PPDC
Registration
Review
Workgroup
Meeting
Agenda
September
28,
2004
8:
30
­
9:
00
am
Arrive
and
Sign
In
9:
00
­
9:
10
am
Welcome
Jim
Jones
9:
10
­
9:
30
am
Review
Agenda
Jay
Ellenberger
Introductions,
Ground
Rules
9:
30
­
9:
45
am
General
Update
Vivian
Prunier
Schedule
for
Registration
Review
Rule
9:
45
­
10:
00
am
Break
10:
00
­
10:
30
am
Discussion
on
Regulatory
and
Science
Changes
since
1984
Rich
Dumas
ESA/
Endocrine
Disruptors
Jay
Ellenberger
10:
30
­
10:
45
am
Introduction
to
Feasibility
Study
Susan
Lewis
10:
45
­
12:
00
noon
Conventional
Study
Ray
Kent,
Dana
Spatz
Group
Discussion
12:
00
­
1:
00
pm
Lunch
1:
00
­
2:
00
pm
BPPD
Study
Linda
Hollis
Group
Discussion
2:
00
­
3:
00
pm
Antimicrobial
Study
Jack
Housenger,
Debbie
Smegal
Group
Discussion
3:
00
­
3:
15
pm
Break
3:
15
­
3:
45
pm
Discussion
of
Aggregate
Findings
Susan
Lewis
3:
45
­
4:
15
pm
Plan
Presentation
to
Full
PPDC
Meeting
in
October
Jay
Ellenberger
4:
15
­
5:
00
pm
Discussion
of
Future
Projects
Jay
Ellenberger,
Vivian
Prunier
End­
Use
Registrations
Documentation
of
Decisions
10/
5/
04
3
Registration
Review
Rule
Development
PPDC
Registration
Review
Workgroup
September
28,
2004
10/
5/
04
4
Rule­
making
Process
°
ANPRM
­­
2000
°
PPDC
recommendations
 
May
2004
 
Design
of
registration
review
process
 
Test
the
design
°
Feasibility
study
­­
NOW
°
Publish
proposed
rule
­­
2005
°
Final
rule
­­
2006
10/
5/
04
5
Design
Requirements
for
Registration
Review
°
High
efficiency
­­
50
chemical
cases
(
80
AIs)

per
year
°
Sound
science,
transparent,
open
process,

credible/
value­
added
decisions
°
Flexible
process
that's
built
to
last
10/
5/
04
6
PPDC
Recommendations
°
Need
reliable,
predictable
schedule
°
Address
new
issues
when
they
arise
­

outside
of
registration
review
°
Tailor
review
to
depth/
scope
of
issues
 
new
data
may
be
required
°
Registration
review
should
be
a
safety
net
10/
5/
04
7
PPDC's
"
Tailored
Approach"

°
Assemble
baseline
information
for
each
case
 
current
registrations
 
bibliography
of
studies
 
last
risk
assessments
 
use
patterns
 
incidents
°
Invite
public
comment
on
baseline
information
°
Ask,
"
What's
changed
since
last
risk
assessments?"

°
Are
new
data
or
new
risk
assessment
needed?

°
Invite
public
comment
on
findings
8
Registration
Review
Flowchart
Identify/
Assemble
information
stakeholder
input
Review
information
Decision:

Are
new
assessments
required?

NO
YES
Decision:

Are
data
currently
available?

Conduct
new
assessment(
s).
Registrant
provides
data;

Agency
reviews.

YES
NO
Complete
Registration
Review
Decision/
Document
10/
5/
04
10
Part
158
Guidelines
Promulgated
1984
Began
performing
shortterm
and
intermediate
term
human
health
risk
assessments
1995
Implementation
Paper
for
the
New
Paradigm
for
Ecological
Risk
Assessment
1993
Antimicrobial
and
Biopesticides
divisions
established
1995
*
Full
Implementation
of
WPS
*
Agricultural
Reentry
DCI
*
Occupational/
Residential
Turf
DCI
1996
Began
Performing
Probabilistic
Dietary
Risk
Assessments.

FQPA
°
Aggregate
Risk
Assessments
°
Cumulative
Risk
Assessments
°
Sanitizers
and
food
contact
disinfectants
to
EPA
°
Indirect
food
additives
jointly
regulated
by
EPA
&
FDA
°
Safety
Factor
for
sensitivity
to
infants
and
children
1996
1998
Highlights
of
Changes
since
1984
Joint
Counterpart
Endangered
Species
Act
Section
7
Consultation
Regulations
and
Technical
Overview
Document
2004
.
*
Endocrine
testing
program
*
More
Probabilistic
Risk
Assessments
°
Update
Biochemical
and
Microbial
data
requirements
°
Revise
Part
158
Guidelines
2005­
2006
10/
5/
04
12
Feasibility
Study
PPDC
Registration
Review
Workgroup
September
28,
2004
10/
5/
04
13
Feasibility
Study
°
At
the
May
2004
meeting,
PPDC
recommended
a
study
to
test
the
registration
review
decision
process
°
EPA
agreed
with
this
suggestion
°
Feasibility
study
was
conducted
in
June
and
July
2004
°
Letters/
calls
to
registrants
of
the
28
cases
10/
5/
04
14
Feasibility
Study
°
Purpose:
test
the
decision
process
and
gather
data
on
program
costs.

°
This
is
a
simulation,
not
a
"
pilot"

°
Randomly
select
28
cases
among
potential
candidates
for
first
five
years
of
program
 
283
total
cases
in
program
°
Assemble
"
baseline"
information
 
Current
uses,
bibliography
of
studies,
last
risk
assessments,
incidents
10/
5/
04
15
Feasibility
Study
°
Ask:
What
do
we
know,
what
do
we
need
to
know,
and
what
is
the
value
of
the
new
information?

°
Possible
outcomes
 
No
new
assessment
 
New
assessment,
no
new
data
 
New
assessment,
new
data
10/
5/
04
16
The
Feasibility
Study
Did
Not
°
Consult
with
registrants
or
other
stakeholders
°
Prepare
use/
usage
reports
°
Search
open
literature
°
Conduct
new
assessments
°
Call
in
new
data
10/
5/
04
17
General
Findings
°
Process
is
feasible
°
Highlighted
importance
of
consultation
°
Information
technology/
management
needs
°
Identified
regulatory
issues
°
Identified
process
design
issues
10/
5/
04
19
Registration
Review
Process
Proposed
Conventional
Pesticide
Case
Study
PPDC
Workgroup
Meeting
Ray
Kent,
Health
Effects
Dana
Spatz,
Environmental
Fate
and
Effects
September
28,
2004
10/
5/
04
20
Conventional
Pesticide
Case
Background
Regulatory
History
°
First
registered:
late
1980'
s
Use
Profile
°
Post
emergence
herbicide
°
Acts
through
foliar
uptake
°
Controls
wide
range
of
broadleaf
weeds
in
cereal
crops
°
Also
has
non­
food
uses
°
Applied
by
air
and
ground
equipment
10/
5/
04
21
Conventional
Pesticide
Case
Background
Human
Health
Risk
Assessment
Status
°
Recent
dietary
risk
assessment
°
Recent
aggregate
food
&
water
assessment
°
No
residential
uses
 
no
assessment
needed
°
Last
occupational
assessment
at
time
of
first
registration
10/
5/
04
22
Conventional
Pesticide
Case
Background
Hazard
Profile
For
Human
Health
°
Low
to
moderate
acute
toxicity
via
the
oral,
inhalation,
and
dermal
routes
of
exposure
°
It
is
a
skin
sensitizer
and
a
mild
eye
irritant
°
Repeated
dose
oral
toxicity
studies
resulted
primarily
in
decreased
body
weights
and
body
weight
gains
accompanied
by
decreased
food
consumption
°
No
evidence
for
significant
toxicity
to
specific
target
organs
10/
5/
04
23
Conventional
Pesticide
Case
Background
Hazard
Profile
For
Human
Health
(
cont.)

°
No
evidence
of
neurotoxicity
or
neuropathy
from
available
studies
°
Developmental
and
reproductive
toxicity
studies
indicated
no
increased
susceptibility
of
offspring
°
Based
on
carcinogenicity
studies,
the
chemical
is
classified
as
Group
C
(
possible
human
carcinogen)

°
Negative
for
mutagenicity
°
Complete
toxicology
data
base
10/
5/
04
24
Conventional
Pesticide
Case
Background
FQPA
Factor
for
Human
Health
°
The
Special
FQPA
default
safety
factor
(
10x)
is
reduced
to
1x
since
there
is
no
indication
of
increased
susceptibility
in
developmental
toxicity
studies
in
rats
and
rabbits
and
rat
reproduction
studies,
and
conservative
exposure
estimates
are
unlikely
to
underestimate
risk.
10/
5/
04
25
Conventional
Pesticide
Case
Background
Human
Health
Risk
Assessment
Profile:

Occupational
and
Residential
Exposure
and
Risk
°
Most
recent
occupational
risk
assessment
conducted
during
initial
registration
of
chemical
(
not
included
in
recent
assessment).

°
No
residential
uses
Dietary
Exposure
and
Risks
°
Tox
studies
suggest
an
acute
dietary
risk
assessment
is
unnecessary.

°
Chronic
dietary
exposure
estimates
are
<
1%
of
the
dose
that
would
be
of
concern.

°
Dietary
assessment
is
considered
protective
of
potential
cancer
concerns
10/
5/
04
26
Conventional
Pesticide
Case
Background
Human
Health
Risk
Assessment
Profile
(
cont.)

Drinking
Water
and
Aggregate
Risk
°
Drinking
water
risk
assessment
completed
recently.

°
Aggregate
risk
assessment
completed
recently
°
Food
and
water
chronic
exposures
are
<
1%
of
the
dose
that
would
be
of
concern
for
all
population
subgroups.
10/
5/
04
Standard
Evaluation
Procedures
including
methodology
for
conducting
ecological
risk
assessments.

1986
Rejection
Rate
Analysis
provided
guidance
which
helped
registrants
improve
studies
submitted
for
registration/

reregistration.

1993
Implementation
Paper
for
the
New
Paradigm
instituted
the
use
of
risk
quotients
and
comparisons
to
levels
of
concern.
Also
required
ground
water
monitoring
to
insure
effectiveness
of
mitigation.

1993
Implementation
of
refined
modeling
for
estimated
concentrations
in
the
aquatic
environment.

1995
Guidelines
for
Ecological
Risk
Assessment
standardizes
the
methods
and
procedures
for
conducting
ecological
risk
assessments.
1998
Science
Policy
Council
Handbook
 
Risk
Characterization,
provides
guidance
for
enhanced
ecological
risk
characterizations.

FQPA
requires
estimated
concentrations
of
pesticides
and
their
degradates
in
drinking
water.
As
a
result,

number
of
modeling
scenarios
for
ecological
risk
assessment
increases.
1996
2000
Major
Milestones
in
Ecological
Risk
Assessments
and
Drinking
Water
Exposure
Assessments
Conducted
in
OPP
1984
 
Present
and
Future
Joint
Counterpart
Endangered
Species
Act
Section
7
Consultation
Regulations
requires
Agency
to
use
best
available
scientific
and
commercial
information,
consider
critical
habitat,
and
indirect
effects.
Publication
of
the
Overview
of
the
Ecological
Risk
Assessment
Process
in
OPP:
Endangered
and
Threatened
Species
Effects
Determinations
2004
Industry
begins
to
submit
Probabilistic
Risk
Assessments.

2001
Implementation
of
Probabilistic
Models,

based
in
part
on
the
recommendations
of
ECOFRAM,
a
multistakeholder
group
convened
in
1997.

2005­
2006
10/
5/
04
28
Conventional
Pesticide
Case
Background
Ecological
Effects
Risk
Assessment
°
Ecotoxicity
and
environmental
fate
assessments
were
completed
in
late
1980'
s
°
More
recently,
a
drinking
water
exposure
assessment
was
conducted
for
a
tolerance
reassessment
decision
°
No
new
uses
added
since
the
initial
registration
10/
5/
04
29
Stressor­
Response
Profile
For
Ecological
Effects
°
Practically
non­
toxic
to
birds
on
an
acute
and
dietary
basis
°
Practically
non­
toxic
to
both
warmwater
and
coldwater
fish
°
Practically
non­
toxic
to
aquatic
invertebrates
Conventional
Pesticide
Case
Background
10/
5/
04
30
Status
of
Ecotoxicity
Studies
°
Studies
submitted
since
registration
include:

 
Avian
reproduction
 
Seed
germination/
seedling
emergence
 
Vegetative
vigor
 
Aquatic
plant
growth
°
Avian
reproduction
and
aquatic
plant
studies
have
been
screened
°
Terrestrial
plant
data
have
been
reviewed,
but
not
yet
incorporated
into
a
risk
assessment
Conventional
Pesticide
Case
Background
10/
5/
04
31
Environmental
Exposure
Profile
°
Primary
routes
of
dissipation
are
hydrolysis
and
microbial
degradation
°
Half­
lives
are
less
than
one
week
in
acidic
environments
and
1­
4
weeks
under
more
alkaline
conditions
°
High
mobility
in
soil
based
on
laboratory
studies
°
Little
mobility
observed
in
field
studies
°
Volatilization
and
bioaccumulation
are
not
important
pathways
Conventional
Pesticide
Case
Background
10/
5/
04
32
PPDC
Workgroup
Response
Discussion
Opinion:

°
Easy
Off?

°
Need
New
Risk
Assessment(
s)?

°
Need
New
Risk
Assessment(
s),
New
Data?
10/
5/
04
33
OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
10/
5/
04
34
OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
Major
Issues
For
Human
Health
°
Occupational
risk
should
be
updated
because
it
has
not
been
updated
since
the
first
registration
of
the
chemical.

°
No
new
studies
are
required
to
update
risk
assessments.
10/
5/
04
35
Ecological
Risk
Assessment
°
An
ecological
risk
assessment
has
not
been
completed
for
this
chemical.

°
What
exists
today
is
an
ecological
hazard
assessment
and
an
exposure
assessment.

°
Represents
what
was
commonly
done
prior
to
the
early
1990'
s
°
At
the
time
of
its
registration,
the
use
of
risk
quotients
(
RQs)

and
their
comparison
to
Agency
levels
of
concern
had
not
been
fully
implemented.

OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
10/
5/
04
36
OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
Ecological
Risk
Assessment
°
The
registration
was
granted
conditional
on
satisfying
several
data
gaps,
including
non­
target
plant
data.

°
The
registrant
submitted
data
to
satisfy
the
conditions
of
the
registration.

°
Based
upon
the
information
available
for
this
chemical
and
other
chemicals
in
its
class,
OPP
expects
that
the
potential
risks
of
concern
will
be
primarily
for
non­
target
plants,

including
endangered
species.
10/
5/
04
37
Major
Issues
for
Ecological
Risk
(
cont.)

°
An
ecological
risk
assessment
needs
to
be
completed.

°
Hazard
and
exposure
need
to
be
integrated
into
an
ecological
risk
assessment
to
determine
if
there
are
any
level
of
concern
(
LOC)
exceedences.

°
An
FQPA
drinking
water
assessment
was
recently
completed,

therefore
no
further
work
is
required
in
this
area.

OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
10/
5/
04
38
OPP's
Illustrative
Results
For
Conventional
Pesticide
Case
Study
Major
Issues
For
Ecological
Risk
(
cont.)

°
In
order
for
the
risk
assessment
to
conform
with
EPA's
agreements
on
ESA
as
a
result
of
the
Joint
Counterpart
Endangered
Species
Act
Section
7
Consultation
Regulations,
the
Agency
will
also
need
to:

1)
incorporate
the
best
available
scientific
and
commercial
information
(
literature
search);

2)
consider
critical
habitat;
and
3)
address
indirect
effects.

°
Possible
consultation
with
the
Services
and/
or
mitigate
risk
10/
5/
04
40
Registration
Review
Proposed
Process
­

Biochemical
Pesticide
Case
Study
PPDC
Workgroup
Meeting
Linda
Hollis
September
28,
2004
10/
5/
04
41
Biochemical
Pesticide
Case
Background
Regulatory
Background
°
First
Registered:
1970s
°
RED:
1990s
°
In
the
mid­
1980s,
EPA
compiled
the
scientific
information
and
EPA
policies
on
the
regulation
of
pheromones
and
other
semiochemicals
°
This
compilation
provided
the
basis
for
regulatory
relief
based
on
the
low
toxicity
of
the
class
of
compounds
and
low
exposure
when
used
in
a
trap
and/
or
at
low
application
rates
10/
5/
04
42
Use
Profile
°
While
use
sites
include
what
would
be
considered
food
or
feed
sites,
the
use
pattern
is
classified
as
Terrestrial
Non­

Food
Crop.
The
chemical
is
used
in
a
trap
and
not
applied
directly
to
food
or
feed.

°
Terrestrial
Non­
Food
Crop:
agricultural
crops,
soils
and
vegetables,
orchards
and
deciduous
fruit
trees,
grapes
and
other
food
commodities
°
Terrestrial
Non­
Food
&
Outdoor
Residential:

ornamental
shade
trees,
ornamental
herbaceous
plants,

ornamental
non­
flowering
plants,
ornamental
woody
shrubs
and
vines
Biochemical
Pesticide
Case
Background
10/
5/
04
43
Biochemical
Pesticide
Case
Background
Nature
of
Biochemical
Pesticides
°
Natural
substances,
or
synthetically
derived
compounds
that
are
structurally
and
functionally
equivalent
°
Non­
toxic
to
the
target
pest
and
generally
non­
toxic
to
other
organisms
°
Typically
used
at
low
application
rates
°
Compounds
do
not
have
toxic
endpoints
for
Tier
I
studies,
and
therefore
do
not
trigger
higher
tiered
studies
such
as
subchronic
or
chronic
studies.
10/
5/
04
44
Biochemical
Pesticide
Case
Background
Hazard
Profile
For
Human
Health
°
Mammalian
toxicology
database
is
complete
and
sufficient
to
characterize
the
toxicity
and
assess
the
risk
of
the
chemical
°
Very
low
acute
toxicity
for
all
routes
of
exposure
°
Exposure
is
limited
because
of
use
pattern
(
used
in
traps)
10/
5/
04
45
Biochemical
Pesticide
Case
Background
Hazard
Profile
For
Ecological
Effects,
Exposure
and
Risks
°
Effects
to
non­
target
organisms
are
not
expected
because
mode
of
action
is
specific
to
target
pest
°
Exposures
to
birds,
fish,
or
aquatic
organisms
are
not
expected
because
the
chemical
is
enclosed
in
a
dispenser
within
a
trap
10/
5/
04
46
Biochemical
Pesticide
Case
Background
Occupational/
Residential
Exposure
&
Risks
°
No
occupational
studies
triggered
due
to
lack
of
significant
toxicological
concerns
°
Limited
exposure
if
label
instructions
are
followed
 
The
chemical
is
used
in
small
quantities
and
enclosed
in
a
retrievable
trap
resulting
in
very
low
exposure
 
Release
rate
from
the
trap
is
comparable
to
the
release
from
insect
pest
during
peak
infestation
periods
 
Individuals
setting
up
trap
are
exposed
to
higher
concentrations
than
emitted
from
the
trap
 
There
is
no
toxicological
concern
to
the
user
if
a
trap
is
only
set
up
once
a
year
10/
5/
04
47
Biochemical
Pesticide
Case
Discussion
Opinion:

°
Easy
Off?

°
Need
New
Risk
Assessment(
s)?

°
Need
New
Risk
Assessment(
s),
New
Data?
10/
5/
04
48
OPP's
Illustrative
Results
For
Biochemical
Pesticide
Case
Study
10/
5/
04
49
OPP's
Illustrative
Results
For
Biochemical
Pesticide
Case
Study
Human
Health
Risk
and/
or
Ecological
Risk
Assessment
°
All
data
requirements
are
satisfied
°
Risk
assessment
completed
in
the
1990s
is
still
valid
°
No
new
or
modified
human
health
or
ecological
risk
assessment
needed
°
EPA
has
determined
that
a
tolerance
or
tolerance
exemption
are
not
needed
for
this
chemical
when
used
in
a
trap
due
to
lack
of
pesticides
residues
found
on
food
or
feed
commodities
10/
5/
04
51
PPDC
Workshop
Registration
Review
September
28,
2004
Antimicrobials
Division
Office
of
Pesticide
Programs
10/
5/
04
52
Background
°
AD
was
created
in
August
1996.

°
Second
Multidisciplinary
Division
in
OPP.

°
AD
is
a
One
Stop­
Shopping
Division
 
All
Science
and
Regulatory
Decisions
are
made
within
the
Division
for
the
Registration
and
Reregistration
of
Antimicrobial
Products.
10/
5/
04
53
Antimicrobial
Registration
Facts
°
Actives
registered
=
>
250
°
Products
registered
=
>
5000
°
Approximately
50%
of
registered
antimicrobials
are
public
health
products.

°
Use
=
>
3.3
billion/
lbs/
yr*

 
*
When
chlorine
water
treatment
is
included
10/
5/
04
54
What
Is
An
Antimicrobial
Pesticide?

The
definition
in
FIFRA
is:

A
pesticide
that
intended
to
disinfect,
sanitize,

reduce
or
mitigate
growth
or
development
of
microorganisms
or
it
protects
inanimate
objects,

industrial
processes
or
systems,
surfaces,
water,

or
other
chemical
substances
from
contamination,

fouling,
or
deterioration
caused
by
bacteria,

viruses,
fungi,
protozoa,
algae,
or
slime.
10/
5/
04
55
What
Is
Considered
To
Be
A
Pest?
(
40
CFR
152.5)

An
antimicrobial
pest
is
any
fungus,

bacterium,
virus
or
other
microorganism,
except
for
those
on
or
in
living
man
or
other
living
animals,

and
those
on
or
in
processed
food
or
processed
animal
feed,
beverages,

drugs
and
cosmetics.
10/
5/
04
56
Antimicrobial
Efficacy
°
Non­
public
health
products
 
Wood
preservatives
 
Antifoulant
paints
 
Material
preservatives
°
Public
health
products
 
Hospital
disinfectants
 
Food
contact
sanitizers
10/
5/
04
57
Levels
of
Efficacy
°
Sterilant
(
ETO,
Gluteraldehyde)

°
Disinfectant
(
Quats,
Hydrogen
peroxide)

°
Sanitizer
(
Quats,
Hydrogen
peroxide)

°
Bacteriostat
(
inhibition
of
bacterial
growth)

(
Triclosan,
Silver)

°
Other
(
i.
e.,
fruit
and
vegetable
rinses,
treated
articles
with
public
health
claims,
unique
delivery
systems
i.
e.,
sponges)
58
Use
Patterns
 
Agricultural
premises
and
equipment
 
Food
handling/
storage
establishments,
premises
and
equipment
 
Commercial,
institutional
and
industrial
premises
and
equipment
 
Residential
and
public
access
equipment
 
Medical
premises
and
equipment
 
Human
drinking
water
systems
 
Materials
preservatives
 
Industrial
processes
and
water
systems
 
Antifouling
coatings
 
Wood
preservatives
 
Swimming
pools
 
Aquatic
areas
10/
5/
04
59
Reregistration/
Registration
Review
°
AD
has
to
make
reregistration
and
registration
review
decisions
for
its
own
chemicals.

°
Challenging
due
to
dual
jurisdictional
issues,

history,
and
broad
use
patterns
and
labeling.
10/
5/
04
60
Food
Use
Jurisdiction
°
FDA
°
EPA
°
FDA/
EPA
Dual
Jurisdiction
10/
5/
04
61
What
is
an
Antimicrobial
"
Food
Use"?

°
Direct
contact
with
food
 
Fruit
and
vegetable
wash
in
field
°
Sodium
hypochlorite
°
Indirect
food
contact
 
Food
contact
adhesive/
coating
 
Pulp
and
paperboard
use
 
Preservatives
10/
5/
04
62
Dual
Jurisdiction
Uses
(
EPA
and
FDA)

°
FDA
is
responsible
for
granting
the
indirect
food
additive
clearance
under
FFDCA
section
409
°
EPA
is
responsible
for
granting
the
registration
under
FIFRA
10/
5/
04
63
Dual
Jurisdiction
Uses
(
EPA
and
FDA)

°
Prior
to
FQPA
 
EPA
did
not
review
the
safety
determination
made
by
FDA
for
the
indirect
food
additive
clearance
under
section
409
°
After
FQPA
 
Section
2(
bb)
of
FIFRA
required
EPA
to
not
only
assess
all
dietary
risks
from
use
of
a
pesticide,
but
also
to
ensure
that
it
met
the
standards
of
section
408
10/
5/
04
64
Dual
Jurisdiction
Uses
(
EPA
and
FDA)

°
Section
2(
bb):
Unreasonable
Adverse
Effects
on
the
Environment.

 
"
The
term
means .(
2)
a
human
dietary
risk
from
residues
that
result
from
a
use
of
any
pesticide
in
or
on
any
food
inconsistent
with
the
standard
under
section
408 "
10/
5/
04
65
Typical
Toxicology
Data
Requirements
for
An
Antimicrobial
Chemical
Indirect
Food
Acute
toxicity
battery
90
sub­
chronic
study
in
rodent
and
non­
rodent
developmental
toxicity
study
Mutagenicity
battery
2
Generation
Reproductive
study
Food
Use
Indirect
food
+

Other
data
case­
by­
case
10/
5/
04
66
Dual
Jurisdiction
Uses
(
EPA
and
FDA)

°
Issues
created
 
Standards
for
408
and
409
are
different
 
FDA
requires
less
data
than
EPA
and
EPA
needs
data
to
show
that
408
standards
are
met
 
Many
dual
jurisdiction
food
uses
never
assessed
10/
5/
04
67
Antimicrobial
Uses/
Labels
°
Broad
use
patterns
as
material
preservatives
 
Exposure
scenarios
not
covered
by
current
SOPs
 
Many
times
not
evaluated
at
time
of
registration
 
Aggregation
issues
with
other
antimicrobial
uses
10/
5/
04
68
Antimicrobial
Uses/
Labels
°
Example
of
an
aggregation
nightmare
 
Antimicrobial
X
is
used
as:

°
a
material
preservative
in
plastics
and
textiles
°
a
slimicide
in
pulp/
paper
mills
°
a
swimming
pool
disinfectant
°
a
carpet
sanitizer
10/
5/
04
69
Consequences
and
Next
Steps
°
Develop
policies,
methodologies
and
SOPs
as
reregistration
and
registration
review
are
ongoing
°
Require
data
to
confirm
our
analyses
°
Require
that
labels
are
more
"
use
specific"
10/
5/
04
71
Registration
Review
Proposed
Process
Antimicrobial
Pesticide
Case
Study
PPDC
Workgroup
Meeting
Deborah
Smegal
September
28,
2004
10/
5/
04
72
Antimicrobial
Pesticide
Case
Background
Regulatory
History
°
First
Registered:
Mid­
1980s
°
RED:
Mid
1990s,
Pre­
FQPA
°
Pesticide
Type:

°
Disinfectant
°
Algaecide
°
Bacteriostat
regulator
°
Microbiocide/
Microbiostat
°
Fungicide/
Fungistat
10/
5/
04
73
Use
Profile
°
Indirect
food
uses:
Pulp/
paper,
dishwashing
liquids
(
products
touch
food­
contact
surfaces);
has
FDA
409
clearance
°
Non­
food
indoor
uses:
Cleaners,
laundry
detergents,

textiles/
fabrics,
consumer/
institutional
products,
paints,
oil
field
systems,
air
washer
systems,
air
conditioning/
humidifying
systems,

cooling
water
systems,
papermills,
absorbent
clays,
metal
working
fluids,
printing
inks,
adhesives
°
Outdoor
uses:
Open
industrial
waste
water
systems,
sewage
settling
ponds,
sewage
systems,
ground
wood/
saw
dust
(
as
an
absorbent)

Antimicrobial
Pesticide
Case
Background
10/
5/
04
74
Antimicrobial
Pesticide
Case
Background
Last
Major
Assessments
°
Registration
Eligibility
Decision
(
RED):
Mid
1990s,
Pre­
FQPA
°
Toxicology
Assessment
(
complete
database)

°
Occupational
Assessment
(
complete
assessment
at
time,
not
all
application
methods
evaluated,
exposure
database
has
significant
limitations)

°
Residential
Assessment
(
very
limited,
children
not
assessed,

not
all
uses
evaluated;
lacked
residential
Standard
Operating
Procedures)
10/
5/
04
75
Antimicrobial
Pesticide
Case
Background
Last
Major
Assessments
Cont.

°
Ecological
Toxicity
Assessment
(
hazard
only,
no
plant
data
or
chronic
fish
or
invertebrate
data)

°
Environmental
Fate
Assessment
°
Ecological
risks
not
estimated
(
no
Risk
Quotients
or
levels
of
concern
estimated;
not
standard
practice
at
that
time)

°
No
dietary,
drinking
water
or
aggregate
assessments
(
no
SOP's
at
that
time)

°
Recent
Heating
Ventilation
and
Air­
Conditioning
(
HVAC)

Assessment
°
Occupational
Assessment
°
Residential
Assessment
10/
5/
04
76
Hazard
Profile
For
Human
Health
°
High
to
moderate
toxicity
for
acute
oral,
dermal,
eye
and
skin
irritation
°
Severe
gastrointestinal
irritant
following
repeated
oral
exposure
°
Developmental
and
reproductive
effects
only
in
the
presence
of
maternal
toxicity
°
Negative
for
genotoxicity
°
No
evidence
of
carcinogenicity
in
two
chronic
rodent
studies
°
No
reported
human
incidence
data
Antimicrobial
Pesticide
Case
Background
10/
5/
04
77
Antimicrobial
Pesticide
Case
Background
Occupational/
Residential
Exposure
&
Risks
°
No
risks
of
concern
for
all
worker
scenarios
in
RED
after
mitigation
measures
°
No
risks
of
concern
for
residential
handlers
of
paints
or
adhesives
using
a
paintbrush
°
No
risks
of
concern
from
HVAC
use
10/
5/
04
78
Environmental
Fate
°
Stable
to
hydrolysis
under
normal
conditions;
may
rapidly
hydrolyze
at
warmer
temperature
and/
or
high
pH
°
Parent
compound
expected
to
have
a
relatively
short
half­
life
in
the
environment
(
photoreactive
in
water)

°
The
major
degradate
has
a
much
longer
half­
life
than
the
parent
raising
chronic
concerns
°
Unlikely
to
bioaccumulate
Antimicrobial
Pesticide
Case
Background
79
Antimicrobial
Pesticide
Case
Background
Hazard
Profile
for
Ecological
Effects,
Exposure,
&
Risk
°
Only
have
acute
studies
°
Practically
non­
toxic
to
slightly
toxic
to
birds
°
Slightly
to
moderately
toxic
to
freshwater
fish
and
terrestrial
invertebrates
°
Moderately
to
highly
toxic
to
estuarine/
marine
invertebrates
°
Slightly
toxic
to
estuarine/
marine
fish
°
Exposure
to
non­
target
aquatic
organisms
is
expected
from
industrial
discharges
to
surface
water
°
Discharges
may
adversely
affect
aquatic
life.
Chronic
effects
to
invertebrates
are
also
possible
due
to
slow
degradation
of
degradates
°
In
the
RED,
deferred
to
Office
of
Water,
since
aquatic
environments
are
regulated
under
National
Pollution
Discharge
Elimination
System
(
NPDES)

permitting
program
(
current
practice
in
mid­
1990s).
10/
5/
04
80
PPDC
Workgroup
Response
Discussion
Opinion:

°
Easy
Off?

°
Need
New
Risk
Assessment(
s)?

°
Need
New
Risk
Assessment(
s),
New
Data?
10/
5/
04
81
OPP's
Illustrative
Results
For
Antimicrobial
Pesticide
Case
Study
82
OPP's
Illustrative
Results
For
Antimicrobial
Pesticide
Case
Study
Human
Health
Risk
Assessment
°
Dietary
[
FQPA
changed
OPP
policy;
Pre­
FQPA,
AD
was
not
required
to
conduct
dietary
assessment
for
indirect
food
uses
that
have
an
FDA
409
clearance
(
such
as
pulp
and
paper
uses)]

°
Residential
(
many
uses
not
evaluated
 
lacked
SOPs)

°
Residential
handler
cleaning
floors
(
mopping)

°
Child
crawling
on
treated
floors
°
Textiles/
fabrics
°
Hand
soap/
consumer
products
°
Occupational
(
high
end
use
scenarios
not
assessed,
e.
g.,
airless
sprayer
for
painting
scenario;
worker
cleaning
floors)

°
Drinking
water
assessment
from
industrial
discharges
to
surface
water
(
new
models
available)

°
Aggregate
assessment
(
not
previously
required)
10/
5/
04
83
OPP's
Illustrative
Results
For
Antimicrobial
Pesticide
Case
Study
Ecological
Risk
Assessment
°
Complete
assessment
is
not
available
(
only
hazard
and
environmental
fate
assessments)

°
Need
to
evaluate
endangered
species
10/
5/
04
84
OPP's
Illustrative
Results
For
Antimicrobial
Pesticide
Case
Study
Potential
Data
Needs
°
May
need
up
to
8
worker/
residential
exposure
studies
and
activity
descriptions;
existing
data
have
significant
limitations[
American
Chemistry
Council
(
ACC)
Biocides
task
force
developing
database]

°
May
need
up
to
5
ecological
toxicity
studies
and
possibly
6
environmental
fate
studies
based
on
vague
label
language
for
potential
outdoor
uses
that
trigger
additional
data
and
new
data
requirements
°
Studies
may
not
be
needed
if
labels
are
clarified
to
remove
"
open
industrial
waste
water"
(
or
clarify
that
it
is
not
a
once­
through
use)
and
preclude
outdoor
wood
preservation
uses
(
i.
e.,
ground
wood
as
an
absorbent)

°
Studies
include:
plant
toxicity
data,
chronic
invertebrate
toxicity
data,

aerobic
and
anaerobic
soil,
aerobic
and
anaerobic
aquatic,

absorption/
desorption,
special
wood
leaching
10/
5/
04
85
OPP's
Illustrative
Results
For
Antimicrobial
Pesticide
Case
Study
Other
Issues
°
Label's
uses
need
clarification
based
on
consultation
with
registrant
°
Seeking
to
work
with
OW
NPDES
permitting
program
°
Coordinate
with
FDA;
previously
deferred
to
them
10/
5/
04
87
Feasibility
Study
Aggregate
Results
The
ultimate
outstanding
data
needs
in
a
given
case
are
expected
to
be
significantly
influenced
by
internal
and
external
consultations.
For
practical
reasons,
this
step
was
omitted
in
the
pilot.

17.7%

83.3%

58.3­
75.0%

0.0%

New
Assessment,

New
Data
5.9%

0.0%

25.0­
33.3%

8.3­
16.7%

New
Assessment,

No
New
Data
76.4%

16.7%

0.0­
8.3%

83.3­
91.7%

No
New
Assessment
Environmental
Human
Health
Biopesticides
(
10
cases)

Antimicrobials
(
6
cases)

Conventionals
(
12
cases)
