Proposed
Issues
and
Background
for
the
National
Pollution
Prevention
and
Toxics
Advisory
Committee
(
NPPTAC)

Prepared
by
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)

National
Pollution
Prevention
and
Toxics
Advisory
Committee
(
NPPTAC)
Meeting
November
4­
5,
2003
Table
of
Contents
Question
1:
HPV
Challenge
Program
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1
Question
1a:
Prioritizing
the
HPV
Hazard
Data
for
Further
Action
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4
Question
1b:
Obtaining
Additional
Data
Where
Needed
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4
Question
1c:
Promoting
Use
of
the
HPV
Data
by
Making
the
Data
Accessible,
Available,
and
Useable
to
Stakeholders
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6
Question
1d:
Communication
of
HPV
Data
Evaluation
Results
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7
Question
1e:
Evaluation
of
the
Category
Approach
in
the
HPV
Challenge
Program.
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7
Question
1f:
HPV
Chemicals
Beyond
the
Challenge
Program
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9
Question
2:
Risk
Assessment/
Risk
Management
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10
Question
3:
New
Chemicals
Program
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16
Question
4:
Pollution
Prevention
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21
Question
5:
State/
Tribal
Partnerships
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24
Question
6:
Future
Directions
for
OPPT
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27
1
Environmental
Defense
1997.
Toxic
Ignorance.
New
York,
New
York,
(
Summer
1997).
Copies
can
be
obtained
by
accessing
ED's
web
site
(
non­
EPA
site)
at
http://
www.
environmentaldefense.
org/
documents/
243_
toxicignorance.
pdf
or
by
calling
1
 
800
 
684
 
3322.

2
EPA,
OPPT.
Chemical
Hazard
Data
Availability
Study:
What
Do
We
Really
Know
About
the
Safety
of
High
Production
Volume
Chemicals?
(
April
1998)
(
http://
www.
epa.
gov/
opptintr/
chemtest/
hazchem.
htm).

3
ACC
1998.
Public
Availability
of
SIDS
Related
Testing
Data
for
U.
S.
High
Production
Volume
Chemicals
(
June
12,
1998).
Copies
of
ACC's
report
can
be
obtained
by
writing
to
ACC
at
1300
Wilson
Blvd.,
Arlington,
VA
22209
or
by
calling
ACC
at
(
703)
741
 
5226.
(
Note:
The
Chemical
Manufacturers
Association
(
CMA)
is
now
the
American
Chemistry
Council
(
ACC)).

1
Question
1(
a­
f):
Background
Information
and
Issues
Relating
to
the
High
Production
Volume
(
HPV)
Chemicals
Program
Introduction
In
1997,
the
Environmental
Defense
Fund
(
now
Environmental
Defense
or
ED)
published
Toxic
Ignorance:
The
Continuing
Absence
of
Basic
Health
Testing
for
Top­
Selling
Chemicals
in
the
United
States.
1
The
ED
report
stated
that
approximately
75%
of
the
high
production
volume
(
HPV)
chemicals
in
commerce
do
not
have
publicly
available
basic
hazard
information
associated
with
them.
ED
analyzed
searches
of
public
databases
for
one
hundred
of
the
approximately
3,000
HPV
chemicals.

An
analysis
by
the
U.
S.
Environmental
Protection
Agency
(
EPA)
in
19982
confirmed
that
very
little
basic
toxicity
data
was
publicly
available
on
most
of
the
HPV
chemicals
listed
on
the
Toxic
Substances
Control
Act
(
TSCA)
Chemical
Substance
Inventory
("
Inventory").
EPA
found
that,
of
the
2,800
non­
polymeric
organic
substances
produced
or
imported
in
amounts
equal
to
or
greater
than
one
million
pounds
per
year
based
on
1990
Inventory
Update
Rule
(
IUR)
reporting,
only
7%
have
a
full
data
set
of
publicly
available,
internationally
recognized
basic
health
and
environmental
fate/
effects
screening
test
data,
while
43%
have
no
publicly
available
basic
hazard
data.
For
the
remaining
chemicals,
limited
amounts
of
the
data
are
available.
A
third
study
performed
by
industry
arrived
at
a
similar
conclusion.
3
This
lack
of
available
hazard
data
limits
EPA's
and
others'
ability
to
determine
whether
these
HPV
chemicals
pose
potential
risks
to
human
health
or
the
environment.
In
addition,
the
lack
of
publicly
available
data
restricts
the
public's
right­
to­
know
about
the
hazards
of
chemicals
that
may
be
found
in
their
environment,
their
homes,
their
workplaces,
and
the
products
that
they
buy.
Thus,
on
April
21,
1998,
a
national
initiative,
known
as
"
Chemical
Right­
To­
Know
(
ChemRTK),"
was
announced
in
order
to
provide
citizens
with
information
about
the
highest
volume
chemicals
in
commerce.
The
ChemRTK
Initiative
is
an
effort
to
fill
this
knowledge
gap
by
rapidly
collecting
and
making
basic
information
about
chemicals
publicly
available.
The
ChemRTK
Initiative
includes
the
HPV
Challenge
Program
and
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP).

This
background
document
will
focus
on
the
HPV
Challenge
Program.
4
Federal
Register.
Data
Collection
and
Development
on
High
Production
Volume
(
HPV)
Chemicals.
65
FR
81686,
December
26,
2000.

5
OECD
Secretariat,
April,
2003.
Manual
for
the
Investigation
of
HPV
Chemicals.
Available
at:
http://
www.
oecd.
org/
document/
7/
0,2340,
en_
2649_
34379_
1947463_
1_
1_
1_
1,00.
html.

2
The
Challenge
and
Industry's
Response
The
framework
for
the
HPV
Challenge
Program
was
developed
by
Environmental
Defense
and
the
American
Chemistry
Council.
U.
S.
producers
and
importers
of
HPV
chemicals
participate
voluntarily
in
the
HPV
Challenge
Program
by
collecting
and
submitting
to
EPA
basic
hazard
data
on
the
HPV
chemicals
they
produce
or
import.
4
Industry
has
responded
to
the
challenge
by
sponsoring
over
2,100
HPV
chemicals
in
the
Challenge
Program.
As
of
October
3,
2003,
333
U.
S.
chemical
companies
and
97
consortia
(
companies
working
together
to
meet
the
Challenge)
volunteered
to
provide
EPA
and
the
public
with
data
on
2,167
HPV
chemicals
over
a
five­
year
period.
Since
the
spring
of
2000,
industry
has
been
submitting
existing
data
and/
or
providing
test
plans
for
generating
and
submitting
data.
Full
data
sets
for
each
sponsored
chemical
or
category
of
chemicals
take
approximately
two
years
to
complete,
so
chemicals
that
were
started
in
the
first
full
year
of
the
program
are
just
now
completing
the
process.

EPA
has
issued
a
proposed
test
rule
under
TSCA
§
4
to
obtain
hazard
information
on
a
portion
of
the
HPV
chemicals
that
have
not
been
sponsored.
The
first
such
rulemaking
was
proposed
in
December
2000,
covering
37
HPV
chemicals.
The
final
rule
is
planned
for
promulgation
in
2003.
Additional
HPV
test
rules
addressing
other
unsponsored
chemicals
are
also
under
consideration.

What
Are
Basic
Hazard
Data?

The
information
relevant
to
understanding
the
basic
health
and
environmental
hazards
of
HPV
chemicals
is
derived
from
a
battery
of
tests
agreed
upon
by
the
international
community
as
appropriate
for
hazard
screening
purposes.
The
battery
of
endpoints
has
been
developed
and
adopted
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
and
is
known
as
the
OECD's
Screening
Information
Data
Set
(
SIDS).
These
data
include:
physicochemical
properties
(
melting
point,
boiling
point,
vapor
pressure,
water
solubility,
and
octanol/
water
partition
coefficient);
environmental
fate
(
biodegradation,
hydrolysis,
and
estimates
of
distribution/
transport
and
photodegradation);
ecotoxicity
(
acute
toxicity
to
aquatic
vertebrates,
invertebrates,
and
plants);
and
studies
in
laboratory
animals
to
assess
human
health
effects
(
acute
and
repeat­
dose
toxicity,
effects
on
the
gene
and
chromosome,
and
effects
on
reproduction
and
the
developing
organism).
5
How
the
HPV
Program
Works:
The
Process
One
of
the
key
components
of
the
HPV
Program
is
making
the
hazard
data
described
above
publicly
available.
Once
a
company
or
consortium
makes
a
commitment
to
"
sponsor"
a
chemical
or
group
of
chemicals
(
categories),
then
the
company
is
agreeing
to
follow
the
Program's
procedures
(
additional
information
may
be
found
at
http://
www.
epa.
gov/
chemrtk/
volchall.
htm).
6
EPA
has
developed
numerous
guidance
documents
for
the
Challenge
Program.
For
example,
guidance
documents
for
developing
robust
summaries
and
evaluating
data
adequacy
exist
for
each
of
the
SIDS
endpoints
(
http://
www.
epa.
gov/
chemrtk/
guidocs.
htm).

7
EPA,
OPPT.
Development
of
Chemical
Categories
in
the
HPV
Challenge
Program
(
Draft
guidance
document
dated
August
25,
1999
and
available
at
http://
www.
epa.
gov/
chemrtk/
guidocs.
htm).

3
An
HPV
Challenge
Submission
consists
of
a
cover
letter,
a
Test
Plan,
and
Robust
Summaries.
The
cover
letter
generally
identifies
the
company(
ies),
chemical(
s)
and
usually
whether
any
new
testing
is
being
proposed.
The
Test
Plan
can
be
a
table
or
narrative
(
or
both)
that
describes
whether
data
exist
for
a
given
endpoint,
an
evaluation
of
the
data
adequacy,
an
opinion
that
no
new
testing
is
necessary.
Where
no
data
exist,
or
the
existing
data
are
considered
inadequate,
the
sponsor
proposes
to
conduct
a
test(
s)
for
that
endpoint.
The
Robust
Summaries
are
summaries
generated
for
each
individual
study/
experiment
for
each
SIDS
endpoint.
6
They
are
designed
to
provide
information
to
a
technical
audience
in
sufficient
detail
so
it
would
not
be
necessary
to
retrieve
or
look
at
the
original
study
report.

Once
a
submission
is
received
by
EPA,
it
is
posted
on
EPA's
website
noted
above
for
a
120­
day
comment
period.
This
allows
interested
parties,
EPA,
and
the
general
public
an
opportunity
to
comment
on
a
test
plan
or
perhaps
bring
forward
information
and
data
unknown
to
the
sponsor.
All
comments
are
publicly
available
and
posted
on
the
website.
EPA
strongly
encourages
companies
which
make
commitments
under
the
HPV
Challenge
Program
to
sponsor
a
chemical
or
chemicals
not
to
make
Confidential
Business
Information
(
CBI)
claims
on
the
chemical­
company
linkage.

Once
the
comment
period
is
over,
sponsors
may
respond
to
comments,
revise
original
submissions,
and
begin
any
new
testing.
Once
new
testing
is
complete,
new
information
(
in
the
form
of
Robust
Summaries)
is
submitted
to
EPA
for
posting
on
the
website
in
order
to
make
the
submission
complete.

Over
85%
of
the
chemicals
currently
on
the
HPV
Program
website
are
part
of
a
category.
This
means
that
the
sponsor
has
made
an
argument
that
a
group
of
chemicals
can
be
considered
together
in
addressing
the
SIDS
endpoints.
In
other
words,
the
sponsor
argues
that
existing
data
(
or
proposed
testing)
on
some
members
of
a
category
of
chemicals
may
be
applied
to
other,
untested
members.
7
Unlike
single
chemical
submissions,
completion
of
a
category
submission
(
once
proposed
testing
is
done)
includes
a
Category
Analysis
Document
to
determine
whether
the
original
category
proposal
was
valid.

General
Overview
of
Areas
for
Which
EPA
is
Requesting
NPPTAC
Advice
The
expected
influx
of
a
large
amount
of
hazard
information
on
HPV
chemicals
will
pose
many
challenges
for
EPA
and
others
interested
in
using
the
data
for
a
variety
of
purposes.
EPA
is
requesting
advice
and
recommendations
on
the
key
elements
of
an
overall
approach
to
using
the
HPV
data,
including
the
most
important
actions
to
be
taken
as
completed
HPV
data
are
received.
EPA
is
also
requesting
advice
on
how
best
to
share
the
summarized
data
and
other
information
4
obtained
on
HPV
chemicals
with
the
public,
other
Federal
agencies,
and
any
other
interested
parties.
EPA
requests
NPPTAC
advice
on
the
following
priority
areas:

°
Using
the
HPV
Hazard
Data
to
Prioritize
Chemicals
for
Further
Action
°
Obtaining
Additional
Data
Where
Needed
°
Making
the
HPV
Data
More
Useable
to
Stakeholders
°
Communication
of
HPV
Data
Evaluation
Results
°
Evaluation
of
the
Category
Approach
in
the
HPV
Challenge
Program
°
Addressing
HPV
Chemicals
Not
Part
of
the
Challenge
Program.

Specific
questions
are
asked
for
each
of
these
areas
below.

Question
1a:
Prioritizing
the
HPV
Hazard
Data
for
Further
Action
Question
1a.
What
would
be
the
appropriate
factors/
criteria
to
use
to
prioritize
the
HPV
chemicals
for
further
action?

The
HPV
Challenge
Program
will
provide
hazard
data
that
can
be
used
in
initial
screening
to
prioritize
the
HPV
chemicals
for
further
action,
data
collection,
or
analysis
for
risk
assessment
or
risk
management
purposes.
The
screening
process
will
determine
which
HPV
chemicals
warrant
further
assessment,
and
assign
a
screening
outcome
(
e.
g.,
classification
into
priority
groups
and
actions
associated
with
each
priority
group).

EPA
is
asking
for
advice
on
the
key
elements
that
should
be
considered
in
the
development,
piloting,
and
implementation
of
a
screening
process
and
methodology,
as
well
as
characteristics
of
tools
or
models
that
could
be
used
as
part
of
an
initial
screening
to
enable
EPA
to
set
priorities.

Question
1b:
Obtaining
Additional
Data
Where
Needed
Question
1b.
When
a
chemical
is
identified
as
a
priority
how
can
relevant
exposure
and
use
data
(
and
additional
hazard
data)
be
best
obtained
and
made
available
to
government,
industry,
non­
governmental
organizations
and
others
to
adequately
inform
risk
assessment
and
risk
management
decisions
for
HPV
chemicals?

For
HPV
chemicals
identified
as
chemicals
of
concern
based
on
the
hazard
data
provided
under
the
HPV
Challenge
Program,
it
is
likely
that
additional
data
will
be
needed
in
order
to
adequately
assess
the
potential
risks
posed
by
these
chemicals.
This
additional
data
could
be
additional
hazard,
exposure
and/
or
use
data.
In
some
cases,
the
HPV
submission
may
already
have
some
limited
exposure
information.

The
submitted
HPV
hazard
data
may
suggest
the
need
for
additional
information
to
either
clarify
or
address
a
potential
issue
for
future
risk
assessment
and/
or
risk
management
actions.
For
example,
results
of
a
repeated­
dose
toxicity
test
may
identify
some
neurotoxicity
effects
that
8
Industry
or
other
submitting
companies
may
claim
certain
information
as
Confidential
Business
Information
(
CBI)
under
TSCA
§
14(
a).
The
provision
prohibits
EPA
from
disclosing
such
claimed
information
to
the
public,
except
in
certain
limited
circumstances.

9
The
statutory
findings
include
that
there
are
insufficient
data
available
to
determine
the
effects
of
the
substance
on
health
and/
or
the
environment;
and
testing
is
necessary
to
provide
such
data;
and
the
substance
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,"
(
known
as
the
"
risk­
based
finding");
and/
or
may
be
produced
at
substantial
quantities
and
is
reasonably
expected
to
enter
the
environment
in
substantial
quantities;
or
may
result
in
significant
or
substantial
human
exposure
(
known
as
the
"
exposure­
based
finding").

5
may
need
to
be
assessed
in
a
more
specific,
focused
study
designed
to
observe
and
assess
such
effects.

Alternatively,
the
HPV
hazard
data
may
also
help
identify
exposure
scenarios
of
most
concern;
for
example,
hazard
data
may
indicate
a
special
concern
for
a
given
pathway
of
exposure
such
as
inhalation
or
dermal
exposure.
In
many
cases
the
needed
additional
data
will
be
use
and
exposure
information
and
could
include
either
known
or
estimated
values
for:
environmental
releases
and
worker
exposure
during
manufacture
and
disposal
processes;
bioaccumulation
or
other
mechanisms
or
pathways
that
could
lead
to
dietary
exposures;
presence
in
consumer
products
and
the
likelihood
of
release
and
exposure
from
those
products;
and
the
likelihood
of
release
and
exposure
from
final
disposal
of
the
chemical
(
or
products
containing
the
chemical)
in
landfills
or
incinerators.

EPA
has
several
regulatory
tools
to
obtain
needed
data.
8
Under
TSCA
§
4,
EPA
can
require
the
development
of
data
via
rulemaking
or
through
an
Enforceable
Consent
Agreement
(
ECA),
or
receive
reporting
by
industry
via
TSCA
§
8
(
i.
e.,
inventory
information
through
§
8(
a)
and
substantial
risk
information
through
§
8(
e)).

In
order
to
issue
a
test
rule
under
TSCA
§
4,
EPA
must
make
certain
statutory
findings
about
the
substance
involved.
9
Rulemaking
under
TSCA
§
4
has
generally
been
both
lengthy
and
resource­
intensive.
As
a
result,
data
have
been
generated
under
TSCA
§
4
test
rules
on
only
approximately
140
chemicals
since
the
1970s.
An
ECA
is
a
publicly
negotiated
agreement
between
EPA
and
interested
parties
that
requires
the
generation
and
submission
of
data
to
EPA.
ECAs
are
usually
less
resource­
intensive
than
test
rules
and
can
be
a
much
quicker
way
to
obtain
data.
Since
October
1984,
EPA
has
issued
a
number
of
ECAs
covering
approximately
60
chemicals.

The
rulemaking
authority
under
TSCA
§
8
provides
EPA
with
a
mechanism
to
obtain
certain
exposure
data
from
manufacturers
and
processors
of
HPV
chemicals.
As
a
result
of
recent
Inventory
Update
Rule
Amendments
(
IURA)
(
68
FR
Number
4,
January
7,
2003,
pp.
848­
906),
beginning
with
the
2006
reporting
year,
initial
screening
level
exposure­
related
data
about
uses,
number
of
processing
and
use
sites,
and
workers
exposed
to
HPV
chemicals
will
be
reported
to
EPA/
OPPT.
A
previous
voluntary
effort
called
the
Use
and
Exposure
Information
Project
(
UEIP)
demonstrated
that
useful
screening
level
exposure
information
is
available
from
industry
and
can
be
used
to
prepare
screening
level
exposure
assessments.
The
UEIP
was
a
cooperative
effort
begun
in
the
fall
of
1992
between
government
and
industry
in
recognition
of
the
difficulties
encountered
in
obtaining
accurate
and
up­
to­
date
exposure
information
on
HPV
chemicals.
Data
6
collected
by
EPA
under
the
UEIP
were
similar
to
those
now
being
required
under
IURA.
In
contrast
to
the
IURA,
however,
the
UEIP
only
provided
onetime
reporting
of
information
by
a
subset
of
the
manufacturers
of
a
small
number
of
selected
HPV
chemicals
(
68
FR
Number
4,
January
7,
2003,
p.
853)

One
recent
example
of
how
EPA
has
entered
into
discussion
with
industry
and
others
on
the
collection
of
additional
data
short
of
regulatory
action
is
the
work
being
done
associated
with
PFOA
(
perfluorooctanoic
acid
and
its
salts).
PFOA
is
a
synthetic
chemical
used
as
an
essential
processing
aid
in
the
manufacture
of
fluoropolymers
in
many
industry
segments
including
automotive,
building/
construction,
electrical
and
electronics,
and
carpet
and
textile
industries
(
e.
g.,
non­
stick
surfaces
on
cookware
and
protective
finishes
on
carpets
and
clothing).
Industry
has
collected
initial
human
biomonitoring
data
that
indicates
potential
exposure
of
the
U.
S.
general
population
to
PFOA
at
very
low
levels.
EPA
has
identified
areas
where
additional
information
could
be
very
helpful
in
allowing
the
Agency
to
develop
a
more
accurate
assessment
of
the
potential
risks
posed
by
PFOA,
and
is
requesting
additional
data
and
public
comment
on
its
preliminary
scientific
findings.

EPA
is
interested
in
the
advice
of
the
NPPTAC
on
the
best
ways
to
obtain
additional
hazard
data
and
use
and
exposure
information
on
those
HPV
chemicals
identified
as
a
priority.

Question
1c:
Promoting
Use
of
the
HPV
Data
by
Making
the
Data
Accessible,
Available,
and
Useable
to
Stakeholders
Question
1c.
What
tools,
models
or
other
infrastructure
should
EPA
provide
to
promote
the
use
of
the
HPV
test
summary
data
by
regions
and
States/
Tribes,
industry
and
other
technical
audiences?

The
HPV
Challenge
data
are
submitted
in
the
form
of
Robust
Summaries
that
are
included
on
EPA's
website.
The
current
format
of
these
summaries
is
primarily
viewed
as
useful
to
technical
audiences.
EPA
is
interested
in
input
from
the
NPPTAC
on
what
other
formats
would
be
most
useful
to
technical
audiences
including
the
regions,
States,
and
industry.
EPA
is
in
the
process
of
defining
core
requirements
for
a
searchable
database
that,
once
completed,
will
provide
the
infrastructure
needed
to
house
HPV
data
and
make
it
more
accessible
and
available
in
ways
that
are
more
useful
to
diverse
technical
audiences.

In
addition
to
the
packaging
and
display
of
the
technical
information
(
the
database),
EPA
wishes
to
facilitate
the
use
of
this
information.
For
example,
one
use
is
the
ability
of
technical
audiences
to
conduct
independent
analyses
of
the
HPV
data
to
understand
hazard
and
potential
risks
of
interest
to
them
and
possibly
others.
Current
EPA
tools
and
models
that
have
been
developed
by
OPPT
over
the
years
to
evaluate
both
new
and
existing
chemicals
might
be
of
value
in
this
regard
.

EPA
is
seeking
the
advice
of
the
NPPTAC
on
both
the
HPV
database
and
the
appropriate
"
tool
box"
of
models
that
would
be
useful
to
technical
audiences
interested
in
using
the
HPV
data.
7
Question1d:
Communication
of
HPV
Data
Evaluation
Results
Question
1d.
In
communicating
HPV
Challenge
information
to
interested
parties,
what
specific
information
elements
(
e.
g.,
raw
data,
technical
reports,
fact
sheets,
industry
summaries,
EPA
summaries)
should
be
conveyed
and
in
what
form
(
e.
g.,
internet,
hard
copy,
etc.)?
How
would
this
need
change
as
non­
SIDS
endpoints
(
including
any
available
exposure
information)
become
available?

OPPT
has
a
commitment
under
the
auspices
of
the
HPV
Challenge
Program
to
ensure
transparency
of
and
public
access
to
HPV
data.
In
addition
to
making
the
technical
information
publicly
available,
EPA
recognizes
that
for
some
audiences
additional
ways
of
communicating
the
data
must
be
considered.
As
steps
are
taken
to
evaluate
the
HPV
hazard
data,
and
any
related
exposure
and
use
information,
the
results
of
such
evaluations
should
also
be
made
publicly
available.
OPPT
realizes
that
there
are
many
potential
audiences
for
such
information
beyond
technical
audiences,
and
that
each
of
these
have
their
own
needs
(
e.
g.,
workers,
general
public,
etc.).
There
are
two
main
topics
of
interest:
the
appropriate
communication
venue
and
the
appropriate
content/
substance
of
the
communication.

The
Internet
is
an
excellent
tool
for
communicating
large
amounts
of
data.
Yet,
not
everyone
has
easy
access
to
the
Internet
or
may
know
how
to
search
it
effectively.
Communication
through
other
media
(
e.
g.,
brochures,
reports,
newspaper,
broadcast)
may
be
needed.
Use
of
local
partners
may
help
target
selected
information
to
specific
local
needs.

The
robust
summaries
currently
on
EPA
website
serve
the
purpose
of
providing
hazard
information
to
a
technical
audience.
There
are
three
issues
associated
with
making
this
information
available
to
a
wider,
public
audience:
(
1)
making
the
hazard
information
meaningful
to
the
lay
public;
(
2)
interpretation
of
the
hazard
data
per
se
and
in
conjunction
with
exposure
information/
scenarios
to
provide
an
assessment
of
potential
risks;
and
(
3)
how
best
to
communicate
pollution
prevention
and
risk
mitigation
options.
EPA
is
seeking
the
advice
of
the
NPPTAC
in
all
of
these
areas.

Question
1e:
Evaluation
of
the
Category
Approach
in
the
HPV
Challenge
Program
Question
1e.
What
have
all
parties
learned
from
applying
the
category
approach
thus
far
and
are
there
approaches
that
could
improve
application
of
categories
in
the
HPV
program?

A
key
feature
of
the
HPV
Program
is
the
use
of
categories,
where
scientifically
justified,
in
generating
and
making
publicly
available
a
minimum
hazard
data
set
for
the
sponsored
HPV
chemicals.
A
chemical
category,
for
the
purposes
of
the
HPV
Program,
is
a
group
of
chemicals
whose
physicochemical
and
toxicological
properties
are
likely
to
be
similar
or
follow
a
regular
pattern
as
a
result
of
structural
similarity.
These
structural
similarities
may
create
a
predictable
pattern
in
any
or
all
of
the
following
parameters:
physicochemical
properties,
environmental
fate
8
and
environmental
effects,
and
human
health
effects.
The
similarities
may
be
based
on
the
following:

a.
a
common
functional
group
(
e.
g.,
aldehyde,
epoxide,
ester,
etc.);
or
b.
the
likelihood
of
common
precursors
and/
or
breakdown
products,
via
physical
or
biological
processes,
which
result
in
structurally
similar
chemicals
(
e.
g.,
the
"
family
approach"
of
examining
related
chemicals
such
as
acid/
ester/
salt);
and
c.
an
incremental
and
constant
change
across
the
category
(
e.
g.,
the
dimethylene
group
difference
between
adjacent
members
of
the
alpha­
olefins)

Categories
can
sometimes
apply
to
series
of
chemical
reaction
products
or
chemical
mixtures
that
are,
again,
related
in
some
regular
fashion.
Analogous
to
the
basic
"
discrete
chemical"
category
model,
in
a
mixture
category
some,
but
not
all,
of
the
individual
mixtures
may
undergo
testing.
Categories
accomplish
the
goal
of
the
HPV
Program
to
obtain
screening
level
hazard
information
through
the
strategic
application
of
testing
some,
but
not
all,
members
of
a
category.
If
these
test
results
show
that
the
chemicals
in
the
category
behave
in
a
similar
or
predictable
manner,
then
interpolation
and/
or
extrapolation
can
be
used
to
assess
the
chemicals
in
lieu
of
conducting
additional
screening­
level
testing.

For
example,
under
the
OECD
HPV
SIDS
Program,
some
instances
have
been
identified
where,
using
chemical
category
approaches,
less
than
a
full
set
of
SIDS
data
for
every
chemical
in
the
category
has
been
judged
sufficient
for
screening
purposes.
This
alternative
helps
to
reduce
burden
on
industry,
as
well
as
minimize
animal
testing
concerns.
Guidance
on
the
development
and
implementation
of
categories
in
the
HPV
program
is
provided
on
the
website
at
http://
www.
epa.
gov/
chemrtk/
categuid.
htm.

The
category
approach
has
been
applied
in
the
majority
of
the
HPV
submissions
to
date.
As
of
October
3,
2003,
928
chemicals
were
submitted
as
part
of
the
96
category
submissions.
These
928
chemicals
represent
86%
of
the
total
1,081
chemicals
that
have
been
submitted.
The
number
of
chemicals
in
a
given
category
range
from
2
to
as
many
as
161
HPV
chemicals.
The
different
approaches
used
by
sponsors
have
varied
widely
and
have
shown
a
variety
of
complicating
factors.
For
example,
in
some
cases,
public
comments
on
a
category
have
raised
questions
about
the
technical
soundness
of
a
category
proposal.
Also,
some
category
proposals
 
whether
they
were
questioned
in
terms
of
their
technical
soundness
or
not
 
did
not
propose
any
additional
testing.
In
such
cases,
the
submission
is
simply
a
proposal
that
the
members
of
the
category
belong
together,
without
an
analysis
showing
how
each
category
member
should
be
"
treated"
in
terms
of
a
hazard
analysis.
This
is
important
for
understanding
how
"
untested"
category
members
should
be
characterized
in
a
hazard
screening
exercise.
The
HPV
Program
has
reached
the
point
where
most
of
the
early
category
proposals
have
completed
their
proposed
testing
and
some
of
the
sponsors
are
in
the
process
of
reviewing
the
data
to
determine
whether
their
original
category
hypothesis
holds.
OPPT
has
recently
begun
receiving
these
analyses.

EPA
is
interested
in
the
NPPTAC's
advice
on
use
of
the
category
approach
thus
far
and
potential
approaches
that
could
improve
application
of
categories
in
the
HPV
program.
9
Question
1f:
HPV
Chemicals
Beyond
the
Challenge
Program
Question
1f.
How
should
HPV
chemicals
that
were
not
covered
under
the
HPV
Challenge
(
because
they
were
inorganic
or
were
not
identified
in
the
1990
IUR
reporting)
be
addressed?

The
Program
has
provided
a
jump
start
for
the
collection
of
basic
screening
level
hazard
information
on
hundreds
of
chemicals.
Additionally,
this
information
has
been
made
public
on
the
EPA
HPV
Challenge
Program
website
(
http://
www.
epa.
gov/
chemrtk/
volchall.
htm).

This
Program
was
established
to
include
a
finite
group
of
HPV
(
primarily
organic)
chemicals
identified
in
the
1990
IUR
reporting
cycle.
EPA
is
interested
in
recommendations
from
the
NPPTAC
on
how
EPA
and
its
partners
should
deal
with:

a.
orphan
chemicals
under
the
current
HPV
Challenge
Program
that
are
not
sponsored;
and
b.
HPV
chemicals
that
are
reported
in
the
1994,
1998
or
2002
IUR
reporting
cycles,
but
that
were
not
identified
in
the
1990
reporting
cycle;

EPA
is
also
interested
in
the
NPPTAC's
advice
on
if
and
when
HPV
inorganic
chemicals
should
be
addressed.
In
this
regard,
note
that
reporting
on
production
for
inorganic
chemicals
will
commence
in
2006
under
the
IURA.
10
Question
2:
Background
Information
and
Issues
Relating
to
Enhancing
Chemical
Risk
Assessment
and
Risk
Management
in
OPPT's
Programs
Question
2
OPPT
believes
it
is
important
to
assess
existing
chemicals
and
effectively
identify
and
reduce
risks
for
many
more
chemicals
at
a
much
faster
pace
than
ever
before.
Given
this
objective,
and
the
opportunities
to
evaluate
existing
chemicals
which
are
presented
by
data
and
information
that
are
being
made
available
(
examples
include
the
HPV
Challenge
Program,
TSCA
§
8(
e),
PFOS/
PFOA,
and
VCCEP)
:
°
How
much
emphasis
should
be
placed
on
regulatory
action
and
how
much
on
voluntary
alternatives
when
collecting
information,
and
assessing
and
managing
risks
of
chemicals?
°
What
approaches
(
regulatory
or
voluntary)
could
OPPT
take
to
ensure
that
risk
assessments
are
transparent,
clear,
consistent
and
reasonable
yet
are
completed
on
a
timely
basis?
°
What
approaches
could
OPPT
undertake
to
ensure
sufficient
and
timely
risk
management
action?
°
Are
there
ways
in
which
EPA
can
more
effectively
use
TSCA
Section
6
to
mitigate
risk?
°
What
factors/
criteria
should
OPPT
use
to
determine
which
chemicals
should
be
addressed
and
managed
as
chemicals
of
national
concern
requiring
a
high
level
of
attention
by
OPPT?
°
How
should
OPPT
approach
the
risk
assessment/
management
of
newly
identified
chemicals
of
national
concern?
What
directions
could
be
pursued
to
further
address
the
current
chemicals
of
national
concern
(
e.
g.
lead,
mercury)?
°
Under
what
circumstances
could
parties
other
than
EPA
(
e.
g.,
industry,
non­
governmental
organizations,
state
agencies,
Tribes,
or
others)
play
a
role
in
developing
and
making
publicly
available
risk
assessments,
and
in
participating
in
risk
management
actions?
Under
what
circumstances
could
these
parties
provide
assessment
tools
and
models.
What
role
should
EPA
play
in
such
a
context
of
shared
stewardship
(
provide
guidance,
comments,
data/
information,
tools
and
models,
a
common
forum,
etc.)?

OPPT
currently
applies
a
mix
of
regulatory
and
non­
regulatory
approaches
to
assess
and
manage
toxic
chemicals.
In
some
cases
Congress
has
legislated
specific
actions
to
manage
risk
of
particular
chemicals
that
have
posed
a
significant
risk
to
public
health
and
the
environment
(
e.
g.,
polychlorinated
biphenyls
(
PCBs),
asbestos,
and
lead).
In
other
cases,
OPPT
relied
upon
implementing
the
regulatory
framework
under
the
Toxic
Substances
Control
Act
(
TSCA)
of
10
The
statutory
findings
include
that
there
are
insufficient
data
available
to
determine
the
effects
of
the
substance
on
health
and/
or
the
environment;
and
testing
is
necessary
to
provide
such
data;
and
the
substance
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,"
(
known
as
the
"
risk­
based
finding");
and/
or
may
be
produced
at
substantial
quantities
and
is
reasonably
expected
to
enter
the
environment
in
substantial
quantities;
or
may
result
in
significant
or
substantial
human
exposure
(
known
as
the
"
exposure­
based
finding").

11
1976
for
assessing
and
managing
chemical
risk.
OPPT
has
done
this
by
using
its
authority
under
TSCA
§
§
4
and
8
to
require
the
hazard
and
exposure
information
necessary
to
assess
and
potentially
manage
risk.
More
recently,
OPPT
has
increasingly
relied
upon
voluntary
action
by
the
regulated
community
as
a
complementary
approach
to
the
regulatory
scheme.

Obtaining
Relevant
Information
for
Risk
Assessment
Purposes
EPA
defines
risk
assessment
as
the
process
used
to
evaluate
the
degree
and
probability
of
harm
to
human
health
and
the
environment
from
such
stressors
as
pollution
or
habitat
loss.
The
risk
assessment
process
the
Agency
follows
is
based
on
a
proposal
by
the
National
Academy
of
Sciences
and
consists
of:

°
Exposure
Assessment
­
describing
the
populations
or
ecosystems
exposed
to
stressors
and
the
magnitude,
duration,
and
spatial
extent
of
exposure
°
Hazard
Identification
­
identifying
adverse
effects
(
e.
g.
short­
term
illness,
cancer)
that
may
occur
from
exposure
to
environmental
stressors.
°
Dose­
Response
Assessment
­
determining
the
toxicity
or
potency
of
stressors
°
Risk
Characterization
­
using
the
data
collected
in
the
first
three
steps
to
estimate
and
describe
the
effects
of
human
or
ecological
exposure
to
stressors.

There
are
relatively
few
chemicals
in
commerce
for
which
extensive
and
sufficient
data
exist
for
evaluating
potential
health
or
environmental
hazards,
or
exposures
for
risk
assessment
purposes.
TSCA
provides
several
regulatory
tools
for
EPA
to
obtain
needed
data.
Under
TSCA
§
4,
EPA
can
require
the
development
of
data
via
rulemaking
or
through
an
Enforceable
Consent
Agreement
(
ECA),
or
receive
reporting
by
industry
via
TSCA
§
8
(
i.
e.,
inventory
information
through
§
8(
a)
and
substantial
risk
information
through
§
8(
e)).

In
order
to
issue
a
test
rule
under
TSCA
§
4,
EPA
must
make
certain
statutory
findings
about
the
substance
involved.
10
Rulemaking
under
TSCA
§
4
has
generally
been
both
lengthy
and
resource­
intensive.
As
a
result,
data
have
been
generated
under
TSCA
§
4
test
rules
on
only
approximately
140
chemicals
since
the
1970s.
An
ECA
is
a
publicly
negotiated
agreement
between
EPA
and
interested
parties
that
requires
the
generation
and
submission
of
data
to
EPA.
ECAs
are
usually
less
resource­
intensive
than
test
rules
and
can
be
a
much
quicker
way
to
obtain
data.
Since
October
1984,
EPA
has
issued
a
number
of
ECAs
covering
approximately
60
chemicals.

An
example
of
a
current
ECA
under
development
is
the
effort
to
obtain
additional
information
for
PFOA
(
perfluorooctanoic
acid
and
its
salts),
a
synthetic
chemical
used
as
an
essential
processing
aid
in
the
manufacture
of
fluoropolymers
in
many
industry
segments.
In
response
to
emerging
concerns,
industry
has
voluntarily
helped
assemble
and
submit
initial
data
on
exposure,
facilitating
the
preparation
of
EPA's
preliminary
risk
assessment,
which
was
12
released
in
April
2003.
EPA
has
also
identified
areas
where
additional
information
could
be
helpful
in
allowing
the
Agency
to
develop
a
more
accurate
assessment
of
the
potential
risks
posed
by
PFOA,
and
is
currently
requesting
additional
data
and
public
comment
on
its
preliminary
scientific
findings.

The
rulemaking
authority
under
TSCA
§
8
provides
EPA
with
a
mechanism
to
obtain
certain
exposure
data
from
manufacturers
and
processors
of
HPV
chemicals.
As
a
result
of
a
recent
Inventory
Update
Rule
Amendments
(
IURA)
(
68
FR
Number
4,
January
7,
2003,
pp.
848­
906),
beginning
with
the
2006
reporting
year,
initial
screening
level
exposure­
related
data
about
uses,
number
of
processing
and
use
sites,
and
workers
exposed
to
HPV
chemicals
will
be
reported
to
EPA/
OPPT.
A
previous
voluntary
effort
called
the
Use
and
Exposure
Information
Project
(
UEIP)
demonstrated
that
useful
screening
level
exposure
information
is
available
from
industry
and
can
be
used
to
prepare
screening
level
exposure
assessments.
The
UEIP
was
a
cooperative
effort
begun
in
the
fall
of
1992
between
government
and
industry
in
recognition
of
the
difficulties
encountered
in
obtaining
accurate
and
up­
to­
date
exposure
information
on
HPV
chemicals.
Data
collected
by
EPA
under
the
UEIP
were
similar
to
those
now
being
required
under
IURA.
In
contrast
to
the
IURA,
however,
the
UEIP
only
provided
onetime
reporting
of
information
by
a
subset
of
the
manufacturers
of
a
small
number
of
selected
HPV
chemicals
(
68
FR
Number
4,
January
7,
2003,
p.
853).

As
a
complement
to
the
regulatory
actions
used
to
obtain
data
and
assess
risk,
OPPT
has
increasingly
relied
upon
voluntary
action
by
the
regulated
community
as
an
alternative
way
of
obtaining
information.
OPPT's
most
extensive
efforts
to
obtain
screening
data
are
being
conducted
under
several
voluntary
programs
that
will
provide
an
abundance
of
hazard
data
on
a
relatively
large
number
of
chemicals.
The
High
Production
Volume
(
HPV)
Challenge
Program
and
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
have
enabled
EPA
to
obtain
needed
data
on
existing
chemicals
on
a
scale
not
previously
seen.
Through
the
HPV
Challenge
Program,
industry
has
volunteered
to
publicly
provide
screening­
level
hazard
data
on
over
2,100
high
production
volume
chemicals
(
i.
e.,
those
chemicals
produced
in
quantities
of
one
million
pounds
or
more
per
year)
through
2005,
and
in
VCCEP,
to
provide
data
on
20
chemicals
thought
to
be
of
particular
concern
to
children.

Risk
Management
Activities
at
OPPT
EPA's
most
extensive
chemical
risk
management
actions
under
TSCA
have
been
taken
in
cases
where
Congress
specified
in
the
legislation
comprehensive
risk
assessments
and/
or
mitigation
for
chemicals
that
have
presented
serious
concerns
of
a
national
scope
(
e.
g.
PCBs,
lead,
asbestos).
These
legislated
chemicals
are
part
of
a
small
set
of
chemicals
of
national
concern
(
national
program
chemicals)
where
OPPT
has
undertaken
longer­
term
comprehensive
efforts
to
manage
risk.
These
national
program
chemicals
are
ubiquitous,
environmentally
persistent,
and
toxic.
Other
chemicals
of
national
concern
(
but
without
the
clear
legislative
drivers
associated
with
PCBs,
lead,
and
asbestos)
include
mercury
and
dioxin.
In
most
cases,
risk
assessments
have
been
completed
or
are
in
their
final
stages
for
these
chemicals.
The
national
program
chemicals
provide
examples
of
where
OPPT's
efforts
are
extensively
focused
on
risk
management
activities,
ranging
from
efforts
that
have
nearly
completed
their
legislated
11
TSCA
§
9
addresses
EPA's
authority
to
regulate
chemical
substances
and
associated
activities
that
fall
under
both
TSCA
and
other
federal
laws.
It
includes
procedures
under
which
EPA
can
refer
the
regulation
of
chemicals
to
other
agencies
and
requirements
to
coordinate
actions
taken
under
activities
with
other
federal
agencies
"
for
the
purpose
of
achieving
maximum
enforcement
of
this
act
[
TSCA]
while
imposing
the
least
burdens
of
duplicative
requirements
on
those
subject
to
the
Act
and
for
other
purposes".

12
TSCA
§
6(
a)
gives
EPA
the
authority
to
regulate
the
manufacture
(
including
import),
processing,
use,
distribution
in
commerce,
and
disposal
of
chemical
substances
and
mixtures
that
present
or
will
present
an
unreasonable
risk
to
human
health
and
the
environment.

13
mandates
(
e.
g.,
lead),
to
ones
that
are
the
subject
of
legislative
proposals
and
other
emerging
mandates
(
e.
g.,
mercury).

TSCA
§
6
provides
EPA
with
authority
to
regulate
the
manufacture
(
including
import),
processing,
distribution
in
commerce,
use,
and
disposal
of
chemical
substances
and
mixtures
that
"
present
or
will
present
an
unreasonable
risk
of
injury
to
health
or
the
environment."
EPA
and
the
courts
have
interpreted
the
"
unreasonable
risk"
standard
to
involve
a
consideration
of
the
risks
posed
to
health
or
the
environment
by
a
particular
activity
involving
a
chemical
or
mixture
as
compared
to
the
benefits
associated
with
such
activity,
along
with
a
consideration
of
the
availability
of
substitutes.
Under
TSCA
§
6
authority,
EPA
may
ban
the
manufacture
or
distribution
in
commerce,
limit
use,
require
labeling,
or
place
other
restrictions
on
chemicals
that
pose
unreasonable
risks
 
after
making
the
necessary
statutory
findings.
TSCA
§
6
directs
EPA
to
select
requirements
necessary
to
protect
adequately
against
the
identified
risk
using
the
least
burdensome
requirements.
Therefore,
in
promulgating
regulations
under
TSCA
§
6,
EPA
must
consider:

°
The
effects
of
the
chemical
substance
on
health
and
the
magnitude
of
human
exposure.
°
The
effects
of
the
chemical
substance
on
the
environment
and
the
magnitude
of
environmental
exposure.
°
The
benefits
of
the
chemical
substance
and
the
availability
of
substitutes.
°
The
economic
consequences
of
the
rule.

TSCA
§
6
©
)
and
§
911
also
require
EPA
to
consider
whether
other
Federal
statutes
and
regulations
are
available
to
address
a
risk
that
would
otherwise
merit
regulatory
action
under
TSCA
Section
§
6(
a)
12.

EPA
has
regulated
a
number
of
substances
under
TSCA
§
6
via
proposed
and
final
rulemaking
procedures:
metalworking
fluids
(
40
CFR
part
747)
and
hexavalent
chromium
chemicals
(
40
CFR
part
749).
In
addition,
polychlorinated
biphenyls
(
PCBs)
(
40
CFR
part
761),
and
asbestos
(
40
CFR
part
763)
risk
management
actions
have
also
been
promulgated
under
TSCA
§
6;
however,
in
both
cases
statutory
requirements
were
followed
(
TSCA
§
6(
e)
and
TSCA
§
203
[
part
of
Title
II
of
TSCA],
respectively).
Table
1
provides
a
summary
of
the
actions
proposed
and/
or
finalized
pursuant
to
TSCA
§
6
authority
Some
EPA
TSCA
§
6
proposals
have
either
been
remanded
(
asbestos)
or
withdrawn
(
acrylamide).
In
1989,
the
Asbestos
Ban
and
Phase­
Out
Rule
(
ABPO)
under
TSCA
§
6
banned
asbestos
and
asbestos­
containing
products,
such
as
pipeline
wraps,
vinyl
tiles,
and
disc
break
14
Table
1.
Proposed
or
Final
Control
Actions
Using
TSCA
Section
6
Authority
Action
Proposal
Date
Final
Date
Prompting
Action
Present
Status
Ban
on
manufacture,
processing,
distribution
in
commerce
of
fully
halogenated
chlorofluoralkanes
for
aerosol
propellents
5/
13/
77
3/
17/
78
Component
of
federal
actions
regarding
ozone­
depleting
CFCs
Superceded
by
later
air
regulations
Ban
on
manufacturing,
processing,
distribution
in
commerce
and
use
of
PCBs
6/
7/
78
5/
31/
79
Implemented
statutory
ban
on
PCBs
Ban
in
place
­­
numerous
other
actions
taken
to
regulate
certain
PCBs
uses
Ban
on
storage
and
disposal
of
dioxin­
contaminated
waste
at
one
facility
in
Arkansas
3/
11/
80
5/
19/
80
Imminent
Hazard
(
withdrawn
in
light
of
RCRA
authority)
Superceded
by
1984
RCRA
rule.

Limited
certain
uses
of
metalworking
fluids
(
3
separate
actions)
½
3/
84
6/
14/
84
9/
20/
84
Unreasonable
risk
of
injury
to
human
health
Bans
presently
in
place
Ban
on
manufacture,
importation,
processing,
and
distribution
of
asbestos
½
9/
861
7/
12/
89
Unreasonable
risk
of
injury
to
human
health
Ban
on
existing
uses
overturned
("
Corrosion
Proof
Fittings"
case)
in
court
in
1991;
Ban
on
new
uses
remains
in
effect
Ban
on
hexavalent
chromium
chemicals
in
comfort
cooling
towers
3/
29/
88
1/
30/
90
Final
EPA
health
assessment
for
chromium
and
subsequent
listing
as
a
hazardous
air
pollutant
Ban
presently
in
place
Regulation
of
"
Land
Application
of
Sludge
from
Pulp
and
Paper
Mills
Using
Chlorine
and
Chlorine
Derivative
Bleaching
Processes"
5/
10/
91
Unreasonable
risks
to
wildlife
and
humans
presented
by
dioxins
and
furans
in
certain
paper
mill
sludges
MOAs2
entered
into
with
pulp
and
paper
industry;
Water
rule
promulgated
Ban
on
acrylamide/
 
methylacrylamide
grouts
10/
2/
91
Worker
exposure
issue
 
known
human
neurotoxicant,
probable
human
carcinogen
Proposal
withdrawn
(
12/
2/
2002)
based
on
development
of
PPE3
Ban
on
lead
fishing
sinkers
3/
9/
94
Response
to
Citizen's
Petition
Final
action
under
development
1
Advanced
notice
of
proposed
rulemaking
(
ANPR)
issued
on
10/
17/
79.
2
MOAs
=
Memoranda
of
Understanding.
3
PPE
=
personal
protective
equipment.
It
was
determined
that
the
newly
developed
PPE
provided
adequate
protection
from
exposure
to
acrylamide.
15
pads
(
54
FR
29460,
July
12,
1989).
In
1991,
the
United
States
Court
of
Appeals
for
the
Fifth
Circuit
Court
overturned
much
of
the
ABPO.
Today,
only
a
few
items
remain
on
the
list
as
banned
products,
including
roofing
felt,
millboard,
rollboard;
commercial,
corrugated,
specialty
paper,
and
any
new
uses
for
asbestos
(
regulated
under
TSCA);
spray­
applied
asbestos­
containing
materials
and
wet­
applied
or
pre­
applied
asbestos
pipe
insulation
(
regulated
under
CAA)
(
58
FR
58964,
November
5,
1993
and
59
FR
33208,
June
28,
1994).

In
the
acrylamide
case,
EPA
proposed
a
rule
to
prohibit
the
manufacture,
distribution
in
commerce,
and
use
of
acrylamide
grout
(
56
FR
49863,
October
2,
1991)
in
order
to
protect
grouters
from
alleged
neurotoxic
and
carcinogenic
risks
arising
from
significant
dermal
and
inhalation
exposure
to
the
acrylamide
and
N­
methylolacrylamide
(
NMA)
in
these
grouts.
The
proposal
was
withdrawn
11
years
later
based
on
the
development
of
affordable
personal
protective
equipment
that
could
provide
adequate
protection
from
exposure
to
the
acrylamide
and
NMA
in
these
grouts
(
67
FR
71524,
December
2,
2002).

Another
regulatory
risk
management
tool
used
for
chemicals
is
TSCA
§
5(
a)(
2)
­
Significant
New
Use
Rules
(
SNURs).
Under
TSCA
§
5(
a)(
2),
EPA
is
authorized
to
designate
a
use
of
a
chemical
as
a
significant
new
use,
based
on
consideration
of
several
factors,
including
the
anticipated
extent
and
type
of
exposure
to
humans
and
the
environment.
A
SNUR
requires
that
manufacturers,
importers,
and
processors
of
such
substances
notify
EPA
at
least
90
days
before
beginning
any
activity
(
via
a
Significant
New
Use
Notification,
or
SNUN)
that
EPA
has
designated
as
a
"
significant
new
use"
(
40
CFR
721).
OPPT
reviews
the
SNUN
to
determine
whether
it
is
necessary
or
appropriate
to
further
regulate
the
substance
under
TSCA
§
§
5(
e)
or
6,
for
example,
before
the
new
use
begins.

The
perfluoralkyl
sulfonates
(
PFAS)
SNUR
is
a
recent
example
of
an
existing
chemical
SNUR
(
proposed
FR
65
62319,
October
18,
2000;
supplemented
67
FR
11014,
March
11,
2002;
and
finalized
67
FR
72854,
December
9,
2002).
Seventy­
five
substances
are
identified
in
the
rule,
and
the
intended
manufacture
or
import
of
any
of
them
for
any
use
not
identified
in
the
rule
would
trigger
the
SNUR
reporting
requirements.

EPA
is
requesting
advice
from
the
NPPTAC
on
how
to
identify
and
implement
the
best
"
mix"
of
regulatory
and
voluntary
options
to
achieve
sufficient
and
timely
risk
assessments
and
risk
management
actions
for
existing
chemicals
in
U.
S.
commerce,
and
what
opportunities
exists
for
partnership
with
industry,
non­
governmental
organizations,
States,
Tribes,
and
others.
13
There
are
exemptions
to
the
90­
day
review
period
including
the
low
volume
exemption
(
LVE),
the
polymer
exemption,
the
test
marketing
exemption
(
TME),
and
the
low
releases/
low
exposures
(
LoRex)
exemption.

16
Question
3:
Background
Information
and
Issues
Relating
to
Enhancing
OPPT's
New
Chemicals
Program
Question
3
.
Based
on
domestic
and
international
experience
and
approaches,
how
can
the
U.
S.
enhance
its
new
chemicals
assessment
scheme?
°
Do
the
current
PMN
reporting
requirements,
in
conjunction
with
EPA's
assessment
(
hazard,
exposure,
risk),
risk
management,
and
pollution
prevention
approaches
to
new
chemicals,
provide
an
adequate
and
informed
basis
for
preventing
chemicals
of
significant
risk
to
human
health
and
the
environment
from
entering
commerce?
°
Are
there
other
approaches
that
can
be
taken
in
the
New
Chemicals
Program
to
further
enhance
efficiency
and
effectiveness
of
the
program,
and
improve
awareness
of
potential
impacts
of
chemicals
early
on?
°
Given
the
globalization
of
the
chemical
industry,
are
there
approaches
being
used
in
other
countries
that
may
have
value
in
the
US
scheme?

EPA's
New
Chemicals
Program
Under
the
Toxic
Substances
Control
Act
(
TSCA),
all
chemicals
in
U.
S.
commerce
are
required
to
be
listed
on
the
TSCA
Chemical
Substances
Inventory
("
Inventory").
Chemicals
not
listed
on
the
TSCA
Inventory
are
considered
new
chemicals,
and
notification
must
be
provided
to
EPA
before
they
are
manufactured
or
imported
for
commercial
purposes.
Certain
genetically
modified
microorganisms
are
also
considered
new
chemicals.
EPA's
New
Chemicals
Program
was
established
to
help
manage
the
potential
risk
from
chemicals
new
to
the
marketplace.
The
New
Chemicals
Program
reviews
new
chemicals
notification
and
assesses
the
need
for
and,
if
necessary,
sets
restrictions
on
the
manufacture
or
use
of
new
chemicals
before
they
enter
commerce.

To
review
the
new
chemical
notifications
OPPT
has
developed
the
TSCA
§
5
Premanufacture
Notification
(
PMN)
Review
Process.
Manufacturers
(
which
includes
importers)
of
new
chemicals
must
give
EPA
a
90­
day
advance
notification
of
their
intent
to
manufacture
a
new
chemical
by
filing
a
PMN
application.
13
The
PMN
review
process
consists
of
four
successive
technical
phases,
structured
to
quickly
assess
and
"
drop"
substances
of
low­
risk
from
review
and
to
assess
in
more
detail
those
substances
of
potential
greater
risk.
These
phases
include
the:
chemistry
review,
hazard
17
(
toxicity)
review,
exposure
evaluation,
and
risk
assessment/
risk
management
review.
If
within
the
90­
day
review
period
the
Agency
does
not
take
regulatory
action
on
the
new
chemical,
then
the
company
may
begin
manufacture
and
must
file
a
Notice
of
Commencement
(
NOC)
form
within
30­
days
of
initial
manufacture.
Following
receipt
of
the
NOC,
the
chemical
substance
is
added
to
the
Inventory.
Almost
90
percent
of
PMNs
submitted
to
EPA
complete
the
review
process
without
being
restricted
or
regulated.
However,
if
it
is
determined
that
the
substance
or
its
use
may
or
will
pose
an
unreasonable
risk,
EPA
has
authority
to
limit
or
ban
the
substance
through
regulation
and/
or
to
require
the
development
of
information
needed
to
adequately
assess
the
risk.

The
PMN
Review
Process
is
designed
to
accommodate
the
large
number
of
PMNs
received
(
over
1,500
annually),
to
assess
the
risks
posed
by
each
substance
adequately
within
the
strict
timeframe
prescribed
by
TSCA,
and
to
maximize
the
efficiency
of
staff
resources.
The
information
required
on
the
PMN
application
is:
company
name;
chemical
identity;
production
volume;
intended
use;
manufacture,
process
and
use
information;
and
worker
exposure
and
environmental
release
information.
Although
TSCA
does
not
require
that
the
submitter
conduct
laboratory
tests
to
evaluate
potential
hazards
of
the
chemicals,
PMN
submissions
must
include
any
existing
human
health/
environmental
effects
data
in
the
possession
of
the
submitter,
parent
company,
or
affiliates.

EPA
has
developed
and
relies
on
Structure
Activity
Relationship
(
SAR)
analysis
to
assess
physical/
chemical
properties,
environmental
fate,
and
human
and
environmental
effects
of
new
chemicals,
based
on
their
structural
similarity
to
chemicals
for
which
data
are
available.
A
SAR
is
the
relationship
between
the
chemical
structure
of
a
molecule
and
its
properties,
including
any
possible
interaction
with
the
environment
or
organisms.
The
PMN
process
is
largely
reliant
on
SAR
analysis
since
67%
of
PMNs
include
no
test
data,
and
85%
include
no
health
data
(
EPA,
2003.
Presentation
on
the
PMN
Structure
Activity
Team
http://
www.
epa.
gov/
oppt/
newchems/
denver/).
EPA's
New
Chemicals
Program
has
established
55
chemical
categories
to
facilitate
the
PMN
review/
regulatory
process
(
http://
www.
epa.
gov/
oppt/
newchems/
chemcat.
htm).
EPA
is
continuing
to
refine
the
boundaries
and
definitions
of
such
categories.

If
it
is
determined
during
the
PMN
review
that
a
new
substance
presents
or
will
present
an
unreasonable
risk,
EPA
has
authority
to
limit
or
ban
it
through
regulation
under
TSCA
§
6.
EPA
may
also
limit
or
ban
a
new
chemical
substance
under
a
TSCA
§
5(
e)
(
Consent)
Order
pending
development
of
information
needed
to
adequately
assess
the
risks
if
EPA
determines
that
(
1)
insufficient
information
exists
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
a
chemical
substance,
and
(
2)
the
chemical
substance
may
present
an
unreasonable
risk
to
health
or
the
environment,
or
it
will
be
produced
in
substantial
quantities
and
may
either
enter
the
environment
in
substantial
quantities
or
lead
to
significant
or
substantial
14
OPPT's
new
chemicals
program
criteria
for
exposure­
based
policy
testing
were
announced
to
the
chemical
industry
in
1988
(
see
www.
epa.
gov/
opptintr/
newchems/
expbased.
htm
).
The
policy
defines
produced
in
substantial
quantities
as
substantial
production
(
100,000
kg/
yr)
AND
substantial
or
significant
human
exposure
(
various
combinations
of
numbers
of
workers
and
levels
of
exposure
in
mg/
day
by
exposure
route;
or
presence
in
consumer
product
where
exposures
are
likely;
or
exposure
to
the
ambient
general
population
at
levels
greater
than
or
equal
to
0.003
mg/
kg/
day
via
drinking
water,
air,
or
groundwater;
or
greater
than
or
equal
to
10,000
kg/
year
release
to
environmental
media)
OR
substantial
release
to
the
environment
(
greater
than
or
equal
to
1,000
kg/
year
total
release
to
surface
water
calculated
after
wastewater
treatment).

15
The
P2
Framework
is
an
approach
to
using
screening­
level
models
to
screen
new
chemicals
for
development.
One
of
those
tools
is
the
PBT
Profiler,
which
is
a
screening
tool
to
estimate
persistence,
bioaccumulation
potential,
and
toxicity.

18
human
exposure.
14
Thus,
TSCA
§
5(
e)
offers
effective
and
flexible
regulatory
tools
to
obtain
needed
information,
manage
risk,
and
accomplish
P2
objectives
relative
to
new
chemicals.

Another
regulatory
risk
management
tool
applicable
to
new
chemicals
is
TSCA
§
5(
a)(
2)
­
Significant
New
Use
Rules
(
SNURs).
Under
TSCA
§
5(
a)(
2),
EPA
is
authorized
to
designate
a
use
of
a
new
chemical
as
significant
new
use,
based
on
consideration
of
several
factors,
including
the
anticipated
extent
and
type
of
exposure
to
humans
and
the
environment.
EPA
generally
promulgates
a
"
new
chemical
SNUR"
under
TSCA
§
5(
a)(
2)
on
a
given
chemical
to
mimic
any
§
5(
e)
Consent
Order
applicable
to
the
PMN
submitter
of
the
chemical
to
bind
all
other
manufacturers
and
processors
of
the
former
new
chemical
to
the
terms
and
conditions
contained
in
the
Consent
Order.
The
SNUR
requires
that
manufacturers,
importers,
and
processors
of
such
substances
notify
EPA
at
least
90
days
before
beginning
any
activity
that
EPA
has
designated
as
a
"
significant
new
use"
(
40
CFR
721).
Such
a
SNUR
would
require
the
submission
of
a
Significant
New
Use
Notification
(
SNUN)
90
days
prior
to
commercial
manufacture
not
conforming
to
the
conditions
of
the
SNUR.

OPPT
has
taken
regulatory
actions
(
or
obtained
voluntary
testing
commitments)
on
approximately
3,536
(~
10%
of
the
total
PMNs
submitted)
PMNs
from
1979
­
September
30,
2002.
Included
in
this
number
were
PMNs
withdrawn
voluntarily
by
the
submitter
(
almost
half
­
1,552),
often
in
the
face
of
potential
action
by
EPA.

The
success
of
OPPT's
New
Chemicals
Program
was
recently
recognized
by
the
U.
S.
Office
of
Management
and
Budget
(
OMB)
which
rated
the
program
the
highest
of
eleven
EPA
programs
evaluated
(
http://
www.
whitehouse.
gov/
omb/
budget/
fy2004/
pma.
html
).

Although
the
New
Chemicals
program
does
not
require
the
submission
of
hazard
data
up
front,
companies
are
encouraged
to
assess
the
potential
hazard/
risk
associated
with
new
chemicals
voluntarily.
For
example,
through
the
Sustainable
Futures
Initiative
(
67
FR
76282­
76292,
December
11,
2002)
voluntary
pilot
project,
companies
are
encouraged
to
voluntarily
use
tools
such
as
the
Pollution
Prevention
(
P2)
Framework15
to
assess
potential
hazard/
risk
of
new
chemicals
prior
to
submitting
a
PMN.
The
goal
of
this
pilot
project
is
to
encourage
the
application
of
P2
principles
during
the
development
of
new
chemicals
submitted
as
PMNs
and
the
development
of
inherently
low
hazard
chemicals.
Furthermore,
OPPT
seeks
to
gain
16
McBain,
D.
and
J.
A.
Hewitt.
"
Mutual
Acceptance
of
Notifications
 
Recent
Developments
and
Outlook."
Presentation
at
the
ChemCon
2002
International
Conference
on
Chemical
Control
Regulations,
June
3rd
to
7th,
2002,
Basel,
Switzerland.

19
additional
data
and
experience
regarding
the
P2
and
risk
reduction
benefits
of
the
use
of
hazard,
exposure,
and
risk
screening
methodologies
in
new
product
development
efforts.

Approaches
to
New
Chemicals
in
Other
Countries
There
are
various
approaches
to
addressing
new
chemicals
across
the
globe.
Because
chemicals
in
commerce
are
an
international
business,
knowledge
of
other
non­
U.
S.
regulatory
approaches
may
be
informative
regarding
the
U.
S.
New
Chemicals
Program.
New
chemicals
programs
may
differ
in
the
point
at
which
a
notification
is
required
(
premanufacture
or
premarketing),
in
terms
of
data
required
to
be
submitted
with
the
new
chemical
application,
and
approaches
to
hazard
and
risk
assessment
during
the
new
chemical
review
process.
For
instance,
in
contrast
to
the
U.
S.
(
which
requires
manufacturers
to
submit
chemical
test
data
only
if
it
is
already
available),
countries
such
as
Australia,
Canada,
Switzerland,
the
European
Union,
and
Japan
all
have
requirements
for
submission
of
certain
types
of
data
at
the
time
of
notification.
The
type
of
data
required
in
these
countries
often
depends
on
factors
such
as
the
quantity
of
the
substance
produced
and
the
projected
risk/
exposure.
For
example,
in
addition
to
basic
toxicity/
ecotoxicity
and
human
health
data,
Australia
requires
test
data
on
biodegradability
and
bioaccumulation
for
a
standard
notification.
However,
biodegradability/
bioaccumulation
data
is
not
required
in
Australia
for
notifications
on
chemicals
of
lesser
concern,
such
as
low
volume
chemicals.
Japan
requires
a
biodegradability
test,
and
in
the
case
of
low
biodegradability,
subsequent
testing
for
bioaccumulation,
and
mutagenicity.
New
Zealand
requires
information
on
disposal,
uses
through
the
substance's
life
cycle,
and
inclusion
of
any
evaluations
from
other
countries.
Canada
allows
data
to
be
supplied
as
test
data
or
surrogate
data
(
i.
e.,
non­
test,
calculated
data).
Another
example
of
differences
in
handling
new
chemicals
across
the
globe
is
regarding
the
hazard/
risk
assessment
process.
For
example,
in
Japan,
all
chemicals
are
classified
by
a
government
hazard
and
risk
assessment
committee
as
to
whether
they
are
mutagens
(
strong,
weak,
or
negative).
In
Switzerland,
a
new
chemical
manufacturer
is
required
to
conduct
an
environmental
hazard
and
risk
assessment
and
submit
an
environmental
impact
report
to
the
government
for
hazard
and
risk
review.
The
European
Union
(
EU)
currently
requires
a
"
base
set"
test
package
that
is
considered
a
minimum
premarketing
data
set
(
MPD).
The
MPD
includes
physicochemical
properties,
environmental
fate
(
biodegradation)
information,
ecotoxicity
(
acute
aquatic
toxicity
in
fish
and
invertebrates),
and
health
effects
data
(
acute,
repeated
dose
and
genotoxicity
studies)
(
Directive
79/
831/
EEC).

As
a
result
of
the
globalization
of
the
chemical
industry,
many
companies
are
faced
with
the
increasing
challenges
and
costs
of
compliance
with
many
different
laws
and
regulations
for
new
chemicals
that
vary
among
countries.
16
At
the
same
time,
resources
available
to
authorities
have,
in
many
cases,
remained
static
or
been
diverted
to
other
areas
relating
to
chemicals.
Thus,
organizations
such
as
the
Organization
for
Economic
Co­
operation
and
Development
(
OECD)
have
recognized
a
need
for
 
and
value
in
 
better
aligning
new
chemicals
systems
in
the
global
market
(
e.
g.,
to
reduce
economic
burdens
for
industry,
facilitate
exchange
of
information
and
assessments
among
governments,
and
reconcile
inconsistencies).
The
OECD
recently
20
established
a
New
Chemicals
Task
Force
with
the
objective
of
working
towards
increased
cooperation
and
efficiency
of
new
chemical
notification
and
assessment
systems
in
the
global
market.
The
Task
Force
is
engaging
in
activities
such
as
the
development
of
a
standard
notification
form
to
simplify
reporting
and
facilitate
data
sharing,
a
standard
format
for
assessment
of
new
chemicals,
and
harmonized
exclusions
and
standard
exemptions.
Although
the
various
country
requirements
for
protecting
Confidential
Business
Information
(
CBI)
is
a
significant
challenge
to
overcome,
the
Task
Force
has
made
some
progress.
Another
important
goal
of
the
Task
Force
is
to
develop
a
system
for
using
notification
and
assessment
information
on
a
new
industrial
chemical
in
one
OECD
country
to
facilitate
the
process
in
other
countries
(
e.
g.,
notified
once,
accepted
everywhere)
through
a
Mutual
Acceptance
of
Notifications
(
MAN)
process.
Although
consensus
on
the
concept
of
MAN
has
not
yet
been
reached
internationally,
the
OECD
continues
to
work
on
advancing
understanding
and
implementing
terms
of
the
MAN
concept.

EPA
is
interested
in
advice
from
the
NPPTAC
on
how
the
U.
S.
can
enhance
its
new
chemicals
assessment
scheme.
21
Question
4:
Background
Information
and
Issues
Relating
to
Pollution
Prevention
in
Chemicals
Management
Question
4.
What
are
the
avenues
for
increasing
the
use
of
pollution
prevention
(
P2)
solutions
in
managing
risks
of
chemicals?
For
example:
°
What
practical
steps
and
implementation
strategies
could
be
pursued
in
the
TSCA
program
that
would
contribute
to
preventing
pollution
and/
or
potential
risk
from
chemicals?
°
How
could
OPPT's
existing
tools
and
approaches
(
e.
g.,
P2
Framework,
TSCA
§
§
5(
a)(
2)
and
5(
e))
be
further
integrated
to
prevent
pollution
and
manage
the
risk
of
chemicals
more
broadly?
°
What
are
opportunities
to
broaden
pollution
prevention
solutions
in
the
realm
of
existing
chemicals?
Do
barriers
exist
to
broadening
pollution
prevention
in
OPPT's
new
and
existing
chemicals
programs,
and,
if
so,
how
could
they
be
broken
down?
°
What
incentives
(
economic
or
others)
can
be
created
to
encourage
prevention
as
a
key
mechanism
for
managing
risks
of
chemicals?
°
What
should
be
the
pollution
prevention
components
in
a
successful
product
stewardship
program?

In
the
mid
to
late
1970s,
EPA
focused
on
the
control
of
current
sources
of
pollution
using
"
end­
of­
pipe
command
and
control"
approaches.
Over
the
next
two
decades,
the
approach
to
environmental
protection
evolved
to
include
a
stronger
emphasis
on
prevention
of
pollution,
or
"
source
reduction".
Although
pollution
prevention
(
P2)
at
EPA
in
the
1980s
was
largely
limited
to
TSCA
new
chemicals
review,
waste
minimization
activities
and
a
few
facility­
specific
projects,
P2
gained
additional
momentum
in
1990
with
the
implementation
of
a
series
of
EPA
prevention­
focused
programs
and
the
passage
of
the
Pollution
Prevention
Act
(
PPA).
In
the
mid­
1990s,
the
Agency
committed
to
incorporating
formalized
prevention
practices
into
its
mainstream
activities
through
regulations,
permitting,
technical
assistance,
and
enforcement.
The
Agency
established
P2
objectives
for
partnerships,
public
information
policies,
technological
innovation,
and
regulations,
as
well
as
encouraged
other
government
agencies
to
continually
renew
their
commitment
to
P2
efforts.

In
managing
EPA's
chemicals
program,
OPPT
has
actively
sought
opportunities
to
promote
P2
and
pollution
reduction
in
managing
risks
of
chemicals.
OPPT
promotes
regulatory
and
voluntary
efforts
for
the
design,
development,
and
application
of
safer
chemical
processes
and
technologies.
OPPT's
efforts
have
included,
for
example,
consideration
of
P2
opportunities
22
when
assessing
new
chemical
applications,
P2
information
(
when
available)
and
options
when
performing
assessments
of
existing
chemicals,
and
technical
support
for
P2
via
grants
to
States.

OPPT's
voluntary
P2
tools
and
approaches
include:

°
Sustainable
Futures:
a
pilot
project
designed
to
encourage
the
application
of
P2
principles
during
the
development
of
new
chemicals
submitted
as
Premanufacture
Notifications
(
PMNs)
under
TSCA
§
5.
°
Pollution
Prevention
(
P2)
Framework:
a
compilation
of
models
that
OPPT
developed.
To
support
the
Sustainable
Futures
pilot
program,
OPPT
is
using
the
P2
Framework
to
predict
risk­
related
properties
of
chemicals
using
structure
activity
relationships
(
SARs)
and
standard
(
default)
scenarios.
The
P2
Framework
combines
several
of
OPPT's
models
to
estimate
physical
and
chemical
properties
and
environmental
fate
(
EPI
SUITE),
models
to
estimate
hazards
to
humans
and
the
environment
(
OncoLogic,
ECOSAR,
PBT
Profiler),
and
models
to
estimate
exposure
and/
or
risk
(
E­
FAST
and
ChemSTEER).
The
P2
Framework
Project
presents
these
models
to
industry
with
the
hope
that
the
models
will
be
useful
in
identifying
potential
problem
chemicals
and
processes
early
in
the
research
and
development
(
R&
D)
process.
°
Design
for
the
Environment
(
DfE):
a
voluntary
partnership
program
that
helps
businesses
design
or
redesign
products,
processes,
and
management
systems
that
are
cleaner,
more
cost­
effective,
and
safer
for
workers
and
the
public;
projects
look
at
cross­
media
impacts,
energy
and
resource
use,
and
the
potential
risks
from
chemicals.

°
Green
Chemistry
Program:
an
initiative
under
EPA's
DfE
Program
that
focuses
on
P2
through
the
environmentally
conscious
design
of
chemical
products
and
processes.
°
Green
Engineering:
an
initiative
under
the
DfE
program
designed
to
promote
the
development
and
commercialization
of
environmentally
beneficial
design
methods,
risk­
based
design
tools,
and
green
technologies
via
education,
outreach,
and
partnering
with
the
academic,
research,
and
industrial
communities.
°
Environmentally
Preferable
Purchasing
(
EPP):
a
federal
government­
wide
program
managed
by
EPA
that
assists
Executive
agencies
in
the
purchasing
of
environmentally
preferable
products
and
services.
°
Green
Suppliers
Network
(
GSN):
a
collaborative
venture
between
industry
and
EPA
that
works
with
all
levels
of
the
manufacturing
supply
chain;
links
manufacturing
and
technical
assistance
resources;
emphasizes
environmental
and
economic
benefits
through
improved
performance,
minimization
of
waste,
and
removal
of
institutional
roadblocks.
°
Hospitals
for
a
Healthy
Environment
(
H2E):
a
voluntary
partnership
between
EPA,
the
American
Hospital
Association
(
AHA),
and
its
members,
to
implement
P2
practices
in
hospitals.

P2
has
primarily
been
achieved
through
voluntary
and
assistance
programs,
such
as
the
ones
described
above.
Some
innovative
techniques
have
been
used
to
merge
the
voluntary
and
regulatory
approaches
by
directly
or
indirectly
promoting
pollution
prevention
as
a
means
for
organizations
to
reduce
their
regulatory
burden.
One
example
is
the
use
of
measurement
and
public
reporting
as
an
incentive
for
P2
efforts.
The
Toxics
Release
Inventory
(
TRI)
Program,
formerly
in
OPPT
and
currently
implemented
through
the
Office
of
Environmental
Information
17
If
it
is
determined
during
the
PMN
review
that
a
new
substance
may
or
will
pose
an
unreasonable
risk,
EPA
has
authority
to
limit
or
ban
it
through
regulation.
This
includes
the
issuance
of
a
TSCA
§
5(
e)
Consent
Order
to
prohibit
or
limit
activities
associated
with
the
new
chemical,
where
EPA
determines
that
insufficient
information
exists
to
evaluate
the
human
health
and
environmental
effects
of
the
substance,
and
that
it
may
present
an
unreasonable
risk
or
be
produced
in
substantial
quantities.

23
(
OEI)
 
a
regulatory
chemical
release
reporting
program
 
also
achieved
voluntary
pollution
prevention
benefits.
The
public
reporting
and
notification
of
chemical
releases
under
the
TRI
Program
has
enabled
public
pressure
to
serve
as
a
strong
incentive
for
companies
to
reduce
the
releases
of
TRI
chemicals
they
manufacture
or
use.
Local
government
agencies
have
also
used
TRI
to
set
priorities,
measure
pollution
prevention
progress,
and
target
areas
of
special
and
immediate
concern
for
source
reduction
efforts.

Other
innovative
approaches
include
EPA's
support
for
green
alternatives
for
chemical
use
and
production,
multimedia
approaches
for
the
management
of
certain
chemicals
of
concern,
and
full
or
limited
life­
cycle
assessments
and
approaches.
There
have
also
been
initiatives
to
reduce
regulatory
burden
on
organizations
adopting
environmental
management
systems
and
those
that
reduce
their
chemical
use
through
pollution
prevention.

The
concept
of
pollution
prevention
is
also
a
key
element
in
the
development
and
implementation
of
product
stewardship
programs.
Product
stewardship
is
a
product­
centered
approach
to
environmental
protection,
that
uses
a
life­
cycle
perspective
to
identify
strategic
opportunities
for
risk
reduction,
pollution
prevention
and
resource
conservation.
Product
stewardship
calls
on
those
involved
in
the
product
life
cycle
 
manufacturers,
retailers,
users,
and
disposers
 
to
share
responsibility
for
reducing
the
environmental
impacts
of
products.
Product
stewardship
can
act
as
a
catalyst
for
environmental
improvements
by
providing
incentives
to
manufacturers
to
consider
and
take
responsibility
for
the
entire
life­
cycle
impacts
of
a
product.
Although
some
regulatory
policies
have
been
put
in
place
in
the
U.
S.
for
specific
products
or
waste
streams,
to
date
the
implementation
of
domestic
product
stewardship
policies
has
overwhelmingly
been
a
voluntary
effort.
Countries
within
the
European
Union
have
taken
a
more
regulatory
approach
through
product­
oriented
legislation,
such
as
mandatory
take­
back
programs
that
require
certain
manufacturers
(
e.
g.,
the
automotive
and
electronics
industries)
to
take
back
their
products
at
the
end
of
their
life
and
recycle
or
properly
dispose
of
them.

In
addition
to
voluntary
approaches
to
P2,
OPPT
has
certain
regulatory
tools
available
that
can
also
help
to
achieve
P2
objectives.
For
example,
chemicals
new
to
the
marketplace
are
reviewed
by
OPPT
before
they
are
produced
or
imported
through
the
Premanufacture
Notification
(
PMN)
review
process.
As
part
of
that
review,
P2
solutions
that
reduce
risk
may
be
identified.
In
this
instance,
EPA
can
use
its
authority
under
TSCA
§
5(
e)
and
control
new
chemical
risks
via
implementation
of
P2­
based
requirements.
17
There
may
also
be
opportunities
for
creative
use
of
§
5(
a)(
2)
(
SNURs)
or
other
TSCA
provisions
to
advance
P2
objectives
on
existing
chemicals.

As
OPPT
moves
forward,
these
and
other
P2
approaches
may
present
opportunities
for
broader
application
and
further
integration
in
OPPT's
direction
of
chemicals
management
programs.
EPA
is
seeking
advice
from
the
NPPTAC
on
ways
to
increase
the
use
of
pollution
prevention
(
P2)
solutions
in
managing
risks
of
chemicals.
24
Question
5:
Background
Information
and
Issues
Relating
to
Enhancing
Partnerships
with
States
and
Tribes
in
Implementing
OPPT's
Programs
Question
5.
Are
there
opportunities
for
States
and
Tribes
to
assume
a
greater
partnership
role
in
furthering
the
goals
of
the
national
program?
If
so,
what
role(
s)
would
be
optimal?
Are
there
ways
to
better
share
chemical
data
with
the
States
and
Tribes
while
continuing
to
safeguard
TSCA
confidential
business
information
(
CBI)?

OPPT
manages
an
extensive
and
varied
national
program
for
identifying
and
controlling
chemical
hazards
and
risks
to
human
health
and
the
environment.
The
Toxic
Substances
Control
Act
(
TSCA)
provides
the
legislative
basis
for
this
program.
However,
unlike
other
major
national
environmental
legislation
(
such
as
the
Clean
Air
Act),
TSCA,
with
the
exception
of
its
programs
for
lead
and
asbestos,
does
not
define
a
specific
role
for
States
and
Tribes.

TSCA
§
10(
g)
authorizes
EPA
to
coordinate
a
system
for
exchanging
and
standardizing
chemical
research
results
among
Federal,
State
and
local
authorities.
TSCA
§
14
limits
the
access
that
the
general
public,
including
States
and
Tribes,
may
have
to
certain
chemical
information
claimed
as
confidential.
Under
TSCA
§
14(
a)
and
EPA's
Regulations
on
the
Confidentiality
of
Business
Information
(
CBI),
EPA
is
prohibited
from
disclosing
trade
secrets,
or
commercial
or
financial
information
that
is
privileged
or
confidential,
to
the
public,
except
in
certain
extremely
limited
circumstances
(
such
as
where
necessary
to
protect
against
an
unreasonable
risk
of
injury
to
health
or
the
environment).

Effective
implementation
of
OPPT's
programs,
especially
those
directed
at
existing
chemicals,
can
greatly
benefit
from
the
involvement
of
States,
Tribes,
and
communities.
Historically,
partnership
arrangements
between
EPA
and
States/
Tribes
have
proven
to
be
beneficial
in
protecting
the
environment
and
providing
better
coordination
of
regulatory
and
voluntary
efforts.
For
example,
there
is
a
history
of
significant
interaction
between
States/
Tribes
and
OPPT
regarding
voluntary
efforts
for
pollution
prevention
(
P2)
such
as
the
Forum
on
State
and
Tribal
Toxics
Action
(
FOSTTA)
and
the
P2
Grants
Programs
managed
by
OPPT.
OPPT
is
interested
in
other
ways
to
improve
coordination
between
its
statutory
program
and
the
States/
Tribes.

Existing
Coordination
Efforts
with
States
and
Tribes
EPA
Regional
Offices
play
a
pivotal
role
in
communication
between
OPPT
and
the
States,
Tribes,
and
communities.
They
routinely
work
with
those
entities
to
help
them
develop
the
technical
and
legal
capability
to
facilitate
the
implementation
of
standards
and
regulations
developed
by
EPA.
The
role
of
a
State
or
Tribe
in
implementing
a
particular
regulation
or
voluntary
program
can
vary,
but
may
include:
compliance
assistance,
monitoring
or
incentives;
education
and
outreach;
promotion
of
a
new
strategy
or
initiative;
and
facilitation
of
interaction
25
with
stakeholders.
Some
States
have
grant
arrangements
to
perform
inspections,
cite
violations,
etc.
in
support
of
Agency
efforts
to
enforce
TSCA
regulations.

Over
the
years,
OPPT's
coordination
with
the
States
and
Tribes
has
focused
on:

°
TSCA
requirements
related
to
lead
and
asbestos,
°
Voluntary
programs
and
pilot
projects,
and
°
Participation
in
partnership
organizations.

Coordination
on
Lead
and
Asbestos
TSCA
specifies
the
role
States
should
play
with
regards
to
lead
and
asbestos
management.
For
example,
TSCA
§
404
mandates
a
process
under
which
EPA
will
approve
state
programs
for
training
and
certification
of
lead­
based
paint
contractors
and
for
performing
the
lead
education
and
outreach
required
under
TSCA.
EPA
has
promulgated
a
model
state
program
that
may
be
used
by
States
seeking
to
administer
training
and
certification
programs.
All
state
programs
must
be
at
least
as
protective
as
the
Federal
program
and
must
provide
adequate
enforcement.
In
those
States
lacking
their
own
programs,
EPA
must
establish,
administer,
and
enforce
Federal
programs.
EPA
Regions
implement
OPPT's
lead
program
in
States
that
have
not
accepted
responsibility
for
the
program.
EPA
is
also
authorized
to
make
grants
to
States
to
develop
and
carry
out
the
authorized
programs.

Partnerships
with
States
and
Tribes
EPA
Headquarters
and
its
Regional
Offices
work
with
States
and
Tribes
to
implement
many
initiatives
and
programs.
For
example,
to
achieve
the
U.
S.
voluntary
PCB
decommissioning
goals
supported
by
OPPT,
efforts
have
largely
built
on
the
Region
5
(
Chicago)
PCB
Phasedown
Program
and
may
seek
the
use
of
cooperative
agreements
and
consultations
with
States
and
Tribes
in
the
future.
For
over
10
years,
Illinois
EPA
(
IEPA)
has
performed
PCB
inspections
and
prepared
enforcement
cases
under
a
grant
arrangement
with
EPA
Region
5.

OPPT
coordinates
and
partners
with
States
and
Tribes
through
a
variety
of
organizations.
The
National
Conference
of
State
Legislators
(
NCSL)
was
founded
in
1975
to
provide
an
open,
bipartisan,
national
forum
for
the
lawmakers
and
staffs
of
the
nation's
states,
its
commonwealths
and
territories
to
communicate
with
one
another
and
share
ideas.
NCSL
facilitates
ongoing
efforts
of
the
States
and
Tribes
to
identify,
discuss,
and
address
toxics­
related
issues,
and
to
continue
the
dialogue
on
how
Federal
environmental
programs
can
best
be
implemented.
One
example
of
a
NCSL
project
related
to
OPPT
efforts
is
the
NCSL
Lead
Hazards
Project.
This
project
assists
States
on
the
issue
of
lead
poisoning
prevention
by
facilitating
information
exchange
among
the
States
and
by
promoting
improved
coordination
between
the
States
and
OPPT.

The
Forum
on
State
and
Tribal
Toxics
Action
(
FOSTTA)
is
a
partnership
between
OPPT
and
state
and
tribal
leaders
to
increase
understanding
and
improve
collaboration
on
toxics
and
P2
issues
and
to
continue
a
dialogue
on
how
federal
environmental
programs
can
best
be
implemented
among
the
States
and
Tribes.
Created
in
1991,
FOSTTA
is
currently
operated
26
under
a
cooperative
agreement
with
the
Environmental
Council
of
the
States
(
ECOS)
and
the
National
Tribal
Environmental
Council
(
NTEC).
ECOS
is
a
national
non­
profit,
non­
partisan
association
of
State
and
territorial
environmental
commissioners.
NTEC
is
a
membership
organization
dedicated
to
working
with
and
assisting
all
federally
recognized
Tribes
in
the
protection
and
preservation
of
the
reservation
environment.
NTEC
membership
is
open
to
federally
recognized
Tribes
throughout
the
United
States,
and
currently
has
108
member
Tribes.

ECOS,
NTEC,
and
OPPT
co­
sponsor
meetings
of
FOSTTA
twice
each
year
to
examine,
among
themselves
and
with
EPA
officials,
the
nature
and
direction
of
EPA's
chemical
and
prevention
programs.
FOSTTA
has
been
moving
in
a
new
direction
since
2000,
building
upon
EPA's
national
HPV
chemical
initiative
that
provides
an
opportunity
for
EPA
to
realign
and
invigorate
its
chemical
and
prevention
programs
and
to
stimulate
the
development
of
new
state­
based
capabilities
in
these
areas.
OPPT
restructured
its
existing
FOSTTA
state
projects
into
a
new
"
Chemicals
Information
and
Management
Project"
(
CIMP),
an
existing
"
P2
Project",
and
a
strengthened
"
Tribal
Affairs
Project"
(
TAP).
CIMP
focuses
on
EPA's
toxics
program
and
works
to
develop
a
more
coordinated
effort
involving
Federal,
State,
and
Tribal
agencies
in
chemical
assessment
and
management
decisions.
The
P2
Project
promotes
integrating
chemical
P2
into
mainstream
environmental
activities
at
both
the
Federal
level
and
among
the
States.
TAP
concentrates
on
chemical
and
prevention
issues
that
are
most
relevant
to
the
Tribes,
including
lead
control
and
abatement,
traditional/
subsistence
lifeways,
and
hazard
communications
and
outreach.

Another
point
of
collaboration
between
OPPT
and
the
State
and
local
governments
is
the
National
Pollution
Prevention
Roundtable
(
NPPR).
The
NPPR
is
an
organization
to
collaborate
on
pollution
prevention
technical
assistance
and
capacity
building
initiatives.

Pollution
Prevention
Grants
The
Pollution
Prevention
(
P2)
Grant
Program
was
created
under
the
authority
of
the
Pollution
Prevention
Act
(
PPA)
of
1990.
The
program
provides
matching
funds
to
States
and
Tribes
to
support
pollution
prevention
activities.
The
goal
is
to
give
the
State
programs
the
capability
to
assist
business
and
industry
to
identify
better
environmental
strategies,
identify
solutions
to
comply
with
Federal
and
State
regulations,
improve
business
competitiveness
without
increasing
environmental
impacts.
The
type
of
projects
funded
under
the
P2
Grant
Program
include:
technical
assistance,
training,
outreach,
education,
regulatory
integration,
data
collection,
research
and
demonstration
projects.

EPA
is
seeking
advice
from
the
NPPTAC
on
potential
opportunities
for
States
and
Tribes
to
assume
a
greater
partnership
role
in
furthering
the
goals
of
the
national
program,
as
well
as
ways
to
better
share
chemical
data
with
the
States
and
Tribes
while
continuing
to
safeguard
TSCA
confidential
business
information
(
CBI).
27
Question
6:
Background
Information
and
Issues
Relating
to
Future
Directions
for
OPPT's
Chemical
Management
Programs
Question
6.
What
challenges
and
opportunities
face
OPPT,
working
in
partnership
with
States,
Tribes,
industry
and
NGOs
in
managing
and
reducing
risk
associated
with
toxic
chemicals
over
the
next
20
years?
What
approaches
can
be
taken
in
the
interim
(
next
5
or
10
years)
to
prepare
to
meet
those
challenges
successfully?
How
might
the
increased
international
interest
and
activities
of
governments,
industry,
and
NGOs
in
global
chemicals
management
impact
domestic
approaches
for
reducing
and
preventing
chemical
risk?
What
approaches
should
OPPT
consider
in
planning
chemicals
management
and
prevention
for
the
future?

The
development
of
chemicals
management
in
the
U.
S.
has
evolved
and
been
shaped
by
various
forces
over
the
last
three
decades.
The
regulatory
command­
and­
control
approach
under
the
Toxic
Substances
Control
Act
(
TSCA)
of
1976
has
increasingly
been
complemented
with
voluntary
and
partnership
approaches
with
industry
and
non­
governmental
organizations
(
NGOs).
For
example,
the
High
Production
Volume
(
HPV)
Challenge
Program,
initiated
in
1998,
emphasizes
partnerships
with
industry
and
NGOs
and
a
general
new
approach,
while
still
linking
to
and
coordinating
with
the
regulatory
mandates
of
TSCA.
U.
S.
producers
and
importers
of
HPV
chemicals
(
industrial
chemicals
that
are
produced
in
or
imported
into
the
U.
S.
in
volumes
of
1
million
pounds
or
more
per
year)
voluntarily
participate
in
the
HPV
Challenge
Program
by
"
sponsoring"
a
chemical:
identifying
and
assessing
the
adequacy
of
existing
hazard
information,
conducting
new
testing
(
if
adequate
information
does
not
exist),
and
making
the
new
and
existing
test
results
available
to
EPA
and
the
public.

The
initial
emphasis
on
mitigating
chemical
risk
has
also
been
expanded,
under
the
1990
Pollution
Prevention
Act
(
PPA),
to
incorporate
the
prevention
of
pollution
at
the
source
and
the
development
of
new
technologies
and
approaches.
For
example,
in
the
spirit
of
the
PPA,
OPPT's
Green
Chemistry
program
was
developed
to
encourage
the
design
of
environmentally
conscious
chemical
products
and
processes;
the
Green
Engineering
program
educates
engineers
in
techniques
for
applying
pollution
prevention
and
risk
reduction
to
engineering
designs;
and
the
Environmentally
Preferable
Purchasing
program,
a
federal
government­
wide
program
managed
by
EPA,
requires
and
assists
Executive
agencies
in
the
purchasing
of
environmentally
preferable
products
and
services.

EPA
has
also
worked
to
enhance
its
partnerships
with
States,
for
example,
through
programs
such
as
the
Forum
on
State
and
Tribal
Toxics
Action
(
FOSTTA).
FOSTTA
is
a
partnership
between
OPPT
and
state
and
tribal
leaders
to
increase
understanding
and
improve
collaboration
on
chemicals
management
and
P2
issues
and
to
continue
a
dialogue
on
how
federal
environmental
programs
can
best
be
implemented
among
the
States
and
Tribes.
28
The
advances
of
communications
in
the
Information
Age
and
the
expansion
of
right­
toknow
approaches
(
e.
g.,
the
HPV
Challenge
Program)
have
created
new
audiences
and
increased
pressure
for
accurate
and
meaningful
information
on
managing
risks
of
chemicals.
Concerns
have
evolved
from
an
initial
emphasis
on
cancer,
birth
defects,
and
mutagenicity
to
encompass
a
wide
array
of
issues
such
as
developmental
toxicity,
reproductive
toxicity,
neurotoxicity,
endocrine
disruption,
persistent
bioaccumulative
toxics,
cumulative
effects
of
exposures
to
multiple
chemicals,
environmental
justice,
and
sensitive
populations.

The
increased
importance
of
a
global
economy
has
also
expanded
the
focus
of
chemical
management
from
mitigating
risks
within
U.
S.
borders
to
increasing
coordination
and
engagement
with
other
countries
to
address
environmental
issues
collaboratively
and,
where
appropriate,
via
global
approaches.

An
example
of
chemicals
management
in
a
regional
context
is
the
work
of
the
Sound
Management
of
Chemicals
(
SMOC)
program
under
the
North
American
Commission
for
Environmental
Cooperation
(
CEC)
to
address
environmental
issues
across
Canada,
the
U.
S.
and
Mexico.
By
working
through
the
CEC's
SMOC
program,
OPPT
has
assisted
in
the
development
of
the
North
American
Regional
Action
Plans
(
NARAPs)
for
PCBs
and
mercury
and
is
currently
participating
in
the
development
of
a
NARAPs
for
lead
and
for
dioxins,
furans
and
hexachlorobenzene.

On
a
more
global
scale,
intergovernmental
organizations
have
grown
and
matured
to
promote
greater
coordination
and
collaboration
among
governments,
as
well
as
global
chemicals
management.
For
example,
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
and
the
Intergovernmental
Forum
on
Chemical
Safety
(
IFCS)
are
intergovernmental
groups
working
towards
coordinating
and
collaborating
international
efforts
to
promote
environmental,
health,
and
chemical
safety.

The
OECD
is
an
international
organization
consisting
of
representatives
from
30
industrialized
countries
in
Europe,
North
America,
Asia
and
the
Pacific.
It
has
developed
such
programs
as
the
Screening
Information
Data
Set
(
SIDS)
Program
to
facilitate
the
coordinated
investigation
of
HPV
chemicals;
the
Globally
Harmonized
System
(
GHS)
of
Classification
and
Labeling
to
promote
better
exchange
of
information
on
the
hazards
of
chemicals
and
mixtures
to
human
health
and
the
environment;
and
the
agreement
among
OECD
countries
to
accept
OECD
Test
Guideline­
run
studies
for
review
regardless
of
where
the
study
is
performed
(
the
Mutual
Acceptance
of
Data,
or
MAD).
The
IFCS
was
established
in
1994
in
response
to
the
request
of
governments
at
the
United
Nations
Conference
on
Environment
and
Development,
and
reaffirmed
in
the
2000
Bahia
Declaration,
with
the
goal
of
strengthening
international
cooperation
in
improved
chemical
safety.

Other
organizations,
such
as
the
United
Nations
Environmental
Program
(
UNEP),
work
to
promote
national,
and
where
appropriate,
global
efforts
on
chemicals.
UNEP
was
established
in
1972
under
the
United
Nations
system,
and
includes
a
chemicals
unit
tasked
with
helping
governments
take
needed
actions
for
the
sound
management
of
chemicals,
by
promoting
the
exchange
of
information
on
chemicals,
and
by
helping
to
build
the
capacities
of
countries
around
the
world
to
use
chemicals
safely.
UNEP
has
supported
multilateral
activities
such
as
the
Rotterdam
Convention
on
Prior
Informed
Consent
(
PIC),
which
prevents
export
of
harmful
29
pesticides
and
industrial
chemicals
unless
the
importing
country
agrees
to
accept
them,
and
the
Stockholm
Convention
on
Persistent
Organic
Pollutants
(
POPs),
which
is
a
global
treaty
to
protect
the
environment
from
POPs.
In
coordination
with
IFCS,
UNEP
is
developing
a
Strategic
Approach
to
International
Chemicals
Management
(
SAICM),
which
is
based
on
existing
international
commitments
and
takes
into
account
economic,
social,
and
environmental
aspects
of
chemicals
management.

At
the
World
Summit
on
Sustainable
Development
(
WSSD)
held
in
September,
2002
in
Johannesburg,
South
Africa,
an
implementation
plan
was
adopted.
The
plan
addresses
the
management
of
chemicals
and
says,
in
part,
"....(
R)
enew
the
commitment,
as
advanced
in
Agenda
21,
to
sound
management
of
chemicals
throughout
their
life
cycle
and
of
hazardous
wastes
for
sustainable
development
as
well
as
for
the
protection
of
human
health
and
the
environment,
inter
alia,
aiming
to
achieve,
by
2020,
that
chemicals
are
used
and
produced
in
ways
that
lead
to
the
minimization
of
significant
adverse
effects
on
human
health
and
the
environment....."
(
see
Paragraph
23
at
http://
www.
johannesburgsummit.
org/
html/
documents/
summit_
docs/
131302_
wssd_
report_
reissued.
pdf).

As
these,
and
future
events
continue
to
influence
and
shape
chemicals
management
domestically
and
internationally
through
the
21st
century,
EPA
and
its
partners
will
need
to
recognize
and
anticipate
important
developments
in
order
to
meet
the
needs
of
the
future.

EPA
is
seeking
advice
from
the
NPPTAC
on
challenges
and
opportunities
that
face
OPPT
in
managing
and
reducing
risk
associated
with
chemicals
over
the
next
20
years,
approaches
that
can
be
taken
in
the
interim
(
next
5
or
10
years)
to
prepare
to
meet
those
challenges
successfully,
domestic
impacts
of
increased
international
interest
and
activities
of
governments,
industry,
and
NGOs
in
chemicals
management,
and
approaches
that
OPPT
should
consider
in
planning
for
the
future
of
its
chemicals
management
and
prevention
programs.
