Document ID: EPA-HQ-OPP-2002-0233-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-13T04:00Z

[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Food
and
Feed
Residue
Studies
/
1
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M7
Reviewer:
Esther
Seto
,
Date
February
8,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________

STUDY
TYPE:
Food
and
Feed
Residue
Studies
PMRA
DATA
CODE
M7
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa,
STF
REVIEWER'S
COMMENTS
AND
CONCLUSION:

According
to
its
proposed
use
pattern,
Sporodex
L
will
be
applied
by
foliar
spray
to
rose
and
cucumber
plants.

An
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
Pseudozyma
flocculosa
(see
Part
M2
review).
The
fungitoxic
unsaturated
C­
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
Neither
this
organism
nor
its
close
relatives
are
listed
among
microbial
contaminants
of
food
(Bakalinski
1992).

In
an
acute
oral
toxicity
study
(see
review
for
Part
M4.2.2),
groups
of
fasted,
6
­
7
week
old
Fisher
344
rats
(12/
sex)
were
given
a
single
oral
dose
of
Sporodex
WP
(an
alternative
end­
use
formulation
of
Pseudozyma
flocculosa)
in
USP
sterile
water
for
injection
at
doses
of
5.
8
x
10
8
colony­
forming
units
(CFU)
per
animal
for
males
and
5.
6
x
10
8
CFU
per
animal
for
females.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
No
mortalities
occurred.
There
were
no
clinical
signs
of
toxicity
and
all
of
the
animals
gained
weight
during
the
study.
No
gross
findings
were
observed
at
necropsy.
Pseudozyma
flocculosa
was
classified
as
being
of
LOW
Toxicity
based
on
the
LD50
in
female
Fisher
344
rats.

Based
on
the
results
of
the
acute
oral
toxicity
study
and
the
absence
of
reports
of
mammalian
toxin
production,
the
establishment
of
a
maximum
residue
limit
is
not
required
for
Pseudozyma
flocculosa
under
section4(
d)
of
theFood
and
Drugs
Act
(adulteration
of
food)
as
defined
under
Division
15,
Section
B15.
002
of
the
Food
and
Drugs
Regulations.
[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Food
and
Feed
Residue
Studies
/
2
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M7
Literature
Cited
Bakalinski,
A.
T.
(1992)
Food
Biopreservatives
of
Microbial
Origin.
Chapter
12:
347­
371.