Document ID: EPA-HQ-OW-2003-0007-0007
Agency: epa
Document Type: Rule
Title: Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Final Rule.
Posted Date: 2003-02-26T05:00Z

EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
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Guidelines,
Pretreatment
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New
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Performance
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Final
Rule
[
Federal
Register:
September
21,
1998
(
Volume
63,
Number
182)]
[
Rules
and
Regulations]
[
Page
50387­
50437]
From
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wais.
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[
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fr21se98­
25]

[[
Page
50387]]

_______________________________________________________________________

Part
III
Environmental
Protection
Agency
_______________________________________________________________________

http://
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epa.
gov/
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EPA­
WATER/
1998/
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
40
CFR
Parts
136
and
439
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
[[
Page
50388]]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Parts
136
and
439
[
FRL­
6135­
7]
RIN
2040­
AA13
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
AGENCY:
Environmental
Protection
Agency.

ACTION:
Final
rule.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
final
regulation
limits
the
discharge
of
pollutants
into
navigable
waters
of
the
United
States
and
into
publicly
owned
treatment
works
(
POTWs)
by
existing
and
new
pharmaceutical
manufacturing
facilities.
This
regulation
revises
limitations
and
standards
for
four
subcategories
of
the
pharmaceutical
manufacturing
Point
Source
Category:
Subcategory
A
(
Fermentation),
Subcategory
B
(
Extraction),

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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Subcategory
C
(
Chemical
Synthesis):
and
Subcategory
D
(
Mixing,
Compounding,
and
Formulating);
and
reformats
and
clarifies
language
without
revision
to
certain
specified
provisions
of
these
four
subcategories
and
a
fifth
subcategory:
Subcategory
E
(
Research).
This
regulation
establishes
effluent
limitations
guidelines
and
standards
under
the
Clean
Water
Act
including
  
best
conventional
pollutant
control
technology
(
BCT)
and
  
best
available
technology
economically
achievable
(
BAT)''
for
existing
direct
dischargers,
  
new
source
performance
standards
(
NSPS)''
for
new
direct
dischargers
and
pretreatment
standards
for
existing
and
new
indirect
dischargers
(
PSES
and
PSNS).
This
regulation
also
amends
and
clarifies
some
of
the
limitations
based
on
  
best
practicable
control
technology
(
BPT)''
for
pharmaceutical
manufacturing
facilities
and
establishes
analytical
methods
for
certain
organic
pollutants
contained
in
this
regulation.
EPA
is
today
also
publishing
final
Maximum
Available
Control
Technology
(
MACT)
standards
under
the
Clean
Air
Act
(
CAA)
for
the
pharmaceutical
manufacturing
industry
elsewhere
in
today's
Federal
Register.
The
MACT
standards
final
rule
will
control
emissions
of
hazardous
air
pollutants
(
HAPs)
from
pharmaceutical
manufacturing
emission
sources
including
wastewater
collection
and
treatment
systems.
The
Offices
of
Water
and
Air
and
Radiation
have
coordinated
the
development
of
these
regulations
and
have
used
a
common
technology
basis
in
developing
limitations
and
standards
for
the
volatile
organic
compounds
(
VOCs).
The
final
MACT
standards
and
effluent
limitations
guidelines
and
standards
rules
will
benefit
the
environment
by
removing
a
total
of
85.4
million
pounds
per
year
of
conventional,
nonconventional
and
toxic
(
priority)
pollutants
from
water
discharges.
The
effluent
limitations
guidelines
and
standards
portion
of
those
removals
is
13.9
million
pounds
per
year
of
nonconventional
and
16.0
million
pounds
per
year
of
organic
pollutants
including
VOCs.

DATES:
This
regulation
shall
become
effective
November
20,
1998.
The
incorportion
by
reference
of
certain
publications
listed
in
Part
136
is
approved
by
the
Director
of
the
Federal
Register
as
of
November
20,
1998.

ADDRESSES:
For
additional
technical
information
write
to
Dr.
Frank
H.
Hund,
Engineering
and
Analysis
Division
(
4303),
U.
S.
EPA,
East
Tower,

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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169)
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
401
M
Street
SW,
Washington,
D.
C.
20460
or
send
E­
mail
to:
hund.
frank@
epamail.
epa.
gov
or
call
at
(
202)
260­
7182.
For
additional
economic
information
contact
Mr.
William
Anderson
at
the
address
above
or
by
calling
(
202)
260­
5131
or
send
E­
mail
to:
anderson.
william@
epamail.
epa.
gov.
The
complete
record
(
excluding
confidential
business
information)
for
this
Clean
Water
Act
rulemaking
is
available
for
review
at
EPA's
Water
Docket,
Room
EB57;
401
M
Street,
SW,
Washington,
DC
20460.
For
access
to
Docket
materials,
call
(
202)
260­
3027
between
9
a.
m.
and
3:
30
p.
m.
for
an
appointment.
The
EPA
public
information
regulation
(
40
CFR
part
2)
provides
that
a
reasonable
fee
may
be
charged
for
copying.
The
Technical
Development
Document
and
Economic
Impact
Analysis
supporting
today's
final
water
rule
may
be
obtained
by
writing
to
the
EPA
Office
of
Water
Resource
Center
(
RC­
4100),
401
M
Street
SW.,
Washington,
DC
20460,
or
calling
(
202)
260­
7786.

FOR
FURTHER
INFORMATION
CONTACT:
For
additional
technical
information
call
Dr.
Frank
H.
Hund
at
(
202)
260­
7182.
For
additional
information
on
the
economic
impact
analyses
contact
Mr.
William
Anderson
at
(
202)
260­
5131.
SUPPLEMENTARY
INFORMATION:

Judicial
Review
In
accordance
with
40
CFR
23.2,
the
rule
will
be
considered
promulgated
for
purposes
of
judicial
review
at
1:
00
p.
m.
Eastern
time
on
October
5,
1998.
Under
section
509(
b)(
1)
of
the
Act,
judicial
review
of
this
regulation
can
be
obtained
only
by
filing
a
petition
for
review
in
the
United
States
Court
of
Appeals
within
120
days
after
the
regulation
is
considered
promulgated
for
purposes
of
judicial
review.
Under
section
509
(
b)(
2)
of
the
Act,
the
requirements
in
this
regulation
may
not
be
challenged
later
in
civil
or
criminal
proceedings
brought
by
EPA
to
enforce
these
requirements.

Regulated
Entities
Entities
potentially
regulated
by
this
action
include:

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Category
Examples
of
regulated
entities
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
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.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

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
applicability
criteria
in
Secs.
439.1,
439.10,
439.20,
439.30,
439.40
and
439.50
of
this
final
rule.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
information
person
listed
in
the
preceding
FOR
FURTHER
INFORMATION
CONTACT
section.

Compliance
Dates
The
compliance
date
for
PSES
is
as
soon
as
possible,
but
no
later
than
September
21,
2001.
The
compliance
dates
for
NSPS
and
PSNS
are
the
dates
the
new
source
commences
discharging.

[[
Page
50389]]

Deadlines
for
compliance
with
BPT,
BCT,
and
BAT
are
established
in
the
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permits.

Organization
of
This
Document
I.
Legal
Authority
II.
Background
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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21/
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
A.
Clean
Water
Act
1.
Best
Practicable
Control
Technology
Currently
Available
(
BPT)
2.
Best
Available
Technology
Economically
Achievable
(
BAT)
(
Section
304(
b)(
2)
of
the
Act)
3.
Best
Conventional
Pollutant
Control
Technology
(
BCT)
(
Section
304(
b)(
4)
of
the
Act)
4.
New
Source
Performance
Standards
(
NSPS)
(
Section
306
of
the
Act)
5.
Pretreatment
Standards
for
Existing
Sources
(
PSES)
(
Section
307(
b)
of
the
Act)
6.
Pretreatment
Standards
for
New
Sources
(
PSNS)
(
Section
307(
b)
of
the
Act)
B.
Section
304(
m)
Requirements
and
the
Pollution
Prevention
Act
C.
Updated
Profile
of
the
Industry
D.
Existing
and
Proposed
Rules
1.
Clean
Water
Act
Proposal
2.
Clean
Air
Act
Proposal
3.
Clean
Water
Act
Federal
Register
Notice
of
Availability
E.
Discussion
of
Final
Clean
Air
Act
Rule
Published
Elsewhere
in
Today's
Federal
Register
F.
Relationship
Between
the
MACT
and
CWA
Rules
G.
Final
Clean
Water
Act
Effluent
Limitations
Guidelines
and
Standards
Rule
III.
Summary
of
Most
Significant
Changes
to
Water
Rules
From
Proposal
A.
Limitations
and
Standards
for
Volatile
Organic
Compounds
B.
Change
in
BAT
Technology
Basis
for
Organic
Pollutants
C.
BPT
and
BAT/
BCT
Limitation
Changes
D.
Pollutant
Selection
IV.
The
Final
Clean
Water
Act
Regulation
A.
Applicability
and
Scope
of
the
Final
Rule
B.
Options
Selection
C.
Best
Practicable
Control
Technology
Currently
Available
(
BPT)
D.
Best
Available
Technology
Economically
Achievable
E.
Pretreatment
Standards
for
Existing
Sources
(
PSES)
F.
New
Source
Performance
Standards
(
NSPS)
G.
Pretreatment
Standards
for
New
Sources
(
PSNS)

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
H.
Best
Conventional
Pollutant
Control
Technology
(
BCT)
V.
Assessment
of
Costs
and
Impacts
for
the
Final
Pharmaceutical
Regulations
A.
Introduction
B.
Summary
of
Economic
Analysis
Methodology
and
Data
C.
Changes
to
the
Economic
Analysis
Since
Proposal
D.
Estimated
Economic
Impacts
1.
Costs
of
Compliance
2.
Economic
Impacts
on
Facilities
3.
Economic
Impacts
on
Firms
4.
Impacts
on
Output
and
Employment
5.
Other
Secondary
Impacts
6.
Impacts
on
New
Sources
E.
Regulatory
Flexibility
Analysis
F.
Cost­
Benefit
Analysis
G
Cost­
Effectiveness
Analysis
VI.
Environmental
Benefits
VII.
Non­
Water
Quality
Environmental
Impacts
A.
Air
Pollution
B.
Solid
Waste
C.
Energy
Requirements
VIII.
Regulatory
Implementation
A.
Implementation
of
the
Limitations
and
Standards
B.
Upset
and
Bypass
Provisions
C.
Variances
and
Modifications
1.
Fundamentally
Different
Factors
Variances
2.
Removal
Credits
D.
Analytical
Methods
IX.
Regulatory
Assessment
Requirements
A.
Executive
Order
12866
B.
Regulatory
Flexibility
Act
and
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA)
C.
Submission
to
Congress
and
the
General
Accounting
Office
D.
Paperwork
Reduction
Act
E.
Unfunded
Mandates
Reform
Act
F.
Executive
Order
12875
Enhancing
Intergovernmental
Partnership
G.
National
Technology
Transfer
and
Advancement
Act
http://
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WATER/
1998/
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Day­
21/
w21027.
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
H.
Executive
Order
13045
and
Protecting
Children's
Health
X.
Summary
of
Public
Participation
A.
Summary
of
Proposal
Comments
and
Responses
B.
Summary
of
Notice
of
Availability
Comments
and
Responses
Appendix
A
to
the
Preamble­­
List
of
Abbreviations,
Acronyms,
Definitions
and
Other
Terms
Used
in
This
Document
I.
Legal
Authority
This
final
regulation
establishes
effluent
limitations
guidelines
and
standards
of
performance
and
analytical
methods
for
the
pharmaceutical
manufacturing
point
source
category
under
the
authorities
of
sections
301,
304,
306,
307,
308,
402
and
501
of
the
Clean
Water
Act
(  
the
Act''),
33
U.
S.
C.
1311,
1314,
1316,
1317,
1318,
1342
and
1361.

II.
Background
A.
Clean
Water
Act
The
Federal
Water
Pollution
Control
Act
Amendments
of
1972
established
a
comprehensive
program
to
  
restore
and
maintain
the
chemical,
physical,
and
biological
integrity
of
the
Nation's
waters,''
(
section
101(
a)).
To
implement
the
Act,
EPA
is
to
issue
effluent
limitations
guidelines,
pretreatment
standards
and
new
source
performance
standards
for
industrial
dischargers.
These
guidelines
and
standards
are
summarized
briefly
below:
1.
Best
Practicable
Control
Technology
Currently
Available
(
BPT)
(
Section
304(
b)(
1)
of
the
Act)
BPT
effluent
limitations
apply
to
all
discharges
from
existing
direct
dischargers.
BPT
effluent
limitations
guidelines
are
generally
based
on
the
average
of
the
best
existing
performance
by
plants
of
various
sizes,
ages,
and
unit
processes
within
the
category
or
subcategory
for
control
of
pollutants.
In
establishing
BPT
effluent
limitations
guidelines,
EPA
considers
the
total
cost
of
achieving
effluent
reductions
in
relation
to
the
effluent
reduction
benefits,
the
age
of
equipment
and
facilities
involved,
the
processes
employed,
process
changes
required,
engineering
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
aspects
of
the
control
technologies,
non­
water
quality
environmental
impacts
(
including
energy
requirements)
and
other
factors
as
the
EPA
Administrator
deems
appropriate
(
Section
304(
b)(
1)(
B)
of
the
Act).
The
Agency
considers
the
category
or
subcategory­
wide
cost
of
applying
the
technology
in
relation
to
the
effluent
reduction
benefits.
Where
existing
performance
is
uniformly
inadequate
within
a
category
or
subcategory,
BPT
may
be
transferred
from
a
different
subcategory
or
category.
2.
Best
Available
Technology
Economically
Achievable
(
BAT)
(
Section
304(
b)(
2)
of
the
Act)
In
general,
BAT
effluent
limitations
represent
the
best
existing
economically
achievable
performance
of
plants
in
the
industrial
subcategory
or
category,
based
upon
available
technology.
The
Act
establishes
BAT
as
the
principal
national
means
of
controlling
the
direct
discharge
of
toxic
and
nonconventional
pollutants
to
navigable
waters.
The
factors
considered
in
assessing
BAT
include
the
age
of
equipment
and
facilities
involved,
the
process
employed,
potential
process
changes,
and
non­
water
quality
environmental
impacts
(
including
energy
requirements)
(
Section
304(
b)(
2)(
B)).
The
Agency
retains
considerable
discretion
in
assigning
the
weight
to
be
accorded
these
factors.
As
with
BPT,
where
existing
performance
is
uniformly
inadequate
within
a
category
or
subcategory,
BAT
may
be
transferred
from
a
different
subcategory
or
category.
BAT
may
include
process
changes
or
internal
controls,
even
when
these
technologies
are
not
common
industry
practice.

[[
Page
50390]]

3.
Best
Conventional
Pollutant
Control
Technology
(
BCT)
(
Section
304(
b)(
4)
of
the
Act)
The
1977
Amendments
to
the
Act
established
BCT
for
discharges
of
conventional
pollutants
from
existing
industrial
point
sources.
Section
304(
a)(
4)
designated
the
following
as
conventional
pollutants:
Biochemical
oxygen
demanding
pollutants
(
BOD<
INF>
5</
INF>),
total
suspended
solids
(
TSS),
fecal
coliform,
pH,
and
any
additional
pollutants
defined
by
the
Administrator
as
conventional.
The
Administrator
designated
oil
and
grease
as
an
additional
conventional
pollutant
on
July
30,
1979
(
44
FR
44501).

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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Day­
21/
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htm
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169)
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
BCT
is
not
an
additional
limitation,
but
replaces
BAT
for
the
control
of
conventional
pollutants.
In
addition
to
other
factors
specified
in
Section
304(
b)(
4)(
B),
the
Act
requires
that
BCT
limitations
be
established
in
light
of
a
two
part
  
costreasonableness
test.
American
Paper
Institute
v.
EPA,
660
F.
2d
954
(
4th
Cir.
1981).
EPA's
current
methodology
for
the
general
development
of
BCT
limitations
was
issued
in
1986
(
51
FR
24974;
July
9,
1986).
4.
New
Source
Performance
Standards
(
NSPS)
(
Section
306
of
the
Act)
NSPS
are
based
on
the
best
available
demonstrated
control
technology.
New
plants
have
the
opportunity
to
install
the
best
and
most
efficient
production
processes
and
wastewater
treatment
technologies.
As
a
result,
NSPS
should
represent
the
most
stringent
numerical
values
attainable
through
the
application
of
the
best
available
control
technology
for
all
pollutants
(
e.
g.,
conventional,
nonconventional,
and
toxic
pollutants).
In
establishing
NSPS,
EPA
is
directed
to
take
into
consideration
the
cost
of
achieving
the
effluent
reduction
and
any
non­
water
quality
environmental
impacts
and
energy
requirements.
5.
Pretreatment
Standards
for
Existing
Sources
(
PSES)
(
Section
307(
b)
of
the
Act)
PSES
are
designed
to
prevent
the
discharge
of
pollutants
that
pass
through,
interfere
with,
or
are
otherwise
incompatible
with
the
operation
of
publicly
owned
treatment
works
(
POTWs).
The
Act
authorizes
EPA
to
establish
pretreatment
standards
for
pollutants
that
pass
through
POTWs
or
interfere
with
POTWs'
treatment
processes
or
sludge
disposal
methods.
The
legislative
history
of
the
1977
Act
indicates
that
pretreatment
standards
are
to
be
technology­
based
and
analogous
to
the
BAT
effluent
limitations
guidelines
for
removal
of
toxic
pollutants.
For
the
purpose
of
determining
whether
to
promulgate
national
category­
wide
pretreatment
standards,
EPA
generally
determines
that
there
is
pass
through
of
a
pollutant
and
thus
a
need
for
categorical
standards
if
the
nation­
wide
average
percent
removal
of
a
pollutant
removed
by
well­
operated
POTWs
achieving
secondary
treatment
is
less
than
the
percent
removed
by
the
BAT
model
treatment
system.
The
General
Pretreatment
Regulations,
which
set
forth
the
framework
for
the
implementation
of
categorical
pretreatment
standards,
are
found
at
40
CFR
Part
403.
(
Those
regulations
contain
a
definition
of
pass
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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169)
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
through
that
addresses
localized
rather
than
national
instances
of
pass
through
and
does
not
use
the
percent
removal
comparison
test
described
above.
See
52
FR
1586,
January
14,
1987.)
6.
Pretreatment
Standards
for
New
Sources
(
PSNS)
(
Section
307(
b)
of
the
Act)
Like
PSES,
PSNS
are
designed
to
prevent
the
discharges
of
pollutants
that
pass
through,
interfere
with,
or
are
otherwise
incompatible
with
the
operation
of
POTWs.
PSNS
are
to
be
issued
at
the
same
time
as
NSPS.
New
indirect
dischargers,
like
new
direct
dischargers,
have
the
opportunity
to
incorporate
into
their
plants
the
best
available
demonstrated
technologies.
The
Agency
considers
the
same
factors
in
promulgating
PSNS
as
it
considers
in
promulgating
NSPS.

B.
Section
304(
m)
Requirements
and
the
Pollution
Prevention
Act
Section
304(
m)
of
the
Clean
Water
Act
(
33
U.
S.
C.
1314(
m)),
added
by
the
Water
Quality
Act
of
1987,
requires
EPA
to
establish
schedules
for
(
i)
reviewing
and
revising
existing
effluent
limitations
guidelines
and
standards
(  
effluent
guidelines''),
and
(
ii)
promulgating
new
effluent
guidelines.
On
January
2,
1990,
EPA
published
an
Effluent
Guidelines
Plan
(
55
FR
80),
in
which
schedules
were
established
for
developing
new
and
revised
effluent
guidelines
for
several
industry
categories.
One
of
the
industries
for
which
the
Agency
established
a
schedule
was
the
Pharmaceutical
Manufacturing
Point
Source
Category.
Natural
Resources
Defense
Council,
Inc.
(
NRDC)
and
Public
Citizen,
Inc.,
challenged
the
Effluent
Guidelines
Plan
in
a
suit
filed
in
U.
S.
District
Court
for
the
District
of
Columbia
(
NRDC
et
al
v.
Reilly,
Civ.
No.
89­
2980).
The
plaintiffs
charged
that
EPA's
plan
did
not
meet
the
requirements
of
sec.
304(
m).
A
Consent
Decree
in
this
litigation
was
entered
by
the
Court
on
January
31,
1992.
The
terms
of
the
Consent
Decree
are
reflected
in
the
Effluent
Guidelines
Plan
published
on
September
8,
1992
(
57
FR
41000).
This
plan,
as
modified,
required,
among
other
things,
that
EPA
propose
effluent
guidelines
for
the
pharmaceutical
manufacturing
category
by
February,
1995
and
take
final
action
on
these
effluent
guidelines
by
April,
1998.
Recently
EPA
filed
an
unopposed
motion
requesting
an
extension
of
time
until
July
30,
1998
for
the
Administrator
to
sign
the
final
rule.
The
Pollution
Prevention
Act
of
1990
(
PPA)
(
42
U.
S.
C.
13101
et
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
11
of
169)
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8:
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
seq.,
Pub.
L.
101­
508,
November
5,
1990)
  
declares
it
to
be
the
national
policy
of
the
United
States
that
pollution
should
be
prevented
or
reduced
whenever
feasible;
pollution
that
cannot
be
prevented
should
be
recycled
in
an
environmentally
safe
manner,
whenever
feasible;
pollution
that
cannot
be
prevented
or
recycled
should
be
treated
in
an
environmentally
safe
manner
whenever
feasible;
and
disposal
or
release
into
the
environment
should
be
employed
only
as
a
last
resort...''
(
Sec.
6602;
42
U.
S.
C.
13101(
b).
In
short,
preventing
pollution
before
it
is
created
is
preferable
to
trying
to
manage,
treat
or
dispose
of
it
after
it
is
created.
This
effluent
guideline
was
reviewed
for
its
incorporation
of
pollution
prevention
as
part
of
this
Agency
effort.
According
to
the
PPA,
source
reduction
reduces
the
generation
and
release
of
hazardous
substances,
pollutants,
wastes,
contaminants
or
residuals
at
the
source,
usually
within
a
process.
The
term
source
reduction
  
include[
s]
equipment
or
technology
modifications,
process
or
procedure
modifications,
reformulation
or
redesign
of
products,
substitution
of
raw
materials,
and
improvements
in
housekeeping,
maintenance,
training,
or
inventory
control.''
The
term
  
source
reduction''
does
not
include
any
practice
which
alters
the
physical,
chemical,
or
biological
characteristics
or
the
volume
of
a
hazardous
substance,
pollutant,
or
contaminant
through
a
process
or
activity
which
itself
is
not
integral
to
or
necessary
for
the
production
of
a
product
or
the
providing
of
a
service.''
42
U.
S.
C.
13102(
5)
In
effect,
source
reduction
means
reducing
the
amount
of
a
pollutant
that
enters
a
waste
stream
or
that
is
otherwise
released
into
the
environment
prior
to
out­
of­
process
recycling,
treatment,
or
disposal.
The
PPA
directs
the
Agency
to,
among
other
things,
  
review
regulations
of
the
Agency
prior
and
subsequent
to
their
proposal
to
determine
their
effect
on
[[
Page
50391]]

source
reduction''
(
Sec.
6604;
42
U.
S.
C.
13103(
b)(
2).
This
directive
led
the
Agency
to
implement
a
pilot
project
called
the
Source
Reduction
Review
Project
that
would
facilitate
the
integration
of
source
reduction
in
the
Agency's
regulations,
including
the
technology­
based
effluent
guidelines
and
standards.
In
the
preamble
to
the
proposed
regulations,
EPA
discussed
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
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21/
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htm
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
possible
pollution
prevention
alternatives
available
in
pharmaceutical
manufacturing.
At
that
time,
EPA
indicated
that
pollution
prevention
opportunities
were
limited
in
the
active
ingredient
manufacturing
subcategories
(
namely,
fermentation,
natural
extraction
and
chemical
synthesis)
but
the
use
of
water­
based
coatings
in
the
formulation
subcategory
operations
was
a
viable
pollution
prevention
approach
which
eliminates
the
need
for
solvents
in
tablet
coating
operations.
This
approach
may
only
be
applicable
to
some
and
not
most
tablet
coating
operations,
however.
Since
the
proposal,
EPA
has
received
two
suggestions
for
incorporating
pollution
prevention
into
the
final
regulations
which
were
discussed
in
the
August
8,
1997
Notice
of
Availability
at
62
FR
42720.
One
suggestion
presented
to
the
Agency
was
that
Subcategories
B
and
D
dischargers
that
incorporate
best
management
practices
(
BMPs),
which
reduce
their
discharge
of
any
of
the
regulated
pollutants
should
not
have
to
monitor
for
the
specific
regulated
pollutants,
and
possibly
only
monitor
for
the
conventional
pollutants
and
COD.
This
pollution
prevention
approach
is
similar
to
the
one
adopted
in
the
Pesticide
Formulators,
Packagers
and
Repackagers
(
PFPR)
final
regulation
which
was
published
in
the
Federal
Register
on
November
6,
1996
at
61
FR
57518.
(
It
should
be
noted
that
PFPR
facilities
that
use
the
promulgated
pollution
prevention
option
have
to
assess
their
wastewater
and
may
be
required
to
treat
wastewater
prior
to
discharge.)
EPA
evaluated
this
suggestion
and
decided
that
since
EPA
is
not
promulgating
BAT
limitations
for
specific
organic
pollutants,
this
pollution
prevention
suggestion
was
not
relevant
to
compliance
by
subcategory
B
and
D
direct
dischargers
with
final
BAT
limitations.
For
PSES,
EPA
believes
the
suggestion
may
be
workable
for
indirect
dischargers,
since
standards
for
specific
organic
pollutants
are
contained
in
the
final
rule;
however,
no
information
was
submitted
to
identify
the
pollution
prevention
practices
that
would
be
incorporated
into
the
rule,
and
EPA
has
been
unable
to
identify
any.
Another
pollution
prevention
approach
suggested
to
EPA
was
that
Subcategories
A
and
C
facilities
that
can
demonstrate
a
reduction
in
the
use
of
a
regulated
pollutant
and
resultant
lowered
air
emissions
or
water
discharges
should
receive
a
higher
effluent
discharge
limitation.
As
suggested,
the
higher
effluent
discharge
limitation
would
be
directly
proportional
to
the
amount
of
reduction
achieved
in
the
use
of
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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Day­
21/
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htm
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
the
regulated
pollutant.
Along
with
this
suggestion,
the
commenters
provided
examples
of
how
this
pollution
prevention
suggestion
could
work
in
individual
instances.
In
evaluating
this
suggestion
including
the
examples
provided,
EPA
was
concerned
about
the
amount
and
type
of
process
information
that
would
have
to
be
obtained
from
facilities
and
the
methodology
for
estimating
the
pollutant
reductions
as
the
result
of
any
pollution
prevention
practices.
Another
concern
of
the
Agency
had
to
do
with
the
determination
of
when,
in
the
new
product
development
phase
of
work,
the
practice
represents
a
pollution
prevention
activity
or
is
just
part
of
normal
process
development
work
in
bringing
a
new
product
process
to
full
scale
production.
EPA
was
also
concerned
that
pollutant
discharge
or
emission
reductions
achieved
in
the
bench
scale
or
pilot
scale
product
development
activities
may
not
be
realized
during
full
scale
production
operations.
In
the
period
following
publication
of
the
NOA,
the
Agency
did
not
receive
sufficient
information
relative
to
these
concerns
to
enable
it
to
develop
a
viable
pollution
prevention
alternative
based
on
this
suggestion.

C.
Updated
Profile
of
the
Industry
The
pharmaceutical
manufacturing
industry
covered
by
this
rulemaking
is
made
up
of
566
facilities
located
in
39
states,
Puerto
Rico
and
the
Virgin
Islands.
EPA
estimates
that
304
of
these
facilities
could
be
affected
by
today's
final
rule.
The
major
concentrations
of
manufacturing
facilities
are
located
in
the
Northeast,
the
Midwest
and
Puerto
Rico.
The
pharmaceutical
manufacturing
industry
is
defined
by
four
types
of
manufacturing
operations
or
processes.
These
activities
result
in
subcategorization
for
purposes
of
this
rulemaking.
The
four
subcategories
are
referred
to
as:
<
bullet>
Subcategory
A:
Fermentation
<
bullet>
Subcategory
B:
Natural
Extraction
<
bullet>
Subcategory
C:
Chemical
Synthesis
<
bullet>
Subcategory
D:
Formulating,
Mixing
and
Compounding
A
complete
discussion
of
each
subcategory's
manufacturing
operations
and
wastewater
characteristics
may
be
found
in
Sections
3
and
5
of
the
final
Technical
Development
Document
(
TDD),
  
Development
http://
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epa.
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WATER/
1998/
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21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Document
for
Final
Effluent
Limitations
Guidelines
and
Standards
for
the
Pharmaceutical
Manufacturing
Point
Source
Category''
(
EPA
821­
R­
98­
005).
A
fifth
subcategory,
Subcategory
E:
Research,
was
excluded
from
regulation
beyond
the
existing
BPT
regulation
promulgated
on
October
27,
1983
at
48
FR
49808.
The
Research
subcategory
is
defined
by
benchscale
activities
or
operations
related
to
the
research
on
and
development
of
pharmaceutical
products.
BAT/
BCT
limitations
for
this
subcategory
are
determined
on
a
case
by
case
best
professional
judgment
(
BPJ)
basis.
For
indirect
dischargers,
the
general
prohibition
in
40
CFR
part
403
apply;
in
addition
POTWs
will
establish
local
pretreatment
limits
on
a
case
by
case
basis
as
necessary.

D.
Existing
and
Proposed
Rules
EPA
promulgated
interim
final
BPT
regulations
for
the
pharmaceutical
manufacturing
point
source
category
on
November
17,
1976
(
41
FR
50676;
40
CFR
Part
439,
Subparts
A
through
E).
The
five
subcategories
of
the
pharmaceutical
manufacturing
industry
(
40
CFR
part
439)
were
defined
at
that
time
as:
<
bullet>
Subpart
A­­
Fermentation
Products
Subcategory
<
bullet>
Subpart
B­­
Extraction
Products
Subcategory
<
bullet>
Subpart
C­­
Chemical
Synthesis
Subcategory
<
bullet>
Subpart
D­­
Mixing,
Compounding,
and
Formulating
Subcategory
<
bullet>
Subpart
E­­
Research
Subcategory
The
1976
BPT
regulations
set
monthly
limitations
for
biochemical
oxygen
demand
(
BOD<
INF>
5</
INF>)
and
chemical
oxygen
demand
(
COD)
based
on
percent
removal
for
all
subcategories.
No
daily
maximum
effluent
limitations
were
established
for
these
parameters.
The
pH
was
set
within
the
range
of
6.0
to
9.0
standard
units.
The
regulations
also
set
maximum
30
day
average
concentration­
based
limitations
for
total
suspended
solids
(
TSS)
for
subcategories
B,
D
and
E.
No
TSS
limitations
were
established
for
subcategories
A
and
C.
Subpart
A
was
amended
(
42
FR
6813)
on
February
4,
1977,
to
improve
the
language
referring
to
separable
mycelia
and
solvent
recovery.
The
amendment
also
allowed
the
inclusion
of
spent
beers
(
broths)
in
the
calculation
of
raw
waste
loads
for
Subpart
A
in
those
instances
where
the
spent
beer
is
actually
http://
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
treated
in
the
wastewater
treatment
system.

[[
Page
50392]]

On
October
27,
1983,
at
48
FR
49808,
EPA
revised
the
subcategory
names
to
those
currently
applicable
and
promulgated
revised
BPT,
BAT,
PSES
and
PSNS
for
Subparts
A
thru
D
to
cover
the
toxic
pollutant
cyanide,
conventional
pollutants
BOD<
INF>
5</
INF>,
TSS
and
pH,
and
the
nonconventional
pollutant
COD.
The
1983
regulations
kept
intact
the
percent
reduction
regulations
for
BOD5
and
COD
established
in
1976
but
added
floor
concentration­
based
limitations
for
these
parameters
applicable
to
subcategories
B,
D
and
E.
The
revisions
for
TSS
consisted
of
deriving
the
limitations
by
the
use
of
a
multiplication
factor
of
1.7
times
each
plant's
BOD<
INF>
5</
INF>
discharge.
EPA
also
promulgated
BPT,
BAT,
PSES
and
PSNS
for
pH
(
6.0­
9.0)
and
BAT
concentration­
based
limitations
controlling
the
discharge
of
cyanide
for
subcategory
A
through
D.
The
Agency
also
proposed
NSPS
for
BOD<
INF>
5</
INF>,
TSS
and
pH
in
the
October
1983
notice,
but
did
not
publish
final
NSPS
for
these
parameters.
On
December
16,
1986,
at
51
FR
45094,
EPA
promulgated
BCT
effluent
limitations
guidelines
for
BOD<
INF>
5</
INF>,
TSS
and
pH
for
subcategories
A
thru
D.
That
final
rule
set
BCT
effluent
limitations
equal
to
the
existing
BPT
effluent
limitations
guidelines
for
BOD<
INF>
5</
INF>,
TSS,
and
pH.
1.
Clean
Water
Act
Proposal
On
May
2,
1995
at
60
FR
21592,
EPA
proposed
revised
BPT
concentration
based
limitations
for
BO<
INF>
5</
INF>,
COD
and
TSS
based
on
advanced
biological
treatment
for
all
subcategories
and
cyanide
limitations
based
on
hydrogen
peroxide
oxidation
technology
for
the
A
(
Fermentation)
and
C
(
Chemical
Synthesis)
subcategories.
For
BAT,
EPA
proposed
end­
of­
pipe
limitations
for
53
organic
pollutants
plus
ammonia,
cyanide
and
COD
for
subcategories
A
and
C.
For
subcategories
B
(
Natural
Extraction)
and
D
(
Formulating,
Mixing
and
Compounding),
EPA
proposed
BAT
limitations
for
53
organic
pollutants
and
COD.
The
technology
basis
for
the
volatile
organic
compounds
(
VOCs)
limitations
was
steam
stripping
plus
advanced
biological
treatment
for
subcategories
A
and
C
and
advanced
biological
treatment
for
subcategories
B
and
D.
The
technology
basis
for
the
non­
volatile
http://
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
organics
was
advanced
biological
treatment
only,
and
the
proposed
ammonia
limitations
were
based
on
nitrification.
The
proposed
BAT
cyanide
limitations
were
equivalent
to
the
BPT
limitations,
and
the
BCT
limitations
were
also
proposed
equal
to
BPT
for
all
manufacturing
subcategories.
For
NSPS,
EPA
proposed
end­
of­
pipe
standards
for
53
organic
pollutants
plus
ammonia,
BO<
INF>
5</
INF>,
TSS,
cyanide
and
COD
for
subcategories
A
and
C
and
end­
of­
pipe
standards
for
53
organic
pollutants
plus
BO<
INF>
5</
INF>,
TSS,
and
COD
for
subcategories
B
and
D.
The
BO<
INF>
5</
INF>,
COD,
and
TSS
standards
were
based
on
two
sets
of
performance
data
from
the
best
performing
plants
in
each
of
the
A
or
C
and
B
or
D
subcategories.
The
end­
of­
pipe
VOC
limitations
were
based
on
steam
stripping
with
distillation
and
advanced
biological
treatment.
For
PSES
EPA
detailed
two
coproposals
(
A
and
B)
to
control
VOCs
in
all
subcategories.
Coproposal
A
had
pretreatment
standards
for
12
highly
volatile
organic
compounds
and
33
less
volatile
organic
compounds.
To
show
compliance
with
the
pretreatment
standards,
monitoring
for
the
12
highly
volatile
compounds
would
have
been
required
in­
plant.
Coproposal
B
had
only
the
pretreatment
standards
for
the
12
highly
volatile
compounds.
In
addition,
EPA
proposed
cyanide
(
identical
to
BPT)
and
ammonia
standards
(
based
on
steam
stripping)
for
subcategories
A
and
C.
The
proposed
PSNS
differed
from
PSES
in
that
the
standards
for
all
volatile
organic
compounds
were
based
on
steam
stripping
plus
distillation
technologies.
Finally,
EPA
proposed
that
pilot
plant
wastewater
would
not
be
regulated
by
Subcategory
E
(
Research)
limitations
but
under
appropriate
manufacturing
subcategory
limitations.
2.
Clean
Air
Act
Proposal
On
April
2,
1997
at
62
FR
15753,
EPA
proposed
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAPs)
for
the
Pharmaceuticals
Production
Source
Category.
In
that
proposed
rule,
the
Agency
proposed
Maximum
Available
Control
Technology
(
MACT)
standards
for
controlling
emissions
of
hazardous
air
pollutants
(
HAPs)
from
process
vents,
storage
tanks,
equipment
leaks,
wastewater
collection
and
treatment
systems
and
heat
exchange
systems
at
pharmaceutical
manufacturing
facilities
that
are
determined
to
be
major
sources
of
HAPs.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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17
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169)
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8:
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01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
The
proposed
MACT
standards
for
wastewater
emission
sources
contained
two
alternative
formats
for
achieving
compliance,
a
percent
removal
and
a
reference
control
technology.
Applicability
determination,
definitions,
and
control
requirements
were
similar
to
the
Hazardous
Organic
NESHAPs
(
HON)
MACT
standards
for
wastewater.
The
proposed
standard
required
facilities
to
control
wastewater
streams
that
exceed
the
concentration
cutoff
where
the
process
wastewater
stream
exits
the
pharmaceutical
process
equipment
identified
as
the
point
of
determination
(
POD).
The
proposed
concentration
cutoffs
were
1,300
parts
per
million
by
weight
(
ppmw)
for
partially
soluble
HAPs
and
5,200
ppmw
for
total
HAPs
at
processes
or
PODs
with
annual
HAP
loads
of
1
megagram
per
year
or
metric
ton
per
year
(
Mg/
yr).
Also,
the
proposed
standard
required
all
streams
having
a
HAP
concentration
of
10,000
ppmw
to
be
controlled
at
facilities
with
annual
HAP
loads
of
1
Mg/
yr
or
greater.
The
proposed
standards
required
that
the
control
of
wastewater
emissions
be
accomplished
in
one
of
the
following
manners:
(
1)
Using
a
design
biotreatment
system
for
soluble
HAPs;
(
2)
Demonstrating
removals
achieving
99
percent
by
weight
of
partially
soluble
HAPs
and
90
percent
by
weight
of
soluble
HAPs
from
treatment
systems;
or
(
3)
Demonstrating
a
removal
of
95
percent
by
weight
of
total
organic
HAP
from
the
treatment
system.
The
MACT
standard
proposal
also
discussed
options
for
CWA
controls
in
light
of
the
CAA
MACT
standard
proposal
for
controlling
emissions
from
wastewater
streams
at
pharmaceutical
facilities
being
covered
by
the
proposed
effluent
limitations
guidelines
and
standards.
EPA's
intent
was
that
the
effluent
limitations
guidelines
and
standards
build
on
the
MACT
standards,
and
the
discussion
suggested
several
options
to
accomplish
this.
3.
Clean
Water
Act
Federal
Register
Notice
of
Availability
EPA
published
a
Notice
of
Availability
(
NOA)
in
the
Federal
Register
on
August
8,
1997
at
62
FR
42720.
EPA
published
this
Notice
in
order
to:
allow
public
comment
on
the
data
received
since
the
May
2,
1995
CWA
proposal,
further
develop
and
revise
options
for
the
control
of
the
VOCs
that
were
presented
in
the
April
2,
1997
CAA
MACT
proposal,
and
suggest
responses
to
some
comments
on
the
1995
CWA
proposal.
In
section
II
of
the
NOA,
EPA
provided
the
results
of
an
EPA
sampling
study
designed
to
provide
information
concerning
the
pass
http://
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
through
analysis
for
water
soluble
organic
pollutants
such
as
methanol
and
discussed
the
pass
through
analysis
that
EPA
would
be
performing
with
respect
to
these
and
other
pollutants.
In
section
III,
EPA
presented
revisions
of
the
pretreatment
options
which
were
earlier
described
in
the
MACT
proposal,
and
presented
options
for
reducing
the
discharge
loadings
of
VOCs
not
controlled
by
the
proposed
MACT
[[
Page
50393]]

standards.
One
option
was
compliance
with
the
proposed
MACT
standards
together
with
additional
PSES
requirements
for
all
VOCs
except
alcohols
and
related
compounds
based
on
the
performance
database
used
in
the
1995
proposal.
A
second
option
included
coverage
of
additional
pollutants
including
alcohols
and
related
compounds.
EPA
also
presented
costs
and
loadings
for
two
scenarios
involving
these
two
options.
One
scenario
would
exclude
facilities
that
discharged
less
than
10,000
pounds
per
year
of
pollutants
of
concern,
while
the
other
scenario
would
not
exclude
them.
In
section
IV,
EPA
presented
the
results
of
analyses
with
respect
to
the
proposed
data
base
for
NSPS
requirements
for
the
conventional
pollutants,
COD
and
ammonia,
pollutant
exclusions,
use
of
surrogate
pollutants
for
compliance
monitoring,
small
facility
exclusion
and
changes
to
engineering
costs
and
loadings
removal
estimates.
In
addition,
EPA
presented
data
editing
criteria
and
methodologies
for
deriving
BPT
and
BAT
effluent
limitations
and
PSES.
On
pages
42722­
42724
of
the
NOA,
EPA
presented
BPT,
BAT
limitations
and
PSES
being
considered.

E.
Discussion
of
Final
Clean
Air
Act
Rule
Published
Elsewhere
in
Today's
Federal
Register
EPA
received
a
number
of
comments
on
the
proposed
MACT
standards
for
wastewater
streams.
While
certain
changes
were
made
(
see
the
final
MACT
rule
published
elsewhere
in
today's
Federal
Register)
the
controls
required
by
the
proposed
MACT
standards
have
not
changed.
As
proposed,
the
final
MACT
incorporates
the
HON
wastewater
standards,
thereby
clarifying
the
MACT
requirements
for
off­
site
treatment
of
wastewater.

http://
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WATER/
1998/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Under
specified
conditions,
a
source
can
transfer
affected
wastewater
streams
containing
soluble
HAPs
and
less
than
50
ppmw
partially
soluble
HAPs
off­
site
for
treatment.
In
addition,
if
the
off­
site
treatment
facility
is
a
POTW
with
uncovered
headworks
(
grit
chamber,
primary
settling
tanks,
etc.)
a
demonstration
that
less
than
five
percent
of
the
total
soluble
HAPs
are
emitted
is
required.
For
POTWs
with
completely
covered
headworks,
the
final
rule
does
not
require
a
demonstration
that
less
than
five
percent
of
the
total
soluble
HAPs
are
emitted.

F.
Relationship
Between
the
MACT
and
CWA
Rules
As
noted
above,
the
CAA
MACT
rule
being
promulgated
today
sets
emission
standards
for
HAPs
from
wastewater
collection
and
treatment
systems
at
major
source
pharmaceutical
manufacturing
facilities.
The
CWA
final
effluent
limitations
guidelines
and
standards
control
the
discharge
of
toxic,
conventional
and
nonconventional
pollutants
in
wastewater
discharges
from
pharmaceutical
manufacturing
facilities.
Some
of
the
water
pollutants
being
controlled
by
today's
effluent
guidelines
and
standards
are
also
HAPs
and
thus
these
pollutants
are
being
controlled
by
both
the
MACT
and
CWA
final
rules.
The
extent
of
the
coverage
of
waterborne
HAPs
by
the
air
and
water
rules
will
be
discussed
in
subsequent
sections,
as
will
the
joint
economic
analysis
and
environmental
benefits
assessment
that
were
conducted
for
the
two
rules.

G.
Final
Clean
Water
Act
Effluent
Guidelines
Limitations
and
Standards
Rule
Today
EPA
is
promulgating
revised
BPT
limitations
only
for
COD
based
on
advanced
biological
treatment
for
all
four
subcategories.
For
subcategories
A
and
C,
EPA
is
promulgating
BAT
limitations
for
COD
equal
to
the
revised
BPT
limitations
and
for
30
organic
pollutants,
including
28
VOCs
(
of
which
13
are
HAPS)
based
on
advanced
biological
treatment
identified
as
a
basis
for
the
revised
COD
limitations.
In
addition,
for
subcategories
A
and
C,
EPA
is
promulgating
BAT
ammonia
limitations
based
on
nitrification
technology,
and
is
modifying
the
BAT
compliance
monitoring
requirements
for
the
existing
cyanide
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
20
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
limitations.
For
subcategories
B
and
D,
EPA
is
adding
BAT
limitations
for
COD
equal
to
the
revised
BPT
requirements,
and
is
withdrawing
the
existing
BPT
and
BAT
cyanide
limitations
since
the
facilities
in
these
subcategories
do
not
generate
cyanide
in
their
wastewaters.
The
Agency
is
promulgating
PSES
for
23
VOCs
(
10
of
which
are
HAPs)
plus
ammonia
for
subcategories
A
and
C,
and
is
also
clarifying
the
compliance
requirements
for
the
existing
cyanide
pretreatment
standards.
For
subcategories
B
and
D,
EPA
is
promulgating
PSES
for
the
5
VOCs
(
1
of
which
is
a
HAP)
and,
for
the
same
reason
given
above,
is
withdrawing
the
existing
cyanide
standards.
Subcategories
A
and
C
facilities
must
continue
to
comply
with
the
cyanide
standards,
and
achieve
compliance
with
the
standards
for
ammonia
and
the
23
organic
pollutants
within
three
years.
Subcategories
B
and
D
facilities
must
achieve
compliance
with
the
5
organic
pollutant
standards
within
three
years.
The
compliance
times
of
up
to
three
years
is
being
given
because
of
the
design
and
installation
of
technologies
used
as
a
basis
for
the
standards,
such
as
steam
stripping
and
nitrification
require
sufficient
lead
times
for
implementation.
EPA
is
promulgating
NSPS
for
subcategories
A
and
C
equal
to
the
BAT
limitations
for
COD,
ammonia
and
the
organic
pollutants,
including
the
VOCs,
and
revised
limitations
for
BOD<
INF>
5</
INF>
and
TSS
based
on
advanced
biological
treatment.
EPA
is
also
promulgating
NSPS
for
subcategories
B
and
D
equal
to
BAT
for
COD
and
revised
limitations
for
BOD<
INF>
5</
INF>
and
TSS
based
on
advanced
biological
treatment,
and
is
withdrawing
the
existing
cyanide
NSPS
for
these
two
subcategories.
For
PSNS
EPA
is
promulgating
standards
equal
to
PSES
for
all
pollutants
and
subcategories
and
is
withdrawing
the
existing
cyanide
PSNS
for
subcategories
B
and
D.
Finally,
EPA
is
promulgating
BCT
limitations
equal
to
the
existing
BPT
limitations
for
BOD<
INF>
5</
INF>,
TSS
and
pH.
In
today's
rule,
EPA
has
republished
many
parts
of
the
existing
guideline
in
Part
439
to
make
the
changes
made
today
easier
to
understand,
and
also
reformated
the
guideline
to
make
it
more
clear
and
easier
to
use.
The
republication
or
reformatting
of
existing
requirements
is
not
intended
to
introduce
substantive
changes
to
these
regulatory
provisions.
For
that
reason,
EPA
believes
prior
notice
and
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
21
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
comment
on
these
provisions
is
unnecessary.

III.
Summary
of
Most
Significant
Changes
to
Water
Rules
From
Proposal
This
section
describes
the
most
significant
changes
to
the
rule
since
proposal.
Many
of
these
changes
have
resulted
from
the
comments
that
are
discussed
below
(
see
section
X).
This
section
will
discuss
the
major
changes
in
the
rule
concerning
revisions
to
the
limitations
and
standards
for
VOCs,
changes
in
the
BAT
technology
basis
and
changes
in
the
BPT
and
BAT
limitations
for
pollutants
other
than
the
VOCs.
More
detailed
explanations
for
changes
may
be
found
in
the
comment
response
document
in
the
record
of
the
final
rule.

A.
Limitations
and
Standards
for
Volatile
Compounds
In
today's
final
rule,
EPA
is
not
requiring
that
the
limitations
for
VOCs
be
measured
in­
plant
as
proposed.
For
all
four
subcategories,
BAT,
NSPS,
PSES,
and
PSNS
limitations
and
standards,
except
for
cyanide
limitations
and
standards
in
subcategories
A
and
C,
this
rule
does
not
alter
the
generally
applicable
rule
[[
Page
50394]]

(
122.45(
h)
or
403.6(
e))
that
limitations
generally
are
measured
at
the
end­
of­
pipe
discharge
point.
This
rule
provides
clarification
of
the
existing
in­
plant
monitoring
for
cyanide
as
discussed
in
the
Implementation
Section
of
this
preamble
(
see
section
VIII
A).
At
proposal,
EPA
proposed
PSES
for
13
alcohols
and
related
pollutants
(
compounds)
under
coproposal
B.
These
pollutants
were
methanol,
ethanol,
n­
propanol,
isopropanol,
n­
butyl
alcohol,
tert­
butyl
alcohol,
amyl
alcohol,
formamide,
N,
N­
dimethylaniline,
pyridine,
1,4­
dioxane,
aniline,
and
petroleum
naphtha.
No
PSES/
PSNS
are
being
promulgated
for
these
pollutants
today
because
EPA
determined
these
pollutants
do
not
pass
through
POTWs
or
interfere
with
the
treatment
works.
(
See
section
IV.
E
for
a
discussion
of
the
passthrough
analysis
for
these
pollutants).

B.
Change
in
BAT
Technology
Basis
for
Organic
Pollutants
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
22
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
In
the
August
8,
1997
NOA,
EPA
discussed
changing
the
technology
basis
for
BAT
organic
pollutant
limitations
for
subcategories
A
and
C
facilities
from
in­
plant
steam
stripping
and
advanced
biological
treatment
to
advanced
biological
treatment
only.
EPA
received
comments
supporting
this
change
in
technology
basis.
The
final
MACT
standards
being
promulgated
today
will
control
most
emissions
of
VOCs
from
wastewaters
at
subcategories
A
and
C
direct
discharging
facilities
based
on
the
use
of
steam
stripping
technology.
Accordingly,
EPA
believes
that
it
is
not
necessary
or
appropriate
to
include
this
technology
in
the
BAT
technology
basis;
the
CWA
limitations
and
standards
are
calculated
from
a
data
base
representing
advanced
biological
treatment
only.
Thus,
EPA
is
promulgating
BAT
limitations
for
all
of
the
30
organic
pollutants
for
subcategories
A
and
C
facilities
based
on
advanced
biological
treatment
only.
EPA
notes
that
one
facility
not
covered
by
the
MACT
standards
would
need
to
install
steam
stripping
technology
in
order
to
achieve
the
effluent
limitations
following
the
biological
treatment
system.

C.
BPT
and
BAT/
BCT
Limitation
Changes
Based
on
the
receipt
of
new
data
from
commenters,
proposed
limitations
were
revised
for
the
nonconventional
pollutants
COD
and
ammonia
and
a
number
of
the
organic
pollutants.
In
addition,
commenters
on
the
proposed
limitations
for
the
conventional
pollutants
BOD5
and
TSS,
as
well
as
COD,
indicated
that
EPA
should
eliminate
all
nonprocess
wastewater
in
the
calculation
of
limitations
for
these
parameters.
In
developing
limitations
for
the
proposal,
EPA
did
not
back
out
the
estimated
non­
process
wastewater
from
the
total
wastewater
flow
and
adjust
the
concentration
accordingly
because
the
non­
process
flow
data
provided
by
facilities
in
the
data
sets
were
only
gross
estimates
and
were
not
based
on
daily
measurements
of
non­
process
flow.
Despite
requesting
more
precise
information
(
such
as
daily
non­
process
flow
data)
from
facilities
that
generated
the
data
sets
used
to
calculate
the
proposed
limitations
for
BOD5,
TSS
and
COD,
EPA
did
not
obtain
this
information.
However,
in
the
NOA,
EPA
presented
revised
proposed
limitations
for
BOD5
and
TSS
and
COD
that
were
calculated
from
the
existing
plant
data
sets
using
the
gross
estimates
of
non­
process
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
23
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
flow,
as
described
below,
to
adjust
the
concentrations
in
addition
to
several
new
data
sets
from
plants
other
than
those
used
for
the
proposal.
In
a
previous
EPA
effluent
limitations
guidelines
and
standards
rulemaking
for
the
Organic
Chemicals,
Plastics
and
Synthetic
Fibers
(
OCPSF)
industry
(
52
FR
42522),
only
plant
data
sets
that
contained
less
than
25
percent
non­
process
wastewater
through
treatment
were
used
in
calculating
limitations.
Thus,
the
25
percent
level
of
non­
process
wastewater
dilution
was
determined
as
a
benchmark
in
order
to
evaluate
biological
treatment
performance.
For
the
purposes
of
the
NOA,
in
cases
where
the
non­
process
flow
was
estimated
to
be
more
than
25
percent
of
the
total
flow,
the
non­
process
wastewater
was
backed
out
of
the
total
flow
volume
and
the
parameters
corrected
for
the
absence
of
this
nonprocess
wastewater.
However,
for
the
final
rule,
limitations
for
COD
are
developed
from
data
sets
in
which
the
reported
flow
volume
contains
less
than
25
percent
non­
process
wastewater
and
the
limitations
are
calculated
without
correcting
the
data
sets
for
the
non­
process
flow
dilution.
This
change
is
discussed
further
in
section
IV.
D
below.
As
further
discussed
below,
limitations
for
BOD5
and
some
of
the
remaining
TSS
are
not
being
revised
at
this
time
since
the
revised
COD
limits
requiring
advanced
biological
treatment
will
incidentally
remove
a
large
portion
of
the
remaining
BOD5
and
TSS.
Another
change
to
the
proposal
involved
the
limitations
and
standards
proposed
for
cyanide.
EPA
proposed
BPT,
BAT,
NSPS,
PSES
and
PSNS
limitations
and
standards
for
cyanide
based
on
the
performance
of
hydrogen
peroxide
oxidation
technology.
Following
the
proposal,
EPA
received
comments
indicating
that
the
use
of
the
hydrogen
peroxide
technology
to
destroy
cyanide
could
possibly
result
in
equipment
explosions
with
certain
types
of
wastewater.
Other
commenters
indicated
that
hydrogen
peroxide
technology
may
not
be
an
appropriate
cyanide
destruction
technology
for
all
treatment
situations.
Along
with
these
comments,
EPA
received
additional
data
on
the
performance
of
alkaline
chlorination
technology
in
destroying
cyanide.
Based
on
these
comments
and
the
new
performance
data,
EPA
indicated
in
the
NOA
that
it
was
considering
promulgating
two
sets
of
cyanide
limitations,
one
based
on
the
performance
of
hydrogen
peroxide
technology
and
the
other
based
on
the
performance
of
alkaline
chlorination
technology.
In
the
NOA,
EPA
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
24
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
indicated
that
only
those
facilities
that
could
demonstrate
that
a
potential
safety
hazard
could
result
from
their
use
of
hydrogen
peroxide
technology
would
be
subject
to
the
alkaline
chlorination
limitations
and
standards.
EPA
also
solicited
information
and
comments
regarding
wastestreams
with
high
organic
content
as
evidenced
by
high
COD
or
total
organic
carbon
(
TOC)
levels,
and
at
what
levels
these
pollutants
would
indicate
that
the
wastestream(
s)
high
organic
content
would
present
a
safety
concern
and
would
more
appropriately
be
controlled
by
limitations
based
on
alkaline
chlorination.
After
consideration
of
the
information
provided
in
response
to
the
solicitation
in
the
NOA,
particularly
new
performance
data
representing
current
(
post
1990
base
year)
loadings,
EPA
has
decided
not
to
revise
the
existing
limitations
and
standards
for
cyanide
based
on
the
small
amount
of
cyanide
discharge
loadings
that
would
be
removed.
However,
the
final
rule
continues
to
require
compliance
with
the
cyanide
limitations
be
established
in­
plant,
prior
to
commingling
the
cyanide
bearing
wastestreams
with
non­
cyanide
wastestreams
for
those
facilities
where
the
cyanide
levels
would
be
below
the
level
of
detection
at
the
end­
of­
pipe
monitoring
location.
Along
with
comments
on
its
proposed
numerical
limitations
and
standards
for
ammonia
and
organic
pollutants,
EPA
received
data
concerning
the
performance
of
steam
strippers,
advanced
biological
treatment
and
nitrification
in
connection
with
these
proposed
limitations.
EPA
evaluated
these
data,
and
provided
revised
numerical
limitations
and
standards
in
the
NOA
for
ammonia,
several
organic
pollutants
controlled
by
BAT
technology
(
advanced
biological
treatment)
and
several
VOCs
controlled
[[
Page
50395]]

by
steam
stripping
technology
for
PSES.
As
the
result
of
the
data
received
and
evaluated,
along
with
comments
on
the
NOA,
EPA
has
changed
the
numerical
BAT
limitations
for
ammonia.
In
response
to
comments
in
the
NOA
indicating
that
indirect
dischargers
should
be
able
to
achieve
the
PSES
ammonia
limitations
using
either
two­
step
nitrification
technology
or
steam
stripping,
EPA
has
decided
to
set
the
PSES
ammonia
limitations
equal
to
the
BAT
ammonia
limitations,
and
to
provide
that
indirect
discharging
subcategories
A
and
C
facilities
discharging
to
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
25
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
POTWs
with
nitrification
capability
need
not
comply
with
the
categorical
limit
for
ammonia.
EPA
has
also
changed
the
numerical
BAT
limitations
and
PSES
for
several
organic
pollutants
based
on
its
analysis
of
data
received
in
response
to
the
proposal.

D.
Pollutant
Selection
EPA
received
several
comments
concerning
the
reasoning
behind
the
regulation
of
certain
pollutants
as
well
as
the
overall
rationale
for
selecting
pollutants
for
regulation.
In
the
NOA,
EPA
indicated
that
it
had
reviewed
the
loadings
bases
of
all
the
pollutants
selected
for
regulation
and
had
determined
that
in
the
case
of
eight
pollutants,
insufficient
amounts
of
the
pollutants
are
being
discharged
to
justify
national
regulation.
These
pollutants
are
diethyl
ether,
cyclohexane,
chloromethane,
dimethylamine,
methylamine,
furfural,
2­
methylpyridine
and
trichlorofluoromethane.
Since
the
NOA,
EPA
has
reevaluated
its
final
loadings
database
and
has
determined
that
the
exclusion
of
these
pollutants
along
with
an
additional
15
pollutants
is
appropriate.
The
additional
15
pollutants
are
excluded
from
the
BAT
regulation
based
on
the
lack
of
removals
from
current
discharge
or
the
control
of
discharges
of
the
pollutant
by
other
regulated
pollutant
parameters.
These
pollutants
are
butanone,
formaldehyde,
n­
butanol,
tertiary
butanol,
n­
propanol,
ethylene
glycol,
polyethylene
glycol
600,
aniline,
petroleum
naphtha,
1,4­
dioxane,
formamide
and
dimethyl
formamide,
dimethylaniline,
dimethylacetamide
and
pyridine.
EPA
proposed
PSES
for
45
organic
pollutants,
37
of
which
are
VOCs,
under
co­
proposal
A
with
compliance
for
the
standards
for
12
of
the
VOCs
to
be
monitored
in­
plant,
and
compliance
for
the
standards
for
the
remaining
33
organics
to
be
monitored
at
the
end­
of­
pipe.
In
the
NOA,
EPA
presented
two
revised
PSES
options,
under
which
EPA
would
promulgate
pretreatment
standards
for
VOCs
with
end­
of­
pipe
monitoring.
The
pollutants
not
regulated
under
one
of
these
PSES
options
include
water
soluble
alcohols
such
as
methanol
and
related
compounds.
After
consideration
of
comments
and
evaluating
the
results
of
the
Barcelonetta
POTW
study
and
its
implications
on
the
final
pass
through
analysis
(
see
further
discussion
of
pass
through
analysis
in
section
IV
E
below)
and
further
evaluation
of
incidental
removals
and
the
amount
of
or
discharge
removals
for
the
pollutants,
EPA
is
promulgating
PSES
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
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21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
and
PSNS
for
23
VOCs
for
subcategories
A
and
C
and
5
VOCs
for
subcategories
B
and
D.
The
PSES
and
PSNS
do
not
include
the
alcohols
and
related
compounds,
and
are
based
on
monitoring
at
the
end­
of­
pipe
unless
the
POTW
determines
it
to
be
impractical
per
40
CFR
403.6(
e).

IV.
The
Final
Clean
Water
Act
Regulation
This
section
discusses
the
applicability
of
the
final
rule,
regulatory
options
considered
and
the
rationale
for
the
selected
options
for
BPT,
BCT,
BAT,
PSES,
PSNS
and
NSPS.

A.
Applicability
and
Scope
of
the
Final
Rule
Today's
final
effluent
limitations
guidelines
and
standards
are
intended
to
cover
pollutants
in
process
wastewater
discharges
from
existing
and
new
pharmaceutical
manufacturing
facilities.
Based
on
comments,
EPA
has
revised
the
proposed
scope
of
the
rule.
This
final
rule
contains
revisions
to
the
effluent
limitations
guidelines
and
standards
in
four
subcategories
(
A
thru
D)
of
the
pharmaceutical
manufacturing
point
source
category,
EPA
is
not
revising
the
scope
of
the
applicability
for
the
fifth
subcategory
(
Subcategory
E­
Research).
With
regard
to
subcategory
E
facilities,
EPA
proposed
to
revise
the
description
of
the
research
subcategory
in
the
applicability
section
of
the
existing
subcategory
E
regulations
to
exclude
pilot
or
full­
scale
operations
that
generate
wastewater
using
fermentation,
extraction,
chemical
synthesis
or
mixing,
compounding
and
formulating
from
the
scope
of
subpart
E,
and
these
operations
were
proposed
to
be
covered
by
the
appropriate
subcategory
A
through
D.
After
considering
the
comments
received
concerning
the
regulation
of
wastewaters
from
pilot­
scale
operations,
EPA
has
decided
not
to
change
the
existing
description
of
the
research
subcategory
in
the
applicability
section.
EPA
believes
that
it
does
not
have
sufficient
information
concerning
subcategory
E
generated
wastewaters
to
change
the
existing
description.
Subpart
E
facilities
remain
subject
to
the
BPT
limitations
in
the
existing
guidelines.
If
pilot
scale
operations
occur
at
either
stand
alone
research
facilities
or
during
operations
at
manufacturing
facilities,
then
BAT
and
BCT
limits
for
these
wastewaters
can
be
determined
by
permit
writers
on
a
best
professional
judgment
(
BPJ)
basis,
or
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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Day­
21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
similarly,
such
wastewater
generated
at
indirect
discharging
facilities
may
be
addressed
by
the
regulations
found
at
40
CFR
403.5
and
by
local
limits
on
a
case­
by­
case
basis.
Pharmaceutical
manufacturers
use
many
different
raw
materials
and
manufacturing
processes
to
create
a
wide
range
of
products.
These
products
include
medicinal
and
feed
grades
of
all
organic
chemicals
having
therapeutic
value,
whether
obtained
by
chemical
synthesis,
fermentation,
extraction
from
naturally
occurring
plant
or
animal
substances,
or
by
refining
a
technical
grade
product.
The
pharmaceutical
products,
processes
and
activities
covered
by
the
manufacturing
subcategories
in
this
final
regulation
include,
but
are
not
limited
to:
a.
Biological
products
covered
by
the
U.
S.
Department
of
Commerce,
Bureau
of
the
Census
Standard
Industrial
Classification
(
SIC)
Code
No.
2836,
with
the
exception
of
diagnostic
substances.
(
Products
covered
by
SIC
Code
No.
2836
were
formerly
covered
under
the
1977
SIC
Code
No.
2831.)
b.
Medicinal
chemicals
and
botanical
products
covered
by
SIC
Code
No.
2833;
c.
Pharmaceutical
products
covered
by
SIC
Code
No.
2834;
d.
All
fermentation,
biological
and
natural
extraction,
chemical
synthesis
and
formulation
products
considered
to
be
pharmaceutically
active
ingredients
by
the
Food
and
Drug
Administration
that
are
not
covered
by
SIC
Code
Nos.
2833,
2834,
and
2836;
e.
Multiple
end­
use
products
derived
from
pharmaceutical
manufacturing
operations
(
e.
g.,
components
of
formulations,
intermediates,
or
final
products,
provided
that
the
primary
use
of
the
product
is
intended
for
pharmaceutical
purposes);
f.
Products
not
covered
by
SIC
Code
Nos.
2833,
2834,
and
2836
or
other
categorical
limitations
and
standards
if
they
are
manufactured
by
a
pharmaceutical
manufacturer
by
processes
that
generate
wastewaters
that
in
turn
closely
correspond
to
those
of
pharmaceutical
products.
(
An
example
of
such
a
product
is
citric
acid.)
g.
Cosmetic
preparations
covered
by
SIC
Code
No.
2844
that
contain
pharmaceutically
active
ingredients
or
[[
Page
50396]]

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www.
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gov/
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21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
ingredients
intended
for
treatment
of
some
skin
condition.
(
This
group
of
preparations
does
not
include
products
such
as
lipsticks
or
perfumes
that
serve
to
enhance
appearance
or
to
provide
a
pleasing
odor,
but
do
not
provide
skin
care.
In
general,
this
also
excludes
deodorants,
manicure
preparations,
shaving
preparations
and
non­
medicated
shampoos
that
do
not
function
primarily
as
a
skin
treatment.)
A
number
of
products
and/
or
activities
such
as
surgical
and
medical
manufacturing
and
medical
laboratory
activity
are
not
part
of
the
pharmaceutical
manufacturing
category.
A
descriptive
listing
of
the
products
and
activities
that
are
specifically
excluded
from
the
pharmaceutical
manufacturing
category
are
contained
in
the
applicability
provision
of
the
final
rule
and
in
sections
2
and
3
of
the
final
TDD.
In
the
NOA,
EPA
indicated
that
it
was
considering
excluding
from
the
scope
of
the
regulation
organic
chemical
manufacturers
covered
by
the
OCPSF
regulation
(
40
CFR,
Part
414)
that
manufacture
pharmaceutical
intermediates
and
active
ingredients
provided
that
the
pharmaceutical
portion
of
the
process
wastewater
is
less
than
50
percent
of
the
total
process
wastewater.
EPA
received
no
adverse
comments
concerning
this,
and
has
decided
to
promulgate
this
exclusion
as
described
in
the
NOA.
Thus
facilities
will
be
covered
by
the
existing
OCPSF
regulation
for
both
their
OCPSF
and
pharmaceutical
manufacturing
process
wastewaters
provided
that
the
pharmaceutical
portion
of
the
process
wastewater
at
the
facility
is
less
than
50
percent
of
the
total.

B.
Options
Selection
EPA
evaluated
final
technology
options
for
BPT,
BAT,
BCT,
NSPS,
PSES
and
PSNS
limitations
and
standards
for
all
four
subcategories
A
thru
D.
The
options
considered
for
each
level
of
control
are
discussed
below
in
sections
IV.
C
thru
H.

C.
Best
Practicable
Control
Technology
Currently
Available
(
BPT)

EPA
proposed
to
revise
BPT
for
the
conventional
pollutants
BOD<
INF>
5</
INF>
and
TSS,
the
nonconventional
pollutant
COD,
and
the
toxic
pollutant
cyanide
for
subcategories
A
and
C,
and
for
subcategories
B
and
D,
proposed
to
revise
BPT
limitations
for
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
29
of
169)
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
BOD<
INF>
5</
INF>,
TSS,
and
COD
and
to
withdraw
the
cyanide
limitations.
In
response
to
this
proposal,
EPA
received
comments
claiming
that
EPA
lacks
the
legal
authority
to
revise
BPT
for
the
conventional
pollutants
since
the
proposed
revised
BPT
limitations
did
not
pass
the
BCT
costreasonableness
test.
EPA
also
received
comments
claiming
that
COD
and
cyanide
should
not
be
regulated
at
BPT
but
only
at
the
BAT
level.
In
today's
rulemaking,
EPA
is
revising
BPT
limitations
only
as
to
COD.
The
current
BPT
limitations
for
BOD<
INF>
5</
INF>,
TSS
and
cyanide
will
continue
to
apply
(
except
for
subcategories
B
and
D
where
EPA
is
withdrawing
the
BPT
limitations
for
cyanide).
Accordingly,
issues
raised
by
commenters
regarding
EPA's
legal
authority
to
revise
BPT
for
BOD<
INF>
5</
INF>,
TSS,
or
cyanide
do
not
need
to
be
addressed
in
this
rulemaking.
Nonetheless,
EPA
continues
to
believe
that
it
has
the
legal
authority
to
revise
BPT
limitations
as
appropriate.
EPA
further
believes
it
can
do
so
for
conventional
pollutants
without
having
to
apply
the
BCT
cost­
reasonableness
test.
Because
EPA's
authority
to
revise
BPT
limitations
for
conventional
pollutants
or
cyanide
is
no
longer
an
issue
in
this
rulemaking,
EPA
is
providing
only
a
general
statement
of
its
statutory
authority
to
revise
BPT.
For
example,
section
304(
b)
of
the
CWA
directs
EPA
to
revise
all
effluent
limitation
guidelines,
including
those
based
on
BPT,
at
least
annually
if
appropriate.
Similarly,
section
304(
m)
directs
EPA
to
establish
a
schedule
  
for
the
annual
review
and
revision
of
promulgated
effluent
guidelines,
in
accordance
with
subsection
(
b)
of
this
section.''
EPA
does
not
believe
that
the
addition
of
the
BCT
provisions
to
the
CWA
supplanted
the
BPT
provisions.
When
enacting
the
more
recent
BCT
provisions,
Congress
did
not
strip
EPA
of
its
explicit
authority
to
revise
or
update
BPT
as
necessary
and
appropriate.
Moreover,
the
different
purposes
of
BPT
and
BCT
limitations
would
support
an
EPA
decision
to
promulgate
best
  
practicable''
control
technology
for
conventional
pollutant
control
(
represented
by
BPT),
rather
than
the
higher
  
best
available''
standard
(
represented
by
BCT).
Similarly,
it
is
the
Agency's
position
that
it
is
not
required
to
regulate
COD
or
cyanide
only
at
the
BAT
level.
As
noted
above,
section
304(
b)
of
the
CWA
as
well
as
section
304(
m)
directs
EPA
to
revise
all
effluent
limitations
guidelines,
including
those
based
on
BPT,
at
least
annually
if
necessary
and
appropriate.
It
is
EPA's
view
that
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
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21/
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htm
(
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169)
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
addition
of
BAT
provisions
to
the
CWA
did
not
supplant
the
BPT
provisions.
When
enacting
the
more
recent
BAT
provisions,
Congress
did
not
strip
EPA
of
its
authority
to
revise
or
update
BPT
as
necessary
and
appropriate.
Further,
the
different
purposes
of
BPT
and
BAT
limitations
would
support
an
EPA
decision
to
promulgate
revised
effluent
limitation
guidelines
for
nonconventional
or
toxic
pollutants
that
reflect
simply
the
next
generation
of
best
  
practicable''
control
technology
(
represented
by
BPT),
rather
than
the
higher
  
best
available''
standard
(
represented
by
BAT).
Since
EPA
is
not
revising
BPT
limitations
for
cyanide
(
but
rather
is
modifying
the
compliance
monitoring
requirements
for
cyanide
for
subcategories
A
and
C,
and
withdrawing
the
limitations
as
to
subcategories
B
and
D),
the
issue
need
not
be
addressed
further
in
this
rulemaking.
EPA
believes
that
the
decision
of
whether
or
not
to
revise
BPT
for
nonconventional
pollutants
should
be
made
based
upon
consideration
of
a
number
of
factors,
including,
but
not
necessarily
limited
to,
cost,
the
technology
being
considered
and
the
relative
performance
being
achieved
(
best
  
practicable''
versus
best
  
available''),
the
anticipated
pollutant
reductions,
and
implementation
burden
on
permit
writers.
In
this
case,
EPA
has
made
a
determination
that
the
costs
and
removals
associated
with
the
implementation
of
advanced
biological
treatment
at
a
best
  
practicable''
level
warrant
revision
of
COD
at
BPT.
This
is
in
part
due
to
the
relatively
high
concentrations
of
COD
in
the
effluent
that
are
allowed
under
the
existing
percent
removal
BPT
limitations
which
are
unique
to
this
industry.
In
other
cases,
the
Agency
has
decided
not
to
revise
BPT
(
see,
for
example,
Effluent
Limitation
Guidelines
for
the
Pulp,
Paper,
and
Paperboard
Category,
subparts
B
and
E,
63
FR
18534,
April
15,
1998).
As
noted
above,
EPA
proposed
to
revise
BPT
for
the
conventional
pollutants
BOD<
INF>
5</
INF>
and
TSS,
the
nonconventional
pollutant
COD,
and
the
toxic
pollutant
cyanide
for
subcategories
A
and
D,
and
for
subcategories
B
and
D,
to
revise
BPT
limitations
for
BOD<
INF>
5</
INF>,
TSS,
and
COD
and
to
withdraw
the
existing
cyanide
limitations.
The
technology
basis
of
the
proposed
BPT
limitations
was
advanced
biological
treatment.
EPA
also
determined
that
the
level
of
performance
necessary
for
a
plant
to
be
considered
as
a
best
performer
at
the
best
http://
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epa.
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EPA­
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1998/
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
  
practicable''
level
was
full
compliance
with
the
existing
BPT
limitations.
Of
the
plants
considered
as
best
performers
at
proposal,
EPA
selected
five
A
and
C
subcategory
plants
and
two
B
and
D
subcategory
plants.
The
Agency
then
calculated
long­
term
average
performance
concentrations
for
regulated
pollutants
from
the
best
performing
A
and
C
and
B
and
D
plants.
In
developing
the
final
BPT
limitations,
EPA
has
essentially
[[
Page
50397]]

followed
the
proposal
methodology
except
that
EPA
used
only
data
sets
representing
less
than
25
percent
non­
process
wastewater
through
treatment
and
included
the
additional
data
sets
received
since
proposal
in
its
final
limitations
determinations.
Except
for
one
facility
which
adds
non­
process
wastewater
after
treatment
but
before
the
end­
of­
pipe
sample
point,
the
BPT
data
sets
were
not
corrected
for
non­
process
wastewater
and
the
final
limitations
were
calculated
using
the
plant
flow
that
included
some
non­
process
wastewater.
EPA
did
not
back
out
the
estimated
non­
process
wastewater
in
developing
the
proposed
BPT
concentration
based
limitations
because
non­
process
flow
data
available
at
that
time
were
only
gross
estimates
not
identified
in
sufficient
detail
and
were
not
based
on
daily
measurements
of
non­
process
flow.
Regarding
the
proposed
BPT
limitations,
commenters
indicated
that
EPA
should
eliminate
all
nonprocess
wastewater
from
the
calculation
of
BPT
limitations.
EPA
did
not
have
information
such
as
daily
non­
process
flow
data
from
facilities
that
generated
the
data
sets
used
in
the
calculation
of
BPT
and
BAT
limitations
for
BOD<
INF>
5</
INF>,
TSS
and
COD
to
allow
adjustment.
In
the
recent
NOA,
EPA
presented
BPT
limitations
for
BOD<
INF>
5</
INF>
and
TSS
and
BAT
COD
limitations
that
were
calculated
from
plant
data
sets
which
included
the
additional
data
submissions
obtained
since
proposal
from
which
the
non­
process
wastewater
had
been
backed
out.
In
cases
where
the
non­
process
flow
was
estimated
by
EPA
to
be
more
than
25
percent
of
the
total
flow
using
the
available
data,
the
fraction
of
the
non­
process
to
process
flow
volume
was
used
to
calculate
a
correction
factor
and
the
long­
term
average
concentration
values
for
each
of
the
BPT
parameters
were
adjusted
to
reflect
the
parameters
absence
of
this
non­
process
wastewater.
No
corrections
were
made
to
data
sets
where
the
http://
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epa.
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fedrgstr/
EPA­
WATER/
1998/
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21/
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htm
(
32
of
169)
[
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
non­
process
flow
was
estimated
to
be
less
than
25
percent
of
the
total
flow.
EPA
received
no
adverse
comments
regarding
these
adjusted
limitations.
However,
based
on
further
analysis,
EPA
believes
that
it
is
more
appropriate
to
follow
the
methodology
used
in
developing
the
final
Organic
Chemicals,
Plastics,
and
Synthetic
Fibers
(
OCPSF)
regulation
(
52
FR
52522)
final
BPT
limitations.
In
that
rule,
only
plant
data
sets
that
contained
less
than
25
percent
non­
process
wastewater
through
treatment
were
used
in
the
calculation
of
BPT
limits,
and
the
effluent
data
were
not
adjusted
to
take
into
account
plant
data
sets
that
contained
more
than
25
percent
non­
process
wastewater
through
treatment.
EPA
selected
this
approach
in
calculating
the
final
BPT
limitations
in
this
rule
for
the
same
two
reasons
used
during
development
of
the
OCPSF
rule.
(
See
52
FR
42522).
First,
using
data
sets
with
greater
than
25
percent
non­
process
wastewater
through
treatment
introduces
considerable
uncertainty
into
the
limitation
calculations
because
the
flow
data
that
would
be
used
are
only
in
part
based
on
daily
flow
measurements
whereas
the
concentration­
based
limitations
are
calculated
from
the
long
term
average
of
daily
measurements
over
long
periods
of
time
(
12­
24
months).
Second,
the
final
limitations
should
represent
as
much
as
possible
the
performance
of
treatment
technology
on
process
wastewater.
In
determining
permit
mass
limits,
permit
writers
and,
where
applicable,
pretreatment
control
authorities
should
identify
the
amount
of
non­
process
wastewater
being
treated.
The
flow
volume
representing
25
percent
or
less
of
the
total
flow
should
be
included
in
the
volume
used
to
calculate
allowable
mass
discharges.
Any
additional
volume
would
have
to
be
evaluated
on
a
caseby
case
basis
to
determine
what,
if
any,
mass
allowances
are
appropriate.
EPA
considered
four
options
for
the
final
BPT
limitations.
Under
the
first
option,
EPA
would
not
revise
the
existing
BPT
limitations
for
BOD<
INF>
5</
INF>,
TSS,
COD
and
cyanide.
No
costs
or
removals
are
associated
with
this
option.
Under
the
second
option,
EPA
would
revise
the
BPT
limitations
based
on
advanced
biological
treatment
only
for
COD,
and
revise
the
monitoring
requirements
for
the
existing
cyanide
limitations.
Under
option
three,
EPA
would
revise
BPT
limitations
for
BOD<
INF>
5</
INF>
and
TSS
based
on
advanced
biological
treatment
and
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
33
of
169)
[
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21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
revise
the
monitoring
requirements
for
the
existing
cyanide
limitations.
Under
the
fourth
option,
EPA
would
revise
BPT
limitations
for
BOD<
INF>
5</
INF>,
TSS,
and
COD
based
on
advanced
biological
treatment,
and
revise
the
monitoring
requirements
for
the
existing
cyanide
limitations.
The
options
for
all
subcategories
are
the
same,
except
as
to
cyanide
where
the
option
for
subcategories
B
and
D
contains
the
option
to
withdraw
the
cyanide
limitations
rather
than
just
modify
the
monitoring
requirements.
The
pretax
total
annualized
costs,
pollutant
removals,
and
costs
per
pound
removed
associated
with
the
options,
except
the
  
no
action''
option,
are
shown
below
in
Table
IV.
C.
1.

Table
IV.
C.
1.­­
BPT
Pretax
Option
Costs,
Pollutant
Removals
and
Cost
per
Pound
Removed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
annualized
Pollutant
Cost
per
pound
Treatment
option
cost
($
removals
($
1996/
lb)
million
1997)
(
lbs)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
A/
C
Subcategory
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Clarify
cyanide
monitoring,
revise
COD
only.....................
$
2.48
14,352,000
$
0.17
Clarify
cyanide
monitoring,
revise
BOD<
INF>
5
&
TSS...................
2.61
4,692,000
0.56
Clarify
cyanide
monitoring,
revise
BOD<
INF>
5,
TSS,
&
COD.............
3.10
15,731,000
0.20
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
B/
D
Subcategory
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
34
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Withdraw
cyanide,
revise
COD
only...............................
$
1.38
539,000
$
2.56
Withdraw
cyanide,
revise
BOD<
INF>
5
&
TSS.............................
1.89
588,000
3.21
Withdraw
cyanide,
revise
BOD<
INF>
5,
TSS,
&
COD.......................
2.16
598,000
3.62
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
selecting
these
treatment
options,
EPA
considered
the
total
cost
in
relation
to
the
effluent
reduction
benefits,
the
age
of
equipment
and
facilities
involved,
the
processes
employed,
process
changes
required,
engineering
aspects
of
the
control
technologies,
non­
water
quality
environmental
impacts
(
including
energy
requirements)
and
[[
Page
50398]]

other
factors
in
accordance
with
section
304(
b)(
1)(
B)
of
the
CWA.
EPA
has
determined
to
revise
BPT
effluent
limitations
only
for
COD.
EPA
is
also
clarifying
the
compliance
monitoring
requirements
for
the
existing
BPT
limitations
for
cyanide
for
subcategories
A
and
C,
and
withdrawing
the
existing
cyanide
limitations
for
subcategories
B
and
D.
As
discussed
above,
EPA
believes
that
it
has
the
statutory
authority
to
revise
BPT
and
that
it
has
the
discretion
to
determine
whether
to
revise
BPT
effluent
limitations
guidelines
in
particular
circumstances.
The
CWA
requires
EPA,
when
setting
BPT,
to
examine
the
total
cost
of
treatment
technologies
in
relation
to
the
effluent
reduction
benefits
achieved.
In
addition,
in
determining
whether
to
set
BCT
limitations,
the
Agency
needs
to
consider
the
reasonableness
of
the
cost
of
reducing
conventional
pollutants
and
compare
the
cost
of
removing
those
pollutants
by
regulated
plants
and
by
POTWs.
Accordingly,
EPA
examined
the
use
of
advanced
biological
treatment
as
a
basis
for
both
BPT
and
BCT
limitations
for
BOD<
INF>
5</
INF>
and
TSS.
The
Agency
found
that
the
reductions
in
these
conventional
contaminants
achieved
by
this
technology
were
not
commensurate
with
the
costs,
largely
because
of
the
large
operational
costs
associated
with
the
removal
of
TSS.
While
it
is
EPA's
view
that
it
can
revise
BPT
limitations
for
conventional
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
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21/
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htm
(
35
of
169)
[
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21/
2003
8:
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01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
pollutants
without
passing
the
BCT
cost
test
(
where
the
BPT
effluent
reduction
ratio
is
favorable),
the
Agency
is
not
generally
inclined
to
do
so
unless
the
removals
achieved
by
the
existing
BPT
limitations
are
significantly
fewer
than
would
be
achieved
through
revision
of
BPT.
That
was
not
the
case
here.
Revising
BPT
(
and
BAT)
for
COD
plants
will
not
only
remove
large
amounts
of
COD,
but
also
achieve
significant
incidental
removals
of
BOD<
INF>
5</
INF>
and
TSS.
For
this
reason,
EPA
has
determined
that
it
is
not
necessary
to
separately
revise
the
BPT
limits
for
BOD<
INF>
5</
INF>
and
TSS
in
this
case.
EPA
has
determined
to
revise
BPT
for
COD
because
the
biological
treatment
technology
used
as
a
basis
for
the
limitations
really
represents
BPT
technology
and
is
widely
used
in
the
industry.
The
bulk
parameter
and
nonconventional
pollutant
COD
is
an
indicator
of
organic
matter
in
the
wastestream
that
is
susceptible
to
strong
oxidation,
and
as
such
would
also
measure
organic
material
susceptible
to
biochemical
oxidation,
as
well
as
some
that
is
more
difficult
to
oxidize
biochemically.
In
addition,
limited
studies
and
discharge
monitoring
data
have
identified
toxicity
associated
with
the
COD
levels
contained
in
effluents
from
pharmaceutical
manufacturing
facilities.
Further
discussion
of
the
toxicity
levels
measured
in
the
effluents
from
pharmaceutical
manufacturing
facilities
is
contained
in
Section
6
of
the
TDD.
The
revised
COD
limitations
are
estimated
to
remove
approximately
14.9
million
pounds
annually,
including
incidental
removal
of
2.7
million
pounds
of
BOD
at
an
annualized
cost
of
$
2.48
million
($
1997).
The
revised
COD
provisions
require
the
use
of
either
the
new
effluent
concentration
limitations
or
the
existing
74
percent
reduction
requirement,
depending
upon
which
method
determines
the
more
stringent
plant
permit
limitation.
This
is
being
done
in
order
to
avoid
backsliding
issues
for
existing
plants
that
because
of
low
influent
concentration
already
meet
lower
effluent
limits
for
COD.
With
regard
to
cyanide,
EPA
is
retaining
the
existing
BPT
limitations
for
the
A
and
C
subcategories.
Further
revision
of
the
BPT
cyanide
limitations
was
not
selected
since
the
removals
were
estimated
to
be
less
than
42
pounds
per
year,
thus,
determined
not
to
be
beneficial
in
relation
to
the
annualized
costs
of
over
$
200,000
($
1997).

http://
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epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
36
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[
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2003
8:
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01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
However,
EPA
is
modifying
the
requirements
for
compliance
monitoring
(
for
subcategories
A
and
C).
The
current
limitations
require
compliance
monitoring
after
cyanide
treatment
and
before
dilution
with
other
wastestreams,
or
in
the
alternative,
monitoring
after
mixing
with
other
wastestreams
based
on
a
standard
dilution
factor.
Today's
rule
does
not
change
the
prohibition
on
dilution
to
meet
the
effluent
limitations
for
cyanide.
The
rule
continues
to
require
monitoring
for
compliance
with
the
existing
limitations
in­
plant,
prior
to
the
commingling
of
cyanide­
bearing
wastestreams
with
non­
cyanide
bearing
wastestreams
for
those
facilities
where
the
cyanide
levels
would
be
below
the
level
of
detection
at
the
end­
of­
pipe
monitoring
location.
The
only
change
in
the
monitoring
requirements
is
to
eliminate
the
current
dilution
standard
that
applied
industry­
wide,
and
to
allow
individual
facilities
to
demonstrate
that
end­
of­
pipe
monitoring
for
cyanide
is
feasible
(
i.
e.,
cyanide
is
detectable);
those
facilities
may
continue
to
monitor
at
the
end
of
pipe.
The
ability
of
EPA
to
require
in­
plant
monitoring
has
recently
been
questioned
in
connection
with
the
Great
Lakes
water
quality
guidance
program.
American
Iron
and
Steel
Institute
(
AISI)
v.
EPA,
115
F.
3d
979
(
D.
C.
Cir.
1997).
The
Court
held
that
although
EPA
has
the
authority
to
require
monitoring
of
internal
wastestreams,
see
AISI,
115
F.
3d
at
995,
the
CWA
does
not
authorize
EPA
to
require
compliance
with
water
quality
based
effluent
limitations
at
a
point
inside
the
facility
and
thereby
deprive
a
permittee
of
the
ability
to
choose
its
own
control
system
to
meet
the
limitations,
see
id.
at
966.
EPA
does
not
believe
that
decision
controls
here.
The
AISI
court
did
not
consider
the
question
whether
EPA
has
authority
to
regulate
internal
wastestreams
in
the
context
of
technology­
based
controls
such
as
BPT/
BAT,
PSES
and
NSPS/
PSNS.
Unlike
water
quality­
based
effluent
limitations,
which
are
calculated
to
ensure
that
water
quality
standards
for
the
receiving
water
are
attained,
technology­
based
limitations
and
standards
are
derived
to
measure
the
performance
of
specific
model
technologies
that
EPA
is
required
by
statute
to
identify.
In
identifying
these
technologies,
EPA
is
directed
to
consider
precisely
the
type
of
internal
controls
that
are
irrelevant
to
the
development
of
water
quality­
based
effluent
limitations,
such
as
the
processes
employed,
process
changes,
and
the
engineering
aspects
of
various
types
of
http://
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epa.
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fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
37
of
169)
[
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21/
2003
8:
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
control
techniques.
EPA's
technology­
based
effluent
limitations
are
intended
to
reflect,
for
each
industrial
category
or
subcategory,
the
  
base
level''
of
technology
(
including
process
changes)
and
to
ensure
that
  
in
no
case
*
*
*
should
any
plant
be
allowed
to
discharge
more
pollutants
per
unit
of
production
than
is
defined
by
that
base
level.''
E.
I.
du
Pont
de
Nemours
&
Co.
v.
Train,
430
U.
S.
at
129
(
1973).
EPA
believes
that
it
can
require
in­
plant
monitoring
to
demonstrate
compliance
with
technology­
based
effluent
limitations
in
accordance
with
the
CWA
and
its
regulations
at
40
CFR
122.44(
i),
122.45(
h),
125.3(
e)
and
403.6(
e).
In
today's
rule,
EPA
is
continuing
to
require
in­
plant
monitoring
for
cyanide
except
where
cyanide
can
be
detected
in
the
final
effluent.
Were
EPA
to
require
compliance
monitoring
of
the
final
effluent
without
adjustment
for
the
amount
of
dilution
in
cyanide­
bearing
waste
streams,
there
would
be
no
way
to
determine
whether
the
facility
had
adequately
controlled
for
cyanide
or
whether
the
effluent
has
simply
been
diluted
below
the
analytical
detection
level.
Diluting
pollutants
in
this
manner
rather
than
preventing
their
discharge
is
inconsistent
with
achieving
the
removals
represented
by
the
technology­
based
levels
of
control
and
hence
with
[[
Page
50399]]

the
purposes
of
the
limitations.
It
is
also
inconsistent
with
the
goals
of
the
CWA
in
general.

D.
Best
Available
Technology
Economically
Achievable
EPA
proposed
adding
new
end­
of­
pipe
BAT
limitations
for
53
organic
pollutants
plus
ammonia,
revising
the
existing
cyanide
limitations
and
adding
the
BPT
revised
COD
limitations
for
subcategories
A
and
C.
For
subcategories
B
and
D,
EPA
proposed
adding
new
end­
of­
pipe
BAT
limitations
for
53
organics,
BPT
revised
COD
limitations
and
withdrawing
the
existing
cyanide
limitations.
The
technology
basis
for
the
limitations
for
VOCs
was
steam
stripping
plus
advanced
biological
treatment
for
subcategories
A
and
C
and
advanced
biological
treatment
for
subcategories
B
and
D.
The
technology
basis
for
the
ammonia
limitations
was
nitrification.
The
revised
cyanide
limitations
for
the
A
and
C
subcategories
were
the
same
as
the
revised
BPT
proposed
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
38
of
169)
[
3/
21/
2003
8:
05:
01
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
limitations.
For
subcategories
B
and
D
cyanide
limitations
were
proposed
to
be
withdrawn
since
facilities
in
these
subcategories
do
not
use
or
generate
cyanide
in
their
wastewaters.
EPA
received
a
number
of
comments
indicating
that
steam
stripping
technology
was
not
appropriate
for
the
treatment
of
VOCs
and
that
emissions
of
these
pollutants
from
wastewater
should
be
controlled
by
CAA
regulations.
In
the
preamble
to
the
proposed
MACT
standards,
EPA
indicated
that,
in
view
of
the
MACT
proposed
wastewater
standards,
that
it
was
considering
changing
the
BAT
technology
basis
for
subcategory
A
and
C
VOCs
limitations
to
end­
of­
pipe
advanced
biological
treatment.
In
the
NOA,
EPA
reiterated
this
option
and
provided
cost
information
which
compared
the
original
proposal
technology
basis
(
steam
stripping
and
advanced
biological
treatment)
to
the
advanced
biological
treatment
technology
basis.
EPA
also
received
comments
on
its
proposed
ammonia
limitations.
Commenters
indicated
that
the
ammonia
limitations
were
inadequately
supported
by
nitrification
data.
In
the
NOA,
EPA
indicated
that
after
reevaluating
its
nitrification
data
base,
it
intended
to
base
the
BAT
ammonia
limitations
on
both
one
or
two
stage
nitrification
technology,
presented
compliance
costs
estimates
based
on
two
stage
nitrification
technology
and
revised
limitations
based
on
incorporating
additional
data,
including
data
representing
two
stage
nitrification,
into
the
data
base.
In
comments
on
the
NOA,
commenters
indicated
that
some
plants
employing
the
proposed
technology
basis
did
not
believe
that
they
could
achieve
consistent
compliance
with
the
revised
limitations.
In
order
to
respond
to
these
commenters,
EPA
evaluated
additional
nitrification
data
received
from
facilities
after
the
August
8,
1997
publication
of
the
NOA.
As
a
result
of
this
evaluation,
EPA
has
recalculated
the
ammonia
limitations
that
were
presented
in
the
NOA.
In
doing
so,
EPA
used
only
data
that
showed
evidence
that
nitrification
was
occurring
and
compared
separate
sets
of
limitations
developed
using
single­
stage
and
two­
stage
nitrification
data
sets,
respectively.
The
results
of
this
comparison
gave
final
limitations
less
stringent
than
those
calculated
for
the
NOA,
but
reflective
of
systems
that
nitrify
continuously
whether
they
are
one
or
two
stage
systems.
EPA
considered
three
regulatory
options
as
the
basis
for
BAT
limitations
for
subcategory
A
and
C
facilities.
All
three
options
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
39
of
169)
[
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21/
2003
8:
05:
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
modify
the
existing
BAT
regulations
to
parallel
the
BPT
regulations
and
to
clarify
the
compliance
monitoring
point
for
the
existing
cyanide
limitations.
The
first
option
is
a
no
cost
revision
which
incorporates
the
BPT
clarification
for
cyanide
and
revised
BPT
limitations
for
COD.
The
second
option
adds
limitations
for
30
organic
pollutants
based
on
advanced
biological
treatment
and
revised
limitations
for
COD
equal
to
the
final
BPT
limitations
and
clarifies
the
compliance
monitoring
point
for
cyanide.
The
third
option
adds
limitations
for
30
organic
pollutants
based
on
advanced
biological
treatment,
ammonia
limitations
based
on
one
or
two
stage
biological
nitrification
technology,
incorporates
the
revised
COD
limitations
and
clarifies
the
compliance
monitoring
point
for
cyanide.
The
pretax
total
annualized
compliance
costs
and
pollutant
removals
associated
with
the
second
and
third
options
(
only
options
incurring
costs)
are
shown
below
in
Table
IV.
D.
1
for
subcategories
A
and
C:

Table
IV.
D.
1­­
BAT
Pretax
Options
Costs,
and
Pollutant
Removals
for
Subcategory
A
and
C
Direct
Dischargers
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Pollutant
annualized
removals
Regulatory
option
cost
($
(
million
lbs
million
1997)
per
yr)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Add
Organics
and
COD
and
clarify
cyanide
$
2.3
1.4
Add
Organics,
Ammonia
and
COD
and
clarify
cyanide........................
3.6
2.2
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

EPA
evaluated
the
costs
and
economic
impacts
associated
with
each
option
and
determined
that
all
the
options
were
economically
achievable.
After
considering
the
pollutant
load
removals,
the
costs,
as
well
as
the
non­
water
quality
environmental
impacts
associated
with
the
options,
EPA
selected
the
third
option
which
adds
effluent
limitations
for
30
organic
pollutants,
ammonia
and
COD
and
modifies
the
cyanide
monitoring
requirements.
EPA
believes
that
this
option
is
economically
achievable
and
there
are
no
significant
adverse
non­
water
quality
impacts
associated
with
it.
In
addition,
EPA
believes
the
http://
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epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
40
of
169)
[
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21/
2003
8:
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
discharge
loadings
of
ammonia,
COD
and
the
organic
pollutants
are
significant
from
subcategory
A
and
C
facilities,
and
that
limitations
on
these
discharges
are
appropriate.
EPA
has
also
evaluated
the
technology
bases
of
the
final
BAT
limitations
in
the
context
of
the
BAT
statutory
factors,
i.
e.,
the
age
of
equipment
and
facilities
involved,
the
process(
s)
employed,
potential
process
changes
and
non­
water
quality
impacts
such
as
energy
requirements.
EPA
believes
the
final
BAT
limitations
are
appropriate
based
on
its
assessment
of
these
factors
in
relation
to
A
and
C
subcategory
facilities.
For
facilities
with
subcategories
B
and
D
operations,
EPA
has
identified
only
the
pollutant
COD
for
control
by
BAT
limitations
based
on
advanced
biological
treatment
(
the
technology
selected
as
the
basis
for
the
BPT
limitations).
As
discussed
under
BPT,
cyanide
is
not
a
pollutant
of
concern
for
subcategories
B
and
D
operations
and
EPA
is
withdrawing
the
current
BAT
cyanide
limitations
for
facilities
with
subcategories
B
and
D
operations.
EPA
[[
Page
50400]]

also
has
determined
that
ammonia
is
not
a
pollutant
of
concern
for
these
subcategories
since
ammonia
is
not
found
in
significant
amounts
in
wastewaters
from
these
operations.
Thus,
for
subcategories
B
and
D,
EPA
considered
two
final
BAT
regulatory
options.
The
first
option
is
a
no
cost
option
consisting
of
the
withdrawal
of
the
existing
cyanide
limitations,
the
same
as
the
final
BPT
withdrawal
of
cyanide
control
and
the
addition
of
the
BPT
revised
COD
limitations.
The
second
option
includes
the
withdrawal
of
the
existing
cyanide
limitations
and
the
addition
of
the
BPT
revised
COD
limitations
and
limitations
based
only
on
advanced
biological
treatment
for
30
of
the
same
organic
pollutants
selected
for
regulation
at
the
subcategories
A
and
C
facilities.
The
total
annualized
cost
and
annual
pollutant
removal
associated
with
the
second
option
are
$
0.410
million
($
1997)
and
22,300
pounds
per
year.
EPA
has
evaluated
the
discharge
loadings
of
organic
pollutants
from
subcategories
B
and
D
facilities
and
has
determined
that
95
percent
of
the
discharge
of
organic
pollutants
is
from
two
facilities.
Most
direct
discharging
subcategories
B
and
D
facilities
do
not
discharge
any
http://
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epa.
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EPA­
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1998/
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htm
(
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2003
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
organic
pollutants.
EPA
believes
these
organic
pollutant
discharges
are
not
sufficient
to
justify
national
regulations
for
these
subcategories.
If
permit
writers
determine
the
need
to
further
control
the
organic
pollutants
from
the
two
facilities,
the
appropriate
limits
contained
in
the
subcategories
A
and
C
BAT
regulations
may
be
used.
For
this
final
rule,
EPA
has
selected
the
first
option,
which
is
to
only
add
the
BPT
revised
COD
limitations
to
BAT
for
subcategories
B
and
D
facilities,
and
to
withdraw
the
existing
cyanide
limitations.

E.
Pretreatment
Standards
for
Existing
Sources
(
PSES)

EPA
proposed
pretreatment
standards
for
45
organic
pollutants
(
including
37
VOCs),
with
in­
plant
monitoring
for
12
VOCs
and
end­
ofpipe
monitoring
for
the
remaining
33
organics
(
25
of
which
are
VOCs)
under
coproposal
A;
and
in­
plant
monitoring
only
for
the
12
VOCs
under
coproposal
B.
EPA
received
considerable
comment
on
its
proposal
pass
through
analysis
which
indicated
that
the
45
organic
pollutants
passed
through
POTW
treatment
works.
Thirty­
seven
of
the
organic
pollutants,
including
13
alcohols
and
related
compounds
had
Henry's
Law
Constants
greater
than
10
<
SUP>­
6</
SUP>
atm
m<
SUP>
3</
SUP>/
gmole,
which
was
the
physical
property
used
to
consider
a
pollutant
to
be
too
volatile
to
be
treated
properly
at
POTWs.
The
other
eight
organic
pollutants
were
determined
to
pass
through
based
on
the
BAT
technology
percent
removal
exceeding
that
of
well
operated
activated
sludge
treatment
represented
by
EPA's
50
POTW
data
base.
Many
commenters
objected
to
the
assumption
that
pollutants
with
Henry's
Law
constants
greater
than
10<
SUP>­
6</
SUP>
atm
m<
SUP>
3</
SUP>/
gmole
would
be
considered
to
pass
through
based
on
their
volatility.
The
pollutants
commenters
identified
as
being
insufficiently
volatile
and
highly
biodegradable
included:
methanol,
ethanol
and
other
pollutants
with
Henry's
Law
constants
lower
than
1
x
10<
SUP>­
5</
SUP>
atm
m<
SUP>
3</
SUP>/
gmole.
Commenters
indicated
that
many
of
the
alcohols
and
related
compounds
were
easily
biodegraded
by
POTWs
and
did
not
pass
through.
EPA
also
received
a
number
of
comments
concerning
the
proposed
inplant
monitoring
point
for
the
12
VOCs.
Commenters
indicated
that
CAA
MACT
standards
not
CWA
pretreatment
standards
should
control
in­
plant
emissions
of
these
pollutants
from
internal
wastestreams.

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1998/
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
In
order
to
address
these
and
other
comments
related
to
controlling
the
alcohols
and
related
compounds,
EPA
conducted
a
sampling
study
in
August
1996
at
a
POTW
in
Barceloneta,
Puerto
Rico.
This
POTW
treats
pharmaceutical
industry
wastewaters
containing
measurable
amounts
of
the
predominant
alcohols
and
related
compounds,
such
as
methanol,
ethanol
and
isopropanol.
The
purpose
of
the
sampling
study
was
to
determine
the
extent
to
which
methanol
and
other
compounds
with
similar
Henry's
Law
Constants
volatilize
in
the
primary
treatment
works
(
aerated
grit
chambers
and
primary
clarifiers)
prior
to
the
biodegradation
unit
process.
Amounts
volatilized
prior
to
the
biodegradation
unit
are
not
considered
to
be
treated.
In
the
NOA,
EPA
published
the
preliminary
results
of
the
study
along
with
those
of
a
separate
bench­
scale
study
of
anaerobic
degradation
in
the
Barceloneta
primary
clarifiers
conducted
by
industry.
EPA
indicated
in
the
NOA
that
it
was
considering
a
finding
of
no
pass
through
for
13
of
the
organic
pollutants
(
methanol
and
other
alcohols
and
related
compounds)
based
on
the
belief
that
the
volatization
of
these
pollutants
in
the
primary
works
of
POTWs
is
roughly
equivalent
to
that
observed
in
the
primary
works
of
direct
discharging
BAT
level
facilities.
Thus,
the
treatment
of
these
pollutants
by
a
well
operated
POTW
is
roughly
equivalent
to
that
achieved
by
industrial
facilities
meeting
BAT.
As
noted
earlier
in
section
III.
D.
EPA
proposed
PSES
for
45
organic
pollutants,
and
subsequently
removed
eight
pollutants
based
on
no
pass
through
at
the
POTWs,
thus
making
a
total
of
21
(
with
the
alcohols
and
related
compounds)
not
passing
through
POTWs.
In
addition
to
discussing
results
of
its
pass
through
analyses
in
the
NOA,
EPA
presented
two
revised
pretreatment
options
for
all
four
subcategories,
with
end­
of­
pipe
monitoring
for
all
VOCs
including
the
12
volatile
pollutants
for
which
in­
plant
monitoring
for
PSES/
PSNS
had
been
proposed.
In
the
NOA,
EPA
indicated
that
PSES
for
these
12
pollutants
were
unnecessary
because
they
would
be
controlled
by
the
MACT
wastewater
standards
which
require
an
in­
plant
compliance
demonstration
for
10
of
the
12
VOCs
which
are
HAPs.
The
remaining
12
VOCs,
in
addition
to
the
two
non­
HAPs
that
are
part
of
the
12
VOCs
discussed
above,
are
controlled
by
end­
of­
pipe
limits
based
on
steam
stripping,
with
removals
incidental
to
controlling
HAPs
either
directly
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htm
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Source
Performance
Standards;
Final
Rule
by
the
MACT
standards
or
separately
from
the
MACT
standards
at
smaller
facilities
not
covered
by
the
MACT
rule
but
controlled
by
this
CWA
final
rule.
In
finalizing
the
methodology
for
the
pass
through
analysis
discussed
above,
EPA
relied
on
three
criteria
that
had
to
be
met
before
a
pollutant
was
deemed
to
pass
through.
These
criteria
included
volatility,
solubility
in
water,
and
the
BAT
and
POTW
technologies
percent
removal
comparison.
With
regard
to
volatility,
EPA
raised
its
Henry's
Law
Constant
threshold
for
volatility
from
1
x
10<
SUP>­
</
SUP>\<
SUP>
6</
SUP>\
atm/
gmole/
m
\
3\
to
1
x
10<
SUP>­
</
SUP>\<
SUP>
5</
SUP>\
atm/
gmole/
m\
3\
based
on
comments
that
the
Henry's
Law
Constant
used
at
proposal
was
not
consistent
with
what
was
used
for
the
OCPSF
final
rule.
Pollutants
with
Henry
Law
Constants
greater
than
1
x
10<
SUP>­</
SUP>\<
SUP>
5</
SUP>\
atm/
gmole/
m
\
3\
were
believed
to
volatilize
significantly
before
reaching
treatment
at
a
POTW.
In
connection
with
volatility,
in
order
to
be
consistent
with
the
MACT
standards
approved
for
controlling
water
soluble
HAPs,
EPA
also
considered
whether
a
pollutant
was
water
soluble
because
water
soluble
compounds
are
less
likely
to
volatilize
than
compounds
that
are
partially
soluble.
Finally,
EPA
considered
differences
in
removal
percentages
for
organic
pollutants
obtained
by
comparing
the
BAT
model
treatment
system
percentage
removal
to
the
average
pollutant
removal
percentage
achieved
by
well­
operated
POTWs
achieving
secondary
treatment
performance
standards.
In
developing
BAT
pollutant
removal
percentages,
EPA
only
used
pollutant
data
pairs
where
the
influent
[[
Page
50401]]

concentrations
were
greater
than
ten
times
the
pollutant
method
detection
limits
which
was
the
approach
used
in
developing
the
supporting
information
for
the
NOA.
In
developing
the
final
POTW
pollutant
removal
percentages,
EPA
utilized
the
acclimated
data
from
the
same
sources
used
to
develop
these
percentages
for
the
NOA.
These
removal
percentages
are
the
POTW
removal
percentages
used
in
the
final
comparison.
Thus,
in
order
for
a
pollutant
to
be
deemed
to
pass
through,
it
had
to
have
a
Henry's
Law
Constant
greater
than
1
x
10<
SUP>­</
SUP>\<
SUP>
5</
SUP>\
atm/
gmole/
m
\
3\,
be
less
than
totally
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Source
Performance
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Final
Rule
soluble
in
water,
and
have
a
BAT
removal
percentage
greater
than
its
POTW
removal
percentage.
Based
on
this
analysis,
EPA
has
determined
that
23
organic
pollutants
in
subcategories
A
and
C
and
5
organic
pollutants
in
subcategories
B
and
D,
that
pass
through
POTWs
are
regulated
by
pretreatment
standards
in
today's
rule.
A
more
detailed
description
of
this
analysis
may
be
found
in
section
17
of
the
final
TDD.
In
addition
to
pretreatment
standards
for
VOCs,
EPA
proposed
ammonia
standards
based
on
either
steam
stripping
or
two­
stage
nitrification.
In
May
1995
EPA
proposed
ammonia
pretreatment
standards
based
only
on
steam
stripping
technology.
The
Agency
received
a
number
of
comments
concerning
the
proposed
ammonia
pretreatment
standards.
Some
commenters
indicated
that
steam
stripping
may
not
be
a
reliable
treatment
technology.
Others
questioned
the
need
for
national
ammonia
standards
because
many
POTWs
have
imposed
local
limits
for
ammonia
and
others
have
nitrification
capability.
EPA
discussed
both
of
these
concerns
in
the
NOA.
EPA
suggested
in
the
NOA
that
ammonia
does
not
pass
through
POTWs
with
nitrification,
and
requested
comments
on
the
preliminary
discussion
not
to
set
pretreatment
standards
for
industrial
users
which
discharge
to
POTWs
with
this
technology.
Comments
from
POTW
control
authorities
and
industry
supported
this
approach
to
developing
PSES
ammonia
standards.
The
final
rule
contains
ammonia
pretreatment
standards
only
for
subcategories
A
and
C,
based
on
the
BAT
technology
of
nitrification
and
is
applicable
to
those
facilities
discharging
to
POTWs
without
nitrification
capability.
EPA
determined
that
cyanide
passes
through
POTWs
based
on
the
percent
removal
comparison
with
the
hydrogen
peroxide
(
BAT)
technology.
Thus,
EPA
proposed
revised
cyanide
pretreatment
standards
based
on
hydrogen
peroxide
technology
but
maintaining
that
the
standards
based
on
in­
plant
monitoring
for
the
requirements.
EPA
received
comments
raising
safety
concerns
using
this
technology
for
high
organic
strength
wastes.
Based
on
these
comments
and
additional
data
submitted
by
facilities,
in
the
NOA,
EPA
proposed
establishing
two
sets
of
cyanide
standards.
One
standard
would
be
identical
to
the
proposed
standards
based
on
hydrogen
peroxide
technology,
while
the
other
standard
would
be
based
on
alkaline
chlorination
technology
and
applicable
only
to
those
facilities
that
could
demonstrate,
due
to
safety
concerns,
that
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Final
Rule
hydrogen
peroxide
technology
was
not
an
appropriate
technology
to
use
with
their
wastewater.
EPA
estimated
compliance
costs
and
loadings
removals
to
be
the
same
for
both
sets
of
standards
because
it
was
assumed
that
the
vast
majority
of
facilities
would
meet
these
standards
based
on
the
use
of
the
more
expensive
and
efficient
hydrogen
peroxide
technology.
In
developing
the
final
PSES
for
subcategories
A
and
C,
EPA
considered
three
options.
The
first
option
was
not
to
develop
pretreatment
standards
for
ammonia
or
any
of
the
VOC
pollutants,
and
to
modify
the
monitoring
requirements
for
the
existing
cyanide
standards.
The
second
option
would
build
on
compliance
with
the
MACT
standard
with
additional
pretreatment
standards
for
23
VOCS
based
on
steam
stripping
technology
and
ammonia
based
on
steam
stripping
or
nitrification
and
modify
the
cyanide
monitoring
requirements.
The
third
option
would
be
the
same
as
the
second
option,
with
the
addition
of
revised
pretreatment
standards
for
cyanide.
The
annualized
compliance
costs
(
1997
dollars)
and
pollutant
removals
for
the
second
and
third
options
(
the
only
ones
incurring
costs)
are
shown
below
in
Table
IV.
E.
1.
EPA
did
not
consider
additional
options
involving
small
facility
exclusions
because
results
of
the
economic
analyses
for
the
small
facilities
using
the
costs
for
both
options
described
above
showed
that
both
options
are
economically
achievable
(
see
section
V
of
this
preamble
for
more
discussion).

Table
IV.
E.
1­­
PSES
Pretax
Options
Costs
and
Pollutant
Removals
for
Subcategories
A
and
C
Indirect
Dischargers
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
annualized
Pollutant
Treatment
option
cost
($
removals
million
1996)
(
million
lbs)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Add
organics
and
ammonia
and
modify
cyanide
monitoring
requirements........
$
44.5
10.653
Add
organics
and
ammonia
and
revise
cyanide
limits.........................
44.8
10.654
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

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htm
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Guidelines,
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and
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Source
Performance
Standards;
Final
Rule
Due
to
the
low
pollutant
removals
achievable
by
the
revised
cyanide
standards
(
approximately
1000
lbs
per
year
with
97
percent
of
the
removals
coming
from
one
facility)
in
relation
to
the
compliance
costs,
EPA
has
decided
not
to
revise
the
existing
cyanide
standards,
and
has
selected
the
option
to
add
organics
and
ammonia
only
and
modify
the
current
cyanide
monitoring
requirements.
The
selected
option
adds
standards
for
ammonia
and
the
23
organic
pollutants
determined
to
pass
through
(
see
previous
discussion
in
this
section),
and
modifies
the
monitoring
point
for
the
current
cyanide
pretreatment
standards
for
subcategories
A
and
C.
EPA
is
setting
pretreatment
standards
for
ammonia
for
subcategories
A
and
C
because
of
the
high
loads
of
ammonia
currently
being
discharged
by
a
number
of
pharmaceutical
facilities
to
POTWs
that
do
not
have
nitrification
capability
and
receive
wastewaters
from
subcategories
A
and
C
facilities.
However,
EPA
is
aware
that
some
POTWs
treating
pharmaceutical
wastewaters
from
these
subcategories
have
nitrification
capability,
and
EPA
has
made
a
determination
of
no
passthrough
for
ammonia
at
these
POTWS.
Thus,
PSES
ammonia
limitations
will
not
apply
to
subcategory
A
and
C
facilities
discharging
to
POTWs
with
nitrification
capability.
POTWs
with
nitrification
capability
oxidize
ammonium
salts
to
nitrites
(
via
Nitrosomonas
bacteria)
and
the
further
oxidize
nitrites
to
nitrates
via
Nitrobacter
bacteria
and
achieve
greater
removals
of
ammonia
than
POTWs
[[
Page
50402]]

without
nitrification.
Nitrification
can
be
accomplished
in
either
a
single
or
two­
stage
activated
sludge
system.
In
addition,
POTWs
that
have
wetlands
which
are
developed
and
maintained
for
the
expressed
purpose
of
removing
ammonia
with
a
marsh/
pond
configuration
are
also
examples
of
having
nitrification
capability.
Indicators
of
nitrification
capability
are:
(
1)
biological
monitoring
for
ammonia
oxidizing
bacteria
(
AOB)
and
nitrite
oxidizing
bacteria
(
NOB)
to
determine
if
nitrification
is
occurring,
and
(
2)
analysis
of
the
nitrogen
balance
to
determine
if
nitrifying
bacteria
reduce
the
amount
of
ammonia
and
increase
the
amount
of
nitrite
and
nitrate.
For
subcategories
B
and
D,
EPA
considered
two
options.
The
first
option
was
not
to
add
regulated
pollutants
to
the
existing
PSES
and,

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Performance
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Final
Rule
since
cyanide
is
not
present
in
wastewaters
for
these
subcategories
facilities,
to
withdraw
the
existing
cyanide
standards.
Thus,
compliance
with
the
MACT
standard
would
be
the
only
requirement
for
controlling
VOC
pollutants.
The
second
option
was
to
add
pretreatment
standards
for
5
VOCs
(
not
including
the
alcohols
and
related
compounds
and
19
pollutants
determined
not
to
be
present
in
subcategory
B
and
D
wastewaters)
based
on
steam
stripping
in
addition
to
withdrawing
the
existing
cyanide
standards.
No
ammonia
standards
were
considered
since
facilities
in
these
subcategories
do
not
generate
significant
levels
of
ammonia
in
their
wastewaters.
The
pretax
annualized
compliance
cost
for
this
second
option
is
$
8.8
million
($
1997)
and
annual
pollutant
removals
are
3.35
million
pounds.
For
PSES
for
subcategories
B
and
D,
EPA
has
selected
the
second
option.
EPA
is
basing
this
selection
on
the
fact
that
the
5
pollutants
(
VOCs)
have
been
determined
to
passthrough,
and
the
pollutant
removals
are
relatively
high
with
respect
to
the
compliance
costs.
The
costs
are
economically
achievable
and
the
nonwater
quality
environmental
impacts
are
acceptable.

F.
New
Source
Performance
Standards
(
NSPS)

EPA
proposed
NSPS
for
53
organic
pollutants,
BOD<
INF>
5</
INF>,
TSS
and
COD
based
on
steam
stripping
or
distillation
and
advanced
biological
treatment
for
subcategories
A
and
C.
EPA
also
proposed
NSPS
for
ammonia
and
cyanide
based
on
nitrification
and
hydrogen
peroxide
oxidation
technologies,
respectively
for
these
two
subcategories.
EPA
received
comments
indicating
that
distillation
technology
was
not
a
demonstrated
technology
for
removing
soluble
VOCs
(
such
as
methanol),
and
therefore,
should
not
be
part
of
the
technology
basis
of
NSPS.
EPA
has
reevaluated
its
steam
stripping
and
distillation
database
and
has
concluded
that
distillation
technology
is
sufficiently
demonstrated
to
be
considered
BADT
(
Best
Available
Demonstrated
Technology).
However,
after
taking
into
account
the
high
removal
of
these
pollutants
achievable
by
steam
stripping
and
advanced
biological
treatment,
the
addition
of
distillation
technology
is
unnecessary.
Consequently
EPA
did
not
consider
distillation
technology
as
part
of
final
NSPS
model
technology.
EPA
evaluated
technology
options
capable
of
achieving
greater
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Source
Performance
Standards;
Final
Rule
pollutant
removal
of
conventional
pollutants
(
BOD<
INF>
5</
INF>
and
TSS),
COD,
Organics,
Cyanide
and
Ammonia
than
those
selected
as
the
basis
for
existing
source
limitations
(
BPT,
BCT
and
BAT).
The
only
option
potentially
capable
of
achieving
additional
removals
involves
the
use
of
granular
activated
carbon
(
GAC)
adsorption
technology.
This
technology
is
capable
of
reducing
the
COD
from
some
direct
discharging
A
and
C
subcategory
facilities.
However,
there
is
only
limited
GAC
performance
data
available,
from
one
pilot
study.
For
subcategories
B
and
D,
EPA
proposed
NSPS
for
53
organic
pollutants,
BOD<
INF>
5</
INF>,
TSS
and
COD
based
on
in­
plant
steam
stripping
with
distillation
and
end­
of­
pipe
advanced
biological
treatment.
As
was
the
case
with
the
proposed
NSPS
for
subcategories
A
and
C,
EPA
received
comments
stating
that
use
of
distillation
technology
as
BADT
for
new
sources
is
inappropriate
because
its
ability
to
remove
methanol
and
other
water
soluble
organic
pollutants
has
not
been
demonstrated
with
respect
to
representative
wastestreams.
For
subcategories
A
and
C,
EPA
is
promulgating
NSPS
equal
to
the
final
BAT
effluent
limitations
for
30
organic
pollutants,
cyanide
and
ammonia.
For
subcategories
B
and
D,
EPA
is
promulgating
NSPS
equal
to
BAT
(
including
withdrawal
of
the
existing
cyanide
standards).
EPA
is
also
promulgating
revised
NSPS
for
BOD<
INF>
5</
INF>,
COD
and
TSS
for
all
four
subcategories
at
a
level
equal
to
the
discharge
characteristics
of
the
best
performing
BPT
plants
which
for
COD
is
also
the
BAT/
BPT
level
of
control.
These
final
standards
are
based
on
the
best
available
demonstrated
control
technologies,
which
include
advanced
biological
treatment,
cyanide
destruct
and
nitrification.
In
developing
these
final
standards,
the
Agency
considered
factors
including
the
cost
of
achieving
effluent
reductions,
non­
water
quality
environmental
impacts,
and
energy
requirements.
EPA
finds
that
the
final
standards
represent
the
best
available
demonstrated
control
technologies,
are
economically
achievable
and
do
not
present
a
barrier
to
entry
and
have
acceptable
non­
water
quality
environmental
impacts.

G.
Pretreatment
Standards
for
New
Sources
(
PSNS)

EPA
proposed
PSNS
for
45
organic
pollutants,
cyanide
and
ammonia
for
subcategories
A
and
C,
and
the
same
45
organic
pollutants
only,
for
subcategories
B
and
D.
The
technology
basis
for
the
proposed
organic
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epa.
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
pollutant
standards
was
steam
stripping
with
distillation,
and
the
technology
bases
for
the
proposed
cyanide
and
ammonia
standards
were
hydrogen
peroxide
oxidation
and
steam
stripping
technologies,
respectively.
The
proposed
pretreatment
standards
for
new
sources
were
more
stringent
than
the
proposed
PSES.
However,
for
the
final
rule,
EPA
was
unable
to
identify
a
technology
that
would
achieve
greater
removal
of
the
pollutants
to
be
controlled
by
the
PSES
being
promulgated
today
and
is
therefore
promulgating
PSNS
equal
to
PSES
for
all
four
subcategories.

H.
Best
Conventional
Pollutant
Control
Technology
(
BCT)

EPA
proposed
BCT
equal
to
BPT
for
the
conventional
pollutants
BOD<
INF>
5</
INF>
and
TSS
for
all
four
subcategories.
The
Agency
indicated
that
it
had
not
identified
technologies
that
achieve
greater
removals
of
conventional
pollutants
other
than
those
associated
with
the
proposed
revision
of
BPT
limits,
and
that
these
technologies
did
not
pass
the
two­
part
BCT
cost
reasonable
test.
EPA
has
not
received
any
comments
concerning
its
proposal
BCT
cost
test
analysis.
The
Agency
has
repeated
the
cost
test
with
the
postproposal
data,
with
the
same
results.
Based
on
the
failure
to
identify
any
incremental
conventional
pollutant
removal
technology
options
that
pass
the
BCT
cost
reasonable
test,
EPA
is
promulgating
BCT
limitations
equal
to
the
existing
BPT
limitations
for
BOD<
INF>
5</
INF>
and
TSS
for
all
subcategories.

V.
Assessment
of
Costs
and
Impacts
for
the
Final
Pharmaceutical
Regulations
A.
Introduction
The
economic
analysis
for
the
final
pharmaceutical
effluent
limitations
guidelines
and
standards
assesses
the
costs
and
impacts
of
these
guidelines.
The
results
of
this
analysis
are
contained
in
the
record
for
this
final
[[
Page
50403]]

rule
and
are
summarized
in
a
document
entitled
Economic
Analysis
for
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
50
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169)
[
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2003
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05:
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Final
Effluent
Guidelines
and
Standards
for
the
Pharmaceutical
Industry
(
EPA­
821­
B­
98­
009).
Included
in
the
Economic
Analysis
(
EA)
and
summarized
below
are
(
1)
the
annualized
costs
of
the
rule
by
subcategory,
separately
and
together
with
the
costs
of
the
MACT
standards
rule
discussed
previously;
(
2)
the
impacts
of
the
rule
both
separately
and
together
with
the
MACT
standards
on
pharmaceutical
facilities,
both
existing
and
new
sources;
(
3)
the
impacts
of
these
rules
on
pharmaceutical
firms;
(
4)
the
impacts
of
these
rules
on
employment
and
communities;
and
(
5)
other
secondary
impacts
on
trade,
inflation,
POTWs,
environmental
justice,
and
distributional
equity.
Also
included
in
the
EA
are
a
Final
Regulatory
Flexibility
Analysis
as
required
under
the
Regulatory
Flexibility
Act
and
a
Cost­
Benefit
Analysis,
as
required
under
the
Unfunded
Mandates
Reform
Act
(
UMRA)
and
Executive
Order
12866,
which
are
summarized
in
Sections
V.
E
and
V.
F
of
this
preamble.
An
additional
document,
Cost
Effectiveness
Analysis
for
Effluent
Limitations
Guidelines
and
Standards
for
the
Pharmaceutical
Industry
(
EPA­
821­
B­
98­
010),
assesses
the
cost­
effectiveness
of
the
rule.
The
results
of
this
analysis
are
summarized
below
in
Section
V.
G.

B.
Summary
of
the
Economic
Analysis
Methodology
and
Data
EPA
determined
the
annualized
costs
of
compliance
in
exactly
the
same
way
as
was
done
for
proposal,
with
the
exception
of
the
choice
of
discount
rate
(
discussed
in
V.
C).
Costs
are
annualized
at
seven
percent
over
16
years
(
a
1­
year
installation
period
a
15­
year
project
life
is
assumed).
The
cost
annualization
also
accounts
for
tax
shields
on
both
O&
M
and
depreciation
(
calculated
using
the
modified
accelerated
cost
recovery
system
allowed
by
IRS
rules)
to
develop
a
posttax
estimate
of
annual
costs
(
see
Section
4
of
the
Economic
Analysis
for
a
detailed
discussion).
For
analytical
consistency,
MACT
standards
costs
are
also
annualized
in
the
same
way,
both
pretax
and
posttax.
This
is
slightly
different
from
the
way
EPA
annualized
the
MACT
standards
costs
in
the
preamble
to
the
MACT
standards
rule,
where
costs
are
annualized
at
seven
percent
over
ten
years
(
with
no
delay
for
installation)
to
create
a
pretax
annual
cost
(
i.
e.,
without
accounting
for
tax
shields).
Additionally,
the
MACT
standards
costs
presented
in
the
preamble
to
the
MACT
standards
rule
include
costs
for
new
sources,
which
are
not
included
in
this
preamble.
Despite
the
differences
in
annualization
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
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Day­
21/
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htm
(
51
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169)
[
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
method,
the
current
cost
annualization
approach
in
no
way
conflicts
with
the
alternative
analysis.
To
assess
impacts
on
firms
and
facilities,
EPA
has
set
up
three
baselines
in
the
analysis.
Baseline
1
is
the
usual
baseline
analyzed
in
all
effluent
guidelines.
It
is
a
scenario
that
reflects
a
baseline
condition
without
additional
regulation,
that
is,
no
additional
effluent
limitations
guidelines
and
standards
or
MACT
standards
costs
are
considered.
This
baseline
is
taken
from
the
current
(
i.
e.,
1990
Survey)
financial
data.
Baseline
2
incorporates
certain
MACT
standards
costs
pertaining
only
to
wastewater
emission
controls,
and
does
not
include
costs
for
controlling
emissions
from
process
vents,
equipment
leaks
and
storage
tanks.
This
baseline
is
presented
in
the
EA,
but
results
of
this
baseline
(
which
are
not
appreciably
different
from
those
for
Baseline
1)
are
not
discussed
at
length
in
this
preamble.
Baseline
3
incorporates
costs
for
all
components
associated
with
the
MACT
standards
rule.
EPA
estimated
the
capital
and
operating
costs
for
MACT
standards
cost
components
for
emission
controls
on
wastewater
streams
(
on
which
Baseline
2
is
based),
as
well
as
the
capital
and
operating
costs
for
all
MACT
components
(
on
which
Baseline
3
is
based)
as
a
part
of
the
Agency's
MACT
standards
rulemaking
process.
To
model
Baseline
2,
EPA
used
the
capital
and
operating
costs
associated
with
the
wastewater
emission
controls
for
all
facilities
in
the
MACT
analysis
for
which
costs
were
developed
and
matched
them
to
the
facilities
that
are
also
in
the
effluent
guidelines
analysis.
However,
a
number
of
facilities
in
the
effluent
guidelines
analysis
are
not
covered
by
the
MACT
standards
and
were
not
assigned
MACT
costs.
EPA
annualized
the
costs
at
seven
percent
over
16
years
in
the
cost
annualization
model
and
also
developed
a
present
value
of
posttax
compliance
costs
over
this
same
time
frame.
EPA
subtracted
the
present
value
posttax
compliance
costs
from
the
Baseline
1
present
value
posttax
facility
earnings
(
derived
from
the
Survey
data)
to
determine
Baseline
2
posttax
earnings
for
each
facility
in
the
effluent
guidelines
analysis.
EPA
used
this
same
approach
to
derive
Baseline
3
posttax
earnings
(
for
those
facilities
without
MACT
standards
costs,
earnings
are
the
same
in
all
three
baselines).
A
facility
whose
posttax
earnings
are
zero
or
negative
in
Baseline
1
is
counted
as
a
Baseline
1
closure;
a
facility
whose
posttax
earnings
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
52
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169)
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8:
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
are
zero
or
negative
in
Baseline
2
is
counted
as
a
Baseline
2
closure;
and
a
facility
whose
posttax
earnings
are
zero
or
negative
in
Baseline
3
is
counted
as
a
Baseline
3
closure.
EPA
then
incorporated
the
present
value
posttax
costs
of
the
effluent
guidelines
into
each
of
the
baselines
in
the
same
way
as
MACT
standards
costs
were
incorporated
to
calculate
postcompliance,
posttax
earnings.
EPA
then
tallied
the
closure
results
(
in
terms
of
whether
postcompliance,
posttax
earnings
are
zero
or
negative)
by
counting
postcompliance
closures
incrementally
from
each
baseline.
In
other
words,
EPA
considered
any
closures
that
occurred
additional
to
those
occurring
in
each
of
the
baselines
as
postcompliance
closures
under
the
three
baseline
scenarios.
Any
facilities
that
certified
that
the
effluent
guidelines
would
have
no
impact
on
them
were
assumed
not
to
close
under
any
baseline
or
in
postcompliance.
Note
that
as
in
the
proposal
Economic
Impact
Analysis
(
EIA),
impacts
on
single­
facility
firms
were
assessed
at
the
firm
level.
MACT
standards
costs
were
also
incorporated
into
firm­
level
data
under
the
same
three
baseline
scenarios.
In
the
firm­
level
analysis,
however,
the
key
data
that
could
change
were
assets,
liabilities,
and
earnings
before
interest
and
taxes,
which
were
used
in
an
equation
called
Altman's
Z,
a
multi­
discriminant
ratio
analysis
approach
to
identifying
relative
firm
health.
This
equation
is
composed
of
several
common
financial
ratios
that
are
weighted
according
to
their
relative
ability
to
predict
bankruptcy
based
on
empirical
industry
data.
The
result
of
this
equation
is
called
the
Altman's
Z­
score.
Scores
below
a
certain
value
are
considered
indicative
of
poor
financial
health
and
a
high
likelihood
of
bankruptcy.
For
Baseline
1,
EPA
used
the
current
survey
data
in
the
Altman's
Z
model
to
determine
a
Baseline
1
Altman's
Z­
score.
For
Baseline
2,
EPA
took
the
MACT
standards
capital
costs
aggregated
at
the
firm
level
(
since
firms
often
own
more
than
one
facility)
and
adjusted
both
assets
and
liabilities
to
reflect
the
acquisition
of
capital
equipment
through
an
increase
in
debt.
EPA
then
adjusted
earnings
before
interest
and
taxes
by
subtracting
the
annualized
amount
of
operating
costs
plus
depreciation
computed
by
the
cost
annualization
model,
given
the
Baseline
2
MACT
standards
capital
and
operating
costs
(
also
aggregated
at
the
firm
level)
and
then
computed
a
Baseline
2
Altman's
Z­
score.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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53
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169)
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05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
EPA
used
the
same
approach
using
the
Baseline
3
MACT
standards
operating
and
capital
costs
to
create
the
Baseline
3
Altman's
Z­
score.
If
any
of
[[
Page
50404]]

these
three
baseline
scores
were
below
the
cutoff
point
considered
a
sign
of
poor
financial
health,
EPA
considered
the
firm
a
baseline
failure.
Compliance
costs
for
the
effluent
guidelines
were
then
used
in
the
same
manner
to
further
adjust
the
financial
data
used
in
the
Altman's
Z
model
in
each
of
the
baselines.
Where
the
Altman's
Z­
score
changed
from
one
reflecting
a
healthy
firm
or
one
in
indeterminate
status
in
any
of
the
baselines
to
one
of
poor
financial
health,
EPA
considered
the
firm
to
be
a
postcompliance
firm
failure
relative
to
the
baseline
under
consideration.
EPA's
methodology
for
computing
output
and
employment
effects
is
discussed
in
detail
in
Section
V.
C.
These
effects
are
presented
as
net
effects
in
Section
V.
D.
4.
To
compute
net
effects,
EPA
calculated
both
losses
and
gains
in
output
and
employment
and
subtracted
losses
from
gains
(
or
vice
versa).
Thus
EPA
calculated
net
national­
level
output
effects,
net
national­
level
employment
effects,
and
net
direct
employment
effects
(
employment
losses
in
the
pharmaceutical
industry
driven
by
output
losses
in
the
industry).
EPA
also
estimated
the
employment
losses
estimated
to
occur
as
a
result
of
closures
and
failures.
These
types
of
losses
were
used
to
determine
whether
any
community­
level
impacts
are
likely.
Trade
impacts
were
assessed
in
the
same
way
as
in
the
EIA
for
the
proposal,
except
that
a
profit
margin
analysis
has
been
added,
as
described
below
in
Section
V.
C.
Impacts
on
inflation
were
assessed
by
comparing
the
cost
of
the
regulation
to
gross
domestic
product
(
GDP).
The
potential
for
distributional
impacts
was
assessed
by
identifying
facilities
where
compliance
costs
were
greater
than
10
percent
of
operating
costs
and
determining
what
types
of
products
might
be
most
affected
if
costs
are
passed
through
to
consumers.
The
users
of
these
products
were
then
qualitatively
identified
to
determine
if
these
potential
users
might
be
disproportionately
represented
by
economically
disadvantaged
groups.
Impacts
on
environmental
justice
were
also
http://
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gov/
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
qualitatively
addressed.

C.
Changes
to
the
Economic
Analysis
Since
Proposal
The
most
significant
change
in
the
EA
since
proposal
is
associated
with
the
change
in
costs.
The
costs
of
the
effluent
limitations
guidelines
and
standards
for
the
pharmaceutical
industry
point
source
category
are
now
substantially
lower
than
those
estimated
at
proposal
because
the
costs
of
controlling
air
emissions
are
now
a
part
of
EPA's
MACT
standards.
Impacts
from
the
final
rule
do
not
change
measurably
from
proposal,
however,
mostly
because
impacts
both
now
and
at
proposal
were
estimated
to
be
very
small.
Costs
for
control
of
air
pollutants,
previously
assigned
to
the
effluent
guidelines
at
proposal,
are
now
assigned
to
the
MACT
standards
requirements.
The
economic
analyses
show
the
impacts
of
the
effluent
guidelines
against
three
separate
regulatory
baselines:
no
MACT
standards
requirements
in
place,
wastewater
emissions
control
and
treatment
system
requirements
in
place,
and
all
MACT
standards
requirements
in
place
(
see
Section
II.
E.
of
this
preamble
for
a
description
of
MACT
standards
requirements).
In
this
way,
EPA
can
present
impacts
from
the
effluent
guidelines
alone
and
in
combination
with
impacts
from
the
MACT
standards
requirements.
The
methods
EPA
used
to
assess
the
impact
of
MACT
standards
on
the
baselines
against
which
the
effluent
guidelines
are
measured
were
discussed
in
Section
V.
B.
EPA
is
now
using
a
seven
percent
discount
rate
in
all
of
its
analyses.
Previously,
the
Agency
used
the
seven
percent
rate
only
in
determining
the
pretax
cost
of
the
regulation.
EPA
has
chosen
to
use
a
seven
percent
social
discount
rate
(
in
real
terms)
in
this
analysis,
rather
than
the
11.4
percent
discount
rate
used
in
the
proposal,
for
two
reasons.
First,
the
seven
percent
discount
rate
is
strongly
recommended
by
the
Office
of
Management
and
Budget
for
use
in
economic
analyses
(
see
the
EA
for
more
details).
Second,
the
cost
of
capital
has
generally
declined
since
1990.
This
change
in
discount
rate,
however,
has
little
effect
on
the
analysis.
A
comparison
of
estimated
impacts
in
the
proposal
to
impacts
as
estimated
here
show
that
the
analyses
are
not
sensitive
to
assumptions
about
discount
rates
in
the
ranges
used.
In
terms
of
content,
the
economic
analyses
are
now
presented
as
a
more
comprehensive
report,
in
which
the
EIA
and
Regulatory
Impact
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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169)
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05:
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Analysis
(
RIA)
have
been
combined
into
one
report
(
the
EA).
The
costbenefit
portion
of
the
RIA
is
now
contained
in
Section
10
of
the
EA
report.
EPA
has
also
made
a
few
methodological
changes
in
its
firm
and
facility
analyses.
In
the
EIA
for
the
proposal,
EPA
included
salvage
value
in
the
calculations
for
the
facility
closure
analysis
for
projection
of
baseline
closures
(
i.
e.,
before
compliance
costs
are
considered)
and
postcompliance
closures.
EPA
recognized
some
potential
difficulties
with
the
salvage
value
calculations
and,
in
the
proposal
EIA,
investigated
the
effects
of
assuming
salvage
value
does
not
play
a
role
in
determining
facility
viability.
EPA
found
that
the
facility
closure
projections
were
not
sensitive
to
the
alternate
salvage
value
assumption.
Furthermore,
industry
also
commented
that
using
salvage
value
overstated
baseline
closures.
Thus
EPA
believes
that
its
current
analysis,
which
does
not
consider
salvage
value
but
rather
uses
negative
posttax
earnings
as
the
indicator
of
closure,
is
the
best
methodology
to
use,
given
the
uncertainty
of
salvage
value
data.
An
additional
difference
in
the
closure
analysis
addresses
the
issue
of
non­
self­
supporting
facilities
(
baseline
facility
closures).
In
the
current
analysis,
EPA
investigates
all
baseline
closures
at
the
firm
level
to
determine
if
a
multi­
facility
firm
could
install
and
operate
pollution
control
equipment
at
all
of
its
affected
facilities,
including
those
estimated
as
baseline
closures.
If
the
firms
can
continue
to
support
a
baseline
closure
facility
without
risk
of
failure,
EPA
determines
that
impacts
to
the
firm
and
its
affected
facilities
are
minimal.
EPA
performed
this
analysis
under
the
assumption
that
if
the
facility
was
not
expected
to
support
itself
in
the
baseline,
the
firm
level
is
the
appropriate
level
at
which
to
assess
impacts.
EPA
also
modified
the
methodology
for
determining
impacts
on
firms.
In
response
to
comments
that
baseline
firm
failures
were
overstated
because
the
Agency
used
benchmarks
that
identified
lowest
quartile
firms
as
baseline
failures,
EPA
reassessed
the
methodology
and
turned
to
a
more
sophisticated
method
for
determining
firm
financial
health.
EPA
used
a
multi­
discriminant
analysis
approach
for
evaluating
the
financial
health
of
firms.
This
analysis,
developed
by
Edward
Altman,
is
known
as
Altman's
Z­
score
analysis.
This
approach
allows
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
simultaneous
analysis
of
several
common
financial
ratios
and
answers
the
question
of
how
to
determine
financial
health
when
some
ratios
appear
strong
and
some
appear
weak.
The
equation
developed
by
Altman
assigns
relative
weights
to
the
various
ratios
on
the
basis
of
how
well
they
predict
bankruptcy
(
determined
using
actual
firm
data
and
information
on
whether
the
firms
did
in
fact
go
bankrupt).
This
approach
reduced
the
proportion
of
firms
considered
baseline
failures
from
28
percent
in
the
EIA
for
the
proposal
to
about
10
percent
(
see
Section
V.
D.
3),
thus
allowing
for
substantially
more
firms
to
be
evaluated
at
the
firm
level
in
the
postcompliance
[[
Page
50405]]

analysis.
The
Altman's
Z
analysis
is
also
described
in
Section
V.
B
above
and
is
fully
described
in
Section
6
of
the
EA
Report.
The
Agency
has
added
an
analysis
of
national­
level
output
and
employment
effects
to
the
EA
for
the
final
rule.
Output
is
measured
in
terms
of
revenues,
and
under
the
assumption
that
industry
cannot
pass
through
compliance
costs
to
consumers,
the
worst­
case
output
loss
to
the
pharmaceutical
industry
is
equal
to
the
pretax
costs
of
compliance.
The
output
losses
occurring
in
the
pharmaceutical
industry
(
direct
effects)
affect
input
industries,
which
are
industries
that
provide
inputs
(
e.
g.,
raw
chemicals)
to
the
pharmaceutical
industry.
These
effects
are
known
as
indirect
effects.
The
direct
output
losses
also
affect
consumption,
as
workers
lose
jobs
or
work
fewer
hours
and
their
households
reduce
purchases
of
goods
and
services.
These
effects
are
called
induced
effects.
Thus
a
dollar
of
output
lost
in
the
pharmaceutical
industry
can
also
result
in
additional
dollars
lost
in
the
U.
S.
economy
as
a
whole
through
indirect
and
induced
effects.
EPA
calculates
these
additional
losses
at
the
national
level
using
inputoutput
analysis.
The
relevant
multipliers
used
in
the
analysis
were
developed
by
the
U.
S.
Department
of
Commerce's
Bureau
of
Economic
Analysis
(
BEA).
In
addition
to
output
losses,
EPA
calculates
national­
level
output
gains
based
on
output
gains
in
pollution
control
industries.
These
industries
receive
revenues
from
the
pharmaceutical
industry
for
pollution
control
equipment
and
operations.
Using
BEA
multipliers,
the
Agency
calculates
the
subsequent
effect
of
these
gains
on
the
pollution
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
control
industries'
input
industries
and
consumption
(
i.
e.,
indirect
and
induced
effects).
By
comparing
national­
level
output
losses
and
gains,
EPA
develops
a
net
national­
level
output
loss
or
gain.
In
the
EA,
EPA
no
longer
relies
exclusively
on
employment
losses
from
closures
and
failures
to
calculate
employment
losses
in
the
pharmaceutical
industry
or
national­
level
employment
losses.
Because
output
effects
and
employment
are
linked
in
input­
output
analysis,
EPA
calculates
employment
losses
based
on
output
effects
using
BEA's
final
demand
and
direct
effect
multipliers.
EPA
uses
final
demand
employment
multipliers
to
compute
the
total
number
of
jobs
lost
(
including
direct,
indirect,
and
induced
job
losses)
given
the
total
loss
of
output
in
millions
of
dollars
in
the
pharmaceutical
industry
and
uses
direct
effect
multipliers
to
compute
the
total
number
of
job
losses
occurring
just
in
the
pharmaceutical
industry
(
direct
losses),
given
the
total
jobs
lost
nationwide
(
which
include
direct,
indirect,
and
induced
losses).
Output­
based
employment
losses
can
be
thought
of
as
longer­
term
losses
associated
with
longer­
term
market
equilibrium,
whereas
losses
associated
with
closures
and
failures
can
be
considered
the
more
immediate
impact
of
the
rule
before
market
equilibrium
is
achieved.
Thus
output­
based
employment
losses
may
be
greater
than
or
less
than
the
losses
estimated
on
the
basis
of
closures
and
failures,
which
means
that
nonclosing
facilities
might
gain
or
lose
production
and
employment
depending
on
how
many
facilities
close.
If
no
facilities
close,
nonclosing
facilities
might
lose
some
production
and
employment.
If
many
facilities
close,
nonclosing
facilities
might
actually
gain
production
and
employment
if
closure
losses
  
overshoot''
the
expected
losses
at
market
equilibrium.
Note,
however,
that
both
the
output­
based
employment
effects
and
the
closure/
failure
employment
effects
derived
here
are
worst­
case
impacts
within
the
pharmaceutical
industry
since
EPA
assumes
the
industry
cannot
pass
through
the
costs
of
compliance
to
consumers.
EPA
also
computes
employment
gains
on
the
basis
of
output
gains
in
pollution
control
industries
in
much
the
same
way
as
was
done
for
the
EIA
for
the
proposal.
The
approach
has
been
changed
slightly
to
accommodate
labor
costs
estimated
as
a
part
of
the
engineering
cost
analysis
rather
than
relying
on
assumed
labor
shares.
EPA
compares
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
employment
losses
and
gains
to
estimate
a
net
gain
or
loss
in
employment
both
at
the
national
level
and
in
the
pharmaceutical
industry
alone
(
some
gains
will
occur
in
the
pharmaceutical
industry
since
labor
to
operate
pollution
control
equipment
is
required).
EPA
now
performs
an
assessment
of
impacts
on
profit
margins
to
address
commenter
concerns
that
pharmaceutical
firms
will
locate
(
or
relocate)
facilities
outside
of
the
U.
S.
because
of
environmental
regulatory
requirements.
EPA
assumes
that
those
firms
most
likely
to
consider
relocating
facilities
are
those
with
measurable
differences
in
profitability
with
sufficient
means
to
effect
a
relocation.
EPA
also
addresses
comments
that
reductions
in
loadings
to
POTWs
will
result
in
substantial
impacts
on
POTWs.
All
other
methodologies
used
and
analyses
undertaken
in
the
EA
remain
substantively
the
same
as
those
in
the
EIA
for
the
proposal.

D.
Estimated
Economic
Impacts
1.
Costs
of
Compliance
Table
V.
D.
1
presents
a
summary
of
compliance
costs
for
the
effluent
limitations
guidelines
and
standards
and
for
the
MACT
standards.
EPA
estimated
annualized
compliance
costs
on
both
a
pre­
tax
and
post­
tax
basis;
both
sets
of
costs
are
shown
in
Table
V.
D.
1.
Post­
tax
costs
reflect
tax
savings
accruing
to
the
industry
from
the
installation
and
operation
of
pollution
control
equipment;
the
post­
tax
costs
are
used
in
the
economic
analysis
to
assess
impacts
to
facilities
and
firms
in
the
industry.
Pre­
tax
costs
are
a
component
of
the
total
social
cost
of
the
regulatory
action
(
see
Section
V.
F).
EPA
describes
the
cost
annualization
procedure
in
Section
V.
B
and
in
the
EA.
The
annualized
costs
in
Table
V.
D.
1
for
both
the
effluent
limitations
guidelines
and
standards
and
the
MACT
standards
rule
incorporate
the
same
annualization
period
assumptions.
The
annualized
costs
reported
in
the
preamble
to
the
MACT
standards
rule
are
based
on
another
annualization
period
and
thus,
do
not
correspond
exactly
to
Table
V.
D.
1.
As
noted
in
Section
V.
B,
costs
are
annualized
over
16
years
(
with
an
1­
year
installation
period
and
a
15­
year
project
life),
while
in
the
preamble
to
the
MACT
standards
rule,
costs
are
annualized
over
10
years
(
with
no
delay
for
installation).
As
an
illustration,
Table
V.
D.
1
reports
pre­
tax
annualized
costs
for
the
MACT
standards
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
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169)
[
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
rule
for
all
facilities
(
referred
to
as
  
existing
sources''
in
the
MACT
standards
rule)
at
$
58.4
million.
In
the
preamble
to
the
MACT
standards
rule,
the
corresponding
annualized
costs
are
reported
at
$
64.8
million.
The
annualized
post­
tax
compliance
costs
for
effluent
guidelines
for
the
selected
options
are
$
39.4
million.
The
annualized
post­
tax
compliance
costs
of
the
MACT
standards
for
the
subset
of
facilities
also
subject
to
effluent
guidelines
are
$
32.4
million.
The
total
annualized
costs
for
facilities
covered
by
both
the
effluent
guidelines
and
MACT
standards
are
$
71.8
million,
and
the
total
annualized
costs
for
all
facilities
(
i.
e.,
including
those
facilities
covered
by
MACT
standards
only)
are
$
77.5
million.

[[
Page
50406]]

Table
V.
D.
1­­
Annualized
Costs
of
Compliance
for
Effluent
Guidelines
and
MACT
Requirements
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Posttax
Pretax
annualized
annualized
cost
of
cost
of
Subcategory
Option
compliance
compliance
(
million
(
million
1997$)
1997$)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
A/
C
Direct....................................
BPT=
Revise
COD
and
modify
$
1.6
$
2.5
cyanide.
BAT=
Add
organics,
ammonia
and
http://
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epa.
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
2.3
3.6
COD
and
modify
cyanide.
B/
D
Direct....................................
Revise
BPT
COD
and
withdraw
0.9
1.4
cyanide.
A/
C
Indirect..................................
PSES=
Add
organics
and
ammonia
28.8
44.5
and
modify
cyanide.
B/
D
Indirect..................................
PSES=
Add
organics
and
withdraw
5.8
8.8
cyanide.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Annualized
Cost
of
Effluent
................................
39.4
60.8
Guidelines
for
all
Selected
Options.
Cost
of
MACT
Standards........................
Effluent
Guidelines
Facilities..
32.4
49.6
All
Facilities..................
38.1
58.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Annualized
Cost
of
Effluent
................................
71.8
110.4
Guidelines
and
MACT
Standards
for
Effluent
Guidelines
Facilities.

===============================
Total
Annualized
Costs
of
Effluent
................................
77.5
119.2
Guidelines
and
MACT
Standards
for
All
Facilities.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

2.
Economic
Impacts
on
Facilities
EPA
determined
on
the
basis
of
zero
or
negative
posttax
earnings
that
18
facilities,
or
9
percent
of
all
facilities
in
the
analysis,

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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
would
be
likely
to
close
even
without
the
effect
of
the
effluent
guidelines
or
MACT
standards
requirements.
The
impacts
to
the
firms
of
installing
and
operating
pollution
control
equipment
at
these
facilities
are,
however,
assessed
at
the
firm
level
to
determine
if
the
firms
can
continue
to
support
these
facilities
postcompliance
(
see
below
under
results
of
the
firm
analysis).
When
all
MACT
standards
costs
are
incorporated
into
the
initial
baseline
financial
conditions
(
Baseline
3),
no
additional
facilities
close.
When
the
costs
of
compliance
for
this
final
effluent
guidelines
rule
are
incorporated
into
the
financial
conditions
of
facilities
in
the
analysis
(
the
postcompliance
analysis),
only
one
additional
facility
closes
(
an
A/
C
indirect).
Even
though
this
facility
does
not
close
when
faced
with
costs
of
meeting
this
effluent
guidelines
rule
alone,
EPA
conservatively
attributes
this
closure
to
the
effluent
guidelines.
In
general,
however,
neither
MACT
standards
costs
nor
effluent
guidelines
costs
singly
or
together
have
major
impacts
on
pharmaceutical
facilities
operated
by
multifacility
firms.
3.
Economic
Impacts
on
Firms
EPA
projected
that
18
firms
would
be
likely
to
fail
even
without
the
effect
of
the
effluent
guidelines
or
MACT
standards
requirements
(
Baseline
1).
Two
additional
firms
are
projected
to
fail
before
effluent
guidelines
costs
are
considered
when
all
MACT
standards
costs
are
included
in
the
initial
baseline
financial
conditions
(
Baseline
3).
In
the
postcompliance
analysis,
EPA
estimated
that
four
firms
would
fail
under
the
Baseline
1
scenario
and
two
firms
would
fail
under
the
Baseline
3
scenario.
(
There
are
two
fewer
postcompliance
firm
failures
under
the
Baseline
3
scenario
because
these
failures
were
estimated
to
be
precompliance
failures
when
all
MACT
standards
costs
were
included.)
Thus
at
most,
regardless
of
baseline,
four
firms
fail
postcompliance.
To
be
conservative
in
the
EA,
EPA
attributes
these
failures
to
the
Pharmaceutical
Effluent
Guidelines
alone.
Out
of
the
four
firm
failures
projected
to
occur,
EPA
estimates
only
one
will
result
in
both
a
firm
failure
and
a
facility
closure
(
because
earnings
become
negative
at
the
only
facility
owned
by
the
firm).
The
other
three
firms
will
incur
substantial
impacts,
up
to
and
including
firm
failure,
but
own
financially
viable
facilities.
Because
the
facilities
are
selfsupporting
they
are
likely
to
be
attractive
for
acquisition
by
http://
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epa.
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fedrgstr/
EPA­
WATER/
1998/
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Day­
21/
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htm
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
financially
stronger
firms.
Therefore,
the
three
failing
firms
with
viable
facilities
might
not
fail,
but
instead
might
be
forced
to
sell
their
facilities.
As
discussed
in
Section
V.
D.
2,
EPA
evaluated
all
facilities
projected
to
close
in
the
baseline
analysis
at
the
firm
level,
under
the
assumption
that
perhaps
these
facilities
are
not
expected
to
be
self­
supporting
and
thus
might
not
close
in
the
baseline.
If
this
is
so,
the
appropriate
level
of
analysis
is
the
firm.
EPA
determined
that
all
facilities
projected
to
close
in
the
baseline
facility
closure
analysis
can
continue
to
be
supported
by
their
firms
postcompliance
without
significant
impact
on
these
firms.

Table
V.
D.
3
Firm
Failure
Analysis
Results
(
Baseline
1)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Failures
only
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Type
of
discharger
Number
Percentage
of
Percentage
of
Failures
with
total
firms
in
Number
total
firms
in
closures
subcategory
subcategory
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
A/
C
Direct....................................
0
0
0
0
B/
D
Direct....................................
0
0
0
0
A/
C
Indirect..................................
2
3.2
1
1.6
B/
D
Indirect..................................
1
1.2
0
0
[[
Page
50407]]

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Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Total
All
Firms...........................
3
1.8
1
0.6
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

4.
Impacts
on
Output
and
Employment
EPA
estimates
that
at
the
national
level,
output
gains
will
exceed
output
losses.
EPA
determines
a
net
output
gain
of
about
$
21.7
million
(
1996$)
as
a
result
of
the
effluent
guidelines.
Net
output
gains
for
the
combined
rulemakings
(
including
MACT
standards
for
facilities
in
the
effluent
guidelines
analysis
only)
will
total
$
40.1
million
(
1996$).
EPA
also
determines
that
employment
gains
will
exceed
employment
losses
at
the
national
level.
The
net
gain
in
national­
level
employment
as
a
result
of
the
effluent
guidelines
alone
will
total
218
full­
time
equivalents
(
a
full­
time
equivalent,
or
FTE,
equals
2,080
hours
per
year
of
labor),
and
net
employment
gains
for
the
combined
rulemakings
(
including
MACT
standards
for
facilities
in
the
effluent
guidelines
analysis
only)
will
total
407
FTEs.
Despite
net
employment
gains
at
the
national
level,
EPA
calculates
that
losses
will
exceed
gains
in
the
pharmaceutical
industry.
Direct
losses
in
the
pharmaceutical
industry
are
composed
of
two
types
of
losses­­
output­
based
losses
and
closure/
failure
type
losses.
As
noted
in
Section
V.
C.,
closure/
failure
employment
losses
might
be
less
than
the
output­
based
employment
losses
that
are
driven
by
the
contraction
in
the
pharmaceutical
industry
as
it
responds
to
the
compliance
costs
and
a
new
market
equilibrium
is
achieved.
Closure/
failure
employment
losses
can
also
be
greater
than
these
output­
based
losses
if
they
  
overshoot''
the
expected
market
equilibrium
result.
In
this
case,
the
direct
losses
computed
on
the
basis
of
output
losses
(
and
net
of
gains
in
employment
in
the
industry
due
to
the
need
to
operate
the
pollution
control
equipment)
are
slightly
greater
than
the
closure/
failure
losses
(
which
are
estimated
to
total
139
FTEs).
Output­
based
losses
total
138
FTEs,
or
0.1
percent
of
pharmaceutical
employment
in
the
analysis.
With
MACT
standards
costs
for
facilities
included
in
the
effluent
guidelines
analysis,
net
direct
employment
losses
will
total
254
FTEs,
or
0.1
percent
of
employment.

http://
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21/
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Because
output­
based
employment
losses
are
greater
than
closure/
failure
employment
losses,
nonclosing
facilities
might
experience
some
small
reductions
in
labor
hours
and
production
over
time
that
are
additional
to
the
losses
of
labor
hours
and
production
associated
with
facilities
that
close
or
fail
(
assuming
a
worst­
case
scenario
where
no
costs
can
be
passed
through
to
consumers).
The
losses
in
employment
due
to
closures/
failures
will
have
a
negligible
impact
on
individual
communities.
No
community
is
expected
to
experience
a
change
in
its
unemployment
rate
exceeding
0.4
percent.
5.
Other
Secondary
Impacts
No
trade
losses
or
major
changes
in
the
balance
of
payments
are
associated
with
closures/
failures
of
firms
or
facilities,
as
these
firms
and
facilities
indicate
no
foreign
shipments.
Thus
EPA
finds
that
neither
rule,
together
or
separately,
will
have
a
substantial
impact
on
trade
or
the
balance
of
payments.
An
analysis
of
profit
margin
shows
only
a
few
firms
will
experience
impacts
on
profit
margin
as
a
result
of
the
effluent
guidelines.
A
total
of
8
firms
(
6
percent
of
the
firms
analyzed)
have
a
greater
than
10
percent
change
(
e.
g.,
go
from
a
5
percent
profit
margin
to
a
4.5
percent
profit
margin)
in
their
profit
margin.
Most
of
these
firms
are
considered
the
least
likely
to
relocate
their
facilities
to
foreign
countries.
These
firms
tend
to
be
small,
and
generally,
they
are
unlikely
to
have
experience
in
international
locations.
The
transaction
costs
of
learning
how
to
operate
in
foreign
countries,
along
with
the
expense
of
relocating,
are
likely
to
be
prohibitively
expensive
for
these
firms.
With
the
MACT
standards
costs
included
for
the
facilities
analyzed
as
part
of
this
effluent
guidelines
final
rule,
one
additional
firm
shows
a
greater
than
10
percent
change
in
profit
margin.
Thus
EPA
has
determined
that
even
under
the
combined
effect
of
the
two
rules,
firms
are
unlikely
to
relocate
to
foreign
countries
to
escape
the
impacts
on
profitability
induced
by
the
two
rules.
The
rules,
together
or
separately,
will
have
no
major
impact
on
inflation,
as
the
costs
of
the
two
rules
are
at
most
only
0.001
percent
of
gross
domestic
product
(
GDP).
Although
the
Agency
received
comments
on
the
proposal
arguing
otherwise,
EPA
expects
that
impacts
on
POTWS
will
be
minimal.
EPA
is
promulgating
pretreatment
standards
for
24
VOCs
for
all
four
http://
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Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
subcategories
and
ammonia
for
subcategories
A
and
C.
The
Agency
expects
that
the
reduction
in
the
BOD
discharged
to
POTWs
as
the
result
of
compliance
with
PSES
for
these
pollutants
will
be
minimal.
As
a
result,
EPA
believes
that
any
reduction
in
revenue
to
POTWs
that
charge
industrial
users
subject
to
the
PSES
will
be
insignificant.
Since
many
of
these
pollutants
are
highly
volatile
and
are
volatilized
in
the
POTWs
primary
units
before
they
can
be
biodegraded,
EPA
believes
that
the
final
PSES
should
not
have
any
substantial
effect
on
the
variable
operating
costs
of
POTWs
as
well.
In
summary,
EPA
believes
that
compliance
with
the
final
PSES
by
pharmaceutical
facilities
should
not
have
any
significant
effect
on
the
POTW
revenues.
Furthermore,
EPA
believes
that
the
benefits
associated
with
reduced
discharges
of
VOCs
and
ammonia
to
POTWs
by
pharmaceutical
industrial
users
will
outweigh
any
revenue
losses.
Based
on
the
analysis
in
the
proposal
EIA
and
further
investigation
in
the
EA
for
this
final
rule,
the
MACT
standards
and
effluent
guidelines,
together
or
separately,
will
have
no
major
distributional
impacts.
Compliance
costs
are
generally
a
very
small
percentage
of
baseline
operating
costs,
thus
any
cost
increases
are
likely
to
be
very
small
and
are
not
likely
to
have
any
major
effect
on
any
one
group
of
consumers.
Impacts
on
environmental
justice
also
should
be
minimal.
As
noted
above,
any
price
increases
on
drugs
will
be
very
small
and
impacts
on
disadvantaged
groups
such
as
the
poor
and
certain
minority
groups
will
be
minimal.
Furthermore,
many
of
these
groups
will
benefit
from
the
effluent
guidelines
final
rule.
A
large
portion
of
the
affected
facilities
are
located
in
urban
areas
where
poor
or
minority
populations
tend
to
be
high.
Although
everyone
benefits,
it
is
these
populations
that
will
[[
Page
50408]]

likely
benefit
the
most
from
the
cleaner
water
resulting
from
both
rules.
6.
Impacts
on
New
Sources
The
selected
options
for
new
sources
are
equivalent
to
the
selected
options
for
existing
sources.
Because
the
costs
for
designing
in
pollution
control
technologies
are
generally
no
more
expensive
than
and
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
are
usually
less
expensive
than
retrofitting
pollution
control
technologies,
costs
for
new
facilities
will
be
no
more
expensive
than
costs
for
existing
facilities.
Because
EPA
has
shown
that
the
requirements
for
existing
sources
are
economically
achievable,
they
should
be
economically
achievable
for
new
sources.
Furthermore,
since
the
requirements
for
new
sources
will
not
be
more
expensive
than
those
for
existing
sources,
the
rule
will
not
pose
a
barrier
to
entry
for
new
sources.
In
response
to
proposal
comments,
EPA
also
investigated
whether
impacts
from
the
effluent
guidelines
rule
(
with
and
without
MACT
standards)
might
contribute
to
firms
locating
new
facilities
in
foreign
countries.
EPA
found
the
median
percentage
of
capital
costs
of
compliance
to
total
costs
to
build
a
new
facility
to
be
negligible
(
0.21
percent,
on
average
including
MACT
standards
costs
among
surveyed
newer
facilities).
Thus
compliance
costs
are
unlikely
to
be
a
major
impetus
to
locating
new
facilities
outside
the
U.
S.

E.
Regulatory
Flexibility
Analysis
There
are
no
major
changes
to
EPA's
Regulatory
Flexibility
Analysis
(
RFA),
except
that
the
Agency
has
undertaken
a
revenue
test
in
addition
to
the
closure
analysis
to
better
assess
the
potential
impact
on
small
firms.
The
revenue
test
measures
impact
on
the
basis
of
annual
compliance
costs
as
a
percentage
of
annual
revenues.
The
analysis
indicates
that
out
of
145
firms
considered
small
(
i.
e.,
firms
with
fewer
than
750
employees),
only
four
firms
will
experience
annual
compliance
costs
that
are
greater
than
one
percent
of
annual
revenues
(
six
with
MACT
costs
included).
No
firms
will
experience
annual
compliance
costs
exceeding
3
percent.
When
MACT
standards
costs
are
included
only
one
small
firm
will
experience
annual
compliance
costs
that
exceed
three
percent
of
annual
revenues,
but
this
firm
is
not
estimated
to
incur
any
effluent
guideline
costs.
The
RFA
further
also
considered
impacts
to
small
firms
in
terms
of
firm
failures
or
facility
closures.
Five
small
firms
are
significantly
affected
by
the
rule.
The
regulatory
action
is
found
to
be
economically
achievable
for
all
dischargers,
including
small
entities
as
detailed
in
Section
V.
D.
Further,
the
analysis
indicates
no
disproportionate
effect
on
small
entities,
compared
to
large
entities.
Based
on
these
findings,
EPA
certifies
that
this
final
rule
does
not
have
a
significant
impact
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
on
a
substantial
number
of
small
entities.

F.
Cost­
Benefit
Analysis
Because
the
combined
costs
of
the
rules
are
at
the
level
that
defines
a
major
rule
both
under
Executive
Order
12866
and
UMRA
(
although
neither
rule
considered
separately
would
be
near
this
level),
EPA
has
undertaken
a
cost­
benefit
analysis.
As
in
the
proposal,
pretax
costs
for
all
facilities
are
used
as
a
proxy
for
social
cost.
The
major
portion
of
the
social
cost
of
the
effluent
guidelines
is
the
total
pretax
annual
cost,
which
is
$
60.8
million
(
1997$).
Adding
in
the
cost
of
administering
the
rule
and
providing
administrative
services
to
the
unemployed
(
the
only
other
significant
cost
categories),
the
total
social
cost
of
the
rule
is
$
61.0
million
(
1997$).
Combined
with
the
costs
of
the
MACT
standards
rule
for
facilities
in
the
effluent
guidelines
analysis,
the
two
rules
together
have
annual
social
cost
of
$
110.7
million
(
1997$).
(
Costs
of
both
rules
including
MACT
standards
costs
to
facilities
that
will
not
be
affected
by
the
effluent
guidelines
are
$
119.5
million
(
1997$)).
Benefits
include
the
benefits
of
water
removals
and
benefits
of
air
removals.
Types
of
benefits
analyzed
include
human
health
risk,
recreational
use
benefits,
benefits
to
POTWs,
and
benefits
of
reductions
in
VOCs
(
other
than
human
health).
The
benefits
to
POTWs,
however,
could
not
be
monetized
(
see
Section
VI.
E.
of
this
preamble
for
more
details).
Total
monetizable
benefits
of
the
effluent
guidelines
alone
total
$
0.93
to
$
14.0
million
(
1997$),
while
the
combined
benefits
of
the
two
rules
total
$
4.06
to
$
81.1
million
(
1997$).

Table
V.
F.
1
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Costs
($
millions)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Social
Cost
of
Effluent
Guidelines.
$
61.0
Total
Social
Cost
of
MACT
(
ELG
facilities
49.7
only).
Total
Social
Cost
of
MACT
(
all
58.4
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
facilities).
Social
Cost
of
Combined
Rules
(
ELG
110.7
facilities
only).
Social
Cost
of
Combined
Rules
(
all
119.5
facilities).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Benefits
($
millions)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
Guidelines......................
0.9
to
14.0
MACT
Standards...........................
3.9
to
67.2
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total................................
4.8
to
81.1
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

G.
Cost­
Effectiveness
Analysis
Cost­
effectiveness
evaluates
the
relative
efficiency
of
options
in
removing
toxic
pollutants.
Costs
evaluated
include
direct
compliance
costs,
such
as
capital
expenditures
and
operation
and
maintenance
costs.
Cost­
effectiveness
results
are
expressed
in
terms
of
the
incremental
and
average
costs
per
pound­
equivalent
removed.
A
pound
equivalent
is
a
measure
that
addresses
differences
in
the
toxicity
of
pollutants
removed.
Total
pound­
equivalents
are
derived
by
taking
the
number
of
pounds
of
a
pollutant
removed
and
multiplying
this
number
by
a
toxic
weighting
factor.
EPA
calculates
the
toxic
weighting
factor
using
ambient
water
quality
criteria
and
toxicity
values.
The
toxic
weighting
factors
are
then
standardized
by
relating
them
to
a
particular
pollutant,
in
this
case
copper.
EPA's
standard
procedure
is
to
rank
the
options
considered
for
each
subcategory
in
order
of
increasing
pounds­
equivalent
(
PE)
removed.
The
Agency
calculates
incremental
cost­
effectiveness
as
the
ratio
of
the
incremental
annual
costs
to
the
incremental
pounds­
equivalent
removed
under
each
option,
compared
to
the
previous
(
less
effective)
option.
Average
costeffectiveness
is
calculated
for
each
option
as
a
ratio
of
total
costs
to
total
pounds­
equivalent
removed.
EPA
reports
annual
costs
for
all
cost­
effectiveness
analyses
in
1981
dollars
to
enable
limited
comparisons
of
the
cost­
effectiveness
among
regulated
industries.

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Category
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Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Table
V.
G.
1
presents
the
results
of
the
cost­
effectiveness
analysis
for
all
subcategories.
As
the
table
shows,
the
average
and
incremental
cost­
effectiveness
of
the
selected
BAT
option
for
subcategories
A
and
C
is
$
224/
lb.
eq.,
the
average
and
incremental
cost­
effectiveness
of
the
selected
PSES
option
for
subcategories
A
and
C
is
$
96/
lb.
eq.
and
the
average
and
incremental
cost­
effectiveness
of
the
selected
PSES
option
for
subcategories
B
and
D
is
$
66/
lb.
eq.
The
selected
BAT
option
for
the
subcategories
B
and
D
directs
is
the
no
additional
action
alternative,
so
no
cost­
effectiveness
results
are
calculated.
The
cost­
effectiveness
determined
for
this
rule
does
not
represent
an
estimate
of
the
removal
of
the
toxic
pounds
resulting
from
the
removal
of
COD.
As
discussed
previously
in
section
IV.
C.,
discharges
from
pharmaceutical
manufacturing
facilities
exhibit
toxicity
as
measured
by
the
whole
effluent
[[
Page
50409]]

toxicity
test
and
reported
as
part
of
the
routine
NPDES
discharge
monitoring
reports
(
DMRs).
One
study
conducted
by
EPA
at
a
pharmaceutical
manufacturing
facility
showed
a
significant
decrease
in
toxicity
with
a
corresponding
decrease
in
COD
level
for
the
tested
effluent
sample
from
the
facility
and
a
sample
effluent
of
a
pilot
scale
biological
treatment
plant
study.
Because
of
the
limited
amount
of
data,
and
the
inability
to
identify
the
different
mix
of
specific
organic
compounds
represented
by
the
COD
measurement,
the
total
amount
of
toxic
pound­
equivalent
represented
by
the
nonconventional
pollutant
parameter
of
COD
could
not
be
determined.
Based
on
the
lack
of
pound­
equivalents
associated
with
COD
removals
the
cost­
effectiveness
analysis
results
understates
the
true
costeffectiveness
of
this
rule.
EPA
therefore
considers
these
options
to
be
cost­
effective.

Table
V.
G.
1­­
Cost/
Effectiveness
Analysis
Results
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Annual
Incremental
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
C­
E
Incremental
C­
Option
Lb.
eq.
Lb.
eq.
($/
lb.
eq.)
E
($/
lb.
eq.)
removed
Cost
(
1981$)
removed
Cost
(
1981$)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
A/
C
Direct
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
MACT
Only...............................................
0
$
0
0
$
0
NA
NA
Advanced
Bio............................................
9,780
2,186,106
9,780
2,186,106
$
224
$
224
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
A/
C
Indirect
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
MACT
Only...............................................
0
0
0
0
NA
NA
Steam
Stripping
no
alcohols.............................
282,614
26,990,998
282,614
26,990,998
96
96
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
B/
D
Indirect
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
MACT
Only...............................................
0
0
0
0
NA
NA
Steam
Stripping
no
alcohols.............................
80,807
5,353,790
80,807
5,353,790
66
66
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

http://
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EPA­
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1998/
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(
71
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

VI.
Environmental
Benefits
In
addition
to
costs
and
impacts,
EPA
also
estimated
the
environmental
and
human
health
benefits
of
implementing
CWA
requirements.
Benefits
identified
as
a
result
of
this
final
rule
are
associated
with
improvements
in
both
water
quality
and
air
quality,
since
many
of
the
regulated
and
incidentally
controlled
pollutants
are
prone
to
volatilization
from
the
effluent
waste
streams.
Section
IV
of
this
preamble
and
Section
IX
of
the
TDD
describe
the
estimated
reductions
in
effluent
discharges,
and
those
reductions
and
the
estimates
of
incremental
environmental
improvements
noted
in
Section
IV
are
derived
compared
to
a
baseline
consisting
of
current
discharges.
Because
current
discharges
are
a
function
of
current
technology,
this
is
the
same
baseline
that
is
used
to
establish
the
costs
of
complying
with
this
rule.
EPA
is
confident
that
its
estimation
of
compliance
costs
is
a
full
and
accurate
account
of
such
costs;
however,
EPA
is
less
confident
that
the
estimation
of
benefits
is
similarly
complete.
EPA
is
not
currently
able
to
quantitatively
evaluate
all
human
health
and
ecosystem
benefits
associated
with
air
and
water
quality
improvements.
EPA
is
even
more
limited
in
its
ability
to
assign
monetary
values
to
these
benefits.
A
comparison
of
costs
to
only
the
limited
monetized
subset
compromises
the
validity
of
the
cost­
benefit
analysis.
The
economic
benefit
values
described
below
and
in
Section
10.4
of
the
EA
should
be
considered
a
limited
subset
of
the
total
benefits
of
this
rule
and
should
be
evaluated
along
with
descriptive
assessments
of
benefits
and
the
acknowledgment
that
even
these
may
fall
short
of
the
real­
world
benefits
that
may
result
from
this
rule.
For
example,
the
analyses
consider
the
impacts
of
toxic
pollutants,
but
do
not
evaluate
the
impacts
of
other
pollutants
(
such
as
BOD<
INF>
5</
INF>,
COD,
and
TSS)
which
can
produce
significant
adverse
environmental
impacts.
Within
these
limitations,
EPA
analyzes
the
effects
of
current
air
and
water
emissions
and
assesses
the
benefits
of
reductions
in
these
emissions
resulting
from
this
final
regulation.
EPA
expects
a
variety
of
human
health,
environmental,
and
economic
benefits
to
result
from
these
reductions
in
effluent
loadings
and
air
emissions
(
See
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
72
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Environmental
Assessment
of
the
Final
Effluent
Guidelines
for
the
Pharmaceutical
Manufacturing
Industry,
(
July
1998,
EPA­
821­
B­
98­
008).
In
particular,
the
benefits
assessment
addresses
the
following
benefit
categories:
human
health
and
agricultural
benefits
due
to
reductions
in
emissions
of
ozone
precursors
(
i.
e.,
reductions
in
VOC
emissions);
human
health
benefits
due
to
reductions
in
excess
cancer
risk;
human
health
benefits
due
to
reductions
in
non­
carcinogenic
hazard
(
systemic);
ecological
and
recreational
benefits
due
to
improved
water
quality
with
respect
to
toxic
pollutants,
including
intrinsic
benefits;
and
benefits
to
publicly
owned
treatment
works
(
POTWs)
from
reductions
in
interference,
pass
through,
and
sludge
contamination
problems,
improvements
in
worker
health
and
safety,
and
elimination
of
some
of
the
efforts
associated
with
establishing
local
pretreatment
limits.
EPA
monetizes
the
estimated
benefits
for
reductions
in
air
emissions
of
ozone
precursors,
cancer
risk
reductions,
improvements
in
recreational
fishing
opportunities,
and
improvements
in
intrinsic
value,
but
is
unable
to
quantify
the
dollar
magnitude
of
benefits
from
the
other
benefit
categories.
Air
benefits
due
to
reductions
in
emissions
of
ozone
precursors,
are
estimated
using
the
methods
and
data
summarized
in
the
November
5,
1997
OAQPS
memorandum
titled
  
Benefits­
Transfer
Analysis
for
Pulp
and
Paper''.
This
methodology
is
based
on
the
recently
published
benefits
analyses
provided
in
the
Regulatory
Impact
Analyses
for
the
Particulate
Matter
and
Ozone
National
Ambient
Air
Quality
Standards
and
Proposed
Regional
Haze
Rule.
The
methodology
and
data
used
in
the
estimate
of
all
benefits
are
described
in
detail
in
the
Environmental
Assessment.

[[
Page
50410]]

a.
Reduced
Emissions
of
Ozone
Precursors
These
final
effluent
guidelines
are
expected
to
result
in
reductions
in
ambient
ozone
concentrations
due
to
reductions
in
VOC
emissions.
Controlling
VOC
emissions
is
beneficial
because
some
VOCs
are
precursors
to
ozone,
which
negatively
affects
human
health
and
plant
life.
EPA
estimates
that
the
annual
monetized
benefits
resulting
from
reductions
in
VOC
emissions
due
to
this
final
rule
range
from
$
755,000
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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73
of
169)
[
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2003
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05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
to
$
9.8
million
($
1997).
The
benefits
are
monetized
using
a
benefitstransfer
based
approach.
Specifically,
the
estimated
reductions
in
VOC
emissions
in
nonattainment
areas
alone,
and
in
both
nonattainment
and
attainment
areas
(
1,254
Mg
to
3,608
Mg,
respectively)
are
multiplied
by
an
existing
estimate
of
the
range
of
the
value
of
a
unit
reduction
in
VOC
emissions
($
602/
Mg
to
$
2,723/
Mg,
$
1997).
This
range
is
based
on
the
ozone
National
Ambient
Air
Quality
Standard
(
NAAQS)
benefits
analysis,
which
used
new
scientific
studies
to
quantify
the
association
between
ozone
exposure
and
premature
mortality.
The
$
602/
Mg
estimate
does
not
include
mortality
effects
associated
with
ozone
exposure,
while
the
$
2,723/
Mg
estimate
includes
mortality
effects.
The
overall
benefit
estimate
for
ozone
precursor
reduction
also
includes
an
estimate
of
the
potential
adverse
effects
which
may
result
from
increased
emissions
of
particulate
matter
(
PM)
and
sulfur
dioxide
(
SO<
INF>
2</
INF>)
related
to
steam
stripping
of
the
VOCs.
Emissions
of
PM
and
SO<
INF>
2</
INF>
arise
from
the
use
of
fossil
fuels
as
an
energy
source
for
the
steam
stripping
technology
basis.
The
quantity
of
these
emissions
is
based
on
the
type
of
fossil
fuel
(
natural
gas
or
fuel
oil)
used.
Particulate
matter
is
associated
with
adverse
human
health
and
welfare
effects.
EPA
estimates
that
the
annual
monetized
adverse
environmental
impact
resulting
from
increases
in
PM
emissions
due
to
this
final
rule
is
$
266,000
($
1997).
This
value
was
obtained
by
using
an
estimated
increase
in
PM
emissions
of
20
Mg
multiplied
by
an
estimate
of
the
value
of
a
unit
reduction
in
PM
emissions
of
$
13,325
per
Mg
($
1997).
This
value
is
based
on
the
PM
NAAQS
benefits
analysis.
Sulfur
dioxide
is
associated
with
the
adverse
human
health
effects
and
environmental
impacts,
including
  
acid
rain.''
EPA
estimates
that
the
annual
monetized
adverse
environmental
impact
resulting
from
increases
in
SO<
INF>
2</
INF>
emissions
range
from
$
311,000
to
$
688,000
($
1997).
This
value
was
obtained
using
an
estimated
increase
in
SO<
INF>
2</
INF>
emissions
of
52.1
Mg
(
51.8
Mg
eastern
U.
S.
and
0.3
Mg
western
U.
S.)
multiplied
by
an
estimate
of
the
value
of
a
unit
reduction
in
SO<
INF>
2</
INF>
emissions
of
$
5,984
to
$
13,251
per
Mg
($
1997)
for
the
eastern
U.
S.
and
$
4,329
to
$
5,164
per
Mg
($
1997)
for
the
western
U.
S.
These
ranges
are
based
on
the
PM
NAAQS
benefits
analysis
and
assumes
emission
reductions
of
SO<
INF>
2</
INF>
are
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
74
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169)
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2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
proportional
to
emission
reductions
of
PM.
The
lower
values
include
a
measure
of
premature
mortality
due
to
short­
term
exposure,
and
the
higher
values
use
a
measure
of
premature
mortality
due
to
long­
term
exposure.
The
benefits
transfer
method
is
utilized
to
value
the
pollutants
discussed
above
(
VOCs,
PM,
and
SO<
INF>
2</
INF>).
This
method
relies
on
previous
benefit
studies
that
have
been
conducted
for
the
same
pollutants
that
are
identified
in
this
rulemaking.
These
studies
provide
useful
data
that
can
be
transferred
across
contexts
in
order
to
approximate
the
benefits
of
the
pharmaceuticals
industry's
emission
reductions.
The
impacts
and
benefits
associated
with
the
different
emission
components
are
aggregated
by
adding
the
lower
values
separately
from
the
higher
values
to
give
a
maximum
total
range.
Using
this
method
of
analysis,
the
total
monetized
air
benefits
from
reduction
of
ozone
precursors,
including
associated
PM
and
SO<
INF>
2</
INF>
increases,
range
from
an
adverse
environmental
impact
of
$
0.20
million
($
1997)
to
a
benefit
of
$
9.2
million
($
1997).

b.
Reduced
Human
Health
Cancer
Risk
The
benefits
from
the
final
rule
include
human
health
benefits
from
reductions
in
excess
cancer
risk.
EPA
expects
the
final
rule
to
reduce
loadings
of
toxic
substances
that
otherwise
would
volatilize
and
pose
a
cancer
risk
to
humans,
resulting
in
reductions
in
excess
cancer
risk
in
exposed
populations
from
inhalation
of
VOCs.
In
addition,
EPA
expects
that
reduced
loadings
to
surface
waters
will
improve
water
quality
and
thus
reduce
cancer
risk
to
the
exposed
populations
from
consumption
of
contaminated
drinking
water
and
fish
tissue.
Based
on
the
cancer
risk
assessment
conducted
for
fugitive
air
emissions,
EPA
estimates
that
the
final
guidelines
will
result
in
0.15
excess
cancer
cases
avoided
per
year
nationwide
due
to
reduced
exposure
to
four
identified
pollutants
(
benzene,
chloroform,
1,2­
dichloroethane,
and
methylene
chloride).
The
estimated
monetized
value
of
the
human
health
benefits
from
these
cancer
risk
reductions
ranges
from
$
350,000
to
$
1.9
million
($
1997)
annually.
EPA
developed
these
benefit
estimates
by
applying
an
existing
estimate
of
the
value
of
a
statistical
life
to
the
estimated
number
of
excess
cancer
cases
avoided.
The
estimated
range
of
the
value
of
a
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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169)
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
statistical
life
used
in
this
analysis
is
$
2.3
million
to
12.6
million
($
1997).
This
estimated
range
is
based
on
EPA's
Office
of
Policy,
Planning
and
Evaluation
(
OPPE)
review
of
willingness­
to­
pay
studies
for
valuing
an
avoided
event
of
premature
mortality
or
a
statistical
life
saved.

c.
Reduced
Noncarcinogenic
Human
Health
Hazard
Exposure
to
toxic
substances
poses
risk
of
systemic
and
other
effects
to
humans,
including
effects
on
the
circulatory,
respiratory
or
digestive
systems
and
neurological
and
developmental
effects.
This
final
rule
is
expected
to
generate
human
health
benefits
by
reducing
exposure
to
these
substances,
thus
reducing
the
hazards
of
these
associated
effects.
As
in
the
case
of
the
cancer
risk
assessment,
systemic
hazards
from
exposure
to
fugitive
air
emissions
and
consumption
of
contaminated
fish
tissue
and
drinking
water
are
evaluated.
Based
on
this
analysis,
reductions
in
fugitive
air
emissions
are
expected
to
result
in
reduced
systemic
hazard
to
32,300
individuals
due
to
reduced
exposure
to
four
identified
toxic
pollutants
(
ammonia,
chlorobenzene,
methyl
cellosolve,
and
triethylamine).
No
systemic
hazards
reductions
are
expected
to
result
from
reduced
exposure
to
contaminated
fish
tissue
or
drinking
water.
Sufficient
data
to
quantify
these
benefits
further
are
not
available.

d.
Improved
Ecological
Conditions
and
Recreational
Activity
EPA
expects
this
final
rule
to
generate
environmental
benefits
by
improving
water
quality.
There
are
a
wide
range
of
benefits
associated
with
the
maintenance
and
improvement
of
water
quality.
These
benefits
include
use
values
(
e.
g.,
recreational
fishing),
ecological
values
(
e.
g.,
preservation
of
habitat),
and
passive
use
(
intrinsic)
values
(
e.
g.,
aesthetics).
For
example,
water
pollution
might
affect
the
quality
of
the
fish
and
wildlife
habitat
provided
by
water
resources,
thus
affecting
the
species
using
these
resources.
This
in
turn
might
affect
the
quality
and
value
of
recreational
experiences
of
users,
such
as
anglers
fishing
in
the
affected
streams.
EPA
considers
the
value
of
the
recreational
fishing
benefits
and
intrinsic
benefits
resulting
from
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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169)
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Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
this
final
rule,
but
does
not
evaluate
the
[[
Page
50411]]

other
types
of
ecological
and
environmental
benefits
(
e.
g.,
increased
assimilative
capacity
of
the
receiving
stream,
protection
of
terrestrial
wildlife
and
birds
that
consume
aquatic
organisms,
and
improvements
to
other
recreational
activities,
such
as
swimming,
boating,
water
skiing,
and
wildlife
observation)
due
to
data
limitations.
To
estimate
some
of
the
benefits
from
the
improvements
in
water
quality
expected
to
result
from
this
rule,
instream
concentration
estimates
are
modeled
and
then
compared
to
both
aquatic
life
and
human
health
ambient
water
quality
criteria
(
AWQC)
or
toxic
effect
levels
to
evaluate
whether
these
discharges
pose
risk
to
aquatic
organisms
or
to
human
health.
The
projected
reductions
in
toxic
loadings
to
surface
waters
and
POTWs
are
significant.
Modeled
end­
of­
pipe
pollutant
loadings
are
estimated
to
decline
by
71
percent,
from
11.2
million
pounds
per
year
under
current
conditions
to
3.3
million
pounds
per
year
under
this
final
rule.<
SUP>
1</
SUP>
The
analysis
comparing
instream
concentration
levels
to
AWQC
estimates
that
current
discharge
loadings
result
in
excursions
of
AWQC
at
five
locations.
The
analysis
also
indicates
that
no
excursions
are
expected
to
occur
at
these
five
sites
under
this
final
rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
1
2
3\
These
benefits
are
a
result
of
the
CAA
MACT
Rule
and/
or
the
CWA
Rule.
Monetized
benefits
of
$
290,000
to
$
1.0
million
($
1997)
of
the
total
recreational
benefit
to
anglers
can
be
solely
attributed
to
the
CWA
Rule.
Monetized
benefits
of
$
140,000
to
$
510,000
($
1997)
of
the
total
intrinsic
benefit
can
be
solely
attributed
to
the
CWA
Rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

EPA
estimates
that
the
annual
monetized
recreational
benefits
to
anglers
associated
with
the
expected
changes
in
water
quality
range
from
$
520,000
to
$
1.8
million
($
1997).<
SUP>
2</
SUP>
EPA
evaluates
these
recreational
benefits,
applying
a
model
that
considers
the
increase
in
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
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77
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169)
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
value
of
a
  
contaminant­
free
fishery''
to
recreational
anglers
resulting
from
the
elimination
of
pollutant
concentrations
in
excess
of
AWQC
at
these
five
sites.
The
monetized
value
of
impaired
recreational
fishing
opportunity
is
estimated
by
first
calculating
the
baseline
value
of
the
receiving
stream
using
a
value
per
person
day
of
recreational
fishing,
and
the
number
of
person­
days
fished
on
the
receiving
stream.
The
value
of
improving
water
quality
in
this
fishery,
based
on
the
increase
in
value
to
anglers
of
achieving
contaminant­
free
fishing,
is
then
calculated.
In
addition,
EPA
estimates
that
the
annual
monetized
intrinsic
benefits
to
the
general
public,
as
a
result
of
the
same
improvements
in
water
quality,
range
from
at
least
$
260,000
to
$
920,000
($
1997).<
SUP>
3</
SUP>
These
intrinsic
benefits
are
estimated
as
half
of
the
recreational
benefits
and
may
be
significantly
underestimated.

e.
Improved
POTW
Operations/
Conditions
EPA
considers
three
potential
sources
of
benefits
to
POTWs
from
this
final
regulation:
(
1)
reductions
in
the
likelihood
of
interference,
pass
through,
and
sewage
sludge
contamination
problems;
(
2)
reductions
in
health
and
safety
risks
to
POTW
workers;
and
(
3)
reductions
in
costs
potentially
incurred
by
POTWs
in
analyzing
toxic
pollutants
and
determining
whether
to,
and
the
appropriate
level
at
which
to,
set
local
limits.
Although
the
benefits
from
reducing
these
effects
at
POTWs
might
be
substantial,
the
EPA
does
not
quantify
all
of
these
benefits
due
to
data
limitations.
First,
regarding
potential
interference,
pass
through
and
sewage
sludge
contamination
problems,
this
final
rule
is
expected
to
help
reduce
these
problems
by
reducing
toxic
loadings
in
the
industry's
effluent
and
reducing
shock
releases.
Anecdotal
evidence
from
POTW
responses
to
an
EPA
survey
and
sampling
results
indicate
that
such
effects
can
occur.
In
addition,
based
on
an
analysis
comparing
POTW
influent
levels
to
available
data
on
inhibition
levels,
inhibition
problems
are
projected
to
occur
at
three
POTWs
for
five
pollutants
(
acetonitrile,
diethylamine,
N,
N­
dimethylacetamide,
N,
Ndimethylformamide
and
triethylamine)
under
current
conditions.
Inhibition
problems
are
projected
to
remain
at
the
same
three
POTWs
for
three
of
these
pollutants
(
acetonitrile,
N,
N­
dimethylacetamide,
and
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Source
Performance
Standards;
Final
Rule
N,
N­
dimethylformamide)
after
this
final
rule.<
SUP>
4</
SUP>
While
this
rule
is
not
expected
to
completely
eliminate
inhibition
problems,
the
reduction
in
pollutant
loadings
is
expected
to
reduce
the
severity
of
the
impact.
Sufficient
data
are
not
available
to
further
quantify
this
benefit
category.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
4\
This
benefit
is
a
result
of
the
CAA
MACT
Rule
and/
or
the
CWA
Rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Furthermore,
toxic
substances,
particularly
the
VOCs,
in
effluent
discharges
to
POTWs
pose
health
risks
to
POTW
workers.
This
final
rule
is
expected
to
reduce
these
risks,
thus
generating
human
health
benefits.
Based
on
the
assessment
of
the
risk
posed
to
POTW
workers
from
exposure
to
the
toxic
pollutants
(
primarily
acetonitrile,
benzene,
chloroform,
diethylamine,
n­
heptane,
n­
hexane,
methylene
chloride,
toluene,
and
triethylamine),
this
final
rule
is
estimated
to
reduce
occupational
risk
at
nine
POTWs.<
SUP>
5</
SUP>
Data
are
not
available
to
monetize
this
benefit
category.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
5\
This
benefit
is
a
result
of
the
CAA
MACT
Rule
and/
or
the
CWA
Rule.
Reduction
of
occupational
risk
at
five
POTWs
can
be
solely
attributed
to
the
CWA
Rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Finally,
reducing
the
pollutant
load
to
local
POTWs
may
eliminate
some
of
the
efforts
associated
with
establishing
local
pollutant
limits.
Local
limits
are
sometimes
required
to
protect
against
passthrough
and
interference,
and
to
protect
worker
health
and
safety.
Establishing
local
limits
involves
labor
and
analytical
costs
to
determine
the
relative
contribution
of
each
industrial
discharger
and
to
set
limits
which
will
be
protective
of
the
treatment
works,
the
workers,
and
the
receiving
environment.
Several
POTWs
contacted
in
EPA's
survey
indicated
that
establishment
of
more
effective
national
pretreatment
standards
would
help
them
avoid
these
significant
costs.
In
addition,
they
indicated
that
where
local
limits
are
still
required,

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Source
Performance
Standards;
Final
Rule
stricter
national
pretreatment
standards
will
bolster
the
validity
of
the
limits
they
set.
Furthermore,
reducing
the
discharge
of
toxic
pollutants
reduces
the
likelihood
that
the
POTW
effluents
will
exhibit
excessive
toxicity.
When
POTW
effluent
exhibits
excessive
toxicity,
the
POTW
must
enact
a
rigorous,
costly
analytical
program
to
identify
and
reduce
the
source
of
toxicity.

f.
Other
Unquantified
Benefits
The
above
benefit
analyses
focus
mainly
on
identified
compounds
with
quantifiable
toxic
or
carcinogenic
effects.
This
leads
to
a
potentially
large
underestimation
of
benefits,
since
some
significant
pollutant
characterizations
are
not
considered.
For
example,
the
analyses
do
not
include
the
benefits
associated
with
reducing
the
particulate
load
(
measured
as
TSS),
or
the
oxygen
demand
(
measured
as
BOD
and
COD)
of
the
effluents.
TSS
loads
can
degrade
ecological
habitat
by
reducing
light
penetration
and
primary
productivity,
and
from
accumulation
of
solid
particles
that
alter
benthic
spawning
grounds
and
feeding
habitats.
BOD
and
COD
loads
can
deplete
oxygen
levels,
which
can
produce
mortality
or
other
adverse
effects
in
fish,
as
well
as
reduce
biological
diversity.
The
benefits
of
COD
reduction
extend
beyond
reducing
oxygen
depletion,
since
COD
also
represents
the
presence
of
organic
chemicals
in
a
waste
stream.
Due
to
a
lack
of
analytical
methods,
not
all
of
the
compounds
represented
by
COD
are
identified.
In
this
benefits
[[
Page
50412]]

assessment,
specifically
identified
compounds
represent
only
2.2
million
pounds
of
the
11.5
million
pounds
of
COD
projected
to
be
removed.
This
limits
the
estimate
of
benefits,
since
the
analysis
relies
on
comparing
instream
concentrations
to
established
criteria,
and
there
are
obviously
no
established
criteria
for
unidentified
compounds.
However,
there
is
inherent
value
in
reducing
pollutant
loads,
despite
(
or
perhaps
due
to)
the
lack
of
quantifiable
effects.
The
benefits
analyses
are
further
limited
because
they
concentrate
on
projected
excursions
from
established
minimum
standards,
and
do
not
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Source
Performance
Standards;
Final
Rule
account
for
protection
of
higher
quality
conditions.
Likewise,
they
do
not
account
for
prevention
of
future
impacts
which
could
occur
due
to
increased
effluent
loadings.

g.
Summary
of
Benefits
from
Effluent
Limitations
Guideline
Final
Rule
EPA
estimates
that
the
annual
monetized
benefits
resulting
from
this
final
effluent
guidelines
rule
will
range
from
$
0.93
million
to
$
14
million
($
1997).
This
range
includes
$
0.34
to
$
1.2
million
that
cannot
be
differentiated
between
the
effluent
guidelines
rule
and
the
wastewater
portion
of
the
MACT
standard.
Table
XI.
B.
9.
g
summarizes
these
benefits,
by
category.
The
range
reflects
the
uncertainty
in
evaluating
the
effects
of
this
final
rule
and
in
placing
a
dollar
value
on
these
effects.
As
indicated
in
the
table,
these
monetized
benefits
ranges
do
not
reflect
many
of
the
benefit
categories
expected
to
result
under
this
final
rule,
including
reduced
noncarcinogenic
human
health
hazards;
improved
ecological
conditions
from
improvements
in
water
quality;
improved
POTW
operations;
and
improved
worker
health
and
safety
at
POTWs.
Therefore
the
reported
benefit
estimate
understates
the
total
benefits
of
this
final
rule.

h.
Benefits
of
the
MACT
Rule
The
CAA
MACT
Rule
will
regulate
an
estimated
101
facilities.
The
Rule
is
expected
to
produce
environmental
and
human
health
benefits
due
to
reductions
in
fugitive
air
emissions
from
four
planks:
wastewater,
process
vents,
storage
tanks,
and
equipment
leaks.
EPA
conducted
analyses
on
the
23
facilities
covered
under
the
wastewater
plank,
based
on
site­
specific
raw
loadings
data
from
the
1990
Pharmaceuticals
Section
308
Questionnaire.
These
analyses
were
conducted
using
the
same
methodologies,
within
the
same
limitations,
as
those
conducted
to
evaluate
the
CWA
Rule
as
discussed
in
the
previous
Sections.
Data
on
emission
reductions
from
the
other
planks
were
obtained
by
OAQPS,
however,
a
detailed
benefit
analysis
of
these
planks
was
not
conducted
due
to
data
limitations
(
specifically,
the
lack
of
site­
specific
data).
Within
these
limitations,
the
estimated
benefits
are
as
follows:
Reduced
Emissions
of
Ozone
Precursors
EPA
estimates
that
the
final
MACT
Rule
will
produce
benefits
due
to
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Performance
Standards;
Final
Rule
reductions
in
fugitive
VOC
emissions
from
wastewater,
process
vents,
storage
tanks,
and
equipment
leaks
at
pharmaceutical
manufacturing
facilities.
Considering
the
wastewater
plank
only,
EPA
estimates
that
the
annual
monetized
benefits
range
from
$
1.2
million
to
$
45
million
($
1997).
These
benefits
are
based
on
estimated
emission
reductions
in
VOC
emissions
in
nonattainment
areas
alone,
and
in
both
nonattainment
and
attainment
areas
(
2,057
Mg
to
16,619
Mg,
respectively).
The
annual
monetized
adverse
environmental
impacts
for
these
23
facilities
due
to
increases
in
PM
emissions
is
estimated
by
EPA
at
$
56,000
($
1997).
This
value
is
based
on
an
estimated
increase
in
PM
emissions
of
4.2
Mg.
EPA
also
estimates
that
the
annual
monetized
adverse
environmental
impacts
for
these
23
facilities
due
to
increases
in
SO<
INF>
2</
INF>
emissions
due
to
the
final
MACT
Rule
range
from
$
65,000
to
$
143,000
based
on
an
estimated
increase
in
SO<
INF>
2</
INF>
emissions
of
11.0
Mg
(
10.6
Mg
eastern
U.
S.,
and
0.4
Mg
western
U.
S.).
The
total
monetized
air
benefits
from
reductions
of
ozone
precursors
from
wastewater,
after
correction
for
PM
and
SO<
INF>
2</
INF>
increases,
range
from
$
1.0
million
to
$
45
million
($
1997).
In
addition,
based
on
the
analysis
of
the
101
pharmaceutical
manufacturing
facilities
covered
by
the
MACT
rule,
EPA
estimates
that
the
reductions
in
fugitive
VOC
emissions
from
process
vents,
storage
tanks,
and
equipment
leaks
would
result
in
a
range
of
annual
monetized
air
benefits
of
$
0.77
million
to
$
11
million
($
1997).
These
benefits
are
based
on
estimated
reductions
in
VOC
emissions
in
nonattainment
areas
alone,
and
in
both
nonattainment
and
attainment
areas
(
1,278
Mg
to
4,027
Mg,
respectively).
Adverse
impacts
due
to
increased
energy
consumption
from
control
of
these
planks
are
not
quantified
due
to
data
limitations.
The
total
monetized
benefits
from
reductions
in
VOC
emissions
from
all
four
planks
are
estimated
to
be
$
1.8
million
to
$
56
million
($
1997).
Reduced
Human
Health
Cancer
Risk
The
estimated
monetized
value
of
the
human
health
benefits
from
cancer
risk
reductions
due
to
reductions
in
fugitive
air
emissions
from
wastewater
ranges
from
$
2.1
million
to
$
11
million
($
1997)
annually.
This
is
based
on
EPA
estimates
that
the
MACT
Rule
will
result
in
0.88
cancer
cases
avoided
per
year
nationwide,
considering
an
inhalation
exposure
route.
EPA
also
expects
that
reduced
loadings
to
surface
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Final
Rule
waters
will
improve
water
quality
and
thus
reduce
cancer
risk
to
the
exposed
populations
from
consumption
of
contaminated
drinking
water
and
fish
tissues.
EPA
estimates
that
cancer
risk
will
be
further
reduced
due
to
reductions
in
fugitive
air
emissions
from
process
vents,
storage
tanks,
and
equipment
leaks.
However,
these
reductions
were
not
quantified
due
to
lack
of
site­
specific
data.
Reduced
Noncarcinogenic
Human
Health
Hazard
EPA
estimates
that
reductions
in
fugitive
air
emissions
from
wastewater
are
expected
to
result
in
reduced
systemic
hazard
to
370,000
individuals
due
to
reduced
exposure
to
four
identified
toxic
pollutants.
EPA
also
expects
that
reductions
in
fugitive
air
emissions
from
process
vents,
storage
tanks,
and
equipment
leaks
will
result
in
reduced
systemic
hazard.
However,
EPA
does
not
quantify
these
benefits
due
to
data
limitations.
No
systemic
hazard
reductions
are
expected
to
result
from
reduced
exposure
to
contaminated
fish
tissue
or
drinking
water.
Improved
Ecological
Conditions
and
Recreational
Activity
EPA
estimates
that
the
annual
monetized
recreational
benefits
to
anglers
associated
with
the
expected
changes
in
water
quality
at
two
locations
range
from
$
230,000
to
$
820,000
($
1997).
The
annual
monetized
intrinsic
benefits
to
the
general
public
range
from
at
least
$
115,000
to
$
410,000
($
1997).
These
benefits
are
a
result
of
the
CAA
MACT
Rule
and/
or
the
CWA
Rule.
These
monetized
benefits
cannot
be
solely
attributed
to
the
MACT
Rule.
Improved
POTW
Operations
Inhibition
problems
are
projected
by
EPA
to
occur
at
three
POTWs
for
five
pollutants
under
current
conditions.
Inhibition
problems
are
projected
to
remain
at
the
same
three
POTWs
for
three
of
these
pollutants.
The
benefits
cannot
be
solely
attributed
to
the
MACT
Rule.

[[
Page
50413]]

Additionally,
the
MACT
Rule
is
expected
to
reduce
health
risks
to
POTW
workers.
This
rule
is
estimated
to
reduce
occupational
risks
at
four
POTWs.
However,
these
benefits
cannot
be
solely
attributed
to
the
MACT
Rule.
Summary
of
Benefits
From
MACT
Final
Rule
http://
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epa.
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(
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
EPA
estimates
that
the
annual
monetized
benefits
resulting
from
the
MACT
final
rule
will
range
from
at
least
$
3.9
million
to
$
67
million
($
1997).
Additional
annual
monetized
benefits
that
cannot
be
solely
attributed
to
the
CAA
portion
of
this
final
rule
will
range
from
$
0.34
million
to
$
1.2
million
($
1997).
Table
VI.
B.
9.
h
summarizes
these
benefits,
by
category.
As
explained
previously
in
Section
g,
the
expected
benefit
estimate
understates
the
total
benefits
of
the
MACT
rule.
The
estimate
is
further
constrained
by
data
limitations.

Table
VI.
B.
9.
g.­­
Potential
Economic
Benefits
From
Final
Effluent
Limitations
Guidelines
for
the
Pharmaceutical
Industry
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Millions
of
1997
dollars
Benefit
category
per
year
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Reduced
Emissions
of
Ozone
Precursors........
­$
0.20
to
$
9.2.
Reduced
Cancer
Risk..........................
$
0.35
to
$
1.9.
Reduced
Noncarcinogenic
Hazard...............
Unquantified.
Improved
Ecological
Conditions...............
Unquantified.
Improved
Recreational
Activity...............
$
0.52
to
$
1.8.
Improved
Intrinsic
Value.....................
$
0.26
to
$
0.92.
Improved
POTW
Operations
(
Inhibition
and
Unquantified.
Sludge
Contamination).
Improved
Occupational
Conditions
at
POTWs....
Unquantified.
­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Monetized
Benefits.................
$
0.93
to
$
14.0.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Note:
These
benefits
include
a
portion
of
recreational
and
intrinsic
monetized
benefits
attributed
to
the
CAA
Rule.
Specifically,
two
facilities
included
in
the
modeling
were
required
to
have
MACT
strippers
and
were
also
costed
for
additional
strippers
to
meet
the
CWA
effluent
guidelines.
Overall
removals
due
to
these
strippers
cannot
be
differentiated
between
MACT
and
CWA
requirements.
These
two
facilities
represent
a
total
of
$
0.34
to
$
1.2
million
based
on
improved
recreational
activity
and
improved
intrinsic
value.

Table
VI.
B.
9.
h.­­
Potential
Economic
Benefits
From
CAA
MACT
Rule
for
the
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Pharmaceutical
Industry
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Millions
of
1997
dollars
per
year
Benefit
category
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Wastewater
Other
fugitive
emissions\
1\
Total
benefits
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Reduced
Emissions
of
Ozone
$
1.0
to
$
45.................
$
0.77
to
$
11$..............
$
1.8
to
$
56.
Precursors.
Reduced
Cancer
Risk...........
$
2.1
to
$
11.................
Unquantified...............
$
2.1
to
$
11.
Reduced
Noncarcinogenic
Hazard
Unquantified................
Unquantified...............
Unquantified.
Improved
Ecological
Conditions
Unquantified................
Unquantified...............
Unquantified.
Improved
POTW
Operations
Unquantified................
Unquantified...............
Unquantified.
(
Inhibition
and
Sludge
Contamination).
Improved
Occupational
Unquantified................
Unquantified...............
Unquantified.
Conditions
at
POTWs.
Total
Monetized
Benefits..
$
3.1
to
$
56.................
$
0.77
to
$
11...............
$
3.9
to
$
67.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Includes
process
vents,
storage
tanks,
and
equipment
leaks.
Notes:
These
benefits
exclude
a
portion
of
the
recreational
and
intrinsic
monetized
benefits
attributed
to
the
CAA
Rule.
Specifically,
two
facilities
included
in
the
modeling
were
required
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
to
have
MACT
strippers
and
were
also
costed
for
additional
strippers
to
meet
the
CWA
effluent
guidelines.
Overall
removals
due
to
these
strippers
cannot
be
differentiated
between
MACT
and
CWA
requirements.
These
two
facilities
represent
a
total
of
$
0.34
to
$
1.2
million
dollars,
based
on
improved
recreational
activity
and
improved
intrinsic
value.
The
benefits
analysis
for
the
MACT
Rule
is
particularly
limited
due
to
data
constraints.

VII.
Non­
Water
Quality
Environmental
Impacts
The
elimination
or
reduction
of
one
form
of
pollution
may
create
or
aggravate
other
environmental
problems.
Therefore,
Sections
304(
b)
and
306
of
the
Act
call
for
EPA
to
consider
the
non­
water
quality
environmental
impacts
of
effluent
limitations
guidelines
and
standards.
Accordingly,
EPA
has
considered
the
effect
of
these
regulations
on
air
pollution,
solid
waste
generation,
and
energy
consumption.

A.
Air
Pollution
EPA
estimated
the
impacts
of
the
selected
technology
options
for
the
existing
source
BAT
and
PSES
regulations
and
the
technology
basis
for
the
MACT
standard
on
air
emissions.
EPA
considered
emissions
of
HAPs
and
non­
HAPs
as
well
as
criteria
air
pollutants
(
CO,
No<
INF>
X</
INF>,
SO<
INF>
2</
INF>
and
particulate
matter)
in
its
analysis.
EPA
estimates
that
the
MACT
standards
steam
strippers
will
reduce
air
emissions
of
HAPs
and
non­
HAPs
at
direct
and
indirect
subcategory
A
and
C
facilities
by
14.1
and
41.4
million
lbs.
per
year,
respectively.
No
emission
reductions
have
been
estimated
for
B
and
D
subcategory
direct
and
indirect
dischargers
as
the
result
of
the
MACT
standard
because
these
facilities
are
not
  
major
sources''
of
hazardous
air
pollutants
(
HAPs)
(
defined
as
facilities
with
total
annual
emissions
of
HAPs
greater
than
25,000
metric
tons).
EPA
has
estimated
the
reduction
in
air
emissions
of
HAPs
and
non­
HAPs
as
the
result
of
steam
strippers
that
may
be
installed
to
comply
with
PSES
for
VOC
pollutants
for
A
and
C
and
B
and
D
subcategory
facilities
to
be
10.7
and
3.3
million
lbs.
per
year,
respectively.
With
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Limitations
Guidelines,
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Performance
Standards;
Final
Rule
[[
Page
50414]]

respect
to
criteria
pollutants,
EPA
estimates
that
as
a
result
of
steam
generation
requirements
for
PSES
steam
strippers,
emissions
of
criteria
pollutants
will
increase
by
616,000
pounds
per
year.

B.
Solid
Waste
EPA
has
estimated
the
increases
in
solid
waste
generation
as
from
the
use
of
advanced
biological
treatment
(
the
basis
for
BPT/
BCT
limitations),
and
steam
stripping
technology
(
the
basis
for
PSES).
EPA
also
estimated
an
increase
in
waste
hydrogen
chloride
due
to
scrubber
liquor
generated
by
facilities
with
wastewater
containing
ammonia.
EPA
estimates
that
compliance
with
the
BPT/
BCT
limitations
will
increase
the
mass
of
wastewater
treatment
sludge
by
subcategories
A
and
C
and
B
and
D
direct
dischargers
by
343
and
194
tons
per
year,
respectively.
Compliance
with
BAT
ammonia
and
organic
limitations
by
A
and
C
subcategory
plants
is
expected
to
increase
wastewater
sludge
generation
by
308
tons
per
year.
No
increase
in
sludge
generation
is
expected
as
the
result
of
the
subcategories
B
and
D
BAT
COD
limitations
because
these
limitations
are
equivalent
to
the
BPT
COD
limitations
and
there
are
no
BAT
organic
compound
limitations
for
these
subcategories.
EPA
does
expect
that
indirect
discharging
A
and
C
facilities
will
generate
an
increase
in
waste
aqueous
hydrogen
chloride
resulting
from
the
use
of
wet
hydrogen
chloride
scrubbers
to
control
air
emissions
from
steam
strippers
used
to
remove
ammonia
from
wastewater.
EPA
estimates
that
waste
aqueous
hydrogen
chloride
generation
will
increase
by
283
tons
per
year.
Compliance
with
PSES
subcategory
A
and
C
and
subcategory
B
and
D
facilities
is
expected
to
increase
the
amount
of
waste
solvents
generated.
This
increase
in
waste
solvent
generation
is
due
to
the
waste
solvents
recovered
from
the
in­
plant
steam
stripping
operations
at
these
facilities.
EPA
anticipates
that
10,600
and
3,310
tons/
yr
of
waste
solvents
will
be
generated
at
subcategory
A
and
C
and
B
and
D
facilities,
respectively.
Ten
of
the
pollutants
being
regulated
by
BAT
limitations
and
pretreatment
standards
are
solvents
listed
as
hazardous
waste
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Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
constituents
(
F0002,
F0003,
and
F0005)
under
40
CFR
261.31.
These
pollutants
are
acetone,
4­
methyl­
2­
pentanone
(
MIBK),
ethyl
acetate,
methanol,
benzene,
toluene,
xylenes,
methylene
chloride,
chlorobenzene,
and
o­
dichlorobenzene.
EPA
is
promulgating
PSES
for
nine
of
these
pollutants
and
has
included
costs
for
disposal
of
all
overheads
from
steam
stripping
as
hazardous
wastes
in
its
steam
stripping
cost
estimates.
As
noted
above,
EPA
has
estimated
increased
sludge
generation
as
a
result
of
compliance
with
BAT
limitations
for
29
pollutants
including
the
10
pollutants
listed
above.
EPA
has
assumed
that
this
sludge
will
be
incinerated
in
developing
its
final
BAT
cost
estimates,
but
does
not
believe
that
the
increased
sludge
generated
will
be
considered
as
hazardous.

C.
Energy
Requirements
EPA
has
estimated
the
energy
impacts
on
the
pharmaceutical
manufacturing
industry
associated
with
compliance
with
the
final
BPT,
BAT
and
PSES
regulations.
The
Agency
estimates
that
electrical
usage
would
increase
for
subcategory
A
and
C
and
subcategory
B
and
D
facilities
by
5.9
x
10<
SUP>
6</
SUP>
and
1.07
x
10<
SUP>
6</
SUP>
kilowatt
hours
(
kWh)
as
the
result
of
the
final
BPT
and
BAT
regulations.
This
increase
is
equivalent
to
a
0.1
percent
increase
above
current
electrical
usage
by
the
industry.
EPA
also
estimated
the
increase
in
electrical
usage
as
the
result
of
increased
steam
generation.
The
increased
steam
generation
is
required
to
operate
the
steam
strippers
that
EPA
anticipates
will
be
installed
to
comply
with
the
pretreatment
standards
for
VOCs.
(
The
impacts
of
the
BPT
and
BAT
regulations
on
electrical
usage
for
steam
generation
are
negligible).
EPA
estimates
that
electrical
usage
for
steam
generation
will
increase
for
subcategories
A
and
C
and
subcategories
B
and
D
indirect
dischargers
by
454
x
10<
SUP>
6</
SUP>
and
58.8
x
10<
SUP>
6</
SUP>
kWh,
respectively.
The
total
of
these
two
increases
in
electrical
usage
is
equivalent
to
an
eight
percent
overall
increase
in
electrical
usage
above
current
levels.

VIII.
Regulatory
Implementation
The
purpose
of
this
section
is
to
provide
assistance
and
direction
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Guidelines,
Pretreatment
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Performance
Standards;
Final
Rule
to
permit
writers
and
control
authorities
to
aid
in
their
implementation
of
this
regulation
and
its
unique
compliance
alternative.
This
section
also
discusses
the
relationship
of
upset
and
bypass
provisions,
variances
and
modifications,
and
analytical
methods
to
the
final
limitations
and
standards.

A.
Implementation
of
the
Limitations
and
Standards
Upon
the
promulgation
of
these
regulations,
the
effluent
limitations
for
the
appropriate
subcategory
must
be
applied
in
all
Federal
and
State
NPDES
permits
issued
to
direct
dischargers
in
the
pharmaceutical
manufacturing
industry.
In
addition,
the
pretreatment
standards
are
directly
applicable
to
indirect
dischargers.
Permit
writers
and
pretreatment
authorities
need
to
be
aware
of
special
circumstances
involving
compliance
with
the
cyanide
limitations
and
standards,
ammonia
pretreatment
standards,
pH
monitoring
and
the
portion
of
nonprocess
wastewater
in
the
final
effluent.
In
the
case
of
the
cyanide
limitations
and
standards,
EPA
determined
that
the
monitoring
point
for
purposes
of
compliance
with
the
cyanide
will
generally
be
in­
plant
at
a
point
before
the
cyanide­
bearing
wastewaters
are
commingled
with
noncyanide­
bearing
waste
streams
in
accordance
EPA
permit
and
pretreatment
program
regulations
at
40
CFR
122.44(
i)(
1)(
iii)
for
direct
dischargers
and
Sec.
403.6(
e)
for
indirect
dischargers.
These
regulations
allow
permit
writers
and
pretreatment
control
authorities
to
establish
in­
plant
monitoring
points
for
regulated
pollutants
in
cases
where
it
is
impractical
or
infeasible
to
monitor
at
the
normal
end­
of­
pipe
monitoring
point
e.
g.,
because
the
regulated
pollutant
is
not
detectable
at
the
end­
of­
pipe.
This,
in
turn,
is
the
result
of
the
wastewater
stream
bearing
the
regulated
pollutant
being
commingled
with
significantly
higher
volume
streams
not
bearing
the
regulated
pollutant.
EPA's
analysis
of
waste
stream
flow
data,
from
subcategories
A
and
C
facilities
containing
cyanide
in
their
wastewaters,
indicate
that
the
volume
of
cyanide­
bearing
wastewaters
is,
on
average,
less
than
2.1
percent
of
the
total
process
wastewater
flow
and
that
all
but
two
of
the
facilities
required
to
monitor
for
cyanide
do
so
at
an
in­
plant
monitoring
point.
Facilities
that
can
demonstrate
that
it
is
not
impractical
or
infeasible
to
monitor
for
cyanide
at
the
normal
end­
of­
pipe
point,
i.
e.,
cyanide
can
be
detected
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Source
Performance
Standards;
Final
Rule
at
the
end­
of­
pipe
point,
may
do
so.
In
connection
with
the
ammonia
pretreatment
standards
being
promulgated
for
subcategories
A
and
C,
EPA
has
determined
that
the
pollutant
ammonia
does
not
passthrough
POTWs
that
possess
nitrification
capability.
As
a
result,
ammonia
pretreatment
standards
would
not
apply
to
subcategories
A
and
C
industrial
users
that
discharge
to
these
POTWs.
In
order
to
provide
guidance
to
pretreatment
authorities,
EPA
describes
the
treatment
system
requirements
under
which
nitrification
is
considered
to
occur
in
section
17
of
the
final
TDD
and
defines
the
basis
for
considering
a
POTW
to
have
acceptable
nitrification
capability
in
Sec.
439.1
of
the
final
rule.
POTWs
that
nitrify
should
impose
local
limits
for
[[
Page
50415]]

ammonia
if
they
believe
that
the
ammonia
load
from
the
pharmaceutical
industrial
user(
s)
will
nevertheless
pass
through
their
facilities
(
see
40
CFR
403.5).
During
the
post­
proposal
period,
EPA
has
received
comments
from
industry
commenters
that
complying
with
the
pH
requirements
100
percent
of
the
time
when
using
continuous
monitoring
is
not
practical
for
many
facilities.
Direct
discharging
pharmaceutical
facilities
are
required
by
today's
final
regulation
to
maintain
effluent
pH
in
the
6.0­
9.0
range.
The
general
pretreatment
regulations
specifically
in
40
CFR
403.5(
b)(
2),
set
a
pH
minimum
of
5.0,
except
in
certain
design
conditions,
but
do
not
set
an
upper
boundary.
EPA
has
addressed
the
problem
of
random
excursions
at
40
CFR
401.17
for
direct
discharging
facilities.
This
regulation
recognizes
that
random
excursions
from
the
pH
range
(
6.0­
9.0)
may
occur
in
the
process
of
continuous
monitoring
and
these
random
excursions
should
not
be
treated
as
violations.
EPA
is
developing
a
proposal
for
a
similar
provision
for
indirect
dischargers
and
expects
to
propose
this
provision
by
the
end
of
this
year.
In
implementing
the
final
limitations
and
standards,
permit
writers
need
to
account
for
the
facility's
nonprocess
wastewater
contained
in
the
effluent
being
discharged
in
developing
either
mass
or
concentration
based
permit
limits.
As
discussed
previously,
in
section
IV
of
this
preamble,
the
final
limitations
and
standards
are
developed
from
data
sets
from
plants
which
had
less
than
25
percent
nonprocess
http://
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gov/
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EPA­
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htm
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169)
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
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New
Source
Performance
Standards;
Final
Rule
wastewater
in
the
total
plant
discharge.
The
flow
basis
of
the
final
limitations
and
standards
is
discussed
in
section
13
of
the
TDD.
In
addition,
examples
of
BPT
and
BAT
permit
limit
calculations
involving
different
plant
flow
configurations
are
provided
in
Appendix
A
to
the
TDD.
In
addition,
permitting
authorities
have
requested
clarification
on
whether
certain
operations
performed
at
pharmaceutical
facilities
would
cause
those
facilities
to
be
regulated
under
additional
effluent
guidelines.
Specifically,
guidance
has
been
requested
in
cases
where
pharmaceutical
facilities,
during
routine
maintenance
and
cleaning
periods,
use
acid
containing
solutions
on
or
in
stainless
steel
processing
equipment.
Some
permitting
authorities
have
inquired
whether
these
operations
are
considered
passivation
operations
which
would
place
the
wastewater
generated
during
such
cleaning
operations
under
the
limitations
set
forth
by
40
CFR
Part
433,
the
Metal
Finishing
Point
Source
Category.
The
Food
and
Drug
Administration
requires
that
pharmaceutical
products
must
be
of
high
purity
and
cannot
be
contaminated
with
dirt,
biological
organisms,
or
corrosion
products.
The
pharmaceutical
production
equipment
includes
many
interconnected
pipes,
storage
vessels,
and
reactors.
Most
of
the
piping
system
and
tanks
are
fabricated
from
austenitic
stainless
steel
similar
to
AISI
304.
The
Agency
is
aware
of
several
pharmaceutical
facilities
which
clean
production
equipment
with
a
mild
alkaline
  
soap''
followed
by
a
flush
with
an
acid
containing
solution.
Some
of
these
acid
solutions
contain
nitric
acid.
The
alkaline
cleaner/
acid­
rinse
operation
is
usually
performed
during
plant
shut­
downs
or
routine
preventative
maintenance.
Because
much
of
the
plant
piping
is
fabricated
from
austenitic
stainless
steel,
and
such
stainless
steels
are
known
to
be
  
passivated''
using
nitric
acid
solutions,
it
has
been
asked
if
the
nitric­
acid­
based
process
used
by
the
pharmaceutical
facilities
would
be
considered
  
passivation''
or
  
cleaning''
for
the
purpose
of
regulation
under
the
40
CFR
Part
433
Metal
Finishing
regulation.
The
  
Development
Document
for
Effluent
Limitations
Guidelines,
New
Source
Performance
Standards
for
the
Metal
Finishing
Point
Source
Category''
describes
the
  
coating''
unit
operation,
which
includes
  
passivation'',
as
one
of
the
six
key
  
trigger''
processes,
while
the
  
cleaning''
operation
description
includes
a
discussion
of
acid
cleaning
as
an
operation
that
is
not
one
of
the
six
  
trigger''

http://
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epa.
gov/
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EPA­
WATER/
1998/
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Day­
21/
w21027.
htm
(
91
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169)
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2003
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
processes.
For
a
process
wastestream
to
be
regulated
under
40
CFR
Part
433,
a
facility
must
perform
one
of
the
six
  
trigger''
operations.
To
determine
the
status
of
the
alkaline
  
soap''/
acid­
based
operations
performed
at
pharmaceutical
facilities,
key
provisions
of
the
  
passivation''
and
  
cleaning''
definitions
were
reviewed.
From
the
definitions
provided
in
the
Development
Document
  
passivation''
is
a
process
in
which
iron
particles
are
removed
from
a
surface,
while
a
protective
coating
is
formed.
  
Cleaning''
is
a
process
in
which
acid
can
be
used
in
combination
with
detergent
to
remove
soil
from
metal
surfaces.
Based
on
these
definitions
from
the
Metal
Finishing
Development
Document,
the
process
conducted
at
pharmaceutical
facilities
should
be
considered
cleaning
for
the
following
three
reasons:
1.
The
processes
in
question
use
both
acid
and
detergent.
2.
The
processes
in
question
are
not
used
to
remove
imbedded
iron
particles.
3.
The
processes
in
question
are
not
used
to
form
a
coating
on
stainless
steel
piping.
(
This
conclusion
can
be
reached
based
on
the
inherent
vulnerability
of
non­
passivated
stainless
to
corrosion.
If
the
pipes
in
this
system
were
not
already
passivated,
they
would
corrode
during
the
production
operations
and
contaminate
the
pharmaceutical
products.)
For
the
reasons
listed
above,
the
pharmaceutical
production
operations
performed
at
these
facilities
should
be
considered
  
acid
cleaning''
and
non
  
passivation''
with
respect
to
40
CFR
Part
433
Metal
Finishing.
Because
the
facilities
only
perform
  
acid
cleaning''
and
not
  
passivation''
there
is
no
metal
finishing
  
trigger''
process
performed
at
the
facility
and
therefore
the
facility
would
not
be
regulated
using
40
CFR
Part
433.

B.
Upset
and
Bypass
Provisions
A
recurring
issue
is
whether
industry
limitations
and
standards
should
include
provisions
authorizing
noncompliance
with
effluent
limitations
during
periods
of
  
upset''
or
  
bypass''.
An
upset,
sometimes
called
an
  
excursion,''
is
an
unintentional
and
temporary
noncompliance
with
technology
based
effluent
limitations
occurring
for
reasons
beyond
the
reasonable
control
of
the
permittee.
EPA
believes
http://
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(
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
that
upset
provisions
are
necessary
to
recognize
an
affirmative
defense
for
an
exceptional
incident.
Because
technology­
based
limitations
can
require
only
what
properly
designed,
maintained
and
operated
technology
can
achieve,
it
is
claimed
that
liability
for
such
situations
is
improper.
While
an
upset
is
an
unintentional
episode
during
which
effluent
limitations
are
exceeded,
a
bypass
is
an
act
of
intentional
noncompliance
during
which
wastewater
treatment
facilities
are
circumvented
in
emergency
situations.
EPA
has
both
upset
and
bypass
provisions
in
NPDES
permits,
and
has
promulgated
NPDES
and
pretreatment
regulations
which
include
upset
and
bypass
provisions.
(
40
CFR
122.41(
m),
122.41(
n)
and
40
CFR
403.16
and
403.17.)
The
upset
provision
establishes
an
upset
as
an
affirmative
defense
to
prosecution
for
violation
of
technology­
based
effluent
limitations.
The
bypass
provision
provides
that
EPA
may
enforce
against
facilities
that
bypass
except
where
necessary
to
prevent
loss
of
life,
personal
injury,
or
severe
property
damage;
there
were
no
feasible
alternatives;
or
permittee
submitted
notices
as
required
under
122.41(
n)(
3).

C.
Variances
and
Modifications
Upon
the
promulgation
of
these
regulations,
the
effluent
limitations
for
[[
Page
50416]]

the
appropriate
subcategory
must
be
applied
in
all
Federal
and
State
NPDES
permits
issued
to
direct
dischargers
in
the
pharmaceutical
manufacturing
industry.
In
addition,
the
pretreatment
standards
are
directly
applicable
to
indirect
dischargers.

1.
Fundamentally
Different
Factors
Variances
For
the
BPT
effluent
limitations,
the
only
exception
to
the
binding
limitations
is
EPA's
  
fundamentally
different
factors''
(  
FDF'')
variance
(
40
CFR
Part
125
Subpart
D).
This
variance
recognizes
factors
concerning
a
particular
discharger
which
are
fundamentally
different
http://
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
from
the
factors
considered
in
this
rulemaking.
Although
this
variance
clause
was
set
forth
in
EPA's
1973­
1976
effluent
guidelines,
it
is
now
included
in
the
NPDES
regulations
and
not
the
specific
industry
regulations.
(
See
44
FR
32854,
32893
[
June
7,
1979]
for
an
explanation
of
the
  
fundamentally
different
factors''
variance).
The
procedures
for
application
for
a
BPT
FDF
variance
are
set
forth
at
40
CFR
122.21(
m)(
1)(
I)(
A).
Dischargers
subject
to
the
BAT
limitations
and
PSES
in
these
final
regulations
may
also
apply
for
an
FDF
variance,
under
the
provisions
of
sec.
301(
n)
of
the
Act,
which
regulates
BAT,
BCT,
and
PSES
for
existing
sources
pretreatment
FDFs.
(
See
40
CFR
122.21
and
40
CFR
403.13,
respectively)
In
addition,
BAT
limitations
for
nonconventional
pollutants
may
be
modified
under
sec.
301(
c)
(
for
economic
reasons)
and
301(
g)
(
for
water
quality
reasons)
of
the
Act.
Under
sec.
301(
l)
of
the
Act,
these
latter
two
statutory
modifications
are
not
applicable
to
  
toxic''
or
conventional
pollutants.
2.
Removal
Credits
Congress,
in
enacting
Section
307(
b)
of
the
CWA,
recognized
that,
in
certain
instances,
POTWs
could
provide
some
or
all
of
the
treatment
of
an
industrial
user's
wastestream
that
would
be
required
pursuant
to
the
pretreatment
standard.
Consequently,
Congress
established
a
discretionary
program
for
POTWs
to
grant
  
removal
credits''
to
their
indirect
dischargers.
The
credit,
in
the
form
of
a
less
stringent
pretreatment
standard,
allows
an
increased
amount
of
pollutants
to
flow
from
the
indirect
discharger's
facility
to
the
POTW.
Section
307(
b)
of
the
CWA
establishes
a
three­
part
test
for
obtaining
removal
credit
authority
for
a
given
pollutant.
Removal
credits
may
be
authorized
only
if
(
1)
the
POTW
  
removes
all
or
any
part
of
such
toxic
pollutant,''
(
2)
the
POTW's
ultimate
discharge
would
  
not
violate
that
effluent
limitation,
or
standard
which
would
be
applicable
to
that
toxic
pollutant
if
it
were
discharged''
directly
rather
than
through
a
POTW
and
(
3)
the
POTW's
discharge
would
  
not
prevent
sludge
use
and
disposal
by
such
[
POTW]
in
accordance
with
section
[
405].
.
.
.''
Section
307(
b).
EPA
has
promulgated
removal
credit
regulations
in
40
CFR
403.7.
The
United
States
Court
of
Appeals
for
the
Third
Circuit
has
interpreted
the
statute
to
require
EPA
to
promulgate
comprehensive
sewage
sludge
http://
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
regulations
before
any
removal
credits
could
be
authorized.
NRDC
v.
EPA,
790
F.
2d
289,
292
(
3rd
Cir.
1986)
cert.
denied.
479
U.
S.
1084
(
1987).
Congress
made
this
explicit
in
the
Water
Quality
Act
of
1987
which
provided
that
EPA
could
not
authorize
any
removal
credits
until
it
issued
the
sewage
sludge
use
and
disposal
regulations
required
by
section
405(
d)(
2)(
a)(
ii).
Section
405
of
the
CWA
requires
EPA
to
promulgate
regulations
which
establish
standards
for
sewage
sludge
when
used
or
disposed
for
various
purposes.
These
standards
must
include
sewage
sludge
management
standards
as
well
as
numerical
limits
for
pollutants
which
may
be
present
in
sewage
sludge
in
concentrations
which
may
adversely
affect
public
health
and
the
environment.
Section
405
requires
EPA
to
develop
these
standards
in
two
phases.
On
February
19,
1993,
EPA
published
the
Round
One
sewage
sludge
regulations
establishing
standards,
including
numerical
pollutant
limits,
for
the
use
and
disposal
of
sewage
sludge.
58
FR
9248.
EPA
established
pollutant
limits
for
ten
metals
when
sewage
sludge
is
applied
to
land,
for
three
metals
when
it
is
disposed
of
at
surface
disposal
sites
and
for
seven
metals
and
total
hydrocarbons,
a
surrogate
for
organic
pollutant
emissions,
when
sewage
sludge
is
incinerated.
These
requirements
are
codified
at
40
CFR
Part
503.
At
the
same
time
EPA
promulgated
the
Round
One
regulations,
EPA
also
amended
its
pretreatment
regulations
to
provide
that
removal
credits
would
be
available
for
certain
pollutants
regulated
in
the
sewage
sludge
regulations.
See
58
FR
at
9386.
The
amendments
to
Part
403
provide
that
removal
credits
may
be
made
potentially
available
for
the
following
pollutants:
(
1)
If
a
POTW
applies
its
sewage
sludge
to
the
land
for
beneficial
uses,
disposes
of
it
on
surface
disposal
sites
or
incinerates
it,
removal
credits
may
be
available,
depending
on
which
use
or
disposal
method
is
selected
(
so
long
as
the
POTW
complies
with
the
requirements
in
Part
503).
When
sewage
sludge
is
applied
to
land,
removal
credits
may
be
available
for
ten
metals.
When
sewage
sludge
is
disposed
of
on
a
surface
disposal
site,
removal
credits
may
be
available
for
three
metals.
When
the
sewage
sludge
is
incinerated,
removal
credits
may
be
available
for
seven
metals
and
for
57
organic
pollutants.
See
40
CFR
403.7(
a)(
3)(
iv)(
A).
(
2)
In
addition,
when
sewage
sludge
is
used
on
land
or
disposed
of
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
95
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
on
a
surface
disposal
site
or
incinerated,
removal
credits
may
also
be
available
for
additional
pollutants
so
long
as
the
concentration
of
the
pollutant
in
sludge
does
not
exceed
a
concentration
level
established
in
Part
403.
When
sewage
sludge
is
applied
to
land,
removal
credits
may
be
available
for
two
additional
metals
and
14
organic
pollutants.
When
the
sewage
sludge
is
disposed
of
on
a
surface
disposal
site,
removal
credits
may
be
available
for
seven
additional
metals
and
13
organic
pollutants.
When
the
sewage
sludge
is
incinerated,
removal
credits
may
be
available
for
three
other
metals.
See
40
CFR
403.7(
a)(
3)(
iv)(
B).
(
3)
When
a
POTW
disposes
of
its
sewage
sludge
in
a
municipal
solid
waste
landfill
that
meets
the
criteria
of
40
CFR
Part
258
(
MSWLF),
removal
credits
may
be
available
for
any
pollutant
in
sewage
sludge.
See
40
CFR
403.7(
a)(
3)(
iv)(
C).
Thus,
given
compliance
with
the
requirements
of
EPA's
removal
credit
regulations,
following
promulgation
of
the
pretreatment
standards
in
today's
rule,
removal
credits
may
be
authorized
for
any
pollutant
subject
to
pretreatment
standards
if
the
applying
POTW
disposes
of
its
sewage
sludge
in
a
MSWLF
that
meets
the
requirements
of
40
CFR
Part
258.
Currently
there
are
two
pretreatment
programs
authorized
to
issue
removal
credits.
EPA
is
not
promulgating
pretreatment
standards
for
metals,
thus
removal
credits
for
metals
are
not
applicable.
Given
compliance
with
Sec.
403.7,
removal
credits
may
be
available
for
the
following
organic
pollutants
(
depending
on
the
method
of
use
or
disposal)
if
the
POTW
uses
or
disposes
of
its
sewage
sludge:
benzene,
chloroform,
1,2­
dichloroethane,
methylene
chloride
and
toluene.

D.
Analytical
Methods
Section
304(
h)
of
the
Act
directs
EPA
to
promulgate
guidelines
establishing
test
methods
for
the
analysis
of
pollutants.
These
methods
are
used
to
determine
the
presence
and
concentration
of
pollutants
in
wastewater,
and
are
used
for
compliance
monitoring
and
for
filing
applications
for
the
NPDES
program
[[
Page
50417]]

under
40
CFR
122.21,
122.41,
122.44
and
123.25,
and
for
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
96
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
implementation
of
the
pretreatment
standards
under
40
CFR
403.10
and
403.12.
To
date,
EPA
has
promulgated
methods
for
conventional
pollutants,
toxic
pollutants,
and
for
some
nonconventional
pollutants.
The
five
conventional
pollutants
are
defined
at
40
CFR
401.16.
Table
IB
at
40
CFR
Part
136
lists
the
analytical
methods
approved
for
these
pollutants.
The
65
toxic
metals
and
organic
pollutants
and
classes
of
pollutants
are
defined
at
40
CFR
401.15.
From
the
list
of
65
classes
of
toxic
pollutants
EPA
identified
a
list
of
126
  
Priority
Pollutants.''
This
list
of
Priority
Pollutants
is
shown,
for
example,
at
40
CFR
Part
423,
Appendix
A.
The
list
includes
non­
pesticide
organic
pollutants,
metal
pollutants,
cyanide,
asbestos,
and
pesticide
pollutants.
Currently
approved
methods
for
metals
and
cyanide
are
included
in
the
table
of
approved
inorganic
test
procedures
at
40
CFR
136.3,
Table
I­
B.
Table
I­
C
at
40
CFR
136.3
lists
approved
methods
for
measurement
of
non­
pesticide
organic
pollutants,
and
Table
I­
D
lists
approved
methods
for
the
toxic
pesticide
pollutants
and
for
other
pesticide
pollutants.
Dischargers
must
use
the
test
methods
promulgated
at
40
CFR
136.3
or
incorporated
by
reference
in
the
tables,
when
available,
to
monitor
pollutant
discharges
from
the
pharmaceutical
manufacturing
industry,
unless
specified
otherwise
by
the
permitting
authority.
As
a
part
of
today's
final
rule,
EPA
is
promulgating
additional
test
methods
for
the
additional
pollutants
to
be
regulated
under
Part
439
by
adding
a
new
Table
IF
at
40
CFR
136.3
listing
test
methods
for
the
pharmaceutical
pollutants.
To
support
the
Part
439
regulations
at
the
time
of
proposal,
EPA
published
test
methods
developed
specifically
for
the
pharmaceutical
industry
in
a
compendium
entitled,
  
Analytical
Methods
for
the
Determination
of
Pollutants
in
Pharmaceutical
Manufacturing
Industry
Wastewater,''
EPA­
821­
B­
94­
001.
These
proposed
test
methods
were
discussed
in
the
proposed
rule.
The
proposed
test
methods
have
been
revised
in
response
to
public
comment
and
the
revised
test
methods
are
available
for
monitoring
some
pollutants
covered
by
today's
final
rule.
The
revised
test
methods
have
been
published
in
a
revised
compendium
(
the
  
Pharmaceutical
Methods
Compendium,
Revision
A'';
EPA­
821­
B­
98­
016
[
A,
July
1998]
with
the
same
title
as
the
proposed
compendium.
EPA
does
not
anticipate
that
any
dischargers
from
industrial
categories
other
than
the
pharmaceutical
manufacturing
industry
will
ever
need
to
monitor
for
the
additional
pollutants
(
with
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
97
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
methods
listed
in
Table
1F).
In
addition,
EPA
is
allowing
use
of
applicable
drinking
water
methods
that
have
been
promulgated
at
40
CFR
part
141
and
use
of
ASTM
Methods
D3371,
D3695,
and
D4763,
for
monitoring
of
the
pollutants
included
in
this
rulemaking.
The
final
rule
allows
for
use
of
these
additional
test
methods
for
several
reasons:
(
1)
it
allows
greater
flexibility
in
monitoring
as
requested
by
some
commenters;
(
2)
it
conforms
use
of
methods
in
EPA's
drinking
water
and
wastewater
programs,
(
3)
it
moves
toward
a
performance­
based
measurement
system,
and
(
4)
it
allows
use
of
technical
standards
as
contemplated
by
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA;
see
Section
IX.
G.).
For
pollutants
to
be
monitored
under
today's
final
rule,
EPA
has
included
a
new
table
of
methods
in
Sec.
136.3(
a).
The
methods
in
this
table
are
in
addition
to
other
methods
approved
at
40
CFR
136.3.
The
listed
methods
are
incorporated
by
reference
into
this
rule.
With
the
allowed
use
the
methods
included
in
the
new
Table
IF
at
40
CFR
136.3,
in
addition
to
those
already
approved
in
other
Tables
at
40
CFR
136.3,
EPA
believes
that
dischargers
in
the
pharmaceutical
manufacturing
point
source
category
will
have
great
flexibility
in
selection
of
a
method
for
monitoring
the
pollutants
being
regulated
in
today's
final
rule.
On
October
6,
1997,
EPA
published
a
Notice
of
the
Agency's
intent
to
implement
a
Performance
Based
Measurement
System
(
PBMS)
in
all
of
its
programs
to
the
extent
feasible
(
62
FR
52098).
The
Agency
is
currently
determining
the
specifics
steps
necessary
to
implement
PBMS
in
its
programs
and
preparing
an
implementation
plan.
Final
decisions
have
not
yet
been
made
concerning
the
implementation
of
PBMS
in
water
programs.
However,
EPA
is
currently
evaluating
what
relevant
performance
characteristics
should
be
specified
for
monitoring
methods
used
in
the
water
programs
under
a
PBMS
approach
to
ensure
adequate
data
quality.
EPA
would
then
specify
performance
requirements
in
its
regulations
to
ensure
that
any
method
used
for
determination
of
a
regulated
analyte
is
at
least
equivalent
to
the
performance
achieved
by
other
currently
approved
methods.
EPA
expects
to
publish
its
PBMS
implementation
strategy
for
water
programs
in
the
Federal
Register
by
the
end
of
calendar
year
1998.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
98
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Once
EPA
has
made
its
final
determinations
regarding
implementation
of
PBMS
in
programs
under
the
Clean
Water
Act,
EPA
would
incorporate
specific
provisions
of
PBMS
into
its
regulations,
which
may
include
specification
of
the
performance
characteristics
for
measurement
of
the
regulated
pollutants
in
today's
final
rule.

IX.
Regulatory
Assessment
Requirements
A.
Executive
Order
12866
Under
Executive
Order
12866,
(
58
FR
51735
(
October
4,
1993))
the
Agency
must
determine
whether
the
regulatory
action
is
  
significant''
and
therefore
subject
to
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
this
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
of
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
this
Executive
Order.
Pursuant
to
the
terms
of
the
Executive
Order,
it
has
been
determined
that
this
rule
is
a
  
significant
regulatory
action''
As
such,
this
action
was
submitted
to
OMB
for
review.
Changes
made
in
response
to
suggestions
or
recommendations
are
documented
in
the
public
record.

B.
Regulatory
Flexibility
Act
and
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA)

Under
the
Regulatory
Flexibility
Act
(
RFA),
5
U.
S.
C.
601
et
seq.,
as
amended
by
SBREFA,
EPA
generally
is
required
to
conduct
a
regulatory
flexibility
analysis
describing
the
impact
of
the
regulatory
action
on
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
99
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
small
entities
as
part
of
the
rulemaking.
However,
under
section
605
(
b)
of
the
RFA,
EPA
is
not
required
to
prepare
the
regulatory
flexibility
analysis
if
EPA
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.

[[
Page
50418]]

Pursuant
to
section
605(
b)
of
the
RFA,
the
Administrator
certifies
that
this
rule
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities.
Nevertheless,
the
Agency
prepared
a
small
business
analysis,
which
is
presented
in
the
Economic
Analysis
for
Final
Effluent
Guidelines
and
Standards
for
the
Pharmaceutical
Industry
and
summarized
in
Section
V.
E.
of
this
document.
Briefly,
EPA
estimates
that
145
small
businesses
will
incur
costs
to
comply
with
this
rule
(
based
on
a
small
business
definition
of
750
or
fewer
employees
as
recommended
by
the
U.
S.
Small
Business
Administration).
EPA
evaluated
the
compliance
costs
of
the
regulatory
action
relative
to
the
company's
annual
revenue.
When
considering
the
effluent
limitations
guidelines
and
standards
costs
only,
four
small
firms
are
estimated
to
incur
annualized
compliance
costs
exceeding
one
percent
of
revenue
and
no
firms
are
estimated
to
incur
annualized
compliance
costs
exceeding
three
percent
of
revenue.
When
considering
the
aggregate
costs
of
the
effluent
limitations
guidelines
and
standards
and
the
MACT
standards,
six
small
firms
are
estimated
to
incur
annualized
compliance
costs
exceeding
one
percent
of
revenue
and
one
firm
is
estimated
to
incur
annualized
compliance
costs
exceeding
three
percent
of
revenue.
No
firms
are
expected
to
incur
annualized
compliance
costs
in
excess
of
four
percent
of
revenue.
Further,
EPA's
economic
achievability
analysis
considers
the
potential
for
facility
closure
and
corporate
bankruptcy.
The
analysis
indicates
no
disproportionate
effects
for
small
businesses
compared
to
large
businesses.
The
regulatory
action
is
found
to
be
economically
achievable
for
all
dischargers,
including
small
businesses.

C.
Submission
to
Congress
and
the
General
Accounting
Office
Under
5
U.
S.
C.
801(
a)(
1)(
A)
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
EPA
submitted
a
report
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
100
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives
and
the
Comptroller
General
of
the
General
Accounting
Office
prior
to
publication
of
the
rule
in
today's
Federal
Register.
This
rule
is
not
a
  
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

D.
Paperwork
Reduction
Act
This
rule
contains
no
new
information
collection
activities
requiring
an
information
collection
request,
and
therefore,
no
information
collection
request
was
submitted
to
OMB
for
review
under
the
provisions
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
OMB
has
approved
information
collection
requirements
for
existing
regulations
(
40
CFR
Part
439)
and
assigned
OMB
Control
No.
2040­
0110
in
connection
with
NPDES
related
information
collection
requirements
and
No.
2040­
0009
in
connection
with
pretreatment
information
collection
requirements.
The
information
collection
requirements
resulting
from
the
regulations
being
promulgated
today
are
covered
by
these
OMB
control
numbers.

E.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
P.
L.
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
cost
effective
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
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
101
of
169)
[
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21/
2003
8:
05:
02
AM]
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Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
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
CWA
rule
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
for
State,
local
or
tribal
governments,
in
the
aggregate,
or
the
private
sector
in
any
one
year.
EPA
estimates
that
the
annual
compliance
costs
to
the
private
sector
are
$
61.0
million
($
1996).
Thus,
this
rule
is
not
subject
to
the
requirements
of
sections
202
and
205
of
UMRA.
EPA
has
also
determined
that
this
rule
contains
no
regulatory
requirements
that
might
significantly
or
uniquely
affect
small
governments
and
thus,
this
rule
is
not
subject
to
the
requirements
of
section
203
of
UMRA.
Nevertheless,
EPA
has
consulted
with
state
and
local
governments
pertaining
to
implementation
issues.
EPA's
evaluation
of
their
comments
is
reflected
in
the
final
rules.

F.
Executive
Order
12875
Enhancing
Intergovernmental
Partnership
To
reduce
the
burden
of
Federal
regulations
on
States
and
small
governments,
the
President
issued
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership,
on
October
28,
1993
(
58
FR
58093).
Under
Executive
Order
12875,
EPA
may
not
issue
a
regulation
that
is
not
required
by
statute
and
that
creates
a
mandate
upon
a
State,
local
or
Tribal
government
unless
the
Federal
government
provides
the
necessary
funds
to
pay
the
direct
costs
incurred
by
the
State,
local
or
Tribal
government
or
EPA
provides
to
the
Office
of
Management
and
Budget
a
description
of
the
extent
of
the
Agency's
prior
consultation
and
written
communications
with
elected
officials
and
other
representatives
of
affected
State,
local
and
Tribal
governments,
the
nature
of
their
concerns,
and
an
Agency
statement
supporting
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
102
of
169)
[
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2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
need
to
issue
the
regulation.
In
addition,
Executive
Order
12875
requires
EPA
to
develop
an
effective
process
permitting
elected
officials
and
other
representatives
of
State,
local
and
Tribal
governments
  
to
provide
meaningful
and
timely
input
in
the
development
of
regulatory
proposals
containing
significant
unfunded
mandates.''
As
discussed
above
in
paragraph
IX.
E,
this
regulation
would
not
result
in
expenditures
to
state,
local
and
tribal
governments
of
$
100
million
or
more
in
any
one
year.
The
discussion
of
the
Unfunded
Mandates
Reform
Act
of
1995
that
precedes
this
paragraph
applies
to
Executive
Order
12875
as
well
and
is
incorporated
here
by
reference.
Since
this
rule
does
not
impose
a
significant
unfunded
mandate
on
governments
subject
to
this
Executive
Order,
the
provisions
of
the
Order
do
not
apply.
Nonetheless,
EPA
did
consult
with
State
and
local
[[
Page
50419]]

governments
during
development
of
this
rule.
In
particular,
EPA
has
had
numerous
discussions
with
representatives
of
the
North
Shore
Sanitary
District
regarding
PSES
for
pharmaceutical
plants.
In
addition,
EPA
also
consulted
with
the
Puerto
Rico
Aqueducts
and
Sewer
Authority
(
PRASA)
regarding
discharges
of
VOCs
by
pharmaceutical
industrial
users.
In
addition,
prior
to
the
proposal,
EPA
sent
a
questionnaire
concerning
pharmaceutical
discharges
to
a
number
of
POTWs
receiving
significant
amounts
of
these
discharges.
The
meeting
summaries
and
questionnaire
responses
may
be
found
in
the
record
of
this
rule.

G.
National
Technology
Transfer
and
Advancement
Act
Under
Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
(
NTTAA),
the
Agency
is
required
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,
etc.)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
Where
available
and
potentially
applicable
voluntary
consensus
standards
are
not
used
by
EPA,
the
Act
requires
the
Agency
to
provide
Congress,
through
the
Office
of
Management
and
Budget
(
OMB),
an
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
103
of
169)
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
explanation
of
the
reasons
for
not
using
such
standards.
EPA
performed
a
search
of
the
technical
literature
to
identify
any
applicable
analytical
test
methods
from
industry,
academia,
voluntary
consensus
standard
bodies,
and
other
parties
that
could
measure
the
analytes
in
this
rule.
EPA's
search
revealed
that
there
are
consensus
standards
for
many
of
the
analytes
specified
in
the
tables
at
40
CFR
136.3.
Even
prior
to
enactment
of
the
NTTAA,
EPA
has
traditionally
included
any
applicable
consensus
test
methods
in
its
regulations.
Consistent
with
the
requirements
of
the
CWA,
those
applicable
consensus
test
methods
are
incorporated
by
reference
in
the
tables
at
40
CFR
136.3.
The
consensus
test
methods
in
these
tables
include
American
Society
for
Testing
Materials
(
ASTM)
and
Standard
Methods.
Today's
rule
requires
dischargers
to
monitor
for
31
organic
pollutants,
ammonia
nitrogen
and
COD.
Examples
of
pollutants
with
consensus
methods
promulgated
by
reference
in
today's
rule
include
various
volatile
organics
such
as
benzene,
chlorobenzene,
chloroform,
chloromethane,
methylene
chloride,
and
toluene.
In
addition,
EPA
developed
several
test
methods
for
certain
nonconventional
pollutants
not
included
in
the
tables
at
40
CFR
136.3
in
support
of
the
pharmaceutical
rule
and
these
methods
were
discussed
in
the
proposal.
Examples
of
the
pollutants
for
which
methods
were
developed
are
acetone,
cyclohexane,
diethylamine,
ethanol
and
methylamine.
The
test
methods
being
promulgated
for
those
pollutants
without
test
methods
listed
at
40
CFR
136.3
are
EPA
Methods
1665,
1666,
1667,
1671
and
1673
which
are
found
in
a
Methods
Compendium,
and
EPA
Method
8015.
EPA
notes
that
no
applicable
consensus
methods
were
found
for
those
pollutants.

H.
Executive
Order
13045
and
Protecting
Children's
Health
The
Executive
Order
  
Protection
of
Children
From
Environmental
Health
Risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997)
applies
to
any
rule
that
EPA
determines
(
1)
  
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
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
104
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169)
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
reasonably
feasible
alternatives
considered
by
the
Agency.
EPA
interprets
the
E.
O.
13045
as
encompassing
only
those
regulatory
actions
that
are
risk
based
or
health
based,
such
that
the
analysis
required
under
section
5­
501
of
the
E.
O.
has
the
potential
to
influence
the
regulation.
This
rule
is
not
subject
to
E.
O.
13045
because
it
does
not
involve
decisions
regarding
environmental
health
or
safety
risks.

X.
Summary
of
Public
Participation
The
following
section
describes
the
major
comments
on
the
proposed
rule
and
the
NOA,
and
EPA's
responses.
The
full
comment
summary
and
response
document
can
be
found
in
the
public
record
for
this
rulemaking.

A.
Summary
of
Proposal
Comments
and
Response
Summary
Sixty
six
different
commenters
provided
detailed
comments
on
all
aspects
of
the
May
2,
1995
proposal.
In
all,
the
comments
dealt
with
27
separate
aspects
of
the
proposal.
In
this
comment
and
response
summary,
only
major
comments
and
responses
will
be
summarized.
Responses
to
all
comments
are
contained
in
the
Comment
Response
Document
in
the
record
for
this
final
rule.
In
selecting
comments
and
responses
for
summary
in
this
section,
the
Agency
has
selected
those
major
and
controversial
issues
that
received
considerable
numbers
and
types
of
comments.
Alternatively,
comments
and
responses
on
other
less
controversial
issues
and
issues
where
EPA
essentially
agrees
with
the
commenters
are
not
included
in
the
comment
and
response
summaries
below.
Comment:
EPA's
decision
to
set
in­
plant
limits
is
primarily
based
on
controlling
air
emissions.
The
appropriate
statutory
authority
for
regulating
air
emissions
from
wastewater
is
under
the
MACT
rule,
therefore,
in­
plant
wastewater
limits
should
not
be
used
for
the
purpose
of
controlling
air
emissions.
The
intention
of
the
Clean
Water
Act
is
to
set
limits
at
the
end­
of­
pipe
to
protect
surface
water
quality
and
POTW's
from
pass
through
and
interference.
Application
of
end­
of­
pipe
standards
and
limitations
will
fulfill
this
intent.
Response:
EPA
agrees
that
the
intention
of
the
Clean
Water
Act
is
to
set
limits
to
protect
surface
water
quality
and
POTWs
from
pass
through
and
interference.
EPA
is
promulgating
effluent
limitations
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
105
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169)
[
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8:
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
guidelines
and
standards
for
which
compliance
will
generally
be
monitored
end­
of­
pipe,
except
for
cyanide.
EPA
has
the
authority
to
control
any
pollutants
found
in
wastewater.
Although
in­
plant
air
emissions
will
be
regulated
under
the
MACT
standards
rule,
organic
pollutants
in
wastewater
will
be
controlled
by
this
effluent
guidelines
rule
using
limits
monitored
at
end­
of­
pipe
except
in
cases
where
endof
pipe
monitoring
is
impractical
as
authorized
in
Sec.
122.45
or
Sec.
403.6(
e).
Comment:
Oxygenated
organic
solvents
such
as
methanol,
ethanol,
acetone,
and
isopropanol
should
not
be
regulated
by
pretreatment
standards
because
they
do
not
volatilize
in
appreciable
amounts
and
do
not
typically
pass
through
the
POTW
or
interfere
with
POTW
operations.
Response:
EPA
agrees
that
oxygenated
organic
solvents
such
as
methanol,
ethanol,
acetone
and
isopropanol
with
Henry's
Law
Constants
less
than
1.0
x
10<
SUP>­
5</
SUP>
atm/
gmole/
m<
SUP>
3</
SUP>
will
not
volatilize
in
appreciable
amounts
in
POTWs
and
sewers,
and
will
biodegrade
in
POTW
biological
treatment
units
to
a
large
extent.
EPA
has
made
this
determination
based
on
information
submitted
by
PhRMA
which
estimated
sewer
losses
of
VOCs
and
EPA
and
PhRMA
empirical
sampling
and
modeling
data
from
the
Barceloneta
POTW
sampling
episode.
Based
on
an
evaluation
of
this
data,
EPA
agrees
that
[[
Page
50420]]

the
oxygenated
(
alcohols
and
related)
compounds
under
normal
conditions
will
not
pass
through
or
interfere
with
POTW
operations.
Therefore,
EPA
is
not
promulgating
categorical
pretreatment
standards
for
these
pollutants
for
the
pharmaceutical
industry.
However,
local
control
authorities
can
set
local
limits
for
these
compounds
to
take
care
of
any
site
specific
pass
through
or
interference
problems
that
may
occur
(
Sec.
403.5.
b.
2).
Comment:
Steam
stripping
with
distillation
is
not
a
demonstrated
treatment
technology
for
the
pharmaceutical
industry
since
the
Agency
has
not
demonstrated
the
performance
of
this
technology
for
any
pollutant
other
than
methanol
and
the
data
set
used
for
proposing
limits
and
standards
was
generated
during
treatment
of
a
clean
process
wastewater
which
is
not
representative
of
typical
industry
process
wastewaters.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
106
of
169)
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8:
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02
AM]
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Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Response:
EPA
agrees
that
the
distillation
data
set
used
at
proposal
for
setting
limitations
and
standards
based
on
steam
stripping
with
distillation
for
alcohols
were
generated
during
treatment
of
a
wastewater
for
a
process
which
generated
mostly
methanol
in
the
wastewater.
EPA
has
not
used
these
performance
data
in
the
calculation
of
final
BAT
limitations
for
the
alcohols.
Since
the
alcohols
are
not
being
regulated
at
PSES
or
PSNS
because
they
do
not
pass
through
or
interfere
with
the
POTW
operation,
use
of
steam
stripping
with
distillation
technology
is
not
an
issue.
Comment:
Solgar
is
a
small
business
with
process
wastewater
flow
of
approximately
100
gallons
per
day.
They
manufacture
vitamins
of
natural
origin
and
are
not
under
the
jurisdiction
of
the
FDA.
The
definition
of
Subcategory
D
includes
products
and
processes
covered
by
SIC
No.
2833
(
Medical
and
Botanical
Products).
Being
a
regulated
facility
creates
an
adverse
economic
effect
because
of
the
operating
costs
related
to
permitting,
sampling,
analysis
and
reporting.
EPA
should
consider
exempting
such
facilities
from
the
definition
of
pharmaceutical
manufacturing.
Response:
EPA
has
estimated
compliance
costs
for
all
of
the
pharmaceutical
manufacturing
facilities
which
discharge
pollutants
for
which
effluent
limitations
and
standards
have
been
developed.
If
a
facility
does
not
discharge
regulated
pollutants,
the
compliance
costs
connected
with
sampling
and
analysis
will
be
minimal.
Permitting
costs
were
not
included
in
the
cost
estimates
because
these
costs
would
be
incurred
by
all
dischargers
regardless
of
category
and
are
not
specific
to
this
regulation.
EPA
does
not
believe
that
small
facilities
such
as
the
one
described
in
the
comment
will
incur
significant
costs
in
complying
with
the
final
rule.
In
a
part
of
the
economic
analysis
for
this
rule,
special
emphasis
was
placed
on
small
businesses
as
required
by
the
Regulatory
Flexibility
Act.
Results
of
this
analysis
showed
that
there
are
no
significant
adverse
impacts
on
small
facilities
or
firms.
(
See
the
Economic
Analysis
Report)
Comment:
Facilities
should
not
be
required
to
monitor
for
constituents
that
they
do
not
use.
In
lieu
of
annual
testing,
facilities
could
submit
annual
(
or
on
other
frequencies)
certifications
regarding
the
constituent
used
or
expected
in
the
wastewater
based
on
a
review
of
all
raw
materials
used
and
an
assessment
of
all
chemical
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
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21/
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htm
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169)
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
processes
used,
considering
resulting
products
and
by­
products.
This
would
avoid
incorrect
data
created
by
inflow
of
contaminated
groundwater
in
facility
sewers.
Most
commenters
supported
the
certification
approach.
Response:
EPA
agrees
that
facilities
should
not
be
required
to
monitor
for
constituents
that
they
do
not
use.
EPA
disagrees
that
in
lieu
of
annual
testing,
facilities
could
submit
annual
certifications
regarding
the
constituents
used
or
expected
in
the
wastewater
based
on
a
review
of
all
raw
materials
used
and
an
assessment
of
all
chemical
processes
used.
Facilities
will
not
have
permit
limits
or
be
required
to
monitor
regularly
for
constituents
not
used
in
their
pharmaceutical
processes,
and
EPA
agrees
that
most
commenters
support
the
certification
approach.
In
cases
where
groundwater
may
be
contaminated
by
regulated
pollutants
which
are
not
used
in
manufacturing
operations
at
a
facility,
the
facility
should
submit
groundwater
sampling
data
along
with
the
other
certification
information
to
avoid
regular
monitoring
for
these
regulated
pollutants.
Comment:
Provisions
d
and
f
of
the
applicability
section
of
the
Preamble,
Section
IV.
B,
would
have
the
effect
of
extending
the
applicability
of
the
proposed
regulations
to
many
diagnostic
products
listed
in
SIC
Code
2835.
The
processes
used
in,
and
the
wastewater
produced
from
the
manufacture
of
many
of
these
products
is
substantially
different
from
products
listed
in
SIC
code
no.
2833,
2834,
and
2836.
EPA
should
define
applicability
by
SIC
code,
without
the
exceptions
contained
in
provisions
d
and
f,
and
excluding
SIC
code
no.
2835.
Provisions
d
and
f
will
be
difficult
to
administer
because
they
are
based
on
subjective
determinations.
Response:
Defining
applicability
strictly
by
SIC
code
could
result
in
considerable
amounts
of
wastewater
at
some
facilities
not
being
covered
by
any
categorical
limitations
and
standards
and
therefore
the
Agency
has
not
adopted
this
approach
in
the
final
regulation.
The
Agency
agrees
that
regulatory
decisions
based
on
applicability
section
IV.
B.
f.
may
require
a
subjective
judgement
by
the
permit
writer
or
pretreatment
authority
with
regard
to
the
nature
of
the
wastewater
generated
by
the
manufacture
of
the
products
in
question.
In
order
to
remove
any
ambiguity
that
may
be
associated
with
this
applicability
section,
EPA
has
revised
the
applicability
provision
of
the
final
rule
http://
www.
epa.
gov/
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EPA­
WATER/
1998/
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Day­
21/
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htm
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02
AM]
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
in
439.1.

B.
Summary
of
Notice
of
Availability
Comments
and
Responses
EPA
received
comments
on
the
August
8,
1997
Notice
of
Availability
from
25
commenters
regarding
seven
major
topics
and
35
subtopics.
A
summary
of
the
major
comments
and
EPA
responses
is
provided
below.
Responses
to
all
of
the
comments
are
contained
in
the
Comment
Response
Document
in
the
record
for
this
final
rule.
Comment:
The
commenters
support
Option
1
for
PSES
and
PSNS
that
provided
for
compliance
with
the
MACT
standards
plus
some
regular
monitoring.
Option
1
will
reduce
redundant
regulation,
needless
cost,
confusion,
and
potentially
contradictory
rulemakings.
Response:
EPA
disagrees
with
the
commenters.
EPA
is
promulgating
PSES/
PSNS
limitations
based
on
Option
2
because
this
option
controls
VOC
wastewater
discharges
from
pharmaceutical
wastewaters
that
are
not
controlled
by
the
final
MACT
standard
for
the
pharmaceutical
industry.
Therefore,
EPA
does
not
believe
that
selecting
Option
2
will
result
in
a
redundant,
confusing,
and
potentially
contradictory
regulation.
EPA
is
directed
to
control
pollutants
found
in
wastewater
that
pass
through
or
interferes
with
POTWs.
EPA
has
taken
into
account
the
effects
of
the
MACT
rule
in
estimating
the
compliance
costs
for
the
industry
to
meet
the
final
effluent
guidelines
and
standards.
Comment:
The
commenters
believe
EPA
should
also
exclude
benzene
and
o­
dichlorobenzene
from
coverage
under
this
regulation
because
they
are
each
discharged
by
only
one
plant.
The
fact
that
a
pollutant
is
a
priority
pollutant
is
not
justification
for
regulating
it
when
it
is
found
at
a
small
number
of
sources
within
an
industrial
point
source
category.
EPA
excluded
20
priority
[[
Page
50421]]

pollutants
from
regulation
by
the
Organic
Chemicals,
Plastics,
and
Synthetic
Fibers
(
OCPSF)
effluent
guidelines
under
the
authority
of
Paragraph
8(
a)(
iii)
of
the
then
applicable
consent
decree
(
Table
VI­
3,
OCPSF
Development
Document,
EPA
440/
1­
87/
009).
Another
reason
for
excluding
benzene
is
that
the
one
plant
that
currently
discharges
this
chemical
has
permanently
shut
down
the
process
generating
this
http://
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fedrgstr/
EPA­
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21/
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htm
(
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of
169)
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2003
8:
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AM]
EPA:
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
pollutant.
Response:
Benzene
and
o­
dichlorobenzene
were
reported
in
the
1990
Questionnaire
as
discharged
from
one
facility;
however,
EPA
sampling
data
found
they
were
present
at
more
than
one
facility.
Using
industry
supplied
data,
EPA
has
determined
that
benzene
and
o­
dichlorobenzene
were
discharged
in
1990
at
quantities
of
approximately
120,200
and
21,500
lbs
per
year,
respectively,
well
above
the
3,000
lbs/
year
small
discharge
limit
and
there
are
estimated
removals
in
excess
of
1000
lbs/
year.
Both
criteria
that
are
used
to
determine
which
pollutants
are
excluded
from
this
regulation.
In
addition,
given
the
variable
nature
of
the
pharmaceutical
industry,
EPA
has
not
excluded
pollutants
from
regulation
that
may
be
present
at
more
that
one
facility.
Benzene
is
a
good
case
in
point,
since
even
though
only
one
facility
identified
it
as
discharged
in
1990,
it
was
found
to
be
present
in
10
of
the
samples
taken
by
EPA
in
August
1996
at
the
Barceloneta
Regional
Wastewater
Treatment
Plant,
which
is
a
POTW
that
receives
predominately
pharmaceutical
wastewaters.
Comment:
Several
commenters
will
be
requesting
fundamentally
different
factor
(
FDF)
variances
for
ammonia
production
because
EPA
has
not
properly
developed
nitrification­
based
BAT
ammonia
limits.
(
1)
EPA
did
not
properly
identify
facilities
that
may
have
to
treat
ammonia,
(
2)
it
excluded
data
from
the
biological
nitrification
database
for
plants
that
had
influent
ammonia
concentrations
of
greater
than
100
mg/
L,
(
3)
it
assumed
ammonia
in
process
wastewaters
are
all
ammonium
hydroxide
and
not
ammonium
nitrate
or
ammonium
phosphate,
(
4)
and
it
did
not
consider
the
effects
of
high
organic
nitrogen
loading
present
with
high
ammonia
nitrogen
loading.
Because
of
the
incorrect
chemistry
and
engineering
assumptions,
EPA
has
overestimated
the
feasibility
to
meet
the
proposed
BAT
limits
on
ammonia­
nitrogen.
Therefore,
commenters
would
request
that
EPA
handle
wastewater
discharges
of
ammonia­
nitrogen
from
certain
facilities
in
a
fundamentally
different
manner.
Response:
In
response
to
point
one,
EPA
has
identified
all
facilities
that
may
have
to
treat
ammonia
from
information
provided
in
the
1990
questionnaire
responses
and
data
submissions
provided
in
response
to
the
proposal.
With
regard
to
point
two,
the
five
plant
data
sets
used
to
develop
the
final
limits
included
numerous
influent
ammonia
concentration
points
greater
than
100
mg/
L.
With
regard
to
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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169)
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AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
point
three,
EPA
has
converted
all
ammonium
salt
and
hydroxide
loadings
to
NH3
nitrogen
loadings.
In
response
to
point
four,
EPA
did
consider
the
effect
of
the
presence
of
high
organic
ammonia
along
with
high
ammonia
nitrogen
with
respect
to
achieving
compliance
with
the
final
ammonia
limitations.
EPA
has
concluded
that
ability
of
nitrification
systems
to
nitrify
ammonia
is
not
affected
by
large
loadings
of
organic
amines
because
these
compounds
are
biodegraded
to
ammonia
in
the
advanced
biological
treatment
along
with
other
carbonaceous
waste.
The
ammonia
thus
generated
is
then
nitrified
in
the
nitrification
system.
In
certain
cases,
where
organic
amine
levels
are
sufficiently
high,
two­
stage
nitrification
will
be
necessary.
The
limitations
and
standards
for
ammonia
in
the
final
rule
were
determined
using
all
of
the
data
(
one
and
two
stage),
after
comparing
the
single
stage
and
two
stage
performance
data,
and
then
setting
the
limits
at
the
levels
that
were
reflected
by
the
data
bases
being
examined
separately.
In
conclusion,
EPA
costed
compliance
with
the
limits
by
two­
stage
nitrification,
and
believes
the
final
BAT
limits
based
on
two
stage
nitrification
technology
are
appropriate.

Appendix
A
to
the
Preamble­­
Lists
of
Abbreviations,
Acronyms,
Defintions
and
Other
Terms
Used
in
This
Document
I.
Definitions,
Acronyms,
and
Abbreviations
1990
Detailed
Questionnaire­­
The
1990
Pharmaceutical
Manufacturing
Survey.
A
questionnaire
sent
by
EPA
to
certain
facilities
in
the
pharmaceutical
manufacturing
industry
in
September
1991
to
gather
technical
and
financial
information.
The
questionnaire
was
sent
to
those
facilities
likely
to
be
affected
by
promulgation
of
revised
effluent
limitations
guidelines,
pretreatment
standards,
and
new
source
performance
standards
for
this
industry.
Administrator­­
The
Administrator
of
the
U.
S.
Environmental
Protection
Agency.
Agency­­
The
U.
S.
Environmental
Protection
Agency.
Mass
loading
at
the
relevant
point
of
measurement).
Average
monthly
discharge
limitation­­
The
highest
allowable
average
of
  
daily
discharges''
over
a
calendar
month,
calculated
as
http://
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epa.
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EPA­
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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
the
sum
of
all
  
daily
discharges''
measured
during
a
calendar
month
divided
by
the
number
of
  
daily
discharges''
measured
during
that
month.
BAT­­
The
best
available
technology
economically
achievable,
as
described
in
Section
304(
b)(
2)
of
the
Clean
Water
Act.
Bench­
scale
operation­­
Laboratory
testing
of
materials,
methods,
or
processes
on
a
small
scale,
such
as
on
a
laboratory
worktable.
BCT­­
The
best
conventional
pollutant
control
technology,
as
described
in
section
304(
b)(
4)
of
the
Clean
Water
Act.
BID­­
Background
Information
Document,
which
presents
the
technical
basis
for
air
pollution
controls
under
the
Clean
Air
Act.
Biological
and
Natural
Extraction­­
The
chemical
and
physical
extraction
of
pharmaceutically
active
ingredients
from
natural
sources
such
as
plant
roots
and
leaves,
animal
glands,
and
parasitic
fungi.
The
process
operations
involving
biological
and
natural
extraction
define
subcategory
B
(
40
CFR
Part
439,
subpart
B).
BMP
or
BMPs­­
Best
management
practices,
as
described
in
section
304(
e)
of
the
Clean
Water
Act.
BOD<
INF>
5</
INF>­­
Five­
Day
Biochemical
Oxygen
Demand.
A
measure
of
biochemical
decomposition
of
organic
matter
in
a
water
sample.
It
is
determined
by
measuring
the
dissolved
oxygen
consumed
by
microorganisms
to
oxidize
the
organic
contaminants
in
a
water
sample
under
standard
laboratory
conditions
of
five
days
and
20
deg.
C.
BOD<
INF>
5</
INF>
is
not
related
to
the
oxygen
requirements
in
chemical
combustion.
BPT­­
The
best
practicable
control
technology
currently
available,
as
described
in
section
304(
b)(
1)
of
the
Clean
Water
Act.
CAA­­
Clean
Air
Act.
The
Air
Pollution
Prevention
and
Control
Act
(
42
U.
S.
C.
7401
et
seq.),
as
amended,
inter
alia,
by
the
Clean
Air
Act
Amendments
of
1990
(
Pub.
L.
101­
549,
104
Stat.
2399).
Chemical
Synthesis­­
The
process(
es)
of
using
a
chemical
reaction
or
a
series
of
chemical
reactions
to
manufacture
pharmaceutically
active
ingredients.
The
chemical
synthesis
process
operations
define
subcategory
C
(
40
CFR
Part
439,
subpart
C).
Clarifier­­
A
treatment
unit
designed
to
remove
suspended
materials
from
wastewater,
typically
by
sedimentation.
CN­­
Abbreviation
for
total
cyanide.

http://
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Category
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Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
COD­­
Chemical
oxygen
demand
(
COD)­­
A
nonconventional
bulk
parameter
that
measures
the
total
oxygen­
consuming
capacity
of
wastewater.
This
parameter
is
a
measure
of
materials
in
water
or
wastewater
that
are
biodegradable
and
materials
that
are
resistant
(
refractory)
to
biodegradation.
Refractory
compounds
slowly
exert
demand
on
downstream
receiving
water
resources.
Certain
of
the
compounds
measured
by
this
parameter
have
been
found
to
have
carcinogenic,
mutagenic,
and
similar
adverse
effects,
either
singly
or
in
combination.
It
is
expressed
as
the
amount
of
oxygen
consumed
by
a
chemical
oxidant
in
a
specific
test.
Condensate­­
Any
material
that
has
condensed
from
a
gaseous
phase
into
a
liquid
phase.
Controlled­
release
discharge­­
A
discharge
that
occurs
at
a
rate
that
is
intentionally
varied
to
accommodate
fluctuations
in
receiving
stream
assimilative
capacity
or
for
other
reasons.
Conventional
pollutants­­
The
pollutants
identified
in
section
304(
a)(
4)
of
the
Clean
[[
Page
50422]]

Water
Act
and
the
regulations
thereunder
(
i.
e.,
biochemical
oxygen
demand
(
BOD<
INF>
5</
INF>),
total
suspended
solids
(
TSS),
oil
and
grease,
fecal
coliform
and
pH).
CWA­­
Clean
Water
Act.
The
Federal
Water
Pollution
Control
Act
Amendments
of
1972
(
33
U.
S.
C.
1251
et
seq.),
as
amended,
inter
alia,
by
the
Clean
Water
Act
of
1977
(
Pub.
L.
95­
217)
and
the
Water
Quality
Act
of
1987
(
Pub.
L.
100­
4).
Daily
discharge­­
The
discharge
of
a
pollutant
measured
during
any
calendar
day
or
any
24­
hour
period
that
reasonably
represents
a
calendar
day
for
purposes
of
sampling.
For
pollutants
with
limitations
expressed
in
units
of
mass,
the
daily
discharge
is
calculated
as
the
total
mass
of
the
pollutant
discharged
over
the
day.
For
pollutants
with
limitations
expressed
in
other
units
of
measurement,
the
daily
discharge
is
calculated
as
the
average
measurement
of
the
pollutant
over
the
day.
Direct
discharger­­
A
facility
that
discharges
or
may
discharge
treated
or
untreated
process
wastewaters,
non­
contact
cooling
waters,
or
non­
process
wastewaters
(
including
stormwater
runoff)

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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
into
waters
of
the
United
States.
Effluent­­
Wastewater
discharges.
Effluent
limitation­­
Any
restriction,
including
schedules
of
compliance,
established
by
a
State
or
the
Administrator
on
quantities,
rates,
and
concentrations
of
chemical,
physical,
biological,
and
other
constituents
which
are
discharged
from
point
sources
into
waters
of
the
United
States,
the
waters
of
the
contiguous
zone,
or
the
ocean.
Emission­­
Passage
of
air
pollutants
into
the
atmosphere
via
a
gas
stream
or
other
means.
EOP
effluent­­
Final
plant
effluent
discharged
to
waters
of
the
United
States
or
to
a
POTW.
EOP
treatment­­
End­
of­
pipe
treatment
facilities
or
systems
used
to
treat
process
wastewaters,
non­
process
wastewaters
(
including
stormwater
runoff)
after
the
wastewaters
have
left
the
process
area
of
the
facility
and
prior
to
discharge.
End­
of­
pipe
treatment
generally
does
not
include
facilities
or
systems
where
products
or
by­
products
are
separated
from
process
wastewaters
and
returned
to
the
process
or
directed
to
air
emission
control
devices.
EPA­­
The
U.
S.
Environmental
Protection
Agency.
General
Provisions­­
General
Provisions
for
national
emission
standards
for
hazardous
air
pollutants
and
other
regulatory
requirements
pursuant
to
section
112
of
the
Clean
Air
Act,
as
amended
November
15,
1990.
The
General
Provisions,
located
in
subpart
A
of
part
63
of
title
40
of
the
Code
of
Federal
Regulations,
codify
procedures
and
criteria
to
implement
emission
standards
for
stationary
sources
that
emit
(
or
have
the
potential
to
emit)
one
or
more
of
the
189
chemicals
listed
as
hazardous
air
pollutants
in
section
112(
b)
of
the
Clean
Air
Act
as
amended
in
1990.
EPA
published
the
NESHAP
General
Provisions
in
the
Federal
Register
on
March
16,
1993
(
59
FR
12408).
The
term
General
Provisions
also
refers
to
the
General
Provisions
for
the
effluent
limitations
guidelines
and
standards
proposed
today,
to
be
located
at
40
CFR
part
439.
Fermentation­­
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.
Process
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
operations
that
utilize
fermentation
to
manufacture
pharmaceutically
active
ingredients
define
subcategory
A
(
40
CFR
Part
439,
subpart
A).
HAP­­
Hazardous
Air
Pollutant.
Any
of
the
189
chemicals
listed
under
section
112(
b)
of
the
Clean
Air
Act.
HON­­
Hazardous
Organic
NESHAP.
As
used
in
this
document,
it
refers
to
the
standard
published
by
EPA
for
the
Synthetic
Organic
Chemical
Manufacturing
Industry
(
SOCMI)
on
April
22,
1994
(
59
FR
19402).
Incinerator­­
An
enclosed
combustion
device
that
is
used
for
destroying
organic
compounds.
Auxiliary
fuel
may
be
used
to
heat
waste
gas
to
combustion
temperatures.
Any
energy
recovery
section
present
is
not
physically
formed
into
one
manufactured
or
assembled
unit
with
the
combustion
section;
rather,
the
energy
recovery
section
is
a
separate
section
following
the
combustion
section
and
the
two
are
joined
by
ducts
or
connections
carrying
flue
gas.
Indirect
discharger­­
A
facility
that
discharges
or
may
discharge
wastewaters
into
a
publicly
owned
treatment
works.
In­
plant
Control
Technologies­­
These
include
controls
or
measures
applied
within
the
manufacturing
process
to
reduce
or
eliminate
pollutant
and
hydraulic
loadings;
these
also
include
technologies,
such
as
steam
stripping
and
cyanide
destruction,
applied
directly
to
wastewater
generated
by
manufacturing
processes.
IU­­
Industrial
User.
Synonym
for
  
Indirect
Discharger.''
Junction
box­­
A
manhole
access
point
to
a
wastewater
sewer
system
or
a
lift
station.
LTA­­
Long­
term
average.
For
purposes
of
proposed
effluent
limitations
guidelines
and
standards,
average
pollutant
levels
achieved
over
a
period
of
time
by
a
plant,
subcategory,
or
technology
option.
LTAs
were
used
in
developing
the
limitations
and
standards
in
today's
proposed
regulation.
MACT­­
Maximum
Achievable
Control
Technology.
Technology
basis
for
the
national
emission
standards
for
hazardous
air
pollutants.
Major
source­­
As
defined
in
section
112(
a)
of
the
Clean
Air
Act,
major
source
is
any
stationary
source
or
group
of
stationary
sources
located
within
a
contiguous
area
and
under
common
control
that
emits
or
has
the
potential
to
emit,
considering
controls,
in
the
aggregate
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Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
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New
Source
Performance
Standards;
Final
Rule
10
tons
per
year
or
more
of
any
hazardous
air
pollutant
or
25
tons
per
year
or
more
of
any
combination
of
hazardous
air
pollutants.
Maximum
daily
discharge
limitation­­
The
highest
allowable
daily
discharge
of
a
pollutant
measured
during
a
calendar
day
or
any
24
hour
period
that
reasonably
represents
a
calendar
day
for
purposes
of
sampling.
Mg­­
Megagram.
One
million
(
10<
SUP>
6</
SUP>)
grams,
or
one
metric
ton.
Metric
ton­­
One
thousand
(
10<
SUP>
3</
SUP>)
kilograms
(
abbreviated
as
kkg),
or
one
megagram.
A
metric
ton
is
equal
to
2,204.5
pounds.
Minimum
level­­
The
level
at
which
an
analytical
system
gives
recognizable
signals
and
an
acceptable
calibration
point.
Mixing/
Compounding/
Formulating­­
Processes
through
which
pharmaceutically
active
ingredients
are
put
in
dosage
forms.
Processes
involving
mixing/
compounding/
formulating
define
subcategory
D
(
40
CFR
part
439,
subpart
D).
NESHAP­­
National
Emission
Standard
for
Hazardous
Air
Pollutants.
Emission
standard
promulgated
that
has
been
or
will
be
promulgated
under
section
112(
d)
of
the
Clean
Air
Act
for
hazardous
air
pollutants
listed
in
section
112(
b)
of
the
Clean
Air
Act.
New
Source­­
As
defined
in
40
CFR
122.2,
122.29,
and
403.3(
k),
a
new
source
is
any
building,
structure,
facility,
or
installation
from
which
there
is
or
may
be
a
discharge
of
pollutants,
the
construction
of
which
commenced
(
1)
for
purposes
of
compliance
with
New
Source
Performance
Standards,
after
the
promulgation
of
such
standards
being
proposed
today
under
CWA
section
306;
or
(
2)
for
the
purposes
of
compliance
with
Pretreatment
Standards
for
New
Sources,
after
the
publication
of
proposed
standards
under
CWA
section
307(
c),
if
such
standards
are
thereafter
promulgated
in
accordance
with
that
section.
Nitrification­­
Nitrification
is
the
oxidation
of
ammonium
salts
to
nitrites
(
via
nitrosomonas
bacteria)
and
the
further
oxidation
of
nitrite
to
nitrate
via
nitrobacter
bacteria.
Nitrification
can
be
accomplished
in
either
a
single
or
two­
stage
activated
sludge
system.
Indicators
of
nitrification
capability
are
(
1)
biological
monitoring
for
ammonia
oxidizing
bacteria
(
AOB)
and
nitrite
oxidizing
bacteria
(
NOB)
to
determine
if
nitrification
is
occurring,

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Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
and
(
2)
analysis
of
the
nitrogen
balance
to
determine
if
nitrifying
bacteria
reduce
the
amount
of
ammonia
and
increase
the
amount
of
nitrite
and
nitrate.
Nonconventional
pollutants­­
Pollutants
that
are
neither
conventional
pollutants
nor
toxic
pollutants.
Non­
detect
value­­
A
concentration­
based
measurement
reported
below
the
minimum
level
that
can
reliably
be
measured
by
the
analytical
method
for
the
pollutant.
Non­
water
quality
environmental
impact­­
An
environmental
impact
of
a
control
or
treatment
technology,
other
than
to
surface
waters.
NPDES­­
The
National
Pollutant
Discharge
Elimination
System
authorized
under
section
402
of
the
CWA.
The
Clean
Water
Act
requires
NPDES
permits
for
discharge
of
pollutants
from
any
point
source
into
waters
of
the
United
States.
NRDC­­
Natural
Resources
Defense
Council.
NSPS­­
New
Source
Performance
Standards.
As
used
in
this
notice,
this
term
refers
to
standards
for
new
sources
under
section
306
of
the
CWA.
OMB­­
Office
of
Management
and
Budget.
Outfall­­
The
mouth
of
conduit
drains
and
other
conduits
from
which
a
plant
discharges
effluent
into
receiving
waters.
Pharmaceutically
active
ingredient­­
Any
substance
considered
to
be
an
active
ingredient
by
Food
and
Drug
Administration
regulations
(
21
CFR
210.3(
6)(
7)).
Pilot­
scale
operation­­
The
trial
operation
of
processing
equipment,
which
is
the
intermediate
stage
between
laboratory
experimentation
and
full­
scale
operation
in
the
development
of
a
new
process
or
product.

[[
Page
50423]]

Point
of
Determination­­
The
location
where
the
process
wastewater
stream
exits
the
pharmaceutical
process
equipment.
Point
source
category­­
A
category
of
sources
of
water
pollutants
that
are
included
within
the
definition
of
  
point
source''
in
section
502(
14)
of
the
Clean
Water
Act.
Pollutant
(
to
water)­­
Dredged
spoil,
solid
waste,
incinerator
residue,
filter
backwash,
sewage,
garbage,
sewage
sludge,
munitions,

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Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
chemical
wastes,
biological
materials,
certain
radioactive
materials,
heat,
wrecked
or
discarded
equipment,
rock,
sand,
cellar
dirt,
and
industrial,
municipal,
and
agricultural
waste
discharged
into
water.
See
CWA
section
502(
6);
40
CFR
122.2.
POTW
or
POTWs­­
Publicly
owned
treatment
works,
as
defined
at
40
CFR
403.3(
o).
Pretreatment
standard­­
A
regulation
specifying
industrial
wastewater
effluent
quality
required
for
discharge
to
a
POTW.
Primary
fuel­­
The
fuel
that
provides
the
principal
heat
input
to
a
combustion
device.
To
be
considered
primary,
the
fuel
must
be
able
to
sustain
operation
of
the
combustion
device
without
the
addition
of
other
fuels.
Priority
pollutants­­
The
toxic
pollutants
listed
in
40
CFR
part
403,
Appendix
A
(
printed
immediately
following
40
CFR
423.17).
Process
changes­­
Alterations
in
process
operating
conditions,
equipment,
or
chemical
use
that
reduce
the
formation
of
chemical
compounds
that
are
pollutants
and/
or
pollutant
precursors.
Process
unit­­
A
piece
of
equipment,
such
as
a
chemical
reactor
or
fermentation
tank,
associated
with
pharmaceutical
manufacturing
operations.
Process
wastewater­­
Any
water
that,
during
manufacturing
or
processing,
comes
into
direct
contact
with
or
results
from
the
production
or
use
of
any
raw
material,
intermediate
product,
finished
product,
byproduct,
or
waste
product.
Process
wastewater
includes
surface
runoff
from
the
immediate
process
area
that
has
the
potential
to
become
contaminated.
(
1)
For
purposes
of
this
part,
the
following
materials
are
excluded
from
the
definition
of
process
wastewater:
1.
Trimethyl
silanol;
2.
Any
active
anti­
microbial
materials;
3.
Wastewater
from
imperfect
fermentation
batches;
and
4.
Process
area
spills
(
2)
For
purposes
of
this
part,
the
following
waters
and
wastewaters
are
excluded
from
the
definition
of
process
wastewater:
noncontact
cooling
water,
utility
wastewaters,
general
site
surface
runoff,
groundwater
(
e.
g.,
contaminated
groundwaters
from
on­
site
or
off­
site
groundwater
remediation
projects),
and
other
water
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Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
generated
on
site
that
are
not
process
wastewaters.
The
discharge
of
such
waters
and
wastewaters
must
be
regulated
separately.
Process
wastewater
collection
system­­
A
piece
of
equipment,
structure,
or
transport
mechanism
used
in
conveying
or
storing
a
process
wastewater
stream.
Examples
of
process
wastewater
collection
system
equipment
include
individual
drain
systems,
wastewater
tanks,
surface
impoundments,
and
containers.
Process
wastewater
stream­­
When
used
in
connection
with
CAA
obligations,
any
HAP­
containing
liquid
that
results
from
either
direct
or
indirect
contact
of
water
with
organic
compounds.
Process
water­­
Water
used
to
dilute,
wash,
or
carry
raw
materials
or
any
other
materials
used
in
pharmaceutical
manufacturing
processes.
PSES­­
Pretreatment
standards
for
existing
sources
of
indirect
discharges,
under
section
307(
b)
of
the
CWA.
PSNS­­
Pretreatment
standards
for
new
sources
of
indirect
discharges,
under
sections
307<
SUP><
greek­
l></
SUP>
of
the
CWA.
RCRA­­
Resource
Conservation
and
Recovery
Act
of
1976,
as
amended
(
42
U.
S.
C.
6901,
et
seq.).
Research­­
Bench­
scale
activities
or
operations
used
in
research
and/
or
product
development
of
a
pharmaceutical
product.
The
Research
operations
define
subcategory
E
(
40
CFR
part
439,
Subpart
E).
SIC­­
Standard
Industrial
Classification.
A
numerical
categorization
system
used
by
the
U.
S.
Department
of
Commerce
to
denote
segments
of
industry.
An
SIC
code
refers
to
the
principal
product,
or
group
of
products,
produced
or
distributed,
or
to
services
rendered
by
an
operating
establishment.
SIC
codes
are
used
to
group
establishments
by
the
primary
activity
in
which
they
are
engaged.
Source
Category­­
A
category
of
major
or
area
sources
of
hazardous
air
pollutants.
Source
Reduction­­
The
reduction
or
elimination
of
waste
generation
at
the
source,
usually
within
a
process.
A
source
reduction
practice
is
any
practice
that
(
1)
reduces
the
amount
of
any
hazardous
substance,
pollutant,
or
contaminant
entering
any
waste
stream
or
otherwise
released
into
the
environment
(
including
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Performance
Standards;
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Rule
fugitive
emissions)
prior
to
recycling,
treatment,
or
disposal;
and
(
2)
reduces
the
hazards
to
public
health
and
the
environment
associated
with
the
release
of
such
substances,
pollutants,
or
contaminants.
Stationary
source­­
Any
building,
structure,
facility,
or
installation
that
emits
or
may
emit
any
air
pollutant.
See
CAA
section
111(
a)(
3).
Toxic
pollutants­­
the
pollutants
designated
by
EPA
as
toxic
in
40
CFR
401.15.
Variability
factor­­
The
daily
variability
factor
is
the
ratio
of
the
estimated
99th
percentile
of
the
distribution
of
daily
values
divided
by
the
expected
value,
or
mean,
of
the
distribution
of
the
daily
data.
The
monthly
variability
factor
is
the
estimated
95th
percentile
of
the
monthly
averages
of
the
data
divided
by
the
expected
value
of
the
monthly
averages.
VOC­­
Any
organic
pollutant
with
a
Henry's
Law
Constant
greater
than
or
equal
to
3.97
x
10<
SUP>­
7</
SUP>
atm/
gmole/
m<
SUP>
3</
SUP>.
Waters
of
the
United
States­­
the
same
meaning
set
forth
in
40
CFR
122.2.
Zero
discharge
(
ZD)­­
No
discharge
of
pollutants
to
waters
of
the
United
States
or
to
a
POTW.

List
of
Subjects
40
CFR
Part
136
Environmental
protection,
Incorporation
by
reference,
Reporting
and
recordkeeping
requirements,
Water
pollution
control.

40
CFR
Part
439
Environmental
protection,
Pharmaceutical
manufacturing
pollution
prevention,
Waste
treatment
and
disposal,
Water
pollution
control.

Dated:
July
30,
1998.
Carol
M.
Browner,
Administrator.

For
the
reasons
set
out
in
the
preamble,
title
40,
chapter
I
of
the
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Performance
Standards;
Final
Rule
Code
of
Federal
Regulations
is
amended
as
follows:

PART
136­­[
AMENDED]

1.
The
authority
citation
for
part
136
continues
to
read
as
follows:

Authority:
Secs.
301,
304(
h),
307,
and
501(
a)
Pub.
L.
95­
217,
Stat.
1566,
et
seq.
(
33
U.
S.
C.
1251,
et
seq.)
(
The
Federal
Water
Pollution
Control
Act
Amendments
of
1972
as
amended
by
the
Clean
Water
Act
of
1977).

2.
Section
136.3
is
amended
by
revising
paragraph
(
a)
introductory
text
and
by
adding
a
new
Table
IF
in
numerical
order
to
the
end
of
paragraph
(
a)
and
revising
paragraph
(
b)
introductory
text
and
adding
paragraph
(
b)(
40)
to
read
as
follows:

Sec.
136.3
Identification
of
test
procedures.

(
a)
Parameters
or
pollutants,
for
which
methods
are
approved,
are
listed
together
with
test
procedure
descriptions
and
references
in
Tables
IA,
IB,
IC,
ID,
IE,
and
IF.
The
full
text
of
the
referenced
test
procedures
are
incorporated
by
reference
into
Tables
IA,
IB,
IC,
ID,
IE,
and
IF.
The
references
and
the
sources
which
are
available
are
given
in
paragraph
(
b)
of
this
section.
These
test
procedures
are
incorporated
as
they
exist
on
the
day
of
approval
and
a
notice
of
any
change
in
these
test
procedures
will
be
published
in
the
Federal
Register.
The
discharge
parameter
values
for
which
reports
are
required
must
be
determined
by
one
of
the
standard
analytical
test
procedures
incorporated
by
reference
and
described
in
Tables
IA,
IB,
IC,
ID,
IE,
and
IF,
or
by
any
alternate
test
procedure
which
has
been
approved
by
the
Administrator
under
the
provisions
of
paragraph
(
d)
of
this
section
and
Secs.
136.4
and
136.5.
Under
certain
circumstances
(
paragraph
(
b)
or
(
c)
of
this
section
or
40
CFR
401.13)
other
test
procedures
may
be
used
that
may
be
more
advantageous
when
such
other
test
procedures
have
been
previously
approved
by
the
Regional
Administrator
of
the
Region
in
which
the
discharge
occur,
and
providing
the
Director
of
the
State
in
which
such
discharge
will
occur
does
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Rule
[[
Page
50424]]

not
object
to
the
use
of
such
alternate
test
procedure.
*
*
*
*
*

Table
IF.­­
List
of
Approved
Methods
for
Pharmaceutical
Pollutants
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pharmaceuticals
pollutants
CAS
registry
No.
Analytical
method
number
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
acetonitrile...................
75­
05­
8............................
1666/
1671/
D3371/
D3695.
n­
amyl
acetate.................
628­
63­
7...........................
1666/
D3695.
n­
amyl
alcohol.................
71­
41­
0............................
1666/
D3695
benzene........................
71­
43­
2............................
D4763/
D3695/
502.2/
524.2.
n­
butyl­
acetate................
123­
86­
4...........................
1666/
D3695.
tert­
butyl
alcohol.............
75­
65­
0............................
1666.
chlorobenzene..................
108­
90­
7...........................
502.2/
524.2.
chloroform.....................
67­
66­
3............................
502.2/
524.2/
551.
o­
dichlorobenzene..............
95­
50­
1............................
1625C/
502.2/
524.2.
1,2­
dichloroethane.............
107­
06­
2...........................
D3695/
502.2/
524.2.
diethylamine...................
109­
89­
7...........................
1666/
1671.
dimethyl
sulfoxide.............
67­
68­
5............................
1666/
1671.
ethanol........................
64­
17­
5............................
1666/
1671/
D3695.
ethyl
acetate..................
141­
78­
6...........................
1666/
D3695.

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Source
Performance
Standards;
Final
Rule
n­
heptane......................
142­
82­
5...........................
1666/
D3695.
n­
hexane.......................
110­
54­
3...........................
1666/
D3695.
isobutyraldehyde...............
78­
84­
2............................
1666/
1667.
isopropanol....................
67­
63­
0............................
1666/
D3695.
isopropyl
acetate..............
108­
21­
4...........................
1666/
D3695.
isopropyl
ether................
108­
20­
3...........................
1666/
D3695.
methanol.......................
67­
56­
1............................
1666/
1671/
D3695.
Methyl
Cellosolve<
Register>....
109­
86­
4...........................
1666/
1671
methylene
chloride.............
75­
09­
2............................
502.2/
524.2
methyl
formate.................
107­
31­
3...........................
1666.
4­
methyl­
2­
pentanone
(
MIBK)....
108­
10­
1...........................
1624C/
1666/
D3695/
D4763/
524.2.
phenol.........................
108­
95­
2...........................
D4763.
n­
propanol.....................
71­
23­
8............................
1666/
1671/
D3695.
2­
propanone
(
acetone)..........
67­
64­
1............................
D3695/
D4763/
524.2.
tetrahydrofuran................
109­
99­
9...........................
1666/
524.2.
toluene........................
108­
88­
3...........................
D3695/
D4763/
502.2/
524.2.
triethlyamine..................
121­
44­
8...........................
1666/
1671.
xylenes........................
(
Note
1)...........................
1624C/
1666.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Table
1F
note:
1.
1624C:
m­
xylene
108­
38­
3,
o,
p­
xylene
E­
14095
(
Not
a
CAS
number;
this
is
the
number
provided
in
the
Environmental
Monitoring
Methods
Index
(
EMMI)
database.);
1666:
m,
p­
xylene
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Performance
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Rule
136777­
61­
2,
o­
xylene
95­
47­
6.

*
*
*
*
*
(
b)
The
full
texts
of
the
methods
from
the
following
references
which
are
cited
in
Tables
IA,
IB,
IC,
ID,
IE,
and
IF
are
incorporated
by
reference
into
this
regulation
and
may
be
obtained
from
the
sources
identified.
All
costs
cited
are
subject
to
change
and
must
be
verified
from
the
indicated
sources.
The
full
texts
of
all
the
test
procedures
cited
are
available
for
inspection
at
the
National
Exposure
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
26
West
Martin
Luther
King
Dr.,
Cincinnati,
OH
45268
and
the
Office
of
the
Federal
Register,
800
North
Capitol
Street,
NW.,
Suite
700,
Washington,
DC.
*
*
*
*
*
(
40)
EPA
Methods
1666,
1667,
and
1671
listed
in
the
table
above
are
published
in
the
compendium
titled
Analytical
Methods
for
the
Determination
of
Pollutants
in
Pharmaceutical
Manufacturing
Industry
Wastewaters
(
EPA
821­
B­
98­
016).
EPA
Methods
502.2
and
524.2
have
been
incorporated
by
reference
into
40
CFR
141.24
and
are
in
Methods
for
the
Determination
of
Organic
Compounds
in
Drinking
Water,
EPA­
600/
4­
88­
039,
December
1988,
Revised,
July
1991,
and
Methods
for
the
Determination
of
Organic
Compounds
in
Drinking
Water­
Supplement
II,
EPA­
600/
R­
92­
129,
August
1992,
respectively.
These
EPA
test
method
compendia
are
available
from
the
National
Technical
Information
Service,
NTIS
PB91­
231480
and
PB92­
207703,
U.
S.
Department
of
Commerce,
5285
Port
Royal
Road,
Springfield,
Virginia
22161.
The
toll­
free
number
is
800­
553­
6847.
ASTM
test
methods
D3371,
D3695,
and
D4763
are
available
from
the
American
Society
for
Testing
and
Materials,
100
Barr
Harbor
Drive,
West
Conshohocken,
PA
19428­
2959.
*
*
*
*
*

PART
439­­[
AMENDED]

1.
The
authority
citation
for
part
439
is
revised
to
read
as
follows:

Authority:
Secs.
301,
304,
306,
307,
308,
402
and
501
of
the
Clean
Water
Act,
as
amended;
33
U.
S.
C.
1311,
1314,
1316,
1317,
1318,

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Source
Performance
Standards;
Final
Rule
1342
and
1361.

2.
Part
439
is
amended
by
revising
the
undesignated
heading
  
GENERAL
PROVISIONS''
to
read
  
General''.
3.
Section
439.0
is
revised
to
read
as
follows:

Sec.
439.0
Applicability.

(
a)
This
part
applies
to
process
wastewater
discharges
resulting
from
the
research
and
manufacture
of
pharmaceutical
products,
which
are
generally,
but
not
exclusively,
reported
under
SIC
2833,
SIC
2834
and
SIC
2836
(
1987
Standard
Industrial
Classification
Manual).
(
b)
Although
not
reported
under
SIC
2833,
SIC
2834
and
SIC
2836,
discharges
from
the
manufacture
of
other
pharmaceutical
products
to
which
this
part
applies
include
(
but
are
not
limited
to):
(
1)
Products
manufactured
by
one
or
more
of
the
four
types
of
manufacturing
[[
Page
50425]]

processes
described
in
subcategories
A,
B,
C
or
D
of
this
part,
and
considered
by
the
Food
and
Drug
Administration
to
be
pharmaceutical
active
ingredients;
(
2)
Multiple
end­
use
products
(
e.
g.,
components
of
formulations,
chemical
intermediates,
or
final
products)
derived
from
pharmaceutical
manufacturing
operations
and
intended
for
use
primarily
in
pharmaceutical
applications;
(
3)
Pharmaceutical
products
and
intermediates
not
subject
to
other
categorical
limitations
and
standards,
provided
the
manufacturing
processes
generate
process
wastewaters
that
are
similar
to
those
derived
from
the
manufacture
of
pharmaceutical
products
elsewhere
(
an
example
of
such
a
product
is
citric
acid);
(
4)
Cosmetic
preparations
that
are
reported
under
SIC
2844
and
contain
pharmaceutical
active
ingredients,
or
active
ingredients
that
are
intended
for
the
treatment
of
a
skin
condition.
(
These
preparations
do
not
include
products
such
as
lipsticks
or
perfumes
that
serve
to
enhance
appearance,
or
provide
a
pleasing
odor,
but
do
not
enhance
skin
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Rule
care.
Also
excluded
are
deodorants,
manicure
preparations,
shaving
preparations
and
non­
medicated
shampoos
that
do
not
function
primarily
as
a
skin
treatment.)
(
c)
The
provisions
of
this
part
do
not
apply
to
wastewater
discharges
resulting
from
the
manufacture
of
the
following
products,
or
as
a
result
of
providing
one
or
more
of
the
following
services:
(
1)
Surgical
and
medical
instruments
and
apparatus
reported
under
SIC
3841;
(
2)
Orthopedic,
prosthetic,
and
surgical
appliances
and
supplies
reported
under
SIC
3842;
(
3)
Dental
equipment
and
supplies
reported
under
SIC
3843;
(
4)
Medical
laboratory
services
reported
under
SIC
8071;
(
5)
Dental
laboratory
services
reported
under
SIC
8072;
(
6)
Outpatient
care
facility
services
reported
under
SIC
8081;
(
7)
Health
and
allied
services
reported
under
SIC
8091,
and
not
classified
elsewhere;
(
8)
Diagnostic
devices
other
than
those
reported
under
SIC
3841;
(
9)
Animal
feed
products
that
include
pharmaceutical
active
ingredients
such
as
vitamins
and
antibiotics,
where
the
major
portion
of
the
product
is
non­
pharmaceutical,
and
the
resulting
process
wastewater
is
not
characteristic
of
process
wastewater
from
the
manufacture
of
pharmaceutical
products;
(
10)
Food
and
beverage
products
fortified
with
vitamins
or
other
pharmaceutical
active
ingredients,
where
the
major
portion
of
the
product
is
non­
pharmaceutical,
and
the
resulting
process
wastewater
is
not
characteristic
of
process
wastewater
from
the
manufacture
of
pharmaceutical
products;
(
11)
Pharmaceutical
products
and
intermediates
subject
to
the
provisions
of
40
CFR
part
414,
provided
their
manufacture
results
in
less
than
50
percent
of
the
total
flow
of
process
wastewater
that
is
regulated
by
40
CFR
part
414
at
the
facility.
4.
Section
439.1
is
revised
to
read
as
follows:

Sec.
439.1
General
definitions.

As
used
in
this
part:
(
a)
The
general
definitions,
abbreviations
and
methods
of
analysis
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Category
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Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
in
40
CFR
part
401
shall
apply.
(
b)
The
term
bench­
scale
operation
means
the
laboratory
testing
of
materials,
methods,
or
processes
on
a
small
scale,
such
as
on
a
laboratory
worktable.
(
c)
The
term
cyanide
(
T)
means
the
parameter
total
cyanide.
(
d)
The
term
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
enroute
to
the
end­
of­
pipe.
(
e)
The
term
minimum
level
means
the
level
at
which
an
analytical
system
gives
recognizable
signals
and
an
acceptable
calibration
point.
(
f)
The
term
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
increase
in
the
concentrations
of
nitrites
and
nitrates.
(
g)
The
term
non­
detect
(
ND)
means
a
concentration
value
below
the
minimum
level
that
can
be
reliably
measured
by
the
analytical
method.
(
h)
The
term
pilot­
scale
operation
means
processing
equipment
being
operated
at
an
intermediate
stage
between
laboratory­
scale
and
fullscale
operation
for
the
purpose
of
developing
a
new
product
or
manufacturing
process.
(
i)
The
term
POTW
means
publicly
owned
treatment
works
(
40
CFR
403.3).
(
j)
The
term
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
anti­
microbial
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
onsite
or
off­
site
groundwater
remediation
projects),
and
other
nonprocess
water
generated
on
site.
Discharges
of
such
waters
and
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Category
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New
Source
Performance
Standards;
Final
Rule
wastewaters
are
not
subject
to
the
limitations
and
standards
of
this
part.
(
k)
The
term
non­
conventional
pollutants
means
parameters
that
are
neither
conventional
pollutants
(
40
CFR
401.16),
nor
  
toxic''
pollutants
(
40
CFR
401.15).
(
l)
The
term
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
to
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.
(
m)
The
term
xylenes
means
a
combination
of
the
three
isomers:
oxylene
p­
xylene,
and
m­
xylene.
5.
Section
439.3
is
added
under
the
undesignated
center
heading
  
General''
to
read
as
follows:

Sec.
439.3
General
pretreatment
standards.

Any
source
subject
to
this
part
that
introduces
process
wastewater
pollutants
into
a
publicly
owned
treatment
works
(
POTW)
must
comply
with
40
CFR
part
403.
6.
Section
439.4
is
added
under
the
undesignated
center
heading
  
General''
to
read
as
follows:

Sec.
439.4
Monitoring
requirements.

Permit
limits
and
compliance
monitoring
are
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
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
required
for
regulated
pollutants
that
are
neither
[[
Page
50426]]

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
recommendation
of
any
surrogate
must
be
submitted
with
permit
applications
for
approval
by
the
permitting
authority,
and
reconfirmed
by
an
annual
chemical
analysis
of
wastewater
from
each
monitoring
location,
and
the
measurement
of
a
non­
detect
value
for
each
regulated
pollutant
or
its
surrogate.
Permits
shall
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.

Subpart
A­­[
Amended]

7.
Section
439.10
is
revised
to
read
as
follows:

Sec.
439.10
Applicability.

This
subpart
applies
to
discharges
of
process
wastewater
resulting
from
the
manufacture
of
pharmaceutical
products
by
fermentation.
8.
Section
439.11
is
revised
to
read
as
follows:

Sec.
439.11
Specialized
definitions.

For
the
purpose
of
this
subpart:
(
a)
The
term
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)
The
term
product
means
pharmaceutical
products
derived
from
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Category
Effluent
Limitations
Guidelines,
Pretreatment
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and
New
Source
Performance
Standards;
Final
Rule
fermentation
processes.
9.
Section
439.12
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.12
Effluent
limitations
attainable
by
the
application
of
the
best
practicable
control
technology
currently
available
(
BPT).

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
BPT:
(
a)
The
average
monthly
effluent
limitation
for
BOD<
INF>
5</
INF>,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
3.0.
(
1)
The
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
process
wastewater
(
i.
e.,
the
base
number
to
which
the
percent
reduction
is
applied)
is
defined
as
the
average
daily
BOD<
INF>
5</
INF>
load
during
any
calendar
month,
over
12
consecutive
months
within
the
most
recent
36
months,
and
must
include
one
or
more
periods
during
which
production
was
at
a
maximum.
(
2)
To
assure
equity
in
the
determination
of
NPDES
permit
limitations
regulating
discharges
subject
to
this
subpart,
calculation
of
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
in
the
influent
to
the
wastewater
treatment
system
must
exclude
any
portion
of
the
load
associated
with
separable
mycelia
and
solvents,
except
for
residual
amounts
of
mycelia
and
solvents
remaining
after
the
practices
of
recovery
and/
or
separate
disposal
or
reuse.
These
residual
amounts
may
be
included
in
the
calculation
of
the
average
influent
BOD<
INF>
5</
INF>
loading.
(
3)
The
practices
of
recovery,
and/
or
separate
disposal
or
reuse
include:
physical
separation
and
removal
of
separable
mycelia;
recovery
of
solvents
from
waste
streams;
incineration
of
concentrated
solvent
wastestreams
(
including
tar
still
bottoms);
and
concentration
of
broth
for
disposal
other
than
to
the
treatment
system.
This
part
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
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Category
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Guidelines,
Pretreatment
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and
New
Source
Performance
Standards;
Final
Rule
rationale
for
determining
NPDES
permit
limitations.
The
effluent
limitation
for
BOD<
INF>
5</
INF>
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.
(
b)
The
average
monthly
effluent
limitation
for
TSS,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
be
calculated
as
1.7
times
the
BOD<
INF>
5</
INF>
limitation
determined
in
paragraph
(
a)
of
this
section.
(
c)
Except
as
provided
in
paragraph
(
d)
of
this
section,
the
effluent
limitations
for
COD
and
pH
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
COD...........................................
1675
856
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.

(
d)
If
the
average
monthly
COD
concentrations
in
paragraph
(
c)
of
this
section
are
higher
than
concentration
values
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
average
monthly
effluent
limitations
for
COD
corresponding
to
the
lower
concentration
values
must
be
applied.
(
e)
The
effluent
limitations
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
f)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
effluent
limitations
in
paragraph
(
e)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
g)
Compliance
with
the
limitation
in
paragraph
(
e)
or
(
f)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
the
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
10.
Section
439.13
is
revised
to
read
as
follows:

Sec.
439.13
Effluent
limitations
attainable
by
the
application
of
the
best
conventional
pollutant
control
technology
(
BCT).

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
BCT:
Limitations
for
BOD<
INF>
5</
INF>,
TSS
and
pH
are
the
same
as
the
corresponding
limitations
in
Sec.
439.12.
11.
Section
439.14
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.14
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
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
point
source
subject
to
this
subpart
must
achieve
the
following
effluent
limitations
representing
the
application
of
BAT:

[[
Page
50427]]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N).......................
84.1
29.4
2
Acetone..............................
0.5
0.2
3
4­
Methyl­
2­
pentanone
(
MIBK)..........
0.5
0.2
4
Isobutyraldehyde.....................
1.2
0.5
5
n­
Amyl
acetate.......................
1.3
0.5
6
n­
Butyl
acetate......................
1.3
0.5
7
Ethyl
acetate........................
1.3
0.5
8
Isopropyl
acetate....................
1.3
0.5
9
Methyl
formate.......................
1.3
0.5
10
Amyl
alcohol........................
10.0
4.1
11
Ethanol.............................
10.0
4.1
12
Isopropanol.........................
3.9
1.6
13
Methanol............................
10.0
4.1
14
Methyl
Cellosolve...................
100.0
40.6
15
Dimethyl
Sulfoxide..................
91.5
37.5
16
Triethyl
Amine......................
250.0
102.0
17
Phenol..............................
0.05
0.02
18
Benzene.............................
0.05
0.02
19
Toluene.............................
0.06
0.02
20
Xylenes.............................
0.03
0.01
21
n­
Hexane............................
0.03
0.02
22
n­
Heptane...........................
0.05
0.02
23
Methylene
chloride..................
0.9
0.3
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
133
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
24
Chloroform..........................
0.02
0.01
25
1,2­
Dichloroethane..................
0.4
0.1
26
Chlorobenzene.......................
0.15
0.06
27
o­
Dichlorobenzene...................
0.15
0.06
28
Tetrahydrofuran.....................
8.4
2.6
29
Isopropyl
ether.....................
8.4
2.6
30
Diethyl
amine.......................
250.0
102.0
31
Acetonitrile........................
25.0
10.2
32
pH..................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
of
6.0­
9.0.

(
a)
The
effluent
limitations
for
COD
are
the
same
as
the
corresponding
limitations
in
Sec.
439.12(
c)
and
(
d).
(
b)
The
effluent
limitations
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
effluent
limitations
in
paragraph
(
b)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
Compliance
with
the
limitation
in
paragraph
(
b)
or
(
c)
of
this
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
134
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
a
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
12.
Section
439.15
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.15
Standards
of
performance
for
new
(
point)
sources
(
NSPS).

Any
new
source
subject
to
this
subpart
must
achieve
the
following
performance
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
BOD<
INF>
5.................................
267
111
2
TSS..................................
472
166
3
COD..................................
1675
856
4
Ammonia
(
as
N).......................
84.1
29.4
5
Acetone..............................
0.5
0.2
6
4­
Methyl­
2­
pentanone
(
MIBK)..........
0.5
0.2
7
Isobutyraldehyde.....................
1.2
0.5
8
n­
Amyl
acetate.......................
1.3
0.5
[[
Page
50428]]

9
n­
Butyl
acetate......................
1.3
0.5
10
Ethyl
acetate.......................
1.3
0.5
11
Isopropyl
acetate...................
1.3
0.5
12
Methyl
formate......................
1.3
0.5
13
Amyl
alcohol........................
10.0
4.1
14
Ethanol.............................
10.0
4.1
15
Isopropanol.........................
3.9
1.6
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
135
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
16
Methanol............................
10.0
4.1
17
Methyl
Cellosolve...................
25.0
10.2
18
Dimethyl
Sulfoxide..................
91.5
37.5
19
Triethyl
Amine......................
250.0
102.0
20
Phenol..............................
0.05
0.02
21
Benzene.............................
0.05
0.02
22
Toluene.............................
0.06
0.02
23
Xylenes.............................
0.03
0.01
24
n­
Hexane............................
0.03
0.02
25
n­
Heptane...........................
0.05
0.02
26
Methylene
chloride..................
0.9
0.3
27
Chloroform..........................
0.02
0.01
28
1,2­
Dichloroethane..................
0.4
0.1
29
Chlorobenzene.......................
0.15
0.06
30
o­
Dichlorobenzene...................
0.15
0.06
31
Tetrahydrofuran.....................
8.4
2.6
32
Isopropyl
ether.....................
8.4
2.6
33
Diethyl
amine.......................
250.0
102.0
34
Acetonitrile........................
25.0
10.2
35
pH..................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
of
6.0­­
9.0.

(
a)
The
performance
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Performance
standards
­­­­­­­­­­­­\
1\­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
136
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
(
b)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
performance
standards
in
paragraph
(
a)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
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
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
Secs.
439.13
and
439.14.
(
d)
Compliance
with
the
standard
in
paragraph
(
a)
or
(
b)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
the
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
13.
Section
439.16
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.16
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
to
achieve
compliance
with
cyanide
pretreatment
standards
and
achieve
compliance
with
all
the
other
pretreatment
standards
by
September
21,
2001.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N)
\
2\..................
84.1
29.4
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
137
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
2
Acetone.............................
20.7
8.2
3
4­
Methyl­
2­
pentanone
(
MIBK).........
20.7
8.2
4
Isobutyraldehyde....................
20.7
8.2
5
n­
Amyl
acetate......................
20.7
8.2
6
n­
Butyl
acetate.....................
20.7
8.2
7
Ethyl
acetate.......................
20.7
8.2
8
Isopropyl
acetate...................
20.7
8.2
[[
Page
50429]]

9
Methyl
formate......................
20.7
8.2
10
Methyl
Cellosolve...................
275.0
9.7
11
Isopropyl
ether.....................
20.7
8.2
12
Tetrahydrofuran.....................
9.2
3.4
13
Benzene.............................
3.0
0.6
14
Toluene.............................
0.3
0.1
15
Xylenes.............................
3.0
0.7
16
n­
Hexane............................
3.0
0.7
17
n­
Heptane...........................
3.0
0.7
18
Methylene
chloride..................
3.0
0.7
19
Chloroform..........................
0.1
0.03
20
1,2­
Dichloroethane..................
20.7
8.2
21
Chlorobenzene.......................
3.0
0.7
22
o­
Dichlorobenzene...................
20.7
8.2
23
Diethyl
amine.......................
255.0
100.0
24
Triethyl
amine......................
255.0
100.0
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Not
applicable
to
sources
that
discharge
to
a
POTW
with
nitrification
capability.

(
a)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
Sec.
439.2(
f))
are
not
required
to
achieve
the
pretreatment
standard
for
ammonia.
(
b)
The
pretreatment
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
138
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Pretreatment
standards\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
standards
in
paragraph
(
b)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
403.6(
e)(
2)
and
(
4).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
Compliance
with
the
limitation
in
paragraph
(
b)
or
(
c)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
the
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
14.
Section
439.17
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.17
Pretreatment
standards
for
new
sources
(
PSNS).

Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
must
achieve
the
following
pretreatment
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
139
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N)
\
2\..................
84.1
29.4
2
Acetone.............................
20.7
8.2
3
4­
Methyl­
2­
pentanone
(
MIBK).........
20.7
8.2
4
Isobutyraldehyde....................
20.7
8.2
5
n­
Amyl
acetate......................
20.7
8.2
6
n­
Butyl
acetate.....................
20.7
8.2
7
Ethyl
acetate.......................
20.7
8.2
8
Isopropyl
acetate...................
20.7
8.2
9
Methyl
formate......................
20.7
8.2
10
Methyl
Cellosolve...................
275.0
59.7
11
Isopropyl
ether.....................
20.7
8.2
12
Tetrahydrofuran.....................
9.2
3.4
13
Benzene.............................
3.0
0.7
14
Toluene.............................
0.3
0.1
15
Xylenes.............................
3.0
0.7
16
n­
Hexane............................
3.0
0.7
17
n­
Heptane...........................
3.0
0.7
18
Methylene
chloride..................
3.0
0.7
19
Chloroform..........................
0.1
0.03
20
1,2­
Dichloroethane..................
20.7
8.2
21
Chlorobenzene.......................
3.0
0.7
22
o­
Dichlorobenzene...................
20.7
8.2
23
Diethyl
amine.......................
255.0
100.0
[[
Page
50430]]

24
Triethyl
amine......................
255.0
100.0
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm)
\
2\
Not
applicable
to
sources
that
discharge
to
a
POTW
with
nitrification
capability.

(
a)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
Sec.
439.2(
f))
are
not
required
to
achieve
the
pretreatment
http://
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EPA­
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
standard
for
ammonia.
(
b)
The
pretreatment
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
standards
in
Sec.
439.17(
b)
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
403.6(
e)(
2)
and
(
4).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
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
Sec.
439.16.
(
e)
Compliance
with
the
standards
in
paragraph
(
b)
or
(
c)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
a
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
15.
Section
439.20
is
revised
to
read
as
follows:

Sec.
439.20
Applicability.

http://
www.
epa.
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fedrgstr/
EPA­
WATER/
1998/
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htm
(
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[
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
This
subpart
applies
to
discharges
of
process
wastewater
resulting
from
the
manufacture
of
pharmaceutical
products
by
extraction.
16.
Section
439.21
is
revised
to
read
as
follows:

Sec.
439.21
Specialized
definitions.

For
the
purpose
of
this
subpart:
(
a)
The
term
extraction
means
process
operations
that
derive
pharmaceutically
active
ingredients
from
natural
sources
such
as
plant
roots
and
leaves,
animal
glands,
and
parasitic
fungi
by
chemical
and
physical
extraction.
(
b)
The
term
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.
17.
Section
439.22
is
revised
to
read
as
follows:

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

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
BPT:
(
a)
The
average
monthly
effluent
limitation
for
BOD<
INF>
5</
INF>,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
3.0.
(
1)
The
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
process
wastewater
(
i.
e.,
the
base
number
to
which
the
percent
reduction
is
applied)
is
defined
as
the
average
daily
BOD<
INF>
5</
INF>
load
during
any
calendar
month,
over
12
consecutive
months
within
the
most
recent
36
months,
and
must
include
one
or
more
periods
during
which
production
was
at
a
maximum.
(
2)
To
assure
equity
in
the
determination
of
NPDES
permit
limitations
regulating
discharges
subject
to
this
subpart,
calculation
http://
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WATER/
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htm
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
of
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
in
the
influent
to
the
wastewater
treatment
system
must
exclude
any
portion
of
the
load
associated
with
separable
mycelia
and
solvents,
except
for
residual
amounts
of
mycelia
and
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
BOD<
INF>
5</
INF>
loading.
(
3)
The
practices
of
recovery,
and/
or
separate
disposal
or
reuse
include:
physical
separation
and
removal
of
separable
mycelia;
recovery
of
solvents
from
wastestreams;
incineration
of
concentrated
solvent
wastestreams
(
including
tar
still
bottoms);
and
broth
concentration
for
disposal
other
than
to
the
treatment
system.
This
part
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
BOD<
INF>
5</
INF>
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.
(
b)
The
average
monthly
effluent
limitation
for
TSS,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
be
calculated
as
1.7
times
the
BOD<
INF>
5</
INF>
limitation
determined
in
paragraph
(
a)
of
this
section.
(
c)
Except
as
provided
in
paragraph
(
d)
of
this
section,
effluent
limitations
for
COD
and
pH
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
COD...........................................
228
86
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.
http://
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epa.
gov/
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EPA­
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htm
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2003
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
(
d)
If
the
average
monthly
COD
concentrations
in
paragraph
(
c)
of
this
section
are
higher
than
concentration
values
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
average
monthly
effluent
limitations
for
COD
corresponding
to
the
lower
concentration
values
must
be
applied.
18.
Section
439.23
is
revised
to
read
as
follows:

Sec.
439.23
Effluent
limitations
attainable
by
the
application
of
the
best
conventional
pollutant
control
technology
(
BCT).

Except
as
provided
in
40
CFR
125.30
through
125.32,
any
existing
point
[[
Page
50431]]

source
subject
to
this
subpart
must
achieve
the
following
effluent
limitations
representing
the
application
of
BCT:
Limitations
for
BOD<
INF>
5</
INF>,
TSS
and
pH
are
the
same
as
the
corresponding
limitations
in
Sec.
439.22.
19.
Section
439.24
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.24
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:
Limitations
for
COD
are
the
same
as
the
corresponding
limitations
in
Sec.
439.22(
c)
and
(
d).
20.
Section
439.25
is
revised
to
read
as
follows:

Sec.
439.25
Standards
of
performance
for
new
(
point)
sources
(
NSPS).

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
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htm
(
144
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169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Any
new
source
subject
to
this
subpart
must
achieve
the
following
performance
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Performance
standards\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
BOD<
INF>
5
.........................................
35
18
TSS...........................................
58
31
COD...........................................
228
86
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.

(
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
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
Secs.
439.23
and
439.24.
21.
Section
439.26
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
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
pretreatment
standards
by
October
22,
2001:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
http://
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epa.
gov/
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EPA­
WATER/
1998/
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Day­
21/
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htm
(
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[
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
standards\
1\
­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Acetone........................................
20.7
8.2
2
n­
Amyl
acetate.................................
20.7
8.2
Ethyl
acetate...................................
20.7
8.2
4
Isopropyl
acetate..............................
20.7
8.2
5
Methylene
chloride.............................
3.0
0.7
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

22.
Section
439.27
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.27
Pretreatment
standards
for
new
sources
(
PSNS).

(
a)
Except
as
provided
in
40
CFR
403.7,
this
subpart
must
achieve
the
following
pretreatment
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Acetone........................................
20.7
8.2
2
n­
Amyl
acetate.................................
20.7
8.2
3
Ethyl
acetate..................................
20.7
8.2
http://
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epa.
gov/
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EPA­
WATER/
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
4
Isopropyl
acetate..............................
20.7
8.2
5
Methylene
chloride.............................
3.0
0.7
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
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
in
Sec.
439.27,
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
Sec.
439.26.
23.
Section
439.30
is
revised
to
read
as
follows:

Sec.
439.30
Applicability.

This
subpart
applies
to
discharges
of
process
wastewater
resulting
from
the
manufacture
of
pharmaceutical
products
by
chemical
synthesis.
24.
Section
439.31
is
revised
to
read
as
follows:

Sec.
439.31
Specialized
definitions.

For
the
purpose
of
this
subpart:
(
a)
The
term
chemical
synthesis
means
using
one
or
a
series
of
chemical
reactions
in
the
manufacturing
process
of
a
specified
product.
(
b)
The
term
product
means
any
pharmaceutical
product
manufactured
by
chemical
synthesis.
25.
Section
439.32
is
amended
by
removing
the
OMB
control
number
cite
and
revising
the
section
to
read
as
follows:

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

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
BPT:
(
a)
The
average
monthly
effluent
limitation
for
BOD<
INF>
5</
INF>,

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
147
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
3.0.
(
1)
The
long­
term
average
daily
BOD<
INF>
5
</
INF>
load
of
the
raw
process
wastewater
(
i.
e.,
the
base
number
to
which
the
percent
reduction
is
applied)
is
defined
as
the
average
daily
BOD<
INF>
5</
INF>
load
during
any
calendar
month,
over
12
consecutive
months
within
the
most
recent
36
months,
and
must
include
one
or
more
periods
during
which
production
was
at
a
maximum.
(
2)
To
assure
equity
in
the
determination
of
NPDES
permit
limitations
regulating
discharges
subject
to
this
subpart,
calculation
of
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
in
the
influent
to
the
wastewater
treatment
system
must
exclude
any
portion
of
the
load
associated
with
separable
mycelia
and
solvents,
except
for
residual
amounts
of
mycelia
and
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
BOD<
INF>
5</
INF>
loading.
(
3)
The
practices
of
recovery,
and/
or
separate
disposal
or
reuse
include:
physical
separation
and
removal
of
separable
mycelia;
recovery
of
solvents
from
wastestreams;
incineration
of
concentrated
solvent
wastestreams
(
including
tar
still
bottoms);
and
concentration
of
broth
for
disposal
other
than
to
the
treatment
system.
This
part
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
BOD<
INF>
5</
INF>
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.

[[
Page
50432]]

(
b)
The
average
monthly
effluent
limitation
for
TSS,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
be
calculated
as
1.7
times
the
BOD<
INF>
5</
INF>
limitation
determined
in
paragraph
(
a)
of
this
section.
(
c)
Except
as
provided
in
paragraph
(
d)
of
this
section,
the
effluent
limitations
for
COD
and
pH
are
as
follows:

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
148
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
COD...........................................
1675
856
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.

(
d)
If
the
average
monthly
COD
concentrations
in
paragraph
(
c)
of
this
section
are
higher
than
concentration
values
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
average
monthly
effluent
limitations
for
COD
corresponding
to
the
lower
concentration
values
must
be
applied.
(
e)
The
effluent
limitations
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T).................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
149
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
(
f)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
effluent
limitations
in
Sec.
439.32(
e)
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
g)
Compliance
with
the
limitation
in
paragraph
(
e)
or
(
f)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
the
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
26.
Section
439.33
is
revised
to
read
as
follows:

Sec.
439.33
Effluent
limitations
attainable
by
the
application
of
the
best
conventional
pollutant
control
technology
(
BCT).

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
BCT:
Limitations
for
BOD5,
TSS
and
pH
are
the
same
as
the
corresponding
limitations
in
Sec.
439.32.
27.
Section
439.34
is
amended
by
removing
the
OMB
control
number
cite
and
revising
the
section
to
read
as
follows:

Sec.
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:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
150
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N)......................
84.1
29.4
2
Acetone.............................
0.5
0.2
3
4­
Methyl­
2­
pentanone
(
MIBK).........
0.5
0.2
4
Isobutyraldehyde....................
1.2
0.5
5
n­
Amyl
acetate......................
1.3
0.5
6
n­
Butyl
acetate.....................
1.3
0.5
7
Ethyl
acetate.......................
1.3
0.5
8
Isopropyl
acetate...................
1.3
0.5
9
Methyl
formate......................
1.3
0.5
10
Amyl
alcohol........................
10.0
4.1
11
Ethanol.............................
10.0
4.1
12
Isopropanol.........................
3.9
1.6
13
Methanol............................
10.0
4.1
14
Methyl
Cellosolve...................
25.0
10.2
15
Dimethyl
Sulfoxide..................
91.5
37.5
16
Triethyl
amine......................
250.3
101.5
17
Phenol..............................
0.05
0.02
18
Benzene.............................
0.05
0.02
19
Toluene.............................
0.06
0.02
20
Xylenes.............................
0.03
0.01
21
n­
Hexane............................
0.03
0.02
22
n­
Heptane...........................
0.05
0.02
23
Methylene
chloride..................
0.9
0.3
24
Chloroform..........................
0.02
0.01
25
1,2­
Dichloroethane..................
0.4
0.1
26
Chlorobenzene.......................
0.15
0.06
27
o­
Dichlorobenzene...................
0.15
0.06
28
Tetrahydrofuran.....................
8.4
2.6
29
Isopropyl
ether.....................
8.4
2.6
30
Diethyl
amine.......................
250.0
102.0
31
Acetonitrile........................
25.0
10.2
32
pH..................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
of
6.0­
9.0.
E.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
151
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
[[
Page
50433]]

(
a)
Effluent
limitations
for
COD
are
the
same
as
the
corresponding
limitations
in
Sec.
439.32(
c)
and
(
d).
(
b)
The
effluent
limitations
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
effluent
limitations
in
paragraph
(
a)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
Compliance
with
the
limitation
in
Sec.
439.34(
b)
or
(
c)
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
a
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
28.
Section
439.35
is
amended
by
removing
the
OMB
control
number
cite
and
revising
the
section
to
read
as
follows:

Sec.
439.35
Standards
of
performance
for
new
(
point)
sources
(
NSPS).

Any
new
source
subject
to
this
subpart
must
achieve
the
following
performance
standards:

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
152
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169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
BOD
<
INF>
5...............................
267
111
2
TSS.................................
472
166
3
COD.................................
1675
856
4
Ammonia
(
as
N)......................
84.1
29.4
5
Acetone.............................
0.5
0.2
6
4­
Methyl­
2­
pentanone
(
MIBK).........
0.5
0.2
7
Isobutyraldehyde....................
1.2
0.5
8
n­
Amyl
acetate......................
1.3
0.5
9
n­
Butyl
acetate.....................
1.3
0.5
10
Ethyl
acetate.......................
1.3
0.5
11
Isopropyl
acetate...................
1.3
0.5
12
Methyl
formate......................
1.3
0.5
13
Amyl
alcohol........................
10.0
4.1
14
Ethanol.............................
10.0
4.1
15
Isopropanol.........................
3.9
1.6
16
Methanol............................
10.0
4.1
17
Methyl
Cellosolve...................
100.0
40.6
18
Methyl
Sulfoxide....................
91.5
37.5
19
Triethyl
amine......................
250.0
102.0
20
Phenol..............................
0.05
0.02
21
Benzene.............................
0.05
0.02
22
Toluene.............................
0.06
0.02
23
Xylenes.............................
0.02
0.01
24
n­
Hexane............................
0.03
0.02
25
n­
Heptane...........................
0.05
0.02
26
Methylene
chloride..................
0.9
0.3
27
Chloroform..........................
0.02
0.01
28
1,2­
Dichloroethane..................
0.4
0.1
29
Chlorobenzene.......................
0.15
0.05
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
153
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
30
o­
Dichlorobenzene...................
0.15
0.06
31
Tetrahydrofuran.....................
8.4
2.6
32
Isopropyl
ether.....................
8.4
2.6
33
Diethyl
amine.......................
250.0
102.0
34
Acetonitrile........................
25.0
10.2
35
pH..................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
of
6.0­
9.0.

(
a)
The
performance
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Performance
standards
­­­­­­­­­­­­\
1\­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T)...................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
b)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
standards
in
paragraph
(
a)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
122.44(
i)
and
122.45(
h).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
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
in
the
earlier
version
of
this
section
until
the
expiration
of
the
applicable
time
period
specified
in
40
CFR
122.29(
d)(
1),
after
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
154
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
[[
Page
50434]]

which
the
source
must
achieve
the
standards
specified
in
Secs.
439.33
and
439.34.
(
d)
Compliance
with
the
standards
in
paragraph
(
a)
or
(
b)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
a
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
29.
Section
439.36
is
amended
by
removing
the
OMB
control
number
cite
and
revising
the
section
to
read
as
follows:

Sec.
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
to
achieve
compliance
with
cyanide
pretreatment
standards
and
achieve
compliance
with
all
other
pretreatment
standards
by
September
21,
2001.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N)
\
2\..................
84.1
29.4
2
Acetone.............................
20.7
8.2
3
4­
Methyl­
2­
pentanone
(
MIBK).........
20.7
8.2
4
Isobutyraldehyde....................
20.7
8.2
5
n­
Amyl
acetate......................
20.7
8.2
6
n­
Butyl
acetate.....................
20.7
8.2
7
Ethyl
acetate.......................
20.7
8.2
8
Isopropyl
acetate...................
20.7
8.2
9
Methyl
formate......................
20.7
8.2
10
Methyl
Cellosolve...................
275.0
54.7
11
Isopropyl
ether.....................
20.7
8.2
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
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155
of
169)
[
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2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
12
Tetrahydrofuran.....................
9.2
3.4
13
Benzene.............................
3.0
0.7
14
Toluene.............................
0.3
0.1
15
Xylenes.............................
3.0
0.7
16
n­
Hexane............................
3.0
0.7
17
n­
Heptane...........................
3.0
0.7
18
Methylene
chloride..................
3.0
0.7
19
Chloroform..........................
0.1
0.03
20
1,2­
Dichloroethane..................
20.7
8.2
21
Chlorobenzene.......................
3.0
0.7
22
o­
Dichlorobenzene...................
20.7
8.2
23
Diethyl
amine.......................
255.0
100.0
24
Triethyl
amine......................
255.0
100.0
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Not
applicable
to
sources
that
discharge
to
a
POTW
with
nitrification
capability.

(
a)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
Sec.
439.2(
f))
are
not
required
to
achieve
the
pretreatment
standard
for
ammonia.
(
b)
The
pretreatment
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T).................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
156
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
cyanide
pretreatment
standards
in
paragraph
(
b)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
403.6(
e)
(
2)
and
(
4).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
Compliance
with
the
pretreatment
standards
in
paragraph
(
b)
or
(
c)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
the
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
30.
Section
439.37
is
amended
by
removing
the
OMB
control
number
cite
and
revising
the
section
to
read
as
follows:

Sec.
439.37
Pretreatment
standards
for
new
sources
(
PSNS).

Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
must
achieve
the
following
pretreatment
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
daily
monthly
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Ammonia
(
as
N)\
2\...................
84.1
29.4
2
Acetone.............................
20.7
8.2
3
4­
Methyl­
2­
pentanone
(
MIBK).........
20.7
8.2
4
Isobutyraldehyde....................
20.7
8.2
5
n­
Amyl
acetate......................
20.7
8.2
[[
Page
50435]]

6
n­
Butyl
acetate.....................
20.7
8.2
7
Ethyl
acetate.......................
20.7
8.2
8
Isopropyl
acetate...................
20.7
8.2
9
Methyl
formate......................
20.7
8.2
http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
157
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
10
Methyl
Cellosolve...................
275.0
59.7
11
Isopropyl
ether.....................
20.7
8.2
12
Tetrahydrofuran.....................
9.2
3.4
13
Benzene.............................
3.0
0.7
14
Toluene.............................
0.3
0.1
15
Xylenes.............................
3.0
0.7
16
n­
Hexane............................
3.0
0.7
17
n­
Heptane...........................
3.0
0.7
18
Methylene
chloride..................
3.0
0.7
19
Chloroform..........................
0.1
0.03
20
1,2­
Dichloroethane..................
20.7
8.2
21
Chlorobenzene.......................
3.0
0.7
22
o­
Dichlorobenzene...................
20.7
8.2
23
Diethyl
amine.......................
255.0
100.0
24
Triethyl
amine......................
255.0
100.0
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Not
applicable
to
sources
that
discharge
to
a
POTW
with
nitrification
capability.

(
a)
Sources
that
discharge
to
a
POTW
with
nitrification
capability
(
defined
at
Sec.
439.2(
f))
are
not
required
to
achieve
the
pretreatment
standard
for
ammonia.
(
b)
The
pretreatment
standards
for
cyanide
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitation
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Cyanide
(
T).................................
33.5
9.4
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
158
of
169)
[
3/
21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
(
c)
When
monitoring
for
cyanide
at
the
end­
of­
pipe
is
impractical
because
of
dilution
by
other
process
wastewaters,
compliance
with
the
cyanide
pretreatment
standards
in
paragraph
(
b)
of
this
section
must
be
demonstrated
at
in­
plant
monitoring
points
pursuant
to
40
CFR
403.6(
e)
(
2)
and
(
4).
Under
the
same
provisions,
the
permitting
authority
may
impose
monitoring
requirements
on
internal
wastestreams
for
any
other
parameter(
s)
regulated
by
this
section.
(
d)
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
Sec.
439.37,
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
Sec.
439.36.
(
e)
Compliance
with
the
standard
in
paragraph
(
b)
or
(
c)
of
this
section
may
be
achieved
by
certifying
to
the
permit
issuing
authority
that
a
facility's
manufacturing
processes
neither
use
nor
generate
cyanide.
31.
Section
439.40
is
revised
to
read
as
follows:

Sec.
439.40
Applicability.

This
subpart
applies
to
discharges
of
process
wastewater
resulting
from
the
manufacture
of
pharmaceutical
products
by
mixing,
compounding
and
formulating
operations.
32.
Section
439.41
is
revised
to
read
as
follows:

Sec.
439.41
Specialized
definitions.

For
the
purpose
of
this
subpart:
(
a)
The
term
mixing,
compounding,
and
formulating
operations
means
processes
that
put
pharmaceutical
products
in
dosage
forms.
(
b)
The
term
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.

http://
www.
epa.
gov/
fedrgstr/
EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
159
of
169)
[
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21/
2003
8:
05:
02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
33.
Section
439.42
is
amended
by
removing
the
OMB
control
number
and
revising
the
section
to
read
as
follows:

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

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
BPT:
(
a)
The
average
monthly
effluent
limitation
for
BOD<
INF>
5</
INF>,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
variability
factor
of
3.0.
(
1)
The
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
process
wastewater
(
i.
e.,
the
base
number
to
which
the
percent
reduction
is
applied)
is
defined
as
the
average
daily
BOD<
INF>
5</
INF>
load
during
any
calendar
month,
over
12
consecutive
months
within
the
most
recent
36
months,
and
must
include
one
or
more
periods
during
which
production
was
at
a
maximum.
(
2)
To
assure
equity
in
the
determination
of
NPDES
permit
limitations
regulating
discharges
subject
to
this
subpart,
calculation
of
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
in
the
influent
to
the
wastewater
treatment
system
must
exclude
any
portion
of
the
load
associated
with
separable
mycelia
and
solvents,
except
for
residual
amounts
of
mycelia
and
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
BOD<
INF>
5</
INF>
loading.
(
3)
The
practices
of
recovery,
and/
or
separate
disposal
or
reuse
include:
physical
separation
and
removal
of
separable
mycelia;
recovery
of
solvents
from
wastestreams;
incineration
of
[[
Page
50436]]

concentrated
solvent
wastestreams
(
including
tar
still
bottoms);
and
broth
concentration
for
disposal
other
than
to
the
treatment
system.

http://
www.
epa.
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EPA­
WATER/
1998/
September/
Day­
21/
w21027.
htm
(
160
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[
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2003
8:
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02
AM]
EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
This
part
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
BOD<
INF>
5</
INF>
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.
(
b)
The
average
monthly
effluent
limitation
for
TSS,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
be
calculated
as
1.7
times
the
BOD<
INF>
5</
INF>
limitation
determined
in
paragraph
(
a)
of
this
section.
(
c)
Except
as
provided
in
paragraph
(
d)
of
this
section,
effluent
limitations
for
COD
and
pH
are
as
follows:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Effluent
limitations\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
COD...........................................
228
86
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.

(
d)
If
the
average
monthly
COD
concentrations
in
paragraph
(
c)
of
this
section
are
higher
than
concentration
values
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
average
monthly
effluent
limitations
for
COD
corresponding
to
the
lower
concentration
values
must
be
applied.
34.
Section
439.43
is
revised
to
read
as
follows:

Sec.
439.43
Effluent
limitations
attainable
by
the
application
of
the
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
best
conventional
pollutant
control
technology
(
BCT).

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
BCT:
Limitations
for
BOD<
INF>
5</
INF>,
TSS
and
pH
are
the
same
as
the
corresponding
limitations
in
Sec.
439.42.
35.
Section
439.44
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
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.
Limitations
for
COD
are
the
same
as
the
corresponding
limitations
in
Sec.
439.42
(
c)
and
(
d).
36.
Section
439.45
is
amended
by
removing
the
OMB
control
number
citation
and
revising
the
section
to
read
as
follows:

Sec.
439.45
Standards
of
performance
for
new
(
point)
sources
(
NSPS).

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

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Performance
standards
­­­­­­­­­­­­\
1\­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
BOD<
INF>
5..........................................
35
18
TSS...........................................
58
31
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
COD...........................................
228
86
pH............................................
(\
2\)
(\
2\)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
Mg/
L
(
ppm).
\
2\
Within
the
range
6.0
to
9.0.

(
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
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
Sec.
439.43
and
439.44.
37.
Section
439.46
is
amended
by
removing
the
OMB
control
number
cite,
and
revising
the
section
to
read
as
follows:

Sec.
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
pretreatment
standards
by
September
21,
2001:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Acetone.....................................
20.7
8.2
2
n­
Amyl
acetate..............................
20.7
8.2
3
Ethyl
acetate...............................
20.7
8.2
4
Isopropyl
acetate...........................
20.7
8.2
5
Methylene
chloride..........................
3.0
0.7
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

http://
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
\
1\
Mg/
L
(
ppm).

38.
Section
439.47
is
amended
by
removing
the
OMB
control
number
cite,
and
revising
the
section
to
read
as
follows:

Sec.
439.47
Pretreatment
standards
for
new
sources
(
PSNS).

(
a)
Except
as
provided
in
40
CFR
403.7,
any
new
source
subject
to
this
subpart
must
achieve
the
following
pretreatment
standards:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Pretreatment
standards
\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­
Average
Regulated
parameter
Maximum
monthly
daily
discharge
discharge
must
not
exceed
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1
Acetone.....................................
20.7
8.2
2
n­
Amyl
acetate..............................
20.7
8.2
3
Ethyl
acetate...............................
20.7
8.2
4
Isopropyl
acetate...........................
20.7
8.2
5
Methylene
chloride..........................
3.0
0.7
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
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
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
Sec.
439.46.
39.
Section
439.50
is
revised
to
read
as
follows:

Sec.
439.50
Applicability.

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EPA:
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Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
This
subpart
applies
to
discharges
of
process
wastewater
resulting
from
pharmaceutical
research.
40.
Section
439.51
is
revised
to
read
as
follows:

Sec.
439.51
Specialized
definitions.

For
the
purpose
of
this
subpart,
the
term
product
means
products
or
services
resulting
from
research
and
product
development
activities.
41.
Section
439.52
is
revised
to
read
as
follows:

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

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
BPT:
(
a)
The
average
monthly
effluent
limitation
for
BOD<
INF>
5</
INF>,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
reflect
not
less
than
90
percent
reduction
in
the
long­
term
average
daily
BOD<
INF>
5</
INF>
load
of
the
raw
(
untreated)
process
wastewater,
multiplied
by
a
[[
Page
50437]]

variability
factor
of
3.0.
No
facility
shall
be
required
to
attain
a
limitation
for
BOD<
INF>
5</
INF>
that
is
less
than
the
equivalent
of
45
mg/
L.
(
b)
The
average
monthly
effluent
limitation
for
COD,
expressed
as
mass
loading
(
pounds,
kilograms)
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.
(
c)
The
long­
term
average
daily
BOD<
INF>
5</
INF>
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
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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
BOD<
INF>
5</
INF>
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
long­
term
average
daily
BOD<
INF>
5</
INF>
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
BOD<
INF>
5</
INF>
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
part
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
BOD<
INF>
5</
INF>
or
COD
may
be
achieved
by
any
of
several,
or
a
combination,
of
these
practices.
(
d)
The
average
monthly
effluent
limitation
for
TSS,
expressed
as
mass
loading
(
pounds,
kilograms)
per
day,
must
be
calculated
as
1.7
times
the
BOD<
INF>
5</
INF>
limitation
determined
in
paragraph
(
a)
of
this
section.
(
e)
The
pH
must
be
within
the
range
6.0
to
9.0.

Secs.
439.33
through
439.57
[
Removed]

41.
Sections
439.53
through
439.57
are
removed.

Appendix
A
to
part
439
[
Added]

42.
Appendix
A
is
added
to
part
439
to
read
as
follows:

Appendix
A
to
Part
439­­
Tables
Table
1.­­
Surrogate
Parameters
for
Direct
Dischargers
[
Utilizing
biological
treatment
technology]
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
http://
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EPA­
WATER/
1998/
September/
Day­
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w21027.
htm
(
166
of
169)
[
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2003
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EPA:
Federal
Register:
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
Regulated
parameter
Treatability
class
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Amyl
alcohol.......................
Alcohols.
Ethanol............................
Isopropanol........................
Methanol...........................
Phenol.............................
Isobutyraldehyde...................
Aldehydes.
n­
Heptane..........................
Alkanes.
n­
Hexane...........................
Diethylamine.......................
Amines.
Triethylamine......................
Benzene............................
Aromatics.
Toluene............................
Xylenes............................
Chlorobenzene......................
o­
Dichlorobenzene..................
Chloroform.........................
Chlorinated
Alkanes.
Methylene
chloride.................
1,2­
Dichloroethane.................
Ethyl
acetate......................
Esters.
Isopropyl
acetate..................
n­
Amyl
acetate.....................
n­
Butyl
acetate....................
Methyl
formate.....................
Tetrahydrofuran....................
Ethers.
Isopropyl
ether....................
Acetone............................
Ketones.
4­
Methyl­
2­
pentanone
(
MIBK)........
Ammonia
(
aqueous)..................
Miscellaneous.
Acetonitrile.......................
Methyl
Cellosolve..................
Dimethyl
Sulfoxide.................
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Notes:
1.
Parameters
in
bold
may
be
used
as
a
surrogate
to
represent
other
parameters
in
the
same
treatability
class.

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Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Final
Rule
2.
Surrogates
have
not
been
identified
for
the
  
Miscellaneous''
treatability
class.

Table
2.­­
Surrogate
Parameters
for
Indirect
Dischargers
[
Utilizing
steam
stripping
treatment
technology]
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Regulated
parameters
Treatability
class
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Benzene............................
High
strippability.
Toluene............................
Xylenes............................
n­
Heptane..........................
n­
Hexane...........................
Chloroform.........................
Methylene
chloride.................
Chlorobenzene......................
Methyl
cellosolve..................
Ammonia
(
aqueous)..................
Medium
strippability.
Diethyl
amine......................
Triethyl
amine.....................
Acetone
4­
Methyl­
2­
pentanone
(
MIBK)
n­
Amyl
acetate.....................
n­
Butyl
acetate....................
Ethyl
acetate......................
Isopropyl
acetate..................
Methyl
formate.....................
Isopropyl
ether....................
Tetrahydrofuran....................
1,2­
Dichloroethane.................
o­
Dichlorobenzene..................
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Notes:
1.
Parameters
in
bold
may
be
used
as
a
surrogate
to
represent
other
parameters
in
the
same
treatability
class.

[
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98­
21027
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18­
98;
8:
45
am]
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