svEPA
United States
Environmental Protection
Agency
Permit Guidance Document:
Pharmaceutical Manufacturing Point
Source Category (40 CFR Part 439)
January 2006
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Permit Guidance Document: Pharmaceutical Manufacturing Point
Source Category (40 CFR Part 439)
U.S. Environmental Protection Agency
Office of Water
Engineering and Analysis Division
1200 Pennsylvania Avenue, NW(4303T)
Washington, DC 20460
EPA821-F-05-006
January 2006
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Disclaimer
The discussion in this document is intended solely as guidance. The statutory provisions and regulations
of the U.S. Environmental Protection Agency (EPA) described in this document contain legally binding
requirements. This document is not a regulation itself, nor does it change or substitute for those
provisions and regulations. Thus, it does not impose legally binding requirements on EPA, States or the
regulated community. This guidance does not confer legal rights or impose legal obligations upon any
member of the public.
While EPA has made every effort to ensure the accuracy of the discussion in this guidance, the
obligations of the regulated community are determined by statutes, regulations or other legally binding
requirements. In the event of a conflict between the discussion in this document and any statute or
regulation, this document would not be controlling.
The general descriptions provided here may not apply to particular situations based upon the
circumstances. Interested parties are free to raise questions and objections about the substance of this
guidance and the appropriateness of the application of this guidance to a particular situation. EPA and
other decision makers retain the discretion to adopt approaches on a case-by-case basis that differ from
those described in this guidance where appropriate.
Mention of trade names or commercial products does not constitute an endorsement or recommendation
for their use.
This document may be revised periodically without public notice. EPA welcomes public input on this
document at any time.
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Executive Summary
On September 21, 1998, the U.S. Environmental Protection Agency (EPA) promulgated revised
regulations for the pharmaceutical industry to control both effluent discharges and air emissions. The
purpose of this guidance document is to help permit writers and pretreatment coordinators develop
appropriate National Pollutant Discharge Elimination System (NPDES) permits and pretreatment
requirements for pharmaceutical facilities with the following types of operations: fermentation, extraction,
chemical synthesis, mixing, compounding and formulating and research. For an overview of the NPDES
and National Pretreatment Programs, refer to the U.S. EPA NPDES Permit Writer's Manual (EPA-833-B-
96-003) as well as the Industrial User Permitting Guidance Manual (EPA-833/R-89-001).
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Contents
1. Introduction 1-1
2. Overview of NPDES Program and National Pretreatment Program 2-1
2.1 What is the NPDES Permit Program? 2-1
2.1.1 What Are Effluent Limitations Guidelines and Standards? 2-1
2.1.2 What Are Water-Quality-Based Effluent Limitations? 2-1
2.2 What Is the National Pretreatment Program? 2-1
2.2.1 What Are National Pretreatment Standards? 2-2
2.3 Applicability of Effluent Limitations Guidelines and Standards 2-3
3. Scope of 40 CFR Part 439 3-1
4. What are the Pollutants Regulated by the Rule 4-1
5. What are the Technological Bases for Effluent Limitations Guidelines and Standards for Subparts
A, B, C, and D 5-1
5.1 What are the Model Process Technologies and Wastewater Treatment Systems? 5-1
5.1.1 Regulatory Bases of Effluent Limitations Guidelines and Standards Applicable to
Direct and Indirect Dischargers 5-1
5.1.2 Model Technologies That Form the Bases of Effluent Limitations Guidelines and
Standards 5-2
6. Where Are Facilities Required to Demonstrate Compliance? 6-1
7. What are the Effluent Limitations Guidelines and Standards for Subparts A, B, C, D, and E7....7-1
7.1 Direct Dischargers 7-1
7.1.1 BPT, BAT and NSPS 7-1
7.2 Indirect Dischargers 7-4
7.2.1 PSES and PSNS 7-4
8. How Are Permits Developed for Facilities with Operations in Subparts A, B, C, D, and E? 8-1
8.1 Reviewing Permit Applications 8-2
8.2 Developing Permit Limits 8-3
8.2.1 How Are Annual Average Process Wastewater Discharges Calculated? 8-4
8.2.2 How Are Mass-Based Permit Limitations Calculated For Direct Dischargers?...8-5
8.2.3 What Type of Permit Limitations Should Be Used for Cyanide? 8-6
8.2.4 Should the NPDES Permit Include Limits Based on Effluent Limitations
Guidelines or WQBELs? 8-6
8.3 Developing Monitoring Requirements 8-7
8.3.1 What Are the Monitoring Locations? 8-7
8.3.2 What Are the Monitoring Frequencies and Sampling Protocols? 8-7
8.3.3 How May Certification of Non-Use of Regulated Chemicals be Achieved? 8-8
8.3.4 What If the Annual Chemical Analysis Scan Identifies Discharge of a Regulated
Pollutant Not Covered by a Facility's Permit? 8-8
8.3.5 How May Surrogates Be Used to Demonstrate Compliance? 8-8
8.3.6 Can Surrogates Be Used if Neither Advanced Biological Treatment Nor Steam
Stripping Are Part of the Facility's Treatment System? 8-9
8.3.7 What Are the Appropriate Analytical Methods? 8-9
8.3.8 What Is the Level of Detection Required to Demonstrate Compliance? 8-12
8.3.9 What Are The Reporting Requirements? 8-12
8.4 Compliance with New Source Standards 8-13
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8.4.1 When Must New Sources Comply with the September 21, 1998 Promulgated
Rules? 8-13
8.5 Developing Special Conditions 8-14
8.5.1 What Are the Special Conditions for Cyanide Limitations? 8-14
8.5.2 When Is Ammonia Regulated at Indirect Discharging Facilities? 8-14
8.5.3 What Are the Special Conditions for pH Monitoring? 8-15
8.5.4 How Should Permit Writers Account for Nonprocess Wastewater in the Final
Effluent? 8-15
8.5.5 What Is EPA's Guidance with Regard to Coverage of Full Scale Bioengineered
Product Manufacturing? 8-15
8.5.6 Are Tank Passivating and Electropolishing Wastewaters Considered Metal
Finishing Operation Wastewaters Regulated by 40 CFR Part 433? 8-16
9. Case Studies 9-1
9.1 Case Study #1 9-1
9.1.1 General Site Description 9-1
9.1.2 Relevant Information for Establishing Permit Limits 9-1
9.1.3 Determining Permit Limits for Pollutants Regulated Under BPT 9-3
9.1.4 Determining Permit Limits for Pollutants Regulated Under BAT 9-7
9.1.5 Final Limits as They Would Appear in a Permit for Facility A 9-9
9.2 Case Study #2 9-10
9.2.1 General Site Description 9-10
9.2.2 Relevant Information for Establishing Permit Limits 9-10
9.2.3 Determining Limits for Pollutants Regulated Under PSES 9-10
9.2.4 Determining Compliance Monitoring for PSES Pollutants 9-14
9.2.5 Final Limits as They Would Appear in a Permit for Facility B 9-14
9.3 Case Study #3 9-15
9.3.1 General Site Description 9-15
9.3.2 Relevant Information for Establishing Permit Limits 9-15
9.3.3 Determining Permit Limits for Pollutants Regulated Under BPT 9-16
9.3.4 Determining Permit Limits for Pollutants Regulated Under BAT 9-21
9.3.5 Final Limits as They Would Appear in a Permit for Facility C 9-24
9.4 Case Study #4 9-25
9.4.1 General Site Description 9-25
9.4.2 Relevant Information for Establishing Permit Limits 9-25
9.4.3 Determining Permit Limits for Pollutants Regulated Under BPT 9-26
9.4.4 Determining Permit Limits for Pollutants Regulated Under BAT 9-31
9.4.5 Final Limits as They Would Appear in a Permit for Facility D 9-33
10. Where to Get Additional Help 10-1
10.1 Information Relating to the Pharmaceutical Rule 10-2
10.1.1 Documents Supporting the 1998 Promulgated Rule 10-2
10.1.2 General Information About Permits and NPDES Program 10-3
10.1.3 Databases 10-3
10.1.4 Websites 10-4
10.2 Other Sources and Contacts 10-4
10.2.1 EPA Headquarters Information Resource Center 10-4
10.2.2 National Technical Information Service (NTIS) 10-4
Appendix A Glossary A-1
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Tables
Table 2-1: Contents of 40 CFR Part 403 2-2
Table 2-2: Description of Effluent Limitations Guidelines and Standards 2-3
Table 2-3: Effluent Limitations Guidelines and Standards Applicable to Each Program 2-4
Table 4-1: Pollutants Regulated Under BPT 4-1
Table 4-2: Pollutants Regulated Under BCT 4-1
Table 4-3: Pollutants Regulated Under BAT 4-2
Table 4-4: Pollutants Regulated Under NSPS 4-3
Table 4-5: Pollutants Regulated Under PSES and PSNS 4-4
Table 5-1: Technology Basis for BPT, BAT, NSPS, PSES, and PSNS 5-3
Table 7-1: BPT Effluent Limitations Guidelines for Direct Dischargers 7-1
Table 7-2: BAT Effluent Limitations Guidelines for Subpart A and C Operations 7-2
Table 7-3: BAT Effluent Limitations Guidelines for Subpart B and D Operations 7-3
Table 7-4: NSPS for Subpart A and C Operations 7-3
Table 7-5: NSPS for Subpart B and D Operations 7-4
Table 7-6: PSES and PSNS for Subpart A and C Operations 7-5
Table 7-7: PSES and PSNS for Subpart B and D Operations 7-6
Table 8-1: Surrogates for Subpart A/C Direct Dischargers (Biotreatment) 8-10
Table 8-2: Steam Stripping Surrogates for Indirect Dischargers 8-11
Table 9-1: Information Needed to Establish Permit Limits for Case Study #1 9-3
Table 9-2: Flow Breakdown for Facility A 9-4
Table 9-3: Regulated Organic Pollutants Found in the Wastewater of Facility A 9-7
Table 9-4: Final Limits for Facility A 9-9
Table 9-5: Information Needed to Establish Permit Limits for Case Study #2 9-10
Table 9-6: Flow Breakdown for Facility B 9-12
Table 9-7: Regulated Pollutants Found in the Wastewater of Facility B 9-12
Table 9-8: Final Limits forFacility B 9-15
Table 9-9: Information Needed to Establish Permit Limits for Case Study #3 9-15
Table 9-10: Flow Breakdown forFacility C 9-18
Table 9-11: Regulated Pollutants Found in the Wastewater of Facility C 9-21
Table 9-12: Final Limits for Facility C 9-25
Table 9-13: Information Needed to Establish Permit Limits for Case Study #4 9-26
Table 9-14: Flow Breakdown forFacility D 9-28
Table 9-15: Regulated Pollutants Found in the Wastewater at Facility D 9-31
Table 9-16: Final Limits for Facility D 9-34
IV
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Figures
Figure 3-1: Product Applicability Basis of the September 21, 1998 Pharmaceutical Manufacturing
Effluent Limitations Guidelines 3-2
Figure 9-1: Flow Schematic for Facility A 9-2
Figure 9-2: Flow Schematic for Facility B 9-11
Figure 9-3: Flow Schematic for Facility C 9-17
Figure 9-4: Flow Schematic for Facility D 9-27
Figure 10-1: Information Resources Map 10-2
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1. Introduction
On September 21, 1998, the U.S. Environmental Protection Agency (EPA) promulgated final effluent
limitations guidelines and standards under the Clean Water Act (CWA). These regulations amended
existing effluent limitations guidelines and standards codified at 40 Code of Federal Regulations (CFR)
Part 439.
EPA had first promulgated regulations for the pharmaceutical manufacturing point source category in
1976 (41 Federal Register (FR) 50676) for the following five subcategories of the industry:
• Subpart A - Fermentation Products Subcategory
• Subpart B - Extraction Products Subcategory
• Subpart C - Chemical Synthesis Subcategory
• Subpart D - Mixing, Compounding, and Formulating Subcategory
• Subpart E - Research Subcategory
The 1976 regulations established monthly best practicable control technology currently available (BPT)
limitations for biochemical oxygen demand (BOD5) and chemical oxygen demand (COD) for all
subcategories. EPA did not establish daily maximum effluent limitations for these parameters. EPA
established a pH limitation within the range of 6.0 to 9.0 standard units. The regulations also set
maximum 30 day average concentration-based limitations for total suspended solids (TSS) forsubparts
B, D and E. EPA established no TSS limitations forsubparts A and C.
On October 27, 1983, at 48 FR 49808, EPA revised the Subcategory names to those used currently and
promulgated revised BPT limitations as well as best available technology economically achievable (BAT)
limitations and pretreatment standards for new sources (PSNS) and pretreatment standards for existing
sources (PSES) for subparts A thru D to cover the toxic pollutant cyanide, conventional pollutants, BOD5,
TSS and pH and the nonconventional pollutant COD. The 1983 regulations retained the regulations for
BOD5 and COD established in 1976 but added concentration-based limitations for these parameters
applicable to subparts B, D and E. EPA also promulgated BPT, BAT, PSES and PSNS for pH (6.0-9.0)
and BAT concentration-based limitations controlling the discharge of cyanide for subpart A through D.
While the Agency also had proposed new source performance standards (NSPS) for BOD5, TSS and pH
in the October 1983 notice, it did not adopt NSPS for these parameters. On December 16, 1986, at 51 FR
45094, EPA promulgated best conventional pollutant control technology (BCT) effluent limitations
guidelines for BOD5, TSS and pH for subparts A thru D. That final rule set BCT effluent limitations equal
to the existing BPT effluent limitations guidelines for BOD5, TSS, and pH.
The 1998 regulations amended the effluent limitations guidelines for subparts A through D. Facilities or
operations involved in research continue to be subject to the regulations in subpart E.
Direct discharging facilities with operations in the four manufacturing subcategories were required to
comply with the 1998 regulations by November 20, 1998. The compliance date for existing source indirect
discharging facilities was as soon as possible, but no later than September 21, 2001. Permit writers and
control authorities are required to issue permits (or other control mechanisms) to ensure that affected
facilities are complying with the new regulations. This document is specifically written to provide
guidance to permitting and pretreatment control authorities in issuing National Pollutant
Discharge Elimination System (NPDES) permits and permits (or other control mechanisms) to
pharmaceutical facilities with manufacturing operations in the four subcategories discussed
above.
Permitting or pretreatment control authorities will need to determine which facilities fall under 40 CFR Part
439 and how to write the permits or pretreatment agreements for these facilities to ensure their
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compliance under the new regulations. EPA has provided information in Sections 2 -10 to help permit
writers and pretreatment control authorities in this process.
• Section 2 presents a brief overview of the NPDES Program and the National Pretreatment
Program;
• Section 3 presents the scope of the promulgated final effluent limitations guidelines and
standards and describes which facilities are subject to the rule;
• Section 4 discusses the pollutants regulated under 40 CFR Part 439 for facilities with operations
in subparts A, B, C, D and E;
• Section 5 discusses the technology bases for the effluent limitations guidelines and standards
promulgated for facilities with operations in subparts A, B, C, D, and E;
• Section 6 discusses the in-process and end-of-pipe points where affected facilities must
demonstrate compliance with the rule;
• Section 7 presents the effluent limitations guidelines and standards promulgated for facilities with
operations in subparts A, B, C, D, and E;
• Section 8 walks through the process of establishing permit limits for facilities with operations in
subparts A, B, C, D, and E;
• Section 9 presents five case studies as examples for establishing permits for facilities with
operations in subparts A, B, C, D, and E; and
• Section 10 contains a list of resources for additional guidance in establishing permits for affected
facilities.
EPA's objective here is to provide guidance on issuing permits and pretreatment control mechanisms to
facilities with operations in the above subcategories in an easy-to-read format. While this manual
attempts to address many permitting issues and situations that may be covered by the regulation, there
are other sources that may be helpful in developing permits/pretreatment control mechanism for facilities
with operations in subparts A, B, C, D, and E. The manual identifies and references other sources
throughout the text that can be accessed to get additional guidance. Also included in Section 10 is a list of
these and other sources and how to order them, as well as a list of EPA and other authorities to contact
for more guidance.
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2. Overview of NPDES Program and National
Pretreatment Program
This section presents a brief overview of the NPDES Permit program and the National Pretreatment
Program. For more background information regarding EPA's programs to develop national standards for
point source categories, refer to the U.S. EPA NPDES Permit Writer's Manual (EPA-833-B-96-003). In
addition, a permit writer should also consult the Industrial User Permitting Guidance Manual (EPA-833/R-
89-001).
2.1 What is the NPDES Permit Program?
Section 301 (a) of the CWA prohibits the discharge of pollutants except in compliance with CWA Section
402, among other sections. Section 402 authorizes the issuance of NPDES permits for direct dischargers
(i.e., existing or new industrial facilities that discharge process wastewaters from any point source into
receiving waters). Permit writers must develop NPDES permits to control these discharges, using effluent
limitations guidelines and standards and water-quality based effluent limitations.
2.1.1 What Are Effluent Limitations Guidelines and Standards?
EPA establishes effluent limitations guidelines and standards to require a minimum level of treatment for
industrial point sources. EPA bases its effluent limitations guidelines and standards on the demonstrated
performance of model process and treatment technologies that are found to be economically achievable
by an industrial category orsubcategory. Although effluent limitations guidelines and standards are based
on the performance of model process and treatment technologies, EPA does not mandate the use of
specific technologies. Dischargers are free to use any available control technique to meet the limitations.
2.1.2 What Are Water-Quality-Based Effluent Limitations?
All receiving waters have ambient water quality standards that are established by the states or EPA to
maintain and protect designated uses of the receiving water (e.g., aquatic life-warm water habitat, public
water supply, primary contact recreation). Permit writers may find that the application of the effluent
limitations guidelines result in pollutant discharges that exceed the water quality standards in particular
receiving waters. In such cases, permit writers are required by the CWA and federal guidelines to develop
more stringent water-quality-based effluent limitations (WQBELs) for the pollutant to ensure that the water
quality standards are met. States can use the total maximum daily load (TMDL) process as one way of
quantifying the allowable pollutant loadings in receiving waters, based on the relationship between
pollution sources and in-stream water quality standards.
Because EPA and state permitting authorities are familiar with their respective water quality standards
and knowledgeable in waste load allocations and other procedures to maintain water quality standards
these issues are not addressed in this document. To learn more about how TMDLs are developed, refer
to Guidance for Water-Quality-Based Decisions: The TMDL Process (EPA 440/4-91-001). To learn how to
apply water quality standards in NPDES permits, refer to the Technical Support Document for Water
Quality-Based Toxics Control (EPA/505/2-90-001).
2.2 What Is the National Pretreatment Program?
The CWA requires EPA to promulgate nationally applicable pretreatment standards that restrict pollutant
discharges from facilities that discharge wastewater indirectly through sewers flowing to publicly-owned
treatment works (POTWs). (See Section 307(b) and (c), 33 U.S.C. 1317(b) & (c)). National pretreatment
standards are established for those pollutants in wastewater from indirect dischargers that may pass
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through, interfere with, or are otherwise incompatible with POTW operations. Generally, pretreatment
standards are designed to ensure that wastewaters from direct and indirect industrial dischargers are
subject to similar levels of treatment. In addition, all POTWs that must develop local pretreatment
programs are required to implement specific local treatment limits applicable to their industrial indirect
dischargers to prevent pass through and interference and to prevent the introduction into POTWs of
certain pollutants (e.g., pollutants that create a fire or explosion hazard, corrosion or pollutants that result
in toxic gases that may cause acute worker health or safety problems). All other POTWs must establish
local limits to prevent pass through or interference to ensure compliance with the POTWs NPDES permit
or sewage sludge uses. (See 40 CFR 403.5). CWA Section 402(b)(8) requires that permits for certain
POTWs receiving pollutants from significant industrial sources subject to pretreatment standards under
CWA Section 307(b) must establish a pretreatment program to ensure compliance with these standards.
EPA has published regulations to define the requirements of this POTW pretreatment control program.
2.2.1 What Are National Pretreatment Standards?
40 CFR Part 403 presents the general pretreatment regulations for existing and new sources of pollution.
The following table presents the content of each section of 40 CFR Part 403.
Table 2-1: Contents of 40 CFR Part 403
40 CFR Section
403.1
403.2
403.3
403.4
403.5
403.6
403.7
403.8
403.9
403.10
403.11
403.12
403.13
403.14
403.15
403.16
403.17
403.18
Content
Purpose and applicability
Objective of general pretreatment regulations
Definitions
State or local law
National pretreatment standards: prohibited discharges
National pretreatment standards: categorical standards
Removal credits
Pretreatment program requirements: development and implementation by
POTW
POTW pretreatment programs and/or authorization to revise
standards: submission for approval
Development and submission of NPDES state pretreatment
Approval procedures for POTW pretreatment programs and
of removal credits.
pretreatment
programs
POTW granting
Reporting requirements for POTWs and industrial users
Variances from categorical pretreatment standards for fundamentally different
factors
Confidentiality
Net/gross calculation
Upset provision
Bypass
Modification of POTW pretreatment programs
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40 CFR 403.5(a)(1) generally prohibits users of a POTW (indirect dischargers) from discharging
pollutants to the POTW that cause pass-through or interference. Pass-through is defined as a discharge
that exits the POTW into waters of the United States in quantities or concentrations that, alone or in
conjunction with a discharge or discharges from other sources, causes a violation of any requirement of
the POTWs NPDES permit. Interference is defined as a discharge that, alone or in conjunction with a
discharge or discharges from other sources, both: (1) inhibits or disrupts the POTW, its treatment
processes, or its operations; or its sludge processes, use, or disposal; and (2) causes the POTW to
violate any requirement of its NPDES permit, or prevents sewage sludge use or disposal (40 CFR 403.3).
40 CFR 403.5(c) and 40 CFR 403.8 specify that POTWs that have flows greater than 5.0 million gallons
per day (mgd) and that receive pollutants that pass through or interfere with their operations or are
otherwise subject to categorical pretreatment standards must develop and enforce local limits to comply
with the National Pretreatment Standards.
2.3 Applicability of Effluent Limitations Guidelines and Standards
Pharmaceutical facilities that discharge waters to receiving streams or POTWs are required to meet one
(or more) of the following effluent limitations guidelines and standards established by the CWA.
Table 2-2: Description of Effluent Limitations Guidelines and Standards
Acronym
BPT
BCT
BAT
NSPS
PSES
PSNS
Guideline or Standard
Best practicable control technology
currently available
Best conventional pollutant control
technology
Best available technology
economically achievable
New source performance standards
Pretreatment standards for existing
sources
Pretreatment standards for new
sources
Applicable pollutants and discharge type (a>
Conventional pollutants at an existing direct
discharger*'
Conventional pollutants at an existing direct
discharger
Toxic and nonconventional pollutants at an
existing direct discharger
Conventional, toxic, and nonconventional
pollutants at a new source, direct discharger
Toxic and nonconventional pollutants at an
existing indirect discharger
Toxic and nonconventional pollutants at a new
source, indirect discharger
These terms are defined in the glossary.
Nonconventional and priority pollutants can also be controlled by BPT regulations.
With the September 21, 1998 promulgation of the regulation, EPA has revised BPT, BAT, NSPS, PSES,
and PSNS for the pharmaceutical manufacturing point source category. Note that although this
document focuses on these new effluent limitations guidelines and standards, those limitations
and standards that were not revised remain in effect unless otherwise stated in the September 21,
1998 promulgated rule. Table 2-3 summarizes the applicability of these effluent limitations guidelines
and standards.
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Table 2-3: Effluent Limitations Guidelines and Standards Applicable to Each
Program
Program
NPDES Permit
Program
National
Pretreatment
Program
Type of
Discharger
Direct
Discharger
Indirect
Discharger
Existing or
New Source?
Existing Source
New Source
Existing Source
New Source
Applicable Guidelines
and Standards
Previously Established
BCT
BPT
BAT
NSPS
PSES
PSNS
Additional Guidelines
and Standards (from
9/21/98 Rule)
BPT
BAT
NSPS
PSES
PSNS
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3. Scope of 40 CFR Part 439
The revisions to the effluent limitations guidelines and standards promulgated on September 21, 1998
apply only to subparts A through D of the pharmaceutical manufacturing industry. Subpart E (Research)
was not revised by the September 21, 1998 final regulations. Subpart E operations at stand-alone
facilities or at manufacturing facilities with subpart A, B, C, and/or D operations continue to be subject to
the existing BPT effluent limitations guidelines for subpart E, revised October 27, 1983 (40 CFR 439.52).
Pharmaceutical manufacturers use many different raw materials and manufacturing processes to create a
wide range of products with therapeutic value. Pharmaceutical products are produced by a number of
processes. These include the following: chemical synthesis, fermentation, extraction from naturally
occurring plant or animal substances, mixing, compounding, and formulating operations, or by refining a
technical grade product.
The regulations establish different requirements depending on whether a manufacturing operation is an
existing source or a new source. The pharmaceutical manufacturing industry regularly may make
equipment and process changes to existing manufacturing processes. Consequently, permitting
authorities should carefully review EPA regulations before deciding whether a particular source of
discharge is an existing source or a new source.
The definition of new source for direct dischargers is at 40 CFR 122.2 and the new source definition for
indirect dischargers is at 40 CFR 403.3. Direct discharging pharmaceutical new sources have to meet
more stringent BOD5 and TSS standards than existing sources. In the case of indirect facilities, PSES and
PSNS are identical.
The pharmaceutical guidelines and standards regulation applies generally, but not exclusively, to process
wastewater discharges resulting from the manufacture of pharmaceutical products and from
pharmaceutical research reported within three specified U.S. Department of Commerce Bureau of the
Census Standard Industrial Classification system (SIC) groups and to the manufacture of certain
pharmaceutical products not reported under the three SIC codes. The regulation does not apply to
dischargers from the manufacture of pharmaceutical products included in eight other SIC subgroups and
three other identified pharmaceutical products. Which pharmaceutical product process wastewaters are,
and are not, subject to this regulation is explained in further detail at 40 CFR 439.0. The currently
applicable regulations may be found in any edition of the CFR dated July, 1999 or later.
A logic chart presenting the applicability of the September 21, 1998 pharmaceutical effluent limitations
guidelines and standards is presented in Figure 3-1.
The pharmaceutical products, processes, and activities covered by this regulation include:
• Products covered by the U.S. Department of Commerce, Bureau of the Census Standard
Industrial Classification (SIC) Code No. 2836, with the exception of diagnostic substances.
(Products covered by SIC Code No. 2836 were formerly covered under the 1977 SIC Code No.
2831.)
• Medicinal chemicals and botanical products covered by SIC Code No. 2833.
• Pharmaceutical products covered by SIC Code No. 2834.
• All fermentation, natural extraction, chemical synthesis and formulation products considered to be
pharmaceutically active ingredients by the Food and Drug Administration (21 CFR 210.3(b)(7))
that are not covered by SIC Code Nos. 2833, 2834, or 2836.
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Identify the product and the
manufacturing process
Specify which SIC code it
falls under
SIC 2835, 3841, 3842, 3843,
8071, 8072, 8081, 8091
Not covered by the new
regulation
If you cannot specify the SIC
code or if it fails under
another SIC code
Is it an FDA regulated
pharmaceutical active
ingredient and generated by
a fermentation, from natural
sources or extraction, or
chemical synthesis process?
No
Not covered by the new
regulation
Is it a cosmetic preparation
intended for treatment of a
skin condition?
No
Not covered by the new
regulation
Covered by the
new regulation
No
Is it a diagnostic
substance?
Yes
Not covered by
the new regulation
Yes
Is its primary use intended
forpharm. purposes?
Yes,
Covered by the new
regulation
No
V
Not covered by the new
regulation
Yes
Covered by the new
regulation
Figure 3-1: Product Applicability Basis of the September 21, 1998 Pharmaceutical
Manufacturing Effluent Limitations Guidelines
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• Multiple end-use products derived from pharmaceutical manufacturing operations (e.g.,
components of formulations, intermediates, or final products, provided that the primary use of the
product is intended for pharmaceutical purposes).
• Products not covered by SIC Code Nos. 2833, 2834, and 2836 or other categorical limitations
and standards if they are manufactured by a pharmaceutical manufacturer by processes that
generate wastewaters that in turn closely correspond to those of pharmaceutical products. (An
example of such a product is citric acid.)
• Cosmetic preparations covered by SIC Code No. 2844 that contain pharmaceutically active
ingredients or ingredients intended for treatment of some skin condition. (This group of
preparations does not include products such as lipsticks or perfumes that serve to enhance
appearance or to provide a pleasing odor, but do not provide skin care. In general, this also
excludes deodorants, manicure preparations, shaving preparations and non-medicated
shampoos that do not function primarily as a skin treatment.)
Products or activities specifically excluded from the pharmaceutical manufacturing category are:
• Surgical and medical instruments and apparatus reported under SIC Code No. 3841.
• Orthopedic, prosthetic, and surgical appliances and supplies reported under SIC Code No. 3842.
• Dental equipment and supplies reported under SIC Code No. 3843.
• Medical laboratories services reported under SIC Code No. 8071.
• Dental laboratories services reported under SIC Code No. 8072.
• Outpatient care facility services reported under SIC Code No. 8081.
• Health and allied services reported under SIC Code No. 8091, and not classified elsewhere.
• Diagnostic devices other than those reported under SIC Code No. 3841.
• Animal feeds that include pharmaceutical active ingredients such as vitamins and antibiotics,
where the major portion of the product is non-pharmaceutical, and the resulting process
wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical
products.
• Foods and beverage products fortified with vitamins or other pharmaceutical active ingredients,
where the major portion of the product is non-pharmaceutical, and the resulting process
wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical
products.
Since the final pharmaceutical manufacturing regulations were promulgated on Sept. 21, 1998, many
pharmaceutical and other manufacturers have begun producing bioengineered products using
bioengineering techniques developed from bench scale research operations. While these operations are
generally similar to those of Part 439, the provisions of these subparts do not apply to these
bioengineering operations. Thus, permit writers should develop applicable limitations and standards for
these operations based on best professional judgment. The limitations and standards in Part 439 may be
a useful resource to the permit writer in determining appropriate limitations and standards when the
character of the wastewater from the bioengineering operations is similar to that of the Part 439
wastewater from like operations.
3-3
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QA/QC laboratory wastewaters which do not come in contact with pharmaceutical manufacturing
operations and are discharged separately (i.e., are not commingled with other regulated waste streams
upstream of the compliance monitoring point) are excluded from the subpart A, B, C, and D limitations.
In addition, facilities regulated by the organic chemicals, plastics and synthetic fibers (OCPSF) effluent
limitations guidelines and standards (40 CFR Part 414) that manufacture pharmaceutical products and
intermediates will be subject to the OCPSF effluent limitations guidelines and standards provided that the
wastewater generated as a result of the manufacture of pharmaceutical products and intermediates is
less than 50% of the total process wastewater flow at the facility.
Example 1: A facility manufactures medicated shampoo that treats dandruff and is classified in
SIC Code 2844. Is this facility covered under the pharmaceutical September 21,1998
regulation?
This facility would be subject to the pharmaceutical regulation since it
manufactures products which contain a pharmaceutically active ingredient
generated by a fermentation, natural source (plant and animal), extraction,
chemical synthesis, or formulation process.
Example 2: A facility manufactures herbal medicines that do not contain an FDA regulated
pharmaceutically active ingredient (as defined in 21 CFR 210.3(b)(7)). Is this facility subject to
the pharmaceutical September 21, 1998 regulation?
This facility would not be subject to the pharmaceutical regulation since it does
not manufacture or process a pharmaceutically active ingredient.
3-4
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4. What are the Pollutants Regulated by the Rule
The tables below show what pollutants are regulated under the pharmaceutical regulations.
Permit writers and others should recall that different standards will apply to sources that are new
depending on when the sources was a new source. EPA amended paragraph (c) in four sections of the
regulation (439.15(c), 439.25(c), 439.35(c), and 439.45(c)) to state clearly that any new source that
commenced discharging after November 21, 1988 and before November 20, 1998 must continue to
achieve the standards specified for 40 CFR Part 439 in the October 27, 1983 Federal Register (48 FR
49808). These standards applied until the applicable time period specified in 40 CFR 122.29(d)(1) (10
years) had expired. After this, the facility must meet the current BCT and BAT requirements.
Table 4-1: Pollutants Regulated Under BPT
Pollutants
BOD5
COD
TSS
PH
Cyanide
Subpart A
/
/
/
/
/
Subpart B
/*
/
/
/
Subpart C
/
/
/
/
/
Subpart D
/*
/
/
/
Subpart E
/
/
/
/
Table 4-2: Pollutants Regulated Under BCT
Pollutants
BOD5
TSS
PH
Subpart A
/
/
/
Subpart B
/
/
/
Subpart C
/
/
/
Subpart D
/
/
/
Subpart E
*On March 13, 2003, EPA corrected the omission of a minimum BOD5 limitation from two sections of the
regulation promulgated on September 21, 1998 by adding to §§ 439.22(a) and 439.42(a) the phrase
"except that no facility shall be required to attain a monthly average limitation for BOD5 that is less than
the equivalent of 45 mg/L."
4-1
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Table 4-3: Pollutants Regulated Under BAT
Pollutants
COD
Acetone
Acetonitrile
Ammonia
n-Amyl acetate
Amyl alcohol
Benzene
n-Butyl alcohol
Chlorobenzene
Chloroform
Cyanide
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Dimethyl sulfoxide
Ethanol
Ethyl acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropanol
Isopropyl acetate
Isopropyl ether
Methanol
Methyl cellosolve
Methyl formate
Methyl isobutyl
ketone (MIBK)
Methylene chloride
Phenol
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
Subpart A
/
/
/
/
/
/
/
/
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart B
/
(a)
Subpart C
/
/
/
/
/
/
/
/
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart D
/
(a)
Subpart E
(a)
These pollutants were regulated by the previous regulations.
4-2
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Table 4-4: Pollutants Regulated Under NSPS
Pollutants
BOD5
COD
PH
TSS
Acetone
Acetonitrile
Ammonia
n-Amyl acetate
Amyl alcohol
Benzene
n-Butyl acetate
Chlorobenzene
Chloroform
Cyanide
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Dimethyl sulfoxide
Ethanol
Ethyl acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropanol
Isopropyl acetate
Isopropyl ether
Methanol
Methyl cellosolve
Methyl formate
Methyl isobutyl
ketone (MIBK)
Methylene chloride
Phenol
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
Subpart A
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/ *a'
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart B
/
/
/(a)
/
(a)
Subpart C
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart D
/
/
/(a)
/
(a)
Subpart E
(a)
These pollutants were regulated by the previous regulations.
4-3
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Table 4-5: Pollutants Regulated Under PSES and PSNS
Pollutants
Acetone
Ammonia
n-Amyl acetate
Benzene
n-Butyl acetate
Chlorobenzene
Chloroform
Cyanide
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Ethyl acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropyl acetate
Isopropyl ether
Methyl formate
Methyl isobutyl
ketone (MIBK)
Methylene chloride
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
Subpart A
/
/
/
/
/
/
/
/(a)
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart B
/
/
(a)
/
/
/
Subpart C
/
/
/
/
/
/
/
/ (a)
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Subpart D
/
/
(a)
/
/
/
Subpart E
(a)
These pollutants were regulated by the previous regulations.
4-4
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5. What are the Technological Bases for Effluent
Limitations Guidelines and Standards for
Subparts A, B, C, and D
EPA established numerical effluent limitations guidelines and pretreatment standards for subparts A, B,
C, and D based on model process technologies and wastewater treatment technologies. Although effluent
limitations guidelines and standards must be applied in the NPDES permit or pretreatment permit or
control mechanism, facilities with operations in subparts A, B, C, and D are not required to use the
specific process and/or technologies on which EPA based the effluent limitations guidelines and
standards. Facility owners and operators may use any combination of process technologies and in-
process or end-of-pipe wastewater treatment technologies to comply with the required limits.
5.1 What are the Model Process Technologies and Wastewater
Treatment Systems?
This section outlines the various technology levels and model technologies that form the regulatory bases
of the effluent limitations guidelines and standards presented in Section 4.
5.1.1 Regulatory Bases of Effluent Limitations Guidelines and Standards
Applicable to Direct and Indirect Dischargers
BPT
Effluent limitations guidelines based on BPT apply to direct discharges and are generally based on the
average of the best existing performance, in terms of treated effluent discharged, by facilities in a
subcategory. BPT focuses on end-of-pipe treatment technology and such process changes and internal
controls that are common industry practice.
BAT
Effluent limitations guidelines based on BAT represent the best existing economically achievable
performance of plants in the industrial subcategory. The CWA establishes BAT as the principal national
means of controlling the direct discharge of priority pollutants and nonconventional pollutants to waters of
the United States.
BCT
The CWA requires EPA to identify effluent reduction levels for conventional pollutants associated with
BCT technology for discharges from existing industrial point sources. BCT is not an additional limitation,
but replaces BAT for control of conventional pollutants. In addition to other factors, the CWA requires that
EPA establish BCT limitations after consideration of a two part "cost reasonableness" test.
NSPS
The basis for NSPS under Section 306 of the CWA is the best available demonstrated technology. New
source industrial dischargers have the opportunity to design and install the best and most efficient
manufacturing processes and wastewater treatment systems at new plants. Accordingly, Congress
directed EPA to consider the best demonstrated alternative processes, process changes, in-plant control
measures, and end-of-pipe wastewater treatment technologies that reduce pollution to the maximum
extent feasible in establishing NSPS.
5-1
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PSES
Pretreatment standards for existing sources are designed to prevent the discharge of pollutants which
pass through, interfere with, or are otherwise incompatible with the operation of POTWs. The Agency also
requires pretreatment for pollutants that pass through POTWs due to the pollutants exhibiting significant
volatilization prior to treatment by a POTW. The transfer of a pollutant to another media (air) through
volatilization does not constitute treatment. PSES are technology-based and analogous to BAT for the
control of priority and nonconventional pollutants.
PSNS
Pretreatment standards for new sources are designed to prevent the discharge of pollutants that pass
through, interfere with, or are otherwise incompatible with the operation of POTWs. The CWA requires
pretreatment for pollutants that pass through POTWs or limit POTW sludge management alternatives,
including the beneficial use of sludges on agricultural lands.
The development of regulatory options for PSNS is analogous to the development of options for NSPS, in
that the new source has the opportunity to design and install the best and most efficient manufacturing
processes and wastewater treatment facilities. Accordingly, Congress directed EPA to consider the best
demonstrated alternative processes, process changes, in-plant control measures, and end-of-pipe
wastewater treatment technologies that reduce pollution to the maximum extent feasible in developing
PSNS.
5.1.2 Model Technologies That Form the Bases of Effluent Limitations
Guidelines and Standards
The effluent limitations guidelines and standards developed for the pharmaceutical manufacturing
industry are based on the performance of several model technologies. Facilities are not required to use
any specific technology, but rather may use any combination of pollution prevention, source reduction,
process changes and internal controls, and treatment technology in order to comply with the effluent
limitations guidelines and standards.
The model technology basis of BPT for facilities in subparts A and C is advanced biological treatment.
BPT limitations under subparts A and C also include revised monitoring requirements for cyanide. The
model technology basis of BPT for facilities in subparts B and D is advanced biological treatment. BCT
limitations are the same as the BPT limitations for the conventional pollutants BOD5, TSS and pH. The
BCT model technologies are therefore the same as those under BPT.
The model technology basis of BAT and NSPS for facilities in subparts A and C is advanced biological
treatment with nitrification. Nitrification is required for facilities in subparts A and C for control of ammonia.
BAT and NSPS limitations under subparts A and C also include revised monitoring requirements for
cyanide. The model technology basis of BAT and NSPS for facilities in subparts B and D is advanced
biological treatment.
For indirect dischargers, the model technology basis of PSES and PSNS for facilities in subparts A and C
is in-plant stream stripping for the volatile organic pollutants and either steam stripping or biological
treatment with nitrification for ammonia control. The model technology basis of PSES and PSNS for
facilities in subparts B and D is in-plant steam stripping.
The amended regulations removed the cyanide limitations which previously applied to both direct and
indirect discharging subpart B and D facilities. Cyanide limitations based on alkaline chlorination for direct
and indirect subpart A and C facilities were not revised. The 1998 amendments revised the monitoring
requirements for cyanide for facilities with subpart A and C operations to clarify the effluent limitations
guidelines compliance point.
5-2
-------
Table 5-1 outlines the model technologies used to form the regulatory basis of BPT, BCT, BAT, NSPS,
PSES, and PSNS. For a complete description of each technology element, refer to the Technical
Development Document for Effluent Limitations Guidelines and Standards for the Pharmaceutical
Manufacturing Point Source Category, EPA-821-R-98-005.
Table 5-1: Technology Basis for BPT, BAT, NSPS, PSES, and PSNS
Regulation
BPT
BCT
BAT
NSPS
PSES
PSNS
Technology Basis
Subpart A and C Facilities
Advanced biological treatment
Advanced biological treatment
Advanced biological treatment with
nitrification
Advanced biological treatment with
nitrification
In-plant steam stripping for organic
compounds, in-plant steam stripping or
nitrification for ammonia
In-plant steam stripping for organic
compounds, in-plant steam stripping or
nitrification for ammonia
Subpart B and D Facilities
Advanced biological treatment
Advanced biological treatment
Advanced biological treatment
Advanced biological treatment
In-plant steam stripping for organic
compounds
In-plant steam stripping for organic
compounds
5-3
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6. Where Are Facilities Required to Demonstrate
Compliance?
This section discusses where a pharmaceutical manufacturing facility with subpart A, B, C, D, and E
operations should monitor to establish compliance.
The BPT, BAT, and NSPS effluent limitations guidelines and standards for wastewaters from subpart A,
B, C, D, and E operations for ammonia, COD, cyanide, conventional pollutants as well as for priority and
nonconventional organic pollutants are end-of-pipe limitations. A facility would normally measure for
purposes of demonstrating compliance with the BPT, BAT and NSPS limitations and standards at the
end-of-pipe monitoring point. However, in cases where a pollutant that is known to be present in the
influent to the treatment system cannot be detected using approved analytical methods at the end-of-pipe
monitoring point because of dilution from process and non-process wastewater not containing that
pollutant, EPA regulations provide that a facility should monitor at a point before the dilution occurs. One
case where upstream or in-plant monitoring may be required is in the case of compliance monitoring for
the pollutant cyanide. In the study supporting the final pharmaceutical regulations, EPA found that eight of
ten facilities monitored their cyanide-bearing waste streams for compliance at a point immediately after
the cyanide destruction or treatment process occurs. This was the case because the flows of the cyanide-
bearing waste streams were so small in relation to the remainder of the effluents at these facilities that
end-of-pipe measurement of cyanide is not practical or feasible using approved analytical methods for
measuring cyanide.
Similarly, the normal monitoring point for all pollutants controlled by the final pretreatment standards
(PSES and PSNS) would be the end-of-pipe monitoring point. However, upstream or in-plant compliance
monitoring may be required for any regulated pollutant in cases where it is not practical or feasible to
monitor for a given pollutant at the end-of-pipe monitoring point. Dilution with large amounts of process
and non-process wastewater may prevent detection of a pollutant at the end-of-pipe monitoring point. As
a result, the permitting or control authority cannot determine whether the reduction in the concentration of
a pollutant is the result of dilution or treatment. Consequently, a facility should monitor at a point before
dilution occurs. Another case where in-plant monitoring may be necessary involves a situation where a
pollutant is generated at a concentration below the regulatory levels and consequently does not require
treatment. In such cases, it may be necessary to monitor at the point where the pollutant is introduced
into the wastewater. In general, the monitoring point for a given pollutant should be where compliance is
achieved through treatment and not dilution.
6-1
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7. What are the Effluent Limitations Guidelines and
Standards for Subparts A, B, C, D, and E?
This section presents the numerical effluent limitations guidelines and standards forsubparts A, B, C, D,
and E. Tables 7-1 through 7-7 list the applicable numerical effluent limitations guidelines and standards
by discharge status and subpart.
7.1 Direct Dischargers
7.1.1 BPT, BAT and NSPS
This section lists the BPT, BAT, and NSPS effluent limitations guidelines and standards promulgated for
direct dischargers with operations in subparts A, B, C, D, and E.
Table 7-1: BPT Effluent Limitations Guidelines for Direct Dischargers
Subpart
A - Fermentation Operations
B - Biological and Natural
Extraction Operations
C - Chemical Synthesis
Operations
D - Mixing, Compounding, or
Formulating Operations
E - Research
Pollutant or
Property
COD
COD
COD
COD
COD
BPT Effluent Limitations for
End-of-Pipe Monitoring Points
Maximum for any
one day (mg/L)
1,675
228
1,675
228
Monthly Average
(mg/L) (a)
856
86
856
86
0.26 x raw waste x 2.2
or
220 mg/L
( whichever is greater)
(a) Forsubparts A, B, C, and D, if the average monthly COD concentrations are higher than concentration
values reflecting a reduction in the long-term average daily COD load in the raw (untreated) process
wastewater of 74% multiplied by a variability factor of 2.2, then the effluent limitations for COD
corresponding to the lower concentration values must be applied.
BAT effluent limitations forsubparts A and C are presented in Table 7-2. BAT effluent limitations for
subparts B and D are presented in Table 7-3. There are no BAT limitations for subpart E operations.
7-1
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Table 7-2: BAT Effluent Limitations Guidelines for Subpart A and C Operations
Pollutant or Pollutant Property
Maximum for any one day
(mg/L)
Monthly Average (mg/L)
BAT Effluent Limitation for In-Plant Monitoring Points
Cyanide
33.5
9.4
BAT Effluent Limitations for End-of-Pipe Monitoring Points
COD
Ammonia as N
Acetone
Acetonitrile
n-Amyl Acetate
Amyl Alcohol
Benzene
n-Butyl Acetate
Chlorobenzene
Chloroform
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Dimethyl Sulfoxide
Ethanol
Ethyl Acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropanol
Isopropyl Acetate
Isopropyl Ether
Methanol
Methyl Cellosolve
Methylene Chloride
Methyl Formate
MIBK
Phenol
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
1,675
84.1
0.5
25.0
1.3
10.0
0.05
1.3
0.15
0.02
0.15
0.4
250.0
91.5
10.0
1.3
0.05
0.03
1.2
3.9
1.3
8.4
10.0
100.0
0.9
1.3
0.5
0.05
8.4
0.06
250.0
0.03
856 (a)
29.4
0.2
10.2
0.5
4.1
0.02
0.5
0.06
0.013
0.06
0.1
102.0
37.5
4.1
0.5
0.02
0.02
0.5
1.6
0.5
2.6
4.1
40.6
0.3
0.5
0.2
0.02
2.6
0.02
102.0
0.01
(a) If the average monthly COD concentrations are higher than concentration values reflecting a reduction
in the long-term average daily COD load in the raw (untreated) process wastewater of 74% multiplied by
a variability factor of 2.2, then the average monthly effluent limitations for COD corresponding to the lower
concentration values must be applied.
7-2
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Table 7-3: BAT Effluent Limitations Guidelines for Subpart B and D Operations
Pollutant or Pollutant Property
COD
BAT Effluent Limitation for End-of-Pipe Monitoring Points
Maximum for any one day
(mg/L)
228
Monthly Average
(mg/L)
86
NSPS forsubparts A and C are presented in Table 7-4. NSPS forsubparts B and D are presented in
Table 7-5. There are no NSPS limitations forsubpart E operations.
Table 7-4: NSPS for Subpart A and C Operations
Pollutant or Pollutant Property
Maximum for any one day
(mg/L)
Monthly Average
(mg/L)
NSPS for In-Plant Monitoring Points
Cyanide (a)
33.5
9.4
NSPS for End-of-Pipe Monitoring Points
BOD5
COD
TSS
Ammonia as N
Acetone
Acetonitrile
n-Amyl Acetate
Amyl Alcohol
Benzene
n-Butyl Acetate
Chlorobenzene
Chloroform
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Dimethyl Sulfoxide
Ethanol
Ethyl Acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropanol
Isopropyl Acetate
Isopropyl Ether
Methanol
267
1,675
472
84.1
0.5
25.0
1.3
10.0
0.05
1.3
0.15
0.02
0.15
0.4
250.0
91.5
10.0
1.3
0.05
0.03
1.2
3.9
1.3
8.4
10.0
111
856
166
29.4
0.2
10.2
0.5
4.1
0.02
0.5
0.06
0.013
0.06
0.1
102.0
37.5
4.1
0.5
0.02
0.02
0.5
1.6
0.5
2.6
4.1
7-3
-------
Pollutant or Pollutant Property
Methyl Cellosolve
Methylene Chloride
Methyl Formate
MIBK
Phenol
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
Maximum for any one day
(mg/L)
100.0
0.9
1.3
0.5
0.05
8.4
0.06
250.0
0.03
Monthly Average
(mg/L)
40.6
0.3
0.5
0.2
0.02
2.6
0.02
102.0
0.01
(a)
Cyanide effluent limit established in the 1983 final rule.
Table 7-5: NSPS for Subpart B and D Operations
Pollutant or Pollutant Property
BOD5
COD
TSS
NSPS for End-of-Pipe Monitoring Points
Maximum for any one day
(mg/L)
35
228
58
Monthly Average
(mg/L)
18
86
31
7.2 Indirect Dischargers
7.2.1 PSESandPSNS
This section lists PSES and PSNS for existing and new indirect dischargers with operations in subparts A,
B, C, and D. Subpart E operations are not regulated by PSES or PSNS.
EPA did not revise the existing PSES standards for cyanide for subpart A and C facilities. EPA did
regulate organics and ammonia, and clarified the current cyanide monitoring requirements for these
facilities.
EPA set pretreatment standards for ammonia for subparts A and C because of the high loads of ammonia
currently being discharged by a number of pharmaceutical facilities to POTWs that do not have
nitrification capability and receive wastewaters from subpart A and C facilities. However, EPA is aware
that some POTWs treating pharmaceutical wastewaters from these subcategories have nitrification
capability, and EPA has made a determination of no pass through for ammonia at these POTWs. Thus,
PSES ammonia limitations will not apply to subpart A and C facilities discharging to POTWs with
nitrification capability. POTWs that nitrify should impose local limits for ammonia if they believe that the
ammonia load from the pharmaceutical industrial user(s) will nevertheless pass through their facilities.
POTWs with nitrification capability are defined as being able to oxidize ammonium salts to nitrites (via
Nitrosomonas sp. bacteria) and then further oxidize nitrites to nitrates (via Nitrobacter sp. bacteria) and
achieve greater removals of ammonia than POTWs without nitrification. Nitrification can be accomplished
in either a single- or two-stage activated sludge system. Indicators of nitrification capability are: (1)
biological monitoring for ammonia oxidizing bacteria (AOB) and nitrite oxidizing bacteria (NOB) to nitrite
oxidizing bacteria (NOB) to determine if nitrification is occurring; or (2) analysis of the nitrogen balance
7-4
-------
across the biological treatment unit(s) to determine if nitrifying bacteria reduce the amount of ammonia
and increase the amount of nitrite and nitrate in the wastewater. At POTWs where the nitrogen balance is
not usable because nitrites and nitrates are not present in the effluent in significant concentrations, such
as at a POTW with nitrification-denitrification treatment or one with a wetlands treatment unit, the
identification of the AOB and NOB will demonstrate that nitrification is occurring. Thus, the use of one of
the aforementioned methods is sufficient for demonstrating nitrification capability.
The PSES and PSNS forsubpart A and C operations are presented in Table 7-6. The PSES and PSNS
forsubpart B and D operations are presented in Table 7-7.
Table 7-6: PSES and PSNS for Subpart A and C Operations
Pollutant or Pollutant Property
Maximum for any one day
(mg/L)
Monthly Average
(mg/L)
PSES/PSNS for In-Plant Monitoring Points
Cyanide (a)
33.5
9.4
PSES/PSNS for End-of-Pipe Monitoring Points
Ammonia as N (b)
Acetone
n-Amyl Acetate
Benzene
n-Butyl Acetate
Chlorobenzene
Chloroform
o-Dichlorobenzene
1,2-Dichloroethane
Diethylamine
Ethyl Acetate
n-Heptane
n-Hexane
Isobutyraldehyde
Isopropyl Acetate
Isopropyl Ether
Methylene Chloride
Methyl Formate
MIBK
Tetrahydrofuran
Toluene
Triethylamine
Xylenes
84.1
20.7
20.7
3.0
20.7
3.0
0.1
20.7
20.7
255.0
20.7
3.0
3.0
20.7
20.7
20.7
3.0
20.7
20.7
9.2
0.3
255.0
3.0
29.4
8.2
8.2
0.6
8.2
0.7
0.03
8.2
8.2
100.0
8.2
0.7
0.7
8.2
8.2
8.2
0.7
8.2
8.2
3.4
0.2
100.0
0.7
(a) Cyanide effluent limit established in the 1983 final rule.
(b) Ammonia is only regulated for indirect dischargers that discharge to non-nitrifying POTWs.
7-5
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Table 7-7: PSES and PSNS for Subpart B and D Operations
Pollutant or Pollutant Property
Acetone
N-Amyl acetate
Ethyl acetate
Isopropyl acetate
Methylene chloride
PSES/PSNS for End-of-Pipe Monitoring Points
Maximum for any one day
(mg/L)
20.7
20.7
20.7
20.7
3.0
Monthly Average
(mg/L)
8.2
8.2
8.2
8.2
0.7
7-6
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8. How Are Permits Developed for Facilities with
Operations in Subparts A, B, C, D, and E?
This section discusses the step-by-step process of establishing permit limits using effluent limitations
guidelines and standards for facilities with operations in subparts A, B, C, D, and E. The discussion
covers the following steps to aid permit writers and control authorities in establishing permits:
STEP 1
Reviewing Permit Applications
STEP 2
Developing Permit Limits
STEP 3
Developing Monitoring Requirements
STEP 4
Compliance with New Source Standards
STEPS
Developing Special Conditions
8-1
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STEP 2
Developing Permit Limits
STEPS
Developing Monitoring Requirements
STEP 4
Compliance with New Source Standards
STEP 5
Developing Special Conditions
STEP 1: Reviewing Permit Applications
8.1 Reviewing Permit Applications
All facilities that discharge process wastewaters into receiving streams must submit the following forms,
or the state control authority's applicable forms, where the state has an authorized NPDES permit
program, when applying for an NPDES permit:
1. Form 1, which includes basic facility information and the SIC codes for the products
manufactured; and
2. Form 2C (existing sources) or Form 2D (new sources), which includes outfall information, flow
information or projections, and production information or projections.
Additional supporting information, associated with the facility's receiving stream, may include Total
Maximum Daily Loads (TMDLs), Whole Effluent Toxicity (WET) test data, existing waste load allocations,
and in-stream data and studies. These forms and supporting material provide the information necessary
for establishing NPDES permits for facilities.
8-2
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STEP1
Reviewing Permit Applications
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STEPS
Developing Monitoring Requirements
STEP 4
Compliance with New Source Standards
STEP 5
Developing Special Conditions
STEP 2: Developing Permit Limits
• How Are Annual Average Process Wastewater
Discharges Calculated?
• How Are Mass-Based Permit Limitations
Calculated?
• What Type of Permit Limitations Should Be Used
for Cyanide?
• Should the Permit Include Limits Based on
Effluent Limitations Guidelines and Standards or
WQBELs?
8.2 Developing Permit Limits
As part of the permit process, permit writers must apply the effluent limitations guidelines and standards
developed by EPA to establish numerical permit limits for facilities. Note that permits may also include
WQBELs (see section 2). This document; however, focuses on the development of permit limits based
on effluent limitations guidelines and standards for the pharmaceutical point source category.
As discussed in the body of the Development Document for Effluent Limitations Guidelines and
Standards for the Pharmaceutical Manufacturing Point Source Category (EPA 821-R-98-005), the
pharmaceutical manufacturing industry effluent limitations guidelines and standards are concentration
based and adhere to the "building block" concept, where applicable. Where applicable, each regulated
wastestream in an outfall is assigned a mass-based discharge allowance based on a calculation of its
applicable concentration-based limitation and appropriate process flow. The sum of the allowances is the
total mass discharge allowance for the outfall.
Mass limitations for unregulated process wastewater streams and dilution streams at direct discharging
facilities are established by the NPDES permit authority using best professional judgment (BPJ). Where
process effluent is mixed prior to treatment with wastewaters other than those generated by the regular
process (e.g., unregulated process wastewater streams and dilution streams) at indirect discharging
facilities, the Control Authority may develop alternate limitations (see 40 CFR 403.12(a) and 40 CFR
403.3) by using the combined waste stream formula (see 40 CFR 403.6(e)(i),(ii)).
Permit writers may elect to develop limitations or standards for excluded wastes which are not regulated
on a national level, in a facility permit under certain conditions. In the case of an indirect discharge, the
pretreatment authority must develop local limits for excluded wastes under certain conditions (pass
through or interference or as necessary to prevent violations of the POTWs NPDES permit). For the
specific circumstances, see 40 CFR 403.5. A pretreatment authority may also develop limits for excluded
wastes where otherwise authorized or required under state law. The permit writer or pretreatment
authority decides if a facility may or may not discharge an excluded waste and sets the conditions
whereby a facility may or may not discharge this waste. Excluded wastes include off-specification
fermentation batches, trimethyl silanol, and active antimicrobial materials.
8-3
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8.2.1 How Are Annual Average Process Wastewater Discharges Calculated?
In implementing the final BPT, BAT, and NSPS limitations and standards, permit writers need to account
for the facility's nonprocess wastewater contained in the effluent being discharged in developing either
mass or concentration based permit limits. EPA developed the final effluent limitations guidelines and
standards from data gathered at plants which had less than 25 percent nonprocess wastewater in the
total plant discharge that is subject to the regulations. Therefore, when permit writers develop end-of-pipe
effluent limitations, they should use a reasonable estimate of process wastewater discharge flow, allowing
for up to 25 percent nonprocess water through treatment. The flow estimates and the concentration-
based limitations are used to develop mass-based limitations for the NPDES permit.
"Process wastewater discharge" is defined, in general, by 40 CFR 122.2. In the case of pharmaceutical
manufacturing operations, wastewater resulting from the manufacture of pharmaceutical products include
those wastewaters that come in direct contact with raw materials, intermediate products, and final
products, and surface runoff from the immediate process area that has the potential to become
contaminated. Noncontact cooling waters, utility wastewaters, general site surface runoff, groundwater,
and other nonprocess water generated on site are specifically excluded from this definition. The
appropriate process wastewater discharge flow for each stream to be used when developing mass-based
limitations must be determined by permit writers on a case-by-case basis using current information
provided by the facility seeking the permit. Both the NPDES permit regulations and the general
pretreatment regulations prohibit the use of dilution flows in determining mass limitations in cases where
permit writers deem the process wastewater discharge flow claimed by the permittee are excessive and
represent dilution flows. Permit writers may develop a more appropriate process wastewater discharge
flow for use in computing the mass-based permit limitations. Permit writers should review the following
items to evaluate whether process wastewater discharge flow reflects the addition of dilution flows:
• The component flows to ensure that the claimed flows are, in fact, process wastewater discharge
flows as defined by 40 CFR 122.2.
• The plant operations to ensure that sound water conservation practices are being followed.
Examples include minimization of process water uses and reuse or recycle of intermediate
process waters or treated wastewaters at the process area and in wastewater treatment
operations (pump seals, equipment and area washdowns, etc.)
• Barometric condenser use at the process level. Often, barometric condensers will generate
relatively large volumes of slightly contaminated water. Replacing barometric condensers with
surface condensers can reduce wastewater volumes significantly and result in collection of
condensates that may be returned to the process.
To establish a NPDES permit for a direct discharging facility, permit writers should determine which
subcategories the facility's operations fall within and use the corresponding concentration-based effluent
limitations as a basis for developing the mass-based limitations. Permit writers should evaluate the
facility's long-term average process and nonprocess wastewater discharge flow. The flow volume
representing 25% or less of the total flow should be included in the volume used to calculate allowable
mass discharges. Any additional volume would have to be evaluated on a case-by-case basis to
determine what, if any, mass allowances are appropriate. The permit writer should consider only the
sources of "process wastewater discharge," as defined previously, and only sources of nonprocess
wastewater such that the percentage of nonprocess wastewaters in the total regulated flow is no more
than 25%. The long-term average flow is defined as the average of daily flow measurements calculated
over at least a year (usually at least three years of flow data are used to account for fluctuations).
However, permit writers have flexibility when determining a facility's long-term average flow rate. If a
facility is expecting significant changes in production as represented by previous year(s) data, permit
writers may establish a flow rate expected to be representative during the permit term.
8-4
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In the event that no historical data or actual process wastewater flow data exist (such as for a new
source), permit writers should establish a reasonable estimate of the facility's projected flow. This may
include a request for the facility to measure process wastewater flows for a representative period of time
to establish a flow basis. Permit writers are advised to establish a flow rate that is expected to be
representative during the entire term of the permit. If a plant is planning significant changes in production
during the effective period of the permit, permit writers may consider establishing multiple tiers of
limitations as a function of these changes. Alternatively, a permit may be modified during its term, either
at the request of the permittee, permitter, or another party, or on EPA's initiative, to increase or decrease
the flow basis in response to a significant change in production (40 CFR 124.5, 122.62). A change in
production may be an "alteration" of the permitted activity or "new information" that would provide the
basis fora permit modification (40 CFR 122.62(a)).
8.2.2 How Are Mass-Based Permit Limitations Calculated For Direct
Dischargers?
For NPDES permits, after determining the facility's long-term average process wastewater flow, permit
writers can use the long-term average daily flow rate or other established flow rate to convert
concentration-based limitations into mass-based limitations. The following equation can be used by the
permit writer to convert a concentration-based limitation into a mass-based limitation:
Lm = Lc x F x k1
where:
Lm = mass-based effluent limitation, Ibs/day
Lc = concentration-based limitation, mg/L
F = long-term average process wastewater discharge, gal/day
k1 = unit conversion factor, (L x ibs)/(gal x mg).
For this example, the unit conversion factor, k-i is used to convert from [(mg/L)x(gal/day)] to (Ibs/day) as
follows:
1L lg lib .6 Lib
k= x x = 8.345 x 10 x
0.264179 gal 1,000 mg 453.592 g gal mg
If the concentration based limitations are expressed as ^g/L, the unit conversion factor k2 can be used to
convert from [(^g/L) x (gal/day)] to (Ibs/day) as follows:
1L lg lib 9 Lib
x x = 8.345x 10 x
0.264179 gal l,000,000/£ 453.592 g gal/£
8-5
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8.2.3 What Type of Permit Limitations Should Be Used for Cyanide?
EPA expects that permit limitations for cyanide, based on the 1983 PSES limitations, at in-plant locations
will be concentration-based, and not converted to mass limits. A concentration basis should be used for
cyanide because it offers a direct benchmark to assess whether the in-plant control technology is
achieving the intended PSES and PSNS levels. In-plant wastestreams that require control may be
generated or treated on a variable, batch basis. In such a setting, mass-based permit limitations are
difficult to establish accurately, and compliance is hindered because the permitted facility cannot make a
direct measurement to determine if its control technology is performing at the required level.
Concentration-based permit limitations eliminate these problems and offer a direct measure of cyanide to
both the permitting authority and the permitted facility that PSES and PSNS performance levels are being
achieved.
8.2.4 Should the NPDES Permit Include Limits Based on Effluent Limitations
Guidelines or WQBELs?
All receiving waters have water quality standards that are established by the states or EPA that protect
the designated uses of the receiving water. After determining the allowable limits based on effluent
limitations guidelines and standards, permit writers must compare them to the receiving water's WQBELs.
If limits based on effluent limitations guidelines and standards for a particular pollutant result in
discharges that exceed the WQBELs for the receiving water, permit writers must establish permit limits
that are based on WQBELs (see Section 2 for more information regarding WQBELs).
STEP1
Reviewing Permit Applications
STEP 4
Compliance with New Source Standards
STEPS
Developing Special Conditions
STEP 3: Developing Monitoring Requirements
• What are the Monitoring Locations?
• What are the Monitoring Frequencies?
• How may Certification of non-use of Regulated
Chemicals be Achieved?
• What if the Annual Chemical Analysis Scan
Identifies Discharge of a Regulated Pollutant Not
Covered by a Facility's Permit?
• How may Surrogates be Used to Demonstrate
Compliance?
• Can Surrogates Be Used if Neither Advanced
Biological Treatment Nor Steam Stripping Are
Part of the Facility's Treatment System?
• What are the Appropriate Analytical Methods?
• What is the Level of Detection Required to
Demonstrate Compliance?
• What are Reporting and Recordkeeping
Reauirements?
8-6
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8.3 Developing Monitoring Requirements
One of the permit writer's responsibilities is to establish monitoring requirements for facilities with
operations in subparts A, B, C, D, and E. NPDES permits require dischargers to monitor their effluent to
ensure that they are complying with permit limitations. As specified in 40 CFR 122.41, 122.44, and
122.48, all NPDES permits must specify requirements for using, maintaining, and installing (if appropriate)
monitoring equipment; monitoring frequencies; analytical methods; and reporting and recordkeeping.
Control authorities generally require similar monitoring techniques and frequencies at indirect discharging
facilities. In addition to monitoring, etc., this section also focuses on the following unique aspects of the
revised rule that relate to compliance monitoring:
• How may facilities certify non-use of a regulated chemical?
• How may surrogates be used to demonstrate compliance?
• What are the required analytical methods and the minimum levels of detection of each method?
• What other process parameters must be monitored to demonstrate that samples are
representative?
8.3.1 What Are the Monitoring Locations?
Permit writers must require facilities to monitor their effluent in order to determine compliance with the
effluent limitations guidelines and standards promulgated by EPA (see Section 6). The BPT, BAT, and
NSPS effluent limitations for ammonia, BOD5, TSS, pH, COD, and the organic pollutants are end-of-pipe
limitations that are applicable to the process wastewater fraction of the final effluent at the point of
discharge to waters of the United States. Compliance monitoring for cyanide at facilities with operations in
subparts A or C should occur immediately after cyanide destruction, before commingling cyanide-bearing
wastestreams with noncyanide-bearing wastestreams, unless a facility can demonstrate that cyanide is
detectable at the end-of-pipe sampling point and sufficient information exists to use the end-of-pipe
monitoring results to determine compliance at the required in-plant location.
The PSES and PSNS for ammonia and the organic pollutants are applicable at an end-of-pipe discharge
point prior to discharge to the POTW sewer system. Compliance monitoring for cyanide at facilities with
operations in subparts A or C should occur immediately after cyanide destruction, before commingling
cyanide-bearing wastestreams with noncyanide-bearing wastestreams, unless a facility can demonstrate
that cyanide is detectable at the end-of-pipe sampling point and sufficient information exists to use the
end-of-pipe monitoring results to determine compliance at the required in-plant location. In some cases,
where there are detection or compliance determination issues, in-plant monitoring for organics may be
used.
8.3.2 What Are the Monitoring Frequencies and Sampling Protocols?
Permit writers must determine an appropriate frequency for compliance monitoring for ammonia, BOD5,
COD, TSS, pH, and other organic constituents. EPA's monitoring costs for this regulation assumed
compliance monitoring for ammonia and all regulated organic constituents on a weekly basis, and
monitoring for BOD5, COD, TSS, and pH on a daily basis. However, the permit writer has the obligation to
set a monitoring frequency in accordance with 40 CFR 122.41 that is representative of the monitored
activity. For indirect dischargers subject to pretreatment standards, EPA also assumed weekly monitoring
for regulated pollutants. The General Pretreatment Regulation (40 CFR Part 403) establish a minimum
monitoring frequency of twice per year (see 40 CFR 403.12 (e)).
8-7
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Compliance monitoring for cyanide should be performed on a representative number of batches of treated
wastewater, taking into consideration the in-situ methods of monitoring the cyanide destruction operation,
when the cyanide is being monitored at an in-plant location prior to commingling with other wastewaters.
Cyanide sampling must be performed using grab samples and the presence of oxidizing agents must be
determined and ascorbic acid added if such agents are present. Each individual grab sample must be
preserved in accordance with 40 CFR Part 136.
For most organic pollutants, compositing is required. Compositing requirements are listed in 40 CFR
122.21 (4)(viii) which discusses the use of 24-hour composite samples. Facilities may obtain the
composite samples by collecting 4 or more grab samples and compositing the samples in the laboratory
under chilled conditions by injecting separate aliquots from each grab into the purge cell in the GC/MS
instrument. Alternatively, facilities can analyze each grab separately with the composite calculated as the
mean of the individual grab samples.
8.3.3 How May Certification of Non-Use of Regulated Chemicals be Achieved?
As indicated in 40 CFR 439.4, permit limits and compliance monitoring are required for each regulated
pollutant generated or used at a pharmaceutical manufacturing facility, except where the regulated
pollutant is monitored as a surrogate parameter. Permit limits and compliance monitoring are not required
for regulated pollutants that are neither used nor generated at the facility. This determination along with
recommendations of any surrogates must be submitted with permit applications for approval by the
permitting authority and reconfirmed by an annual chemical analysis of wastewater from each monitoring
location. Therefore, the list of pollutants for which monitoring would be required should be updated
periodically based on consideration of raw materials and process changes throughout the facility. EPA
recommends an annual scan for all pollutants listed in Tables 7-1 through 7-5 for direct dischargers, and
Tables 7-6 and 7-7 for indirect dischargers. The annual scan should be performed at the compliance
monitoring point(s) to identify any regulated pollutants in the wastewater. Permit monitoring and
compliance should be required at all monitoring locations for all pollutants detected at any locations.
Facilities that do not use a regulated chemical and that can demonstrate a non-detect value for the
regulated chemical from their annual scan may certify that they do not use the regulated chemical. In
these cases, the facility would not have to monitor for the chemical until an annual scan indicated the
presence of the regulated chemical.
8.3.4 What If the Annual Chemical Analysis Scan Identifies Discharge of a
Regulated Pollutant Not Covered by a Facility's Permit?
If the annual scan identifies that a regulated pollutant, previously certified as a non-use regulated
chemical, is being discharged, then the list of pollutants for which limits and compliance monitoring would
be required should be updated. Permits should be developed with a re-opener clause such that
identification of pollutants from the annual scan can result in their addition to the permit through a
modification.
8.3.5 How May Surrogates Be Used to Demonstrate Compliance?
Facilities discharging more than one regulated organic pollutant within a treatability group may monitor for
a single surrogate pollutant if they demonstrate an appropriate degree of control for a specified group of
pollutants. (See 40 CFR439.1(o) and Appendix A) For the purpose of identifying surrogates, pollutants
are grouped according to treatability classes. Table 8-1 presents the treatability classes identified for
advanced biological treatment which is the BAT/NSPS technology basis for organic pollutant limitations.
Table 8-2 presents the treatability classes identified for steam stripping, which is the PSES/PSNS
technology basis for organic pollutant limitations. For treatability classes with more than one possible
surrogate pollutant, the analyte with the highest concentration or loadings should be chosen as the
surrogate pollutant. Plants may monitor for a surrogate pollutant(s) only if they demonstrate that all other
8-8
-------
pollutants receive the same degree of treatment. All BAT and NSPS pollutants must go through the same
treatment system to use the surrogates listed in Table 8-1. All PSES and PSNS pollutants must go
through the same treatment system to use the surrogates listed on Table 8-2.
An individual plant may choose to demonstrate that monitoring is feasible by selecting a given treatability
class and maintaining documentation, including flow information and sampling results, that all pollutants
in that treatability class receive equivalent treatment. The documentation is then submitted to the permit
authority for approval, prior to the reissued or new permit by the permit writer or control authority. It should
be noted that participation in a surrogate monitoring program is voluntary on the part of the permittee and
must be approved by the permit writer or control authority.
Caution should be taken in selecting surrogate pollutants, as an exceedence of a permit limit for the
surrogate pollutant represents an exceedence for all pollutants represented by that surrogate unless
appropriate analytical data demonstrate otherwise.
8.3.6 Can Surrogates Be Used if Neither Advanced Biological Treatment Nor
Steam Stripping Are Part of the Facility's Treatment System?
If a facility uses a technology other than steam stripping or biological treatment and would like to use
surrogates, the permit writer or control authority should request the facility to monitor the facility's
technology performance for all applicable regulated pollutants to show the relationship between the
treatability of potential surrogate pollutants and that of other pollutants in the wastewater. Based on the
performance data, appropriate surrogates can be chosen. The permittee must show equivalent reduction
for the pollutants and provide data to show that the pollutant covered by the surrogate will be treated to
the same extent that the surrogate is treated. The permit writer or control authority will not want to use
pollutants with lower influent concentrations as surrogates because it may be difficult for a facility to
demonstrate removal of these surrogates.
8.3.7 What Are the Appropriate Analytical Methods?
Dischargers may use the test methods promulgated at 40 CFR 136.3 or incorporated by reference in the
tables of that Part, when available, to monitor pollutant discharges from the pharmaceutical
manufacturing industry, unless specified otherwise in Part 439 (See 40 CFR 401.13) or by the permitting
authority.
As a part of the final rule, EPA promulgated additional test methods for the pollutants to be regulated
under Part 439 for which there are no test methods listed at 40 CFR 136.3. To support the Part 439
regulations at the time of proposal, EPA published test methods developed specifically for the
pharmaceutical industry in a compendium entitled, Analytical Methods for the Determination of Pollutants
in Pharmaceutical Manufacturing Industry Wastewater, EPA-821-B-94-001. These test methods were
discussed in the proposed rule and were revised in response to public comment. The revised test
methods are available for monitoring some pollutants covered by the final rule. The revised test methods
have been published in a revised compendium (Pharmaceutical Methods Compendium, Revision A; EPA-
821-B-98-016, 1998) with the same title as the proposed compendium.
In addition EPA is allowing use of applicable drinking water methods that have been promulgated at 40
CFR Part 141 and use of ASTM Methods D3371, D3695, and D4763 for monitoring of the regulated
pollutants.
8-9
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Table 8-1: Surrogates for Subpart A/C Direct Dischargers (Biotreatment)
Group
Alcohols
Aldehydes
Alkanes
Amides & Amines
Aromatics
Chlorinated Alkanes
Esters & Ethers
Ketones
Miscellaneous
Compound
Ethanol
Isopropanol
Methanol
Phenol
Amyl alcohol
Isobutyraldehyde
n-Heptane
n-Hexane
Triethylamine
Diethylamine
Toluene
Xylenes
Chlorobenzene
o-Dichlorobenzene
Benzene
Methylene chloride
Chloroform
1,2-Dichloroethane
Ethyl acetate
Tetrahydrofuran
Isopropyl acetate
n-Amyl acetate
Isopropyl ether
n-Butyl acetate
Methyl formate
Acetone
MIBK
Ammonia (aqueous)
Acetonitrile
Dimethyl sulfoxide
Methyl cellosolve
Surrogate (yes/no)
Yes
Yes
Yes
No
No
No
Yes
Yes
No
No
Yes
Yes
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
Yes - May be a surrogate pollutant for the group.
No - Should not be used as a surrogate pollutant for the group.
8-10
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Table 8-2: Steam Stripping Surrogates for Indirect Dischargers
Strippability Group
High
Medium
Compound
Methylene Chloride
Toluene
Chloroform
Xylenes
n-Heptane
n-Hexane
Chlorobenzene
Benzene
Acetone
Ammonia as N
Ethyl acetate
Tetrahydrofuran
Triethyamine
MIBK
Isopropyl acetate
Diethylamine
1,2-Dichloroethane
n-Amyl acetate
Isopropyl ether
n-Butyl acetate
Methyl formate
Isobutraldehyde
o-Dichlorobenzene
Surrogate (Yes/No)
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes - May be a surrogate pollutant for the group.
No - Should not be used as a surrogate pollutant for the group.
8-11
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In summary, the industrial users may use any of the following analytical methods:
• 40 CFR 136.3, including those incorporated by reference;
• EPA-821-B-94-001;
• 40 CFR 141; and
• ASTM Methods D3371, D3695, and D4763.
Please see Analytical Methods for the Determination of Pollutants in Pharmaceutical Manufacturing
Industry Wastewater, EPA 821-B-98-016, and Analytical Methods Guidance for the Pharmaceutical
Manufacturing Point Source Category, EPA 821 -B-99-003, for specific information on methods to use and
minimum levels. Contact EPA for possible additional methods approved after the publication of this
document.
8.3.8 What Is the Level of Detection Required to Demonstrate Compliance?
For various pollutants, EPA has established effluent limitations guidelines and standards that are near the
minimum level (ML). The permit authority must require facilities to demonstrate compliance with those
limitations and standards using the appropriate methods (which have ML values at or below the specified
limitations and standards). Appropriate methods and MLs for each pollutant are listed in Analytical
Methods for the Determination of Pollutants in Pharmaceutical Manufacturing Industry Wastewater, EPA
821-B-98-016. Facilities cannot demonstrate compliance using an analytical method with an ML above
the limitations and standards.
The ML specified for each method is the lowest level at which laboratories calibrate their equipment. To
do this, laboratories use standards (i.e., samples at several known concentrations). Calibration is
necessary because laboratory equipment does not measure concentration directly, but rather generates
signals or responses from analytical instruments that must be converted to concentration values. The
calibration process establishes a relationship between the signals and the known concentration values of
the standards. This relationship is then used to convert signals from the instruments for samples with
unknown concentrations. In the calibration process, one of the standards will have a concentration value
at the ML for the pollutant analyzed. Because the ML is the lowest level for which laboratories calibrate
their equipment, measurements below the ML are to be reported as
-------
STEP1
Reviewing Permit Applications
STEP 2
Developing Permit Limits
STEPS
Developing Monitoring Requirements
STEP 4: Compliance with New Source
Standards
When Must New Sources Comply with the
September 21,1998 Promulgated Rules?
STEP 5
Developing Special Conditions
8.4 Compliance with New Source Standards
8.4.1 When Must New Sources Comply with the September 21, 1998 Promulgated
Rules?
A direct discharging facility which began discharging as a new source subject to the 1983 NSPS on
November 21, 1993, for example, is required to be in compliance with the 1998 BCT and BAT regulations
after Nov. 21,2003. Compliance for existing source indirect discharging facilities was as soon as possible,
but no later than September 21, 2001. Indirect dischargers covered by the 1983 PSNS would then be
covered by the September 21,1998 PSES requirements after September 21, 1998. A new source direct
or indirect discharger that commenced discharging after the September 1998 promulgation date must be
in compliance with the applicable NSPS or PSNS when they begin discharging.
8-13
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STEP1
Reviewing Permit Applications
STEP 2
Developing Permit Limits
STEPS
Developing Monitoring Requirements
STEP 4
Compliance with New Source Standards
STEP 5: Developing Special Conditions
• What are the Special Conditions for Cyanide
Limitations?
• When is Ammonia Regulated at Indirect
Discharging Facilities?
• What are the Special Conditions for pH
Monitoring?
• How Should Permit Writers Account for
Nonprocess Wastewater in the Final Effluent?
• What is EPA's Guidance with Regard to
Coverage of Full Scale Bioengineered Product
Manufacturing?
• Are Tank Passivating and Electropolishing
Wastewaters Considered Metal Finishing
Operation Wastewaters Regulated by 40 CFR
Part 433?
8.5 Developing Special Conditions
Permit writers and pretreatment authorities need to be aware of special circumstances involving
compliance with the cyanide limitations and standards, ammonia pretreatment standards, pH monitoring,
and the portion of nonprocess wastewater in the final effluent.
8.5.1 What Are the Special Conditions for Cyanide Limitations?
In the case of the cyanide limitations and standards, EPA determined that the compliance monitoring
point should be in-plant at a point before the cyanide-bearing wastewaters are commingled with
noncyanide-bearing waste streams in accordance with EPA permit and pretreatment program regulations.
EPA's analysis of waste stream flow data from subpart A and C facilities containing cyanide in their
wastewaters indicates that the volume of cyanide-bearing wastewaters is, on average, less than 2.1
percent of the total process wastewater flow and that all but two of the facilities required to monitor for
cyanide do so at an in-plant monitoring point. However, facilities that can demonstrate that it is feasible to
monitor for cyanide at the end-of-pipe point may do so.
8.5.2 When Is Ammonia Regulated at Indirect Discharging Facilities?
In connection with the ammonia pretreatment standards promulgated forsubparts A and C, EPA has
determined that the pollutant ammonia does not pass through POTWs that possess nitrification capability.
As a result, ammonia pretreatment standards would not apply to subpart A and C industrial users that
discharge to these POTWs. POTWs (including those with nitrification) may impose more stringent local
limits for ammonia.
8-14
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8.5.3 What Are the Special Conditions for pH Monitoring?
During the post-proposal period, EPA received comments from industry commenters that complying with
the pH requirements 100% of the time when using continuous monitoring is not practical for many
facilities. Direct discharging pharmaceutical facilities are supposed to maintain effluent pH in the 6.0-9.0
range. The general pretreatment regulations at 40 CFR 403.5(b)(2) set a pH minimum of 5.0, except in
certain design conditions, but do not set an upper boundary. EPA has addressed the problem of random
excursions at 40 CFR 401.17 for direct discharging facilities. This regulation recognizes that random
excursions from the pH range (6.0-9.0) may occur in the process of continuous monitoring and these
random excursions should not be treated as violations. Currently, there is no similar provision for indirect
dischargers.
8.5.4 How Should Permit Writers Account for Nonprocess Wastewater in the
Final Effluent?
In implementing the final limitations and standards, permit writers need to account for the facility's
nonprocess wastewater contained in the effluent being discharged in developing either mass or
concentration based permit limits. As discussed previously, the final limitations and standards for direct
dischargers and for indirect dischargers with respect to ammonia when biological treatment is used are
developed from data sets from plants which had less than 25% nonprocess wastewater in the total plant
discharge. Examples are presented in the next section which show how to incorporate facility flow with
dilution water.
8.5.5 What Is EPA's Guidance with Regard to Coverage of Full Scale
Bioengineered Product Manufacturing?
At the time the final regulations were developed, full-scale bioengineering activities had not been
evaluated and the manufacture of bioengineered products was not addressed in the documents
supporting the final regulation. Bioengineering activities at the time, which were considered to be subpart
E (research) activities, were discussed in a response to three different comments. The basis for the
response was information obtained during an engineering site visit to a pharmaceutical manufacturing
plant which was engaged in bioengineering related activities. EPA's position with regard to these small
scale laboratory or bench scale research or manufacturing activities was that they did not involve
generation of significant quantities of wastewater and/or pollutants and the disposal of wastewater
containing bioengineered microorganisms was addressed by guidance from the National Institutes of
Health (NIH). Therefore, coverage of these wastewaters at research facilities by the final pharmaceutical
manufacturing rule was not deemed appropriate as noted in comment responses.
Since the final pharmaceutical manufacturing regulations were promulgated on Sept. 21, 1998,
pharmaceutical and other manufacturers have begun producing bioengineered products using
bioengineering techniques developed from bench scale research operations. In manufacturing these
bioengineered pharmaceutical products, various facilities have used processes that are similar to the
fermentation process more generally defined in 40 CFR 439.11 and described in the Development
Document. In some cases, the processes generate wastewater in quantities comparable to that
generated by fermentation operations described in the Development Document but do not utilize solvents
in the operation. In still other cases, non-pharmaceutical manufacturers such as pesticide active
ingredient manufacturers have used the same kind of manufacturing to produce pesticide active
ingredients. However, because of restrictive definition of fermentation in Part 439, in EPA's view, the
fermentation subcategory does not include the manufacture of bioengineered products.
It may be argued by permit applicants and industrial users that not covering bioengineering research
activities that were in place at the time the rule was promulgated provides a blanket exclusion for all
bioengineering related manufacturing operations. However, such an interpretation ignores the facts that
EPA's exclusion with regard to bioengineering activities conducted prior to promulgation was based on
8-15
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the following: (1) the wastewater and/or pollutants generated from these operations was considered
insignificant; and (2) the disposal of wastewater containing bioengineered microorganisms from these
operations was addressed in guidance from the National Institutes of Health (NIH) and EPA did not revise
the subpart E (research) requirements in the 1998 rule. In addition, EPA indicated in the preamble to the
final regulations that the wastewaters from these operations were not evaluated or characterized by EPA
prior to promulgation of the final rule.
In EPA's view, product classification and wastewater characteristics should determine whether limitations
similar to those in the pharmaceutical rule apply to wastewater from a bioengineering process. If a
product is similar to those regulated in 40 CFR 439.0 and the wastewater generated during its production
is similar in quantity and quality to wastewater generated by one of the four manufacturing subcategories,
then permit writers may consider developing appropriate limitations on a BPJ basis for the manufacturing
wastewater.
8.5.6 Are Tank Passivating and Electropolishing Wastewaters Considered Metal
Finishing Operation Wastewaters Regulated by 40 CFR Part 433?
The metal finishing operation regulations in 40 CFR Part 433 covering wastewaters generated by tank
passivation and/or electropolishing are not meant to be applied to insignificant process sources that are
coincidental to the metal finishing industry and are not related to metal finishing products. Therefore,
passivation and/or electropolishing wastewaters periodically generated in tank cleaning at pharmaceutical
manufacturing facilities are not covered by 40 CFR Part 433. If a POTW pretreatment authority identifies
a concern over metals that could be contained in any spent passivation or electropolishing solution and
rinse, the authority may require the facility generating such wastewaters to hold the solution on site until it
can be analyzed for metals and discharged according to the results.
8-16
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9. Case Studies
Because there are complex permitting issues associated with 40 CFR Part 439, this section presents four
case studies showing the development of NPDES and pretreatment authority permits for facilities subject
to BPT, BAT, and PSES under subparts A, B, C, D, and E. The case studies cover a variety of facility
types and complexity. Each case study presents the following:
Facility's current permit status;
General site description;
Information about facility operations relevant to establishing permit limits;
Step-by-step approach to determining limits for each regulation (e.g., BPT, BAT); and
Final limits as they would appear in each example facility's permit.
9.1 Case Study #1
Facility A is an existing multiple-subcategory,
direct discharging pharmaceutical manufacturing
facility which has on-site treatment and
discharges to the Blue River. The facility has
submitted an application for a new NPDES
permit.
Case Study #1 highlights:
1. Permit process for direct discharging
facility with operations in subparts A, C,
D,and E.
2. Dilution water is less than 25% of facility
flow.
9.1.1 General Site Description
The flow schematic for Facility A shows the flow from each operation, and is presented in Figure 9-1.
9.1.2 Relevant Information for Establishing Permit Limits
Table 9-1 summarizes the information from the permit application needed to calculate discharge limits for
the reissued NPDES permit.
9-1
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Figure 9-1: Flow Schematic for Facility A
-------
Table 9-1: Information Needed to Establish Permit Limits for Case Study #1
What type of discharger is the facility?
Under which subparts do the facility's operations fall?
The facility is subject to which effluent limitations guidelines
and standards?
Is the dilution water at the facility >25% of the total flow?
Direct
Subparts A, C, D, and E
BPT (40 CFR Part 439)
BCT (40 CFR Part 439)
BAT (40 CFR Part 439)
No
9.1.3 Determining Permit Limits for Pollutants Regulated Under BPT
The 1998 final BPT effluent limitations guidelines revised the 1983 COD effluent limitations forsubpart A,
B, C, and D operations at direct discharging facilities. In 1983, EPA promulgated COD effluent limitations
guidelines requiring 74% reduction in the long-term daily COD load in the raw (untreated) wastewater
multiplied by a variability factor of 2.2. Under the 1998 revised BPT COD regulations, facilities must
comply with the new COD concentration limitations or the 1983 BPT regulations, whichever is more
stringent. Which limitation applies is determined by comparing the monthly average effluent limitations
specified by the 1998 and 1983 limitations. The BPT effluent limitations guidelines for BOD5, TSS and pH
were not changed. The BPT effluent limitations guidelines for subpart E operations are established in the
1983 final rule. The other conventional pollutants, fecal coliform and oil & grease, are not regulated by
BPT for the pharmaceutical manufacturing point source category.
The effluent limitations guidelines are concentration-based and, as such, do not regulate wastewater flow.
The permit writer must use a reasonable estimate of process wastewater discharge flow and the
concentration-based limitations to develop mass-based limitations for the NPDES permit. Table 7-1
presents the maximum daily and monthly average BPT effluent limitations for subpart A, B, C, D, and E
operations at direct discharging facilities.
The limitations for COD will be applied to the final effluent. An example calculation of the BPT maximum
for any one day and monthly average COD limitations for this facility is shown in the following sections.
Step 1. Determining Allowable Wastewater Discharge Flow
The first step in establishing permit limitations is to determine the types of wastestreams (i.e., regulated
process, unregulated process, and dilute) at the facility. The flow breakdown for Facility A is shown in
Table 9-2.
9-3
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Table 9-2: Flow Breakdown for Facility A
Waste Stream
1 . Fermentation operations
2. Product recovery
3. In-plant scrubbers for chemical synthesis
4. Chemical synthesis
5. Mixing/compounding and formulation
6. Power house boiler blowdown
7. Research and development
Total wastewater flow:
Total regulated process flow:
Total dilute flow:
Flow (gal/day)
1,330,000
55,000
30,000
105,000
10,000
2,000
300
1,532,300
1,530,300
2,000
(Regulated, subpart A)
(Regulated, subpart A)
(Regulated, subpart C)
(Regulated, subpart C)
(Regulated, subpart D)
(Dilute)
(Regulated, subpart E)*
*For monthly average limitations only
Under BPT, streams 1,2,3, 4, 5, and 7 are considered regulated wastestreams as effluent limitations
have been established for fermentation operations (subpart A), chemical synthesis operations (subpart
C), formulating operations (subpart D), and research operations (subpart E). Air pollution control
wastewaters are considered process wastewaters corresponding to the subcategory operations the air
pollution control devices control. Stream 6 is considered to be dilution stream.
Using BPJ, the permit writer determines Facility A's annual average wastewater discharge. Assuming the
facility production and wastewater flow are not expected to change significantly during the permit term,
the historical data provided by Facility A are used to establish the annual discharge flow, which is then
used to develop mass-based effluent limitations. If wastewater stream 6 is commingled with the process
waste streams prior to treatment, the allowable WW discharge flow used to calculate the mass -based
limitations is calculated as follows:
Process WW discharge
Allowable WW discharge
(1 - 0.25)Allowable WW discharge
Allowable WW discharge
1,530,300 gal/day
(0.25) Allowable WW discharge + Process WW
discharge
Process WW discharge
Process WW discharge / (0.75)
1,530,300 gal/day/(0.75)
2,040,400 gal/day
The allowable wastewater discharge flow used to establish the COD mass-based limitations can include
up to (2,040,400 -1,530,300) = 510,100 gallons per day of non-process wastewater before this water
would be considered as dilution water. Facility A has only 2,000 gallons per day of nonprocess
wastewater and, therefore, has less than 25 % nonprocess water in the final effluent. Thus, the total
effluent flow of 1,532,300 gal/day will be used to establish the COD mass-based limitations.
Table 7-1 presents the maximum daily and monthly average BPT effluent limitations for subpart A, B, C,
and D operations at direct discharging facilities. The BPT limitations forsubparts A and C are the same
and the limitations for subparts B and D are the same. Daily maximum limitations have not been
promulgated for subpart E operations. Monthly average limitations for subpart E operations have been
promulgated and are found at 40 CFR 439.52.
9-4
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To calculate the mass limits for the allowable nonprocess water, concentration limits for each subpart are
applied to a percentage of the total allowable nonprocess water flow. The allowable nonprocess water
flow is divided between subcategories based on the subpart A and C and subpart B and D process flow
compared to the total process flow. The calculation for Facility A is shown below:
Subpart A and C process water flow
1,330,000 + 55,000 + 30,000 + 105,000 gal/day = 1,520,000 gal/day
Subpart B and D process water flow
= 10,000 gal/day
Total process water flow
1,520,000 + 10,000 gal/day = 1,530,000 gal/day
Allowable nonprocess water flow:
Subpart A and C concentration limits apply
= 1,520,OOP gal/day x 2,000 gal/day = 1,987 gal/day
1,530,000 gal/day
Subpart B and D concentration limits apply
= 10,OOP gal/day x 2,000 gal/day =13 gal/day
1,530,000 gal/day
When calculating mass-based effluent limitations, 1,987 gallons per day of nonprocess water should be
multiplied by the subpart A and C concentration limits, and 13 gallons per day of nonprocess water should
be multiplied by the subpart B and D concentration limits.
Step 2. Determining the Use of Monthly Average Limitations vs. Percent Reduction for COD
Limitations
Facility A must comply with either the revised COD concentration limitations or the previously
promulgated COD limit requiring a reduction in the long-term average daily COD load in the raw
(untreated) process wastewater of 74 percent multiplied by a variability factor of 2.2, whichever is more
stringent. Permit authorities should compare the revised monthly average effluent limitations, which apply
to subpart A, B, C and D operations, with the previously promulgated guidelines to determine which is
more stringent. As mentioned previously, monthly average limitations for subpart E operations were not
revised in the 1998 final rule; the effluent limitations guidelines presented in 40 CFR 439.52 requiring a 74
percent reduction in the long-term daily COD load or an average monthly discharge of 220 mg/L,
whichever is greater, continue to apply.
Assuming subpart A, B, C and D operations at Facility A have an influent COD concentration of 2,000
mg/L in the wastewater treatment plant, a 74 percent reduction in the long-term daily COD load multiplied
by a variability factor of 2.2 would result in a final effluent discharge limitation of 1,144 mg/L. The revised
COD limitations require a maximum monthly average of 856 mg/L for subpart A and C operations and 86
mg/L for subpart B and D operations. The revised COD limitations are more stringent, and therefore
Facility A must comply with the mass-based limitations derived from the concentration-based COD
limitations promulgated in 1998.
For subpart E operations, the percent reduction or the floor limitation of 220 mg/l, whichever is greater,
will continue to apply. Assuming Facility A has a COD concentration of 250 mg/L from subpart E
operations, a 74 percent reduction in the long-term daily COD load multiplied by a variability factor of 2.2
results in an average effluent discharge limitation of 143 mg/L. Since the floor limitation of 220 mg/l is
greater, the 220 mg/l limitation will apply to subpart E wastewater.
9-5
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856 mg/L x (1,520,000 + 1,987) gal/day x [8.345 x 10"6 (L x |b)/( gal x mg)]
86 mg/L x (10,000 + 13) gal/day x [8.345 x 10"6 (L x |b)/( gal x mg)]
220 mg/L x 300 gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
The total monthly average BPT COD limitations can be calculated as follows:
Subpart A and C limitations:
/Lx
= 10,872lbs/day
Subpart B and D limitations:
_ x (
= 7.2 Ibs/day
Subpart E limitations:
ng
= 0.55 Ibs/day
TOTAL =10,880 Ibs/day
The monthly average effluent limitation for COD in the combined waste stream would be 10,880 Ibs/day.
This monthly average limitation is compared to the average of all daily mass discharge amounts in a
calendar month to determine facility compliance.
Step 3. Determining Maximum Effluent Limitations for Any One Day
Daily maximum effluent limitations can be calculated using the same calculations performed for the
monthly average effluent limitations. For our example, Facility A includes subpart E operations (waste
stream 7). Since maximum limitations for any one day have not been promulgated for subpart E
operations, waste stream 7 is considered an unregulated waste stream in the calculation of daily
maximum limitations and can be combined with the other dilute stream (waste stream 6) for the
calculation as follows:
Allowable nonprocess water flow:
Subpart A and C concentration limits apply
1,520,000 gal/dav x 2,300 gal/day = 2,285 gal/day
1,530,000 gal/day
Subpart B and D concentration limits apply
= 10,OOP gal/dav x 2,300 gal/day = 15 gal/day
1,530,000 gal/day
The total BPT COD maximum allowable discharge for any one day can be calculated as follows:
Subpart A and C limitations:
1,675 mg/L x (1,520,000 + 2,285) gal/day x [8.345 x 10'6 (L x lb)/(gal x mg)]
= 21,278 Ibs/day
228 mg/L x (10,000 + 15) gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
Subpart B and D limitations:
/Lx
= 19 Ibs/day
TOTAL = 21,297 Ibs/day
Therefore, the maximum for any one day effluent limitations for COD in the combined wastestream would
be 21,297 Ibs/day.
9-6
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9.1.4 Determining Permit Limits for Pollutants Regulated Under BAT
Tables 7-2 and 7-3 present the maximum daily and monthly average BAT effluent limitations guidelines
for subparts A and C, and subparts B and D, respectively. BAT for ammonia and the organic pollutants
listed in these tables are applicable to the final effluent discharged to the waters of the United States.
Previously promulgated BAT limitations for cyanide are also presented in Table 7-2 and are applicable to
subpart A and C operations. Compliance monitoring for cyanide should occur immediately after cyanide
destruction, before commingling cyanide-bearing wastestreams with noncyanide-bearing wastestreams,
unless a facility can demonstrate that cyanide is detectable at the end-of-pipe sampling point and
applicable information exists to use the end-of-pipe monitoring results to determine compliance. In-plant
monitoring is required at those facilities unable to detect cyanide at the end-of-pipe monitoring point.
We will assume that Facility A has provided the permit writer with an accurate characterization of its
process wastestreams by means available such as solvent use and disposition data, and chemical
analysis of each stream. Permit writers should establish permit limitations and require compliance
monitoring for each regulated pollutant generated or used at a pharmaceutical manufacturing facility.
Routine compliance monitoring is not required for regulated pollutants not generated or used at a facility.
Facilities should make a determination that regulated pollutants are not generated or used based on a
review of all raw materials used, and an assessment of all chemical processes used, and consideration of
resulting products and by-products. The determination that a regulated pollutant is not generated or used
should be confirmed by annual chemical analyses of wastewater from each monitoring location, and
these analyses must be submitted to the permit writer. Such confirmation is provided if the pollutant is not
detected above the ML of an EPA-approved analytical method.
Table 9-3 presents a summary of the regulated pollutants expected to be found in this facility's waste
streams:
Table 9-3: Regulated Organic Pollutants Found in the Wastewater of Facility A
Stream
1
2
3
4
5
6
7
Subpart
A
A
C
C
D
N/A
E
Flow (gal/day)
1,330,000
55,000
30,000
105,000
10,000
2,000
300
Pollutant
Methylene chloride, acetone
Methylene chloride, acetone
Methylene chloride, acetone
Methylene chloride, acetone
No regulated organic pollutants
No regulated organic pollutants
No regulated organic pollutants
Based on the above data, permit writers should use reasonable estimates of the process discharge flow,
allowing generally for up to 25% nonprocess wastewater, and the concentration-based standards in
Tables 7-3 and 7-4 to develop limitations for methylene chloride and acetone.
Subpart B, D, and E wastewater is unregulated for organic pollutants. However, EPA's NPDES
regulations generally require consideration of dilution water in establishing limitations. See 40 CFR
122.45 (f)(1)(iii). Thus, the permit writer should determine whether unregulated streams should be
considered dilution. For this example, subpart D (stream 5) and subpart E (stream 7) are considered
unregulated process wastewater, and the permit authority may use BPJ to calculate limits to account for
the organic pollutants present in these streams.
9-7
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Step 1. Determining BAT Maximum Limitations for Any One Day for Organic Pollutants and COD
As shown in Table 7-2, the following maximum for any one day limitations apply for subpart A and C
operations:
Methylene chloride: 0.9 mg/L
Acetone: 0.5 mg/L
Methylene chloride and acetone are present only in waste streams in which organic pollutants are
regulated (i.e. subpart A and C waste streams). The allowable wastewater flow for Facility A is calculated
as shown below.
Process wastewater flow (regulated subpart A and C):
= Stream 1 (subpart A) + Stream 2 (subpart A) + Stream 3 (subpart C) + Stream 4 (subpart C)
= (1,330,000 + 55,000 + 30,000 + 105,000) gal/day
= 1,520,000 gal/day
Allowable wastewater flow:
= Process wastewater flow/(0.75)
= 1,520,000 gal/day/(0.75)
= 2,026,667 gal/day
Total nonprocess wastewater flow, including unregulated process wastewater (subpart B, D, and E
operations):
= Stream 5 (subpart D) + Stream 6 (dilution) + Stream 7 (subpart E)
= (10,000 + 2,000 + 300) gal/day = 12,300 gal/day
The allowable wastewater flow for calculating BAT mass-based effluent limitations is 2,026,667 gal/day.
Facility A's total flow of 1,532,300 gal/day does not exceed this allowance and the total discharge flow
can be used to calculate effluent limitations.
The daily maximum mass-based effluent limitation for acetone is calculated as follows:
Lm = Lc x F x K!
0.5 mg/L x 1,532,300 gal/day x [8.345 x 10'6 (L x |b)/(gal x mg)]
6.39 Ibs/day
The total facility maximum daily discharge limitation for acetone is 6.39 Ibs/day. The maximum daily
effluent limitations for methylene chloride can be calculated in a similar manner.
The maximum one day effluent limitation for COD under BAT is the same as the limitation set under BPT.
Therefore, the resulting COD daily maximum mass-based effluent limitation is 21,297 Ibs/day as
calculated above for BPT.
Step 2. Determining BAT Monthly Average Limitations for Organic Pollutants and COD
The monthly average limitations for Facility A are calculated in a similar manner as the maximum daily
effluent limitations. The following monthly average effluent limitations are presented in Table 7-2 and
apply to subpart A and C operations:
Methylene chloride: 0.3 mg/L
Acetone: 0.2 mg/L
9-8
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The allowable wastewater discharge flow of 2,026,667 gallons per day applies in the calculated mass-
based effluent limitations for acetone and methylene chloride, as calculated previously. For Facility A, the
monthly average mass-based limitation calculation for methylene chloride is shown below:
Lm = Lc x F x k1
0.3 mg/L x 1,532,300 gal/day x [8.345 x 10"6 (L x lb)/(gal x mg)]
3.84 Ibs/day
The monthly average discharge limitation for methylene chloride = 3.84 Ibs/day.
This monthly average limitation is compared to the average of all daily discharge amounts in a calendar
month to determine facility compliance. The monthly average effluent limitations for acetone can be
calculated in a similar manner.
The monthly average limitation for COD under BAT is the same as the limitation set under BPT.
Therefore, the resulting COD monthly average mass-based effluent limitation is 10,880 Ibs/day as
calculated above for BPT.
Step 3. Determining Compliance Monitoring for BAT Pollutants
For our example, Facility A should perform compliance monitoring at Point A prior to discharge into the
Blue River.
Facilities discharging more than one regulated pollutant may request to monitor for a single surrogate
pollutant to demonstrate an appropriate degree of control fora specified group of pollutants. For the
purpose of identifying surrogates, pollutants have been grouped according to treatability classes; Table 8-
1 presents the treatability classes identified for advanced biological treatment. The choice of surrogate
pollutant, when multiple pollutants are appropriate, can be based on the pollutant with the highest
concentration. Ultimately, if the use of surrogates is requested by a facility, the permit writer may decide
on a facility-by-facility basis whether surrogate pollutants are appropriate and which pollutant may be
used as a surrogate. For Facility A, the two regulated organic pollutants in the facility's wastewater are
not part of the same treatability class and use of a surrogate would not apply.
9.1.5 Final Limits as They Would Appear in a Permit for Facility A
Table 9-4 presents the final limits as they would appear in a permit for Facility A on a mass-basis. Permit
writers can choose to show limits on a concentration-basis in addition to the mass-based limits.
Table 9-4: Final Limits for Facility A
Pollutant or Pollutant Property (a)
Chemical Oxygen Demand (COD)
Acetone
Methylene chloride
Effluent Limitations for In-Plant and End Of Pipe (EOP)
Monitoring Points
Maximum for any one day
(Ib/day)
21,297
6.39
11.5
Monthly
Average
(Ib/day)
10,880
2.56
3.84
Monitoring
Point
EOP
EOP
EOP
pH, BOD5, and TSS limits are not shown here since they have not been changed by the September 21, 1998 promulgated rule.
These limits would be calculated as they have been in the past.
The limitations presented in Table 9-4 would be effective on November 20, 1998 or upon reissuance of the current permit,
whichever is later.
9-9
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9.2 Case Study #2
Facility B is an existing multiple-subcategory
indirect discharging pharmaceutical
manufacturing facility which discharges to a
municipal POTW.
9.2.1 General Site Description
The flow schematic for Facility B shows the flow
from each operation, and is presented in Figure 9-2.
Case Study #2 highlights:
1. Permit process for indirect discharging
facility with operations in subparts C and
D and the facility has pilot-scale
operations under subpart E.
2. Concentration-based examples provided.
9.2.2 Relevant Information for Establishing Permit Limits
Table 9-5 summarizes the information from the permit application needed to calculate discharge limits for
the reissued pretreatment permit.
Table 9-5: Information Needed to Establish Permit Limits for Case Study #2
What type of discharger is the facility?
Under which subparts do the facility's operations fall?
The facility is subject to which effluent limitations guidelines and
standards?
Indirect
Subparts C, D and E
PSES (40 CFR Part 439)
9.2.3 Determining Limits for Pollutants Regulated Under PSES
PSES has been revised for subparts A, B, C and D. The final effluent limitation standards are
concentration-based and, as such, do not regulate wastewater flow. The limitations apply at the end-of-
pipe, except for cyanide. If end-of-pipe measurement is infeasible, control authorities may set a
monitoring point at a more suitable location. Compliance monitoring for cyanide should occur in-plant,
prior to commingling with non-cyanide bearing wastewaters. EPA has regulated 24 priority and
nonconventional pollutants (including ammonia, where applicable, and cyanide) for indirect dischargers in
subparts A and C. The effluent limitations for subpart A and C operations are presented in Table 7-6. EPA
has regulated five priority and nonconventional pollutants for indirect dischargers in subparts B and D.
Table 7-7 presents the effluent limitations for subpart B and D operations.
The first step in establishing permit limitations is to determine the types of wastestreams (i.e., regulated
process, unregulated process, and dilute). The flow breakdown for Facility B is shown in Table 9-6.
9-10
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To POTW
Research and
Development
Chemical Synthesis
Operations
Figure 9-2: Flow Schematic for Facility B
9-11
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Table 9-6: Flow Breakdown for Facility B
Waste Stream
Flow (gal/day)
1. Administration
2. Chemical synthesis
3. Cyanide-bearing chemical synthesis
4. Mixing/compounding and formulation
5. Power house boiler blowdown
6. Research and development chemical
synthesis
Total measured wastewater flow:
Total regulated process flow:
Total unregulated process flow:
49,500
5,500
30,000
100
200
85,300
85,000
200
No measurement
(Regulated, subpart C)*
(Regulated, subpart C)*
(Regulated, subpart D)*
(Dilute)
(Unregulated, subpart E)
*Pollutants regulated at subpart C operations may not be regulated at subpart D operations.
Streams 2, 3, and 4 are regulated process wastestreams because effluent limitations have been
established for chemical synthesis operations (subpart C) and mixing, formulating, and compounding
operations (subpart D). However, only five pollutants are regulated at subpart D, therefore the facility may
have a pollutant regulated in streams 2 and 3 but unregulated in stream 4.
We will assume that Facility B has provided the permit writer with an accurate characterization of its
process wastestreams by means available such as solvent use and disposition data, and chemical
analysis of each stream. Permit writers should establish permit limitations and require compliance
monitoring for each regulated pollutant generated or used at a pharmaceutical manufacturing facility.
Routine compliance monitoring is not required for regulated pollutants not generated or used at a facility.
Facilities should make a determination that regulated pollutants are not generated or used based on a
review of all raw materials used, and an assessment of all chemical processes used, and consideration of
resulting products and by-products. The determination that a regulated pollutant is not generated or used
should be confirmed by annual chemical analyses of wastewater from each monitoring location, and
these analyses must be submitted to the permit writer. Such confirmation is provided if the pollutant is
not-detected above the ML of an EPA-approved analytical method.
Table 9-7 presents a summary of regulated pollutants found in this facility's wastestreams:
Table 9-7: Regulated Pollutants Found in the Wastewater of Facility B
Stream
1
2
3
4
5
6
Subpart
N/A
C
C
D
N/A
E
Flow (gal/day)
Not Measured
49,500
5,500
30,000
100
200
Pollutant
No PSES pollutants
Acetone, chloroform, toluene
Acetone, cyanide
Acetone, isopropyl acetate, toluene
No PSES pollutants
Chloroform, toluene
9-12
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Based on the above data, permit limitations would be established for acetone, chloroform, cyanide,
isopropyl acetate, and toluene. Acetone and isopropyl acetate are regulated in wastewater discharges
from subpart A, B, C, and D operations. Chloroform, cyanide and toluene are regulated in wastewater
discharges from subpart A and C operations only.
Step 1. Determining PSES Maximum Limitations for Any One Day
In this case study, the total flow going to the POTW cannot be measured, as the amount of water from the
administrative building cannot be determined. Thus, it is not possible to calculate the appropriate
concentration of pollutants at the end of pipe. In this case study, the limitations for all pollutants except
cyanide would be applied at monitoring point A. Cyanide limitations would apply in-plant at point B prior to
any dilution or commingling with non-cyanide-bearing wastestreams unless the facility can show cyanide
is detectable at point A.
Concentration-based limits for indirect discharging facilities are listed in Tables 7-6 and 7-7.
In our example, the following maximum for any one day effluent limitations apply:
Acetone: 20.7 mg/L (subpart C & D)
Chloroform: 0.1 mg/L (subpart C)
Cyanide: 33.5 mg/L (subpart C)
Isopropyl acetate: 20.7 mg/L (subpart C & D)
Toluene: 0.3 mg/L (subpart C)
The concentration-based limit for acetone is 20.7 mg/L for both subpart C and D operations. This limit
would be applied at monitoring point A, after the steam-stripping unit operations on streams 2 and 3.
Concentration-based limits for chloroform, isopropyl acetate, and toluene would be applied in a similar
manner.
Step 2. Determining PSES Monthly Average Limitations
Concentration-based monthly average effluent limitations for each of the pollutants can be calculated in
the same manner as the daily maximum effluent limitations. The following monthly average limitations
apply for Facility B:
Acetone: 8.2 mg/L (subpart C and D)
Chloroform: 0.03 mg/L (subpart C)
Cyanide: 9.4 mg/L (subpart C)
Isopropyl acetate: 8.2 mg/L (subpart C and D)
Toluene: 0.2 mg/L (subpart C)
Facility B would show compliance by averaging the daily maximum values in a 30-day period and
showing the monthly average concentrations as equal to or less than the numbers above. For this
example, Facility B should perform compliance monitoring at point A on Figure 9-2 for all regulated
pollutants, except cyanide.
Monthly average limitations for cyanide would be calculated using the flow from stream 3 of subpart C
operations, as other streams do not contain cyanide. The concentration-based monthly average limitation
is 9.4 mg/L. This monthly average limitation is compared to the average of daily discharge amounts in a
calendar month to determine facility compliance. If only one sample is taken in the calendar month, the
sample must meet both the daily maximum limitation and the monthly average limitation.
9-13
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9.2.4 Determining Compliance Monitoring for PSES Pollutants
Facilities discharging more than one regulated pollutant may request to monitor for a single surrogate
pollutant to demonstrate an appropriate degree of control fora specified group of pollutants. For the
purpose of identifying surrogates, pollutants have been grouped according to treatability classes; Table 8-
2 presents the treatability classes identified for steam stripping.
For this example, the control authority may require compliance at Point A prior to dilution with nonprocess
or un-regulated process wastewater or may require compliance at the point of discharge to the POTW by
using the combined wastestream formula, if the additional dilution or non-regulated flows are known.
However, cyanide should be monitored in-plant at point B on Figure 9-2, prior to commingling with non-
cyanide-bearing wastewaters, unless Facility B can show a cyanide value other than non-detect at point A
or the discharge point to the POTW.
Since Facility B performs steam stripping wastewater treatment on the subpart C wastewaters, Table 8-2
can be used as a guide to determine if surrogate pollutants may be appropriate for compliance
monitoring. If the facility performs advanced biological treatment of its wastewater, treatability groups and
surrogates identified in Table 8-1 could be used as a guide.
In Table 8-2, chloroform and toluene are both classified in the high strippability group, and both are listed
as appropriate surrogate pollutants for that group. Acetone and isopropyl acetate are both classified in the
medium strippability group, and acetone is listed as an appropriate surrogate pollutant for that group. If
the use of surrogates is requested by a facility, control authorities may decide on the use and choice of
surrogate pollutants on a facility-by-facility basis.
In this example, the choice of surrogate pollutant for the high strippability group will be based on the
pollutant concentrations since two pollutants (chloroform and toluene) are listed as appropriate
surrogates. Assuming the average pollutant concentrations are known to be 0.01 mg/L for chloroform and
0.1 mg/L for toluene, the permit writer would choose toluene as the surrogate pollutant. For the medium
strippability group, the permit writer can base the choice of surrogate pollutant on the guidance provided
in Table 8-2; thus, acetone would be chosen as the surrogate pollutant.
Therefore, Facility B would be required to routinely monitor for toluene and acetone at monitoring point A
or the discharge point to the POTW, and for cyanide at monitoring point B, assuming cyanide is not
detectable at point A.
9.2.5 Final Limits as They Would Appear in a Permit for Facility B
Table 9-8 presents the final limits as they would appear in a permit for Facility B on a concentration basis.
If all cyanide-bearing waste streams are diverted to a cyanide destruction unit, self-monitoring for cyanide
should be conducted after cyanide treatment and before dilution with other streams.
9-14
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Table 9-8: Final Limits for Facility B
Pollutant
Acetone
Chloroform
Cyanide
Isopropyl acetate
Toluene
Effluent Limitations for Point A
Monitoring Points
Maximum for
any one day
(mg/L)
20.7
0.1
—
20.7
0.3
Monthly
Average
(mg/L)
8.2
0.03
—
8.2
0.2
Effluent Limitation for Point B
Monitoring Points
Maximum for
any one day
(mg/L)
—
—
33.5
—
—
Monthly
Average
(mg/L)
—
—
9.4
—
—
If sufficient flow information is available, the permit writer may determine compliance concentrations at the
discharge to the POTW point using the combined waste stream formula (CWF).
The limitations presented in Table 9-8 should have been complied with on or before September 21, 2001.
9.3 Case Study #3
Facility C is an existing multiple-subcategory, direct discharging pharmaceutical manufacturing facility
which has on-site treatment and discharges to the Red River. The facility has submitted an application for
a new NPDES permit.
9.3.1 General Site Description
The flow schematic for Facility C shows the flow from each operation, and is presented in Figure 9-3.
9.3.2 Relevant Information for Establishing Permit Limits
Table 9-9 summarizes relevant information for establishing permit limits for pollutants with effluent
limitations guidelines.
Table 9-9: Information Needed to Establish Permit Limits for Case Study #3
What type of discharger is the facility?
Under which subparts do the facility's operations
fall?
The facility is subject to which effluent limitations
guidelines and standards?
Is the dilution flow >25% of total flow?
Direct
Subpart B and C
BPT (40 CFR Part 439)
BCT (40 CFR Part 439)
BAT (40 CFR Part 439)
Yes
9-15
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9.3.3 Determining Permit Limits for Pollutants Regulated Under BPT
The 1998 final BPT effluent limitations guidelines revise the 1983 COD effluent limitations for subpart A,
B, C, and D operations at direct discharging facilities. In 1983, EPA promulgated COD effluent limitations
requiring 74% reduction in the long-term daily COD load in the raw (untreated) wastewater multiplied by a
variability factor of 2.2. Under the 1998 revised BPT COD regulations, facilities must comply with the new
COD concentration limitations or the 1983 BPT regulations, whichever is more stringent. This comparison
would be based on the monthly average effluent limitations specified by the 1998 and 1983 guidelines.
The BPT effluent limitations guidelines for BOD5, TSS and pH have not been revised. The BPT effluent
limitations for subpart E operations, established in the 1983 final rule, have also not been revised. The
other conventional pollutants, fecal coliform and oil & grease, are not regulated by BPT for the
pharmaceutical manufacturing point source category.
The effluent limitations guidelines are concentration-based and, as such, do not regulate wastewater flow.
The permit writer must use a reasonable estimate of process wastewater discharge flow and the
concentration-based limitations to develop mass-based limitations for the NPDES permit. Table 7-1
presents the maximum daily and monthly average BPT effluent limitations for subpart A, B, C, and D
operations at direct discharging facilities.
The limitations for COD will be applied to the final effluent. An example calculation of the BPT maximum
for any one day and monthly average COD limitations for this facility is shown in the following sections.
9-16
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Chemical
Synthesis #1
Biological
Extraction
Power House
Administration
cp
o
CD
"o
§
CQ
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D.
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O
o
o
o
CQ
•a
CO
o
o
o
fl
a.
01
o
o
o
(Q
Treatment
System
Outfall #1
Outfall #2
Figure 9-3: Flow Schematic for Facility C
-------
Step 1. Determining Allowable Wastewater Discharge Flow
The first step in establishing permit limitations is to determine the types of wastestreams (i.e., regulated
process, unregulated process, and dilute) at the facility. The flow breakdown for Facility C is shown in
Table 9-10.
Table 9-10: Flow Breakdown for Facility C
Waste Stream
Flow (gal/day)
Outfall #001
1. Chemical synthesis
2. Biological extraction
3. Power house boiler blowdown
4. Administration
Total wastewater flow:
Total regulated process flow:
Total unregulated process flow:
Total dilute flow:
35,000
10,000
3,000
15,000
(Regulated, subpart C)
(Regulated, subpart B)
(Dilute or un-regulated)
(Dilute or un-regulated)
63,000
45,000
0
18,000
Outfall #002
a. Chemical synthesis non-contact cooling
b. Biological extraction non-contact cooling
Total non-contact cooling:
Total wastewater flow:
Total regulated process flow:
Total unregulated process flow:
Total dilute flow:
300,000
250,000
550,000
550,000
0
0
550,000
Streams 1 and 2 are considered regulated wastestreams because effluent limitations have been
established for chemical synthesis operations (subpart C) and biological extraction operations (subpart
B). Streams 3 and 4 are considered to be either dilution water or un-regulated streams. Depending on the
pollutant loads for specific parameters, such as BOD5, COD, orTSS, and the percent of the total flow,
permit writers may consider streams 3 and 4 as un-regulated wastestreams instead of dilution. The non-
contact cooling waters are not considered to be dilute streams since the discharge goes to a separate
outfall. We have assumed the permit writer has sufficient information from the permit application to
establish applicable permit limits for this separate outfall.
Using BPJ, the permit writer determines the annual average wastewater discharge flow for Facility C.
Assuming the facility production and wastewater flow are not expected to change significantly during the
permit term, the historical data provided by Facility C are used to establish the annual discharge flow. The
discharge flow can then be used to develop mass-based effluent limitations. Only sources of "process
wastewater discharge" and an allowance for up to 25 percent nonprocess wastewater should be
considered. The allowable wastewater (WW) discharge flow used to establish the mass-based limitations
is calculated as follows:
Process WW discharge
Allowable WW discharge
(1 - 0.25) Allowable WW discharge
Allowable WW discharge
= 45,000 gal/day
= (0.25)Allowable WW discharge + Process WW discharge
= Process WW discharge
= Process WW discharge / (0.75)
= 45,000 gal/day / (0.75)
= 60,000 gal/day
9-18
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The allowable wastewater discharge flow used to establish the mass-based limitations can include
(60,000 - 45,000) = 15,000 gallons per day of nonprocess wastewater. However, Facility C has 18,000
gallons per day of nonprocess wastewater (dilute). Since Facility C has greater than 25% nonprocess
water, the maximum allowable wastewater discharge, 60,000 gal/day, will be used to establish mass-
based effluent limitations.
For this example, 15,000 gallons per day of nonprocess water would be assigned pollutant mass limits
and would be considered to be part of the regulated waste stream, not a dilution stream. However, the
remaining 3,000 gallons per day of nonprocess (e.g. dilution) water greater than the 25% allowance
would be considered to be dilution water and would not be assigned pollutant mass limits.
Table 7-1 presents the BPT effluent limitations for subpart A, B, C, and D operations at direct discharging
facilities. Daily maximum limitations have not been promulgated for the pollutants BOD5 and TSS for all
subcategories, although EPA has promulgated daily maximum limitations on COD forsubparts A, B, C,
and D. Monthly average limitations for subpart E operations were promulgated in 1983 and are presented
in 40 CFR 439.52.
To calculate the mass limits for the allowable nonprocess water, concentration limits for each subpart are
applied to a percentage of the total allowable nonprocess water flow. This allowable nonprocess flow is
divided between subparts based on the subpart A and C and subpart B and D process flow compared to
the total process flow. The calculation for Facility C is shown below:
Subpart A and C process water flow = 35,000 gal/day
Subpart B and D process water flow = 10,000 gal/day
Total process water flow = 45,000 gal/day
Allowable nonprocess water flow:
Subpart A and C concentration limits apply
= 35,000 gal/day x 15,000 gal/day = 11,667 gal/day
45,000 gal/day
Subpart B and D concentration limits apply
= 10,OOP gal/day x 15,000 gal/day = 3,333 gal/day
45,000 gal/day
When calculating mass-based effluent limitations, 11,667 gallons per day of nonprocess water should be
multiplied by the subpart A and C concentration limits, and 3,333 gallons per day of nonprocess water
should be multiplied by the subpart B and D concentration limits.
Step 2. Determining the Use of Monthly Average Limitations vs. Percent Reduction for COD
Limitations
Facility C must comply with either the revised COD concentration limitations or the previously
promulgated COD limit requiring a reduction in the long-term average daily COD load in the raw
(untreated) process wastewater of 74 percent multiplied by a variability factor of 2.2, whichever is more
stringent. Permit authorities should compare the revised monthly average effluent limitations, which apply
to subpart A, B, C and D operations, with the previously promulgated guidelines to determine which is
more stringent. As mentioned previously, monthly average limitations for subpart E operations were not
revised in the 1998 rule; the effluent limitations guidelines presented in 40 CFR 439.52, requiring a 74
percent reduction in the long-term daily COD load multiplied by a variability factor of 2.2, or 220 mg/L,
whichever is greater, continue to apply.
9-19
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Assuming subpart C operations at Facility C have an influent COD concentration of 1,000 mg/L in the
wastewater treatment plant, a 74 percent reduction in the long-term average COD load multiplied by a
variability factor of 2.2 would result in a final effluent discharge limitation of 572 mg/L. The revised COD
limitations require a maximum monthly average of 856 mg/L for subpart A and C operations. Thus, the 74
percent reduction in COD is more stringent than the revised limits for COD. The monthly average limit for
COD for the subpart C wastestream is 572 mg/L. This concentration of 572 mg/L would be converted to a
mass-based limit in the NPDES permit. [Note: the permit writer may need to request that the facility
collect and supply raw subpart A and/or C process wastewater COD concentration data to
conduct this analysis.]
For the purpose of this case study, we assume subpart B operations at Facility C have an influent COD
concentration of 700 mg/L in the wastewater treatment plant. However, the 1983 regulations stipulated
that B, D, and E operations would not be required to maintain a monthly average COD effluent limitation
of less than 220 mg/L. Since the September 21, 1998 regulation requires a COD monthly average of 86
mg/L or less, the 1998 regulation monthly average will always be more stringent. Thus, the monthly
average limit for COD for subpart B wastestreams at Facility C is 86 mg/L.
The monthly average COD limitations for facility C would be calculated as shown below:
Subpart A and C limitations:
(35,000 + 1
222.8 Ibs/day
Subpart B and D concentration limits apply
(10,000 +3
= 9.6 Ibs/day
Total mass limitation = 232.4 Ibs/day
The monthly average effluent limitation for COD at Outfall #1 would be 232 Ibs/day. This monthly average
limitation is compared to the average of all daily mass discharge amounts in a calendar month to
determine facility compliance.
Step 3. Determining Maximum Effluent Limitations for Any One Day
The permit writer must develop a daily maximum effluent limitation for subpart C flows. In Step 2, monthly
average COD limits for Facility C's subpart C flows were calculated as 572 mg/L, using the 1983 COD
limit because it was more stringent than the 1998 limit. The daily maximum effluent limitation should be
developed from the 1983-based COD limits. However, the 1983 regulation does not specify maximum
effluent limitations for any one day. The permit writer should therefore use the relationship between the
1998 daily maximum (1,675 mg/L) and the 1998 monthly average (856 mg/L) to calculate a 1983-based
daily maximum for Facility C's subpart C flows.
The BPT COD maximum allowable discharge for any one day could be calculated as shown below:
Subpart A and C limitations:
= (35,000 + 11, 667) gal/day x 572 mg/L x [1, 675 mg/L/856 mg/L] x
[8.345>
= 436 Ibs/day
(35,000 + 11,667) gal/day x 572 mg/L x [8.345x10'6 (L x |b)/(gal x mg)]
(10,000 + 3,333) gal/day x 86 mg/L x [8.345x10~6 (L x lb)/(gal x mg)]
[8.345x10"6 (L x lb)/(gal x mg)]
Facility C's subpart B wastestreams are subject to the 1998 BPT regulations for COD for both the monthly
average and the maximum for any one day.
9-20
-------
Subpart B and D limitations:
= (10,000 + 3,333) gal/day x 228 mg/L x [8.345x10"6 (L x lb)/(gal x mg)]
= 25.4 Ibs/day
Total mass limitation = 461.4 Ibs/day COD
Therefore, the maximum for any one day effluent limitation for COD at Outfall #1 would be 461 Ibs/day.
9.3.4 Determining Permit Limits for Pollutants Regulated Under BAT
Tables 7-2 and 7-3 present the proposed maximum daily and monthly average BAT effluent limitations
guidelines for subparts A and C, and subparts B and D, respectively. BAT for ammonia and the organic
pollutants listed in these tables are applicable to the final effluent discharged to the waters of the United
States.
Previously promulgated BAT limitations for cyanide are also presented in Table 7-2 and are applicable to
subpart A and C operations. Compliance monitoring for cyanide should occur immediately after cyanide
destruction, before commingling cyanide-bearing wastestreams with noncyanide-bearing wastestreams,
unless a facility can demonstrate that cyanide is detectable at the end-of-pipe sampling point and
applicable information exists to use the end-of-pipe monitoring results to determine compliance. In-plant
monitoring is required at those facilities unable to detect cyanide at the end-of-pipe monitoring point.
We will assume that Facility C has provided the permit writer with an accurate characterization of its
process wastestreams by means available such as solvent use and disposition data, and chemical
analysis of each stream. Permit writers should establish permit limitations and require compliance
monitoring for each regulated pollutant generated or used at a pharmaceutical manufacturing facility.
Routine compliance monitoring is not required for regulated pollutants not generated or used at a facility.
Facilities should make a determination that regulated pollutants are not generated or used based on a
review of all raw materials used, and an assessment of all chemical processes used, and consideration of
resulting products and by-products. The determination that a regulated pollutant is not generated or used
should be confirmed by annual chemical analyses of wastewater from each monitoring location, and
these analyses must be submitted to the permit writer. Such confirmation is provided if the pollutant is
not-detected above the ML of an EPA-approved analytical method.
Table 9-11 presents a summary of the regulated pollutants expected to be found in this facility's waste
streams:
Table 9-11: Regulated Pollutants Found in the Wastewater of Facility C
Stream
1
2
3
4
Subpart
C
B
N/A
N/A
Flow (gal/day)
35,000
10,000
3,000
15,000
Pollutant
Methylene chloride, tetrahydrofuran,
acetone, methanol, toluene, COD
Methanol, tetrahydrofuran, COD
No BAT pollutants
No BAT pollutants
Based on the above data, permit writers would use reasonable estimates of the process wastewater
discharge flow, allowing for up to 25% nonprocess wastewater, and the concentration-based standards in
Tables 7-3 and 7-4 to develop limitations for methylene chloride, tetrahydrofuran, acetone, methanol, and
toluene in the NPDES permit. Permit limitations would also be established for COD under BAT.
9-21
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Step 1. Determining Maximum Limitations for Any One Day for Organic Pollutants and COD under
BAT
As shown in Table 7-2, methylene chloride, acetone, methanol, tetrahydrofuran and toluene have the
following maximum daily limitations forsubparts A and C.
Methylene chloride: 0.9 mg/L
Acetone: 0.5 mg/L
Methanol: 10.0 mg/L
Tetrahydrofuran: 8.4 mg/L
Toluene: 0.06 mg/L
Methylene chloride, acetone and toluene are present only in waste streams in which organic pollutants
are regulated (i.e. subpart A and C waste streams). The allowable wastewater flow for Facility C is
calculated as shown below.
Process wastewater flow (regulated subpart A and C):
= Stream 1 (subpart C) = 35,000 gal/day
Allowable wastewater flow:
= Process wastewater flow/(0.75)
35,000 gal/day/(0.75)
46,667 gal/day
Total nonprocess wastewater flow, including unregulated process wastewater (subpart B, D, and E
operations):
= Stream 2 (subpart B) + Stream 3 (dilution) + Stream 4 (dilution)
10,000 + 3,000 + 15,000 = 28,000 gal/day
The allowable wastewater flow for calculating BAT mass-based effluent limitations is 46,667 gal/day.
Facility C total flow of 63,000 gal/day exceeds this allowance, therefore the allowable wastewater flow
(46,667 gal/day) will be used to calculate effluent limitations.
The daily maximum mass-based effluent limitation for acetone is calculated as follows:
Lm = Lc x F x k1
0.5 mg/L x 46,667 gal/day x [8.345 x 10'6 (L x |b)/(gal x mg)]
0.19lbs/day
The total facility maximum daily discharge limitation for acetone is 0.19 Ibs/day. The maximum daily
effluent limitations for methylene chloride and toluene can be calculated in a similar manner.
Methanol and tetrahydrofuran are both present in stream 1, a regulated waste stream for organic
pollutants, and stream 2, an unregulated waste stream for organic pollutants. Permit writers use BPJ to
set unregulated waste stream limitations and calculate maximum daily discharge limitations using the
combined wastestream formula. Permit writers may calculate the maximum daily discharge limitations
using the combined waste stream formula (CWF) shown below:
N
I F
1=1 '
9-22
-------
where: MT = Alternative mass limit for the pollutant in the combined
wastestream (mass per day).
Mj = Treatment standard for the pollutant in the regulated stream i
(mass per day)
FJ = Average daily flow (at least 30 day average) of the regulated
stream i
FD = Average daily flow (at least 30 day average) of dilute
wastestream(s) entering the combined treatment system
FT = Average daily flow (at least 30 day average) through the
combined treatment facility (including regulated, unregulated,
and dilute wastestreams)
N = Total Number of regulated streams
In this example, the maximum one day effluent limitation fortetrahydrofuran is calculated as follows:
M1 = Mass limit of tetrahydrofuran in stream 1 (subpart C)
8.4 mg/L x 35,000 gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
2.5 Ibs/day
MNP = Mass limit of tetrahydrofuran in nonprocess water stream
8.4 mg/L x 11,667 gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
0.82 Ibs/day
FT = Total flow = 63,000
FD = Dilution flow = 3,000 (excluding 25% allowable nonprocess water flow)
F1 = Flow in stream 1 = 35,000 gal/day
FNP = Nonprocess water flow = 11,667 gal/day
X Mi = 3.3 Ibs/day
X Fi = 46,667 gal/day
MT = 3.3 Ibs/day x [63,000 - 3,0001 gal/day = 4.2 Ibs/day
46,667 gal/day
The maximum one day effluent limitation fortetrahydrofuran is equal to 4.2 Ibs/day. The maximum one-
day effluent limitation for methanol can be calculated in a similar manner.
The maximum one day effluent limitation for COD under BAT can be calculated like the maximum one
day effluent limitation for acetone. The resulting daily maximum mass-based effluent limitation is 677
Ibs/day. However, in setting permit limits for this facility, the limit calculated under BPT based on the 74%
reduction for the subpart A and C wastewater and the September 21, 1998 promulgated limit of 86 mg/L
for the subpart B and D wastewater is 461 Ib/day, which is more stringent than the monthly average of
677 Ib/day (based on the September 21, 1998 BAT limits). So, in this instance, the BPT limit of 461
Ibs/day is controlling and forms the basis of the permit limits.
Step 2. Determining Monthly Average Limitations for Organic Pollutants and COD under BAT
The following monthly average limitations, listed in Table 7-2, apply for Facility C pollutants methylene
chloride, acetone, methanol, tetrahydrofuran and toluene:
Methylene chloride: 0.3 mg/L
Acetone: 0.2 mg/L
Methanol: 4.1 mg/L
Tetrahydrofuran: 2.6 mg/L
Toluene: 0.02 mg/L
Methylene chloride, acetone and toluene are present only in waste streams in which organic pollutants
are regulated (i.e. subpart A and C waste streams). The concentration based limitations for these
pollutants can be converted to monthly average mass-based limitations by the same methodology used in
9-23
-------
calculating maximum limitations for any one day. Below is the calculation for monthly average limitations
for toluene.
Lm = Lc x p x k1
0.02 mg/L x 46,667 gal/day x [8.345 x 10"6 (L x |b)/( gal x mg)]
0.008 Ibs/day
The total facility monthly average discharge limitation for toluene is 0.008 Ibs/day. The monthly average
limitation is compared to the average of all daily mass discharge amounts in a calendar month to
determine facility compliance. The maximum daily effluent limitations for methylene chloride and acetone
can be calculated in a similar manner.
Methanol and tetrahydrofuran are both present in stream 1, a regulated waste stream for organic
pollutants, and stream 2, an unregulated waste stream for organic pollutants. Permit writers use BPJ to
set unregulated waste stream limitations. Permit writers may calculate the monthly average discharge
limitations using the combined waste stream formula (CWF):
In this example, the mass-based monthly average effluent limitation for methanol is calculated as follows:
M1 = Mass limit of methanol in stream 1 (subpart C)
4.1 mg/L x 35,000 gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
1.2 Ibs/day
MNP = Mass limit of methanol in nonprocess water allowance stream
4.1 mg/L x 11,667 gal/day x [8.345 x 10'6 (L x |b)/( gal x mg)]
= 0.40 Ibs/day
FT = Total flow = 63,000
FD = Dilution flow = 3,000 (excluding 25% allowable nonprocess water flow)
F1 = Flow in stream 1 = 35,000 gal/day
FNP = Nonprocess water allowance flow = 11,667 gal/day
X Mi = 1.6 Ibs/day
£ F; = 46,667 gal/day
MT = 1.6 Ibs/day x [63,000 - 3,0001 gal/day =2.1 Ibs/day
46,667 gal/day
The total facility monthly average effluent limitation for methanol is 2.1 Ibs/day. The monthly average
limitation is compared to the average of all daily mass discharge amounts in a calendar month to
determine facility compliance. The monthly average effluent limitation for tetrahydrofuran can be
calculated in a similar manner.
The monthly average effluent limitations for COD can be calculated like the monthly average COD
limitation under BPT. In fact, the promulgated BPT and BAT monthly average effluent limitations
guidelines for COD concentrations are the same. However, in setting permit limits for this facility, the limit
calculated under BPT based on the 74% reduction for the subpart A and C wastewater and the
September 21, 1998 promulgated limit of 86 mg/L for the subpart B and D wastewater is 232 Ib/day,
which is more stringent than the monthly average of 343 Ib/day (based on the September 21, 1998 BAT
limits). So, in this instance, the BPT limit of 232 Ibs/day is controlling and forms the basis of the permit
limits.
9.3.5 Final Limits as They Would Appear in a Permit for Facility C
Table 9-12 presents the final limits as they would appear in a permit for Facility C on a mass-basis. Permit
writers can choose to show limits on a concentration-basis, in addition to the mass-based limits.
9-24
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Table 9-12: Final Limits for Facility C
Pollutant or
Pollutant Property (a)
Chemical Oxygen Demand (COD)
Acetone
Methanol
Methylene Chloride
Tetrahydrofuran
Toluene
Effluent Limitations for In-Plant and EOP Monitoring Points
Maximum for Any One Day
(Ib/day)
461
0.19
5.0
0.35
4.2
0.02
Monthly
Average
(Ib/day)
232
0.08
2.1
0.12
1.3
0.008
Monitoring
Point
EOP
EOP
EOP
EOP
EOP
EOP
(a) pH, BOD5, and TSS limits are not shown here since they have not been changed by the September 21,
1998 promulgated rule. These limits will be calculated as they have been in the past.
Note: A facility must be able to show compliance with mass-based limitations at the end-of-pipe
monitoring point. If excessive dilution waters are mixed with regulated process wastewaters prior
to the end-of-pipe monitoring point, it is possible that compliance would require measurement of
a pollutant below its detection level. If that were to occur, the permit authority should require
monitoring at a point prior to the addition of dilution flow.
In this example, the required concentration for each monitored organic pollutant to demonstrate
compliance with the mass-based limitations is above each pollutant's detection limit.
The limitations presented in Table 9-12 would be effective on November 20, 1998 or upon reissuance of
the current permit, whichever is later.
9.4 Case Study #4
Facility D is a direct discharging manufacturing
facility with operations in two industrial categories.
This facility manufactures Pharmaceuticals as well
as bulk organic chemicals.
9.4.1 General Site Description
Case Study #4 highlights:
1. BPT/BAT for a multiple industrial
category facility (OCPSF and
Pharmaceutical Manufacturing).
The flow schematic for Facility D shows the flow from each operation and is presented in Figure 9-4.
9.4.2 Relevant Information for Establishing Permit Limits
Table 9-13 summarizes the relevant information from the permit application needed to calculate
discharge limits.
9-25
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Table 9-13: Information Needed to Establish Permit Limits for Case Study #4
What type of discharger is the facility?
Under which subparts do the facility's operations
fall?
The facility is subject to which effluent limitations
guidelines and standards?
Direct (pharmaceutical and OCPSF wastewater)
Subpart A and C - Pharmaceuticals
BPT (40 CFR Part 439)
BCT (40 CFR Part 439)
BAT (40 CFR Part 439)
OCPSF (40 CFR Part 41 4)
9.4.3 Determining Permit Limits for Pollutants Regulated Under BPT
The 1998 final BPT effluent limitations guidelines revise the 1983 COD effluent limitations for subpart A,
B, C, and D direct discharging facilities. In 1983, EPA promulgated COD limits requiring 74% reduction in
the long-term daily COD load of the raw (untreated) wastewater multiplied by a variability factor of 2.2.
Under the 1998 revised BPT COD regulations, facilities must comply with the new COD concentration
limitations orthe1983 BPT regulations, whichever is more stringent. This comparison is based on the
monthly average effluent limitations specified by the 1998 and 1983 limitations. As described in Case
Study 1, the BOD5, TSS and pH effluent limits have not been amended, and other conventional pollutants
are not regulated by BPT for the pharmaceutical manufacturing point source category.
The effluent limitations guidelines are concentration-based and, as such, do not regulate wastewater flow.
The permit writer must use a reasonable estimate of process wastewater discharge flow and the
concentration-based limitations to develop mass-based limitations for the NPDES permit. Table 7-1
presents the maximum daily and monthly average BPT effluent limitations for subpart A, B, C, and D
direct discharging facilities.
The limitations for COD will be applied to the final effluent at monitoring point B in Figure 9-4. An example
calculation of the BPT maximum day and monthly average COD limitations for this facility follows.
9-26
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To River
To River
Figure 9-4: Flow Schematic for Facility D
9-27
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Step 1. Determining Allowable Wastewater Discharge Flow
The first step in establishing permit limitations is to determine the types of wastestreams present. The
flow breakdown for facility D is shown in Table 9-14.
Table 9-14: Flow Breakdown for Facility D
Waste Stream
1 . Fermentation
3. Chemical Synthesis
4. Bulk Organic Chemicals
5. Pilot-Scale Chemical Synthesis
6. Power House Boiler Slowdown
Total Wastewater Flow:
Total Regulated Process:
Total Unregulated Process:
Total Dilute:
2. Noncontact Cooling Water
500,000
80,000
105,000
5,000
1,000
691,000
690,000
0
1,000
100,000
Flow (gal/day)
(Regulated, subpart A)
(Regulated, subpart C)
(Regulated, OCPSF)
(Regulated, subpart C)
(Dilute)
(Dilute)
Streams 1,3,4, and 5 are considered regulated waste streams as effluent limitations have been
established for fermentation operations (subpart A), chemical synthesis operations (subpart C), and
OCPSF bulk organic chemical operations. Pharmaceutical effluent limitations apply to facilities handling
>50% pharmaceutical process wastewater. Facility E handles [(500,000 + 80,000 + 5,000)7690,000] x
100% = 84% pharmaceutical wastewaters.
Using BPJ, Facility D's annual average wastewater discharge flow can be established. Assuming the
facility production and wastewater flow is not expected to change significantly during the permit term, the
historical data provided by Facility D will be used to establish the annual discharge flow used to develop
mass-based effluent limitations. Only sources of "process wastewater discharge" and an allowance for up
to 25 percent nonprocess wastewater should be considered. The allowable wastewater (WW) discharge
flow used to establish the mass-based limitations is calculated as follows:
Process WW discharge
Allowable WW discharge
(1 - 0.25) Allowable WW discharge
Allowable WW discharge
= 690,000 gal/day
= (0.25)Allowable WW discharge + Process WW discharge
= Process WW discharge
= Process WW discharge / (0.75)
= 690,000 gal/day/(0.75)
= 920,000 gal/day
The allowable wastewater discharge flow used to establish the COD mass-based limitations can include
(920,000 - 690,000) = 230,000 gallons per day of nonprocess wastewater. However, Facility D only has
1,000 gallons per day of nonprocess wastewater (stream 6), and therefore, the annual average
wastewater discharge flow is determined to be (690,000 + 1,000) = 691,000 gallons per day.
For this example, stream 6 would be assigned a mass limit and would be considered to be a regulated
waste stream, not a dilution stream. However, any nonprocess (e.g. dilution) water greater than the 25%
allowance would be considered to be a dilution stream and would not be assigned a mass limit.
9-28
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To calculate the mass limits for stream 6, concentration limits for each subpart are applied to a
percentage of the total stream 6 flow. Facility D only has subpart A and C operations, and therefore,
subpart A and C effluent limitations will be applied to stream 6.
Table 7-1 presents the proposed maximum daily and monthly average BPT effluent limitations for subpart
A, B, C, and D operations. 40 CFR 414.71 presents the maximum daily and monthly average BPT
effluent limitations for bulk organic chemical OCPSF wastewaters.
Step 2. Determining the Use of Monthly Average Limitations vs. Percent Reduction for COD
Limitations
Facility D must comply with either the revised COD concentration limitations or the previously
promulgated COD limit requiring a reduction in the long-term average daily COD load in the raw
(untreated) process wastewater of 74 percent multiplied by a variability factor of 2.2, whichever is more
stringent. Permit authorities should compare the revised monthly average effluent limitations, which apply
to subpart A, B, C and D operations, with the previously promulgated guidelines to determine which is
more stringent. As mentioned previously, monthly average limitations for subpart E operations were not
revised in the 1998 final rule; the effluent limitations guidelines presented in 40 CFR 439.52, requiring a
74 percent reduction in the long-term daily COD load multiplied by a variability factor of 2.2, or 220 mg/L,
whichever is greater, continue to apply.
Assuming subpart A and C operations at Facility E have an influent COD concentration of 2,500 mg/L in
the wastewater treatment plant, a 74 percent reduction in the long-term daily COD load multiplied by a
variability factor of 2.2 would result in a final effluent discharge limitation of 1,430 mg/L. The revised COD
limitations require a maximum monthly average of 856 mg/L for subpart A and C operations. The revised
COD limitations of 856 mg/L are more stringent. Therefore, Facility D must comply with the mass-based
limitations derived from the concentration-based COD limitations promulgated in 1998.
Step 3. Determining Maximum COD Effluent Limitation for Any One Day
COD is not regulated in wastewater from chemical synthesis operations at OCPSF facilities (40 CFR Part
414). In cases where OCPSF wastewaters are combined with pharmaceutical wastewaters and treated in
a central unit, the maximum daily and monthly average limitations for COD can be calculated by
determining the mass discharge allowance using the CWF shown below:
N
FT-FD
MT= I M
' ' 1=1
where: MT = Alternative mass limit for the pollutant in the combined wastestream
(mass per day).
Mj = Treatment standard for the pollutant in the regulated stream i (mass per
day)
FJ = Average daily flow (at least 30 day average) of the regulated stream i
FD = Average daily flow (at least 30 day average) of dilute wastestream(s)
entering the combined treatment system
FT = Average daily flow (at least 30 day average) through the combined
treatment facility (including regulated, unregulated, and dilute
wastestreams)
N = Total Number of regulated streams
The OCPSF waste stream (stream 4) is considered to be unregulated for COD; permit writers can use the
CWF for calculating the mass-based effluent limitation applied at the end-of-pipe for Facility D.
9-29
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In this example, the previously listed variables are calculated as follows:
8,191 Ibs [691,000gpd- Ogpdl ft „,.„ 1U (J ^^
MT = — x : — ^— = 9,659 Ibs/day COD
T day |_ 586,000 gpd J
M1 = Mass limit for COD in stream 1 (subpart A)
Mi = 1,675 mg/L x 500,000 gal/day x [8.345 x 10'6 (L x |b)/(gal x mg)]
6,989 Ibs/day
M3 = Mass limit for COD in stream 3 (subpart C)
M3 = 1,675 mg/L x 80,000 gal/day x[8.345 x 10'6 (L x |b)/(gal x mg)]
1,118 Ibs/day
M5 = Mass limit for COD in stream 5 (subpart C)
M5 = 1,675 mg/L x 5,000 gal/day x [8.345 x 10'6 (L x |b)/(gal x mg)]
70 Ibs/day
M6 = Mass limit for allowable nonprocess water
M6 = 1,675 mg/L x 1,000 gal/day x [8.345 x 10'6 (L x lb)/(gal x mg)]
14 Ibs/day
FT = Total flow = 691,000 gal/day
FD = Dilution flow = 0 (all dilution water is included in the allowable
nonprocess water flow)
F-i = Flow in stream 1 = 500,000 gal/day
F3 = Flow in stream 3 = 80,000 gal/day
F5 = Flow in stream 5 = 5,000 gal/day
F6 = Flow in stream 6 = 1,000 gal/day
£Mi = 8,191 Ibs/day
£Fi = 586,000 gal/day
Total facility discharge limitation for any one day for COD is 9,659 Ibs/day.
Step 4. Determining Monthly Average Effluent Limitations
Monthly average limitations for COD can be calculated in a similar manner as the maximum daily
limitations. We will use the CWF from the previous section to determine mass-based COD monthly
average limitations as shown below:
4,186lbs [691,000 gpd-Ogpdl . „„ .. .. „_
M T = — x : ^- ^— = 4,936 Ibs/day COD
T day |_ 586,000 gpd J
M1 = 856mg/Lx500,OOOgal/dayx [8.345 x iO"6(Lx |b)/(gal x mg)]
3,572 Ibs/day
856 mg/L x (
571 Ibs/day
856 mg/L x
36 Ibs/day
M3 = 856 mg/L x 80,000 gal/day x [8.345 x 10"6 (L x lb)/(gal x mg)]
M5 = 856mg/Lx5,OOOgal/dayx [8.345 x iO"6(Lx |b)/(galx mg)]
M6 = 856 mg/L x 1,000 gal/day x [8.345 x 10'6 (L x |b)/(gal x mg)]
7 Ibs/day
FT = Total flow = 691,000 gal/day
FD = Dilution flow = 0 (dilute included in nonprocess water allowance)
£Mi = 4,186 Ibs/day
£Fi = 586,000 gal/day
9-30
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Total facility monthly average discharge limitation for COD is 4,936 Ibs/day. This monthly average
limitation is compared to the average of all the daily mass discharges in a calendar month to determine
facility compliance.
9.4.4 Determining Permit Limits for Pollutants Regulated Under BAT
Tables 7-2 and 7-3 present the proposed maximum daily and monthly average BAT effluent limitations
guidelines forsubparts A and C, and subparts B and D, respectively.
We will assume that Facility D has provided the permit writer with an accurate characterization of its
process wastestreams by means available such as solvent use and disposition data, and chemical
analysis of each stream. Permit writers should establish permit limitations and require compliance
monitoring for each regulated pollutant generated or used at a pharmaceutical manufacturing facility.
Routine compliance monitoring is not required for regulated pollutants not generated or used at a facility.
Facilities should make a determination that regulated pollutants are not generated or used based on a
review of all raw materials used, and an assessment of all chemical processes used, and consideration of
resulting products and by-products. The determination that a regulated pollutant is not generated or used
should be confirmed by annual chemical analyses of wastewater from each monitoring location, and
these analyses must be submitted to the permit writer. Such confirmation is provided if the pollutant is
not-detected above the ML of an EPA-approved analytical method.
Table 9-15 presents a summary of the regulated pollutants expected to be found in this facility's
wastestreams:
Table 9-15: Regulated Pollutants Found in the Wastewater at Facility D
Stream
1
2
3
4
5
6
Subpart
A
N/A
C
OCPSF
C
N/A
Flow (gal/day)
500,000
100,000
80,000
105,000
5,000
1,000
Pollutant
Methylene chloride
Methanol
Toluene
None
Cyanide
Acetonitrile
Methylene chloride
Methanol
Acetonitrile
Methylene chloride
Methanol
None
Concentration
(mg/L)
100
1,000
700
None
50
500
200
100
100
150
250
None
Based on the above data, permit limitations would be established for acetonitrile, cyanide, methanol,
methylene chloride, and toluene. The limitations for all organic pollutants listed above except cyanide
would be applied to the final effluent at monitoring point B.
BAT effluent limitations for cyanide should be applied in-plant before commingling with non-cyanide
bearing wastewaters, unless a facility can show cyanide is detectable at the end-of-pipe monitoring point.
The cyanide standards are applicable to wastewaters from subpart A and C operations that contain
cyanide. Therefore, the concentration-based limitations for cyanide will apply to process wastestream 3 at
point A, prior to dilution or mixing with any non-cyanide bearing wastewater.
9-31
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Step 1. Determining BAT Maximum Effluent Limitations for Any One Day
The following maximum effluent limitations for any one day apply to pharmaceutical subpart A and C
operations:
Methylene chloride: 0.9 mg/L
Methanol: 10.0 mg/L
Toluene: 0.06 mg/L
Cyanide: 33.5 mg/L
Acetonitrile: 25.0 mg/L
For our example, the allowable mass discharge of methylene chloride for any one day will be calculated.
Methylene chloride is present and regulated in both pharmaceutical and OCPSF bulk chemicals
wastewater. We are assuming Facility D produces more than five million pounds of OCPSF chemicals per
year, and have applied the methylene chloride daily limitation for OCPSF wastewaters listed in 40 CFR
414.91 as shown below. The maximum daily limitations for methylene chloride for pharmaceutical
subparts A and C is 0.9 mg/L and for OCPSF wastewater is 89 ^g/L . Since monitoring points for organic
pollutants under BAT are at end-of-pipe locations and all process wastewaters will be combined at this
location, a mass discharge limitation for each waste stream will be determined.
Stream 1 (subpart A): 0.9 mg/L x 500,000 gal/day x [8.345 x 10~6 (L x lb)/(gal x mg)]
= 3.8 Ibs/day
0.9 mg/L x 80
= 0.6 Ibs/day
89 ,wg/L x 105
= 0.078 Ibs/day
0.9 mg/L x 5,00(
= 0.038 Ibs/day
Stream 3 (subpart C): 0.9 mg/L x 80,000 gal/day x [8.345 x 10~6 (L x lb)/(gal x mg)]
Stream 4 (OCPSF): 89 ^g/L x 105,000 gal/day x[ 8.345 x 10"9 (L x lb)/(gal x ^g)]
Stream 5 (subpart C): 0.9 mg/L x 5,000 gal/day x [8.345 x 10~6 (L x lb)/(gal x mg)]
Stream 6 (Nonprocess 0.9 mg/L x 1,000 gal/day x [8.345 x 10"6 (L x lb)/(gal x mg)]
Wastewater Allowance) = 0.0075 Ibs/day
Total = 4.5 Ibs/day
The total maximum daily discharge for methylene chloride is 4.5 Ibs/day.
The maximum daily effluent limitations for methanol, toluene, and acetonitrile can be calculated in a
similar manner. The maximum daily effluent limitation for cyanide is calculated using the flow for stream 3
only.
Step 2. Determining BAT Monthly Average Limitations
Monthly average limitations for organic pollutants, ammonia and cyanide can be calculated using the
same method used to determine the mass-based maximum daily effluent limitations. The following
monthly average effluent limitations apply to pharmaceutical subpart A and C operations:
Methylene chloride: 0.3 mg/L
Methanol: 4.1 mg/L
Toluene: 0.02 mg/L
Cyanide: 9.4 mg/L
Acetonitrile: 10.2 mg/L
9-32
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The monthly average effluent limitations for OCPSF operations is listed in 40 CFR 414.91. The following
calculations can be performed to determine the mass-based monthly average effluent limitations for
methylene chloride.
Pharmaceutical subparts A and C allowable discharge:
0.3 mg/L x (500,000 gal/day + 80,000 gal/day + 5,000 gal/day + 1,000 gal/day)
x [8.345 x I0~6(l_x |b)
OCPSF Bulk Chemicals Subcategory:
[8.345 x 10"6 (L x lb)/(gal x mg)] = 1.5 Ibs/day
40 ,wg/L x 105,000 gal/day x [8.345 x 10"9 (L x lb)/(gal x ^g)] = 0.035 Ibs/day
Total = 1.5 Ibs/day
The monthly average discharge limitation for methylene chloride is 1.5 Ibs/day. The monthly average
limitations for methanol, toluene, and acetonitrile can be calculated in a similar manner. The monthly
average limitation for cyanide is calculated using the flow for stream 3 only. The monthly average
limitations calculated as shown above are compared to the average of all the daily mass discharge
amounts for a pollutant during a calendar month to determine facility compliance.
Step 3. Determining Compliance Monitoring for BAT Pollutants
Facilities discharging more than one regulated pollutant may request to monitor for a single surrogate
pollutant to demonstrate an appropriate degree of control fora specified group of pollutants. For the
purpose of identifying surrogates, pollutants have been grouped according to treatability classes; Tables
8-1 and 8-2 present the treatability classes identified for advanced biological treatment and steam
stripping, respectively.
Facility D wastewater treatment is advanced biological treatment, and we can use Table 8-1 as a guide to
determine if surrogate pollutants may be appropriate for compliance monitoring. None of the pollutants at
Facility D are classified in the same treatability class, however, if a facility requests to use surrogate
pollutants, a permit writer may decide on a facility-by-facility basis whether surrogate pollutants are
appropriate and which pollutant may be used as a surrogate. For this example, we did not identify any
appropriate surrogates, therefore Facility D should routinely monitor for all regulated pollutants generated
or used on-site.
For this example, Facility D should perform compliance monitoring at Point B in Figure 9-4, directly after
the wastewater treatment facility for all pollutants except cyanide, unless cyanide is detectable at the end-
of-pipe monitoring point. If cyanide is not detectable at the end-of-pipe monitoring point, compliance
monitoring should occur in-plant at Point A in Figure 9-4.
9.4.5 Final Limits as They Would Appear in a Permit for Facility D
Table 9-16 presents the final limits as they would appear in a permit for Facility D. Permit writers can
choose to apply cyanide limits at end-of-pipe, provided that the cyanide value can be detected.
The limitations presented in Table 9-16 were effective on November 20, 1998 or upon reissuance of the
current permit, whichever is later.
9-33
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Table 9-16: Final Limits for Facility D
Pollutant or Pollutant
Property (a)
COD (BPT and BAT)
Cyanide
Acetonitrile
Methanol
Methylene Chloride
Toluene
Effluent Limitation for End-of-Pipe
Monitoring Points
Maximum for any
one day (Ib/day)
9,659
—
144
58
4.5
0.36
Monthly Average
(Ib/day)
4,936
—
59
24
1.5
0.12
Effluent Limitation for In-Plant
Monitoring Points
Maximum for any
one day (Ib/day)
—
22.4
—
—
—
—
Monthly Average
(Ib/day)
—
6.3
—
—
—
—
(a)
pH, BOD5, and TSS limits are not shown here since they have not been changed by the September 21,
1998 promulgated rule. These limits would be calculated as they have been in the past.
9-34
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10. Where to Get Additional Help
This section presents additional sources of information, as well as EPA contacts, that may help permit
writers and control authorities obtain additional information related to implementation of the final
pharmaceutical effluent limitations guidelines and standards forsubparts A, B, C, D, and E. Specifically,
this section presents a list of selected documents, databases, and websites either relating generally to the
pharmaceutical industry, or specifically to the September 21, 1998 Promulgated Rule. These lists also
include information on how to reach EPA program personnel and how to access these information
sources.
Questions specifically related to the effluent limitations guidelines and standards for the pharmaceutical
industry should be directed to:
Headquarters:
Meghan Hessenauer
Engineering and Analysis Division
Office of Water
U.S. EPA
1200 Pennsylvania Ave., NW
Washington, DC 20460
Email: hessenauer.meghan@epa.gov
Regional Contacts:
Region 1
Justin Pimpare
1 Congress Street, Suite 1100
Boston, MA 02114-2023
Email: pimpare.iustin@epa.gov
Region II
Jacqueline Rios
290 Broadway
New York, NY 10007-1866
Email: rios.iacqueline@epa.gov
Region IV
Dee Stewart
61 Forsyth Street, S.W.
Atlanta, GA 30303-8960
Email: stewart.dee@epa.gov
Region V
Matthew Gluckman
77 West Jackson Boulevard
Chicago, IL 60604-3507
Email: gluckman.matthew@epa.gov
Region IX
Keith Silva
75 Hawthorne Street
San Francisco, CA 94105
Email: silva.keith@epa.gov
10-1
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10.1 Information Relating to the Pharmaceutical Rule
This manual is one element in a broad spectrum of materials that are available related to the regulations
promulgated September 21, 1998 for pharmaceutical manufacturing facilities with operations in subparts
A, B, C, D, and E. Figure 10-1 illustrates some of the information resources currently available.
Documents Supporting the 1998
Promulgated Rule
Pharmaceutical Final Rule Support Documents
EPA Internet Homepage
General Information About
Permits and NPDES Program
NPDES Permit Writers Guide
WQBEL Documents
NPDES Compliance Inspection Manual
Databases
PCS
IDEA
ERNS
TRI
Websites
EPA Internet Homepage
EPA/OST Pharmaceutical Website
EPA/OAQPS Pharmaceutical Website
PhRMA Website
Figure 10-1: Information Resources Map
10.1.1 Documents Supporting the 1998 Promulgated Rule
• Development Document for Effluent Limitations Guidelines and Standards for the
Pharmaceutical Manufacturing Point Source Category, EPA-821-R-98-005, July 1998.
• Environmental Assessment of the Final Effluent Limitations Guidelines and Standards for
the Pharmaceutical Manufacturing Industry, EPA 821-B-98-008, July 1998.
• Statistical Support Document for Final Effluent Limitations Guidelines and Standards for
the Pharmaceutical Manufacturing Industry, EPA 821-B-98-007, July 1998.
• National Emission Standards for Hazardous Air Pollutants for the Pharmaceutical
Manufacturing Industry; Summary of Public Comments and Responses, EPA 450-R-98-
002, July 1998.
10-2
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10.1.2 General Information About Permits and NPDES Program
• NPDES Permit Writer's Manual, EPA-833-B-96-003. This 1996 EPA manual was
prepared to provide the basic regulatory framework and technical considerations that
support the development of wastewater discharge permits as required under the NPDES
program.
• NPDES Compliance Inspection Manual, EPA 305-X-03-004, July 2004. This EPA manual
was developed to support personnel that conduct NPDES inspections of wastewater
treatment plants, industrial storm water and construction site dischargers, pretreatment
facilities, biosolids handling and treatment facilities, Concentrated Animal Feeding
Operations, municipal wastewater collection systems, as well as pollution prevention and
multimedia concerns. The manual presents standard procedures for inspections and
specific technical information necessary to conduct the full range of NPDES compliance
inspection activities. This document is available from EPA's Web site at:
http://www.epa.gov/compliance/resources/publications/monitoring/inspections/np
desinspect/index.html
• Guidance for Water Quality-Based Decisions: The TMDL Process, EPA-440-4-91. This
document is intended to define and clarify the requirements under Section 303(d) of the
Clean Water Act. Its purpose is to aid state water-quality program managers in
understanding the application of total maximum daily loads within the water quality-based
approach to establish pollution control limits for waters not meeting water quality
standards.
• Technical Support Document for Water Quality-Based Toxics Control, EPA/505/2-90-001.
This document was prepared as technical guidance for assessing and regulating the
discharge of toxic substances to waters of the United States.
• Industrial User Permitting Guidance, EPA#833R89001, September 1989.
10.1.3 Databases
• PCS. The Permit Compliance System (PCS) is a national information system that
automates entry, updating and retrieval of NPDES data and tracks permit issuance,
permit limits, and monitoring data for NPDES facilities. Public access is available by
obtaining a mainframe account on EPA's National Computer Center. See
http://www.epa.gov/compliance/data/systems/index.html for further details.
• IDEA. The Integrated Data for Enforcement Analysis System (IDEA) is an interactive data
retrieval and integration system developed by EPA's Office of Enforcement and
Compliance Assurance. Users can retrieve data for performing multimedia analyses of
regulated facilities, produce compliance histories of individual facilities, identify a group of
facilities that meet user-defined criteria, and produce aggregated data on selected
industries. Public access is available by obtaining a mainframe account on EPA's
National Computer Center. See
http://www.epa.gov/compliance/data/systems/index.html for further details.
• ERNS. Through The Emergency Response Notification System, EPA maintains a
database of reported spills of oil and other materials. See
http://www.epa.gov/compliance/data/systems/waste/index.html for further details.
• TRI Data. The Toxics Release Inventory (TRI) provides the public with information on
toxic chemicals being used, manufactured, transported, or released into the environment.
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See http://www.epa.gov/opptintr/tri for access to numerous TRI topics, including;
"What is TRI", "Accessing and Using TRI Data", "Tri Forms and Reporting Requirements",
"TRI chemicals", "TRI Program Development", "TRI National and International Programs",
"TRI Contacts", and "What's New with TRI". See
http://www.epa.gov/opptintr/tri/ttpubacc.htm to learn more about TRI information
found on CD-ROM, the Right-to-Know Network (RTK NET), Envirofacts, TOXNET (user
fee), and TRI User Support (TRI-US).
10.1.4 Websites
• EPA on the World Wide Web. EPA's webserver is the primary public access
mechanism on the Internet for EPA. The webserver provides a range of EPA-generated
information in electronic format, and also offers access to EPA's Online Library Service
(OLS), the national online catalog of the EPA library network. It includes the catalogs of
the Headquarters Information Resource Center and all the Regional libraries.
Via Internet:
EPA's homepage on the World Wide Web: http://www.epa.gov
EPA's pharmaceutical rulemaking actions homepages on the World Wide Web:
http://www.epa.gov/ost/guide/pharm (water documents)
http://www.epa.gov/ttn/oarpg (air documents)
10.2 Other Sources and Contacts
10.2.1 EPA Headquarters Information Resource Center
The EPA Headquarters Information Resource Center provides information support services to EPA staff
and maintains a varied collection of environmental resources, including CD-ROMs, an online catalog, and
other program-specific services. The library provides services to the general public and develops several
publications, including newsletters and brochures. Library hours are 8:00 a.m. to 5:00 p.m. ET, Monday
through Friday. EPA's Online Library Service (OLS) is available through Telnet: "epaibm.rtpnc.epa.gov."
10.2.2 National Technical Information Service (NTIS)
Located in the U.S. Department of Commerce, the National Technical Information Service (NTIS) is the
central source for the public sale of U.S. Government-sponsored research, development, and engineering
reports. It is also a central source of federally generated machine processible data files. It contains
reports on air pollution, acid rain, water pollution, marine pollution, marine ecosystems, land use planning,
fisheries management, solar energy, offshore oil drilling, solid wastes, traffic noise, and radiation
monitoring.
For more information, contact:
Chief, Order Processing Branch
National Technical Information Service
5285 Port Royal Road
Springfield, Virginia 22161
Tel: (703) 487-4650
Fax:(703)321-8547
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Appendix A Glossary
Biochemical oxygen demand (BOD5) - Five-Day Biochemical Oxygen Demand. A measure of
biochemical decomposition of organic matter in a water sample. It is determined by measuring the
dissolved oxygen consumed by microorganisms to oxidize the organic contaminants in a water sample
under standard laboratory conditions of five days at 20°C. BOD5is not related to the oxygen
requirements in chemical combustion.
Chemical oxygen demand (COD) - A bulk parameter that measures the oxygen-consuming capacity of
organic and inorganic matter present in water or wastewater. It is expressed as the amount of oxygen
consumed from a chemical oxidant in a specific test.
Continuous discharge - Discharge that occurs without interruption throughout the operating hours of the
facility.
Conventional pollutants - The pollutants identified in sec. 304(a)(4) of the CWA and the regulations
thereunder (biochemical oxygen demand (BOD5), total suspended solids (TSS), oil and grease, fecal
coliform, and pH).
Daily discharge - The discharge of a pollutant measured during any calendar day or any 24-hour period
that reasonably represents a calendar day. For pollutants with limitations expressed as mass, the daily
discharge is calculated as the total mass of the pollutant discharged over the day. For pollutants with
limitations expressed in other units of measurement, the daily discharge is calculated as the average
measurement of the pollutant over the day.
Direct discharger - A facility that discharges or may discharge treated or untreated process wastewaters,
non-contact cooling waters, or non-process wastewaters (including stormwater runoff) into waters of the
United States.
Effluent limitation - Any restriction, including schedules of compliance, established by a State or the
Administrator on quantities, rates, and concentrations of chemical, physical, biological, and other
constituents which are discharged from point sources into navigable waters, the waters of the contiguous
zone, or the ocean.
End of the pipe - The point at which final facility effluent is discharged to waters of the United States or
introduced to a POTW.
Final effluent - Facility wastewater discharges to receiving waters including streams, lakes, and other
waters of the U.S.
Indirect discharger - A facility that discharges or may discharge wastewaters into a publicly owned
treatment works or a treatment works not owned by the discharging facility.
Influent - Facility wastes, water, and other liquids, which can be raw or partially treated, flowing into a
treatment plant, reservoir, basin, or holding pond.
Maximum daily discharge limitation - The highest allowable daily discharge of a pollutant measured
during a calendar day or any 24-hour period that reasonably represents a calendar day.
Minimum level (ML) - The level at which the analytical system gives recognizable signals and an
acceptable calibration point.
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Non-continuous discharge - Discharge that occurs only during specific periods of time (seasons, or
operating shift variations). Does not apply to treatment plant or process upset conditions; periods of no
discharge are at least 24 hours in duration.
Nonconventional pollutants - Pollutants that are neither conventional pollutants nor toxic pollutants (see
40 CFR Sections 401.15, 401.16 and Part 423, Appendix A).
NPDES - National Pollutant Discharge Elimination System. The NPDES program is authorized by the
Clean Water Act and requires permits for the discharge of pollutants from any point source into waters of
the United States.
POTW - Publicly-owned treatment works as defined at 40 CFR 403.3(o).
Pretreatment standard - A regulation addressing industrial wastewater effluent quality required for
discharge to a POTW.
Process water - Water used to dilute, wash, or carry raw materials and any other materials used in the
manufacturing process.
Toxic pollutants - Pollutants designated as toxic pursuant to Section 307(a)(1) of the Act and listed in 40
CFR Section 401.15.
Wastewater - Water carrying waste materials from a facility. It is a mixture of water, and dissolved and
suspended pollutants.
Waters of the United States - As defined in 40 CFR 122.2. This definition includes all waters that are
currently used, may be used in the future, or were used in the past, in interstate or foreign commerce
(including all waters subject to the ebb and flow of the tide) and adjacent wetlands.
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