Document ID: EPA-HQ-OW-2003-0007-0002
Agency: epa
Document Type: Proposed Rule
Title: Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards for the Pharmaceutical Manufacturing Point Source Category; Proposed Rule.
Posted Date: 2003-03-13T05:00Z

12276
Federal
Register
/
Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Proposed
Rules
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
439
[
FRL
 
7462
 
7]

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

SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
is
proposing
to
amend
certain
provisions
of
the
effluent
guidelines
for
the
Pharmaceutical
Manufacturing
Point
Source
Category,
which
were
published
on
September
21,
1998
(
63
FR
50424).
First,
EPA
is
clarifying
the
date
on
which
a
discharger
subject
to
the
New
Source
Performance
Standards
(
NSPS)
and
the
Pretreatment
Standards
for
New
Sources
(
PSNS)
would
be
subject
to
effluent
limitations
and
pretreatment
standards
established
in
the
1998
regulation.
Second,
this
rule
re­
establishes
a
minimum
concentration
for
the
maximum
monthly
average
BOD5
limitation
that
EPA
inadvertently
omitted
from
the
Best
Practicable
Control
Technology
(
BPT)
requirements
in
two
subcategories
of
the
1998
regulation.
Next,
the
amendments
correct
an
error
in
EPA's
pass­
through
analysis
prepared
in
support
of
the
1998
rule
and,
as
a
result,
methyl
Cellosolve
(
2­
methoxyethanol)
from
the
pretreatment
standards
in
two
subcategories
and
from
Appendix
A,
Table
2,
``
Surrogate
Parameters
for
Indirect
Dischargers.''
Finally,
the
Agency
is
making
other
non­
substantive
editorial
and
format
changes
such
as
removing
redundancies,
and
adding
definitions.

DATES:
Comments
must
be
received
by
May
12,
2003.
Comments
postmarked
after
this
date
may
not
be
considered.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Please
mail
comments
to
the
Water
Docket,
Environmental
Protection
Agency,
Mailcode:
4101T,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
or
submit
them
electronically
to
http://
www.
epa.
gov/
edocket.
Send
either
to
the
Attention
of
Docket
ID
No.
OW
 
2003
 
0007.
See
section
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
section
for
more
information
on
submitting
comments.

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

SUPPLEMENTARY
INFORMATION:

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

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

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
Docket
ID
No.
OW
 
2003
 
0007.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Water
Docket
in
the
EPA
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Public
Reading
Room
is
(
202)
566
 
1744,
and
the
telephone
number
for
the
Water
Docket
is
(
202)
566
 
2426.
For
access
to
docket
materials,
please
call
ahead
to
schedule
an
appointment.
Every
user
is
entitled
to
copy
100
pages
before
incurring
a
charge.
The
Docket
may
charge
15
cents
a
page
for
each
page
over
the
100­
page
limit.
2.
Electronic
Access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
``
EPA
Dockets.''
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
identification
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
confidential
business
information
(
CBI)
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
section
I.
B.
1.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.

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Federal
Register
/
Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Proposed
Rules
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
For
additional
information
about
EPA's
electronic
public
docket
visit
EPA
Dockets
online
or
see
67
FR
38102,
May
31,
2002.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
Please
submit
with
your
comments
any
references
cited
in
your
comments.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
identification
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments;
however,
late
comments
may
be
considered
if
time
permits.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
section
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
below,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e­
mail
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
 
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
 
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
To
access
EPA's
electronic
public
docket
from
the
EPA
Internet
Home
Page,
select
``
Information
Sources,''
``
Dockets,''
and
``
EPA
Dockets.''
Once
in
the
system,
select
``
search,''
and
then
key
in
Docket
ID
No.
OW
 
2003
 
0007.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
electronic
mail
(
e­
mail)
to
OW
 
Docket@
epa.
gov,
Attention
Docket
ID
No.
OW
 
2003
 
0007.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
email
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
Docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
 
ROM.
You
may
submit
comments
on
a
disk
or
CD
 
ROM
that
you
mail
to
the
mailing
address
identified
in
section
1.
C.
2.
These
electronic
submissions
will
be
accepted
in
Word
Perfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
Mail.
Send
an
original
and
three
(
3)
copies
of
your
comments
to
the
Water
Docket,
Environmental
Protection
Agency,
Mail
Code
4101T,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Attention
Docket
ID
No.
OW
 
2003
 
0007.
3.
By
Hand
Delivery
or
Courier.
Deliver
your
comments
to:
Water
Docket,
EPA
Docket
Center,
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
DC,
Attention
Docket
ID
No.
OW
 
2003
 
0007.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
in
section
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
Send
information
identified
as
CBI
by
mail
only
to
the
following
address:
Office
of
Science
and
Technology,
Mail
Code
4303T,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
Attention:
Frank
Hund,
Docket
ID
No.
OW
 
2003
 
0007.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
 
ROM,
mark
the
outside
of
the
disk
or
CD
 
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
 
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
 
ROM,
mark
the
outside
of
the
disk
or
CD
 
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.

II.
Discussion
of
Direct
Final
Rulemaking
In
the
``
Rules
and
Regulations''
section
of
today's
Federal
Register,
EPA
is
promulgating
these
revisions
as
a
direct
final
rule
without
prior
proposal
because
we
view
them
as
noncontroversial
revisions
and
anticipate
no
adverse
comment.
We
have
explained
our
reasons
for
these
revisions
in
the
preamble
to
the
direct
final
rule.
If
we
receive
no
adverse
comment,
we
will
not
take
further
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Vol.
68,
No.
49
/
Thursday,
March
13,
2003
/
Proposed
Rules
action
on
this
proposed
rule.
If
we
receive
adverse
comment,
we
will
withdraw
the
direct
final
rule
or
portions
thereof,
and
the
direct
final
rule
or
portions
thereof
will
not
take
effect.
We
will
address
all
public
comments
in
a
subsequent
final
rule
based
on
this
action.
We
will
not
institute
a
second
comment
period
on
this
action.
Any
parties
interested
in
commenting
must
do
so
at
this
time.
III.
Related
Acts
of
Congress,
Executive
Orders,
and
Agency
Initiatives
For
the
various
statutes
and
Executive
Orders
that
require
findings
for
rulemaking,
EPA
incorporates
the
findings
from
the
direct
final
rule
into
this
companion
proposal
for
the
purpose
of
providing
public
notice
and
opportunity
for
comment.
List
of
Subjects
in
40
CFR
Part
439
Environmental
protection,
Drugs,
Reporting
and
recordkeeping
requirements,
Waste
treatment
and
disposal,
Water
pollution
control.

Dated:
February
28,
2003.
Christine
Todd
Whitman,
Administrator.
[
FR
Doc.
03
 
5715
Filed
3
 
12
 
03;
8:
45
am]

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