August
10,
2005
Document
Processing
Desk
(
PETN)
Office
of
Pesticide
Programs
(
7504C)
Antimicrobials
Division
Product
Manager
33
1801
Bell
Street
Arlington,
VA.
22202
Re:
Pesticide
Petition
Proposing
to
Amend
40
C.
F.
R.
§
180.1021
by
Establishing
a
Tolerance
Exemption
for
Copper
Sulfate
Pentahydrate
in
or
on
All
Meat
Petitioner:
ArchAngel
LLC
Dear
Mr.
Swindell:

On
behalf
of
ArchAngel
LLC,
I
am
submitting
a
pesticide
petition,
pursuant
to
Section
408(
d)(
1)
and
(
2)
of
the
Federal
Food,
Drug
and
Cosmetic
Act
("
FFDCA")
and
40
C.
F.
R.
§
180.7,
with
respect
to
the
pesticide
chemical
copper
sulfate
pentahydrate.

Attached
hereto,
in
triplicate
or
referenced,
and
constituting
a
part
of
the
petition
are
the
following:

A)
The
name,
chemical
identity
and
composition
of
copper
sulfate
pentahydrate.
B)
The
amount,
frequency
and
time
of
application
of
copper
sulfate
pentahydrate.
C)
A
discussion
of
the
safety
of
copper
sulfate
pentahydrate
D)
A
discussion
of
the
nature
of
the
residue
resulting
from
the
application
of
copper
sulfate
pentahydrate
E)
Practicable
methods
for
removing
residues
that
exceed
any
proposed
tolerance.
F)
Proposed
tolerance
exemption
for
copper
sulfate
pentahydrate
G)
Reasonable
grounds
in
support
of
the
petition
H)
Supplemental
information
I
have
also
included
3
copies
each
of
two
pieces
of
literature
data
for
your
use.
These
two
documents
are
entitled:

Evaluation
of
Copper
Sulfate
and
a
Copper
Lysine
Complex
as
Growth
Promoters
for
Weanling
Swine
MRID
____________________________

Tribasic
Copper
Chloride
and
Copper
Sulfate
as
Copper
Sources
for
Weanling
Pigs.

MRID
_____________________________
These
documents
discuss
the
need
for
copper
sulfate
in
animal
diets
and
identify
fairly
high
levels
of
consumption.

Please
note
that
currently
40
CFR,
§
180.1021
specifically
exempts
copper
sulfate
pentahydrate
from
the
requirement
of
a
tolerance
when
applied
as
a
fungicide
to
growing
crops
or
raw
agricultural
commodities
after
harvest
(
with
no
limitation).
Copper
is
exempted
from
the
requirement
of
a
tolerance
in
meat,
poultry,
eggs,
fish,
shellfish
and
irrigated
crops
for
various
uses,
but
the
specific
use
of
adding
copper
to
animal
bedding
was
not
specifically
identified.

FDA
has
determined
that
Copper
sulfate
is
a
direct
food
substance
affirmed
as
generally
recognized
as
safe
(
GRAS)
(
Title
21,
§
184.1261).
They
have
indicated
that
this
ingredient
is
to
be
used
in
food
with
no
limitation
other
than
current
good
manufacturing
practice.
It
may
be
used
in
infant
formula
in
accordance
with
section
412(
g)
of
FFDCA.

ArchAngel
LLC
recently
submitted
a
fee
waiver
document
with
the
application
for
registration
75526­
R,
and
that
fee
waiver
was
granted.
We
request
that
the
same
fee
waiver
be
applied
to
the
fee
for
this
petition.

If
you
have
any
questions
about
this
petition,
please
contact
me
at
202­
393­
3903
ext.
20,
or
email
me
at
bbrennis@
lewisharrison.
com
.

Sincerely,

Robert
S.
Brennis
Agent
for,
ArchAngel
LLC
Enclosures
