,3,4,5
42814404
*
For
guidelines
82­
3
and
82­
4,
at
least
one
is
required
to
be
fulfilled;
not
both
(
for
both
food
and
non­
food
uses).

**
Only
required
for
food
use.

ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
of
Parent
and
Degradates
2,3,4,5
waived
Please
Note:
Although
the
Open
Literature
studies
do
not
satisfy
any
of
the
Agency's
testing
guideline
requirements,
this
information
is
considered
adequate
for
characterizing
the
potential
hazard
from
exposure
to
triethylene
glycol.
Therefore,
no
additional
mammalian
toxicity
data
will
be
required
at
this
time.
49
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
South
Bell
Street,
Arlington,
VA
22202.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4:
00
pm.

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

°
Triethylene
Glycol
(
TEG):
Antimicrobials
Division's
Review
of
the
Disciplinary
Sciences
for
Issuance
of
the
Reregistration
Eligibility
Decision
(
RED)
Document.
Reregistration
Case
No.:
3146,
PC
Code:
083501.
CAS
Registry
No.:
112­
27­
6
°
Triethylene
Glycol­
Revised
Report
of
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee.
PC
Code
083501,
Case
3146,
Antimicrobials
Division,
11/
21/
05,
Timothy
F.
McMahon,
Ph.
D.,
Chair,
ADTC
°
Product
Chemistry
Science
Chapter.
PC
Code
083501,
Case
3146,
Antimicrobials
Division,
8/
13/
03,
A.
Najm
Shamim,
Ph.
D.,
Chemist
°
Environmental
Fate
Studies
and
Environmental
Fate
Assessment.
PC
Code
083501,
Case
3146,
Antimicrobials
Division,
8/
13/
03,
A.
Najm
Shamim,
Ph.
D.

°
Revised
Toxicology
Disciplinary
Chapter.
PC
Code
083501,
Case
3146,
Antimicrobials
Division,
10/
11/
05,
Michelle
Centra
°
Occupational
and
Residential
Exposure.
PC
Code
083501,
Case
No.
3146,
Antimicrobials
Division,
5/
24/
05,
Timothy
Leighton,
Environmental
Scientist
°
Ecological
Hazard
and
Environmental
Risk
Characterization.
PC
Code
083501,
Case
3146,
Antimicrobials
Division,
8/
4/
04,
Kathryn
Montague,
M.
S.

°
Review
of
Phase
IV
Response
Submissions
in
Support
of
FIFRA
88.
Memorandum:
G.
Reddy,
12/
22/
93
°
Triethylene
Glycol:
Incident
Report
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
PC
Code:
083501.
Case
No.
3146
(
Memorandum:
J.
Chen,
9/
22/
03).

°
Triethylene
Glycol
Estimated
Drinking
Water
Concentrations
(
Memorandum:
S.
Abel,
9/
26/
03).

Appendix
D:
Bibliography
Citations
50
MRID
Number
Citation
40228401
Mayer,
F.
L.
(
1986)
Acute
Toxicity
Handbook
of
Chemicals
to
Estuarine
Organisms.
Prepared
by
U.
S.
EPA
Office
of
Research
and
Development,
Environmental
Research
Laboratory,
Gulf
Breeze,
FLA
EPA/
600/
X­
36/
231.

42211801
Reed,
G.
(
1992)
Product
Chemistry
Data:
Ozium
Glycolized
Air
Sanitizer.
Unpublished
study
prepared
by
Blue
Coral,
Inc.
10
p.

42814404
Davis,
K.(
1993)
Compilation
of
Toxicology
Data
References
for
Triethylene
Glycol:
Lab
Project
Number:
TEGTOX.
Unpublished
study
prepared
by
RegWest
Co.
131
p.

42814401
Davis,
K.
(
1993)
Product
Chemistry
Data
of
Triethylene
Glycol:
Lab
Project
Number:
TEG61.
Unpublished
study
prepared
by
RegWest
Co.
6
p.

42814402
Davis,
K.
(
1993)
Product
Chemistry
Data
of
Triethylene
Glycol:
Lab
Project
Number:
TEG62.
Unpublished
study
prepared
by
RegWest
Co.
13
p.

42814403
Davis,
K.
(
1993)
Physical
&
Chemical
Characteristics
of
Triethylene
Glycol:
Lab
Project
Number:
TEG63.
Unpublished
study
prepared
by
RegWest
Co.
91
p.

EPA
ID
Document
Number
OTS0527779­
1
Guzzie,
P.,
Slesinski,
F.
Frank,
et
al.
(
1986a)
Triethylene
Glycol
Salmonella/
Microsome
(
Ames)
Bacterial
Mutagenicity
Assay.
Bushy
Run
Research
Center,
Export,
PA.
Project
Report
49­
58.
April
29,
1986.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Guzzie,
P.,
Slesinski,
F.
Frank,
et
al.
(
1986b)
Triethylene
Glycol:
In
vitro
Chromosome
Aberration
Study.
Bushy
Run
Research
Center,
Export,
PA.
Project
Report
49­
82.
July
1,
1986.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Slensinski,
R.,
F.
Frank,
and
P.
Guzzie
(
1986a)
Triethylene
Glycol:
In
vitro
Genotoxicity
Studies:
CHO/
HGPRT
Mutation
Test;
Sister
Chromatid
Exchange
Assay.
Bushy
Run
Research
Center,
Export,
PA.
51
Project
Report
49­
83.
June
26,
1986.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Slensinski,
R.,
F.
Frank,
and
P.
Guzzie
(
1986b)
Triethylene
Glycol:
In
vitro
Mammalian
Cell
Gene
Mutation
Assay
in
CHO
Cells.
Bushy
Run
Research
Center,
Export,
PA.
Project
Report
49­
82.
June
26,
1986.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Union
Carbide
(
1989)
Triethylene
Glycol:
Fourteen­
day
Dietary
Toxicity
Study
in
Fischer
344
Rats.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Union
Carbide
(
1990a)
Triethylene
Glycol:
Ninety­
day
Dietary
Toxicity
Study
in
Fischer
344
Rats.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
1
Union
Carbide
(
1990b)
Developmental
Toxicity
Study
of
Triethylene
Glycol
Administered
by
Gavage
to
CD­
1
Mice.
NTIS
Report
No.
OTS0527779­
1.
Unpublished.

OTS0527779­
2
Nachreiner,
D.
J.
(
1991)
Triethylene
Glycol
(
TEG)
Acute
Aerosol
Inhalation
Toxicity
Test
in
Rats.
Bushy
Run
Research
Center;
Project
Report
53­
139
(
BRCC
No.
90­
22­
40272),
March
4,
1991;
NTIS
Report
No.
OTS0527779­
2.
Unpublished.

OTS0527779­
4
Union
Carbide
(
1991)
Developmental
Toxicity
Study
of
Triethylene
Glycol
Administered
by
Gavage
to
CD
(
Sprague­
Dawley)
Rats.
NTIS
Report
No.
OTS0527779­
4.
Unpublished.

OTS0537563­
1
Norris,
J.
and
W.
Kintigh
(
1994)
Triethylene
Glycol:
Nine­
day
Aerosol
Inhalation
(
Nose­
only
Exposure)
toxicity
study
in
Rats.
Bushy
Run
Research
Center,
Union
Carbide
Corporation,
Inc.,
Export,
PA.
Laboratory
Project
ID:
93U1293,
October
26,
1994.
NTIS
Report
No.
OTS0537563­
1.
Unpublished.

OTS0537563­
1
Sun,
J.
and
W.
Kintigh
(
1992)
Triethylene
Glycol:
Nine­
day
Aerosol
Inhalation
study
in
Rats.
Bushy
Run
Research
Center,
Union
Carbide
Chemicals
and
Plastics
Company,
Inc.,
Export,
PA.
Laboratory
Project
ID:
91U0027,
December
14,
1992.
NTIS
Report
No.
OTS0537563­
1
with
cover
letter
dated
010693
(
1992).
Unpublished.

Open
Literature
Citations
52
Bossert,
N.
L.,
et
al.
(
1992)
Reproductive
Toxicity
of
Triethylene
Glycol
and
its
Diacetate
and
Dimethyl
ether
Derivatives
in
a
Continuous
Breeding
Protocol
in
Swiss
CD­
1
mice.
Fund.
Appl.
Pharmacol.
18:
602­
608.

Budavari,
S.,
M.
J.
O'Neill,
A.
Smith,
and
P.
E.
Heckelman
(
eds.)
1989.
The
Merck
Index:
An
Encyclopedia
of
Chemicals,
Drugs,
and
Biologicals.
Rahway
(
eleventh
edition),
NJ:
Merck
&
Co.,
Inc.

Clayton,
G.
D.
and
F.
E.
Clayton
(
eds.).
Patty's
Industrial
Hygiene
and
Toxicology:
Volume
2A,
2B,
2C:
Toxicology.
3rd
ed.
New
York:
John
Wiley
Sons,
1981­
1982.
3839.

Fitzhugh,
O.
G.
and
Nelson,
A.
A.
(
1946)
Comparison
of
the
Chronic
Toxicity
of
Triethylene
Glycol
with
that
of
Diethylene
Glycol.
J.
Ind.
Hyg.
Toxicol.
28(
2):
40­
43.

Geiger,
D.
L.,
Call,
D.
J.,
and
Brooke,
L.
T.
(
Eds).
1988.
Acute
Toxicities
of
Organic
Chemicals
to
Fathead
Minnows
(
Pimephales
promelas).
Vol.
IV.
Superior
Wisconsin:
University
of
Wisconsin­
Superior.
131.

Goldstein,
I.,
et
al.
(
1970)
Toxicity
of
Glycol
Derivatives.
Igenia,
19:
209.

Guillot,
J.
P.,
et
al.
(
1982)
Safety
Evaluation
of
Some
Humectants
and
Moisturizers
Used
in
Cosmetic
Formulations.
International
J.
Cosmetic
Sci.,
4:
67.

Handbook
of
Environmental
Fate;
Fate
and
Exposure
Data
For
Organic
Chemicals,
Volume
IV,
Solvents
2.
Philip
H.
Howard,
Lewis
Publishers,
1989,
pp
546.

Handbook
of
Physics
and
Chemistry,
64th
edition
(
CRC
Press).
Product
Chemistry
Data
for
Triethylene
Glycol,
1983.

Hazard
Substances
Databank
(
HSDB),
A
Database
of
the
National
Library
of
Medicine's
TOXNET
System;
Product
Chemistry
Data
for
Triethylene
Glycol,
2003.

Lamb,
I.
V.
et
al.
(
1997)
Triethylene
Glycol.
Environ.
Health
Perspectives,
105(
Suppl
1):
235­
236.
Also
available
as
an
NTP
Report
No.
PB85­
137073.

Lauter,
W.
M.
and
V.
L.
Vria
(
1940)
Toxicity
of
Triethylene
Glycol
and
the
Effect
of
Paraamino
benzene
Sulfonamide
Upon
the
Toxicity
of
this
Glycol.
J.
Am.
Pharmaceutical
Assoc.
29:
5­
8.

McKennis,
Jr.,
et
al.
(
1962)
The
Excretion
and
Metabolism
of
Triethylene
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Toxic.
53
Appl.
Pharmacol.,
91:
52.

Robertson,
O.
H.,
et
al.
(
1947)
Tests
for
the
Chronic
Toxicity
of
Propylene
Glycol
and
Triethylene
Glycol
on
Monkeys
and
Rats
by
vapor
inhalation
and
Oral
Administration.
J.
Pharm.
Exp.
Ther.,
91:
52.

Smyth,
H.
F.
et
al
(
1941)
The
single
dose
toxicity
of
some
glycol
derivatives.
J.
Ind.
Hyg.
Toxicol.
23(
6):
259­
268.

Stenger,
E.
G.,
er
al.
(
1968)
Zur
Toxikologie
des
Triathylenglkol.
Arzneimittel­
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18:
1536.

Verschuren,
K.
1983.
Handbook
of
Environmental
Data
of
Organic
Chemicals.
2nd
ed.
New
York,
NY:
Van
Nostrand
Reinhold
Co.
1153.

Supporting
Documentation
NIH.
2003.
NIH's
Hazard
Substances
Databank
(
HSDB),
A
Database
of
the
National
Library
of
Medicine's
TOXNET
System.
http://
www.
nih.
gov/
TOXNET
USEPA.
1997.
Pesticide
Handler
Exposure
Database
(
PHED,
Version
1.1),
Surrogate
Exposure
Guide;
Estimates
of
Worker
Exposure,
May
1997.

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

USEPA.
2003.
Estimation
of
Physical/
Chemical
Properties
Program.
http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuitedl.
htm
USEPA.
2004.
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
January
24,
04,
Appendix
A,
Section
IIB,
pg.
81.
http://
www.
epa.
gov/
oppfead1/
endanger/
consultation/
ecoriskoverview
pdf
54
Appendix
E:
Generic
Data
Call­
In
The
Agency
does
not
intend
to
issue
a
Generic
Data
Call­
In
at
this
time.
55
Appendix
F:
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
at
a
later
date.
56
Appendix
G:
Batching
of
End­
Use
Products
Antimicrobial
Division's
Batching
of
Products
Containing
Triethylene
Glycol
as
the
Active
Ingredient
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
the
active
ingredient
triethylene
glycol,
the
Agency
has
batched
products
which
can
be
considered
similar
in
terms
of
acute
toxicity.
(
The
PC
Code
of
triethylene
glycol
is
083501;
the
CAS
Number
is
112­
27­
6.)
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(
identity,
percent
composition
and
biological
activity),
product
form
(
liquid,
paste,
solid,
etc.),
labeling
(
e.
g.,
signal
word,
precautionary
labeling,
etc.)
and
acute
toxicity
data.

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
set
of
six
acute
toxicity
studies
to
represent
all
the
products
within
that
batch.
Registrants
have
the
option
of
participating
with
all
or
some
other
registrants
of
products
in
their
product's
batch,
to
deal
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
or
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
or
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards
(
see
the
attached
acceptance
criteria),
the
formulation
tested
is
considered
by
EPA
to
be
similar
in
terms
of
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
Registrants
may
not
support
their
product
using
data
conducted
on
a
product
from
a
different
batch,
unless
this
batching
appendix
specifically
states
so.
The
Antimicrobials
Division
must
approve
any
new
or
canceled
formulations
(
that
were
presented
to
the
Agency
after
the
publication
of
the
RED)
before
data
derived
from
them
can
be
used
to
cover
other
products
in
a
batch.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material
by
EPA
Registration
Number.
If
more
than
one
confidential
statement
of
formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
(
DCI)
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
or
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
or
she
must
select
one
of
the
following
57
options:
Developing
New
Data
(
Option
1),
Submitting
an
Existing
Study
(
Option
4),
Upgrading
an
Existing
Study
(
Option
5)
or
Citing
an
Existing
Study
(
Option
6).
If
a
registrant
depends
on
another's
data,
he
or
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
or
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,
they
need
to
submit
detailed
information
on
their
product,
including
a
detailed
rationale
for
the
inclusion
of
their
product
into
a
batch.
An
MSDS
for
each
"
inert"
ingredient
should
be
included
where
possible.
However,
registrants
and
manufacturers
should
realize
that
the
more
unique
their
formulation
is,
the
less
likely
it
is
to
be
able
to
batch
that
product.
AD/
PSB
notes
that
there
were
no
registered
Technical
Grade
Active
Ingredient
(
TGAI)
products
to
be
reviewed
in
this
batching
chapter.

Table
1
displays
the
batch
for
the
active
ingredient
Triethylene
Glycol.

Table
1.

Batch
Registration
Number
Percent
Active
Ingredient
51838­
1
Triethylene
Glycol
...
4.4%
Propylene
Glycol
...
4.4%
1
51838­
2
Triethylene
Glycol
...
4.4%
Propylene
Glycol
...
4.4%

4822­
293
Triethylene
Glycol
...
6.0%
2
4822­
531
Triethylene
Glycol
...
6.0%
58
Table
2
lists
the
products
in
the
"
No
Batch"
group.
These
products
can
not
be
batched
because
they
were
not
considered
to
be
similar
to
other
the
products
in
terms
of
acute
toxicity
or
because
there
was
insufficient
information
available
to
assist
in
making
the
decision.

Table
2.
The
"
No
Batch
Group"
of
Products
Containing
Triethylene
Glycol
as
an
Active
Ingredient
Registration
Number
Percent
Active
Ingredient
9444­
19
Triethylene
Glycol
...
6.000%
Dipropylene
Glycol
...
4.000%
n­
Alkyl
dimethyl
benzyl
ammonium
chloride
...
0.20%

9444­
136
Triethylene
Glycol
...
9.15%
Dipropylene
Glycol
...
3.43%
n­
Alkyl
dimethyl
benzyl
ammonium
chloride
...
0.17%

10807­
24
Triethylene
Glycol
...
4.5%
Propylene
Glycol
...
3.0%
n­
Alkyl
dimethyl
benzyl
ammonium
chloride
...
0.10%

10807­
37
Triethylene
Glycol
...
3.00%
Dipropylene
Glycol
...
3.00%
n­
Alkyl
dimethyl
benzyl
ammonium
chloride
...
0.10%
n­
Alkyl
dimethyl
ethylbenzyl
ammonium
chloride
...
0.10%

10807­
43
Triethylene
Glycol
...
7.7%
Propylene
Glycol
...
5.13%
n­
Alkyl
dimethyl
benzyl
ammonium
chloride
...
0.17%

11715­
20
Triethylene
Glycol
...
0.10%
Propylene
Glycol
...
0.10%
Pyrethrins
...
0.09%
Piperonyl
butoxide
...
0.18%
n­
Octyl
bicycloheptene
dicarboximide
...
0.30%

44446­
20
Triethylene
Glycol
...
6.00%
n­
Alkyl
dimethyl
ammonium
chloride
...
0.10%
n­
Alkyl
dimethyl
ethylbenzyl
ammonium
chloride
...
0.10%
Isopropanol
...
50.20%
59
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.
60
Appendix
I:
List
of
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:

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

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

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

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

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

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

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

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

8570­
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
for
ms/
8570­
1.
pdf
8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
for
ms/
8570­
4.
pdf
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
for
ms/
8570­
5.
pdf
8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
for
ms/
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/
for
ms/
8570­
25.
pdf
61
8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
for
ms/
8570­
27.
pdf
8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
for
ms/
8570­
28.
pdf
8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
for
ms/
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/
for
ms/
8570­
32.
pdf
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
P
R_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
P
R_
Notices/
pr98­
5.
pdf
8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
P
R_
Notices/
pr98­
1.
pdf
8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
P
R_
Notices/
pr98­
1.
pdf
Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/
62
Dear
Registrant:

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

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

2.
Pesticide
Registration
(
PR)
Notices
a.
83­
3
Label
Improvement
Program­­
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(
Chemigation)
e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
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
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)
63
Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:

1.
The
Office
of
Pesticide
Programs'
website.

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

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

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

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
website:
http://
npic.
orst.
edu/

The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self­
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

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

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

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