Current
TSCA
Activities
Related
to
Brominated
Flame
Retardants
April
29,
2003
Ken
Moss,
USEPA
moss.
kenneth@
epa.
gov
Background

Environmental
studies
indicate
presence
of
certain
brominated
FRs
(
BFRs)
in
biota,

including
human
breast
milk
and
serum

polybrominated
diphenyl
ethers
(
PBDEs)
and
(
to
a
lesser
extent)
tetrabromobisphenol
A
(
TBBPA)
and
hexabromocyclododecane
(
HBCD)


Need
to
distinguish
among
hazards,
risk,
uses
of
these
BFRs

Existing
hazard
and
exposure
information
is
incomplete

Balance
fire
safety
and
environmental
quality
BFR
Human
Health
Concerns

Neurodevelopmental
toxicity,
endocrine
disruption,
cancer,
immunotoxicity,
liver
effects,
disruption
of
thyroid
hormone
levels,
and
developmental
toxicity
concerns
identified,
but
significance
is
uncertain.


Concerns
tend
to
be
higher
for
the
lower
brominated
PBDE
mixtures.
Addressing
Information
Needs

Understand
how
these
chemicals
are
getting
into
human
tissue

Research
and
testing
on
health
and
environmental
effects,
environmental
chemistry,
environmental
fate

Evaluation
of
substitutes
TSCA
Approaches

New
Chemicals
Program

Significant
New
Use
Rules

Voluntary
Programs
TSCA
New
Chemicals
Program

Section
5
of
TSCA

Manufacturer
or
importer
of
a
new
chemical
substance
must
submit
a
"
premanufacture
notice"
(
PMN)
to
EPA
90
days
before
the
date
of
intended
start
of
production
or
import
of
the
subject
chemical.
New
Chemicals
Program
(
cont'd)


Designed
to
prevent
health
and/
or
environmental
risks
before
they
occur

Regulatory
decisions
are
often
made
in
the
absence
of
data

Hazard
and
exposure
screening
models

Structure
Activity
Relationships

Over
40,000
PMNs
and
PMN
exemption
notices
have
been
reviewed
since
1979.

Chemical
Review/
Search
Strategy
(
CRSS)

Meeting

Day
8­
12

Structure
Activity
Team
(
SAT)
Meeting

Day
9­
13

Exposure/
Release
Profile
developed

Day
10­
19

Focus
Meeting

Day
15­
20

Standard
Review

Day
21­
85
90­
day
Review
Process
Regulatory
Actions
 
Drop
 
Drop
with
Concern
Letter
 
Significant
New
Use
Rule
(
SNUR)

 
Section
5(
e)
Consent
Order
 
5(
e)
Ban
Pending
Upfront
Testing
 
Section
5(
f)
Action
 
Standard
Review
Factors
that
EPA
Considers
in
Taking
Regulatory
Action
under
TSCA

Magnitude
and
Type
of
Hazard

Type
of
Human/
Environmental
Exposure

Substitutes
(
Relative
Risks)


Benefits
(
Environmental/
Human
Health)


Other
Uses
(
Increased
Risks?)


Regulatory
History
(
Consistency
in
Risk
Management
Decisions)
PentaBDE
Substitutes
Activity
in
the
New
Chemicals
Program

Aluminum­
based,
Phosphates
and
Brominated
Aromatics

No
discrete
chemical
structural
categorywide
decisions

Uses:
in
flexible
and
rigid
foam,


Not
much
evidence
of
risk
screening
prior
to
submission
Factors
to
consider
when
submitting
PentaBDE
substitutes

Migration
from
foam

Relative
toxicity
and
risks
to
existing
product

PBT
potential

Environmental
fate/
pathways
(
breakdown
products)


Life
cycle
analysis
(
e.
g.,
municipal
incineration
generate
dioxins/
furans
or
lower
brominated
compounds?
Recyclability
of
foam?)
Chemical
Risk
Screening
Resources

P2
Framework
www.
epa.
gov/
oppt/
p2framework/


PBT
Profiler
 
www.
pbtprofiler.
net

Sustainable
Futures
www.
epa.
gov/
oppt/
newchems/
sustainablefutures.
htm
EPA's
P2
Framework

A
set
of
computer
models
that
predict
hazards
and
exposures
of
chemicals
using
structure
activity
relationships
(
SARs),
exposure
assessment
models
and
databases,
and
standard
(
default)
scenarios.


Models
have
been
developed
over
a
20­
year
period
by
EPA
and
others
in
the
scientific
and
technical
community
to
screen
new
chemicals
in
the
presence
of
limited
data.
P2
Framework
Models

Once
released,
will
the
chemical
go
to
air,

water,
soil,
sediment?


How
long
will
the
chemical
stay
in
media?


Will
the
chemical
present
a
hazard?


Could
this
be
a
PBT?


Who
will
be
exposed
and
for
how
long?
PCKOCWIN
HENRYWIN
ECOSAR
BCFWIN
BIOWIN
STPWIN
OncoLogic
ChemSTEER
AOPWIN
MPBPVP
WSKOWWIN
HYDROWIN
KOWWIN
E­
FAST
PBT
Profiler
P,
B
&
T
Criteria
>
2
d
>
2
d
<
2
d
2
d
Air
Air
>
180
d
>
180
d
>
60
d
60
d
<
60
d
<
60
d
Water,
soil,
sediment
Water,
soil,
sediment
Persistent
Persistent
Not
Persistent
Not
Persistent
Persistence
ersistence
>
5,000
5,000
>
1,000
1,000
<
1,000
<
1,000
Fish
BCF
Fish
BCF
Bioaccumulative
Bioaccumulative
Not
Not
Bioaccumulative
Bioaccumulative
Bioaccumulation
ioaccumulation
<
0.1
mg/
L
<
0.1
mg/
L
0.1
0.1­
10
10
mg/
L
mg/
L
>
10
mg/
L
>
10
mg/
L
Or
No
Effects
at
Or
No
Effects
at
Saturation
Saturation
Fish
Fish
ChV
ChV
(
EPA
New
Chemical
(
EPA
New
Chemical
Program
Criteria)

Program
Criteria)
Toxic
Toxic
Not
Toxic
Not
Toxic
Toxicity
oxicity
Results
 
PBT
Criteria
Exceeded
Flame
Retardants:

Continuum
of
PBT
Concern
Non­
halogenated
Aluminum
or
Phosphate
based
compounds
Halogenated
Aromatics
Lower
Higher
Design
for
low
persistence,
low
bioaccumulation,
low
toxicity
and
reactive
versus
additive
where
possible
Significant
New
Use
Rule
(
SNUR)


EPA's
authority
to
issue
SNURs
comes
from
TSCA
section
5(
a).


SNURs
require
manufacturers,
importers,

or
processors
to
notify
EPA
90
days
in
advance
of
commercialization
of
a
chemical
for
a
significant
new
use.


If
necessary,
EPA
can
take
action
to
limit
or
prohibit
use.
CPSC
Flammability
Standard

SNUR
would
complement
a
national
flammability
standard
for
residential,

upholstered
furniture
(
RUF)
under
consideration
by
CPSC.


Although
standard
would
not
prescribe
the
use
of
FR
chemicals,
it
could
result
in
new
uses
of
certain
FR
chemicals
in
outer
fabric
of
RUF.
CPSC
Standard
(
cont'd)


A
SNUR
could
ensure
that
no
inappropriate
chemicals
are
used
to
meet
standard.


SNUR
could
cover
any
or
all
of
the
16
FR
chemicals
(
including
HBCD
and
DecaBDE)
or
categories
of
chemicals
identified
by
CPSC
and
evaluated
by
National
Academy
of
Sciences
as
likely
to
be
used
to
flame
retard
fabrics
on
RUF.
Voluntary
Efforts
to
Address
BFR
Data
Needs

EPA's
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)


PBDEs
are
3
of
the
23
chemicals
selected.


Selection
of
all
chemicals
based
on
biomonitoring
data
showing
presence
in
human
tissues/
fluids,
and
monitoring
data
indicating
presence
in
food,
drinking
water
or
indoor
air.


EPA
High
Production
Volume
(
HPV)
Challenge
Program
­
HBCD
and
TBBPA

EPA
Region
9
conference
on
BFRs
and
electronics,
September,
2002.
VCCEP
Peer
Consultation
on
PBDEs

Forum
for
stakeholder
groups
to
exchange
scientific
views
on
sponsor's
assessments
 
balanced
participation.


April
2­
3
(
decaBDE)
and
June
3­
5
(
octa­
and
pentaBDE)
in
Cincinnati.


Outcomes
­
Are
data
sufficient
to
adequately
characterize
the
risks
of
the
chemical
to
children?


Risk
communication
and
(
if
necessary)
risk
management.
Next
Steps

VCCEP
Peer
Consultations/
Reports

National
Toxicology
Program
to
conduct
chronic/
subchronic
studies
on
commercial
pentaBDE
mixture,
as
well
as
the
major
individual
chemicals
present
in
the
mixture.


Update
EPA
Integrated
Risk
Information
System
(
IRIS)
assessments
on
PBDEs

Development
of
SNUR
for
FRs
used
on
RUF
Next
Steps
(
cont'd)


Completion
of
HPV
Challenge
Program
commitments
for
HBCD
and
TBBPA

Continuing
coordination
with
OECD
on
BFRs

Ongoing
substitutes
analysis/
risk
screening
in
the
new
chemicals
program,
dialogue
with
manufacturers
and
users

April
29­
30,
EPA
Region
9,
San
Francisco:

Conference
on
BFRs
in
flexible
polyurethane
foam;
Design
for
Environment
Alternative
Flame
Retardants
project.
