Document ID: EPA-HQ-OPP-2005-0062-0024
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-02T04:00Z

United
States
Office
of
Prevention,
Pesticides
Environmental
Protection
and
Toxic
Substances
Agency
(
7508P)

Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
for
Boric
Acid/
Sodium
Borate
Salts
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
for
Boric
Acid/
Sodium
Borate
Salts
Approved
By:

Debra
Edwards,
Ph.
D.
Director,
Special
Review
and
Reregistration
Division
Date
_____________________
Table
of
Contents
I.
Regulatory
Determination
..................................................................................................
1
II.
Tolerance
Reassessment
.....................................................................................................
2
A.
Toxicity
Categories
.....................................................................................................
2
B.
Toxicity
Endpoints
..........................................................................................................
3
C.
FQPA
Safety
Factor
Considerations...................................................................................
6
D.
Dietary
Risks
from
Food
and
Drinking
Water
.....................................................................
6
E.
Residential
Risks
..............................................................................................................
7
F.
Incident
Reports
............................................................................................................
10
G.
Aggregate
Risk..............................................................................................................
11
III.
Regulatory
Decision.........................................................................................................
11
A.
FQPA
Assessment
Supporting
Tolerance
Reassessment
Decision
.................................
11
B.
Cumulative
Risk............................................................................................................
13
C.
Endocrine
Disruptor
Effects
..........................................................................................
13
D.
Risk
Mitigation
.............................................................................................................
14
E.
Data
Needs....................................................................................................................
14
IV.
References
.......................................................................................................................
14
1
I.
Regulatory
Determination
The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
the
Environmental
Protection
Agency
(
hereafter
referred
to
as
EPA
or
the
Agency)
to
reassess
all
the
tolerances
for
registered
chemicals
in
effect
on
the
day
before
enactment
of
the
FQPA
on
August
3,
1996.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
When
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
Existing
tolerance
exemptions
associated
with
boric
acid/
sodium
borate
salts
must
be
reassessed
in
accordance
with
FFDCA,
as
amended
by
FQPA.

The
Food
Quality
Protection
Act
(
FQPA)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
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."
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
boric
acid,
and
boric
acid
does
not
produce
a
toxic
metabolite
produced
by
other
substances.
Therefore,
for
the
purposes
of
tolerance
reassessment,
EPA
has
not
assumed
that
boric
acid
shares
a
common
mechanism
of
toxicity
with
other
compounds.
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
of
toxicity
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

References
to
the
terms
"
boric
acid
and
sodium
borate
salts,"
and
or
"
boric
acid/
sodium
borate
salts"
in
this
document
refer
to
boric
acid
and
several
borate
salts
including
sodium
tetraborate
decahydrate,
sodium
tetraborate
pentahydrate,
sodium
tetraborate
anhydrous,
disodium
octaborate
tetrahydrate,
disodium
octaborate
anhydrous,
and
sodium
metaborate.
Risks
summarized
in
this
document
are
from
boric
acid
and
these
sodium
borate
salts
only.

Boric
acid
and
sodium
borate
salts
are
used
as
acaricides,
algaecides,
fungicides,
herbicides,
and
insecticides.
Boric
acid
and
sodium
borate
salts
are
frequently
used
for
control
of
insects
such
as
ants
or
roaches
by
application
in
non­
agricultural
food
and
feed
areas.
Boric
acid
and
sodium
borate
salts
have
herbicide
qualities
causing
desiccation,
fungicidal
properties
by
inhibiting
the
growth
of
fungi
by
preventing
the
production
of
conidia
or
asexual
spores,
and
insecticidal
properties
by
acting
as
a
stomach
poison
against
ants,
cockroaches,
silverfish,
and
termites.
Use
sites
include
animal
housing,
turf,
wood
products,
forests,
sewage
systems,
transportation
and
storage
facilities,
medical/
veterinary
2
institutions,
uncultivated
agricultural/
nonagricultural
areas,
refuse/
solid
waste
sites,
swimming
pool
(
algae
control),
paved
areas
and
aquatic
structures.
Boric
acid
and
sodium
borate
salts
are
also
used
as
inert
ingredients
in
pesticide
products
as
sequestrants.

The
Agency's
human
health
and
residential
risk
findings
for
the
pesticide
boric
acid
and
sodium
borate
salts
are
summarized
in
the
following
documents:
Boric
Acid/
Sodium
Borate
Salts:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED),
Supplement
to
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED),
and
Boric
Acid:
Residential
Exposure
Assessment
for
the
Tolerance
Reregistration
Eligibility
Decision
Document.
For
further
details,
please
refer
to
these
risk
assessments
and
other
technical
documents
pertaining
to
the
boric
acid/
sodium
borate
salts
TRED,
which
are
available
on
the
internet
at
http://
www.
regulations.
gov
and
in
the
public
docket.

Ecological
and
occupational
assessments
were
conducted
when
the
reregistration
eligibility
decision
(
RED)
was
issued
for
boric
acid/
sodium
borate
salts
in
1994.
Therefore,
no
ecological
or
occupational
assessments
were
conducted
as
part
of
this
TRED
for
boric
acid/
sodium
borate
salts.

Although
boric
acid/
sodium
borate
salts
are
registered
for
use
on
numerous
food/
feed
crops,
dietary
risk
assessments
were
not
necessary
since
the
pesticidal
use
on
food
items
contributes
negligible
amounts
of
boron
relative
to
the
naturally
occurring
background
of
boron.
The
aggregate
risk
assessment
for
boric
acid/
sodium
borate
salts
is
based
on
the
residential
uses,
including
exposures
from
pesticides,
inerts
and
consumer
uses.

The
Agency
has
evaluated
the
human
health
risks
associated
with
all
currently
registered
uses
including
inert
ingredient
uses
of
boric
acid/
sodium
borate
salts
and
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
non­
occupational
exposure
to
the
pesticide
chemical
risks
for
most
of
the
scenarios
assessed.
The
Agency
used
exposure
studies
submitted
by
the
registrants
in
the
public
comment
period
to
assess
wood
treatments
and
a
risk
assessment
conducted
by
California
Department
of
Pesticide
Regulation
for
the
carpet
and
the
crack
and
crevice
treatments.
The
risks
associated
with
these
scenarios
are
below
the
Agency's
level
of
concern
with
this
additional
exposure
information.
Additional
data
will
be
required
to
confirm
the
exposure
assumptions
from
the
summaries.
In
addition,
some
of
the
residential
postapplication
scenarios
for
higher
application
rate
uses
in
swimming
pools
and
spas
which
were
assessed
in
the
risk
assessment
exceed
the
Agency's
level
of
concern
(
LOC)
for
children's
incidental
ingestion
during
swimming
activities.
These
scenarios
are
discussed
later
in
the
TRED
and
the
Agency
has
identified
risk
mitigation
measures
that
reduce
the
risks
to
below
the
Agency's
LOC.

II.
Tolerance
Reassessment
A.
Toxicity
Categories
3
The
available
toxicity
data
on
boric
acid/
sodium
borate
salts
are
adequate
to
assess
boric
acid/
sodium
borate
salts
hazard
potential.
Table
1
below
presents
the
acute
toxicity
profile
for
boric
acid
and
Table
2
presents
the
acute
toxicity
profile
for
sodium
tetraborate
decahydrate
(
borax).
These
represent
the
acute
toxicity
information
for
the
boric
acid/
sodium
borate
salts.

Table
1.
Acute
Toxicity
Profile
on
Boric
Acid
Guideline
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
oral
toxicity
/
rat
00006719
LD50
males=
3,450
mg/
kg
LD50
females=
4080
mg/
kg
III
870.1100
Acute
oral
toxicity/
beagle
dog
00064208
LD50>
631
mg/
kg
III
870.1200
Acute
dermal
toxicity/
rabbit
00106011
LD50
>
2
g/
kg
III
870.1300
Acute
inhalation
toxicity
/
rat
00005592
LC50
>
0.16
mg/
L
II
870.2400
Acute
eye
irritation
/
rabbit
000064209
Conjunctival
irritation
clearing
by
Day
4
III
870.2500
Acute
dermal
irritation
/
rabbit
00106011
Irritant
III
Table
2.
Acute
Toxicity
Profile
on
Sodium
Tetraborate
Decahydrate
(
Borax)

Guideline
Study
Type
MRID
Results
Toxicity
Category
870.1100
Acute
oral
toxicity
/
rat
40692303
LD50
males=
4,550
mg/
kg
LD50
females=
4,980
mg/
kg
III
870.1100
Acute
oral
toxicity/
dog
40692304
LD50>
974
mg/
kg
III
870.1200
Acute
dermal
toxicity/
rabbit
43553201
LD50
>
2000
mg/
kg
III
870.2400
Acute
eye
irritation
/
rabbit
43553203
Corrosive
I
870.2500
Acute
dermal
irritation
/
rabbit
43553202
Non­
irritating
IV
B.
Toxicity
Endpoints
(
For
a
complete
discussion,
see
Section
4
of
the
Boric
Acid/
Sodium
Borate
Salts:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
by
L.
Hansen
and
J.
4
Evans
dated
6/
26/
06
(
D320894).)

In
general,
the
toxicological
database
for
boric
acid/
sodium
borate
salts
is
adequate
for
hazard
characterization
and
sufficient
data
are
available
to
assess
potential
susceptibility
to
the
young.
The
toxicological
data
and
findings
are
presented
fully
in
the
document,
Boric
Acid/
Sodium
Borate
Salts
HED
Risk
Assessment
for
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.

Boric
acid
and
sodium
borate
salts
exist
as
undissociated
boric
acid
in
aqueous
solution
at
physiological
pH.
For
this
reason,
they
are
considered
together
as
a
group
for
purposes
of
hazard
and
risk
characterization
and
individual
toxicology
studies
on
each
active
ingredient
are
not
required.
The
moiety
of
toxicological
concern
is
boron.
Dose
comparisons
are
normalized
by
conversion
to
boron
equivalents,
allowing
comparison
of
studies
on
boric
acid
or
borax.
Boric
acid/
sodium
borate
salts
are
well
absorbed
via
the
gastrointestinal
tract
and
via
inhalation,
but
not
via
the
dermal
route
through
intact
skin.
Boric
acid/
sodium
borate
salts
distribute
evenly
across
the
body
and
do
not
accumulate
in
the
soft
tissue.
A
limited
amount
of
literature
exists
on
the
mechanism
of
action
on
the
testes
and
skeletal
abnormalities
and
growth
retardation.
However,
the
exact
mechanism
of
action
is
unknown.

Boron
is
a
ubiquitous
element
that
occurs
naturally
in
plants
and
water.
Humans
ingest
naturally
occurring
boron
in
the
diet,
and
there
is
some
data
to
suggest
that
trace
levels
are
required
in
the
human
diet.
At
higher
exposure
levels,
boron
causes
toxicity.
Based
on
animal
studies,
it
appears
that
males
are
most
sensitive
to
boric
acid/
boric
salts.
A
major
target
organ
of
boric
acid/
boric
salts
is
the
testes
(
signs
of
toxicity
include
seminiferous
tubule
degeneration,
atrophy,
reduction
in
sperm
count,
and
reduced
testicular
weight).
Neurotoxicity
is
also
reported
in
rat
studies.
However
evidence
of
clinical
signs
of
neurotoxicity
occurs
only
at
high
dose
levels
that
are
above
the
exposure
levels
causing
other
signs
of
toxicity.
Developmental
effects
on
the
brain
(
enlarged
lateral
ventricles)
were
observed
in
the
rat
at
doses
above
those
causing
the
most
sensitive
effect
(
skeletal
variation
and
malformations).
Since
developmental
and
neurotoxicity
effects
occur
at
doses
well
above
the
regulatory
endpoint,
a
developmental
neurotoxicity
(
DNT)
study
is
not
required
and
an
additional
database
uncertainty
factor
is
not
necessary
for
the
lack
of
a
DNT
study.

The
toxicological
endpoints
for
boric
acid/
sodium
borate
salts
are
summarized
in
Table
3.
For
the
residential
exposure
assessment,
EPA
used
a
weight
of
evidence
approach
from
three
dog
reproductive
studies
to
set
the
NOAEL
and
LOAEL.
The
oral
NOAEL
of
8.8
mg/
kg/
day
boron
equivalents
came
from
a
two
year
dog
dietary
study
(
MRID
40692310).
The
NOAEL
from
this
study
was
reported
from
the
highest
dose
tested,
thus
no
LOAEL
was
reported.
The
Agency
used
a
weight
of
evidence
approach
from
two
other
dog
studies
to
confirm
the
NOAEL
reported
in
the
2­
year
study.
Evidence
of
testicular
atrophy
and
slight
anemia
at
the
LOAEL
of
32
mg/
kg/
day
boron
equivalents
was
seen
in
a
90­
day
dog
study
(
MRID
40692307).
In
a
separate
study,
testicular
atrophy
was
reported
at
a
LOAEL
of
40
mg/
kg
from
a
38­
week
dog
study
(
MRID
40692308).
Although
the
exact
onset
of
the
testicular
effects
is
not
known
from
the
three
studies,
testicular
effects
are
clearly
evident
by
90
days.
5
The
NOAEL
was
selected
for
the
short­
term
(<
1
month)
incidental
oral
endpoint
as
well
as
the
intermediate­
term
(
1­
6
month)
incidental
oral
endpoint.
For
inhalation
exposures,
100%
absorption
of
the
oral
dose
was
conservatively
assumed.

Boric
acid
and
sodium
borate
salts
are
classified
under
the
current
carcinogen
assessment
guidelines
as
"
not
likely
to
be
carcinogenic
to
humans."
Available
genotoxicity
studies
do
not
indicate
mutagenic
potential.
A
two­
year
dietary
study
in
the
rat
and
a
mouse
carcinogenicity
study
did
not
show
clear
evidence
of
increased
cancer
incidence.

Table
3.
Summary
of
Toxicological
Endpoints
Boric
Acid/
Sodium
Borate
Salts
Exposure
Scenario
Factor
Used
in
Risk
Assessment
Study
and
Endpoint
of
Risk
Assessment
Dietary
Risk
Assessment
Dietary
(
Acute
and
Chronic)­
all
populations
NA
The
contribution
of
boron
residues
from
food/
feed
crop
application
of
boric
acid/
sodium
borate
salts
to
the
total
naturally
occurring
background
dietary
boron
intake
from
food
and
water
is
not
considered
to
be
significant.
Endpoints
for
acute
and
chronic
dietary
exposure
were
not
selected
for
this
risk
assessment
because
it
was
determined
that
a
dietary
risk
assessment
(
food
plus
drinking
water
exposure)
was
not
necessary
at
this
time.

Residential
Risk
Assessment
(
Adults
and
Toddlers)

Acute
Oral
Exposure
(
Toddlers)

Acute,
Short­
term
and
Intermediate­
term
Level
of
Concern
MOE=
100
MRID
no:
40692310
Chronic
(
2­
year)
toxicity
(
dogs)
NOAEL
=
8.8
mg/
kg/
day
LOAEL
was
not
determined
MRID
no:
40692308
Chronic
(
38­
week)
toxicity
(
dogs)
NOAEL
was
not
determined
LOAEL=
40
mg/
kg/
day
males
and
46
mg/
kg/
day
females
Based
on
decreased
body
weight
gain
in
males
and
females
and
testicular
atrophy
in
males.

MRID
no
40692307
Subchronic
(
90­
day)
toxicity
(
dogs)
NOAEL=
4.1
mg/
kg/
day,
males
LOAEL=
32
mg/
kg/
day,
males
based
on
testicular
atrophy,
anemia
in
subchronic
study.
6
Table
3.
Summary
of
Toxicological
Endpoints
Boric
Acid/
Sodium
Borate
Salts
Exposure
Scenario
Factor
Used
in
Risk
Assessment
Study
and
Endpoint
of
Risk
Assessment
Inhalation
Short­
term
and
Intermediate­
term
Level
of
Concern
MOE=
100
(
Assumes
inhalation
absorption
=
oral
absorption
MRID
no:
40692310
Chronic
toxicity
(
dogs)
NOAEL
=
8.8
mg/
kg/
day
Dermal
NA
No
evidence
of
absorption
across
intact
skin.

Cancer
Not
likely
to
be
carcinogenic
to
humans
MOE
=
margin
of
exposure
LOAEL=
lowest
observed
adverse
effect
level
NOAEL=
no
observed
adverse
effect
level
C.
FQPA
Safety
Factor
Considerations
The
FFDCA,
as
amended
by
the
FQPA,
directs
the
Agency
to
use
an
additional
tenfold
(
10X)
safety
factor
to
take
into
account
potential
pre­
and
post­
natal
toxicity
and
completeness
of
the
data
with
respect
to
exposure.
For
boric
acid,
the
FQPA
safety
factor
can
be
reduced
to
1X
because
there
are
no
residual
uncertainties
with
regard
to
pre­
and/
or
postnatal
toxicity.
Also
there
were
no
effects
on
male
reproductive
function
in
the
rat
and
mouse
reproductive
toxicity
studies
at
doses
greater
than
the
endpoint
used
for
this
risk
assessment
suggesting
that
there
is
no
increased
developmental
sensitivity.
And
thirdly
the
residential
risk
assessment
and
the
background
assumptions
regarding
dietary
exposures
are
not
expected
to
underestimate
boric
acid
exposures.
For
all
exposure
scenarios,
uncertainty
factors
of
10X
for
interspecies
and
10X
for
interspecies
variation
(
total
UF
of
100x)
were
used.

D.
Dietary
Risks
from
Food
and
Drinking
Water
(
For
a
complete
discussion,
see
Section
6
of
the
Boric
Acid/
Sodium
Borate
Salts:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
by
L.
Hansen
and
J.
Evans
dated
6/
26/
06
(
D320894).)

Use
of
boric
acid/
sodium
borate
salts
on
agricultural
crops
to
control
disease
and
insect
infestations
has
historically
been
a
minor
use
and
as
of
this
assessment
there
are
few
agricultural
uses.
The
"
screening
level"
usage
data
for
boric
acid/
sodium
borate
salts
available
for
California
indicates
very
low
usage.
Only
broccoli
(
4,000
lb
ai/
yr)
and
grapes
(
2,000
lb
ai/
yr)
had
usage
higher
than
500
lb
ai/
yr.
Based
on
a
review
of
the
currently
registered
products,
which
currently
have
low
application
rates
and
low
concentrations
and
7
percent
considering
the
use
of
these
chemicals
as
inert
ingredients
in
pesticide
products,
EPA
has
no
reason
to
believe
that
the
residue
from
current
agricultural
practices
will
significantly
contribute
to
the
total
dietary
boron
intake
in
humans.

An
assessment
of
dietary
(
food
and
water)
exposure
was
not
conducted.
Boron
is
a
naturally
occurring
component
of
food
and
water
and
may
be
a
necessary
nutrient
at
trace
levels,
although
no
minimum
daily
requirement
has
been
established.
Background
food
and
drinking
water
exposures
were
not
included
in
this
risk
assessment
based
on
the
assumption
that
there
is
also
background
exposure
from
dietary
and
drinking
water
to
the
laboratory
animals
used
in
toxicology
studies
on
boric
acid/
sodium
borate
salts.
As
active
and
inert
ingredients,
boric
acid
and
sodium
borate
salts
are
exempt
from
tolerances
and
therefore
residue
data
were
not
submitted
for
the
food/
feed
uses.

EPA
has
recently
received
registration
applications
for
new
agricultural
crop
uses.
EPA
has
requested
that
the
registrants
submitting
the
registration
applications
for
these
uses
also
submit
magnitude
of
residue
data
on
some
agricultural
crops
to
ascertain
the
amount
of
residue
found
on
the
plant.
In
the
future,
EPA
will
use
these
data
to
determine
if
boron
tolerances
are
necessary
for
any
expansion
of
use.

E.
Residential
Risks
For
a
complete
discussion,
see
the
following
document:
 
Section
6
of
the
Boric
Acid/
Sodium
Borate
Salts:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
by
L.
Hansen
and
J.
Evans
dated
6/
26/
06
(
D320894).

Boric
acid/
sodium
borate
salts
are
used
as
active
and
inert
ingredients
in
pesticide
formulations.
Residential
use
products
are
most
commonly
applied
indoor
as
a
broadcast
spray
(
e.
g.,
decks
and
carpets)
and
crack
and
crevice
treatments.
Boric
acid/
sodium
borate
salts
are
applied
in
wood
preservatives
through
pressure
treatment
and
deck
spray,
and
are
added
to
suppress
algae
growth
in
swimming
pools
and
as
a
buffer
and
chlorine
extender.
There
is
a
variety
of
use
patterns
and
formulations
(
e.
g.,
liquids,
dusts,
and
granulars)
for
boric
acid/
sodium
borate
salts.

For
boric
acid/
sodium
borate
salts,
EPA
assessed
short­
term
(<
1
month)
and
intermediate­
term
(
1
to
6
month)
residential
risks.
Long­
term
exposures
were
not
considered
to
be
realistic
based
on
the
use
patterns.
Since
dermal
absorption
is
negligible,
a
dermal
exposure
assessment
was
not
necessary.
However,
EPA
did
assess
inhalation
exposure
to
residential
applicators.

EPA
evaluated
non­
cancer
risks
by
calculating
the
margin
of
exposure
(
MOE)
which
is
the
ratio
of
the
estimated
exposure
to
the
NOAEL.
Estimated
MOEs
are
compared
to
a
level
of
concern
(
LOC)
which
reflects
the
dose
selected
for
risk
assessment
and
uncertainty
factors
8
(
UFs)
applied
to
that
dose.
The
UF
for
boric
acid/
sodium
borate
salts
is
100x,
which
includes
10x
for
interspecies
extrapolation
(
to
account
for
differences
between
laboratory
animals
and
humans)
and
10x
for
intraspecies
variation
(
to
account
for
differences
between
laboratory
animals
and
humans).
EPA
determined
that
the
available
data
support
the
removal
of
the
10X
FQPA
safety
factor.
Thus,
scenarios
that
yield
MOEs
less
than
100
may
trigger
concern.

No
inhalation
exposure
scenarios
resulted
in
exceedances
of
the
LOC.
Calculated
handler
(
e.
g,
applicator)
inhalation
MOEs
ranged
from
a
low
of
800
for
mixing,
loading,
applying
dusts
containing
boric
acid
via
a
shaker
can
to
a
high
of
5,600,000
for
the
application
of
pouron
ready­
to­
use
formulations
containing
sodium
teraborate
pentahydrate.
The
scenarios
assessed
included
applying
with
aerosol
cans,
shaker
cans,
applying
by
trigger­
pump
and
hand­
wand
sprayers,
and
making
a
granular
bait
application.

EPA's
preliminary
risk
assessment,
which
used
screening­
level
assumptions
in
lieu
of
actual
data,
indicated
post­
application
risks
of
concern
to
children
resulting
from
incidental
ingestion
of
residues
from
wood
products,
crack
and
crevices,
and
carpets.
During
and
after
the
public
comment
period,
the
registrant
and
the
California
Department
of
Pesticide
Regulation
(
CDPR)
provided
additional
information
on
potential
exposures
and
risks
which
allowed
the
Agency
to
refine
the
initial
assessment.
The
registrant
submitted
wood
residue
information
(
Lake
and
McIntyre
(
2006))
and
dislodgeable
transfer
assumptions
(
J.
D.
Lloyd,
1996)
to
support
treated
wood
uses.
Additionally,
EPA
received
a
CDPR
memorandum
(
CDPR,
1996)
which
presented
boron
surface
residue
measurements
to
refine
the
carpet
and
crack
and
crevice
use.
Using
this
information,
EPA
recalculated
the
post­
application
risks
for
these
scenarios
resulting
in
significantly
higher
MOEs
which
do
not
exceed
the
LOC
and
are
not
of
concern.
The
Agency
is
requiring
the
boric
acid/
sodium
borate
salts
registrants
to
provide
complete
studies
that
confirm
the
exposure
assumptions
made
based
on
these
summaries.
The
residential
uses
for
which
confirmatory
data
are
required
are
listed
below
in
Table
4
with
the
MOEs
calculated
with
the
summary
information.
9
Table
4:
Summary
of
Representative
Post­
Application
Exposures
for
Young
Children
Based
on
Hand­
to­
Mouth
Transfer
from
the
Treated
Surface
Exposure
Scenario
Application
Rate
Dislodgeable
Surface
Residue
(
µ
g/
cm2)
Boron
Average
Daily
Dose
(
mg/
kg­
day
MOE
Dust/
Carpet
0.02
lb
ai/
sq
ft
0.498
0.05
170
Crack
and
Crevice
Dust
Carpet
0.02
lb
ai
/
sq
ft
0.249
0.03
330
Pressure
Treated
Wood
10,340
µ
g
boron/
sq
ft
1.1
0.015
590
Deck
Spray
(
in
situ)
462,470
µ
g
boron/
sq
ft
3.73
0.05
180
For
the
scenarios
presented
in
Table
4,
the
carpet
assessment
is
based
on
exposure
information
from
a
CDPR
Memorandum
(
HSM­
96004);
from
T.
Formoli,
Worker
Health
and
Safety
Branch
to
Karen
Fletcher,
Pesticide
Registration
Branch;
Re:
Evaluation
of
Human
Exposure
Potential
to
eco­
fresh
Carpet
Treatment
for
Fleas
(
CDPR,
1996).
The
assessment
for
crack
and
crevice
treatments
is
based
on
considering
the
carpet
dislodgeable
residue
measurement
in
carpets.
It
is
assumed
that
half
the
carpet
residues
are
available
for
crack
and
crevice
exposure
scenarios.
The
Agency
will
require
confirmatory
data
for
all
residential
uses,
including
confirmatory
data
based
on
surface
wipe/
press
samples
representing
the
various
boron
containing
compounds
(
in
dry,
bait
and
sprayable
formulations).

The
wood
preservative
assessment
has
boron
concentration
measurements
based
on
summary
data
presented
in
a
MeadWestvaco
Memorandum
dated
April
21,
2006
(
Lake
and
McIntyre,
2006).
For
pressure
treated
wood,
the
dislodgeable
surface
residue
was
calculated
by
assuming
a
10%
dislodgeable
factor
(
J.
D.
Lloyd,
1996).
For
the
deck
spray,
the
dislodgeable
surface
residue
was
calculated
by
assuming
a
1%
dislodgeable
factor
(
J.
D.,
Lloyd,
1996).
Confirmatory
data
supporting
the
boron
wood
measurements
presented
in
Lake
and
McIntyre
(
2006)
and
dislodgeable
data
factors
of
J.
D.
Lloyd
(
1996)
will
be
required.

Post­
application
incidental
oral
exposure
to
adults
and
children
may
be
anticipated
from
swallowing
swimming
pool
water
containing
sodium
tetraborate
pentahydrate
from
products
which
may
be
applied
to
both
swimming
pools
and
spas.
A
range
of
maximum
application
rates
were
reported
from
the
product
labels.
The
rates
reported
were
4.5
lb
ai
per
1,000
gallons
(
540
mg/
L
pool
water
concentration),
4
lb
ai
per
1,000
gallons
(
480
mg/
L
pool
water
concentration),
10
and
2
lb
ai
per
1,000
gallons
(
240
mg/
L).
These
products
are
all
designed
to
reduce
algae
growth
in
swimming
pool
water.
Also
boric
acid
use
as
an
inert
ingredient
resulted
in
spa/
pool
water
maximum
pool
water
concentrations
of
5.4
mg/
L.
Exposure
to
adult
and
older
child
swimmers
did
not
result
in
risks
which
exceed
the
LOC;
however,
the
higher
boron
concentrations
in
pool
and
spa
water
resulted
in
risks
for
children
7
to
10
years
of
age
which
do
exceed
the
LOC.
The
values
are
listed
in
Table
5.

Table
5.
Post­
application
Exposures
to
Non­
Competitive
Child
(
7
to
10
year
old)
Swimmers
Scenario
Chemical
concentration
in
water
(
mg/
L)
Adjusted
ADD
(
mg/
kg/
day)
MOE
540
0.134
65
480
0.119
74
240
0.059
150
Incidental
oral
exposure
while
swimming.

5.4
0.0016
5,600
For
inert
uses,
such
as
laundry
detergent
and
general
purpose
cleaners,
the
residential
exposures
were
calculated
and
the
risks
were
not
of
concern
for
children
(
e.
g.,
MOE
 

16,000).
The
use
of
other
products
containing
boric
acid
and
its
sodium
salts
as
inert
ingredients
were
also
examined;
however,
many
of
the
scenarios
were
identical
to
that
of
the
active
ingredient.
Thus,
those
active
scenarios
which
were
not
a
risk
concern
for
the
actives
were
also
determined
not
to
be
a
risk
concern
for
the
inerts
because
the
concentration
was
much
less.

F.
Incident
Reports
For
a
complete
discussion,
see
the
following
documents:
 
Section
5
of
the
Boric
Acid/
Sodium
Borate
Salts:
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Decision
Document
by
L.
Hansen
and
J.
Evans
dated
6/
26/
06.
 
Review
of
Boric
Acid
Incident
Reports
(
DP320914)
dated
9/
22/
05.

EPA
reviewed
the
available
incident
data
from
the
OPP
Incident
Data
System
(
IDS),
Poison
Control
Centers
(
PCCs),
California
Department
of
Pesticide
Regulation,
National
Pesticide
Information
Center
(
NPIC),
and
NIOSH.
In
summary,
from
1984­
1991,
NPIC
reports
that
boric
acid
ranked
25th
on
the
list
of
the
top
200
chemicals
which
NPIC
received
calls.
OPP
has
tracked
PCC
data
from
1993
to
2003.
The
PCC
has
reported
that
the
largest
number
of
incidents
were
related
to
children,
with
children
under
six
years
of
age
comprising
over
80%
of
the
incidents
reported.
The
most
common
symptoms
included
vomiting,
eye
irritation,
coughing,
difficulty
breathing
nausea,
and
oral
irritation.
Several
incidents
were
the
11
result
of
improper
applications
of
carpet
and
crack
and
crevice
uses.
Inadvertent
exposure
of
infants
and
small
children
to
boric
acid
seldom
produces
a
moderate
or
severe
risk
and
lifethreatening
incidents
are
rare;
however,
ingestions
of
substantial
amounts
pose
serious
risks.

G.
Aggregate
Risk
In
examining
aggregate
exposure,
EPA
takes
into
account
the
available
and
reliable
information
concerning
exposures
to
pesticide
residues
in
food
and
drinking
water,
and
nonoccupational
pesticide
exposures.
A
risk
assessment
was
not
conducted
for
boric
acid/
sodium
borate
salts
to
characterize
the
risk
from
dietary
intake
(
food
and
drinking
water).
An
aggregate
assessment
was
not
considered
necessary
for
the
different
residential
uses
since
the
Agency
believes
it
is
unlikely
that
indoor
and
outdoor
uses
will
co­
occur.
The
carpet
treatment
is
for
fleas,
the
crack
and
crevice
treatments
are
for
ants
and
cockroaches
and
the
in
situ
deck
treatments
are
for
termites.
A
homeowner
is
not
likely
to
treat
for
three
different
pests
at
the
same
time.
In
addition,
the
swimming
pool
exposures
were
assessed
for
a
different
age
group
(
7
years
to
adult)
than
for
the
incidental
oral
exposure
from
hand­
tomouth
intake
(
toddler)
and
would
therefore
not
be
combined.

III.
Regulatory
Decision
A.
FQPA
Assessment
Supporting
Tolerance
Reassessment
Decision
The
Agency
has
reassessed
the
current
exemptions
from
the
requirement
for
tolerances
from
boric
acid/
sodium
borate
salts
(
see
Table
6
for
tolerance
exemptions).
As
a
result
of
this
assessment,
the
Agency
determined
that
the
active
tolerances
exemptions
should
be
maintained
and
are
considered
reassessed
as
safe
under
section
408(
q)
of
the
FFDCA.
It
should
be
noted
however
that
the
higher
application
rates
for
the
swimming
pool
uses
resulted
in
residential
post­
application
scenarios
which
exceed
the
Agency's
LOC.
The
high
rates
for
these
pool
and
spa
uses
must
be
deleted
from
the
end­
use
product
labels.
Registrants
have
agreed
to
amend
their
labels
by
removing
the
higher
application
rates
to
Agency
acceptable
levels.

Taking
into
consideration
the
available
information
on
all
uses;
including
the
inert
ingredient
uses,
of
boric
acid,
sodium
metaborate,
and
sodium
tetraborate,
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
when
considering
dietary
exposure
and
all
other
remaining
non­
occupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.
Therefore,
the
three
exemptions
from
the
requirement
of
a
tolerance
established
for
residues
of
boric
acid,
sodium
metraborate,
and
sodium
tetraborate
in/
on
raw
agricultural
commodities
under
40
CFR
§
180.920
and
the
exemptions
for
tolerances
established
for
the
boric
acid/
sodium
borate
salts
under
40
CFR
§
180.1121
are
considered
reassessed
as
safe
under
section
408(
q)
of
the
FFDCA.
12
The
Agency
has
conducted
risk
assessments
to
ensure
that
the
boric
acid/
sodium
borate
salts
meet
the
safety
standards
established
by
FFDCA,
as
amended
by
FQPA.
These
recent
risk
assessments
for
boric
acid/
sodium
borate
salts
include
evaluation
of
potential
susceptibility
to
infants
and
children
to
aggregate
risk
from
residential
uses.

Table
6:
Tolerance
Exemptions
for
Boric
Acid/
Sodium
Borate
Salts
Chemical
Name
and
CAS
Nos.
PC
Code
Use
Pattern
Under
40
CFR
180.1121
Boric
Acid:
10043­
35­
3
11113­
50­
1
41685­
84­
1
011001
Acaricide,
algaecide,
fungicide,
herbicide,
insecticide
Sodium
tetraborate
decahydrate:
1303­
96­
4
12447­
40­
4
011102
Fungicide,
insecticide,
herbicide
Sodium
tetraborate
pentahydrate:
11130­
12­
04
12178­
04­
3
011110
Algaecide,
herbicide,
insecticide
Sodium
tetraborate:
1330­
43­
4
12007­
42­
0
011112
Acaricide,
herbicide,
insecticide
Disodium
octaborate
tetrahydrate:
12008­
41­
2
12280­
03­
4
011103
Fungicide,
insecticide
Disodium
octaborate:
12008­
41­
2
12280­
03­
4
011107
Fungicide
Sodium
metaborate:
15293­
77­
3
7775­
19­
1
011104
Herbicide
Under
40
CFR
180.920
Boric
Acid:
10043­
35­
3
11113­
50­
1
011001
Sequestrant
Sodium
tetraborate:
1330­
43­
4
011102
Buffering
Agent;
corrosion
inhibitor
Sodium
metaborate:
7775­
19­
1
011104
Sequestrant
In
reaching
this
determination,
the
Agency
has
considered
the
available
information
on
the
potential
sensitivity
of
infants
and
children.
Although
boric
acid/
sodium
borate
salts
are
registered
for
use
on
food/
feed
crops,
dietary
or
drinking
water
risk
assessments
were
not
necessary.
For
residential
uses,
the
Agency
conducted
handler
and
postapplication
assessments.
Handler
risks
were
below
the
Agency's
LOC.
Post­
application
exposures
were
13
above
the
LOC
for
swimming
pool
treatments
at
rates
above
240
mg/
L.
The
higher
swimming
pool
application
rates
must
be
deleted
from
the
end­
use
product
labels.
Therefore,
the
Agency
has
made
a
safety
finding
for
the
boric
acid
tolerance
exemptions.

B.
Cumulative
Risk
FQPA
requires
that
EPA
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
Agency
considers
other
substances
because
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect,
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
boric
acid/
sodium
borate
salts.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
boric
acid/
sodium
borate
salts
and
any
other
substances.
In
addition,
boric
acid/
sodium
borate
salts
does
not
produce
a
toxic
metabolite
produced
by
other
substances
which
have
tolerances
in
the
U.
S.
Therefore,
for
the
purposes
of
tolerance
reassessment,
EPA
has
not
assumed
that
boric
acid/
sodium
borate
salts
shares
a
common
mechanism
of
toxicity
with
other
compounds.

C.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
"
may
have
an
effect
in
humans
that
is
similar
to
endocrine
effects."
The
potential
for
disruption
of
the
endocrine
system
by
boric
acid/
sodium
borate
salts
is
not
known
at
this
time.
Boric
acid
and
sodium
borate
salts
are
known
to
inhibit
spermiation
in
multiple
species.
Studies
indicate
that
at
high
dose
levels,
boric
acid
causes
a
mild
reduction
in
basal
serum
testosterone
levels
in
male
rats
and
that
this
effect
may
be
CNS­
mediated,
based
on
lack
of
apparent
effects
on
steroidogenic
function
on
isolated
Leydig
cells.
Fail,
et
al(
1998)
have
noted
that
boron
is
unlikely
to
act
as
an
endocrine
disruptor
because
the
hormonal
changes
appear
to
be
secondary
to
testicular
cytotoxicity.
However,
the
mechanism
by
which
inhibition
of
spermiation,
as
well
as
effects
on
the
ovary,
occur
in
vivo
have
not
been
fully
characterized.
The
NOAEL
of
8.8
mg/
kg/
day
chosen
for
the
current
risk
assessment
based
on
the
effect
of
testicular
atrophy
is
considered
to
be
protective
of
effects
caused
by
endocrine
disruption.
When
additional
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruption
Screening
Program
(
EDSP)
have
been
developed,
boric
acid/
sodium
borate
salts
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
14
D.
Risk
Mitigation
A
risk
assessment
was
conducted
for
exposures
to
boric
acid/
sodium
borate
salts
resulting
from
inert
and
pesticidal
exposures
of
boric
acid
and
borate
salts,
and
the
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels
for
most
uses.

Sodium
borate
applications
to
swimming
pools
and
spas
resulted
in
unacceptable
risks
for
some
of
the
higher
boron
concentrations
in
pool
water
(
e.
g.,
concentration
in
water
of
480
mg/
L
and
540
mg/
L);
however,
the
lower
concentration
of
240
mg/
L
did
not
result
in
risks
of
concern.
Therefore,
the
end­
use
product
labels
for
swimming
pool
products
must
be
revised
to
delete
application
rates
above
240
mg/
L.
Registrants
have
agreed
to
amend
their
labels
by
removing
the
higher
application
rates
to
Agency
acceptable
levels.

E.
Data
Needs
Additional
exposure
data
in
accordance
with
Series
875.2100
guidelines
for
dislodgeable
surface
residues
in
carpet,
crack
and
crevice,
and
wood
treatments
are
required
to
confirm
our
safety
finding
for
these
uses.
The
Agency
will
be
issuing
a
DCI
for
these
data.

IV.
References
Lake,
M.
A.
and
McIntyre,
M.
A.
(
2006)
Formosan
Termite
Response
to
Weathered
Borate­
Treated
Wood:
Paper
given
at
the
Forest
Products
Society
Meeting
in
New
Orleans,
LA
on
March
2006.

Lloyd,
J.
D.
(
1996)
Indicative
Study
of
the
Post
In
Situ
Treatment
Pick­
Up
of
Disodium
Octaborate
Tetrahdrate..

California
Department
of
Pesticide
Regulation
(
CDPR)
(
1996).
Memorandum
from
T.
Formoli,
Worker
Health
and
Safety
Branch,
to
Karen
Fletcher.
HSM­
96004