Document ID: EPA-HQ-OW-2003-0007-0008
Agency: epa
Document Type: Rule
Title: Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Correcting Amendments.
Posted Date: 2003-02-26T05:00Z

48103
Federal
Register
/
Vol.
64,
No.
170
/
Thursday,
September
2,
1999
/
Rules
and
Regulations
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
The
EPA
submitted
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
today's
Federal
Register.
This
rule
is
not
a
``
major
rule''
defined
by
5
U.
S.
C.
804(
2).

Paperwork
Reduction
Act
Under
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.,
Federal
agencies
must
consider
the
paperwork
burden
imposed
by
any
information
request
contained
in
a
proposed
rule
or
a
final
rule.
This
rule
will
not
impose
any
information
requirements
upon
the
regulated
community.

Executive
Order
12875
Enhancing
Intergovernmental
Partnerships
Under
E.
O.
12875,
the
EPA
may
not
issue
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
funds
necessary
to
pay
the
direct
compliance
costs
incurred
by
those
governments.
If
the
mandate
is
unfunded,
the
EPA
must
provide
to
the
OMB
a
description
of
the
extent
of
EPA's
prior
consultation
with
representatives
of
affected
State,
local
and
tribal
governments,
the
nature
of
their
concerns,
copies
of
any
written
communications
from
the
governments,
and
a
statement
supporting
the
need
to
issue
the
regulation.
In
addition,
E.
O.
12875
requires
the
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.
This
rule
does
not
create
a
mandate
on
State,
local
or
tribal
governments.
The
rule
does
not
impose
any
enforceable
duties
on
these
entities.
Accordingly,
the
requirements
of
section
1(
a)
of
E.
O.
12875
do
not
apply
to
this
rule.

Executive
Order
13084
Consultation
and
Coordination
With
Indian
Tribal
Governments
Under
E.
O.
13084,
the
EPA
may
not
issue
a
regulation
that
is
not
required
by
statute,
that
significantly
or
uniquely
affects
the
communities
of
Indian
tribal
governments,
and
that
imposes
substantial
direct
compliance
costs
on
those
communities,
unless
the
Federal
government
provides
the
funds
necessary
to
pay
the
direct
compliance
cost
incurred
by
the
tribal
governments.
If
the
mandate
is
unfunded,
the
EPA
must
provide
to
the
OMB,
in
a
separately
identified
section
of
the
preamble
to
the
rule,
a
description
of
the
extent
of
the
EPA's
prior
consultation
with
representatives
of
affected
tribal
governments,
a
summary
of
the
nature
of
their
concerns,
and
a
statement
supporting
the
need
to
issue
the
regulation.
In
addition,
E.
O.
13084
requires
the
EPA
to
develop
an
effective
process
permitting
elected
and
other
representatives
of
Indian
tribal
governments
``
to
provide
meaningful
and
timely
input
in
the
development
of
regulatory
policies
on
matters
that
significantly
or
uniquely
affect
their
communities.
This
rule
is
not
subject
to
E.
O.
13084
because
it
does
not
significantly
or
uniquely
affect
the
communities
of
Indian
governments.
The
State
of
Louisiana
is
not
authorized
to
implement
the
RCRA
hazardous
waste
program
in
Indian
country.
This
action
has
no
effect
on
the
hazardous
waste
program
that
the
EPA
implements
in
the
Indian
country
within
the
State.

List
of
Subjects
in
40
CFR
Part
271
Environmental
protection,
Administrative
practice
and
procedure,
Confidential
business
information,
Hazardous
materials
transportation,
Hazardous
waste,
Indian
lands,
Intergovernmental
relations,
Penalties,
Reporting
and
recordkeeping
requirements,
Water
pollution
control,
Water
supply.

Authority
This
document
is
issued
under
the
authority
of
sections
2002(
a),
3006,
and
7004(
b)
of
the
Solid
Waste
Disposal
Act
as
amended,
42
U.
S.
C.
6912(
a),
6926,
6974(
b).

Dated:
June
15,
1999.

Jerry
Clifford,

Acting
Regional
Administrator,
Region
6.
[
FR
Doc.
99
 
22627
Filed
9
 
1
 
99;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
439
[
FRL
 
6431
 
8]

RIN
2040
 
AA13
Pharmaceutical
Manufacturing
Category
Effluent
Limitations
Guidelines,
Pretreatment
Standards,
and
New
Source
Performance
Standards;
Correcting
Amendments
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Correcting
amendments.

SUMMARY:
EPA
is
correcting
minor
errors
in
the
effluent
limitations
guidelines
and
standards
for
the
pharmaceutical
manufacturing
point
source
category
which
appeared
in
the
Federal
Register
on
September
21,
1998.
DATES:
These
corrections
shall
become
effective
September
2,
1999.
In
accordance
with
40
CFR
23.2,
this
rule
will
be
considered
promulgated
for
purposes
of
judicial
review
at
1:
00
p.
m.
Eastern
Time
on
September
16,
1999.
FOR
FURTHER
INFORMATION
CONTACT:
Dr.
Frank
H.
Hund,
Office
of
Water,
Engineering
and
Analysis
Division
(
4303),
U.
S.
Environmental
Protection
Agency,
401
M
St.,
SW,
Washington,
DC
20460,
(
202)
260
 
7182,
hund.
frank@
epamail.
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
Background
In
a
final
rule
published
on
September
21,
1998
(
63
FR
50388),
EPA
established
final
effluent
limitations
and
standards
for
the
pharmaceutical
manufacturing
point
source
category
for
the
control
of
wastewater
pollutants.
The
final
rule
omitted
a
clarifying
abbreviation
and
contained
four
incorrect
subsections.
This
notice
inserts
a
clarifying
abbreviation,
deletes
four
incorrect
subsections,
changes
the
parenthetical
letters
identifying
two
subsections
and
deletes
the
parenthetical
letters
identifying
two
other
subsections.
The
clarifying
abbreviation
``
Mg/
L''
(
milligrams
per
liter)
is
necessary
to
avoid
confusion
with
the
abbreviation
``
Mg
``
(
megagrams)
which
is
used
in
the
preamble
section
devoted
to
the
discussion
of
the
MACT
rule
which
was
promulgated
at
the
same
time
as
the
pharmaceuticals
effluent
guidelines
rule.
The
subsection
deletions
are
in
the
Pretreatment
Standards
for
New
Sources
(
PSNS)
sections
of
the
rule.
These
subsections
contained
a
cite
from
the
regulations
concerning
new
source
direct
dischargers
which
is
inconsistent
48104
Federal
Register
/
Vol.
64,
No.
170
/
Thursday,
September
2,
1999
/
Rules
and
Regulations
with
the
definition
of
new
source
contained
in
section
403.3(
k)
of
the
general
pretreatment
regulations.
As
a
result
of
today's
correction,
the
PSNS
sections
of
the
pharmaceuticals
effluent
guidelines
will
be
consistent
with
the
general
pretreatment
regulations.
The
PSNS
sections
will
also
be
consistent
with
PSNS
sections
in
other
recently
promulgated
effluent
guidelines
rules.
Today's
correction
also
``
renumbers''
(
by
revising
or
deleting)
the
labels
for
the
PSNS
sections.
For
example,
if
paragraph
(
d)
is
deleted,
paragraph
(
e)
is
renamed
as
(
d).

II.
Administrative
Requirements
Under
Executive
Order
12886
(
58
FR
51735,
October
4,
1993),
this
is
not
a
``
significant
regulatory
action''
and,
is
therefore
not
subject
to
review
by
the
Office
of
Management
and
Budget.
In
addition,
this
action
does
not
impose
any
enforceable
duty,
contain
any
unfunded
mandate,
or
impose
any
significant
or
unique
impact
on
small
governments
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Pub.
L.
104
 
4).
This
rule
also
does
not
require
prior
consultation
with
State,
local,
and
tribal
government
officials
as
specified
by
Executive
Order
12875
(
58
FR
58093,
October
28,
1993)
or
Executive
Order
13084
(
63
FR
27655,
May
10,
1998),
or
involve
special
consideration
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898
(
59
FR
7629,
February
16,
1994).
Because
this
action
is
not
subject
to
the
notice­
and­
comment
requirements
under
the
Administrative
Procedure
Act,
5
U.
S.
C.
533,
or
any
other
statute,
it
is
not
subject
to
the
regulatory
flexibility
provisions
of
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et.
seq.).
This
rule
also
is
not
subject
to
Executive
Order
13045
(
62
FR
19885,
April
23,
1997)
because
it
is
not
economically
significant
as
defined
under
E.
O.
12866.
Further,
EPA
interprets
E.
O.
13045
as
applying
only
to
those
regulatory
actions
that
are
based
on
health
and
safety
risks,
such
that
the
analysis
required
under
section
5
 
501
of
the
Order
has
the
potential
to
influence
the
regulation.
This
rule
is
not
subject
to
E.
O.
13045
because
it
does
not
establish
an
environmental
standard
intended
to
mitigate
health
or
safety
risks.
This
rule
is
not
subject
to
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
Pub.
L.
104
 
113)
because
it
does
not
involve
any
technical
standards.
This
action
contains
no
information
collection
requirements.
Therefore,
it
is
not
subject
to
the
Paperwork
Reduction
Act
of
1980,
44
U.
S.
C.
1501,
et
seq.
EPA's
compliance
with
these
statutes
and
Executive
Orders
for
the
underlying
rule
is
discussed
in
the
Federal
Register
notice
of
September
21,
1998.
The
revisions
in
this
final
rule
are
not
substantive.
These
revisions
add
a
clarifying
abbreviation,
delete
four
incorrect
subsections
of
the
rule,
change
parenthetical
letters
identifying
two
subsections
and
delete
parenthetical
letters
identifying
two
other
subsections.
For
this
reason,
EPA
has
determined
that
public
participation
in
this
action
is
unnecessary
and
constitutes
good
cause
for
issuing
this
rule
without
notice
and
comment.
For
the
same
reason,
the
Agency
has
determined
that
good
cause
exists
to
waive
the
requirement
for
a
30­
day
period
before
the
amendments
become
effective.
Therefore,
the
amendments
are
effective
immediately.
The
Congressional
Review
Act
(
CRA),
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
Section
808
allows
the
issuing
agency
to
make
a
good
cause
finding
that
notice
and
public
procedure
is
impracticable,
unnecessary
or
contrary
to
the
public
interest.
This
determination
must
be
supported
by
a
brief
statement.
5
U.
S.
C.
Section
808(
2).
As
stated
previously,
EPA
has
made
such
a
good
cause
finding,
including
the
reasons
therefor,
and
established
an
effective
date
of
September
2,
1999.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
439
Environmental
protection,
Reporting
and
recordkeeping
requirements,
Water
pollution
control.

Dated:
August
25,
1999.
J.
Charles
Fox,
Assistant
Administrator
for
Water.

For
reasons
set
out
in
the
preamble,
part
439,
title
40,
chapter
I
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
439
 
PHARMACEUTICAL
MANUFACTURING
POINT
SOURCE
CATEGORY
1.
The
authority
citation
for
part
439
continues
to
read:
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,
1342,
and
1361.

2.
Section
439.1
is
amended
by
adding
paragraph
(
n)
to
read
as
follows:

§
439.1
General
definitions.

*
*
*
*
*
(
n)
The
abbreviation
Mg/
L
means
milligrams
per
liter
or
parts
per
million
(
ppm).

§
439.17
[
Amended]

3.
Section
439.17
is
amended
by
removing
paragraph
(
d)
and
redesignating
paragraph
(
e)
as
(
d).
4.
Section
439.27
is
amended
by
removing
paragraph
(
b)
and
removing
the
paragraph
designation
from
paragraph
(
a)
and
revising
the
newly
designated
introductory
text
before
the
table
to
read
as
follows:

§
439.27
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:
*
*
*
*
*

§
439.37
[
Amended]

5.
Section
439.37
is
amended
by
removing
paragraph
(
d)
and
redesignating
paragraph
(
e)
as
(
d).

§
439.47
[
Amended]

6.
Section
439.47
is
amended
by
removing
the
paragraph
designation
from
paragraph
(
a)
and
by
removing
paragraph
(
b).

[
FR
Doc.
99
 
22745
Filed
9
 
1
 
99;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
DEPARTMENT
OF
TRANSPORTATION
Federal
Highway
Administration
49
CFR
Parts
383
and
384
[
FHWA
Docket
No.
FHWA
 
97
 
3103]

RIN
2125
 
AE28
Commercial
Driver
Disqualification
Provision
AGENCY:
Federal
Highway
Administration
(
FHWA),
DOT.
ACTION:
Final
rule.

SUMMARY:
The
FHWA
revises
its
regulations
to
require
that
commercial
motor
vehicle
(
CMV)
drivers
who
are
convicted
of
violating
Federal,
State,
or
local
laws
or
regulations
pertaining
to
railroad­
highway
grade
crossings
be
disqualified
from
operating
a
CMV.
Penalties
also
will
be
assessed
against