[Federal Register Volume 62, Number 153 (Friday, August 8, 1997)]
[Proposed Rules]
[Pages 42720-42732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20979]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL 5872-6]


Notice of Availability; Effluent Limitations Guidelines, 
Pretreatment Standards, and New Source Performance Standards: 
Pharmaceutical Manufacturing Category

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: On May 2, 1995, EPA proposed Clean Water Act (CWA) effluent 
limitations guidelines, new source performance standards, and 
pretreatment standards for the introduction of pollutants into publicly 
owned treatment works to reduce the discharge of pollutants from the 
pharmaceutical manufacturing industry (60 FR 21592). This document 
describes new information the Agency has obtained since the proposal, 
provides detailed information concerning regulatory options under the 
CWA which were identified in the April 2, 1997 (62 FR 15753) Maximum 
Achievable Control Technology (MACT) Standard Clean Air Act (CAA) 
proposal, and presents the results of analyses of old and newly 
acquired data and suggested modifications to the proposal. This 
document also solicits public comments regarding any of the information 
presented in this document and the record supporting this notice of 
data availability.

DATES: Comments on this document are solicited and will be accepted 
until September 22, 1997. Comments are to be submitted in triplicate, 
and also in electronic format (diskettes) if possible.

ADDRESSES: Comments are to be submitted to Dr. Frank H. Hund at the 
following address: Engineering and Analysis Division (4303), EPA, 401 M 
Street, S.W., Washington, D.C. 20460.
    The data and analyses being announced today are available for 
review in the EPA Water Docket at EPA Headquarters at Waterside Mall, 
room M2616, 401 M Street, SW, Washington, DC 20460. For access to the 
Docket materials, call (202) 260-3027 between 9:00 a.m. and 3:30 p.m. 
for an appointment. A reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: For additional technical information, 
contact Dr. Frank H. Hund at the following address: Engineering and 
Analysis Division (4303), EPA, 401 M Street, S.W., Washington, D.C. 
20460, telephone number (202) 260-7182. For information on economic 
impacts, contact Mr. William Anderson at the same address, telephone 
number (202) 260-5131.

SUPPLEMENTARY INFORMATION:

Contents of this Document

I. Summary of the CWA Regulatory Options Identified in the Maximum 
Achievable Control Technology (MACT) Standard Proposal and Purpose 
of this Notice
II. Data Acquired Since the May 2, 1995 Proposal
    A. Individual Plant Submissions
    1. Biological and Advanced Biological Treatment Data 
(Biochemical Oxygen Demand (BOD<INF>5</INF>), Chemical Oxygen Demand 
(COD), Total Suspended Solids (TSS) and Ammonia)
    2. Biological and Advanced Biological Treatment Organics Data
    3. Steam Stripping Performance Data
    4. Technology Performance Data for Cyanide
    B. Data Editing Criteria and Limitations
    1. Biological and Advanced Biological Treatment Data 
(Biochemical Oxygen Demand (BOD<INF>5</INF>), Chemical Oxygen Demand 
(COD), Total Suspended Solids (TSS) and Ammonia)
    2. Biological and Advanced Biological Treatment Organics Data
    3. Steam Stripping Performance Data
    4. Technology Performance Data for Cyanide
    C. EPA and PhRMA Sampling Results
III. Analysis of Best Available Technology (BAT) and Pretreatment 
Standards for Existing Sources (PSES) Options Identified in the 
Maximum Achievable Control Technology (MACT) Proposal
    A. BAT Option
    B. PSES Analysis
    1. Pass-Through
    a. New Data Related to Pass-Through
    b. Possible Alternative Pass-Through Analysis
    2. Preliminary Costs and Loading Removals Assuming Two Different 
Pass-Through Scenarios for Modified Options
IV. Results of Analyses of Pre-Proposal and Newly Acquired Data With 
Respect to Various Comment Issues
    A. New Source Performance Basis
    B. Ammonia Limitations and Standards
    C. Pollutant Exclusions
    D. Use of Surrogate Pollutants
    E. Small Facility Exclusion
    F. Changes to Engineering Cost and Load Removal Estimates
V. Discussion of Pollution Prevention Approach
VI. Solicitation of Data and Comments
    A. Determination of the Pass Through for Water Soluble 
Pollutants for POTWs with Covered Headworks and Primary Tanks or 
Demonstrating Less than 5% Volatilization
    B. Determination of Pass-through at POTWs with Nitrification
    C. Information from Facilities with Higher Ammonia Loadings Than 
Were Shown in their 1990 Questionnaire Responses
    D. Information on Land Availability for Two-Stage Nitrification 
Treatment
    E. Information from Subcategory B/D facilities on Number of 
Operating Days per Week
    F. Proposed Exemption for OCPSF Manufacturers of Bulk 
Pharmaceutical Intermediates and Active Ingredients with Less than 
50% Pharmaceutical Wastewater
    G. Wastewater from Pilot Plant Operations
    H. Basis for Determining Which Cyanide Standards Apply

I. Summary of the CWA Regulatory Options Identified in the Maximum 
Achievable Control Technology (MACT) Standard Proposal and Purpose 
of This Notice

    On May 2, 1995 (60 FR 21592), EPA proposed regulations to reduce 
discharges to navigable waters of toxic, conventional, and 
nonconventional pollutants in treated wastewater from the 
Pharmaceutical Manufacturing Category. In that proposed rule the Agency 
indicated that it would be proposing a Maximum Achievable Control 
Technology (MACT) standard for the Pharmaceutical Manufacturing 
Industry. Under the CAA on April 2, 1997 at 62 FR 15753, EPA proposed 
MACT Standards to control emissions of Hazardous Air Pollutants (HAPs) 
from storage tanks, process vents, equipment leaks and wastewater (the 
MACT proposal). In the preamble to the MACT proposal (62 FR 15760), EPA 
also indicated it was considering modifications to its effluent 
guidelines proposal of May 2, 1995 in order to avoid duplicative 
regulations.
    For direct discharging fermentation (subcategory A) and chemical 
synthesis (subcategory C) facilities, EPA discussed changing its model 
BAT technology basis for Volatile Organic Pollutants (VOCs), which 
include many of the HAPs intended for control by the MACT Standards, 
from in-plant steam stripping followed by advanced biological treatment 
to advanced biological treatment. This change was based on the

[[Page 42721]]

fact that the MACT Standards control many of the wastestreams 
containing VOCs. Since the MACT Standards use steam stripping as the 
technology basis, certain costs previously associated with steam 
stripping in the effluent guidelines proposal are now being considered 
as part of the costs of the MACT Standards. However, for a small number 
of the wastewater streams that are not controlled by the MACT 
Standards, additional costs associated with steam stripping will be 
identified as costs resulting from compliance with the effluent 
limitations guidelines and standards.
    For PSES, three modifications to the 1995 proposal were discussed. 
Option 1 would be compliance with the wastewater MACT Standards with 
the addition of some effluent monitoring. Options 2 and 3 were intended 
to control the additional discharge of VOCs not controlled by the MACT 
Standards. Option 2 would require compliance with the wastewater MACT 
Standards as well as compliance with additional pretreatment standards 
for volatile HAPs and non-HAPs not covered by the MACT Standards and 
basing the pretreatment standards on the MACT percent reduction 
approach. Option 3 would require the same compliance as Option 2 except 
that the additional pretreatment standards would be based on the 
performance database for the same control technology as the 1995 
proposed PSES for VOCs. For the purpose of this notice, EPA has dropped 
Option 2 since it considers the data supporting Option 3 to be adequate 
for developing pretreatment standards, and has incorporated several 
scenarios into Option 3. Hereafter, the options being discussed include 
option 1 as discussed above and the option scenarios derived using 
Option 3.
    Thus, the new PSES/PSNS option designations and descriptions are: 
Option 1--compliance with the MACT Standards plus some regular 
monitoring, Option 2--compliance with the MACT Standards plus 
additional PSES based on the performance database for the 1995 proposed 
PSES for all VOCs except alcohols and related pollutants, and Option 
3--same as option 2 except the additional pollutants include alcohols 
and related pollutants. EPA has received numerous comments and data 
submissions concerning the 1995 proposal and in this notice, EPA is 
making these new data submissions available for comment and is 
providing a discussion of the results of analyses performed relating to 
specific issues raised by commenters. EPA will also solicit information 
and comments on a variety of other issues or questions.

II. Data Acquired Since the May 2, 1995 Proposal

    Since the proposal, EPA has acquired a significant amount of data 
and information from the industry, and the Agency has included these 
new data and information in Section 13.1 of the supporting record of 
this Notice in order that the new data can be reviewed by interested 
parties. The Agency solicits comments based on reviews of these data. 
The new data submitted include: (1) Technology performance data for 
Biochemical Oxygen Demand (BOD<INF>5</INF>), Chemical Oxygen Demand 
(COD), and Total Suspended Solids (TSS) for advanced biological 
treatment systems; (2) nitrification in biological treatment systems 
data for ammonia; (3) advanced biological treatment systems data for 
organic pollutants; (4) steam stripping performance data for volatile 
organic pollutants; and (5) technology performance data for treatment 
of cyanide. Below are summaries of each type of new data and the 
results of additional analysis of these data by the Agency.

A. Individual Plant Submissions

1. Biological and Advanced Biological Treatment Data (Biochemical 
Oxygen Demand (BOD<INF>5</INF>), Chemical Oxygen Demand (COD), Total 
Suspended Solids (TSS) and Ammonia)
    Additional BOD<INF>5</INF>, COD, and TSS data were submitted with 
comments on the proposed CWA effluent limitations guidelines and 
standards from five facilities. The data from three of the facilities 
represent additional years of data that supplement the 1990 year data 
that were previously part of the best CWA technology performance 
database. Data from one other facility represent a new source of 
BOD<INF>5</INF>, COD, and TSS performance data, while data from the 
fifth facility included only one data pair and were not included in the 
long-term means determination.
    Performance data on ammonia nitrification from one facility were 
used as the basis of ammonia limitations at proposal. This facility has 
provided additional multi-year effluent ammonia data. Also since 
proposal, EPA has collected additional ammonia nitrification data from 
three other facilities. One facility did not show a period of 
consistent nitrification and data from this facility were therefore not 
included. The other new ammonia data from biological treatment have 
been added to the existing ammonia database.
    In response to the various CWA proposal comments related to 
BOD<INF>5</INF>, COD, TSS, and ammonia, EPA has incorporated the newly 
submitted data with the data used for the proposal and revised its 
proposed limitations for the various parameters. These revised 
limitations and, in some cases, alternate control levels are discussed 
further in Section II.B.1 below. EPA requests comments on the newly 
submitted data (see Notice Record Section 13.1.1).
2. Biological and Advanced Biological Treatment Organics Data
    New organics biological treatment performance data were submitted 
with CWA proposal comments from six facilities. Four of these 
facilities represented performance of advanced biological treatment. 
Advanced biological treatment was defined in the CWA proposal as, 
``treatment systems that consistently surpass, on a long-term basis, 
90% BOD<INF>5</INF> reduction and 74% COD reduction in pharmaceutical 
manufacturing wastewater, as required by the existing BPT effluent 
limitations guidelines (40 CFR Part 439)''. The additional data include 
some information on 45 organic pollutants and describe the removal 
performance with respect to 16 of the pollutants for which limitations 
were proposed. Removal performance for the remaining 29 organic 
pollutants was not provided, however. In response to the various CWA 
proposal comments related to the proposed organics limitations, EPA has 
incorporated the newly submitted data with the data used for the 
proposal and has revised its proposal limitations for the various 
parameters. Those revised limitations and, in some cases, alternative 
control levels are discussed further in Section II.B.2 below. EPA 
requests comments on the newly submitted data (see Notice Record 
Section 13.1.2) and their use.
3. Steam Stripping Performance Data
    New data representing the performance of steam stripping technology 
in removing volatile organic pollutants were submitted with CWA 
proposal comments by three facilities. The additional data reflect 
treatment by four stream strippers of 23 of the pollutants for which 
standards were proposed. In response to the CWA proposal comments 
related to steam stripping of volatile organics, EPA has incorporated 
the newly submitted data with the data used at proposal and revised its 
proposal pretreatment standards for the various parameters. These 
revised standards and, in some cases, alternate control levels are 
discussed in Section II.B.3. below. EPA

[[Page 42722]]

requests comments on the newly submitted data (see Notice Record 
Section 13.1.3) and their use.
4. Technology Performance Data for Cyanide
    EPA received additional cyanide treatment performance data from 
three facilities. Two of these facilities use alkaline chlorination 
treatment and one of these facilities uses hydrolysis treatment. For 
one facility, the new data include the individual effluent data points 
corresponding to the facility's Section 308 Questionnaire average 1990 
effluent cyanide concentration. For the second facility, the new data 
include (1) part of the raw 1990 data used in developing the facility's 
Section 308 Questionnaire average effluent cyanide concentration (the 
other part of the raw 1990 data used in the reported averages could not 
be located by the plant) and (2) additional 1994 cyanide destruction 
data. For the third facility, the new data include 1994 cyanide 
destruction data. In response to the CWA comments related to cyanide, 
EPA has incorporated the newly submitted data with the data used at 
proposal and revised its proposed limitations and standards for 
cyanide. These revised standards and, in some cases, alternate control 
levels are discussed in Section II.B.4. below. EPA requests comments on 
the newly submitted data (see Notice Record Section 13.1.4) and their 
use.

B. Data Editing Criteria and Limitations

    After considering comments on the proposed CWA effluent limitations 
guidelines and standards, EPA has developed data editing criteria and 
methodologies for developing alternative limitations. The new data 
editing criteria and methodologies address comments on the proposed 
limitations; these comments and the approach(s) to respond to them are 
discussed below.
1. Biological and Advanced Biological Treatment Data (Biochemical 
Oxygen Demand (BOD<INF>5</INF>), Chemical Oxygen Demand (COD), Total 
Suspended Solids (TSS) and Ammonia)
    The data used in determining limitations for BOD<INF>5</INF>, COD 
and TSS, were selected based on the following criteria which were 
discussed in the proposal. First, the treatment at the facility must 
qualify as advanced biological treatment as defined in section II.A.2. 
Next, the facilities must treat a majority (49% or more by volume) of 
pharmaceutical process wastewater in relation to other process 
wastewater. Finally, the treatment facilities must be representative of 
conventional treatment technologies. Using these criteria facilities 
were selected to provide data used in determining limitations for 
BOD<INF>5</INF>, COD and TSS.
    The data used in determining limitations for ammonia were selected 
based on biological nitrification. Facility input and nitrate levels 
helped to determine which facilities nitrified. Some of these 
facilities only experienced occasional nitrification. For these cases, 
the data representing nitrification were extracted from the data which 
did not. These data sets were used in determining limitations for 
ammonia.
    EPA received several comments indicating that in developing the 
proposed BPT limitations on BOD<INF>5</INF>, COD, and TSS, EPA did not 
take into account significant amounts of non-process water present in 
the effluent of some best performing facilities. In evaluating this 
comment, EPA has recalculated long-term means, limitations, and 
facility effluent concentrations for BOD<INF>5</INF>, COD, and TSS from 
biological treatment using the following methodology. If 25% or more of 
the treated plant flow was non-process wastewater, then the non-process 
wastewater flow was assumed to be dilution water and the plant 
performance data were then reaveraged using the corrected parameter 
concentrations. The 25% or more non-process wastewater cutoff was 
chosen because dilution above this level would cause any concentration 
data reported to reflect too much uncertainty for the data to determine 
the performance of the technology used as a basis of effluent numerical 
limits. This is the same cutoff of acceptable dilution relied on in the 
Organic Chemicals, Plastics, and Synthetic Fibers (OCPSF) regulation.
    In applying this methodology to best performers in the BPT 
database, EPA revised the performance from three facilities. The 
resulting limitations are less stringent than the proposed limitations 
and are presented in Table 1. These limitations would be converted to 
mass standards by the permit authority using the pharmaceutical process 
wastewater flow of the facility and not the end-of-pipe treatment flow. 
EPA requests comments on the newly calculated BPT limitations for 
BOD<INF>5</INF> and TSS, the newly calculated BAT limitations for COD 
and ammonia, and the methodology used to calculate them (see Notice 
Record Section 14.6.1).

    Table 1.--Long-Term Mean Concentrations and BPT and BAT Effluent    
                               Limitations                              
------------------------------------------------------------------------
                                                       BPT/BAT effluent 
                                                          limitations   
                                     Long-term mean  -------------------
       Pollutant parameter         concentration(mg/   Maximum          
                                           l)          for any   Monthly
                                                       one day   average
                                                       (mg/l)    (mg/l) 
------------------------------------------------------------------------
Subcategory A/C:                                                        
BOD<INF>5.............................          125.0         647.0     202.0
COD*.............................          951.0       2,150.0   1,210.0
TSS..............................          347.0       1,980.0     594.0
Ammonia*.........................            2.1           9.2       3.8
                                                                        
Subcategory B/D:                                                        
BOD<INF>5.............................           13.7          64.4      21.1
COD*.............................           72.4         282.0     110.0
TSS..............................           33.8         164.0      52.4
------------------------------------------------------------------------
*BAT Limitations.                                                       

2. Biological and Advanced Biological Treatment Organics Data
    The data used in determining the BAT limitations for organic 
pollutants were selected based on the following criteria which were 
discussed in the proposal. First, the treatment at the facility must 
qualify as advanced biological treatment as defined in section II.A.2. 
Next, the facilities must treat a majority (49% or more by volume) of 
pharmaceutical process wastewater in relation to other process 
wastewater. Then, pollutant data sets must contain detected influent 
values which are greater than ten times the detection level of the 
pollutant in the effluent. In the proposal, data sets that showed 
influent levels of pollutants 10 times effluent levels were considered 
to show evidence of treatment. EPA excluded pollutant data sets which 
did not show pollutant removal through treatment or which had pollutant 
effluent values greater than influent values. Additionally, EPA 
excluded data sets which consisted of average pollutant influent values 
which were low (i.e., less than 10 times the long term mean of the 
effluent value for that pollutant), thus, did not represent technology 
performance. Finally, EPA received several comments stating that data 
sets with a small number of data points should not be used in 
limitations and standards development. Therefore, EPA excluded data 
sets with less than three data points. From these criteria, data were 
selected to be used in determining limitations for organic pollutants.
    Several commenters on the CWA proposal indicate that in developing 
the proposed BAT limitations on nonconventionals, EPA did not take into

[[Page 42723]]

account significant amounts of non-process water present in the 
effluent of some best performing facilities. In evaluating this 
comment, EPA has recalculated long-term means, limitations, and 
facility effluent concentrations for nonconventionals from biological 
treatment using the following methodology. If 25% or more of the 
treated plant flow was non-process wastewater, then the non-process 
wastewater flow was assumed to be dilution water and the plant 
performance data were then reaveraged using the corrected pollutant 
concentrations.
    The new candidate BAT limitations based on advanced biological 
treatment were developed using the data editing criteria listed above 
and incorporating the dilution water corrections. They are in Table 2. 
These limitations would be converted to mass standards by the permit 
authority using the pharmaceutical process wastewater flow of the 
facility and not necessarily the total end-of-pipe treatment facility 
discharge flow. EPA requests comments on the newly calculated candidate 
BAT limitations and the methodology used to calculate them (see Notice 
Record Section 14.6.2).

  Table 2.--Long-Term Mean Concentrations and BAT Effluent Limitations  
------------------------------------------------------------------------
                                               BAT effluent limitations 
                                 Long-term   ---------------------------
 Pollutant code and pollutant       mean       Maximum for     Monthly  
             name              concentration   any one day  average (mg/
                                   (mg/L)        (mg/L)          L)     
------------------------------------------------------------------------
003--Acetonitrile............        0.05          0.2           0.09   
010--n-Amyl Acetate..........        0.3           1.1           0.5    
011--Amyl Alcohol............        1.1           3.7           1.8    
012--Aniline.................        0.03          0.1           0.05   
015--Benzene.................        0.002         0.009         0.004  
025--2-Butanone (MEK)........        0.04          0.2           0.08   
026--n-Butyl Acetate.........        0.3           1.1           0.5    
027--n-Butyl Alcohol.........        1.1           3.7           1.8    
029--tert-Butyl Alcohol......        1.1           3.7           1.8    
035--Chlorobenzene...........        0.03          0.1           0.05   
037--Chloroform..............        0.01          0.02          0.01   
048--o-Dichlorobenzene.......        0.03          0.1           0.05   
051--1,2-Dichloroethane......        0.05          0.4           0.1    
055--Diethylamine............        0.01          0.05          0.02   
060--N,N-Dimethylacetamide...        0.01          0.05          0.02   
062--N,N-Dimethylaniline.....        0.03          0.1           0.05   
064--N,N-Dimethylformamide...        0.01          0.05          0.02   
066--Dimethyl Sulfoxide......        0.05          0.2           0.1    
067--1,4-Dioxane.............        0.8           8.4           2.6    
070--Ethanol.................        1.1           3.7           1.8    
071--Ethyl Acetate...........        0.3           1.1           0.5    
077--Ethylene Glycol.........        1.1           3.7           1.8    
079--Formaldehyde............        0.3           1.2           0.5    
080--Formamide...............        0.01          0.05          0.02   
084--n-Heptane...............        0.005         0.02          0.009  
087--n-Hexane................        0.01          0.03          0.02   
093--Isobutyraldehyde........        0.3           1.2           0.5    
094--Isopropanol.............        0.8           3.3           1.4    
095--Isopropyl Acetate.......        0.3           1.1           0.5    
096--Isopropyl Ether.........        0.8           8.4           2.6    
097--Methanol................        1.7           5.0           2.6    
101--Methyl Cellosolve.......        1.1           3.7           1.8    
102--Methylene Chloride......        0.1           0.9           0.3    
103--Methyl Formate..........        0.3           1.1           0.5    
105--4-Methyl-2-Pentanone                                               
 (MIBK)......................        0.1           0.4           0.2    
113--Petroleum Naphtha.......        0.01          0.06          0.02   
114--Phenol..................        0.01          0.05          0.02   
115--Polyethylene Glycol 600.        0.8           8.4           2.6    
117--n-Propanol..............        1.1           3.7           1.8    
118--Acetone.................        0.1           0.4           0.2    
124--Pyridine................        0.03          0.1           0.05   
129--Tetrahydrofuran.........        0.8           8.4           2.6    
130--Toluene.................        0.01          0.06          0.02   
136--Triethylamine...........        0.01          0.05          0.02   
139--Xylenes.................        0.005         0.02          0.01   
------------------------------------------------------------------------

3. Steam Stripping Performance Data
    The steam stripping data used in determining the new candidate PSES 
limitations for volatile organic pollutants shown in Table 3 were 
selected based on the following criteria which also were discussed in 
the CWA proposal:
    <bullet> All data point pairs with influent concentrations below 
detection limit were deleted;
    <bullet> All data points that were collected from a flash tank or 
distillation pot were deleted;
    <bullet> All data point pairs with a negative percent removal or 
that showed no removal after treatment were deleted;

[[Page 42724]]

    <bullet> All data point pairs with an influent lower than the long 
term means shown in Table 3 were deleted;
    <bullet> All data point pairs collected from a steam stripper with 
inadequate steam to feed ratios or an inadequate number of equilibrium 
stages in the stripper were deleted;
    <bullet> Effluent concentrations that were reported below the 
detection limit were assumed to have a concentration equal to the 
detection limit; and
    <bullet> Data which came from a single wastewater stream at one 
facility that was deemed to have an atypical matrix, i.e., did not lend 
itself to BAT performance, were not used. Similarly, other data points 
which were not considered representative of BAT technology performance 
were not used.
    The data sets used in the development of the limitations are 
included in the record for this notice. The new candidate PSES (Table 
3) are based on air stripping for ammonia and steam stripping for VOCs, 
and were developed using the data editing criteria listed above. EPA 
requests comments on the newly calculated candidate PSES and the 
methodology used to calculate them (see Notice Record Section 14.6.3).

   Table 3.--Long-Term Mean Concentrations and PSES Effluent Standards  
------------------------------------------------------------------------
                                                PSES effluent standards 
                                 Long-term   ---------------------------
 Pollutant code and pollutant       mean       Maximum for     Monthly  
             name              concentration   any one day  average (mg/
                                   (mg/L)        (mg/L)          L)     
------------------------------------------------------------------------
009--Ammonia as N............        9.9          12.9          10.9    
010--n-Amyl Acetate..........        4.1          20.7           8.2    
011--Amyl Alcohol............       11.8          47.4          20.6    
012--Aniline.................    1,240         3,160         1,760      
015--Benzene.................        0.2           3.0           0.6    
025--2-Butanone (MEK)........      121         1,440           430      
026--n-Butyl Acetate.........        4.1          20.7           8.2    
027--n-Butyl Alcohol.........    1,240         3,160         1,760      
029--tert-Butyl Alcohol......       11.8          47.4          20.6    
035--Chlorobenzene...........        0.2           3.0           0.6    
037--Chloroform..............        0.01          0.1           0.03   
048--o-Dichlorobenzene.......        4.1          20.7           8.2    
051--1,2-Dichloroethane......        4.1          20.7           8.2    
055--Diethylamine............        4.1          20.7           8.2    
062--N,N-Dimethylaniline.....       11.8          47.4          20.6    
067--1,4-Dioxane.............    1,240         3,160         1,760      
070--Ethanol.................      355         1,900           724      
071--Ethyl Acetate...........        4.1          20.7           8.2    
080--Formamide...............       11.8          47.4          20.6    
084--n-Heptane...............        0.2           3.0           0.6    
087--n-Hexane................        0.2           3.0           0.6    
093--Isobutyraldehyde........        4.1          20.7           8.2    
094--Isopropanol.............       11.8          47.4          20.6    
095--Isopropyl Acetate.......        4.1          20.7           8.2    
096--Isopropyl Ether.........        4.1          20.7           8.2    
097--Methanol................    1,240         3,160         1,760      
101--Methyl Cellosolve.......        0.2           3.0           0.6    
102--Methylene Chloride......        0.2           3.0           0.6    
103--Methyl Formate..........        4.1          20.7           8.2    
105--4-Methyl-2-Pentanone                                               
 (MIBK)......................        4.1          20.7           8.2    
113--Petroleum Naphtha.......    1,240         3,160         1,760      
117--n-Propanol..............      355         1,900           724      
118--Acetone.................        4.1          20.7           8.2    
124--Pyridine................       43.1         569           163      
129--Tetrahydrofuran.........        1.5           9.2           3.4    
130--Toluene.................        0.1           0.3           0.1    
136--Triethylamine...........        4.1          20.7           8.2    
139--Xylenes.................        0.2           3.0           0.6    
------------------------------------------------------------------------

4. Technology Performance Data for Cyanide
    Commenters indicated that the hydrogen peroxide technology basis 
used to determine the CWA proposal limitations and standards for 
cyanide when used to oxidize cyanide in certain mixtures containing 
organic synthesis waste products, could cause equipment explosions and 
accordingly raised plant safety concerns. Other commenters have 
indicated that the technology basis for cyanide limitations and 
standards should not be limited to hydrogen peroxide oxidation 
technology since it may not be appropriate to all cyanide treatment 
situations. In addressing these comments, EPA has reevaluated all of 
the cyanide destruction data in its data base. Data representing the 
performance of hydrogen peroxide, alkaline chlorination, and hydrolysis 
technologies were reevaluated from a performance standpoint. EPA has 
excluded from consideration those data sets that consist of only one 
data point pair and those datasets for which the influent or effluent 
cyanide concentrations are unknown. The Agency is developing two sets 
of possible limitations, the one based on hydrogen peroxide oxidation 
technology, and the other based on alkaline chlorination technology. 
EPA is considering promulgating two sets of limitations, one of these 
based on hydrogen peroxide technology would be used by the great 
majority of facilities.

[[Page 42725]]

Facilities with a potential safety hazard would be required to comply 
with limitations based on alkaline chlorination. We invite comments on 
parameters to define which cyanide limits would apply. Some commenters 
have suggested that cyanide wastestreams with high organic content as 
evidenced by high COD and TOC (total organic carbon) would be more 
appropriately controlled by limitations based on alkaline chlorination. 
EPA requests data to define these levels and any other data persons 
believe relevant to determining the performance and safety aspects of 
these technologies (see Notice Record Section 14.6.4).

------------------------------------------------------------------------
                                  Long-term                             
                                     mean       Maximum for    Monthly  
          Technology            concentration   any one day  average (mg/
                                    (mg/L)        (mg/L)          L)    
------------------------------------------------------------------------
Hydrogen peroxide oxidation...           0.24          0.8           0.4
Alkaline chlorination.........           4.8          22.9           9.8
------------------------------------------------------------------------

C. EPA and PhRMA Sampling Results

    In August of 1996, EPA and the Pharmaceutical Research and 
Manufacturers Association (PhRMA) conducted sampling at the Barceloneta 
POTW in Barceloneta, Puerto Rico. The purpose of the sampling visit was 
to obtain data on the removal of alcohols (methanol, ethanol and 
isopropanol) and other oxygenates in the primary treatment works of a 
POTW. Specifically, EPA was attempting to determine the extent to which 
these compounds volatilize in the grit chambers and primary clarifiers 
of a POTW prior to the secondary (biodegradation) treatment process. 
The Barceloneta POTW was selected for sampling because the influent of 
this POTW was known to contain measurable quantities of alcohols and 
other pollutants for which pretreatment standards were proposed in May, 
1995. In addition to the wastewater sampling for the alcohols and other 
pollutants, EPA conducted a separate biodegradation study to determine 
the extent to which the alcohol pollutants were being aerobically 
biodegraded in the aerated grit chambers. Split samples were obtained 
by PhRMA representatives for some of the wastewater samples as well as 
the biodegradation samples. The data from this sampling episode are 
being considered by EPA in its pass-through determination for alcohols.
    The results of the sampling study are summarized in Table 4 below. 
EPA sampling results indicate that most of the methanol is lost in the 
grit chambers through volatilization while most of the ethanol and 
isopropanol are lost through aerobic biodegradation. Based on an 
evaluation of the results of the sampling episode, EPA believes that 
the losses of the methanol, ethanol, and isopropanol in the primary 
treatment units are due to volatilization. In a follow-up study, PhRMA 
conducted an anaerobic biodegradation study on primary clarifier 
influent and has suggested that the losses of the alcohols in the 
primary clarifier may be due to anaerobic degradation either chemical 
or biochemical. In this study, PhRMA attempted to measure the decrease 
in alcohol concentration under anoxic (anaerobic conditions). EPA's 
analysis of these data indicates that the level of uncertainty 
connected with the analytical measurements is much greater than the 
differences in concentration of alcohol over time. EPA has included 
both study reports in the supporting documentation for this notice (see 
Notice Record Section 13.2.4) and solicits comments on both study 
reports.

                            Table 4.--Percent Losses of Alcohols in Primary Treatment                           
----------------------------------------------------------------------------------------------------------------
                                                 Average      Average      Overall                              
                                    Average        grit       primary      percent    Volatization  Volatization
            Pollutant               influent     chamber     clarifier      loss,      loss, range   loss, range
                                   Mass, lbs     effluent     effluent     primary         EPA          PhRMA   
                                                mass, lbs    mass, lbs    treatment                             
----------------------------------------------------------------------------------------------------------------
Methanol........................        9,046        7,964        7,314         19.1  14.2-16.1     12.5-15.9   
Ethanol.........................       10,593        9,325        7,908         25.3  4.1-8.8       3.9-8.9     
Isopropanol.....................        5,054        4,756        4,476         11.4  0.0-5.1       0.0-3.9     
----------------------------------------------------------------------------------------------------------------

    Based on the results shown above, EPA believes that there is 
general agreement between the EPA results and the results measured by 
analyzing the samples obtained by PhRMA on the overall percentage 
losses through volatization of the three pollutants, methanol, ethanol, 
and isopropanol. The general ranges of volatization losses of these 
three pollutants are 12.5-16.1% for methanol, 3.9-8.9% for ethanol, and 
0.0-5.1% for isopropanol. Results of the estimates of volatization for 
these three pollutants, along with those for four other VOCs (acetone, 
chloroform, methylene chloride, and toluene) were used to develop an 
alternative method of evaluating pass-through. The use of these results 
are discussed in Section II. B. below.

II. Analysis of Best Available Technology (BAT) and Pretreatment 
Standards for Existing Sources (PSES) Options Identified in the 
Maximum Achievable Control Technology (MACT) Proposal

    In section seven of the preamble to the proposal (62 FR 15760), EPA 
identified options for controlling the load of VOCs not controlled by 
the proposed MACT wastewater standards. EPA outlined options for 
controlling the remaining load generated by direct and indirect 
dischargers. In Section I options were identified and modifications to 
them based on analysis subsequent to the MACT Standards proposal were 
described. In the sections that follow, the Agency will discuss in more 
detail the current status of these options, discuss the reasoning 
behind any modifications and provide preliminary information on annual 
cost estimate and loading removal results.

A. BAT Option

    In the MACT proposal preamble, EPA indicated that in view of the 
MACT proposed wastewater standards, it was considering changing the BAT 
technology basis for subcategories A and C to advanced biological 
treatment only from in-plant steam stripping plus

[[Page 42726]]

advanced biological treatment. EPA believes that this revised approach 
is still appropriate and has estimated the annual costs to meet CWA 
requirements to be $3.8 million (1990 dollars). These costs represent a 
significant difference from the VOC control costs ($30.6 million, 1990 
dollars) for the May 1995 proposed BAT option which included in-plant 
steam stripping costs. This decrease in costs is due simply to the fact 
that the main responsibility for VOC control and its costs at these 
facilities will be incurred under the CAA MACT rule. EPA has estimated 
that the removal of VOCs achieved by the proposed MACT wastewater 
standards and the BAT option currently being considered is of the same 
degree or greater than that achieved by the original proposed CWA 
option, alone.
    The costs cited above (3.8 million 1990 dollars) associated with 
the effluent guidelines compliance with BAT for direct dischargers are 
mainly to achieve compliance with end-of-pipe organic limitations, but 
also contain some costs for cyanide, ammonia and COD control. These 
costs also include costs for two steam strippers for VOC control not 
controlled by the MACT Standards. The end-of-pipe long-term means used 
in the compliance cost estimation were developed after consideration of 
comments and newly received data and were discussed in greater detail 
in section B.2. of this notice.

B. PSES Analysis

    EPA has received a significant number of comments on its pass-
through analysis and its decision to propose regulations for water 
soluble organic compounds such as methanol and ethanol. In the 1995 CWA 
proposal, EPA performed a pass-through analysis on all pollutants for 
which regulations were proposed including the alcohols and other water 
soluble organic compounds using the BAT and POTW removal data available 
then. Since the proposal additional information has been obtained, 
including the Barceloneta sampling episode analysis results discussed 
above, and an alternative pass-through analysis has been conducted; 
these are discussed below.
1. Pass-Through
    In performing its pass-through analysis for water soluble volatiles 
(e.g., methanol) and other pollutants prior to the proposal of the CWA 
pharmaceutical effluent limitations guidelines and standards, EPA 
compared the average pollutant removal achieved by well operated POTWs 
achieving secondary treatment (based on data available then) to the 
pollutant removal achieved by application of the proposed BAT 
technology. For the VOCs, including water soluble volatiles, the 
percent removal analysis did not use numerical percent removals since 
there were no data on actual treatment (biodegradation versus 
volatization). However, since volatization occurs in both BAT and POTW 
biological treatment systems, and since no data concerning the relative 
amounts of volatization in these systems were available, volatilization 
was assumed to be equal between the two for the purposes of the pass-
through analysis done in 1995 to support the proposed CWA requirements. 
Some commenters on that proposal have indicated that EPA underestimated 
the amount of biodegradation of methanol and other water soluble 
pollutants, and overestimated the extent to which the pollutants 
volatilize in sewers, POTW headworks, and secondary treatment works. In 
order to address these and other comments concerning water soluble 
organic pollutants, EPA sampled the Barceloneta, Puerto Rico POTW which 
was discussed above in Section II.C. Additionally, EPA has received 
some data concerning the issue of volatization of water soluble 
organics and will be discussing these data below.
    a. New Data Related to Pass-Through. Since proposal EPA has 
received and reviewed the results of computer-based modeling which 
attempted to simulate the behavior of water soluble organics in sewer 
systems, and has conducted modeling on the water soluble and other 
pollutants using data from the Barceloneta POTW study. The latter 
modeling efforts were conducted in order to obtain a realistic estimate 
of how much volatization of volatile organic pollutants occurs 
throughout the entire POTW system. The computer modeling study report 
entitled ``Emissions of High-Solubility VOCs from Municipal Sewers'' is 
part of the supporting record for this notice (see Notice Record 
Section 13.1.5). The results of this study indicate that volatilization 
of methanol and ethanol in closed sewers is expected to be minimal with 
maximum emission rates of 0.03 and 0.19% being projected under most 
sewer conditions. However, under open sewer conditions, volatilization 
percentages of methanol and ethanol could be as high as 6.5 and 20%, 
respectively.
    Using the influent concentration data obtained from the 
Barceloneta, PR sampling visit, EPA has modeled the relative degrees of 
volatilization and biodegradation in the overall treatment works of 
this plant. EPA's modeling results using the WATER8 model program and 
its biodegradation and volatization rate constants are shown below in 
Table 5.

                                         Table 5.--Water 8 Modeling Results for Primary and Secondary Treatment                                         
                                                                      [In percent]                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Volatization  Biodegradation  Volatization  Biodegradation     Overall        Overall   
                           Pollutant                             in primary     in primary    in secondary   in secondary   volatization  biodegradation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methanol......................................................           2.1            0.0            2.0           90.8            4.0           90.5 
Ethanol.......................................................           2.2            0.0            0.5           97.7            2.7           92.9 
Isopropanol...................................................           4.2            0.0           10.8           74.0           14.3           77.0 
Acetone.......................................................           8.0            0.0            3.2           94.9           10.7           84.8 
Chloroform....................................................          40.9            0.0           58.7           40.5           71.2           23.9 
Methylene Chloride............................................          38.9            0.0           70.4           28.6           78.2           17.8 
Toluene.......................................................          46.1            0.0           36.9           62.7           60.4          32.4  
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Volatilization and biodegradation percentages may not add up to 100% since some of the compound remains in the effluent and some goes out with the
  sludge.                                                                                                                                               

    Results of this modeling for methanol, ethanol, and isopropanol 
shows less volatization in the primary treatment portion than the 
empirical data from the Barceloneta POTW sampling shown in Table 4.

[[Page 42727]]

    b. Possible Alternative Pass-Through Analysis. EPA has conducted a 
pass-through analysis for all pollutants which are considered to be 
candidates for regulation at this time by comparing well operated 
secondary treatment POTW median percent removals with the BAT percent 
removals. This method of conducting the pass-through analysis includes 
the volatization in the percent removals and assumes that they are 
equal for both POTW and BAT removal processes. The results of this 
analysis, using a strict comparison of removal percentages, indicate 
that 33 pollutants pass through POTWs. Nonetheless, while this analysis 
may be appropriate for moderately soluble volatile organics such as 
chloroform, methylene chloride, and toluene, where volatization rates 
at POTWs are higher (see Table 5 results), the analysis may not be 
appropriate for biodegradable water soluble volatile organics mentioned 
earlier in the previous section. The assumption that the BAT and POTW 
volatization percentages are equal may not be accurate for these 
pollutants. It is possible that the BAT volatization could be greater 
than POTW volatization due to higher influent concentrations at 
pharmaceutical facility treatment works, and, as a result, some or all 
of these compounds may not be determined to pass through the POTW. 
However, given the higher biodegradability of the water soluble 
volatile compounds, its expected that the biodegradation will be the 
predominant removal pathway in biological and advanced systems at both 
POTWs and direct discharger BAT plants and, thus, one could conclude 
that these compounds do not pass-through. Additionally, EPA has 
identified other pollutants for which it has proposed pretreatment 
standards that have lower Henry's law constants (less tendency to 
volatilize than acetone) which along with the alcohols in question may 
or may not pass through POTWs. These pollutants are formamide, N,N-
dimethylaniline, pyridine, 1,4 dioxane, aniline and petroleum naphtha. 
Consequently, the Agency is contemplating incorporation of the alcohol 
pass-through scenarios into the options selection for the final rule. 
EPA requests data from any BAT level direct dischargers regarding 
volatization of these compounds in their biological treatment system, 
especially in the primary portion of their facility. EPA also solicits 
comment on the differences between the Water8 model results and the 
empirical data in estimating volatization and biodegradation in the 
primary portion of biological treatment works and on the use of these 
results in the pass-through analysis (Section 14.14).
2. Preliminary Costs and Loading Removals Assuming Two Different Pass-
Through Scenarios for Modified Options
    Based on the use of the alternate pass-through analysis approaches, 
EPA has developed compliance cost and pollutant removal estimates for 
two categorical pretreatment options, one involving regulation of 
alcohols and related pollutants and the other with no regulation of 
alcohols and related pollutants via categorical pretreatment standards. 
The alcohols and related pollutants in question are methanol, ethanol, 
n-propanol, isopropanol, n-butyl alcohol, tert-butyl alcohol, amyl 
alcohol, formamide, N,N-dimethylaniline, pyridine, 1,4-dioxane, 
aniline, and petroleum naphtha. For Option 2, under which alcohols and 
related pollutants would not be regulated under PSES, EPA estimates 
annual compliance costs of $40.0 million (1990 dollars) for A/C 
subcategory facilities and organic pollutant removals of 6.9 million 
pounds per year. For B/D subcategory facilities EPA estimates annual 
compliance costs of $8.4 million and organic pollutant removals of 3.3 
million pounds per year. For Option 3, where alcohols and related 
pollutants would be regulated, EPA estimates annual compliance costs of 
$44.6 million for A/C subcategory facilities and organic pollutant 
removals of 11.9 million pounds per year. For B/D subcategory 
facilities, EPA estimates annual compliance costs of $10.8 million per 
year and organic pollutant removals of 5.4 million pounds per year.
    Several commenters suggested that EPA exclude small facilities 
based on their flow and concentration from categorical pretreatment 
standards. While EPA has not decided whether it is appropriate to 
exclude small facilities from these categorical pretreatment standards, 
because the economic analysis for the final rule will be redone and may 
show increased economic impacts on small facilities when completed, EPA 
has conducted two alternative cost scenarios under which small 
facilities would be excluded from PSES for VOCs. If small facilities 
(those that discharge less than 10,000 lbs per year of regulated 
pollutants) are excluded from these pretreatment standards, the Option 
2 annual compliance costs are $36.5 million and 6.5 million pounds per 
year for A/C subcategory facilities and $5.0 million and 2.6 million 
pounds per year for subcategory B/D facilities. The Option 3 costs and 
removals for non-excluded A/C facilities are $40.7 million and 11.5 
million pounds per year while the costs and removals for non-excluded 
B/D facilities are $6.6 million and 4.1 million pounds per year. EPA 
estimates that assuming the 10,000 pound per year cut-off, 34 A/C 
facilities and 67 B/D facilities would be excluded from pretreatment 
standards for organic pollutants. The cost and removal information is 
summarized in Table 6 below.

                                        Table 6.--PSES Costs and Removals                                       
----------------------------------------------------------------------------------------------------------------
                                                                                                   Total annual 
                                                                                   Total annual      organics   
             Option/subcategory                            Scenario               costs (million/     removal   
                                                                                        yr)       million lbs/yr
----------------------------------------------------------------------------------------------------------------
2/A/C......................................  No small plant exclusion...........           $40.0             6.9
2/A/C......................................  34 small plants excluded...........            36.5             6.5
3/A/C......................................  No small plant exclusion...........            44.6            11.9
3/A/C......................................  34 small plants excluded...........            40.7            11.5
2/B/D......................................  No small plants exclusion..........             8.4             3.3
2/B/D......................................  67 small plants excluded...........             5.0             2.6
3/B/D......................................  No small plants exclusion..........            10.8             5.4
3/B/D......................................  67 small plants excluded...........             6.6             4.1
----------------------------------------------------------------------------------------------------------------

    The costing methodology used as well as the individual plant cost 
estimates may be found in Section 14.8 of the supporting documentation 
for this notice. The long-term mean concentrations used to calculate

[[Page 42728]]

pollutant removals may also be found in the supporting documentation. 
Individual facilities are encouraged to examine the input data used to 
make cost and loadings estimates for their facility and verify their 
accuracy based on 1990 Questionnaire responses.

IV. Results of Analyses of Pre-Proposal and Newly Acquired Data 
With Respect to Various Comment Issues

    Since proposal the Agency has been evaluating comments made with 
respect to various regulatory issues and analyzing existing and newly 
submitted data in the context of the proposal comments. As a result of 
these analyses, EPA is considering approaches on specific issues that 
differ from the positions taken by EPA at proposal. The issues and new 
approaches to them are discussed below. A more complete discussion of 
the analyses performed with respect to each issue may be found in the 
supporting documentation for this notice.

A. New Source Performance Basis

    EPA received comments on its subcategory A/C new source performance 
standards for the pollutant parameters BOD<INF>\5\, </INF>COD and TSS 
which are based on the performance data from one facility. The 
commenters indicated that the production range of this facility is too 
narrow to adequately represent new source A/C facilities. In response 
to this comment, EPA is reassessing the Subcategory A/C NSPS for 
BOD<INF>5</INF>, COD, and TSS using data from two best performer 
facilities (Facility 30701 and Facility 31121). EPA is also reassessing 
the Subcategory C NSPS for BOD<INF>5</INF>, COD, and TSS that would be 
based on activated carbon pretreatment of Subcategory C wastewaters 
only, followed by advanced biological treatment. EPA requests comment 
on the appropriateness of using the additional plant data.

B. Ammonia Limitations and Standards

    EPA has received additional ammonia treatment performance data 
representative of steam stripping and biological nitrification 
technologies. With respect to the proposed BAT ammonia limitations, EPA 
is evaluating revised limitations based on an expanded nitrification 
database. The Agency is costing two stage nitrification for those 
facilities with 1990 Questionnaire response data which indicate an end-
of-pipe ammonia as N (Nitrogen) concentration above the long-term mean 
developed from the expanded database. EPA has converted the ammonium 
hydroxide loadings data from the 1990 Questionnaire into an ammonia as 
N end-of-pipe concentration for this purpose.
    At proposal, EPA developed a PSES for ammonia for indirect A/C 
facilities based on air stripping performance data. In the proposal 
preamble, the Agency indicated that they believed that steam stripper 
treatability performance would be as good as or better than the 
demonstrated air stripping performance. Newly submitted steam stripping 
performance data for ammonia as N (Nitrogen) supports this belief and 
shows better performance and lower effluent concentrations than the air 
stripping data used to develop the proposed PSES (see Section 13.1.3 of 
the Record). Therefore, EPA does not currently intend to revise the 
proposal. EPA solicits comment on the new BAT nitrification data.
    The BAT technology basis for controlling ammonia is nitrification 
at biological or advanced biological treatment systems and some POTWs 
with biological or advanced biological treatment have nitrification. 
Accordingly, EPA is requesting comments on its intention to allow the 
pass-through analysis to consider whether nitrification is part of the 
POTW technology in determining whether ammonia discharges from 
pharmaceutical industrial users pass-through POTWs. Additionally, EPA 
is requesting information from pharmaceutical facilities with higher 
current ammonia loadings than were shown in their 1990 questionnaire 
responses and information from facilities on the availability of land 
for two-stage nitrification treatment. (See Sections VI C and D.)

C. Pollutant Exclusions

    EPA received several comments questioning the reasoning behind the 
regulation of certain pollutants as well as the overall rationale for 
selecting pollutants for regulation. Other commenters indicated that 
EPA was regulating too many pollutants. In response, EPA has reviewed 
the loadings bases for all of the pollutants selected for regulation 
and has determined that in the case of eight pollutants, insufficient 
amounts of the pollutants are being discharged to justify national 
regulation. These pollutants are diethyl ether, cyclohexane, 
chloromethane, dimethylamine, methylamine, furfural, 2-methylpyridine 
and trichlorofluoromethane. EPA's revised pollutants to regulate 
analysis is presented in Section 14.4 of the record for this rule.

D. Use of Surrogate Pollutants

    In an effort to respond to comments concerning excessive monitoring 
for regulated organic pollutants, EPA is considering permitting 
facilities that discharge more than one regulated organic pollutant be 
allowed to monitor for surrogate pollutants. Plants would be allowed to 
monitor for a surrogate pollutant(s) only if they certify that the 
other pollutants are receiving the same degree of treatment as the 
surrogate pollutant(s) and all of the pollutants discharged are in the 
same treatability class(s) as the surrogate pollutant(s). Treatability 
classes have been identified for both steam stripping and biological 
treatment technologies, the PSES and BAT technology bases for 
limitations controlling the organics. Individual plants may choose to 
certify by selecting a pollutant for monitoring in a given treatability 
class and providing documentation for approval by the permit or 
pretreatment authorities that the other pollutants in that treatability 
class are treated to the same extent as the monitored pollutant. This 
documentation should include appropriate engineering documentation that 
demonstrates that all of the regulated pollutants in a given 
treatability class are being treated using identical treatment. The 
permit or pretreatment authorities may require the surrogate pollutant 
to be the pollutant present in the highest concentration. EPA has also 
developed a list of surrogate pollutants for guidance for the permit or 
pretreatment authority based on the following criteria: (1) the number 
of facilities discharging the pollutant, i.e., the larger the number of 
facilities discharging the pollutant, the more appropriate would be its 
use as a surrogate; (2) the total quantity of a pollutant discharged, 
i.e., the more a pollutant is discharged the more suitable it is for 
use as a surrogate, and (3) the number of streams containing a 
pollutant, i.e., the more streams containing a pollutant, the more 
suitable for use as a surrogate. Both the treatability classes and the 
suggested surrogate pollutants are presented in Tables 7 and 8.

[[Page 42729]]



  Table 7.--Potential Surrogates for Direct Dischargers (Biotreatment)  
------------------------------------------------------------------------
                                             Number of                  
                                            facilities       Quantity   
                Compound                     reporting      discharged  
                                            constituent      (lbs/yr)   
------------------------------------------------------------------------
                Alcohols                                                
Ethanol.................................              97       6,802,384
Isopropanol.............................              85       4,565,370
Methanol................................              82      15,388,273
n-Butyl alcohol.........................              18         675,189
Phenol..................................              12          10,974
Ethylene glycol.........................              10         225,188
Amyl alcohol............................               6         197,635
tert-Butyl alcohol......................               5         121,408
n-Propanol..............................               5          12,238
                Aldehydes                                               
Formaldehyde............................              27         334,527
Isobutyraldehyde........................               2          35,659
                                                                        
                 Alkanes                                                
n-Heptane...............................              12          28,044
n-Hexane................................               9          11,265
Petroleum naphtha.......................               3         261,137
                                                                        
             Amides & Amines                                            
N,N-Dimethylformamide...................              22         494,837
Triethylamine...........................              15         633,225
N,N-Dimethylacetamide...................               7       1,046,333
Diethylamine............................               7         219,374
Formamide...............................               4           7,544
                                                                        
                Aromatics                                               
Toluene.................................              43         783,364
Xylenes.................................              14          53,724
Pyridine................................              10         212,581
Chlorobenzene...........................               4           5,616
Aniline.................................               4           4,603
o-Dichlorobenzene.......................               2          21,499
N,N-Dimethylaniline.....................               2          19,155
Benzene.................................               1         121,400
                                                                        
           Chlorinated Alkanes                                          
Methylene chloride......................              47       3,590,640
Chloroform..............................              17         409,317
1,2-Dichloroethane......................               6          27,559
                                                                        
             Esters & Ethers                                            
Ethyl acetate...........................              27         390,584
Tetrahydrofuran.........................              17         478,669
Isopropyl acetate.......................               9         184,550
Polyethylene glycol 600.................               8          31,219
1,4-Dioxane.............................               6          24,927
n-Amyl acetate..........................               5         293,408
Isopropyl ether.........................               5          12,387
n-Butyl acetate.........................               3         512,926
Methyl formate..........................               3         157,727
                                                                        
                 Ketones                                                
Acetone.................................              55       4,573,766
MIBK....................................               9         635,677
2-Butanone (MEK)........................               4          17,426
                                                                        
              Miscellaneous                                             
Ammonia (aqueous).......................              32       1,365,741
Acetonitrile............................              16         433,041
Dimethyl sulfoxide......................              14         753,157
Methyl cellosolve.......................               4         758,637
------------------------------------------------------------------------
Notes: Compounds in bold represent the surrogate parameters for each    
  individual category. Miscellaneous compounds have no particular       
  surrogate compound identified. Compounds sorted in order of # of      
  facilities reporting constituent, in each individual category.        


                    Table 8.--Potential Surrogates for Indirect Dischargers (Steam Stripping)                   
----------------------------------------------------------------------------------------------------------------
                                               Number of                                                        
                                               facilities      Quantity       Henry's law constant (atm/gmole/  
                  Compound                     reporting   discharged (lbs/                 m\3\)               
                                              constituent        yr)                                            
----------------------------------------------------------------------------------------------------------------
             High Strippability                                                                                 
Methylene chloride..........................           47      3,590,640    2.68E-03                            
Toluene.....................................           43        783,637    5.93E-03                            
Chloroform..................................           17        409,317    3.39E-03                            
Xylenes.....................................           14         53,724    5.10E-03                            
n-Heptane...................................           12         28,044    2.8E+00                             
n-Hexane....................................            9         11,265    1.55E+00                            
Methyl cellosolve...........................            4        758,637    2.90E-03                            
Chlorobenzene...............................            4          5,616    3.93E-03                            
Benzene.....................................            1        121,400    5.55E-03                            
            Medium Strippability                                                                                
Acetone.....................................           55      4,573,766    3.67E-05                            
Ammonia (aqueous)...........................           32      1,365,741    3.28E-04                            
Ethyl Acetate...............................           27        390,584    1.20E-04                            
Tetrahydrofuran.............................           17        478,669    1.10E-04                            
Triethylamine...............................           15        633,225    1.38E-04                            
MIBK........................................            9        635,677    9.40E-05                            
Isopropyl acetate...........................            9        184,550    3.17E-04                            
Diethylamine................................            7        219,374    1.10E-04                            
1,2-Dichloroethane..........................            6         27,559    1.10E-03                            
n-Amyl acetate..............................            5        293,408    3.91E-04                            
Isopropyl ether.............................            5         12,387    2.24E-03                            

[[Page 42730]]

                                                                                                                
2-Butanone (MEK)............................            4         17,426    4.36E-05                            
n-Butyl acetate.............................            3        512,926    4.68E-04                            
Methyl formate..............................            3        157,727    8.10E-05                            
Isobutyraldehyde............................            2         35,659    1.47E-04                            
o-Dichlorobenzene...........................            2         21,499    1.94E-03                            
              Low Strippability                                                                                 
Ethanol.....................................           97      6,802,384    6.26E-06                            
Isopropanol.................................           85      4,565,370    8.07E-06                            
Methanol....................................           82     15,388,273    2.70E-06                            
N-Butyl alcohol.............................           18        675,189    5.57E-06                            
Pyridine....................................           10        212,581    5.30E-06                            
Amyl alcohol................................            6        197,635    2.23E-05                            
1,4-Dioxane.................................            6         24,927    4.88E-06                            
tert-Butyl alcohol..........................            5        121,408    1.17E-05                            
n-Propanol..................................            5         12,238    6.85E-06                            
Methylamine.................................            4         23,717    1.11E-05                            
Formamide...................................            4          7,544    1.92E-05                            
Aniline.....................................            4          4,603    2.90E-06                            
Petroleum naphtha...........................            3        261,137    2.70E-06                            
N,N-Dimethylaniline.........................            2         19,155    1.75E-05                            
----------------------------------------------------------------------------------------------------------------
Notes: Compounds in bold represent the surrogate parameters for each individual category. Compounds sorted in   
  order of number of facilities reporting constituents, in each individual category.                            

    EPA solicits comment on these surrogate pollutant approaches, the 
suggested surrogate pollutants, the biotreatment and steam stripping 
treatability classes presented in Tables 7 and 8, what type of POTW and 
permit approval process is necessary and an estimate of the amount of 
burden hours (costs) the suggested approach would take in developing 
and certifying the necessary documentation and for POTW/permit 
authority approval.

E. Small Facility Exclusion

    As noted in the preceding section, based on comments on the CWA 
proposal and the potential for some economic impact from the costs 
associated with the combination of the MACT Standards and Effluent 
Limitations Guidelines and Standards, EPA has identified two groups of 
facilities in the A (Fermentation) and C (Chemical Synthesis) 
subcategories and B (Natural Extraction) and D (Formulation) 
subcategories which are smaller waste load dischargers. These 
facilities discharge less than 10,000 pounds of organic pollutants per 
year. In the options presented in the preceding section, EPA has 
presented PSES approaches which exclude 34 Subcategory A/C and 67 
Subcategory B/D facilities from PSES.

F. Changes in Engineering Cost and Load Removal Estimates

    The Agency has made several changes to the cost model used to 
calculate costs and loading removals for the pharmaceutical 
manufacturing effluent guidelines based on proposal comments and new 
data. These changes are detailed in the ``Post-proposal Documentation 
Report for the Pharmaceutical Manufacturing Industry Engineering Cost 
Model'' which is located in Section 14.8 of the record for this notice. 
A summary of the major cost model changes follow.
    EPA has re-evaluated the unit costs used in the cost model at 
proposal. EPA has incorporated additional unit cost data related to 
steam, electrical, labor, and steam stripper overheads disposal costs 
submitted with proposal comments. EPA has also incorporated separate 
steam and electrical costs for domestic plants and plants in Puerto 
Rico.
    EPA has modified the biological treatment module to change the 
sequence of design to design BAT first, and BPT, second. EPA has also 
modified this module to account for MACT Standards removals for the CWA 
pollutants of concern. For those facilities that were identified during 
the development of the MACT Standards proposal as requiring control, 
pollutant load removals from the MACT Standards have been subtracted 
out prior to assessing the costs and removals for facilities subject to 
the effluent guidelines and standards. EPA has also modified the 
biological treatment cost module to assess facility end-of-pipe 
concentrations after correcting for non-process dilution wastewaters. 
In addition, EPA has modified the biological treatment module to cost 
for two-stage nitrification where ammonia treatment is deemed 
necessary.
    EPA has modified the steam stripping module to incorporate a 
revised approach for determining stream characteristics. At proposal, 
the cost model utilized data from the 1990 Detailed Questionnaire from 
Table 3-2 (pollutant loadings) and from Table 4-8 (process area stream 
data). EPA has revised the steam stripping module to incorporate the 
Table 3-2 pollutant loadings data and distribute the process wastewater 
flow and load according to the disaggregation approach used in the MACT 
Standards. Under this approach, it is assumed that pharmaceutical 
process wastewaters can be represented by four streams with the 
following breakdown in percent flow and load:

                              [In percent]                              
------------------------------------------------------------------------
                                                                Process 
                                                   Pollutant  wastewater
                                                     load        flow   
------------------------------------------------------------------------
Stream 1........................................           1          44
Stream 2........................................           2           9
Stream 3........................................           6          19
Stream 4........................................          91          28
------------------------------------------------------------------------

    For those facilities that were identified in the work on the MACT 
proposal as requiring control, pollutant load removals associated with 
the MACT Standards and costs for steam stripping at these facilities 
have been subtracted out prior to assessing the facility need for 
control of any remaining VOCs by effluent guidelines and standards. 
After application of the MACT Standards, EPA determined that additional 
control is required under the effluent guidelines. Steam strippers are 
costed starting with control of the most concentrated streams, until 
end-of-pipe concentrations meet the long-term means developed from 
EPA's steam stripping performance database. In addition, based on 
proposal comments, EPA has re-evaluated the steam stripper component 
pieces that should be costed and is including costs for the following 
additional steam stripping equipment: an overheads distillate pump, a 
distillate receiver tank, and a bottoms pump.
    EPA has revised the cyanide destruction cost module to allow for

[[Page 42731]]

alkaline chlorination treatment for those facilities where hydrogen 
peroxide treatment cannot be used due to safety considerations. For 
facilities whose 1990 Detailed Questionnaire data indicate that the 
facility is not in compliance with the cyanide treatment long-term 
means, EPA costed a treatment system upgrade, wastewater storage, and 
monitoring costs. For facilities whose 1990 Detailed Questionnaire data 
indicate that the facility is in compliance with the cyanide treatment 
long-term means, treatment system upgrades are not required but 
wastewater storage and analysis costs were developed to make certain 
that compliance is met by the approved cyanide method.
    EPA has revised the wastewater compliance monitoring cost module to 
reflect the change from in-plant standards to end-of-pipe standards for 
all pollutants (except cyanide). In addition, EPA has gathered updated 
analysis costs for the proposed analytical methods.

V. Discussion of Pollution Prevention Approach

    EPA discussed pollution prevention in the preamble of the proposed 
CWA effluent guidelines and standards and in the proposed technical 
development document. EPA is interested in incorporating pollution 
prevention into this regulation wherever possible and welcomes 
pollution prevention suggestions. Since proposal, the Agency has 
received suggestions regarding relief from or waivers of effluent 
limitations and standards in connection with pollution prevention 
programs which result in the reduction or elimination of pollutant use 
at a facility. One suggestion presented to the Agency was that 
Subcategory B/D dischargers that incorporate best management practices 
(BMPs), which reduce their discharge of any of the regulated pollutants 
should not have to monitor for the specific regulated pollutants, and 
possibly only monitor for the conventional pollutants and COD. This 
pollution prevention approach is similar to the one adopted in the 
Pesticide Formulators, Packagers and Repackagers (PFPR) final 
regulation which was published in the Federal Register on November 6, 
1996 at 61 FR 57518. It should be noted that PFPR facilities that use 
the promulgated pollution prevention option will have to assess their 
wastewater and put in appropriate treatment before any wastewater can 
be discharged.
    Another pollution prevention approach suggested to EPA was that 
Subcategory A/C facilities that can demonstrate a reduction in the use 
of a regulated pollutant and resultant lowered emissions/discharges to 
all media (i.e., less non-water quality environmental impacts) should 
receive a higher effluent discharge limitation. As suggested, the 
higher effluent discharge limitation would be directly proportional to 
the amount of reduction achieved in the use of the regulated pollutant.
    More detailed discussion about each approach may be found in the 
supporting documentation for this notice (see Notice Record Section 
19.2). Although EPA is interested in incorporating pollution prevention 
into regulations wherever possible, the Agency has concerns about the 
identification of benchmarks or reward criteria for the above suggested 
approaches. EPA invites comments on both suggested approaches, as well 
as information on any additional pollution prevention-based 
suggestions.

VI. Solicitation of Data and Comments

    In addition to soliciting comments and data relating to any of the 
material presented in this notice, EPA is specifically interested in 
receiving comments and data regarding a number of specific issues which 
are discussed below. In commenting or providing data with respect to a 
specific issue, commenters should refer to the specific issue which the 
comments address.

A. Determination of the Pass Through for Water Soluble Pollutants for 
POTWs With Covered Headworks and Primary Tanks or Demonstrating Less 
Than 5% Volatilization

    EPA is considering providing in the categorical pretreatment 
standards that if a POTW covers or encloses its headworks and primary 
tanks or the POTW can demonstrate that less than 5% volatilization of 
water soluble organics such as methanol occurs during the treatment 
process that no pass-through of water soluble organics occurs for their 
pharmaceutical industrial users. In order to be able to determine that 
pass-through does not occur for a water soluble pollutant, the POTW 
must have its primary treatment works covered or enclosed or must 
demonstrate through appropriate sampling and analyses that 
volatilization of less than 5% of a specific water soluble pollutant is 
occurring. This sampling and analysis must follow the sampling 
protocols used in the EPA Barceloneta POTW study discussed previously 
in this notice and use 40 CFR part 126 approved analytical methods. EPA 
requests comments and data regarding the use of specific POTW criteria 
for the pass-through determination for water soluble organics.

B. Determination of Pass-through at POTWs with Nitrification

    EPA is aware that certain POTWs which treat pharmaceutical 
discharges possess nitrification capability. New data from a POTW with 
nitrification were received as part of comments on the CWA proposal and 
are included in the record (Section 13.1.5.) In order to more 
accurately determine whether pass-through occurs, the Agency is 
considering providing in the categorical pretreatment standards that 
ammonia does not pass-through at POTWs with nitrification. EPA requests 
comments on this POTW specific pass-through determination for ammonia.

C. Information From Facilities With Higher Ammonia Loadings Than Were 
Shown in Their 1990 Questionnaire Responses

    In the 1990 Detailed Questionnaire, facilities supplied ammonium 
hydroxide (aqueous ammonia) loadings data in Table 3-2. EPA has 
converted these loadings data to an ammonia as N effluent load and 
concentration to assess facility compliance with the proposed ammonia 
long-term means. EPA is specifically requesting effluent ammonia as N 
concentration data (including the supporting analytical reports) from 
those facilities whose effluent ammonia as N loadings are higher than 
those calculated from the reported ammonium hydroxide loads in the 1990 
questionnaire in Table 3.2. The data may be for any time period after 
1989 including 1990 if these data indicate higher loadings than were 
reported in the facilities questionnaire response.

D. Information on Land Availability for Two-Stage Nitrification 
Treatment

    EPA is requesting information from direct discharging facilities 
that would be subject to ammonia limitations about the availability of 
land on site for the construction of two-stage nitrification treatment. 
Plants that claim that land for two-stage nitrification is not 
available should provide sufficient documentation in the form of plant 
property plans and other information with their comments. Plants for 
which land for two stage nitrification is available should provide 
information concerning any difficulties or problems they expect to 
encounter with the installation of two-stage nitrification at their 
facilities.

[[Page 42732]]

E. Information From Subcategory B/D Facilities on Number of Operating 
Days per Week

    EPA is requesting information from Subcategory B/D facilities 
concerning the number of days per week of operation at these facilities 
(does the facility operate five days per week or seven days per week.) 
The Agency needs this information in order to perform accurate 
compliance cost estimates and economic impact analyses. Subcategory B/D 
facilities should supply this information as well as facilities whose 
hours of operation have changed since 1990.

F. Proposed Exclusion for Organic Chemicals, Plastics, and Synthetic 
Fibers (OCPSF) Manufacturers of Bulk Pharmaceutical Intermediates and 
Active Ingredients With Less Than 50% Pharmaceutical Wastewater

    EPA requests comment on the exclusion of organic chemical 
manufacturers covered by the OCPSF regulation (40 CFR 414) that 
manufacture pharmaceutical intermediates and active ingredients from 
the final pharmaceutical regulation provided that the pharmaceutical 
portion of the process wastewater is less than 50 percent of the total 
process wastewater. The Agency believes it may not be necessary to 
cover the pharmaceutical wastewater at these facilities because most of 
the pollutants that would be controlled by pharmaceutical limitations 
and standards are already being controlled by the OCPSF limitations and 
standards. The pollutants found in pharmaceutical facility discharges 
and not specifically regulated such as some of the water soluble 
organics by the OCPSF regulations are either not present in wastewaters 
being discharged from the type of pharmaceutical operations occurring 
at these facilities or are well treated by the biological treatment 
systems found at these facilities or their POTWs. The Agency emphasizes 
that any process wastewater covered by such an exclusion must be 
covered by OCPSF effluent limitations guidelines and standards. EPA 
requests comments concerning such an exclusion and any information 
regarding the bases that EPA has suggested to justify an exclusion for 
these facilities.

G. Wastewater From Pilot Plant Operations

    EPA has received a number of comments on its proposal to consider 
wastewater from pilot plant operations as production wastewater and not 
as subcategory E (Research) wastewater. The Agency solicits comments 
specifically from facilities that will experience difficulty with 
having to treat pilot plant wastewater with their normal production 
wastewater. EPA is specifically interested in learning details of the 
problems that might be encountered in complying with the proposal 
definition of pilot plant wastewater.

H. Basis for Determining Which Cyanide Standards Apply

    EPA has developed two sets of cyanide limitations and standards 
based on hydrogen peroxide oxidation and alkaline chlorination 
technologies. The Agency is requesting suggestions from commenters 
concerning what parameter levels describing cyanide wastestreams should 
be used to determine which standards are appropriate. Individual 
commenters have suggested that cyanide wastestreams with high organic 
content as evidenced by high COD and TOC (total organic carbon) would 
be more appropriately controlled by standards based on alkaline 
chlorination. EPA invites information and comments concerning the 
parameters and levels which could determine which set of standards will 
be appropriate for individual facilities.

    Dated: August 1, 1997.
Robert Perciasepe,
Assistant Administrator for Water.
[FR Doc. 97-20979 Filed 8-7-97; 8:45 am]
BILLING CODE 6560-50-P