[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 (BOD5), 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 (BOD5), 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 (BOD5), 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 (BOD5), Chemical Oxygen Demand (COD), Total
Suspended Solids (TSS) and Ammonia)
Additional BOD5, 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
BOD5, 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
BOD5, 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% BOD5 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 (BOD5), Chemical Oxygen Demand (COD), Total
Suspended Solids (TSS) and Ammonia)
The data used in determining limitations for BOD5, 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
BOD5, 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 BOD5, 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 BOD5, 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
BOD5 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:
BOD5............................. 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:
BOD5............................. 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:
All data point pairs with influent concentrations below
detection limit were deleted;
All data points that were collected from a flash tank or
distillation pot were deleted;
All data point pairs with a negative percent removal or
that showed no removal after treatment were deleted;
[[Page 42724]]
All data point pairs with an influent lower than the long
term means shown in Table 3 were deleted;
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;
Effluent concentrations that were reported below the
detection limit were assumed to have a concentration equal to the
detection limit; and
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\5\, 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
BOD5, COD, and TSS using data from two best performer
facilities (Facility 30701 and Facility 31121). EPA is also reassessing
the Subcategory C NSPS for BOD5, 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
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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.
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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