Document ID: EPA-HQ-OPPT-2004-0095-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-05-20T04:00Z

25
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
A
Toxic
Substances
Control
Act
(
TSCA)
Section
8(
a)
(
15
USC
2607a)
26
TITLE
15
­
COMMERCE
AND
TRADE
CHAPTER
53
­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I
­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2607.
Reporting
and
retention
of
information
(
a)
Reports
(
1)
The
Administrator
shall
promulgate
rules
under
which
­

(
A)
each
person
(
other
than
a
small
manufacturer
or
processor)
who
manufactures
or
processes
or
proposes
to
manufacture
or
process
a
chemical
substance
(
other
than
a
chemical
substance
described
in
subparagraph
(
B)(
ii))
shall
maintain
such
records,
and
shall
submit
to
the
Administrator
such
reports,
as
the
Administrator
may
reasonably
require,
and
(
B)
each
person
(
other
than
a
small
manufacturer
or
processor)
who
manufactures
or
processes
or
proposes
to
manufacture
or
process
­

(
i)
a
mixture,
or
(
ii)
a
chemical
substance
in
small
quantities
(
as
defined
by
the
Administrator
by
rule)
solely
for
purposes
of
scientific
experimentation
or
analysis
or
chemical
research
on,
or
analysis
of,
such
substance
or
another
substance,
including
any
such
research
or
analysis
for
the
development
of
a
product,

shall
maintain
records
and
submit
to
the
Administrator
reports
but
only
to
the
extent
the
Administrator
determines
the
maintenance
of
records
or
submission
of
reports,
or
both,
is
necessary
for
the
effective
enforcement
of
this
chapter.

The
Administrator
may
not
require
in
a
rule
promulgated
under
this
paragraph
the
maintenance
of
records
or
the
submission
of
reports
with
respect
to
changes
in
the
proportions
of
the
components
of
a
mixture
unless
the
Administrator
finds
that
the
maintenance
of
such
records
or
the
submission
of
such
reports,
or
both,
is
necessary
for
the
effective
enforcement
of
this
chapter.
For
purposes
of
the
compilation
of
the
list
of
chemical
substances
required
under
subsection
(
b)
of
this
section,
the
Administrator
shall
promulgate
rules
pursuant
to
this
subsection
not
later
than
180
days
after
January
1,
1977.

(
2)
The
Administrator
may
require
under
paragraph
(
1)
maintenance
of
records
and
reporting
with
respect
to
the
following
insofar
as
known
to
the
person
making
the
report
or
insofar
as
reasonably
ascertainable:
27
(
A)
The
common
or
trade
name,
the
chemical
identity,
and
the
molecular
structure
of
each
chemical
substance
or
mixture
for
which
such
a
report
is
required.
(
B)
The
categories
or
proposed
categories
of
use
of
each
such
substance
or
mixture.

(
C)
The
total
amount
of
each
such
substance
and
mixture
manufactured
or
processed,
reasonable
estimates
of
the
total
amount
to
be
manufactured
or
processed,
the
amount
manufactured
or
processed
for
each
of
its
categories
of
use,
and
reasonable
estimates
of
the
amount
to
be
manufactured
or
processed
for
each
of
its
categories
of
use
or
proposed
categories
of
use.

(
D)
A
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use,
or
disposal
of
each
such
substance
or
mixture.

(
E)
All
existing
data
concerning
the
environmental
and
health
effects
of
such
substance
or
mixture.

(
F)
The
number
of
individuals
exposed,
and
reasonable
estimates
of
the
number
who
will
be
exposed,
to
such
substance
or
mixture
in
their
places
of
employment
and
the
duration
of
such
exposure.

(
G)
In
the
initial
report
under
paragraph
(
1)
on
such
substance
or
mixture,
the
manner
or
method
of
its
disposal,
and
in
any
subsequent
report
on
such
substance
or
mixture,
any
change
in
such
manner
or
method.

To
the
extent
feasible,
the
Administrator
shall
not
require
under
paragraph
(
1),
any
reporting
which
is
unnecessary
or
duplicative.

(
3)(
A)(
i)
The
Administrator
may
by
rule
require
a
small
manufacturer
or
processor
of
a
chemical
substance
to
submit
to
the
Administrator
such
information
respecting
the
chemical
substance
as
the
Administrator
may
require
for
publication
of
the
first
list
of
chemical
substances
required
by
subsection
(
b)
of
this
section.

(
ii)
The
Administrator
may
by
rule
require
a
small
manufacturer
or
processor
of
a
chemical
substance
or
mixture
­

(
I)
subject
to
a
rule
proposed
or
promulgated
under
section
2603,
2604(
b)(
4),
or
2605
of
this
title,
or
an
order
in
effect
under
section
2604(
e)
of
this
title,
or
(
II)
with
respect
to
which
relief
has
been
granted
pursuant
to
a
civil
action
brought
under
section
2604
or
2606
of
this
title,

to
maintain
such
records
on
such
substance
or
mixture,
and
to
submit
to
the
Administrator
such
reports
on
such
substance
or
mixture,
as
the
Administrator
may
reasonably
require.
A
rule
under
28
this
clause
requiring
reporting
may
require
reporting
with
respect
to
the
matters
referred
to
in
paragraph
(
2).

(
B)
The
Administrator,
after
consultation
with
the
Administrator
of
the
Small
Business
Administration,
shall
by
rule
prescribe
standards
for
determining
the
manufacturers
and
processors
which
qualify
as
small
manufacturers
and
processors
for
purposes
of
this
paragraph
and
paragraph
(
1).
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
B
Display
Related
to
OMB
Control
#
2070­
0054
­
Listings
of
Related
Regulations
in
40
CFR
9.1.
30
Display
Related
to
OMB
Control
#
2070­
0054
­
Listings
of
Related
Regulations
in
40
CFR
9.1
As
of
May
10,
1993,
the
OMB
approval
numbers
for
EPA
regulations
in
Chapter
I
of
Title
40
of
the
Code
of
Federal
Regulations
(
CFR)
appear
in
a
listing
in
40
CFR
9.1
(
58
FR
27472).
This
listing
fulfills
the
display
requirements
in
section
3507(
f)
of
the
Paperwork
Reduction
Act
(
PRA)
for
EPA
regulations.
The
listing
at
40
CFR
9.1
displays
this
OMB
Control
number
for
the
following
regulations:

Program
Title
40
CFR
citation
Chemical
Information
Rules
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
712.5
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
712.7
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
712.20
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
712.28
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
712.30
Dibenzo­
para­
dioxin/
Dibenzofurans
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.35(
b)(
1)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.35(
b)(
2)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.35(
b)(
4)(
iii)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.35(
c)(
1)(
i)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.35(
c)(
1)(
ii)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
766.38
Good
Laboratory
Practice
Standards
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Part
792
31
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
C
40
CFR
Part
712
This
attachment
can
also
be
accessed
online
via
Internet
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr712_
00.
html.
32
TITLE
40­­
PROTECTION
OF
ENVIRONMENT
CHAPTER
I­­
ENVIRONMENTAL
PROTECTION
AGENCY
PART
712­­
CHEMICAL
INFORMATION
RULES­­
Table
of
Contents
Subpart
A­­
General
Provisions
Sec.
712.1
Scope
and
compliance.
712.3
Definitions.
712.5
Method
of
identification
of
substances
for
reporting
purposes.
712.7
Report
of
readily
obtainable
information
for
subparts
B
and
C.
712.15
Confidentiality.

Subpart
B
­­
Manufacturers
Reporting
­­
Preliminary
Assessment
Information
712.20
Manufacturers
and
importers
who
must
report.
712.25
Exempt
manufacturers
and
importers.
712.28
Form
and
instructions.
712.30
Chemical
lists
and
reporting
periods.

Authority:
15
U.
S.
C.
2607(
a).

Source:
47
FR
26998,
June
22,
1982,
unless
otherwise
noted.

SUBPART
A
­­
GENERAL
PROVISIONS
§
712.1
Scope
and
compliance.

(
a)
This
part
establishes
procedures
for
chemical
manufacturers
and
processors
to
report
production,
use,
and
exposure­
related
information
on
listed
chemical
substances.
Subpart
A
establishes
requirements
that
apply
to
all
reporting
under
this
part.
Subpart
B
covers
manufacturers'
and
processors'
reporting.

(
b)
Chemical
substances,
mixtures,
and
categories
of
substances
or
mixtures
which
have
been
recommended
by
the
Interagency
Testing
Committee
for
testing
consideration
by
the
Agency
but
not
designated
for
Agency
response
within
12
months,
will
be
added
to
§
712.30
using
the
procedure
specified
in
§
712.30(
c)
only
to
the
extent
that
the
total
number
of
designated
and
recommended
chemicals
has
not
exceeded
50
in
any
1
year.
Additional
recommended
but
not
designated
chemicals
may
be
added
after
proposal,
and
consideration
of
public
comment.
33
[
47
FR
26998,
June
22,
1982,
as
amended
at
50
FR
34809,
Aug.
28,
1985;
60
FR
31921,
June
19,
1995]
§
712.3
Definitions.

The
definitions
in
section
3
of
TSCA,
15
U.
S.
C.
2602,
apply
for
this
part.
In
addition,
the
following
definitions
apply:

(
a)
Byproduct
means
any
chemical
substance
or
mixture
produced
without
a
separate
commercial
intent
during
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance
or
mixture.

(
b)
EPA
means
the
U.
S.
Environmental
Protection
Agency.

(
c)
Import
in
bulk
form
means
to
import
a
chemical
substance
(
other
than
as
part
of
a
mixture
or
article)
in
any
quantity,
in
cans,
bottles,
drums,
barrels,
packages,
tanks,
bags,
or
other
containers
used
for
purposes
of
transportation
or
containment,
if
the
chemical
substance
has
an
end
use
or
commercial
purpose
separate
from
the
container.

(
d)
Importer
means
anyone
who
imports
a
chemical
substance,
including
a
chemical
substance
as
part
of
a
mixture
or
article,
into
the
customs
territory
of
the
U.
S.
and
includes
the
person
liable
for
the
payment
of
any
duties
on
the
merchandise,
or
an
authorized
agent
on
his
behalf.
Importer
also
includes,
as
appropriate:

(
1)
The
consignee.

(
2)
The
importer
of
record.

(
3)
The
actual
owner
if
an
actual
owner's
declaration
and
superseding
bond
has
been
filed
in
accordance
with
19
CFR
141.20.

(
4)
The
transferee,
if
the
right
to
withdraw
merchandise
in
a
bonded
warehouse
has
been
transferred
in
accordance
with
subpart
C
of
19
CFR
part
144.
For
the
purposes
of
this
definition,
the
customs
territory
of
the
U.
S.
consists
of
the
50
states,
Puerto
Rico,
and
the
District
of
Columbia.

(
e)
Impurity
means
a
chemical
substance
unintentionally
present
with
another
chemical
substance
or
mixture.

(
f)
Intermediate
means
any
chemical
substance
that
is
consumed,
in
whole
or
in
part,
in
chemical
reactions
used
for
the
intentional
manufacture
of
other
chemical
substances
or
mixtures,
or
that
is
intentionally
present
for
the
purpose
of
altering
the
rates
of
such
chemical
reactions.
(
See
also
paragraph
(
j)
of
this
section.)
34
(
g)
Known
to
or
reasonably
ascertainable
by
means
all
information
in
a
person's
possession
or
control,
plus
all
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
know,
or
could
obtain
without
unreasonable
burden.
(
h)
Manufacture
for
commercial
purposes
means
to
import,
produce,
or
manufacture
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
manufacturer
and
includes,
among
other
things,
such
"
manufacture"
of
any
amount
of
a
chemical
substance
or
mixture:

(
1)
For
commercial
distribution,
including
for
test
marketing.

(
2)
For
use
by
the
manufacturer,
including
use
for
product
research
and
development,
or
as
an
intermediate.
Manufacture
for
commercial
purposes
also
applies
to
substances
that
are
produced
coincidentally
during
the
manufacture,
processing,
use,
or
disposal
of
another
substance
or
mixture,
including
byproducts
and
coproducts
that
are
separated
from
that
other
substance
or
mixture,
and
impurities
that
remain
in
that
substance
or
mixture.
Byproducts
and
impurities
may
not
in
themselves
have
commercial
value.
They
are
nonetheless
produced
for
the
purpose
of
obtaining
a
commercial
advantage
since
they
are
part
of
the
manufacture
of
a
chemical
produced
for
a
commercial
purpose.

(
i)
Mixture
means
any
combination
of
two
or
more
chemical
substances
if
the
combination
does
not
occur
in
nature
and
is
not,
in
whole
or
in
part,
the
result
of
a
chemical
reaction;
except
that
mixture
does
include
(
1)
any
combination
which
occurs,
in
whole
or
in
part,
as
a
result
of
a
chemical
reaction
if
the
combination
could
have
been
manufactured
for
commercial
purposes
without
a
chemical
reaction
at
the
time
the
chemical
substances
comprising
the
combination
were
combined,
and
if
all
of
the
chemical
substances
comprising
the
combination
are
included
in
the
EPA,
TSCA
Chemical
Substance
Inventory
after
the
effective
date
of
the
premanufacture
notification
requirement
under
40
CFR
part
720,
and
(
2)
hydrates
of
a
chemical
substance
or
hydrated
ions
formed
by
association
of
a
chemical
substance
with
water.
The
term
mixture
includes
alloys,
inorganic
glasses,
ceramics,
frits,
and
cements,
including
Portland
cement.

(
j)
Non­
isolated
intermediate
means
any
intermediate
that
is
not
intentionally
removed
from
the
equipment
in
which
it
is
manufactured,
including
the
reaction
vessel
in
which
it
is
manufactured,
equipment
which
is
ancillary
to
the
reaction
vessel,
and
any
equipment
through
which
the
substance
passes
during
a
continuous
flow
process,
but
not
including
tanks
or
other
vessels
in
which
the
substance
is
stored
after
its
manufacture.
(
See
also
paragraph
(
f)
of
this
section.)

(
k)
Owned
or
controlled
by
the
parent
company
means
the
parent
owns
or
controls
50
percent
or
more
of
the
other
company's
voting
stock
or
other
equity
rights,
or
has
the
power
to
control
the
management
and
policies
of
the
other
company.

(
l)
Person
means
any
natural
person,
firm,
company,
corporation,
joint
venture,
partnership,
sole
proprietorship,
association,
or
any
other
business
entity,
any
State
or
political
subdivision
thereof,
any
municipality,
any
interstate
body,
and
any
department,
agency,
or
instrumentality
of
the
35
Federal
government.

(
m)
Process
for
commercial
purposes
means
the
preparation
of
a
chemical
substance
or
mixture,
after
its
manufacture,
for
distribution
in
commerce
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
processor.
Processing
of
any
amount
of
a
chemical
substance
or
mixture
is
included.
If
a
chemical
or
mixture
containing
impurities
is
processed
for
commercial
purposes,
then
those
impurities
are
also
processed
for
commercial
purposes.

(
n)
Site
means
a
contiguous
property
unit.
Property
divided
only
by
a
public
right­
of­
way
shall
be
considered
one
site.
There
may
be
more
than
one
manufacturing
plant
on
a
single
site.

(
o)
Test
marketing
means
distributing
in
commerce
a
limited
amount
of
a
chemical
substance
or
mixture,
or
article
containing
such
substance
or
mixture,
to
a
defined
number
of
potential
customers,
during
a
predetermined
testing
period,
to
explore
market
capability
prior
to
broader
distribution
in
commerce.

(
p)
TSCA
means
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2601
et
seq.

§
712.5
Method
of
identification
of
substances
for
reporting
purposes.

(
a)
Report
on
TSCA­
regulable
quantities.
Unless
specifically
otherwise
required,
respondents
must
report
only
about
quantities
of
a
chemical
that
is
defined
as
a
chemical
substance
under
TSCA
section
3(
2).

(
b)
Chemicals
from
natural
sources.
A
manufacturer
of
a
chemical
substance
which
is
extracted
from
an
ore,
from
oil,
or
from
any
other
natural
source
must
report
only
about
the
manufacturing
steps
for,
and
the
uses
of,
that
chemical,
not
about
production
of
the
natural
source
material
or
other
crude
precursors
derived
from
the
natural
source
material.

For
example,
persons
who
manufacture
a
chemical
substance
such
as
"
sweetened
naphtha,
64741­
87­
3,"
but
do
not
refine
the
naphtha
to
produce
"
hexane,
110­
54­
3"
would
not
report
on
hexane.
Only
the
production
of
"
hexane"
as
an
isolated
product
must
be
reported
­­
not
previous
production
of
more
crude,
complex
substances
such
as
naphtha
from
which
hexane
is
extracted.
Thus,
persons
who
produce
crude
oil,
ores,
and
other
crude
natural
materials,
but
do
not
carry
them
through
further
manufacturing
steps
that
produce
a
listed
chemical
have
no
reporting
responsibilities
under
this
Part.
Note,
however,
that
any
method
of
extraction,
refinement,
or
purification
of
a
listed
chemical
substance
is
considered
to
be
manufacturing
for
the
purposes
of
this
rule.

(
c)
Chemical
substances
as
marketed.
This
part
requires
reporting
about
chemical
substances
as
they
are
marketed
or
used
in
practice.
The
following
preparations
of
a
chemical
substance
must
be
reported
as
the
substance
itself,
not
as
a
mixture,
since
these
preparations
are
regarded
as
the
36
substance
in
practice.

(
1)
The
chemical
substance
in
aqueous
solution.

(
2)
The
chemical
substance
containing
an
additive
(
such
as
a
stabilizer
or
other
chemical)
to
maintain
the
integrity
or
physical
form
of
the
substance.

(
3)
The
chemical
substance
in
any
grade
of
purity.

§
712.7
Report
of
readily
obtainable
information
for
subparts
B
and
C.

TSCA
section
8(
a)
authorizes
EPA
to
require
persons
to
report
information
that
is
known
to
or
reasonably
ascertainable
by
them.
For
purposes
of
subpart
B,
however,
a
lesser
standard
applies.
Companies
must
report
information
that
is
readily
obtainable
by
management
and
supervisory
employees
responsible
for
manufacturing,
processing,
distributing,
technical
services,
and
marketing.
Extensive
file
searches
are
not
required.

[
47
FR
26998,
June
22,
1982,
as
amended
at
60
FR
31921,
June
19,
1995]

§
712.15
Confidentiality.

(
a)
Any
person
submitting
information
under
this
part
may
assert
business
confidentiality
claims
for
the
information
as
described
in
the
pertinent
reporting
form
and
its
instructions.
Any
information
covered
by
a
claim
will
be
disclosed
by
EPA
only
as
provided
in
the
procedures
set
forth
at
40
CFR
part
2.

(
b)
Persons
must
certify
to
the
validity
of
a
claim
of
confidentiality
they
make
for
information
reported
under
this
part,
as
specified
on
the
reporting
form.

(
c)
If
no
claim
accompanies
the
information
at
the
time
it
is
submitted
to
EPA
or
if
certification
as
to
the
claim
is
not
made
on
the
reporting
form,
EPA
may
place
the
information
in
an
open
file
available
to
the
public
without
further
notice
to
the
submitter.

SUBPART
B
­­
MANUFACTURERS
REPORTING
­­
PRELIMINARY
ASSESSMENT
INFORMATION
§
712.20
Manufacturers
and
importers
who
must
report.

Except
as
described
in
§
712.25,
at
the
time
a
chemical
substance
is
listed
in
§
712.3,
the
following
persons
must
submit
the
"
Manufacturer's
Report
­­
Preliminary
Assessment
Information"
(
as
described
in
§
712.28)
for
each
plant
site
at
which
they
manufactured
or
imported
the
chemical
substance
during
the
reporting
period
specified
in
§
712.30:
37
(
a)
Persons
who
manufactured
one
or
more
of
the
chemical
substances
listed
in
§
712.30
for
commercial
purposes.

(
b)
Persons
who
imported
in
bulk
form
one
or
more
of
the
chemical
substances
listed
in
§
712.30
for
commercial
purposes.

§
712.25
Exempt
manufacturers
and
importers.

(
a)
Persons
who
manufactured
or
imported
the
chemical
substance
during
the
reporting
period,
solely
for
purposes
of
scientific
experimentation,
analysis,
or
research,
including
research
or
analysis
for
product
development,
are
not
subject
to
reporting
under
§
712.20.

(
b)
Persons
who,
during
the
reporting
period,
manufactured
or
imported
fewer
than
500
kilograms
(
1100
pounds)
of
the
chemical
substance
at
a
single
plant
site
are
not
subject
to
reporting
for
that
site
under
§
712.20.

(
c)
Persons
who
qualify
as
small
manufacturers
or
importers
in
respect
to
a
specific
chemical
substance
listed
in
§
712.30
are
exempt.
However,
this
exemption
does
not
apply
with
respect
to
any
chemical
in
§
712.30
designated
by
an
asterisk.
A
manufacturer
is
qualified
as
small
and
is
exempt
from
submitting
a
report
under
this
subpart
for
a
chemical
substance
manufactured
at
a
particular
plant
site
if
both
of
the
following
criteria
are
met:

(
1)
Total
annual
sales
taken
together
of
all
sites
owned
or
controlled
by
the
foreign
or
domestic
parent
company
were
below
$
30
million
for
the
reporting
period;

(
2)
Total
production
of
the
listed
substance
for
the
reporting
period
was
below
45,400
kilograms
(
100,000
pounds)
at
the
plant
site.

(
d)
Persons
are
not
subject
to
reporting
under
§
712.20
if
they
manufactured
or
imported
the
chemical
substance
during
the
reporting
period
only
in
the
following
forms:

(
1)
As
a
byproduct
that
was
not
used
or
sold
or
that
was
formed
as
described
in
40
CFR
710.4(
d)
(
3)
through
(
7).

(
2)
As
a
non­
isolated
intermediate.

(
3)
As
an
impurity.

[
47
FR
26998,
June
22,
1982;
47
FR
28382,
June
30,
1982]

§
712.28
Form
and
instructions.

(
a)
Manufacturers
and
importers
subject
to
this
subpart
must
submit
a
single
EPA
Form
No.
38
7710­
35,
"
Manufacturer's
Report
­­
Preliminary
Assessment
Information,"
for
each
plant
site
manufacturing
or
importing
a
chemical
substance
listed
in
§
712.30.

(
b)
Reporting
companies
may
submit
their
reports
through
individual
plant
sites
or
company
headquarters
as
they
choose.
A
separate
form
must
be
submitted
for
each
plant
site
manufacturing
the
chemical
substance.

(
c)
Forms
must
be
sent
(
preferably
by
certified
mail)
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
8(
a)
PAIR
Reporting.

(
d)
Form
7710­
35,
Manufacturer's
Report­­
Preliminary
Assessment
Information
or
PAIR
form
and
instructions
may
be
obtained
by
telephoning
or
writing
the
Environmental
Assistance
Division.
The
telephone
number
and
the
address
of
the
Environmental
Assistance
Division
is:
Phone
Number
(
202)
554­
1404,
TDD
(
202)
554­
0551.
Address:
Environmental
Assistance
Division
(
7406),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

[
47
FR
26998,
June
22,
1982,
as
amended
at
52
FR
20083,
May
29,
1987;
53
FR
12523,
Apr.
15,
1988;
60
FR
31921,
June
19,
1995;
60
FR
34463,
July
3,
1995]

§
712.30
Chemical
lists
and
reporting
periods.

(
a)(
1)
Persons
subject
to
this
subpart
B
must
submit
a
Preliminary
Assessment
Information
Manufacturer's
Report
for
each
chemical
substance
or
mixture
that
is
listed
or
designated
in
this
section.

(
2)
Unless
a
respondent
has
already
prepared
a
Manufacturer's
Report
in
conformity
with
conditions
set
forth
in
paragraph
(
a)(
3)
of
this
section,
the
information
in
each
Manufacturer's
Report
must
cover
the
respondent's
latest
complete
corporate
fiscal
year
as
of
the
effective
date.
The
effective
date
will
be
30
days
after
the
FEDERAL
REGISTER
publishes
a
rule
amendment
making
the
substance
or
mixture
subject
to
this
subpart
B.

(
3)
Persons
subject
to
this
subpart
B
need
not
comply
with
the
requirements
of
paragraph
(
a)(
2)
of
this
section
if
they
meet
either
one
of
the
following
conditions:

(
i)
The
respondent
has
previously
and
voluntarily
provided
EPA
with
a
Manufacturer's
Report
on
a
chemical
substance
or
mixture
subject
to
this
subpart
B,
which
contains
data
for
a
one­
year
period
ending
no
more
than
three
years
prior
to
the
effective
date
described
in
paragraph
(
a)(
2)
of
this
section.
Respondents
meeting
this
condition
must
notify
EPA
by
letter
of
their
desire
to
have
the
voluntary
submission
used
in
lieu
of
a
current
data
submission
and
must
verify
the
completeness
and
current
accuracy
of
the
voluntarily
submitted
data.
Such
letters
must
contain
the
following
language:
"
I
hereby
certify
that,
to
the
best
of
my
knowledge
and
belief,
all
39
information
entered
on
this
form
is
complete
and
accurate.
I
agree
to
permit
access
to,
and
the
copying
of
records
by,
a
duly
authorized
representative
of
the
EPA
Administrator,
in
accordance
with
the
Toxic
Substances
Control
Act,
to
document
any
information
reported
on
the
form."
Notification
letters
must
be
submitted
prior
to
the
reporting
deadline.

(
ii)
The
respondent
has
previously
submitted
a
Manufacturer's
Report
on
a
chemical
substance
or
mixture
subject
to
this
subpart
B
to
the
Interagency
Testing
Committee,
but
not
to
EPA,
and
that
Report
contained
data
for
a
one­
year
period
ending
less
than
three
years
prior
to
the
effective
date
described
in
paragraph
(
a)(
2)
of
this
section.
Respondents
meeting
this
condition
must
submit
a
copy
of
the
Manufacturer's
Report
to
EPA,
and
must
submit
an
accompanying
letter
notifying
EPA
of
the
respondent's
intent
that
the
submission
be
used
in
lieu
of
a
current
Manufacturer's
Report.
The
notification
letter
must
verify
the
completeness
and
current
accuracy
of
the
voluntarily
submitted
data.
Such
a
letter
must
contain
the
following
language:
"
I
hereby
certify
that,
to
the
best
of
my
knowledge
and
belief,
all
information
entered
on
this
form
is
complete
and
accurate.
I
agree
to
permit
access
to,
and
the
copying
of
records
by,
a
duly
authorized
representative
of
the
EPA
Administrator,
in
accordance
with
the
Toxic
Substances
Control
Act,
to
document
any
information
reported
on
the
form."
The
submission
must
be
made
prior
to
the
reporting
deadline.

(
b)
Except
as
provided
in
paragraph
(
c)
of
this
section,
chemical
substances
and
designated
mixtures
will
be
added
after
a
notice
of
proposed
amendment
of
this
subpart
is
published
in
the
FEDERAL
REGISTER.
There
will
be
a
30
day
public
comment
period
on
each
notice;
after
consideration
of
the
comments,
a
final
amendment
will
identify
the
substances
and
mixtures
added.

(
c)
Chemical
substances,
mixtures,
and
categories
of
substances
or
mixtures
that
have
been
added
by
the
Interagency
Testing
Committee,
established
under
section
4(
e)
of
TSCA,
to
the
section
4(
e)
Priority
List,
for
testing
consideration
by
the
Agency,
will
be
added
to
this
section
30
days
after
EPA
issues
for
publication
in
the
FEDERAL
REGISTER
a
rule
amendment
listing
these
chemical
substances,
mixtures
and
categories.
A
Preliminary
Assessment
Information
­­
Manufacturer's
Report
must
be
submitted
for
each
chemical
substance
and
mixture
within
60
days
after
the
effective
date
of
the
listing.
At
the
discretion
of
the
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances,
a
listed
substance,
mixture
or
category
may
be
withdrawn,
for
good
cause,
from
the
rule's
reporting
requirements
prior
to
the
effective
date.
Any
information
submitted
showing
why
a
substance,
mixture
or
category
should
be
removed
from
the
rule
must
be
received
by
EPA
within
14
days
after
the
date
of
publication
of
the
notice
under
this
paragraph.
If
a
substance,
mixture
or
category
is
removed,
a
FEDERAL
REGISTER
notice
announcing
this
decision
will
be
published
no
later
than
the
effective
date
of
the
amendment.
Any
information
submitted
must
be
addressed
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
8(
a)
Auto­
ITC.

(
d)
Manufacturers
and
importers
of
the
substances
listed
below
must
submit
a
Preliminary
40
Assessment
Information
Manufacturer's
Report
for
each
site
at
which
they
manufacture
or
import
each
substance
by
the
reporting
date
shown
in
the
table
below.
The
substances
are
listed
in
Chemical
Abstracts
Service
Registry
Number
order.
Typically
EPA
lists
the
trivial
or
common
name
first,
then,
following
the
symbol
"­
­",
EPA
lists
the
substance
by
its
TSCA
Chemical
Substance
Inventory
name.
Whenever
EPA
lists
a
single
name,
the
name
may
be
either
the
TSCA
Chemical
Substance
Inventory
name,
a
trivial
name,
or
a
common
name.
Generally,
when
a
single
name
is
listed,
it
is
the
TSCA
Chemical
Substances
Inventory
name.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effective
Reporting
CAS
No.
Substance
date
date
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
90­
30­
2
N­
Phenyl­
1­
naphthylamine......................
9/
30/
91
11/
27/
91
100­
40­
3
4­
Vinylcyclohexene..............................
1/
11/
90
3/
12/
90
108­
95­
5
Thiophenol...........................................
1/
26/
94
3/
28/
94
118­
79­
6
2,4,6­
tribromophenol................................
1/
11/
90
3/
12/
90
143­
33­
9
Sodium
cyanide......................................
10/
29/
90
12/
27/
90
632­
79­
1
Tetrabromophthalic
anhydride.................
1/
11/
90
3/
12/
90
637­
92­
3
Ethyl
tert­
butyl
ether...............................
12/
28/
94
2/
27/
95
994­
05­
8
Tert­
amyl
methyl
ether............................
12/
28/
94
2/
27/
95
1163­
19­
5
Decabromodiphenyl
ether........................
1/
11/
90
3/
12/
90
3194­
55­
6
Hexabromocyclododecane.......................
1/
11/
90
3/
12/
90
3296­
90­
0
Dibromoneopentyl
glycol.........................
1/
11/
90
3/
12/
90
12185­
10­
3
White
phosphorus....................................
1/
26/
94
3/
28/
94
32534­
81­
9
Pentabromodiphenyl
ether.......................
1/
11/
90
3/
12/
90
32536­
52­
0
Octabromodiphenyl
ether.........................
1/
11/
90
3/
12/
90
32588­
76­
4
Ethylene
Bis­(
tetrabromophthalimide)...
1/
11/
90
3/
12/
90
37853­
59­
1
1,2­
Bis(
tribromophenoxy)
ethane...........
1/
11/
90
3/
12/
90
41291­
34­
3
Ethylene(
5,6­
dibromonorbornane­
2,3­
dicarboximide)
1/
11/
90
3/
12/
90
52907­
07­
0
Ethylene
bis(
5,6­
dibromonorbornane­
2,3­
dicarboximide)
1/
26/
94
3/
28/
94
57137­
10­
7
Tribrominated
polystyrene......................
1/
11/
90
3/
12/
90
61262­
53­
1
Ethylene
bis(
pentabromophenoxide)......
1/
11/
90
3/
12/
90
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
e)
Manufacturers
and
importers
of
the
substances
listed
below
by
category
must
submit
a
Preliminary
Assessment
Information
Manufacturers
Report
for
each
site
at
which
they
manufacture
or
import
each
substance
by
the
reporting
date
shown
in
the
table
below.
The
categories
are
listed
in
alphabetic
order
with
the
chemical
substances
within
each
category
listed
by
ascending
numerical
CAS
number.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
41
Effective
Reporting
CAS
No.
Substance
date
date
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Aldehydes:
66­
77­
3.....................
1­
Naphthalenecarboxaldehyde...................
9/
30/
91
11/
27/
91
75­
07­
0.....................
Acetaldehyde..........................................
9/
30/
91
11/
27/
91
75­
87­
6.....................
Acetaldehyde,
trichloro­............................
9/
30/
91
11/
27/
91
78­
84­
2.....................
Propanal,
2­
methyl­...................................
9/
30/
91
11/
27/
91
78­
85­
3.....................
2­
Propenal,
2­
methyl­.................................
9/
30/
91
11/
27/
91
80­
54­
6.....................
Benzenepropanal,
4­(
1,1­
dimethylethyl)­.
alpha.­
methyl­.
9/
30/
91
11/
27/
91
84­
83­
3.....................
Acetaldehyde,
(
1,3­
dihydro­
1,3,
3­
trimethyl­
2H­
indol­
2­
ylidene)
89­
98­
5.....................
Benzaldehyde,
2­
chloro­............................
9/
30/
91
11/
27/
91
90­
02­
8.....................
Benzaldehyde,
2­
hydroxy­.........................
9/
30/
91
11/
27/
91
93­
02­
7.....................
Benzaldehyde,
2,5­
dimethoxy­...................
9/
30/
91
11/
27/
91
93­
53­
8.....................
Benzeneacetaldehyde,
.
alpha.­
methyl­........
9/
30/
91
11/
27/
91
95­
01­
2.....................
Benzaldehyde,
2,4­
dihydroxy­...................
9/
30/
91
11/
27/
91
97­
51­
8.....................
Benzaldehyde,
2­
hydroxy­
5­
nitro­.............
9/
30/
91
11/
27/
91
98­
01­
1.....................
2­
Furancarboxaldehyde.............................
9/
30/
91
11/
27/
91
98­
03­
3.....................
2­
Thiophenecarboxaldehyde......................
9/
30/
91
11/
27/
91
100­
10­
7....................
Benzaldehyde,
4­(
dimethylamino)­............
9/
30/
91
11/
27/
91
100­
50­
5....................
3­
Cyclohexene­
1­
carboxaldehyde.............
9/
30/
91
11/
27/
91
100­
52­
7....................
Benzaldehyde..........................................
9/
30/
91
11/
27/
91
101­
39­
3....................
2­
Propenal,
2­
methyl­
3­
phenyl­...............
9/
30/
91
11/
27/
91
101­
86­
0....................
Octanal,
2­(
phenylmethylene)­.................
9/
30/
91
11/
27/
91
103­
95­
7....................
Benzenepropanal,
.
alpha.­
methyl­
4­(
1­
methylethyl)­
9/
30/
91
11/
27/
91
104­
09­
6....................
Benzeneacetaldehyde,
4­
methyl­...............
9/
30/
91
11/
27/
91
104­
55­
2....................
2­
Propenal,
3­
phenyl­...............................
9/
30/
91
11/
27/
91
104­
87­
0....................
Benzaldehyde,
4­
methyl­..........................
9/
30/
91
11/
27/
91
104­
88­
1....................
Benzaldehyde,
4­
chloro­...........................
9/
30/
91
11/
27/
91
106­
23­
0....................
6­
Octenal,
3,7­
dimethyl­...........................
9/
30/
91
11/
27/
91
106­
26­
3....................
2,6­
Octadienal,
3,7­
dimethyl­,
(
Z)­...........
9/
30/
91
11/
27/
91
106­
72­
9....................
5­
Heptenal,
2,6­
dimethyl­.........................
9/
30/
91
11/
27/
91
107­
02­
8....................
2­
Propenal............................................
9/
30/
91
11/
27/
91
107­
20­
0....................
Acetaldehyde,
chloro­................................
9/
30/
91
11/
27/
91
107­
22­
2....................
Ethanedial............................................
9/
30/
91
11/
27/
91
107­
75­
5....................
Octanal,
7­
hydroxy­
3,7­
dimethyl­.............
9/
30/
91
11/
27/
91
110­
41­
8....................
Undecanal,
2­
methyl­...............................
9/
30/
91
11/
27/
91
110­
62­
3....................
Pentanal..............................................
9/
30/
91
11/
27/
91
111­
30­
8....................
Pentanedial...........................................
9/
30/
91
11/
27/
91
111­
71­
7....................
Heptanal..............................................
9/
30/
91
11/
27/
91
112­
31­
2....................
Decanal...............................................
9/
30/
91
11/
27/
91
42
112­
44­
7....................
Undecanal.............................................
9/
30/
91
11/
27/
91
112­
45­
8....................
10­
Undecenal..........................................
9/
30/
91
11/
27/
91
112­
54­
9....................
Dodecanal.............................................
9/
30/
91
11/
27/
91
120­
14­
9....................
Benzaldehyde,
3,4­
dimethoxy­................
9/
30/
91
11/
27/
91
120­
21­
8....................
Benzaldehyde,
4­(
diethylamino)­.............
9/
30/
91
11/
27/
91
120­
57­
0....................
1,3­
Benzodioxole­
5­
carboxaldehyde........
9/
30/
91
11/
27/
91
121­
32­
4....................
Benzaldehyde,
3­
ethoxy­
4­
hydroxy­.......
9/
30/
91
11/
27/
91
121­
33­
5....................
Benzaldehyde,
4­
hydroxy­
3­
methoxy­......
9/
30/
91
11/
27/
91
122­
40­
7....................
Heptanal,
2­(
phenylmethylene)­................
9/
30/
91
11/
27/
91
122­
78­
1....................
Benzeneacetaldehyde.................................
9/
30/
91
11/
27/
91
123­
05­
7....................
Hexanal,
2­
ethyl­.....................................
9/
30/
91
11/
27/
91
123­
08­
0....................
Benzaldehyde,
4­
hydroxy­........................
9/
30/
91
11/
27/
91
123­
11­
5....................
Benzaldehyde,
4­
methoxy­.......................
9/
30/
91
11/
27/
91
123­
38­
6....................
Propanal..............................................
9/
30/
91
11/
27/
91
124­
13­
0....................
Octanal...............................................
9/
30/
91
11/
27/
91
124­
19­
6....................
Nonanal...............................................
9/
30/
91
11/
27/
91
126­
15­
8....................
4a(
4H)­
Dibenzofurancarboxaldehyde,
1,5a,
6,9,9a,
9b­
hexahydro­
9/
30/
91
11/
27/
91
135­
02­
4....................
Benzaldehyde,
2­
methoxy­.......................
9/
30/
91
11/
27/
91
141­
27­
5....................
2,6­
Octadienal,
3,7­
dimethyl­,
(
E)­..........
9/
30/
91
11/
27/
91
143­
14­
6....................
9­
Undecenal...........................................
9/
30/
91
11/
27/
91
455­
19­
6....................
Benzaldehyde,
4­(
trifluoromethyl)­...........
9/
30/
91
11/
27/
91
505­
57­
7....................
02­
Hexenal............................................
9/
30/
91
11/
27/
91
552­
89­
6....................
Benzaldehyde,
2­
nitro­.............................
9/
30/
91
11/
27/
91
590­
86­
3....................
Butanal,
3­
methyl­....................................
9/
30/
91
11/
27/
91
597­
31­
9....................
Propanal,
3­
hydroxy­
2,2­
dimethyl­...........
9/
30/
91
11/
27/
91
939­
97­
9....................
Benzaldehyde,
4­(
1,1­
dimethylethyl)­.......
9/
30/
91
11/
27/
91
1121­
60­
4...................
2­
Pyridinecarboxaldehyde.........................
9/
30/
91
11/
27/
91
1200­
14­
2...................
Benzaldehyde,
4­
butyl...............................
9/
30/
91
11/
27/
91
1331­
92­
6...................
2­
Propenal,
3­
phenyl­,
monopentyl
deriv..
9/
30/
91
11/
27/
91
1334­
78­
7...................
Benzaldehyde,
methyl­..............................
9/
30/
91
11/
27/
91
1423­
46­
7...................
3­
Cyclohexene­
1­
carboxaldehyde,
2,4,6­
trimethyl­
9/
30/
91
11/
27/
91
1504­
74­
1...................
2­
Propenal,
3­(
2­
methoxyphenyl)­............
9/
30/
91
11/
27/
91
2591­
86­
8...................
1­
Piperidinecarboxaldehyde......................
9/
30/
91
11/
27/
91
3132­
99­
8...................
Benzaldehyde,
3­
bromo­...........................
9/
30/
91
11/
27/
91
3268­
49­
3...................
Propanal,
3­(
methylthio)­..........................
9/
30/
91
11/
27/
91
3613­
30­
7...................
Octanal,
7­
methoxy­
3,7­
dimethyl­............
9/
30/
91
11/
27/
91
4501­
58­
0...................
3­
Cyclopentene­
1­
acetaldehyde,
2,2,3­
trimethyl­
9/
30/
91
11/
27/
91
5435­
64­
3...................
Hexanal,
3,5,5­
trimethyl­..........................
9/
30/
91
11/
27/
91
5780­
07­
4...................
1,3­
Benzodioxole­
5­
carboxaldehyde,
7­
methoxy­
9/
30/
91
11/
27/
91
43
5949­
05­
3...................
6­
Octenal,
3,7­
dimethyl­,
(
S)­...................
9/
30/
91
11/
27/
91
5988­
91­
0...................
Octanal,
3,7­
dimethyl­...............................
9/
30/
91
11/
27/
91
10031­
82­
0.................
Benzaldehyde,
4­
ethoxy­..........................
9/
30/
91
11/
27/
91
13586­
68­
0.................
2­
Propenal,
3­
4­(
1,1­
dimethylethyl)
phenyl­
2­
methyl­
9/
30/
91
11/
27/
91
17754­
90­
4.................
Benzaldehyde,
4­(
diethylamino)­
2­
hydroxy­
9/
30/
91
11/
27/
91
26266­
68­
2.................
Hexenal,
2­
ethyl­.....................................
9/
30/
91
11/
27/
91
27939­
60­
2.................
3­
Cyclohexene­
1­
carboxaldehyde,
dimethyl­
9/
30/
91
11/
27/
91
28602­
27­
9.................
Benzaldehyde,
(
dimethylamino)­.............
9/
30/
91
11/
27/
91
31906­
04­
4.................
3­
Cyclohexene­
1­
carboxaldehyde,
4­(
4­
hydroxy­
4­
methylpentyl)­
9/
30/
91
11/
27/
91
37677­
14­
8.................
3­
Cyclohexene­
1­
carboxaldehyde,
4­(
4­
methyl­
3­
pentenyl)­.
9/
30/
91
11/
27/
91
39515­
51­
0.................
Benzaldehyde,
3­
phenoxy­.......................
9/
30/
91
11/
27/
91
52475­
86­
2.................
3­
Cyclohexene­
1­
carboxaldehyde,
1­
methyl­
4­(
4­
methyl­
3­
pentenyl)­
9/
30/
91
11/
27/
91
66327­
54­
6.................
3­
Cyclohexene­
1­
carboxaldehyde,
1­
methyl­
4­(
4­
methylpentyl)­
9/
30/
91
11/
27/
91
Alkyl­,
Chloro­,
and
Hydroxymethyl
Diaryl
Ethers.
3061­
36­
7...................
1,4­
Diphenoxybenzene..............................
04/
12/
93
06/
10/
93
3586­
14­
9...................
Benzene,
1­
methyl­
3­
phenoxy­.................
04/
12/
93
06/
10/
93
13826­
35­
2.................
Benzenemethanol,
3­
phenoxy­,................
04/
12/
93
06/
10/
93
28299­
41­
4.................
Benzene,
1,1,­
oxybis[
methyl­...................
04/
12/
93
06/
10/
93
28984­
89­
6.................
1,1­
Biphenyl,
phenoxy­............................
04/
12/
93
06/
10/
93
42874­
96­
4.................
2­
Chloro­
1­(
3­
methylphenoxy)­
4­(
trifluoromethyl)
benzene
04/
12/
93
06/
10/
93
50594­
77­
9.................
Phenol,
3­[
2­
chloro­
4­(
trifluoromethyl)
phenoxy]­,
acetate
04/
12/
93
06/
10/
93
50789­
44­
1.................
Benzenemethanol,
3­
phenoxy­,
acetate....
04/
12/
93
06/
10/
93
51632­
16­
7.................
Benzene,
1­(
bromomethyl)­
3­
phenoxy­..
04/
12/
93
06/
10/
93
61702­
88­
3.................
Benzene,
1,1­
oxybis[(
1,1,3,3­
tetramethylbutyl)­.
04/
12/
93
06/
10/
93
63734­
62­
3.................
Benzoic
acid,
3­[
2­
chloro­
4­(
trifluoromethyl)
phenoxy]­
04/
12/
93
06/
10/
93
69834­
19­
1.................
Benzene,
1,1­
oxybis[
dodecyl­................
04/
12/
93
06/
10/
93
72252­
48­
3.................
Benzoic
acid,
3­[
2­
chloro­
4­(
trifluoromethyl)
phenoxy]­,
potassium
salt
04/
12/
93
06/
10/
93
Alkylphenols
and
Alkylphenol
Ethoxylates:.
80­
46­
6.....................
4­
tert­
Pentylphenol...................................
3/
29/
96
5/
29/
96
88­
18­
6.....................
2­
tert­
Butylphenol....................................
3/
29/
96
5/
29/
96
94­
06­
4.....................
4­(
1­
Methylbutyl)
phenol..........................
3/
29/
96
5/
29/
96
98­
54­
4.....................
4­
tert­
Butylphenol....................................
3/
29/
96
5/
29/
96
99­
71­
8.....................
4­
sec­
Butylphenol.....................................
3/
29/
96
5/
29/
96
44
104­
40­
5....................
4­
Nonylphenol.........................................
3/
29/
96
5/
29/
96
104­
43­
8....................
4­
Dodecylphenol......................................
3/
29/
96
5/
29/
96
949­
13­
3....................
2­
Octylphenol.........................................
3/
29/
96
5/
29/
96
1300­
16­
9...................
Nonylphenol
(
mixed
isomers)..................
3/
29/
96
5/
29/
96
1322­
69­
6...................(
1,1,3,3­
Tetramethylbutyl)
phenol
(
mixed
isomers)
3/
29/
96
5/
29/
96
1331­
57­
3...................
Dodecylphenol
(
mixed
isomers)...............
3/
29/
96
5/
29/
96
1638­
22­
8...................
4­
n­
Butylphenol.......................................
3/
29/
96
5/
29/
96
1806­
26­
4...................
4­
Octylphenol.........................................
3/
29/
96
5/
29/
96
2315­
66­
4...................
Decaethylene
glycol
4­
isooctylphenyl
ether
3/
29/
96
5/
29/
96
2497­
58­
7...................
Hexaethylene
glycol
4­
isooctylphenyl
ether
3/
29/
96
5/
29/
96
3180­
09­
4...................
2­
Butylphenol.........................................
3/
29/
96
5/
29/
96
3884­
95­
5...................
2­(
1,1,3,3­
Tetramethylbutyl)
phenol..........
3/
29/
96
5/
29/
96
9002­
93­
1...................
Polyethylene
glycol
4­(
tert­
octyl)
phenyl
ether5/
29/
96
9036­
19­
5...................
Polyethylene
glycol
mono(
octyl)
phenyl
ether
3/
29/
96
5/
29/
96
11066­
49­
2.................
Isononylphenol
(
mixed
isomers).............
3/
29/
96
5/
29/
96
14938­
35­
3.................
4­
Pentylphenol........................................
3/
29/
96
5/
29/
96
17404­
66­
9.................
4­(
1­
Methyloctyl)
phenol..........................
3/
29/
96
5/
29/
96
25154­
52­
3.................
Nonylphenol
(
mixed
isomers)..................
3/
29/
96
5/
29/
96
27178­
34­
3.................
tert­
Butylphenol
(
mixed
isomers)............
3/
29/
96
5/
29/
96
27193­
28­
8.................(
1,1,3,3­
Tetramethylbutyl)
phenol
(
mixed
isomers)......
3/
29/
96
5/
29/
96
27193­
86­
8.................
Dodecylphenol
(
mixed
isomers)..............
3/
29/
96
5/
29/
96
27985­
70­
2.................(
1­
Methylheptyl)
phenol
(
mixed
isomers)
3/
29/
96
5/
29/
96
29932­
96­
5.................(
1,1,3,3­
Tetramethylbutyl)
phenol
(
mixed
isomers)......
3/
29/
96
5/
29/
96
30105­
54­
5.................(
1,1,3,3­
Tetramethylbutyl)
phenol
(
mixed
isomers)......
3/
29/
96
5/
29/
96
31195­
95­
6.................
Isobutylphenol
(
mixed
isomers)..............
3/
29/
96
5/
29/
96
54932­
78­
4.................
4­(
2,2,3,3­
Tetramethylbutyl)
phenol.........
3/
29/
96
5/
29/
96
62744­
41­
6.................(
1,1,3,3­
Tetramethylbutyl)
phenol
(
mixed
isomers)
3/
29/
96
5/
29/
96
68987­
90­
6.................
Poly(
oxy­
1,2­
ethanediyl),
<
greek­
a>­(
octylphenyl)­<
greek­
oh>­
hydroxy­,
branched.
3/
29/
96
5/
29/
96
84852­
15­
3.................
Branched
4­
nonylphenol
(
mixed
isomers)
3/
29/
96
5/
29/
96
Alkyl
phosphates:
78­
40­
0.....................
Phosphoric
acid,
triethyl
ester...................
10/
29/
90
12/
27/
90
78­
42­
2.....................
Phosphoric
acid,
tris(
2­
ethylhexyl)
ester....
10/
29/
90
12/
27/
90
78­
51­
3.....................
Ethanol,
2­
butoxy­,
phosphate
(
3:
1).........
10/
29/
90
12/
27/
90
107­
66­
4....................
Phosphoric
acid,
dibutyl
ester..................
10/
29/
90
12/
27/
90
126­
71­
6....................
Phosphoric
acid,
tris(
2­
methylpropyl)
ester
10/
29/
90
12/
27/
90
126­
73­
8....................
Phosphoric
acid
tributyl
ester....................
10/
29/
90
12/
27/
90
298­
07­
7....................
Phosphoric
acid,
bis(
2­
ethylhexyl)
ester.....
10/
29/
90
12/
27/
90
45
812­
00­
0....................
Phosphoric
acid,
monomethyl
ester...........
10/
29/
90
12/
27/
90
1070­
03­
7...................
Phosphoric
acid,
mono(
2­
ethylhexyl)
ester
10/
29/
90
12/
27/
90
1498­
51­
7...................
Phosphorodichloridic
acid,
ethylester.....
10/
29/
90
12/
27/
90
1623­
15­
0...................
Phosphoric
acid,
monobutyl
ester.............
10/
29/
90
12/
27/
90
1623­
24­
1...................
Phosphoric
acid,
mono(
1­
methylethyl)
ester10/
29/
90
12/
27/
90
2958­
09­
0...................
Phosphoric
acid,
monooctadecyl
ester......
10/
29/
90
12/
27/
90
3900­
04­
7...................
Phosphoric
acid,
monohexyl
ester.............
10/
29/
90
12/
27/
90
3991­
73­
9...................
Phosphoric
acid,
monooctyl
ester..............
10/
29/
90
12/
27/
90
7057­
92­
3...................
Phosphoric
acid,
didodecyl
ester...............
10/
29/
90
12/
27/
90
7332­
46­
9...................
Ethanol,
2­(
2­
butoxyethoxy)­,
phosphate
(
3:
1)
10/
29/
90
12/
27/
90
12645­
31­
7.................
Phosphoric
acid,
2­
ethylhexyl
ester..........
10/
29/
90
12/
27/
90
12751­
23­
4.................
Phosphoric
acid,
dodecyl
ester.................
10/
29/
90
12/
27/
90
27215­
10­
7.................
Phosphoric
acid,
diisooctyl
ester..............
10/
29/
90
12/
27/
90
Brominated
flame
retardants:
74­
97­
5.....................
Methane,
bromochloro­.............................
10/
29/
90
12/
27/
90
87­
10­
5.....................
Benzamide,
3,5­
dibromo­
N­(
4­
bromophenyl)­
2­
hydroxy­
10/
29/
90
12/
27/
90
87­
83­
2.....................
Benzene,
pentabromomethyl­....................
10/
29/
90
12/
27/
90
87­
84­
3.....................
Cyclohexane,
1,2,3,4,5­
pentabromo­
6­
chloro­............
10/
29/
90
12/
27/
90
96­
13­
9.....................
1­
Propanol,
2,3­
dibromo­.........................
10/
29/
90
12/
27/
90
593­
60­
2....................
Ethene,
bromo­........................................
10/
29/
90
12/
27/
90
615­
58­
7....................
Phenol,
2,4­
dibromo­...............................
10/
29/
90
12/
27/
90
4162­
45­
2...................
Ethanol,
2,2'­((
1­
methylethylidene)
bis((
2,6­
dibromo­
4,1­
phenylene)
oxy))
bis­
10/
29/
90
12/
27/
90
25327­
89­
3.................
Benzene,
1,1'­(
1­
methylethylidene)
bis(
3,5­
dibromo­
4­(
2­
propenyloxy)­
10/
29/
90
12/
27/
90
30554­
72­
4.................
Cyclohexane,
tetrabromodichloro­...........
10/
29/
90
12/
27/
90
30554­
73­
5.................
Cyclohexane,
tribromotrichloro­..............
10/
29/
90
12/
27/
90
36483­
57­
5.................
1­
Propanol,
2,2­
dimethyl­,
tribromo
deriv
10/
29/
90
12/
27/
90
55205­
38­
4.................
2­
Propenoic
acid,
(
1­
methylethylidene)
bis(
2,6­
dibromo­
4,1­
phenylene)
ester
10/
29/
90
12/
27/
90
68955­
41­
9.................
Alkanes,
C10­
18,
bromochloro­.............
10/
29/
90
12/
27/
90
69882­
11­
7.................
Phenol,
2,4(
or
2,6)­
dibromo­,
homopolymer10/
29/
90
12/
27/
90
88497­
56­
7.................
Benzene,
ethenyl­,
homopolymer,
brominated
10/
29/
90
12/
27/
90
Chloralkyl
phosphates
34621­
99­
3.................
1,2­
Ethanediyltetrakis(
2­
chloro­
1­
methylethylene)
phosphate
6/
14/
93
8/
12/
93
38051­
10­
4.................
2,2­
Bis(
chloromethyl)­
1,3­
propanediyltetrakis(
2­
chloroethyl)
phosphate
6/
14/
93
8/
12/
93
53461­
82­
8.................
Oxydi­
2,1­
ethanediyltetrakis(
2­
chloroethyl)
phosphate
6/
14/
93
8/
12/
93
46
76649­
15­
5.................
2­
Chloro­
1­
methylethylbis(
2­
chloropropyl)
phosphate
Cyanoacrylates:
137­
05­
3....................
2­
Propenoic
acid,
2­
cyano­,
methyl
ester.
1/
26/
94
3/
28/
94
1069­
55­
2...................
2­
Propenoic
acid,
2­
cyano­,
isobutyl
ester
1/
26/
94
3/
28/
94
6197­
30­
4...................
2­
Propenoic
acid,
2­
cyano­
3,3­
diphenyl­,
2­
ethylhexyl
ester
1/
26/
94
3/
28/
94
6606­
65­
1...................
2­
Propenoic
acid,
2­
cyano­,
butyl
ester.....
1/
26/
94
3/
28/
94
7085­
85­
0...................
2­
Propenoic
acid,
2­
cyano­,
ethyl
ester....
1/
26/
94
3/
28/
94
7324­
02­
9...................
2­
Propenoic
acid,
2­
cyano­,
2­
propenyl
ester1/
26/
94
3/
28/
94
10586­
17­
1.................
2­
Propenoic
acid,
2­
cyano­,
1­
methylethyl
ester
1/
26/
94
3/
28/
94
21982­
43­
4.................
2­
Propenoic
acid,
2­
cyano­,
ethoxyethyl
ester
1/
26/
94
3/
28/
94
23023­
91­
8.................
2­
Propenoic
acid,
2­
cyano­,
2,2,2­
trifluoromethyl
ester
1/
26/
94
3/
28/
94
27816­
23­
5.................
2­
Propenoic
acid,
2­
cyano­,
2­
methoxyethyl
ester
1/
26/
94
3/
28/
94
64992­
16­
1.................
Ethanaminium,
2­[[
2­
cyano­
3­[
4­(
diethylamino)
phenyl]­
1­
oxo­
2­
propenyl]
oxy]­
N,
N,
N­
trimethyl­,
chloride
1/
26/
94
3/
28/
94
IRIS
Chemicals:
51­
28­
5.....................
2,4
Dinitrophenol.....................................
9/
30/
91
11/
27/
91
95­
65­
8.....................
3,4
Dinethylphenol....................................
9/
30/
91
11/
27/
91
Isocyanates:
91­
97­
4.....................
1,1'­
Biphenyl,
4,4'­
diisocyanato­
3,3'­
dimethyl­
10/
29/
90
12/
27/
90
100­
28­
7....................
Benzene,
1­
isocyanato­
4­
nitro­................
10/
29/
90
12/
27/
90
101­
68­
8....................
Benzene,
1,1'­
methylenebis(
4­
isocyanato­
10/
29/
90
12/
27/
90
102­
36­
3....................
Benzene,
1,2­
dichloro­
4­
isocyanato­.......
10/
29/
90
12/
27/
90
103­
71­
9....................
Benzene,
isocyanato­...............................
10/
29/
90
12/
27/
90
104­
12­
1....................
Benzene,
1­
chloro­
4­
isocyanato­..............
10/
29/
90
12/
27/
90
104­
49­
4....................
Benzene,
1,4­
diisocyanato­......................
10/
29/
90
12/
27/
90
109­
90­
0....................
Ethane,
isocyanato­.................................
10/
29/
90
12/
27/
90
110­
78­
1....................
Propane,
1­
isocyanato­............................
10/
29/
90
12/
27/
90
111­
36­
4....................
Butane,
1­
isocyanato­..............................
10/
29/
90
12/
27/
90
112­
96­
9....................
Octadecane,
1­
isocyanato­.......................
10/
29/
90
12/
27/
90
123­
61­
5....................
Benzene,
1,3­
diisocyanato­......................
10/
29/
90
12/
27/
90
329­
01­
1....................
Benzene,
1­
isocyanato­
3­(
trifluoromethyl)­
10/
29/
90
12/
27/
90
614­
68­
6....................
Benzene,
1­
isocyanato­
2­
methyl­.............
10/
29/
90
12/
27/
90
622­
58­
2....................
Benzene,
1­
isocyanato­
4­
methyl­.............
10/
29/
90
12/
27/
90
624­
83­
9....................
Methane,
isocyanato­...............................
10/
29/
90
12/
27/
90
1476­
23­
9...................
1­
Propene,
3­
isocyanato­...........................
10/
29/
90
12/
27/
90
2422­
91­
5...................
Benzene,
1,1',
1''­
methylidynetris(
4­
isocyanato­
10/
29/
90
12/
27/
90
47
2493­
02­
9...................
Benzene,
1­
bromo­
4­
isocyanato­..............
10/
29/
90
12/
27/
90
2909­
38­
8...................
Benzene,
1­
chloro­
3­
isocyanato­...............
10/
29/
90
12/
27/
90
2949­
22­
6...................
Acetic
acid,
isocyanato­,
ethyl
ester..........
10/
29/
90
12/
27/
90
3173­
53­
3...................
Cyclohexane,
isocyanato­..........................
10/
29/
90
12/
27/
90
4035­
89­
6...................
Imidodicarbonic
diamide,
N,
N',
2­
tris(
6­
isocyanatohexyl)­
10/
29/
90
12/
27/
90
4098­
71­
9...................
Cyclohexane,
5­
isocyanato­
1­(
isocyanatomethyl)­
1,3,3­
trimethyl­
10/
29/
90
12/
27/
90
4151­
51­
3...................
Phenol,
4­
isocyanato­,
phosphorothioate
(
3:
1)
(
ester)
10/
29/
90
12/
27/
90
5124­
30­
1...................
Cyclohexane,
1,1'­
methylenebis(
4­
isocyanato­..........
10/
29/
90
12/
27/
90
5873­
54­
1...................
Benzene,
1­
isocyanato­
2­((
4­
isocyanatophenyl)
methyl)­
10/
29/
90
12/
27/
90
10031­
75­
1.................
Benzene,
1,1'­(
diisocyanatomethylene)
bis­
10/
29/
90
12/
27/
90
15646­
96­
5.................
Hexane,
1,6­
diisocyanato­
2,4,4­
trimethyl­
10/
29/
90
12/
27/
90
16938­
22­
0.................
Hexane,
1,6­
diisocyanato­
2,2,4­
trimethyl­
10/
29/
90
12/
27/
90
25854­
16­
4.................
Benzene,
bis(
isocyanatomethyl)­..............
10/
29/
90
12/
27/
90
26447­
40­
5.................
Benzene,
1,1'­
methylenebis(
isocyanato­..
10/
29/
90
12/
27/
90
26603­
40­
7.................
1,3,5,­
Triazine­
2,4,6(
1H.
3H,
5H­
trione,
1,3,5­
tris(
3­
isocyanatomethyl­
phenyl)­
10/
29/
90
12/
27/
90
26747­
90­
0.................
1,3­
Diazetidine­
2,4­
dione,
1,3­
bis(
3­
isocyanatomethylphenyl)­
10/
29/
90
12/
27/
90
28178­
42­
9.................
Benzene,
2­
isocyanato­
1,3­
bis(
1­
methylethyl)­
10/
29/
90
12/
27/
90
28556­
81­
2.................
Benzene,
2­
isocyanato­
1,3­
dimethyl­.......
10/
29/
90
12/
27/
90
30674­
80­
7.................
2­
Propenoic
acid,
2­
methyl­,
2­
isocyanatoethyl
ester
10/
29/
90
12/
27/
90
34893­
92­
0.................
Benzene,
1,3­
dichloro­
5­
isocyanato­....
10/
29/
90
12/
27/
90
68239­
06­
5.................
Cyclohexane,
2­
heptyl­
3,4­
bis(
9­
isocyanatononyl)­
1­
pentyl­
10/
29/
90
12/
27/
90
73597­
26­
9.................
2­
Propenoic
acid,
2­
methyl­,
2­(((((
5­
isocyanato­
1,3,3­
trimethylcyclo­
hexyl)
methyl)
amino)
carbonyl)
oxy)
ethyl
ester
10/
29/
90
12/
27/
90
Methyl
ethylene
glycol
ethers
and
esters:
3121­
61­
7...................
Ethylene
glycol
monomethyl
ether
acrylate
1/
26/
94
3/
28/
94
23783­
42­
8.................
Tetraethylene
glycol
monomethyl
ether
1/
26/
94
3/
28/
94
Nonylphenol
ethoxylates
07311­
27­
5.................
Ethanol,
2­[
2­[
2­[
2­(
p­
nonylphenoxy)
ethoxy]
ethoxy]
ethoxy]­
11/
29/
96
1/
27/
97
09016­
45­
9
and
20636­
48­
0...
Nonylphenol
polyethylene
glycol
ether
11/
29/
96
1/
27/
97
20427­
84­
3.................
Ethanol,
2­[
2­(
p­
nonylphenoxy)
ethoxy]­
11/
29/
96
1/
27/
97
26027­
38­
3
and
26064­
02­
8...
p­
Nonylphenol
polyethylene
glycol
ether
48
11/
29/
96
1/
27/
97
26571­
11­
9.................
Nonylphenol
octa(
oxyethylene)
ethanol
11/
29/
96
1/
27/
97
27176­
93­
8
and
27177­
01­
1...
Nonylphenoxydiglycol
11/
29/
96
1/
27/
97
27177­
05­
5.................
Nonylphenol
hepta(
oxyethylene)
ethanol
11/
29/
96
1/
27/
97
27177­
08­
8.................
Nonylphenolnona(
oxyethylene)
ethanol
11/
29/
96
1/
27/
97
27986­
36­
3.................
Nonylphenoxy
ethanol
11/
29/
96
1/
27/
97
37205­
87­
1.................
Poly(
oxy­
1,2­
ethanediyl),
alpha­(
isononylphenyl)­
omega­
hydroxy
11/
29/
96
1/
27/
97
OSHA
Chemicals
in
Need
of
Dermal
Absorption
Testing:
60­
29­
7.....................
Ethyl
ether...........................................
1/
26/
94
3/
28/
94
61­
82­
5.....................
Amitrole..............................................
3/
11/
94
5/
10/
94
74­
96­
4.....................
Ethyl
bromide.........................................
3/
11/
94
5/
10/
94
75­
05­
8.....................
Acetonitrile..........................................
8/
4/
95
10/
3/
95
75­
12­
7.....................
Formamide.............................................
8/
4/
95
10/
3/
95
75­
15­
0.....................
Carbon
disulfide......................................
3/
11/
94
5/
10/
94
75­
25­
2.....................
Bromoform.............................................
3/
11/
94
5/
10/
94
75­
34­
3.....................
1,1­
Dichloroethane...................................
3/
11/
94
5/
10/
94
75­
35­
4.....................
Vinylidene
chloride...................................
8/
4/
95
10/
3/
95
75­
65­
0.....................
tert­
Butyl
alcohol....................................
1/
26/
94
3/
28/
94
76­
22­
2.....................
Camphor...............................................
1/
26/
94
3/
28/
94
77­
73­
6.....................
Dicyclopentadiene.....................................
8/
4/
95
10/
3/
95
77­
78­
1.....................
Dimethyl
sulfate......................................
3/
11/
94
5/
10/
94
78­
59­
1.....................
Isophorone............................................
8/
4/
95
10/
3/
95
78­
87­
5.....................
Propylene
dichloride.................................
8/
4/
95
10/
3/
95
78­
92­
2.....................
sec­
Butyl
alcohol.....................................
1/
26/
94
3/
28/
94
79­
20­
9.....................
Methyl
acetate........................................
1/
26/
94
3/
28/
94
79­
46­
9.....................
2­
Nitropropane........................................
3/
11/
94
5/
10/
94
88­
72­
2.....................
o­
Nitrotoluene........................................
3/
11/
94
5/
10/
94
89­
72­
5.....................
o­
sec­
Butylphenol....................................
3/
11/
94
5/
10/
94
90­
04­
0.....................
o­
Anisidine...........................................
3/
11/
94
5/
10/
94
91­
20­
3.....................
Naphthalene...........................................
8/
4/
95
10/
3/
95
92­
52­
4.....................
Biphenyl..............................................
8/
4/
95
10/
3/
95
95­
13­
6.....................
Indene................................................
3/
11/
94
5/
10/
94
95­
49­
8.....................
o­
Chlorotoluene.......................................
3/
11/
94
5/
10/
94
95­
50­
1.....................
o­
Dichlorobenzene....................................
8/
4/
95
10/
3/
95
96­
18­
4.....................
1,2,3­
Trichloropropane............................
8/
4/
95
10/
3/
95
97­
77­
8.....................
Disulfiram............................................
1/
26/
94
3/
28/
94
98­
29­
3.....................
t­
Butylcatechol.......................................
8/
4/
95
10/
3/
95
99­
08­
1.....................
m­
Nitrotoluene........................................
8/
4/
95
10/
3/
95
99­
65­
0.....................
m­
Dinitrobenzene....................................
3/
11/
94
5/
10/
94
99­
99­
0.....................
p­
Nitrotoluene........................................
8/
4/
95
10/
3/
95
100­
00­
5....................
p­
Nitrochlorobenzene..............................
3/
11/
94
5/
10/
94
100­
01­
6....................
p­
Nitroaniline........................................
3/
11/
94
5/
10/
94
49
100­
44­
7....................
Benzyl
chloride.......................................
3/
11/
94
5/
10/
94
100­
25­
4....................
p­
Dinitrobenzene.....................................
1/
26/
94
3/
28/
94
100­
63­
0....................
Phenylhydrazine.......................................
3/
11/
94
5/
10/
94
105­
46­
4....................
sec­
Butyl
acetate.....................................
1/
26/
94
3/
28/
94
106­
42­
3....................
p­
Xylene..............................................
1/
26/
94
3/
28/
94
106­
46­
7....................
p­
Dichlorobenzene..................................
8/
4/
95
10/
3/
95
106­
49­
0....................
p­
Toluidine...........................................
3/
11/
94
5/
10/
94
107­
06­
2....................
Ethylene
dichloride..................................
8/
4/
95
10/
3/
95
107­
31­
3....................
Methyl
formate........................................
1/
26/
94
3/
28/
94
107­
66­
4....................
Dibutyl
phosphate....................................
1/
26/
94
3/
28/
94
108­
03­
2....................
1­
Nitropropane........................................
1/
26/
94
3/
28/
94
108­
44­
1....................
m­
Toluidine...........................................
3/
11/
94
5/
10/
94
108­
87­
2....................
Methylcyclohexane..................................
1/
26/
94
3/
28/
94
108­
90­
7....................
Chlorobenzene.........................................
3/
11/
94
5/
10/
94
108­
93­
0....................
Cyclohexanol..........................................
8/
4/
95
10/
3/
95
109­
66­
0....................
Pentane...............................................
1/
26/
94
3/
28/
94
109­
99­
9....................
Tetrahydrofuran.......................................
3/
11/
94
5/
10/
94
110­
12­
3....................
Methyl
isoamyl
ketone.............................
8/
4/
95
10/
3/
95
110­
83­
8....................
Cyclohexene...........................................
1/
26/
94
3/
28/
94
111­
84­
2....................
Nonane................................................
1/
26/
94
3/
28/
94
120­
80­
9....................
Catechol..............................................
8/
4/
95
10/
3/
95
121­
14­
2....................
2,4­
Dinitrotoluene...................................
3/
11/
94
5/
10/
94
121­
69­
7....................
Dimethylaniline.......................................
8/
4/
95
10/
3/
95
122­
39­
4....................
Diphenylamine.........................................
3/
11/
94
5/
10/
94
123­
42­
2....................
Diacetone
alcohol.....................................
8/
4/
95
10/
3/
95
123­
92­
2....................
Isoamyl
acetate.......................................
1/
26/
94
3/
28/
94
126­
99­
8....................
beta­
Chloroprene......................................
3/
11/
94
5/
10/
94
127­
19­
5....................
Dimethyl
acetamide..................................
8/
4/
95
10/
3/
95
142­
82­
5....................
Heptane
(
n­
Heptane)...............................
1/
26/
94
3/
28/
94
150­
76­
5....................
p­
Methoxyphenol....................................
3/
11/
94
5/
10/
94
287­
92­
3....................
Cyclopentane..........................................
1/
26/
94
3/
28/
94
528­
29­
0....................
o­
Dinitrobenzene.....................................
3/
11/
94
5/
10/
94
532­
27­
4....................
a­
Chloroacetophenone.............................
1/
26/
94
3/
28/
94
540­
59­
0....................
1,2­
Dichloroethylene...............................
3/
11/
94
5/
10/
94
540­
88­
5....................
tert­
Butyl
acetate....................................
1/
26/
94
3/
28/
94
542­
92­
7....................
Cyclopentadiene......................................
8/
4/
95
10/
3/
95
626­
17­
5....................
m­
Phthalodinitrile....................................
3/
11/
94
5/
10/
94
628­
63­
7....................
n­
Amyl
acetate........................................
1/
26/
94
3/
28/
94
768­
52­
5....................
N­
Isopropylaniline...................................
3
/
11/
94
5/
10/
94
1300­
73­
8...................
Xylidine..............................................
3/
11/
94
5/
10/
94
6423­
43­
4...................
Propylene
glycol
dinitrate.........................
3/
11/
94
5/
10/
94
7631­
90­
5...................
Sodium
bisulfite......................................
1/
26/
94
3/
28/
94
7681­
57­
4...................
Sodium
metabisulfite...............................
1/
26/
94
3/
28/
94
50
25013­
15­
4.................
Vinyl
toluene.........................................
3/
11/
94
5/
10/
94
34590­
94­
8.................
Dipropylene
glycol
methyl
ether.............
8/
4/
95
10/
3/
95
Propylene
glycol
ethers
and
esters:
108­
65­
6....................
Propylene
glycol
monomethyl
ether
acetate1/
26/
94
3/
28/
94
110­
98­
5....................
Dipropylene
glycol...................................
1/
26/
94
3/
28/
94
770­
35­
4....................
1­
Phenoxy­
2­
propanol.............................
1/
26/
94
3/
28/
94
20324­
32­
7.................
1­(
2­
Methoxy­
1­
methylethoxy)­
2­
propanol
1/
26/
94
3/
28/
94
20324­
33­
8.................
Tripropylene
glycol
methyl
ether.............
1/
26/
94
3/
28/
94
28677­
93­
2.................
Methoxy­
1­
propanol.................................
1/
26/
94
3/
28/
94
29387­
86­
8.................
Propylene
glycol
monobutyl
ether............
1/
26/
94
3/
28/
94
29911­
28­
2.................
Dipropylene
glycol
butyl
ether.................
1/
26/
94
3/
28/
94
42978­
66­
5.................
Tripropylene
glycol
diacrylate..................
1/
26/
94
3/
28/
94
57018­
52­
7.................
Propylene
glycol
mono­
tert­
butyl
ether....
1/
26/
94
3/
28/
94
88917­
22­
0.................
Dipropylene
glycol
monomethyl
ether
acetate
1/
26/
94
3/
28/
94
Siloxanes:
107­
46­
0....................
Hexamethyldisiloxane..............................
10/
12/
93
2/
28/
94
107­
50­
6....................
Tetradecamethylcycloheptasiloxane.........
10/
12/
93
2/
28/
94
107­
51­
7....................
Octamethyltrisiloxane..............................
10/
12/
93
2/
28/
94
107­
52­
8....................
Tetradecamethylhexasiloxane..................
10/
12/
93
2/
28/
94
107­
53­
9....................
Tetracosamethylundecasiloxane...............
10/
12/
93
2/
28/
94
141­
62­
8....................
Decamethyltetrasiloxane..........................
10/
12/
93
2/
28/
94
141­
63­
9....................
Dodecamethylpentasiloxane.......................
10/
12/
93
2/
28/
94
540­
97­
6....................
Dodecamethylcyclohexasiloxane...............
10/
12/
93
2/
28/
94
541­
01­
5....................
Hexadecamethylheptasiloxane.................
10/
12/
93
2/
28/
94
541­
02­
6....................
Decamethylcyclopentasiloxane................
10/
12/
93
2/
28/
94
541­
05­
9....................
Hexamethylcyclotrisiloxane.....................
10/
12/
93
2/
28/
94
546­
56­
5....................
Octaphenylcyclotetrasiloxane.....................
10/
12/
93
2/
28/
94
556­
67­
2....................
Octamethylcyclotetrasiloxane..................
10/
12/
93
2/
28/
94
556­
68­
3....................
Hexadecamethylcyclooctasiloxane...........
10/
12/
93
2/
28/
94
556­
69­
4....................
Octadecamethyloctasiloxane....................
10/
12/
93
2/
28/
94
556­
70­
7....................
Docosamethyldecasiloxane......................
10/
12/
93
2/
28/
94
556­
71­
8....................
Octadecamethylcyclononasiloxane...........
10/
12/
93
2/
28/
94
999­
97­
3....................
Hexamethyldisilazane..............................
10/
12/
93
2/
28/
94
2370­
88­
9...................
Tetramethylcyclotetrasiloxane..................
10/
12/
93
2/
28/
94
2374­
14­
3...................
Trifluoropropylmethylcyclotrisiloxane.....
10/
12/
93
2/
28/
94
2471­
08­
1...................
Hexacosamethyldodecasiloxane...............
10/
12/
93
2/
28/
94
2471­
09­
2...................
Octacosamethyltridecasiloxane................
10/
12/
93
2/
28/
94
2471­
10­
5...................
Triacontamethyltetradecasiloxane............
10/
12/
93
2/
28/
94
2471­
11­
6...................
Dotriacontamethylpentadecasiloxane........
10/
12/
93
2/
28/
94
2554­
06­
5...................
Methylvinylcyclosiloxane.........................
10/
12/
93
2/
28/
94
2627­
95­
4...................
Tetramethyldivinyldisiloxane...................
10/
12/
93
2/
28/
94
2652­
13­
3...................
Eicosamethylnonasiloxane........................
10/
12/
93
2/
28/
94
70131­
67­
8.................
Siloxanes
and
silicones,
di­
Me,
hydroxy­
terminated
51
10/
12/
93
2/
28/
94
9004­
73­
3...................
Methylpolysiloxane...................................
10/
12/
93
2/
28/
94
18766­
38­
6.................
Docosamethylcycloundecasiloxane..........
10/
12/
93
2/
28/
94
18772­
36­
6.................
Eicosamethylcyclodecasiloxane...............
10/
12/
93
2/
28/
94
18844­
04­
7.................
Hexatriacontamethylheptadecasiloxane...
10/
12/
93
2/
28/
94
18919­
94­
3.................
Tetracosamethylcyclododecasiloxane......
10/
12/
93
2/
28/
94
23523­
12­
8.................
Hexatriacontamethylcyclooctadecasiloxane
10/
12/
93
2/
28/
94
23523­
14­
0.................
Triacontamethylcyclopentadecasiloxane..
10/
12/
93
2/
28/
94
23732­
94­
7.................
Hexacosamethylcyclotridecasiloxane.......
10/
12/
93
2/
28/
94
36938­
50­
8.................
Tetratriacontamethyl
hexadecasiloxane...
10/
12/
93
2/
28/
94
36938­
52­
0.................
Octatriacontamethyl
octadecasiloxane.....
10/
12/
93
2/
28/
94
63148­
62­
9.................
Dimethyl
silicones
and
siloxanes.............
10/
12/
93
2/
28/
94
67762­
90­
7.................
Dimethyl
silicones
and
siloxane,
reaction
products
with
silica
0/
12/
93
2/
28/
94
67762­
94­
1.................
Dimethylmethylvinylsiloxane..................
10/
12/
93
2/
28/
94
68037­
59­
2.................
Dimethylhydropolylsiloxane....................
10/
12/
93
2/
28/
94
68037­
74­
1.................
Dimethylpolysiloxanes.............................
10/
12/
93
2/
28/
94
68083­
14­
7.................
Dimethyldiphenylsiloxane........................
10/
12/
93
2/
28/
94
69430­
24­
6.................
Cyclopolydimethylsiloxane......................
10/
12/
93
2/
28/
94
115361­
68­
7...............
Dimethylmethyl
3,3,3­
trifluoropropyl
siloxane
10/
12/
93
2/
28/
94
149050­
40­
8...............
Octacosamethylcyclotetradecasiloxane...
10/
12/
93
2/
28/
94
150026­
95­
2...............
Dotriacontamethylcyclohexadecasiloxane
10/
12/
93
2/
28/
94
150026­
96­
3...............
Tetratriacontamethylcycloheptadecasiloxane
10/
12/
93
2/
28/
94
150026­
97­
4...............
Octatriacontamethylcyclononadecasiloxane
10/
12/
93
2/
28/
94
150026­
98­
5...............
Tetracontamethylcycloeicosasiloxane.....
10/
12/
93
2/
28/
94
150026­
99­
6...............
Tetracontamethylnonadecasiloxane........
10/
12/
93
2/
28/
94
150027­
00­
2...............
Dotetracontamethyleicosasiloxane..........
10/
12/
93
2/
28/
94
not
available...............
Polymethyloctadecylsiloxane....................
10/
12/
93
2/
28/
94
Substantially
produced
chemicals
in
need
of
subchronic
tests:
80­
51­
3.....................
p,
p'­
Oxybis(
benzenesulfonylhydrazide)....
9/
30/
91
11/
27/
91
81­
84­
5.....................
Naphthalenedicarboxylic
anhydride............
9/
30/
91
11/
27/
91
84­
51­
5.....................
2­
Ethylanthraquinone................................
9/
30/
91
11/
27/
91
87­
02­
5.....................
7­
Amino­
4­
hydroxy­
2­
naphthalenesulfonic
acid
9/
30/
91
11/
27/
91
90­
15­
3.....................
1­
Naphthol.............................................
9/
30/
91
11/
27/
91
92­
70­
6.....................
3­
Hydroxy­
2­
naphthoic
acid.....................
9/
30/
91
11/
27/
91
94­
28­
0.....................
Triethylene
glycol
bis(
2­
ethylhexanoate)...
9/
30/
91
11/
27/
91
95­
32­
9.....................
2­(
4­
Morpholinyldithio)­
benzothiazole......
9/
30/
91
11/
27/
91
97­
88­
1.....................
N­
Butyl
methacrylate...............................
9/
30/
91
11/
27/
91
98­
48­
6.....................
1,3­
Benzenedisulfonic
Acid.......................
9/
30/
91
11/
27/
91
99­
54­
7.....................
3,4­
Dichloronitrobenzene.........................
9/
30/
91
11/
27/
91
99­
63­
8.....................
Isophthaloyl
chloride.................................
9/
30/
91
11/
27/
91
52
100­
20­
9....................
Terephthaloyl
chloride.............................
9/
30/
91
11/
27/
91
100­
29­
8....................
4­
Ethoxynitrobenzene................................
9/
30/
91
11/
27/
91
102­
01­
2....................
Acetoacetanilide......................................
9/
30/
91
11/
27/
91
106­
31­
0....................
Butyric
anhydride....................................
9/
30/
91
11/
27/
91
106­
63­
8....................
Isobutyl
acrylate.....................................
9/
30/
91
11/
27/
91
111­
96­
6....................
Diethylene
glycol
dimethyl
ether..............
9/
30/
91
11/
27/
91
112­
15­
2....................
Ethanol,
2­(
2­
ethoxyethoxy)­,
acetate........
9/
30/
91
11/
27/
91
116­
81­
4....................
Bromamine
acid......................................
9/
30/
91
11/
27/
91
119­
33­
5....................
4­
Methyl­
2­
nitro­
phenol..........................
9/
30/
91
11/
27/
91
121­
60­
8....................
4­(
Acetylamino)
benzenesulfonyl
chloride.
9/
30/
91
11/
27/
91
123­
54­
6....................
2,4­
Pentanedione......................................
9/
30/
91
11/
27/
91
123­
62­
6....................
Propanoic
anhydride................................
9/
30/
91
11/
27/
91
142­
16­
5....................
Bis(
2­
ethylhexyl)­
2­
butenedioate.............
9/
30/
91
11/
27/
91
311­
89­
7....................
Perfluorotributylamine.............................
9/
30/
91
11/
27/
91
355­
42­
0....................
Perfluoro­
N­
hexane.................................
9/
30/
91
11/
27/
91
594­
42­
3....................
Trichloromethanesulfenyl
chloride............
9/
30/
91
11/
27/
91
616­
21­
7....................
1,2­
Dichlorobutane....................................
9/
30/
91
11/
27/
91
626­
17­
5....................
1,3­
Dicyanobenzene.................................
9/
30/
91
11/
27/
91
760­
23­
6....................
3,4­
Dichlorobutene....................................
9/
30/
91
11/
27/
91
929­
06­
6....................
2­(
2­
Aminoethoxy)­
ethanol.....................
6/
30/
92
9/
28/
92
1047­
16­
1...................
Quinacridone..........................................
9/
30/
91
11/
27/
91
1111­
78­
0...................
Ammonium
carbamate..............................
9/
30/
91
11/
27/
91
3089­
11­
0...................
Hexa(
methoxymethyl)
melamine..............
9/
30/
91
11/
27/
91
Sulphones:
67­
71­
0.....................
Dimethylsulfone.......................................
9/
30/
91
11/
27/
91
77­
79­
2.....................
3­
Sulfolene...........................................
9/
30/
91
11/
27/
91
80­
07­
9.....................
Sulfonyl
bis­(
4­
chlorobenzene).................
9/
30/
91
11/
27/
91
80­
08­
0.....................
4,4'­
Diaminodiphenyl
sulfone.....................
9/
30/
91
11/
27/
91
80­
09­
1.....................
Bisphenol
S...........................................
9/
30/
91
11/
27/
91
98­
30­
6.....................
2­
Amino­
4­(
methylsulfonyl)
phenol............
9/
30/
91
11/
27/
91
126­
33­
0....................
Sulfolane.............................................
9/
30/
91
11/
27/
91
127­
63­
9....................
Diphenylsulfone.......................................
9/
30/
91
11/
27/
91
2580­
77­
0...................
2,2'­
Sulfonyl
bis­
ethanol...........................
9/
30/
91
11/
27/
91
3278­
22­
6...................
1,1'­[
Methylene
bis(
sulfonyl)]
bisethene...
9/
30/
91
11/
27/
91
5246­
57­
1...................
2­[(
3­
Aminophenyl)
sulfonyl]
ethanol........
9/
30/
91
11/
27/
91
16588­
67­
3.................
3­[
N­
Ethyl­
4­[[
6­(
methylsulfonyl)­
2­
benzothiazolyl]
azo]­
m­
toluidino]­
propionitrile
9/
30/
91
11/
27/
91
17557­
67­
4.................
6­(
Methylsulfonyl)­
2­
benzothiazolamine
9/
30/
91
11/
27/
91
17601­
96­
6.................
2­
Amino­
4­[(
2­
hydroxyethyl)
sulfonyl]
phenol
9/
30/
91
11/
27/
91
17688­
68­
5.................
4­
Phenylthiomorpholine,
1,1­
dioxide......
9/
30/
91
11/
27/
91
17741­
62­
7.................
4­[
4­[(
2,6­
Dichloro­
4­
nitrophenyl)
azo]
phenyl]
thiomorpholine,
1,1­
dioxide­
9/
30/
91
11/
27/
91
53
18760­
44­
6.................
3­(
Decyloxy)
tetrahydrothiophene
1,1­
dioxide
9/
30/
91
11/
27/
91
20018­
09­
1.................
1­(
Diiodomethyl)
sulfonyl­
4­
methyl
benzene
9/
30/
91
11/
27/
91
26750­
50­
5.................
1,1'­[
Oxybis(
methylenesulfonyl)]
bisethene
9/
30/
91
11/
27/
91
36724­
43­
3.................
2,2'­[
Oxybis(
methylenesulfonyl)]
bisethanol
9/
30/
91
11/
27/
91
41123­
59­
5.................
1,1'­[
Methylenebis(
sulfonyl)]
bis­
2­
chloroethane
9/
30/
91
11/
27/
91
41123­
69­
7.................
2,2'­[
Methylenebis(
sulfonyl)]
bisethanol..
9/
30/
91
11/
27/
91
41687­
30­
3.................
2­[(
3­
Nitrophenyl)
sulfonyl]
ethanol.........
9/
30/
91
11/
27/
91
52218­
35­
6.................
2­[(
6­
Amino­
2­
naphthalenyl)
sulfonyl]
ethanol
9/
30/
91
11/
27/
91
53061­
10­
2.................
1,1'­[
Oxybis(
methylenesulfonyl)]
bis­
2­
chloroethane
9/
30/
91
11/
27/
91
63134­
33­
8.................
4­[[
4­(
Phenylmethoxy)
phenyl]
sulfonyl]
phenol
9/
30/
91
11/
27/
91
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
(
Secs
8(
a)
and
8(
d),
90
Stat.
2027,
2029;
15
U.
S.
C.
2607
(
a)
and
(
d))

[
47
FR
26998,
June
22,
1982]
54
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
D
PAIR
Reporting
Form
(
EPA
Form
7710­
35)
and
Instructions
Available
electronically
in
Portable
Document
Format
via
Internet
at
http://
www.
epa.
gov/
opptintr/
chemtest/
pairform.
pdf
Note:
The
Notice
to
Submitters
contained
in
the
electronic
file
will
be
amended
to
reflect
the
Agency's
new
estimated
average
burden
per
response.
This
notice
is
provided
to
submitters
of
EPA
Form
7710­
35,
"
Manufacturer's
Report
­­
Preliminary
Assessment
Information,"
in
accordance
with
the
Paperwork
Reduction
Act,
to
disclose
public
reporting
burden
information.
In
addition,
EPA
wishes
to
inform
submitters
that
the
reporting
requirements
on
EPA
Form
7710­
35
have
not
changed
with
this
notice.
For
further
information
on
Preliminary
Assessment
Information
reporting,
refer
to
the
Code
of
Federal
Regulations
­
Title
40
­
Part
712.
Upon
OMB
approval,
the
revised
statement
will
read
as
follows:

OMB
Control
No.
2070­
0054
PAPERWORK
REDUCTION
ACT
NOTICE
The
public
reporting
and
record
keeping
burden
for
this
collection
is
estimated
to
average
28.45
hours
per
report,
with
2.44
reports
per
respondent
for
a
per
respondent
burden
of
69.41
hours,
including
the
time
for
reviewing
the
instructions,
searching
existing
data
sources,
gathering
and
maintaining
the
data
needed,
and
completing
and
reviewing
the
collection
of
information.
Send
comments
regarding
this
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
this
burden
to:
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
Mail
Code
2822),
1200
Pennsylvania
Avenue
N.
W.,
Washington,
D.
C.
20460;
or
to:
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget
(
OMB),
Attention:
Desk
Officer
for
EPA,
725
17th
Street,
N.
W.,
Washington,
DC
20503.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
form
or
report
to
this
address.
The
actual
information
or
form
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
information
or
form,
specified
in
the
corresponding
regulation.
55
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
E
40
CFR
766
This
attachment
can
also
be
accessed
online
via
Internet
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr766_
00.
html
56
TITLE
40­­
PROTECTION
OF
ENVIRONMENT
CHAPTER
I­­
ENVIRONMENTAL
PROTECTION
AGENCY
PART
766­­
DIBENZO­
PARA­
DIOXINS/
DIBENZOFURANS
Subpart
A
 
General
Provisions
Sec.
766.1
Scope
and
Purpose.
766.2
Applicability
and
duration
of
this
part.
766.3
Definitions.
766.5
Compliance.
766.7
Submission
of
information.
766.10
Test
standards.
766.12
Testing
guidelines.
766.14
Contents
of
protocols.
766.16
Developing
the
analytical
test
method.
766.18
Method
sensitivity.

Subpart
B
 
Specific
Chemical
Testing/
Reporting
Requirements
766.20
Who
must
test.
766.25
Chemical
substances
for
testing.
766.27
Congeners
and
LOQs
for
which
quantitation
is
required.
766.28
Expert
review
of
protocols.
766.32
Exclusions
and
waivers.
766.35
Reporting
requirements.
766.38
Reporting
on
precursor
chemical
substances.

AUTHORITY:
15
U.
S.
C.
2603
and
2607
SOURCE:
52
FR
21437,
June
5,
1987,
unless
otherwise
noted.

SUBPART
A
 
GENERAL
PROVISIONS
§
766.1
Scope
and
purpose.

(
a)
This
part
identifies
requirements
for
testing
under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA),
15
U.
S.
C.
2603,
to
ascertain
whether
certain
specified
chemical
substances
may
be
contaminated
with
halogenated
dibenzodioxins
(
HDDs)/
dibenzofurans
(
HDFs)
as
defined
in
§
766.3,
and
requirements
for
reporting
under
section
8
of
TSCA,
15
U.
S.
C.
2607.
57
(
b)
Section
766.35(
b)
requires
manufacturers
and
processors
of
chemical
substances
identified
in
§
766.25
to
submit
to
EPA:
(
1)
Any
existing
test
data
showing
analysis
of
the
chemical
substances
for
concentrations
of
HDDs/
HDFs,
applicable
protocols,
and
the
results
of
the
analysis
for
HDDs/
HDFs,
(
2)
allegations
of
significant
adverse
reactions
to
HDDs/
HDFs,
compiled
in
accordance
with
part
717
of
this
chapter,
and
(
3)
health
and
safety
studies
on
the
HDDs/
HDFs,
in
accordance
with
applicable
provisions
of
part
716
of
this
chapter.

(
c)
Section
766.35(
a)
requires
manufacturers
and,
under
certain
circumstances,
processors
of
chemical
substances
identified
in
§
766.25
to
submit
letters
of
intent
to
test
and
protocols
for
the
analysis
of
the
chemical
substances
for
the
presence
of
HDDs/
HDFs.
Section
766.20
requires
these
manufacturers
and
processors
to
test
their
chemical
substances
for
the
presence
of
HDDs/
HDFs.
Any
submissions
must
be
in
accordance
with
the
EPA
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
contained
in
part
790
of
this
chapter
and
any
modifications
to
such
procedures
contained
in
this
part.

(
d)
Section
766.32
specifies
conditions
under
which
persons
required
to
test
may
request
an
exclusion
or
waiver
from
testing.

(
e)
Deadlines
for
submission
to
EPA
of
protocols,
reports,
studies,
and
test
results
are
specified
in
part
790,
subpart
C
and
§
766.35.

(
f)
Sections
766.10,
766.12,
766.14,
766.16,
and
766.18
prescribe
analytical
methods
required;
§
766.27
prescribes
target
levels
of
quantitation
(
LOQ)
for
each
congener
for
which
quantitation
is
required.

(
g)
If
results
of
existing
tests
or
tests
performed
under
this
part
indicate
the
presence
of
HDDs/
HDFs
in
the
identified
chemical
substance
above
the
LOQ
specified
in
§
766.27,
§
766.35(
c)
requires
the
following
additional
reporting
on
the
specified
chemicals:
production,
process,
use,
exposure
and
disposal
data
under
section
8(
a)
of
TSCA;
health
and
safety
studies
under
section
8(
d)
of
TSCA;
and
reports
of
allegations
of
significant
adverse
reactions
under
section
8(
c)
of
TSCA.
In
some
cases,
additional
reporting
may
be
required
of
manufacturers
reporting
no
contamination
of
the
identified
chemical
substances
under
§
766.35(
c)(
2).

(
h)
Section
766.38
requires
manufacturers
of
chemical
substances
produced
from
chemical
substances
identified
as
possible
precursors
to
HDD/
HDF
formation,
to
report
on
chemical
substances
produced
from
such
precursors.

§
766.2
Applicability
and
duration
of
this
part.

(
a)
Chemical
substances
subject
to
testing.
(
1)
This
part
is
applicable
to
each
person
who,
at
any
time
during
the
duration
of
this
part,
manufactures
(
and/
or
imports),
or
processes,
a
chemical
substance
identified
under
§
766.25.
58
(
2)
The
duration
of
this
part
for
any
testing
requirement
for
any
chemical
substance
is
the
period
commencing
with
the
effective
date
of
this
part
to
the
end
of
the
reimbursement
period,
as
defined
in
§
766.3,
for
each
chemical
substance.
All
reporting
requirements
for
any
chemical
substance
listed
under
§
766.25
shall
be
in
effect
for
the
same
period
as
the
testing
requirement.

(
b)
Precursor
chemical
substances.
(
1)
This
part
is
applicable
to
each
person
who
manufactures
(
and/
or
imports)
a
chemical
substance
from
any
precursor
chemical
substance
identified
in
§
766.38.

(
2)
The
requirement
for
precursor
reporting
under
§
766.38
shall
be
in
effect
until
three
years
after
the
effective
date
of
this
part.

(
3)
Small
manufacturers
are
exempt
from
reporting
process
and
reaction
condition
data
on
chemical
substances
made
from
precursor
chemical
substances
listed
under
§
766.38.

§
766.3
Definitions.

The
definitions
in
section
3
of
TSCA
and
the
definitions
of
§
§
704.3,
716.3,
717.3,
and
790.3
of
this
chapter
also
apply
to
this
part.

Congener
means
any
one
particular
member
of
a
class
of
chemical
substances.
A
specific
congener
is
denoted
by
unique
chemical
structure,
for
example
2,3,7,8­
tetrachlorodibenzofuran.

Dibenzofuran
means
any
of
a
family
of
compounds
which
has
as
a
nucleus
a
triple­
ring
structure
consisting
of
two
benzene
rings
connected
through
a
pair
of
bridges
between
the
benzene
rings.
The
bridges
are
a
carbon­
carbon
bridge
and
a
carbon­
oxygen­
carbon
bridge
at
both
substitution
positions.

Dibenzo­
p­
dioxin
or
dioxin
means
any
of
a
family
of
compounds
which
has
as
a
nucleus
a
triple­
ring
structure
consisting
of
two
benzene
rings
connected
through
a
pair
of
oxygen
atoms.

Guidelines
means
the
Midwest
Research
Institute
(
MRI)
publication
Guidelines
for
the
Determination
of
Polyhalogenated
Dioxins
and
Dibenzofurans
in
Commercial
Products,
EPA
contract
No.
68­
02­
3938;
MRI
Project
No.
8201­
A(
41),
1985.

HDD
or
2,3,7,8­
HDD
means
any
of
the
dibenzo­
p­
dioxins
totally
chlorinated
or
totally
brominated
at
the
following
positions
on
the
molecular
structure:
2,3,7,8;
1,2,3,7,8;
1,2,3,4,7,8;
1,2,3,6,7,8;
1,2,3,7,8,9;
and
1,2,3,4,7,8,9.

HDF
or
2,3,7,8­
HDF
means
any
of
the
dibenzofurans
totally
chlorinated
or
totally
brominated
at
the
following
positions
on
the
molecular
structure:
2,3,7,8;
1,2,3,7,8;
2,3,4,7,8;
1,2,3,4,7,8;
1,2,3,6,7,8;
1,2,3,7,8,9;
2,3,4,6,7,8;
1,2,3,4,6,7,8;
and
1,2,3,4,7,8,9.
59
Homolog
means
a
group
of
isomers
that
have
the
same
degree
of
halogenation.
For
example,
the
homologous
class
of
tetrachlorodibenzo­
p­
dioxins
consists
of
all
dibenzo­
p­
dioxins
containing
four
chlorine
atoms.
When
the
homologous
classes
discussed
in
this
part
are
referred
to,
the
following
abbreviations
for
the
prefix
denoting
the
number
of
halogens
are
used:
tetra­,
T
(
4
atoms)
penta­,
Pe
(
5
atoms)
hexa­,
Hx
(
6
atoms)
hepta­,
Hp
(
7
atoms)

HRGC
means
high
resolution
gas
chromatography.

HRMS
means
high
resolution
mass
spectrometry.

Level
of
quantitation
or
LOQ
means
the
lowest
concentration
at
which
HDDs/
HDFs
can
be
reproducibly
measured
in
a
specific
chemical
substance
within
specified
confidence
limits,
as
described
in
this
part.

Polybrominated
dibenzofurans
refers
to
any
member
of
a
class
of
dibenzofurans
with
two
to
eight
bromine
substituents.

Polybrominated
dibenzo­
p­
dioxin
or
PBDD
means
to
any
member
of
a
class
of
dibenzo­
p­
dioxins
with
two
to
eight
bromine
substituents.

Polychlorinated
dibenzofuran
means
any
member
of
a
class
of
dibenzofurans
with
two
to
eight
chlorine
substituents.

Polychlorinated
dibenzo­
p­
dioxin
or
PCDD
means
any
member
of
a
class
of
dibenzo­
p­
dioxins
with
two
to
eight
chlorine
substituents.

Polyhalogenated
dibenzofuran
or
PHDF
means
any
member
of
a
class
of
dibenzofurans
containing
two
to
eight
chlorine,
bromine,
or
a
combination
of
chlorine
and
bromine
substituents.

Polyhalogenated
dibenzo­
p­
dioxin
or
PHDD
means
any
member
of
a
class
of
dibenzo­
p­
dioxins
containing
two
to
eight
chlorine
substituents
or
two
to
eight
bromine
substituents.

Positive
test
result
means:
(
1)
Any
resolvable
gas
chromatographic
peak
for
any
2,3,7,8­
HDD
or
HDF
which
exceeds
the
LOQ
listed
under
§
766.27
for
that
congener,
or
(
2)
exceeds
LOQs
approved
by
EPA
under
§
766.28.

Precursor
means
a
chemical
substance
which
is
not
contaminated
due
to
the
process
conditions
under
which
it
is
manufactured,
but
because
of
its
molecular
structure,
and
under
favorable
process
conditions,
it
may
cause
or
aid
the
formation
of
HDDs/
HDFs
in
other
chemicals
in
which
it
is
used
as
a
feedstock
or
intermediate.
60
QA
means
quality
assurance.

QC
means
quality
control.

Reimbursement
period
means
the
period
that
begins
when
the
data
from
the
last
test
to
be
completed
under
this
part
for
a
specific
chemical
substance
listed
in
§
766.25
is
submitted
to
EPA,
and
ends
after
an
amount
of
time
equal
to
that
which
had
been
required
to
develop
that
data
or
5
years,
whichever
is
later.

TSCA
means
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2601
et
seq.

§
766.5
Compliance.

Any
person
who
fails
or
refuses
to
comply
with
any
aspect
of
this
part
is
in
violation
of
section
15
of
TSCA.
Section
15(
1)
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
comply
with
any
rule
or
order
issued
under
section
4.
Section
15(
3)
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
submit
information
required
under
this
part.
Section
16
provides
that
a
violation
of
section
15
renders
a
person
liable
to
the
United
States
for
a
civil
penalty
and
possible
criminal
prosecution.
Under
section
17
of
TSCA,
the
district
courts
of
the
United
States
have
jurisdiction
to
restrain
any
violation
of
section
15.

§
766.7
Submission
of
information.

All
information
(
including
letters
of
intent,
protocols,
data,
forms,
studies,
and
allegations)
submitted
to
EPA
under
this
part
must
bear
the
applicable
Code
of
Federal
Regulations
(
CFR)
section
number
(
e.
g.,
§
766.20)
and
must
be
addressed
to:
Document
Control
Office,
(
7407),
Information
Management
Division,
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
Dioxin/
Furan
Report.

[
52
FR
21437,
June
5,
1987,
as
amended
at
60
FR
31922,
June
19,
1995]

§
766.10
Test
standards.

Testing
required
under
subpart
B
of
this
part
must
be
performed
using
the
protocols
submitted
to
and
reviewed
by
the
EPA
expert
panel
established
under
§
766.28.
All
new
data,
documentation,
records,
protocols,
specimens,
and
reports
generated
as
a
result
of
testing
under
subpart
B
of
this
part
must
be
fully
developed
and
retained
in
accordance
with
part
792
of
this
chapter.
These
items
must
be
made
available
during
an
inspection
or
submitted
to
EPA
upon
request
by
EPA
or
its
authorized
representative.
Laboratories
conducting
testing
for
submission
to
EPA
in
response
to
a
test
rule
promulgated
under
section
4
of
TSCA
must
adhere
to
the
TSCA
Good
Laboratory
Practices
(
GLPs)
published
in
part
792
of
this
chapter.
Sponsors
must
notify
the
laboratory
that
the
testing
is
being
conducted
pursuant
to
TSCA
section
4.
Sponsors
are
also
responsible
for
61
ensuring
that
laboratories
conducting
the
testing
abide
by
the
TSCA
GLP
standards.
At
the
time
test
data
are
submitted,
manufacturers
must
submit
a
certification
to
EPA
that
the
laboratory
performing
the
testing
adhered
to
the
TSCA
GLPs.

§
766.12
Testing
guidelines.
Analytical
test
methods
must
be
developed
using
methods
equivalent
to
those
described
or
reviewed
in
Guidelines
for
the
Determination
of
Polyhalogenated
Dibenzo­
p­
dioxins
and
Dibenzofurans
in
Commercial
Products.
Copies
are
available
from
the
Director,
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
E­
543B,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Telephone:
(
202)
554­
1404,
TDD:
(
202)
544­
0551.
Copies
are
also
located
in
the
public
docket
for
this
part
(
Docket
No.
OPPTS­
83002)
and
are
available
for
inspection
in
the
Non­
Confidential
Information
Center
(
NCIC)
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
B­
607
NEM,
401
M
St.,
SW.,
Washington,
DC
20460,
between
the
hours
of
12
p.
m.
and
4
p.
m.
weekdays
excluding
legal
holidays.

[
60
FR
34466,
July
3,
1995]

§
766.14
Contents
of
protocols.

Protocols
should
include
all
parts
of
the
Quality
Assurance
Plan
for
Measurement
of
Brominated
or
Chlorinated
Dibenzofurans
and
Dibenzodioxins,
as
stated
in
the
Guidelines.
For
each
chemical
substance
and
each
process,
the
manufacturer
must
submit
a
statement
of
how
many
grades
of
the
chemical
substance
it
produces,
a
justification
for
selection
of
the
specific
grade
of
chemical
substance
for
testing,
specific
plans
for
collection
of
samples
from
the
process
stream,
naming
the
point
of
collection,
the
method
of
collecting
the
sample,
and
an
estimate
of
how
well
the
samples
will
represent
the
material
to
be
characterized;
a
description
of
how
control
samples
(
blanks)
and
HDD/
HDF­
reinforced
control
samples,
or
isotopically
labeled
compounds
(
standards)
and
duplicate
samples
will
be
handled;
a
description
of
the
chemical
extraction
and
clean
up
procedures
to
be
used;
how
extraction
efficiency
and
measurement
efficiency
will
be
established;
and
a
description
of
instrument
hardware
and
operating
conditions,
including
type
and
source
of
columns,
carrier
gas
and
flow
rate,
operating
temperature
range,
and
ion
source
temperature.

§
766.16
Developing
the
analytical
test
method.

Because
of
the
matrix
differences
of
the
chemicals
listed
for
testing,
no
one
method
for
sample
selection,
preparation,
extraction
and
clean
up
is
prescribed.
For
analysis,
High
Resolution
Gas
Chromatography
(
HRGC)
with
High
Resolution
Mass
Spectrometry
(
HRMS)
is
the
method
of
choice,
but
other
methods
may
be
used
if
they
can
be
demonstrated
to
reach
the
target
LOQs
as
well
as
HRGC/
HRMS.

(
a)
Sample
selection.
The
chemical
product
to
be
tested
should
be
sampled
so
that
the
specimens
collected
for
analysis
are
representative
of
the
whole.
Additional
guidance
for
sample
selection
is
62
provided
under
§
766.12.

(
b)
Sample
preparation.
The
sample
must
be
mechanically
homogenized
and
subsampled
as
necessary.
Subsamples
must
be
spiked
or
reinforced
with
surrogate
compounds
or
with
standard
stock
solutions,
and
the
surrogates
or
standards
must
be
thoroughly
incorporated
by
mechanical
agitation.
Additional
guidance
is
provided
under
§
766.12.
(
c)
Sample
extraction
and
cleanup.
The
spiked
samples
must
be
treated
to
separate
the
HDDs/
HDFs
from
the
sample
matrix.
Methods
are
reviewed
in
the
Guidelines
under
§
766.12,
but
the
final
method
or
methods
are
left
to
the
discretion
of
the
analyst,
provided
the
instrumental
response
of
the
surrogates
meets
the
criteria
listed
in
the
Quality
Assurance
Plan
for
Measurement
of
Brominated
or
Chlorinated
Dibenzofurans
and
Dibenzodioxins,
Appendixes
B
and
C
of
the
Guidelines.
Cleanup
techniques
are
described
in
the
Guidelines.
These
are
chosen
at
the
discretion
of
the
analyst
to
meet
the
requirements
of
the
chemical
matrix.

(
d)
Analysis.
The
method
of
choice
is
High
Resolution
Gas
Chromatographic/
High
Resolution
Mass
Spectrometric
Determination,
(
HRGC/
HRMS)
but
alternate
methods
may
be
used
if
the
manufacturer
can
demonstrate
that
the
method
will
reach
the
target
LOQs
as
well
as
HRGC/
HRMS.
Specific
operating
requirements
are
found
in
the
Guidelines.

§
766.18
Method
sensitivity.

The
target
level
of
quantitation
required
under
§
766.27
for
each
HDD/
HDF
congener
is
the
level
which
must
be
attempted
for
each
resolved
HRGC
peak
for
that
congener.
For
at
least
one
product
sample,
at
least
two
analyses
of
the
same
isotopically
labeled
HDD/
HDF
internal
calibration
standards
spiked
to
a
final
product
concentration
equal
to
the
LOQ
for
that
congener
must
be
reproducibly
extracted,
cleaned
up,
and
quantified
to
within
±
20
percent
of
each
other.
For
each
spiked
product
sample,
the
signal
to
noise
ratio
for
the
calibration
standard
peaks
after
complete
extraction
and
cleanup
must
be
10:
1
or
greater.
The
recovery
of
the
internal
calibration
standards
in
the
extracted
and
cleaned
up
product
samples
must
be
within
50
to
150
percent
of
the
amount
spiked,
and
the
results
must
be
corrected
for
recovery.

SUBPART
B
­­
SPECIFIC
CHEMICAL
TESTING/
REPORTING
REQUIREMENTS
§
766.20
Who
must
test.

(
a)
Any
person
who
manufactures,
imports,
or
processes
a
chemical
substance
listed
in
§
766.25
must
test
that
chemical
substance
and
must
submit
appropriate
information
to
EPA
according
to
the
schedules
described
in
§
766.35.
Chemical
substances
manufactured,
imported
or
processed
between
January
1,
1984
and
the
date
of
promulgation
of
this
part
are
subject
to
testing
upon
the
effective
date
of
this
part.
All
other
chemical
substances
are
subject
to
testing
immediately
upon
manufacture,
import
or
processing.
EPA
expects
that
only
manufacturers
and
importers
will
perform
testing,
and
that
the
cost
of
testing
will
be
passed
on
to
processors
through
the
pricing
mechanism,
thereby
enabling
them
to
share
in
the
cost
of
testing.
However,
processors
will
be
63
called
upon
to
sponsor
testing
should
manufacturers
and
importers
fail
to
do
so.
A
processor
may
apply
for
an
exemption
from
testing
upon
certification
to
EPA
that
a
manufacturer
or
importer
is
testing
the
chemical
substance
which
that
person
processes.

(
b)
If
no
manufacturer
or
importer
described
in
§
766.20
submits
a
letter
of
intent
to
perform
testing
within
the
period
described
under
§
766.35(
a),
or
an
exemption
application
under
§
790.45(
a),
or
a
request
for
an
exclusion
or
waiver
under
§
766.32,
EPA
will
issue
a
notice
in
the
FEDERAL
REGISTER
to
notify
all
processors
of
that
chemical
substance.
The
notice
will
state
that
EPA
has
not
received
any
of
the
documents
described
in
the
previous
sentence,
and
that
current
processors
will
have
30
days
to
submit
either
a
letter
of
intent
to
perform
the
test
or
submit
an
exemption
application.

(
c)
If
no
manufacturer,
importer
or
processor
submits
a
letter
of
intent
to
perform
testing
of
a
specific
chemical
substance
produced
by
a
specific
process,
EPA
will
notify
all
manufacturers,
importers,
and
processors,
either
by
notice
in
the
FEDERAL
REGISTER
or
by
letter,
that
all
exemption
applications
will
be
denied
and
that
within
30
days
all
manufacturers,
importers,
and
processors
will
be
in
violation
of
this
part
until
a
proposed
study
plan
is
submitted
for
required
testing.

(
d)
Manufacturers,
importers,
and
processors
who
are
subject
to
this
part
must
comply
with
the
test
rule
development
and
exemption
procedures
in
part
790
of
this
chapter,
except
as
modified
in
this
part.

§
766.25
Chemical
substances
for
testing.

(
a)
Listing
of
chemical
substances.
Chemical
substances
required
to
be
tested
for
HDDs/
HDFs
under
this
rule
are
listed
in
this
section.
The
listing
is
by
Chemical
Abstracts
Service
(
CAS)
Number
and
common
name.

Note:
For
purposes
of
guidance
only,
EPA
lists
the
chemical
substances
subject
to
testing
under
this
part
in
two
classes
­­
those
known
to
be
manufactured
or
imported
between
January
1,
1984,
and
promulgation
of
this
part,
and
those
not
known
to
be
manufactured
or
imported
at
the
time
of
promulgation
of
this
part.

(
1)
Chemicals
substances
known
to
be
manufactured
between
January
1,
1984
and
date
of
promulgation
of
this
part.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
CAS
No.
Chemical
name
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
79­
94­
7
Tetrabromobisphenol­
A.
118­
75­
2
2,3,5,6­
Tetrachloro­
2,5­
cyclohexadiene­
1,4­
dione.
118­
79­
6
2,4,6­
Tribromophenol.
64
120­
83­
2
2,4­
Dichlorophenol.
1163­
19­
5
Decabromodiphenyloxide.
4162­
45­
2
Tetrabromobisphenol­
A­
bisethoxylate.
21850­
44­
2
Tetrabromobisphenol­
A­
bis­
2,3­
dibromopropyl
ether.
25327­
89­
3
Allyl
ether
of
tetrabromobisphenol­
A.
32534­
81­
9
Pentabromodiphenyloxide.
32536­
52­
0
Octabromodiphenyloxide.
37853­
59­
1
1,2­
Bis(
tribromophenoxy)­
ethane.
55205­
38­
4
Tetrabromobisphenol­
A
diacrylate.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
2)
Chemicals
not
known
to
be
manufactured
between
January
1,
1984
and
the
date
of
promulgation
of
this
part.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
CAS
No.
Chemical
name
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
79­
95­
8
Tetrachlorobisphenol­
A.
87­
10­
5
3,4',
5­
Tribromosalicylanilide.
87­
65­
0
2,6­
Dichlorophenol.
95­
77­
2
3,4­
Dichlorophenol.
95­
95­
4
2,4,5­
Trichlorophenol.
99­
28­
5
2,6­
Dibromo­
4­
nitrophenol.
120­
36­
5
2[
2,4­(
Dichlorophenoxy)]­
propionic
acid.
320­
72­
9
3,5­
Dichlorosalicyclic
acid.
488­
47­
1
Tetrabromocatechol.
576­
24­
9
2,3­
Dichlorophenol.
583­
78­
8
2,5­
Dichlorophenol.
608­
71­
9
Pentabromophenol.
615­
58­
7
2,4­
Dibromophenol.
933­
75­
5
2,3,6­
Trichlorophenol.
1940­
42­
7
4­
Bromo­
2,5­
dichlorophenol.
2577­
72­
2
3,5­
Dibromosalicylanilide.
3772­
94­
9
Pentachlorophenyl
laurate.
37853­
61­
5
Bismethylether
of
tetrabromobisphenol­
A.
Alkylamine
tetrachlorophenate.
Tetrabromobisphenol­
B.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
b)
Grade
to
be
tested.
If
the
same
process
is
used
to
manufacture
all
grades
of
the
same
chemical
substance,
only
one
grade
need
be
tested.
The
grade
to
be
tested
must
be
the
grade
subject
to
the
most
intense
heat
and
alkalinity
for
the
longest
duration
of
time,
manufactured
under
each
different
process.
If
the
heat,
alkalinity
and
duration
of
reaction
do
not
differ
for
various
grades,
the
test
substance
must
be
the
grade
of
chemical
substance
with
the
highest
volume
of
sales.
65
§
766.27
Congeners
and
LOQs
for
which
quantitation
is
required.

Quantitation
at
the
target
LOQ
shown
for
each
of
the
following
HDDs/
HDFs
which
may
be
present
in
the
chemical
substances
is
required
for
the
chemical
substances
listed
under
§
766.25.
Analysis
must
take
place
for
either
chlorinated
or
brominated
dibenzodioxins
or
dibenzofurans,
whichever
is
predominantly
expected
to
occur
in
the
chemical
substance
to
be
tested.
Only
chlorinated
and
brominated
congeners
need
be
quantified;
for
chemical
substances
containing
predominantly
chlorine
atoms,
only
congeners
totally
chlorinated
at
the
numbered
positions
need
be
quantified;
for
chemical
substances
containing
predominantly
bromine
atoms,
only
congeners
totally
brominated
at
the
numbered
positions
need
be
quantified.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Chlorinated
dioxins
Brominated
dioxins
LOQ
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
2,3,7,8­
TCDD..........................
2,3,7,8­
TBDD............
0.1
ppb.
1,2,3,7,8­
PeCDD.....................
1,2,3,7,8­
PeBDD........
0.5
ppb.
1,2,3,4,7.8­
HxCDD.................
1,2,3,4,7,8­
HxBDD....
2.5
ppb.
1,2,3,6,7,8­
HxCDD.................
1,2,3,6,7,8­
HxBDD....
2.5
ppb.
1,2,3,7,8,9­
HxCDD.................
1,2,3,7,8,9­
HxBDD....
2.5
ppb.
1,2,3,4,6,7,8­
HpCDD..............
1,2,3,4,6,7,8­
HpBDD.
100
ppb.
2,3,7,8­
TCDF..........................
2,3,7,8­
TBDF............
1
ppb.
1,2,3,7,8­
PeCDF......................
1,2,3,7,8­
PeBDF........
5
ppb.
2,3,4,7,8­
PeCDF......................
2,3,4,7,8­
PeBDF........
5
ppb.
1,2,3,4,7,8­
HxCDF..................
1,2,3,4,7,8­
HxBDF....
25
ppb.
1,2,3,6,7,8­
HxCDF..................
1,2,3,6,7,8­
HxBDF....
25
ppb.
1,2,3,7,8,9­
HxCDF..................
1,2,3,7,8,9­
HxBDF....
25
ppb.
2,3,4,6,7,8­
HxCDF..................
2,3,4,6,7,8­
HxBDF....
25
ppb.
1,2,3,4,6,7,8­
HpCDF...............
1,2,3,4,6,7,8­
HpBDF.
1
ppm.
1,2,3,4,7,8,9­
HpCDF...............
1,2,3,4,7,8,9­
HpBDF.
1
ppm.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

§
766.28
Expert
review
of
protocols.

EPA
will
gather
a
panel
of
experts
in
analysis
of
chemical
matrices
for
HDDs/
HDFs
to
review
the
protocols
for
testing
submitted
to
EPA.
The
panel
members
will
be
employees
of
EPA
and/
or
of
other
U.
S.
Government
agencies
who
have
had
experience
in
analysis
of
chemical
matrices
and/
or
chemical
wastes
for
HDDs/
HDFs.
The
panel
will
recommend
to
the
Director,
EPA
Office
of
Pollution
Prevention
and
Toxics,
whether
the
protocol
submitted
is
likely
to
allow
analysis
down
to
the
target
LOQs,
or
if
not,
whether
the
protocol
represents
a
good
faith
effort
on
the
part
of
the
tester
to
achieve
the
lowest
possible
LOQs.
The
final
determination
to
accept
or
reject
the
protocol
will
be
made
by
the
Director,
Office
of
Pollution
Prevention
and
Toxics.
EPA
will
review
the
submitted
protocols
as
rapidly
as
possible
and
will
complete
the
review
within
90
days
after
receipt.
EPA
may
require
submission
of
revised
protocols.
Comments
and
66
recommendations
will
be
transmitted
to
the
submitter,
and
if
revisions
are
required,
a
final
protocol
must
be
submitted
to
EPA
within
90
days
after
EPA
transmits
such
recommendations.

§
766.32
Exclusions
and
waivers.

(
a)
Reasons
for
exclusions
and
waivers.
Any
person
subject
to
the
testing
requirements
of
this
part
may
request
an
exclusion
or
waiver
from
testing
for
any
one
of
the
following
reasons:

(
1)
Exclusions
may
be
granted
if.
(
i)
Testing
of
the
appropriate
grade
of
the
chemical
substance
has
already
been
carried
out,
either
analytical
testing
at
the
lowest
LOQ
possible,
with
appropriate
QA/
QC,
or
a
well­
designed
bioassay
with
appropriate
QA/
QC
or;

(
ii)
Process
and
reaction
conditions
of
the
chemical
substance
such
that
no
HDDs/
HDFs
could
be
produced
under
those
conditions;

(
2)
Waivers
may
be
granted
if.
(
i)
A
responsible
company
official
certifies
that
the
chemical
substance
is
produced
only
in
quantities
of
100
kilograms
or
less
per
year,
only
for
research
and
development
purposes;
or
(
ii)
In
the
judgement
of
EPA,
the
cost
of
testing
would
drive
the
chemical
substance
off
the
market,
or
prevent
resumption
of
manufacture
or
import
of
the
chemical
substance,
if
it
is
not
currently
manufactured,
and
the
chemical
substance
will
be
produced
so
that
no
unreasonable
risk
will
occur
due
to
its
manufacture,
import,
processing,
distribution,
use,
or
disposal.
(
In
this
case,
the
manufacturer
must
submit
to
EPA
all
data
supporting
the
determination.)

(
iii)
Waivers
may
be
appropriately
conditioned
with
respect
to
such
factors
as
time
and
conditions
of
manufacture
or
use.
The
grade
of
decabromodiphenyl
oxide
produced
by
Dow
Chemical
Company
(
Dow)
for
the
National
Toxicology
Program
(
NTP)
bioassay
on
that
chemical
is
excluded
from
the
testing
requirement
under
this
part.
Provided,
however,
that
this
exclusion
will
not
apply
if
Dow
fails
to
supply
to
EPA
within
60
days
of
the
effective
date
of
this
section
evidence
showing
which
grade
was
used
for
the
NTP
bioassay.

(
b)
Timing.
Exclusion
or
waiver
requests
and
detailed
supporting
data
must
be
submitted
to
EPA
within
60
days
from
the
effective
date
of
this
part
for
persons
manufacturing,
importing
or
processing
a
chemical
substance
as
of
the
date
of
promulgation,
or
60
days
prior
to
the
date
of
resumption
of
manufacture
or
import
for
a
chemical
substance
produced
by
a
specific
process
if
the
chemical
substance
is
not
manufactured,
imported
or
processed
as
of
the
date
of
promulgation.

(
c)
Publication.
Within
10
days
of
receipt
of
any
exclusion
or
waiver
request,
EPA
will
issue
in
the
FEDERAL
REGISTER
a
notice
of
such
receipt.
EPA
will
also
issue
a
notice
of
its
decision
on
each
exclusion
or
waiver
request
within
60
days
of
receipt.
67
(
d)
Decision.
The
EPA
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
will
make
the
decision
to
grant
or
deny
waivers
or
exclusions.

§
766.35
Reporting
requirements.

(
a)
Letters
of
intent,
exemption
applications,
and
protocols
­­
(
1)
Letters
of
Intent.
(
i)
Persons
who
have
manufactured
or
imported
chemical
substances
listed
under
§
766.25
between
January
1,
1984,
and
the
effective
date
of
this
part
are
required
to
submit
under
§
790.45
of
this
chapter
a
letter
of
intent
to
test
or
an
exemption
application.
These
letters
must
be
submitted
no
later
than
September
3,
1987.

(
ii)
Persons
who
commence
manufacture,
import
or
processing
of
a
chemical
substance
listed
under
§
766.25
that
has
not
been
manufactured,
imported
or
processed
between
January
1,
1984
and
the
effective
date
of
this
part
must
submit
under
§
790.45
of
this
chapter,
within
60
days
after
the
commencement
of
manufacture,
import,
or
processing
of
the
chemical
substance,
a
letter
of
intent
to
test
or
an
exemption
application.

(
iii)
Persons
who
commence
manufacture,
import
or
processing
of
a
chemical
substance
listed
under
§
766.25
between
the
effective
date
of
this
part
and
the
end
of
the
reimbursement
period
for
that
particular
chemical
substance
produced
by
a
specific
process
must
submit
under
§
790.45
of
this
chapter,
within
60
days
after
the
commencement
of
manufacture,
import
or
processing
of
the
chemical
substance,
a
letter
of
intent
to
test
or
an
exemption
application.

(
2)
Protocols.
(
i)
Each
person
who
is
manufacturing
or
processing
a
chemical
substance
listed
in
§
766.25
as
of
the
effective
date
of
this
part
who
submits
a
notice
of
intent
to
test
under
§
766.35(
a)(
1)
must
submit
a
protocol
for
the
test
as
follows:

(
A)
The
protocols
for
each
chlorinated
chemical
substance
produced
by
each
process
to
be
tested
must
be
submitted
to
EPA
no
later
than
12
months
after
the
effective
date
of
this
part.

(
B)
The
protocol
for
each
brominated
chemical
substance
produced
by
each
process
to
be
tested
must
be
submitted
to
EPA
no
later
than
24
months
after
the
effective
date
of
this
part
except
for
the
following
chemicals.

(
1)
The
deadline
for
submitting
the
protocols
for
tetrabromobisphenol­
A
(
CAS
No.
79­
94­
7);
2,4,6
tribromophenol
(
CAS
No.
118­
79­
6);
decabromodiphenyloxide
(
CAS
No.
1163­
19­
5);
and
1,2­
bis(
tribromophenoxy)­
ethane
(
CAS
No.
37853­
59­
1)
is
January
31,
1991.

(
2)
The
deadline
for
submitting
protocols
for
octabromodiphenyloxide
(
CAS
No.
32536­
52­
0)
and
allyl
ether
of
tetrabromobisphenol­
A
(
CAS
No.
25327­
89­
3)
is
January
31,
1991.

(
3)
The
deadline
for
submitting
protocols
for
pentabromodiphenyloxide
(
CAS
No.
32534­
81­
9)
is
February
6,
1995.
The
deadline
for
submitting
tetrabromobisphenol­
A­
bisethoxylate
(
CAS
No.
68
4126­
45­
2)
is
January
31,
1991.

(
4)
The
deadline
for
submitting
protocols
for
3,4',
5­
tribromosalicylanilide
(
CAS
No.
87­
10­
5)
is
September
5,
1990.

(
ii)
For
chemical
substances
produced
by
a
specific
process
not
manufactured
or
processed
as
of
the
effective
date
of
this
part,
a
person
who
begins
manufacture
and
submits
a
notice
of
intent
to
test
must
submit
protocols
for
the
test
as
follows:

(
A)
Except
as
noted
for
the
submitter
and
substance
specified
in
the
following
table,
protocols
for
testing
must
be
submitted
12
months
after
manufacture
or
importation
begins
for
chlorinated
chemical
substances.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
CAS
No.
Submitter
Chemical
Due
date
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
118­
75­
2
Rhone­
Poulenc..........
2,3,5,6­
tetrachloro­
2,5­
cyclohexaniene­
March
4,
1994
1,4­
dione.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
B)
Protocols
for
testing
must
be
submitted
24
months
after
manufacture
begins
for
brominated
chemical
substances.

(
iii)
For
persons
who
have
been
granted
exemptions,
waivers
or
exclusions
from
testing,
protocols
must
be
submitted
12
months
after
expiration
of
the
exemption,
waiver
or
exclusion
for
chlorinated
chemical
substances,
and
24
months
after
expiration
of
the
exemption,
waiver
or
exclusion
for
brominated
chemical
substances.

(
b)
Information
that
must
be
submitted
to
EPA.
(
1)
Persons
who
manufacture
or
import
a
chemical
substance
listed
under
§
766.25
must
report
no
later
than
October
5,
1987
or
90
days
after
the
person
first
manufactures
or
imports
the
chemical
substance,
whichever
is
later,
the
results
of
all
existing
test
data
which
show
that
chemical
substance
has
been
tested
for
the
presence
of
HDDs/
HDFs.

(
2)
Any
manufacturer
or
importer
of
a
chemical
substance
listed
in
§
766.25
in
possession
of
unpublished
health
and
safety
studies
on
HDDs/
HDFs
is
required
to
submit
copies
of
such
studies
to
EPA
no
later
than
October
5,
1987
or
90
days
after
the
person
first
manufactures
or
imports
the
chemical
substance,
whichever
is
later.
The
following
provisions
of
part
716
of
this
chapter
apply
to
submission
of
these
studies:
§
§
716.3,
716.10(
a)
(
1)
and
(
4);
716.20(
a)
(
1),
(
2),
(
3),
(
4),
(
7),
(
8)
and
(
10);
716.25;
716.30;
716.35(
a)
(
1),
(
2),
and
(
4)
[
if
applicable];
716.35
(
b)
and
(
c);
716.40
(
a)
and
(
b);
716.50;
716.55;
and
716.60(
a)(
2).
69
(
3)
No
later
than
October
5,
1987
or
90
days
after
the
person
first
manufactures
or
imports
the
substance
listed
in
§
766.25,
any
manufacturer
or
importer
of
a
chemical
substance
listed
in
§
766.25
must
submit
records
required
to
be
held
under
part
717
of
this
chapter
on
any
HDDs/
HDFs.

(
4)
Test
results.
(
i)
Test
results
must
be
submitted
to
EPA
not
later
than
270
days
after
EPA's
transmission
of
comments
or
180
days
after
a
final
protocol
is
submitted
to
EPA,
whichever
is
shorter,
except
as
noted
for
the
submitters
and
substances
specified
in
the
following
table:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
CAS
No.
Submitter
Chemical
Due
Date
Effective
Date
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
79­
94­
7
Great
Lakes
Tetrabromobisphenol­
A
May
26,
1992
May
28,
1993
79­
94­
7
Ethyl
Tetrabromobisphenol­
A
August
10,
1992
May
28,
1993
79­
94­
7
Ameribrom
Tetrabromobisphenol­
A
April
15,
1994
September
29,
1995
87­
10­
5
Pfister
3,4',
5­
tribromosalicylanilide
45
days
after
protocol
May
28,
1993
approval
118­
75­
2
Rhone­
Poulenc.
2,3,5,6­
tetrachloro­
2,5­
July
5,
1996
June
30,
1997
Inc.
cyclohexadiene­
1,4­
dione
118­
79­
6
Great
Lakes
2,4,6­
Tribromophenol
May
26,
1992
May
28,
1993
1163­
19­
5
Ameribrom
Decabromodiphenyloxide
April
15,
1994
September
29,
1995
1163­
19­
5
Ethyl
Decabromodiphenyloxide
May
26,
1992
May
28,
1993
1163­
19­
5
Great
Lakes
Decabromodiphenyloxide
May
26,
1992
May
28,
1993
4162­
45­
2
Great
Lakes
Tetrabromobisphenol­
A­
June
2,
1993
September
8,
1994
bisethoxylate
25327­
89­
3
Great
Lakes
Allyl
Ether
of
August
10,
1992
May
28,
1993
Tetrabromobisphenol­
A
32534­
81­
9
Great
Lakes
Pentabromodiphenyloxide
March
22,
1993
September
8,
1994
32534­
81­
9
Akzo
Chemicals
Pentabromodiphenyloxide
February
6,
1995
September
29,
1995
Inc.

32534­
81­
9
Ameribrom
Pentabromodiphenyloxide
March
22,
1993
September
8,
1994
32536­
52­
0
Ameribrom
Octabromodiphenyloxide
January
8,
1993
September
29,
1995
32536­
52­
0
Ethyl
Octabromodiphenyloxide
May
15,
1994
May
28,
1993
32536­
52­
0
Great
Lakes
Octabromodiphenyloxide
May
26,
1992
May
28,
1993
70
37853­
59­
1
Great
Lakes
1,2­
bis(
tribromo­
January
24,
1995
September
29,
1995
phenoxy)
ethane
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
ii)
For
purposes
of
reporting
test
results
to
EPA,
and
for
further
reporting
triggered
by
a
positive
test
result
under
§
766.35(
c),
a
positive
test
result
is
defined
at
§
766.3.

(
iii)
Reporting
of
test
results
must
follow
procedures
set
out
in
part
790
of
this
chapter,
except
as
modified
in
this
part.

(
c)
Information
required
to
be
submitted
to
EPA
after
submission
of
a
positive
test
result.
(
1)
Any
person
who
submits
a
positive
test
result
for
a
specific
chemical
substance
listed
under
§
766.25
must
submit
to
EPA
no
later
than
90
days
after
the
date
of
submission
of
the
positive
test
result
the
following:

(
i)
A
completed
form
(
EPA
7710­
51)
for
that
chemical
substance.
The
form
and
instructions
are
available
from
the
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
One
form
must
be
submitted
for
each
chemical
substance
for
which
a
positive
test
result
has
been
submitted.

(
ii)
Health
and
safety
studies
for
the
chemical
substance
for
which
a
positive
test
result
has
been
reported.
The
following
provisions
of
part
716
of
this
chapter
apply
to
submission
of
these
studies:
§
§
716.3;
716.10
(
a)
(
1),
(
2),
(
3)
and
(
4);
716.20;
716.25;
716.30;
716.35(
a)
(
1),
(
2),
and
(
4),
[
if
applicable];
716.35
(
b)
and
(
c);
716.40
(
a)
and
(
b);
716.50;
716.55;
716.60(
a)(
2).

(
iii)
Copies
of
records
on
the
chemical
substances
required
to
be
held
under
part
717
of
this
chapter.

(
2)
If
a
positive
test
result
on
a
chemical
substance
is
received
from
one
person
but
not
from
others,
EPA
may
issue
a
notice
in
the
FEDERAL
REGISTER
listing
that
chemical
substance
and
requiring
any
person
manufacturing,
importing
or
processing
that
chemical
substance
who
has
not
submitted
a
positive
test
result
to
submit
the
information
required
in
Part
II
of
EPA
Form
7710­
51.
Such
a
notice
will
be
published
only
if
EPA
needs
additional
process
data
to
make
a
determination
of
unreasonable
risk.

(
d)­(
e)
[
Reserved]

(
f)
Effective
date.
(
1)
The
effective
date
of
this
final
rule
is
July
6,
1987,
except
for
paragraphs
(
a)(
2)(
i)(
B)
introductory
text,
(
a)(
2)(
i)(
B)(
1),
(
a)(
2)(
i)(
B)(
2),
(
a)(
2)(
i)(
B)(
3),
(
a)(
2)(
i)(
B)(
4),
the
table
in
paragraph
(
a)(
2)(
ii)(
A),
and
the
table
in
paragraph
(
b)(
4)(
i)
of
this
section.

(
2)
The
effective
date
for
paragraph
(
a)(
2)(
i)(
B)
introductory
text,
(
a)(
2)(
i)(
B)(
1),
(
a)(
2)(
i)(
B)(
2),
and
(
a)(
2)(
i)(
B)(
4),
is
May
21,
1991.
The
effective
date
of
paragraphs
(
a)(
2)(
i)(
B)(
3),
and
the
71
table
in
paragraph
(
a)(
2)(
ii)(
A)
is
September
29,
1995.
The
effective
date
of
paragraph
(
b)(
4)(
i)
introductory
text
is
May
28,
1993,
and
the
effective
date
of
the
entries
in
the
table
in
paragraph
(
b)(
4)(
i)
is
shown
in
the
effective
dates
column
of
the
table.

(
3)
The
guidelines
and
other
test
methods
cited
in
this
rule
are
referenced
as
they
exist
on
the
effective
date
of
the
final
rule.

[
52
FR
21437,
June
5,
1987,
as
amended
at
56
FR
23229,
May
21,
1991;
57
FR
24960,
June
12,
1992;
58
FR
30991,
May
28,
1993,
58
FR
34205,
June
23,
1993;
59
FR
46356,
Sept.
8,
1994;
60
FR
31922,
June
19,
1995;
60
FR
50433,
Sept.
29,
1995;
60
FR
56955,
Nov.
13,
1995;
62
FR
35105,
June
30,
1997]

§
766.38
Reporting
on
precursor
chemical
substances.

(
a)
Identification
of
precursor
chemical
substances.
Precursor
chemical
substances
are
produced
under
conditions
that
will
not
yield
HDDs
and
HDFs,
but
their
molecular
structure
is
conducive
to
HDD/
HDF
formation
under
favorable
reaction
conditions
when
they
are
used
to
produce
other
chemicals
or
products.
The
following
precursor
chemical
substances
are
identified
by
Chemical
Abstract
Service
(
CAS)
number
and
name.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
CAS
No.
Chemical
name
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
85­
22­
3..........................
Pentabromoethylbenzene.
87­
61­
6..........................
1,2,3­
Trichlorobenzene.
87­
84­
3..........................
1,2,3,4,5­
Pentabromo­
6­
chloro­
cyclohexane.
89­
61­
2..........................
1,4­
Dichloro­
2­
nitrobenzene.
89­
64­
5..........................
4­
Chloro­
2­
nitrophenol.
89­
69­
0..........................
2,4,5­
Trichloronitrobenzene.
92­
04­
6..........................
2­
Chloro­
4­
phenylphenol.
94­
74­
6..........................
4­
Chloro­
o­
toloxy
acetic
acid.
94­
81­
5..........................
4­(
2­
Methyl­
4­
chlorophenoxy)
butyric
acid.
95­
50­
1..........................
o­
Dichlorobenzene.
95­
56­
7..........................
o­
Bromophenol.
95­
57­
8..........................
o­
Chlorophenol.
95­
88­
5..........................
4­
Chlororesorcinol.
95­
94­
3..........................
1,2,4,5­
Tetrachlorobenzene.
97­
50­
7..........................
5­
Chloro­
2,4­
dimethoxyaniline.
99­
30­
9..........................
2,6­
Dichloro­
4­
nitroaniline.
99­
54­
7..........................
1,2­
Dichloro­
4­
nitrobenzene.
106­
46­
7.........................
p­
Dichlorobenzene.
108­
70­
3.........................
1,3,5­
Trichlorobenzene.
108­
86­
1.........................
Bromobenzene.
72
108­
90­
7.........................
Chlorobenzene.
117­
18­
0.........................
1,2,4,5­
Tetrachloro­
3­
nitrobenzene.
120­
82­
1.........................
1,2,4­
Trichlorobenzene.
348­
51­
6.........................
o­
Chorofluorobenzene.
350­
30­
1.........................
3­
Chloro­
4­
fluoronitrobenzene.
615­
67­
8.........................
Chlorohydroquinone.
626­
39­
1.........................
1,3,5­
Tribromobenzene.
827­
94­
1.........................
2,6­
Dibromo­
4­
nitroaniline.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
b)
Persons
required
to
report.
All
persons
who
manufacture
or
import
a
chemical
product
produced
using
any
of
the
chemical
substances
listed
in
paragraph
(
a)
of
this
section
as
feedstocks
or
intermediates
must
report
no
later
than
September
29,
1987.
Small
manufacturers
and
those
manufacturers
and
importers
who
produce
the
precursor
chemical
substances
in
quantities
of
100
kilograms
or
less
per
year
only
for
research
and
development
purposes
are
not
required
to
report
under
this
section
(
c)
Data
to
be
reported.
Manufacturers
and
importers
of
chemical
products
made
from
precursor
chemical
substances
identified
in
paragraph
(
a)
of
this
section
must
report
process
and
reaction
condition
data
on
Part
II
of
EPA
Form
7710­
51
for
each
chemical
product.
A
separate
EPA
Form
7710­
51
must
be
submitted
for
each
chemical
product
reported,
and
the
precursor
chemical
substance
used
must
be
identified.
All
forms
must
be
submitted
to
EPA
no
later
than
September
29,
1987.

[
52
FR
21437,
June
5,
1987,
as
amended
at
60
FR
31922,
June
19,
1995]
73
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
F
Dioxin/
Furan
Report
(
EPA
Form
7710­
51)

[
Note:
An
electronic
copy
of
this
attachment
is
not
available.
Please
contact
the
Environmental
Protection
Agency
at
the
address
noted
in
the
Federal
Register
notice
for
a
complete
copy
of
this
ICR.]
74
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
G
40
CFR
792
This
attachment
can
also
be
accessed
online
via
Internet
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr792_
00.
html
75
TITLE
40­­
PROTECTION
OF
ENVIRONMENT
CHAPTER
I­­
ENVIRONMENTAL
PROTECTION
AGENCY
PART
792
­­
GOOD
LABORATORY
PRACTICE
STANDARDS
Subpart
A
­­
General
Provisions
Sec.
792.1
Scope.
792.3
Definitions.
792.10
Applicability
to
studies
performed
under
grants
and
contracts.
792.12
Statement
of
compliance
or
non­
compliance.
792.15
Inspection
of
a
testing
facility.
792.17
Effects
of
non­
compliance.

Subpart
B
­­
Organization
and
Personnel
792.29
Personnel.
792.31
Testing
facility
management.
792.33
Study
director.
792.35
Quality
assurance
unit.

Subpart
C
­­
Facilities
792.41
General.
792.43
Test
system
care
facilities.
792.45
Test
system
supply
facilities.
792.47
Facilities
for
handling
test,
control,
and
reference
substances.
792.49
Laboratory
operation
areas.
792.51
Specimen
and
data
storage
facilities.

Subpart
D
­­
Equipment
792.61
Equipment
design.
792.63
Maintenance
and
calibration
of
equipment.

Subpart
E
­­
Testing
Facilities
Operation
76
792.81
Standard
operating
procedures.
792.83
Reagents
and
solutions.
792.90
Animal
and
other
test
system
care.

Subpart
F
­­
Test,
Control,
and
Reference
Substances
792.105
Test,
control,
and
reference
substance
characterization.
792.107
Test,
control,
and
reference
substance
handling.
792.113
Mixtures
of
substances
with
carriers.

Subpart
G
­­
Protocol
for
and
Conduct
of
A
Study
792.120
Protocol.
792.130
Conduct
of
a
study.
792.135
Physical
and
chemical
characterization
studies.

Subparts
H­
I
[
Reserved]

Subpart
J
­­
Records
and
Reports
792.185
Reporting
of
study
results.
792.190
Storage
and
retrieval
of
records
and
data.
792.195
Retention
of
records.

Authority:
15
U.
S.
C.
2603.

Source:
54
FR
34043,
Aug.
17,
1989,
unless
otherwise
noted.

SUBPART
A
­­
GENERAL
PROVISIONS
§
792.1
Scope.

(
a)
This
part
prescribes
good
laboratory
practices
for
conducting
studies
relating
to
health
effects,
environmental
effects,
and
chemical
fate
testing.
This
part
is
intended
to
ensure
the
quality
and
integrity
of
data
submitted
pursuant
to
testing
consent
agreements
and
test
rules
issued
under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA)
(
Pub.
L.
94­
469,
90
Stat.
2006,
15
U.
S.
C.
2603
et
seq.).

(
b)
This
part
applies
to
any
study
described
by
paragraph
(
a)
of
this
section
which
any
person
77
conducts,
initiates,
or
supports
on
or
after
September
18,
1989.

(
c)
It
is
EPA's
policy
that
all
data
developed
under
section
5
of
TSCA
be
in
accordance
with
provisions
of
this
part.
If
data
are
not
developed
in
accordance
with
the
provisions
of
this
part,
EPA
will
consider
such
data
insufficient
to
evaluate
the
health
and
environmental
effects
of
the
chemical
substances
unless
the
submitter
provides
additional
information
demonstrating
that
the
data
are
reliable
and
adequate.

§
792.3
Definitions.

As
used
in
this
part
the
following
terms
shall
have
the
meanings
specified:

Batch
means
a
specific
quantity
or
lot
of
a
test,
control,
or
reference
substance
that
has
been
characterized
according
to
§
792.105(
a).

Carrier
means
any
material,
including
but
not
limited
to,
feed,
water,
soil,
and
nutrient
media,
with
which
the
test
substance
is
combined
for
administration
to
a
test
system.

Control
substance
means
any
chemical
substance
or
mixture,
or
any
other
material
other
than
a
test
substance,
feed,
or
water,
that
is
administered
to
the
test
system
in
the
course
of
a
study
for
the
purpose
of
establishing
a
basis
for
comparison
with
the
test
substance
for
chemical
or
biological
measurements.

EPA
means
the
U.
S.
Environmental
Protection
Agency.

Experimental
start
date
means
the
first
date
the
test
substance
is
applied
to
the
test
system.

Experimental
termination
date
means
the
last
date
on
which
data
are
collected
directly
from
the
study.

FDA
means
the
U.
S.
Food
and
Drug
Administration.

Person
includes
an
individual,
partnership,
corporation,
association,
scientific
or
academic
establishment,
government
agency,
or
organizational
unit
thereof,
and
any
other
legal
entity.

Quality
assurance
unit
means
any
person
or
organizational
element,
except
the
study
director,
designated
by
testing
facility
management
to
perform
the
duties
relating
to
quality
assurance
of
the
studies.

Raw
data
means
any
laboratory
worksheets,
records,
memoranda,
notes,
or
exact
copies
thereof,
that
are
the
result
of
original
observations
and
activities
of
a
study
and
are
necessary
for
the
reconstruction
and
evaluation
of
the
report
of
that
study.
In
the
event
that
exact
transcripts
of
raw
data
have
been
prepared
(
e.
g.,
tapes
which
have
been
transcribed
verbatim,
dated,
and
78
verified
accurate
by
signature),
the
exact
copy
or
exact
transcript
may
be
substituted
for
the
original
source
as
raw
data.
"
Raw
data"
may
include
photographs,
microfilm
or
microfiche
copies,
computer
printouts,
magnetic
media,
including
dictated
observations,
and
recorded
data
from
automated
instruments.

Reference
substance
means
any
chemical
substance
or
mixture,
or
analytical
standard,
or
material
other
than
a
test
substance,
feed,
or
water,
that
is
administered
to
or
used
in
analyzing
the
test
system
in
the
course
of
a
study
for
the
purposes
of
establishing
a
basis
for
comparison
with
the
test
substance
for
known
chemical
or
biological
measurements.

Specimen
means
any
material
derived
from
a
test
system
for
examination
or
analysis.

Sponsor
means:

(
1)
A
person
who
initiates
and
supports,
by
provision
of
financial
or
other
resources,
a
study;

(
2)
A
person
who
submits
a
study
to
the
EPA
in
response
to
a
TSCA
section
4(
a)
test
rule
and/
or
a
person
who
submits
a
study
under
a
TSCA
section
4
testing
consent
agreement
or
a
TSCA
section
5
rule
or
order
to
the
extent
the
agreement,
rule
or
order
references
this
part;
or
(
3)
A
testing
facility,
if
it
both
initiates
and
actually
conducts
the
study.

Study
means
any
experiment
at
one
or
more
test
sites,
in
which
a
test
substance
is
studied
in
a
test
system
under
laboratory
conditions
or
in
the
environment
to
determine
or
help
predict
its
effects,
metabolism,
environmental
and
chemical
fate,
persistence,
or
other
characteristics
in
humans,
other
living
organisms,
or
media.
The
term
"
study"
does
not
include
basic
exploratory
studies
carried
out
to
determine
whether
a
test
substance
or
a
test
method
has
any
potential
utility.

Study
completion
date
means
the
date
the
final
report
is
signed
by
the
study
director.

Study
director
means
the
individual
responsible
for
the
overall
conduct
of
a
study.

Study
initiation
date
means
the
date
the
protocol
is
signed
by
the
study
director.

Test
substance
means
a
substance
or
mixture
administered
or
added
to
a
test
system
in
a
study,
which
substance
or
mixture
is
used
to
develop
data
to
meet
the
requirements
of
a
TSCA
section
4(
a)
test
rule
and/
or
is
developed
under
a
TSCA
section
4
testing
consent
agreement
or
section
5
rule
or
order
to
the
extent
the
agreement,
rule
or
order
references
this
part.

Test
system
means
any
animal,
plant,
microorganism,
chemical
or
physical
matrix,
including
but
not
limited
to,
soil
or
water,
or
components
thereof,
to
which
the
test,
control,
or
reference
substance
is
administered
or
added
for
study.
"
Test
system"
also
includes
appropriate
groups
or
components
of
the
system
not
treated
with
the
test,
control,
or
reference
substance.
79
Testing
facility
means
a
person
who
actually
conducts
a
study,
i.
e.,
actually
uses
the
test
substance
in
a
test
system.
"
Testing
facility"
encompasses
only
those
operational
units
that
are
being
or
have
been
used
to
conduct
studies.

TSCA
means
the
Toxic
Substances
Control
Act
(
15
U.
S.
C,
2601
et
seq.)

Vehicle
means
any
agent
which
facilitates
the
mixture,
dispersion,
or
solubilization
of
a
test
substance
with
a
carrier.

§
792.10
Applicability
to
studies
performed
under
grants
and
contracts.

When
a
sponsor
or
other
person
utilizes
the
services
of
a
consulting
laboratory,
contractor,
or
grantee
to
perform
all
or
a
part
of
a
study
to
which
this
part
applies,
it
shall
notify
the
consulting
laboratory,
contractor,
or
grantee
that
the
service
is,
or
is
part
of,
a
study
that
must
be
conducted
in
compliance
with
the
provisions
of
this
part.

§
792.12
Statement
of
compliance
or
non­
compliance.

Any
person
who
submits
to
EPA
a
test
required
by
a
testing
consent
agreement
or
a
test
rule
issued
under
section
4
of
TSCA
shall
include
in
the
submission
a
true
and
correct
statement,
signed
by
the
sponsor
and
the
study
director,
of
one
of
the
following
types:

(
a)
A
statement
that
the
study
was
conducted
in
accordance
with
this
part;
or
(
b)
A
statement
describing
in
detail
all
differences
between
the
practices
used
in
the
study
and
those
required
by
this
part;
or
(
c)
A
statement
that
the
person
was
not
a
sponsor
of
the
study,
did
not
conduct
the
study,
and
does
not
know
whether
the
study
was
conducted
in
accordance
with
this
part.

§
792.15
Inspection
of
a
testing
facility.

(
a)
A
testing
facility
shall
permit
an
authorized
employee
or
duly
designated
representative
of
EPA
or
FDA,
at
reasonable
times
and
in
a
reasonable
manner,
to
inspect
the
facility
and
to
inspect
(
and
in
the
case
of
records
also
to
copy)
all
records
and
specimens
required
to
be
maintained
regarding
studies
to
which
this
part
applies.
The
records
inspection
and
copying
requirements
shall
not
apply
to
quality
assurance
unit
records
of
findings
and
problems,
or
to
actions
recommended
and
taken,
except
the
EPA
may
seek
production
of
these
records
in
litigation
or
formal
adjudicatory
hearings.

(
b)
EPA
will
not
consider
reliable
for
purposes
of
showing
that
a
chemical
substance
or
mixture
does
not
present
a
risk
of
injury
to
health
or
the
environment
any
data
developed
by
a
testing
facility
or
sponsor
that
refuses
to
permit
inspection
in
accordance
with
this
part.
The
80
determination
that
a
study
will
not
be
considered
reliable
does
not,
however,
relieve
the
sponsor
of
a
required
test
of
any
obligation
under
any
applicable
statute
or
regulation
to
submit
the
results
of
the
study
to
EPA.

(
c)
Since
a
testing
facility
is
a
place
where
chemicals
are
stored
or
held,
it
is
subject
to
inspection
under
section
11
of
TSCA.

§
792.17
Effects
of
non­
compliance.

(
a)
The
sponsor
or
any
other
person
who
is
conducting
or
has
conducted
a
test
to
fulfill
the
requirements
of
a
testing
consent
agreement
or
a
test
rule
issued
under
section
4
of
TSCA
will
be
in
violation
of
section
15
of
TSCA
if:

(
1)
The
test
is
not
being
or
was
not
conducted
in
accordance
with
any
requirement
of
this
part;

(
2)
Data
or
information
submitted
to
EPA
under
this
part
(
including
the
statement
required
by
§
792.12)
include
information
or
data
that
are
false
or
misleading,
contain
significant
omissions,
or
otherwise
do
not
fulfill
the
requirements
of
this
part;
or
(
3)
Entry
in
accordance
with
§
792.15
for
the
purpose
of
auditing
test
data
or
inspecting
test
facilities
is
denied.
Persons
who
violate
the
provisions
of
this
part
may
be
subject
to
civil
or
criminal
penalties
under
section
16
of
TSCA,
legal
action
in
United
States
district
court
under
section
17
of
TSCA,
or
criminal
prosecution
under
18
U.
S.
C.
2
or
1001.

(
b)
EPA,
at
its
discretion,
may
not
consider
reliable
for
purposes
of
showing
that
a
chemical
substance
or
mixture
does
not
present
a
risk
of
injury
to
health
or
the
environment
any
study
which
was
not
conducted
in
accordance
with
this
part.
EPA,
at
its
discretion,
may
rely
upon
such
studies
for
purposes
of
showing
adverse
effects.
The
determination
that
a
study
will
not
be
considered
reliable
does
not,
however,
relieve
the
sponsor
of
a
required
test
of
the
obligation
under
any
applicable
statute
or
regulation
to
submit
the
results
of
the
study
to
EPA.

(
c)
If
data
submitted
to
fulfill
a
requirement
of
a
testing
consent
agreement
or
a
test
rule
issued
under
section
4
of
TSCA
are
not
developed
in
accordance
with
this
part,
EPA
may
determine
that
the
sponsor
has
not
fulfilled
its
obligations
under
section
4
of
TSCA
and
may
require
the
sponsor
to
develop
data
in
accordance
with
the
requirements
of
this
part
in
order
to
satisfy
such
obligations.

SUBPART
B
­­
ORGANIZATION
AND
PERSONNEL
§
792.29
Personnel.

(
a)
Each
individual
engaged
in
the
conduct
of
or
responsible
for
the
supervision
of
a
study
shall
have
education,
training,
and
experience,
or
combination
thereof,
to
enable
that
individual
to
81
perform
the
assigned
functions.

(
b)
Each
testing
facility
shall
maintain
a
current
summary
of
training
and
experience
and
job
description
for
each
individual
engaged
in
or
supervising
the
conduct
of
a
study.

(
c)
There
shall
be
a
sufficient
number
of
personnel
for
the
timely
and
proper
conduct
of
the
study
according
to
the
protocol.

(
d)
Personnel
shall
take
necessary
personal
sanitation
and
health
precautions
designed
to
avoid
contamination
of
test,
control,
and
reference
substances
and
test
systems.

(
e)
Personnel
engaged
in
a
study
shall
wear
clothing
appropriate
for
the
duties
they
perform.
Such
clothing
shall
be
changed
as
often
as
necessary
to
prevent
microbiological,
radiological,
or
chemical
contamination
of
test
systems
and
test,
control,
and
reference
substances.

(
f)
Any
individual
found
at
any
time
to
have
an
illness
that
may
adversely
affect
the
quality
and
integrity
of
the
study
shall
be
excluded
from
direct
contact
with
test
systems,
test,
control,
and
reference
substances
and
any
other
operation
or
function
that
may
adversely
affect
the
study
until
the
condition
is
corrected.
All
personnel
shall
be
instructed
to
report
to
their
immediate
supervisors
any
health
or
medical
conditions
that
may
reasonably
be
considered
to
have
an
adverse
effect
on
a
study.

§
792.31
Testing
facility
management.

For
each
study,
testing
facility
management
shall:

(
a)
Designate
a
study
director
as
described
in
§
792.33
before
the
study
is
initiated.

(
b)
Replace
the
study
director
promptly
if
it
becomes
necessary
to
do
so
during
the
conduct
of
a
study.

(
c)
Assure
that
there
is
a
quality
assurance
unit
as
described
in
§
792.35.

(
d)
Assure
that
test,
control,
and
reference
substances
or
mixtures
have
been
appropriately
tested
for
identity,
strength,
purity,
stability,
and
uniformity,
as
applicable.

(
e)
Assure
that
personnel,
resources,
facilities,
equipment,
materials
and
methodologies
are
available
as
scheduled.

(
f)
Assure
that
personnel
clearly
understand
the
functions
they
are
to
perform.

(
g)
Assure
that
any
deviations
from
these
regulations
reported
by
the
quality
assurance
unit
are
communicated
to
the
study
director
and
corrective
actions
are
taken
and
documented.
82
§
792.33
Study
director.

For
each
study,
a
scientist
or
other
professional
of
appropriate
education,
training,
and
experience,
or
combination
thereof,
shall
be
identified
as
the
study
director.
The
study
director
has
overall
responsibility
for
the
technical
conduct
of
the
study,
as
well
as
for
the
interpretation,
analysis,
documentation,
and
reporting
of
results,
and
represents
the
single
point
of
study
control.
The
study
director
shall
assure
that:

(
a)
The
protocol,
including
any
change,
is
approved
as
provided
by
§
792.120
and
is
followed.

(
b)
All
experimental
data,
including
observations
of
unanticipated
responses
of
the
test
system
are
accurately
recorded
and
verified.

(
c)
Unforeseen
circumstances
that
may
affect
the
quality
and
integrity
of
the
study
are
noted
when
they
occur,
and
corrective
action
is
taken
and
documented.

(
d)
Test
systems
are
as
specified
in
the
protocol.

(
e)
All
applicable
good
laboratory
practice
regulations
are
followed.

(
f)
All
raw
data,
documentation,
protocols,
specimens,
and
final
reports
are
transferred
to
the
archives
during
or
at
the
close
of
the
study.

§
792.35
Quality
assurance
unit.

(
a)
A
testing
facility
shall
have
a
quality
assurance
unit
which
shall
be
responsible
for
monitoring
each
study
to
assure
management
that
the
facilities,
equipment,
personnel,
methods,
practices,
records,
and
controls
are
in
conformance
with
the
regulations
in
this
part.
For
any
given
study,
the
quality
assurance
unit
shall
be
entirely
separate
from
and
independent
of
the
personnel
engaged
in
the
direction
and
conduct
of
that
study.
The
quality
assurance
unit
shall
conduct
inspections
and
maintain
records
appropriate
to
the
study.

(
b)
The
quality
assurance
unit
shall:

(
1)
Maintain
a
copy
of
a
master
schedule
sheet
of
all
studies
conducted
at
the
testing
facility
indexed
by
test
substance
and
containing
the
test
system,
nature
of
study,
date
study
was
initiated,
current
status
of
each
study,
identity
of
the
sponsor,
and
name
of
the
study
director.

(
2)
Maintain
copies
of
all
protocols
pertaining
to
all
studies
for
which
the
unit
is
responsible.

(
3)
Inspect
each
study
at
intervals
adequate
to
ensure
the
integrity
of
the
study
and
maintain
written
and
properly
signed
records
of
each
periodic
inspection
showing
the
date
of
the
inspection,
the
study
inspected,
the
phase
or
segment
of
the
study
inspected,
the
person
83
performing
the
inspection,
findings
and
problems,
action
recommended
and
taken
to
resolve
existing
problems,
and
any
scheduled
date
for
re­
inspection.
Any
problems
which
are
likely
to
affect
study
integrity
found
during
the
course
of
an
inspection
shall
be
brought
to
the
attention
of
the
study
director
and
management
immediately.

(
4)
Periodically
submit
to
management
and
the
study
director
written
status
reports
on
each
study,
noting
any
problems
and
the
corrective
actions
taken.

(
5)
Determine
that
no
deviations
from
approved
protocols
or
standard
operating
procedures
were
made
without
proper
authorization
and
documentation.

(
6)
Review
the
final
study
report
to
assure
that
such
report
accurately
describes
the
methods
and
standard
operating
procedures,
and
that
the
reported
results
accurately
reflect
the
raw
data
of
the
study.

(
7)
Prepare
and
sign
a
statement
to
be
included
with
the
final
study
report
which
shall
specify
the
dates
inspections
were
made
and
findings
reported
to
management
and
to
the
study
director.

(
c)
The
responsibilities
and
procedures
applicable
to
the
quality
assurance
unit,
the
records
maintained
by
the
quality
assurance
unit,
and
the
method
of
indexing
such
records
shall
be
in
writing
and
shall
be
maintained.
These
items
including
inspection
dates,
the
study
inspected,
the
phase
or
segment
of
the
study
inspected,
and
the
name
of
the
individual
performing
the
inspection
shall
be
made
available
for
inspection
to
authorized
employees
or
duly
designated
representatives
of
EPA
or
FDA.

(
d)
An
authorized
employee
or
a
duly
designated
representative
of
EPA
or
FDA
shall
have
access
to
the
written
procedures
established
for
the
inspection
and
may
request
testing
facility
management
to
certify
that
inspections
are
being
implemented,
performed,
documented,
and
followed
up
in
accordance
with
this
paragraph.

SUBPART
C
­­
FACILITIES
§
792.41
General.

Each
testing
facility
shall
be
of
suitable
size
and
construction
to
facilitate
the
proper
conduct
of
studies.
Testing
facilities
which
are
not
located
within
an
indoor
controlled
environment
shall
be
of
suitable
location
to
facilitate
the
proper
conduct
of
studies.
Testing
facilities
shall
be
designed
so
that
there
is
a
degree
of
separation
that
will
prevent
any
function
or
activity
from
having
an
adverse
effect
on
the
study.

§
792.43
Test
system
care
facilities.

(
a)
A
testing
facility
shall
have
a
sufficient
number
of
animal
rooms
or
other
test
system
areas,
as
84
needed,
to
ensure:
proper
separation
of
species
or
test
systems,
isolation
of
individual
projects,
quarantine
or
isolation
of
animals
or
other
test
systems,
and
routine
or
specialized
housing
of
animals
or
other
test
systems.

(
1)
In
tests
with
plants
or
aquatic
animals,
proper
separation
of
species
can
be
accomplished
within
a
room
or
area
by
housing
them
separately
in
different
chambers
or
aquaria.
Separation
of
species
is
unnecessary
where
the
protocol
specifies
the
simultaneous
exposure
of
two
or
more
species
in
the
same
chamber,
aquarium,
or
housing
unit.

(
2)
Aquatic
toxicity
tests
for
individual
projects
shall
be
isolated
to
the
extent
necessary
to
prevent
cross­
contamination
of
different
chemicals
used
in
different
tests.

(
b)
A
testing
facility
shall
have
a
number
of
animal
rooms
or
other
test
system
areas
separate
from
those
described
in
paragraph(
a)
of
this
section
to
ensure
isolation
of
studies
being
done
with
test
systems
or
test,
control,
and
reference
substances
known
to
be
biohazardous,
including
volatile
substances,
aerosols,
radioactive
materials,
and
infectious
agents.

(
c)
Separate
areas
shall
be
provided,
as
appropriate,
for
the
diagnosis,
treatment,
and
control
of
laboratory
test
system
diseases.
These
areas
shall
provide
effective
isolation
for
the
housing
of
test
systems
either
known
or
suspected
of
being
diseased,
or
of
being
carriers
of
disease,
from
other
test
systems.

(
d)
Facilities
shall
have
proper
provisions
for
collection
and
disposal
of
contaminated
water,
soil,
or
other
spent
materials.
When
animals
are
housed,
facilities
shall
exist
for
the
collection
and
disposal
of
all
animal
waste
and
refuse
or
for
safe
sanitary
storage
of
waste
before
removal
from
the
testing
facility.
Disposal
facilities
shall
be
so
provided
and
operated
as
to
minimize
vermin
infestation,
odors,
disease
hazards,
and
environmental
contamination.

(
e)
Facilities
shall
have
provisions
to
regulate
environmental
conditions
(
e.
g.,
temperature,
humidity,
photoperiod)
as
specified
in
the
protocol.

(
f)
For
marine
test
organisms,
an
adequate
supply
of
clean
sea
water
or
artificial
sea
water
(
prepared
from
deionized
or
distilled
water
and
sea
salt
mixture)
shall
be
available.
The
ranges
of
composition
shall
be
as
specified
in
the
protocol.

(
g)
For
freshwater
organisms,
an
adequate
supply
of
clean
water
of
the
appropriate
hardness,
pH,
and
temperature,
and
which
is
free
of
contaminants
capable
of
interfering
with
the
study
shall
be
available
as
specified
in
the
protocol.

(
h)
For
plants,
an
adequate
supply
of
soil
of
the
appropriate
composition,
as
specified
in
the
protocol,
shall
be
available
as
needed.

§
792.45
Test
system
supply
facilities.
85
(
a)
There
shall
be
storage
areas,
as
needed,
for
feed,
nutrients,
soils,
bedding,
supplies,
and
equipment.
Storage
areas
for
feed,
nutrients,
soils,
and
bedding
shall
be
separated
from
areas
where
the
test
systems
are
located
and
shall
be
protected
against
infestation
or
contamination.
Perishable
supplies
shall
be
preserved
by
appropriate
means.

(
b)
When
appropriate,
plant
supply
facilities
shall
be
provided.
These
include:

(
1)
Facilities,
as
specified
in
the
protocol,
for
holding,
culturing,
and
maintaining
algae
and
aquatic
plants.
(
2)
Facilities,
as
specified
in
the
protocol,
for
plant
growth,
including
but
not
limited
to,
greenhouses,
growth
chambers,
light
banks,
and
fields.

(
c)
When
appropriate,
facilities
for
aquatic
animal
tests
shall
be
provided.
These
include
but
are
not
limited
to
aquaria,
holding
tanks,
ponds,
and
ancillary
equipment,
as
specified
in
the
protocol.

§
792.47
Facilities
for
handling
test,
control,
and
reference
substances.
(
a)
As
necessary
to
prevent
contamination
or
mixups,
there
shall
be
separate
areas
for:

(
1)
Receipt
and
storage
of
the
test,
control,
and
reference
substances.

(
2)
Mixing
of
the
test,
control,
and
reference
substances
with
a
carrier,
e.
g.,
feed.

(
3)
Storage
of
the
test,
control,
and
reference
substance
mixtures.

(
b)
Storage
areas
for
test,
control,
and/
or
reference
substance
and
for
test,
control,
and/
or
reference
mixtures
shall
be
separate
from
areas
housing
the
test
systems
and
shall
be
adequate
to
preserve
the
identity,
strength,
purity,
and
stability
of
the
substances
and
mixtures.

§
792.49
Laboratory
operation
areas.

Separate
laboratory
space
and
other
space
shall
be
provided,
as
needed,
for
the
performance
of
the
routine
and
specialized
procedures
required
by
studies.

§
792.51
Specimen
and
data
storage
facilities.

Space
shall
be
provided
for
archives,
limited
to
access
by
authorized
personnel
only,
for
the
storage
and
retrieval
of
all
raw
data
and
specimens
from
completed
studies.

SUBPART
D
­­
EQUIPMENT
§
792.61
Equipment
design.

Equipment
used
in
the
generation,
measurement,
or
assessment
of
data
and
equipment
used
for
86
facility
environmental
control
shall
be
of
appropriate
design
and
adequate
capacity
to
function
according
to
the
protocol
and
shall
be
suitably
located
for
operation,
inspection,
cleaning,
and
maintenance.
§
792.63
Maintenance
and
calibration
of
equipment.

(
a)
Equipment
shall
be
adequately
inspected,
cleaned,
and
maintained.
Equipment
used
for
the
generation,
measurement,
or
assessment
of
data
shall
be
adequately
tested,
calibrated,
and/
or
standardized.

(
b)
The
written
standard
operating
procedures
required
under
§
792.81(
b)(
11)
shall
set
forth
in
sufficient
detail
the
methods,
materials,
and
schedules
to
be
used
in
the
routine
inspection,
cleaning,
maintenance,
testing,
calibration,
and/
or
standardization
of
equipment,
and
shall
specify,
when
appropriate,
remedial
action
to
be
taken
in
the
event
of
failure
or
malfunction
of
equipment.
The
written
standard
operating
procedures
shall
designate
the
person
responsible
for
the
performance
of
each
operation.

(
c)
Written
records
shall
be
maintained
of
all
inspection,
maintenance,
testing,
calibrating,
and/
or
standardizing
operations.
These
records,
containing
the
date
of
the
operation,
shall
describe
whether
the
maintenance
operations
were
routine
and
followed
the
written
standard
operating
procedures.
Written
records
shall
be
kept
of
nonroutine
repairs
performed
on
equipment
as
a
result
of
failure
and
malfunction.
Such
records
shall
document
the
nature
of
the
defect,
how
and
when
the
defect
was
discovered,
and
any
remedial
action
taken
in
response
to
the
defect.

SUBPART
E
­­
TESTING
FACILITIES
OPERATION
§
792.81
Standard
operating
procedures.

(
a)
A
testing
facility
shall
have
standard
operating
procedures
in
writing,
setting
forth
study
methods
that
management
is
satisfied
are
adequate
to
insure
the
quality
and
integrity
of
the
data
generated
in
the
course
of
a
study.
All
deviations
in
a
study
from
standard
operating
procedures
shall
be
authorized
by
the
study
director
and
shall
be
documented
in
the
raw
data.
Significant
changes
in
established
standard
operating
procedures
shall
be
properly
authorized
in
writing
by
management.

(
b)
Standard
operating
procedures
shall
be
established
for,
but
not
limited
to,
the
following:

(
1)
Test
system
room
preparation.

(
2)
Test
system
care.

(
3)
Receipt,
identification,
storage,
handling,
mixing,
and
method
of
sampling
of
the
test,
control,
and
reference
substances.
87
(
4)
Test
system
observations.

(
5)
Laboratory
or
other
tests.

(
6)
Handling
of
test
systems
found
moribund
or
dead
during
study.

(
7)
Necropsy
of
test
systems
or
postmortem
examination
of
test
systems.

(
8)
Collection
and
identification
of
specimens.

(
9)
Histopathology.

(
10)
Data
handling,
storage
and
retrieval.

(
11)
Maintenance
and
calibration
of
equipment.

(
12)
Transfer,
proper
placement,
and
identification
of
test
systems.

(
c)
Each
laboratory
or
other
study
area
shall
have
immediately
available
manuals
and
standard
operating
procedures
relative
to
the
laboratory
or
field
procedures
being
performed.
Published
literature
may
be
used
as
a
supplement
to
standard
operating
procedures.
(
d)
A
historical
file
of
standard
operating
procedures,
and
all
revisions
thereof,
including
the
dates
of
such
revisions,
shall
be
maintained.

§
792.83
Reagents
and
solutions.

All
reagents
and
solutions
in
the
laboratory
areas
shall
be
labeled
to
indicate
identity,
titer
or
concentration,
storage
requirements,
and
expiration
date.
Deteriorated
or
outdated
reagents
and
solutions
shall
not
be
used.

§
792.90
Animal
and
other
test
system
care.

(
a)
There
shall
be
standard
operating
procedures
for
the
housing,
feeding,
handling,
and
care
of
animals
and
other
test
systems.

(
b)
All
newly
received
test
systems
from
outside
sources
shall
be
isolated
and
their
health
status
or
appropriateness
for
the
study
shall
be
evaluated.
This
evaluation
shall
be
in
accordance
with
acceptable
veterinary
medical
practice
or
scientific
methods.

(
c)
At
the
initiation
of
a
study,
test
systems
shall
be
free
of
any
disease
or
condition
that
might
interfere
with
the
purpose
or
conduct
of
the
study.
If
during
the
course
of
the
study,
the
test
systems
contract
such
a
disease
or
condition,
the
diseased
test
systems
should
be
isolated,
if
necessary.
These
test
systems
may
be
treated
for
disease
or
signs
of
disease
provided
that
such
88
treatment
does
not
interfere
with
the
study.
The
diagnosis,
authorization
of
treatment,
description
of
treatment,
and
each
date
of
treatment
shall
be
documented
and
shall
be
retained.

(
d)
Warm­
blooded
animals,
adult
reptiles,
and
adult
terrestrial
amphibians
used
in
laboratory
procedures
that
require
manipulations
and
observations
over
an
extended
period
of
time,
or
in
studies
that
require
these
test
systems
to
be
removed
from
and
returned
to
their
test
system­
housing
units
for
any
reason
(
e.
g.,
cage
cleaning,
treatment,
etc.),
shall
receive
appropriate
identification
(
e.
g.,
tattoo,
color
code,
ear
tag,
ear
punch,
etc.).
All
information
needed
to
specifically
identify
each
test
system
within
the
test
system­
housing
unit
shall
appear
on
the
outside
of
that
unit.
Suckling
mammals
and
juvenile
birds
are
excluded
from
the
requirement
of
individual
identification
unless
otherwise
specified
in
the
protocol.

(
e)
Except
as
specified
in
paragraph
(
e)(
1)
of
this
section,
test
systems
of
different
species
shall
be
housed
in
separate
rooms
when
necessary.
Test
systems
of
the
same
species,
but
used
in
different
studies,
should
not
ordinarily
be
housed
in
the
same
room
when
inadvertent
exposure
to
test,
control,
or
reference
substances
or
test
system
mixup
could
affect
the
outcome
of
either
study.
If
such
mixed
housing
is
necessary,
adequate
differentiation
by
space
and
identification
shall
be
made.

(
1)
Plants,
invertebrate
animals,
aquatic
vertebrate
animals,
and
organisms
that
may
be
used
in
multispecies
tests
need
not
be
housed
in
separate
rooms,
provided
that
they
are
adequately
segregated
to
avoid
mixup
and
cross
contamination.

(
2)
[
Reserved]

(
f)
Cages,
racks,
pens,
enclosures,
aquaria,
holding
tanks,
ponds,
growth
chambers,
and
other
holding,
rearing,
and
breeding
areas,
and
accessory
equipment,
shall
be
cleaned
and
sanitized
at
appropriate
intervals.

(
g)
Feed,
soil,
and
water
used
for
the
test
systems
shall
be
analyzed
periodically
to
ensure
that
contaminants
known
to
be
capable
of
interfering
with
the
study
and
reasonably
expected
to
be
present
in
such
feed,
soil,
or
water
are
not
present
at
levels
above
those
specified
in
the
protocol.
Documentation
of
such
analyses
shall
be
maintained
as
raw
data.

(
h)
Bedding
used
in
animal
cages
or
pens
shall
not
interfere
with
the
purpose
or
conduct
of
the
study
and
shall
be
changed
as
often
as
necessary
to
keep
the
animals
dry
and
clean.

(
i)
If
any
pest
control
materials
are
used,
the
use
shall
be
documented.
Cleaning
and
pest
control
materials
that
interfere
with
the
study
shall
not
be
used.

(
j)
All
plant
and
animal
test
systems
shall
be
acclimatized
to
the
environmental
conditions
of
the
test,
prior
to
their
use
in
a
study.
89
SUBPART
F
­­
TEST,
CONTROL,
AND
REFERENCE
SUBSTANCES
§
792.105
Test,
control,
and
reference
substance
characterization.

(
a)
The
identity,
strength,
purity,
and
composition,
or
other
characteristics
which
will
appropriately
define
the
test,
control,
or
reference
substance
shall
be
determined
for
each
batch
and
shall
be
documented
before
its
use
in
a
study.
Methods
of
synthesis,
fabrication,
or
derivation
of
the
test,
control,
or
reference
substance
shall
be
documented
by
the
sponsor
or
the
testing
facility,
and
such
location
of
documentation
shall
be
specified.

(
b)
When
relevant
to
the
conduct
of
the
study
the
solubility
of
each
test,
control,
or
reference
substance
shall
be
determined
by
the
testing
facility
or
the
sponsor
before
the
experimental
start
date.
The
stability
of
the
test,
control
or
reference
substance
shall
be
determined
before
the
experimental
start
date
or
concomitantly
according
to
written
standard
operating
procedures,
which
provide
for
periodic
analysis
of
each
batch.

(
c)
Each
storage
container
for
a
test,
control,
or
reference
substance
shall
be
labeled
by
name,
chemical
abstracts
service
number
(
CAS)
or
code
number,
batch
number,
expiration
date,
if
any,
and,
where
appropriate,
storage
conditions
necessary
to
maintain
the
identity,
strength,
purity,
and
composition
of
the
test,
control,
or
reference
substance.
Storage
containers
shall
be
assigned
to
a
particular
test
substance
for
the
duration
of
the
study.

(
d)
For
studies
of
more
than
4
weeks
experimental
duration,
reserve
samples
from
each
batch
of
test,
control,
and
reference
substances
shall
be
retained
for
the
period
of
time
provided
by
§
792.195.

(
e)
The
stability
of
test,
control,
and
reference
substances
under
storage
conditions
at
the
test
site
shall
be
known
for
all
studies.

§
792.107
Test,
control,
and
reference
substance
handling.

Procedures
shall
be
established
for
a
system
for
the
handling
of
the
test,
control,
and
reference
substances
to
ensure
that:

(
a)
There
is
proper
storage.

(
b)
Distribution
is
made
in
a
manner
designed
to
preclude
the
possibility
of
contamination,
deterioration,
or
damage.

(
c)
Proper
identification
is
maintained
throughout
the
distribution
process.

(
d)
The
receipt
and
distribution
of
each
batch
is
documented.
Such
documentation
shall
include
the
date
and
quantity
of
each
batch
distributed
or
returned.
90
§
792.113
Mixtures
of
substances
with
carriers.

(
a)
For
each
test,
control,
or
reference
substance
that
is
mixed
with
a
carrier,
tests
by
appropriate
analytical
methods
shall
be
conducted:

(
1)
To
determine
the
uniformity
of
the
mixture
and
to
determine,
periodically,
the
concentration
of
the
test,
control,
or
reference
substance
in
the
mixture.

(
2)
When
relevant
to
the
conduct
of
the
experiment,
to
determine
the
solubility
of
each
test,
control,
or
reference
substance
in
the
mixture
by
the
testing
facility
or
the
sponsor
before
the
experimental
start
date.

(
3)
To
determine
the
stability
of
the
test,
control
or
reference
substance
in
the
mixture
before
the
experimental
start
date
or
concomitantly
according
to
written
standard
operating
procedures,
which
provide
for
periodic
analysis
of
each
batch.

(
b)
Where
any
of
the
components
of
the
test,
control,
or
reference
substance
carrier
mixture
has
an
expiration
date,
that
date
shall
be
clearly
shown
on
the
container.
If
more
than
one
component
has
an
expiration
date,
the
earliest
date
shall
be
shown.

(
c)
If
a
vehicle
is
used
to
facilitate
the
mixing
of
a
test
substance
with
a
carrier,
assurance
shall
be
provided
that
the
vehicle
does
not
interfere
with
the
integrity
of
the
test.

SUBPART
G
­­
PROTOCOL
FOR
AND
CONDUCT
OF
A
STUDY
§
792.120
Protocol.

(
a)
Each
study
shall
have
an
approved
written
protocol
that
clearly
indicates
the
objectives
and
all
methods
for
the
conduct
of
the
study.
The
protocol
shall
contain
but
shall
not
necessarily
be
limited
to
the
following
information:

(
1)
A
descriptive
title
and
statement
of
the
purpose
of
the
study.

(
2)
Identification
of
the
test,
control,
and
reference
substance
by
name,
chemical
abstracts
service
(
CAS)
number
or
code
number.

(
3)
The
name
and
address
of
the
sponsor
and
the
name
and
address
of
the
testing
facility
at
which
the
study
is
being
conducted.

(
4)
The
proposed
experimental
start
and
termination
dates.

(
5)
Justification
for
selection
of
the
test
system.
91
(
6)
Where
applicable,
the
number,
body
weight,
sex,
source
of
supply,
species,
strain,
substrain,
and
age
of
the
test
system.

(
7)
The
procedure
for
identification
of
the
test
system.

(
8)
A
description
of
the
experimental
design,
including
methods
for
the
control
of
bias.

(
9)
Where
applicable,
a
description
and/
or
identification
of
the
diet
used
in
the
study
as
well
as
solvents,
emulsifiers
and/
or
other
materials
used
to
solubilize
or
suspend
the
test,
control,
or
reference
substances
before
mixing
with
the
carrier.
The
description
shall
include
specifications
for
acceptable
levels
of
contaminants
that
are
reasonably
expected
to
be
present
in
the
dietary
materials
and
are
known
to
be
capable
of
interfering
with
the
purpose
or
conduct
of
the
study
if
present
at
levels
greater
than
established
by
the
specifications.

(
10)
The
route
of
administration
and
the
reason
for
its
choice.

(
11)
Each
dosage
level,
expressed
in
milligrams
per
kilogram
of
body
or
test
system
weight
or
other
appropriate
units,
of
the
test,
control,
or
reference
substance
to
be
administered
and
the
method
and
frequency
of
administration.

(
12)
The
type
and
frequency
of
tests,
analyses,
and
measurements
to
be
made.

(
13)
The
records
to
be
maintained.

(
14)
The
date
of
approval
of
the
protocol
by
the
sponsor
and
the
dated
signature
of
the
study
director.

(
15)
A
statement
of
the
proposed
statistical
method.

(
b)
All
changes
in
or
revisions
of
an
approved
protocol
and
the
reasons
therefor
shall
be
documented,
signed
by
the
study
director,
dated,
and
maintained
with
the
protocol.

§
792.130
Conduct
of
a
study.

(
a)
The
study
shall
be
conducted
in
accordance
with
the
protocol.

(
b)
The
test
systems
shall
be
monitored
in
conformity
with
the
protocol.

(
c)
Specimens
shall
be
identified
by
test
system,
study,
nature,
and
date
of
collection.
This
information
shall
be
located
on
the
specimen
container
or
shall
accompany
the
specimen
in
a
manner
that
precludes
error
in
the
recording
and
storage
of
data.

(
d)
In
animal
studies
where
histopathology
is
required,
records
of
gross
findings
for
a
specimen
92
from
postmortem
observations
shall
be
available
to
a
pathologist
when
examining
that
specimen
histopathologically.

(
e)
All
data
generated
during
the
conduct
of
a
study,
except
those
that
are
generated
by
automated
data
collection
systems,
shall
be
recorded
directly,
promptly,
and
legibly
in
ink.
All
data
entries
shall
be
dated
on
the
day
of
entry
and
signed
or
initialed
by
the
person
entering
the
data.
Any
change
in
entries
shall
be
made
so
as
not
to
obscure
the
original
entry,
shall
indicate
the
reason
for
such
change,
and
shall
be
dated
and
signed
or
identified
at
the
time
of
the
change.
In
automated
data
collection
systems,
the
individual
responsible
for
direct
data
input
shall
be
identified
at
the
time
of
data
input.
Any
change
in
automated
data
entries
shall
be
made
so
as
not
to
obscure
the
original
entry,
shall
indicate
the
reason
for
change,
shall
be
dated,
and
the
responsible
individual
shall
be
identified.

§
792.135
Physical
and
chemical
characterization
studies.

(
a)
All
provisions
of
the
GLPs
shall
apply
to
physical
and
chemical
characterization
studies
designed
to
determine
stability,
solubility,
octanol
water
partition
coefficient,
volatility,
and
persistence
(
such
as
biodegradation,
photodegradation,
and
chemical
degradation
studies).

(
b)
The
following
GLP
standards
shall
not
apply
to
studies
designed
to
determine
physical
and
chemical
characteristics
of
a
test,
control,
or
reference
substance:

Section
792.31
(
c),
(
d),
and
(
g)

Section
792.35
(
b)
and
(
c)

Section
792.43
Section
792.45
Section
792.47
Section
792.49
Section
792.81(
b)
(
1),
(
2),
(
6)
through
(
9),
and
(
12)

Section
792.90
Section
792.105
(
a)
through
(
d)

Section
792.113
Section
792.120(
a)
(
5)
through
(
12),
and
(
15)
93
Section
792.185(
a)
(
5)
through
(
8),
(
10),
(
12),
and
(
14)

Section
792.195
(
c)
and
(
d)

SUBPARTS
H­
I
[
RESERVED]

SUBPART
J
­­
RECORDS
AND
REPORTS
§
792.185
Reporting
of
study
results.

(
a)
A
final
report
shall
be
prepared
for
each
study
and
shall
include,
but
not
necessarily
be
limited
to,
the
following:

(
1)
Name
and
address
of
the
facility
performing
the
study
and
the
dates
on
which
the
study
was
initiated
and
was
completed,
terminated,
or
discontinued.

(
2)
Objectives
and
procedures
stated
in
the
approved
protocol,
including
any
changes
in
the
original
protocol.

(
3)
Statistical
methods
employed
for
analyzing
the
data.

(
4)
The
test,
control,
and
reference
substances
identified
by
name,
chemical
abstracts
service
(
CAS)
number
or
code
number,
strength,
purity,
and
composition,
or
other
appropriate
characteristics.

(
5)
Stability,
and
when
relevant
to
the
conduct
of
the
study,
the
solubility
of
the
test,
control,
and
reference
substances
under
the
conditions
of
administration.

(
6)
A
description
of
the
methods
used.

(
7)
A
description
of
the
test
system
used.
Where
applicable,
the
final
report
shall
include
the
number
of
animals
or
other
test
organisms
used,
sex,
body
weight
range,
source
of
supply,
species,
strain
and
substrain,
age,
and
procedure
used
for
identification.

(
8)
A
description
of
the
dosage,
dosage
regimen,
route
of
administration,
and
duration.

(
9)
A
description
of
all
circumstances
that
may
have
affected
the
quality
or
integrity
of
the
data.

(
10)
The
name
of
the
study
director,
the
names
of
other
scientists
or
professionals
and
the
names
of
all
supervisory
personnel,
involved
in
the
study.

(
11)
A
description
of
the
transformations,
calculations,
or
operations
performed
on
the
data,
a
94
summary
and
analysis
of
the
data,
and
a
statement
of
the
conclusions
drawn
from
the
analysis.

(
12)
The
signed
and
dated
reports
of
each
of
the
individual
scientists
or
other
professionals
involved
in
the
study,
including
each
person
who,
at
the
request
or
direction
of
the
testing
facility
or
sponsor,
conducted
an
analysis
or
evaluation
of
data
or
specimens
from
the
study
after
data
generation
was
completed.

(
13)
The
locations
where
all
specimens,
raw
data,
and
the
final
report
are
to
be
stored.

(
14)
The
statement
prepared
and
signed
by
the
quality
assurance
unit
as
described
in
§
792.35(
b)(
7).

(
b)
The
final
report
shall
be
signed
and
dated
by
the
study
director.

(
c)
Corrections
or
additions
to
a
final
report
shall
be
in
the
form
of
an
amendment
by
the
study
director.
The
amendment
shall
clearly
identify
that
part
of
the
final
report
that
is
being
added
to
or
corrected
and
the
reasons
for
the
correction
or
addition,
and
shall
be
signed
and
dated
by
the
person
responsible.
Modification
of
a
final
report
to
comply
with
the
submission
requirements
of
EPA
does
not
constitute
a
correction,
addition,
or
amendment
to
a
final
report.

(
d)
A
copy
of
the
final
report
and
of
any
amendment
to
it
shall
be
maintained
by
the
sponsor
and
the
test
facility.

§
792.190
Storage
and
retrieval
of
records
and
data.

(
a)
All
raw
data,
documentation,
records,
protocols,
specimens,
and
final
reports
generated
as
a
result
of
a
study
shall
be
retained.
Specimens
obtained
from
mutagenicity
tests,
specimens
of
soil,
water,
and
plants,
and
wet
specimens
of
blood,
urine,
feces,
and
biological
fluids,
do
not
need
to
be
retained
after
quality
assurance
verification.
Correspondence
and
other
documents
relating
to
interpretation
and
evaluation
of
data,
other
than
those
documents
contained
in
the
final
report,
also
shall
be
retained.

(
b)
There
shall
be
archives
for
orderly
storage
and
expedient
retrieval
of
all
raw
data,
documentation,
protocols,
specimens,
and
interim
and
final
reports.
Conditions
of
storage
shall
minimize
deterioration
of
the
documents
or
specimens
in
accordance
with
the
requirements
for
the
time
period
of
their
retention
and
the
nature
of
the
documents
of
specimens.
A
testing
facility
may
contract
with
commercial
archives
to
provide
a
repository
for
all
material
to
be
retained.
Raw
data
and
specimens
may
be
retained
elsewhere
provided
that
the
archives
have
specific
reference
to
those
other
locations.

(
c)
An
individual
shall
be
identified
as
responsible
for
the
archives.

(
d)
Only
authorized
personnel
shall
enter
the
archives.
95
(
e)
Material
retained
or
referred
to
in
the
archives
shall
be
indexed
to
permit
expedient
retrieval.

§
792.195
Retention
of
records.

(
a)
Record
retention
requirements
set
forth
in
this
section
do
not
supersede
the
record
retention
requirements
of
any
other
regulations
in
this
subchapter.

(
b)(
1)
Except
as
provided
in
paragraph
(
c)
of
this
section,
documentation
records,
raw
data,
and
specimens
pertaining
to
a
study
and
required
to
be
retained
by
this
part
shall
be
retained
in
the
archive(
s)
for
a
period
of
at
least
ten
years
following
the
effective
date
of
the
applicable
final
test
rule.

(
2)
In
the
case
of
negotiated
testing
agreements,
each
agreement
will
contain
a
provision
that,
except
as
provided
in
paragraph
(
c)
of
this
section,
documentation
records,
raw
data,
and
specimens
pertaining
to
a
study
and
required
to
be
retained
by
this
part
shall
be
retained
in
the
archive(
s)
for
a
period
of
at
least
ten
years
following
the
publication
date
of
the
acceptance
of
a
negotiated
test
agreement.

(
3)
In
the
case
of
testing
submitted
under
section
5,
except
for
those
items
listed
in
paragraph
(
c)
of
this
section,
documentation
records,
raw
data,
and
specimens
pertaining
to
a
study
and
required
to
be
retained
by
this
part
shall
be
retained
in
the
archive(
s)
for
a
period
of
at
least
five
years
following
the
date
on
which
the
results
of
the
study
are
submitted
to
the
agency.

(
c)
Wet
specimens,
samples
of
test,
control,
or
reference
substances,
and
specially
prepared
material
which
are
relatively
fragile
and
differ
markedly
in
stability
and
quality
during
storage,
shall
be
retained
only
as
long
as
the
quality
of
the
preparation
affords
evaluation.
Specimens
obtained
from
mutagenicity
tests,
specimens
of
soil,
water,
and
plants,
and
wet
specimens
of
blood,
urine,
feces,
biological
fluids,
do
not
need
to
be
retained
after
quality
assurance
verification.
In
no
case
shall
retention
be
required
for
longer
periods
than
those
set
forth
in
paragraph
(
b)
of
this
section.

(
d)
The
master
schedule
sheet,
copies
of
protocols,
and
records
of
quality
assurance
inspections,
as
required
by
§
792.35(
c)
shall
be
maintained
by
the
quality
assurance
unit
as
an
easily
accessible
system
of
records
for
the
period
of
time
specified
in
paragraph
(
b)
of
this
section.

(
e)
Summaries
of
training
and
experience
and
job
descriptions
required
to
be
maintained
by
§
792.29(
b)
may
be
retained
along
with
all
other
testing
facility
employment
records
for
the
length
of
time
specified
in
paragraph
(
b)
of
this
section.

(
f)
Records
and
reports
of
the
maintenance
and
calibration
and
inspection
of
equipment,
as
required
by
§
792.63
(
b)
and
(
c),
shall
be
retained
for
the
length
of
time
specified
in
paragraph
(
b)
of
this
section.
96
(
g)
If
a
facility
conducting
testing
or
an
archive
contracting
facility
goes
out
of
business,
all
raw
data,
documentation,
and
other
material
specified
in
this
section
shall
be
transferred
to
the
archives
of
the
sponsor
of
the
study.
The
EPA
shall
be
notified
in
writing
of
such
a
transfer.

(
h)
Specimens,
samples,
or
other
non­
documentary
materials
need
not
be
retained
after
EPA
has
notified
in
writing
the
sponsor
or
testing
facility
holding
the
materials
that
retention
is
no
longer
required
by
EPA.
Such
notification
normally
will
be
furnished
upon
request
after
EPA
or
FDA
has
completed
an
audit
of
the
particular
study
to
which
the
materials
relate
and
EPA
has
concluded
that
the
study
was
conducted
in
accordance
with
this
part.

(
i)
Records
required
by
this
part
may
be
retained
either
as
original
records
or
as
true
copies
such
as
photocopies,
microfilm,
microfiche,
or
other
accurate
reproductions
of
the
original
records.
97
OMB
Control
No.
2070­
0054;
EPA
ICR
No.
0586.10
Attachment
H
List
of
Chemicals
Covered
by
Final
PAIR
Rules,
2001­
2003
98
Chemicals
listed
in
July
26,
2001
Section
8(
a)
PAIR
­
66
FR
38955
Burden
assessment
is
discussed
in
detail
on
page
38957.

The
public
reporting
burden
for
this
final
rule
was
estimated
to
be
1,165.1
hours.
Of
that
total,
an
estimated
287
hours
was
estimated
to
be
spent
in
an
initial
review
of
the
rule,
and
the
remaining
878.1
hours
were
associated
with
actual
reporting
activities.

Indiums
(
37)
and
additionals
(
4)

CAS
No.
Substance
923­
34­
2
Triethylindium
1303­
11­
3
Indium
arsenide
1312­
41­
0
Indium
antimonide
1312­
43­
2
Indium
(
III)
oxide
1312­
45­
4
Indium
(
III)
telluride
4194­
69­
8
Indium
(
III)
citrate
7440­
74­
6
Indium
7783­
52­
0
Indium
(
III)
fluoride
10025­
82­
8
Indium
(
III)
chloride
12018­
95­
0
Copper
indium
diselenide
12030­
14­
7
Indium
(
II)
sulfide
12030­
24­
9
Indium
(
III)
sulfide
12056­
07­
4
Indium
selenide
12672­
70­
7
Indium
chloride
12672­
71­
8
Indium
oxide
13464­
82­
9
Indium
(
III)
sulfate
13465­
09­
3
Indium
(
III)
bromide
13465­
10­
6
Indium
(
I)
chloride
13510­
35­
5
Indium
(
III)
iodide
13709­
93­
8
Indium
(
III)
borate
13770­
61­
1
Indium
(
III)
nitrate
13966­
94­
4
Indium
(
I)
iodide
14166­
78­
0
Indium
(
III)
fluoride
14280­
53­
6
Indium
(
I)
bromide
14405­
45­
9
Indium
tris(
acetylacetonate)
20661­
21­
6
Indium
(
III)
hydroxide.
22398­
80­
7
Indium
(
I)
phosphide
25114­
58­
3
Indium
(
III)
acetate
25617­
98­
5
Indium
nitride
27765­
48­
6
Indium
(
III)
tetrafluoroborate
50926­
11­
9
Indium
tin
oxide
99
55326­
87­
9
Indium
hydroxide
66027­
93­
8
Indium
(
III)
sulfamate
66027­
94­
9
Hydroxybis(
trifluoroacetato­
O)
indium
67816­
06­
2
Indium
(
III)
2­
ethylhexanoate
68310­
35­
0
Indium
(
III)
neodecanoate
71243­
84­
0
Indium
tin
oxide
(
In1.69Sn0.1502O2.85)

133­
49­
3
Pentachlorothiophenol
1198­
55­
6
Tetrachloropyrocatechol.
1806­
24­
2
p­
toluidine,
5­
chloro­.
alpha.,.
alpha.,.
alpha.­
1198­
55­
6
Tetrachloropyrocatechol
1806­
24­
2
p­
toluidine,
5­
chloro­.
alpha.,.
alpha.,.
alpha.­

Chemicals
Listed
in
June
11,
2003
Section
8(
a)
PAIR
­
68
FR
34832
Burden
assessment
is
discussed
in
detail
on
page
34835.

The
public
reporting
burden
for
this
final
rule
was
estimated
to
be
1,330.3
hours.
Of
that
total,
an
estimated
329
hours
was
estimated
to
be
spent
in
an
initial
review
of
the
rule,
and
the
remaining
1,001.3
hours
were
associated
with
actual
reporting
activities.

CAS
No.
Substance
136­
35­
6
1­
Triazene,
1,3­
diphenyl­
3278­
89­
5
Benzene,
1,3,5­
tribromo­
2­(
2­
propenyloxy)­
29091­
20­
1
Benzenamine,
3­
chloro­
2,6­
dinitro­
N,
N­
dipropyl­
4­
(
trifluoromethyl)­.
68928­
76­
7
Stannane,
dimethylbis[(
1­
oxoneodecyl)
oxy]­

IRIS
Chemicals
(
43):

1314­
34­
7
Vanadium
oxide
(
V2O3)
[
Vanadium
trioxide]
1314­
62­
1
Vanadium
oxide
(
V2O5)
[
Vanadium
pentoxide]
1686­
22­
2
Vanadium,
triethoxyoxo­,
(
T­
4)­
[
Triethyl
orthovanadate].
3153­
26­
2
Vanadium,
oxobis
(
2,4­
pentanedionato­
.
kappa.
O,.
kappa.
O')­,
(
SP­
5­
21)­.
5588­
84­
1
Vanadium,
oxotris(
2­
propanolato)­,
(
T­
4)­
[
Vanadium
triisopropoxide
oxide].
7440­
62­
2
Vanadium
7632­
51­
1
Vanadium
chloride
(
VCl4),
(
T­
4)­
[
Vanadium
tetrachloride].
100
7718­
98­
1
Vanadium
chloride
(
VCl3)
[
Vanadium
trichloride]
7727­
18­
6
Vanadium,
trichlorooxo­,
(
T­
4)­
[
Vanadium
oxytrichloride].
7803­
55­
6
Vanadate
(
VO31­),
ammonium
[
Ammonium
metavanadate]

10049­
16­
8
Vanadium
fluoride
(
VF4)
[
Vanadium
tetrafluoride]
10213­
09­
9
Vanadium,
dichlorooxo­
[
Vanadyl
dichloride]
10580­
52­
6
Vanadium
chloride
(
VCl2)
[
Vanadium
dichloride]
11099­
11­
9
Vanadium
oxide
[
Polyvanadic
acid]
11115­
67­
6
Ammonium
vanadium
oxide
11130­
21­
5
Vanadium
carbide
12007­
37­
3
Vanadium
boride
(
VB2)
12035­
98­
2
Vanadium
oxide
(
VO)
12036­
21­
4
Vanadium
oxide
(
VO2)
12070­
10­
9
Vanadium
carbide
(
VC)
12083­
48­
6
Vanadium,
dichlorobis
(.
eta.
5­
2,4­
cyclopentadien­
1­
yl)­
12166­
27­
7
Vanadium
sulfide
(
VS)
12439­
96­
2
Vanadium,
oxo[
sulfato(
2­)­.
kappa.
O]­,
pentahydrate
[
Vanadyl
sulfate
(
VOSO4),
pentahydrate].
12604­
58­
9
Vanadium
alloy,
base,
V,
C,
Fe
(
Ferrovanadium)
13470­
26­
3
Vanadium
bromide
(
VBr3)
13476­
99­
8
Vanadium,
tris(
2,4­
pentanedionato­.
kappa.
O,.
kappa.
O')­
,
(
OC­
6­
11)­
[
Vanadium
tris(
acetylacetonate)]
13497­
94­
4
Silver
vanadium
oxide
(
AgVO3)
13517­
26­
5
Sodium
vanadium
oxide
(
Na4V2O7)
[
Sodium
pyrovanadate]
13718­
26­
8
Vanadate
(
VO31­),
sodium
[
Sodium
metavanadate]
13721­
39­
6
Sodium
vanadium
oxide
(
Na3VO4)
[
Sodium
orthovanadate]
13769­
43­
2
Vanadate
(
VO31­),
potassium
[
Potassium
metavanadate]
13930­
88­
6
Vanadium,
oxo[
29H,
31H­
phthalocyaninato(
2­)­
*
COM001*.
kappa.
N29,.
kappa.
N30,.
kappa.
N31,.
kappa.
N32]­
,
(
SP­
5­
12)­.
14059­
33­
7
Bismuth
vanadium
oxide
(
BiVO4)
19120­
62­
8
Vanadium,
tris(
2­
methyl­
1­
propanolato)
oxo­,
(
T­
4)­
[
Isobutyl
orthovanadate]
24646­
85­
3
Vanadium
nitride
(
VN)
27774­
13­
6
Vanadium,
oxo[
sulfato(
2­)­.
kappa.
O]­
[
Vanadyl
sulfate]
30486­
37­
4
Vanadium
hydroxide
oxide
(
V(
OH)
2O)
39455­
80­
6
Ammonium
sodium
vanadium
oxide
53801­
77­
7
Bismuth
vanadium
oxide
65232­
89­
5
Vanadium
hydroxide
oxide
phosphate
68130­
18­
7
Vanadium
hydroxide
oxide
phosphate
(
V6(
OH)
3O3(
PO4)
7)
68815­
09­
8
Naphthenic
acids,
vanadium
salts
68990­
29­
4
Balsams,
copaiba,
sulfurized,
vanadium
salts