1
Supporting
Statement
for
Renewal
of
Existing
Information
Collection
Request
for
Confidentiality
Rules
1.
Identification
of
the
Information
Collection
1(
a)
Renewal
of
Existing
Information
Collection
Request
for
Confidentiality
Rules;
EPA
ICR
No.
1665.06,
OMB
CONTROL
No
2020­
0003.

1(
b)
Short
Characterization
The
U.
S.
Environmental
Protection
Agency
(
EPA)
originally
established
the
procedures
described
in
40
CFR,
part
2,
subpart
B,
in
1976
to
protect
the
confidentiality
of
information
while
also
respecting
the
rights
of
the
public
to
obtain
access
to
information
under
the
Freedom
of
Information
Act
(
FOIA,
5
U.
S.
C.
§
552).

This
request
for
the
renewal
of
an
existing
information
collection
request
(
ICR)
covers
the
existing
provisions
in
40
CFR,
part
2,
subpart
B.
These
provisions
describe:


the
procedures
industry
must
follow
in
asserting
and
justifying
confidentiality
claims;


the
procedures
EPA
must
follow
in
reviewing
business
information
claimed
as
confidential,
notifying
and
providing
affected
businesses
with
an
opportunity
to
comment,
reviewing
industry
substantiations,
and
making
final
confidentiality
determinations;
and

the
requirement
for
the
signing
and
maintenance
of
confidentiality
agreements
by
all
contractor/
subcontractor
employees
who
are
given
access
to
confidential
information
in
the
course
of
performing
work
for
EPA.

2.
Need
For
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection
EPA
administers
a
number
of
environmental
protection
statutes,
(
e.
g.,
the
Clean
Water
Act;
the
Clean
Air
Act;
the
Toxic
Substances
Control
Act;
the
Resource
Conservation
and
Recovery
Act;
and
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act)
under
which
the
Agency
collects
information,
such
as
data
on
toxic
chemicals,
waste
streams,
industrial
processes,
and
regulatory
compliance,
from
facilities
in
many
economic
sectors.
In
addition,
businesses
submit
information
to
EPA
without
the
Agency
requesting
it.
In
many
instances,
companies
consider
the
information
they
submit
to
EPA
to
be
confidential
business
information
(
CBI).

In
accordance
with
40
CFR
part
2,
subpart
B,
when
EPA
finds
it
necessary
to
make
a
2
final
confidentiality
determination
(
e.
g.,
in
response
to
a
FOIA
request
or
in
the
course
of
rulemaking
or
litigation),
or
an
advance
confidentiality
determination,
it
notifies
the
affected
business
by
sending
a
letter
requesting
substantiation
of
the
confidentiality
claim.
This
letter
provides
the
affected
business
with
an
opportunity
to
submit
comments
(
i.
e.,
a
substantiation).
Industry
comments
are
very
helpful
to
EPA
in
making
final
confidentiality
determinations.

When
EPA
utilizes
contractor/
subcontractor
services
for
activities
involving
CBI,
the
contractor/
subcontractor
must
ensure
that
all
its
employees
who
will
be
given
access
to
CBI
have
signed
confidentiality
agreements.
These
agreements
state
that
employees
shall
use
the
confidential
information
only
for
the
work
in
the
contract/
subcontract,
shall
refrain
from
disclosing
the
information,
and
shall
return
all
copies
of
the
information
to
EPA
upon
request
or
completion
of
the
project.
The
contractor/
subcontractor
company
must
also
maintain
a
file
of
these
confidentiality
agreements.

The
procedures
laid
out
in
40
CFR,
part
2,
subpart
B,
derive
their
authority
from
FOIA,
as
amended,
5
U.
S.
C.
552,
the
Trade
Secrets
Act,
as
amended,
18
U.
S.
C.
1905,
the
Federal
housekeeping
statute,
as
amended,
5
U.
S.
C.
301,
the
Administrative
Procedure
Act,
as
amended,
5
U.
S.
C.
553,
and
the
confidentiality
provisions
of
environmental
statutes
administered
by
EPA,
as
follows:

°
§
§
114,
206,
208,
301,
and
307,
Clean
Air
Act,
as
amended
(
42
U.
S.
C.
7414,
7525,
7542,
7601,
7607)
°
§
§
308,
501,
and
509(
a),
Clean
Water
Act,
as
amended
(
33
U.
S.
C.
1318,
1361,
1369(
a))
°
§
13,
Noise
Control
Act
of
1972,
as
amended
(
42
U.
S.
C.
4912)
°
§
§
1445
and
1450,
Safe
Drinking
Water
Act,
as
amended
(
42
U.
S.
C.
300j­
4,
300j­
9)
°
§
§
2002,
3001,
3007,
and
9005,
Resource
Conservation
and
Recovery
Act,
as
amended
(
42
U.
S.
C.
6912,
6921,
6927,
6991d)
°
§
§
8(
c),
11,
12(
b),
and
14,
Toxic
Substances
Control
Act,
as
amended
(
15
U.
S.
C.
2607(
c),
2610,
2611(
b),
2613)
°
§
§
10,
12,
and
25,
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
as
amended,
(
7
U.
S.
C.
136h,
136j,
136w)
°
§
408(
i),
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
(
21
U.
S.
C.
346a(
i))
°
§
§
104(
f)
and
108,
Marine
Protection
Research
and
Sanctuaries
Act
of
1972,
as
amended
(
33
U.
S.
C.
1414(
f),
1418)
°
§
§
104
and
115,
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980,
as
amended
(
42
U.
S.
C.
9604,
9615)
°
§
505,
Motor
Vehicle
Information
and
Cost
Savings
Act,
as
amended
(
15
U.
S.
C.
2005)
[
REPEALED]

2(
b)
Use/
Users
of
the
Data
EPA
will
use
the
information
received
from
industry
to
help
determine
whether
3
particular
information
has
been
claimed
as
confidential,
whether
the
Agency
needs
to
make
a
formal
confidentiality
determination,
and
whether
the
information
in
question
is
indeed
entitled
to
confidential
treatment
under
Exemption
4
of
FOIA.

3.
Non­
Duplication,
Consultations
and
Other
Collection
Criteria
3(
a)
Non­
Duplication
This
information
is
not
elsewhere
collected
from
businesses.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
EPA
published
a
notice
of
the
renewal
of
the
existing
information
collection
request
for
confidentiality
rules
in
the
Federal
Register
on
April
10,
2003
(
68
FR
17631)
and
invited
public
comments.
EPA
received
comments
from
one
organization,
CDM
Federal
Programs
Corporation
(
CDM),
which
provided
a
burden
estimate
for
preparing
a
standard
substantiation
(
no
search
and
review
of
documents
required)
of
a
CBI
claim.
CDM
estimates
that
it
takes
up
to
4
hours
at
an
average
cost
of
$
125.00
to
prepare
a
standard
substantiation
of
a
CBI
claim.
This
burden
estimate
was
added
to
the
data
sets
for
the
prior
renewal
information
collection
request
(
2000
Renewal
ICR)
to
determine
an
average
total
hour
burden
per
substantiation
request.
CDM
stated
that
the
burden
to
prepare
a
substantiation
may
increase
substantially
if
they
are
required
to
search,
locate,
and
review
documents
stored
off­
site.

3(
c)
Consultations
For
the
2000
Renewal
ICR,
EPA
contacted
a
sample
of
nine
businesses
to
evaluate
the
industry
burden
associated
with
preparing
a
substantiation.
Four
of
these
nine
businesses
responded,
reporting
burden
estimates
varying
from
6
to
18
hours.
The
hourly
wages
for
the
employees
involved
in
the
substantiation
process
ranged
from
$
50.00/
hour
to
$
140.00/
hour.
In
addition,
EPA
requested
burden
estimates
from
EPA
program
and
regional
offices.
Their
responses
provided
the
basis
for
the
Agency
burden
estimates.

As
part
of
its
efforts
for
renewing
this
ICR,
EPA
sought
to
evaluate
whether
the
burden
to
small
businesses
associated
with
preparing
substantiations
fell
within
the
burden
range
established
in
the
2000
Renewal
ICR.
Using
contact
information
provided
by
multiple
EPA
offices,
the
Agency
contacted
a
number
of
small
businesses
to
identify
those
that
have
substantiated
CBI
claims
and
were
willing
to
provide
estimates
of
the
burden
associated
with
preparing
a
substantiation.
Most
of
the
businesses
EPA
contacted
had
never
received
a
substantiation
request,
and
many
had
no
knowledge
of
the
substantiation
process.
See
Attachment
A
for
further
details
on
the
Agency's
efforts
to
identify
and
survey
small
businesses.
4
However,
three
small
businesses
did
respond
to
EPA's
survey,
providing
their
burden
estimates.
These
estimates
were
added
to
the
industry
burden
data
sets
for
the
2000
Renewal
ICR
to
determine
an
average
total
hour
burden
per
substantiation
request.

EPA
also
received
a
comment
from
Eastman
Chemical
Company
("
Eastman")
on
the
Federal
Register
notice
that
announced
that
EPA
was
forwarding
the
ICR
paperwork
to
OMB
for
review
(
68
FR
52766;
September
5,
2003).
Eastman
did
not
comment
on
the
burden
estimates
or
the
labor
estimates.
The
company
did
comment
on
the
wording
of
the
letters,
and
asked
for
changes
in
certain
language
in
the
questions
to
align
the
questions
better
with
the
regulations
on
which
the
letters
are
based
(
40
CFR
§
2.204(
e)(
4)).
EPA
found
merit
with
several
of
the
points
made
in
the
comment
and
made
changes
to
the
questions
in
the
letters
based
on
the
comment.
However,
the
changes
are
meant
to
clarify
the
language
and
should
not
affect
the
burden
estimates.
Details
of
the
changes
can
be
found
in
the
response
to
comment,
which
EPA
is
placing
in
the
docket.

3(
d)
Effects
of
Less
Frequent
Collection
The
letters
are
sent
only
when
EPA
finds
it
necessary
to
make
a
final
confidentiality
determination
(
e.
g.,
in
response
to
a
FOIA
request
or
in
the
course
of
rulemaking
or
litigation)
or
an
advance
confidentiality
determination.
The
affected
business
is
notified
by
sending
a
letter
requesting
substantiation
of
the
confidentiality
claim.
This
letter
provides
the
affected
business
with
an
opportunity
to
submit
comments
(
i.
e.,
a
substantiation).
If
the
letters
were
sent
to
affected
entities
less
frequently,
these
entities
would
lose
the
opportunity
to
substantiate
their
CBI
claims.
This
would
be
a
disservice
to
the
public.

3(
e)
General
Guidelines
Only
one
provision
of
this
collection
exceeds
the
Paperwork
Reduction
Act
guidelines
at
5
CFR
1320.5(
d)(
2).
This
collection
calls
for
responses
to
be
furnished
to
EPA
within
15
working
days
after
the
business
receives
the
letter
requesting
substantiation.
Under
5
CFR
1320.5(
d)(
2)(
ii),
EPA
must
justify
why
the
response
needs
to
be
prepared
within
a
period
shorter
than
30
days
after
receipt
of
the
collection.
In
the
context
of
addressing
the
time­
frame
for
determinations
under
the
FOIA,
EPA
"
tentatively"
determined
that
15
days
is
"
a
reasonable
period
for
the
business
to
furnish
comments
and
substantiating
data
concerning
its
claim."
40
FR
21987,
21988,
21989
(
May
20,
1975)
and
41
FR
36902,
36908
(
September
1,
1976).
EPA
has
found
through
experience
in
the
years
since
these
regulations
were
promulgated
(
at
40
CFR
part
2)
that
15
days
fits
well
with
the
general
timetable
of
FOIA
responses.
In
addition,
the
15­
day
period
enables
EPA
to
commence
other
activities
such
as
rulemaking
in
a
timely
manner
since
the
final
CBI
determination
can
be
made
with
relatively
little
delay.
5
3(
f)
Confidentiality
and
Sensitive
Questions
1.
Confidentiality
Under
EPA's
current
CBI
regulations
(
40
CFR
part
2,
subpart
B),
respondents
may
claim
substantiations
submitted
to
EPA
as
confidential.

2.
Sensitive
Questions
Not
applicable.
This
information
collection
does
not
include
questions
of
a
sensitive
nature.

4.
The
Respondents
and
the
Information
Requested
4(
a)
Respondents/
SIC
Codes
Respondents
could
potentially
include
any
business
submitting
a
document
to
EPA
that
it
claims
as
CBI.
EPA
receives
such
information
from
both
the
manufacturing
(
SIC
codes
20­
39)
and
non­
manufacturing
sectors
(
no
SIC
codes
identified).

4(
b)
Information
Requested
A.
Substantiation
of
confidentiality
claim
Whenever
EPA
finds
it
necessary
to
determine
the
confidentiality
of
information
that
has
been
claimed
as
CBI
(
e.
g.,
in
response
to
a
FOIA
request
or
in
connection
with
rulemaking
or
litigation,
or
with
regard
to
an
advance
confidentiality
determination)
(
40
CFR
2.204
(
a),
(
c)
and
(
d),
2.206),
it
must
notify
affected
businesses
orally
and
in
writing
and
provide
them
with
an
opportunity
to
comment
(
40
CFR
2.204(
e)).

With
this
Renewal
ICR,
EPA
is
proposing
to
use
an
updated
Request
for
Substantiation
letter
("
proposed
letter").
The
proposed
letter
is
made
up
of
two
separate
sample
letters
that
address
different
factual
situations:
Sample
Letter
A,
which
requests
a
substantiation
in
response
to
a
FOIA
request,
and
Sample
Letter
B,
which
requests
a
substantiation
in
support
of
Agency
rulemaking
or
litigation,
in
the
case
of
an
advance
confidentiality
determination,
or
for
any
other
Agency
purpose.
The
use
of
two
letters
is
a
clarification
of
existing
EPA
procedures.

Some
of
the
information
requested
differs
slightly
from
the
current
Request
for
Substantiation
letter,
concerning
the
possible
voluntary
nature
of
the
submission
and
the
issue
of
substantial
competitive
harm,
and
takes
into
account
the
vast
amount
of
information
now
available
electronically.

1.
Data
Items
6
The
written
notice
from
EPA
(
40
CFR
2.204(
e)(
1)
and
(
4))
invites
the
business's
comments
on
the
following:

(
i)
The
portions
of
the
information
which
are
alleged
to
be
entitled
to
confidential
treatment;
(
ii)
The
period
of
time
for
which
confidential
treatment
is
desired
by
the
business
(
e.
g.,
until
a
certain
date,
until
the
occurrence
of
a
specified
event,
or
permanently);
(
iii)
The
purpose
for
which
the
information
was
furnished
to
EPA
and
the
approximate
date
of
submission,
if
known;
(
iv)
Whether
a
business
confidentiality
claim
accompanied
the
information
when
it
was
received
by
EPA;
(
v)
Measures
taken
by
the
business
to
guard
against
undesired
disclosure
of
the
information
to
others;
(
vi)
The
extent
to
which
the
information
has
been
disclosed
to
others,
and
the
precautions
taken
in
connection
therewith;
(
vii)
Pertinent
confidentiality
determinations,
if
any,
by
EPA
or
other
Federal
agencies;
and
a
copy
of
any
such
determination,
or
reference
to
it,
if
available;
(
viii)
Whether
the
business
asserts
that
disclosure
of
the
information
would
be
likely
to
result
in
substantial
harmful
effects
on
the
business's
competitive
position,
and
if
so,
what
those
harmful
effects
would
be,
why
they
should
be
viewed
as
substantial,
and
an
explanation
of
the
causal
relationship
between
disclosure
and
such
harmful
effects;
and
(
ix)
Whether
the
business
asserts
that
the
information
is
voluntarily
submitted
information
as
defined
in
40
CFR
§
2.201(
i),
and
if
so,
whether
and
why
disclosure
of
the
information
would
tend
to
lessen
the
availability
to
EPA
of
similar
information
in
the
future.

2.
Respondent
Activities
To
complete
the
collection,
the
respondent
must:

a.
Read
EPA's
request
for
comments;
b.
Review
the
information
claimed
as
confidential;
and
c.
Prepare
and
submit
a
substantiation
to
EPA.

B.
Designation
by
Business
of
Addressee
for
Notices
and
Inquiries
Pursuant
to
40
CFR
2.213,
a
business
may
elect
to
designate
an
official
contact
for
inquiries
and
notices
concerning
confidentiality
claims.

1.
Data
Items
Name
and
address
of
the
business
making
the
designation,
and
the
name
and
address
7
of
the
designated
person
or
office.

2.
Respondent
Activities
To
identify
and
submit
the
information
to
EPA.

C.
Confidentiality
agreements
When
EPA
utilizes
the
services
of
contractors/
subcontractors,
all
contractor/
subcontractor
employees
who
may
be
given
access
to
confidential
information
must
first
sign
confidentiality
agreements
stating
that
they
will
honor
the
terms
of
the
contract/
subcontract
which
requires
protection
of
CBI.
See,
e.
g.,
40
CFR
2.301(
h)(
2)(
ii).

1.
Data
Items
Signed
confidentiality
agreements.

2.
Respondent
activities
The
contractor
must:
a.
Require
each
employee
given
access
to
CBI
to
read
and
sign
a
confidentiality
agreement,
and
b.
Maintain
a
file
of
such
agreements.
See
40
CFR
2.301(
h)(
2)(
iv).

In
addition
to
the
information
collections
discussed
above,
when
EPA
intends
to
disclose
CBI
to
contractors/
subcontractors,
other
Federal
agencies,
or
Congress,
EPA
generally
notifies
affected
businesses.
During
a
specified
period
of
time
prior
to
disclosure,
businesses
may
submit
comments.
Industry
has
rarely
submitted
comments
to
EPA
under
these
circumstances.

5.
The
Information
Collected
 
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
1.
Review
and
make
a
preliminary
determination
of
whether
business
information
may
be
entitled
to
confidential
treatment.
This
review
would
be
undertaken
in
response
to
a
FOIA
request
or
when
EPA
desires
to
determine
the
confidentiality
of
information
within
its
possession
for
other
purposes
(
e.
g.,
rulemaking,
litigation,
or
an
advance
confidentiality
determination).
It
would
involve
determining
whether
a
business
confidentiality
claim
exists
or
whether
a
Federal
court
or
an
EPA
legal
office
has
previously
determined
that
the
information
in
question
is
entitled
to
treatment
as
CBI.
8
2.
Notify
the
affected
business
orally
and
in
writing
that
the
Agency
is
determining
the
confidentiality
of
the
information
and
provide
the
business
with
an
opportunity
to
comment.
3.
Review
the
substantiation
received
(
if
any)
and
make
a
final
determination
whether
the
business
information
in
question
is
entitled
to
confidential
treatment.
This
determination
will
be
made
by
the
appropriate
EPA
legal
office
as
described
in
40
CFR
2.205.

5(
b)
Collection
Methodology
and
Management
The
types
of
information
that
are
requested
are
described
under
4(
b)
above.
EPA
notifies
affected
businesses
orally
and
in
writing
that
it
is
determining
the
confidentiality
of
information
they
have
submitted
and
affords
them
the
opportunity
to
comment.
Affected
businesses
may
submit
comments
by
the
date
specified
in
the
notice
(
i.
e.,
postmarked
or
hand
delivered
no
later
than
the
specified
date);
or
if
a
request
for
an
extension
of
the
comment
period
is
made
by
the
business
and
approved
by
the
EPA
legal
office
before
the
comments
are
due,
the
comment
period
may
be
extended
(
40
CFR
2.205(
b)(
2)).

Confidential
information
that
is
submitted
to
EPA
is
protected
in
accordance
with
the
policies
and
procedures
discussed
in
(
1)
Chapter
8,
"
Information
Security,"
of
EPA's
Information
Resources
Management
(
IRM)
Policy
Manual,
Directive
2100,
revised
December
20,
1999;
(
2)
the
EPA
Information
Security
Manual,
Directive
2195A1,
December
20,
1999;
and
(
3)
information
security
procedures
issued
by
EPA
organizations
with
statutory
authority
for
the
information
[
e.
g.,
EPA's
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
has
developed
specific
procedures
for
protecting
the
confidentiality
of
information
obtained
under
the
Toxic
Substances
Control
Act
(
TSCA)
and
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)].

5(
c)
Small
Entity
Flexibility
EPA
does
not
have
the
flexibility
to
waive
the
need
for
substantiations
from
small
entities
for
several
reasons:
(
1)
EPA
is
required
to
disclose
information
that
is
requested
under
FOIA,
unless
the
information
is
specifically
exempt;
(
2)
if
EPA
discloses
information
that
is
entitled
to
confidential
treatment,
the
Federal
government
could
be
held
liable
under
the
Federal
Tort
Claims
Act
and
individual
Federal
employees
could
be
subject
to
criminal
liability
under
the
Trade
Secrets
Act
and
other
statutes,
and
(
3)
the
submitter
of
the
information
is
in
the
best
position
to
explain
why
particular
information
should
be
entitled
to
confidential
treatment.

5(
d)
Collection
Schedule
The
collection
of
substantiations
occurs
on
a
case­
by­
case
basis
as
needed.
9
6.
Estimating
the
Burden
and
Cost
of
the
Collection
See
Table
1
for
a
summary
of
the
burden
on
both
EPA
and
respondents,
Table
2
for
the
estimated
burden
on
respondents,
and
Table
3
for
the
estimated
burden
on
EPA.

6(
a)
Estimating
Respondent
Burden
and
Cost
A.
Substantiation
of
confidentiality
claim
EPA
receives
approximately
1384
FOIA
requests
for
information
that
is
claimed
as
CBI
each
year.
In
addition,
there
are
approximately
617
other
instances
per
year
that
require
EPA
to
examine
the
confidentiality
of
business
information.
Yet
formal
confidentiality
determinations
are
not
always
required.
For
example,
after
consulting
with
an
individual
who
requested
information
under
FOIA,
the
Agency
may
be
able
to
provide
the
information
that
is
of
most
interest
to
the
requester
without
disclosing
any
CBI.
In
other
cases,
EPA
may
find
that
a
Federal
Court
or
EPA
legal
office
has
previously
determined
that
the
information
in
question
is
entitled
to
confidential
treatment,
and
further
examination
of
the
information
may
not
be
required.

EPA
estimates
that
in
accordance
with
the
procedures
outlined
in
40
CFR
part
2,
subpart
B,
the
Agency
would
notify
543
businesses
annually
that
a
final
confidentiality
determination
on
information
the
business
has
previously
claimed
as
CBI
(
or
which
could
be
expected
to
be
CBI)
is
being
made,
and
provide
them
with
an
opportunity
to
submit
comments
explaining
why
previously
submitted
information
should
be
treated
as
confidential.
Each
affected
business
then
has
an
opportunity
to
submit
comments
explaining
why
the
information
should
be
protected
(
i.
e.,
a
substantiation).
Of
the
543
businesses,
EPA
estimates
that
approximately
443
businesses
would
respond
by
submitting
substantiations.

EPA
estimates
that
it
takes
industry
approximately
14.20
hours
(
2.20
attorney
hrs.,
4.00
manager
hrs.,
7.00
technical
hrs.,
and
1.00
clerical
hr.)
and
$
1,106.70
($
60.00/
attorney
hr.,
$
33.22/
manager
hr.,
$
35.01/
technical
hr.,
and
$
17.05/
clerical
hr.;
wages
are
multiplied
by
2.1
to
ensure
costs
are
fully
loaded
to
include
additional
administrative
costs)
in
labor
to
prepare
and
submit
each
substantiation;
or
a
total
of
6,290.60
hours
at
a
cost
of
$
490,268.10
in
labor
for
all
443
substantiations.
For
those
100
businesses
that
do
not
submit
substantiations,
they
are
still
likely
to
spend
about
1
hour
(
0.50
manager
hr.
and
0.50
technical
hour)
at
a
cost
of
$
71.64
($
33.22/
manager
hr.
and
$
35.01/
technical
hr.
multiplied
by
2.1)
in
labor
to
review
EPA's
notice,
examine
the
information
in
question,
and
make
a
decision
not
to
respond;
or
a
total
of
100
hours
at
a
cost
of
$
7,164.00
in
labor
costs
for
reviewing
and
deciding
not
to
respond
in
100
cases.
The
total
burden
on
industry
to
review
and,
if
desired,
respond
to
543
EPA
substantiation
requests
is
6,390.60
hours
at
a
cost
of
$
497,432.10
in
labor.
10
B.
Confidentiality
agreements
When
EPA
utilizes
the
services
of
contractors/
subcontractors
in
implementing
40
CFR,
part
2,
subpart
B,
all
contractor/
subcontractor
employees
who
may
be
given
access
to
confidential
information
must
first
sign
confidentiality
agreements
stating
that
they
will
honor
the
terms
of
the
contract
which
requires
the
protection
of
CBI.
In
addition,
the
contractor/
subcontractor
businesses
must
maintain
a
file
of
all
such
agreements.
EPA
estimates
that
there
are
about
129
contractor/
subcontractor
businesses
that
handle
CBI
in
connection
with
their
work
for
EPA
each
year.
These
129
contractor/
subcontractor
businesses
together
have
a
total
of
approximately
658
employees
who
must
sign
confidentiality
agreements
each
year.
Each
employee
would
need
approximately
0.10
hour
to
review
and
sign
an
agreement,
at
a
cost
of
$
6.98
in
labor
(
0.10
manager
hr.
at
$
33.22/
manager
hr.
multiplied
by
2.1);
employees'
review
and
signature
of
all
agreements
would
require
approximately
65.80
hours
at
a
cost
of
$
4,592.84
in
labor
per
year.
In
addition,
each
subcontractor/
contractor
business
would
need
approximately
0.50
hour
at
a
cost
of
$
17.90
in
labor
per
year
to
maintain
a
file
of
employee
confidentiality
agreements
(
0.50
clerical
hr.
at
$
17.05/
clerical
hr.
multiplied
by
2.1);
the
129
contractor/
subcontractor
businesses
together
would
require
a
total
of
64.50
hours
at
a
labor
cost
of
$
2,309.10
to
maintain
a
file
of
confidentiality
agreements.
The
total
burden
for
signing
and
maintaining
confidentiality
agreements
would
thus
be
130.30
hours
at
a
cost
of
$
6,901.94.

C.
Overall
Respondent
Burden
The
overall
burden
for
handling
confidentiality
claims
 
including
the
substantiation
process
and
the
signing/
maintaining
of
confidentiality
agreements
 
would
be
6,520.90
hours
at
a
total
labor
cost
of
$
504,334.04
per
year.
EPA
estimates
that
no
capital
costs
or
operation
and
maintenance
costs
would
be
incurred
as
a
result
of
this
information
collection.

6(
b)
Estimating
Agency
Burden
and
Cost
The
burden
on
EPA
involved
in
evaluating
confidentiality
claims,
notifying
affected
businesses,
and
making
final
confidentiality
determinations
varies
depending
on
the
complexity
of
the
claim.
In
some
cases,
the
information
that
industry
claims
as
confidential
is
specific
and
easy
to
identify;
yet
in
other
cases,
entire
reports
may
be
claimed
as
confidential.
In
the
latter
case,
a
significant
amount
of
time
may
be
required
just
to
review
the
information
in
question.
In
other
cases,
EPA
may
be
able
to
satisfy
a
FOIA
request
without
going
through
the
entire
substantiation
process,
if
after
conferring
with
a
requestor,
the
Agency
is
able
to
provide
the
information
of
interest
without
releasing
CBI.

Based
on
past
experience,
EPA
estimates
that
on
average,
it
takes
approximately
7
hours
(
4
attorney
hrs.,
2
technical
hrs.,
and
1
clerical
hour)
at
a
cost
of
$
388.88
11
($
39.31/
attorney
hr.,
GS­
14,
Step
5;
$
33.26/
technical
hr.,
GS­
13,
Step
5;
and
$
19.29/
clerical
hr.,
GS­
9,
Step
5;
wages
are
multiplied
by
1.6
to
ensure
costs
are
fully
loaded
to
include
additional
administrative
costs)
to
conduct
an
initial
review
of
a
confidentiality
claim
and
prepare
and
request
a
substantiation
from
the
submitter.
Thus,
in
order
to
review
the
information
in
question
and
prepare
approximately
543
substantiation
requests
per
year,
EPA
would
spend
a
total
of
3,801.00
hours
in
staff
time
at
a
total
labor
cost
of
$
211,161.84.

In
addition,
after
industry
comments
are
received,
it
takes
approximately
8
hours
(
6
attorney
hrs.
and
2
technical
hrs.)
at
a
cost
of
$
483.81
($
39.31/
attorney
hr.,
GS­
14,
Step
5
and
$
33.26/
technical
hr.,
GS­
13,
Step
5
multiplied
by
1.6)
to
review
the
comments
and
determine
whether
the
information
that
is
claimed
as
confidential
is
indeed
entitled
to
confidential
treatment.
It
would
take
EPA
a
total
of
3,544.00
hours
at
a
total
labor
cost
of
$
214,327.83
to
review
the
approximately
443
substantiations
that
would
be
submitted
by
industry.
(
Of
the
543
businesses,
EPA
estimates
that
approximately
443
businesses
would
respond
by
submitting
substantiations.)

The
total
burden
to
EPA
to
review
the
initial
information
submitted
to
EPA,
make
a
preliminary
determination
of
confidentiality,
request
comments
from
industry,
review
the
substantiations
received,
and
make
final
confidentiality
determinations
would
be
approximately
7,345.00
hours
at
a
total
labor
cost
of
$
425,489.67
per
year.

6(
c)
Bottom
Line
Burden
Hours
and
Cost
1.
Substantiation
of
Confidentiality
Claims
For
443
Businesses
Submitting
Substantiations:
Burden:
14.20
hrs.
x
443
=
6,290.60
hrs.
Costs:
$
1,106.70
x
443
=
$
490,268.10
For
100
Businesses
Deciding
Not
To
Respond:
Burden:
1
hr.
x
100
=
100
hrs.
Costs:
$
71.64
x
100
=
$
7,164.00
Totals:
6,290.60
+
100
=
6,390.60
hrs.
$
490,268.10
+
$
7,164.00
=
$
497,432.10
2.
Confidentiality
agreements
For
658
Contractor/
Subcontractor
Employees
To
Review
and
Sign
Confidentiality
Agreements:
Burden:
0.10
hours
x
658
respondents/
year
=
65.80
hrs.
Costs:
$
6.98
x
658
=
$
4,592.84
12
For
129
Contractor/
Subcontractor
Businesses
to
Maintain
and
File
Confidentiality
Agreements:
Burden:
0.50
hours
x
129
respondents/
year
=
64.50
hours
Costs:
$
17.90
x
129
respondents/
year
=
$
2,309.10
Totals:
65.80
hrs.
+
64.50
hrs.
=
130.30
hrs.
Costs:
$
4,592.84
+
$
2,309.10
=
$
6,901.94
3.
Total
Burden
and
Costs
for
Respondents:

Burden:
6,390.60
hrs.
+
130.30
=
6,520.90
hours
Costs:
$
497,432.10
+
$
6,901.94
=
$
504,334.04
4.
The
Agency
Tally
For
Initial
Review,
Preliminary
Determination,
and
Request
for
Substantiation:
Burden:
7
hrs.
x
543
=
3,801.00
hrs.
Costs:
$
388.88
x
543
=
$
211,161.84
For
Review
of
Substantiations
and
Final
Confidentiality
Determination:
Burden:
8
hrs.
x
443
=
3,544.00
hrs.
Costs:
$
483.81
x
443
=
$
214,327.83
Totals:
Burden:
3,801.00
hrs.
+
3,544.00
hrs.
=
7,345.00
hrs.
Costs:
$
211,161.84
+
$
214,327.83
=
$
425,489.67
5.
Variations
in
the
Annual
Bottom
Line
Variations
in
the
annual
burden
on
EPA
and
respondents
could
potentially
occur
due
to
changes
in:

°
the
number
of
FOIA
requests
that
EPA
receives
for
information
that
has
been
claimed
as
confidential;
°
the
number
of
times
that
EPA
determines
that
a
formal
confidentiality
determination
is
necessary
and
notifies
affected
businesses,
providing
them
with
an
opportunity
to
comment;
and
°
the
number
of
times
that
affected
businesses
decide
to
submit
substantiations.

At
this
time,
EPA
does
not
foresee
any
significant
changes
in
the
annual
burdens
outlined
above.

6(
d)
Reasons
for
Change
in
Burden
13
EPA
estimates
that
the
overall
burden
will
not
be
affected
by
the
new
Request
for
Substantiation
letter
(
i.
e.,
proposed
letter).
EPA
anticipates
that
the
letter's
new
inquiries
will
not
require
any
research
beyond
that
needed
to
answer
the
questions
that
appear
in
the
current
letter,
or
generally
needed
to
prepare
the
substantiation.
Also,
the
Agency
anticipates
that
the
respondents
will
be
able
to
answer
these
new
inquiries
with
a
minimal
amount
of
time
and
effort.

Adding
the
new
data
sets
collected
for
this
Renewal
ICR
to
the
data
collected
for
the
2000
Renewal
ICR
results
in
an
average
hours
per
substantiation
request
estimate
of
10.80
hours.
A
review
of
these
new
data
sets
reveals
that
the
burden
to
these
four
businesses
(
three
small
businesses)
associated
with
preparing
substantiations
falls
within
the
same
burden
range
as
reported
for
the
2000
Renewal
ICR.
In
addition,
these
new
data
points
represent
a
small
sample
size
of
small
businesses
and
low
hourly
burden
estimates
characteristic
of
substantiations
requiring
minimal
document
search
and
review
efforts.
As
such,
consideration
of
these
new
data
points
does
not
merit
modifying
the
14.00
hour
industry
burden
estimate
reported
in
the
2000
Renewal
ICR.

The
total
hours
per
request
estimate
reported
in
section
6(
a)
A.
(
14.20
hours)
includes
0.20
hours
per
request
for
an
attorney
to
read
EPA's
request
for
a
substantiation.
This
change
reflects
a
minor
adjustment
to
the
2000
Renewal
ICR
burden
estimate
to
correct
an
oversight
when
preparing
the
prior
burden
estimate.
The
previous
estimate
for
the
total
hours
per
request
only
incorporated
burden
estimates
for
one
manager
and
one
technical
employee
to
review
EPA's
request
for
substantiation.
As
new
burden
data
did
not
result
in
a
significant
burden
change,
and
burden
will
be
unaffected
by
the
new
Request
for
Substantiation
letter,
no
other
adjustments
have
been
made
to
the
estimate
of
14.00
hours
per
request
(
calculated
for
the
2000
Renewal
ICR).

Hourly
wages
for
private
industry
for
each
employee
category
were
revised
to
reflect
2001
wages
reported
by
the
Bureau
of
Labor
Statistics.
Hourly
wages
for
EPA
employees
for
each
category
were
revised
to
reflect
current
wages
according
to
the
U.
S.
Office
of
Personnel
Management's
2003
General
Schedule.
Wages
were
fully
loaded
to
include
all
administrative
costs
in
addition
to
labor
costs.
These
adjustments
led
to
an
increase
in
the
overall
cost
burden.

6(
e)
Burden
Statement
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
4.90
hours
per
response
(
6,520.90
hrs./
1330
responses
=
4.90
hrs./
response).
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
14
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OEI­
2003­
0003,
which
is
available
for
public
viewing
at
the
OEI
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Avenue.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
OEI
Docket
is
(
202)
566­
1752.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
(
OEI­
2003­
0003)
and
OMB
control
number
(
2020­
0003)
in
any
correspondence.
15
Attachment
A
Efforts
to
Identify
Small
Businesses
to
Survey
to
Solicit
Input
on
the
Burden
Associated
with
Substantiating
CBI
Claims

EPA
National
Center
for
Environmental
Research,
Small
Business
Innovation
Research,
FY
2003
Awards
­
contacted
a
list
of
46
small
businesses.
None
of
the
small
businesses
have
ever
substantiated
a
CBI
claim.


EPA
Small
Business
Ombudsman's
Office
°
Provided
a
list
of
trade
associations
to
contact
to
identify
small
businesses
that
may
have
substantiated
CBI
claims.
°
Received
contact
information
for
two
small
businesses.
°
Interviewed
one
small
business
regarding
the
burden
to
substantiate
CBI
claims.
°
The
other
business
did
not
meet
the
definition
of
a
small
business.
°
Provided
the
EPA
contractor,
Industrial
Economics,
Incorporated
(
IEc),
with
a
contact
in
the
Pesticides
Ombudsman's
Office.
°
Pesticides
Ombudsman's
Office
does
not
track
businesses
that
substantiate
CBI
claims.


EPA
National
Environmental
Performance
Track
Member
Website
­
contacted
17
small
businesses.
None
of
the
small
businesses
have
ever
substantiated
a
CBI
claim.


EPA
WasteWise
Membership
Listing
­
contacted
four
small
businesses.
None
of
the
small
businesses
have
ever
substantiated
a
CBI
claim.


EPA
Office
of
Pesticide
Programs
°
Provided
a
list
of
three
small
businesses
that
have
substantiated
CBI
claims
in
the
past.
°
One
business
stated
that
they
have
never
substantiated
a
CBI
claim.
°
One
business
did
not
respond
to
our
calls.
°
Interviewed
a
representative
from
one
business
regarding
the
burden
to
substantiate
a
CBI
claim.


EPA
Contracts
Office
°
Provided
a
list
of
two
small
businesses
that
have
substantiated
CBI
claims
in
the
past.
°
Interviewed
a
representative
from
one
business
regarding
the
burden
to
substantiate
a
CBI
claim.
°
The
other
business
stated
that
they
have
never
substantiated
a
CBI
claim.
