DEVELOPMENT DOCUMENT

                      FOR

      FINAL BEST CONVENTIONAL TECHNOLOGY

        EFFLUENT LIMITATIONS GUIDELINES

                    FOR THE

         PHARMACEUTICAL MANUFACTURING

             POINT SOURCE CATEGORY
                 LEE M. THOMAS
                 ADMINISTRATOR
               DEVEREAUX BARNES
ACTING DIRECTOR, INDUSTRIAL TECHNOLOGY DIVISION
              THOMAS P. O'FARRELL
      CHIEF, CONSUMER COMMODITIES BRANCH
             FRANK H. HUND, Ph.D.
                PROJECT OFFICER
                 DECEMBER 1986
        INDUSTRIAL TECHNOLOGY DIVISION
                OFFICE OF WATER
     U.S. ENVIRONMENTAL PROTECTION AGENCY
            WASHINGTON, D.C.  20460      \

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                        TABLE OF CONTENTS
SECTION
II
III
 IV
 V
 VI
EXECUTIVE SUMMARY                     '•

SUMMARY
CONCLUSIONS
BEST CONVENTIONAL TECHNOLOGY LIMITATIONS
  (BCT)
                                      I
INTRODUCTION                          i
                                      i
PURPOSE AND AUTHORITY
SCOPE OF THIS RULEMAKING
SUMMARY OF METHODOLOGY                |

DESCRIPTION OF THE INDUSTRY

INTRODUCTION                          i
SUBCATEGORIZATION                     '
EXISTING END-OF-PIPE TREATMENT AT
  PHARMACEUTICAL PLANTS

WASTE CHARACTERIZATION

INTRODUCTION                          i
WASTE CHARACTERIZATION                :
RAW  WASTE  CHARACTERISTICS  FOR  SUBCATEGORY
  A  AND C  AND  B AND D FACILITIES      .

DEVELOPMENT OF CONTROL AND TREATMENT |
     OPTIONS
 INTRODUCTION
 CONTROL AND TREATMENT OPTIONS
      BCT Option A
      BCT Option B
      BPT

 COST, ENERGY,  AND NON-WATER QUALITY
     ASPECTS
           INTRODUCTION                         \
           BCT COST TEST METHODOLOGY
           METHODOLOGY FOR DEVELOPMENT OF COSTS ;
                Cost Estimating Criteria
                Revisions Made to the Cost Development
                  Methodology Since Proposal
           APPLICATION OF THE BCT COST TEST METHODOLOGY
           COSTS, ENERGY, AND NON-WATER QUALITY|IMPACTS
 1
 1

 2

 5

 5
 6
 7
 9
 9

10

13

13
13

13


21

21
21
21
22
22


27

27
27
28
28

30
33
34

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 SECTION

 VII
VIII

IX
                   TABLE OF CONTENTS (Continued)
 BEST CONVENTIONAL TECHNOLOGY EFFLUENT
 LIMITATIONS GUIDELINES'	:	 ~	

 GENERAL
 IDENTIFICATION  OF THE  TECHNOLOGY  BASIS OF
   FINAL  BCT LIMITATIONS
 FINAL BCT
 RATIONALE FOR THE SELECTION  OF BCT
   CANDIDATE OPTIONS
 METHODOLOGY USED  FOR DEVELOPMENT  OF
   FINAL  BCT
 COST  OF  APPLICATION AND EFFLUENT
   REDUCTION BENEFITS
 NON-WATER QUALITY ENVIRONMENTAL IMPACTS

REFERENCES

ACKNOWLEDGEMENTS
PAGE


 49

 49

 49
 49

 49

 49

 50
 50

 53

 55
                             11

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NUMBER

Section !_

1-1


Section
                         LIST OF TABLES

                              TITLE
          Final BCT Limitations for the Pharmaceutical
          Manufacturing Category
        III
         IV
III-l


III-2


Section

IV-1


IV-2


IV-3



IV-4


Section V

V-l



V-2



 V-3
          Summary of Method of Discharge at Pharmaceutical
          Plants

          In-Place  Treatment  Technology at Direct
          Discharging  Pharmaceutical  Plants      !
           Raw Waste and Final Effluent Characteristics
           of Direct Discharging Pharmaceutical Plants

           Average Raw Waste Characteristics of  !
           Subcategory A and C Plants            i

           Average Raw Waste Characteristics of  j
           Subcategory B and D Plants Employing
           Biological Treatment                  ;

           Average Plant Raw Waste Characteristics
           Final Effluent Characteristics of Best:
           Performing Subcategory A and C Pharmaceutical
           Plants Employing Advanced Biological Treatment

           Final Effluent Characteristics of Best
           Performing Subcategory B and D Pharmaceutical
           Plants Employing Advanced Biological Treatment
           Final  Effluent Characteristics of
           Plants Employing Advanced Biological
           and  Effluent  Filtration
Pharmaceutical
                                                Dreatment
                                                             PAGE
                 11
                 11
                 15


                 17



                 18

                 19
                  24
                  25
                                                               26
                                111

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                   LIST OP TABLES  (Continued)

 NUMBER                        TITLE
 Section VI

 VI-1      Cost Estimating  Criteria

          S'^JS^'.^^Ss;*.!?-*™ E*p—o

VI-3
 VI-4



 VI-5


 VI-6


 VI-7


 VI-8


 VI-9


 VI-10


 VI-11
            nMon
           Option
        n                               y
        Dischargers  to Meet BPT Effluent Levels

              °f the Treat^nt Elements to be
                  ment ^^ems to Meet BCT
                  Levels

              °f the Filtration System to  be
 Subcategory AC Raw Waste Load to BPT
 Increment of Treatment - Costs and Removals

 Subcategory AC BPT to BCT Option A Increment
 of  Treatment - Costs and Removals
    ro     BPV° BCT °Ption B increment
   Treatment - Costs and Removals

Subcategory BD Raw Waste Load to BPT Increment
of Treatment - Costs and Removals    ±ncrement
     ef   n° BCT °ption A Cerement
   Treatment - Costs and Removals

Subcategory BD BPT to BCT Option B Increment
of Treatment - Costs and Removals  increment

Summary of  BCT Cost Test Calculations  for  the
               Manufacturing Industry  (1982
Section VII

VII-1
          Conventional Pollutant
                                           Technology
                                                          PAGE
  35



  36



 39



 41


 42


 43


 44


 45


 46


47



48
                                                            51
                            IV

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                            SECTION I
                        EXECUTIVE SUMMARY
SUMMARY

This   document   presents  the  technical  rationale  for   best
S^enttSSSTJechnSlogy (BCT) effluent limitationsj guidelines for
the   pharmaceutical  manufacturing  point  so"c?= 7ca^g°rjctnf
required by the Clean Water Act of 1977 (P.L. 95-217,,  the Act  ).
This document describes the technologies considered as the  bases
for BCT limitations.

EPA developed these limitations and standards after undertaking a
compIeT p?ogram utilizing i^uatry data obtained under authority
of  SectiSn  308  of the Act,  supplemented  by  additional  data
collection programs for selected portions  of the industry.

Plants  in the pharmaceutical manufacturing point source   category
produce  biological  products,   medicinal  chemicals,  b°tanical
products   and   pharmaceutical  products  covered   by    Standard
industrial  Classification Code  (SIC)  Numbers   2831,   2833,   and
2834,  and other commodities  described  within this jreport.

The   industry  is characterized by  diversity  of  product,   process,
plant size,  and process  stream  complexity.    Subcategories  based
on process characteristics were  defined  for  purposes of technical
evaluation.  These  subcategories were  found  to be  appropriate  for
regulatory purposes.

Section  II  of this document summarizes  the   rulemaking  process.
Sections   III   through  V   describe   the  technical  data   and
 engineeling   analyses  Ssed to develop  the  regulatory  technology
SStiSns    The costs and removals  associated with each technology
Sption  for   each plant and  the  application of the,BCT cost  test
 methodology are presented in Section VI.   BCT limitations  based
 In  the belt conventional pollutant control technplogy are to  be
 achieved by existing direct  discharging facilities.
 CONCLUSIONS
                       Protection  Agency   (EPA)  j is   finalizing
The   Environmental   ^±^^^.^ «_*~~  --3	j   , -  ,                j__,
regulations   that   would  limit  the  discharge^  of   five-day
biochemical oxygen demand (BOD5) and total suspended solids (TSS)
into  waters  of  the United States by existing sources  in  four
subcategories  of the pharmaceutical manufacturing  point  source
category.   This  document addresses best conventional technology
(BCT) limitations for conventional pollutants required under  the
Clean Water Act.

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BEST CONVENTIONAL POLLUTANT  LIMITATIONS rgCTj_

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                                 TABLE 1-1

                       FINAL BCT LIMITATIONS FOR THE
                   PHARMACEUTICAL MANUFACTURING CATEGORY
Subcategory

    A
       30-Day
Maximum Average

0.10 x long-term
average raw waste
concentration x 3
(variability factor)

0.10 x long-term
average raw waste
concentration x 3
(variability factor)
or 45 mg/1, whichever
is higher

0.10 x long-term
average raw waste
concentration x 3
(variability factor)

0.10 x long-term
average raw waste
concentration x 3
(variability factor)
or 45 mg/1, whichever
is higher
  TSS 30-Day
Maximum Average

1.7 x BOD5 30-day
maximum average•
limitation      i
                                           1.7 x BOD5 30-day
                                           maximum average;
                                           limitation
                                           1.7 x BOD5 30-day
                                           maximum average
                                           limitation
                                           1.7 x BOD5 30-day
                                           maximum  average
                                           limitation     i
6.0-9.0
units at
all  times
                       6.0-9.0
                       units at
                       all times
                       6.0-9.0
                       units at
                       all times
                       6.0-9.0
                       units at
                       all times

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                           SECTION II
                          INTRODUCTION
PURPOSE AND AUTHORITY                            ;

The  Federal  Water  Pollution  Control Act  Amendments  of  1972



required  to issue effluent limitations guidelines,  pretreatment
standards,  and  new source performance standards', for  industrial
dischargers.

EPA  promulgated  effluent limitations guidelines based  on  Best
PracticaSle^echnology and Best Available Technology,  New Source
Performance Standards and New Source Performance .Standards   based
on Best Available Demonstrated Technology as well as pretreatment
           for  existing and new  sources for   the  pharmaceutical
              category on October 27,  1983  at  48 PR 49808.
 The   1977   amendments   to   the   Clean   Water   Act   added   Section
 301(b)(2)(E)   establishing   "best  conventional pollutant   control
 technology" (BCT)  for  discharges of  conventional pollutants   from
 existing  industrial point  sources.    Conventional  pollutants are
 those  defined in  Section  304(a) (4)  [biological oxygen demanding
 (BOD5),  total suspended solids (TSS),  fecal colitorm,   and PH] ,
 and   any  additional pollutants defined by the Administrator  as
 "conventional" (oil and grease, 44 FR  44501,  July  JO,  1979).

 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   assessed  in  light  of  a  two   P*rt    cost
 reasonableness" test,   American Paper  Institute v.   EPA,  660 F 2d
 954   (4th  Cir.  1981).   The  first test compares the  cost  for
 private  industry to reduce its conventional pollutants with  the
 costs  to  publicly owned treatment works for similar  levels  of
 reductioS  in thei? discharge of these  pollutants.   The  second
 test   examines  the  cost effectiveness of  additional  treatment
 beyond BPT.   EPA must find that limitations more stringent  than
 BPT are "reasonable" under both tests before establishing them as
 BCT     If  they  are  not  found "reasonable" then  BCT  will  be
 established   ai  equal  to  BPT.   In no case  may  BCT  be  less
 stringent  than BPT.                             ;

 EPA  published its  methodology  for carrying  out j the BCT  analysis
 on Aucmst  24,  1979 (44 FR 50732).    In  the  case mentioned  above,
 ?n~e  Court  of  Appeals  ordered  EPA to  correct  data    errors
 underlying EPA's calculation of the first  test,! and  to apply  the
 second test  (EPA had  argued  that  a  second  test was not required) .
 Ihe  Agency  proposed  a   revised  methodology  ; for   the  general
 development of BCT limitations on October  29,  1982  (47 FR  49176)

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                                                                  1
 is.






 EPA  is  promulgating  this  regulation under  the
                                     water Act
 SCOPE OF THIS RULEMAKING
T
               sss-a
2
                                     as  the


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However,  a  BCT methodology has recently been promulgated by EPA
at  51 FR 24974 on July 9,  1986.   The Agency has  applied  this
methodology  to two technology options for plants in the A and_ C
and  B  and D subcategories.   As a result,  EPA is  promulgating
final BCT limitations for the A, B, C, and D subcategories of_the
pharmaceutical  manufacturing category.   This document_ provides
technical   support  for  the  final  BCT  effluent   _limitations
guidelines  and  has been developed after  consideration  of  the
public comments and newly acquired data.          |

The  public comments considered and responded to by the Agency  in
this  rulemaking  were  submitted in  response  to  three  Federal
Register    publications    by   the   Agency   which    concerned
pharmaceutical BCT limitations.  Comments were initially received
in  response  to the publication of proposed BCT  limitations_  on
November  26,  1982  at 47  FR 53584.   The Agency  also received
comments on NSPS proposed on October  27,  1983 at 48  FR 49832 and
on a notice of availability concerning new cost  information  to  be
used in the development of  BCT  limitations on March 9,  1984  at  49
FR 8697.   The comments on  the  proposed  NSPS have beien  considered
in  the context of BCT because  the  technology options  considered
as  the  basis  for NSPS  were identical  to   those  considered   as
candidate  BCT options.   The Agency  stated  this  in its March   9,
1984 notice.
 SUMMARY OF METHODOLOGY
 EPA's  implementation of the Act required a  compdex  development
          ^ _     ..  —   •    -*.«T   •	  J_l__  T^ «• «.••>*. jn^ r+ ** j«3  T"\^^ ^"«1 1 Tlrt ^ rt t"  ^/"\ T"
 program,
 Effluent
described  in
 Limitations
detail  in
Guidelines
the  Proposed  Document  for
 and   Standards   for   the
 PharmaceuticalPoint Source Category (U.S.  EPA,  November 1982)
 7Tj—First,  EPA studied the pharmaceutical industry to determine
 the  impact of raw material usage,  final products  manufactured,
 process  equipment,  size  and age of  manufacturing  faci-lities,
 water  use,  and  other  factors on  the  level  iof  conventional
 pollutants  discharged  from  plants  in  this  industry.    This
 required  the  identification  of raw waste  and  final  effluent
 characteristics, including the sources and volumes of water used,
 the   manufactuirng  processes  employed,   and  the  sources  of
 pollutants and wastewaters within the' industry.  !

 EPA  then  identified all subcategories for which BCT  should  be
 proposed  and characterized the raw waste conventional  pollutant
 discharges  from  plants  in  these  subcategories.    Next,  EPA
 identified  several distinct control and  treatment  technologies
 which are  in use or capable of being used to control conventional
 pollutants  in pharmaceutical industry wastewaters.   The  Agency
 compiled   and  analyzed  historical and newly-generated  data  on
 effluent   quality  resulting  from  the  application  of   these
 technologies.     The    long-term    performance,    operational
 limitations, and reliability of each of the treatment and  control
 technologies were also  identified.   In addition,  EPA considered
 the    non-water   quality   environmental   impacts   of    these

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                                                                        1
 technologies,  including  impacts  on air  quality,  solid  waste
 generation, and energy requirements.                        waste

 The  Agency  then  estimated  the  costs  for  each  control  and
 treatment  technology from unit cost curves developed by a?and«d
 engineering  analysis as applied to the  specific  pharmaceutical
 industry  wastewater characteristics.   EPA derivedun™  process
 costs from model plant characteristics (flow, pollutant raw SaJte
 loads)  applied to each treatment process unit^ost curve  (H
 nri™Y clariflcatlon' activated sludge,  filtration).  These unit
 process   costs  were  combined  to  yield  the  total   installed
 ??PnP?!r-  T^ at f^.^tment level.   Total capital  costs were
 then derived from the installed equipment costs.
                                                pollutant  removals
    i    a     h                      of  treatment.    These   data  as
 well    as  the  incremental   cost   estimates   were  used   in  the
 application of   the   BCT  cost  test methodology  in  order  to
 determine the  technological  basis  of  final  BCT limitations     ThS
 ^h0?01?97-, f °r  estfmatin9 individual plant costs  asSoctated with
 S52S  technology  option and the calculation  of  pollutant   rivals
 document          ****  °Pti°n 3re discussed  in  section VI  o£   ?his


 Prior   to  applying  the BCT cost  test  methodology,  the  Aaencv
            ^i COmTntS ^ceived concerning  the technology optlonl
 as    bnpSir-°  ?*r aspe°ts  of the Proposed BCT limitations  such
 as  subcategorization  and cost  estimation.   Responses  to  all
 o?  Co^Ln? the Pf°P°sed BCT  limitations may be foSnd in
 of  Comments and Responses on the November  26,  1982 Prooosed
K9Uiatl8nS'   the October 27, 1983 Proposed NSPS RegulI?ionS    d
 the March 9,   1984 Notice of Availability for the  Phamaceuticat
Manufacturing  industry."  Thereafter,  EPA applied   ™
             rn
                                                             -

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                           SECTION III
                   DESCRIPTION OF THE INDUSTRY
INTRODUCTION
                                                  i
Pharmaceutical plants manufacture biological products,  medicinal
chemicals, botanical products, and other pharmaceutical products.
~"-"   identified  465  operating  facilities  involved   in   the
                                     in
                                     of
                                      of
                                                              the
                                                              the
EPA
manufacture   of   pharmaceutical   products.     Most
pharmaceutical  industry  is located in the eastern half
United States.  The most prevalent manufacturing operation in the
industry is the formulating,  mixing,  and compounding operation;
batch-type  production  is the most common mode of  manufacturing
for this industry.

The  wastewaters  produced and discharged by  the  pharmaceutical
industry are very diverse.   Plant size, products,; processes, and
materials   to   which  wastewater  is  exposed   vary   greatly.
Additionally,  the  ratio of finished product to the quantity  of
raw  materials,  solvents,  and  other  processing  materials_ is
generally very low.   A detailed discussion of the pharmaceutical
industry  is  included in Section III of  the  final  development
document   and  in  Section  III  of  the  proposed   development
document.(1){2)                                   |
SUBCATEGORIZATION

As  described   in Section II of the proposed NSPS  document,   the
Agency  is maintaining the original BPT subcategorization   scheme,
under   which   the  pharmaceutical  manufacturing  industry    was
segmented into  the  following five subcategories:
      Subcategory A:
      Subcategory B:
      Subcategory C:
      Subcategory D:
      Subcategory E:
Fermentation Products        i
Extraction Products          i
Chemical Synthesis Products  !
Mixing/Compounding and Formulation
Research
 A  detailed  description  of  the  manufacturing  processes   and  raw
 materials  used  in  each of subcategories  A,   B,   C,  and  D  is
 presented  in  Sections  III  and  IV of   the   proposed   development
 document (1)  and in the  final development document  (2).    EPA did
 not   propose   BCT   for the   research    subcategory    because
 pharmaceutical research  does not involve production,   nor does it
 generate wastewater in appreciable quantities  on a  regular basis.
 Therefore,   the  Agency  is not promulgating final BCT  limitations
 for the research subcategory (E).

 The  Agency received no  comments on its decision to maintain  the
 original  BPT  subcategorization  scheme.     The  rationale   for
 maintaining   the  original   subcategorization  is  discussed  in

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 Section IV of the 1980  final development  document.(2)    Since  the
 Agency   believes  that  this  scheme   is  the   most    reasonable
 regulatory scheme available,  final  BCT are being promulgated   in
 accordance with this  subcategorization  scheme.


 EXISTING  END-OF-PIPE  TREATMENT AT  PHARMACEUTICAL PLANTS

 Table   III-l   presents  information on the methods  of  wastewater
 discharge  employed  at the  465 pharmaceutical manufacturing plants
 in  the  Agency's   data base.   At  11  percent  of  the  plants,
 wastewater  is  treated  on-site in  a  treatment system operated  by
 plant  personnel and  discharged directly  to waters of the  United
 States.    At   60  percent   of the  pharmaceutical  facilities,
 wastewater  is  discharged to a publicly  owned  treatment  works
 (POTW).  At 29  percent  of  the pharmaceutial plants, wastewater is
 not  generated  or all of the  wastewater that is  generated is  not
 discharged to navigable waters.

 Table  III-2  presents  information  on the  types  of  treatment
 currently  in-place at direct discharging pharmaceutical  plants
 Seventy-five  percent  of the direct discharging  plants  in  the
 industry  utilize  biological treatment,  and 16 percent  of  the
direct  discharging plants employ filtration systems in  addition
to biological treatment.
                              10

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                                TABLE III-l

                       SUMMARY OF METHOD OF  DISCHARGE
                          AT PHARMACEUTICAL  PLANTS
Method of Discharge

Direct Dischargers

Indirect Dischargers

Zero Dischargers
No. of Plants
          f
     52

    279
          I

    134
Total Plants
                                                     465
Since proposal, it has been learned two direct discharging plants have
become indirect and one plant is no longer manufacturing Pharmaceuticals
(see Table  III-l  in the Proposed Development Document  for comparison).
                                TABLE  III-2

                       IN-PLACE TREATMENT  TECHNOLOGY  AT
                  DIRECT DISCHARGING PHARMACTEUTICAL  PLANTS
 Treatment Techno!ogy

 Biological  Treatment

 Biological  Treatment Plus Filtration

 Physical Chemical

 Other

 Unknown
 Total Plants
 No.  of PI ants

     32

      8

      3

      4

      1
                                                      48*
 * Four direct discharging plants primarily produce products other than
   Pharmaceuticals and, therefore, have not been included in the data base,
                                        11

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12

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                           SECTION IV
                     WASTE CHARACTERIZATION
INTRODUCTION                                   [

The  Agency  conducted  an extensive data  gathering  effort  and
developed   qualitative  and  quantitative  information  on   the
characteristics    of   the   wastewaters   discharged   by   the
phfrmSceutfci?  industry.    This  .section  summarizes  available
information  on  the  characteristics  of  raw : waste  and  final
e?f?uent   discharges  from  direct  discharging   pharmaceutical
plants.   Only conventional pollutant data are presented in  this
document.                                      |
WASTE CHARACTERIZATION

Table   IV-1  presents a  summary
effluent BODJ5 and TSS data  for
plants.   This  table  is   an
appeared  in the proposed NSPS
September   1983)  and  includes
proposal.   It  is identical to
NSPS development document  (U.S.
                                of available raw waste and  final
                               direct discharging  pharmaceutical
                               updated version of  the  one  that
                               development  document  (U.S.  EPA,
                                 all data  submitted  after  that
                               the one that appears in the  final
                                EPAr June 1986).
      WASTE  CHARACTERISTICS FOR SUBCATEGORY A AND C AND B
                                                           AND  D
RAW  	
FACILITIES

Lona-term  average  raw  waste BOD5_ concentrations for 27  of  50
dirlct  discharging pharmaceutical plants may be found  in  Table
IV-1    Using  these  reported  values,  the Agency was  able  to
compute the required BODS and TSS long-term performance  averages
w£Ich  would  be in compliance with existing BPT  limitations  on
these  pollutants.   These averages are also found in Table IV-1.
Th!  Agency  also  developed Option A and  Option  B  performance
levels for BOD5 and TSS based on BCT candidate.technology options
A and B.  The derivation of these performance  levels is discussed
in detail in sections IV and V of "Development Document for Final
New   Source   Performance  Standards  for   the   Pharmaceutical
Manufacturing Point Source Category,"  (U.S. EPA, June 1986).

For   regulatory purposes,  the Agency  has grouped the  data   from
subcategory  A   (fermentation)   facilities  _with  the  data   from
lubcategory  C  (chemical synthesis)  facilities and the data   from
subcategory   B    (extraction)   facilities  with  subcategory   D
!formu!Sion  facilities).    Tables   IV-2 and  IV-3  present   the
available   average data   on   flow  and raw  waste< BOD5   and   TSS
concentrations  for A  and C and B and D pharmaceutical  facilities,
 respectively.   These  data  along  with other  information  from these
 facilities  have been  used  in  the application  of  the  BCT  cost  test
methodology   to   four  subcategories  of    the   pharmaceutical
                                 13

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manufacturing   point  source  category.    This  aonlication  i«
discussed in the remaining sections of this document
                             14

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16

-------
                                     TABLE  IV-2                 !

          AVERAGE RAW WASTE CHARACTERISTICS OF SUBCATEGORY A AND C  PLANTS
                                           Raw Waste Characteristics
                                Flow (MGD)         BODsJmg/11  i      TSS  (mg/Tj
M am,
11111
12022
12036
12073
12132
12161
12187
12406
12462
20246
20257
20298
55555
Average
ouu>-aocyui jr
C
A,C
A,C,Dt
C
A,C
A,C,D**
C
C
A
C
C
C
C

0.042
1.448
1.092
0.015
1.04
1.700
1.065
0.994
0.170
1.590
0.107
0.0005
0.1215
0.722
2,733
2,142
1,571
NA
2,916
1,464
NA
NA
1,856
NA
484
NA
1,454
1,922*
NA
NA
1,059
NA
NA
659
NA
420
1,400
NA
NA
NA
411
731*
N.A. = Not available


t   slbcatlgor^D supplies  2.0  percent  hydraulic  load  and 0.1 percent of BOD load
**  Subcategory D is less than  2 percent of production

Flow Weighted Average Inf.  BOD  =   (Flow x Inf. BOD)            -

                                                               i
Flow Weighted Average Inf. TSS =   (Flow x Inf. TSS)
                                           Flow       - 731  mg/Lj
                                           17

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                                      TABLE IV-3

           AVERAGE RAW WASTE CHARACTERISES OF SUBCATE60RY B AND D PLANTS
                            EMPLOYING BIOLOGICAL TREATMENT
Plant         Subcategory
           Raw Waste Characteristics
Flow (MGD)        BOD5 (mg/1)        'iSS
12001
12014
12015
12053
12085
12089
12098
12104
12117
12160
12205
12248
12283
12287
12298
12307
12308
12317*
12338
12459
12463
12471
20037
20201
20319
44444
Average
N.A. = Not
* BOD atyf
TCif FT r\LJ_ii/a :
D
B
D
D
D
B,D
D
D
B
D
D
D
D
D
D
0
D
D
D
D
B,D
B
D
D
D
D

available
n'cal of other
0.140
0.387
0.101
0.0185
0.0008
0.350
0.006
1.800
0.101
0.029
0.036
0.110
0.025
0.430
0.007
0.010
0.032
0.740
0.004
0.049
0.056
N.A.
-0.037
0.002
0.052
0.016
0.182

B/D production therefore not
N.A.
N.A.
233
768
N.A.
N.A.
N.A.
N.A.
35
490
N.A.
294
N.A.
N.A.
N.A.
N.A.
130
N.A.
200
70
102
N.A.
N.A.
N.A.
N.A.
333
208**

used
i -j*j \'»y/ i /
N.A.
N.A.
124
560
N.A.
N.A.
N.A.
N.A.
N.A.
1,615
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
67
41
200 '
59
N.A.
N.A.
N.A.
N.A.
N.A.
270
111**


                                        18

-------
                                 TABLE  IV-4

                  AVERAGE PLANT RAW WASTE CHARACTERISTICS
Subcategory A and C
 Plant Group

Subcategory B and D
 Plant Group
                                       Raw Waste Character!
                                             BODc
1922


 208
              sties (mg/1)
                TSS
731


111
                                        19

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                                         1
20

-------
                            SECTION V
          DEVELOPMENT OF CONTROL AND TREATMENT CiPTIONS
INTRODUCTION

EPA considered two technology options for BCT to control BOD5 and
?SS  Discharges from existing direct  discharging  pharmaceutical
plants.   These  options were developed after an analysis of  all
the  available  data  on the operation  of  biological  treatment
sylteST by  pharmaceutical manufacturing plants.   Both  options
entail more stringent control of BOD5 and TSS discharges than
required by existing BPT regulations.           j
is
                                                j
CONTROL AND TREATMENT OPTIONS

The two options that have been developed for consideration as the
basis of BCT effluent limitations are as follows.
BCT Option A                                    ,

Promulgate  BCT  concentration-based  limitations controlling   BOD5
and   TSS  based  on  the performance of  the best  plants   employing
SSvanced  biological treatment.   BCT  limitations: for  subcategory  A
tfemSntation) plants would  be  identical to  those  for subcategory
C (chemical synthesis) plants.   BCT  limitations for  subcategory  B
 (eiSrSSJiSn)  p?antB would be identical to those for  subcategory  D
 (formulation)  plants.

Tables  V-l and  V-2 present  the long-term average  final  effluent
BODS  and TSS  concentrations  discharged from  best performing  A and
C  and  B  and D subcategory plants   having   advanced   biological
 treatment  in-place.  Also   presented  in these  tables  are  the
 number!  of observations used to compute the  pollutant  averages
 and  the  lognormal means of the  pollutant   distributions.    The
 Agency,  in  response to public comments,  has decided  not to use
 oblervatioS-weighted performance averages.    Instead,   the Agency
 Sill use the  lognormal means of the pollutant value distributions
 as the performance averages.   The Agency believes that since the
 pollutant value distributions of the best performing A and C  and
 B  and D plants are essentially lognormal in nature,  the  truest
 estimate  of  the mean of each plant's pollutant distribution  is
 the mean of the lognormal distribution. .In all cases these means
 differ  only slightly from  the arithemetic means.    As a  result,
 the   long-term Option A performance averages for subcategories  A
 and C are 47.0 and  68.8 mg/1 for BOD5 and TSS,,respectively.
                                 21

-------
  BCT Option B
  TSS
  TSS
                                                               and
     b      °°nc??;trati°2-based limitations  controlling BODS
     based  on  the  performance of  the  best  plants
           bl°i°?ical  treatment  in  combination  with
          '   *hts .°Ption is identical  to the technology  optin
which  was  the basis for the proposed and final (see  Section  v
"Development Document for Final New Source Performance  StanSSrds
for the Pharmaceutical Manufacturing Point Source Category" -us
EPA,  June   1986).   Two sets of limitations would apply 7onese^
for  subcategory  A and subcategory C facilities and one set  for
subcategory B and subcategory D facilities.

Table   V^-3   presents  the   long-term  average  BODS
concentrations  achieved after  advanced  biological

                                            "
and
                                                              TSS
                                                              and
                                                               £y
 TS   nn™   ,.        7f P^sents  the  long-term average BODS and
 TSS  concentrations  achieved by two  subcategory  D  plants "with
 advanced  biological treatment and  effluent filtration  in-place
 Also included in these tables are the number of observations usSd
 in  computing  the arithmetic average and the lognorml?

 S  ca

 3    fr.       ^£^^^^^
 equal   to  those achieved by plant 12161,  the^nl? A aSd  C  planl
 with  advanced biological treatment and effluent  filtration   in-
 place,   or of  setting the BODS standard equal  to the  Option  A
 standard (47.0 mg/1) and the TSS standard at half  of the  Opt iSn A
 standard  (34 .4 mg/1).'  EPA selected the latter approach because
 this  approach involves the use of more of the   best
     i.
                     Sl*
                        These
                                           . 3
BPT

If  both option A and  B  fail the BCT cost test   RPT  Umi+- = <-•  '
controlling  BOD5  and  TSS will be set  equll' to  exis?inf  BP?
regulations.    BPT  limitations  are based^n the application   of
                              22

-------
biological  treatment and require subcategory A arid C  facilities
?o  achieve not less than 90 percent BODS reduction on an  annual

                                                        1
                    u-                   c
else  will a B and/or D facility be required to achieve an annual
average  BOD5  concentration of less than 15 mg/1 and  an  annual
average concentration of less than 26.5 mg/1.
                                 23

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26

-------
                           SECTION VI
           COST, ENERGY AND NON-WATER QUALITY ASPECTS
INTRODUCTION                                    |

^"^^ctlons describe the development of candidate£aO?tions
THE  BCT  COST  TEST  METHODOLOGY
iQft2
s
S
the
                                    proposed a revised methodology


  less  than  this benchmark  figure.
                                        option technology, must ^be
  I^^aSdirtf oir^cor^^ti e? ss ^  f f cSLUlate,

  the raw waste to BPT removal must be less .than 1.29.




             an                           23
                                  27

-------
                                 o
included in  he calculaions becae
                                                             S

candidate technologies

for BCT wiU be the
                           as
                                              " Pr?fess«  of  the

                                            aCCePtable PH  interval
 observations.

 those
               The  raw   ste levels

               by the
                                           •
                                                  Calculations were
                ..   mixed  plants   were  not  Dar   0. ,







 subcategory  D  Wastewa?«  along    "      " ^""311  "Iont  °f
                            .
      in the A/C subcategorj?
                                                           of  the
 METHODOLOGY FOR DEVELOPMENT OF COSTS
                          e
limitation! (see 47 FR 49538)
to  a  number of these
March  9,  1984  at 49 PR

                       2 *
                               in
                                               the  Pr°P°sed   BCT

                                             r^sponded' in effect,
                                              Register  notice  on

Cost Estimating Criteria
                                   cand










expected  to  hlve^ vS?uSiftK"ln9- ?°St  """teS  and  .i;


estimate of abour^' With  tMS  type  °f
                               28

-------
Capital Cost Criteria                           :
 on  the technology component.

                                                  t  are   directly
                                                  nt  facilities.
                                                  the  technology
                                                  onstruction and
                                                  on the  capital
                                                  of   technology
                                                    spare  parts/
Annual Fixed Charges
The  annual fixed charges  are  the annual costs tha
related  to the construction of pollution  >abateme
These  charges  commonly include depreciation ot
equipment,  interest  on the capital borrowed for c
installation  of  technology equipment,  ^terebt
borrowed   for  construction   and  installation
components,  and  costs for maintenance materials,,
insurance, and taxes.
The  useful  life of each structure and mechanical  unit  varies.

           rssr ^^^^^^^^^
       a n^Pful life of 40 to  50 years or more.    Interest on  the

               hs^s^s^^^"
 co?po1a?l bonds  or through conventional  lending  markets.

 in  calculating  annual fixed charges  for  capital  equipment,  EPA
 used  an  average rate of  22 percent of total capital  costs.   The
 annual "fixed  charge includes costs for   interest,  depreciation,
 and  capital equipment expenses discussed  above.  EPA  realizes
 no adverse comments  on the  use of 22 percent as
 charge rate or capital recovery rate.         .

 in calculating total annual costs, EPA included c
 labo? fSr operation  and maintenance of equipment,
 Energy  costs were based on an average national e
 SO 0495/kwh.   This   figure  is the average retai
 industrial  users  f romprivately owned utilities
 operating  revenues   were  $100 million   dollars
 averaae nonsupervisory labor rate was estimated t
 Sour  in  ?982?   Average total benefits  for  the
                                                     annual
                                                  osts for  energy,
                                                    and chemicals .
                                                  lectric cost   of
                                                  l  electric  for
                                                   whose  el ectric
                                                   in  1982    The
                                                  o be $10.18  per
                                                  year  1982  were
                                 29

-------
Revisions Made to  the cost  Development Methodology since Proposal
                      *9ency has made a number of changes in  the
                                                              £or
                                           u
consdered  a   tebasisf     for tnA
                             30

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Equalization,  Trickling  Filter,  and Chlorination|

           ,
2:
         "r^u?;0
changes  in  thlse  model treatment trains may  be   necessary  to
pSe that they include only those technology elements  needed to
cSmpl?  Sith the promulgated* BPT regulations.    The  Agency  agrees
 SSSffion           e
 Anenoi   colluded  that  it was not necessary for A and  C  model
 and B and D model treatment plant  costs.
 Biological Kinetics
 At
                                                     basins
                    were
                      k-
At  proposal,  the  sizes  (volumes) of the aeration
dete?mineT using the Grau equation and assuming a bxological
ratJ factor of 1.0 day'1 for  all  facilities.   In response to


  plant specific  data are not available.
  The  subcateqory  average biological k-rate used to size  the  BPT

  Tfirs?  s?agl° aeration basins for model A and.C plants was  3.6

  day£! while9the average rate  constant used to size the second
 day"*  rate
               constants  represent  average
        constant
                                                           fe
                                                           for
                                 31

-------
  existing A and  C  and B and D plants achieving BPT,  respectively
  Biological System Staging
                                                          .
                                                      an
 Secondary  Clarifier Overflow Rates
                                                            -
-"
                    ss
                             ,.  ,
                                              -        •
Filtration Technology Costs
                              32

-------
f?ltrftion  cSst  curves for gravity units (see; Leather  Tanning
Public Record Section 3-i Volume 2).
Costs and Conventional Pollutant Removals


                      r                     \Sn-t*
    ateaorv plants.   The cost estimating criteria used are found
in  Table VI-1 while the treatment system design bases are  found
in  Tables VI-2 through VI-5.   The estimated total  capital  and
annual  costs  of achieving BPT conventional pollutant  discharge
?eve?s  f?om raw waste levels for A/C and B/D subcategory  plants
are found ?n Tables VI-5 and VI-8,  respectively.   Also found in

                 ^
Table   v-6  and VI-9 provide analogous costs and Removals  for




 respectively.


 APPLICATION OF  THE BCT COST TEST  METHODOLOGY

 The  Agency  applied  the  BCT  cost   test   methodology  described
 earlie?  in  this  section  to two  candidate  BCT  options  for   four
 ISbcateqories  of  the pharmaceutical  industry.    For  purposes  of
 Se ^BCT colt test,  one set of BCT  candidate opt ions was  applied
 to  the  A  and  C  subcategories and one  set  to  the  B   and  D
 sSbcatSgorieS.    The options were identified and discussed in the
 nreviou!  section and in section V of "Development  Document  for
        Sew  Soiree Performance Standards for  the  Pharmaceutical
       a
                                             B%S.
 VI-10.
 The   results  in Table VI-11 indicate that both; candidate  options
 fafl   Coth  cost tests in four subcategories of^the pharmaceutical
 manufacturing  point   source   category.     Consequently,   BCT
 limitations  for   each  subcategory  are set   equal  to
 limitations.
the
BPT
                                 33

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COST, ENERGY, AND NON-WATER QUALITY IMPACTS
                             34

-------
                                TABLE  VI-1

                        COST ESTIMATING CRITERIA1
1.  Capital  costs are expressed as 1982 annual  average dollars:

    ENR = 3825

2.  Annual fixed (amortized) costs are 22% of capital expenditures
3.  Energy
Electrical
4.  Operation and Maintenance:
    Labor:


    Chemicals
General
Solids disposal

polymer
85% phosphoric acid
anhydrous ammonia
100%  sulfuric  acid
hydrated lime
                                            $0.0495/kwh.
$14.76/hr
$11.41/hr    |

$  6.06/kg
$  0.63/kg   !
$220   /kkg dry basis
$ 83.6 /kkg
$ 46.8 /kkg
 1  Sources of cost data:

                             U.S. Bureau of the Census, April  1978.
    Employment Benefits 1977.. Chamber of Commerce of the USA,, April  1978.

    Energy User News. Vol. 3, No. 32, August 7, 1978.

    Engineering News Record, March 23, 1978.              !

    Monthly Energy Review.  U.S. Department of Energy, January 1984.

    Municipal Sludge 'Landfills, EPA-625/1-78-010, U.S. Environmental Protection
    Agency", Process  Design Manual, October  1978.          j

    Chemical  Marketing  Reporter. November 6,  1978.
                                        35

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                                  TABLE VI.-2
              r™-  DESIGN BASIS OF THE TREATMENT SYSTEMS
              EX£E£IED T0 BE EMPLOYED AT PHARMACEUTICAL  INDUSTRY
                DIRECT DISCHARGERS TO MEET BPT EFFLUENT  LEVELS
  Wastewater Pumping
   Design flow:
   Basis for power cost:
  Flow Equalization
   Detention time:
   Aerator/Mixer Hp:       0.01 hg/m3 (40 hp/mg)
 Diversion Basin (Subcategory A-C only)
   Detention  time:          43 hours
 Neutralization  (Subcategory  A-C  only)
       1.5 x annual  average flow
       12m (40 ft) total dynamic head, 70% efficient
       12  hrs  in  concrete  basin  for  Subcategory A-C  plants
       48  hrs  in  concrete  basin  for  Subcategory B-D  plants
  Detention time:
  Chemical dosage:
      20 minutes
      lime = 0.3 kg/m3 (l.l ton/mg)
Primary Clarification  (Subcategory A-C only)
  Overflow rate:
  Sidewater depth:
Activated Sludge Basin
  Number of basins:
  Basin volume:
      24 m3/d/m2 (600  gpd/ft2)
      4 m (12 ft)
                          nri6 determined f™n the k-rate equation
                          presented below or an eight-hour minimum detention.
             k = So (So - Se)
                    x t Se
             where
Se = effluent BOD (dissolved), mg/1
So = influent BOD (dissolved), mg/1
x  = mixed liquor volatile suspended solids,  mq/1
t  = aeration time, days
k  = BOD removal  rate coefficient, days-*
     3.6 for Subcategory A-C plants  (Subcategory Average)
     2.0 for Subcategory B-D plants  (Subcategory Average)
                                     36

-------
                          TABLE  VI-2  (continued)

                  DESIGN BASIS OF THE TREATMENT SYSTEMS      !
            EXPECTFO TO BE EMPLOYED AT PHARMACEUTICAL  INDUSTRY
              DIRECT DISCHARGERS TO MEET BPT EFFLUENT  LEVELS
Activated Sludge Basin (continued)
  Nutrient Feed:          BOD applied: N:P = 100:5:1
  Aeration design requirements:
                          0? required = 1 kg 02/kg BODr (1 Ib 02/lb BODr)
                          02 supplied = 16.3 kg 02/hp-day (36 Ib 02/hp-day)
                              Safety Factor =1.5
  Mixing requirement:     0.03 hp/m3 (100 hg/mg)

 Secondary Clarification
   Overflow  rate:
   Sidewater depth:
16 m3/d/m2 (400 gpd/ft2)
4 m (12 ft)
 Gravity  Sludge  Thickener  (Subcategory  A-C only)

   Loading  rate:           29  kg/m2/day (6 tbs/ft2/day)

 Aerobic  Digester

   Detention time:          20  days

 Sludge Storage Tank

   Provides storage for 3 days of sludge generation.

 Solids Dewatering
   Type:
   Loading:
   Chemical dosage:

  Polishing  Ponds  (Subcategory  A-C  only):
 Vacuum filter  press
 20 kg/hr/m2 (4 lb/hr/ft2)  -  Subcategory  A-C
 10 kg/hr/m2 (2 lb/hr/ft2)  -  Subcategory  B-D
 4 kg polymer/kkg solids  (8 Ib/t  solids)
    Detention  Time:
    Solids  removal:
 2 days
 Pumping from multiple bottom draw-offs
                                         37

-------
                           TABLE VI-2 (continued)


                   DESIGN BASIS OF THE TREATMENT SYSTEMS

               no^2 T° BE EMPLOYED AT PHARMACEUTICAL  INDUSTRY
               DIRECT DISCHARGES TO MEET BPT EFFLUENT LEVELS
Primary/Biological Sludge Transportation
  Haul distance:
  Sludge content:
 16  km  (10 miles)

 primary and biological sludge at 30 percent
 sonds (w/w)
Primary/Biological  Sludge Landfill


  Sludge content:


  Landfill  design:
primary and biological sludge at 30 pecent
solids (w/w)

normal landfill  compaction and covering techniques
                                    38

-------
                              TABLE VI-3                 I

           DESIGN  BASIS  OF  THE TREATMENT  ELEMENTS  TO  BE  ADDED
     TO  BPT TREATMENT  SYSTEMS TO  MEET  BCT  OPTION A EFFLUENT  LEVELS
Wastewater Pumping

  Design flow:
  Basis for power cost:

Activated Sludge Basin

  Number of basins:
  Basin of volume:
                         1.5 x annual  average flow
                         12m (40 ft) total  dynamic head, 70% efficient
                         Subcategory A-C costs are based on the addition
                         of a second-stage basin.
                         Subcategory B-D costs are based on an enlarged
                         first-stage basin.              ;
                k = So (So - Se)
                      xv t Se

                where   Se = effluent BOD  (dissolved), mg/1
                        So = influent BOD  (dissolved), mg/1
                        x  = mixed  liquor  volatile suspended solids, mg/I
                        t  = aeration time,  days
                        k  = BOD  removal  rate  coefficient, days'1
                             Subcategory  A-C First-stage  average
                                                 k  =  3.6 days'1
                                             Second-stage average
                                                 k  =  0.155 days"1
                              Subcategory  B-D Single-stage average
                                                 k  =  2.0 days-1
                                                          i

Nutrient'Feed:            BOD applied:N:P: = 100:5:1
Aeration design requirements:

                          0? required =  1  kg 02/kg  BODr (1 Ib 02/lb BODr)
                          02 supplied = 16.3 kg !2/hp-day  (36 Ib 02/hp-day)
                               Safety Factor =1.5

Mixing requirements:      0.03 hp/m3 (100 hp/mg)
                                       39

-------
                           TABLE VI-3 (continued)

             DESIGN BASIS OF THE TREATMENT ELEMENTS TO BE ADDED
       TO BPT TREATMENT SYSTEMS TO MEET BCT OPTION A EFFLUENT LEVELS
      	•	
 Activated Sludge Basin (continued)


 First-Stage Clarification (Subcategory  B-D only)

   Overflow  rate:           10 m3/d/m2  (250  gpd/ft2)

   Sidewater depth:         4m  (12 ft)

 Second-Stage Clarification (Subcategory A-C only)
  Overflow rate:
  Sidewater dept:
10m3/d/m2 (250 gpd/ft2)
4 m (12 ft)
 esgn
 1ncluded  to Prov1de  the  incremental  sludge
                            '  "ased  on  the BPT
                C°S> •
                6
       PIT5-1  C°St! Were 1ncluded ^r the necessary additional  O&M and
vacuum fnllr™?^    de*«*?r the BCT incremental  sol ids  on the  BPT
""       e°StS                                          BCT
                                    40

-------
                                TABLE VI-4


  DESIGN BASIS OF THE FILTRATION SYSTEM TO  BE ADDED TO THE  BCT  OPTION  A
  DESIGN B          sySTEM TQ ME£T BCT  opTION B  EFFLUENT  LEVELS
Filtration:


  Type:
  Hydraulic Loading:
Multimedia                   _
0.102 m3/min/m2   (2.5 gpm/ft* .- Subcategory A-C
0.061 m3/m1n/m2   (1.5 gpm/ft?) - Subcategory B-D
                                       41

-------
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                                                                                                                               o
                                                                                                                               CM
                                                                                                                                0)

                                                                                                                                rcs
                                           QOOOOOOOOOQOOOOQOJOOQOCD§§§
                                                                                                                          (/I    O
                                                                                                                          r—    O
                                                                                                                          «5
                                                                  47

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                                  TABLE VI-11

                     SUMMARY OF BCT COST TEST CALCULATIONS
                 FOR THE PHARMACEUTICAL MANUFACTURING INDUSTRY
                                 (1982 Dollars)
Subcategory
(Subpart)
Fermentation (A)
Option A
Option B
Extraction (B)
Option A
Option B
Chemical Synthesis
Option A
Option B
Formulation (D)
Option A
Option B
1 POTW Test =

POTW Testl

$ .86
$ .94

$5.19
$6.43
(C)
t Qfi
$ .94

$5.19
$6.43

ost (BPT->BCT candidate technoloq'
Industry Cost
Test2

2.08
2.27

3.15
3.90


2.08
2.27

3.15
3.90

/) in 1982 dollars
                                                                      s
                            ^
2 Industry Cost Test =
                                                      trrhnnlogr)
                                                      "   -- "
                                            ^
                  cost/ 1 u removed (Raw Waste Load~^~B"PT)

     Candidate technology passes if industry cost test <1.29
                                     48

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                          SECTION VII
   BEST CONVENTIONAL TECHNOLOGY EFFLUENT LIMITATION GUIDELINES
GENERAL
The
     basis  for  best  conventional pollutant  control   technology
      effluent limitation  guidelines under section 304  of  the Act
is best conventional  technology.   As described Jin the   Preceding
section/  EPA selected the basis for BCT following application  of
the  recently  promulgated BCT  cost test methodology (see   51   FR
24974) .


IDENTIFICATION OF THE TECHNOLOGY BASIS OF FINAL BCT LIMITATIONS

The  technology basis selected  for control of BOD5 and TSS  under
Ic? is logical treatment (i.e.,  biological treatment which  is
?£e  basis of effluent limitation felines reflecting the  best
practicable control technology  currently available  (BPT) ) .
 FINAL BCT
 - .                                          ! .

 Table VII-1 presents BCT limitations controlling the conventional

 pollutants BOD5_, TSS, and pH.
                                               I
                                               I

 RATIONALE FOR THE SELECTION OF BCT CANDIDATE OPTIONS
 srs
                         ssrss
 rav be found in section V of this document.   A discussion of the
 mShodolSgy"  used  to  estimate incremental  (beyond  BPT)   costs
 associated with each of these options may be found in Section VI.
 METHODOLOGY USED FOR DEVELOPMENT OF FINAL BCT

 As discussed in Section VI,  EPA used the recently promulgated  BCT
 cost  test  methodology  to   evaluate  two  candidate  technology
 on?ions  for the A/C and B/D subcategories of the  pharmaceutical
 Snu?Sctur?ngth!ndistry.  Both candidate options failed both  the
 POTW  and  industry  cost tests  and,  as  a  result,  f^al  BCT
 limitations  on  BOD5  and  TSS are set  equal . to  existing
 limitations on these pollutants.               !
                                                              BPT
                                49

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COST OF APPLICATION AND EFFLUENT REDUCTION BENEFITS
NON-WATER QUALITY ENVIRONMENTAL IMPACTS












                                           S?

                             50

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                                TABLE  VII-1
                       FINAL BCT LIMITATIONS FOR THE
                   PHARMACEUTICAL MANUFACTURING CATEGORY
Subcategory

    A
  BOD5 30-Day
Maximum Average

0.10 x long-term
average raw waste
concentration x 3
(variability factor)

0.10 x long-term
average raw waste
concentration x 3
(variability factor)
or  45 mg/1, whichever
is  higher

0.10 x long-term
average  raw  waste
concentration  x  3
 (variability  factor)

0.10  x long-term
 average  raw  waste
 concentration x 3
 (variability factor)
 or 45 mg/1,  whichever
 is higher
                                             TSS 30-Day
                                           Maximum Average
day
1.7 x BOD5 30-dc
maximum average
limitation
                                           1.7 x BOD5 30-day
                                           maximum average;
                                           limitation
                                            1.7  x BOD5  30-day
                                            maximum average
                                            limitation
                                            1.7  x BOD5 30-day
                                            maximum average
                                            limitation
6.0-9.0
units at
all times
         6.0-9.0
         units at
         all times
         6.0-9.0
         units  at
         all times
          6.0-9.0
          units  at
          all  times
                                        51

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52

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                          SECTION VIII
                           REFERENCES
i
 '
2
3.
4
6.

7.




8



9.


10
 11
 12
     Proposed  Development  Document  for  Effluent   Limitations
               '                                               rce
     5uTdeTTnes' and
     Category
                                      Pharmaceutical Point Source
EPA, Washington, D.C., November 1982.

                                  New
     Development  Document  for Effluent Guidelines,
     Performance  jtj^jrgs,-nPretreatment gtandards jor
                   ""
                                                           Source
                                                              the
      erorance           ,
     PharmaceuticaT""TteHiIfTcturing Point  Source  Category,  U.S.
     EPA, Washington, D.C., September 1983.     ,

     Economic  Analysis of Effluent Standards and Limitations  for
         Pharmaceutical Industry,  U.S.  EPA,  Washington,  D.C.,
     September 1983

     Proposed  Development   Document   for   Effluent    Limitations
     JurSeTISes  and  Standards  for  the  PTnirmaceutical  Point  Source
     Category, uTsT  EPA,  Washington, D.C.,  September,  198J.

     Gibbons, J.  D.,  Nonparametric Statistical  Inference, McGraw-
     Hill,  1971.

     Wilks,  S. S., Mathematical Statistics, Wiley &  Sons,  1963.

     Development  Document  for Interim Final ggfluent Limitations
     Guidelines  and  Proposed New Source Performance  Standards for
     the Pharmaceutical Manufacturing  Point Source Category, U.S.
     EPA, Washington, D.C., December 1976.       ,

      "National  Survey of Professional, Administrative, Technical,
      and  Clerical Pay,  March 1981,"  U.S.   Department of  Labor,
      September  1981.

      vendor and Supplier Quotations to Environmental Science  and
      Engineering, Inc., Gainesville, Florida, 1982 and 1983.

      "Electric  Utility  Company Monthly Statement,"  March  1980
      Forward:  Federal Energy Regulatory Commission,  Form  5,  as
      cited in Monthly Energy Review,  .U.S.  Department _of Energy,
      Energy  Information  Administration,   DOE/EIA-0035  (81/12),
      December 1981.

      innovative  and Alternative  Technology  Assessment  Manual,
      EPA-430/9-78^Q09, - U^ - EPA^   Office   of  Water  Program
      Operations, February  1980.

      1980 Annual Survey  of  Manufactures, Fuel and Electr ic  gnergg.
          '    — industry Groups and Industries,: M80(AS)-4.1, U.S.
       Department  of  Commerce,  Bureau  of  the  Census
                                 53

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54

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                          SECTION IX
                       ACKNOWLEDGEMENTS
and
                                  a      B0rhn,



                                  "ol Portland, Maine,  for  their
Newton, Office of Water Enforcement.
Glenda Nesby made signif leant
                                            to this
                                                              Mr.
 efforts  is  also  greatly
                                55

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