Final
Report
Analysis
of
Laboratory
Capacity
to
Support
U.
S.
EPA
Chemical
Testing
Program
Initiatives
Prepared
by:

Economics,
Policy,
and
Analysis
Branch
(
7406M)
Office
of
Pollution
Prevention
and
Toxics
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue
NW
Washington,
DC
20460
August
30,
2004
CONTRIBUTORS
The
EPA
analyst
responsible
for
this
report
was
Lynne
Blake­
Hedges.
Analytical
and
draft
preparation
support
was
provided
by
Eastern
Research
Group,
Inc.
under
subcontract
to
Abt
Associates
Inc.
under
EPA
Contract
No.
68­
W­
02­
077.
ii
TABLE
OF
CONTENTS
Page
1.0
INTRODUCTION
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1
2.0
DEMAND
FOR
CHEMICAL
TESTING
SERVICES
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2
2.1
HPV
Testing
in
the
United
States
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2
2.2
HPV
Testing
in
the
European
Union
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3
2.3
OECD/
ICCA
HPV
Testing
Program.
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4
2.4
Comparison
of
U.
S.
and
EU
HPV
Chemical
Testing
Programs
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5
2.5
Impact
of
the
HPV
Challenge
and
REACH
on
Chemical
Testing
Demand
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8
2.6
U.
S.
Testing
for
Endocrine
Disruption
Potential
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11
3.0
SUPPLY
OF
CHEMICAL
TESTING
SERVICES
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17
3.1
Contract
Research
Organizations
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17
3.2
Captive
In­
House
Testing
Labs
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20
3.3
Other
Sources
of
Testing
Capacity
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21
4.0
CURRENT
INDUSTRY
ISSUES
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21
4.1
Issues
Affecting
Demand
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21
4.2
Issues
Affecting
Supply
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23
5.0
CONCLUSIONS
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28
6.0
REFERENCES
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30
1
A
second
and
related
question
is
whether
such
capacity
is
available
at
a
reasonable
price.
This
question,
however,
was
not
explicitly
addressed
in
this
report.

1
1.0
INTRODUCTION
Under
the
authority
of
the
Toxic
Substances
Control
Act
(
TSCA),
the
U.
S.
Environmental
Protection
Agency
(
EPA)
is
authorized
to
request
from
industry
certain
data
on
the
human
health
and
ecological
effects
of
commercially
produced
chemicals,
if
the
Agency
determines
such
test
data
is
necessary
to
assist
it
in
assessing
the
risks
from
such
chemicals.
In
addition
to
such
regulatory­
driven
activities,
industry
has
agreed
to
collect
and
submit
certain
types
of
chemical
testing
data
to
EPA
on
a
voluntary
basis.

In
its
planning
and
decisionmaking
with
respect
to
both
regulatory
and
voluntary
chemical
testing
initiatives,
EPA
wishes
to
be
cognizant
of
the
effects
of
such
programs
on
industry.
One
question
that
has
generated
significant
interest
is
whether
sufficient
laboratory
capacity
is
available
to
satisfy
the
demand
for
chemical
testing
generated
by
such
programs.
1
The
purpose
of
this
document
is
to
improve
EPA's
understanding
of
the
capacity
of
the
chemical
testing
industry
to
respond
to
current
and
future
testing
initiatives.
The
report
summarizes
information
on
the
current
and
potential
future
capacity
in
the
industry
to
perform
certain
kinds
of
chemical
tests
in
the
United
States,
as
well
as
overseas.
Because
the
testing
industry
operates
internationally,
the
report
focuses
not
just
on
U.
S.
testing
initiatives,
but
those
elsewhere
that
also
affect
the
global
chemical
industry,
in
particular
the
proposed
expansion
to
the
testing
program
in
the
European
Union
(
see
Section
2.2).

In
this
report,
the
term
"
chemical
testing
industry"
applies
broadly
to
any
organization
that
has
the
capability
to
use
standard
laboratory
methods
to
determine
the
effects
that
a
particular
chemical
may
have
on
humans
or
the
environment.
These
may
include
contract
research
organizations
(
CROs),
whose
primary
line
of
business
is
analytical
testing;
in­
house
testing
laboratories
maintained
by
chemical
companies
or
others
(
who
may
also
do
work
for
hire);
as
well
as
2
laboratories
maintained
and
operated
by
academic
or
other
institutions.
The
primary
focus
in
this
report
is
on
CROs,
who
are
likely
to
undertake
the
majority
of
the
testing
covered
by
this
report,

although
Section
3
(
supply
of
testing
services)
contains
a
discussion
of
captive,
in­
house
labs
as
well.

This
report
was
prepared
using
public
information
compiled
for
EPA
about
the
chemical
testing
industry,
discussions
with
EPA
and
other
experts
familiar
with
the
industry,
and
information
collected
first
hand
from
laboratories
exhibiting
at
a
major
trade
show
in
the
spring
of
2004.

2.0
DEMAND
FOR
CHEMICAL
TESTING
SERVICES
Laboratories
and
industry
observers
contacted
during
the
preparation
of
this
report
agreed
that
the
primary
driver
for
the
chemical
testing
industry,
presently
at
least,
is
the
demand
for
testing
in
the
biotechnology
and
pharmaceutical
areas.
Contracts
with
biotech
and
pharmaceutical
firms
to
conduct
product
testing
currently
account
for
a
majority
of
CRO
and
in­
house
testing
activity,
and
such
contracts
were
deemed
most
critical
to
the
economic
success
or
failure
of
a
laboratory
(
Piccirillo
2003).
As
a
general
statement,
therefore,
the
demand
for
testing
generated
by
EPAmandated
(
i.
e.,
TSCA)
programs,
as
well
as
voluntary
EPA
testing
programs,
does
not
dominate
the
industry.

It
is
important
to
note
that
activity
levels
in
all
testing
areas
can
change,
and
some
labs
may
be
more
dependent
on
some
programs
than
other.
To
help
understand
trends
in
the
marketplace,
the
sections
below
review
several
major
chemical
testing
programs
underway
in
the
U.
S.,
the
EU,
and
other
countries.

2.1
HPV
Testing
in
the
United
States
In
the
U.
S.,
one
of
the
primary
EPA
testing
initiatives
is
the
"
High
Production
Volume
(
HPV)

Challenge"
chemical
testing
program.
Under
the
HPV
Challenge,
EPA
has
invited
industry
to
3
voluntarily
sponsor
the
collection
of
a
basic
set
of
test
data
for
the
2,089
chemicals
produced
or
imported
into
the
U.
S.
at
volumes
equal
to
or
in
excess
of
one
million
pounds.
The
HPV
Challenge
was
initiated
in
response
to
findings
that
basic
hazard
data
was
unavailable
for
a
substantial
number
of
HPV
chemicals.

Under
the
program,
initiated
in
1998,
any
needed
testing
should
be
completed
by
2004
and
all
data
will
be
made
available
to
the
public
by
2005
(
U.
S.
EPA
2000).
Individual
chemicals
that
remain
unsponsored
may
be
evaluated
by
EPA
as
candidates
for
test
rules
under
Section
4
of
TSCA.

The
HPV
Challenge
uses
a
set
of
15
testing
endpoints
defined
by
OECD's
"
Screening
Information
Data
Set"
(
SIDS).
As
conceived
by
the
OECD,
the
"
SIDS
battery"
of
tests
can
be
used
by
governments
to
conduct
an
initial
assessment
of
the
hazards
and
risks
posed
by
HPV
chemical
substances,
and
prioritize
HPV
chemicals
to
identify
those
in
need
of
more
in­
depth
testing
and
assessment.
More
information
on
the
SIDS
testing
protocols
is
presented
below
in
Section
2.4.

2.2
HPV
Testing
in
the
European
Union
The
European
Union
(
EU)
operates
a
testing
program
for
both
new
chemicals
and
existing
chemicals
produced
at
high
volume,
defined
in
the
EU
as
1,000
metric
tons
or
greater
(
2.2
million
pounds)
(
European
Chemicals
Bureau
2004;
Safepharm
Laboratories
2003).
Currently,
it
maintains
dossiers
on
approximately
10,400
existing
chemicals
(
European
Chemicals
Bureau
2004).

The
EU's
proposed
Registration,
Evaluation
and
Authorisation
of
Chemicals
(
REACH)
program
would
substantially
expand
the
provisions
of
the
existing
chemicals
program
(
Liikanen
and
Wallstöm
2003;
Miller
2003;
Synthetic
Organic
Chemical
Manufacturers
Association
2003;

Squire
&
Sanders
2003).
Under
current
draft
guidelines,
substances
produced
or
imported
in
annual
quantities
of
1,000
metric
tons
(
2.2
million
pounds)
or
more
would
need
to
be
tested
4
within
three
years;
substances
produced
or
imported
at
annual
quantities
of
100
to
1,000
metric
tons
(
220,000
to
2.2
million
pounds)
would
need
to
be
tested
within
six
years;
and
substances
produced
or
imported
at
annual
quantities
of
1
to
100
tons
(
2,200
to
220,000
pounds)
would
need
to
be
tested
within
11
years.
Because
it
extends
coverage
to
lower
volume
chemicals,
the
REACH
proposal
encompasses
far
more
chemicals
than
the
U.
S.
HPV
program 
an
estimated
20,000
chemicals
compared
with
the
2,089
HPV
chemicals
in
the
U.
S.

Table
1.
Proposed
EU
Chemical
Testing
Program
(
REACH)

Threshold
volume
Estimated
Number
of
Chemicals
Time
Frame
to
Complete
Testing
Metric
tons*
Pounds
1,000
or
greater
2.2
million
or
greater
1,799
+
1,061
intermediates
within
3
years
between
100
and
1,000
between
220,000
and
2.2
million
1,645
within
6
years
between
10
and
100
between
22,000
and
220,000
3,466
within
11
years
between
1
and
10
between
2.2
and
22,000
11,711
Total
chemicals
covered
19,682
­­

*
Metric
tons
manufactured
or
imported
to
the
EU
on
an
annual
basis.
Source:
Risk
&
Policy
Analysts
2003.

2.3
OECD/
ICCA
HPV
Testing
Program
In
1998,
the
International
Council
of
Chemical
Associations
(
ICCA),
representing
the
global
chemistry
industry,
announced
an
effort
to
work
with
OECD
to
develop
test
data
for
1,000
priority
OECD
HPV
chemicals
(
ICCA
2002).
The
program
has
a
goal
of
completing
SIDS
testing
and
initial
hazard
assessments
on
these
chemicals
by
the
end
of
2004.
This
program
is
based
on
a
broad
international
collaboration
of
chemical
manufacturers.
Under
the
HPV
Challenge,
EPA
is
recognizing
commitments
made
to
complete
testing
under
the
ICCA
initiative
(
U.
S.
EPA
2004).
5
While
the
bulk
of
the
research
is
originating
in
Germany,
Japan,
the
U.
K.,
and
the
U.
S.,
20
other
nations
are
also
participating,
(
OECD
2004).

2.4
Comparison
of
U.
S.
and
EU
HPV
Chemical
Testing
Programs
EPA's
HPV
Challenge
Program
and
the
EU's
Existing
Chemical
Program
involve
a
similar
set
of
tests
(
U.
S.
EPA
2003c;
European
Chemicals
Bureau
2003;
Commission
of
the
European
Communities
2003;
Piccirillo
2003).
The
EU
REACH
program,
however,
calls
for
several
tiers
of
testing,
with
more
intensive
testing
required
for
chemicals
produced
at
relatively
high
volume
and
less
intensive
testing
required
for
chemicals
produced
at
relatively
low
volume.
Table
2
below
provides
a
comparison
between
these
two
programs.
6
Table
2.
Comparison
of
HPV
and
REACH
Testing
Programs
EPA
HPV
EU
REACH
Proposal
 
Tiered
Testing
Based
on
Annual
Volume
of
Chemical
Produced
or
Imported
to
the
EU
1
to
10
metric
tonnesa
10
to
100
metric
tonnes
100
to
1,000
metric
tonnes
1,000
metric
tonnes
or
more
"
Limited
Set"

(
Described
in
Annex
V)
"
Base
Set"

(
Described
in
Annex
VI)
"
Base
Set
+
"
Level
1"

(
Described
in
Annex
VII)
"
Base
Set"
+
"
Level
1"
+
"
Level
2"

(
Described
in
Annex
VIII)

Estimated
number
of
chemical
substances
being
sponsored
2,089
11,711
+
1,061
intermediatesb
3,466b
1,645b.
It
is
expected
that
some
of
these
will
ultimately
be
exempted
from
Level
1
testing.
1,799b.
It
is
expected
that
some
of
these
will
ultimately
be
exempted
from
Level
1
or
Level
2
testing.

Tests
performed
Physical­
Chemical
Data
C
Melting
point
C
Boiling
point
C
Density
(
relative
density)

C
Vapour
pressure
C
Partition
coefficient
(

noctanol
water)

C
Water
solubility
C
pH
value
and
pKa
value
C
Oxidation­
reduction
potential
C
Adsorption/
desorption
to
soild
C
Melting­
point
C
Boiling­
point
C
Relative
density
C
Vapour
pressure
C
Surface
tension
C
Water
solubility
C
Partition
coefficient
n­
octanol/
water
C
Flash­
point
C
Flammability
C
Explosive
properties
C
Self­
ignition
temperature
C
Oxidizing
properties
C
Granulometry
Same
as
in
column
to
the
left
Tests
described
in
the
column
to
the
left,
plus:

C
Stability
in
organic
solvents
and
identity
of
relevant
degradation
products
C
Dissociation
constant
C
Viscosity
Same
as
in
column
to
the
left
Toxicological
Studies
C
Acute
toxicity
C
Repeated
dose
toxicity
C
Developmental
toxicity/

Teratogenicity
C
Experiences
with
human
exposure
C
Skin
irritation
or
skin
corrosion
C
Eye
irritation
C
Skin
sensitization
C
Mutagenicity:
In
vitro
gene
mutation
study
in
bacteria
Tests
described
in
the
column
to
the
left,

plus:

C
Skin
irritation;
In
vivo
skin
irritation
C
Eye
irritation:
In
vivo
eye
irritation
C
Mutagenicity:
In
vitro
cytogenicity
study
in
mammalian
cells;
In
vitro
gene
mutation
study
in
mammalian
cells
C
Acute
toxicity:
by
oral
route;
by
inhalation;
by
dermal
route
C
Repeated
dose
toxicity:
short­
term
repeated
dose
toxicity
study
(
28
days)

C
Reproductive
toxicity:
screening
for
reproductive/
developmental
toxicity;

developmental
toxicity
study
C
Toxicokinetics
Tests
described
in
the
column
to
the
left,
plus:

C
Repeated
dose
toxicity:

shortterm
repeated
dose
toxicity
study
(
28
days);
sub­
chronic
toxicity
study
(
90
days)

C
Reproductive
toxicity:

developmental
toxicity
study
(
additional);
two­
generation
reproductive
toxicity
study
Tests
described
in
the
column
to
the
left,

plus:

C
Reproductive
toxicity:
two­
generation
reproductive
toxicity
study
(
additional)
Table
2.
Comparison
of
HPV
and
REACH
Testing
Programs
EPA
HPV
EU
REACH
Proposal
 
Tiered
Testing
Based
on
Annual
Volume
of
Chemical
Produced
or
Imported
to
the
EU
1
to
10
metric
tonnesa
10
to
100
metric
tonnes
100
to
1,000
metric
tonnes
1,000
metric
tonnes
or
more
"
Limited
Set"

(
Described
in
Annex
V)
"
Base
Set"

(
Described
in
Annex
VI)
"
Base
Set
+
"
Level
1"

(
Described
in
Annex
VII)
"
Base
Set"
+
"
Level
1"
+
"
Level
2"

(
Described
in
Annex
VIII)

7
Environmental
Fate
and
Pathways
c
C
Photodegradation
C
Stability
in
water
(
hydrolysis)

C
Monitoring
data
(
environment)

C
Transport
and
distribution
between
environmental
compartments
including
estimated
environmental
concentrations
and
distribution
pathways
C
Biodegradation
C
Degradation:
biotic;
abiotic
C
Fate
and
behavior
in
the
environment:

adsorption/
desorption
screening
study
C
Degradation:

biotic(
additional);

identification
of
degradation
products
C
Fate
and
behavior
in
the
environment:
adsorption/

desorption
(
additional);

bioconcentration
in
one
aquatic
species,
preferably
fish
C
Degradation:
biotic(
additional)

C
Fate
and
behavior
in
the
environment
(
additional)

Ecotoxicological
Studies
C
Acute/
prolonged
toxicity
to
fish
C
Acute
toxicity
to
aquatic
invertebrates
(
daphnia)

C
Toxicity
to
aquatic
plants
e.
g.
algae
C
Chronic
toxicity
to
aquatic
invertebrates
(
daphnia)

C
Toxicity
to
terrestrial
organisms
C
Avian
dietary
toxicity
test
C
Avian
reproduction
test
C
Earthworms
acute
toxicity
test
C
Terrestrial
plants,
growth
test
C
Aquatic
toxicity:
Short­
term
toxicity
testing
on
Daphnia
Tests
described
in
the
column
to
the
left,

plus:

C
Aquatic
toxicity:
Growth
inhibition
study
on
algae;
Short­
term
toxicity
testing
on
fish;
Activated
sludge
respiration
inhibition
testing
ests
described
in
the
column
to
the
left,
plus:

C
Aquatic
toxicity:
Long­
term
toxicity
testing
on
Daphnia;

Long­
term
toxicity
testing
on
fish
C
Effects
on
terrestrial
organisms:
Short­
term
toxicity
to
earthworms;
Effects
on
soil
micro­
organisms;
Short­
term
toxicity
to
plants
Tests
described
in
the
column
to
the
left,

plus:

C
Effects
on
terrestrial
organisms:

Longterm
toxicity
to
earthworms;

Longterm
toxicity
to
soil
invertebrates;

Long­
term
toxicity
to
plants
C
Long­
term
toxicity
to
sediment
organisms
C
Long­
term
or
reproductive
toxicity
to
birds
Sources:
US.
EPA
2003c,
Commission
of
the
European
Communities
2003,
Risk
&
Policy
Analysts
2003.

a
Also
required
for
isolated
intermediates
transported
in
quantities
of
greather
than
1,000
tonnes
per
year
bSee
Risk
&
Policy
Analysts
2003,
p.
35
and
37.
Figures
do
not
include
polymers.

c
EU
documentation
lists
these
tests
under
the
category
of
"
Ecotoxicological
Studies"

d
This
test
may
also
be
categorized
under
Environmental
Fate
and
Pathways
2
It
is
important
to
note
that
the
test
plans
reviewed
represent
only
38
percent
of
all
HPV
chemicals.
For
the
remaining
chemicals
it
is
not
known
whether
existing
data
or
modeling
results
will
satisfy
the
testing
requirements
to
the
same
degree.

8
2.5
Impact
of
the
HPV
Challenge
and
REACH
on
Chemical
Testing
Demand
Testing
demand
to
satisfy
data
needs
for
the
HPV
Challenge
has
been
lower
than
initially
expected
because
many
of
the
data
gaps
identified
in
EPA's
HPV
testing
initiative
have
been
filled
using
existing
research,
thereby
avoiding
the
need
for
new
testing.
For
example,
Environmental
Defense's
"
HPV
Tracker"
tool
indicates
that,
based
on
test
plans
filed
through
July
2004,
no
further
testing
is
planned
for
460
of
1,338
chemicals
(
34.4
percent)
(
Environmental
Defense,

2004).

EPA's
own
analysis
indicates
the
amount
of
new
testing
required
may
be
even
lower.
Through
August
2003,
EPA
had
received
and
reviewed
(
but
not
necessarily
approved)
test
plans
covering
approximately
790
HPV
chemicals.
Each
test
plan
addresses
the
15
SIDS
endpoints,
thus
the
test
plans
reviewed
address
a
total
of
11,850
endpoints.
The
reviewed
test
plans
suggest
that
approximately
6,800
endpoints,
or
45
percent
of
the
total,
can
be
satisfied
with
existing
data
(
see
Table
3).
For
another
50
percent,
or
7,400
endpoints,
data
was
submitted
based
on
analogy,

structure­
activity
relationship
modeling,
technical
discussion,
"
read­
across,"
or
computer
and
mathematical
modeling.
Sponsors
plan
to
conduct
actual
new
testing
to
fill
data
gaps
for
only
the
remaining
785
endpoints.
This
would
represent
just
6.5
percent
of
the
endpoints
required
to
fulfill
the
SIDS
testing
requirements
for
these
790
chemicals2
(
U.
S.
EPA
2004b).
9
Table
3.
Summary
of
Test
Requirements
for
790
Sponsored
HPV
Chemicalsa,
b
Testing
Status
Chemical
Properties
Environmental
Fate
and
Pathways
Ecotoxicity
Health
Effects
Totals
Melting
Point
Boiling
Point
Vapor
Pressure
Partition
Coefficient
Water
Solubility
Photodegradation
Biodegradation
Stability
in
Water
Transport/

Distribution
Acute
Fish
Acute
Invertebrates
Acute
Algae
Terrestrial
Toxicity
Acute
Toxicity
(

oral,

dermal,

inhalation)
Genetic
Toxicity
(

in
vitro:

bacterial
Genetic
Toxicity
(

in
vivo)
Repeated
Dose
Toxicity
Reproductive
Developmental
Number
of
Chemicals
Proposed
for
testing
25
38
15
73
89
9
60
32
5
47
57
68
1
7
37
29
47
70
76
785
Analogy,
SAR,
Estimation
290
299
372
444
365
583
343
414
634
363
405
450
8
232
358
418
389
501
477
7,345
Adequate
existing
data
325
385
320
242
307
122
361
141
80
344
292
234
0
532
383
252
330
185
205
5,040
Testing
based
on
results
of
other
category
members
0
0
4
1
1
8
0
3
13
4
4
4
0
0
0
0
0
0
0
42
Reproductive
and
developmental
testing
will
depend
on
results
of
repeat
dose
studies
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
5
3
9
Not
applicable
due
to
physical/
chemical
properties
150
68
79
29
28
68
25
200
57
32
32
34
781
19
11
61
23
26
25
1,748
Not
addressed
in
test
plan
0
0
0
1
0
0
1
0
1
0
0
0
0
0
1
30
0
3
4
41
TOTAL
790
790
790
790
790
790
790
790
790
790
790
790
790
790
790
790
790
790
790
15,010
aBased
on
EPA's
preliminary
review
of
submitted
test
plans
as
of
August
29,
2003.

bThe
columns
show
19
endpoints,
however
only
15
must
be
completed
to
fulfill
the
SIDS
dossier.
For
example:
the
transport
and
distribution
test
is
optional;
submitters
may
complete
the
genetic
toxicity
requirement
using
either
in
vivo
or
in
vitro
methods;
and
submitters
may
complete
either
the
repeated
dose
toxicity
test
or
a
combination
of
the
reproductive
and
developmental
toxicity
testing.
See
U.
S.
EPA
(
2003c)
for
further
details.
10
11
The
EU's
REACH
program
is
still
in
draft
proposal
form
and
it
will
likely
be
several
years
before
legislation
is
put
in
place
to
make
it
law.
Nevertheless,
the
broader
coverage
of
REACH
compared
with
the
HPV
program
makes
it
important
to
look
at
even
now.

From
the
standpoint
of
generating
demand
for
testing,
the
REACH
program
will
likely
exceed
that
of
HPV
for
several
reasons.
To
begin
with,
the
number
of
chemicals
covered
is
substantially
greater
(
approximately
20,000
for
REACH
versus
2,089
for
HPV
Challenge).
The
more
significant
fact,
however,
is
likely
to
be
differences
in
the
availability
of
existing
data
for
thousands
of
lower
volume
REACH
chemicals.
As
noted
above,
U.
S.
experience
shows
that
test
data
exists
already
for
many
HPV
Challenge
chemicals.
But
these
were
chemicals
produced
at
levels
equal
to
or
in
excess
of
one
million
pounds.
The
REACH
program
will
extend
to
chemicals
produced
at
levels
as
low
as
one
metric
ton
(
2,200
pounds)
per
year.
For
these
low
volume
chemicals
the
likelihood
of
industry
producing
existing
test
data
could
be
much
lower
because
the
low
production
volumes
neither
warrant
such
testing
nor
generate
the
profit
margins
needed
to
fund
such
testing.

The
EU
Commissioners
who
introduced
REACH
estimate
that
European
testing
facilities
will
only
be
able
to
provide
25
to
30
percent
of
the
testing
capacity
required
(
Liikanen
and
Wallstöm
2003,
p.
17).
They
anticipate
that
testing
demand
generated
by
REACH
may
be
met
using
"
capacity
from
elsewhere
in
the
world,"
and
suggest
the
possibility
that
"
the
decision
to
establish
REACH
will
lead
to
investment
in
additional
testing
capacity."
It
is
reasonable
to
anticipate,

therefore,
that
REACH
will
significantly
influence
the
world­
wide
chemical
testing
market
in
the
years
to
come.

One
testing
lab,
which
focuses
on
environmental
toxicity
testing,
reports
that
some
of
its
clients
are
already
scheduling
tests
called
for
under
draft
REACH
legislation,
even
though
the
legislation
may
not
be
made
into
law
for
several
more
years
(
Hutchinson
and
Jaber
2004).
These
firms
are
concerned
that
there
could
be
a
temporary
shortage
of
capacity
for
environmental
toxicity
testing
immediately
following
the
passage
of
REACH,
particularly
if
the
timing
coincides
with
the
12
implementation
of
endocrine
disruptor
testing
requirements.

2.6
U.
S.
Testing
for
Endocrine
Disruption
Potential
Scientific
evidence
has
been
accumulating
that
suggests
that
environmental
exposure
to
chemicals
that
mimic
hormones
(
endocrine
disruptors)
may
cause
adverse
health
effects
in
human
and
wildlife
populations.
In
the
U.
S.,
Congress
acted
in
response
to
this
evidence
in
the1996
Food
Quality
Protection
Act,
which
amended
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
and
directed
EPA
"
to
determine
whether
certain
substances
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
effects
as
[
EPA]

may
designate".
When
carrying
out
the
program,
the
statute
requires
EPA
to
"
provide
for
the
testing
of
all
pesticide
chemicals."
The
statute
also
provides
EPA
with
discretionary
authority
to
"
provide
for
the
testing
of
any
other
substance
that
may
have
an
effect
that
is
cumulative
to
an
effect
of
a
pesticide
chemical
if
the
Administrator
determines
that
a
substantial
population
may
be
exposed
to
such
a
substance."
In
addition,
section
1457
of
the
Safe
Drinking
Water
Act
provides
EPA
with
discretionary
authority
to
provide
for
testing,
under
the
FFDCA
408(
p)
screening
program,
"
of
any
other
substances
that
may
be
found
in
sources
of
drinking
water
if
the
Administrator
determines
that
a
substantial
population
may
be
exposed
to
such
substance."

EPA
is
currently
planning
on
using
a
two
tier
system
to
test
chemicals
for
endocrine
disruption
effects.
Tier
1
screening
is
designed
to
detect
chemical
substances
capable
of
interacting
with
the
estrogen,
androgen,
and
thyroid
hormonal
systems.
Tier
2
testing
is
designed
to
determine
whether
a
chemical
may
have
an
effect
similar
to
that
of
naturally
occurring
hormones
and
to
identify,
characterize,
and
quantify
those
effects
for
estrogen,
androgen,
and
thyroid
hormones.

Tier
2
testing
will
be
required
for
chemicals
that
are
identified
as
potential
endocrine
disruptors
by
the
Tier
1
screening
battery.
EPA
is
currently
developing
and
validating
a
number
of
assays,
the
majority
of
which
are
being
considered
for
the
Tier
1
screening
battery.
The
assays
under
consideration
are
described
below.
More
information
is
available
at
http://
www.
epa.
gov/
scipoly/
oscpendo/
assayvalidation/
status.
htm.
13
Table
4.
Endocrine
Disruptor
Screening
Assays
Under
Consideration
Tier
1
Screening
Aromatase
Aromatase
is
an
enzyme
complex
responsible
for
estrogen
biosynthesis
that
converts
androgens
into
estrodiol
and
estrone.
The
Aromatase
assay
focuses
on
this
portion
of
the
steroidogenic
pathway
to
detect
substances
that
inhibit
aromatase
activity.

Steroidogenesis
The
Steroidogenesis
assay
uses
sliced
testes
from
the
rat
to
detect
interference
with
any
steps
leading
to
the
production
of
testosterone.

Estrogen
Receptor
(
ER)
Binding
Chemicals
can
affect
the
endocrine
system
by
binding
to
hormone
receptors
to
either
mimic
the
action
of
the
natural
hormone
or
block
access
of
the
hormone
to
the
site
and
thus
block
hormone
controlled
activity.
The
Estrogen
Receptor
Binding
assay
monitors
chemical
binding
with
an
estrogen
receptor.

Androgen
Receptor
(
AR)
Binding
The
Androgen
Receptor
Binding
assay
monitors
chemical
binding
with
an
androgen
receptor.

Uterotrophic
The
uterotrophic
assay
involves
the
use
of
whole
rats
to
detect
the
ability
of
a
chemical
to
stimulate
or
inhibit
estrogenic
responses
of
the
uterus
(
measured
through
change
in
uterine
weight).

Hershberger
The
Hershberger
assay
involves
the
use
of
whole
rats
to
detect
the
ability
of
a
chemical
to
stimulate
or
inhibit
androgenic
responses
in
secondary
sex
organs
(
e.
g.,
ventral
prostate
and
seminal
vesicle).

Pubertal
Female
The
Pubertal
Female
assay
involves
the
use
of
whole
rats
to
screen
for
estrogenic
and
thyroid
activity
in
females
during
sexual
maturation.
This
assay
examines
abnormalities
associated
with
sex
organs
and
secondary
sexual
characteristics.

Pubertal
Male
The
Pubertal
Male
assay
involves
the
use
of
whole
rats
to
screen
for
estrogenic
and
thyroid
activity
in
males
during
sexual
maturation.
This
assay
examines
abnormalities
associated
with
sex
organs
and
secondary
sexual
characteristics.

Amphibian
Metamorphosis
The
Amphibian
Metamorphosis
assay
involves
the
use
of
whole
tadpoles
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Fish
Screen
The
Fish
Screen
assay
screens
for
estrogenic
and
androgenic
effects.
The
assay
involves
the
use
of
whole
fish
to
examine
abnormalities
associated
with
survival,
reproductive
behavior,
secondary
sex
characteristics,
and
fecundity
(
i.
e.,
number
of
spawns,
number
of
eggs/
spawn,
fertility,
and
development
of
offspring).
Table
4.
Endocrine
Disruptor
Screening
Assays
Under
Consideration
14
Tier
2
Screening
Mammalian
2­
Generation
The
Mammalian
2­
Generation
assay
involves
the
use
of
whole
rats
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Avian
2­
Generation
The
Avian
2­
Generation
assay
involves
the
use
of
whole
birds
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Amphibian
2­
Generation
The
Amphibian
2­
Generation
assay
involves
the
use
of
whole
frogs
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Invertebrate
Lifecycle
The
Invertebrate
Lifecycle
assay
involves
the
use
of
whole
mysid
shrimp
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Fish
Lifecycle
The
Fish
Lifecycle
assay
involves
the
use
of
whole
fish
to
characterize
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Tier
to
be
determined
In
Utero
through
Lactation
The
In
Utero
through
Lactation
assay
involves
the
use
of
whole
rats
to
assess
post­
natal
development
after
in
utero,
lactational,
and
post­
lactational
exposure.

Table
5
summarizes
the
assays
under
consideration.
Some
of
the
assays
list
multiple
substrates
(
such
as
rat
cytosol,
human
placental,
and
human
recombinant).
Testing
for
an
assay
would
only
be
required
for
a
single
substrate
source,
although
there
could
be
optional
substrates
for
some
assays.
Some
of
these
substrates
may
eventually
be
eliminated
from
consideration.
15
Table
5.
Endocrine
Disruptor
Screening
 
Assays
Under
Consideration
Assay
and
substrate
Assay
Description
Tier
1
Screening
Aromatase
Rat
Cytosol
Human
placental
(
post
delivery)
Human
Recombinant
In
vitro.
Aromatase
is
a
cytochrome
P450
enzyme
complex
responsible
for
estrogen
biosynthesis
and
converts
androgens
(
testosterone
and
androstenedione)
into
estrodiol
and
estrone.
The
purpose
of
this
assay
is
to
focus
on
this
portion
of
the
steroidogenic
pathway
to
detect
substances
that
inhibit
aromatase
activity.

Steroidogenesis
Sliced
rat
testes
Cell
based
H295R
In
vitro.
Steroidogenesis
detects
interference
in
any
steps
leading
to
the
production
of
testosterone.

Estrogen
Receptor
(
ER)
Binding
Rat
uterine
cytosol
Human
recombinant
In
vitro.
One
of
the
most
basic
ways
chemicals
affect
the
endocrine
system
is
to
bind
to
hormone
receptors,
to
either
mimic
the
action
of
the
natural
hormone
or
block
access
of
the
hormone
to
the
site
and
thus
block
hormone
controlled
activity.
This
assay
detects
binding
(
or
gene
expression
that
results
from
several
steps
including
binding)
to
the
estrogen
receptor.

Androgen
Receptor
(
AR)
Binding
Rat
prostate
cytosol
Human
recombinant
In
vitro.
Similar
to
Estrogen
Receptor
Binding
above,
but
for
androgen
receptor
binding.

Uterotrophic
(
OECD)
Rat
(
whole):
Detects
ability
of
chemical
to
stimulate
or
inhibit
estrogenic
responses
of
the
uterus
(
i.
e.,
increased
uterus
weight).

Hershberger
(
OECD)
Rat
(
whole):
Detects
the
ability
of
a
chemical
to
stimulate
or
inhibit
androgenic
responses
in
secondary
sex
organs
(
e.
g.,
ventral
prostate
and
seminal
vesicle).

Pubertal
female
Rat
(
whole):
Screens
for
estrogenic
and
thyroid
activity
on
females
during
sexual
maturation.
Examines
abnormalities
associated
with
sex
organs
and
secondary
sexual
characteristics.

Pubertal
male
Rat
(
whole):
Screens
for
androgenic
and
thyroid
activity
in
males
during
sexual
maturation.
Examines
abnormalities
associated
with
sex
organs
and
secondary
sexual
characteristics.

Amphibian
Metamorphosis
Tadpoles
(
whole):
Characterizes
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Fish
Screen
(
OECD)
Fish
(
whole):
Screens
for
estrogenic
and
androgenic
effects.
Examines
abnormalities
associated
with
survival,
reproductive
behavior,
secondary
sex
character
and
fecundity.
Table
5.
Endocrine
Disruptor
Screening
 
Assays
Under
Consideration
Assay
and
substrate
Assay
Description
16
Tier
2
Screening
Mammalian
2­
generation
Rat
(
whole):
Characterizes
dose­
response,
characteristics
and
adverse
reproductive
and
developmental
effects.

Avian
2­
generation
Bird
(
whole):
Characterizes
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Amphibian
2­
generation
Frog
(
whole):
Characterizes
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Invertebrate
Lifecycle
Mysid
shrimp
(
whole):
Characterizes
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Fish
Lifecycle
Fish
(
whole):
Characterizes
dose­
response
characteristics
and
adverse
reproductive
and
developmental
effects.

Tier
to
be
determined
In
Utero
through
Lactation
Rat
(
whole):
Assesses
postnatal
development
after
in
utero,
lactational
and
post­
lactational
exposure
(
F
1
).

Assay
Development
and
Validation
The
FFDCA
required
EPA
to
use
"
appropriate
validated
test
systems
and
other
scientifically
relevant
information"
to
determine
whether
substances
have
an
endocrine
effect.
The
science
related
to
measuring
and
demonstrating
endocrine
disruption
is
relatively
new
and
validated
testing
methods
are
still
being
developed.
EPA
is
putting
the
assays
through
a
process
of
development,
pre­
validation,
validation,
and
peer
review.

Pre­
validation
involves
optimization
and
standardization
of
the
protocol
and
the
development
of
preliminary
data
on
reproducibility
within
a
single
laboratory
(
e.
g,
performance
criteria).

Validation
tests
the
transferability
of
the
protocol
to
other
laboratories,
determines
the
reliability
of
the
protocol,
and
further
documents
its
relevance.
Validation
studies
are
conducted
at
several
different
laboratories
using
the
same
protocol.
After
testing
is
complete,
EPA
compares
the
interlaboratory
results
statistically
to
determine
whether
or
not
the
protocol
meets
the
criteria
for
17
reliability
.
All
EDSP
methods
must
be
peer
reviewed
before
they
are
approved
for
regulatory
use.
The
study
results
generated
during
protocol
development,
pre­
validation,
and
validation
are
combined
into
EDSP
method­
specific
documents.
These
documents
then
undergo
an
external
peer
review
following
Agency
guidelines.
Once
the
Agency
has
considered
the
results
of
the
peer
review
and
the
regulatory
procedures
are
made
known,
the
Agency
can
begin
requiring
the
ED
testing
using
the
optimized
and
validated
protocols.

Number
and
Types
of
Chemicals
Affected
The
number
and
types
of
chemicals
that
may
be
subject
to
testing
for
endocrine
disrupting
potential
is
uncertain.
In
its
December
2002
request
for
comments
on
the
screening
program,

EPA
proposed
to
follow
the
recommendations
of
a
subcommittee
of
the
EPA
Science
Advisory
Board
(
SAB)
and
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
to
initiate
the
Tier
1
screening
program
with
a
set
of
50
to
100
chemicals
and
use
the
results
to
further
refine
the
program.
The
notice
further
goes
on
to
say:

EPA
has
stated
its
intention
to
consider
a
broad
universe
of
chemicals
as
potential
candidates
for
testing
under
the
EDSP
including
pesticide
chemicals,
non­
pesticide
commercial
chemicals,
mixtures,
and
environmental
contaminants
(
63
FR
71542).
However,
for
the
first
group
of
chemicals
to
be
tested,
EPA
is
intending
to
focus
only
on
pesticide
active
ingredients
and
high
production
volume
(
HPV)
chemicals
with
some
pesticidal
inert
uses
(
i.
e.,
the
chemicals
that
are
specifically
mandated
for
testing
under
section
408(
p)
of
FFDCA).
The
pesticide
inerts
to
be
considered
are
those
with
relatively
large
overall
production
volumes
considering
both
pesticide
and
non­
pesticide
uses.
This
approach
will
allow
EPA
to
focus
its
initial
endocrine
screening
efforts
on
a
smaller
and
more
manageable
universe
of
chemicals
that
emphasizes
early
attention
to
the
pesticide
chemicals
that
Congress
specifically
mandated
EPA
to
test
for
possible
endocrine
effects.

(
67
FR
79611;
December
30,
2002)

Thus,
in
all
likelihood
the
program
will
start
small
but
could
expand
to
include
greater
numbers
and
more
types
of
chemicals,
depending
on
the
results
of
the
initial
screening.
3
Table
A­
1
identifies
labs
according
to
their
capabilities
in
each
of
these
areas.
Tables
A­
2
through
A­
10
highlight
each
of
the
nine
areas
of
testing.
Table
A­
11
provides
contact
information
for
each
of
the
50
18
3.0
SUPPLY
OF
CHEMICAL
TESTING
SERVICES
In
this
report,
the
analysis
of
chemical
testing
services
supply
is
based
primarily
on
expert
knowledge
of
the
testing
industry
and
first
hand
discussions
with
laboratory
representatives,
as
EPA
has
not
found
comprehensive
information
on
the
industry
in
published
sources.
The
following
sections
review
the
contract
research
organization
(
CRO)
segment
of
the
market
and
the
in­
house,
captive
testing
segment
of
the
market,
and
other
sources
of
testing
services
supply.

3.1
Contract
Research
Organizations
To
assist
in
assessing
the
number
and
geographic
distribution
of
CROs
capable
of
conducting
the
types
of
testing
required
under
the
programs
identified
above,
an
industry
expert
was
consulted
and
dispatched
to
the
annual
meeting
and
exhibition
of
the
Society
of
Toxicology
(
SOT),
which
took
place
in
Baltimore
from
March
21
to
25,
2004.
This
meeting,
known
as
ToxExpo,
is
billed
as
the
largest
toxicology
meeting
and
exhibit
in
the
world,
attracting
some
6,000
attendees
from
industry,
academia,
and
government
and
over
280
exhibitors
from
the
U.
S.
and
overseas
(
SOT
2004).
Based
on
a
review
of
exhibitor
lists
from
past
SOT
meetings,
EPA
judged
that
the
2004
meeting
was
likely
to
attract
a
majority
of
CROs
with
chemical
testing
capabilities
of
interest
for
this
report
(
Piccirillo
2003).

Prior
to
the
conference,
the
consultant
reviewed
the
list
of
2004
exhibitors
and
identified
those
known
or
believed
to
participate
in
chemical
testing.
At
the
conference,
the
consultant
visited
the
booths
of
50
such
CROs,
picked
up
laboratory
qualifications
statements
and
other
literature,
and
asked
general
questions
about
capabilities.

Following
the
conference,
the
consultant
reviewed
the
materials
and
analyzed
the
capabilities
of
the
labs
based
on
the
information
collected.
Appendix
A
shows
these
results
in
detail.
3
Each
lab
laboratories.

19
has
been
evaluated
to
determine
its
capabilities
in
nine
areas
of
testing:

C
Physical/
chemical
characteristics
C
General
toxicity 
acute
C
General
toxicity 
repeated/
subchronic
C
General
toxicity 
teratogenicity/
developmental
toxicology
C
General
toxicity 
reproductive/
reproduction
C
General
toxicity 
chromosomal
aberation
micronucleus
C
Aquatic
toxicity 
fish/
daphnia/
algae
C
Analytical
chemistry
C
Environmental
fate
The
results
of
the
analysis
are
summarized
in
Table
6
below.

Table
6.
Capability
of
Contract
Research
Organizations
to
Conduct
Chemical
Testing
Type
of
Testing
Number
of
Labs
U.
S.
Non­
U.
S.
Total
Physical/
chemical
characteristics
6
9
15
General
toxicity 
acute
19
22
41
General
toxicity 
repeated/
subchronic
20
23
43
General
toxicity 
teratogenicity/
developmental
toxicology
11
21
32
General
toxicity 
reproductive/
reproduction
11
20
31
General
toxicity 
chromosomal
aberration
micronucleus
8
18
26
Aquatic
toxicity 
fish/
daphnia/
algae
6
10
16
Analytical
chemistry
20
18
38
Environmental
fate
8
11
19
Total
number
of
labs
with
testing
capabilities
27
23
50
Source:
Piccirillo
2004.

As
shown,
the
number
of
U.
S.­
based
labs
exhibiting
at
ToxExpo
that
were
judged
capable
of
20
conducting
the
types
of
testing
needed
to
provide
HPV
data
ranges
from
as
few
as
a
half
dozen
to
twenty,
depending
on
the
type
of
testing.
Generally,
an
equal
or
greater
number
of
labs
outside
the
U.
S.
have
similar
capabilities.
These
include
labs
located
in
Brazil,
Canada,
Denmark,

England,
Germany,
India,
Italy,
Japan,
Korea,
Netherlands,
and
Switzerland
(
see
also
Appendix
A).

Currently,
there
is
no
single
U.
S.
laboratory
that
can
provide
the
full
range
of
capabilities
potentially
required
to
fully
test
the
safety
of
an
industrial
chemical
(
Piccirillo
2004).
A
total
of
six
non­
U.
S.
based
labs
were
judged
to
be
capable
of
conducting
the
full
suite
of
testing,
and
an
additional
four
were
judged
to
be
capable
to
conduct
testing
in
all
but
one
area.
The
mean
number
of
capabilities
(
out
of
a
total
of
nine)
is
5.2
when
averaged
among
all
50
labs.
For
the
27
U.
S.­
based
labs,
the
mean
number
of
capabilities
is
4.0,
while
the
mean
number
of
capabilities
for
the
23
non­
U.
S.­
based
labs
was
6.6.
Thus,
labs
outside
the
U.
S.
on
average
provide
a
somewhat
greater
range
of
capabilities.

According
to
observers
of
the
industry,
CRO
chemical
testing
laboratories
are
generally
specialized
into
two
groups 
those
that
focus
on
mammalian
toxicology
and
those
that
study
toxicology
in
fish
and/
or
birds.
Worldwide,
there
are
only
about
16
CROs
in
the
field
of
aquatic
toxicology
and
11
in
the
field
of
avian
toxicology
(
Hutchinson
and
Jaber
2004).

In
addition,
there
are
approximately
eight
CROs
qualified
to
conduct
testing
in
genetic
toxicology
(
Piccirillo
2004).
There
are
only
three
CROs
in
the
United
States
that
perform
biodegradation
tests,
supplemented
by
a
few
small
labs
in
Europe
and
a
few
major
chemical
manufacturers
(
e.
g.,

ExxonMobil)
that
conduct
in­
house
testing
(
Hutchinson
and
Jaber
2004).
Testing
labs
that
can
conduct
physical
chemical
studies
are
more
common
and
widespread;
the
necessary
expertise
is
more
available
and
the
laboratory
work
can
be
conducted
relatively
quickly.

In
addition
to
first
hand
data
collected
at
ToxExpo,
EPA
reviewed
a
2001
report
from
the
U.
K's
Institute
for
Environment
and
Health
which
estimated
there
to
be
approximately
16
CROs
in
the
4
The
report
defined
a
"
base
set"
as
the
following
set
of
tests:
mammalian
acute
oral
toxicity,
mammalian
acute
dermal
irritation/
corrosion,
mammalian
acute
eye
irritation,
mammalian
skin
sensitization,
mammalian
repeated
dose
28­
day
oral
toxicity,
mammalian
reproductive/
developmental
toxicity
screening,
and
acute
toxicity
in
fish.

21
European
Union
(
EU)
capable
of
performing
chemical
safety
testing
(
Institute
for
Environment
and
Health
2001).
On
average,
each
of
these
laboratories
has
the
capacity
to
conduct
a
full
"
Base
Set"
of
tests
for
40
chemicals
per
year.
4
In
light
of
the
global,
integrated
structure
of
the
chemical
testing
market,
it
is
assumed
that
this
throughput
can
be
taken
as
generally
representative
for
fullservice
testing
labs
throughout
the
world.

3.2
Captive
In­
House
Testing
Labs
Observers
of
the
testing
market
also
note
that
chemical
manufacturers
themselves
are
providing
some
of
the
capacity
for
chemical
testing
through
their
in­
house
laboratories
(
Piccirillo
2004;

Muermann
2004;
Ohne
and
Siddiqui
2004;
Hutchinson
and
Jaber
2004).
Industry
observers
were
unable
to
compare
the
relative
volume
of
testing
work
performed
at
CROs
and
at
in­
house
industrial
laboratories,
but
agreed
that
a
significant
volume
of
testing
is
performed
in­
house.
The
testing
programs
of
Dow,
Dupont,
and
ExxonMobil
were
mentioned
as
particularly
noteworthy.

However,
a
number
of
factors
restrict
the
extent
to
which
chemical
manufacturers
can
rely
on
their
own
testing
facilities.
For
example,
a
Dow­
Corning
representative
stated
that
the
company
had
no
current
in­
house
capacity
to
conduct
genetic
toxicology
testing
(
Ohne
and
Siddiqui
2004).

Factors
that
play
into
in­
house
testing
allocations
include
available
space,
the
particular
expertise
available
in­
house,
the
relative
cost
of
in­
house
testing
versus
outsourcing,
and
the
motivation
to
form
testing
consortia
with
other
manufacturers.
When
several
chemical
manufacturers
agree
to
form
a
consortium
for
the
testing
of
a
particular
chemical,
it
is
often
most
expedient
for
the
consortium
to
use
a
CRO
rather
than
the
in­
house
lab
of
any
one
member,
due
to
concern
over
the
appearance
of
conflict
of
interest
(
Muermann
2004).

3.3
Other
Sources
of
Testing
Capacity
22
Additional
sources
of
laboratory
testing
capacity
may
exist
withing
university
departments
or
other
research
centers
in
the
U.
S.
and
around
the
world.
While
they
may
have
capabilities
to
conduct
some
of
the
testing
described
in
this
report,
such
facilities
are
generally
not
set
up
to
perform
testing
on
a
commercial
scale.
Although
this
report
did
not
examine
these
kinds
of
facilities
in
detail,
industry
observers
consider
it
unlikely
that
significant
commercial
testing
capacity
would
be
available
from
such
sources
(
e.
g.,
Piccirillo
2003).

4.0
CURRENT
INDUSTRY
ISSUES
As
described
in
Section
2,
recent
demand
for
testing
has
in
fact
been
beneath
the
expectations
of
CRO
testing
laboratories.
Among
the
circumstances
contributing
to
lower­
than­
expected
testing
demand
has
been
the
ability
of
industry
to
satisfy
HPV
Challenge
data
needs
using
existing
data,

or
computer
modeling.
As
noted
in
Section
3,
less
than
seven
percent
of
790
chemicals
covered
by
HPV
Challenge
test
plans
reviewed
by
EPA
were
proposing
new
testing.
This
section
discusses
other
issues
identified
that
may
be
affecting
both
the
demand
for
and
supply
of
testing
services.

4.1
Issues
Affecting
Demand
As
noted
above,
demand
for
HPV
testing
has
been
below
expectations,
but
this
may
begin
to
change
as
the
proposed
expansion
to
the
EU
testing
program
gets
underway.
The
EU
REACH
proposal
would
encompass
many
more
chemicals,
albeit
while
applying
a
tiered
testing
approach.

Until
the
testing
demand
driven
by
REACH
begins
to
materialize,
however,
it
appears
that
other
drivers
will
dominate
the
market
for
chemical
testing.

The
primary
"
other"
driver
of
testing
demand
is
the
pharmaceutical
and
biotech
business.
One
major
testing
lab
indicated
that
its
non­
pharmaceutical
market
represents
only
six
to
eight
percent
of
total
sales
(
Muermann
2004).
Because
of
this
reliance
on
pharmaceutical
demand,
changes
in
demand
driven
by
other
factors,
such
as
EPA
testing
activity,
are
not
likely
to
have
great
influence
23
on
capacity
decisions.

Another
factor
that
has
kept
chemical
testing
demand
in
check
has
been
the
recent
trend
towards
consolidation
in
the
chemical
and
agri­
chemical
industries,
reducing
the
number
of
product
lines
that
need
to
be
tested.
Several
labs
that
reported
downward
trends
in
testing
demand
over
the
last
two
or
three
years
attributed
the
change
(
at
least
in
part)
to
consolidations
and
mergers
among
major
clients
(
for
example,
the
recent
merger
of
Bayer
and
Aventis)
(
Holbert
2003,

Hutchinson
and
Jaber
2004).
These
mergers
have
had
several
effects,
including
consolidation
of
product
lines
(
fewer
new
products
means
fewer
new
tests)
and
also
greater
reliance
on
in­
house
testing
capabilities.

Both
chemical
manufacturers
and
testing
laboratories
(
and
regulatory
agencies
as
well)
have
been
under
pressure
from
animal
rights
groups
to
minimize
the
amount
of
animal
testing
being
conducted.
In
the
case
of
upcoming
testing
under
the
EU
REACH
program,
pressure
from
animal
rights
groups
is
likely
to
be
even
more
intense
(
Piccirillo
2003).
One
testing
lab
even
reported
that
it
had
moved
away
from
the
entire
field
of
mammalian
toxicology
because
social
pressure
had
moved
its
primary
clients
(
in
the
cosmetics
industry)
away
from
animal
testing
in
the
early
1990s
(
Kim
2004).

ACC
indicates
that
the
need
for
new
laboratory
work
in
response
to
the
HPV
initiative
is
distributed
fairly
evenly
across
the
fields
of
mammalian
toxicology,
environmental
toxicology,
and
physical/
chemical
properties.
One
possible
exception
is
mammalian
toxicology,
where
there
is
a
somewhat
greater
need
for
new
lab
work
in
the
field
of
reproductive
testing
(
proposed
under
REACH)
and
developmental
testing
(
included
in
HPV
testing
and
proposed
under
REACH)

(
Russell
2003).

Overall,
while
it
is
difficult
to
assess
relative
strength
of
demand
for
particular
types
of
testing,

those
areas
of
testing
in
which
demand
has
been
reported
to
be
particularly
strong
(
relative
to
testing
capacity)
are:
the
testing
of
chemical
toxicity
via
inhalation
pathways,
the
testing
of
24
reproductive
toxicity,
and
the
testing
of
biodegradation
(
Piccirillo
2003).

4.2
Issues
Affecting
Supply
The
ability
of
laboratories
to
respond
to
changes
in
demand
is
of
interest
because
EPA
and
others
who
propose
new
testing
initiatives
need
to
provide
sufficient
lead
time
for
such
testing
to
be
completed.
Preliminary
interviews
indicate
the
HPV
testing
initiative
has
produced
significantly
less
new
business
for
the
chemical
testing
industry
than
was
anticipated
when
the
program
was
announced
(
Picciorillo
2003;
Holbert
2003;
U.
S.
EPA
2004b).
Industry
observers
call
this
the
latest
in
a
"
pattern
of
disappointment"
that
has
followed
past
EPA
testing
initiatives.
This
feeling
of
disappointment
may
contribute
to
future
industry
wariness
to
expand
capacity
in
response
to
testing
initiatives.

The
ability
of
labs
to
expand
capacity
beyond
what
currently
exists
will
depend
on
several
factors,

such
as
equipment
and
buildings
costs.
Capacity
to
conduct
the
most
sophisticated
tests,
such
as
those
that
assay
developmental
or
neurotxicological
effects
may
be
far
more
difficult
to
scale
up,

in
comparison
with
more
standardized
testing
such
as
acute
toxicity
(
Picirrillo
2003).
Among
the
reasons
cited
are
the
lengthy
and
costly
validation
processes
for
these
types
of
testing,
and
the
limited
availability
of
trained
program
managers
and
technicians.
To
validate
tests
in
which
experimenters
make
subtle
observations
(
about
animal
behavior
or
developmental
morphology,

for
example)
each
laboratory
must
conduct
regular
trials
that
demonstrate
the
consistency
and
accuracy
of
their
staff's
judgement.
However,
lab
capacity
to
conduct
screening
level
HPV
tests
(
i.
e.,
the
standard
SIDS
battery)
is
not
limited
by
these
validation
issues 
the
issue
is
more
relevant
with
respect
to
the
advanced
testing
that
HPV
screening
tests
may
prompt.

A
particular
bottleneck
in
testing
capacity
may
exist
in
the
area
of
inhalation
testing,
where
the
expense
and
expertise
necessary
to
custom
build
the
inhalation
apparatus
is
a
significant
factor
limiting
expansion
of
capacity,
particularly
for
new
entrants
into
the
field.
One
firm
that
conducts
inhalation
toxicity
testing
reports
that,
despite
two
rounds
of
capacity
expansion,
it
is
currently
25
running
a
four
month
backlog.
Potential
clients
initially
balk
at
accepting
this
delay
in
beginning
work,
until
they
discover
that
the
firm's
competitors
have
comparable
backlogs
(
Sved
2004).
One
reason
why
capacity
is
particularly
restricted
for
inhalation
testing
of
chemicals
is
that
there
is
little
pharmaceutical
demand
for
such
tests
to
encourage
companies
to
invest
in
the
necessary
equipment
(
Sved
2004,
Hardy
2004).
Even
those
prospective
drugs
which
require
inhalation
toxicity
testing
(
e.
g.,
nasal
aerosols
and
powders)
are
generally
tested
using
a
different
protocol
(
snout­
only)
from
industrial
chemicals
(
whole
body).
Thus,
the
market
for
inhalation
toxicology
testing
is
unusually
small
and
reliant
upon
regulatory
programs
to
generate
business
demand.

There
is
a
great
deal
of
variability
among
tests
in
terms
of
the
industry's
ability
to
adjust
capacity
to
meet
demand
(
Piccirillo
2003;
Holbert
2003).
Acute
toxicity
testing
work
may
be
scaled
up
relatively
easily,
but
more
complex
testing
such
as
two­
generation
developmental
toxicology
studies
may
be
limited
by
available
space
and
staffing.
Two­
generation
developmental
toxicology
studies
in
particular
present
logistical
difficulties
because
they
typically
require
raising
and
housing
over
1,000
animals
(
Piccirillo
2004).
Also,
the
initial
investment
to
enter
certain
fields
of
testing
may
be
prohibitive 
for
example,
it
is
estimated
to
cost
close
to
a
million
dollars
(
in
equipment
and
method
validation)
to
enter
the
field
of
neurotoxicological
testing.
Similarly,
testing
of
toxicity
via
inhalation
pathways
requires
particularly
expensive,
specialized
equipment
(
Hardy
2004,
Sved
2004).

One
CRO
laboratory,
about
65,000
square
feet
in
size,
reports
that
it
currently
performs
between
200
and
300
acute
toxicity
studies
in
a
year
but
could
easily
double
that
volume
if
the
demand
were
present
(
Holbert
2003).
One
ecotoxicology
laboratory
reports
that
it
could
increase
avian
toxicology
testing
by
30
to
40
percent
and
double
avian
toxicology
testing
without
experiencing
any
delays
or
capacity
troubles.
(
Hutschinson
and
Jaber,
2004).
Conversely,
labs
involved
in
other
fields
of
testing
such
as
biodegradation
tests,
tests
of
reproductive
toxicity,
and
toxicity
tests
involving
inhaled
chemicals
are
currently
operating
closer
to
current
capacity
(
Hutchinson
and
Jaber
2004;
Hardy
2004,
Sved
2004).
26
The
availability
of
trained
staff
can
also
present
a
barrier
to
capacity
expansion.
Recruiting
challenges
vary
considerably
depending
on
geography
and
the
particular
skill
sets
required.
For
example,
a
central
Ohio
testing
laboratory
reports
that
the
difficulty
of
finding
suitable
staff
for
its
respiratory
toxicology
work
places
a
significant
constraint
on
testing
capacity
(
Sved
2004).

However,
a
Boston­
area
testing
laboratory
reported
few
problems
finding
staff
to
fill
its
expanded
facilities
for
general
mammalian
toxicology
(
Dreckert
2004).
Sometimes,
the
difficulty
in
finding
suitable
staff
is
overqualification
rather
than
underqualification
(
Newton
2004).
While
some
positions
are
best
filled
by
persons
with
bachelor's
or
master's
degrees,
others
are
best
filled
by
persons
with
associate's
degrees
(
Newton
2004,
Hutchnson
and
Jaber
2004).

Anticipation
of
increased
demand
from
pharmaceutical
companies
subject
to
FDA
regulation
is
the
primary
driver
of
business
expansion
among
chemical
testing
labs.
One
chemical
testing
lab
that
provides
acute,
subchronic,
and
chronic
toxicity
testing
reports
that
it
is
in
the
midst
of
a
major
expansion
of
its
mammalian
toxicology
facilities
(
Deckert
2004).
The
lab
is
also
hopeful
that
the
provisions
of
EU's
REACH
program
will
increase
demand
for
its
laboratory
facilities.

Even
though
capacity
adjustment
may
be
relatively
easier
in
some
fields
than
in
others,
the
chemical
testing
industry
as
a
whole
is
hesitant
to
increase
capacity
in
response
to
upsurges
in
demand.
A
representative
of
the
American
Chemistry
Council
emphasizes
that
there
are
strong
barriers
to
the
expansion
of
the
overall
capacity
of
the
chemical
testing
industry
(
Russell
2003).

He
argues
that
the
supply
of
chemical
testing
is
fairly
inelastic 
recently,
testing
firms
have
been
responding
to
increases
in
demand
by
raising
prices
rather
than
by
expanding
capacity.
In
addition,

the
use
of
customized
testing
protocols
will
tend
to
restrict
capacity,
as
only
the
most
highly
specialized
labs
are
able
to
implement
modified
versions
of
standard
testing
protocols.
Chemical
testing
labs
are
wary
of
over­
reacting
to
short­
term
swings
in
demand
from
temporary
regulatory
initiatives.
One
chemical
testing
company
explained
that
it
deliberately
cross­
trains
its
personnel
in
a
variety
of
fields
so
that
it
can
respond
to
localized
swings
in
demand
for
particular
tests
without
changing
overall
staffing
levels
(
Muermann
2004).
27
When
new
regulations
increase
demand
for
a
particular
kind
of
testing
(
for
example,
FIFRA
between
1989
and
1993),
toxicological
testing
laboratories
tend
to
respond
by
raising
their
prices
and
accumulating
a
backlog
of
assignments
rather
than
expanding
capacity
(
Piccirillo
2004).

However,
a
lab
with
highly
specialized
expertise
in
inhalation
testing
reports
that
it
is
responding
to
increased
demand
by
expanding
its
capacity
(
Sved
2004).
Capacity
expansion
notwithstanding,

two
labs
agreed
that
the
need
for
reproductive
toxicology
studies
of
inhaled
chemicals
is
likely
to
be
a
significant
bottleneck
and
data
gap
for
chemical
testing
in
the
near
future
(
Sved,
2004;
Hardy
2004).

It
is
difficult
to
extrapolate
from
existing
experience
with
the
HPV
Challenge
to
predict
the
effect
of
the
EU's
REACH
program,
particularly
since
the
definite
provisions
of
the
REACH
program
will
not
be
settled
until
at
least
2005
(
Russell
2003;
Cascone
2004;
Dalton
2004).
Even
if
the
EU
REACH
program
is
passed
as
currently
written,
there
remains
significant
uncertainty
about
how
it
will
influence
chemical
policies
in
jurisdictions
outside
the
EU.

Some
labs
have
high
hopes
for
future
business
to
be
generated
by
Tier
1
endocrine
testing.
A
total
of
16
labs
have
been
involved
in
validating
these
Tier
1
endocrine
tests.
There
remains
significant
uncertainty
about
what
the
final
provisions
of
EPA's
endocrine
disruptor
testing
program
will
be
(
Becker
2003;
Silagi
2003).
It
is
not
known
currently
which
tests
will
be
validated
for
use
in
this
program
and
what
the
proposed
pace
of
testing
will
be.
A
representative
from
the
American
Chemistry
Council
pointed
out
that
the
pace
of
testing
will
need
to
be
known
before
the
question
of
capacity
can
be
addressed
(
Russell
2003).

Overall,
based
on
contacts
made
for
this
report,
the
current
economic
condition
of
the
chemical
testing
industry
appears
mixed.
Some
testing
labs
report
slack
demand,
while
others
(
particularly
those
with
a
strong
base
of
clients
in
pharmaceutical
research
and
development)
report
excellent
sales
and
ongoing
facilities
expansion
(
Holbert
2003;
Newton
2004;
Deckert
2004;
Hutchinson
and
Jaber
2004).

As
a
possible
indicator
of
economic
health
of
the
chemical
testing
industry,
EPA
examined
data
28
on
trends
in
lab
accreditation,
specifically
accreditation
under
the
Association
for
the
Assessment
and
Accreditation
of
Laboratory
Animal
Care
(
AAALAC)
standard.
While
AAALAC
accreditation
is
not
legally
required,
it
is
an
important
credential
for
any
commercial
lab
engaged
in
tests
involving
animals.
AALAC
reports
a
relatively
steady,
1
to
2
percent
growth
rate
over
the
last
decade
in
the
accreditation
of
laboratories
that
use
laboratory
animals
as
subjects.
(
AAALAC
2004).
Unfortunately,
more
detailed
data
breaking
out
statistics
for
chemical
testing
labs
(
versus
other
types
of
labs
that
use
animals)
were
not
available
from
AAALAC.
There
does
not
appear
to
be
any
other
body
that
accredits
chemical
testing
labs
specifically.
Although
many
such
labs
must
adhere
to
principles
of
Good
Laboratory
Practice
(
GLP),
GLP
compliance
is
audited
directly
by
clients
or
consultants,
not
by
any
trade
organization
(
Muermann
2004).

One
CRO
reported
that
it
noticed
an
inverse
relationship
between
the
economic
health
of
its
clients
and
the
amount
of
business
it
receives
from
them.
(
Sved
2004).
The
rationale
proposed
for
this
phenomenon
is
that
economic
troubles
encourages
businesses
to
invest
in
research
and
development,
generate
new
products,
and
then
submit
the
new
products
to
the
CRO
for
testing.

A
final
factor
that
may
affect
the
relative
availability
of
testing
capacity
to
U.
S.
chemical
manufacturers
is
the
relative
weakness
of
the
dollar
(
Muermann
2004).
Chemical
testing
is
a
globalized
market,
in
which
a
range
of
international
clients
seek
the
services
of
a
global
array
of
testing
laboratories.
When
the
dollar
devalues
against
the
euro,
the
substantial
portion
of
the
global
testing
market
that
is
located
in
Europe
becomes
less
accessible
to
U.
S.
firms.
As
a
corollary,
a
weaker
dollar
also
means
that
U.
S.
chemical
companies
are
likely
to
face
stiffer
competition
with
European
firms
for
the
limited
testing
capacity
available
in
the
U.
S.
29
5.0
CONCLUSIONS
This
report
examines
the
global
market
for
testing
of
industrial
chemicals
for
evidence
of
effects
on
human
health
and
the
environment.
Such
testing
information
is
required
by
governments
to
assist
in
evaluating
the
risks
to
humans
and
the
environment
from
the
manufacturing,
processing,

transportation,
distribution,
use,
and
disposal
of
such
chemicals.
The
demand
for
such
testing
is
driven
by
government
regulatory
programs
as
well
as
voluntary
programs.
In
the
U.
S.,
the
primary
drivers
for
such
testing
are
programs
authorized
under
the
Toxic
Substances
Control
Act
(
TSCA),
particularly
TSCA
Section
4,
and
voluntary
programs
such
as
the
HPV
Challenge,
also
administered
by
the
U.
S.
Environmental
Protection
Agency
(
U.
S.
EPA).

Because
the
chemicals
industry
is
global
in
nature,
the
testing
and
evaluation
programs
in
other
parts
of
the
world
are
also
of
interest.
The
primary
non­
U.
S.
program
examined
in
this
report
is
the
existing
chemicals
program
of
the
European
Union,
in
particular
the
proposed
expansion
of
the
existing
chemicals
testing
program
known
as
Registration,
Evaluation
and
Authorisation
of
Chemicals,
or
REACH.

The
report
finds
that,
to
date,
the
testing
of
chemicals
for
human
and
environmental
effects
driven
by
regulatory
and
voluntary
programs
such
as
those
managed
by
EPA
(
including
the
HPV
Challenge)
have
not
been
the
major
driver
for
chemical
testing
demand
overall.
In
fact,
testing
to
satisfy
pharmaceutical
and
biotechnology
product
introductions
has
tended
to
overshadow
EPArelated
testing.
Numerous
contract
research
organizations
(
CROs)
report
that
testing
to
support
pharmaceutical
and
biotech
product
market
introduction
dominates
their
testing
programs.

EPA's
own
analysis
indicates
that
the
HPV
Challenge,
while
large
in
scope
(
encompassing
more
than
2,000
high­
volume
chemicals)
has
not
generated
the
volume
of
new
testing
demand
that
was
initially
expected.
To
industry,
this
reinforces
a
pattern
it
has
seen
before:
a
tendency
for
regulatory
programs
to
generate
less
demand
for
testing
than
initially
promised.
As
a
result,

numerous
laboratories
report
taking
a
"
wait
and
see"
attitude
to
EPA
programs.
Much
the
same
30
position
is
taken
towards
REACH
and
towards
other
types
of
testing
on
the
horizon,
such
as
that
for
endocrine
disruption
potential.
At
this
point,
the
ultimate
impact
on
testing
demand
cannot
be
determined,
and
few
labs
are
expanding
capacity
in
anticipation
of
increased
demand.

Based
on
EPA's
analysis
of
the
capabilities
of
labs
exhibiting
recently
at
one
of
the
world's
largest
trade
shows,
there
is
substantial
capability
for
conducting
the
types
of
testing
required
for
HPV
chemicals
in
both
the
U.
S.
and
abroad.
Of
the
50
labs
judged
to
have
at
least
some
capabilities
for
HPV
types
of
testing,
27
were
based
in
the
U.
S.
and
23
were
based
outside
the
U.
S.

The
ability
of
such
labs
to
expand
capacity
in
response
to
increases
in
demand
will
depend
on
the
type
of
testing.
Standardized
types
of
testing
such
as
acute
toxicity
testing
can
be
scaled
up
relatively
quickly
because
the
equipment
needed
to
conduct
such
testing
is
widely
available
at
modest
cost
and
there
is
a
substantial
workforce
trained
in
conducting
such
testing.
For
more
specialized
types
of
testing,
expanding
capacity
can
become
much
more
complicated.
Capacity
to
conduct
sophisticated
tests,
such
as
those
that
assay
developmental
or
neurotxicological
effects,

may
be
far
more
difficult
to
scale
up.
Among
the
reasons
cited
are
the
lengthy
and
costly
validation
processes
for
these
types
of
testing,
and
the
limited
availability
of
trained
program
managers
and
technicians.

One
particular
area
where
capacity
appears
notably
constrained
and
difficult
to
expand
is
toxicity
testing
via
inhalation
routes.
In
this
area,
the
expense
and
expertise
necessary
to
custom
build
the
inhalation
apparatus
is
a
significant
factor
limiting
expansion
of
capacity,
particularly
for
new
entrants
into
the
field.
In
addition,
participants
in
this
market
note
unlike
other
types
of
testing
there
is
an
absence
of
pharmaceutical
demand
in
this
area,
making
those
firms
more
dependant
on
regulatory­
driven
demand.
31
6.0
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4
Information
Collection
Request
(
ICR):
TSCA
Existing
Chemical
Test
Rules,
34
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
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(
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0033;
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May
21,
2004.
APPENDIX
A
CAPABILITIES
OF
U.
S.
AND
FOREIGN
CHEMICAL
TESTING
LABS
EXHIBITING
AT
2004
TOX
EXPO
BALTIMORE,
MD
A­
1
Table
A­
1.
Capabilities
of
2004
ToxExpo
Exhibitors
to
Conduct
Chemical
Testing,
by
Type
of
Testing
No.
Name
of
Lab
Physical/

Chemical
Characteristics
General
Toxicology
Acute
General
Toxicology
Repeated/

Subchronic
General
Toxicology
Teratogenicity/

Developmental
Toxicology
General
Toxicology
Reproductive/

Reproduction
Genetic
Toxicology
Chromsomal
Aberation
Micronucleus
Aquatic
Toxicology
Fish/

Daphnid/

Algae
Analytical
Chemistry
Environmental
Fate
Total
number
of
labs
15
41
44
32
33
26
17
39
19
1
ABC
Labs
x
x
x
x
2
Battelle
x
x
x
3
Bioagri
Pharma
x
x
x
x
x
4
Bioanalytical
Systems
Inc.
(
BASi)
x
x
x
x
x
5
Biological
Testing
Centre
(
BTC)
x
x
x
6
Bio
Reliance
x
x
x
x
7
Calvert
Labs
x
x
x
x
x
x
8
Centre
International
de
Toxicologie
(
CIT)
x
x
x
x
x
x
x
9
Centrel
Toxicology
Labs
(
CTL)
x
x
x
x
x
x
10
Charles
River
Labs
x
x
x
x
x
11
Covance
x
x
x
x
x
x
x
x
12
CTBR
x
x
x
x
x
x
13
Fraunhofer
Institute
of
Toxicology
x
x
x
x
x
x
14
Huntingdon
Life
Sciences
x
x
x
x
x
x
x
x
x
15
IITRI
Research
Institute
x
x
x
x
x
16
INA
Research
x
x
x
x
x
Table
A­
1.
Capabilities
of
2004
ToxExpo
Exhibitors
to
Conduct
Chemical
Testing,
by
Type
of
Testing
No.
Name
of
Lab
Physical/

Chemical
Characteristics
General
Toxicology
Acute
General
Toxicology
Repeated/

Subchronic
General
Toxicology
Teratogenicity/

Developmental
Toxicology
General
Toxicology
Reproductive/

Reproduction
Genetic
Toxicology
Chromsomal
Aberation
Micronucleus
Aquatic
Toxicology
Fish/

Daphnid/

Algae
Analytical
Chemistry
Environmental
Fate
A­
2
17
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
x
x
x
x
x
x
x
x
18
Inveresk
Research
x
x
x
x
x
x
x
x
19
ITRLaboratories
Canada
x
x
x
20
JAI
Research
Institute
x
x
x
x
x
x
x
x
x
21
Korea
Institute
x
x
x
x
x
x
x
x
22
LAB
Research
x
x
x
x
x
x
23
MB
Research
x
x
x
24
Midwest
Research
x
x
x
x
25
MPI
Research
x
x
x
x
x
26
Next
Century
x
27
Northview
Biosciences
x
x
x
28
No
Tox
x
x
x
x
x
x
x
x
x
29
Product
Safety
Labs
x
x
x
x
30
Provident
Preclinical
x
x
x
x
31
Quintiles
x
x
x
x
32
Rallis
Research
Centre
x
x
x
x
x
x
x
x
x
33
RCC
x
x
x
x
x
x
x
x
x
34
Research
Toxicology
Centre
(
RTC)
x
x
x
x
x
x
x
x
35
Ricerca
Biosciences
x
x
x
36
RTI
International
x
x
x
Table
A­
1.
Capabilities
of
2004
ToxExpo
Exhibitors
to
Conduct
Chemical
Testing,
by
Type
of
Testing
No.
Name
of
Lab
Physical/

Chemical
Characteristics
General
Toxicology
Acute
General
Toxicology
Repeated/

Subchronic
General
Toxicology
Teratogenicity/

Developmental
Toxicology
General
Toxicology
Reproductive/

Reproduction
Genetic
Toxicology
Chromsomal
Aberation
Micronucleus
Aquatic
Toxicology
Fish/

Daphnid/

Algae
Analytical
Chemistry
Environmental
Fate
A­
3
37
Safe
Pharm
Labs
x
x
x
x
x
x
x
x
x
38
Scan
Tox
x
x
39
Sequani
x
x
x
x
40
Shin
Nippon
Research
Labs
(
SNBL)
x
x
x
x
x
x
41
Sitek
Research
Labs
x
x
42
Southern
Research
Institute
x
x
x
x
43
Springborn
Smithers
Labs
x
x
44
Stillmeadow
Inc.
x
x
x
x
x
45
TNO
Pharma
x
x
x
x
x
x
46
Toxicology
Research
Labs
x
x
x
x
47
Toxikon
x
x
x
x
x
48
T.
R.
Wilbury
Labs
x
x
x
x
49
WIL
Research
Labs
x
x
x
x
x
x
50
Wildlife
International
x
x
x
x
A­
4
Table
A­
2.
Lab
Capabilities
 
Physical/
Chemical
Characteristics
1.
Covance
USA
2.
Huntingdon
Life
Sciences
UK
3.
Intn'l
Instiute
of
Biotech.
&
Toxicology
(
IIBAT)
India
4.
Inveresk
Research
Scotland
5.
JAI
Research
Institute
India
6.
Midwest
Research
Institute
USA
7.
NoTox
Netherlands
8.
Product
Safety
Labs
USA
9.
Rallis
Research
Centre
India
10.
RCC
Switzerland
11.
SafePharm
Labs
UK
12.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
13.
Stillmeadow
Inc.
USA
14.
T.
R.
Wilbury
Labs
USA
15.
Wildlife
International
USA
A­
5
Table
A­
3.
Lab
Capabilities
 
General
Toxicology
 
Acute
1.
Battelle
USA
2.
Bioagri
Pharma
Brazil
3.
Bioananalytical
Systems
Inc.
(
BASi)
USA
4.
Biological
Testing
Centre
(
BTC)
USA
5.
BioReliance
USA
6.
Calvert
Labs
USA
7.
Central
Toxicology
Labs
(
CTL)
UK
8.
Centre
International
De
Toxicologie
(
CIT)
France
9.
Charles
River
Labs
USA
10.
Covance
USA
11.
CTBR
Canada
12.
Fraunhofer
Institute
of
Toxicology
Germany
13.
Huntingdon
Life
Sciences
UK
14.
IITRI
Research
Institute
USA
15.
INA
Research
Japan
16.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
17.
Inveresk
Research
Scotland
18.
ITR
Laboratories
Canada
Canada
19.
JAI
Research
Institute
India
20.
Korea
Institute
Korea
21.
LAB
Research
Canada
22.
MB
Research
USA
23.
Midwest
Research
USA
24.
MPI
Research
USA
25.
Northview
Biosciences
USA
26.
NoTox
Netherlands
27.
Product
Safety
Labs
USA
28.
Provident
Preclinical
USA
29.
Quintiles
UK
30.
Rallis
Research
Centre
India
31.
RCC
Switzerland
32.
Research
Toxicology
Centre
(
RTC)
Italy
33.
Ricerca
Biosciences
USA
34.
SafePharm
Labs
UK
35.
Sequani
UK
36.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
37.
Southern
Research
Institute
USA
38.
Stillmeadow
Inc.
USA
39.
TNO
Pharma
Netherlands
40.
Toxikon
USA
41
WIL
Research
Labs
USA
A­
6
Table
A­
4.
Lab
Capabilities
 
General
Toxicology
 
Repeated/
Subchronic
1.
Battelle
USA
2.
Bioagri
Pharma
Brazil
3.
Bioanalytical
Systems
Inc.
(
BASi)
USA
4.
Biological
Testing
Centre
(
BTC)
USA
5.
BioReliance
USA
6.
Calvert
Labs
USA
7.
Central
International
De
Toxicologie
(
CIT)
France
8.
Central
Toxicology
Labs
(
CTL)
UK
9.
Charles
River
Labs
USA
10.
Covance
USA
11.
CTBR
Canada
12.
Fraunhofer
Institute
of
Toxicology
Germany
13.
Huntingdon
Life
Sciences
UK
14.
IITRI
Research
Institute
USA
15.
INA
Research
Japan
16.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
17.
Inveresk
Research
Scotland
18.
ITR
Laboratories
Canada
Canada
19.
JAI
Research
Institute
India
20
Korea
Institute
Korea
21
LAB
Research
Canada
22.
MB
Research
USA
23.
Midwest
Research
USA
24.
MPI
Research
USA
25.
Northview
Biosciences
USA
26.
NoTox
Netherlands
27.
Product
Safety
Labs
USA
28.
Provident
Preclinical
USA
29.
Quintiles
UK
30.
Rallis
Research
Centre
India
31.
RCC
Switzerland
32.
Research
Toxicology
Centre
(
RTC)
Italy
33
Ricerca
Biosciences
USA
34.
SafePharm
Labs
UK
35.
ScanTox
Denmark
36.
Sequani
UK
37.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
38.
Southern
Research
Institute
USA
39.
Stillmeadow
Laboratories
USA
40.
TNO
Pharma
Netherlands
41.
Toxicology
Research
Labs
USA
42.
Toxikon
USA
43.
WIL
Research
Labs
USA
A­
7
Table
A­
5.
Lab
Capabilities
 
General
Toxicology
 
Teratogenicity
&
Developmental
Toxicology
1.
Bioagri
Pharma
Brazil
2.
Bioanalytical
Systems
Inc.
(
BASi)
USA
3.
Calvert
Labs
USA
4.
Central
Toxicology
Labs
(
CTL)
UK
5.
Centre
International
De
Toxicologie
(
CIT)
France
6.
Charles
River
Labs
USA
7.
Covance
USA
8.
CTBR
Canada
9.
Fraunhofer
Institute
of
Toxicology
Germany
10.
Huntingdon
Life
Sciences
Uk
11.
IITRI
Research
Institute
USA
12.
INA
Research
Japan
13.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
14.
Inveresk
Research
Scotland
15.
JAI
Research
Institute
India
16.
Korea
Institute
Korea
17.
LAB
Research
Canada
18.
MPI
Research
USA
19.
NoTox
Netherlands
20.
Provident
Preclinical
USA
21.
Quintiles
UK
22.
Rallis
Research
Centre
India
23.
RCC
Switzerland
24.
Research
Toxicology
Centre
(
RTC)
Italy
25.
RTI
International
USA
26.
SafePharm
Labs
UK
27.
Sequani
UK
28.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
29.
Southern
Research
Institute
USA
30.
TNO
Pharma
Netherlands
31.
Toxicology
Research
Labs
USA
32.
WIL
Research
Labs
USA
A­
8
Table
A­
6.
Lab
Capabilities
 
General
Toxicology
 
Reproductive
/
Reproduction
1.
Bioagri
Pharma
Brazil
2.
Bioanalytical
Systems
Inc.
(
BASi)
USA
3.
Calvert
Labs
USA
4.
Central
Toxicology
Labs
(
CTL)
Uk
5.
Centre
International
De
Toxicologie
(
CIT)
France
6.
Charles
River
Labs
USA
7.
Covance
USA
8.
CTBR
Canada
9.
Fraunhofer
Institute
of
Toxicology
Germany
10.
Huntingdon
Life
Sciences
UK
11.
IITRI
Research
Institute
USA
12.
INA
Research
Japan
13.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
14.
Inveresk
Research
Scotland
15.
JAI
Research
Institute
India
16.
Korea
Institute
Korea
17.
LAB
Research
Canada
18.
MPI
Research
USA
19.
NoTox
Netherlands
20.
Provident
Preclinical
USA
21.
Rallis
Research
Centre
India
22.
RCC
Switzerland
23.
Research
Toxicology
Centre
(
RTC)
Italy
24.
RTI
International
USA
25.
SafePharm
Labs
UK
26.
Sequani
UK
27.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
28.
Southern
Research
Institute
USA
28.
TNO
Pharma
Netherlands
30.
Toxicology
Research
Labs
USA
31.
WIL
Research
Labs
USA
A­
9
Table
A­
7.
Lab
Capabilities
 
Genetic
Toxicology
 
Chromosomal
Aberration
/
Micronucleus
1.
Bioagri
Pharma
Brazil
2.
BioReliance
USA
3.
Calvert
Labs
USA
4.
Central
Toxicology
Labs
(
CTL)
UK
5.
Centre
International
De
Toxicologie
(
CIT)
France
6.
Covance
USA
7.
CTBR
Canada
8.
Fraunhofer
Institute
of
Toxicology
Germany
9.
Huntingdon
Life
Sciences
UK
10.
IITRI
Research
Institute
USA
11.
INA
Research
Japan
12.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
13.
Inveresk
Research
Scotland
14.
JAI
Research
Institute
India
15.
Korea
Institute
Korea
16.
LAB
Research
Canada
17.
Next
Century
USA
18.
NoTox
Netherlands
19.
Rallis
Research
Centre
India
20.
RCC
Switzerland
21.
Research
Toxicology
Centre
(
RTC)
Italy
22.
SafePharm
Labs
UK
23.
Sitek
Research
LAbs
USA
24.
TNO
Pharma
Netherlands
25.
Toxikon
USA
A­
10
Table
A­
8.
Lab
Capabilities
 
Aquatic
Toxicology
 
Fish
/
Daphnid
/
Algae
1.
ABC
USA
2.
Huntingdon
Life
Sciences
UK
3.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
India
4.
JAI
Research
Institute
India
5.
Korea
Institute
Korea
6.
NoTox
Netherlands
7.
Rallis
Research
Centre
India
8.
RCC
Switzerland
9.
Research
Toxicology
Centre
(
RTC)
Italy
10.
SafePharm
Labs
UK
11.
ScanTox
Denmark
12.
SpringbornSmithers
Labs
USA
13.
Stillmeadow
Inc.
USA
14.
Toxikon
USA
15.
T.
R.
Wilbury
Labs
USA
16.
Wildlife
International
USA
A­
11
Table
A­
9.
Lab
Capabilities
 
Analytical
Chemistry
1.
ABC
Labs
USA
2.
Bioanalytical
Systems
Inc.
(
BASi)
USA
3.
Biological
Testing
Centre
(
BTC)
USA
4.
BioReliance
USA
5.
Calvert
Labs
USA
6.
Central
Toxicology
Labs
(
CTL)
UK
7.
Centre
International
De
Toxicologie
(
CIT)
France
8.
Charles
River
Labs
USA
9.
Covance
USA
10.
CTBR
Canada
11.
Huntingdon
Life
Sciences
UK
12.
Intn'l
Institute
of
Biotech.
&
Toxicology
(
IIBAT)
INdia
13.
Inveresk
Research
Scotland
14.
ITR
Laboratories
Canada
Canada
15.
JAI
Research
Institute
India
16.
Korea
Institute
Korea
17.
LAB
Research
Canada
18.
MB
Research
USA
19.
Midwest
Research
USA
20.
MPI
Research
USA
21.
Northview
Biosciences
USA
22.
NoTox
Netherlands
23.
Product
Safety
Labs
USA
24.
Quintiles
UK
25.
Rallis
Research
Centre
India
26.
RCC
Switzerland
27.
Research
Toxicology
Centre
(
RTC)
Italy
28.
RTI
International
USA
29.
SafePharm
Labs
UK
30.
Shin
Nippon
Research
Labs
(
SNBL)
Japan
31.
Sitek
Research
Labs
USA
32.
SpringbornSmithers
Labs
USA
33.
TNO
Pharma
Netherlands
34.
Toxicology
Research
Labs
USA
35.
Toxikon
USA
36.
T.
R.
Wilbury
Labs
USA
37.
WIL
Research
Labs
USA
38.
Wildlife
International
USA
A­
12
Table
A­
10.
Lab
Capabilities
 
Environmental
Fate
1.
ABC
USA
2.
Battelle
USA
3.
Centre
International
De
Toxicologie
(
CIT)
France
4.
Covance
USA
5.
Fraunhofer
Institute
of
Toxicology
Germany
6.
Huntingdon
Life
Sciences
UK
7.
Inveresk
Research
Scotland
8.
JAI
Research
Institute
India
9.
Korea
Institute
Korea
10.
NoTox
Netherlands
11.
Rallis
Research
Centre
India
12.
RCC
Switzerland
13.
Research
Toxicology
Centre
(
RTC)
Italy
14.
Ricerca
Biosciences
USA
15.
SafePharm
Labs
UK
16.
Stillmeadow
Inc.
USA
17.
T.
R.
Wilbury
Labs
USA
18.
WIL
Research
Labs
USA
19.
Wildlife
International
USA
A­
13
Table
A­
11.
Lab
Capabilities
 
Lab
Contact
Information
No.
Lab
Name
Address
City
State
Country
Internet
1
ABC
Laboratories
7200
E.
ABC
Lane
Columbia
MO
USA
www.
abclabs.
com
2
Battelle
505
King
Street
Columbus
OH
USA
www.
battelle.
org/
pharmaceutical
3
BioAgri
Pharma
Rodovia
Rio
Clara
Piracicaba
SP
Brazil
wwww.
bioagriata.
com.
br
4
Bioanalytical
Systems,
Inc.

(
BASi)
2701
Kent
Avenue
West
Lafayette
IN
USA
www.
bioanalytical.
com
5
Biological
Testing
Center
(

BTC)
2525
McGAw
Avenue
Irvine
CA
USA
www.
biologicaltestcenter.
com
6
BioReliance
14920
Broschart
Road
Rockville
MD
USA
www.
bioreliance.
com
7
Calvert
Labs
100
Discovery
Drive
Olyphant
PA
USA
www.
calvertlabs.
com
8
Centre
Internatioanle
De
Toxicologie
(
CIT)
9700
Great
Seneca
Highway
Rockville
MD
USA
www.
citox.
com
9
Centrel
Toxicology
Labs
(
CTL)
Alderley
Park
Macclesfield
Cheshire
UK
ann.
evans@
syngenta.
com
10
Charles
River
Labs
15
Worman's
Mill
Ct
Frederick
MD.
USA
www.
criver.
com
11
Covance
3301
Kinsman
Blvd.
Madison
WI
USA
www.
covance.
com
12
CTBR
87
Sennville
Rd.
Sennville
Quebec
Canada
www.
ctbr.
com
13
Fraunhofer
Institute
of
Toxicology
Nikolai­
Fuchs­
Str
1
Hanover
Germany
www.
lifesciences.
fraunhofer.
de
14
Huntingdon
Life
Sciences
Woolley
Road
Alconbury
Cambridgeshi
re
England
www.
huntingdon.
com
15
IITRI
Research
Institute
10
W.
35th
St.
chicago
IL
USA
www.
iitri.
org/
lifesciences
16
INA
Research
Inc.
2148­
188
Nishiminowas
Ina­
Shi
Nagano­
ken
Japan
www.
ina­
research.
co.
jp
17
Intn'l
Institute
of
Biotech.
&
Tox.

(
IIBAT)
Padappi
601
301
Tamil
Nadu
India
fippat@
giasmd01.
vsnl.
net.
in
18
Inveresk
Research
11000
Weston
Carey
NC
USA
www.
inveresk.
com
19
ITR
Laboratories
Canada,
Inc.
19601
Clark
Graham
Baie
d'Urfe
Montreal
Canada
www.
itrlab.
com
20
Jai
Research
Foundation
P.
O.
Box
30
Valsad
Gujarat
India
www.
jrfchemtox.
com
21
Korea
Institute
of
Toxicology
(
KIT)
P.
O.
Box123
Yuseong
Daejon
Korea
www.
kitox.
re.
kr
22
Lab
Research
(
LAB)
445
Armand­
Frappier
Blvd.
Laval
Quebec
Canada
www.
preclin.
com
23
MB
Research
Labs
1765
Wentz
Rd.
Spinnerstown
PA
USA
www.
mbresearch.
com
24
Midwest
Research
Institute
425
Volker
Blvd.
Kansas
City
MO
USA
www.
mriresearch.
org
Table
A­
11.
Lab
Capabilities
 
Lab
Contact
Information
No.
Lab
Name
Address
City
State
Country
Internet
A­
14
25
MPI
Research
54943
North
Main
St.
Mattawan
MI
USA
www.
mpiresearch.
com
26
Next
Century
Inc.
3
Innovation
Way
Newark
DE
USA
www.
nextcenturyinc.
com
27
Northview
Biosciences
1880
Holste
Rd.
Northbrook
IL
USA
www.
northviewlabs.
com
28
NoTox
P.
O.
Box
3476
Hertogenbosch
Netherland
s
www.
notox.
nl
29
Product
Safety
Labs
(
PSL)
2394
Route
130
Dayton
NJ
USA
www.
productsafetylabs.
com
30
Provident
Preclinical
Inc.
2003
Lower
State
Rd.
Doylestown
PA
USA
www.
ppicro.
com
31
Quintiles
10245
Hickman
Mills
Drive
Kansas
City
MO
USA
www.
quintiles.
com
32
Rallis
Research
Centre
Peenya
Industrial
Area
Bangalore
Karnataka
India
www.
rallis.
co.
in
33
RCC
Itingen
Switzerlan
d
www.
rcc.
com
34
Research
Toxicology
Centre
(
RTC)
Via
Tito
Speri
12
Pomezia
Rome
Italy
www.
rtc.
it
35
Ricerca
Biosciences
7528
Auburn
Rd.
Concord
OH
USA
www.
ricerca.
com
36
RTI
International
3040
Cornwallis
RD.
Research
Triangle
Park
NC
USA
www.
rti.
org
37
SafePharm
Laboratories
P.
O.
Box
45
Derby
England
UK
www.
safepharm.
co.
ik
38
ScanTox
Hestehavevej
Ejby
Lille
Skensved
Denmark
www.
scantox.
com
39
Sequani
Bromyard
Rd.
Ledbury
England
UK
www.
sequani.
com
40
Shin
Nippon
Biomedical
Labs
(
SNBL)
6605
Merril
Creek
Parkway
Everett
WA
USA
www.
snblusa.
com
41
Sitek
Research
Laboratories
15235
Shady
Grove
Rd.
Rockville
MD
USA
www.
siteklabs.
com
42
Southern
Research
Institute
2000
Ninth
Avenue
South
Birmingham
AL
USA
www.
southernresearch.
org
43
Springborn
Smithers
Laboratories
790
Main
Street
Wareham
MA
USA
www.
springbornsmithers.
com
44
Stillmeadow
Inc.
12852
Park
One
Drive
Sugar
Land
TX
USA
www.
stillmeadow.
com
45
TNO
Pharma
Utrechtseweg
48
Ziest
Netherland
s
www.
pharma.
tno.
nl
46
Toxicology
Research
Laboratory
University
of
Il.
Chicago
IL
USA
www.
uic.
edu/
labs/
tox
47
Toxikon
15
Wiggins
Ave.
Bedford
MA
USA
www.
toxikon.
com
48
T.
R.
Wilbury
Labs
Inc.
40
Doaks
Lane
Marblehead
MA
USA
ward@
trwilburylabs.
com
Table
A­
11.
Lab
Capabilities
 
Lab
Contact
Information
No.
Lab
Name
Address
City
State
Country
Internet
A­
15
49
WIL
Research
Labs.
Inc.
1407
George
Rd.
Ashland
OH
USA
www.
wilresearch.
com
50
Wildlife
International
Ltd.
8598
Commerce
Drive
Easton
MD
USA
ecotox@
wildlifeinternational.
com
APPENDIX
B
EPA
LIST
OF
LABORATORIES
WITH
CAPABILITIES
IN
ECOLOGICAL
TESTING
B­
1
Table
B­
1.
EPA/
OPPT
List
of
Laboratories
With
Ecological
Testing
Capabilities
No.
Name
of
Laboratory
Location
Country
1
ABC
Laboratories,
Inc.
Columbus,
MO
USA
2
Aqua
Survey,
Inc.
Flemington,
NJ
USA
3
AquaTox
Research,
Inc.
Syracuse,
NY
USA
4
AScI
Corp/
AScI­
Duluth
Environmental
Testing
Division
Duluth,
MN
USA
5
Betz
Laboratories,
Inc.
Trevose,
PA
USA
6
Biological
Monitoring,
Inc.
(
BMI)
Blacksburg,
VA
USA
7
Biomonitoring
Services
Laboratory
Gulf
Breeze,
FL
USA
8
Burlington
Research,
Inc.
Burlington,
NC
USA
9
Carolina
Ecotox,
Inc.
Durham,
NC
USA
10
Chem­
Nuclear
Laboratory
Services
Greenville,
SC
USA
11
DOW
Chemical
Company,
Environmental
Toxicology
and
Chemistry
Research
Laboratory
Midland,
MI
USA
12
EA
Engineering,
Science,
and
Technology,
Inc.,
Hunt
Valley/
Loveton
Center,
Aquatic
Toxicology
Laboratory
Sparks,
MD
USA
13
Eastman
Kodak
Company,
Environmental
Science
Section
Rochester,
NY
USA
14
ENSR,
Environmental
Toxicology
Services
Division
Woods
Hole,
MA
USA
15
Environmental
Science
and
Engineering
Gainesville,
FL
USA
16
Enwright
Environmental
Consulting
Laboratories,
Inc.
(
now
Chem­
Nuclear
Laboratory
Services,
Inc.)
Greenville,
SC
USA
17
ETT
Environmental,
Inc.
Greenville,
SC
USA
18
EXXON
Biomedical
Sciences,
Inc.,
Environmental
Toxicology
Laboratory
East
Millstone,
NJ
USA
19
E.
I.
du
Pont
de
Nemours
and
Co.,
Inc.,
Haskell
Laboratory
for
Toxicology
and
Industrial
Medicine
Newark,
DE
USA
20
Grove
Scientific
Orlando,
FL
USA
21
Hazleton
Wisconsin,
Inc.
Madison,
WI
USA
22
HydroLogic,
Inc.
Morrisville,
NC
USA
23
Laboratory
Technology,
Inc.
Kenner,
LA
USA
24
Malcolm
Pirnie,
Inc.
Tarrytown,
NY
USA
25
Mid­
State
Associates,
Inc.
Baraboo,
WI
USA
26
Parametrix,
Inc.
Bellevue,
WA
USA
27
PETROLITE
CORPORATION,
Environmental
Studies
Group
Webster
Grove,
MO
USA
28
Research
Triangle
Institute
(
RTI),
Comparative
&
Environmental
Toxicology,
Center
for
Life
Sciences
&
Toxicology
Research
Triangle
Park,
NC
USA
29
Resource
Analysts,
Inc.,
EnviroSystems
Division
Hampton,
NH
USA
30
Ricerca,
Inc.
Painesville,
OH
USA
31
Robert
J.
Goldstein
&
Assoc.,
Inc.
Raleigh,
NC
USA
32
SGS
United
States
Testing
Company,
Inc.
Fairfield,
NJ
USA
33
Shealy
Environmental
Services,
Inc.
Cayce,
SC
USA
34
Springborn
Laboratories,
Inc.
Wareham,
MA
USA
35
Stonybrook
Laboratories,
Inc.
Princeton,
NJ
USA
36
Swearingen
Ecology
Associates
Columbia,
SC
USA
37
TAI
Environmental
Sciences,
Inc.
Mobile,
AL
USA
38
Toxikon
Environmental
Sciences
Jupiter,
FL
USA
39
TRAC
Laboratories,
Inc.
Denton,
TX
USA
40
T.
R.
Wilbury
Laboratories,
Inc.
Marblehead,
MA
USA
41
Union
Carbide
Chemicals
and
Plastics
Company,
Inc.
South
Charleston,
WV
USA
Table
B­
1.
EPA/
OPPT
List
of
Laboratories
With
Ecological
Testing
Capabilities
No.
Name
of
Laboratory
Location
Country
B­
2
42
Webb
Technical
Group,
Inc.
Raleigh,
NC
USA
43
Wildlife
International,
Ltd.
Easton,
MD
USA
44
Beak
Consultants
Limited
Brampton,
Ontario
Canada
45
Hazleton
Europe
North
Yorkshire
England
46
Huntingdon
Research
Center,
Ltd.
Cambridgeshire
England
47
Huntington
Life
Sciences,
Limited
Suffolk
England
48
ICI:
Imperial
Chemical
Industries
PLC,
ICI
Group
Environmental
Laboratory
Devon
England
49
Institute
of
Freshwater
Ecology,
The
Windermere
Laboratory
Cumbria
England
50
Life
Science
Research,
Ltd.
Suffolk
England
51
SafePharm
Laboratories
Limited
Derby
England
52
Hazleton
France
Pontcharra­
Sur­
Turdine
France
53
Pharmakon
Europe
L'Arbresle
France
54
BASF
Aktiengesellschaft,
Department
of
Toxicology
Ludwigshafen
Germany
55
Battelle
Europe
Frankfurt
Germany
56
Bayer
AG,
Crop
Protection
Research/
Environmental
Research
Leverkusen
Germany
57
Dr.
U.
Noack­
Laboratory
For
Applied
Biology
Hildesheim
Germany
58
Henkel
KGaA
Dusseldorft
Germany
59
Hoechst
Aktiengesellschaft,
Pharma
Research
Toxicology
and
Pathology/
Pharma
Development
Central
Toxicology
Frankfurt
Germany
60
Huls
Aktiengesellschaft,
Prufinstitut
fur
Biologie
Marl
Germany
61
IBR
International
BioResearch,
Bioanalytical
Centre
Hannover
Germany
62
Institut
Fresenius
Taunusstein
Germany
63
Robdorf
Germany
64
Stockhausen,
Laboratory
for
Toxicology
and
Ecotoxicology
Krefeld
Germany
65
Istituto
di
Ricerche
Biomedicine
Giaasa
(
Torino)
Italy
66
Akzo
Nobel
Central
Research
Arnhem
Netherlands
67
Akzo
Research
Laboratories
Arnhem
Arnhem
Netherlands
68
RCC
NOTOX
B.
V.
Hertogenbosch
Netherlands
69
TNO
Institute
of
Environmental
Sciences
Delft
Netherlands
70
Inveresk
Research
International,
Elphinstone
Research
Center
Tranet
Scotland
71
CIBA­
GEIGY
Limited,
D&
C
Product
Ecology
Basel
Switzerland
72
CIBA­
GEIGY,
Inc.,
Product
Safety
Basel
Switzerland
73
RCC
Umweltchemie
AG
Itingen
Switzerland
Source:
List
maintained
by
Vince
Nabholz,
USEPA/
OPPTS/
HERD/
EEB
(
7403).
