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*po
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)
7TjFirst, 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
nriY 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
-------
manufacturing point source category. This aonlication i«
discussed in the remaining sections of this document
14
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4f CUre-c-DsS^rej^.p-
o >>cjcuto'-oc-re
2- ^ " 4-3 4-> O i O >
4-^ t- t- re CT> CD re
73 CUEOO04JCUQCU
c: 4-3 c_ re <"> Q. re 4-* CD t ^ i ^
re too.' cu cu -o retO^-Jc/)4->
-r- reocurere, o re
«r 4^ oi_icc:c3QQ.D^QQ
cu re
g -^ if ii ii ii ii M ii ii ii
o S
*- *
ii jo s =a; -x *
-jQ 1 }< 4c -Jc 4
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
-------
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
-------
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
-------
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
-------
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
-------
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 fn 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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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
-------
COST OF APPLICATION AND EFFLUENT REDUCTION BENEFITS
NON-WATER QUALITY ENVIRONMENTAL IMPACTS
S?
50
-------
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
-------
52
-------
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
-------
54
-------
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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