Document ID: EPA-HQ-OPPT-2003-0012-0127
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-06-27T04:00Z

U.
S.
Environmental
Protection
Agency
June
20,
2003
Draft
Agenda
ECA
Communications
Workgroup
Meeting
Tuesday,
June
24,
2003
9:
00­
12:
00
PM
Mission
Statement:
The
Communications
Workgroup
will
develop
a
roadmap
to
meaningfully
communicate,
within
the
PFOA
ECA
process,
information
regarding
marketing
data,
test
substance(
s),
and
article
identity
in
a
way
that
preserves
proprietary
information
(
confidential
business
information,
or
CBI)
and
satisfies
the
needs
of
EPA
and
the
interested
parties.
(
EPA
Preliminary
Framework,
OPPT­
2003­
0012­
0056,
Table
1,
Item
1,
and
Table
2,
Item
1;
decisions
will
inform
on
reporting
for
all
other
Framework
items.)

Meeting
Objective:
Scoping
meeting
to:
1.
Identify
the
particular
data
elements
that
interested
parties
are
concerned
may
be
claimed
as
CBI;
2.
Clarify
the
scope
and
importance
of
appropriate
CBI
claims;
3.
Describe
approaches
to
mask
CBI
through
the
use
of
generic
names,
aggregating
data,
describing
selection
criteria,
characterizing
information
according
to
broad
market
descriptions,
and
other
means;
and
4.
Identify
workgroup
next
steps
and
assignments.

Workgroup
Participants:
3M;
CPSC;
EPA;
EWG;
FMG:
TRP;
Tuppers
Plains­
Chester
Water
District
Order
of
Meeting:

°
Introductions:
Chair,
Phil
Oshida,
Director,
Chemical
Control
Division,
U.
S.
EPA
EPA
Technical
Lead:
Harry
Lewis,
Information
Management
Division
°
Presentations
on
CBI
communication
issues
°
Public
interest
groups
°
Industry
°
EPA
°
Discussion
of
approaches
to
meaningfully
communicate
information
in
a
way
that
both
preserves
proprietary
information
and
satisfies
the
needs
of
EPA
and
all
interested
parties
°
Identification
of
workgroup
next
steps;
determination
of
workgroup
assignments
for
workgroup
and
plenary
meetings
on
July
9
and
10,
2003
PFOA
ECA
Communications
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2003
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24,
2003
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APPENDIX
B
GENERIC
NAMES
FOR
CONFIDENTIAL
CHEMICAL
SUBSTANCE
IDENTITIES
The
following
list
contains
generic
chemical
names
for
the
substances
included
in
the
category
"
Chemical
Substances
with
Confidential
Identities,"
which
appears
in
the
TSCA
Inventory.
The
identities
of
these
substances
have
been
claimed
as
confidential
business
information
by
submitters
to
the
Inventory.
The
fact
that
these
substance
identities
are
listed
as
confidential
does
not
mean
that
EPA
has
made
a
determination
that
all
of
these
claims
of
confidentiality
are
valid.
Some
ofthe
substances
that
appeared
asconfidential
in
Volume
I
of
the
Initial
Inventory
or
Cumulative
Supplement
LI
may
have
been
transferred
to
the
non­
confidential
portion
of
the
TSCA
Chemical
Substance
Inventory
1985
EdItion.
This
is
beaiuse
either
EPA
determined
that
the
chemical
identity
fails
to.
meet
the
standard
for
confidential
treatment
in
section
14
of
TSCA,
or
submitters
decided
to
withdraw
their
claims
of
confidentiality.
Also,
the
Agency
may
have
denied
the
confidentiality
claim
based
on
the
fact
that
another
person
submitted
the
same
substance
without
ch~
imingconfidentiality
for
the
chemical
identity.
These
substances
are
published
on
the
non­
confidential
portion
of
the
TSCA
Inventory.
Their
generic
names
and
accession
numbers
havebeen
removed
from
this
list
of
confidential
substances.
The
Agency
encourages
submitters
to
withdraw
their
claims
of
confidentiality
for
chemical
identity
when
confidential
treatment
is
no
longer
needed.
This
appendix
includes
generic
names
for
substances
that
were
submitted
under
the
TSCA
Inventory
Reporting
Regulations
and
claimed
as
confidential
by
their
submitters
as
well
as
generic
names
for
substances
that
were
not
claimed
as
confidential
for
purposes
of
the
Inventory
by
their
submitters,
but
which
include
as
reactants
confidential
trademark
products
manufactured
by
other
companies.
For
these
substances,
the
EPA
has
developed
generic
names
that
mask
only
the
portion
of
the
Inventory
substance
that
represents
the
confidential
trademark
reactant.
This
appendix
also
includes
generic
names
for
substances
that
have
been
placed
on
the
Inventory
following
premanufacture
review
and
receipt
by
EPA
of
a
notice
of
commencement
of
manufacture
or
import.
Companies
must
reassert
and
substantiate
confidential
chemical
identity
claims
at
the
time
of
submitting
a
notice
of
commencement.
EPA
reviews
the
submitter's
substantiation
to
determine
whether
a
claim
of
confidentiality
is
justified.
EPAalso
determines
whether
the
generic
name
submitted
in
the
premanufacture
notice
is
appropriate
for
Inventory
listing
purposes.
In
most
cases,
the
EPA
finds
that
the
submitter's
generic
name
is
too
generic,
and
develops
a
mutually
agreeable
generic
name
following
the
procedures
in
the
Premanufacture
Notice
Requirements
and
Review
Procedures
(
4)
CFR
720.85).
This
generic
name
is
then
listed
in
the
Inventory.
At
the
time
of
this
printing,
a
number
of
commenced
PMN
substances
for
which
notices
of
commencement
have
been
received
were
undergoing
substantiation
review
or
generic
name
development.
To
represent
these
substances
on
the
printed
Inventory,
EPA
has
published
some
generic
names
as
submitted
in
the
premanufacture
notices,
accompanied
by
the
word
PROVISIONAL
in
parentheses
after
the
name.
If
the
claims
of
confidentiality
are
neither
dropped
by
the
submitter
nor
held
invalid
by
EPA,
EPA
will
publish
the
final
generic
names
for
these
substances
in
future
updates
or
supplements
to
the
Inventory:
With
the
exception
of
the
provisional
generic
names,
the
generic
names
in
this
appendix
were
created
according
to
the
guidelines
presented
m
the
following
pages.
These
guidelines
were
published
in
the
introduction
to
Appendix
B
of
the
TSCA
Initial
Inventory
and
made
available
by
EPA
to
assist
persona
who
wished
to
claim
the
precise
identity
of
a
chemical
substance
as
confidential
for
purposes
of
the
Inventory.
Such
persons
were
required
to
submit
a
proposed
generic
name
for
the
reported
substance
that
was
"
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
particular
chemical
substance."
Persons
who
intend
to
manufacture
or
import
for
a
commercial
purpose
a
chemical
substance
that
is
not
included
on
the
Inventory
by
a
specific
chemical
name
but
falls
within
one
of
the
generic
names
included
in
this
list
may
ask
EPA
whether
the
specific
chemical
identity
is
included
on
the
Inventory.
EPA
may
disclose
such
information
provided
the
person
establishes
a
bona
fide
intent
to
manufacture
or
import
the
substance
for
commercial
purposes,
in
accordance
with
the
procedures
outlined
in
section
720.25
of
the
Premanufacture
Notice
Requirements
and
Review
Procedures
(
48
FR
21722).
EPA
assigns
a
unique
five­
digit
accession
number
to
each
confidential
chemical
identity
on
the
TSCAInventory
Eachsubstance
in
this
appendix
is
listed
in
order
of
its
accession
number;
any
applicable
flags
follow
the
accession
number.
The
flags
used
are:
P,
5,
XU,
Yl,
and
Y2.

ILLUSTRATIVE
KEY
TO
ENTRIES
AS
THEY
APPEAR
IN
APPENDIX
B:
GENERIC
NAMES
FOR
CONFIDENTIAL
CHEMICAL
SUBSTANCE
IDENTITIES
(
0
 
'
­
Monosubstituted
methane°
rosin,
majejc
anhydride
polymer
ester
with
pentaerythritol
45251P,
XU
4
Saturated
polyester
(
PROVISIONAL)

69499
XU,
.
Y2
~
3
Polymer
of
(
alkylene
ether)
glycol
and
methylenebis
[
iaocyanatobenzene]

1.
The
Accession
Number
appears
in
boldface
type.

2.
The
Generic
Name
appears
in
lightface
type
under
the
Accession
Number.
3.
The
flags
for
SNUR
substances,
PMN
substances,
et
aL
appear
in
lightface
type
following
the
Accession
Number.
The
following
flags
are
used:

 
P
indicates
a
commenced
PMN
substance.

 
S
indicates
a
substance
identified
in
a
proposed
or
final
Significant
New
Use
Rule.
See
the
SNUR
Index.

 
XU
indicates
a
substance
exempt
from
reporting
under
the
proposed
rule
for
Partial
Updating
of
the
TSCA
Inventory
Data
Base
Production
and
Site
Reports.

 
Yl
indicates
an
exempt
polymer
that
has
a
number­
average
molecular
weight
of
1,000
or
greater.

 
Y2
indicates
an
exempt
polymer
that
is
a
polyester
and
is
made
only
from
the
specified
list
of
low
concern
reactants.

4.
The
label
PROVISIONAL
follows
the
generic
name
and
indicates
that
the
generic
name
is
not
considered
final
by
EPA
and
that
it
is
subject
to
change.

GUIDELINES
FOR
CREATING
PROPOSED
GENERIC
NAMES
FOR
CONFIDENTIAL
CHEMICAL
SUBSTANCE
IDENT1TI~
SFOR
THE
TSCA
INVENTORY
The
procedures
presented
below
were
designed
by
EPA
to
provide
guidance
in
developing
proposed
generic
names
for
chemical
substances
whose
specific
identities
were
claimed
as
confidential
for
purposes
of
the
Inventory.
Theyareincluded
in
this
Appendix
to
assist
a
company
in
deciding
if
a
particular
chemical
substance
is
possibly
included
in
the
class
defined
by
a
generic
name
and,
hence,
on
the
Inventory.
The
company
would
then
file
a
bona
fide
inquiry
to
make
a
more
precise
determination
of
the
Inventory
status
of
the
substance.
These
guidelines
are
based
on
the
masking
of
selected
parts
of
a
specific
substance
name
to
disguise
the
full
identity
of
the
substance.
Although
the
guidelines
illustrate
the
masking
of
a
single
structural
feature,
multiple
masking
is
permitted
if
the
company
reporting
the
substance
justifies
in
writing
the
need
for
such
additional
masking.
Because
of
inherent
differences
in
nnming
Class
1
and
Class
2
chemi~
a1substances,
the
guidelines
address
each
separately.
However,
in
certain
instances
the
procedure
for
creating
proposed
generic
names
for
Class
1
substances
is
applicable
to
the
creation
of
generic
names
for
Class
2
substances~
as
well.

Class
I
Chemical
Substances
The
composition
of
a
Class
1
chemical
substance,
except
for
impurities,
can
be
represented
by
a
definite
chemical
structure
diagram.
The
names
of
Class
1
chemical
substances
normally
disclose
the
following
chemical
structure
information:
1.
Identity
of
parent
structure
(
i.
e.,
a
chain
of
carbon
atoms,
a
ring
system,
or
a
coordinated
metal).

2.
Identity,
number,
and
position
of
chemical
group(
s)
which
are
attached
to
the
parent
structure(
s)
or
to
other
chemical
groups.

3.
Identity
and
number
of
counter
ions
(
for
~
alts).

4.
Stereochemical
relationships.

Generic
chemical
names
are
created
for
Class
1
chemical
substances
by
masking
structurally
descriptive
parts
of
their
specific
chemical
names.
Masking
can
be
accomplished
by
substituting
non­
descriptive
terms
(
e.
g.,
"
substituted
for
descriptive
parts
of
the
name.
The
structurally
descriptive
parts
of
a
Class
1
chemical
name
that
could
be
masked
when
creating
a
proposed
generic
name,
are
listed
below:

1.
A
locant
which
specifies
the
placement
of
a
single
chemical
group.

2.
Locant
and
multiplicative
prefixes
(
e.
g.,
di­,
tn­,
tetra­)
which
together
specify
the
number
and
placement
of
a
given
chemical
group.

3.
Identity
(
but
not
placement
and
number)
of
a
given
chemical
group.

4.
Identity
of
a
given
parent
structure,
and
locants
of
substituent
chemical
groups.

5.
Identity
and
multiplicative
prefixes
(
specifying
the
number)
of
a
given
simple
cation
or
anion
of
a
salt.

Chemical
Group
Masking
Table
1
of
these
guidelines
lists
byname
and
molecular
formula
the
type
of
chemical
groups
which
can
be
masked
to
create
a
proposed
generic
name
for
a
Class
1
chemical
substance.
The
groups
of
atoms
found
in
Table
1
are
common
chemical
structural
units;
a
given
group
may
be
listed
under
more
than
one
name.
Each
group
includes
at
least
one
atom
other
than
carbon
or
hydrogen.
A
chemical
group
which
includes
a
carbon
atom
having
more
than
one
single
free
valence
(
e.
g.,
carbonyl
 
CO­­­­)
can
not
be
masked
if
the
carbon
atom
is
directly
attached
to
an
acyclic
carbon
atom
or
is
included
within
a
ring
system;
in
this
circumstance;
only
the
atom
or
group
of
atoms
attached
to
the
carbon
atom
can
be
masked.
(
See
Example
2,
below,
where
the
oxo
group
is
masked.)
Table
1
lists
most
of
the
common
chemical
functional
groups
which
contain
oxygen,
e.
g.,
H2NCO­.
While
not
always
listed,
the
Group
VIa
element
(
sulfur,
selenium
and
tellurium)
analogs
of
these
functional
groups,
e.
g.,
H2NCSe­,
are
considered
included
within
Table
1
and,
accordingly,
can
be
used
in
masking.

Parent
Masking
A
parent
structure
which
is
a
chain
of
carbon
atoms
or
a
ring
system
can
be
masked
in
the
chemical
name
only
by
the
following
generic
terms:
alkyl
or
alkane
alkenyl
or
alkene
alkynyl
or
alkyne
carbomonocydic
or
carbomonocycle
(
e.
g.,
benzene,
cyclopentane)
carbopolycycic
or
carbopolycycle
(
e.
g.,
naphthalene,
spiroundecane)
heteromonocycic
or
heteromonocycle
(
e.
g.,
pyrrole,
p­
diozane)
heteropolycycic
or
heteropolycycle
(
e.
g.,
indole,
benzothiazole)
In
the
case
of
a
coordinated
metal
compound,
the
identity
of
the
metal
atom
can
be
masked
by
the
term
`~
metal"
in
the
chemical
name.
Only
one
such
parent
group
or
multiple
occurrences
of
the
same
parent
group
can
be
masked.
The
following
examples
show
how
several
hypothetical
compounds
can
be
named
by
masking
only
one
structural
detail
(
other
than
stereochemistry).
(
As
pointed
out
earlier,
multiple
masking
is
allowed
if
the
reporting
company
can
establish
to
the
satisfaction
of
the
Agency
the
need
for
the
additional
masking.)

Example
I
CFCCF,
CN(
CU,
Cfi,
OH),

0
FULLY
DEFINED
NAME:

2,2,3,3,4,4,5,5,6,6,6
 
Undecafluoro.­
N,
N
 
bis(
2­­
hydroxyethyl)
hexanamide
ACCEPTABLE
GENERIC
NAMES:

fluorine
atoms
masked:
N,
N­
Bis(
2
 
hydroxyethyl),
2,2,3,3,4,4,5,5,6,6,6
 
undecasubstituted
bexanarnide
number
of
fluorine
atoms
masked:
Po1yfluoro­
Z%~
N
 
bis(
2­
bydroxyethyl)
hexanarnide
hydroxyl
groups
masked:
2,2,3,3,4,4,5,5,6,6,
 
Undecafluoro­­
N,
N­­
bis(
2­­
substituted
etbyl)
bexanamide
hexane
parent
(
plus
locants)
masked:
Undecafluoro
 
N,
N
.­
bis(
2­
hydroxyethyl)
alkananiide
amide
group
(
plus
nitrogen
locauts)
masked:
2,2,3,3,4,4,5,5,6,6,6
 
Undecafluorobis(
2­­
hydroxyethyl)
hexane
derivative
Example
2
FULLY
DEFINED
NAME:
4­~
3­
Methyl­
2­­
oxo­
4,5­
bis(
trifluoromethyl)­
1­

imidazolidinyl]
benzoic
acid
ACCEPTABLE
GENERIC
NAMES:

oxo
group
masketh
(
NOTE:
Only
the
oxo
and
not
the
carbonyl
groi~
has
been
masked.)
p
fluorine
atoms
masked:
~
3­
Metbyl­
2­
oxo­
4,5­
bis(
trisubstituted
methy1)~..
imidazolidinylj
benzoic
acid
benzene
ring
(
plus
locant).
masked:
[
3­
Methyl­
2­
oxo­
4,5bis(
tnifluoromethy1~
1.
hnidazolidinyl}
carbomonocycic
carboxyjjc
acid
imidazolidine
ring
(
plus
locants)
masked:
4­~
MethyJoxobis(
trifluoromethyJ)
heteromo~~,~
j~
j
benzoic
acid
Class
2
Chemical
Substances
The
composition
of
a
Class2
chemical
substance
ca~
ot
be
represented
by
a
definite
chemical
structure
diag­
r~
The
specific
name
used
to
describe
such
a
substance
on
the
Inventory
was
based,
in
whole
or
in
part,
on
the
supplemental
information
provided
for
each
auhstai~
i.
e.,
the
information
which
further
established
the
identity
of
the
substance.
The
composition
of
some
Class
2
substances
can
be
represented
by
a
partial
or
incomplete
chemical
structure
diagram.
In
other
instances,
the
composition
can
only
be
described
in
terms
of
a
complex
combination
of
several
different
known
or
unknown
components.
The
method
by
which
a
Class
2.
substance
is
nnnuf'~­
tured
can
also
serve
to
identify
the
substance.
For
a
substance
manufactured
by
chemical
reaction,
identification
can
be
stated
in
terms
of
the
immediate
precursor
substances
and
other
reactants
which
participate
in
the
final
reaction
sequence
used
to
manufacture
the
substance
and
the
nature
of
the
reaction,
e.
g.,
ethoxylation,
or
bromination.
For
a
substance
derived
from
a
source
without
chemical
reaction,
processing
information
identifies
the
source
and
method
ofderivation,
e.
g.,
distillation,
or
extraction
with
methylene
chloride.
Because
Class
2
chemical
substance
names
may
be
based
on
such
variable
types
of
information,
these
guideline
procedures
for
creating
proposed
Class
2
generic
names
are
necessarily
stated
in
only
the
most
general
terms.
Nonetheless,
in
instances
such
as
those
described
below,
the
guideline
procedure
presented
earlier
for
creating
generic
names
for
Class
1
substances
may
be
applicable.
The
composition
of
a
Class2
chemical
substance
which
can
be
represented
by
a
partial
or
incomplete
chemical
structure
diagram
can
generally
be
described
by
acornmen
chemical
namewhich
encompasses
the
variability
or
incompleteness
hi
the
structure.
EPA
generally
will
accept
a
proposed
generic
name
for
such
ii.
substance
if
created
by
following
the
guidelines
specified
for
masking
Class
1
chemical
substances.
In
other
instances,
the
preferred
name
for
a
Class
2
chemical
substance
may
identify
a
predominant
component
or
components
of
its
composition,
an
immediate
precursor
or
precursors,
and
other
react
nts
by
specific
chemical
name.
EPA
generally
will
accept
a
proposed
generic
name
for
such
a
substance
if
it
is
constructed
by
masking
the
chemical
name
of
one
such
component,
precursor,
or
reactant
according
to
the
guideline
procedure
specified
for
Class
1
substances.
The
following
example
shows
how
one
hypothetical
substance
could
be
identified
by
names
which
mask
only
one
structural
detail.
4
 
~
3­­
Methyl­­
2­
substituted­­
4,5­­
bis(
trifluoromethyl)­
l­.
iniidazolidinyl]
benzoic
acid
Example
Ethoxylated
mixed
esters
derived
from
hydrogenated
palm
oil
fatty
acids
and
D­
mannitol
FULLY
DEFINED
NAME:

Hydrogenated
palm­
oil
fatty
acids,
esters
with
D­
mannitol,
ethoxylated
ACCEPTABLE
GENERIC
NAMES:

oil
source
masked:

Hydrogenated
fatty
acids,
esters
with
D­
manthtOl,
ethoxylated
hydrogenation
masked:

Modified
palm.
oil
fattyacids,
esters
with
D­
mannitol,
ethoxylated
carbohydrate
masked:

Hydrogenated
palm­
oil
fatty
acids,
esters
with
hexahydroxyalkane,
ethoxylated
ethoxylation
masked:

Hydrogenated
palm­
oil
fatty
acids,
esters,
with
D­
m~
nnitol,
alkoxylated