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

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(
)
)
*
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
2
Overview
of
Potential
Overview
of
Potential
Issue
Areas
Issue
Areas
°
The
High
Production
Volume
Challenge
Program
(
Q1a­
f)

°
Risk
Assessment/
Risk
Management
of
Existing
Chemicals
(
Q2)

°
New
Chemicals
Program
(
Q3)

°
Pollution
Prevention
(
Q4)

°
Partnerships
with
States/
Tribes
(
Q5)

°
Future
Directions
for
OPPT
(
Q6)

November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
3
HPV
Challenge
Program
HPV
Challenge
Program
(
Q1)

(
Q1)

°
History
 
1997­
1998
data
availability
studies
 
1998
EPA
 
43%
of
HPVs
w/
o
hazard
data
publicly
available
°
Prompted
HPV
Challenge
Program
 
Challenged
industry
to
come
forward
with
existing
data
or
generate
the
data
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
4
HPV
Challenge
Program
HPV
Challenge
Program
(
Q1)

(
Q1)

°
HPV
Chemicals
Sponsored
(
October,
2003)

 
334
companies,
98
consortia
and
2,167
chemicals
committed
 
249
submissions
(
1,081
chemicals)
posted
on
EPA
website
°
Content
of
a
Submission
 
Test
Plan
and/
or
Robust
Summaries
 
Single
Chemicals
or
Category
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
5
HPV
Challenge
Program
HPV
Challenge
Program
(
Q1)

(
Q1)

°
Basic
data
consists
of
the
Screening
Information
Data
Set
(
SIDS):

 
Physicochemical
properties
 
Environmental
fate
 
Ecotoxicity
 
Human
health
effects
(
based
on
animal
studies)

°
Non­
SIDS
information,
if
available,
is
also
included
in
an
HPV
submission
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
6
HPV
Challenge
Program
HPV
Challenge
Program
(
Q1)

(
Q1)

Six
subquestions:

a.
Prioritizing
the
data
b.
How
to
obtain
additional
data
if
needed
c.
Making
the
data
available
and
useful
to
technical
audiences
d.
Communicating
data
and
data
evaluation
results
to
the
public
e.
Evaluating
the
category
approach
used
in
the
Program
f.
HPV
chemicals
not
in
the
Challenge
Program
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
7
Prioritizing
the
HPV
Prioritizing
the
HPV
Hazard
Data
(
Q1a)

Hazard
Data
(
Q1a)

We
are
seeking
advice
on
the
key
elements
to
be
considered
in
the
development,
piloting,
and
implementation
of
a
screening
process
for
prioritizing
chemicals
for
further
action,
including
tools
or
models
that
could
be
used
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
8
Obtaining
Additional
Obtaining
Additional
Needed
Data
(
Q1b)

Needed
Data
(
Q1b)

We
are
seeking
advice
on
the
best
ways
to
obtain
additional
hazard
data
and
use
and
exposure
information
on
those
HPV
chemicals
identified
as
a
priority
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
9
Making
HPV
Data
Making
HPV
Data
Available
and
Useable
Available
and
Useable
(
Q1c)

(
Q1c)

We
are
seeking
advice
on
ways
to
make
HPV
data
more
accessible
and
usable
to
technical
audiences:

°
HPV
database
°
Characteristics
of
a
"
toolbox"
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
10
Communicating
Data
and
Communicating
Data
and
Evaluation
Results
(
Q1d)

Evaluation
Results
(
Q1d)

We
are
seeking
advice
on
how
we 

°
interpret
the
hazard
data
 
and
any
available
use
and
exposure
information
­
to
provide
an
integrated
assessment
of
potential
risks
°
make
the
hazard/
risk
information
meaningful
to
the
lay
public
°
best
communicate
pollution
prevention
and
risk
mitigation
options
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
11
Evaluating
the
Category
Evaluating
the
Category
Approach
(
Q1e)

Approach
(
Q1e)

We
are
seeking
your
advice
on
currently
used
approaches
and
other
potential
approaches
that
could
enhance
the
application
of
categories
in
the
HPV
Program
 
86%
of
the
HPV
submissions
to
date
are
part
of
a
category
 
The
approach
has
been
useful
for:


Minimizing
animal
testing
and

Reducing
economic
burden
to
industry
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
12
HPV
Chemicals
Beyond
HPV
Chemicals
Beyond
the
Challenge
Program
the
Challenge
Program
(
Q1f)

(
Q1f)

We
are
seeking
advice
on
how
HPV
chemicals
not
covered
under
the
HPV
Challenge
should
be
addressed
°
HPV
Challenge
is
based
on
1990
IUR
data
 
Chemicals
not
sponsored
 
HPVs
from
1994,
1998,
or
2002
IUR
reporting
cycles
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
13
OPPT
OPPT
Priority
HPV
Questions
Priority
HPV
Questions
OPPT
views
the
following
three
HPV
questions
priorities
for
input
from
the
NPPTAC
in
the
near
term
 
Prioritizing
the
HPV
data
(
Q1a)

 
Making
the
data
available
and
useable
to
technical
audiences
(
Q1c)

 
Communicating
data
and
data
evaluation
results
to
the
public
(
Q1d)
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
14
Risk
Assessment/
Risk
Risk
Assessment/
Risk
Management
of
Existing
Management
of
Existing
Chemicals
(
Q2)

Chemicals
(
Q2)

We
are
seeking
advice
on:

°
How
to
identify
and
implement
the
best
mix
of
regulatory
and
voluntary
options
to
achieve
sufficient
and
timely
risk
assessment
and
risk
management
actions
for
existing
chemicals?

°
What
opportunities
exist
for
partnership
with
industry,
non­
governmental
organizations,
States,

Tribes
and
others?

November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
15
Risk
Assessment/
Risk
Risk
Assessment/
Risk
Management
of
Existing
Management
of
Existing
Chemicals
(
Q2)

Chemicals
(
Q2)

Risk
Assessment
Actions
°
Regulatory
authority
 
TSCA
Section
4
(
test
rules
and
ECAs)

 
TSCA
Section
8
°
Voluntary
submissions
(
HPV
Challenge
Program/
VCCEP)
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
16
Risk
Assessment/
Risk
Risk
Assessment/
Risk
Management
of
Existing
Management
of
Existing
Chemicals
(
Q2)

Chemicals
(
Q2)

Risk
Management
Actions
°
PCBs,
asbestos,
lead
through
statute
[
TSCA
§
6,
TSCA
Titles
II
and
IV]

°
Other
TSCA
§
6
regulatory
actions
 
Initiated
nine
actions,
completed
six
°
Significant
new
uses
rules
[
TSCA
§
5
(
a)
(
2)]

°
Other
chemicals
of
national
concern
(
dioxin,
mercury)

°
Voluntary
actions
(
PFOS/
PFOA)
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
17
New
Chemicals
Program
New
Chemicals
Program
(
Q3)

(
Q3)

We
are
seeking
advice
on
how
the
U.
S.
can
enhance
its
new
chemical
assessment
and
management
scheme
based
on
national
and
international
experience.
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
18
New
Chemicals
Program
New
Chemicals
Program
(
Q3)

(
Q3)

°
Premanufacture
notice
°
EPA
review
based
largely
on
structure­
activity
relationships
(
SARs)
and
proposed
use,
production,
and
exposure/
release
information
°
EPA
determines
if
need
to
prohibit
or
limit
manufacturing,

importing,
processing
or
use
pending
development
of
needed
information
°
After
EPA
review,
if
manufacturing
or
importing
commences,
EPA
is
notified
(~
50%
of
PMNs)

November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
19
New
Chemicals
Program
New
Chemicals
Program
(
Q3)

(
Q3)

°
Consideration
of
international
new
chemical
regulatory
processes
are
key
since
chemicals
are
a
global
business
°
There
are
various
approaches
at
play
around
the
world
to
address
new
chemicals
°
Objective
of
the
OECD
New
Chemicals
Task
Force
is
to
increase
cooperation
and
efficiency
of
new
chemical
notification
and
assessment
systems
in
the
global
market.
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
20
Pollution
Prevention
(
P2)

Pollution
Prevention
(
P2)

(
Q4)

(
Q4)

We
are
seeking
advice
on
how
to
increase
the
use
of
pollution
prevention
in
managing
risks
of
chemicals
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
21
Pollution
Prevention
(
P2)

Pollution
Prevention
(
P2)

(
Q4)

(
Q4)

°
Use
of
TSCA
authority
(
e.
g.,
TSCA
§
5
(
a)
(
2)
 
significant
new
use
rules)

°
Enhancement
of
environmental
stewardship
in
designing
new
chemicals
and
in
making
choices
among
existing
chemicals
°
Better
integration
of
existing
tools
and
approaches
°
Incentives
°
Product
stewardship
program
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
22
Partnerships
with
States
Partnerships
with
States
and
Tribes
(
Q5)

and
Tribes
(
Q5)

We
are
seeking
advice
on .

°
What
opportunities
exist
for
States
and
Tribes
to
assume
a
greater
partnership
role
in
furthering
the
goals
of
the
national
program?

°
What
roles
would
be
optimal
for
States
and
Tribes?

°
Are
there
more
effective
ways
to
share
chemical
data
with
the
States
and
Tribes?

November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
23
Partnerships
with
States
Partnerships
with
States
and
Tribes
(
Q5)

and
Tribes
(
Q5)

OPPT
coordination
with
States
and
Tribes
occurs
primarily
through
°
FOSTTA
partnership
°
P2
Grant
Program
°
Lead
Program
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
24
Future
Directions
for
OPPT
Future
Directions
for
OPPT
(
Q6)

(
Q6)

We
are
seeking
advice
on
°
What
challenges
and
opportunities
face
OPPT
in
managing
and
reducing
chemical
risks
over
the
next
20
years?
How
can
we
best
prepare
over
the
next
5­
10
years?

°
How
might
the
increased
international
interest
and
activities
of
governments,
industry,
and
NGOs
in
chemicals
management
impact
domestic
approaches
for
reducing
and
preventing
chemical
risk?
November
4,
2003
Office
of
Pollution
Prevention
&
Toxics
(
OPPT)
25
OPPT
Proposes
the
OPPT
Proposes
the
Following
Issues
as
Initial
Following
Issues
as
Initial
Priorities
for
NPPTAC
Priorities
for
NPPTAC
Consideration
Consideration
°
HPV
Program
Issues
(
Q1)

 
Prioritizing
the
HPV
data
(
Q1a)

 
Making
the
data
available
and
useable
to
technical
audiences
(
Q1c)

 
Communicating
data
and
data
evaluation
results
to
the
public
(
Q1d)

°
Pollution
Prevention
(
P2)
Issue
(
Q4)

°
Partnerships
with
States/
Tribes
(
Q5)
