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

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.

-----------------------------------------------------------------------

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

[[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