Document ID: EPA-HQ-OW-2002-0026-0870
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-07-09T04:00Z

1
Information
Collection
Request:

Concentrated
Aquatic
Animal
Production
Effluent
Guidelines
Final
Rule
ICR
No.
2087.02,
OMB
No.

Environmental
Protection
Agency
Office
of
Water
Office
of
Science
and
Technology
June
2004
2
Table
of
Contents
1.
Identification
of
the
Information
Collection
a.
Title
of
the
Information
Collection
b.
Short
Characterization
/
Abstract
2.
Need
for
and
Use
of
the
Collection
a.
Need
and
Authority
for
the
Collection
b.
Practical
Utility
and
Uses
of
te
Information
3.
Nonduplication,
Consultations
and
Other
Collection
Criteria
a.
Nonduplication
b.
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
c.
Consultations
d.
Effects
of
Less
Frequent
Collection
e.
General
Guidelines
f.
Confidentiality
g.
Sensitive
Questions
4.
Respondents
and
Information
Requested
a.
Respondents/
NAICS
Codes
b.
Information
Requested
5.
Information
Collected:
Agency
Activities,
Collection
Methodology,
and
Information
Management
a.
Agency
Activities
b.
Collection
Methodology
and
Management
c.
Small
Entity
Flexibility
d.
Collection
Schedule
e.
Information
Management
6.
Estimating
the
Burden
and
Cost
of
the
Collection
a.
Estimating
Respondent
Burden
b.
Estimating
Respondent
Costs
c.
Estimating
Agency
Burden
and
Cost
d.
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
e.
Bottom
Line
Burden
Hours
and
Cost
Tables
f.
Reasons
for
Change
In
Burden
g.
Burden
Statement
3
1.
Identification
of
the
Information
Collection
a.
Title
of
the
Information
Collection
Concentrated
Aquatic
Animal
Production
Point
Source
Category
Effluent
Guidelines
Reporting
and
Recordkeeping
Requirements
EPA
ICR
No.
2087.02
;
OMB
Control
No.
2040­

b.
Short
Characterization/
Abstract
This
ICR
requests
OMB
approval
for
new
information
requirements
in
a
Final
Rulemaking.
The
rule,
titled:
"
Effluent
Limitations
Guidelines
and
Standards
for
Concentrated
Aquatic
Animal
Production
(
CAAP)
Point
Source
Category"
(
Effluent
Guidelines)
establishes
specific
reporting
requirements
that
would
be
required
of
a
segment
of
CAAP
facilities
through
NPDES
permits.
The
rule
covers
facilities
which
are
defined
as
CAAP
facilities
(
see
40
CFR
122.24
and
40
CFR
Part
122
Appendix
C)
and
produce
at
least
100,000
pounds
per
year
in
flow
through,
recirculating
and
net
pen
systems.

In
commenting
on
the
proposed
rule
and
accompanying
ICR,
OMB
questioned
the
utility
of
the
proposed
reporting
requirements
and
BMPs.
EPA
has
subsequently
collected
additional
data
and
information
that
demonstrates
the
extent
to
which
these
BMPs
are
already
in
use
at
CAAP
facilities.
EPA
has
also
evaluated
monitoring
data
which
documents
environmental
benefits
associated
with
these
practices.
The
final
reporting
and
recordkeeping
requirements
have
been
modified
to
reduce
the
burden
on
the
respondents.
EPA
considers
the
reporting
requirements
included
in
the
final
rule,
as
described
below,
necessary
to
provide
permit
authorities
with
information
to
take
action
when
warranted.

The
rule
includes
special
reporting
and
record
keeping
requirements
which
are
the
subject
of
this
Information
Collection
Request.
CAAP
facility
owners
or
operators
are
also
required
to
file
reports
with
the
permitting
authority
when
drugs
with
special
approvals
are
applied
to
the
production
units
or
a
failure
in
the
structural
integrity
occurs
in
the
aquatic
animal
containment
system.

When
CAAP
facilities
apply
either
an
Investigational
New
Animal
Drug
(
INAD)
or
a
drug
that
has
been
prescribed
extra­
label
by
a
veterinarian
to
treat
the
aquatic
animals
at
their
facility
the
owner
or
operator
must
report
this
use
to
the
permitting
authority.
In
addition,
the
owner
or
operator
of
a
CAAP
facility
must
notify
the
permitting
authority
upon
agreeing
to
participate
in
an
INAD
study.

Whenever
a
structural
failure
occurs
in
the
aquatic
animal
containment
system
the
owner
or
operator
must
report
this
to
the
permitting
authority.
For
the
purposes
of
this
requirement
the
aquatic
animal
containment
system
is
defined
as
the
unit(
s)
that
contains
the
aquatic
animals
and
in
which
their
culture
takes
place
as
well
as
the
wastewater
handling
and
treatment
units
4
associated
with
aquatic
animal
production.

CAAP
facilities
subject
to
this
regulation
are
also
required
to
develop
and
implement
a
BMP
plan
that
ensures
that
the
regulatory
requirements
will
be
met.
Upon
completion
of
this
BMP
plan
the
owner
or
operator
must
certify
to
the
permitting
authority
that
the
plan
has
been
developed.

CAAP
facilities
are
also
expected
to
keep
records
on
the
feed
inputs
along
with
an
estimate
of
the
number
and
weight
of
the
animals
being
raised.
These
records
are
to
be
used
to
calculate
the
feed
conversion
ratios
for
the
facility.
Records
must
also
be
kept
documenting
the
frequency
of
facility
inspections,
maintenance
and
repairs
along
with
the
cleaning
the
rearing
units
at
flow
through
and
recirculating
facilities
or
changing
the
nets
at
net
pen
facilities.

2.
Need
for
and
Use
of
the
Collection
a.
Need
and
Authority
for
the
Collection
The
purpose
of
the
Clean
Water
Act
(
CWA)
is
to
restore
and
maintain
the
chemical,
physical,
and
biological
integrity
of
the
Nation's
waters.
To
meet
that
end,
the
CWA
establishes
the
NPDES
program
to
regulate
the
discharge
of
any
pollutant
or
combination
of
pollutants
from
point
sources
into
waters
of
the
United
States.

EPA
is
promulgating
technology­
based
effluent
limitation
guidelines
and
standards
(
ELGs)
for
a
subset
of
CAAP
facilities
required
to
obtain
NPDES
permits.
The
requirements
in
the
ELGs
would
be
incorporated
into
the
NPDES
permits
issued
by
EPA
and
states.
EPA
and
authorized
State
permitting
authorities
already
issue
permits
to
these
facilities.

Section
308(
a)
of
the
CWA
authorizes
the
Administrator
to
require
the
owner
or
operator
of
any
point
source
to
file
reports
as
required
to
carry
out
the
objectives
of
the
Act.
This
ELG
requires
reporting
in
the
event
that
drugs
are
used
which
are
either
under
a
conditional
approval
as
an
Investigative
New
Animal
Drugs
(
INADs)
or
are
prescribed
by
a
licensed
veterinarian
for
treatment
of
a
disease
or
a
species
that
is
outside
the
approved
use
of
the
specific
drug,
referred
to
as
extra­
label
use.
EPA
believes
this
reporting
requirement
is
appropriate
for
these
classes
of
drugs,
because
they
have
not
undergone
the
same
degree
of
review
with
respect
to
their
environmental
affects
as
approved
drugs.
The
final
regulation
also
requires
reporting
when
the
facility
has
a
failure
in
the
structural
integrity
of
the
aquatic
animal
containment
systems.
EPA
believes
this
reporting
is
necessary
to
alert
the
permitting
authority
to
the
release
of
large
quantities
of
material
from
these
facilities.

Any
CAAP
facility
that
agrees
to
participate
in
an
INAD
program
is
required
to
notify
the
permitting
authority
within
7
days
of
agreeing
to
this.
Facilities
are
to
report
the
identity
of
the
INAD,
the
method
of
application,
the
dosage
and
the
disease
or
condition
it
is
intended
to
treat.
This
reporting
provides
the
permitting
authority
with
the
opportunity
to
require
some
monitoring
5
or
even
controls
on
the
discharge
of
the
wastewater
containing
these
drugs
if
they
believe
there
is
any
reason
for
concern.
It
can
also
serve
to
identify
multiple
applications
of
a
specific
extra­
label
drug
or
INAD
in
the
same
watershed
which
could
contribute
to
an
unacceptable
loading
to
that
watershed.
This
has
been
raised
as
a
concern
in
areas
where
there
are
several
CAAP
facilities
located
in
the
same
watershed.

Facilities
are
required
to
file
two
reports
to
the
permitting
authority
whenever
an
INAD
or
extra­
label
drug
is
used
at
their
facility.
The
first
report
is
an
oral
report
which
must
be
made
orally
within
7
days
of
initiating
the
use
of
an
INAD
or
extra­
label
drug.
The
owner
or
operator
shall
notify
the
permitting
authority
of
the
drug
active
ingredient
being
applied
and
the
reason
for
using
it.
The
second
report
must
be
filed
within
30
days
of
the
conclusion
of
application
of
the
drug.
This
report
must
identify
the
drug
added,
the
reason
for
treatment,
the
date(
s),
time(
s)
and
duration
of
addition,
the
total
amount
of
active
ingredient
added,
the
total
amount
of
medicated
feed
added
(
if
that
is
the
application
method)
and
the
estimated
number
of
aquatic
animals
treated
with
the
additions.

Reporting
a
failure
in
the
structural
integrity
of
the
aquatic
animal
containment
system
also
involves
making
two
reports
to
the
permitting
authority.
The
first
report
is
to
be
made
within
24
hours
of
discovery
of
the
system
failure,
and
must
provide
the
likely
cause
of
the
failure
and
an
estimate
of
the
material
released.
Seven
days
following
the
discovery
of
the
failure
the
facility
owner
or
operator
must
file
a
written
report
which
includes
all
the
same
information
that
was
included
in
the
initial
report
as
well
an
estimate
of
the
time
elapsed
until
the
failure
was
repaired
and
steps
being
taken
to
prevent
a
reoccurrence.

Failures
tend
to
be
rare,
especially
at
flow
through
and
recirculating
facilities.
However,
when
they
do
occur
they
can
have
significant
environmental
affects
including
the
discharge
of
large
quantities
of
solids,
fish
carcasses
and
live
fish.

b.
Practical
Utility
and
Uses
of
the
Information
The
information
on
the
use
of
INAD
and
extra­
label
drugs
may
be
used
to
require
action
to
prevent
or
minimize
further
discharges
of
the
drug.
Advance
notice
of
a
CAAP
facility's
participation
in
an
INAD
program
can
provide
the
permitting
authority
an
opportunity
to
obtain
information
concerning
the
affects
of
the
drug
and
determine
if
any
controls
on
the
discharge
of
the
INAD
is
warranted.
If
a
determination
is
made
to
limit
the
discharge
when
the
INAD
is
being
used
in
accordance
with
40
CFR
§
125.3,
and
122.44,
the
facility
can
subsequently
determine
how
the
limits
can
be
achieved.
Furthermore,
in
the
event
that
adverse
environmental
impacts
are
noted
resulting
from
the
use
of
an
investigational
drug,
the
permitting
authority
could
share
the
information
with
FDA.
Based
on
this
information,
FDA
could
withdraw
the
investigational
approval.

The
information
on
the
failure
of
structural
integrity
can
provide
the
permitting
authority
with
some
indication
of
pollutant
slugs
that
are
discharged
to
the
receiving
streams.
These
slugs
6
will
include
solids,
carcasses,
and
fish.
The
impact
on
the
receiving
water
can
be
severe
although
in
most
cases
brief.
In
addition
to
the
solids
loading
the
release
of
fish
from
the
CAAP
facility
may
pose
concerns
if
the
fish
being
produced
are
non­
native,
thus
the
permitting
authority
may
also
decide
to
alert
state
fish
and
game
authorities
when
non­
native
species
have
been
released.
Early
intervention
can
minimize
the
establishment
of
a
species
and
thus
avoid
the
negative
impacts
both
economic
and
environmental
associated
with
establishment
of
a
non­
native
species.

3.
Nonduplication,
Consultations,
and
Other
Collection
Criteria
a.
Nonduplication
EPA
has
examined
all
other
reporting
requirements
contained
in
the
CWA
and
40
CFR
Parts
122,
123,
124,
125,
501,
and
503.
The
Agency
has
met
with
other
Federal
Agencies
including
the
Food
and
Drug
Administration
(
FDA),
National
Marine
Fisheries
Service
(
NMFA)
of
the
Department
of
Commerce,
the
National
Invasive
Species
Council,
and
the
Animal
and
Plant
Health
Inspection
Service
(
APHIS)
of
the
Department
of
Agriculture
(
USDA).
The
Agency
has
also
consulted
with
the
following
sources
of
information
to
determine
if
available
elsewhere:

the
EPA
Information
Systems
Inventory

the
EPA
Inventory
of
Information
Collection
Requests,
and

the
Federal
Information
Locator
System.

Discussions
with
other
Federal
Agencies
did
not
identify
any
reporting
requirement
that
could
be
duplicative
with
existing
requirements.

b.
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
Public
notice
was
provided
with
the
proposed
regulation
published
on
September
12,
2002
and
a
subsequent
Notice
of
Data
Availability
(
NODA)
published
on
December
29,
2003.
EPA
received
comments
in
support
of
and
opposed
to
the
proposed
information
collection
requirements.
Questions
were
raised
about
the
exact
form
the
requirement
for
certification
of
the
BMP
plan
to
the
permitting
authority
would
take.
Several
comments
argued
that
there
is
no
need
to
report
on
the
use
of
drugs
and
chemicals
since
any
concerns
related
to
their
use
had
already
been
considered
at
the
time
they
were
approved
for
use
by
FDA.
The
same
type
of
criticism
was
made
concerning
any
requirement
to
restrict
the
culture
of
non­
native
species
because
this
was
the
jurisdiction
of
State
governments.
EPA's
response
to
these
comments
acknowledges
FDA's
authority
concerning
drug
approval
and
recognizes
that
FDA
examines
the
efficacy
of
the
drug
and
its
affect
on
human
health.
FDA
dos
conduct
an
environmental
assessment
consistent
with
NEPA
requirements,
and
thus,
does
consider
potential
environmental
impacts
associated
with
a
drug's
use
when
a
drug
is
approved.
EPA's
reporting
requirements,
however,
apply
to
INAD
and
extra­
label
drugs,
both
of
which
have
not
undergone
approval
for
the
use
being
made
of
them.
The
reporting
requirements
for
these
drugs
provide
notice
to
the
permitting
authority.
EPA
wants
to
ensure
that
permitting
authorities
are
informed
about
this
use
of
these
drugs
and
in
conjunction
7
with
this
regulation
intends
to
improve
access
to
environmental
information
concerning
the
drugs
to
assist
permit
writers
in
determining
whether
site
specific
requirements
are
warranted.
EPA
is
not
establishing
any
restrictions
specific
to
the
release
or
escape
of
non­
native
organisms.
EPA
is
requiring
CAAP
facilities
to
maintain
structural
integrity
of
the
aquatic
animal
containment
facility
which
should
avoid
release
and
escape
of
the
aquatic
animals
being
raised
at
the
facility.

Others
commented
that
EPA
was
not
requiring
facilities
to
do
enough
to
ensure
the
environment
would
be
protected
from
the
discharge
of
drugs
or
chemicals
or
the
release
of
nonnative
species.
EPA
is
not
establishing
discharge
requirements
for
drugs.
Effluent
guidelines
are
technology
based
requirements,
thus
EPA
did
evaluate
activated
carbon
filtration
technology
which
could
effectively
remove
many
drug
active
ingredients.
However,
this
technology
was
found
to
be
economically
unachievable
on
a
national
basis.
EPA
expects
there
will
be
incidental
removals
achieved
of
several
approved
aquatic
animal
drugs
through
application
of
the
solids
control
requirements
included
in
the
final
regulation.
Should
water
quality
considerations
warrant
more
stringent
controls,
the
permitting
authority
should
establish
water
quality
limits
for
the
discharge
of
drugs.

c.
Consultations
In
addition
to
the
public
comments,
EPA
met
with
several
other
Federal
Agencies
to
better
understand
their
programs
and
how
they
relate
to
EPA's
mission
of
maintaining
water
quality
and
protecting
the
environment.
EPA
met
with
representatives
of
FDA,
the
Animal
and
Plant
Health
Inspection
Service
(
APHIS)
in
USDA,
US
Fish
and
Wildlife
Service
(
USFWS)
in
the
Department
of
Interior,
and
the
National
Marine
Fisheries
Service
of
NOAA
in
the
Department
of
Commerce.
Each
of
these
Agencies
have
some
authority
over
issues
related
to
aquatic
animal
production
and
have
some
ability
to
address
environmental
concerns
related
to
this
sector.

FDA
indicated
that
they
do
not
have
authority
to
control
the
drug
residues
present
in
the
wastewater
discharges
from
CAAP
facilities
that
have
used
a
drug.
The
FDA
does
conduct
an
environmental
assessment
to
evaluate
the
potential
environmental
impacts
that
could
be
associated
with
the
use
and
release
of
the
drug
into
the
environment,
but
they
don't
necessarily
have
the
authority
to
withhold
a
drug's
approval
solely
on
the
basis
of
potential
environmental
impacts.
Further,
the
environmental
assessment
does
not
account
for
all
the
various
site­
specific
conditions
or
the
possible
cumulative
affects
when
several
facilities
use
the
same
drug
and
discharge
wastewater
into
the
same
watershed.
FDA
did
not
have
any
objections
to
EPA
including
the
reporting
requirements
for
INADs
and
extra­
label
drugs
in
the
regulation.

APHIS
is
responsible
for
tracking,
reporting
and
taking
action
when
there
are
disease
outbreaks
at
aquatic
animal
production
facilities.
Diseases
that
require
action
by
APHIS
include
those
identified
by
the
Office
International
des
Epizooties
APHIS
works
with
State
Departments
of
Agriculture
which
typically
have
the
responsibility
to
take
action
when
a
reportable
disease
is
identified
at
a
facility.
Action
can
include
confiscating
and
destroying
the
animals
and
shutting
the
facility
down
for
a
period
of
time
or
until
the
facility
can
demonstrate
that
they
are
disease
free.
8
APHIS
also
has
responsibility
for
preventing
the
entry
of
invasive
species
and
controlling
the
spread
of
established
populations
of
invasive
species.
APHIS
is
responsible
for
implementing
several
Acts
related
to
the
control
of
invasive
species
including
disease.
Since
APHIS
in
conjunction
with
State
Departments
of
Agriculture
have
considerable
authority
to
take
action
to
prevent
the
spread
of
diseases
from
aquaculture
facilities,
EPA
is
not
establishing
any
additional
requirements
specific
to
this
concern.

EPA
also
had
discussions
with
NOAA's
National
Marine
Fisheries
Service
to
discuss
their
program
to
develop
off­
shore
aquaculture.
Some
of
the
concerns
related
to
this
topic
include
the
control
of
pollutants
at
open
water
systems
and
the
potential
for
system
failure.
NOAA
believes
that
many
concerns
related
to
the
development
of
aquaculture
off­
shore
will
be
dealt
with
when
suitable
sites
are
identified
and
indicated
that
new
off­
shore
sites
would
be
subject
to
an
Environment
Impact
Statement
under
NEPA.

d.
Effects
of
Less
Frequent
Collection
EPA
requires
minimal
reporting
in
this
regulation.
Facilities
are
expected
to
certify
to
the
permitting
authority
that
they
have
developed
a
BMP
plan
only
once
over
the
course
of
the
permit
cycle
(
usually
5
years).
The
certification
itself
is
expected
to
consist
of
a
letter
that
states
that
the
BMP
plan
has
been
developed
in
accordance
with
the
requirements
of
the
regulation.

The
other
reporting
associated
with
the
use
of
drugs
or
failure
in
the
structural
integrity
are
only
required
in
the
event
one
of
these
activities
occurs.
The
reporting
itself
for
either
of
these
situations
is
minimal.
EPA
requires
an
oral
report
to
be
made
initially,
followed
by
a
more
detailed
written
report.
EPA
has
determined
less
frequent
reporting
would
impede
the
ability
of
the
permitting
authority
to
take
action
to
minimize
harm
to
the
environment
when
warranted.

E.
General
Guidelines
This
information
collection
complies
with
Paperwork
Reduction
Act
guidelines
at
5CFR
1320.5(
d)(
2).
Requests
for
supplemental
information
for
the
purposes
of
emergency
response
of
enforcement
activities
are
exempt
from
Paperwork
Reduction
Act
requirements.

f.
Confidentiality
This
information
collection
may
contain
confidential
business
information,
especially
the
reporting
requirements
associated
with
investigational
drug
use.
If
this
is
the
case,
the
respondent
may
request
that
such
information
be
treated
as
confidential.
All
confidential
data
will
be
handled
in
accordance
with
40
CFR
122.7,
40
CFR
Part
2
and
EPA's
Security
Manual,
Part
III,
Chapter
9,
dated
August
9,
1976.
However,
CWA
sec.
308(
b)
specifically
states
that
effluent
data
may
not
be
treated
as
confidential.

g.
Sensitive
Questions
9
This
information
collection
does
not
include
sensitive
questions.

4.
Respondents
and
Information
Requested
a.
Respondents/
NAICS
Codes
The
NAICS
codes
that
apply
to
the
CAAP
facilities
included
in
EPA's
proposed
regulation
are
listed
on
Table
X.

Table
X.
NAICS
Codes
Examples
of
Regulated
Entities
include
facilities
engaged
in
aquatic
animal
production
Primary
NAICS
Codes
Finfish
Farming
and
Fish
Hatcheries
112511
Other
Animal
Aquaculture
112519
Not
all
facilities
classified
in
these
two
NAICS
codes
will
be
subject
to
the
reporting
requirements
included
in
this
request.
Prior
rulemaking
has
established
a
subset
of
facilities
engaged
in
aquatic
animal
production
as
concentrated
aquatic
animal
production
facilities
and
by
definition
these
facilities
must
obtain
an
NPDES
permit.
The
definition
of
CAAP
can
be
found
at
40CFR122.24
and
Appendix
C
of
40CFR
Part
122.
The
final
action
subject
to
this
ICR
in
turn
only
applies
to
a
subset
of
CAAP
facilities.
These
facilities
are
defined
in
the
applicability
of
the
final
rule
at
40CFR451.
EPA
estimates
that
242
facilities
will
be
subject
to
these
requirements.

Not
all
of
the
242
regulated
facilities
will
be
subject
to
all
of
the
reporting
requirements
included
in
the
final
rule.
Many
of
the
reporting
requirements
apply
only
when
certain
events
or
conditions
exist
at
the
facility.
EPA
does
not
expect
all
facilities
will
experience
these
conditions
or
events
annually
and
thus
will
not
incur
the
burden
or
cost
associated
with
the
reporting
requirements.

b.
Information
Requested
This
section
presents
the
data
items,
including
record
keeping
requirements
and
required
respondent
activities
in
preparing
and
submitting
those
data
items.

Data
Items,
Including
Reporting
and
Recordkeeping
Requirements
EPA
is
establishing
reporting
and
recordkeeping
requirements
to
ensure
that
the
facility
is
implementing
BMPs
and
to
report
on
the
use
of
certain
classes
of
drugs
and
any
failures
to
the
structural
integrity
of
the
rearing
units,
net
pens
or
wastewater
treatment
structures.
EPA
is
also
establishing
requirements
for
facilities
to
perform
feed
monitoring
at
net
pen
facilities
which
can
include
the
use
of
real­
time
monitoring
systems
such
as
video
monitoring,
the
use
of
sediment
10
sampling,
benthic
monitoring
or
devices
designed
to
capture
solids
that
have
fallen
beneath
the
nets.
Finally,
EPA
is
requiring
facilities
to
maintain
records
on
the
feed
added,
the
number
and
weight
of
the
animals
being
raised
as
well
as
records
on
the
frequency
of
inspections,
maintenance
and
repairs
to
the
facility
aquatic
animal
containment
system.
Also
the
regulation
requires
facilities
keep
records
on
the
frequency
that
the
rearing
units
at
flow
through
and
recirculating
facilities
are
cleaned
or
nets
are
changed
at
net
pen
facilities.

EPA
is
establishing
reporting
requirements
associated
with
the
application
of
Investigative
New
Animal
Drugs
(
INAD)
and
extra­
label
drugs.
When
a
CAAP
facility
agrees
to
participate
in
an
INAD
program
EPA
is
requiring
the
owner
or
operator
to
notify
the
permitting
authority
in
writing
within
7
days
of
the
date
that
the
facility
signed
up
to
participate
in
this
program
The
report
would
include
the
name
of
the
INAD,
the
method
of
application,
the
dosage
and
the
disease
or
condition
it
is
intended
to
treat.
Reporting
is
not
required
if
the
INAD
or
extralabel
drug
use
does
not
exceed
the
approved
dosage
for
the
same
drug
in
used
under
similar
conditions.
When
an
INAD
or
extra­
label
drug
that
does
not
meet
the
exception
is
used
at
a
CAAP
facility
the
owner
or
operator
must
file
two
reports
with
the
permitting
authority
concerning
this
use.
The
first
report
is
made
orally
and
must
be
made
no
later
than
7
days
after
initiating
treatment.
The
facility
owner
or
operator
must
notify
the
permitting
authority
that
either
an
INAD
or
extralabel
drug
application
is
occurring
at
the
facility.
The
report
must
identify
the
drug
and
the
reason
for
its
addition.

The
second
report
is
a
written
report
which
must
be
provided
to
the
permitting
authority
within
30
days
of
concluding
treatment.
The
written
report
must
include
the
identity
of
the
drug,
the
reason
for
treatment,
the
date(
s),
time(
s)
and
duration
of
the
treatment,
the
total
amount
of
active
ingredient
added,
or
the
total
amount
of
medicated
feed
added
when
this
is
the
method
of
application
and
the
estimated
number
of
animals
treated.

FDA's
Center
for
Veterinary
Medicine
(
CVM)
under
the
authority
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
approves
drugs
to
treat
specific
diseases
in
specific
species
of
aquatic
animals.
FDA
also
issues
exemptions
of
approval
for
Investigative
New
Animal
Drugs
that
can
be
used
to
treat
specific
diseases
in
specific
species.
As
part
of
the
evaluation
of
a
drug
for
its
approval
FDA
is
required
to
conduct
an
environmental
assessment.
Thus,
approved
drugs
have
been
studied
for
the
potential
affect
their
use
would
have
on
the
environment.
Although
FFDCA
does
not
provide
FDA
the
authority
to
disapprove
a
drug
solely
on
the
basis
of
environmental
concerns,
the
environmental
assessment
information
is
publicly
available
and
can
be
accessed
by
permit
writers
or
producers
allowing
them
to
take
action
as
needed
on
a
case­
by­
case
basis
to
protect
the
environment
should
residual
drug
active
ingredient
be
discharged
from
the
facility
in
levels
which
pose
environmental
concern.

The
FFDCA
authorizes
veterinarians
to
prescribe
drugs
which
have
been
approved
for
treating
humans
or
animals
of
a
different
species
or
to
treat
a
different
condition.
Veterinarians
prescribe
extra­
label
drugs
when
the
animals
health
is
suffering
or
threatened
however
the
treatment
may
not
result
in
a
violative
food
residue.
11
INADs
and
extra­
label
drugs
used
at
dosages
which
exceed
approved
dosage
and
under
different
conditions
have
not
undergone
the
same
degree
of
scrutiny
for
their
environmental
affects.
Therefore,
EPA
believes
it
is
appropriate
to
establish
requirements
for
CAAP
facility
owners
or
operators
to
report
to
the
permitting
authority
when
these
classes
of
drugs
are
being
used
at
their
facilities.

EPA
is
requiring
facilities
to
report
to
the
permitting
authority
any
time
the
facility
experiences
a
failure
or
damage
to
the
aquatic
animal
containment
system
resulting
in
a
material
discharge
to
waters
of
the
U.
S.
The
aquatic
animal
containment
system
is
defined
as
the
culture
or
rearing
unit
including
raceways,
ponds,
tanks
or
nets
used
to
contain,
hold
or
produce
aquatic
animals.
The
containment
system
also
includes
structures
designed
to
hold
sediments
and
other
materials
as
part
of
the
wastewater
treatment
system.
For
net
pen
systems,
failures
include
physical
damage
to
the
predator
control
nets
or
the
nets
containing
the
aquatic
animals,
which
result
in
a
discharge
of
the
contents
of
the
nets.
Physical
damage
includes
abrasion,
cutting
or
tearing
of
the
nets
and
breakdown
of
the
netting
due
to
rot
or
ultra
violet
exposure.
For
flow
through
and
recirculating
systems,
a
failure
includes
a
collapse
or
damage
of
a
rearing
unit
or
wastewater
treatment
structure;
damage
to
pipes,
valves,
and
other
plumbing
fixtures;
and
damage
or
malfunction
to
screens
or
physical
barriers
in
the
system,
which
would
prevent
the
unit
from
containing
water,
sediment,
and
the
aquatic
animals.
Because
the
determination
of
what
constitutes
damage
resulting
in
a
"
material"
discharge
varies
from
one
facility
to
the
next,
permitting
authorities
are
encouraged
to
include
more
specific
reporting
requirements
defining
these
terms
in
the
permit.
Such
conditions
might
recognize
variations
in
production
system
type
and
environmental
vulnerability
of
the
receiving
waters.
A
failure
of
the
containment
system
that
results
in
a
material
discharge
must
be
reported
within
24
hours
of
discovery
of
the
failure.
This
report
would
be
made
orally
to
the
permitting
authority
and
would
describe
the
cause
of
the
failure
in
the
containment
system
and
identify
materials
that
may
have
likely
been
released
to
the
environment
as
a
result
of
this
failure.
The
facility
would
also
be
required
to
provide
a
written
report
within
seven
days
of
discovery
of
the
failure
documenting
the
cause,
the
estimated
time
elapsed
until
the
failure
was
repaired,
an
estimate
of
the
material
released
as
a
result
of
the
failure,
and
steps
being
taken
to
prevent
a
reoccurrence.

EPA
is
requiring
reporting
of
failures
and
damage
that
lead
to
a
material
discharge
to
ensure
that
permitting
authorities
are
alerted
to
the
release
of
significant
pollutant
loads
over
a
relatively
short
time
frame.
EPA
does
not
expect
this
type
of
failure
to
occur
very
frequently
at
flow
through
and
recirculating
facilities,
although
there
is
one
known
flow
through
facility
that
experienced
failures
resulting
in
the
discharge
of
thousands
of
yards
of
sediment
polluting
the
receiving
stream.
EPA
anticipates
that
there
will
be
a
greater
number
of
these
events
occurring
at
net
pen
facilities.
The
location
of
these
facilities
in
open
water
makes
them
vulnerable
to
damage
from
predators
and
accidents.
Failures
at
net
pen
facilities
have
the
potential
to
release
the
contents
of
the
nets
including
fish
and
fish
carcasses.

EPA
is
including
requirements
that
address
the
structural
maintenance
of
the
aquatic
animal
containment
system
and
is
including
a
requirement
that
facilities
keep
records
on
the
12
frequency
of
inspections,
maintenance
and
repairs
to
the
facility
to
avoid
structural
failures.
The
type
of
records
this
requirement
might
include
would
be
a
log
of
dates
when
inspections
occur
and
brief
notations
when
something
is
found.
Also
records
would
be
kept
on
maintenance
and
repair
activities
including
the
date
and
the
actions
taken.

EPA
is
requiring
reporting
of
any
spills
of
drugs,
pesticides
or
feed
that
results
in
a
discharge
to
waters
of
the
U.
S.
The
regulation
requires
CAAP
facilities
to
ensure
proper
storage
of
these
materials
and
to
implement
procedures
for
properly
containing,
cleaning
and
disposing
of
any
spilled
material.
Therefore,
the
occurrence
of
spills
should
be
minimal.
Since
the
facility
is
operating
in
an
aquatic
environment,
it
would
not
be
difficult
for
any
spill
to
result
in
a
pollutant
discharge.
Therefore,
EPA
believes
this
reporting
requirement
is
important
to
notify
permit
writers
of
the
potential
for
environmental
effects
in
the
receiving
stream.

The
ELG
for
the
CAAP
category
is
based
on
requirements
to
reduce
the
discharge
of
solids,
avoid
spills
of
materials,
and
ensure
the
facility
is
being
properly
operated
and
maintained
through
implementing
BMPs.
Each
of
these
requirements
is
based
on
the
presumption
that
the
CAAP
facilities
will
achieve
compliance
by
implementing
BMPs.
EPA
is
requiring
CAAP
facilities
to
develop
a
BMP
plan
which
identifies
the
BMPs
and
documents
any
associated
activities
such
as
recordkeeping,
and
training
associated
with
the
BMPs.
The
Plan
will
be
maintained
at
the
CAAP
facility,
but
must
be
made
available
to
the
permitting
authority
upon
request.
EPA
is
also
requiring
that
CAAP
facilities
certify
in
writing
to
the
permitting
authority
once
upon
issuance
of
a
permit
that
the
BMP
plan
has
been
developed.

In
addition
to
the
recordkeeping
described
above
related
to
the
inspections,
maintenance
and
repair
of
the
facility,
EPA
is
also
requiring
CAAP
facilities
to
keep
records
on
the
amount
of
feed
added
to
each
rearing
unit
along
with
an
estimate
of
the
number
of
animals
contained
in
the
unit
and
the
weight
of
the
animals.
From
these
records
the
facility
should
calculate
a
representative
feed
conversion
ratio
for
the
animals
produced
at
the
facility.
EPA
also
requires
CAAP
facilities
to
keep
records
on
the
frequency
of
cleaning
the
rearing
units
and
changing
the
nets
at
net
pen
facilities.

Respondent
Activities
All
facilities
subject
to
this
regulation
will
be
required
to
develop,
and
implement
BMPs
which
address
a
variety
of
aspects
at
their
facility.
These
BMPs
must
also
be
documented
into
a
BMP
plan
and
a
letter
certifying
that
the
Plan
has
been
developed
must
be
sent
to
the
permitting
authority.
EPA
estimates
that
these
activities
will
require
49
hours
to
accomplish.
This
activity
is
expected
to
be
done
once
over
the
term
of
the
permit
which
is
typically
five
years.
Thus
the
annual
estimated
burden
pro­
rated
across
the
five
year
permit
term
is
10
hours
per
year.

The
number
of
facilities
that
reported
participating
in
INAD
programs
in
response
to
EPA's
detailed
survey
indicates
that
there
would
likely
be
less
than
20
facilities
annually
affected
by
EPA's
INAD
or
extra­
label
reporting
requirement.
The
rule
specifies
that
facilities
report
13
when
an
INAD
and
extralabel
drug
is
used
and
they
would
file
less
than
40
reports
on
the
use
of
an
INAD
or
extra­
label
drug
in
any
given
year.
All
of
the
facilities
that
reported
participation
in
an
INAD
study
were
non­
commercial
facilities
that
were
either
State
or
Federal
hatcheries.
EPA's
data
do
not
provide
the
details
on
the
use
of
extra­
label
drugs
at
CAAP
facilities.
Thus,
EPA
is
making
an
assumption
that
facilities
will
use
either
extra­
label
or
INAD
drugs
in
any
given
year
and
the
number
of
applications
requiring
reporting
will
be
less
than
40.
EPA
is
assuming
that
the
facilities
that
will
apply
extra­
label
drugs
will
not
be
just
non­
commercial
facilities.
The
number
of
commercial
facilities
is
likely
to
be
substantially
smaller
than
non­
commercial
facilities
in
part
due
to
withdrawal
concerns.

The
burden
associated
with
reporting
for
INADs
and
extra­
label
drugs
will
include
an
hour
of
a
manager's
time
to
prepare
and
mail
a
letter
notifying
the
permitting
authority
that
the
facility
is
participating
in
an
INAD
study.
EPA
estimates
that
a
manager
will
spend
half
an
hour
filing
the
oral
report
on
either
INAD
or
extra­
label
drug
use
and
subsequently
an
additional
hour
writing
the
letter
that
notifies
the
permitting
authority
when
the
treatment
is
concluded.
EPA
also
anticipates
that
unskilled
labor
will
spend
some
time
keeping
records
throughout
the
application
of
the
drug.
This
data
will
be
used
by
the
manager
in
the
written
report.
However,
EPA
expects
that
this
staff
will
also
be
doing
these
activities
to
respond
to
requirements
of
the
INAD
agreement
or
simply
for
the
purposes
of
good
husbandry
in
the
case
of
extra­
label
drug
applications.

EPA
assumes
that
few
flow
through
and
recirculating
facilities
will
experience
structural
failures
in
their
aquatic
animal
containment
systems.
This
is
in
part
based
on
the
very
small
number
of
facilities
that
EPA
is
aware
of
that
have
experienced
such
failures
in
the
past.
EPA
is
estimating
that
5
facilities
will
experience
a
reportable
failure
each
year.
Failures
are
unlikely
to
affect
only
non­
commercial
or
commercial
facilities,
thus
EPA
is
assuming
that
the
failures
will
be
distributed
between
non­
commercial
and
commercial
facilities.
Net
pen
facilities
are
expected
to
experience
reportable
failures
at
a
much
higher
rate
due
to
the
inherent
vulnerabilities
of
the
system.
EPA
is
assuming
that
each
net
pen
facility
will
have
one
reportable
failure
each
year.

Failures
can
be
minimized
through
frequent
inspection
of
the
rearing
units
and
wastewater
treatment
system
and
prompt
repair
of
any
damage
identified.
EPA
is
requiring
that
facilities
keep
records
on
the
frequency
of
the
inspections
and
any
repairs
and
maintenance
activities
performed.
EPA
assumes
the
inspections
will
be
performed
by
each
facility
once
per
week
while
production
is
occurring.
For
the
flow
through
and
recirculating
facilities,
EPA
believes
that
inspections
would
occur
on
each
rearing
unit
and
wastewater
treatment
structure
taking
approximately
5
minutes
per
unit.
Net
pen
inspections
require
divers
to
inspect
the
facility
underwater.
Based
on
available
information,
all
net
pen
facilities
are
believed
to
be
currently
conducting
these
inspections
on
a
regular
basis,
and
these
inspections
are
assumed
to
continue
at
the
same
frequency.

Reporting
of
spilled
drugs,
pesticides
or
feed
that
result
in
a
discharge
to
waters
of
the
U.
S.,
must
be
reported
orally
to
the
permitting
authority
within
24
hours
of
occurrence,
followed
by
a
written
report
within
7
days.
The
report
must
identify
the
material
spilled
and
an
estimated
14
amount.
EPA
does
not
expect
spills
will
occur
very
often,
since
facilities
are
required
to
implement
proper
storage
and
implement
procedures
for
proper
cleaning,
containing
and
disposing
of
the
spilled
material.
Again
for
the
purpose
of
estimating
the
burden,
EPA
is
assuming
that
a
more
net
pen
facilities
will
experience
a
spill
in
any
given
year,
and
noncommercial
flow
through
and
recirculating
facilities
may
experience
a
slightly
higher
rate
of
spills,
since
they
tend
to
report
a
higher
rate
of
drug
and
pesticide
use.

Other
recordkeeping
required
by
the
CAAP
regulation
involves
recording
the
amount
of
feed
added
to
each
rearing
unit
and
tracking
the
number
of
animals
and
the
weight
of
the
animals
contained
in
the
rearing
unit.
The
feed
inputs
are
assumed
to
be
tracked
on
a
weekly
basis
during
periods
when
feeding
occurs.
The
number
of
animals
and
weight
of
the
animals
will
be
tracked
less
frequently.
Animal
numbers
can
be
estimated
using
the
approximate
number
added
to
the
unit
when
stocking
occurred
less
the
mortalities
removed
from
the
unit
over
time.
The
weight
can
be
measured
at
the
time
of
harvest.
These
values
in
aggregate
by
facility
or
by
species
shall
be
used
to
calculate
a
representative
feed
conversion
ratio.
The
feed
conversion
ratio
presents
the
proportion
of
feed
provided
in
relation
to
the
amount
of
weight
gained.
These
records
shall
be
maintained
at
the
facility
and
provided
to
the
permitting
authority
when
requested
or
made
available
to
inspectors.
The
facility
owner
or
operator
should
also
use
this
data
to
evaluate
whether
the
feeding
regime
is
achieving
the
intended
results.

EPA
is
also
including
a
requirement
that
all
net
pen
facilities
conduct
some
form
of
feed
monitoring.
This
monitoring
can
be
in
the
form
of
real­
time
monitoring
such
as
video
monitoring
to
observe
feed
passing
beneath
the
net,
sediment
or
benthic
sampling,
and
physical
devices
designed
to
capture
uneaten
feed
that
passes
below
the
net
or
other
good
husbandry
practice
that
is
approved
by
the
permit
authority.
The
objective
of
this
requirement
is
to
minimize
the
discharge
of
uneaten
feed
from
the
net
pen
system.
Based
on
available
information
and
existing
permits,
all
existing
net
pen
facilities
are
currently
using
one
of
these
techniques
to
minimize
the
discharge
of
uneaten
feed.

5.
Information
Collected:
Agency
Activities,
Collection
Methodology,
and
Information
Management
a.
Agency
Activities
The
Agency's
activities
as
the
NPDES
permitting
authority
for
five
States
and
all
U.
S.
territories
except
the
Virgin
Islands
are
exactly
the
same
for
the
45
NPDES
authorized
States
and
the
Virgin
Islands
and
consists
of
processing
and
reviewing
permit
applications,
and
Notices
of
Intent
(
NOIs).
Permit
authorities
will
also
process
certifications
that
BMP
plans
have
been
developed
and
document
receipt
of
oral
and
written
reports
filed
by
the
permittees
concerning
INAD
and
extra­
label
drugs,
and
the
failure
of
aquatic
animal
containment
structures.

b.
Collection
Methodology
and
Management
15
Each
of
the
NPDES
permitting
authorities
will
have
the
ability
to
access
the
information
kept
by
the
owners
or
operators
at
the
CAAP
facilities.
In
addition,
the
permitting
authorities
will
maintain
records
of
reports
made
under
the
Special
Reporting
Requirements
described
above.
This
data
may
be
made
available
to
the
public
consistent
with
EPA's
regulations
concerning
the
protection
of
Confidential
Business
Information
(
CBI)
(
40
CFR
Part
2).

INADs
can
be
considered
CBI
during
the
investigative
studies.
Reports
required
to
be
filed
with
the
permitting
authority
under
this
regulation
that
contain
CBI
should
be
clearly
marked
and
should
be
handled
by
the
permitting
authority
in
accordance
with
40
CFR
Part
2.

c.
Small
Entity
Flexibility
For
the
proposed
rule,
EPA
conducted
analyses
required
by
the
Regulatory
Flexibility
Act
of
1980
(
RFA)
as
amended
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA).
See
section
XIII.
B.
of
the
preamble
in
the
proposed
rule
for
a
summary
of
these
analyses.

EPA
believes
the
burden
on
small
facilities
is
minimal
since
reporting
is
only
linked
with
specific
conditions
or
occurrences
at
the
facility.

d.
Collection
Schedule
The
regulation
requires
the
development
of
a
BMP
plan
to
assist
in
compliance
with
the
requirements
along
with
a
certification
to
the
effect
that
a
BMP
plan
has
been
developed.
These
activities
will
occur
upon
coverage
under
an
NPDES
permit
that
incorporates
this
regulation.
This
BMP
plan
must
be
completed
and
certification
filed
once
during
the
term
of
the
NPDES
permit.
Reporting
requirements
associated
with
INAD
and
extra­
label
drugs
are
related
to
specific
events.
Likewise
the
reporting
associated
with
an
aquatic
animal
containment
system
failure
is
linked
to
a
specific
event.
The
reporting
requirements
do
have
a
related
time
frame
on
which
the
report
must
be
filed.
INAD
study
participation
must
be
reported
within
7
days
after
agreeing
to
participate
in
an
INAD
study
or
initiating
the
use
of
an
INAD
or
extra­
label
drug
chemical.
In
conjunction
with
the
use
of
the
INAD
or
extra­
label
drug
a
written
report
must
follow
the
initial
oral
report
within
30
days
of
initiation
the
use.
Likewise
reporting
associated
with
a
failure
damage
resulting
in
a
material
discharge
must
be
made
orally
within
24
hours
of
discovery
followed
by
a
written
report
within
7
days
of
the
event.
EPA
considers
this
collection
schedule
to
be
reasonable.
The
certification
of
the
BMP
plan
should
be
a
straightforward
document,
most
likely
taking
the
form
of
a
letter
from
the
owner
or
operator
at
the
CAAP
facility
addressed
to
the
permitting
authority.
This
letter
need
only
be
submitted
once
for
each
permit
cycle
which
is
typically
5
years.
Likewise
the
effort
associated
with
developing
the
BMP
plan
is
expected
to
be
expended
once
during
the
permit
cycle.

The
reporting
of
participation
in
an
INAD
program
is
required
to
occur
within
7
days
of
agreeing
to
participate
in
the
program.
This
time
lapse
provides
the
CAAP
owner
or
operator
16
ample
time
to
assemble
the
required
information
and
prepare
a
letter
that
will
serve
to
notify
the
permitting
authority.
Facilities
are
generally
not
expected
to
require
the
application
of
the
INAD
immediately,
however,
if
agreeing
to
participate
in
the
INAD
program
coincides
with
use
of
the
INAD,
the
facility
would
report
consistent
with
the
use
reporting
requirements.
INAD
and
extralabel
drug
use
reporting
requires
that
an
oral
report
be
filed
as
soon
as
possible,
but
no
later
than
7
days
after
beginning
treatment.
EPA
recognizes
that
facility
owners
and
operators
will
be
focusing
on
the
health
and
welfare
of
the
aquatic
animals
being
treated
and
thus
may
not
be
able
to
file
a
report
immediately,
however,
within
the
first
7
days
of
treatment,
the
owner
or
operator
can
provide
an
oral
report.

The
written
report
related
to
the
use
of
INAD
or
extra­
label
drugs
must
be
filed
within
30
days
following
completion
of
the
treatment.
EPA
does
not
expect
this
time
period
will
impose
any
hardship
on
facilities
to
compile
the
required
information
into
a
letter
that
can
be
sent
to
the
permitting
authority.

The
occurrence
of
a
failure
in
the
aquatic
animal
containment
system
must
be
reported
orally
through
a
phone
call
to
the
permitting
authority
within
24
hours
of
discovery.
The
urgency
associated
with
this
reporting
is
to
allow
the
permitting
authority
to
take
rapid
action
to
mitigate
any
harmful
affects
that
could
occur
as
a
result
of
the
failure's
releasing
pollutant
slugs
into
the
receiving
stream.
The
subsequent
written
report
describing
the
failure
and
steps
taken
to
prevent
its
reoccurrence
among
other
things,
is
due
within
7
days
of
discovering
the
failure.
EPA
expects
that
operators
will
be
busy
taking
steps
to
address
the
failure,
but
also
believes
filing
a
prompt
report
will
ensure
that
the
facility
is
actively
addressing
the
causes
and
looking
for
ways
to
prevent
reoccurrences
to
the
extent
possible.

Spills
of
drugs,
pesticides
and
feed
that
result
in
a
discharge
to
waters
of
the
U.
S.,
must
be
reported
orally
to
the
permitting
authority
within
24
hours
of
occurrence.
A
written
report
must
be
submitted
within
7
days.
The
report
must
identify
the
material
that
spilled
and
an
estimated
amount.

e.
Information
Management
Permitting
Authorities
will
keep
the
written
reports
received
through
this
regulation
in
the
permit
file.
The
information
may
be
made
available
to
the
public
unless
it
is
subject
to
a
claim
of
CBI.
EPA
anticipates
that
there
may
be
such
claims
attached
to
reports
related
to
the
participation
or
use
of
INADs.

The
permitting
authority
may
refer
to
these
reports
in
the
event
that
subsequent
reports
are
filed.
For
example,
previous
reports
of
failures
may
be
reviewed
upon
oral
notification
of
a
failure.
If
the
permitting
authority
determines
that
sufficient
steps
may
not
have
been
taken
to
avoid
further
failures
from
occurring
the
authority
may
require
the
facility
to
take
specific
actions.
17
Upon
receipt
of
a
report
notifying
participation
in
an
INAD
program,
the
permitting
authority
may
choose
to
gather
information
on
the
potential
environmental
affects
of
the
INAD.
EPA
anticipates
that
this
could
involve
some
combination
of
web
searching,
contacts
with
the
FDA
and
academics
and
contacts
with
the
EPA
regional
office
or
Headquarters.
Based
on
findings
from
this
research
the
permitting
authority
may
choose
to
establish
site­
specific
controls
for
the
discharge
when
the
INAD
is
being
used.

Upon
receipt
of
the
oral
report
notifying
the
use
of
an
INAD
or
extra­
label
drug,
the
permitting
authority
may
gather
the
same
type
of
information
described
above
from
the
same
source's.
It
is
unlikely
that
this
information
would
be
used
to
control
that
occurrence
of
the
drugs
use,
but
it
could
lead
to
discharge
requirements
for
any
following
use
of
that
drug.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
In
this
section
EPA
presents
estimated
burden
on
the
CAAP
facilities
and
NPDES
Authorized
States
based
on
the
requirements
included
in
the
final
regulation.
In
most
cases
the
total
burden
per
activity
is
estimated
on
an
annual
basis
and
then
multiplied
by
three
to
derive
the
total
burden
associated
with
this
ICR.
There
are
some
requirements
in
the
effluent
guidelines
regulation
that
are
expected
to
occur
only
once
during
the
permit
cycle
which
is
typically
five
years
long.
The
burden
estimate
for
these
requirements
is
estimated
based
on
the
time
required
to
accomplish
the
activity
divided
by
five
to
provide
an
annual
estimated
burden.

a.
Estimating
Respondent
Burden
There
are
requirements
which
will
affect
all
CAAP
facilities
subject
to
this
effluent
guidelines
regulation,
which
is
an
estimated
population
of
242
facilities.
The
requirements
include
the
identification
of
best
management
practices,
their
incorporation
into
a
BMP
plan
and
the
certification
made
to
the
permitting
authority
that
the
plan
has
been
developed
and
is
being
implemented.

Other
requirements
will
affect
CAAP
facilities
dependent
on
circumstances
or
the
conditions
at
the
facility.
CAAP
facilities
are
required
to
report
a
failure
or
damage
to
the
aquatic
animal
containment
system
which
result
in
a
material
discharge
of
pollutants
to
waters
of
the
U.
S.
Permit
authorities
should
specify
what
constitutes
damage
resulting
in
a
material
discharge
to
waters
of
the
US
when
they
issue
the
permits.
These
determinations
should
take
into
consideration
factors
such
as
the
production
system
type,
sensitivity
of
the
receiving
waters
and
other
relevant
factors.
For
example,
the
requirement
to
report
a
failure
or
damage
in
the
containment
system
is
more
likely
to
affect
facilities
which
are
located
in
open
water
such
as
net
pens
systems.
These
facilities
are
more
vulnerable
to
containment
system
failure
due
to
weather
related
events,
man­
made
accidents,
or
predator
activity.
Therefore,
EPA
has
distinguished
the
burden
imposed
on
this
category
of
facilities
separately
from
land­
based
facilities.

The
tables
presented
below
under
section
d.
provide
the
burden
and
cost
associated
with
18
the
regulation.
The
tables
present
the
information
over
three
tables,
Tables
6­
1
through
6­
3.
EPA
has
estimated
a
separate
burden
and
cost
associated
with
the
two
subcategories,
the
flow
through
and
recirculating
subcategory
and
the
net
pen
subcategory.
Although
both
subcategories
have
essentially
the
same
requirements
under
the
rule,
the
frequency
of
reporting
for
some
of
the
requirements
is
likely
to
be
different.
EPA
is
also
subdividing
the
estimated
burden
for
the
flow
through
and
recirculating
facilities
into
two
tables,
one
table
(
Table
6­
1)
presents
the
burden
and
costs
for
commercial
flow
through
and
recirculating
facilities,
the
second
(
Table
6­
2)
presents
the
burden
and
costs
for
non­
commercial
facilities.
Commercial
facilities
are
those
which
raise
aquatic
animals
for
sale,
the
non­
commercial
facilities
are
mostly
state
or
federal
facilities
and
are
raising
the
animals
for
the
purpose
of
stocking
and
enhancement
of
wild
populations.
The
two
types
of
facilities
are
presented
separately
because
the
frequency
of
reporting
is
likely
to
be
different
for
some
of
the
reporting
and
because
the
labor
rates
of
the
two
types
of
facilities
is
very
different.
Non­
commercial
facilities
are
actively
engaged
in
the
INAD
programs
through
the
US
Fish
and
Wildlife
Service
who
is
has
been
a
sponsor
of
INAD
drug
products.
Other
noncommercial
facilities
are
invited
to
participate
in
these
INAD
programs
and
several
facilities
reported
to
EPA
in
the
detailed
surveys
that
they
have
used
INADs
at
their
facilities.
This
appears
to
be
much
less
prevalent
at
commercial
facilities
although
there
have
been
INAD
programs
that
have
been
focused
on
commercial
producers.

b.
Estimating
Respondent
Costs
EPA
has
estimated
costs
associated
with
the
time
required
to
comply
with
this
regulation.
Since
the
regulation
is
based
on
the
compliance
with
narrative
effluent
standards
which
are
based
on
the
implementation
of
BMPs
rather
than
wastewater
treatment
technologies,
there
is
no
capital
and
operation
and
maintenance
costs
associated
with
this
rulemaking.
EPA
used
the
annual
estimated
hours
required
to
respond
to
the
various
requirements
and
multiplied
these
costs
by
a
national
average
labor
rate
according
to
labor
classification,
management
or
labor.
EPA
also
distinguishes
between
commercial
facilities
and
public
facilities
in
the
estimation
of
the
costs
associated
with
the
information
collection.
Public
facilities
are
subject
to
public
sector
wage
schedules,
the
costs
to
private,
commercial
facilities
was
estimated
based
on
the
information
reported
by
respondents
to
the
detailed
surveys
and
data
included
in
the
comments
on
the
proposed
regulation.
The
costs
presented
in
this
request
are
calculated
using
national
average
hourly
rates,
however,
the
costs
estimated
for
the
purpose
of
assessing
economic
impact
were
based
on
more
regionally
appropriate
wages
when
available.
EPA
received
wage
information
from
CAAP
facilities
in
the
detailed
surveys.

In
two
instances
EPA
has
estimated
the
costs
associated
with
the
requirements
based
on
a
more
regionally
specific
labor
rate.
As
described
above,
net
pen
facilities
are
more
vulnerable
to
system
failures
resulting
in
the
release
of
large
numbers
of
fish
which
are
potentially
non­
native
species.
Thus
for
net
pen
facilities
a
different
reporting
frequency
is
assumed
for
the
reporting
of
the
failure
of
the
aquatic
animal
containment
system.
Net
pen
facilities
are
presently
located
in
the
Northeast
and
Northwest
coastal
waters.
Thus
an
average
labor
rates
reported
in
survey
responses
for
these
two
regions
was
used
to
estimate
the
costs
associated
with
this
requirement.
19
The
same
average
labor
rate
used
to
calculate
costs
for
reporting
non­
native
releases
was
also
used
to
estimate
the
costs
for
the
burden
associated
with
active
feed
monitoring.

The
costs
associated
with
the
structural
failure
reporting
at
flow
through
and
recirculating
CAAP
facilities
are
derived
using
a
national
average
hourly
rate
which
excludes
the
rate
associated
with
net
pen
facilities.

c.
Estimating
Agency
Burden
and
Cost
Burden
on
NPDES
Authorized
States
EPA
estimated
the
burden
for
State
permit
writers
for
the
specific
actions
related
to
the
Alternate
Compliance
Provision
provided
in
the
final
regulation.

All
CAAP
facilities
subject
to
the
Effluent
Guidelines
Regulations
would
be
required
to
develop
and
implement
a
BMP
plan
that
addresses
specific
aspects
of
the
facility.
Facility
owners
or
operators
are
required
to
certify
to
the
permitting
authority
that
the
BMP
plan
has
been
developed
and
is
being
implemented.
As
described
elsewhere
in
this
request,
EPA
assumes
this
certification
will
take
the
form
of
a
letter
addressed
to
the
permitting
authority.
EPA
estimates
that
the
permitting
authorities
will
spend
approximately
20
minutes
per
certification,
reading
over
the
letter
and
filing
it
with
the
facility's
permit
file.
This
certification
will
be
filed
once
in
the
permit
term
of
five
years.
Thus
the
annual
burden
on
the
permitting
authority
per
permitted
facility
is
less
than
one
tenth
of
an
hour.

CAAP
facilities
are
required
to
file
reports
in
conjunction
with
specific
events
at
their
facilities.
When
animals
are
treated
with
a
drug
or
chemical
either
under
a
investigative
approval
from
FDA
(
Investigative
New
Animal
Drug)
or
at
the
direction
of
a
licensed
veterinarian,
the
facility
owner
or
operator
is
required
to
report
it
to
the
permitting
authority.
Related
to
the
use
of
an
INAD
or
extra­
label
drug,
the
owner
or
operator
must
provide
an
oral
report
and
a
written
report.
The
intended
purpose
of
these
reports
is
to
provide
the
permitting
authority
with
the
necessary
information
to
make
decisions
on
the
potential
impact
these
drugs
and
chemicals
may
have
on
the
receiving
stream
and
to
determine
the
need
for
effluent
monitoring
or
controls
associated
with
the
use
of
these
drugs
or
chemicals.
Based
on
the
reports
of
INAD
or
extra­
label
drug
use
reported
in
the
responses
to
the
detailed
survey
of
CAAP
facilities,
EPA
assumes
based
on
responses
to
the
detailed
surveys
that
most
of
the
INAD
applications
will
be
of
the
same
drug
for
repeated
treatments
or
will
be
extra­
label
treatments
with
drugs
which
are
already
widely
used
for
other
applications.
EPA
anticipates
that
permitting
authorities
will
spend
a
minimum
of
two
hours
researching
the
potential
environmental
effects
of
the
drugs
being
reported.
If
there
is
some
concern
that
warrants
further
research
and
the
establishment
of
some
effluent
controls
the
permitting
authority
may
spend
as
much
as
an
additional
8
hours.
For
the
purpose
of
this
ICR,
EPA
is
assuming
an
average
of
3
hours
to
conduct
research
and
an
additional
3
hours
to
determine
limits
or
restrictions
on
the
discharge
of
the
drug.
This
is
considered
a
reasonable
20
estimate,
since
not
all
reports
will
require
this
much
effort
while
others
will
require
more.

Reporting
requirements
associated
with
a
failure
in
the
aquatic
animal
containment
system
will
provide
the
permitting
authority
with
information
concerning
the
release
of
large
quantities
of
pollutants
over
a
short
span
of
time.
It
can
provide
the
permitting
authority
with
the
ability
to
anticipate
possible
stream
impacts
that
could
result
from
this
release
and
if
possible
take
steps
to
mitigate
them.
A
release
of
live
fish
that
are
not
native
to
the
region
may
pose
a
threat
to
native
species.
EPA
anticipates
that
the
permitting
authority
will
notify
the
State
Department
of
Fish
and
Wildlife
so
that
appropriate
action
may
be
taken
to
mitigate
this
release
in
a
timely
manner.
Any
subsequent
failures
at
the
same
facilities
should
also
be
reviewed
in
light
of
the
previous
reports
to
determine
whether
the
facility's
BMP
plan
may
need
to
be
updated.

Costs
to
NPDES
Authorized
States
The
cost
to
NPDES
authorized
States
is
calculated
by
multiplying
the
estimated
total
burden
for
each
respondent
by
the
labor
rate
of
$
29.18
(
2001
dollars).
This
labor
rate
was
derived
from
inflating
the
rate
used
in
the
Stormwater
Phase
II
regulation.
The
Phase
II
rate
was
based
on
the
average
hourly
rate
for
state
and
municipal
employees
as
determined
by
the
U.
S.
Department
of
Labor,
Bureau
of
Labor
Statistics.
EPA
estimates
that
there
are
204
CAAP
facilities
in
NPDES
authorized
States.
Of
these
204
CAAP
facilities,
an
estimated
176
facilities
use
flow­
through
system,
9
facilities
use
recirculating
systems
and
19
facilities
use
net
pens
to
produce
aquatic
animals.
The
cost
for
authorized
states
is
presented
in
Table
6­
4.

The
estimated
burden
to
the
U.
S.
EPA
per
permit
is
estimated
to
be
the
same
as
the
burden
associated
with
state
permitting
authorities.
EPA
is
the
permitting
authority
in
five
states.
There
are
an
estimated
39
regulated
CAAP
facilities
in
these
5
states.
The
estimated
burden
associated
with
the
proposed
BMP
and
reporting
requirements
that
would
be
included
in
the
permits
issued
to
the
39
facilities
in
these
5
states
is
shown
below
in
Table
6­
5.
The
State
of
Idaho
has
the
largest
population
of
CAAP
facilities.
CAAP
facilities
in
Idaho
are
already
subject
to
permits
that
require
them
to
establish
a
BMP
plan
and
keep
records
on
feed,
thus
this
ICR
does
not
account
for
that
burden.
21
d.
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
The
following
tables
present
the
estimated
annual
burden
and
cost
for
regulated
facilities
aggregated
by
subcategory
(
e.
g.,
net
pen
subcategory
and
the
flow
through
and
recirculating
subcategory).
EPA
has
not
estimated
any
capital
start­
up
or
operational
costs.
The
regulation
does
not
require
any
specific
wastewater
treatment
be
installed
and
focuses
the
implementation
of
practices
rather
than
operation
of
technologies
as
the
means
to
ensure
compliance
with
these
requirements.
EPA's
estimated
costs
are
based
on
the
burden
and
associated
labor
rates
to
estimate
the
costs
of
this
ICR.
The
labor
rates
shown
on
the
following
tables
are
averages
of
the
labor
rates
reported
in
EPA's
detailed
survey.
These
are
loaded
labor
rates
as
reported
by
respondents
to
the
detailed
survey.

Facilities
in
the
flow
through
and
recirculating
subcategory
are
subdivided
by
commercial
facilities
and
noncommercial
facilities.
The
majority
of
noncommercial
facilities
are
publicly
owned
either
State
or
Federal
hatcheries
that
are
producing
fish
for
stocking
or
restoration
purposes.
The
reason
these
two
burden
and
costs
estimates
for
these
types
of
facilities
are
presented
separately
is
a
result
of
the
different
wages
paid
to
employees
of
these
two
types
of
facilities
which
has
a
significant
affect
on
the
overall
estimated
costs
of
the
reporting
requirements.

As
discussed
above
in
Section
4.
b.,
there
are
some
different
assumptions
made
in
the
frequency
of
reporting
at
noncommercial
flow
through
and
recirculating
facilities
as
well.
Based
on
data
provided
by
CAAP
facilities
in
response
to
EPA's
detailed
survey,
noncommercial
facilities
have
a
higher
use
of
INAD
drugs.
Survey
responses
from
commercial
facilities
give
no
indication
that
INAD
or
extra­
label
drugs
are
used
at
these
facilities,
however,
EPA
is
assuming
that
one
facility
each
year
will
use
an
INAD
and
will
incur
the
burden
of
reporting
for
that
drug.

EPA's
final
CAAP
regulation
requires
all
facilities
to
develop
a
BMP
plan
and
to
certify
to
the
permitting
authority
that
this
plan
has
been
developed.
EPA
is
including
the
burden
for
the
plan
development
for
all
CAAP
facilities
subject
to
this
regulation
except
for
flow
through
and
recirculating
facilities
located
in
the
States
of
Washington
and
Idaho.
Facilities
in
these
two
States
are
already
required
to
develop
BMP
plans
under
existing
NPDES
permits.
Likewise
facilities
in
these
two
States
are
already
required
to
perform
the
feed
management
practices
and
associated
record
keeping.

All
of
the
existing
net
pen
facilities
indicated
that
they
currently
keep
records
on
the
feed
inputs
and
inspections,
net
changes
and
maintenance
and
repairs.
22
Table
6­
1
Annual
Burden
for
Flow
Through
and
Recirculating
Commercial
Facilities
Activity
Mngmnt
Hrs
(
hrs/
facility/

yr)
Unsklld
Lbr
Hrs
(
hrs/
facility/

yr)
Mngmnt
$

($
20.04
/
hr)
Unsklld
Lbr
$

($
11.58
/
hr)
No.
of
Facilities
Total
Hours
Total
Dollars
BMP
Plan
Development
8
0
$
160
0
59
472
$
9,460
BMP
Plan
Certification
0.25
0
$
5
0
59
15
$
300
Training
for
BMPs
2
4
$
40
$
46
59
354
$
5,075
INAD
Program
Sign­
up
Report
1
0
$
20
0
1
1
$
20
INAD
or
Extra­
Label
Use
Report
1.3
0
$
26
0
1
1.3
$
26
Spill
Report
2
0
$
40
0
2
4
$
80
Structural
Failure
Report
5
0
$
100
0
8
40
$
800
Feed
Management
Records
13
90
$
260
$
1,040
59
6,077
$
76,700
Inspection,
Cleaning,

Maintenance
&
Repair
Records
13
90
$
260
$
1,040
59
6,077
$
76,700
23
Table
6­
2
Annual
Burden
for
Flow
Through
and
Recirculating
Non­
Commercial
Facilities
Activity
Mngmnt
Hrs
(
hrs/
facility/

yr)
Unsklld
Lbr
Hrs
(
hrs/
facility/

yr)
Mngmnt
$

($
26.98
/
hr)
Unsklld
Lbr
$

($
19.17
/
hr)
No.
of
Facilities
Total
Hours
Total
Dollars
BMP
Plan
Development
8
0
$
215
0
122
1,720
$
26,230
BMP
Plan
Certification
0.25
0
$
7
0
122
30.5
$
854
BMP
Training
2
4
$
55
$
77
122
732
$
16,100
INAD
Program
Sign­
up
Report
1
0
$
27
0
15
15
$
400
INAD
or
Extra­
Label
Use
Report
1.3
0
$
35
0
15
20
$
525
Spill
Report
2
0
$
60
0
3
6
$
160
Structural
Failure
Report
5
0
$
135
0
14
70
$
1,890
Feed
Management
Records
13
105
$
350
$
2,015
122
14,400
$
288,500
Inspection,
Cleaning,

Maintenance
&
Repair
Records
13
105
$
350
$
2,015
122
14,400
$
288,500
24
Table
6­
3
Annual
Burden
for
Net
Pen
Facilities
Activity
Mngmnt
Hrs
(
hrs/
facility/

yr)
Unsklld
Lbr
Hrs
(
hrs/
facility/

yr)
Mngmnt
$

($
26.26
/
hr)
Unsklld
Lbr
$

($
12.54
/
hr)
No.
of
Facilities
Total
Hours
Total
Dollars
BMP
Plan
Development
8
0
$
210
0
19
150
$
3,940
BMP
Plan
Certification
0.25
0
$
7
0
19
5
$
130
BMP
Training
2
4
$
55
$
50
19
114
$
3,000
INAD
Program
Sign­
up
Report
1
0
$
30
0
1
1
$
25
INAD
or
Extra­
Label
Use
Report
1.3
0
$
35
0
1
1.3
$
35
Spill
Report
2
0
$
50
0
4
8
$
200
Structural
Failure
Report
5
0
$
130
0
19
95
$
2,500
Feed
Management
Records
0
0
0
0
0
0
0
Inspection,
Net
Replacement,

Maintenance
&
Repair
Records
0
0
0
0
0
0
0
25
Table
6­
4
Annual
Burden
Estimate
for
State
Permitting
Authorities
Activity
Hrs
(
hrs/
permit/
yr)
$/
permit
($
26.98
/
hr)
No.
of
Permits
Total
Hours
Total
Dollars
BMP
Plan
Certification
Receipt
0.05
$
1.5
202
10
$
270
INAD
Program
Sign­
up
Report
Receipt
0.5
$
15
13
7
$
190
Research
on
Environmental
Affects
of
INAD
3
$
80
13
40
$
1,080
Determination
of
Site
Specific
Limits
for
INAD
3
$
80
7
21
$
570
INAD
or
Extra­
Label
Drug
Report
Receipt
0.5
$
15
13
7
$
190
Spill
Report
Receipt
0.5
$
15
7
4
$
100
Structural
Failure
Report
Receipt
0.5
$
15
31
16
$
430
Notify
State
Fish
&
Wildlife
Department
0.5
$
15
24
12
$
325
Review
cause
of
failure
and
past
reports
to
evaluate
effectiveness
of
practices
1
$
30
20
20
$
540
26
Table
6­
5
Annual
Burden
Estimate
for
Federal
Permitting
Authorities
Activity
Hrs
(
hrs/
permit/

yr)
$/
permit
($
26.98/
hr)
No.
of
Permits
Total
Hours
Total
Dollars
BMP
Plan
Certification
Receipt
0.05
$
1.5
8
0.4
$
10
INAD
Program
Sign­
up
Report
Receipt
0.5
$
15
4
2
$
50
Research
on
Environmental
Affects
of
INAD
3
$
80
4
12
$
325
Determination
of
Site
Specific
Limits
for
INAD
3
$
80
1
3
$
80
INAD
or
Extra­
Label
Drug
Report
Receipt
0.5
$
15
4
2
$
50
Spill
Report
Receipt
0.5
$
15
2
1
$
30
Structural
Failure
Report
Receipt
0.5
$
15
10
5
$
135
Notify
State
Fish
&
Wildlife
Department
0.5
$
15
5
2.5
$
70
Review
cause
of
failure
and
past
reports
to
evaluate
effectiveness
of
practices
1
$
30
3
3
$
80
27
e.
Bottom
Line
Burden
Hours
and
Cost
Tables
The
following
table
presents
the
total
estimated
burden
and
cost
for
the
three
year
term
of
this
ICR.

Table
6­
6
Total
Estimated
Burden
for
the
CAAP
Effluent
Guidelines
Regulation
Activity
Flow
Through
&
Recirculating
Net
Pen
Total
Hours
Total
Cost
Total
Hours
Total
Cost
BMP
Plan
Development
6580
$
107,100
450
$
11,820
BMP
Plan
Certification
140
$
3,470
15
$
400
Training
for
BMPs
3,260
$
63,525
340
$
9,000
INAD
Program
Sign­
up
Report
50
$
1,260
3
$
75
INAD
or
Extra­
Label
Use
Report
60
$
1,650
4
$
105
Spill
Report
10
$
240
8
$
200
Structural
Failure
Report
330
$
8,070
285
$
7,500
Feed
Management
Records
61,400
$
1,095,600
0
0
Inspection,
Cleaning,
Maintenance
&
Repair
Records
61,400
$
1,095,600
0
0
Subtotal
by
Subcategory
133,200
$
2,380,000
1,100
$
30,000
TOTAL
RESPONDENT
BURDEN
&
COST
134,300
hours
$
2,410,000
Annual
Respondent
Burden
&
Cost
44,800
hours
$
803,300
28
Table
6­
7
Total
Estimated
Burden
for
Permitting
Authorities
Activity
State
Permitting
Authorities
Federal
Permitting
Authorities
Total
Hours
Total
Cost
Total
Hours
Total
Cost
BMP
Plan
Certification
Receipt
30
$
810
1
$
21
INAD
Program
Sign­
up
Report
Receipt
21
$
570
6
$
150
Research
on
Environmental
Affects
of
INAD
120
$
3,240
36
$
975
Determination
of
Site
Specific
Limits
for
INAD
63
$
1,710
12
$
240
INAD
or
Extra­
Label
Drug
Report
Receipt
21
$
570
6
$
150
Structural
Failure
Report
Receipt
50
$
1,290
15
$
405
Notify
State
Fish
&
Wildlife
Department
36
$
975
8
$
210
Review
cause
of
failure
and
past
reports
to
evaluate
effectiveness
of
practices
60
$
1,620
9
$
240
Subtotal
by
Subcategory
400
hours
$
10,800
90
hours
$
2,400
TOTAL
RESPONDENT
BURDEN
&
COST
500
hours
$
13,200
Annual
Respondent
Burden
&
Cost
170
hours
$
4,400
The
total
estimated
annual
burden
for
the
CAAP
Effluent
Guidelines
Regulation
is
45,000
hours
and
the
estimated
cost
is
$
807,000.
The
total
burden
over
the
three
year
ICR
approval
would
be
135,000
hours
and
$
2,423,000.
29
f.
Reasons
for
Change
In
Burden
EPA
has
modified
some
of
the
requirements
that
were
included
in
the
proposed
regulation
as
described
above
in
Section
3.
b.
As
a
result
some
of
the
reporting
and
record
keeping
requirements
and
associated
burden
that
was
estimated
in
the
proposed
regulation
is
not
included
in
this
ICR.
For
the
requirements
that
are
still
in
the
final
rule,
EPA
has
made
relatively
minor
changes
in
the
estimation
of
the
burden
at
a
given
facility.
The
overall
burden
estimate
for
the
regulated
population
as
a
whole
has
changed
due
to
the
collection
of
data.
The
data
provided
in
response
to
EPA's
detailed
survey
established
information
on
the
frequency
that
INAD
drugs
have
been
used
in
the
past
at
CAAP
facilities.
The
data
also
provided
better
estimates
of
costs,
by
providing
site
specific
wages
paid
to
the
different
labor
classes
at
the
facility.

EPA
did
not
receive
specific
comments
disagreeing
with
the
estimated
burden
in
terms
of
the
time
required
to
respond
to
the
requirements,
therefore,
very
little
has
changed
except
when
the
specific
requirement
has
changed.

g.
Burden
Statement
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
185
hours
per
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
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
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.
OW­
2002­
0026,
which
is
available
for
public
viewing
at
the
Water
Docket
in
the
EPA
Docket
Center,
EPA
West,
Room
B102,
1301
Constitution
Ave.,
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
Water
Docket
is
(
202)
566­
2426.
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
access
to
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
30
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.
OW­
2002­
0026
in
any
correspondence.