Document ID: EPA-HQ-OPP-2003-0226-0001
Agency: epa
Document Type: Notice
Title: Copper Hydroxide; Notice of Filing of a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-02T04:00Z

39554
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
TABLE
4.
 
INTERMEDIATE­
TERM
AGGREGATE
DRINKING
WATER
ASSESSMENT
Population
Subgroup
NOAEL/
MOE
Mg/
Kg/
Day
Aggregate
Exposure
Mg/
Kg/
Day
Maximum
Water
Exposure
mg/
kg/
day
SCI
 
GROW
(
ppb)
FIRST
(
ppb)
DWLOC
(
ppb)

Toddlers
(
1
to
3)
1
0.307
0.217
2.852
0.94
6.24
42,785
1
Assume
70kg
bodyweight
The
estimated
average
concentration
of
dinotefuran
in
surface
water
is
6.24
ppb.
This
value
is
less
than
the
DWLOC
for
dinotefuran
as
a
contribution
to
intermediate­
term
aggregate
exposure
(
42,785
ppb).
Therefore,
taking
into
account
the
proposed
uses,
it
can
be
concluded
with
reasonable
certainty
that
residues
of
dinotefuran
in
residential
environments
and
in
food
and
drinking
water
will
not
result
in
unacceptable
levels
of
human
health
risk.

D.
Cumulative
Effects
The
potential
for
cumulative
effects
of
dinotefuran
and
other
substances
that
have
a
common
mechanism
of
toxicity
has
also
been
considered.
Dinotefuran
belongs
to
a
pesticide
chemical
class
known
as
the
neonicotinoids
and
subclass
nitroguanadines.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
dinotefuran
would
be
cumulative
with
those
of
any
other
chemical
including
another
pesticide.
Therefore,
Mitsui
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
dinotefuran
in
an
aggregate
risk
assessment.

E.
Safety
Determinations
1.
U.
S.
population.
Using
the
chronic
exposure
assumptions
and
the
proposed
RfD
described
above,
the
dietary
exposure
to
dinotefuran
for
the
U.
S.
population
(
48
states,
all
seasons)
was
calculated
to
be
0.32%
of
the
RfD
of
1.27
mg/
kg/
day.
The
resulting
DWLOC,
44,306
ppb,
is
much
greater
than
the
estimated
average
concentration
of
dinotefuran
in
surface
water,
6.24
ppb.
Therefore,
taking
into
account
the
proposed
uses,
it
can
be
concluded
with
reasonable
certainty
that
residues
of
dinotefuran
in
residential
environments
and
in
food
and
drinking
water
will
not
result
in
unacceptable
levels
of
human
health
risk.
2.
Infants
and
children.
FFDCA
section
407
provides
that
EPA
shall
apply
an
additional
safety
factor
for
infants
and
children
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base.
Only
when
there
is
no
indication
of
increased
sensitivity
of
infants
and
children
and
when
the
data
base
is
complete,
may
the
extra
safety
factor
be
removed.
In
the
case
of
dinotefuran,
the
toxicology
data
base
is
complete.
There
is
no
indication
of
increased
sensitivity
in
the
data
base
overall,
and
specifically,
there
is
no
indication
of
increased
sensitivity
in
the
developmental
and
multi­
generation
reproductive
toxicity
studies.
Therefore,
Mitsui
concludes
that
there
is
no
need
for
an
additional
safety
factor;
the
RfD
of
1.27
mg/
kg/
day
and
sub­
chronic
NOAEL
of
307
mg/
kg/
day
are
protective
of
infants
and
children.
Using
the
chronic
exposure
assumptions
and
the
proposed
RfD
described
above,
the
dietary
exposure
to
dinotefuran
for
infants
and
children
(
1
to
6
years)
was
calculated
to
be
0.57%
of
the
reference
dose
of
1.27
mg/
kg
bwt/
day.
The
resulting
DWLOC
for
nonnursing
infants,
12,666
ppb,
is
much
greater
than
the
estimated
average
concentration
of
dinotefuran
in
surface
water,
6.24
ppb.
Using
the
intermediate­
term
exposure
assumptions
and
the
proposed
NOAEL
described
above,
the
intermediate­
term
aggregate
exposure
to
dinotefuran
for
the
toddlers
(
1
to
3
years)
resulted
in
an
MOE
of
1,410.
The
resulting
DWLOC,
42,785
ppb,
is
much
greater
than
the
estimated
average
concentration
of
dinotefuran
in
surface
water,
6.24
ppb.
Therefore,
taking
into
account
the
proposed
uses,
it
can
be
concluded
with
reasonable
certainty
that
residues
of
dinotefuran
in
residential
environments
and
in
food
and
drinking
water
will
not
result
in
unacceptable
levels
of
human
health
risk.

F.
International
Tolerances
No
codex
maximum
residue
levels
have
been
established
for
residues
of
dinotefuran
on
any
crops
at
this
time.

[
FR
Doc.
03
 
16737
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0226;
FRL
 
7315
 
2]

Copper
Hydroxide;
Notice
of
Filing
of
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0226,
must
be
received
on
or
before
August
1,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0226.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0226.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2003
 
0226.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0226.

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/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0226.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?

Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
June
23,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.

Syngenta
Crop
Protection
PP
2E6471
EPA
has
received
a
pesticide
petition
(
PP
2E6471)
from
Syngenta
Crop
Protection,
P.
O.
Box
18300,
Greensboro,
North
Carolina,
27419
 
8300
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
copper
(
II)
hydroxide
in
or
on
raw
agricultural
commodities.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
Copper
hydroxide
is
exempt
from
the
requirement
of
a
tolerance
(
40
CFR
180.1021(
b))
for
use
as
a
broad­
spectrum
foliar
fungicide
on
growing
crops.
It
is
used
at
application
rates
greater
than
an
order
of
magnitude
higher
than
the
proposed
use
as
a
formulation
inert.
As
such,
the
metabolism
and
magnitude
of
the
residue
is
well
understood
at
application
rates
much
higher
than
in
the
current
petition.
2.
Analytical
method.
Copper
ions
are
released
from
copper
hydroxide
by
solubilization
in
the
presence
of
moisture.
A
method
for
copper
is
listed
in
the
January
2002
Pesticide
Analytical
Volume
II.
3.
Magnitude
of
residues.
Copper
hydroxide
is
exempt
from
the
requirement
of
a
tolerance
(
CFR
180.1021(
b))
for
use
as
a
broad­
spectrum
foliar
fungicide
on
growing
crops.
It
is
used
as
a
fungicide
at
application
rates
greater
than
an
order
of
magnitude
higher
than
the
proposed
use
as
a
formulation
inert.
As
such,
the
metabolism
and
magnitude
of
the
residue
is
well
understood
at
application
rates
much
higher
than
in
the
current
petition.
Copper
is
naturally
found
at
significant
levels
in
many
different
types
of
foods.

B.
Toxicological
Profile
Copper
hydroxide
is
a
versatile
and
safe
material
which
is
used
almost
everywhere
where
copper
is
needed
in
chemistry.
Copper
hydroxide
is
used
directly
in
the
planting
and
ceramics
industry,
and
in
agriculture
as
a
fungicide
and
bactericide.
It
is
widely
used
as
a
manufacturing
intermediate
in
numerous
applications,
for
example
to
make
copper
compounds,
for
the
production
of
pigments
containing
copper,
in
the
manufacture
of
copper
fibers,
in
galvanizing,
metallurgy,
pyrotechnics,
and
electronics,
to
name
just
a
few
applications.
Copper
ions
are
released
from
copper
hydroxide
by
solubilization
in
the
presence
of
moisture.
Copper
is
ubiquitous
in
nature
and
is
a
necessary
nutritional
element
for
both
animals
(
including
humans),
and
plants.
Copper
is
found
naturally
in
the
food
we
eat,
in
soils,
in
the
water
we
drink,
in
the
air
we
breathe
and
in
our
bodies.
It
is
one
of
26
elements
found
essential
to
life.
The
copper
ion
is
present
in
the
adult
human
body
at
levels
of
70
 
150
milligrams
(
mg).

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/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
Due
to
its
being
used
in
small
percentages
in
the
proposed
formulations,
oral
ingestion
of
quantifiable
amounts
of
copper
will
not
result
from
use
of
copper
hydroxide
as
an
inert.
Copper
compounds
are
irritating
to
the
gastric
mucosa.
Ingestion
of
large
amounts
of
copper
results
in
prompt
emesis.
This
protective
reflex
reduces
the
amount
of
copper
ion
available
for
absorption
into
the
human
body.
Additionally,
at
high
levels
humans
are
also
sensitive
to
the
taste
of
copper.
Because
of
this
organoleptic
property,
oral
ingestion
would
also
serve
to
limit
high
doses.
Only
a
small
percentage
of
ingested
copper
is
absorbed,
and
most
of
the
absorbed
copper
is
excreted.
The
copper
ion
occurs
naturally
in
many
foods
and
the
metabolism
of
copper
is
well
understood.
There
are
several
factors
unique
to
copper
which
indicate
that
additional
studies
are
not
needed
to
regulate
copper
hydroxide
as
an
inert
in
pesticide
formulations.
One
of
the
foremost
of
these
is
the
fact
that
copper
is
a
required
nutritional
element
for
both
plants
and
animals.
It
appears
that
more
evidence
is
available
to
define
the
adverse
effects
of
a
deficiency
in
the
diet
than
to
show
the
toxic
effects
of
an
excess
intake.
In
fact,
no
account
has
been
found
in
the
literature
reviewed
which
describes
a
toxic
effect
to
normal
humans
from
ingestion
of
common
foodstuffs
containing
copper.
Because
copper
toxicity
to
man
through
the
diet
has
been
shown
in
normal
persons,
little
is
known
about
the
minimum
levels
of
dietary
copper
necessary
to
cause
evidence
of
adverse
effects.
This
situation
is
likely
due,
to
an
effective
homoeostatic
mechanism
that
is
involved
in
the
dietary
intake
of
copper
and
that
protects
man
from
excess
body
copper.
This
complex
mechanism
integrates
absorption,
retention,
and
excretion
to
stabilize
the
copper
body
burden.
Given
that
copper
is
ubiquitous
and
is
routinely
consumed
as
part
of
the
daily
diet,
it
is
unlikely
that
with
current
exposure
patterns
there
would
be
any
long­
term
adverse
effects.
The
hydroxide
ion
is
also
ubiquitous
in
plants,
animals
including
humans,
and
the
environment.
The
use
of
copper
hydroxide
as
an
inert
will
not
result
in
any
increased
burden
on
the
environment
or
living
organisms.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Twelve
Food
and
Drug
Administration
(
FDA)
total
diet
studies,
conducted
from
mid
1982
 
1984,
examined
dietary
intake
of
copper
for
age
groups
14
 
16,
25
 
30,
and
60
 
65
years.
The
copper
intake
ranged
from
0.77
(
14
 
16
year
old
females)
to
1.24
mg/
day
(
25
 
30
year
old
males).
Use
of
copper
hydroxide
as
an
inert
at
rates
at
an
order
of
magnitude
lower
than
current
pesticide
rates
will
not
result
in
any
quantifiable
increase
in
exposure
to
copper
from
dietary
sources.
i.
Food.
The
main
source
of
copper
for
infants,
children,
and
adults,
regardless
of
age,
is
the
diet.
Copper
is
typically
present
in
mineral
rich
foods
like
vegetables
(
potato,
legumes
(
beans
and
peas)),
nuts
(
peanuts
and
pecans),
grains
(
wheat
and
rye),
fruits
(
peach
and
raisins),
and
chocolate
in
levels
ranging
from
0.3
to
3.9
parts
per
million
(
ppm).
A
single
day's
diet
may
contain
10
mg
or
more
of
copper.
The
daily
recommended
allowance
of
copper
for
adults
nutritional
needs
is
2
mg.
ii.
Drinking
water.
Copper
is
a
natural
element
found
in
the
earth's
crust.
As
a
result,
most
of
the
world's
surface
water
and
ground
water
that
is
used
for
drinking
purposes
contains
copper.
Naturally
occurring
copper
in
drinking
water
is
safe
for
human
consumption,
even
in
rare
instances
where
it
is
at
levels
high
enough
to
impart
a
metallic
taste
to
the
water.
The
Agency
has
set
a
maximum
contaminant
level
for
copper
at
1.3
ppm.
Use
of
copper
hydroxide
as
an
inert
at
rates
at
an
order
of
magnitude
lower
than
current
pesticide
rates
will
not
result
in
any
quantifiable
increase
in
exposure
to
copper
from
drinking
water.
2.
Non­
dietary
exposure.
Copper
is
a
naturally
occurring
element
present
in
the
earth's
crust,
and
it
is
therefore
naturally
occurring
in
soil,
water
and
air.
Soils
would
be
considered
copper
deficient
if
they
contain
less
than
2
ppm
available
copper
in
the
context
of
plant
health.
Air
concentrations
of
copper
are
relatively
low.
A
study
based
on
several
thousand
samples
assembled
by
EPA's
Environmental
Monitoring
Systems
Laboratory
showed
copper
levels
ranging
from
0.003
to
7.32
micrograms
per
cubic
meter.
Use
of
copper
hydroxide
as
an
inert
at
rates
at
an
order
of
magnitude
lower
than
current
pesticide
rates
will
not
result
in
quantifiable
increase
in
exposure
to
copper
from
non­
dietary
sources.

D.
Cumulative
Effects
Exposure
to
copper
occurs
over
a
lifetime
from
numerous
sources
and
does
not
result
in
any
known
toxicity.
Use
of
copper
hydroxide
as
an
inert
will
not
result
in
quantifiable
increase
in
cumulative
exposure
to
copper.

E.
Safety
Determination
1.
U.
S.
population.
Copper
is
an
essential
trace
element
for
which
the
National
Academy
of
Sciences
has
issued
a
recommended
daily
allowance
of
up
to
3
mg/
day
for
adults.
Accordingly,
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
of
the
U.
S.
population
to
copper.
The
use
of
copper
hydroxide
as
an
inert
in
pesticide
formulations
will
not
result
in
any
measurable
increase
in
exposure
to
copper.
2.
Infants
and
children.
Copper
is
also
a
component
of
the
diet
of
infants
and
children
and
also
an
essential
element
of
their
diet.
The
use
of
copper
hydroxide
as
an
inert
in
pesticide
formulations
will
not
result
in
any
measurable
increase
in
exposure
of
infants
and
children
to
copper.

F.
International
Tolerances
There
does
not
appear
to
be
any
international
tolerances
for
copper
or
copper
hydroxide,
and
no
CODEX
maximum
residue
levels
has
been
established
for
any
food
crops
at
this
time.
[
FR
Doc.
03
 
16738
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7521
 
6]

Public
Water
Supply
Supervision
Program
Revision
for
the
Commonwealth
of
Puerto
Rico
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
tentative
approval
and
solicitation
of
request
for
a
public
hearing
for
Public
Water
Supply
Supervision
Program
Revision
for
the
Commonwealth
of
Puerto
Rico
SUMMARY:
Notice
is
hereby
given
that
the
Environmental
Protection
Agency
(
EPA)
has
determined
to
approve
an
application
by
the
Commonwealth
of
Puerto
Rico
to
revise
its
Public
Water
Supply
Supervision
Primacy
Program
to
incorporate
regulations
no
less
stringent
than
the
EPA's
National
Primary
Drinking
Water
Regulations
(
NPDWR)
for
the
following:
Lead
and
Copper
Rule
Technical
Correction;
Final
Rule,
promulgated
by
EPA
on
June
30,
1994
(
59
FR
33860),
Synthetic
Organic
Chemicals
and
Inorganic
Chemicals;
Final
Rule,
promulgated
by
EPA
on
July
1,
1994
(
59
FR
34320),
Analytical
Methods
Technical
Corrections;
Final
Rule,
promulgated
by
EPA
on
December
5,
1994
(
59
FR
62456),
Analytical
Methods
Technical
Corrections;
Final
Rule,
promulgated
by
EPA
on
June
29,
1995
(
60
FR
34083),
Analytical
Methods
for
Radionuclides
Technical
Corrections,
promulgated
by
EPA
on
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