Document ID: EPA-HQ-ORD-2006-0384-0073
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-12T04:00Z

FACTS
Dan
Giambattisto
EMD
Chemicals
Inc.

Rona
Cosmetic
Business
Unit
7
Skyline
Drive
Hawthorne,
NY
10532
United
States
Environmental
Protection
Agency
Human
Studies
Review
Board,
Public
Meeting
Washington,
DC
 
June
2006
06/
2006
(
DG)
HRSB
2006
Page
2
What
is
IR3535
®
?

°
IR3535
®
is
an
EPA
registered
biopesticide
with
a
proven
record
of
excellent
safety
and
efficacy
against
a
variety
of
arthropods.

°
It
was
developed
in
the
1970s
based
upon
the
amino
acid
ß­
alanine
°
IR3535
®
has
been
marketed
in
Europe
since
the
late
1970s,
in
Asia
since
the
mid
1990s
and
in
the
US
since
1999
06/
2006
(
DG)
HRSB
2006
Page
3
IR3535
®
Efficacy
Anopheles
Aedes
aegypti
Aedes
albopictus
Culex
quinquefasciatus
Phlebotomus
spp
Ixodes
ricinus
Culicoides
sp.

Ixodes
scapularis
06/
2006
(
DG)
HRSB
2006
Page
4
IR3535
®
:
Safety
EPA
approved
WHO
recommended
full
specification
acc.
to
new
CIPAC
procedure
NRA*
approved
(
Australia)

°
new
name:
APVMA
=

Australian
Pesticides
&
Veterinary
Medicines
Authority
notified
acc.
to
BPD
(
European
Union)

full
dossier
submitted
in
April
2006
06/
2006
(
DG)
HRSB
2006
Page
5
Availability
in
the
US
06/
2006
(
DG)
HRSB
2006
Page
6
Important
business
considerations
°
IR3535
®
is
the
best
selling
DEET
alternative
in
the
US
but  .

°
   ..
Many
more
consumer
product
companies
without
the
resources
to
file
for
EPA
approval
want
to
market
IR3535
®
­
containing
insect
repellent
products.

°
Sales
of
insect
repellent
products
are
seasonal
in
nature
and
a
timely
approval
of
the
EMD
protocols
is
essential
for
products
to
be
on
the
market
in
2007.

°
EPA
has
determined
that
IR3535
®
safe
according
to
the
results
obtained
by
acute
toxicity,
irritation
&
sensitization,

Repeat
dose
toxicity,
Genotoxicity,
Reproduction
toxicity
and
ADME.
06/
2006
(
DG)
HRSB
2006
Page
7
Back
up
information
06/
2006
(
DG)
HRSB
2006
Page
8
more
efficacy
studies
English
name
Species
IR3535
®

Lice
Pediculus
humanus
+++

Stable
flies
Stomoxys
calcitrans
++

Black
flies
Simuliidae
+++

Deer
flies
Tabanidae
++

Sandflies
Phlebotomus
+++

House
flies
Musca
domestica
++

Wasps
Polistes
galliens
+++

IR3535
®
Efficacy
06/
2006
(
DG)
HRSB
2006
Page
9
IR3535
®
:
Market
experience
European
Market
Surveillance
1996,
and
update
2005
Standard
Text
sent
to
Subsidiaries
to
be
answered
by
their
customers:

We,
Company,
Address,
Country
have
been
using
IR3535
®
in
our
consumer
products
since       
alone
or
in
combination
with
the
other
active
ingredients              

During
this
period
we
had
    
reports
of
skin
irritancy
or
adverse
reactions
Country
No.
of
answers
used
since
no.
of
reports
France
11
1986
0,0007%

Poland
2
2001
0
Germany
3
2000
0,0013%

Switzerland
4
1992
0
UK
7
1991
0
Belgium
1
1991
0
Spain
4
1994
0
Feedback:
06/
2006
(
DG)
HRSB
2006
Page
10
Malaysia
Germany
Israel
Spain
Colombia
Thailand
France
Vietnam
IR3535
®
:
Worldwide
acceptance
06/
2006
(
DG)
HRSB
2006
Page
11
Availability
in
the
US
06/
2006
(
DG)
HRSB
2006
Page
12
Availability
in
the
US
Introducing
BullFrog
®
Mosquito
Coast
®

2006