42720 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

operation of law and, hence, do not

impose any Federal intergovernmental

mandate, as defined in section 101 of

the Unfunded Mandates Act.

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, Intergovernmental

relations, Carbon monoxide.

Authority: 42 U.S.C. 7401–7671q.

Dated: August 1, 1997.

Chuck Findley,

Acting Regional Administrator.

[FR Doc. 97–20969 Filed 8–7–97; 8:45 am]

BILLING CODE 6560–50–P

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
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 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
42722 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

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 nonprocess 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 nonprocess wastewater, then the nonprocess 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 nonprocess 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

Pollutant parameter

Longterm

mean

concentration(mg/

l)

BPT/BAT effluent

limitations

Maximum for

any one

day

(mg/l)

Monthly

average

(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
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42723

account significant amounts of nonprocess 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 nonprocess wastewater, then the nonprocess 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

Pollutant code and pollutant name

Long-term

mean concentration

(mg/L)

BAT effluent limitations

Maximum for

any one day

(mg/L)

Monthly average (mg/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;
42724 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

• 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

Pollutant code and pollutant name

Long-term

mean concentration

(mg/L)

PSES effluent standards

Maximum for

any one day

(mg/L)

Monthly average (mg/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.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 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).

Technology

Long-term

mean concentration

(mg/L)

Maximum for

any one day

(mg/L)

Monthly average (mg/

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

Pollutant

Average influent Mass,

lbs

Average grit

chamber effluent mass,

lbs

Average primary clarifier effluent

mass, lbs

Overall percent loss,

primary

treatment

Volatization

loss, range

EPA

Volatization

loss, range

PhRMA

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
42726 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

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 passthrough 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]

Pollutant Volatization

in primary

Biodegradation in primaryVolatization

in secondary

Biodegradation in secondary

Overall

volatization

Overall 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.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42727

b. Possible Alternative Pass-Through

Analysis. EPA has conducted a passthrough 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 passthrough. 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 PassThrough Scenarios for Modified Options

Based on the use of the alternate passthrough 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, nbutyl alcohol, tert-butyl alcohol, amyl

alcohol, formamide, N,Ndimethylaniline, 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

Option/subcategory Scenario

Total annual

costs (million/

yr)

Total annual

organics removal 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
42728 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

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 BOD5

, 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 longterm 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 passthrough 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.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42729

TABLE 7.—POTENTIAL SURROGATES FOR DIRECT DISCHARGERS (BIOTREATMENT)

Compound

Number of facilities reporting

constituent

Quantity discharged (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)

Compound

Number of facilities reporting constituent

Quantity discharged (lbs/yr)Henry’s law constant

(atm/gmole/m3)

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
42730 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

TABLE 8.—POTENTIAL SURROGATES FOR INDIRECT DISCHARGERS (STEAM STRIPPING)—Continued

Compound

Number of facilities reporting constituent

Quantity discharged (lbs/yr)Henry’s law constant

(atm/gmole/m3)

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 nonprocess 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]

Pollutant

load

Process

wastewater

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
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 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.
42732 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

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

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50620C; FRL–5735–3]

RIN 2070–AB27

Butanamide, 2,2′-[3′dichloro[1,1′-

biphenyl]-4,4′-diyl) bisazobis N-2,3-

dihydro-2-oxo-1H-benximdazol-5-yl)-3-

oxo-; Proposed Significant New Use

Rule; Extension of Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Extension of comment period.

SUMMARY: EPA is extending the

comment period for the proposed

significant new use rule (SNUR) for

butanamide, 2,2′-[3′,dichloro[1,1′-

biphenyl]-4,4′-diyl)bisazobis N-2,3-

dihydro-2-oxo-1H-benximdazol-5-yl)-3-

oxo-. As initially published in the

Federal Register of June 26, 1997 (62 FR

34424) (FRL–5723–4), the comments

were to be received on or before July 28,

1997. One commenter requested

additional time to research and submit

comments. EPA is therefore extending

the comment period 30 days in order to

give all interested persons the

opportunity to comment fully.

DATES: Written comments must be

submitted to EPA by August 27, 1997.

ADDRESSES: Each comment must bear

the appropriate docket control number

OPPTS–50620B. All comments should

be sent in triplicate to: OPPT Document

Control Officer (7407), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Rm. G–099, East Tower,

Washington, DC 20460.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: opptncic@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by (OPPTS–50620B).

No confidential business information

(CBI) should be submitted through email. Electronic comment on this

document may be filed online at many

Federal Depository Libraries.

All comments which are claimed

confidential must be clearly marked as

such. Three additional sanitized copies

of any comments containing CBI must

also be submitted. Nonconfidential

versions of comments on the proposed

rule will be placed in the rulemaking

record and will be available for public

inspection.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–543B, 401 M St., SW.,

Washington, DC 20460, telephone: (202)

554–1404, TDD: (202) 554–0551; e-mail:

TSCA-Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: This

extension of the comment period will

allow interested parties who intend to

comment on the proposed rule

additional time to consider their

response.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals,

Hazardous materials, Recordkeeping

and reporting requirements.