Thursday,

March
13,
2003
Part
III
Environmental
Protection
Agency
40
CFR
439
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards
for
the
Pharmaceutical
Manufacturing
Point
Source
Category;
Direct
Final
Rule
and
Proposed
Rule
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/
Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
439
[
FRL
 
7462
 
8]

Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards
for
the
Pharmaceutical
Manufacturing
Point
Source
Category
AGENCY:
Environmental
Protection
Agency.
ACTION:
Direct
final
rule.

SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
is
taking
direct
final
action
to
amend
certain
provisions
of
the
effluent
guidelines
for
the
Pharmaceutical
Manufacturing
Point
Source
Category,
which
were
published
on
September
21,
1998
(
63
FR
50424).
First,
EPA
is
clarifying
the
date
on
which
a
discharger
subject
to
the
New
Source
Performance
Standards
(
NSPS)
and
the
Pretreatment
Standards
for
New
Sources
(
PSNS)
would
be
subject
to
effluent
limitations
and
pretreatment
standards
established
in
the
1998
regulation.
Second,
this
rule
reestablishes
a
minimum
concentration
for
the
maximum
monthly
average
BOD5
limitation
that
EPA
inadvertently
omitted
from
the
Best
Practicable
Control
Technology
(
BPT)
requirements
in
two
subcategories
of
the
1998
regulation.
Next,
the
amendments
correct
an
error
in
EPA's
pass­
through
analysis
prepared
in
support
of
the
1998
rule
and,
as
a
result,
deletes
methyl
Cellosolve
(
2­
methoxyethanol)
from
the
pretreatment
standards
in
two
subcategories
and
from
Appendix
A,
Table
2,
``
Surrogate
Parameters
for
Indirect
Dischargers.''
Finally,
the
Agency
is
making
other
non­
substantive
editorial
and
format
changes
such
as
removing
redundancies,
and
adding
definitions.
DATES:
This
rule
is
effective
on
June
11,
2003
without
further
notice,
unless
EPA
receives
adverse
comment
by
May
12,
2003.
If
we
receive
such
comment,
we
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
this
rule
will
not
take
effect.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Please
mail
comments
to
the
Water
Docket,
Environmental
Protection
Agency,
Mailcode:
4101T,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC,
20460
or
submit
them
electronically
to
http://
www.
epa.
gov/
edocket.
Send
either
to
the
Attention
of
Docket
ID
No.
OW
 
2003
 
0007.
See
section
I.
C.,
of
the
SUPPLEMENTARY
INFORMATION
section
for
more
information
on
submitting
comments.

FOR
FURTHER
INFORMATION
CONTACT:
Dr.
Frank
Hund,
EPA
Office
of
Water
by
phone
at
(
202)
566
 
1027
or
by
e­
mail
at
hund.
frank@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Regulated
Entities
Entities
potentially
regulated
by
this
action
include
facilities
of
the
following
types
that
discharge
pollutants
directly
or
indirectly
to
U.
S.
waters.

Category
Examples
of
regulated
entities
SIC
(
NAICS)
code
Industry
.............
Facilities
that
generate
process
wastewater
from
the
manufacture
of
pharmaceutical
products
and/
or
pharmaceutical
intermediates
by
fermentation,
extraction,
chemical
synthesis
and/
or
mixing,
compounding
and
formulating.
2833,
R834,
2836
(
2834
 
04,
2834
 
98).

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
regulated
by
this
action.
This
table
lists
the
types
of
entities
that
EPA
is
now
aware
could
potentially
be
regulated
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
regulated.
To
determine
whether
your
facility
is
regulated
by
this
action,
you
should
carefully
examine
the
definitions
and
applicability
criteria
in
§
§
439.1,
439.10,
439.20,
439.30,
439.40
and
439.50
of
title
40
of
the
Code
of
Federal
Regulations.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
in
the
preceding
FOR
FURTHER
INFORMATION
CONTACT
section.

B.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OW
 
2003
 
0007.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Water
Docket
in
the
EPA
Docket
Center,
(
EPA/
DC)
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
Public
Reading
Room
is
(
202)
566
 
1744,
and
the
telephone
number
for
the
Water
Docket
is
(
202)
566
 
2426.
For
access
to
docket
materials,
please
call
ahead
to
schedule
an
appointment.
Every
user
is
entitled
to
copy
100
pages
before
incurring
a
charge.
The
Docket
may
charge
15
cents
a
page
for
each
page
over
the
100­
page
limit.
2.
Electronic
Access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
``
EPA
Dockets.''
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
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
appropriate
docket
identification
number.

II.
Legal
Authority
The
U.
S.
Environmental
Protection
Agency
is
promulgating
these
regulations
under
the
authority
of
33
U.
S.
C.
1311,
1314,
1316,
1317,
1318,
1342
and
1361.

III.
Overview
of
Effluent
Limitations
Guidelines
and
Standards
Congress
adopted
the
Clean
Water
Act
(
CWA)
to
``
restore
and
maintain
the
chemical,
physical,
and
biological
integrity
of
the
Nation's
waters''
(
section
101(
a),
33
U.
S.
C.
1251(
a)).
To
achieve
this
goal,
the
CWA
prohibits
the
discharge
of
pollutants
into
navigable
waters
except
in
compliance
with
the
statute.
The
Clean
Water
Act
confronts
the
problem
of
water
pollution
on
a
number
of
different
fronts.
Its
primary
reliance,
however,
is
on
establishing
restrictions
on
the
types
and
amounts
of
pollutants
discharged
from
various
industrial,
commercial,
and
public
sources
of
wastewater.

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Thursday,
March
13,
2003
/
Rules
and
Regulations
Congress
recognized
that
regulating
only
those
sources
that
discharge
effluent
directly
into
the
nation's
waters
would
not
be
sufficient
to
achieve
the
CWA's
goals.
Consequently,
the
CWA
requires
EPA
to
promulgate
nationally
applicable
pretreatment
standards
that
restrict
pollutant
discharges
for
those
who
discharge
wastewater
indirectly
through
sewers
flowing
to
publiclyowned
treatment
works
(
POTWs)
(
section
307(
b)
and
(
c),
33
U.
S.
C.
1317(
b)
and
(
c)).
National
pretreatment
standards
are
established
for
those
pollutants
in
wastewater
from
indirect
dischargers
which
may
pass
through
or
interfere
with
POTW
operations.
Generally,
pretreatment
standards
are
designed
to
ensure
that
wastewater
from
direct
and
indirect
industrial
dischargers
are
subject
to
similar
levels
of
treatment.
In
addition,
POTWs
are
required
to
implement
local
pretreatment
limits
applicable
to
their
industrial
indirect
dischargers
to
satisfy
any
local
requirements
(
40
CFR
403.5).
Direct
dischargers
must
comply
with
effluent
limitations
in
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permits;
indirect
dischargers
must
comply
with
pretreatment
standards.
These
limitations
and
standards
are
established
by
regulation
for
categories
of
industrial
dischargers
and
are
based
on
the
degree
of
control
that
can
be
achieved
using
various
levels
of
pollution
control
technology.
On
November
17,
1976,
(
41
FR
50676)
EPA
promulgated
``
best
practicable
control
technology
currently
available''
(
BPT)
effluent
limitations
guidelines
for
the
Pharmaceutical
Manufacturing
Point
Source
Category.
On
October
27,
1983,
(
48
FR
49808)
the
Agency
revised
the
BPT
limitations
and
promulgated
additional
limitations
covering
the
``
best
available
technology
economically
achievable''
(
BAT)
and
pretreatment
and
new
source
standards
for
this
point
source
category.
On
September
21,
1998,
(
63
FR
50388)
EPA
again
revised
the
effluent
limitations
guidelines
and
standards
for
the
Pharmaceutical
Manufacturing
Point
Source
Category.
We
subsequently
received
comments
from
the
regulated
community
and
after
our
own
analysis
and
review,
we
determined
that
several
minor
amendments
which
are
discussed
below
were
warranted.

IV.
Amendment
to
New
Source
Effective
Dates
Section
306
of
the
Clean
Water
Act
requires
EPA
to
establish,
and
from
time
to
time,
revise
standards
of
performance
for
categories
of
new
sources
which
may
discharge
pollutants.
Under
the
Act,
point
sources
constructed
to
meet
these
NSPS
may
not
be
subject
to
more
stringent
standards
during
a
statutorily
prescribed
period
following
construction
of
such
source,
generally
10
years.
EPA
first
promulgated
NSPS
for
the
Pharmaceutical
Manufacturing
Point
Source
Category
in
1983
when
the
Agency
established
effluent
limitations
guidelines
and
pretreatment
standards
for
this
category.
When
EPA
promulgated
revised
limitations
and
standards,
including
NSPS,
for
the
Pharmaceuticals
Manufacturing
Point
Source
Category
in
1998,
40
CFR
439.15(
c),
439.25(
c),
439.35(
c),
and
439.45(
c)
provided
for
this
protection
period
from
more
stringent
standards.
For
example,
paragraph
(
c)
of
§
439.15
states:

Any
new
source
subject
to
the
provisions
of
this
section
that
commenced
discharging
after
November
21,
1988
and
prior
to
November
20,
1998
must
continue
to
achieve
the
standards
specified
in
the
earlier
version
of
this
section
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
which
the
source
must
achieve
the
standards
specified
in
§
§
439.13
and
439.14.
(
Emphasis
supplied)

In
order
to
remove
any
ambiguity
about
which
regulations
applied
to
dischargers
constructing
new
facilities
and
commencing
discharge
after
the
1983
regulation
but
before
the
effective
date
of
the
1998
regulations,
EPA
is
amending
the
regulation.
EPA
is
amending
paragraph
(
c)
of
each
of
the
four
sections
cited
above
to
state
clearly
that
any
new
source
that
commenced
discharging
after
November
21,
1988,
and
before
November
20,
1998,
must
continue
to
achieve
the
standards
specified
for
40
CFR
part
439
in
the
October
27,
1983,
Federal
Register
(
48
FR
49808)
(
which
are
contained
in
the
1988
edition
of
the
CFR)
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1).
Thereafter,
the
source
must
comply
with
the
applicable
effluent
limitations
specified
in
the
September
21,
1998,
regulation
(
63
FR
50388).
The
amendments
substitute
for
the
phrase
``
earlier
version''
a
specific
reference
to
the
1988
edition
of
40
CFR
part
439.
This
will
remove
any
uncertainty
about
the
standards
with
which
a
point
source
discharger
must
comply.
Section
307(
c)
of
the
CWA
also
requires
EPA
to
promulgate
pretreatment
standards
for
new
sources
simultaneously
with
the
promulgation
of
NSPS
for
a
category
of
sources.
When
EPA
promulgated
the
PSNS
for
the
Pharmaceutical
Manufacturing
Point
Source
Category
in
1998,
PSNS
in
§
§
439.17,
439.27,
439.37,
and
439.47
failed
to
specify
when
a
source
constructed
before
the
date
on
which
the
new
PSNS
became
effective
would
be
subject
to
the
more
stringent
standards.
To
correct
this
oversight,
EPA
is
revising
each
of
these
four
sections
to
read
as
follows:

Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
pretreatment
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439
during
a
tenyear
period
beginning
on
the
date
the
source
commenced
discharge,
or
during
the
period
of
depreciation
or
amortization
of
the
facility,
which
ever
comes
first,
after
which
the
source
must
achieve
the
same
standards
as
specified
in
[
insert
the
appropriate
PSES
section
for
the
subpart].

V.
Amendment
to
BOD
Minimum
Limitation
When
EPA
issued
regulations
for
the
Pharmaceutical
Manufacturing
Point
Source
Category
on
October
27,
1983
(
49
FR
49808),
the
best
practicable
control
technology
(
BPT)
regulation
in
§
§
439.22
and
439.42
provided
for
a
minimum
monthly
average
limitation
for
BOD5,
which
was
qualified
by
the
following
sentence:
``
However,
a
plant
shall
not
be
required
to
attain
a
maximum
30­
day
average
BOD5
effluent
limitation
of
less
than
the
equivalent
of
45
mg/
l.''
EPA
included
this
provision
because
dischargers
with
BOD5
levels
up
to
100
mg/
L
in
their
raw
wastewater
could
not
achieve
the
required
90%
reduction
of
BOD5
using
biological
treatment,
the
technological
basis
for
the
limitation.
Since
biological
treatment
could
not
achieve
the
required
reduction
for
such
dischargers,
EPA
established
a
qualified
provision
for
a
minimum
BOD5
concentration
in
the
1983
regulation.
EPA
inadvertently
omitted
this
qualified
provision
of
the
BOD5
limitations
from
the
final
rule
published
in
1998,
and
this
language
consequently
has
not
been
included
in
subsequent
editions
of
40
CFR
part
439.
Today
EPA
is
correcting
this
omission
by
adding
to
§
§
439.22(
a)
and
439.42(
a)
the
phrase:
``
*
*
*,
except
that
no
facility
shall
be
required
to
attain
a
monthly
average
limitation
for
BOD5
that
is
less
than
the
equivalent
of
45
mg/
L.''

VI.
Amendment
To
Delete
Methyl
Cellosolve
From
Pretreatment
Standards
EPA
is
amending
40
CFR
part
439
by
deleting
the
pretreatment
standards
for
methyl
Cellosolve
from
§
§
439.16,
439.17,
439.36
and
439.37,
and
from
Table
2
of
Appendix
A.
In
the
1998
regulation,
EPA
established
pretreatment
standards
for
methyl
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Vol.
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49
/
Thursday,
March
13,
2003
/
Rules
and
Regulations
Cellosolve
and
other
pollutants
which
EPA's
pass­
through
analysis
concluded
would
pass
through
POTW
treatment
rather
than
be
removed
by
POTW
treatment.
EPA
based
its
determination
on
a
chemical
and
engineering
evaluation
of
which
pollutants
would
not
be
susceptible
to
treatment
in
POTW
biological
treatment
systems.
EPA's
pass­
through
analysis
depended
on
a
number
of
calculations,
relying
in
part
on
a
comparison
of
a
parameter's
Henry's
Law
Constant
(
HL)
with
a
threshold
HL
value.
In
a
letter
to
EPA
dated
November
28,
2000,
the
Pharmaceutical
Research
and
Manufacturers
of
America
(
PhRMA)
indicated
that
EPA
had
used
an
incorrect
HL
value
for
methyl
Cellosolve
in
the
pass­
through
analysis
by
assuming
an
HL
value
of
2.9
×
10
¥
3
atm/
gmole/
m3.
This
was
the
same
HL
value
that
had
been
used
for
methyl
Cellosolve
by
EPA's
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS)
in
establishing
the
Maximum
Air
Control
Technology
(
MACT)
standards
for
pharmaceutical
manufacturers
that
were
promulgated
in
1998,
and
that
had
been
developed
concomitantly
with
revised
pretreatment
standards
for
40
CFR
part
439.
The
OAQPS,
however,
subsequently
revised
its
HL
value
for
methyl
Cellosolve
from
2.9
×
10
¥
3
to
3.3
×
10
¥
7
atm/
gmole/
m3,
based
on
a
value
reported
by
Johanson
G.
and
Dynesius
B.
in
``
Liquid/
air
partition
coefficients
of
six
commonly
used
glycol
ethers,''
British
Journal
of
Industrial
Medicine,
1988,
45:
561
 
564.
The
determination
of
an
incorrect
HL
constant
was
reinforced
when
EPA
also
considered
the
analytical
technique
required
to
measure
low
concentrations
of
methyl
Cellosolve
in
wastewater.
Analytical
methods
to
measure
volatile
organic
analytes
(
VOAs)
utilize
an
inert
gas
purging
technique
to
recover
VOAs
from
a
wastewater
sample.
But
methyl
Cellosolve
does
not
purge
efficiently
and
so
must
be
analyzed
using
a
direct
injection
technique.
This
fact
offered
additional
evidence
that
EPA
had
used
an
inappropriate
HL
value
for
methyl
Cellosolve
in
the
earlier
pass­
through
analysis
of
the
pretreatment
standards.
The
revised
HL
for
methyl
Cellosolve
(
3.3
×
10
¥
7
atm/
gmole/
m3)
is
well
below
the
threshold
HL
value
(
1
×
10
¥
5
atm/
gmole/
m3)
that
EPA
used
to
classify
a
compound
as
a
volatile
organic
compound
(
VOC)
for
purposes
of
the
Agency's
pass­
through
analysis.
Thus,
EPA
relied
on
an
inappropriate
HL
value
for
methyl
Cellosolve
in
the
passthrough
analysis
for
the
1998
rule.
This
caused
this
compound
to
be
identified
as
a
VOC,
which
the
Agency's
passthrough
analysis
determined
would
pass
through
a
POTW's
treatment.
When
EPA
used
the
corrected
lower
HL
value
and
found
that
methyl
Cellosolve
was
not
a
VOC,
the
Agency's
pass­
through
analysis
determined
that
this
compound
would
not
pass
through
a
POTW's
treatment.

VII.
Additional
Edits
to
40
CFR
Part
439
Today's
rule
also
includes
nonsubstantive
edits
and
format
changes
to
the
rule
promulgated
in
1998
in
order
to
shorten
and
clarify
40
CFR
part
439.
The
``
Authority''
citation
was
shortened
to
conform
with
current
guidance
from
the
Federal
Register
Office.
The
text
from
§
439.4
was
merged
into
§
439.2
and
the
heading
of
§
439.2
was
revised
to
read:
``
General
monitoring
requirements.''
Section
439.4
was
re­
designated
under
a
new
heading
``
General
limitation
or
standard
for
pH''
and
the
term
``
Subcategory''
was
removed
from
the
heading
of
all
subparts.
EPA
has
also
added
definitions
of
``
Maximum
daily''
and
``
Maximum
monthly
average''
to
§
439.1.
These
definitions
are
similar
to
those
used
in
other
effluent
limitations
guidelines
and
pretreatment
standards
regulations
and
reflect
the
definitions
used
to
promulgate
the
limits
in
the
existing
40
CFR
part
439.
Finally,
the
initial
phrase,
``
The
term
*
*
*
''
was
removed
from
all
definitions,
column
headings
and
titles
of
all
tables.
Corresponding
text
referencing
these
headings
and
titles
was
also
revised.

VIII.
Rationale
for
Direct
Final
Rule
EPA
is
publishing
this
rule
without
prior
proposal
because
we
view
this
as
a
noncontroversial
amendment
and
anticipate
no
adverse
comment.
The
changes
here
will
facilitate
the
implementation
of
part
439
and
will
not
affect
environmental
impacts
or
compliance
costs.
They
merely
clarify
applicable
dates,
correct
an
inadvertent
error
and
omission,
and
make
other
non­
substantive
edits.
However,
in
the
``
Proposed
Rules''
section
of
today's
Federal
Register,
we
are
publishing
a
separate
document
that
will
serve
as
the
proposal
to
amend
part
439,
as
described
herein,
if
adverse
comments
are
filed.
This
rule
will
be
effective
on
June
11,
2003
without
further
notice,
unless
we
receive
adverse
comment
by
May
12,
2003.
If
EPA
receives
adverse
comment
on
one
or
more
distinct
amendments,
paragraphs,
or
sections
of
this
rulemaking,
we
will
publish
a
timely
withdrawal
in
the
Federal
Register
indicating
which
provisions
will
become
effective
and
which
provisions
are
being
withdrawn
due
to
adverse
comment.
Any
distinct
amendment,
paragraph,
or
section
of
today's
rulemaking
for
which
we
do
not
receive
adverse
comment
will
become
effective
on
the
date
set
out
above,
notwithstanding
any
adverse
comment
on
any
other
distinct
amendment,
paragraph,
or
section
of
today's
rule.
We
will
address
all
adverse
public
comments
in
a
subsequent
final
rule
based
on
the
proposed
rule.
We
will
not
institute
a
second
comment
period
on
this
action.
Any
parties
interested
in
commenting
must
do
so
at
this
time.

IX.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
Under
Executive
Order
12866
(
58
FR
51735,
(
October
4,
1993)),
the
Agency
must
determine
whether
a
regulatory
action
is
``
significant''
and
therefore
subject
to
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
the
Executive
Order.
The
Order
defines
``
significant
regulatory
action''
as
one
that
is
likely
to
result
in
a
rule
that
may:
(
1)
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
local,
or
tribal
governments
or
communities;
(
2)
Create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;
(
3)
Materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
Raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.
It
has
been
determined
that
this
rule
is
not
a
``
significant
regulatory
action''
under
the
terms
of
Executive
Order
12866
and
is
therefore
not
subject
to
OMB
review.

B.
Paperwork
Reduction
Act
This
action
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
It
merely
clarifies
applicable
dates,
corrects
an
inadvertent
error
and
omission,
and
makes
other
non­
substantive
edits.
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
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and
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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;
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.

C.
Regulatory
Flexibility
Act
The
Regulatory
Flexibility
Act
(
RFA),
as
amended
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA),
5
U.
S.
C.
601
et
seq.,
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
organizations
and
small
governmental
jurisdictions.
For
purposes
of
assessing
the
impact
of
today's
final
rule
on
small
entities,
a
small
entity
is
defined
as
(
1)
a
small
business
with
gross
revenue
under
$
6
million
(
based
on
Small
Business
Administration
size
standards);
(
2)
a
small
governmental
jurisdiction
that
is
a
government
of
a
city,
county,
town,
school
district
or
special
district
with
a
population
less
than
50,000;
and
(
3)
a
small
organization
that
is
any
not­
forprofit
enterprise
which
is
independently
owned
and
operated
and
is
not
dominant
in
its
field.
After
considering
the
economic
impacts
of
today's
final
rule
on
small
entities,
I
certify
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
It
merely
clarifies
applicable
dates,
corrects
an
inadvertent
error
and
omission,
and
makes
other
nonsubstantive
edits.
As
explained
above,
the
change
to
the
PSNS
sections
of
the
regulation
merely
removes
any
ambiguity
about
the
applicability
of
the
earlier
1983
pretreatment
standards
during
the
10­
year
protection
period
prior
to
November
20,
1998,
and
makes
them
consistent
with
the
latest
NSPS
sections.
The
PSNS
revision
does
not
establish
any
new
requirements
with
respect
to
those
subject
to
the
regulation.
The
other
changes
similarly
would
have
either
no
effect
on
the
regulated
entities,
or
at
most
an
inconsequential
effect.
The
deletion
of
methyl
Cellosolve
would
reduce
the
economic
impacts
of
the
regulation
on
those
entities,
including
small
entities,
subject
to
pretreatment
standards
in
the
two
subparts
which
currently
contain
methyl
Cellosolve
as
a
regulated
parameter.
In
addition,
as
noted
above,
the
revision
to
re­
establish
the
minimum
concentration
for
BOD5
would
correct
an
earlier
inadvertent
omission
and
reflect
the
requirements
of
existing
discharge
permits.

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
Public
Law
104
 
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effects
of
their
regulatory
actions
on
State,
local,
and
tribal
governments
and
the
private
sector.
Under
section
202
of
the
UMRA,
EPA
generally
must
prepare
a
written
statement,
including
a
cost­
benefit
analysis,
for
proposed
and
final
rules
with
``
Federal
mandates''
that
may
result
in
expenditures
to
State,
local,
and
tribal
governments,
in
the
aggregate,
or
to
the
private
sector,
of
$
100
million
or
more
in
any
one
year.
Before
promulgating
an
EPA
rule
for
which
a
written
statement
is
needed,
section
205
of
the
UMRA
generally
requires
EPA
to
identify
and
consider
a
reasonable
number
of
regulatory
alternatives
and
adopt
the
least
costly,
most
costeffective
or
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule.
The
provisions
of
section
205
do
not
apply
when
they
are
inconsistent
with
applicable
law.
Moreover,
section
205
allows
EPA
to
adopt
an
alternative
other
than
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
if
the
Administrator
publishes
with
the
final
rule
an
explanation
why
that
alternative
was
not
adopted.
Before
EPA
establishes
any
regulatory
requirements
that
may
significantly
or
uniquely
affect
small
governments,
including
tribal
governments,
it
must
have
developed,
under
section
203
of
the
UMRA,
a
small
government
agency
plan.
The
plan
must
provide
for
notifying
potentially
affected
small
governments,
enabling
officials
of
affected
small
governments
to
have
meaningful
and
timely
input
in
the
development
of
EPA
regulatory
proposals
with
significant
Federal
intergovernmental
mandates,
and
informing,
educating,
and
advising
small
governments
on
compliance
with
the
regulatory
requirements.
EPA
has
determined
that
this
final
rule
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
for
State,
local
and
tribal
governments,
in
the
aggregate,
or
the
private
sector
in
any
one
year.
It
merely
clarifies
applicable
dates,
corrects
an
inadvertent
error
and
omission,
and
makes
other
nonsubstantive
edits.
Thus,
today's
rule
is
not
subject
to
the
requirements
of
sections
202
and
205
of
UMRA.
For
the
same
reason,
EPA
has
determined
that
this
final
rule
contains
no
regulatory
requirements
that
might
significantly
affect
small
governments.
The
final
rule
does
not
uniquely
affect
small
governments
because
small
and
large
governments
are
affected
in
the
same
way.
Thus,
today's
rule
is
not
subject
to
the
requirements
of
section
203
of
UMRA.

E.
Executive
Order
13132:
Federalism
Executive
Order
13132,
entitled
``
Federalism''
(
64
FR
43255,
August
10,
1999),
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
does
not
have
federalism
implications.
It
will
not
have
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132.
Today's
rule
amends
effluent
limitations
and
pretreatment
standards
which
impose
requirements
that
apply
to
facilities
when
they
discharge
wastewater
or
introduce
wastewater
to
a
POTW.
It
merely
clarifies
applicable
dates,
corrects
an
inadvertent
error,
and
omission,
and
makes
other
nonsubstantive
edits.
EPA
has
determined
that
there
are
no
pharmaceutical
facilities
owned
and/
or
operated
by
State
or
local
governments
that
would
be
subject
to
today's
rule.
Further,
the
rule
would
only
incidentally
affect
State
and
local
governments
in
their
capacity
as
implementers
of
CWA
NPDES
permitting
programs.
Thus,
Executive
Order
13132
does
not
apply
to
this
rule.

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Vol.
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49
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March
13,
2003
/
Rules
and
Regulations
F.
Executive
Order
13175:
Consultation
and
Coordination
With
Indian
Tribal
Governments
Executive
Order
13175,
entitled
``
Consultation
and
Coordination
with
Indian
Tribal
Governments''
(
65
FR
67249,
November
9,
2000),
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
Federal
government
and
Indian
tribes
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes.
This
final
rule
does
not
have
tribal
implications.
It
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
this
Federal
government
and
Indian
tribes
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes.
It
merely
clarifies
applicable
dates,
corrects
an
inadvertent
error
and
omission,
and
makes
other
non­
substantive
edits.
EPA
has
not
identified
any
pharmaceutical
facilities
covered
by
today's
rule
that
are
owned
and/
or
operated
by
Indian
tribal
governments.
No
Indian
tribes
are
responsible
for
implementing
the
CWA
NPDES
permitting
program.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

G.
Executive
Order
13045:
Protection
of
Children
From
Environmental
Health
Risks
and
Safety
Risks
Executive
Order
13045
``
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997)
applies
to
any
rule
that:
(
1)
Is
determined
to
be
``
economically
significant''
as
defined
under
Executive
Order
12866,
and
(
2)
concerns
an
environmental
health
or
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.
If
the
regulatory
action
meets
both
criteria,
the
Agency
must
evaluate
the
environmental
health
or
safety
effects
of
the
planned
rule
on
children
and
explain
why
the
planned
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
the
Agency.
This
final
rule
is
not
subject
to
Executive
Order
13045
because
it
is
not
an
economically
significant
rule
as
defined
under
Executive
Order
12866.
Further,
this
rule
does
not
concern
an
environmental
health
or
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.

H.
Executive
Order
13211:
Actions
that
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
This
rule
is
not
subject
to
Executive
Order
13211,
``
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355;
May
22,
2001)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.

I.
National
Technology
Transfer
and
Advancement
Act
Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note),
directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
business
practices)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
the
Office
of
Management
and
Budget
(
OMB),
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards.
This
action
does
not
involve
technical
standards.
Therefore,
EPA
did
not
consider
the
use
of
any
voluntary
consensus
standards.

J.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
the
publication
of
the
rule
in
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
This
rule
will
be
effective
June
11,
2003.

List
of
Subjects
in
40
CFR
Part
439
Environmental
protection,
Drugs,
Reporting
and
recordingkeeping
requirements,
Waste
treatment
and
disposal,
Water
pollution
control.
Dated:
February
28,
2003.
Christine
Todd
Whitman,
Administrator.
For
reasons
set
out
in
the
preamble,
part
439,
title
40,
chapter
I
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
439
 
PHARMACEUTICAL
MANUFACTURING
POINT
SOURCE
CATEGORY
1.
The
authority
citation
for
part
439
is
revised
to
read
as
follows:

Authority:
33
U.
S.
C.
1311,
1314,
1316,
1317,
1318,
1342
and
1361.

2.
Section
439.1
is
amended
by
revising
paragraphs
(
b)
through
(
n)
and
adding
paragraphs
(
o)
and
(
p)
to
read
as
follows:

§
439.1
General
definitions.

*
*
*
*
*
(
b)
Bench­
scale
operation
means
the
laboratory
testing
of
materials,
methods,
or
processes
on
a
small
scale,
such
as
on
a
laboratory
worktable.
(
c)
Cyanide
(
T)
means
the
parameter
total
cyanide.
(
d)
In­
plant
monitoring
point
means
a
location
within
a
plant,
where
an
individual
process
effluent
can
be
exclusively
monitored
before
it
is
diluted
or
mixed
with
other
process
wastewaters
en
route
to
the
end­
of­
pipe.
(
e)
Maximum
daily
means
the
highest
allowable
discharge
of
wastewater
pollutants
during
a
calender
day
or
any
24
hour
period
that
reasonably
represents
a
calender
day
for
purposes
of
sampling.
(
f)
Maximum
monthly
average
means
the
highest
allowable
average
of
daily
discharges
of
wastewater
pollutants
over
a
calendar
month,
and
is
calculated
as
the
sum
of
all
daily
values
measured
during
a
calendar
month
divided
by
the
number
of
daily
values
measured
during
that
month.
(
g)
mg/
L
means
milligrams
per
liter
or
parts
per
million
(
ppm)
(
h)
Minimum
level
means
the
level
at
which
an
analytical
system
gives
recognizable
signals
and
an
acceptable
calibration
point.
(
i)
Nitrification
capability
means
the
capability
of
a
POTW
treatment
system
to
oxidize
ammonia
or
ammonium
salts
initially
to
nitrites
(
via
Nitrosomonas
bacteria)
and
subsequently
to
nitrates
(
via
Nitrobacter
bacteria).
Criteria
for
determining
the
nitrification
capability
of
a
POTW
treatment
system
are:
bioassays
confirming
the
presence
of
nitrifying
bacteria;
and
analyses
of
the
nitrogen
balance
demonstrating
a
reduction
in
the
concentration
of
ammonia
or
ammonium
salts
and
an
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increase
in
the
concentrations
of
nitrites
and
nitrates.
(
j)
Non­
detect
(
ND)
means
a
concentration
value
below
the
minimum
level
that
can
be
reliably
measured
by
the
analytical
method.
(
k)
Pilot­
scale
operation
means
processing
equipment
being
operated
at
an
intermediate
stage
between
laboratory­
scale
and
full­
scale
operation
for
the
purpose
of
developing
a
new
product
or
manufacturing
process.
(
l)
POTW
means
publicly
owned
treatment
works
(
40
CFR
403.3).
(
m)
Process
wastewater,
as
defined
at
40
CFR
122.2
and
for
the
purposes
of
this
part,
does
not
include
the
following:
(
1)
Trimethyl
silanol,
any
active
antimicrobial
materials,
process
wastewater
from
imperfect
fermentation
batches,
and
process
area
spills.
Discharges
containing
such
materials
are
not
subject
to
the
limitations
and
standards
of
this
part.
(
2)
Non­
contact
cooling
water,
utility
wastewaters,
general
site
surface
runoff,
groundwater
(
e.
g.,
contaminated
groundwaters
from
on­
site
or
off­
site
groundwater
remediation
projects),
and
other
non­
process
water
generated
on
site.
Discharges
of
such
waters
and
wastewaters
are
not
subject
to
the
limitations
and
standards
of
this
part.
(
n)
Non­
conventional
pollutants
means
parameters
that
are
neither
conventional
pollutants
(
40
CFR
401.16),
nor
``
toxic''
pollutants
(
40
CFR
401.15).
(
o)
Surrogate
pollutant
means
a
regulated
parameter
that,
for
the
purpose
of
compliance
monitoring,
is
allowed
to
serve
as
a
surrogate
for
a
group
of
specific
regulated
parameters.
Plants
would
be
allowed
to
monitor
for
a
surrogate
pollutant(
s),
when
the
other
parameters
for
which
it
stands
are
receiving
the
same
degree
of
treatment
as
the
surrogate
pollutant(
s)
and
all
of
the
parameters
discharged
are
in
the
same
treatability
class(
es)
as
their
respective
surrogate
pollutant(
s).
Treatability
classes
have
been
identified
in
Appendix
A
of
this
part
for
both
steam
stripping
and
biological
treatment
technologies,
which
are
the
respective
technology
bases
for
PSES/
PSNS
and
BAT/
NSPS
limitations
controlling
the
discharge
of
regulated
organic
parameters.
(
p)
Xylenes
means
a
combination
of
the
three
isomers:
o­
xylene,
m­
xylene,
and
p­
xylene.
3.
Section
439.2
is
revised
to
read
as
follows:

§
439.2
General
monitoring
requirements.
(
a)
Permit
compliance
monitoring
is
required
for
each
regulated
pollutant
generated
or
used
at
a
pharmaceutical
manufacturing
facility,
except
where
the
regulated
pollutant
is
monitored
as
a
surrogate
parameter.
Permit
limits
and
compliance
monitoring
are
not
required
for
regulated
pollutants
that
are
neither
used
nor
generated
at
the
facility.
Except
for
cyanide,
for
which
an
alternate
monitoring
requirement
is
established
in
subparts
A
and
C
of
this
part,
a
determination
that
regulated
pollutants
are
neither
used
nor
generated
should
be
based
on
a
review
of
all
raw
materials
in
use,
and
an
assessment
of
the
process
chemistry,
products
and
by­
products
resulting
from
each
of
the
manufacturing
processes.
This
determination
along
with
a
recommendation
of
any
surrogate
must
be
submitted
with
permit
applications
for
approval
by
the
permitting
authority,
reconfirmed
by
an
annual
chemical
analysis
of
wastewater
from
each
monitoring
location,
and
measurement
of
a
non­
detect
value
for
each
regulated
pollutant
or
its
surrogate.
Permits
must
specify
that
such
determinations
will
be
maintained
in
the
facility's
permit
records
with
their
discharge
monitoring
reports
and
will
be
available
to
regulatory
authorities
upon
request.
(
b)
Unless
noted
otherwise,
selfmonitoring
will
be
conducted
at
the
point
where
the
final
effluent
is
discharged.
4.
Section
439.4
is
revised
to
read
as
follows:

§
439.4
General
limitation
or
standard
for
pH.

The
pH
must
remain
within
the
range
6.0
to
9.0
in
any
discharge
subject
to
BPT,
BCT
or
NSPS
limitations
or
standards
in
this
part.
5.
Revise
the
heading
of
subpart
A
to
read
as
follows:

Subpart
A
 
Fermentation
Products
6.
Section
439.11
is
revised
to
read
as
follows:

§
439.11
Special
definitions.

For
the
purpose
of
this
subpart:
(
a)
Fermentation
means
process
operations
that
utilize
a
chemical
change
induced
by
a
living
organism
or
enzyme,
specifically,
bacteria,
or
the
microorganisms
occurring
in
unicellular
plants
such
as
yeast,
molds,
or
fungi
to
produce
a
specified
product.
(
b)
Product
means
pharmaceutical
products
derived
from
fermentation
processes.
7.
Section
439.12
is
amended
by
revising
paragraphs
(
a)
introductory
text,
and
(
b)
through
(
e)
to
read
as
follows:
§
439.12
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

*
*
*
*
*
(
a)
The
maximum
monthly
average
limitation
for
BOD5,
expressed
as
mass
loading
(
lbs.,
kg)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD5
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
3.0.
*
*
*
*
*
(
b)
The
maximum
monthly
average
limitation
for
TSS,
expressed
as
mass
loading
(
lbs.,
kg)
per
day,
must
be
calculated
as
1.7
times
the
BOD5
limitation
determined
in
paragraph
(
a)
of
this
section.
(
c)
Except
as
provided
in
paragraph
(
d)
of
this
section,
the
limitations
for
COD
are
as
follows:

EFFLUENT
LIMITATIONS
(
BPT)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
COD
..........................
1675
856
1mg/
L
(
ppm).

(
d)
If
the
maximum
monthly
average
COD
concentration
in
paragraph
(
c)
of
this
section
is
higher
than
a
concentration
value
reflecting
a
reduction
in
the
long­
term
average
daily
COD
load
in
the
raw
(
untreated)
process
wastewater
of
74
percent
multiplied
by
a
variability
factor
of
2.2,
then
the
monthly
average
limitation
for
COD
corresponding
to
the
lower
concentration
value
must
be
applied.
(
e)
The
effluent
limitations
for
cyanide
are
as
follows:

EFFLUENT
LIMITATIONS
(
BPT)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Cyanide
(
T)
...............
33.5
9.4
1mg/
L
(
ppm).

*
*
*
*
*
8.
Section
439.14
is
revised
to
read
as
follows:

§
439.14
Effluent
limitations
attainable
by
the
application
of
best
available
technology
economically
achievable
(
BAT).

(
a)
Except
as
provided
in
40
CFR
125.30
through
125.32,
any
existing
point
source
subject
to
this
subpart
must
achieve
the
following
effluent
limitations
representing
the
application
of
BAT:

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EFFLUENT
LIMITATIONS
(
BAT)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Ammonia
(
as
N)
...
84.1
29.4
Acetone
.................
0.5
0.2
4­
methyl­
2­
pentanone
.........
0.5
0.2
Isobutyraldehyde
..
1.2
0.5
n­
Amyl
acetate
......
1.3
0.5
n­
Butyl
acetate
......
1.3
0.5
Ethyl
acetate
.........
1.3
0.5
Isopropyl
acetate
..
1.3
0.5
Methyl
formate
......
1.3
0.5
Amyl
alcohol
.........
10.0
4.1
Ethanol
..................
10.0
4.1
Isopropanol
...........
3.9
1.6
Methanol
...............
10.0
4.1
Methyl
Cellosolve
100.0
40.6
Dimethyl
sulfoxide
91.5
37.5
Triethyl
amine
.......
250.0
102.0
Phenol
...................
0.05
0.02
Benzene
................
0.05
0.02
Toluene
.................
0.06
0.02
Xylenes
.................
0.03
0.01
n­
Hexane
..............
0.03
0.02
n­
Heptane
.............
0.05
0.02
Methylene
chloride
0.9
0.3
Chloroform
............
0.02
0.13
1,2­
dichloroethane
0.4
0.1
Chlorobenzene
.....
0.15
0.06
o­
Dichlorobenzene
0.15
0.06
Tetrahydrofuran
....
8.4
2.6
Isopropyl
ether
......
8.4
2.6
Diethyl
amine
........
250.0
102.0
Acetonitrile
............
25.0
10.2
1
mg/
L
(
ppm).

(
b)
The
limitations
for
COD
are
the
same
as
specified
in
§
439.12(
c)
and
(
d).
(
c)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
9.
Section
439.15
is
revised
to
read
as
follows:

§
439.15
New
source
performance
standards
(
NSPS).
(
a)
Any
new
source
subject
to
this
subpart
must
achieve
the
following
standards:

PERFORMANCE
STANDARDS
(
NSPS)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
BOD5
.....................
267
111
TSS
.......................
472
166
COD
......................
1675
856
Ammonia
(
as
N)
...
84.1
29.4
Acetone
.................
0.5
0.2
4­
methyl­
2­
pentanone
.........
0.5
0.2
Isobutyraldehyde
..
1.2
0.5
n­
Amyl
acetate
......
1.3
0.5
n­
Butyl
acetate
......
1.3
0.5
Ethyl
acetate
.........
1.3
0.5
Isopropyl
acetate
..
1.3
0.5
Methyl
formate
......
1.3
0.5
Amyl
alcohol
.........
10.0
4.1
Ethanol
..................
10.0
4.1
PERFORMANCE
STANDARDS
(
NSPS)
 
Continued
Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Isopropanol
...........
3.9
1.6
Methanol
...............
10.0
4.1
Methyl
Cellosolve
100.0
40.6
Dimethyl
sulfoxide
91.5
37.5
Triethyl
amine
.......
250.0
102.0
Phenol
...................
0.05
0.02
Benzene
................
0.05
0.02
Toluene
.................
0.06
0.02
Xylenes
.................
0.03
0.01
n­
Hexane
..............
0.03
0.02
n­
Heptane
.............
0.05
0.02
Methylene
chloride
0.9
0.3
Chloroform
............
0.02
0.13
1,2­
dichloroethane
0.4
0.1
Chlorobenzene
.....
0.15
0.06
o­
Dichlorobenzene
0.15
0.06
Tetrahydrofuran
....
8.4
2.6
Isopropyl
ether
......
8.4
2.6
Diethyl
amine
........
250.0
102.0
Acetonitrile
............
25.0
10.2
1
mg/
L
(
ppm)

(
b)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
(
c)
Any
new
source
subject
to
the
provisions
of
this
section
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439,
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
which
the
source
must
achieve
the
standards
specified
in
§
§
439.13
and
439.14.
10.
Section
439.16
is
revised
to
read
as
follows:

§
439.16
Preatment
standards
for
existing
sources
(
PSES).
(
a)
Except
as
provided
in
40
CFR
403.7
and
403.13,
any
existing
source
subject
to
this
subpart
must
continue
achieving
the
standards
for
cyanide
specified
in
paragraph
(
c)
of
this
section
and
must
achieve
the
following
standards
by
September
21,
2001:

PRETREATMENT
STANDARDS
(
PSES)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Ammonia
(
as
N)
2
...
84.1
29.4
Acetone
...................
20.7
8.2
4­
methyl­
2­
pentanone
...........
20.7
8.2
Isobutyraldehyde
....
20.7
8.2
n­
Amyl
acetate
........
20.7
8.2
n­
Butyl
acetate
........
20.7
8.2
Ethyl
acetate
...........
20.7
8.2
Isopropyl
acetate
....
20.7
8.2
Methyl
formate
........
20.7
8.2
PRETREATMENT
STANDARDS
(
PSES)
 
Continued
Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Isopropyl
ether
........
20.7
8.2
Tetrahydrofuran
......
9.2
3.4
Benzene
..................
3.0
0.7
Toluene
...................
0.3
0.2
Xylenes
...................
3.0
0.7
n­
Heptane
...............
3.0
0.7
n­
Hexane
................
3.0
0.7
Methylene
chloride
3.0
0.7
Chloroform
..............
0.1
0.03
1,2­
dichloroethane
..
20.7
8.2
Chlorobenzene
.......
3.0
0.7
o­
Dichlorobenzene
..
20.7
8.2
Diethyl
amine
..........
255.0
100.0
Triethyl
amine
.........
255.0
100.0
1
mg/
L
(
ppm)
2
Not
applicable
to
sources
that
discharge
to
a
POTW
with
nitrification
capability.

(
b)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
§
439.1(
i))
are
not
required
to
achieve
the
pretreatment
standard
for
ammonia
(
as
N).
(
c)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
11.
Section
439.17
is
revised
to
read
as
follows:

§
439.17
Pretreatment
standards
for
new
sources
(
PSNS).
(
a)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharge
on
November
20,
1998,
or
thereafter
must
achieve
the
same
standards
as
specified
in
§
439.16.
(
b)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
pretreatment
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439
during
a
tenyear
period
beginning
on
the
date
the
source
commenced
discharge,
or
during
the
period
of
depreciation
or
amortization
of
the
facility,
whichever
comes
first,
after
which
the
source
must
achieve
the
same
standards
as
specified
in
§
439.16.
12.
Revise
the
heading
of
subpart
B
to
read
as
follows:

Subpart
B
 
Extraction
Products
13.
Section
439.21
is
revised
to
read
as
follows:

§
439.21
Special
definitions.
For
the
purpose
of
this
subpart:
(
a)
Extraction
means
process
operations
that
derive
pharmaceutically
active
ingredients
from
natural
sources
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13,
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/
Rules
and
Regulations
such
as
plant
roots
and
leaves,
animal
glands,
and
parasitic
fungi
by
chemical
and
physical
extraction.
(
b)
Product
means
any
substance
manufactured
by
an
extraction
process,
including
blood
fractions,
vaccines,
serums,
animal
bile
derivatives,
endocrine
products
and
medicinal
products
such
as
alkaloids
that
are
isolated
from
botanical
drugs
and
herbs.

14.
Section
439.22
is
amended
by
revising
paragraphs
(
a)
introductory
text
and
(
b)
through
(
d)
to
read
as
follows:

§
439.22
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

*
*
*
*
*
(
a)
The
limitation
for
BOD5
is
the
same
as
specified
in
§
439.12(
a).
No
facility
shall
be
required
to
attain
a
monthly
average
limitation
for
BOD5
that
is
less
than
the
equivalent
of
45
mg/
L.
*
*
*
*
*
(
b)
The
limitation
for
TSS
is
the
same
as
specified
in
§
439.12(
b).
(
c)
Except
for
the
provisions
in
paragraph
(
d)
of
this
section,
the
limitations
for
COD
are
as
follows:

EFFLUENT
LIMITATIONS
(
BPT)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
COD
..........................
228
86
1
mg/
L
(
ppm)

(
d)
If
the
maximum
monthly
average
COD
concentration
in
paragraph
(
c)
of
this
section
is
higher
than
a
concentration
value
reflecting
a
reduction
in
the
long­
term
average
daily
COD
load
in
the
raw
(
untreated)
process
wastewater
of
74
percent
multiplied
by
a
variability
factor
of
2.2,
then
a
monthly
average
limitation
for
COD
corresponding
to
the
lower
concentration
value
must
be
applied.

15.
Section
439.25
is
revised
to
read
as
follows:

§
439.25
New
source
performance
standards
(
NSPS).

(
a)
Any
new
source
subject
to
this
subpart
must
achieve
the
following
standards:

PERFORMANCE
STANDARDS
(
NSPS)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
BOD5
.........................
35
18
TSS
...........................
58
31
PERFORMANCE
STANDARDS
(
NSPS)
 
Continued
Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
COD
..........................
228
86
1
mg/
L
(
ppm)

(
b)
Any
new
source
subject
to
the
provisions
of
this
section
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439,
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
which
the
source
must
achieve
the
standards
specified
in
§
§
439.23
and
439.24.
16.
Section
439.26
is
revised
to
read
as
follows:

§
439.26
Pretreatment
standards
for
existing
sources
(
PSES).

Except
as
provided
in
40
CFR
403.7
and
403.13,
any
existing
source
subject
to
this
subpart
must
achieve
the
following
standards
by
September
21,
2001:

PRETREATMENT
STANDARDS
(
PSES)

Regulated
parameter
Maximum
daily
1
Maximum
monthly
average
1
Acetone
.....................
20.7
8.2
n­
Amyl
acetate
..........
20.7
8.2
Ethyl
acetate
.............
20.7
8.2
Isopropyl
acetate
......
20.7
8.2
Methylene
chloride
...
3.0
0.7
1
mg/
L
(
ppm).

17.
Section
439.27
is
revised
to
read
as
follows:

§
439.27
Pretreatment
standards
for
new
sources
(
PSNS).

(
a)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharge
on
November
20,
1998,
or
thereafter
must
achieve
the
same
standards
as
specified
in
§
439.26.
(
b)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
pretreatment
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439
during
a
tenyear
period
beginning
on
the
date
the
source
commenced
discharge,
or
during
the
period
of
depreciation
or
amortization
of
the
facility,
whichever
comes
first,
after
which
the
source
must
achieve
the
same
standards
as
specified
in
§
439.26.
18.
Revise
the
heading
of
Subpart
C
to
read
as
follows:

Subpart
C
 
Chemical
Synthesis
Products
19.
Section
439.31
is
revised,
including
the
section
heading,
to
read
as
follows:

§
439.31
Special
definitions.
For
the
purpose
of
this
subpart:
(
a)
Chemical
synthesis
means
using
one
or
a
series
of
chemical
reactions
in
the
manufacturing
process
of
a
specified
product.
(
b)
Product
means
any
pharmaceutical
product
manufactured
by
chemical
synthesis.
20.
Section
439.32
is
amended
by
revising
paragraphs
(
a)
through
(
d)
and
removing
paragraphs
(
e)
through
(
g)
to
read
as
follows:

§
439.32
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

*
*
*
*
*
(
a)
The
limitation
for
BOD5
is
the
same
as
specified
in
§
439.12(
a).
(
b)
The
limitation
for
TSS
is
the
same
as
specified
in
§
439.12(
b).
(
c)
The
limitations
for
COD
are
the
same
as
specified
in
§
439.12(
c)
and
(
d).
(
d)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
*
*
*
*
*
21.
Section
439.34
is
revised
to
read
as
follows:

§
439.34
Effluent
limitations
attainable
by
the
application
of
best
available
technology
economically
achievable
(
BAT).
Except
as
provided
in
40
CFR
125.30
through
125.32,
any
existing
point
source
subject
to
this
subpart
must
achieve
the
following
effluent
limitations
representing
the
application
of
BAT:
(
a)
The
limitations
are
the
same
as
specified
in
§
439.14(
a).
(
b)
The
limitations
for
COD
are
the
same
as
specified
in
§
439.12(
c)
and
(
d).
(
c)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
22.
Section
439.35
is
revised
to
read
as
follows:

§
439.35
New
source
performance
standards
(
NSPS).
(
a)
Any
new
source
subject
to
this
subpart
must
achieve
the
same
standards
as
specified
in
§
439.15(
a).
(
b)
The
limitations
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).

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Federal
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/
Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Rules
and
Regulations
(
c)
Any
new
source
subject
to
the
provisions
of
this
section
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439,
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
which
the
source
must
achieve
the
standards
specified
in
§
439.33
and
§
439.34.
23.
Section
439.36
is
revised
to
read
as
follows:

§
439.36
Pretreatment
standards
for
existing
sources
(
PSES).
Except
as
provided
in
40
CFR
403.7
and
403.13,
any
existing
source
subject
to
this
subpart
must
continue
achieving
the
standards
for
cyanide
specified
in
paragraph
(
b)
of
this
section
and
must
achieve
the
standards
specified
in
§
439.16(
a)
by
September
21,
2001.
(
a)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
§
439.1(
i))
are
not
required
to
achieve
the
standards
for
ammonia
(
as
N).
(
b)
The
standards
for
cyanide
are
the
same
as
specified
in
§
439.12(
e),
(
f)
and
(
g).
24.
Section
439.37
is
revised
to
read
as
follows:

§
439.37
Pretreatment
standards
for
new
sources
(
PSNS).
(
a)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharge
on
November
20,
1998,
or
thereafter
must
achieve
the
same
standards
as
specified
in
§
439.36.
(
b)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
pretreatment
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439
during
a
tenyear
period
beginning
on
the
date
the
source
commenced
discharge,
or
during
the
period
of
depreciation
or
amortization
of
the
facility,
whichever
comes
first,
after
which
the
source
must
achieve
the
same
standards
as
specified
in
§
439.36.
25.
Revise
the
heading
of
Subpart
D
to
read
as
follows:

Subpart
D
 
Mixing/
Compounding
and
Formulation
26.
Section
439.41
is
revised
to
read
as
follows:

§
439.41
Special
definitions.
For
the
purpose
of
this
subpart:
(
a)
Mixing,
compounding,
and
formulating
operations
means
processes
that
put
pharmaceutical
products
in
dosage
forms.
(
b)
Product
means
any
pharmaceutical
product
manufactured
by
blending,
mixing,
compounding,
and
formulating
pharmaceutical
ingredients.
The
term
includes
pharmaceutical
preparations
for
both
human
and
veterinary
use
such
as
ampules,
tablets,
capsules,
vials,
ointments,
medicinal
powders,
solutions,
and
suspensions.

27.
Section
439.42
is
amended
by
revising
paragraphs
(
a)
through
(
c)
and
removing
paragraph
(
d)
to
read
as
follows:

§
439.42
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

*
*
*
*
*
(
a)
The
limitation
for
BOD5
is
the
same
as
specified
in
§
439.12(
a).
No
facility
shall
be
required
to
attain
a
monthly
average
limitation
for
BOD5
that
is
less
than
the
equivalent
of
45
mg/
L.
(
b)
The
limitation
for
TSS
is
the
same
as
specified
in
§
439.12(
b).
(
c)
The
limitations
for
COD
are
the
same
as
specified
in
§
439.22(
c)
and
(
d).
*
*
*
*
*

28.
Section
439.44
is
revised
to
read
as
follows:

§
439.44
Effluent
limitations
attainable
by
the
application
of
best
available
technology
economically
achievable
(
BAT).

Except
as
provided
in
40
CFR
125.30
through
125.32,
any
existing
point
source
subject
to
this
subpart
must
achieve
the
following
effluent
limitations
representing
the
application
of
BAT:
The
limitations
for
COD
are
the
same
as
specified
in
§
439.22(
c)
and
(
d).

29.
Section
439.45
is
revised
to
read
as
follows:

§
439.45
New
source
performance
standards
(
NSPS).

(
a)
Any
new
source
subject
to
this
subpart
must
achieve
the
same
standards
as
specified
in
§
439.25(
a).
(
b)
Any
new
source
subject
to
the
provisions
of
this
section
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439,
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
which
the
source
must
achieve
the
standards
specified
in
§
439.43
and
§
439.44.
30.
Section
439.46
is
revised
to
read
as
follows:
§
439.46
Pretreatment
standards
for
existing
sources
(
PSES).
Except
as
provided
in
40
CFR
403.7
and
403.13,
any
existing
source
subject
to
this
subpart
must
achieve
the
following
standards
by
September
21,
2001:

PRETREATMENT
STANDARDS
(
PSES)

Regulated
parameter
Maximum
daily1
Maximum
monthly
average1
Acetone
.....................
20.7
8.2
n­
Amyl
acetate
..........
20.7
8.2
Ethyl
acetate
.............
20.7
8.2
Isopropyl
acetate
......
20.7
8.2
Methylene
chloride
...
3.0
0.7
1
mg/
L
(
ppm).

31.
Section
439.47
is
revised
to
read
as
follows:

§
439.47
Pretreatment
standards
for
new
sources
(
PSNS).
(
a)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharge
on
November
20,
1998,
or
thereafter
must
achieve
the
same
standards
as
specified
in
§
439.46.
(
b)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
that
commenced
discharging
after
November
21,
1988,
and
prior
to
November
20,
1998,
must
continue
to
achieve
the
pretreatment
standards
specified
for
this
section
in
the
1988
edition
of
40
CFR
part
439
during
a
tenyear
period
beginning
on
the
date
the
source
commenced
discharge,
or
during
the
period
of
depreciation
or
amortization
of
the
facility,
whichever
comes
first,
after
which
the
source
must
achieve
the
same
standards
as
specified
in
§
439.46.
32.
Revise
the
heading
of
subpart
E
to
read
as
follows:

Subpart
E
 
Research
33.
Section
439.51
is
revised
to
read
as
follows:

§
439.51
Special
definitions.
For
the
purpose
of
this
subpart,
product
means
products
or
services
resulting
from
research
and
product
development
activities.
34.
Section
439.52
is
amended
by
revising
paragraphs
(
a)
through
(
d)
to
read
as
follows:

§
439.52
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

*
*
*
*
*
(
a)
The
limitation
for
BOD5
is
the
same
as
specified
in
§
439.12(
a).
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Federal
Register
/
Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Rules
and
Regulations
facility
shall
be
required
to
attain
a
monthly
average
limitation
for
BOD5
that
is
less
than
the
equivalent
of
45
mg/
L.
(
b)
The
limitation
for
TSS
is
the
same
as
specified
in
§
439.12(
b).
(
c)
The
maximum
monthly
average
limitation
for
COD,
expressed
as
mass
loading
(
lbs,
kg)
per
day,
must
reflect
not
less
than
74
percent
reduction
in
the
long­
term
average
daily
COD
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
2.2.
No
facility
shall
be
required
to
attain
a
limitation
for
COD
that
is
less
than
the
equivalent
of
220
mg/
L.
(
d)
The
long­
term
average
daily
BOD5
or
COD
mass
loading
of
the
raw
process
wastewater
(
i.
e.,
the
base
number
to
which
the
percent
reduction
is
applied)
is
defined
as
the
average
daily
BOD5
or
COD
load
during
any
calendar
month,
over
12
consecutive
months
within
the
most
recent
36
months.
(
1)
To
assure
equity
in
the
determination
of
NPDES
permit
limitations
regulating
discharges
subject
to
this
subpart,
calculation
of
the
longterm
average
daily
BOD5
or
COD
load
in
the
influent
to
the
wastewater
treatment
system
must
exclude
any
portion
of
the
load
associated
with
solvents,
except
for
residual
amounts
of
solvents
remaining
after
the
practices
of
recovery
and/
or
separate
disposal
or
reuse.
Residual
amounts
of
these
substances
may
be
included
in
the
calculation
of
the
average
influent
BOD5
or
COD
loading.
(
2)
The
practices
of
recovery,
and/
or
separate
disposal
or
reuse
include:
recovery
of
solvents
from
wastestreams;
and
incineration
of
concentrated
solvent
wastestreams
(
including
tar
still
bottoms).
This
regulation
does
not
prohibit
the
inclusion
of
such
wastes
in
raw
waste
loads
in
fact,
nor
does
it
mandate
any
specific
practice,
but
rather
describes
the
rationale
for
determining
NPDES
permit
limitations.
The
effluent
limitation
for
BOD5
or
COD
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.
*
*
*
*
*

35.
Table
2
of
Appendix
A
is
revised
to
read
as
follows:

Appendix
A
to
Part
439
 
Tables
*
*
*
*
*
TABLE
2.
 
SURROGATE
PARAMETERS
FOR
INDIRECT
DISCHARGERS
(
UTILIZING
STEAM
STRIPPING
TREATMENT
TECHNOLOGY)

Regulated
parameters
Treatability
class
Benzene
Toluene
1
Xylenes
n­
Heptane
High
strippability.
Chloroform
1
Methylene
chloride
1
Chlorobenzene
Ammonia
(
aqueous)
Diethyl
amine
Triethyl
amine
Acetone
1
4­
methyl­
2­
pentanone
n­
Amyl
acetate
n­
Butyl
acetate
Ethyl
acetate
Medium
strippability.
Isopropyl
acetate
Methyl
formate
Isopropyl
ether
Tetrahydrofuran
1
1,2­
dichloroethane
o­
Dichlorobenzene
1
These
parameters
may
be
used
as
a
surrogate
to
represent
other
parameters
in
the
same
treatability
class.

[
FR
Doc.
03
 
5716
Filed
3
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
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