United Stetes;
EPA 3Q1-B-01-6QS
August 2001
Com liance Tool for
'-''" *
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COMPLIANCE ASSISTANCE TOOL FOR
CLEAN AIR ACT REGULATIONS:
i
SUBPART GGG OF 40 CFR PART 63
NESHAPS FOR SOURCE CATEGORY
PHARMACEUTICAL PRODUCTION
August 2002
Compliance Assessment and Media Programs Division
Office of Compliance
Office of Enforcement and Compliance Assurance
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
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DISCLAIMER
The statements in this document are intended solely as guidance. This document is not intended,
nor can it be relied on, to create any rights enforceable by any party in litigation with the United
States. The U.S. Environmental Protection Agency (EPA) and State officials may decide to
follow the guidance provided in this document, or to act at variance with the guidance, based on
an analysis of site-specific circumstances. This guidance may be revised without public notice to
reflect changes to EPA's policy.
-------
Table of Contents
i Page
Chapter 1 - Purpose .—... 1-1
1.1 Purpose of the Document • 1-1
i ,- ,
1.2 Document Organization ........... ................ ...... 1-1
1.3 Disclaimer J —......... • • «« 1-2
Chapter 2 - Overview of the Regulations „.„..... ....... ..... ... 2-1
2.1 Purpose of the Rule ..« —. • «• 2-1
2.2 Statutory Background — 2-1
!
2.3 Major Components of the Rule ............— —...—« 2-3
i
2.4 Standards ,., •• 2-5
Chapter 3 - Applicability and Compliance Dates 3-1
3.1 Overview .,* • «.«••-••—•• 3-1
3.2 Applicability j , 3-1
i
3.3 Other Important Applicability Definitions 3-7
3.4 Compliance Dates ....j.. .— 3-13
3.5 Consistency with Other Regulations 3-14
Chapter 4 - Requirements for Storage Tanks 4-1
4.1 Overview ...* «... 4-1
i
4.2 Structure of the Regulation 4-1
4.3 Applicability *.....—.... 4-2
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13 Applicability .. 7-2
7.4 Standards . 7-10
7.5 Compliance Demonstration 7-26
Chapter 8 - Initial Compliance Demonstrations and Testing Procedures ....—.........— 8-1
8.1 Overview. ......—....... ......... ....—....... ..........—...—.. 8-1
8.2 Structure of the Regulation —...... 8-2
83 Exemptions from Compliance Demonstrations 8-2
8.4 Compliance Demonstration Procedures - Summary 8-3
8.5 Compliance Demonstration Procedures for Process Vents 8-6
8.6 Compliance Demonstration Procedures for Storage Tanks ..... 8-25
8.7 Initial Compliance Demonstration Procedures for Wastewater Sources .—.... 8-25
8.8 Submittal of Compliance Demonstrations 8-32
Chapter 9 - Monitoring Procedures — 9-1
9.1 Overview 9-1
9.2 Structure of the Regulation 9-1
9.3 Basis for Monitoring Control Devices .... ...... ............................... 9-2
9.4 Establishing Operating Parameters for Monitoring Control Devices 9-3
9.5 Establishing Averaging Periods for Monitoring ..—............................................ 9-8
9.6 Monitoring for the Mass Emissions Limit Standard (2,000 Ib/yr) . 9-9
9.7 Wastewater Monitoring Procedures .—........ .................. 9-9
9.8 Exceedances of Operating Parameters, Excursions, and Violations ................. 9-13
-------
Chapter 13 - Reporting..... ...\ .» 13~1
13.1 Overview ; • 13-1
13.2 Structure of the Regulation .;...................................—...........................—.... 13-1
i
13.3 Reporting Requirements frorii the General Provisions, Subpart A 13-1
!
13.4 Reporting Requirements from the Pharmaceutical MACT, Subpart GGG .. 13-3
i
Appendices . '•
Appendix EE: Emissions Estimation Procedures for Process Vents
Appendix PT: Emissions Performance Testing - Test Methods and Approach
Appendix WWT: Wastewater Treatment Performance Testing - Test Methods and Approach
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: Chapter 1
Purpose
1.1 Purpose of the Document
This document is intended to help owners
and operators of pharmaceutical ;
manufacturing operations understand and
comply with the U.S. Environmental
Protection Agency's (EPA) air pollution
regulations promulgated on September 21,
1998, substantially revised on August 29,
2000 and revised again on August 2,2001,
for the pharmaceutical industry. These
regulations contain new emissions standards
based on the "maximum achievable control
technology" or MACT. On September 2.1,
1998, EPA published new effluent
guidelines, pretreatment standards, and new
source performance standards pursuant to
the Clean Water Act (CWA). These new
CWA provisions are not reviewed in this,
document. ;
This document reviews the primary MACT
provisions of the regulations, and in many
cases, summarizes the regulations in tables
or charts to facilitate a quicker review, j
Within most chapters, questions and answers
provided in shaded boxes should help the
reader with some of the more complex 01*
confusing components. This document,
does not however, attempt to provide
interpretations of the rule. In some cases.,
owners or operators will need to review |
specific issues relating to their particular
production facilities with the appropriate:
regulating agency. !
1.2 Document Organization
The chapters in the document follow the
organization of the Pharmaceutical MACT
LI
1.2
1.3
Chapter 1 at a Glance
Purpose of the Document
Document Organization
Guide
regulations.
Chapter 2 - Overview of the Regulations -
provides an overview of the regulations and
recreates the table of standards for the four
major types of emissions sources: process
vents, storage tanks, wastewater, and
equipment leaks.
Chapter 3 - Applicability and Compliance
Dates - takes the reader through the
applicability provisions of the regulations
and includes several questions and answers
to help the reader determine applicability at
his/her facility.
Chapter 4 - Requirements for Storage
Tanks - describes the kinds of tanks subject
to regulation and reviews provisions specific
to storage tanks, including options for
complying with the standards.
Chapter 5 - Requirements for Process
Vents - describes which vents are subject to
regulation, including individual vents that
may be subject to a more stringent standard,
and discusses the different options available
for process vent standards.
1-1
-------
Chapter 6 - Equipment Leaks - reviews the
equipment leaks provisions, including
identification of leaking equipment, and
monitoring and repair requirements.
Chapter 7 - Requirements for Wastewater
- explains the wastewater regulation,
including standards for vapor suppression,
air emissions control, and wastewater
treatment.
Chapter 8 - Initial Compliance
Demonstrations and Testing Procedures -
reviews the compliance demonstration
requirements that must be followed in
demonstrating initial compliance with the
regulations. This chapter covers compliance
demonstrations for storage tanks, process
vents, and wastewater.
Chapter 9 - Monitoring Procedures -
reviews the monitoring requirements that
owners/operators must follow to ensure on-
going compliance with the regulations.
Chapter 10 - Pollution Prevention - goes
over the pollution prevention options that
are available to existing sources. The
chapter includes examples that show how
emissions baselines are calculated. A
detailed, "real-life" pollution prevention
success story is also described.
Chapter 11 - Emissions Averaging -
describes the emissions averaging provisions
that may be applied to process vents and
storage tanks. The chapter provides an
example for process vents and an example
for tanks.
Chapter 12 - Recordkeeping - includes
comprehensive tables that describe the
recordkeeping requirements in the MACT
regulations.
Chapter 13 - Reporting - also contains
comprehensive tables, specifically for
reporting requirements. Three of the tables
in the chapter are organized according to the
type of report - precompliance, notification
of compliance status, and periodic.
1.3 Disclaimer for the Use of this
Guide
The reader should note that following the
information provided in this document does
not shield the facility from enforcement
actions taken by the EPA or authorized state
agencies. This document provides an
overview and "plain English" explanation of
the new standards. It is not a substitute for
the regulations presented in 40 CFR Part 63,
Subpart GGG.
1-2
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Chapter 2
Overview of the Regulations
2.1 Purpose of the Rule
The purpose of this EPA rule, proposed; on
April 2,1997, promulgated on September
21,1998 and amended on August 29,2000
is to reduce air emissions of hazardous air
pollutants (HAP) from both existing and
new facilities that manufacture ;
pharmaceutical products. EPA estimates
that implementation of the rule will reduce
HAP emissions from existing sources by
approximately 24,000 tons per year. In !
addition, the controls put in place to comply
with these MACT standards also will reduce
volatile organic compounds (VOC)
emissions. This will be accomplished
primarily by limiting emissions from stojrage
tanks, process vents, wastewater system?,
and equipment leaks. This rule will lead to
increased protection of the public by ',
reducing emissions of chemicals that are;
harmful to human health and the ,
environment. !
2.2 Statutory Background ;
!
This new regulation, subpart GGG to Part
63, is based on Congressional direction '
provided hi section 112 of the Clean Air
Act, which was amended in 1990. Section
112(b) contains a list of HAP to be i
regulated. The statutory list contains 18$
substances and categories of substances |
designated as "hazardous air pollutants" ithat
must be regulated. The list includes
methylene chloride, methanol, toluene, and
hydrogen chloride, four commonly-used;
chemicals in the pharmaceutical :
manufacturing industry.
Chapter 2 at a Glance
2-1
'<2&~ '
•$*•-•;.
2-
The EPA used the set of 188 HAP, as
directed under 112(c), to develop a list of
source categories for which emission
standards would be set. This list, published
on July 16,1992, included the
pharmaceutical manufacturing industry.
Therefore, EPA developed this National
Emission Standard for Hazardous Air
Pollutants (NESHAP) specifically for the
pharmaceutical manufacturing industry.
Section 112(d) directs EPA to promulgate
emissions standards that reflect use of the
"maximum achievable control technology"
(MACT). EPA must take into account "the
cost of achieving such emission reduction,
and any non-air quality health and
environmental impacts and energy
requirements....," when setting the standards.
The statute directs EPA to develop standards
for existing sources and for new sources.
New source standards cannot be "less
stringent than the emission control that is
achieved in practice by the best controlled
2-1
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similar source." The standard for existing
sources should be no less stringent than the
average emission control achieved by the
best performing 12 percent of the existing
sources. Therefore, the final rule specifies
different standards for new and existing
sources hi some, but not all, cases.
NOTE: Whenever the terms
"existing sources" or "new sources"
are used in this document, this most
often means "processes subject to existing
source MACT" or "processes subject to new
source MACT."
The pharmaceutical NESHAP rule is
progressive hi that it offers a pollution
prevention standard for pharmaceutical
manufacturers as an alternative to using add-
on controls to limit emissions. Under the
pollution prevention option, owners and
operators can opt to reduce the overall
consumption of HAPs in their processes.
This option is available only for existing
sources and does not apply to HAPs that are
generated in the manufacturing process. The
pollution prevention standard requires that
owners reduce the production-indexed
consumption of HAPs by 75%, using a
baseline consumption factor calculated from
data no earlier than 1987. The production-
indexed consumption factor is expressed as
kg HAP consumed/ kg product produced. A
second pollution prevention alternative
allows the owner or operator to reduce the
production-indexed consumption factor by
50% AND use other add-on controls to
achieve an overall 75% reduction. The
pollution prevention option will be
described in detail hi a later chapter.
Sections of the Pharmaceutical MACT
63.1250 - ApplicgbiHty-Defines affected sources that are •
subject to die rules and sources that ate exempt and sets
compliance deadlines.
63.1251 - Definitions - Provides definitions to terms as
they are used in subpartOGG.
63.1252 - Standards: General - Specifies controls for
closed vent systems, beat exchange systems, certain liquid
streams, and certain halogenated vent streams controlled by
combustion devices. Also presents pollution prevention as ,
an alternative to achieving endk>f-pipe reductions.
63.1253 -Standards: Storage Tanks - Specifies standards
for storage tanks.
63.1254-Standards: Process Vents - Specifies standards
for process vens.
63.1255 - Standards; Equipment Leaks - Specifies work
practices for pumps, compressors, agitators, pressure relief
devices, sampling connection systems, open-ended valves
or lines, valves, connectors, instrumentation systems, ,
control devices, and closed-vent systems hat are in HAP
service (in contact with HAPs at a concentration > 5% total
HAP by weight) for at least 300 hours per year,
63.1256 - Wastewater Provisions - Specifies standards for
wastewater tanks, surface impoundments, containers,
individual drain systems, oil-water separators, treatment
processes, and control devices. Provides control options for
wastewater. *
63.1257 - Tort Methods and Compliance Procedures -
Contains instructions for testing emissions from sources,
and provides specific procedures for demonstrating initial
compliance with standards for storage tanks, process vents,
and wastewater. '
63.1258 - Monitoring Requirements - Contains provisions'
for monitoring specified parameters to determine continued;
compliance. Discusses what constitutes violation of
operating parameters and emission limits.
63.1259 - Recordkeeping - Provides instructions for
keeping records of applicability determinations; startup,
shutdown, and malfunction plans; operating parameters
date, including emissions averaging data; applications for
approval of construction or reconstruction; and leak
detection and repair programs.
63.1260 » Reporting - Gives instructions on submittal of
initial notification, applications for approval of construction
or reconstruction, notification of continuous monitoring
system (CMS) performance evaluation, Precompliance and
Notification of Compliance Status reports, Periodic reports,
notification of process changes, reports on startup,
shutdown, and malfunction, leak detsction and repair
reports, emissions; averaging calculations, and performance
tests.. .. , . '' '":'
63.1261 - Delegation of Authority-Specifies which
authorities cannot be delegated to States.
2-2
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NOTE: The HAPs regulated in this
rule also are subject to regulation
under EPA's water program. ;New
effluent guidelines and pretreatment standards
for the pharmaceutical industry also iwere
published on September 21, 1998. See these
new regulations for further information (40
CFR Part 439). !
2.3 Major Components of the Rule
The MACT regulations for the pharmaceutical
industry contain eleven major sections. In
addition to these standards, portions of Subpart
A of Part 63 - National Emission Standards for
Hazardous Air Pollutants for Source
Categories- apply to the pharmaceutical
manufacturing industry. The applicable
Subpart A provisions are listed in Table 1 to
Subpart GGG hi the rule. i
i
The complete text of the rule, including
appended.Tables, is available via Internet from:
http://www.eBa.gov/fedrgstr/EPA-
AIR/199S/September/Day-2 l/a23168a.htm
and
and
http://www.epa.gov/fedrgstr/EPA-
A!R/2000/August/Pav-29/a21195.htm
llJte;/teww.€pa,gov/fedrgstr/EPA-
AtR/2@e!/August/Pay-02/aI8879.htm
All three documents together comprise the
complete text. Alternatively, an updated
version of the Code of Federal Regulations is
maintained through the Government Printing
Office's website:
jtttp;//www.access.gpo.gov/nara/cfr/cfrhtmi OO/
Title 40/40efr63b OO.htmi
A summary of Table 1 is provided below.
Refer to the full text of Table 1 hi the
regulations for more details.
SnbpartA
.' *- < ,'• - ' :'*' •*.' -.. • ' --- •_ V£ .
Provisions ;
63.1 -Applicability
63.2 -Definitions
633 -Units and
Abbreviations
63.4-J>Tobffi&&
Activities
! Relevance to GGG
-•--.-,...-..-'.. - - - - - •; -J
-.- . --••:- --•-. -"-' .-•! . • , '- - ' :.••••.-'-•
Confirms the general applicability of Part 63, but notes that where there are
overlaps, subpart: GGG takes precedence. Subpart GGG clarifies compliance dates
specific to pharmaceutical operations. Confirms that, as a "major affected source,"
pharmaceutical manufacturing operations are subject to Title V permit
All definitions apply; additional ones are provided in Subpart GGG. Where there
are overlaps, Subpart GGG takes precedence.
All units and abbreviations apply; additional ones are provided in Subpart GGG.
i
All restrictions listed also apply to pharmaceutical manufacturing industry.
2-3
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Subpart A
Provisions
63.5 - Construction
and Reconstruction
63.6 - Compliance with
Standards and
Maintenance
Requirements
63.7 - Performance
Testing Requirements
63.8 -Monitoring
Requirements
63.9 -Notification
Requirements
63.10 - Recordkeeping
Requirements
63.11 - Control Device
Requirements for
Flares
63.12 - State Authority
and Delegations
63.13 - Addresses of
State Air Agencies and
EPA Regions
63.14 - Incorporation
by Reference
Relevance to (5GG
1 -r ' . ' ' ' . - • V V
:-.- .-.•'. • ...,-.,*•,. • • . - - ; • •• ,;, :
Applies to pharmaceutical manufacturing operations. The terms "source" and
"stationary source" are replaced with "affected source."
Most applies to pharmaceutical manufacturing operations; Subpart GGG specifies
compliance dates for new and existing sources. Opacity and visible emission
standards are not applicable. Subpart GGG provides instructions for compliance
extensions.
Applies to pharmaceutical manufacturing operations. Subpart GGG specifies
required testing and compliance procedures, as well as test methods specific to the
industry. Substitute 150 days instead of 180 days in § 63.7(a)(2). A test plan must
be submitted with the notification of performance test
Generally, monitoring requirements apply to pharmaceutical manufacturing
operations; specific CMS requirements are provided in Subpart GGG, however.
Provisions relating to continuous opacity monitoring systems (COMS) do not
apply. References to calibration procedures are in §63.1258;
General notifications requirements apply to pharmaceutical manufacturing
operations. Notification of performance test 60 days before planned test date is
applicable. Requirements relating to CMS and opacity or visible emissions
standards are not applicable. Initial notification and performance evaluation
requirements apply.
General recordkeeping requirements apply to pharmaceutical manufacturing
operations. Subpart GGG specifies requirements with regard to information and
data used in notifications and compliance reports. Requirements relating to CMS
and opacity or visible emissions standards are not applicable.
Applies to pharmaceutical manufacturing operations using flares to comply with
standards.
Applies to state authorities regulating air emissions from the pharmaceutical
industry.
Applies; no changes specific to pharmaceutical industry.
Applies; no changes specific to pharmaceutical industry.
2-4
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Subpart A
63.15 - Availability of
Information and
Relevance to GGG
- «f J ""
" ' i
Applies; no changes specific to pharmaceutical industry.
2.4 Standards
The new emission standards are expressed
differently for the various types of sources.
In some cases, such as with process vents,
one of the standards options is a percentage
reduction standard; this allows owners and
operators flexibility in achieving the
required level of control. In other cases,
such as with equipment leaks, it makes more
sense to specify work practice standards
because it would be difficult, if not
impossible, to regularly measure emissions
levels from the hundreds of pieces of \
equipment at a production facility or to i
require add-on control to reduce the
emissions.
The table below provides a summary of the
standards in the rule. The pollution
prevention option, available for existing
sources, is not presented in the table. It is
covered hi Chapter 10.
2-5
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TABLE 2-1. STANDARDS FOR NEW AND EXISTING SOURCES
Emission
Point
Process Vents *
\
Newer
Existing
?
New
Applicability '';
Applicability
Level
Process
producing an
isolated
intermediate
Cutoff
;>50 ppmv
HAP
Standard
* <• r ' ~
• 98% control or
20 ppmv TOC and 20
ppmv hydrogen halide
and halogen outlet limit
or
• maintain actual
emissions less than 900
kg/yr for sum of all vents
in a process not
controlled to these limits
(i.e., 98% or 20 ppmv)
• 20 ppmv TOC and 20
ppmv hydrogen halide
and halogen (alternative
standard)1
• 20 ppmv TOC and
controlling HO
emissions by at least 95%
with a post combustion
device scrubber
(variation of alternative
standard)
2-6
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Emission
Point :
•, •* - f~
^
v ' -s
-',
'
^
"-.
sKew0fc? ;
.Existing
-"' " .'
*" ' i
Existing
;=*, ";_ Applicability ,,
" *
Applicability
Xevel - -' »/
Process
producing an
isolated
intermediate
i
Large or high
emitting vent1
^ /
cutoff; ;
^ ~
>SO ppmv
HAP
- :-^-- ' Standard; - ^"">
• u. •*/>*,, ' 3
"^ " "^ _/
? * ^*! -STX
^ "-*„ /" ,^_
-------
Emission
Point
Storage Tanks *
New or
Existing
?
New and
existing
Applicability >
Applicability
Level
a; 38m3
(10,000 gal) <
75 m3
(20,000 gal)
;> 75m3 (20,000
gal)
Cutoff " ,
13.1 kPa (1.9
psia) HAP
vapor pressure
of liquid
stored
;> 13.1 kPa (1.9
psia) HAP
vapor pressure
of liquid
stored
"*: , - Standard ' , / *'
* °~ * "
- ''';1' '„ ?"< / "*s~'~
~ " -' .
• 90% control, or
• 20 ppmv TOC and 20
ppmv hydrogen halide
and halogen outlet limit,
or
• enclosed combustion
device w/ minimum res.
time of .5 sec at 760 °C,
or
• 20 ppmv TOC and 20
ppmv hydrogen halide
and halogen outlet
limit1*, or
* use vapor balancing
• 95% control3, or
• 20 ppmv TOC and 20
ppmv hydrogen halide
and halogen outlet limit,
or
• enclosed combustion
device w/ minimum res.
time of .5 sec at 760 °C,
or
• 20 ppmv TOC and 20
ppmv hydrogen halide
and halogen outlet
limit1*, or
• use vapor balancing
2-8
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Emission
P^oiint
- •
Wastewater
Treatment **
New or *
Existing "
?v '»*
3 «W
New and
existing
} " Applicability - x
Applicability
Level
XK25 Mg/yr
total HAP load
from all POD
from PMPU
1
>1 Mg/yr total
HAP load
from facility
1
%
Cutoff
>t300
ppmw at POD
of Table 2
HAP(PSHAP)
(annual
average
concentration)
>S,200
ppmw at POD
of total HAP
load
(annual
average
concentration)
>1 0,000 ppmw
at POD of
total HAP load
(annual
average
concentration)
-
„.„/ , '„*, Standard
„?«' , - ••"" . /"«
"&, £- *~ ~*
^ '; * ' *-•
-ft- i , j* ,
• 99% reduction of Table 2
HAP(PSHAP)
• or to <50 ppmw PSHAP
or treat in RCRA unit or
• 95% reduction of total
HAP using biotreatment
• 99% reduction of Table 2
HAP (PSHAP) or
• to < SO ppmw PSHAP
and
• 90% reduction of Table 3
HAP(SHAP)
• or < 520 ppmw S1SAP or
• enhanced biotreatment
(for SHAP only and only
if PSHAP < 50 ppmw) or
• 9S% reduction of total
HAP using biotreatment
or
RCRA unit
• 99% reduction of Table 2
HAP (PSHAP) or
• < 50 ppmw PSHAP and
• 90% reduction of Table 3
HAP (SHAP) or
• < 520 ppmw SHAP or
• enhanced biotreatment
(for SHAP only and only
if PSHAP < 50 ppmw) or
• 95% reduction of total
HAP using biotreatment
or
• RCRA unit
2-9
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r
Emission
Point
Equipment
Leaks
New or
Existing
New
New and
existing
- ^a^mty -'-,
Applicability
Level
>lMg/yr total
HAP load
from aD POD
fromPMPU
All
components in
HAP service
where total
HAP is ;»5%
by weight
Cutoff
>110,000
ppmw at POD
of Table 3
HAP(SHAP)
(annual
average
concentration)
z 300 hours/yr
HAP service
, 'Standard ' '""'""
A "• /-,;. ' ^ - .
f f 6
• 99% reduction of Table 3
HAP (SHAP) or
• treat in RCRA unit
LDAR program
Alternative Standard - Outlet limit is SO ppmv instead of 20 ppmv if noncombustion devices are
used.
Large Vent - at least 25 tpy uncontrolled HAP emissions from a single process and satisfying flow
specifications, note equations in the rule.
Refer to discussion of grandfathered vents in section 5.4.1 of this document.
For tanks controlled at 90 percent prior to April 2,1997, no additional control is required.
See Chapter 7 on wastewater for more details on vapor suppression and air pollution control
device requirements for wastewater and wastewater residuals.
Wastewater generated from scrubbers relied upon to control PSHAPs is considered "affected"
regardless of concentration.
Treatment options are limited if the facility chooses to "designate" wastewater streams (See
Chapter 7).
* In addition to the standards listed for process vents, storage tanks, and wastewater treatment, the
owner/operator may choose instead to use a flare, compliant boiler, process heater, or RCRA
hazardous waste incinerator.
Note: See pages 7-3 and 7-4 for the list of Partially Soluble Hazardous Air Pollutants
(PSHAPs) and page 7-4 for the list of Soluble Hazardous Air Pollutants (SHAPs).
1.
2.
3.
4.
5.
6.
7.
2-10
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Chapter 3
Applicability and Compliance Dates
3.1 Overview
The applicability section of the MACT
regulations defines what kinds of facilities
must comply with the regulations and
specifies the dates by which those facilities
must comply. It also contains provisions for
instances in which the MACT standards
overlap other regulatory programs. The
applicability provisions of the MACT rule
are based on a set of definitions, all of which
must be reviewed to determine if the
regulations apply at any particular facility.
The discussion below takes the reader
through a series of questions and relevant
definitions.
3.2 Applicability
Chapter 3 at a Glance
3.1 Overview
3.2 Applicability
3.3 Other Important Applicability
Definitions
3.4 Compliance Dates
3.5 Consistency with Other
Regulations
in §63.1251. Furthermore, it is important to
specifically identify the "affected source"
and/or "pharmaceutical manufacturing
process unit (PMPU)" because it is the basis
for decisions regarding "construction" and
"reconstruction," which in turn are the basis-
for determining whether a facility or
manufacturing unit is subject to standards
for existing or new sources. Because
standards for new sources can be more
stringent than those for existing sources,
proper identification of the affected source is
critical. The applicability regulations
provide three criteria that determine whether
a facility has pharmaceutical manufacturing
operations that are subject to subpart GGG:
• Does the facility manufacture a
pharmaceutical product?
• Is the site where the pharmaceutical
manufacturing operation is located
classified as a major source for HAP
emissions?
• Does the pharmaceutical
manufacturing operation use.
process, or produce HAPs?
The following flow-chart takes the reader
through the questions that must be asked to
ascertain applicability of the pharmaceutical
MACT standards to a specific site.
In general, facilities or activities covered by
a National Emissions Standard for
Hazardous Air Pollutants (NESHAP) are
called "affected sources", which is defined
in §63.2. The affected source regulated
under Subpart GGG is the pharmaceutical
manufacturing operations, which is defined
3-1
-------
/ Doesthefacility \
/ manufacture a "*•
; pharmaceutical
product or isolated y
intermediate?
tettiesite -^
where the \
;X pharmaceutical v
X" manufacturing \
\ operations (PMO) are /
- located classified as a.
The facility is not
subject to the
Pharmaceutical MACT
standards
Doesthe v
PMO use, process, ^
Is the PMO a
research and
denlopmsnt
facility
The facility Is subject to
the Pharmaceutical
MACT standards
Pharmaceutical Product =
(1) Anymaleria!describedbytteSICcode2833or2834,
(2) Any material whose manufacturing process is described
by North American industrial classification system
(NA1CS) code 325411 or 325412,
(3) A finished dosage form of a ding, for example, a
tablet, capsule, solution, etc.
(4) Any active ingredient or precujsor that is produced at
& facility whose primary manufacturing operations
are described by SICcode 2833 or 2834, or atafecility
whose primary operations are not described by SIC
code 2833 or 2834, any material whose primary use
is as an active ingredient or precursor,
The term does not include nonrcae live solvents, binders,
fillers, or excipients, but includes coroponents such as raw
starting materials or precursors that undergo chemical
coiaencUveingrediente,
uced in a chemical
t to the HON.
It does not include material
manufacturing unit that is s
Ma/or Source^
Any stationary source or group of aationarygofflces located
within a condguous area under common control that emits
or has the potential to emit considering controls, in the
aggregate) SOtpy or more of any hazardous air pollutant
or 25 tpy or more of any combination of hazardous air
pollutants. The AdministratOT may establish a lesser
quaatity or, in the case of radiowKlicIes, different criteria,
for a major source other than that specified ta the previous
sentence, on the basis of the potency of the air pollutant,
persistence, potential for hioaccrnauiation, other
Any Hazardous Air Pollutant listed in or pursuant to section
112(b) of the Clean Air Act
Research anil Development Facility ]
Any stationary source whose primary purpose is to conduct
research and development into new processes and products,
where such source is operated under close supervision of
technically trained personnel, and is not engaged in die
manufacture of products for commercial safe fa commerce,
except in a deminirnis manner.
Figure 3-1. Guidelines for Determining Subpart GOG Applicability
3-2
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Intermediates
One of the first questions to be askedin
making applicability determinations is
whether the material being produced is a
"pharmaceutical product." TheftiE^
definition of pharmaceutical product is
provided in the flowchart on the previous
page. It is important to note that the
definition of "pharmaceutical product"
includes materials that are not finaljproducts,
such as precursors or active ingredi|ri|s. This
means that pharmaceutical precursors, even
if they are not manufactured at the* same kite
as the final active ingredient, may'be
covered under the rule. •
•f s I
Exclusions I <
i ': i
The term •'pharmaceutical product'! does not
include non-reactive solvents, excipients,
binders, or fillers. An excipient isfa
substance, other than the active drug or
product, that is used in the drug delivery
system to 1) aid the processing of the drug
delivery system during manufacture, 2)
protect, support or enhance stability,
bioavailability, or patient acceptability, 3)
assist hi product identification, or 4) enhance
any other attribute of the overall safety and
effectiveness of the drug delivery system
during storage or use.
In addition, substances produced in a
chemical manufacturing process unit that is
already subject to regulation under 40 CFR
Part 63, Subparts F and G (SOCMT) are not
included hi the definition of pharmaceutical
product.
QandA-Example Applicability Scenarios
-A-
^
engaged in pharmaceutical production, receives a chemical compound /
from an off-site pharmaceutical manufacturer, performs a processing step
on the compound, and then "ships it back to the original manufacturer, is
the chemical specialty company producing a "pharmaceutical product,"
and potentially subject to the MACT standards? , , -
The definition of "pharmaceutical product "in the^MACT^regulations^ould
"- include the chemical compound in th^ example. tt& definition includes >
. active ingredients and precursors that^are processed at facilities outside oj ''"
the 2833 or 2834 SIC code. Such a material is considered a precursor if it
has no recognized non-drug commercial use; is used on site; or sold to a
^pharmaceutical manufacturer, for use in the manufacture of, another ^
pharmaceutical prbductj A precursor is considered a ''pharmaceutical
product/' Clearly, the intermediate in the example is considered a ^ / ,
3-3
-------
Q
A.
0
A
O.
A.
product. " Clearly, the chemical compound in the example is considered a
pharmaceutical product because it is sold back to the pharmaceutical
manufacturer. Therefore* the chemical specialty company is subject to the MACT
standards, provided it meets the other MACT applicability requirements (e.g, ff
major source for HAPs). It is the responsibility of the chemical specialty
company to determine the ultimate use of the chemical compound. For example,
the material would not be subject to regulation as a pharmaceutical product if its
production is subject to regulation under Subpart F and Gfor the Synthetic
Organic Chemicals Manufacturing Industry (HON). Since it has no non-drug
uses it cannot be a commodity chemical Chemicals listed in the "Industrial
Organic Chemical Use Trees" (Final Report, October 1983, USEPA) are
commodity chemicals not regulated under the pharmaceutical MACT. The
chemicals listed in Table 1 of Part 63, Subpart F (HON) are not subject to the
pharmaceutical MACT.
A facility (that is a major source but whose primary SIC code is not 2833 or
2834) makes a product (Product A) that is not pharmacologically active but
uses HAP. The Product A is then shipped off-site and reacted with other
materials to form a pharmacologically active compound. Product A is not
shipped to anyone else or used far any other reactions that the company is
aware of. Is the facility mating Product A covered under the pharmaceutical
MACT? • . '"•••••• •'..'.">--'•• ': ' '""?•:*•'-...: ;:"
Yes; the process would be covered because Product A is a precursor, -which is •**•'
defined as material that undergoes chemical change or processing before it
becomes an active ingredient. In this case because the chemical does not have
any known non-drug use, its primary use must be as a precursor; therefore it is a
pharmaceutical product. ,
In the making of a pharmaceutical intermediate, a reacti^^
blocking agent onto the molecule. Later in the synthesis of the pharmaceutical
product, this blocking agent is removed from the pharmaceutical molecule and
is discarded. Would the manufacture of the blocking agent be covered under
thisNESHAP?
No, because the blocking agent is not subsequently processed into a final drug
product. It does not become an active ingredient or other pharmaceutical product
covered by SIC 2833 or 2834. The blocking agent does not meet the definition of
pharmaceutical intermediate. f
If a HON unit produces HCl as a byproduct and further processes a portion of
this HCl into "pharmaceutical grade" HCl (the primary use of this HCl is for
pharmaceutical manufacturing)* is the process subject to the rule?
No, the HCL is still considered a commodity chemical
3-4
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Q, If atoll manufacturer (thai is a major source and thatuse
produces HAPs) manufactures a pharmaceutical product) what other sources at
, - the facility (e,g*t storage tanks, heat exchange systems, common .solvent ^
a .recovery* operations)\are c#vered,by the pharmaceuticalMACT standards?
T^ **,. * /1' - " j "* x ^ *""" ^ ^ v * j" 7,, -<"? <™
/4. „ "f&edefinition of '"pharmaceutical manufacturing operations" includes the "
^ \ facility-wide collection ofpharmazeufigaimanufdcfuring process units (PMPUs)
AN£> any other equipment (e^g.lheat,exchangers, mtstewater, and waste *
^management units) that arp located at a facility manufacturing pharmaceutical
products, All equipment u&ed in the manufacture of pharmaceutical products
, must comply with GGG. For storage tanks, this may imply issues^ ofpredominant
use. For other sources, issues relating to overlapping MACT standards may be '
involve^. * ,'''<,**'< '*'-- '~~^ '" *
Or, Are vitamins considered pharmaceutical products? 'f\, ^/''", "^
A. - k Yes, vitamins are,comidered pharmaceutical products because fhey are covered
by SfC code 2833.* Thus thflifmanufactt^e^is&ubjecno the Pharmaceutical
-. * Production MACT,. " •''^ ^ " '(-'' - , '- '- ^ - . ' -
Q, '<• Is the production of artificM sweetener covered by the standard?
'A. No; the'processt would notiie cdfaiKed,, because it,does not meet the definition of
pharmaceutical product, Specifically, it is not covered under, SIC codes 283,3,
2834, and the production is not covered under NAlCS,cpdes 325gll or 325412,
- Additionally, as a food additive that is not covered under SIC 2833'or 2834, it is
also not an active ingredient. Finally, it is not a precursor* ^ - , ' -:<_
~' t, •* «
Q. Are preparations manufactured for the treatment of animals classified as -^
"pharmaceutical products?" ,- , — , \
% ' -, ''Sr — 's ** ''"",, " " - '
A, Yes; animal biologies (materials used in the treatment of animals) are included in
the definition of active ingredients and.active ingredients are pharmaceutical •
product.'''""' . ' ' "'" x * 1 - . ' _*• <
- - " ' ' > '-'-
Q, Is the production of animal growth hormone covered by the standard?
A. Yes; "Hormones and derivatives" are covered by SIC code 2833 and the
^ "'* *- x _
corresponding NAICS code 3254H. -_ " ' - '. ,, ~,,, -,.,,, '-- ~/j
" : , ' ' *••„** '<• "~ */", _ • ' - '*-»
Q,> Are all drug ingredients consideredpharmaceutical'products? ; ,
A, A siibsiance that meets the definition of e^cipientis,not included in the
definition of pharmaceutical product Generally, excipients~are used to enhance
the drug delivery system, &nd include substances sueh.as buffers, flavorings,
- , coloring, and inert binding agents, '"•"-'— ' .
3-5
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^^^^^^^^^^^^^^^^——^^^(^^^^^^^((^^•(•••••••••••••••^•••••••^••••••••••^•'''^^^^^^^^^^
Q. Are pilot plants subject to the MACT standards? ;-
A A pilot plant could meet the definition of "research an&devdopment facility " if
its primary purpose is to conduct research and development into new processes
and products, and if it is not engaged in the manufacture of products for
commercial sale, except in a de minimis manner. However,4f the product being
made in anR + D program goes into commercial production, the commercial^ ,
process becomes subject to the MA CT. ' ^,
'',.-!
Q. Do the regulations apply during start-up and shutdown for batch operations?
A Both batch and continuous operations are subject to SSM requirements. The
regulations provide that emission limitations do hot apply 'during periods of start-
up shutdown, and malfunction if the owners operator follows the plan
developed pursuant to §63.1259(a)(3) {or documents and reports deviations from
the plan). The owner or operator is required' to follow, the reporting requirements
for periods of start-up, shutdown, or malfimction, as specified in §63J-26Q(i).
However, the definition of shutdown does mL apply to the routine cessation of .
batch operations at the end of a campaign, for routine maintenance, for rinsing or
washing equipment between batches, or other routine operations. Shutdown for
repairing equipment (if not routine) would count as periods of shutdown, The .
term start-up applies only to the first time a new or reconstructed source begins
production, the first time new equipment is used, or 'the first time anew ,' /
product/process is run in equipment. Therefore, the emission limitations;^' apply,
to start-up and shutdown far batch operations^between batches and betH>een,most,
product campaigns, except when non-routine maintenance or.repair is necessary.
Q. If a pharmaceutical manufacturing process unit (PMPV) at a facility subject to
the MACT standards does not process, use, or produce ffAPs or uses tfAPs
only in de minimis quantities, is the PMPV subject to the MACT standards?
A. No, the applicability provisions specify that the regulations* apply only to,
pharmaceutical manufacturing operations that process, use, or produce HAPs.
Within the regulated PMO, a process, or a^PMPU, that does not process, use, or
produce HAP is not subject to the emission standards. Sections 63. 12600(1) and
(f)(2) indicate that the NOC report must include the results of any applicability
determinations and supporting calculations, There is ho'definition inihe
regulations for "de minimis. " The definitions of process vent, storage tank, and
wastewater stream clarify EPA 's intent ^exclude parts of a plant that do not emit
" ~
The definition of process vent provides that if uncontrolled, undiluted
emissions are less than 50 ppmlUP, the vent to not considered a
regulated process vent;
The definition of storage tank providesAhat a tank that contains HAPa
only as impurities is not considered a regulated storage tank;
3-6
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ofwastewater stream includes only those wastestreams with
an^erq^^ccmeentration of partially soluble and/or soluble HAPs of at
leas£5 ppmw and a load of at least 0.05 kg/yn
3.3 Other Important Applicability
Definitions
Other defined tenns in the regulations need
to be understood for purposes of
applicability determinations. Many of these
terms can be viewed as a set of nested
definitions. The discussion below follows
the definitions from "the top down."
Once a facility owner or operator has
determined that the facility meets the basic
applicability criteria as outlined in 3.2
above, it is important to determine
specifically what the "affected source" is.
As mentioned above, the affected source
regulated under Subpart GGG is the
pharmaceutical manufacturing operation.
Pharmaceutical Manufacturing
Operation
A pharmaceutical manufacturing
operation is defined as the facility-wide
collection of pharmaceutical
manufacturing process units (PMPUs)
AND any other equipment such as heat
exchanger systems or cooling towers,
wastewater and WMU's, that are not ;
associated with an individual PMPU, but
that are located at a facility for the purpose
of manufacturing pharmaceutical products
and are under common control.
PMPU
A pharmaceutical manufacturing process
unit (PMPU) is the process, as defined in
the regulations, and any associated storage
tanks, equipment identified in §63.1252(f),
and components such as pumps,
compressors, agitators, pressure relief
devices, sampling connection systems, open-
ended valves or lines, valves, connectors,
and instrumentation systems that are used in
the manufacture of a pharmaceutical
product.
Process
It is important to define process, because the
process vent control standards are expressed
in terms of "the sum of all process vents
within a process." A process is defined
according to the pharmaceutical product or
isolated intermediate it yields. An "isolated
intermediate" is obtained as the product of a
process and stored before subsequent
processing. Storage occurs when the
intermediate is put in equipment used solely
for storage, such as drums, totes, day tanks,
and storage tanks. Storage of an isolated
intermediate marks the end of a process. The
concept of process is flexible, since different
pieces of equipment may be used for the
manufacture of different products. For
example, four pieces of equipment, A, B, C,
and D, may be configured differently
depending on the product being
manufactured that month:
• Process 1 uses units A + C + D to
yield product 1, manufactured during
January
• Process 2 uses units A + C + B to
yield product 2, manufactured during
February
The regulations do not require, for example,
that unit A meet a certain standard, but
3-7
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instead that emissions from Process 1 and
from Process 2 meet the regulatory standard.
The regulations contain a detailed definition
of process, much of which is provided here,
Process is defined in the regulations as "all
equipment which collectively functions to
produce a pharmaceutical product or isolated
intermediate." The definition then goes on
to add a number of other important
provisions:
• A process may consist of one or
more unit operations. A "process"
includes any, all, or a combination of
reaction, recovery, separation,
purification, or other activity,
operation, manufacture, or treatment
steps which are used to produce a
pharmaceutical product.
• Cleaning operations conducted are
considered part of the process.
• Nondedicated solvent recovery
operations in a contiguous area are
considered single processes that are
used to recover numerous materials
and/or products. For this use,
"nondedicated" means a recovery
operation that receives solvents from
more than one PMPU (i.e., it is not
dedicated to a single process). A
storage tank used to accumulate used
solvent from multiple batches of a
single process for purposes of
solvent recovery does not represent
the end of the process. (i.e., the used
solvent is not an isolated
intermediate)
• Nondedicated formulation operations
occurring within a contiguous area
are considered a single process that
is used to formulate numerous
materials and/or products. Per the
definition in 63.1251,
"nondedicated" hi this instance
means the equipment is not
dedicated to the manufacture of one
product only.
Quality Assurance and Quality
Control laboratories are not
considered part of any process.
Ancillary activities that are not used
hi the processing of raw materials or
in
the manufacture of a pharmaceutical
product are not covered in the
definition of "process." Ancillary
activities include boilers and
incinerators that are not being used
to comply with the MACT standards,
chillers, refrigeration systems, or
other pieces of equipment that
operate in a closed system such that
no process fluids are introduced.
IMPORTANT NOTE: As
mentioned in the beginning of
section 3.2, the decisions about
construction and reconstruction
(which affect decisions regarding "new" vs.
"existing" sources) are made at the "affected
facility" and/or at the PMPU level. Process
vent and wastewater emissions standards
must be met at the "process" or process vent
level.
3-8
-------
The definitions reviewed above are depicted in Figure 3-2.
mm
Figure 3-2, Applicability Terms
3-9
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Storage Tank Ownership
Given ttte variability of process
configurations in pharmaceutical
manufacturing plants, it is possible that
storage tanks are "shared" by different
PMPUs. If an owner or operator produces
only pharmaceutical products, then the
procedures for determining ownership are
only required for purposes of determining
applicability and demonstrating compliance
with the P2 option, or determining new
source applicability for a PMPU dedicated to
manufacturing a single product that has the
potential to emit 10 TPY of a single HAP or
25 TPY combined HAP.
If the owner/operator is not trying to
determine the applicability of new source
standards or is not using the P2 option, it is
not necessary to assign ownership for shared
storage tanks because the tanks will be
subject to the same standards regardless of
ownership.
The regulations at §63.1250(e) provide the
following instructions for assigning
ownership of tanks:
If a storage tnnfc is dedicated to a single PMPU, the
storage tank belongs to that PMPtJ.
If a storage tank is shared among processing unite
(including at least one PMPU), (he storage tank
belongs to the PMPU or other process unit (located
on the same plant site as the storage tank) that has
the predominant use of the storage tank (i.e., has the
greatest input to the tank or greatest output from the
lank, on an annual basis). Predominant use should
he identified in the initial Notification of Compliance
Status Kcport. Any changes in predominant use must
be included in the next Periodic Report (NOTE: If
the predominant use is to a non-rogulafed unit, the
tank can be assigned to that non-regulated unit)
Tank "belongs" to PMPU #1.
3-10
-------
If a predominant use cannot be determined for a storage
tank that is shared among process units (including at
least one PMPU), and one of the PMPUs that uses the
tank is subject to subpart GOG, the storage lank belongs
to that PMPU. .
Tank "belongs" to PMPU #1.
If the predominant use varies from year to
year, then ownership is determined
according to the predominant use in the year
before the rule was promulgated (i.e., the
year before September 21, 1998), for
existing sources. For new sources,
predominant use is based on the first year
after initial startup. For the first operating
year at a new source, the owner or operator
should base ownership decisions on the
anticipated use of storage tanks. Any
changes in predominant use from that
reported in the Notification of Compliance
Status must be reported in the next Periodic
Report.
i
New vs. Existing
Another important applicability concept
relates to the distinction between new and
existing sources. EPA has the statutory
authority to apply stricter standards to new
sources. Also, new and existing sources may
have different compliance deadlines, as
discussed more fully below. In the
pharmaceutical MACT regulations, the
process vent and certain wastewater
standards are more strict for new sources
than for existing. The designation of a
source as new vs. existing hinges on the date
of construction or reconstruction. In
summary, an affected source (PMO) for
which construction or reconstruction began
after April 2,1997 is considered a new
source. A PMPU that is dedicated to the
production of a single product AND that has
the potential to emit at least 10 tons per year
of any one HAP or 25 tons per year of
combined HAP AND for which construction
commenced after April 2,1997, is
considered a new source. When calculating
the potential to emit figure, include
emissions from the PMPU and wastewater
(after controls). Additionally, a
reconstructed, dedicated PMPU with the
potential to emit 10 tons single HAP / 25
tons combined HAP for which the fixed
capital cost of the new components exceeds
50 percent of the fixed capital costs of
constructing a comparable new source,
3-11
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would also be considered new if the
reconstruction commenced after October 21,
1999. (This date is tied to the settlement
discussions after original promulgation of
the rule on September 21,1998.)
Construction and Reconstruction
The definitions of construction and
reconstruction are from §63.2; they were
slightly revised in the MACT rule.
Construction means the on-site fabrication,
erection, or installation of an affected source
or PMPU. Reconstruction means the
replacement of components of an affected
stationary source or pharmaceutical
manufacturing process unit to such an extent
that: (1) The fixed capital cost of the new
component exceeds 50 percent of the fixed
capital cost that would
be required to construct a comparable new
source (PMPU or control device); and (2) It
is technologically and economically feasible
for the reconstructed source to meet
the relevant standards established by the
Administrator (or a State) pursuant to
section 112 of the Clean Air Act.
NOTE: The addition of new
equipment to an existing PMPU
does not constitute construction but
may constitute reconstruction if a
capital expenditure occurs. The term
"reconstruction" has another use besides that
of defining when new sources standards are
triggered. "Grandfathered" control devices
(those not required to meet the 98% control
standard for individual vents due to their
date of installation) ARE required to meet
the 98% when they are "reconstructed" or
replaced.
Q and A -New vs. Existing ; M
Q. If a facility with pharmaceutical operations with thepoieiitial to emit HAPs below the
threshold levels for a "major source" (Le., JO TPY uncontrolled single HAP/2STPV
total HAP), hut several new non-pharmaceutical processes are added at the site after
April 2, 1997 such that the sjte»ow is above the ?major source? threshold, couldm c
pharmaceutical manufacturing operation at the site be considered new? Assume that
none of the new processes have uncontrolled HAP emissions of 10 $PY single HAP/25
TPY total HAP, but that collectively they 'cause 'the jite to exceedihe "major source" .;••.
threshold. - ./.',, ,-' - . -_ /•. • -r.--.^ . ... <•'•'. c:- . ;-ii-. •
A. Upon becoming a major source, the pharmaceutical manufacturing ^peration is subject *
to the MACT standards, and must be in compliance with the standards for existing ,
sources within three years. ThePMPUs cannot be considered new because the standard
was not applicable at the time of construction or reconstruction (because^PMPfJs
were not major sources). Even if the new processes were pharmaceutical, they still
would be subject to the existing source standards, because none o/thewewpfacesse&
individually exceed the 10 TPY/25 TPY thresho
if an existing area source adds anew, major-emitting Dedicated PMPU (or a new area
source later adds a new, major-emitting dedicated PMPU), that new PMPUmust eptnpfy
with the new source standards upon start-up. The existing^rtion of tile source^ould
be subject to the existing source standards andwouldfhave three years to comply. -;•
3-12
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Q. If an existing facility adds anew piece of equipment, could it be considered a PMPU,
and subject to the standards for new sources?
A, While it is unlikely that a single piece of equipment would constitute a PMPU, since the
term PMPU applies to the "process and any associated tanks, equipment identified '
under §63.12520,,..," it is possible for a single piece of equipment to be subject to new
source standards. If the new piece ofequipment will have potential emissions greater
than 10 TPY single HAP/25 TPY total HAP, and it is dedicated to the manufacture of a
single product, then the new source standards would apply.
Qf If a facility adds a non-dedicated major-emitting PMPU to a plant site, but at a later
date changes it to a. dedicated PMPU, does that PMPU become subject to the new
source standards? • > -' -
A. If the unit was bu&tbefore ApHl 2,1997, it could never be classified as "new,"
- regardless ofwhether^or not it. is a dedicated unit. 'Even if the unit was built after April
2,1997, changing to a dedicated process would not trigger the new source standards.
Q. If a new area source (constructed or reconstructed after April 2,1997) becomes a
major source, does this trigger new source standards?
A. No; as with existing area sources that become major sources, a new area source that
becomes a major source has three years to come into compliance with the existing
source standards. New, major-emitting dedicated1 PMPUs would be subject to new -
source standards (see the However discussion in the answer above).
Q. If a dedicated PMPU added to an existing source after April 2,1997 is subject to the
new source standards at the time of construction, but later changes to a non-dedicated
operation, is the PMPU still required to meet the 98% control efficiency requirement?
A. The part of the PMPU that still that still produces the original product that made the
PMPU "dedicated" would remain subject to the new source standards (i.e., 98% control
efficiency). Non-dedicated PMPUs created from components of the original PMPU that
are scavenged or reconfigured would be subject to the standardsfof existing sources. If
the facility reverts back to the original process (whether dedicated or not) that triggered
New Source MACT(NSM), NSM would again be applicable for that process.
3.4 Compliance Dates ,
The dates by which sources must comply
with the pharmaceutical MACT standards
are shown below.
3-13
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e of Affected Source
existing affected source
(63.1250(f)(l))
new or reconstructed source
(63.1250(f)(2)) (see below for
exceptions)
new or reconstructed source that
commenced
construction/reconstruction between
April 2,1997 and September 1,1998
(63.1250(f)(3))
new or reconstructed source that
commenced
construction/reconstruction between
September 21,1998 and April 10,
2000
(63.1250(f)(4))
new or reconstructed source that
commenced
construction/reconstruction between
April 10,2000 and August 29,2000
(63.1250(f)(5))
Compliance Pate
•- '> i.ii.-LJ! LL'.iL-LL-LiL.JiiiJa'
' •"•"^••^^^'•'••g^-LL-
October 21,2002*
August 29,2000, or the date of start-up, whichever is
later.
September 21,2001, if
1) requirements in final amendment are more
stringent than those in effect before August 29,2000
and codified in the July 1,2000 CFR and
2) owner/operator complies with requirements
published on April 2,1997 from the later of start-up
or September 21,1998, until September 21,2001
October 21,2002, if
1) requirements in final amendment are more
stringent than those in effect before August 29,2000
and
2) owner/operator complies with requirements in
effect prior to August 29,2000 from start-up until
October 21,2002
August 29,2001, if
1) requirements are more stringent than those
published on April 10,2000, and
2) owner/operator complies with requirements hi
effect prior to August 29, 2000 between start-up and
August 29.2000.
* A 1-year extension may be granted under some circumstances. A request for an extension must be submitted no
later than 120 days before the compliance date, unless the need for the compliance extension arose after that date.
3.5 Consistency with Other
Regulations
There are a number of instances in which the
new pharmaceutical MACT regulations may
overlap other existing regulations. The
regulations contain provisions relating to
these areas of overlap. The following table
describes what to do in these instances.
3-14
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If pharmaceutical
MACT regulations
- overlap...
Solution is to......
Another subpart of Part 63
After the compliance date, choose the subpart under which you will
maintain records and submit reports to the extent the subparts are
consistent. Identify the chosen subpart in the Notification of
Compliance Report.
Control device monitoring,
recordkeeping, and
reporting requirements in
RCRA subparts AA, BB, or
CC (parts 264 and/or 265)
(63.1250(h)(2)(i))
Choose to con)ply with monitoring, recordkeeping, and reporting
under RCRA OR subpart GGG. If choose to comply with RCRA
provisions, must report all information required in 63.1260 (g)
periodic reports and (i) reports of start-up, shutdown, and
malfunction. Identify in the Notification of Compliance Status report
which monitoring, recordkeeping, and reporting authority will be
followed.
Equipment recordkeeping
and reporting requirements
in RCRA subpart BB (parts
264 and/or 265)
(63.1250(h)(2)(ii))
Choose to comply with the recordkeeping and reporting requirements
under RCRA subpart BB OR Subpart GGG, to the extent that they
overlap. Identify in the Notification of Compliance Status report if
the RCRA requirements will be followed.
NSPS subpart Kb
requirements for storage
tanks with floating roofs
(63.1250(h)(3))
Floating roofs can continue to comply with Kb - this constitutes
compliance with Subpart GGG. Storage tanks with fixed roof, closed
vent system, |and control device subject to 40 CFR 60.112 (b) must
comply wim monitoring, recordkeeping, and reporting under GGG.
Identify tanks fin Notification of Compliance Status report that are
subject to Kb.
Subpart I
(63.1250(h)(4))
Choose whether to comply with Subpart H OR Subpart GGG.
Identify chosen subpart in Notification of Compliance Status report.
NOTE: only components subject to both Subpart I and GGG have the
option to be regulated under GGG.
Other Part 63 requirements
for offsite reloading or
cleaning for storage tanks
using vapor balancing
Choose whether to comply with emissions standards and associated
initial compliance, monitoring, recordkeeping, and reporting
provisions of any other subpart of Part 63 OR with 63.1253(f)(7)(ii)
or (iii). Identify in the Notification of Compliance Status Report
which subpart of part 63 will be followed.
lequirements in 40 CFR
'arts 260-272 (RCRA) for
wastewater
63.1250(h)(5)
Owner/operatoir may determine whether GGG of 40 CFR 260-272 is
more stringent. Compliance with the more stringent components in 40
CFR 260-272 constitutes compliance with GGG. In the Notification
of Compliance Status Report, identify the more stringent provisions of
40 CFR Parts 260-272 that will be followed and explain how
stringency determinations were made. If owner/operator chooses not
to make stringency determinations, must comply with both 40 CFR
Parts 260-272 and GGG.
3-15
-------
If pharmaceutical
MACT regulations
overlap...
Solution is to......
Subpart PPP requirements in
the polyether polyols
NESHAP
(63.1250(h)(6))
Can choose to control all process vents according to PPP rules at
63.1425(b), (c)(l), (c)(3), (d), and/or (f) (the most stringent standards
in PPP) OR identify the process vents subject to the percent reduction
standards in 63.1254 and then controlling those according to the most
stringent PPP standards as listed above. For those PMPUs,
owner/operator must comply with rest of PPP rules (e.g., for storage
tanks, wastewater, and equipment leaks). Identify in the Notification
of Compliance Status report which PMPUs will be controlled under
standards in PPP; include calculations used to identify which process
vents are subject to percent reduction standards in 63.1254. _.
3-16
-------
Chapter 4
Requirements for Storage Tanks
4.1 Overview
The pharmaceutical MACT standards
provide several options for standards for
HAP emissions from certain storage tanks
(raw material tanks and certain tanks storing
materials destined for recovery) that exceed
a specific size and vapor pressure cut-off,
The standards options are expressed as
either percent reduction, TOC limit at the
control device outlet, technology installation
(floating roof), or vapor balancing.
Alternatively, owners may elect to take
advantage of a pollution prevention option
that aims to reduce emissions by reducing
the amount of HAP-containing materials
used at the facility rather than installing end-
of-pipe emissions controls. In some '
instances, owners can use emissions
averaging to achieve emissions reductions.
Existing sources must comply with the
standards by October 21,2002; hi general,
new sources must be in compliance
immediately upon start-up, or by August 29,
2000, whichever is later. For some new
sources, or reconstructed sources, the exact
compliance date may depend on when ;
construction or reconstruction commences,
if there are stringency differences between
the final amendments and/or the draft
amendments or the final rule. Please refer to
the chart on page 3-14.
The initial compliance demonstration for
tanks is done through a performance test or a
design evaluation of those complying with
the percent reduction or TOC limit. For ;
those complying with the floating roof ;
option, the initial compliance demonstration
is done through visual inspections of the
Chapter 4 -Table of Contents
4.1 Overview
4.2 Structure of the Regulation
4.3 Applicability
4.4 Standards
4.5 Emissions Averaging *
4.6 Initial'Compliance
Demonstration
4.7 Monitoring On-Going
Compliance
roof. Thereafter, owners will confirm
continued compliance through monitoring,
recordkeeping, inspection and reporting
activities.
4.2 Structure of the Regulation
Major components of the regulations are
illustrated in the flow diagram 4-1.
Regulatory citations are provided within the
flow diagram. The standards for storage
tanks are given in the regulations at
§63.1253. The compliance procedures for
demonstrating initial compliance are at
§63.1257(c). Monitoring requirements are
in §63.1258. Recordkeeping and reporting
requirements are found at §63.1259 and
§63.1260, respectively. Readers are referred
to •» Chapter 13 - Reporting for
information on what must be included in a
facility's Initial Notification, Precompliance
4-1
-------
Report, Notification of Compliance Status
Report, and Periodic Reports.
How Do I Know if My Tanks are
Subject to Regulation?
4.3 Applicability
Four criteria define the storage tanks subject
to substantive provisions of the MACT
standards:
• Storage tanks or vessels that store
organic HAP-containing materials
(raw material feedstocks or used
solvent for the purpose of solvent
recovery), AND
• Have storage capacity of at least
38m3 (approximately 10,000
gallons), AND
• Store materials with a total HAP
maximum true vapor pressure greater
than or equal to 13.1 kPa (1.9 psia),
AND
• The storage tank is part of a PMPU
subject to the MACT. (Fora
discussion of assigning "ownership"
to tanks, refer to pages 3-10 of this
document and/or §63.1250(e).
A number of tanks and storage vessels are
NOT considered storage tanks:
• Vessels permanently attached to
motor vehicles such as trucks,
railcars, barges, or ships
• Pressure vessels designed to operate
at pressures greater than 204.9 kPa
(30 psia), and without emissions to
the atmosphere
• Vessels storing organic liquids that
contain HAP only as impurities
Wastewater storage tanks
Process tanks, which are defined as
tanks that are used to collect material
discharged from a feedstock storage
tank or unit operation and transfer
this material to another unit
operation within the process or a
product storage tank. Surge control
vessels and bottoms receivers that fit
these conditions are considered
process tanks. Process tanks include
product tanks and isolated
intermediate tanks.
IMPORTANT NOTE: Product
and isolated intermediate tanks are
process tanks and are part of the
PMPU that produced the stored
materials. Vents from these product tanks
are therefore considered process vents.
IMPORTANT NOTE: Storage
•^P^ tanks at pharmaceutical
•^ manufacturing operations that do
not meet the four criteria above are still
subject to minor recordkeeping and
reporting requirements. All applicability
determinations must be reported in the
Initial Notification of Compliance status
report, per §63.1260(f)(l).
4-2
-------
NotKibj«dtotink«
reconftMping ind
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Yos
.,
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i it 0.5 sec
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>-Uciifl»r«.or
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MSforfiPCOs
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f \ -t*i£ ^ ^^^^?" ™S_, £™3t *v » "*»P«
, ControlHAPtto . Equip w«h CVS am) ;, Uwivipof
~" •-•"•"- ;-,lte«onnbuiftm * luhncing
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»760°C
;-U5ofliro, or
S-Usuproeass
•
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j RCRAfncIa«t«or
1
cwitiblilavicofo
^achieve 50 ppmv
;TOC«nd50pjimv
'As an option for the alternative standard, owner/operator may control post-combustion device HC1 emissions by
95% in lieu of achieving 20 ppmv hydrogen halide and halogen emissions.
Figure 4-1. Subpart GGG Storage Tanks, Applicability and Standards
4-3
-------
QandA
Q-
A.
A.
Q-
A.
Q.
A.
Is there an emissions cut-off, under which the standards for tanks do not apply?
No; the standards apply regardless of the emissions level. There is no emissions-
based applicability cut-off*
Are so-called "day tanks," which are used to store HAP-cantaining liquids
temporarily, considered "storage tanks,»and therefore subject to theMACT
regulations?
Day tanks are considered part of the PMPU with which theyiare associated. Bay
tanks meet the definition of process tank- a tank thatis used to collect material
discharged from a feedstock storage tank or unit op
material to another unit operation oraproductstoragetank. Ms such, emissions
from day tanks that meet the definition of process tanks wffl be subjeciio process
vent regulations rather than the storage tanks requirements,
Are tanks that are used to store recovered solvents regulated as storage tanks
under the MACT standards?
It depends on the process:
- If recovered solvent is accumulated from multiple batches, the tank is considered
a storage tank.
-The tank receives recovered material from one or more unit operations in the
same process or batch (e.g., a distillation overhead receiver) and sends it to one or
more unit operations (e.g., a reactor within the same process or batch), the tank is
a step in the process, and therefore considered a process tank rather than a
storage tank.
If a tank holds a mixture of HAP-containing materials, how is the vapor
pressure calculated?
The regulations define "maximum true vapor pressure" as the equilibrium partial
pressure exerted by the total organic HAP in the liquid 1) at the temperatum equal
to the highest calendar-month average of the storage or transfer temperature, for
liquids stored or transferred abovelorbelow ike ambient^temperature or 2) at the
local maximum monthly average temperature as reported by the National Weather
Service, for liquids stored or transferred at the ambient temperature. The
definition also refers to methods to be used in calculating vapor pressure: API
publication 2517 (Evaporative Loss From ExterwlFloating-&a4f Tanks -
incorporated by reference at 6$J4);siandavA reference texts;
D2879-97 (incorporated by reference at
the Administrator, •
4-4
-------
What are the Regulatory Standards
for My Tanks? __^____
4.4 Standards
The regulations specify standards options
according to the size of the tank. Many, but
not all, of the standards options are the same
for "small" and "large" tanks.
In the table below, the differences in
standards for small versus large tanks are
shown in bolded print. Please note that
there is no distinction between new and
existing tanks with regard to standards,
except that new tanks cannot use P2 or
emissions averaging and existing tanks
may qualify for grandfathered control
levels.
Vapor Pressure > 13.1I#a (Iff psia)
(10,000 gal) (20,000 gal)
f"large tanks"
tanks.TSjtt*.
(2(M)008al)
STANDARDS OPTIONS:
1. Fixed roof with internal floating roof
2. External floating roof
3. External floating roof converted to internal
floating roof
4. Closed vent system with device that reduces
inlet emissions of total HAP by 90% or
achieves 20 ppmv TOC and 20 ppmv halogen
outlet limit
5. Closed vent system with enclosed combustion
device that has minimum residence time of
0.5 seconds at 760 °C
6. Closed vent system with flare that meets: the
requirements of §63.11 (b)
7. Closed vent system vented to a boiler, process
heater, or incinerator, as described in
§63.1257(a)(4)
Alternative Standard - Combustion control
device that achieves outlet concentration of
20 ppmv or less TOC (as calibrated on
methane or the predominant HAP) and 20
ppmv or less hydrogen halides and halogens.1
(If emissions are routed to a noncombustion
control device, outlet TOC concentration of
50 ppmv must be achieved, and 50 ppmv
hydrogen halides/halogens.)
9. Vapor balancing, pollution prevention, and
emissions averaging options - see below
STANDARDS OPTIONS:
1. Fixed roof with internal floating roof
2. External floating roof
3. External floating roof converted to internal
floating roof
4. Closed vent system with device that reduces
inlet emissions of total HAP by 95% * or
achieves 20 ppmv TOC and 20 ppmv
halogen outlet limit
5. Closed vent system with enclosed
combustion device that has minimum
residence time of 0.5 seconds at 760 °C
6. Closed vent system with flare that meets the
requirements of §63.1 l(b)
7. Closed vent system vented to a boiler,
process heater, or incinerator, as described in
§63.1257(a)(4)
8. Alternative Standard - Combustion control
device that achieves outlet concentration of
20 ppmv or less TOC (as calibrated on
methane or the predominant HAP) and 20
ppmv or less hydrogen halides and
halogens.1 (If emissions are routed to a
noncombustion control device, outlet TOC
concentration of 50 ppmv must be achieved,
and 50 ppmv hydrogen halides/halogens.)
9. Vapor balancing, pollution prevention, and
emissions averaging options - see below
* If a tank already is equipped before April 2,1997, with a device that is designed to reduce emissions by 90-95%,
the owner/operator is required to achieve 90% reduction (i.e., not required to achieve the additional 5% increment).
1. As an option for the alternative standard, the owner/operator may control post combustion device HC1 emissions
by 95% in lieu of achieving 20 ppmv hydrogen halide and halogen emissions.
4-5
-------
The standards do not apply during periods of
planned routine maintenance of the control
devices. These periods of planned routine
maintenance cannot exceed 240 hours per
year.
It may be possible to have a facility that
chooses to use several standards options
concurrently. For example, an owner or
operator may choose to use the 20 ppm TOC
standard for a group of tanks whose
emissions are routed to a central control
device, but use the 90% reduction standard
for other tanks not vented to the central
control device. These decisions regarding
control options will depend on the
configuration of processes and tanks at the
facility.
Vapor Balancing Option
The final rule contains a vapor balancing
option for new and existing sources. The
vapor balancing system must meet several
criteria:
• The system must be designed and
operated to route vapors from the
tank to the railcar or tank truck from
which the storage tank is filled.
• The tank cars and railcars must have
a current DOT pressure test
certification (49 CFR Part 180 for
tank trucks; 49 CFR 173.31 for
railcars).
• Unloading can occur only when the
railcar's/tank truck's vapor collection
system is connected to the tank's
vapor collection system.
• Pressure relief devices on the tank
truck, railcar, or storage tank should
not open during loading or as a result
of diurnal temperature changes (i.e.,
there should be no breathing losses).
• The pressure relief devices on
storage tanks must be set to no less
than 2.5 psig at all times to prevent
breathing losses.
• During cleaning or reloading,
railcars/tank trucks must either:
(1) be connected to a closed vent
system with a control device that
reduces inlet emissions of HAP by
90 % weight or greater, or
(2) have a system that routes the
displaced vapors from reloading
back to the tank from which the
liquid being transferred originated.
The owner/operator of the facility
where the railcar/tank truck is
reloaded or cleaned must submit a
certification to the storage tank
owner, certifying that the system will
meet (1) or (2). The certifying
facility may however revoke
certification by sending a written
statement to the tank owner, giving
him/her 90 days notice that the
facility will no longer accept
responsibility for complying with (1)
or (2).
What is the Pollution Prevention
Option?
In lieu of the tank standards discussed
above, an owner or operator (O/O) with
existing storage tanks can choose to meet
pollution prevention (P2) standards for the
PMPU. The P2 requirements are either:
• reduce the production-indexed HAP
consumption factor (Ib HAP
consumed/lb of product produced) by
75% from a specified baseline
average established no earlier than
1987, or
• reduce the production-indexed HAP
consumption factor by 50% from a
specified baseline average
established no earlier than 1987
AND reduce total PMPU HAP
emissions divided by the annual
production rate (Ib HAP emitted per
4-6
-------
year/lb produced per year) to a value
greater than 25% of the baseline
production-indexed consumption!
factor (i.e., achieve 50% reduction by
using pollution prevention and
achieve additional 25% by using
add-on control devices). For more
information on the pollution
prevention option, see •* Chapter
10 - Pollution Prevention
Alternative.
4.5 Emissions Averaging
The MACT rule includes provisions for
emissions averaging for tanks. In some <
cases, it may be advisable for an owner to
use emissions averaging when attempting to
demonstrate compliance with the emission
reduction standards. There are some
restrictions: '
• Some states may not allow emissions
averaging, ;
• Only existing tanks may be included
in an averaging group, \
Large tanks (greater than 20,000 gal
capacity) that are already achieving a
90-95% reduction prior to 4/2/97
cannot be included (i.e. tanks
complying with 1253(c)(l)(ii)),
• Storage tanks permanently taken out
of HAP service cannot be included,
• Tanks already controlled on or I
before 11/15/90 cannot be included
unless the level of control is ;
increased after 11/15/90,
• Tanks already subject to control <
because of another State or Federal
rule cannot be included, unless the j
level of control is increased above i
what is required by the other State or
Federal rule, and ,
• No more than 20 tanks can be
included in an averaging group. '
I
Owners or operators interested in finding out
more about using emissions averaging
should refer to •» Chapter 11 - Emissions
Averaging for Process Vents and Storage
Tanks.
How do I Demonstrate Initial
Compliance with the Regulatory
Standard?
4.6 Initial Compliance Demonstration
Documentation proving initial compliance is
required. The exact nature of the
demonstration depends on the standard
chosen by the owner or operator - percent
reduction, add-on device achieving 20 ppm
TOC (or 50 ppm if noncombustion device),
other specific control device, floating roof,
or vapor balancing. The initial compliance
demonstrations are very important in that the
operating parameters that are established
during the compliance demonstration will be
monitored later to confirm on-going
compliance, if complying with the percent
reduction or outlet concentration standard.
The table shown on the next page describes
the general compliance demonstration
procedures according to the standard the
owner/operator is trying to achieve.
The reader is referred to -* Chapter 8 -
Compliance Demonstrations and Testing
Procedures, for detailed instructions on
conducting initial compliance
demonstrations using design evaluations,
performance testing, or TOC measurements
(for alternative standard).
4-7
-------
INITIAL COMPLIANCE DEMONSTRATION*
Ifthe re
-e" '--• - - - "^^
Floating roof
latorv standard nsedjs.....
Percent reduction (either 90% or 95%)
To demonstrate initial compliance, must..
conduct compliance demonstration according to
EK)N regulations (see section on Floating Roof
Demonstration)
either do a design evaluation or conduct
performance testing of control device
Outlet concentration limit (20 ppmv TOC)
conduct performance test
Flares
meet standards of 63.11(b)
Closed vent system with combustion device (0.5
seconds residence time at 760 °C)
prepare design evaluation that documents
residence time and temperature
Process heater or boiler as described in
63.1257(a)(4)
exempt from compliance demonstration
20 ppmv TOC or 50 ppmv TOC if noncombustion
(alternative standard)
conduct CEM monitoring** that demonstrates
outlet TOC is 20 ppmv or less, and outlet
hydrogen halide and halogen concentration is 20
ppmv or less, or 50 ppmv if noncombustion
device
Vapor balancing
the owner/operator of the reloading/cleaning
facility must either do a design evaluation or
conduct performance testing on the control
device to show that it achieves 90% reduction, if
an add-on control device is being used.
Certification from railcar or tank truck owner
that they will comply with applicable standards.
Send certification to facility and Administrator.
Design evaluation or performance testing is not
required if the reloadmg/cleaning facility also
. does vapor balancing at their facility.
*A separate compliance demonstration for tanks is not necessary if the tanks' emissions are routed to a
control device being used for process vents, and a compliance demonstration will be done in accordance
"GEM mmUoring^s'not dwys required for hydrogen halide and halogen (see 63.1258(bX5)(i)(c) and
(d).
4-8
-------
If I Choose to Meet the Standard by
Installing a Floating Roof, What
Must I do to Demonstrate
Compliance?
Floating Roof Demonstration
The floating roof demonstration required
under the pharmaceutical MACT rule is the
same as
that required under the HON regulations at
63.119(b)-(d) (engineering specifications)
and 63.120 (monitoring
provisions).
Some practical wording changes in the
referenced HON regulations are necessary:
Terminology in HON
"storage vessel"
"December 3 1,1992"
"April 22, 1994"
"compliance date specified in
§63.100"
"maximum true vapor pressure of
the total organic HAP's in the
stored liquid falls below the values
defining Group 1 storage vessels
specified in table 5 or table 6 or this
subpart"
What it meansin pharmvMACF ; ®
"storage tank" as used in §63.1250
"April 2, 1997"
"September 21, 1998"
"compliance date specified in §63.1251"
"maximum true vapor pressure of the total organic
HAP in the stored liquid falls below 13.1 kPa (1.9
psiai)"
Owners and operators who plan to use
floating roofs to comply with the emissions
standards should refer to •* guidance >
materials developed for the HON rule: HON
Inspection Tool - EPA-305-B-97-006,
September, 1997. In particular, see Control
Techniques Specific to Storage Vessels -
Floating Roof Vessels (Section 6.4.2),
Storage Vessel Control Requirements
(Section 7.3.3), and Storage Vessel Testing,
Monitoring, Recordkeeping, and Reporting
(Section 7.3.4).
What On-Going Monitoring is
Required (After the Initial
Compliance Demonstration) to
Confirm That My Tanks are Still in
Compliance With the Standards?
4.7 Monitoring On-Going Compliance
for Tanks Complying with the
Percent Reduction Standard
Owners or operators of affected sources are
required to regularly monitor the relevant
control devices used to achieve the
emissions control standards to confirm on-
going compliance with the standards.
4-9
-------
During the initial compliance demonstration,
owners or operators establish maximum or
minimum operating parameter(s).
Information from any performance testing,
calculations, or design evaluations is used to
establish the operating parameter(s). The
specific operating parameters which must be
monitored regularly will depend on the
control devices being used.
The reader is referred to -» Chapter 9 -
Monitoring for a detailed discussion of
establishing monitoring parameters and
conducting monitoring.
IMPORTANT NOTE:
Owners/operators of control devices
that coritrol less than 1 ton/yr HAP
emissions, before control, are not
required to conduct monitoring other than to
verify daily that the device is working
properly. If the control device is used to
control batch processes as well as tank
emissions, the verification may be on a per
batch basis. The owner/operator must
determine how the verification process is to
be conducted. The steps that the owner or
operator will follow in conducting these
demonstrations must be described in the
Precompliance Report to be submitted 6
months prior to the compliance date.
4-10
-------
Chapter 5
Requirements for Process Vents
5.1 Overview
The pharmaceutical MACT specifies air
emissions standards 1) across all process
vents within a process and 2) for large, ;
individual process vents that meet a certain
flowrate threshold. The emissions standards
for process vents at new sources are more
stringent than those for existing sources, as
allowed under the provisions of the Clean
Air Act. As with the standards for
wastewater and storage tanks, there are <
several options with regard to the type of ;
standard and the compliance demonstrations
that are used to prove initial compliance
with the regulations. One option specifies a
HAP mass emission limit that applies to the
sum of all vents within a process.
Additionally, sources can comply through a
percent reduction in HAP emissions (93%
for existing and 98% for new sources) or i
through the alternative standard, where
compliance is demonstrated at the control
device level through the use of a CEM. The
regulations also provide a pollution i
prevention option that allows . ' i
owners/operators of existing sources to : !
incorporate pollution prevention initiatives!
instead of traditional end-of-pipe controls, j
After initial compliance with the standards jis
demonstrated, the owner/operator conducts
periodic monitoring and reporting to confirm
on-going compliance. Owners/operators are
allowed to use emissions averaging for some
processes. !
: j
5.2 Structure of the Regulation
Process vent standards are given in §63.1254
and compliance demonstration procedures in
5.1
5.2
5.3
5.4
5.5
5.6
5.7
Chapter 5 at a Glance
?
Overview
Structure of the Regulation
Standards
Initial Compliance Demonstration
Procedures
Emissions Averaging
Monitoring On-Going
Compliance
§63.1257(d). Monitoring, recordkeeping
and reporting are in §63.1258, §63.1259,
and §63.1260, respectively.
5.3 Applicability
A process vent is defined in the rule as:
• A vent from a unit operation or vents
from multiple unit operations within
a process that are manifolded
together into a common header
through which a HAP-containing gas
stream is, or has the potential to be
released to the atmosphere.
Examples for process vents include, but are
not limited to, vents on:
5-1
-------
condensers used for product
recovery,
bottom receivers,
surge control vessels,
reactors,
filters,
centrifuges, and
process tanks.
The following are NOT considered regulated
process vents:
• Emission streams that are undiluted
and uncontrolled containing less
than 50 ppmv HAP
• Vents from storage tanks regulated
under §63.1253
• Vents on wastewater emission
sources regulated under §63.1256
• Pieces of equipment regulated under
§63.1255
To prove that process vents have less than
50 ppmv HAP, and therefore not considered
regulated process vents, the owner or
operator can:
• use process knowledge to assert that
no HAP are present in the emission
stream,
• use an engineering assessment as
described in §63.1257(d)(2)(ii), or
• use test data from analysis using
Method 18 of 40 CFR, Part 60,
Appendix A or another test method
that has been validated according to
Method 301 in Part 60, Appendix A.
5.4 Standards
All process vents meeting the definition
above at facilities which are major sources
of HAPs, are regulated under this rule. A
summary of options for standards is given in
Table 5-1.
Essentially, for those vents not meeting the
flowrate threshold, existing sources can
choose to comply using the percent
reduction standard, the 20 ppmv TOC and
20 ppmv hydrogen halide/halogen outlet
standard, process heaters or boilers O, or the
mass limit standard @, or the alternative
standard ©. Certain existing sources with
individual vents which do meet the flowrate
threshold must comply with the individual
vent standard (98%) ©. Similarly, new
sources may comply with the percent
reduction standard O, or the mass limit
standard @, or the alternative standard ©.
Please note there are differences between the
standards for new and existing sources.
In addition, the owner/operator of some
vents may choose to comply using emissions
averaging (see Chapter 11) or the pollution
prevention option (see Chapter 10).
NOTE: If a facility chooses Option
2 (mass limit standard), it cannot
switch to Option 1 (percent
reduction) until compliance with
Option 2 has been demonstrated for at least
1 year. However, if a facility chooses
Option 1, it can switch back to Option 2 at
any time. Option 2 entails additional
recordkeeping and reporting requirements,
which can be reviewed in Chapters 12 and
13 of this document.
The alternative standard benefits both
the Agency and the source in reduced
recordkeeping and reporting and
through the initial compliance
demonstration, demonstration.
5-2
-------
Isn't it repetitious that the 20 ppmv TOC
standard offered as an option to the 93% or
98% redaction requirements in the §63.1254(a)
is also offered again as an "alternative
standard" in §63.1254(c) ?
Hie alternative standard was crafted such that
applicability is defined around the control device
rather than the processes that emit HAPs. This
"alternative" standard may make it easier for
owners/operators to install a centralized, add-on
control device that handles emissions manifolded
ftom several processes, j{Piease;note,thatlJ»e „„•. .,„,,
alternative standard is not restricted to manifolds - it
Jean be used for any ;vent sfijeamv) ?.
fa addition, EEAprpvid^ tjie oflier :20 ppmv TOC
standard as an equivalent demonstration of
compliance with the percent reduction standard If
'
_
120 ppmv standard, §63. 1257(a)(6) states that
monitoring will be performed according to , .'•
§63,1258(b)(lH4) - which allows monitoring for
parameters other than TOC (e.g. combustion
temperature) which are established during the
performance test for the initial compliance
demonstration. For the alternative standard,
continuous emissions monitoring must be used to
demonstrate initial and on-going compliance with
)the 20/50 ppmv TOC standard.
5-3
-------
Table 5-1. PROCESS VENT STANDARDS
For Existing Sources
O Process-based Emission Reduction Standard
[63.1254(a)(l)]
Reduce uncontrolled emissions from sum of all
orocess vents w/in a process that do not meet the flow
rate criterion* (see O below) by 93%, or
control to outlet concentration s 20 ppmv TOC
(and £ 20 ppmv hydrogen halides and halogens,
if present***) , or
use a flare that meets the requirements in §63.1 l(b), or
use process heater, boiler, or incinerator as specified in
§63.1257(a)(4)
or
© Process-based Annual Mass Limit Standard
[63.1254(a)(2)]
Limit HAP emissions from sum of all process vents
w/in a process to 900 kg/yr (<2000 Ibs/yr) (limited to
1,800 kg/yr per facility)
(individual vents that meet flowrate criterion* or vents
complying via the alternative standard may be
excluded from the 900 kg calculation)
or
© Alternative Standard****
[63.1254(c)]
Install add-on combustion control device and achieve
outlet concentration of <; 20 ppmv TOC and <; 20
ppmv hydrogen halides and halogens***. If non-
combustion control device is used, must achieve 50
ppmv TOC and 50 ppmv hydrogen
AND
Eor New Sources i
O Process-based Emission Reduction Standard
[63.1254(b)(l)]
Reduce uncontrolled emissions from sum of all
process vents w/in a process by 98%, or
control to outlet concentration ^ 20 ppmv TOC
(and <; 20 ppmv hydrogen halides and halogens,
if present***), or
use a flare that meets the requirements in §63.1 l(b), or
use process heater, boiler, or incinerator as specified in
§63.1257(a)(4)
or
© Process-based Annual Mass Limit Standard
[63.1254(b)(2)]
Limit HAP emissions from sum of all process vents
w/in a process to 900 kg/yr (<2000 Ibs/yr)
(vents complying via the alternative standard may be
excluded from the 900 kg calculation)
[63.1254(b)(2)]
or
© Alternative Standard****
[63.1254(c)3
Install add-on combustion control device and achieve
outlet concentration of <; 20 ppmv TOC and s 20
ppmv hydrogen halides and halogens***. If non-
combustion control device is used, must achieve 50
ppmv TOC and 50 ppmv hydrogen
halides/halogens***
5-4
-------
Table 5-1. PROCESS VENT STANDARDS
For Existing Sources
For New Sources
©Individual Vent Standard***** t
[63.1254(aX3)} ,,
For each individual vent that meets the flowrate
criterion*, reduce uncontrolled emissions by •
98%**, or
control to outlet concentration less than 20 ppmy TOC
(and less than 20 ppmv hydrogen halides and halogens,
if present), or
use a flare that meets the requirements in §63.1 l(b), or
use process heater, boiler, or incinerator as specified in
§63.1257(a)(4), ! !
or
Alternative Standard ©
* Explanation of flowrate criterion is provided below.
** Discussion of grandfathering provisions for 98
-------
below are met, the level of control required is
the level achieved on or before April 2,1997:
• at least one vent in the process meets
the flowrate criterion on or before
April 2,1997,
• the overall level of control on or
before April 2,1997 for the process
containing the large vent was between
93% and 98%, and
• the production-indexed HAP
consumption factor for the 12 months
prior to the compliance date is less
than half of the 3-year average
baseline established no earlier than
the 1987-1989 calendar years.
The last criterion in the list clarifies that this
provision (non-retrofit for grandfathered
vents) applies to processes for which
pollution prevention initiatives are being
used. In some cases, facility
owners/operators may have combined vents
as part of a pollution prevention program,
thus yielding a large vent that meets the
individual vent criterion. EPA does not want
to potentially interfere with or penalize the
pollution prevention program by requiring
98% control of the large vent(s). In these
cases, therefore, the overall level of control
required will continue to be that achieved by
April 2,1997, which must be at least 93%.
Please note that if the level of control
achieved by April 2,1997 was greater than
93%, it must remain at that level. In other
words, there can be no "backsliding" to 93%.
What is the Level of Control
Required for Grandfathered
Processes With Hydrogenation
Vents?
Due to safety concerns at existing facilities, a
similar provision is allowed for processes
with hydrogenation vents.
Processes that contain a vent that met the
flowrate criterion on or before April 2, 1997,
and meeting the two conditions listed below
must be operated to maintain the level of
control achieved on or before April 2,1997:
• processes that are controlled to
between 93% and 98% (by weight),
and
• processes with a hydrogenation vent
that, considered together with the
other process vents in the process that
do not meet the flowrate criterion,
could not meet the percent reduction
standard in §63.1254(a)(l) or the
mass limit standard in §63.1254(a)(2).
Any existing processes meeting just the last
condition hi the list above must be controlled
to 95% or greater by weight, regardless of
installation date of the control device.
What is the Applicability to the 98%
Individual Vent Standard?
There are two questions to be answered in
order in determine whether the 98%
reduction standard applies to individual vents
or to vents manifolded together:
Does the vent (or manifolded vent
system) have uncontrolled emissions
that exceed 25 tons per year from a
single process? If yes, go to the next
question.
Is the flow-weighted average
flowrate (Equation 1 provided below)
less than or equal to the calculated
flowrate index (Equation 2)? If yes,
the 98% standard applies to that vent.
Where:
5-6
-------
= actual flowrate, flow-weighted !
average, scfm , i
Dj = duration of each emission event, j
min • i
FRj= actual flowrate of each emission'
event, scfm ;
n = number of emission events ; j
• |
- •' ' -i
FRI = [0.02 * (HL)]-1000 (2) [
Where:
j
FRI = Calculated flowrate index, scfin'
HL = annual uncontrolled HAP \
emissions, Ibs/yr j
i
If FR,, <; FRI, HAPs hi the individual vent i
must be reduced by 98%. Likewise,
if FR,, > FRI, 98% reduction for the
individual vent is not required.
^ NOTE: Several process vents from a!
shigle process that are manifolded j
together are considered a single j
process vent, and may therefore trigger the j
individual vent standard. I
Example
An example is provided here to
demonstrate how a facility owner or
operator would determine whether any of
the existing process vents would require
control to 98%,
FigureJ
(Factory
"bays".
manufac
accordin
depicts a multi-batch factory
A) that has several production
Each bay can be used to
ture one or more products
g to Table 5-2:
**•,'.,*,
Table 5-2. PRODUCTION
ACTIVITIES AT FACTORY A
Bay
1
2
3
4
5
6
Process
A "~
A
A
A
B
B
C
C
C
C
D
!5-7
-------
What is the Flowrate Index (FRI)
criterion based on ?
The FRI value is the gas flowrate for a
given uncontrolled HAP emission rate at
which EPA has determined the cost
effective limit for controlling HAPs is
98% (i.e., at flows greater than FBI, it is
not cost effective to control HAPs to
98%). Also, for uncontrolled rates less
than 25 tpy (50,000 Ibs/yr), FRI is
negative and therefore, is always lower
than the actual average (FR, > FRJ).
Therefore, if an existing individual
vent has less than 25 tpy emissions, it
will not be subject to the 98% control
requirement. •
Table 5-3 presents a summary of emissions
events characteristics for each process,
including all information necessary to make
a determination of whether the 98 percent
requirement will be triggered. For purposes
of this example, assume that all vents within
each process A-D are manifolded.
5-8
-------
Table 5-3. UNIT OPERATIONS AT A MULTIBATCH FACILITY
AND HAP EliflSSION EPISODES
Unit
operations
Charging of
raw materials
Reaction
Concent ,
•^
f ^
Cryirta.
Filtration
Cleaning
MACT related
parameters
FIow(!SCFM)
Duration (min)
Emission rate (Ib/hr)
Flow(SCFM)
Duration (min)
Emission rate (Ib/hr)
Ffow(SCFM)
V
Duration (min)
Emission rate (Ib/hr) '
Flow(SCFM) ,
Duration (min)
Emission rate (Ib/hr) ,
FIow(SCFM) '
Duration (min)
Emission rate (Ib/hr)
Flow (SCFM)
Duration (min)
Emission rate (Ib/hr)
Totals (Ibs/batch)
Max, No. of batches
Max. emission potential (Ib/yr)
Max. emission potential (tons/yr)
Average (SCFM)*
A
30
20
115
1
1
E
: N/A
' 516
, 6,(JOO
i 20.6
• J20
3;00
2.33
30
: 130
2.33
! [30
; soo
3
2,l'o2.82
150
315,4;22
• 1'57.71
4^5
-•'• .•>••• :- : \,--!!.t:
B
30
60
0.5
20
440
3
425
4,000
14
20
300
3
40
150
3
. 30
500
3
1,003.33
100
100,333
50.16
319
.- . -c, ',,
30
80
0.5
N/A
375
2,500
19
20
300
2.7
40
150
2.7
30
500
3
837.58
60
50,255
25.12
274
": •-B-"':'--,
30
100
0.5
20
300
5
40
1,000
25
20
240
5
40
120
5
30
250
3
485.00
40
19,400
9.7
33
5-9
-------
* Use Equation 1 from the regulations to
calculate the flow-weighted average
flowrate: WhereFR,,^ flow-weighted average
/=!
flowrate for the vent,
scfin
duration of each emission event, min
j = flowrate of each emission event, scfrn
n = number of emission events
* Use Equation 2 from the rule to determine
the calculated flowrate index:
FRI = [0.02 * (HL)] - 1,000
Where:
FRI = calculated flowrate index
HL = annual uncontrolled HAP emissions,
Ib/yr
Table 5-4 presents the results of the
determination. As shown in the table,
processes A and B trigger the 98 percent
vent system control requirement. Therefore,
the control device shown in Figure 5-1
should be demonstrated tq achieve and
maintain 98 percent control when products
A and B are being manufactured in Factory
"A".
The owner/operator may want to reconfigure
the production bays such that processes "C"
and "D" can vent to a control device that
achieves 93% reduction. On the other hand,
the owner/operator may choose to leave the
current configuration as is, and use a control
device that achieves 98% reduction for vent
streams from all of the production bays. The
regulations also allow the owner/operator to
use a control device that controls the outlet
concentration to 20 ppmv TOC and 20 ppmv
hydrogen halides (for Alternative Standard
for combustion devices or Outlet
Concentration standard) or 50 ppmv TOC
and 50 ppmv hydrogen halides (for
Alternative Standard for non-combustion
devices), or to install a flare, process heater,
boiler, or incinerator as specified.
Table 5-4. APPLICATION OF THE FLOWRATE EQUATIONS
AT A MULTTBATCH FACILITY
FR, y .,-,
FRI
Meet Flowrate Condition? (FR,
equal or less than FRI)
A
455
5,308
Yes
98
B
319
1,007
Yes
98
C „
274
5.1
No
93
D - "
33
-612
No
93
5-10
-------
{ • . - -• •-
Figure 5-1 depicts a multi-batch factory\(Factory A) that has several production "bays ". Each
bay can be used to manufacture one or more products according to Table 5-2.
Air Pollution Ccmtro!Devic2
Figure 5-1. Example Multi-Batch Factory
5-11
-------
QandA
Q.
A.
If a process has one large vent that meets theflowrate criterion for the
98% standard for individual vents* does that preclude use of the 900 kgtyr
standard for the remaining vents in the process?
No; the emissions from the vent controlled to 98% would be excluded from
the calculation for the 900 kg/yr standard.
If one of the vents in a process meets theflowrate criterion for the 98%
standard, are all of the vents in that process subject to the 98% standard?
No; it is possible for one vent in a process to be subject to the 98%
standard, while tike other vents are subject to the 93% standard, or some
other standards option.
What are the Provisions for
Planned Routine Maintenance of a
Centralized Combustion Control
Device?
For periods of planned routine maintenance
of a CCCD, up to 240 hours per year, the
owner or operator can either:
• shut down the affected processes, or
• comply with the emissions standards
using a different control device, or
• for a non-dedicated PMPU, follow
specific provisions during the period
of maintenance (NOTE: does not
apply to dedicated PMPUs because it
would be relatively straightforward
to shut down the process in a
dedicated PMPU situation.)
The special provisions for dedicated PMPUs
provide that:
• If the CCCD is being used to comply
with the
- 93% reduction standard,
- outlet concentration standard,
- alternative standard,
- annual mass limit standard,
or
- boiler, process heater, or
hazardous waste incinerator
provisions hi §63.1257(a)(4),
or
- standards for large vents that
exceed the flow rate criteria,
then
the special provisions in §63.1252(h) can be
followed during periods of planned routine
maintenance on the CCCD, as shown in the
table below:
Centralized combustion control device
(CCCD) means enclosed combustion devices
that are used to control process vent
emissions from non-dedicated PMPUs at a
facility. Centralized combustion control
devices may also be used to control
emissions front source types including, but
not limited to, storage tanks, waste
management units, and equipment leaks.
5-12
-------
Table 5-5. EMISSION CONTROL REQUIREMENTS DURING PLANNED ROUTINE
MAINTENANCE ON A CCCD.
If organic HAP emission from the proce
vent are > 15 Ib/day -*
i •< *
If HC1 emissions from the process vent t
> 15 Ib/day -»
When calculating the emissions for organic
HAP and HC1 in the table above, "process
ss
re
the organic HAP emissions must be routed
through a closed-vent system to a condenser
where:
- outlet gas temperature must be < -50° C (-
58° F), if the organic HAP has a partial
pressure greater than 20 kPa (2.9 psia)
- outlet gas temperature must be < -5° C (23°
F), if the organic HAP has a partial pressure
less than or equal to 20 kPa (2.9 psia)
NOTE: the HAP partial pressures must be
determined at 25° C.
the HC1 emissions must be routed through a
caustic scrubber; the pH of the scrubber
effluent must be maintained above 9.
What is the Pollution Prevention
Option?
operation. The emission calculation cannot
be based on the aggregated emission stream
from multiple unit operations that are |
manifolded together into a common header.
During maintenance periods when these'
special standards are being followed, the
process vents cannot be used in emissions
averaging.
In instances where the process vents meet
the flowrate criteria for large vents, the !
planned routine maintenance provisions for
CCCD can be used only if the reason the
planned routine maintenance is needed, and
the reason it cannot be performed at a time
when the large vent is not operating, have
been described hi the Notice of Compliance
Status Report or a Periodic Report submitted
before the maintenance is to occur.
In lieu of the process vent standards
discussed above, an owner or operator can
choose to meet pollution prevention (P2)
standards. The P2 requirements are either:
• reduce the production-indexed HAP
consumption factor (Ib HAP
consumed/lb of product made) by
75% from a 3-year baseline average
established using data no earlier than
1987 through 1989, or
• reduce the production-indexed HAP
consumption factor by at least 50%
from a specified baseline average
established no earlier than 1987
AND reduce total PMPU HAP
emissions divided by the annual
production rate (Ib HAP emitted per
year/lb produced per year) to a value
of at least 25% of the 3-year baseline
average production-indexed
consumption factor (i.e., achieve
50% reduction by using pollution
prevention and achieve additional
5-13
-------
5.5
25% by using standard
control devices). For more
information, see -* Chapter
10 - Pollution Prevention
Alternative.
Initial Compliance Demonstration
Procedures
Compliance demonstration procedures for
process vent standards are listed in
§63.1257(d) - Initial Compliance with
Process Vent Provisions. This section
briefly summarizes the requirements for
demonstrating initial compliance. Further
details can be found in Chapter 8.
Procedures for demonstrating on-going or
continual compliance are listed in §63.1258
(Monitoring Requirements) which are
summarized in Section 5.7 and more fully
discussed in Chapter 9.
Initial compliance demonstration procedures
are summarized below in Table 5-5. To
understand Table 5-5, it may be helpful to
review the various terms for different kinds
of compliance demonstrations.
Emissions estimation methods and
engineering assessments are used to
calculate mass rates, while design
evaluations and performance tests are used
to demonstrate the efficiency of control
devices.
• Emissions estimation methods
make use of equations provided in
the rule to calculate emissions from
eight specific activities - vapor
displacement, purging, heating,
depressurization, vacuum systems,
gas evolution, air drying, and empty
vessel purging, when a condenser is
used as the control device or when
estimating uncontrolled mass
emission rates. Alternate methods
(e.g., ACT/CTG) may be available
for use.
Engineering assessments make use
of other equations or methods (not
provided by EPA) to calculate
emissions, generally from activities
other than the eight specified above
under emissions estimations
methods. (Engineering assessments
can also be used for the eight
specified activities IF the owner or
operator can demonstrate that the
emissions estimation equations are
not appropriate.)
Design evaluations! use the control
device manufacturer's specifications,
engineering principles, and/or test
data to show that the device will
achieve the required control.
Performance testing is actually
testing the equipment under specified
test conditions to prove that it will
achieve the required control.
5-14
-------
Table 5-6. OPTIONS FOR DEMONSTRATING COMPLIANCE WITH PROCESS
VENT! PROVISIONS
Standard
Initial Compliance Demonstration Requirements
. Uncontrolled Mass Rates
Controlled Emission Rates
=s900kgHAPs/'yr
(mass emission
limit)
Emission Estimation
Methods
Engineering
Assessments
If device controls less man 10 tpy, can use:
• Design Evaluations
• Emission Estimation Methods1
If device controls more than 10 tpy, must use:
• Performance Tests
• Previously Conducted Performance Tests
• Emission Estimation Methods
93% or 98%
Reduction
(% reduction) or
Outlet
Concentration
Limit (£20 ppmv
TOC/s;20ppmv
hydrogen halides)
Emission Estimation
Methods :
Engineering
Assessments
If device controls less than 10 tpy, can use:
• Design Evaluations
• Emission Estimation Methods1
If device controls more than 10 tpy, must use2:
• Performance Tests
• Previously Conducted Performance Tests
• Emission Estimation Methods'
s?.OppmvTOC
and 20 ppmv
hydrogen halides
and halogens
(Alternative
standard)
(^50 ppmv and SO
ppmv hydrogen
halides and
halogens if non-
combustion
device)
N/A
Monitor & record outlet TOC (and hydrogen halides
and halogens if necessary) on the initial compliance
date.
If a scrubber is used to achieve 95% post-combustion
control device HC1 emissions, a performance test or
design evaluation is required.
5.6 Emissions Averaging
The MACT rule allows for emissions
averaging among process vents, in both the
initial compliance demonstration and in ;
monitoring on-going compliance. There are
restrictions, however, as to when emissions
averaging may be used:
• Some states may not allow emissions
averaging,
1 Emissions estimations are used only if the control device used is a condenser. There is no distinction
between condensers controlling < or > 10 toy. In addition, the measurement of condenser outlet gas temperatures is
required for all condensers used as APCDs, regardless of whether the standard used is & 900 kg/yr or 93%/98%
reduction.
2 If APCD is a boiler with a heat input > 44
hazardous waste boiler or RCRA hazardous waste incinerator,
demonstration.
MW, or has vent stream fed into flame zone, or is a RCRA
•, the unit is exempt from initial compliance
5-15
-------
• Only existing processes may be
included in the averaging group,
• Processes already controlled on or
before 11/15/90 cannot be included
unless the level of control is
increased after 11/15/90,
• Processes already subject to control
because of another State or Federal
rule cannot be included, unless the
level of control is increased above
what is required by the other State or
Federal rule,
• No more than 20 processes can be
included in an averaging group,
• Processes for which the
owner/operator is using the
"alternative standard" cannot be
included in an averaging group,
• Processes which have been
permanently shutdown cannot be
included in an averaging group, and
• Individual process vents that are
subject to the 98% reduction
standard cannot be included in an
averaging group.
Owners or operators interested in finding out
more about using emissions averaging
should refer to -» Chapter 11 - Emissions
Averaging for Process Vents and Storage
Tanks.
i.
5.7 Monitoring On-Going Compliance
Owners or operators of affected sources
must conduct regular monitoring to confirm
on-going compliance with the emissions
standards. Except when complying with the
alternative standard, during the initial
compliance demonstrations, maximum or
minimum operating parameter levels are
established that will be used in the
monitoring program. Information from the
performance testing, other calculations, or
design evaluations are used to establish the
operating parameter levels. Of course, the
specific operating parameters will depend on
the type of control device being used.
If the owner/operator chooses to use
alternative monitoring parameters, a request
for approval must be included hi the
Precompliance Report. The reader is
referred to -* Chapter 9 - Monitoring for a
detailed discussion of monitoring
requirements, including what parameters
must be monitored for each kind of control
device.
IMPORTANT NOTE:
Owners/operators of control
devices that control less than 1
ton/yr HAP emissions, before control, are
not required to conduct monitoring other
than to verify daily that the device is
working properly. If the control device is
used to control batch processes alone or in
combination verification may be on a per
batch basis. The owner/operator must
determine how the verification process will
be conducted, and must describe the process
hi the Precompliance Report submitted six
months prior to the compliance date.
5-16
-------
Chapter 6
Equipment Leaks
6.1 Overview
The rule contains requirements for
controlling leaking components such as'.
pumps, flanges, valves, pressure relief |
valves, and compressors by either leak
detection and repair (LDAR) using
"sniffing" via Method 21 or pressure testing.
These requirements are based on the
requirements of subpart H of part 63 with
some modifications that include reduced
leak monitoring frequencies for programs
that result in low leak frequencies, the ,
allowance for subgrouping of components to
demonstrate leak frequencies, and the option
to not individually identify all components
subject to LDAR in a master log.
Identification of the subject equipment cfoes
not require physical tagging (the rule does
require that leakers be tagged).
6.2 Structure of the Rule
All requirements are located in §63.1255,
with many references to subpart H. Sections
of §63.1255 are provided below:
(a) General Leak Requirements
(b) References (to applicable portions o:
subpart H of part 63) \
(c) Standards for pumps i
(d) Standards for open-ended valves or
lines
(e) Standards for valves hi gas/vapor
service and light liquid service
(f) Unsafe to monitor, difficult to
monitor, and inaccessible equipment
(g) Recordkeeping ,
(h) Reporting
Chapter 6 at a Glance
6.1 Overview
6*2 Structure of the Rule t
/ •- f"
6.3 Applicability
6.4 References to Subpart H
6.5 Standards
6.3 Applicability
The equipment leak provisions apply to the
following components if these components
are in organic HAP service 300 hours per
calendar year within a source subject to
this subpart. (See Applicability Example 2
below regarding calculation of 300 hours
service.) The definition of "in organic HAP
service" specifies a cut-off of at least 5%
total HAP concentration by weight
[expected annual average concentration -
See 63.180(d)].
• Pumps
• Compressors
• Agitators
• Pressure relief devices
• Sampling connection systems
• Open-ended valves or lines
• Valves
• Connectors
• Instrumentation systems
• Closed vent systems and control
6-1
-------
devices used to control emissions
from the above components
Equipment not subject to the LDAR
requirements includes:
• lines and equipment not containing
process fluids. This would include
utilities, and other non-process lines,
such as heating and cooling systems,
whose materials are not mixed with
those in the process.
• bench-scale processes, even if
located at the same plant site as a
regulated manufacturing unit.
• equipment that is in vacuum service
(equipment operating at an internal
pressure which is at least 5 kPa
below ambient pressure).
• equipment in organic HAP service,
but that is used less than 300 hours
per calendar year (these exempt units
must be recorded however).
Figure 6-1 presents a logic flow diagram for
applicability.
NOTE: PMPUs complying with the
MACT standard through use of the
Pollution Prevention option are not
subject to LDAR requirements.
6-2
-------
, Does MM tee or
equipment eontsbt , .
toKKtHOa /
IJuM contain it
e organic
K cnmpoiind»*li»
'
' pun Mgimte compound % Mo
U constituents b«vino«
'• Only equipment that can reasonably be expected to be in organic HAP service, but is not, needs to retain records
of determination. Equipment not reasonably expected to be in organic HAP service, such as non-HAP solvent
supply lines, needs no records.
Figure 6-1. Logic F
ow Diagram for applicability
6-3
-------
What is the Definition of "In Organic
HAP Service"?
"In organic HAP service" is defined in
§63.1251 and means that a piece of
equipment either contains or contacts a fluid
(liquid or gas) that is at least 5 percent by
weight of total organic HAPs, as determined
according to §63.180(d). Section 63.180(d)
states that "each piece of equipment within a
process unit that can reasonably be expected
to contain equipment in organic HAP
service is presumed to be in organic HAP
service unless an owner or operator
demonstrates that the piece of equipment is
not in organic HAP service." For a piece of
equipment to be considered not in organic
HAP service, it must be determined that the
percent organic HAP content can be
reasonably expected not to exceed 5 percent
by weight on an annual average basis.
Section 63.180(d) allows owners or
operators to use Method 18 of 40 CFR 60,
appendix A (HAP concentration), or "good
engineering judgment" to make the
demonstration.
Applicability Example 1: Determining
Whether a Component is in 5 Percent by
Weight HAP Service.
An owner or operator wishes to be exempt
from the provisions of §63.1255 for
components in a closed vent system
containing 500 ppmv methanol (a HAP) and
the remainder air, as measured using
Method 18. The percent by weight HAP is
determined by multiplying 500 ppmv by the
ratio of molecular weight of methanol (32)
to the molecular weight of air (29) to yield
551 ppmw, or 0.050 percentby weight,
which is well below the 5 percent by weight
criteria for "organic HAP service";
therefore, the closed vent system is not
subject to the provisions of §63.1255.
Applicability Example 2: Determining
Whether a Component is in Service for
300 Hours Per Year.
A line from a batch reactor to a centrifuge is
in contact with a process fluid during
transfer of material from the reactor to the
centrifuge (after each transfer, the line is
purged with nitrogen to a control system to
ensure that there is no fluid left in the line).
The transfer operation lasts a maximum of
15 minutes each time the batch occurs, and
there are a maximum of 50 batches per year
anticipated. Therefore, the components in
the line would be hi service for a maximum
of 12.5 hours per year, well below the
300 hours per year trigger for applicability.
Even through the equipment is exempt,
owners and operators must identify the
exempted equipment per §63.1255(g)(9). If
the same line is used as part of other
processes as well, the portion of tune it is hi
service for those other processes should also
be added to determine the total time in
service.
6-4
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6.4 References to Subpart H
Since subpart GGG contains numerous
references to subpart H, Table 6-1 provides zi
tabular cross reference of the equipment leak
requirements of subpart GGG and
referenced applicable sections of subpart H.
The regulations hi bold print are
applicable to sources regulated under
subpart GGG.
6.4.1 Consistency with Other
Regulations
After the compliance date, for components
subject to subpart GGG as well as
40 CFR 60 or 61, the owner or operator is
required only to comply with subpart GGG
(and specifically, § 63.1255 for equipment
leak components).
After the compliance date, an affected
source with equipment subject to subpart I
of part 63 may elect to comply with either
the subpart GGG leak provisions or the
provisions of subpart H of the HON for all
such equipment (i.e., the owner/operator
cannot choose to comply with H for certain
equipment and subpart GGG for other
components). The O/O shall identify in the
NOC under which subpart s/he will comply.
What are the General Standards in
§ 63.1255?-'
6.5 Standards
Identification of Equipment Subject to
§ 63.1255
Equipment subject to this subpart must be
identified so that it can be readily located
and distinguished from equipment not
subjected to this standard. Physical tagging
is not required; components can be
identified on a plant site plan, in log entries,
or by designation of process boundaries with
weatherproof identifications. Updates for
affected components must be made within
90 calendar days of the change(s), or by the
next Periodic Report, following the end of
the monitoring period for that component,
whichever is later.
Identification of Leaking Equipment
When leaks are detected by visual, audible,
or olfactory means, or by monitoring, a
weatherproof and readily visible
identification, marked with an equipment
identification number or other number- or
color-coded tag, should be attached to the
component. With the exception of valves,
this identification "tag" can be removed
upon successful repair. For valves, the tag
must beleft on until they have been
monitored using Method 21 at least once in
three months after repair and are determined
to be not leaking.
NOTE: Except for components hi
heavy liquid service,
instrumentation systems, and
pressure relief valves hi liquid service,
successful repair means that the component
is shown to not leak using Method 21
immediately after repair. Otherwise,
successful repair should be verified using
the same method used to detect leaks.
6-5
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Table 6-1. SUBPART GGG REFERENCES AND INTERFACE WITH HON
(Note: bolded references are applicable at pharmaceutical manufacturing operations)
Subpart H
Section
63.160
63.161
63.162
63.163
63.164
63.165
63.166
63.167
63.168
63.169
63.170
63.171
63.172
63.173
63.174
63.175
63.176
Description
Applicability and description of source
Definitions
Standards: General
Standards: Pumps in light liquid service
Standards: Compressors
Standards: Pressure relief devices in
gas/vapor service
Standards: Sampling connection systems
Standards: Open-ended valves or lines
Standards: Valves in gas/vapor service and
in light liquid service
Standards: Pumps, valves, connectors and
agitators in heavy liquid service;
instrumentation systems; and pressure relief
devices in liquid service
Standards: Surge control vessels and
bottoms receivers
Standards: Delay of repair
Standards: Closed vent systems and control
devices
Standards: Agitators in gas/vapor service
and in light liquid service
Standards: Connectors in gas/vapor and in
light liquid service.
Quality improvement program for valves
Quality improvement program for pumps
Comparable section ^
subpart G&G (§63.1255) *
63.1255(a)
63.1251
63.1255(a)
63.1255(c)
Direct reference to 63 . 1 64
Direct reference to 63.165
Direct reference to 63. 166
63J255(d)
63.1255(e)
Direct reference to 63.169
63.1254 (these equipment are
covered by the process vent
standards)
Reference to 63.171 with
exceptions noted in
63.1255(b)(4)(i)
Reference to 63.172 with
exceptions noted in
63.1255(b)(4)(ii)
63.1255(c)
References to 63.174, with
exception noted in
63.1255(b)(4)(iii)
No provisions in subpart GGG
No provisions in subpart GGG
6-6
-------
SubpartH
Secltion
Description
Comparable section
subpart GGG (§634255)
Alternative means of emission limitation:
General
Direct reference to 63.177
63.178
Alternative means of emission limitation:
Batch processes < j
Reference to 63.178, with
exceptions noted in
63.1255(b)(4)(iv)
63.179
Alternative means of emission limitation:
Enclosed-vented process units
Direct reference to 63.179
63.180
Test methods and procedures
Direct reference to 63.180, with
exceptions noted in
63.1255(b)(4)(v)
63,181
Recordkeeping
63.1255(g)
63JS2
Reporting
63.1255(h)
Compliance Times
References to periods of time to accomplish [
a specific task (e.g., weekly, monthly, j
quarterly) refer to the standard calendar
periods, unless otherwise specified in the,
rule. j
If the initial compliance date does not j
coincide with the beginning of a standard
calendar period, the owner/operator has [
some options regarding the way he/she ;
wishes to specify time periods. The
owner/operator may elect to : ,
• use a period beginning on the ,
compliance date, or ;
• use a time period agreed upon by ihe
owner/operator and the regulating
agency,or comply before the end of
the standard calendar period within 1
which the initial compliance deadline
occurs, if there remain at least:
- 3 days for tasks that
must be performed
weekly,
— 2 weeks for monthly
tasks,
- 1 month for quarterly
tasks, and
— 3 months for annual
tasks.
In all other cases, compliance is required
before the end of the first full standard
calendar period after the period hi which the
initial compliance deadline occurs.'
If the regulations require completion of a
task during each of multiple successive
periods, the owner/operator can conduct the
task at any time during each period, as long
as the intervals between completion of the
tasks are reasonable. For example, for
quarterly monitoring the facility may choose
to monitor the first week of the first month
of each quarter. It would not be reasonable
to monitor the last week of March and again
6-7
-------
the first week of April.
If a leak is detected, and the owner/operator
does not try to repair the leak within the
specified time period, this is a violation of
the regulations. If a repair is attempted, but
it does not work, this is not a violation.
However, the owner/operator must take
further action as required by the rule if a leak
still exists.
Can Processes be Grouped Together
to Facilitate Calculations of Percent
Leaking Components?
The rule allows owners or operators to
"group" processes together when
determining percent leaking components for
the purposes of selecting the appropriate
monitoring frequency. For example, a
processing building housing non-dedicated
equipment could be designated as a "group
of processes." For valves only, the rule also
allows "subgrouping," in which groups of
processes can be further subdivided into
subgroups. The intent of the rule with
respect to the subgrouping procedure is to
assign components according to their
propensity for leaks, allowing for reduced
monitoring frequencies for some subgroups.
This approach focuses the monitoring,
recordkeeping, and reporting burden on
those processes and types of equipment that
exhibit the most significant leaks.
What are the Standards for Pumps in
Light Liquid Service and Agitators in
Gas/Vapor Service and in Light
Liquid Service?
Figure 6-2 describes the monitoring
requirements for pumps in light liquid
service and agitators in gas/vapor service
and in light liquid service. Once processes
have been grouped, pumps and agitators
must be monitored quarterly using M21 and
must be visually inspected weekly for
indications of liquids dripping.
Percent Leaking Pump Calculation
The calculation must be done to determine
subsequent monitoring frequency unless 90
percent of the pumps hi the group of
processes meet the exemption criteria of
§ 63.1255(c)(5) and (6), which are discussed
below. The percent leaking pumps (%PL)
must be calculated every quarter for a 1-year
rolling average. If, on the 1-year rolling
average, the greater of either 10 percent of
the pumps are found to leak, or at least three
pumps hi a group of processes (on average)
per quarter leak, the monitoring frequency
reverts to monthly and remains monthly for
the group of processes, until the one year
rolling average falls below 10% or 3 pumps.
The owner or operator would conduct
monthly monitoring for three months to
yield a quarterly average. Then the new
quarterly average and the three previous
quarterly averages would be used to
calculate the 1-year rolling average.
Monthly monitoring would continue until
the 1-year rolling average indicates less than.
10% of the total or 3 pumps are leaking.
Note that the percent leaking pump
calculation also allows that pumps within
continuous processes found to leak within
1 quarter of startup are not considered in the
%PL calculation. Also, pumps that are
exempt from monitoring because of their
design must be included in the total pump
count. The equation used to calculate %PL
is presented below:
%PL = [(PL-Ps)/(PT-Ps)]xlOO
6-8
-------
where: !
|
%PL = percent leaking pumps !
PL= number of pumps found
leaking in periodic
monitoring
PT = total pumps, including those
exempted i
Ps= number of pumps in a ,
continuous process leaking
within 1 quarter of startup
during the current monitoring
period.
(See the following page for an example of
calculating leaking pump percentage to
determine the appropriate monitoring ;
frequency.)
Exemptions from Monitoring
If a pump or agitator is equipped with a dual
mechanical seal system that includes a
barrier fluid system, the pump or agitator is
exempt from periodic Method 21 monitoring
if several conditions are met: i
• The system must be:
- operated with a barrier fluid
at a pressure that is greater
than the pump/agitator '
stuffing box pressure OR.!
- equipped with a barrier fluid
degassing reservoir that is
connected by a closed-vent
system to a control device
OR ,
- equipped with a dual i
mechanical seal system with
a closed-loop system that!
purges the barrier fluid back
into a process stream '
. i
AND i
• the barrier fluid is not in light liquid
service, and
• each barrier fluid system has a sensor
that will detect failure of the seal
system, the barrier fluid system, or
both, and
• each pump/agitator is checked by
visual inspections each calendar
week for drips from the seal.
During the weekly inspection, if there are
indications of liquids dripping, the pump or
agitator seal must be monitored immediately
using M21 or the owner/operator must
eliminate the leak before the next weekly
visual inspection. Pumps/ agitators that are
located at "unmanned" plant sites are
exempt from weekly visual inspections. In
lieu of these weekly visual inspections, these
pumps/agitators must be visually inspected
at least monthly.
A pump/agitator designed with no externally
actuated shaft penetrating the pump/agitator
housing is exempt from monitoring. In
addition, pumps/agitators equipped with a
closed-vent system are exempt from
monitoring.
6-9
-------
An example of the calculation of percent
leaking pumps is described below:
Quarter
1
2
3
4
TOTAL
No.
pumps
(including
exempted)
10
10
10
10
40
No.
leakers
1
0
2
0
3
Avg.
No. ;
leakers/
quarter
•••3." ''.
leakers/
4
quarters
= 0.75
%PL = 3/40 = 7,5 percent (less than 10
percent); also, the number of pumps leaking
jer quarter (on average) is 0.75 (less than 3);
.-. Therefore the facility can continue to
monitor quarterly.
•
NOTE: Method 21 (as described in
63.180(b)) monitoring is required
quarterly unless the percent leaker
calculated over a rolling 1-year
period is either 10 percent or an average of
at least three pumps per quarter, in which
case monthly monitoring is required.
Repair Provisions
Leaks must be repaired as soon as
practicable, but no later than 15 calendar
days after detection, unless repair would
require a process shutdown or personnel
would be exposed to an immediate danger if
they attempted a repair without shutting
down the process. The first attempt at repair
must be made within 5 calendar days and
may include measures such as tightening of
packing gland nuts or ensuring that the seal
flush is operating at design pressure and
temperature.
6-10
-------
Visual Inspections
Conduct visual
tarfkation of liquid* N%
.A^i
ji-
processes
iZ~ ~~*
I
sak is detected
ConthictMZI monitoring
' iV?^ ^\
>10,000 ppmv \
forsgiUtors,
S2,000ppmv
forpumps? f"
Yes
First attempt at repair
Iwithin 5 days
>
lairfremonrtorittg
Mithin15days
i For pumps, ealcuiata
i takers (monthly
monitoring may ba
required) 63.1255(c)(4)
Follow delsy of repair
provisions
63.1255{b}(1Mv)
Figure 6-2. Pump/agitator monitoring in light liquid service.
6-11
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What are the Standards for Open-
Ended Valves or Lines?
Standards
Open-ended valves or lines must be
equipped with a cap, blind flange, plug, or
second valve at all times except during
operations that require process fluid flow, or
during maintenance or repair. Owners or
operators have 1 hour after operations stop
or maintenance or repair is completed, to
affix caps, flanges, plugs, or double block
and bleed systems. Records documenting
compliance with the 1 hour standard are not
required.
Other important aspects of the section:
• For open-ended valves or lines
equipped with a second valve
(double block and bleed), the valve
on the process fluid end must be
closed before the second valve is
closed.
• When a double block and bleed
system is used, the bleed valve or
line may remain open during
operations that require venting the
line between the block valves only.
Exemptions
Open-ended valves or lines that meet any of
the following conditions are not required to
be capped, equipped with flanges, plugged,
or equipped with a double block and bleed
system:
• Designed to open automatically
during emergency shutdown
situations,
• Contain materials which would
autocatalytically polymerize,
• Could cause an explosion, serious
overpressure, or other safety hazard,
if closed accordingly.
Example
A pipe used to convey material from a
reactor to an emergency "dump pit" is not
required to be capped, plugged, equipped
with a flange, or equipped with a second
valve because the line is designed to open
automatically during an emergency
shutdown situation.
What are the Standards for Valves
in Gas/Vapor Service and in Light
Liquid Service?
Figure 6-3 describes the monitoring
requirements for valves in gas/vapor service
and light liquid service for the identified
groups of processes. Note that if an affected
source has fewer than 250 valves, they are
exempt from monthly monitoring. There are
two different calculations of percent leaking
valves. The first yields percent leaking
valves, %VL, the value used to determine
appropriate monitoring frequencies. The
second calculation is for %VLO, the percent
overall leaking values, which is used when
the subgrouping option is chosen to
determine on a semiannual basis, whether
the overall percent leaking valves is less
than 2 percent and the compliance strategy is
still valid. Both calculations are presented
below.
6-12
-------
Percent Leaking Valves Calculation (to
determine monitoring frequency)
[VI/VT]XIOO
where:
,
%VL= percent leaking valves as
determined through periodic
monitoring
VL = number of valves found
leaking, excluding
nonrepairables as provided
forin63.1255(e)(6)(iv) '
, i
VT = total valves monitored in k
monitoring period, excluding
valves remonitdred within 3
months after repair, per
63.1255(e)(7)(iii)
Percent Overall Leaking Valves
Calculation (if subgrouping, to determine'
whether subgrouping is allowed) i
subgroupi
n = number of subgroups
Option 1 - no subgrouping
Option 2 - by leakers
Option 3 - by processes
where:
= overall performance of total i
valves in the group of j
processes ! ,
%VU = percent leakhig valves in i
subgroup i, most recent valuej
calculated according to
(eX6)(ii)and(iii) \
i
V = number of valves in ;
6-13
-------
Examples of valve subgrouping
The initial round of monitoring for the group of
processes in Building 1 yields the following results:
Proc T,otal No. No.
Valve kine Leakin
i I
A 600 10 590
B 500 2 498
C 300 0 300
D 200 2 198
1.7
0.4
Q
I
Tota 1600
1
14
1586
0.9
Option 1 - no subgrouping
Option 2 - all the 14 leaks in one group
all the non-leakers in another group
Option 3 • Process A in one subgroup
Process B, C, D in another subgroup
Option 1 - no subgrouping
Without any subgrouping, with a leak percentage of
0.9, the group of processes would require
monitoring of all 1,600 valves every two quarters
(twice a year).
Option 2 * all leakers in one subgroup;
all non-leakers in another group
Under subgrouping Option 2, the owner or operator
could choose to subgroup all 14 leaking valves into
one subgroup, provided these leakers make up 2
percent or less of the total components. The
"leaker" subgroup would require monitoring every
quarter and the remaining subgroup would require
monitoring every 2 years.
Option 3 - Process A in one subgroup;
Processes B, C, & D in another subgroup
If this option were chosen, the facility would be
required to monitor 600 valves every quarter, and
monitor the remaining 1000 valves once a year;
since the leak frequency would be 0.40 (less than
0.5 percent -> yearly monitoring).
Recordkeeping and Reporting Specific to
Subgrouping of Valves in Light Liquid
and Gas/Vapor Service
In addition to the general requirements for
all equipment leaks reporting and
recordkeeping, owners and operators are
also required to record and report
information specific to the subgrouping
option, including:
• Identification of valves assigned to
each subgroup
• Monitoring results and calculations
made for each subgroup and each
monitoring period
• Results of semiannual %VLO
calculation
• Which valves are reassessed and
when they were reassessed.
Finally, as shown in Figure 6-3, the owner or
operator must notify the implementing
agency of the decision to subgroup valves at
least 30 days prior to the beginning of the
next monitoring period and must identify
affected groups of processes and valves
assigned to each subgroup.
Repair Provisions for Valves in Light
Liquid and Gas/Vapor Service
The regulations provide that the leak must
be repaired as soon as practicable; the
owner/operator must at least attempt to
repair the leak within 5 calendar days of its
detection. First attempts to repair include
measures such as tightening the bonnet
bolts, replacing the bonnet bolts, tightening
the packing gland nuts, and injecting
lubricant into lubricated packing. The repair
must be completed within 15 days of
detection, unless there is a legitimate "delay
6-14
-------
of repair" situation (discussed later in this
document). After the leak is repaired arid
the repair is confirmed by monitoring, the
valve must be monitored again at least once
within the first 3 months after the repair.
NOTE: Days mat the valve is not in
H8S, organic HAP service do not count
against the 3-month time period.
'•I
Monitoring after a Repair
i i
The regular periodic monitoring can be done
to satisfy the post-repair 3-month monitoring
check IF the tuning of the regular
monitoring coincides with the timing
required by the repair. Otherwise, the ;
owner/operator will need to conduct some
other monitoring outside the regularly-
scheduled monitoring. If monitoring revjeals
that 'the leak has resumed, this valve must be
counted as a leaking valve for the purposes
of grouping processes IF the monitoring jthat
detected the leak was the regular periodip ;
monitoring. If, however, the owner/operator
used some other schedule for monitoring the
initial leak (after repair to see if the leak jhad
resumed), then the valve does not have t6 bej
counted as a leaking valve IF it is repaired
again, given follow-up monitoring, and
shown not to be leaking by the next periodic!
monitoring.
What are the Standards for
Equipment that is Difficult to
Monitor/Inspect, Unsafe to !
Monitor/Inspect, or Inaccessible?
Equipment that is designated as unsafe to
monitor, unsafe to inspect, difficult to
monitor, difficult to inspect, or inaccessible
is exempt from the monitoring and repair
requirements described in Table 6-2.
However, if inaccessible equipment is
observed by visual, audible, olfactory or
other means to he leaking, the leak is
required to be repaired as soon as
practicable, but no later than 15 calendar
days after detection. Please note that all
equipment must be assigned to a group of
processes.
6-15
-------
Wonlify groups of
processes
*. _ I
Conduct M21 inftZat *unwy
of all vaives within 1 year *
of the compliance date;
teaks tre detected whan I
monitoring Instrument
reads aSOQppmv
Calculate perMtrt VL L«
fteaiK^mwiyvii iff i
,r
•r1"
- - ..- — .-**. I huftArf AH Hlfl
£. ' CfStCUUtfiO1
U_j~
f"" "
Yes J >2SOvalv
niM«wm.n mr<«i««,l -1. ^ at«ff«et*(J (0
^ ^ _,-». ,.__.
U v *
j rnonthry4 •' 1**^«2» ,{ 0.5%- %VL
"* _!._» J
i •
"'""""'r^'" -"r^?|
Calculate perc5nlV(_ as :
•MMMmnnnmtti-tfr afWimfltieiWBriflaofflie 1
latttswperiods '
•; ' •:- , -, •', '"l."|
»*
Optional
/ %n?#!&i£ib4n
fg
' Ca!cul«te percent V[_ts
j arithmetic average of the
last three periods
£iubjirouping
tfoft'of ?,
sabgrciUpinarBquiredno
later than SO days prior to \
Conduct monftotina ftp *,
• esch subgroup b««ed on
this %VL of each {
jf isobfioupaceordlngto ji
:"
..S»mtannua!
._Annual
^
f Calculate percent Vi_o '
*r.'2"*t.ti»fci
yi*»ciUdatapUnt*rtewithf9werthan250valv«sinOrganleHAPservlce 1 .. f
ttth««ffect8d»outi»fc«emptfromiiMM*rymon!toring.lnsteiri.lheowTOr/(^r^ t" - T --^«-
monKor for leaks ORB (kne per quarter or comply with the semi-annual or anr ual teak rats
cattgocto and monitoring is applicable Unsafe^Mnonlttor and inspoct or illfficult-to-
monkof tnd Impact or Inaccawibte equipment Is exempt from fin requlremnnt
Figure 6-3. Monitoring for valves in gas/vapor service and light liquid service.
6-16
-------
Table 6-2. EXEMPTIONS FORDIFFICULT-TO-MONITOR/INSPECT, UNSAFE-TO-
MONITOR/INSPECT. ArkD INACCESSIBLE EQUIPMENT
Component .
Pumps and agitators0
Valves
Closed-vent systems*
Connectors
1 '"• i ,.-.,--.
Exempt requirements
§63.1255(«^(2X(cX3McX4)
\
§ 63.1255(e;)(2) through (e)(7)
•, |
§ 63.172(f)(;l) and (2) and (g);
§63.1255(bX4)(ii)(A)and(B)
§63.174(b)lthrough(e);
§63. 1255(bj(4)(iii)(A)-(F)
Description of exemption
requirements
Monitoring, repair, calculation of
% leakers
Monitoring, repair, calculation of
% leakers
Inspections and monitoring
Monitoring and repair
"Pumps, valves, and closed vent systems cannot be designated as "inaccessible.
bCeramic or ceramic lined connectors are subject to fhe same requirements as inaccessible connectors.
Valves, connectors, agitators, and pumps
maybe designated as unsafe to monitor if
the owner or operator determines that ,
monitoring personnel would be exposed'to
an immediate danger as a consequence of
complying with the monitoring and repair j
requirements identified in Table 6-2 above, i
However, owners and operators designating!
components must have a written plan that j
requires their monitoring as frequently as j
practicable, but not more frequently than j
periodic monitoring would require.
Any part of a closed vent system may be
designated as unsafe to inspect if the owner 1
or operator determines that monitoring
personnel would be exposed to an
immediate danger as a consequence of ' j
complying with the monitoring requirement
identified in Table 6-2 above. However, tihtej
owner or operator must have a written plan i
that requires inspection of the unsafe to
inspect closed vent systems as frequently as
practicable during safe to inspect times, but
not more frequently than periodic
monitoring would require.
A valve, agitator,'or pump may be designed
as difficult to monitor if the owner or
operator determines that the equipment
cannot be monitored without elevating the
monitoring personnel more than 2 meters
above a support service or it is not
accessible in a safe manner when it is in
organic HAP service. At a new affected
source, no more than 3 percent of valves can
be designated as difficult to monitor.
Owners and operators must have a written
plan to require monitoring of each type of
component designated as difficult to
monitor. The monitoring must be conducted
at least once per calendar year or on the
periodic monitoring schedule applicable to
the group of processes in which the
equipment is located, whichever is less
frequent.
Any part of a closed vent system may be
designated as difficult to inspect if the owner
or operator determines that the equipment
6-17
-------
cannot be inspected without elevating the
monitoring personnel more than 2 meters
above a support surface or it is not
accessible in a safe manner when it is in
organic HAP service. The owner or operator
must have a written plan that requires
inspection of the closed vent system at least
once every 5 years.
The "inaccessible" designation may be
applied to connectors that are:
• buried
• insulated in a manner that prevents
access to the connector by a monitor
probe
• obstructed by equipment or piping
that prevents access to the connector
by a monitor probe
• unable to be reached from a wheeled
scissor-lift or hydraulic-type scaffold
which would allow access to
equipment up to 7.6 meters (25 feet)
above ground, or
• unable to be accessed at any time in a
safe manner per §63.1255(f)(4)(i)(E),
• unable to be accessed without
elevating monitoring personnel more
than 2 meters above a permanent
support surface or would require the
erection of a scaffold.
Ceramic or ceramic-lined connectors are
subject to the same requirements as
inaccessible connectors. At a new affected
source, no more than 3 percent of connectors
may be designated as "inaccessible".
If any inaccessible, ceramic, or ceramic-
lined connector is observed by visual,
audible, olfactory, or other means to be
leaking, it must be repaired as soon as
practicable, but no later than 15 calendar
days after detection.
What are the Standards for
Connectors in Gas/Vapor Service
and in Light Liquid Service
Figure 6-4 describes the initial monitoring
requirements for connectors in gas/vapor
service and in light liquid service. Please
note that the use of monitoring data from
before April 22,1994, is subject to some
restrictions.
Percent Leaking Connector Calculation
The initial calculation of percent leaking
connector (%CL), is calculated as:
%G =
CL
(Cr+Cc)
Uioo%
where:
%CL - percent leaking connectors
CL = number of connectors found leaking
CT = number of connectors monitored in a
period
Cc = optional credit for removed
connectors = 0.67 x net
For subsequent monitoring frequencies, the
following equation should be used:
%cL = [(CL -
where:
- cc>] x 100%
%CL = percent leaking connectors
CL = number of connectors found
6-18
-------
•'AN
leaking :
number of allowable !
nonrepairable connectors, not
to exceed 2% of the total
connector population ;
total number of monitored
connectors
optional credit for removed
connectors = 0.67 x net
Optional Credit for Removed Connectors
An owner or operator may choose to : I
eliminate a connector subject to monitoring i
and receive credit for elimination of the j
connector if the following conditions are ;
met: |
' I
1. Connector is welded after date of i
proposal (April 2,1997) of j
SubpartGGG. ' j
2. The integrity of the weld is j
demonstrated by monitoring or by j
testing using x-ray, acoustic I
monitoring, hydrotesting, or any j
other applicable method, j
3 Welds created after April 2,1997, j
but before the date of promulgatipn j
(September 21,1998) of j
Subpart GGG are monitored or tested
by 3 months after the compliance \
date. \
4. Welds created after September 21, j
1998 are monitored or tested within ;
3 months after being welded. j
5. If an inadequate weld is found or the!
connector is not welded completely j
around the circumference, the j
connector is not considered a welded.
connector and is therefore not |
exempt from the provisions of •
SubpartGGG. |
6-19
-------
idtnfify groups o?
ptocossoc
1; •"
i
|— a^*-***^ «••* ~~*^»*» ~ ~
1 Conduct KZ1 inHUI tuiwy
of aS connectors within 1
year of tlm com ptatea date;
for new sources, within 12
months of startup; leaks are
{ detected when monitoring
| instrument roads a MO
• ppmv
!
L—^^
^p
f— r™
( Calculat»p«meritCt_
^:xr
f once per year until
| %Ct <0 5
> lU
**— —,'-**- -
«*™^«~™*1~' WWHmi™*^™ -J#- *
I Calculate percent C|_
I
A
fe &.
?
f
i f . _. f , , „
**nL^* , %CL*O«S I ff.5-%u^ wtthNi 2 years ^ mfthf
'r ¥ _»_«_
«j^itwdt^ftaCT»aaa»MMgaOTaMM»g^smw.'^g'^^^«^»H<<«^m>«^^
, Screwed coanectorte 2
•' • inchnstt). Uonaoredfor
i teiK6 within 3 months ifte
f- „ I returning to HAPsarvica
'> " J ,« -V
i 4^,^^.'- '
r x » »*, ^*i
i
^ J. ^ '" r"/»*»*'^i!~1'
t } wtftln tint 3 months «ftii
J H-jtofes.ortfttfiwath!
r bro*«n.A!JematiVBiy,ma)
1 I ohuotenottemonltof
Ontinnal •• * *iUl to*M 88afe- CanB°l
^...^......"EH"!!!*' /,,,:,,, f i (awintnon-repalnble
| ronrtectoEs in subsequen1
• "If^-ff^f":
^V.-'S^P^Ifcii^* —i^i
.. ^ »««^».-«, », ^~^~ ~~,~. ,
^ 4 *t»*»H*m>*stt***«Vf * f**i Vv*^*» ^^^JJWMS^E^A-raisaaaawWtoFS^ i
' i
* ,
j ;
i *
i. #•
r T , j ,
ffiCi «t5 ** »^«0^ "A * '
iftmuinu^liEa ^ ^^L %VLSO,SKj ^ »
TOrf^up Honltor5(l%d8roupwahte , , . — ,
l'Z!^L;- * tJk. ..** S*ire *»*. i ?
L %CL*OA>
Jf 1
< •^•^S' l:!S?S^I"'i"S2*
fy**?jfeSftorrei!iafiitoB^''' i
, ,^ 90% of group Within , [
£__ f _»_J
Figure 6-4. Initial Monitoring reqiiirements for connectors in gas/vapor service and in
light liquid service.
6-20
-------
What are the Standards for
Compressors? _____
The requirements for compressors are
referenced directly to Subpart H.
Compressors may comply with either an
equipment design standard or a performance]
standard, as discussed below. '•
Equipment Design Standard
Compressors must be equipped with a seal
system that includes a barrier fluid system
that prevents leakage to the atmosphere.
i
Seal System with Barrier Fluid System, the-
regulation requires each compressor seal j
system to meet the following criteria: j
- • ' i
• Each system must be: |
- Operated with the barrier j
fluid at a pressure that is
greater than the compressor :
stuffing box pressure; or !
- Equipped with a degassing |
system that is connected by a
closed-vent system to a }
control device; or i
- Equipped with a system that J
purges the barrier fluid into a;
process stream with zero !
VOC (or volatile HAP) ; j
emissions to the atmosphere.;
j j
• The barrier fluid system is to be j
either in heavy liquid service or not ;
in organic service. !
• Each barrier fluid system is to be: >
equipped with a sensor that will j
detect failure of the seal system, the
barrier fluid system, or both. '
• The regulation requires the owner or;
operator to determine the criterion to
be used to indicate failure of the seal
system, the barrier fluid system or
both.
• Each sensor is to be checked daily or
is to be equipped with an audible
alarm..
• When a leak is detected (either by
visual inspection or by the sensor
indicating a failure), it is to be
repaired as soon as practicable, but
no later than 15 days after it is
detected, except as provided by the
"Delay of Repair" provisions. A first
attempt at repair is to take place no
later than 5 days after a leak is
detected.
The standards for compressors do not
require weekly visual inspection for
indications of a potential leak as is required
for pumps in light liquid service.
Performance Standard
Owners/operators may choose to follow a
performance standard for compressors
instead of an equipment design standard.
Compressors must be equipped with a
closed-vent system designed to capture and
transport leakage from the compressor
driveshaft back to the process or to a control
device achieving at least 95 percent control
efficiency (or 20 ppmv HAP). (See
following discussion on closed vent systems
and combustion devices (Page 6-24)).
6-21
-------
What are the Standards for
Pressure Relief Devices in
Gas/Vapor Service?
Except during pressure releases, pressure
relief devices in gas/vapor service are
required either to operate with no detectable
emissions or to be equipped with a rupture
disk or a closed-vent system and control
device. Pressure relief devices complying
with the no detectable emissions standard
are to be returned to that condition within
5 calendar days after each pressure release,
except as provided in the "Delay of Repair"
provisions. The standards also require the
monitoring of the pressure relief device no
later than 5 calendar days after a pressure
release to confirm that no detectable
emissions has been achieved.
The pressure relief devices need not comply
with the no detectable emissions standard if
they are equipped with a rupture disk
upstream of the PRV or if equipped with a
closed-vent system capable of capturing and
transporting leakage from the pressure relief
device to a control device achieving at least
95% control efficiency or back to the
process. If complying through installation of
a rupture disk, the rupture disk must be
installed upstream of the pressure relief
device as soon as practicable, but no later
than 5 days after each pressure release.
What are the Standards for
Sampling Connection Systems?
Sampling connection systems are to be
equipped with a closed-purge, closed loop,
or a closed-vent system. Each system
should do one of the following:
• Return the purged process fluid
directly into the process line.
• Collect and recycle the purged
process fluid.
• Capture and transport all the purged
process fluid to a control device
achieving at least 95% control
efficiency.
• Collect, store, and transport the
purged process or solid waste fluid to
a waste water management unit, or to
a RCRA treatment, storage or
disposal facility, depending on the
characteristics of the purged fluid.
Subpart H (and GGG) exempt in situ
(without purge) sampling systems.
What are the Standards for Pumps,
Valves, Connectors, and Agitators
in Heavy Liquid Service,
Instrumentation Systems, and
PRV's in Liquid Service?
Pumps, agitators, and valves in heavy liquid
service, pressure relief devices in light liquid
or heavy liquid service, and flanges and
other connectors in heavy liquid service, and
instrumentation systems are to be monitored
within 5 days if evidence of a potential leak
is found by visual, audible, olfactory, or any
other detection method. In lieu of
monitoring, a potential leak can be repaired
as described below. A reading of
s; 10,000 ppmv for agitators, 2,000 ppmv for
pumps, or 500 ppmv for valves, connectors,
instrumentation systems, and PRV's,
indicates a leak.
Repair Provisions
If a leak is detected, a first attempt at repair
6-22
-------
must be made within 5 days after the leak is
detected and the leak must be fixed within
15 calendar days. For the leak to be
considered repaired, visual, audible, or ,
olfactory indications of leaking should be
eliminated; owners and operators can do
leak checks using soap solutions or pressure
tests. The use of M21 is not required to j
certify that the repair is complete if the leak |
was determined to exist without M21 .If j
M21 is used to determine the presence of a j
leak (for heavy liquid) men the repair must j
be certified by M21: :
What if My Repair is Unsuccessful?
...... i. !
If action is taken to repair a leak within the j
specified time, but the repair is not j
successful, this is not considered a violation!
However, the owner or operator is required j
to take further action to repair the leak, i |
' " .1 ' I
What are the Standards for Delay !
of Repair? '
'. |
The following circumstances under which i
repairs may be delayed are provided in the j
rule: • • i"
• Delay of repair of leaking equipment
is allowed if the repair is technically;
infeasible without a process unit !
shutdown. An example of such a j
situation would be a leaking valve j
that could not be isolated from the |
process stream and that would ; j
require complete replacement or'. |
replacement of internal parts. Whenj
a valve cannot be physically isolated
from the process stream, the process!
unit must be shut down to repair the j
valve.
• Delay of repair of leaking
components is allowed if the owner
or operator determines that repair
personnel would be exposed to an
immediate danger if attempting to
repair without a process shutdown.
Delay of repair is allowed for
equipment that is isolated from the
process and does not remain in
organic HAP service. This typically
applies to spare equipment that is out
of service.
Delay of repair for valves,
connectors, and agitators is allowed
if the emissions of purged material
resulting from repair are greater than
the fugitive emissions likely to result
from the delay, and if, during repair,
the purged material is collected and
destroyed or recovered in a control
device achieving > 95% control
efficiency.
Delay of repair for pumps is allowed
if repairs require replacing the
existing seal design with a new
system, or a dual mechanical seal
system that includes a barrier fluid
system, or a pump that meets the
requirements in §63.163(f), or a
closed vent system and control
device that meets the requirements of
§63.163(g). The repair must be
completed as soon as practicable, but
not later than 6 months after the leak
is detected.
Delay of repair beyond a process unit
shutdown is allowed for valves if the
following conditions are met:
- Valve assembly replacement
is necessary during the
.! 6-23
-------
process unit shutdown.
- Valve assembly supplies have
been depleted.
- Valve assembly supplies had
been stocked sufficiently
before the supplies were
depleted.
- Delay of repair beyond the next
process unit shutdown is not
allowed unless the next
process unit shutdown occurs
sooner than 6 months after
the first process unit
shutdown.
Specific recordkeeping requirements relating
to delay of repair are discussed later in this
chapter under Requirements for
Recordkeeping.
What are the Standards for Closed-
Vent Systems Used to Control
Equipment Regulated Under
63.1255?
The regulations require proper operation and
maintenance of a control device and vent
system to control leaks. The closed-vent
system provisions include inspection and
monitoring requirements and requirements
for specific control devices which are at
95 percent efficiency, or achieving outlet
concentrations 20 ppmv HAP. Monitoring
requirements of specific control devices are
covered under other sections of this
document (Chapter 9).
Vent System Requirements
• Initial inspection using M21; annual
visual, audible, olfactory inspection
ifhardpiped: annual M21 inspection
if duct work.
• Leak definition of 500 ppmv or
visual (audible and olfactory)
indication.
First attempt to repair leak should be
made within 5 calendar days of
detection.
• Repair must be completed within 15
calendar days unless there is a
legitimate delay of repair (i.e.,
requires process shutdown or
emissions from immediate repair
would be greater than fugitive
emissions resulting from delay).
Bypass provisions
For any bypass line that could divert a vent
stream away from the control device and to
the atmosphere, either a flow indicator
located at the inlet of the bypass line that
takes a reading every 15 minutes or a lock-
and-key (car seal) type configuration is
required to be installed. For a lock-and-key
or car seal configuration,
a visual inspection of the seal or closure
mechanism is required monthly to ensure
that the valves are maintained hi a
nondiverting position. Records are
generated for the flow indicator or the
inspection, as applicable, as discussed in
Chapter 12 on Recordkeeping.
Exemptions from Bypass Provisions
Low leg drains, high point bleeds, analyzer
vents, open-ended valves or lines, and
PRV's needed for safety purposes are not
required to have either flow indicators or car
seals.
6-24
-------
Exemptions from Closed Vent System,
Provisions 1
Any closed-vent system operating at a ; j
pressure below atmospheric pressure is ! i
exempt from the monitoring and inspection!
provisions. The vent system must be i i
equipped with a pressure measurement 1 I
device that can be read from a readily j
accessible location to verify that negative j
pressure is being maintained in the closed
vent system when it is operating.
Any parts of the closed-vent system thatjare
designated as unsafe to inspect are exempt j
from inspection requirements if personnel j
inspecting would be exposed to an imminent
or potential danger and the o/o has a written;
plan to inspect these pieces of equipmenit j
during safe-to-inspect times, not more than ;
annually. ' !
i
What are the Standards for Batch j
Processes/Alternative Means of \ j
Emission Limitation? : •
™^^™" • i
As an alternative to complying with the ; j
standards for all components (pumps, • j
agitators, connectors, valves, pressure relief
devices, sampling connection systems, open-
ended valves or lines, and instrumentation j
systems), owners or operators may elect to j
comply with equipment leak standards for :
batch processes in two ways: through batch j
pressure testing, or through less frequent ;
monitoring, depending on the percent of j
time that the processes are operating, as j
compared to continuous. Per Table 6-1, !the
provisions of subpart Hare directly
referenced, with the exception that :
continuous processes are also allowed to
undergo batch pressure testing. Pressure
testing also can be applied to supply lines
between storage areas and processing areas.
The source may switch among the
alternatives (pressure testing or monitoring
for leaks) provided the change is
documented.
Pressure Testing
The process train or supply line is required
to be pressure tested each tune equipment is
reconfigured for production of a different
product or intermediate prior to introducing
the HAP into the equipment or at least once
per calendar year for each process carried
out in that equipment. If a leak is detected,
the repair must be completed and the
equipment retested before startup of the
process. Pressure testing is only required for
that equipment which is reconfigured (new
or disturbed) and pressure testing is not
required for routine seal breaks which are
not part of the reconfiguration.
If a leak is detected during pressure testing,
it must be repaired and retested before
process start-up. If the batch process fails
the retest or the second of two consecutive
pressure tests and is started up, it must be
repaired as soon as practicable, but no later
than 30 calendar days after the second
pressure test, unless there is a legitimate
"delay of repair" situation: equipment
supplies are depleted and supplies had been
sufficiently stocked before the supplies were
depleted. The repair must be made no later
than 10 days after delivery of the
replacement equipment.
NOTE: An exception to this
requirement is if the delay of
repair provisions of § 63.178(d)
apply. Delay of repair applies if the reason
6-25
-------
the leak cannot be fixed is because
replacement equipment is needed to fix the
leak, and this equipment is not available;
provided the equipment had been in stock
before supplies were depleted and provided
the repair is made no later than 10 calendar
days after delivery of replacement
equipment. If these conditions apply, the
batch process train can be put into service,
provided it is fixed within 30 calendar days
after the batch test failure. Therefore,
owners and operators have a maximum of 30
days of operation in which the batch process
equipment train can operate without having
passed a pressure test.
Batch Test Methodology
1. Using Gas Pressure for Pressure or
Vacuum Loss
The process equipment should be
pressurized with a gas to a pressure above
the operating pressure of the equipment and
less than the set pressure of any safety relief
device, or placed under vacuum. Once the
pressure or vacuum has been established, the
pressure or source vacuum should be shut
off. A pressure measurement device capable
of measuring ± 2.5 mmHg in the range of
the test pressure or at least ±10 percent of
the test pressure should be used to detect any
change in pressure, in psig/hr, that can occur
over the course of at least 15 minutes; if the
amount of time for the pressure test is 15
minutes exactly, the corresponding change
in pressure to equal a 1 psig/hr change
would be 12.9 mmHg. Therefore, a leak
would be detected if the pressure device
indicates an increase or decrease of 12.9
mmHg. The rate of change in pressure is
calculated according to the following
equation:
t (tf-t,)
where:
delta P/t = change in pressure, psig/hr
Pf = final pressure, psig
PI = initial pressure, psig
elapsed time, hours
A leak is also detected if there is evidence of
a leak by visible, audible, or olfactory
evidence of fluid loss.
2. Using Liquid for Indications of Liquids
Dripping
A batch pressure test can also be conducted
using a liquid, in which the equipment is
filled with the liquid until normal operating
pressure is achieved. Once this occurs, the
liquid source is also shut off. This test
occurs for at least 60 minutes, unless it is
obvious that the test is a failure prior to 60
minutes. Once the operating pressure is
achieved, each seal in the equipment being
tested should be inspected for indications of
liquids dripping or other indications of fluid
loss. Any of these indications constitutes a
leak.
6-26
-------
Table 6-3. BATCH PROCESSES MONITORING FREQUENCIES FOR
EQUIPMENT OTHER THAN CONNECTORS AND PUMPS
** }
," Operating time,
^ % of year f>
Oto<25
25 to <50
50 to <75
75 to 100
Equivalent continuous process monitoring frequency tim^in use ,-* «
Monthly
Quarterly ' |
Quarterly : j
Bimonthly , j
Monthly i i
^Quarterly"" *•'
Annually
Semiannually
Three tunes
Quarterly
^ Semiannually
Annually
Annually
Semiannually
Semiannually
Batch Method 21 Monitoring ;
Owners and operators may also choose to
monitor for leaks using Method 21. The
provisions of subpart H (and subpart GGG,
by reference) allow for reduced monitoring
frequencies for all components, except
connectors and pumps, based on the :
proportion of the year that the process ;
subject to the provisions is operating, |
monitoring must occur at any tune the :
equipment is operating in organic HAP
service, hi use with an acceptable surrogate
VOC which is not a HAP or is in use with
any other detected gas or vapor. For
example, if a batch process and equipment
are operated for one 6-week campaign per
year, the percent operating time is:
-_
^campaign )\. 52 weeks,
11% operating time!
i
Table 6-3 presents the adjusted monitoring
frequencies for batch processes; however, :
for pumps, the frequency is always quarterly
Monitoring is allowed any time during the '-
specified monitoring period (e.g., monthly,:
quarterly, yearly) provided sufficient time j
between scheduled monitoring occurs. For
example, it would not be acceptable to
monitor Dec. 31st of one year and Jan. 1st of
the subsequent year. In addition, if the
equipment is not operating during the
scheduled monitoring period, the monitoring
can be done during the next period when the
process is operating.
In addition to the scheduled monitoring that
must be conducted according to the
frequencies established for various
components, § 63.178(c) also requires that
M21 monitoring be conducted within
30 days of reconfiguration. However, this
monitoring effort is separate from the
scheduled monitoring. Leaks detected
during this effort are not included in
determining percent leaking equipment in
the groups of processes.
If a leak is detected using Method 21, any
leaks detected must be repaired within 15
days of detection, unless there is a legitimate
"delay of repair" situation, as described in
the preceding paragraph.
6-27
-------
What are the Requirements for
Enclosed-Vented Process Units?
Process units that are totally enclosed such
that all emissions from equipment leaks are
vented through a closed vent system to a
control device are exempt from the
monitoring requirements. Negative pressure
must be maintained during process operation
to ensure that all emissions are routed to the
control device.
What are the Requirements for
Recordkeeping?
NOTE: For ease of referencing, the
following list uses the same numbering
found in the regulations at §63.1255(g)(l)-
(10).
• An owner or operator with more than
one group of processes subject to the
leak detection rules can keep all of
the records in one recordkeeping
system if it identifies the program
being done (e.g. quarterly
monitoring) for each type of
equipment. The following
information is required to be
maintained in a manner that can be
readily accessed at the plant site,
either from records kept at the plant
site or accessed from a central
location by computer at the plant
site.
2. General Records
List of Equipment ID Numbers
• List of identification numbers
of all equipment, except for
connectors that have been
designated as inaccessible. If
equipment is not individually
identified, it should be
identified as a group, and the
number of subject items of
equipment within a
designated area associated
with the group recorded. The
list must be completed no
later than the initial survey
required for the component
type and changes noted
within 90 days or in the
Periodic Report that covers
the period hi which the
changes were made,
whichever is later.
List of identification numbers
of equipment complying by
being sent to a closed-vent
system and control device.
List of identification numbers
of compressors designated as
no detectable emissions.
List of identification numbers
for pressure relief devices
subject to monitoring and
those equipped with rapture
disks.
List of instrumentation
systems subject to provisions
(individual components need
not be identified).
List of equipment designated
as difficult-to-monitor,
unsafe-to-monitor, and
inaccessible and a copy of the
written plan for monitoring or
inspecting this equipment.
If credit for removed
connectors is used, list of
connectors removed from and
added to process groupings
6-28
-------
and documentation of the
integrity of the weld. : j
• List of equipment added to ;
batch processes since the last
monitoring period that is j
monitored using Method 21 i
according to the alternative j
means of emission limitation:
for batch processes; this list j
must be completed within 90
days of the completion of
each monitoring period, or by
the next Periodic Report, •
following the end of the j
monitoring period, whichevejr
is later. Also, if the owner or
operator elects to adjust I I
monitoring frequency by the [
time in use provisions in: ;
63.175(c)(3)(iii), record the j
proportion of the year '•
equipment subject to the
standards was in use J
(63.1255(g)(2)(viii). ;
Schedule of Monitoring , j
• Schedule for monitoring of [
connectors and valves in ; ,
gas/vapor service and light |
liquid service. ~ \
1
Design Information ; |
• Design information on pumps
with dual mechanical seal .
systems. '
• Design information on ;
closed-vent system and i
control device, if used to j
control emissions from . :
LDAR components. : I
3. Records of Visual Inspections
• Records of dates of visual
. inspection for pumps,
agitators and closed-vent
systems.
4. Monitoring Records (leaker logs)
When a leak is detected (either by M21 or
visual, audible, or olfactory means), the
following information is required to be
recorded and kept for a total of 5 years
(2 years onsite and an additional 3 years
onsite or offsite):
• Instrument and equipment
identification number and
operator name, initials, or
I.D. number.
• Date leak was detected and
date of first attempt to repair.
• Date of successful repair.
• The maximum instrument
reading measured by M21
after a leak is successfully
repaired or determined to be
nonrepayable.
• "Repair delayed" and reason
for delay of repair, if
applicable.
• If delay of repair involved,
dates of process unit
shutdowns that occurred
while equipment was not
repaired.
• If applicable, the written
procedure that identifies the
conditions that justify delay
of repair.
• The procedures can be
included as part of the
startup/shutdown/malfunction
plan OR can be in a separate
6-29
-------
document that is
kept at the site.
• If the delay was caused by a
depletion of parts,
documentation that the spare
parts had been sufficiently
stocked before depletion and
the reason for depletion.
Also, even if leaks are not detected, the
following information is required to be
recorded and kept for 2 years onsite and
3 years offsite:
• Dates and results of startup or
reconfiguration monitoring
required by monitoring
requirements for batch
processes (§ 63.178(c)(3)) for
equipment added to the
processes since the last
monitoring period and, if no
leaks found, a record that the
inspection was performed.
• If connectors whose seals
have been broken are being
monitored, identification by
list, location (area or
grouping), or tagging of
connectors disturbed since
the last monitoring period.
• Copies of periodic reports.
5. Records of Pressure Tests
Instead of the records in 2., 3., and 4. above,
owners/operators using pressure testing must
keep the following records:
• Identification of each product
produced during the year.
• Dates of pressure tests, test
pressures, and pressure drops
observed during the test.
• Records of any visible,
audible, or olfactory evidence
of fluid loss.
• Identification of equipment
subject to pressure testing.
Physical tagging is not
required. Equipment may be
identified on a plant site plan
hi log entries or other
appropriate methods.
• When a process equipment
train does not pass two
consecutive pressure tests and
is put into HAP service prior
to being repaired and passing
a test, the following
information is required and
must be retained for 2 years:
— date of each pressure
test and date of each
leak repair attempt.
- repair methods
applied in each
attempt
- reason for delay of
repair
- expected date for
delivery of
replacement
equipment and actual
date of delivery
- date of successful
repair.
6. Records of Compressor and Pressure
Relief Device Compliance
Tests and Relief Device Compliance Tests
• Dates and result of each
compliance test required for
compressors designated as
"no detectable emissions,"
including:
— background level
6-30
-------
measured during each
compliance test
- maximum instrument
reading measured'at
the compressor seal
• Dates and results of the
monitoring following each
PRV release, including: i
— background level:
measured during eacl.
compliance test
- maximum instrument
reading measured at
thePRV !
7. Records for Closed Vent Systems (CVS)'
For closed vent systems to which fugitive
emissions are ducted, design specifications {
and performance demonstrations of the : •
control device and piping and '
instrumentation diagrams should be i !
maintained for the life of the equipment.
These include:
detailed schematics, design :
specs of j£he control device,!
and piping and ;
instrumentation diagrams t
dates and descriptions of ;anyj
changes in the design specs ;
the flare design (whether it i^
steam assisted, air ,
assisted, or nonassisted) and «
the results of the compliance]
demonstration j
a description of the :
parameters) monitored and \
an explanation of why the j
parameter(s) were chosen, j
Also, for at least 2 years, records should be
maintained of:
• Dates and duration of non-
operation of the systems
• Dates and duration when
monitored parameters are
outside ranges established in
initial compliance
determination.
• Dates and durations of
startup/shutdown/malfunction
occurrences.
• Records of inspection of CVS
and results (documenting no
leaks or information hi (4.)
above).
• Records of operations of
CVS and control device.
8. Records for Components in Heavy-
Liquid Service
Information used to demonstrate that a
component is in heavy liquid service should
be recorded.
The demonstration should show that the
process fluids do not meet the criteria of "hi
light liquid or gas service." Information
could include records of chemicals
purchased for the process, analyses of
process stream composition, engineering
calculations, or process knowledge, or other
information offered by the owner/operator.
9. Records of Exempt Components
Information used to identify and
identification of equipment hi organic HAP
service less than 300 hours per year should
be recorded. Identification may be either by
list or location.
6-31
-------
10. Records of Alternative Means of
Compliance Demonstration: Enclosed- ;
Vented Unit
Owners and operators complying by
enclosing emissions through a closed vent
system operating under negative pressure
should maintain the following information:
• Identification of processes
and the organic HAP they
handle
• Schematics of the process,
the enclosure, and closed-
vent system
• Description of the system
used to create a negative
pressure in the enclosure to
ensure that all emissions are
routed to the control device.
What are the Reporting
Requirements?
Subpart GGG requires that the following
reports be submitted for equipment subject
to § 63.1255:
• Notification of Compliance Status
Report (NOC) (submitted within
150 days of compliance date)
containing:
— process group
identification
- numbers of each
equipment type
(except equipment in
vacuum service)
— method of compliance
with the standard
— products or product
codes subject to
processes complying
by pressure testing, if
available
- planned schedule for
pressure testing
- identification of
processes complying
with § 63.179
(enclosure to negative
pressure manifold)
and a description of
the system used to
create negative
pressure
Periodic Reports (submitted
semiannual ly 240 days after
NOCSR). The first Periodic Report
covers the 6 months beginning on the
due date of the NOCSR (See section
63.1255(g)(3)(i). Owners/operators
of all equipment except for that
complying through pressure testing
must provide the following:
— the number of valves for
which leaks were detected,
the percent leakers and total
number of valves monitored
- the number of valves for
which leaks were not repaired
and the number of valves that
are nonrepairable
- the number of pumps for
which leaks were detected,
the percent leakers for
pumps, and the total number
of pumps monitored
- the number of pumps and
agitators for which leaks
were not repaired
- the number of compressors
for which leaks were detected
— the number of compressors
for which leaks were not
repaired
6-32
-------
the number of connectors; for j
which leaks were detected, j
the percent of connectors i 1
leaking, and the total number
of connectors monitored j
the number of connectors for j
which leaks were not repaired
and the number of those ' j
determined to be , j
nonrepairable i ;
the facts that explain any j
delay of repairs and when ;
appropriate, why a process j
shutdown was technically
infeasible : |
the results of all monitoring |
of compressors designated as;
no detectable emissions, i j
PRV's, and closed vent [
systems |
if applicable, the initiation of;
monthly monitoring for I i
valves or pumps
if applicable, a change in|
connector monitoring : j
alternatives as described in <
§ 63.174(c)(l) !
for processes complying by
pressure testing, ; j
• the product process • i
equipment train J j
identification ;
• the number of pressure j
tests conducted > ;
• the number of pressure |
tests where equipment j
train failed either the; |
retest or two consecutive;
pressure tests ' !
• the facts that explain ianyj
delay of repairs, and j
• the results of all !
monitoring to determine'
compliance with
§ 63.172(f) of Subpart H.
any revisions to items
reported in the NOC, if the
method of compliance has
changed.
6-33
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-------
.. ... .; CJfaapterT
Requirements for Wastewater
7.1
Overview - Suppression and
Control
The wastewater provisions of the MACT j
differ from the provisions for tanks and : j
process vents in that they are concerned wit|i
both suppressing air emissions within the [
wastewater treatment chain (i.e. individual
drain systems, treatment tanks, etc) as well
as reducing HAP in the wastewater itself
through performance standards. \
Additionally, any air emissions vented ;
during the treatment process must be
controlled via traditional air pollution
control devices and equipment leak :
provisions apply to vapor collection systems,
closed vent systems, roofs, covers or other
enclosures used to comply with the rule.
Residuals created from treatment processes
must either be recycled, returned to the
treatment process or destroyed. Although
not considered wastewater, this
Chapter 7 at a Glance
7.1 Overview
7.2 Structure of the Regulation
7.3 Applicability
7.4 Standards
7.5 , Compliance Demonstration
Procedures
chapter also describes requirements for heat
exchangers and equipment in open systems.
The suppression and control requirements
are summarized below:
TYPE OF STANDARD
MEBIA
PURPOSE
air
Use equipment specs and operating practices to
minimize HAP losses to the air from tanks, surface
impoundments, containers, and individual drain
systems (i.e., cover equipment to limit emissions)
Performance Standards
'" '
Wastewater
Treatment
(WWT)
Air Emissions
Control (EC)
1.
2,
water
air
Use wastewater treatment processes to
reduce the HAP content in the wastewater
(i.e. removal, destruction, treatment in bio
units, etc)
Use control device specs or performance
standards for air pollution control devices
(APCDs) to reduce HAP emissions (i.e., use
APCDs) vented from treatment processes
7-1
-------
These two types of standards - VS and PS
(with EC and WWT subsets) - will appear
throughout this chapter, since they establish
the structure of the regulations for
wastewater.
The rule contains many of the same
requirements found in the wastewater
section of Subpart G of the HON (§63.131-
.149). This includes vapor suppression
requirements, air pollution control device
(APCD) requirements, compliance
demonstration procedures, inspection and
monitoring requirements, and requirements
for certain liquid streams in open systems.
Please be aware that the HON regulations
are not exactly the same as the
pharmaceutical MACT regulations, and the
HON regulations should not be used to
interpret specific requirements of the
pharmaceutical MACT.
7.2 Structure of the Regulation
The pharmaceutical MACT addresses
wastewater requirements in several sections.
General applicability provisions are
contained in §63.1250 and definitions are
provided in §63.1251. More specifically,
§63.1256 covers wastewater standards and
§63.1257(e) covers initial compliance
demonstration procedures for wastewater.
Wastewater also is addressed in §63.1252
(Standards: General) and §63.1258-1260
(Monitoring, Record Keeping and
Reporting). The primary components of the
wastewater provisions are shown in Figure
7-1.
What Wastewaters are Subject to
the Pharmaceutical MACT ?
7.3 Applicability
A wastewater stream is subject to this
regulation if it meets the definition of a
wastewater stream, per §63.1251.
Wastewater Stream Definition
The definition of a wastewater stream is:
1. Water that is discarded from a
PMPU through a single Point of
Determination (POD),
2. Has a concentration of Partially
Soluble HAP (PSHAP) and /or
Soluble HAP (SHAP) compounds of
at least 5 parts per million by weight
(ppmw), and
3. Has a Total HAP load of at least 0.05
kg/yr.
Point of Determination - Point where a
•wastewater streamexits thj; process,
storage tank, or last recopery^device^ If
are not recovered for re^se before
discharge, then the discharge point
from the process eauipment or storage
tank is the POEf^There can be more
than one POD per process or PMPU..,
The regulated wastewater compounds
identified above as Partially Soluble HAP
(PSHAP) and Soluble HAP (SHAP) are
listed in Tables 2 and 3 of the regulation.
The sum of PSHAP and SHAP compounds
is referred to as Total HAP.
7-2
-------
Exemptions
The following are not considered regulated
wastewaters per the definition of wastewater
stream: i
• Stormwater from segregated sewers,
• Water from firefighting & deluge
systems (including testing of such
systems), '.
• Spills,
• Water from safety showers,
• Samples of a reasonable size for
analysis,
• Equipment leaks,
• Wastewater drips from procedures
such as disconnecting hoses after
clearing lines, and \
• Noncontact cooling water.
Scrubber Effluent
If a scrubber is being used to control vent ;
streams containing partially soluble HAP ,
(PSHAP), in order to meet the process vent!
standards in §63.1254, the effluent from the{
scrubber is considered an affected j
wastewater stream and is therefore subject to
the wastewater provisions in the MAGT. !
i I
Multiphase Wastewater Streams
The regulations at §63.1256(a)(3) provide
that a separate phase that can be isolated
through gravity separation cannot be
discharged to a waste management or
treatment unit, unless it is discharged to a
RCRA unit.
Table! to SiabpartGGG. Partially
>Sol«bIeJIAP
1,1,1-Trichloroethane (methyl chloroform)
1,1,2,2-Tetrachloroethane
1,1,2-Trichloroethane
1,1-Dichloroethylene (vinylidene chloride)
l£-Dibr6moethane
1^2-DJchloroethatte (ethylene dichloride)
1 ^-Dichloropropane
1,3-Dichloropropene
2,4,5-Trichlorophenol
2-Butanone (mek)
1^4-IJiphlprobenzene
4-Methyl-2-pentanone (mibk)
Acetaldehyde
AcroleM
Aciyioniftile
Allylchloride
Benzene
Benzyl chloride
Biphenyl '*•"
Bromofprm (tribromomethane)
Brompmefliane ^
Butadiene
Carbon disulfide
Chlorobenzene
Cbloroethane (elhyl chloride)
Chloroform
Chloromethane
Chloroprene
Cumene
Dichloroethyl ether
Dinitrophenol
Epichlorohydrin
Ethyl acrylate ,
Ethylbenzene
Ethylene oxide
Hexachlorobenzene
Hexachlorobutadiene
Hexachloroethane
Methyl methacrylate
Methyl-t-bu^tl ether
Methylene chloride
7-3
-------
Table 2 to Subpart GGG. Partially
Soluble HAP (cont.)
N^f-dimethylaniline
Propionaldehyde
Propylene oxide
Styrene
Tetrachloroethene (perchloroethylene)
Tetrachloromethane (carbon tetrachloride
Toluene
Trichlorobenzene (1,2,4-)
Trichloroethylene
Trimethylpentane
Vinyl acetate
Vinyl chloride
Xylene (m)
Xylene (o)
Xylene (p)
N-hexane
Table 3 to Subpart GGG. Soluble
HAP
1,1-Dimethylhydrazine
1,4-Dioxane
Acetonitrile
Acetophenone
Diethyl sulfate
Dimethyl sulfate
Dinitrotoluene
Ethylene glycol dimethyl ether
Ethylene glycol monobutyl ether acetate
Ethylene glycol monomethyl ether acetate
Isophorone
Methanol (methyl alcohol)
Nitrobenzene
Toluidene
7-4
-------
WW Definittons
.1251
Applicability
Wastewater
Standards
* Wastewater
Compliance
Demonstrations
* -r !•••-•<
Determinations
Vapor Suppre
ssion >-
*' Vapor Silppre|ssion
" Emissions Control
* WWTreatment
- *- WW Exemptions
v ^ "WWConcentration and 4aee,..Mvm
* * j^oad Determinations ^^ll1^?,
k, Affected'ww"
,. Prformance S^ndards- ! . _
, Emissions Ccntrol !
* i Performance SteindaRis-
« WWTreatnfent
Equipment
••*- Specifications
••*' Operating Practices
9* l&WI Procedures
Equipment
** Specifications
^PCD Performance
*** Requirements
Treatment Type
* Standards
_ Treatment Performance
Requirements
.1256(b)-{f)
.12S6(h)(2H4)
.12S6(h)(2H4)
.1256(0)
.1256(g)
Methods for Determining <___..,,,.
*• Applicability .1257(e)(1)
,,, Document Equipment -*•
"' Emissions Control
•> WastesaterTrektment
,i Startup! Shottiown,
'.; and Malfunction
Production (level
~w~>A i *
Monitoring Frequency
.1258(gHh)
.1258(b)
,1258(g)(2-3)
I&M Procedures
APOD Parameters
WWT Parameters
Startup, Shutdown, and
Malfunction Parameters
Productionlevel
Parameters ,
Establish Monitoring .1258(g)(1-3)
Frequency and Averaging Time
Figure 7-1. Primary Components of Wastewater Provisions (not including Recordkeeping or
Reporting)
7-5
-------
Maintenance Wastewater
Wastewater generated during maintenance
activities is not subject to the full extent of
the MACT standards. There are, however,
substantive requirements for maintenance
wastewater. Primarily, the regulations
require that the owner/operator follow a
written plan to control emissions to the
atmosphere.
Maintenance Wastewater - Wastewater
generated by the draining of process fluid
from components in the pharmaceutical
manufacturing process unit into an
individual drain system prior to or during
maintenance activities. Maintenance
wastewater can be generated during
planned and unplanned shutdowns and
during periods not associated with a
shutdown. Examples of activities that can
generate maintenance wastewaters include
descaling of heat exchanger tubing bundles,
cleaning of distillation column traps,
draining of pumps into an individual drain
system, and draining of portions of the
pharmaceutical manufacturing process unit
for repair. Wastewater from cleaning
operations is not considered maintenance
wastewater.
Owners/operators with maintenance
wastewater containing HAPs must comply
with the following four requirements:
1. Prepare a description of management
for wastewater generated from the
emptying and purging of equipment
during temporary shutdowns for
inspections, maintenance, and repair
AND during periods that are not
shutdowns (i.e. routine
maintenance). In the description:
• Identify process equipment or
maintenance tasks that are
anticipated to create
wastewater during
maintenance activities,
• Describe the procedures that
will be followed to manage
the wastewater and control
HAP emissions to the air, and
• Describe the procedures that
will be followed when
clearing materials from
process equipment.
2. Modify the information provided in
1. as needed after each maintenance
procedure, based on actual
procedures followed and wastewater
generated.
3. Follow these plans as part of the
startup, shutdown and malfunction
(SSM) plan required under
§63.6(e)(3).
4. Maintain a record of the information
needed to prepare the description
under 1.) and the adjustments under
2.). The recorded information must
be maintained.
Heat Exchange Systems
Heat exchange systems that cool process
equipment or materials used in a
pharmaceutical manufacturing operation
must be checked for releases of HAPs if the
process equipment contains materials that
are greater than 5% HAPs. The specific
requirements are provided at §63.104 and
63.1252(c)(2). For equipment that meets
current good manufacturing practice
(CGMP) requirements in 2.1 CFR Part 211,
the owner/operator may elect to use the
physical integrity of the reactor as the
surrogate indicator of heat exchanger system
7-6
-------
leaks around the reactor. If a leak is
detected, the system must be repaired no
later than 45 days.
If CGMP is not used to identify leaks in heat!
exchange systems, then one of the following
methods from §63.104 must be used. ! j
Cooling water in heat exchanger systems i j
may be monitored quarterly using HAP, i
TOC, or an alternative constituent that will ;
identify the presence of leaks. If the cooling ;
water in a heat exchange system is subject to,
NPDESpemutlimitsonHAP,TOC,ora '
related compound, and such limits are 1 • ,
ppmw or less, then the NPDES permit ! ,
compliance monitoring can be used to detect j
cooling system leaks. . . •
: !
If the heat exchange system is operated with [
a minimum pressure on the cooling water !
side at least 35 kPa greater than the i
maximum pressure on the process side, •, j
cooling water monitoring is not required. I
If a leak is detected by any of the above \
methods, the system must be repaired no
later than 45 days following detection. |
Equipment in Open Systems - Drains, '
Manholes, Lift Stations, Trenches, Pipes, i
Oil/Water Separators, Tanks \ !
. . j
Section 63.1252(f) of the MAGT regulationsj
requires that steps be taken to prevent i
releases in systems upstream of the point of <
determination (POD). Drains or drain hubs, j
manholes, lift stations, trenches, pipes, : j
oil/water separators, and tanks that handle
affected liquid streams are subject to these i
requirements. The specific requirements are '
listed in Table 5 of the regulations. They !
essentially require tightly-fitting solid j
covers; emissions can be vented to process
or to a control device that meets the
wastewater control device standards at
§63.1256(h)(2). The intent of mis section is
to require the closure of systems such as in-
process recycle/recovery systems. It is not
intended to be applied to process and storage
tanks with vents that are in compliance with
the process vent standards.
7.3.1 Affected Wastewater Criteria
If a wastewater meets the definition of a
"wastewater stream" and the HAP
concentration and load threshold levels
described below, it must meet the
requirements of this regulation. This
document describes the 4 affected
wastewater categories as shown below in
Figure 7-2.
NOTE - PMOs opting to comply with the
wastewater standards by using the 95%
mass reduction option for biological
treatment processes are subject to more
stringent suppression standards. In this
circumstance any wastewater stream (i.&
any stream containing at leasts ppmw
PSHAP or SHAP) is subject to the vapor
suppression standards and all wastewater
, streams must be includedAn the percent
reduction demonstration, JJnder tfye other
compliance options only "affected"
wastewater streams are subject to the vapor
suppression standards.
7-7
-------
New or Basting
Wastewater has total
HAP from the
IKS.!**.******* •<# *
;*'* Annual average
t PSHAP atthe
OR
„»— «
4 Annual average total
HAP at the
* POO > 5200 ppmw
«
A
.1256(a)(1)(i){A)
B
,1256(a)(1}(i}(B}
New or Existing
I Wastewater lias total
HAP from the
{ facilitjf>1 Mg/yr
New
i Wastewater has total
« HAPfromthe
L PMPU>1Mg/yr ' ^
Annua! average total
HAPatthe
* POD>1fl,000,ppmw
.i256(a)(t)(ij(C)
*Note - Regardless of annual loading or concentration, wastewater from a scrubber used to control
PSHAP containing vent streams in order to comply with the process vent standards is considered to be an
affected wastewater stream.
Figure 7-2. Four Affected Wastewater Categories A-D
Note on Wastewater HAP
Concentrations: Wastewater HAP
concentration is used in two ways
throughout this rule. One is what
can be called the wastewater HAP emission
potential concentration and the other is just
the wastewater HAP concentration. The
emission potential concentration is the
portion of a wastewater HAP compound that
theoretically volatilizes into air. Emission
potential values are determined by dividing
true HAP wastewater concentration by the
compound specific fraction measured (Fm)
factors listed in Table 8 of the regulation.
The rule does not specifically use the term
"emission potential concentration," but
whenever Method 305* is mentioned, this
means emission potentials, (i.e., Method
305 is used to determine wastewater HAP
emission potential concentration).
If method 305 is used to determine PSHAP
and SHAP concentrations in wastewater, the
measured concentrations must be adjusted
by
the Fm value to determine if a wastewater is
affected. If any of the other analytical
methods listed in 63.1257(a)(10) are used
for the determination, the measured PSHAP
and SHAP concentrations are not adjusted.
"Method 305 = Measurement of Emissions Potential
of Individual Volatile Organic Compounds in Waste
7»8
-------
Where is a Wastewater Stream
Characterized for Determining
Applicability ?
7.3.2 Characterizing or Designating:
Wastewater as Affected
For determining whether a wastewater is
affected, an owner/operator (O/O) can '
either '"• i:-,''-,'.' . . ;i
1) Characterize a wastewater stream a
each Point of Determination (POD),
DR
2) Designate a wastewater stream as
affected. |
If the
owner/
operator....
Characterizes
the
wastestream
Designates
the
wastestream
Then....
Owner/operator must determine annual
average concentration and load (see 4
categories A-D on previous page) ;
Owner/operator not required to
determine annual average concentration
and load.
Must meet same standards as those <
applicable to characterized streams.
The wastewater handling equipment
upstream of point of determination must
meet vapor suppression and emissions
control standards (discussed in section
7.1). |
Downstream of the point of :
determination, wastewater must meet
treatment standards as well as vapor
suppression and control requirements.
i
Wastewater treatment options for
designated streams do not include
treating streams to 50 ppmw PSHAP,
S20 ppmw SHAP or using enhanced
biological treatment ,
The O/O may use a combination of ; ;
characterization or designation for different:
affected wastewaters generated at the source.
The designation procedure allows an O/O to:
choose a location further downstream of j
multiple potential affected wastewater
streams without having to determine
applicability for each one. There are no
restrictions on where a wastewater stream is
Recovery device - an individual unit of equipment
used for recovering chemicalsfoi-fuelvalue,use,
reuse, or for sale forjfiiet value, usetor reuse.
Examples include decantei-s, strippers, and thin-
designated, other than that it must be at or
downstream from the point of determination
(POD).
7.3.3 POD
If a wastewater stream is to be
characterized for determining applicability,
the characterization must be at a POD. A
POD means the point where the stream exits
the process, storage tank, or last recovery
device. If HAPs are not recovered for reuse
from the water before discharge, the
discharge point at the process equipmjent or
storage tank is the POD, as shown in the
example below for Site #2. If streams are
routed to a recovery device, the discharge
from the recovery device is the POD, as
shown below for Site #1.
There can be more than 1 POD per process
orPMPU.
Figure 7-3 presents sample process
wastewater flow layouts showing example
PODs and PMPUs.
7-9
-------
Figure 7-3. Example Wastewater Flow Scheme Showing POD Locations.
7.4 Standards
If a wastewater stream (including scrubber
blowdown from units that treat PSHAPs)
falls into one of the four criteria categories
(referred to as A-D in Figure 7-2) and is not
excluded as listed above, the facility is
subject to Subpart GGG wastewater
standards. The requirements can be
separated into:
• vapor suppression standards (cover
and operate equipment to avoid
losses to the air),
• performance standards
• wastewater treatment standards
(treat wastewater to remove HAPs)
and
7.4.1
air emissions control standard (use
APCDs to control emissions of
PSHAPs and SHAPs vented during
wastewater treatment)
Vapor Suppression Standards
Summary
Vapor Suppression (VS) requirements are
provided for five kinds of waste
management units:
• wastewater tanks
• surface impoundments
• containers
• individual drain systems
• oil water separators
7-10
-------
Vapor suppression standards, summarized in
Table 7-1 below, include: I i
• equipment specifications ; :
• operating practices, and ; j
• equipment inspection and monitoring
(I and M) procedures.
Table 7-1. SUMMARY OF
WASTEWATER VAPOR
SUPPRESSION STANDARDS
i
Standard
Equipment
Specifications
Operating
Practices
Inspection
and
Monitoring
Procedures
Specification
specified equipment types'
designed to minimize loss of
airborne HAPs to the '
atmosphere (e.g., tank roofs,
surface impoundment covers,
container vent systems,
sewer drain water seals) !
i
specified procedures to
follow to minimize loss of
HAP vapors (e.g. wastewater
container filling guidelines)
periodic inspections ;
conducted to minimize HAP
losses from worn equipment
or improper operating ;
practices (e.g., visually ,
inspect for cracks, gaps, or
holes in wastewater junction
box covers)
In characterizing a wastestream to
determine applicability of M ACT
wastewater provisions, is the owner or
operator required to determine the annual
average concentration of Partially Soluble
HAPs and Soluble HAPs ? The O/O may
choose to designate a wastewater stream as
affected. If this is done, then the annual
averageJPSHAP and SHAP wastewater
concentrations need not be determined.
However, if the O/O chooses to determine
concentrations for assessing (i.e.,
characterize), then it must be done hi such a
way that concentration values represent the
annual average. The annual average is
defined as the total mass of HAP (PSHAP or -
SHAP) occurring in the wastewater during a
calendar year divided by the total mass of
the wastewater. Determinations can be made
using either test methods, knowledge of the
wastewater stream, or bench-scale or pilot
scale test data. If the determination is
made:
1) downstream of the POD where
• two or more streams have joined,
2) after the stream has been treated,
or
3) after losses to the atmosphere
have occurred,
then adjustments must be made to the data so
that it represents conditions at the POD.
Values derived from testing or from applying
knowledge of the wastewater must be
reported in the Notification of Compliance
Status report. Values derived from bench-
scale or pilot scale test data must be
documented in the Precompliance report.
Additionally, if a site conducts wastewater
sampling to characterize the wastewater,
then the site must develop and maintain, on-
site, a Sampling Plan to document measures
taken to ensure that volatization losses are
minimized during sampling.
7-11
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VS: Wastewater Storage Tanks
The first of the vapor suppression standards
is for wastewater tanks, which are provided
in §63.1256(b). These requirements are
summarized in Table 7-2.
Wastewater Tank - a stationary waste
management unit that is designed to contain an
accumulation of Wastewater or residuals and is
constructed primarily ofnonearthen materials
(e.g., wood, concrete, steel, plastic) which ;
provide structural support. Flow equalization
tanks are included in the definition.
If the tank meets certain size and maximum
true vapor pressure criteria, the O/O must
comply with Tank Roof requirements
(Fixed, Floating, etc) and associated Closed
Vent System and APCD requirements (if
applicable). The definition of maximum
true vapor pressure provides guidance on
how to calculate it.
Note on using open or closed
biological treatment processes:
Waste management units
specifically used for biological
treatment are not subject to wastewater
storage tank or surface impoundment
vapor suppression requirements. The
processes must be designed to meet the
definition of either an open biological
treatment process or a closed biological
treatment process in order for the exemption
to apply.
Maximum True Vapor Pressure - the "^
equilibrium partial pressure e$e£ted by thetotali
organicHAPin the stored or transferred liquid
at the temperature equal to the highestcalendar-
month average of the liquid storage or transfer
temperature for liquid$:s(6red or transferred
above or below the ambient temperature or at
the local maximum monthly average temperature
as reportedbythe National Weather Service for
liquids stored or transferred at the ambient
temperature, as determined;;„
• In accord/once with methods described
in Chapter :19^2 of the American
Petroleuminstitute'sManual of
: Petroleum Meast^ement-Standards, ,.
Evaporative Loss From Floating-Roof
Tank (incorporated by reference as'
specifiedin§63.14);:&r
• As obtained from standard reference
texts; or
• As determined by the American Society
for testing and Materials Method
D2879-97, TestMethodfor Vapor
PressurefTemperature'Relationshipand
Initial Decomposition Temperature of ~
,-: Liquids bylsoteniscope (incorporated
by reference as specified in §63.14);
or
Any other method approved by the
Administrator.
7-12
-------
Table 7-2. WASTEWATER STORAGE TANK VAPOR SUPPRESSION STANDARDS
Criteria \
Tank Capacity, T
(m3)
/
t<75
75s:T
-------
Table 7-3. WASTEWATER SURFACE IMPOUNDMENT VAPOR SUPPRESSION
STANDARDS {§63.1256(c)>
Vapor
Suppression
Method (Choice)
Standard
Cover/Closed
Vent System to a
Control Device, fir
A. Unless system is maintained under vacuum, a Cover/Closed Vent System must be
maintained according to 63.1258(h) {Leak inspection provisions for Vapor
Suppression Equipment},
B. Openings maintained in closed position, and
C. Cover used at all times
Floating
Membranes
A. Designed to float and form continuous barrier
B. Constructed from synthetic that is either
1. HOPE >100 mils
2. A material or composite of materials having the equivalent organic
permeability and physical and chemical properties of 100 mils HDPE and
that maintains material integrity for service life of material.
C. No visible cracks, holes, gaps or open spaces between cover section seams or
between the interface of the cover edge and its foundation mountings
D. Each opening equipped w/ closure device that when closed shows no visible
cracks, holes, gaps, or other open spaces in the closure device or between the
perimeter of the cover opening and the closure device.
E. Equipped w/ one or more emergency storm water drains (optional)
F. Closure devices shall be made of suitable material
G. When wastewater is present, openings shall be closed and cover on except during
inspection, maintenance, etc. Shall be maintained (inspected) according to
63.1258(h).
VS: Wastewater Containers
Wastewater Containers standards contained
in §63.1256(d) are summarized in Table 7-4.
The regulation addresses any container with
a capacity greater than or equal to 0.1 m3 (25
gallons) that receives, manages or treats
affected wastewater. For containers with
capacity greater than 0.42 m3 (110 gal), the
standards call for using a cover and openings
to be maintained according to §63.1258(h),
Leak Inspection Provisions for Vapor
Suppression
Equipment. For those less than 0.42 m3 (but
greater than 0.1 m3), the O/O can choose
between meeting existing DOT regulations
(49 CFR part 178) or maintaining w/o leaks
according to 63.1258(h).
Container - as used in the wastewater
provisions, means toy portable waste
management unit that has a capacity greater
''than or equal to 0.1 m3 in which a material is
stored, transported, treated, or otherwise
handled. Examples of containers are drums, ,
barrels, tank trucks, barges, dumpsters, tanli
cars, dump trucks, and ships.
7-14
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Table 7-4. WASTEWATER CON?AltNERS VAPOR SUPPRESSION STANDARDS
{§|63.12S6(d)}
Size
Standard Description (with Section Numbers)
>0.42
in3(110
1. Maintain cover as follows;;
- Maintain cover arid openings according to §63.1258(h),
- Keep cover and openings closed unless for filling, removal, inspection,
sampling, pressure relief or safety related reasons.
2. When filling; j
- Either use submerged pipe when filling, with end of fill pipe no more
than 15 cm or 2 pipe diameters from the bottom of the container, OR
locate container within
enclosure that has closed vent system that routes
organic HAP vapors vented from the container to a control device, OR use
a closed vent system toj vent displaced vapors from the container either to a
control device or back to the equipment from which the wastewater is
transferred. i
- Keep cover and openings closed unless needed for filling
3. When it is necessary for container to be open, locate it w/in an enclosure w/
Closed Vent System that routejs vapors to APCD and:
- Maintain enclosure according to §63.1258(h) - see Monitoring chapter
for I and M requiremeiits, .
- Maintain APCD according to §63.1256(h),
- Inspect Closed Vent System according to §63.1258(h),
- If under vacuum, noj: required to maintain according to §63.1258(h).
* 0.42
m3(I10
1. Maintain cover as follows;!
- Comply with either: i
A. Meet DOT ^9 CFR 178, or
B. Maintain without leaks according to §63.1258(h). See
Monitoring chapter for I and M requirements.
- Keep cover and opeijungs closed unless for filling, removal, inspection,
sampling, pressure relief or safety related reasons.
2. When it is necessary for container to be open, locate it w/in an enclosure w/
Closed Vent System that routes vapors to APCD and:
- Maintain enclosure according to §63.1258(h). See Monitoring chapter
for I and M requirements.
- Maintain APCD accbrding to §63.1256(h),
- Inspect Closed Vent System according to §63.1258(h),
- If under vacuum, not required to maintain according to §63.1258(h).
7-15
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VS: Individual Drain System
Wastewater Individual Drain Systems
standards contained in §63.1256(e) are
summarized in Table 7-5. The standard
addresses any individual drain system that
receives or manages affected wastewater or
residual removed from affected wastewater.
The standards present 2 options for
suppressing emissions from individual drain
systems (IDS). The first option is using a
closed IDS with a Closed Vent System that
is vented to an APCD. The second option is
to minimize emissions using water seals
and/or tightly fitting caps or plugs on all
entrances to the drain systems and for
junction boxes.
Junction boxes may be vented to the
atmosphere if they have minimal water
depth fluctuations, have vapor blocks at
either their entrance(s) or exit(s), and have a
vent pipe that meets specified design
criteria. Building sewers may be vented
through roof vents and outside sewers may
be vented at locations other than at junction
boxes, provided that the vent pipe height (at
least 90 cm) and diameter (no greater than
10.2 cm in inside diameter) are the same as
those for junction box vents AND the sewer
has a water seal at the first downstream
junction box.
7-16
-------
! !
Table 7-5. WASTEWATER INDIVIDUAL DRAIN SYSTEM VAPOR SUPPRESSION
REQUIREMENTS {§63.l2S6(e)> ^^^^
Standard
(choice of
either)
Description
1256(e) (1-
OR
1. Maintain cover on each 0pening. If vented route through Closed Vent System to APCD
and: ! j
- For cover and ppenaigs:
A. Maintain according to 63.1258(h) - see Monitoring chapter for I and M
requirements j
B. Keep in closed position when wastewater is in drain except for
sampling, removal, inspection, maintenance or repair.
- APCD designed/operated/inspected according to 63.1256(h)
- Closed Vent System! inspected according to 63.1258(h),
- If under vacuum, not required to maintain by 63.1258(h), and
- Design individual drain system to segregate vapors from drain systems that do
not manage affected wastewaters and prevent releases to atmosphere.
2 & 3. Inspection and Maintensjnce procedures - in Monitoring chapter
1256(c)(4-iS)
4. Comply w/ following i j
- Equip dram system openings w/ water seal, tightly fitting caps or plugs and
- For water seal, maimain system to verify flow of water hi trap, and
- If water seaj on drain receiving wastewater, discharge pipe must be
submerged or flexible shield installed (except on water seals used on hubs
receiving .wasiewater not subject to this provision)
- Each junction box must have tightly fitting solid cover. If vented, comply w/
either , j
A. Vent to process or to Closed Vent System vented to APCD. Closed .
Vent System maintained according to 63.1258(h) and APCD according to
63.1256(h),oi;
B. If box uses [gravity flow or there is only slight variation in liquid level
then i !
I. Vent pipe > 90 cm length and < 10.2 cm inside diameter, and
2. Water seals installed to restrict ventilation on either the box
influent or effluent.
- Each sewer line carrying affected wastewater must not be vented to atmosphere
unless the sewer line entrance to the first downstream junction box is water sealed
and the sewer line vent pipe is > 90 cm long and < 10.2 cm inside diameter.
5 & 6. Inspection and Maintenance procedures - in Monitoring chapter
I
VS: Oil-Water Separators
Wastewater Oil-Water separators standards
contained in §63.1256(f) are summarized in !
Table 7-6. The regulation addresses any oil-;
water separator that receives, manages, or '
treats affected wastewater or residuals ;
removed from wastewater. Vapors are to be
suppressed using either a Fixed Roof (with a
closed vent system and control device),
Floating Roof, or Equivalent Means. An
Equivalent Means of vapor suppression
must be demonstrated by performance
testing or engineering evaluation.
! 7-17
-------
Table 7-6. WASTEWATER OIL WATER SEPARATORS VAPOR SUPPRESSION
STANDARDS (§63.1256(f)}
Equip
with...
Description (with Section Numbers)
Fixed Roof
with CVS and
Control
Device,
OR
1. Maintain Roof and openings according to §63.1258(h) (see Monitoring chapter for I
and M requirements), and
2. Keep in closed position when wastewater is in oil/water separator except for
sampling, removal, inspection, maintenance or repair, and
3. Design, operate, inspect APCD according to §63.1256(h) (See Table 7-2), and
4. Inspect Closed Vent System according to §63.1258(h)
5. Negative pressure not required to comply with §63.1258(h)
Floating Roof
Design floating roof per §60.693-2(aXl)(i) and 00, (*X2), (a)(3), and (a)(4).
- Primary seal - liquid-mounted or mechanical shoe
- Secondary seal above the primary seal; cover the annular space between the
floating roof and the wall of the separator
- Equip each opening in (he roof with gasketed cover, seal, or lid. Keep closed
except during inspection and maintenance.
- Roof must float on liquid (i.e., off the roof supports) except during abnormal
conditions.
- Roof may be equipped 'with emergency roof drains for removal of stormwater;
use slotted membrane fabric cover that covers at least 90% of the
drain opening area or a flexible fabric sleeve seal.
Perform seal gap measurements according to 40 CFR 60 Subpart QQQ
60.696(d)(l) and scheduled as follows:
- Primary seals: w/in 60 days after installation/wastewater introduction and once
every 5 yrs thereafter, and
- Secondary Seals: w/in 60 days after installation/wastewater introduction and
annually thereafter.
OandA
a-
A.
What are CEFs andlWPs ?
Listed with each vapor suppression standard are inspection procedures for
Control Eqiapment Failures (CEF)a^
for each equipment type. For example, oneoftheCEFs listed for wastewaier
tanks is when a "^sJ^,joint,lidonco\^hasacrajp^ gap or is broken,"
An example of an IWPfor fixed roof tanksis leaving open any access doors
or any other opening when such door or opening is not in me. : /F -^ '•.*
7-18
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What are the Performance
Standards for Wastewater
Treatment? _____
7.4.2 Wastewater Treatment Standards
The wastewater treatment standards are
found in §63.1256(g). Basically, there are
six treatment standards in (g)(8-13). A ;
summary of how they apply to the four i
affected wastewater categories, A-D j
(Figure 7-2), is discussed below and shown
hi Table 7-7. ;
i
Wastewater from New and Existing
Sources
For new or existing sources, the owner must:
Treat an affected PSHAP wastewater
stream (category A) ;
to remove 99% PSHAP, or
to less than 50 ppmw
PSHAP,* or
remove 95% total HAP (from
all wastewaters whether
affected or unaffected) in a
biological treatment unit, or
use a RCRA-permitted (or
interim status) treatment
device, such as an
incinerator, boiler, or
underground injection. ;
Treat an affected Total HAP
wastewater (categories B & Q
to remove 99% PSHAP and
90% SHAP, or j
to less than 50 ppmw PSHAP
and less than 520 ppmw !
SHAP,* or
use enhanced biotreatment
(allowed only if PSHAP is
less than 50 ppmw or if the
wastewater has been treated
upstream in compliance with
(g)(8) (50 ppmw PSHAP or
99% reduction of PSHAP)
and the wastewater is not
designated), or
remove 99% PSHAP and
treat to 520 ppmw SHAP, or
treat to 50 ppmw PSHAP and
remove 90% SHAP, or
to remove 95% Total HAP
(from all wastewaters
whether affected or
unaffected) in a biological
treatment unit, or
use a RCRA-permitted (or
interim status) treatment
device, such as an
incinerator, boiler, or
undergroundinjection.
NOTE(*): Concentration
standards cannot be used (1) when
biological treatment is used or (2)
when the wastewater streams are
designated.
For an existing source that has been
designated as affected (per
§63.1256(a)(l)(ii)), the wastewater
treatment requirements are:
PSHAP reduced by 99% and SHAP
reduced by 90%, or
Total HAP reduced by 95% in a
biotreatment unit, or
Treatment in a RCRA-permitted
treatment device.
Wastewater from New Sources
For new sources, the owner/operator must:
Treat an affected SHAP wastewater
stream with greater than 110,000
ppmw SHAP (category!))
7-19
-------
to remove 99% SHAP, or
use a RCRA-permitted (or
interim status) treatment
device, such as an
incinerator, boiler, or
underground injection.
Management of Residuals from
Wastewater Treatment
i
Wastewater residuals are defined as HAP-
containing liquids or solid materials
removed from a wastewater stream by a
waste management unit or treatment process
that does not destroy organics. Examples of
residuals include:
• the organic layer and bottom residue
removed by a decanter or organic-
water separator, and
• overheads from a steam stripper or
air stripper.
Materials not classified as residuals include:
• silt, mud, or leaves,
• bottoms from a steam stripper or air
stripper, and
• sludges, ash, or other materials from
destructive treatment devices such as
biological treatment units and
incinerators.
There are several options for managing
residuals taken from the treatment of
affected wastewater:
• recycle the residual back into the
production process or sell it to
another firm for recycling. Once the
residual is returned to a production
process, it is no longer subject to
regulation. OR
• return the residual to the treatment
process. OR
• treat the residual to reduce the total
combined mass flow rate of SHAP
and/or PSHAP by 99 percent or
more. (Use the performance tests in
63.1257(e)(2)(iii)(C) -
noncombustion, nonbiological
treatment process - or (D) -
combustion treatment process - to
demonstrate compliance.) OR
• treat the residual in a RCRA-
regulated unit (hazardous waste
incinerator or underground injection
well.
In addition, tanks, surface impoundments,
containers, individual drain systems, and
oil/water separators used for the storage or
management of residuals must meet the
same design and operating requirements that
apply to these units when used for treatment
of affected wastewater (63.1256(b) -
What are the Standards for Air
Emissions Control?
7.4.3 Emissions Control Standards
Standards for control of air emissions vented
during the treatment process and from other
waste management units with covers and
closed vent systems are specified for air
pollution control devices (APCD) as either:
1) equipment specifications - for combustion
devices in terms of residence time and
temperature specifications.
or
2) APCD performance levels - in the form of
7-20
-------
Removal Efficiencies (RE) or APCD outlet
HAP concentrations.
A summary of the standards is shown in ;
Figure 7-4. Basically, there is a choice of 5
control standards as follows: ;
• Combustion device achieving 95%
RE HAP, 20 ppmv outlet TOC @3%
O2, or provide 0.5 sec residence time
at760degC, I
• Vapor recovery system achieving;
95% RE HAP or 20 ppmv outlet
TOC,
• Flare meeting requirements of
§63.1 l(b),
• Scrubber or other APCD achieving
95% RE HAP or 20 ppmv TOC. \
NOTE: The APCD outlet '•
standard of 20 ppmv TOC is not
available for APCDs controlliiig
vent streams from wastewater
surface impoundments or containers.
With regard to repairs to air pollution !
control devices, if gaps, cracks, tears, or
holes are observed in the ductwork, piping,
or connection to covers and control devices
during an inspection, the owner/operator:
must make an attempt within 5 calendar
days to fix the problem. Repair can be j
delayed only if: j
• the repair cannot be done without a
shutdown or if the emissions j
resulting from immediate repair j
would be greater than those i
anticipated to result from delaying
the repair. The equipment must be
repaired by the end of the next
shutdown, OR !
• the equipment is emptied or is no
longer being used to treat affected
wastewater or residuals, OR
if additional time is necessary due to
the unavailability of parts, due to
circumstances beyond the control of
the owner/operator. Repair must be
done as soon as practical, In this
case, the reasons for delaying the
repair must be documented.
7-21
-------
m® shall be ' !
I designed and operated
taceonliRgtooneofthel
technologies listed
•**
Vapor recovery system;
0*, carbon adsorber, ;
condenser, ate) shall j
reduce organic HAP 1
by 95% or TOO1 to ;
| Iasstfian20ppmy ;
i - t> ^^ w^ ^^
I CombusttenW '
4shallcomply«rttlioner r
, shall reduce organic f
sHAPoy95%orTOCi
* to20opnw
ft€Quv@ B r»vi**»ww wuuwt fw i i**»™** *uu™*muw ^
organic HAP > • concentration of 20 • I time of 0.5 sec and ;
by 95% ppmv @ 3% Og ntin. temp of 76Q°C
1 -' ' * ? S1*, Jt-" ? ^
„ ^^t^ -^^^ >#^^1^^^*lff. ^
(hKZX'XB) ',d>K2X()(C)
/•• ts'lheAPCD \
controflinBavent \ *& inaildesorl:—„„—
^stream with >20ppmv^>™—>| 95%orto2pppmv
1. These non-combustion
TOC options cannot be
used for wastewater
surface impoundments
or containers.
IsAPO) ^ s
a boiler
or process heater? x.
^Ves
.-ia^s-i—
Introduce
vent gas into
(tame zone
No
.
I
""** compliance per
t 63.1257
Figure 7-4. Wastewater APCD Requirements in §63.1256(h)
7-22
-------
Table 7-7. WASTEWATER TREATMENT STANDARDS
Treatment
'Options*
treatto<50
ppniw
99% total mass
removal/
destruction of
HAP
treat to <520
ppmw
90% total mass -
removal/
destruction of
HAP
enhanced
biological
treatment
95% mass
removal/
destruction of
total HAP with
biological
treatment unit
"Used
To
Treat
PSHAP
PSHAP
SHAP
SHAP
SHAP
SHAP
Total
PSHAP
and
SHAP
Source Type
new and existing
(categories A, B, ;
andC) ] • I
new and existing i
(categories A, B, !
andC)
new (category i
i>)
new and existing
(categories B ;
andC)
new and existing
(categories B '
andC) '•
!
new and existing
(categories A, B,
andC) }
S *>
1 j
i
new and existing
(categories A, B,'
andC) ' !
i
• i
i
! i
i
t i
i 'f
, Limitations
- no biotreatment or dilution
- not available for designated streams
- only required when SHAP
concentration is 1 10,000 ppmw and the
total PSHAP and SHAP load in
wastewater from me PMPU is >
IMg/yr
- no biotreatment or dilution
- not available for designated streams
- system must meet the definition of
enhanced biological treatment
- may only be used for affected
wastewater with
< 50 ppmw PSHAP, or wastewater that
has been treated to less than 50 ppmw
PSHAP or to 99% reduction of
PSHAP
- not available for designated streams
- biological treatment is required
- all wastewater streams (as defined in
63. 1252) entering the system must
achieve 95% HAP removal, except
wastewater already treated in
compliance with another treatment
option
- all wastewater streams (as defined hi
63.1252) entering the system must be
managed in wastewater management
units (sewers, etc.) in compliance with
theMACT
Citations
.I256(g)(8)(i)
.1256(a)(l)(ii)
.1256(g)(8)(ii)
,1256(g)(12)
.1256(g)(9Xi)
.1256(a)(D(ii)
.1256(gX9Xii)
.1256(g)(10)
.1256(aXlXiO
.1256(g)(ll)
i
7-23
-------
Treatment
Options
RCRA permitted
or interim status
treatment device
Used
To
Treat
PSHAP
and/or
SHAP
Source Type
new and existing
(categories A, B,
C, and D)
Limitations
•'•" ' •-• '•:. • <•/' - ••'-^-'~. --V':4 ; :-.-''. , :
- systems include heaters, incinerators,
boilers, industrial furnaces, and
underground injection
; Citations
.1256(g)(13)
Offsite Treatment or Onsite Treatment by
Someone Other Than Owner/Operator
The owner/operator may elect to transfer
affected wastewater (or a residual removed
from such wastewater) to an offsite
treatment operation or to an on-site
treatment operation being run by someone
else.
Owner/
Operator:
Responsibilities include...
of the
Affected
Source
ensuring that all waste management units on-site handling affected streams are in
compliance with wastewater management requirements (e.g., all drain systems and
tanks containing affected streams must comply with §63.1256(b)-(f)).
submitting a notice with each shipment stating that the wastewater or residual from the
wastewater contains PSHAP and/or SHAP that must be treated in compliance with the
regulations. If the transfer is continuous or ongoing, submit the notice with the first
shipment and whenever there is a change in the treatment required. Keep a record of
the notice in accordance with §63.1259(g).
7-24
-------
Owner/
Onerator:
Responsibilities include...
ofa
Treatment
System
Receiving
the
Wastewater
Submitting to EPA, p"rior|to receiving any affected wastewater, a written certification
stating mat any affected wastewater or affected wastewater residual will be treated in
compliance with: - j • >
§63.1256(bXi) (requirements for tanks, surface impoundments, containers,
individual drain Systems, oil water separators, plus other performance
standards for treatment), or
- Subpart D (if alternative emissions limitations have been approved), or
- §63.6(g) (use of ian alternative nonopacity emission standard), or
- If the affected wastewater streams or residuals contain less than 50 ppmw
partially soluble-HAP, then the person receiving them for treatment can:
I .
i. comply with (g)(10) (enhanced biotreatment for SHAP) and cover
the was^e management units up to the activated sludge unit, or
comply! with (gXl 1)(0 an^ (") (95 percent reduction in a biological
treatment unit), and (h) (emissions control device standards) and
cover the waste management units up to the activated sludge unit, or
comply! with (g)(10) (enhanced biotreatment for SHAP) provided
that the! affected source owner/operator demonstrates that less than
5 percent of the total SHAP is emitted from waste management
units up to the activated sludge unit, or
comply! with (g)(l l)(i) and (ii), (95 percent reduction in a biological
treatment unit), and (h) (emissions control device standards),
provide^ that the affected source owner/operator demonstrates that
less than 5 percent of the total SHAP is emitted from waste
management units up to the activated sludge unit
• Securing the signature ofithe responsible official on the certification, and providing
the name and address of the certifying entity to the EPA Regional office.
I |
NOTE ON REVOKING CERTIFICATION: A written statement must be sent to both EPA
and the owner/operator of thejaffefcted wastewater stating that the transferee is no longer
accepting responsibility for treatment of the affected wastewater. The transferee must give at
least 90 days notice. When the 90'-day period is up, me owner/operator may not transfer
affected wastewater or residuals to the treatment operation.
ii.
in.
IV.
I
QandA
Q-
A.
What are the standards for\ wastewater treatment using multiple treatment
processes in series ? j j
The mass removal/destruction efficiency requirements are the same.
However, efficiency calculation techniques differ for different treatment
configurations. Ifwastewater jfc conveyed bv hard piping then mass removal /
destruction efficiency li'de^rmined across the combination of treatment
processes, if wastewater is not conveyed by hardpipins then efficiency is
determined across each treatment process with total efficiency equal to the
sum of efficiencies from each component process.
7-25
-------
What is the Pollution Prevention
Option?
In lieu of the wastewater standards discussed
above, an owner or operator (O/O) can
choose to meet pollution prevention (P2)
standards. The P2 requirements are either:
• reduce the production-indexed HAP
consumption factor (kg HAP
consumed/kg product produced) by
75% from a specified baseline
average established no earlier than
1987, or
• reduce the production-indexed HAP
consumption factor by at least 50%
from a specified baseline average
established no earlier than 1987
AND reduce total PMPU HAP
emissions divided by the annual
production rate (kg HAP emitted per
year/kg produced per year) to a value
greater than 25% of the average
production-indexed consumption
factor (i.e., achieve 50% reduction by
using pollution prevention and
achieve additional 25% by using
standard control devices). For more
information on the pollution
prevention option, see -» Chapter
10- Pollution Prevention
Alternative.
7.5 Compliance Demonstration
Compliance demonstration procedures for
wastewater standards are listed in
§63.1257(e) - Test Methods and Compliance
Procedures - Compliance with Wastewater
Provisions. This section lists requirements
for demonstrating initial compliance.
Procedures for demonstrating on-going or
continual compliance are listed in §63.1258
(Monitoring Requirements). A complete
description of the required monitoring
procedures can be found in •* Chapter 9 -
Monitoring. The following paragraph
presents a brief introduction to the initial
compliance demonstration requirements for
wastewater. A more complete description of
the requirements can be found in •*
Chapter 8 - Compliance Demonstration
and Testing Procedures.
7-26
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QandA
A.
How do I demonstrate compliance for:
1) wastewater -with multiple phases
2) treatment residuals ? I
Wastestreams with free phase HAP cannot be sent to individual drain systems,
stored in wastewater tanks or surface impoundments, or sent to treatment
units. The free phase HAP can only be discharged to a R&RA treatment unit,
per 63,12S6(a)(3), For wasf.ewater treatment residuals, the O/O must either;
L recycle the residual back to the production process, or sell the material
for the purpose of recycling
2, return the residual back to the treatment process,
3. destroycombine^lPSHAP/SHAP^at^least99%,or
4* treat ^re^t^in-a.RC^ unit f^^^56(g)(13).
. . ],,,-,'., . i - , - .
75? demonstrate compliance lwithoption 1 or 2, the O/O must document
process configuration. To demonstrate compliance with option 3, the O/O
should use compliance demonstration technique Cor Das discussed in
AppendixWWT. ; i
The initial compliance demonstration
procedures as listed in §63.1257(e) are
basically separated into 3 parts:
• Determination of wastewater HAP
concentration and load as it pertains
to wastewater applicability criteria
(i.e. annual concentration and annual
load), j
• Design Evaluation and Performance
Test procedures for demonstrating
compliance with air emissions
control (i.e., APCD) requirements,
and
• Design Evaluation and Performance
Test procedures for demonstrating
compliance with wastewater |
treatment standards.
i
Compliance with the vapor suppression
standards is done primarily through the
reporting provisions of the rule, which
require that the owner or operator document
the results of Inspection and Monitoring
procedures that are followed for wastewater
management units.
The reader is referred to Chapters 8 and 9
for more complete details on compliance
demonstrations and monitoring
requirements.
7-27
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-------
Chapters
Initial Compliance Demonstrations and Testing Procedures
8.1 Overview
The MACT regulations require that affected
sources provide proof that the facility is in
initial compliance with the standards. The,
exact format of the initial compliance
demonstration depends on the nature of the
source and the regulatory standard option
chosen by the owner or operator. In some
cases, performance testing of the control
devices will be necessary; in others, j
engineering calculations can be used to
demonstrate that the emissions will be
controlled to the required level.
Because the owner or operator has
flexibilities or options, with regard to the
regulatory standard chosen, he/she must
develop a strategy mat best suits the facility.
It is important to remember that the
pharmaceutical MACT is process-based. >
This means that the standards apply to a
process (a group of steps that result in the
production of a product or isolated
intermediate), rather than a particular piece
of equipment.
Other than the Alternative Standard, the |
initial compliance demonstration will also
be used to establish monitoring parameter j
levels, as necessary. For example^ during
the initial compliance performance test, thp
O/O will establish control device and/or ;
process monitoring parameter levels to be
used to demonstrate on-going compliance.
Details of this procedure will be discussed in
Chapter 9.
Chapter 8 at a Glance
, <"*•'
8.1 Overview^
8.2 Structure of ihe Regulation
83 Exemptions '-
j
8.4 Compliance Demonstration
Procedures Summary
•, /-
8,5 Compliance Demonstration
Procedures for Process Vents
S.6 _ Compliance Demonstration
Procedures for Storage Tanks
8.7 Compliance Demonstration
Procedures for Wastewater
Sources
8,8 Submittal of Compliance
Demonstrations for All Affected^
Sources -
What are the Elements of a
Compliance Strategy?
For the pharmaceutical manufacturing
operations, the owner or operator should
develop a compliance strategy, considering
at least the following elements:
- Identification of PMPUs,
- Emission sources within each
PMPU,
- The associated standards for those
8-1
-------
PMPUs,
- Control options for emissions
standards
- The associated compliance
demonstration procedures for the
standards, and
- The associated monitoring
requirements.
The owner or operator may need to ask some
questions relating to the overall facility, such
as:
How often do the processes change and how
will this affect the choice of standards and
compliance demonstrations?
Which emission episodes will be controlled
by which control device and to what level?
Will it make sense to vent numerous process
streams to one centralized control device?
Would additional costs incurred in
reconfiguring to a centralized control device
be offset by a reduction in compliance
demonstration and monitoring costs?
Are there pollution prevention technologies
that could be applied instead of using
traditional end-of-pipe controls ?
8.2 Structure of the Regulation
Compliance demonstration requirements are
listed in §63.1257 for the following
categories:
§63.1257(a) General Requirements
§63.1257(b) Methods
§63.1257(c) Storage Tanks
§63.1257(d) Process Vents
§63.1257(e) Wastewater Sources
§63.1257(f) Pollution Prevention *
§63.1257(g) Compliance w/ Storage Tank
Provisions by Using
Emissions Averaging**
§63.1257(h) Compliance with Process
Vent Provisions by Using
Emissions Averaging**
* Compliance information for this section is
covered in Chapter 10.
** Compliance information for these
sections is covered in Chapter 11.
8.3 Exemptions from Compliance
Demonstrations
No initial compliance demonstration is
required if the following devices are used to
control emissions:
• a boiler or process heater with a
design heat input capacity of 44
megawatts or greater,
• a boiler or process heater in which
the emission stream is introduced
with the primary fuel,
i a boiler or process heater that burns
hazardous waste and which is either
permitted under RCRA and in
compliance with Part 266, Subpart H
(Hazardous Waste Burned in Boilers
and Industrial Furnaces) or has
certified compliance with the interim
status requirements of Part 266,
Subpart H,
• a hazardous waste incinerator that is
either permitted under RCRA and in
compliance with Part 264, Subpart O
(Incinerators) or has certified
compliance with the interim status
requirements of Part 265, Subpart O.
A compliance demonstration, per se, is riot
required when the alternative standard is
8-2
-------
being used. The owner/operator must be in !
compliance with the applicable monitoring ;
requirements (63.1258 (b)(5)) on me initial !
compliance date. I
\ \
8.4 Compliance Demonstration ...'.
Procedures - Summary \ \
; I
Table 8-1 details which lands of compliance!
demonstrations are required for each type of!
emission source - process vents, storage \ '
tanks, I
and wastewater, assuming that the owner or ;
operator is not using :one of the control j
devices ;
listed above that are exempt from
compliance demonstrations.
NOTE: Separate compliance
demonstrations are not required for
*' storage tanks if their emissions are
routed to control devices which
have met the process vent compliance
demonstration.
Before the comprehensive table of
compliance demonstration requirements by
source type is reviewed (Table 8-1), it may
be helpful to gain an understanding of some
of the terms used in the regulations for types
of demonstrations:
Type of
Demonstration
Emissions
Estimation
Methods
Engineering
Assessments
{Design:: '"''"" '";*";
Evaluation
Performance
Testing --••••-*•• ,-:
Plain English Definition
:•' ' ' f'
Using a set of equations provided by EPA (or other validated equations) in the rule
to calculate emissions for process vents from eight specific activities - vapor
displacement, purging, heating, depressurization, vacuum systems, gas evolution, air
drying, and empty vessel purging.
Using other methods (e.g., data from previous emissions tests) to calculate emissions
primarily fix>m activities oth«r than the eight listed above. Engineering assessments
can be used to calculate emissions from those eight activities if the emissions estimations
equations aren't accurate or appropriate for the specific process. (NOTE: Must be
approved by EPA) < !
Using control device manufacturer's specifications and other relevant site-specific data
to show that the device will achieve the required efficiency.
Designing and conducting test runs of the process to demonstrate that required emission
reductions are achieved. .Conditions under which testing was conducted must be
carefully documented. Owners/operators must use EPA-specified test methods unless the
source has petitioned and gained approval to use an alternative test method.
Condensers \
Finally, before the table is reviewed, it '
should be understood that if a condenser is
used as the control device, the
owner/operator must use tbe emissions
estimations procedures to demonstrate '
compliance at a measured temperature, j
If the condenser is used as a process
condenser, the owner/operator must initially
demonstrate that the condenser is properly
operated if:
• - the process condenser is not
followed by an APCD, or
• - the APCD following the process
condenser is not a condenser or is not
meeting the 20 ppmv TOC
8-3
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alternative standard (50 ppmv, if
non-combustion device).
The owner or operator must either:
1. Show that the condenser exhaust gas
temperature is less than the boiling
or bubble point of the vessel
contents, or
2. Perform a material balance around
the vessel and condenser to show
that at least 99 percent of the
material that vaporizes is condensed.
Table 8-1. INITIAL COMPLIANCE DEMONSTRATION TECHNIQUES
This initial demonstration must be done for
all appropriate operating scenarios and
documented in the Notification of
Compliance report.
Each kind of compliance demonstration is
indicated with a bold number in Table 8-1
below.
Source
Regulatory Standard
or Criteria
Type of Compliance Demonstration
Storage Tanks
Percent reduction
© Design evaluation or
© Performance testing (note: testing not required if
device also controls emissions from process vents and
compliance has been demonstrated under process
vent provisions.
Alternative standard - 20
ppmv TOC if combustion,
SO ppmv if noncombustion
& TOC Monitoring at outlet of control device.
Monitor must meet Performance Specification 8 (QA
and calibration for CEMs) or 9 (QA and calibration
for GC analysis) of Part 60, Appendix B. Use Method
18 to determine predominant HAP, if monitor is
calibrated on predominant HAP.
floating roof
HON demonstration - Refer to HON Inspection
Tool - EPA 305-B-97-006, September, 1997 for
guidance on engineering specifications in §63.119
(bHd) and monitoring in §63.120.
vapor balancing
Information from reloading/cleaning facility (see
page 8-25)
Wastewater
Effluent
applicability criteria
(PSHAP and SHAP cone.
and loading) (alternatively,
may designate as affected)
® calculation of annual average concentrations
and annual load, using EPA-approved methods,
previous knowledge of wastewater, or bench-
scale/pilot-scale test data
wastewater treatment unit
standards - percent
removal or specific
concentration of PSHAP
or SHAP in ppmw
RCRA units (with RCRA permit or interim status) or
enhanced biological treatment meeting definition in
§63.1251 - no demonstration required under this subpart.
Non-biological or closed biological:
© Wastewater treatment performance testing, or
© Wastewater design evaluation
Open biological:
© Wastewater treatment performance testing
8-4
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Source
Regulatory Standard
or Criteria
Type of Compliance Demonstration
Wastewater
Air Emissions
air pollution control device
standards -percent !
reduction ..- ,
® Performance testing, or
€> Wastewater design evaluation
Outlet TOC standard - 20
ppmTOC
® Design evaluation or testing using Method 25A
Process Vents
Mass emission limit
Percent reduction
Determine uncontrolled HAP: Use either
| © Emission estimation methods, (for vapor
I displacement, purging, heating, depressurization,
vacuum systems, gas evolution, air drying, and empty
vessel purging) or
© Engineering assessments (for operations other than
those listed above).
AND
Determine controlled emissions:
For small devices controlling less than 10 TPY HAP, use:
® Design evaluation (except for condensers), or
© Emission estimation methods (condensers only), or
© Performance testing.
?or large devices controlling 10 TPY or more, use:
© Emission estimation methods (condensers only), or
© Performance testing, or
® Previous performance test performed under
conditions required by §63.12.
© Performance testing, or
Determine uncontrolled HAP: Use either
O Emission estimation methods (for vapor
displacement, purging, heating, depressurization,
vacuum systems, gas evolution, air drying, and empty
vessel purging), or
© Engineering assessments (for operations other than
those listed above or where the owner/operator has
demonstrated that the equations are not appropriate),
AND
Determine controlled emissions:
For small devices controlling less than 10 TPY HAP, use:
® Design evaluation (except for condensers), or
© Emission estimation methods (condensers only), or
© Performance testing.
:«or large devices controlling 10 TPY or more, use:
O Emission estimation methods (condensers only), or
© Performance testing, or
® Previous performance test performed under
conditions required by §63.12.
8-5
-------
Source
Regulatory Standard
or Criteria
Outlet TOC standard - 20
ppm TOG
Alternative TOC Standard
(20 ppmv if combustion,
50 ppmv if non-
combustion)
Type of Compliance Demonstration
© Design evaluation or testing using Method 25A
® TOC Monitoring at outlet of control device.
Monitor must meet Performance Specification 8 (QA
and calibration for CEMs) or 9 (QA and calibration
for GC analysis) of Part 60, Appendix B. Use Method
18 to determine predominant HAP, if monitor is
calibrated on predominant HAP.
A general discussion of compliance
demonstration procedures for each source
type is presented in Sections 8.5 - 8.7. Each
type of compliance demonstration procedure
will be discussed by referencing the
numbering system used in the above table.
8.5 Compliance Demonstration
Procedures for Process Vents
Compliance demonstration procedures for
process vents are listed in §63.1257(d).
Procedures are given to demonstrate
compliance with the following types of
standards:
• Mass emissions limit
• Percent reduction or outlet TOC
concentration
• Alternative standard
To determine mass emission rates and
percent reductions, the rule provides
compliance demonstration procedures for
calculating uncontrolled emissions and
controlled emissions. A further breakdown
of these techniques is given in Figure 8-la
(uncontrolled emissions) and Figure 8-lb
(controlled emissions). Uncontrolled
emission rates from vents are calculated
using emission estimations (equations
provided for eight specified operations that
produce emissions) or engineering
assessment procedures (for emissions events
other than the eight specified or for emission
events not accurately represented by the
emission estimation equations). Controlled
emission rates are determined by design
evaluations, emission estimation or
performance testing.
NOTE: For control devices, except
for condensers, controlling sources
with HAP emissions at least 10 tpy
(large device), performance testing must
be used to determine controlled emissions
(except for sources using the alternative
standard option). Compliance with TOC
standards is demonstrated using parametric
monitoring when monitoring TOC as a.
surrogate for percent reduction and TOC
CEM monitoring when monitoring TOC for
the alternative standard. 9
What are the Emission Estimation
Procedures for Calculating
Uncontrolled Emissions for Process
Vents? '
Equations are provided to calculate
uncontrolled emissions from process vents
for the following emission episodes types:
• Vapor Displacement
8-6
-------
Purging
Heating
Depressurization
Vacuum Systems
Gas Evolution
Air Drying
Empty Vessel Purging
These equations are listed in j ;
§63.1257(d)(2)(I) A through H, respectively]
Basic chemical engineering principles are i
used to calculate mass rates of HAPs. , j
Appendix EE to this tool provides a listing |
of the equations and equation inputs. > j
Equations from the 1978 document "Controlj
of Volatile Organic Emissions from !
Manufacture of Synthesized Pharmaceutical \
Products," EPA - 450/2-78-029 (CTG) and |
equations from the 1994 ACT are included [
in the rule. [
Other equations, as approved by EPA, may
be used for emissions estimations. |
Figure 8-la provides a flow diagram j
illustrating the determination of uncontrolled
emissions from process vents. Figure 8-lb j
shows the determination of controlled j
emissions. :. j
8-7
-------
f- To d« ermine
uncontrolled HAPs ,
, emission rates
uso emissions ost
OR If equations not
appropriate, use !
ongln -
• HAP omission '
; estimation methods j.~.™.».
(u applicable) ;
test
results
^.
i Bonch acafc or
[ 'pilot plant
tasting
' Max loadina as
| listed on permit
V
unainaurlno
assessments
b assessments
xarttplas an folte»Ks)
1 Design analysis i
choica !
:
Figure 8.la. Determining Uncontrolled Emissions from Process Vents
8-8
-------
Controliad by condensers!
[t257W8H!>
yjto,-^^s%»S»«?%...... w^-..--^~H-s—Jp
$> •.»»>;. *-r«sw&'v' ',-i-sr""'<* *•»?>-•.<,'*•.•, s«jsjv >,
, ^^.'^xi^ri.-; .Ic^JSiH^orteMe
* • CHOICE "•' f 1 " APCDs [
dlspliicsmant J
i% „#•*-&-• **
Purging ;
,^^j^»lW 'if*
I Depretcutotion
* i
je ^^rr^^^^D^^>*<^?™s'J.;*'CD
: inlet and outlat to
Air drying {
*
purging
{ OK to dst srfflina rsnga of f
ffjdOTdas "
^L -
Figure 8-lb. Determining Cdntrolled Emissions from Process Vents
8-9
-------
What are the Engineering
Assessments for Calculating
Uncontrolled Emissions for Process
Vents? __
Engineering assessments are used primarily
to calculate uncontrolled process vent
emissions for emissions episodes that are
NOT due to any of the activities described
above under emissions estimations (i.e.,
vapor displacement, purging, heating,
depressurization, vacuum operations, gas
evolution, air drying, or empty vessel
purging). Engineering assessments can also
be used to calculate uncontrolled emissions
for those 8 specific activities if the
owner/operator believes the equations are not
accurate or appropriate for his/her facility;
the Administrator must approve such use of
engineering assessments. In addition,
modified versions of the emissions
estimations methods under Section 63.1257
(d)(2)(ii) can be used if the owner/operator
shows they have been used to meet other
regulatory obligations and they do not affect
applicability determinations or compliance
determinations. Engineering assessments
techniques are given below:
Eneineerinc assessments can include...
Provided that-
Previous test data
Tests are representative of current
operating practices at the process
unit.
Bench-scale or pilot-scale test data
Data are representative of the process
under representative operating
conditions.
Maximum flow rate, HAP emission rate,
concentration, or other relevant parameter
Value is specified or implied within a
permit limit applicable to the process
vent.
Design analysis based on accepted chemical
engineering principles, measurable process
parameters, or physical or chemical laws or
properties (e.g., use of process stoichiometry
to estimate maximum organic HAP
concentrations, estimation of maximum flow
rate based on physical equipment design such
as pump or blower capacities, estimation of
HAP concentrations based on saturation
conditions.)
All data, assumptions, and
procedures used to support
engineering assessments are
documented.
8-10
-------
What are the Design Evaluation I |
Techniques for Calculating
Controlled Emissions for Process ;
Vents? •. ' : !
^^mmm* !
I
The design evaluation must demonstrate !
how the control device being used achieves j
the needed percent reduction to comply with
the rule. Design evaluations can be used for
process vents ONLY if the control device j
controls less than 10 TPY (if £ 10 TPY, j
performance testing must be done unless; • j
control device is a condenser). I
As shown in Figure 8-2, for each type of j
control device, EPA specifies what factors |
must be considered in conducting the design
evaluation and what operating parameters j
' must be established. Each design evaluation
must consider the composition and j
concentration of all gases, vapors and liquids
entering the control device. |
• \ i
For devices controlling process vents, the |
design evaluation must show compliance at,
absolute worst-case condition as determined;
from the emission profile (Information on j
conditions is provided later in this chapter), j
EPA's intent in requiring worst case i
conditions for testing is to document the •
reduction efficiency of the control device |
under the most challenging conditions. It is
presumed that the device will work at least j
as well, and maybe better than, when | i
conditions were at their worst. The emission
profile should include the HAP loading rate j
in Ib/hr and include all emissions episodes in
a process that could contribute to the vent •
stack load. Production scheduling should be
documented to ensure that all processes ;
contributing to each vent are being | j
considered.
What are the Emission Estimation
Procedures for Calculating
Controlled Emissions for Small
Control Devices for Process Vents?
For small control devices, (controlling less
than 10 tpy HAPs) equipped with a condenser
operating as a control device, controlled
emissions can be calculated using emission
estimation equations. These techniques for
the most part are similar to those previously
discussed in uncontrolled emission
estimation procedures with the exception that
temperature values are those at the control
device or receiver (condenser). A full
presentation of equations and input variables
is shown in Appendix EE.
8-11
-------
APCD design
evaluation that
evauao a .
addresses Kerns as i
applicable 1
Enclosed combustion
device with
760*C/0.5 sec
characteristics
Document that these
L
Thermal vapor
Incinerator
Catalytic vapor
Incinerator
BoBer or process
heater
i Carbon adsorber
- (regenerative on-site)
1 Carbon adsorber
, (nonregenerative
L on-slte)
Scrubber
ai ;,
..B-l™-^''1"™*^*™^™?
• Auto ignition temperature f * Design minimum and average temperature of
of the organic HAP ••-#--' combustion zone
• Vent stream flow rate ' l • Combustion zone residence time
Vent stream flow rate
Relative humidity and
temperature
.I."1! .IllL-l'ir '
1 Vent stream mass or
volumetric flow rate '
• Temperature and relative
humidity
: • Vent stream composition!
Constituent concentration
uquidto vapor ratio
Scrubber liquid flow rate
and concentration
Temperature
Chemical reaction kinetics
Condenser
i Vent stream flow rate
' Relative humidity
• Temperature
j Design minimum and averagetemperature
I* across the catalyst bed ^^ **., ^.~~.«™.
^-oSw -*» ~^,^^^-*»"»* •**"
Design minimum and average flame zone
temperature
> Combustion zone residence time
Method and location where vent stream is
i introduced tnto flame zone
«5*'^
, « bssfgn exhaust stream organic HAP concentration
• Adsorption cycle time, number and capacity cf
: beds
| * Design regeneration mass or volumetric flow [
[ • Design carbon bed temp, after regeneration '
i « Design regeneration time
* Design service life of carbon '
is f «S
• « Design exhaust stream oraansc HAP concentration
Capacity of carbon bed
type and working capacity of carbon used for beds '
Design carbon replacement interval based on total '
-, carbon working capacity of APCD and process
* schedule* - ..-—-~ ™ ~ —*-'
i • Design exhaust stream organic HAP concentration
^ * Type and total number of theoretical and actual
. trays
' • Type and surface-area of entire packing column
- and for individual sections (If contains more than '
* one section)
Design outlet organic HAP compound concentration
Design average temperature of the condenser
exhaust vent stream |
Design average temperatures of the coolant fluid
at tee uitet and cutter. ^,, - -~»_^;
- '
Figure 8-2. Emissions Control Device Design Evaluation Requirements
8-12
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What is the Control Device i j
Performance Testing for Process j
Vemts? ' , ' •""•" ••"" I
Performance testing is required to !
demonstrate compliance for large control |
devices (> 10 tpy HAPs). Previous test results
may be used if the tests were conducted using
the same procedures as provided by the rule
at conditions typical of the appropriate worst
case scenario. There are two primary j
objectives which must be considered in
conducting performance tests:
ie .
Demonstrate initial compliance, and
Establish monitoring parameters for ]
demonstrating on-going compliance.!
Performance testing for demonstrating initial
compliance can be broken down into the j
following tasks: i j
1. Test Plan Development and , \
Submittal, j
2. Testing, and \
3. Report Writing and Submittal. j
i |
Test plans are to include the following j
information: „ ;
• Test program summary I
-Listof sources to be tested J
- Test Methods
- Test Conditions
i j
• Test schedule j
• Data quality objectives (precision, •
accuracy, and completeness of data) '
• QA Programs - Internal (assessment j
of precision) and external i
(performance audits) i
: i
Further details on Performance testing are !
given in Appendix PT. Review the following
Qand A boxes for more information on ;
i I
performance testing and emissions profiles. ]
Initial compliance demonstrations for
condensers are based on how the condenser is
used—as an air pollution control device or as
a component of a process? For condensers
used as APCDs: the owner/operator must
determine controlled emissions by measuring
exhaust gas temperatures and calculating
emissions reduction for each batch emission
episode within each unit operation. The
owner/operator should use the equations for
small devices for the eight specific
procedures (vapor displacement, purging,
heating, etc) or other approved equations, as
discussed previously.
For condensers used as part of the process:
In configurations where the process
condenser is not followed by an air pollution
control device or the air pollution control
device following the process condenser is not
a condenser or is not meeting the alternative
standard, the owner/operator must
demonstrate that the process condenser is
operating properly. This can be done by
either:
1) measuring the exhaust gas temperature and
showing that it is less than the boiling or
bubble point of the substances in the vessel or
2) performing a material balance around the
vessel and condenser to show that at least 99
percent of the material that vaporized during
boiling is being condensed. The
demonstration must be conducted for all
appropriate operating scenarios. The
owner/operator must document the results in
the Notification of Compliance Report.
8-13
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QandA
Q>
A.
Q-
A.
Q.
A.
a
A.
How do I demonstrate compliance with percent reduction standards?
The general equation for determining percent reduction requires the
calculation of inlet and outlet mass rate ofHAPs (or TOC) to the control
device. Mass rate is calculated by multiplying HAP or TOC concentration by
gas flaw rate. As listed in Appendix PT, several test methods can be used for
determining individual HAP concentrations, TOC concentration, and gas flow
rate. However, each method has advantages and disadvantages and should be
carefully reviewed before a selection is made.
What emissions test methods should be used?
Table 8-2 lists the emissions test methods to be used. These are taken from 40
CFR Part 60, Appendix A. Appendix PT describes these methods and discusses
the advantages and disadvantages of each method.
Under what test conditions?
Test conditions far process vents, running in batch mode, should be at either
absolute worst case or hypothetical worst case as defined in Table 8-3. These
scenarios should be documented in an emissions profile. The owner or
operator must prepare a site-specific test plan for approval 60 days prior to
testing. The test plan must include a description of proposed testing
procedures as well as an emissions profile of the process.
Testing storage tanks should be conducted during a reasonable maximum
filling rate. Testing wastewaier sources should be conducted under
representative manufacturing process conditions and representative treatment
operation. „
Do I need to determine uncontrolled emissions if I'm complying by ustiug
the outlet concentration standard or the Alternative Standard?
Yes, in the case of the outlet concentration standard. WncontfoUedemissions
determination is needed to identify the worsfcase conditiomfor the
performance test or design evaluation. It is not necessary to determine
uncontrolled emissions if the Alternative StandardwilKbe usedbecause
compliance is directly'measured-no emissionsprofile is necessary.
8-14
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i
Table 8-2. EMISSIONS PERFORMANCE TEST METHODS
What's Being
Measured
Method Number and Name (Appendix A of Fart 60)
Sample and
veloictty.traverse
location.
1 - Sample and Velocity Traverses for Stationary Sources OR
1A - Sample and Velocity traverses for stationary sources with small stocks or ducts
Velocity and
volumetric flow
rates
2 - Determination of stack gas velocity and volumetric flow rate (Type S pitot tube) OR
2A - Direct measurement of (gas volume through pipes and small ducts OR
2C - Determination of stack gas velocity and volumetric flow rate in small stacks or ducts
(standard pitot tube) OR j
2D - Measurements of gas volumetric flow rates in small pipes and ducts
Gas analysis
3 - Gas analysis for carbon dioxide, oxygen, excess air, and dry molecular weight
Stack gas
moisture
4 - Determination of moisture content in stack gases
HAForTOC
concentration
25 - Total gaseous nonmethsne organic emissions
26 or 26A - Determination of hydrogen chloride emissions, hydrogen halide and halogen
from stationary sources
18 - Measurement of gaseous organic compound emissions by gas chromatography
2SA - Determination of total gaseous organic concentration using a flame ionization
analyzer. Can only be used for control efficiency determinations if any of the following
conditions exist: ) j
1. There is only one compound known to exist,
The organic compounds consist of only hydrogen and carbon,
Relative percentages of the compounds are known or can be determined and FID
responses to the compounds are known,
A consistent mixture of the compounds exists both before and after the control
device and only the relative concentrations are to be assessed, or
The FID calibration gas used can be methane or the predominant HAP. The response from
the high-level calibration gas must be at least 20 times the standard duration of die
response from the zero calibration gas when the instrument is zeroed on the most sensitive
scale. The span value of the 'analyzer must be less than 100 ppmv.
NOTE: For determining speciated HAP concentrations, any method which has met EPA Method 301 validation
criteria can also be used with the approval of the test administrator.
8-15
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OandA
Q.
A.
Q-
A.
Who is the test administrator?
The test administrator is the regulator who has responsibility for approving the
test plan, observing the tests, and accepting the test results. Typically, they are
employees with the State or Local Air Pollution Agency who have jurisdiction
over the facility through the issuance of air quality permits. In many cases, test
objectives also include demonstrating compliance with air quality permit
limits.
What should the emissions profile include?
The profile for the vent to the control device must describe the vent stream at
the inlet to the control device under, worst case conditions. The profile can be
prepared using any one of the three following approaches:
• Byprocess:
- include all emission episodes contributing to vent stack load
- describe scheduling that reflects all contributing processes
- describe the HAP load to the device that equals the highest sum of
emissions from the episodes that can vent to the control device in any
given hour
- use uncontrolled emissions calculations (emissions estimation
equations or engineering assessments) to calculate emissions per
episode. If the episode is longer Jthan 1 hour, divide the emissions
figure by the duration of the episode.
• By equipment: ,
- describe emissions that meet or exceed the highest emissions, in Ib/hr,
that would be expected under actual processing conditions
- describe equipment configurations that yield the emission events
described " '
- include volatility of materials processed in the equipment
- describe rationale used to identify and characterize the emissions
(emissions may be based on a compound more volatile thari compounds
actually used in theprocess(es), and emissions may be generatedjrom
all equipment in the processes) or only selected equipment.
• By capture and control device limitations:
- describe the highest emissions, inlb/hr, that can be routed to the
control device, based on maximum flow fate and concentrations
possible because of limitations on conveyance and control equipment*
8-16
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In order to show that large control devices \
(handle at least 10 tons/yr) are achieving the j
required reduction efficiencies, performances
tests must be performed at worst-case
conditions. i
The owner or operator can choose to use
absolute worst-case or hypothetical worst-
case, as defined below in Table 8-3.
Table 8-3. DEFINITIONS OF TYPES OF PERFORMANCE TEST CONDITIONS
Tvoe of Condition
i
Definition
Absolute
Worst-Case
If the maximum load rate is the most challenging condition for die control device,
then absolute worst case equals:
1) period in which inlet will contain at least 50 percent of the maximum HAP load
(in Ib) capable of being (vented to the device over any 8-hr period
OR . ! i • ..
2) period in which inlet will contain the highest HAP mass loading rate (in Ib/hr)
capable of being vented; to the device over a 1-hr period
i i
If condition other than maximum load rate is the most challenging condition for the
control device, then absolute worst case equals:
i
The period of time whesi the HAP loading or .stream composition (including non-
HAP) is the most challenging for the control device (e.g., periods when stream
contains the highest combined VOC and HAP load in Ib/hr, periods when stream
contains HAP constituents that approach limit of solubility for scrubbing media, periods
when stream contains KAP constituents feat approach limit of adsorptivity for carbon
adsorption systems]).
i
I
Hypothetical
Worst-Case
Simulated test conditions that, at a minimum, contain the highest total average
hourly HAP load of emissions that would be predicted to be vented to the control
device, considering information included in the emissions profile.
8-17
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Devising a Compliance Strategy
•Aii Example- ;
The example provided below shows how an emissions profile can be used to develop a compliance
strategy for a specific process. ' , ,
Table 1 lists the series of emissions events in Process A, starting with a methanol (MeOH) charge to,
the weigh tank. This table lists the uncontrolled and controlled emissions of one batch of the existing
process prior to implementation of the MACT rule. Some emissions are controlled by condensers
and/or a carbon adsorber. Some of the emissions are not currently routed to a control device. As
shown at the bottom of the table, uncontrolled emissions for one batch are 673.01 pounds (methanol
and chloroform). The overall control efficiency is 74,57%; controlled emissions are 171.18 pounds
total. Theowner/operatorwillneedtodeteainmewhemeritmakessensetocomplywiththe2,0001b/yr
limits standard or the 93% emission reduction standard.
Table 2 shows one possibility for a control strategy. First, the owner/operator should determine
whether any vents are subject to the individual vent control requirement for 98% reduction. The table
indicates that no individual vents have uncontrolled emissions greater than 50,000/year (25 tons/yr)»
so no vents are subject to the 98% requirement In this case, after determining that no vents are subject
to the 98% requirement, the owner/operator decides to attempt compliance with the 93% emissions
reduction standard.
The gray boxes indicate where previously uncontrolled streams will be vented to the carbon adsorber.
With a 90% reduction efficiency for methanol and a 95% reduction efficiency for chloroform, the new
annual controlled emissions are listed in the coluniinon thefarright side of me table. As shown at the
bottom of that column, the new overall control efficiency is 93.13%, which meets the MACf standard.
To demonstrate that the carbon bed will be able to achieve the standard, it must be tested at the
maximum loading rate. Table 3 provides the emissions profile data for the carbon bed. In looking at
the column labeled "Total HAP sent to CA (lb/hr)"' it is clear that the maximum load occurs during the
drying process, with 34.14 lb/hr sent to the barbort adsorber. This happens 123 hours into the batch.
The owner/operator will conduct performance tests of the carbon adsorber during the dryer emissions
event.
8-18
-------
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-------
QandA
A.
Q.
A.
Why are there two types of testing conditions - absolute worst-case and
hypothetical worst-case? •
The EPA regulations allow the owner/operator the flexibility todefine wot-st-
case in terms of HAP load, HAP mass loading rate, or other factors relating to
the operation of the control device. Hypothetical -worst-case allows the
owner/operator to simulate the worst-case conditions, in the event that it is
very difficult to find a period when the device actually is under worst-case ,
conditions without artificially staging the test and perhaps causing significant
interruptions in production,. , *.,",' , £
( z „ " ,,; ' J
Are there any restrictions on my operationJbased on the type of performance
test I conduct? \ -•;,'',
Yes; the owner or operator^ cannot operate the facility under conditions that
are worse than the conditions under -which the performance test was
conducted. If "worst-case f' conditions were properly identified in the test
design, however, there should not be many, if any, instances where this occurs.
Recall that a violation of an operating limit does not necessarily constitute a
violation of an emission standard, except for condensers. In fact, the
owner/operator may choose to preset multiple parameter levels to account for
variation iri batch emission streams. The owner/operator has the opportunity
to review operating logs during periods ofexceedances to determine if
operating conditionsare different from those under which the device was
tested, ffthisis^iecas^apd the owner/operator has preset multiple
parameter levels to account for these variable periods, the exceedance witt not
count as a violation. ! -.- , , , " , -
What are Acceptable Previous Test : j
Results?
M^^^^M^^^BOHBV^^M^HHi^BMMMMMMMMH^MMMMMMBBBBHBHMHMMIVMVnanMMMBaHlB
i I
Previous test results are acceptable for \
compliance demonstrations if they were; |
• Performed using acceptable test ! \
methods (as listed in Table 8-2) i
• Performed over conditions typical of
appropriate worst case as listed in
Table 8-3 for process vents, j
reasonable maximum filling rate for i
tanks, and representative < i
manufacturing process operation and;
representative wastewater treatment'
operation for wastewater sources; j
What are the TOC Alternative Standards
& Outlet TOC Standards for Compliance
Demonstration for Process Vents, Storage
Tanks, and Wastewater Sources?
Total Organic Compounds, TOC, are
measured as the sum concentration of all
organic compounds in & gas stream. The rule
makes reference to two TOC standards - the
Alternative Standard and, for the sake of
discussion here, the Outlet TOC Standard.
A comparison is shown below in Table 8-4.
The Outlet TOC Standard can be
considered a surrogate of demonstrating
compliance with the percent reduction
8-23
-------
standard, because it allows an
owner/operator to show initial compliance
by measuring TOC. For demonstrating on-
going compliance, the
owner/operator can set operating parameters,
or continue to monitor TOC directly with a
CEM. The Alternative Standard, however,
"locks" the owner/operator into monitoring
TOC with a CEM for on-going compliance
if the owner/operator continues to choose
the alternative standard option for
compliance.
Table 8-4. Comparison of the Alternative Standard and the Outlet TOC Standard
Standard
Standard is an
option for
Standard
applies to
Initial
compliance
demonstration
requirements
Monitoring on-
going
compliance
Alternative Standard
for combustion control devices, <20 ppmv TOC and <20
ppmv hydrogen halides/halogens1;
for noncombustion, <50 ppmv TOC and <50 ppmv
hydrogen halides/halogens
storage tanks and process vents
control device
Use a CEM to meet TOC and HC1 monitoring
requirements in §63.1258(b)(5) by the initial compliance
date.2
Continue TOC monitoring and hydrogen halide and
halogen every 15 minutes during operation
*
K Outlet TdC standard
<20 ppmv TOC and <20 ppmv
hydrogen halides/halogens
< 50 ppmv TOC and <50
ppmv hydrogen halides/HCl
wastewater streams and
process vents
process vents or wastewater
stream
Use methods in 63.1257(b) to
demonstrate 20 ppmv TOC
Meet monitoring requirements
in§63.1258(b)(l)-(4).
Owner/operator sets
monitoring parameters (e.g.,
combustion temp.) during
initial performance test.
1. In lien of achieving the 20 ppmv outlet hydrogen halide and halogen concentrations the owner/operator
may control post-combustion device HCL emissions by 95%.
2. When using a post-combustion control device to comply with the 95% HCI control efficiency option
available under the alternative standard, the owner/operator may use methods in 63.1257(b) to demonstrate
HCI compliance in lieu of a CEM.
NOTE: When a combustion device
is used to comply with the outlet
concentration standard, the actual
TOC, organic HAP, and hydrogen
halide and halogen must be corrected to 3
percent oxygen if supplemental gases are
added to the vent stream or manifold. The
applicable equation for calculating the
corrected concentration is at 63.1257 (a)(3).
8-24
-------
8.6 Compliance Demonstration , j
Procedures for Storage Tanks I
Compliance demonstration procedures for i
storage tanks are listed in 1257(c). j
Procedures are given to comply with the' i
following types of standards: J
• Floating roof ; :
• Percent reduction , • j
• Alternative standard j
• Vapor balancing }
To determine mass emission rates and »
percent reduction, compliance ; |
demonstrations are done by conducting !
design evaluations, (see page 8-10) or ;
performance testing (see page 8-12). !
Compliance with the TOC alternative :
standard is accomplished using TOC j
monitoring (see page 8-22). These methods)
are identical to those described in section 8.5
for process vents. Please note that design ;
evaluations can be used for calculating ;'
controlled emissions from storage tanlcs •
regardless of the quantity of emissions i j
controlled (i.e., there is no <10 TPY \
restriction). Floating roof demonstration, J
requirements are listed in the HON, § |
63.119(b-d) and §63.120(a-c). Because fe\y
pharmaceutical facilities use floating roofs, a
detailed discussion is not included here.! The
reader is referred to the HON Inspection |
Tool (EPA - 305-B-97-006, September, j j
1997). The reader is referred to Appendix !
HON for more details. A separate i i
compliance demonstration for tanks is not [
necessary for a storage tank if emissions are;
routed to a control device being used for |
process vents, and a compliance
demonstration will be done in accordance !
with the process vent regulations. ' •
; j
If the owner or operator uses the vapor ! ;
balancing option, the following requirement^
apply. Railcars or tank trucks that deliver ;
HAPs to an affected source must be reloaded
at a facility that either:
1) controls emissions via a closed vent
system with a device that reduces inlet
emissions of HAP by at least 90% or
2) controls emissions by using a vapor
balancing system to route the collected HAP
vapor back to the storage tank from which
the material was originally transferred.
If option 1 is used to control emissions, the
owner or operator needs to secure
information from the reloading/cleaning
facility that demonstrates compliance with
the 90% reduction standard. Either
performance testing or design evaluations
can be done. If option 2 is used, the owner
or operator must keep records that show
what procedures will be followed when
reloading and when displacing vapors back
to the original storage tank. He/she must
document each time the vapor balancing
system is used to comply with the standard.
8.7 Initial Compliance Demonstration
Procedures for Wastewater
Sources
The initial compliance demonstration
procedures as listed in §63.1257(e) are
basically separated into 3 parts:
• Determination of wastewater HAP
concentration and load as it pertains
to wastewater applicability criteria,
• Design Evaluation and Performance
Test procedures for demonstrating
compliance with wastewater
treatment standards, and
• Design Evaluation and Performance
Test procedures for demonstrating
compliance with APCD
requirements.
The following discussion will address these
three items.
8-25
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How do I Calculate the Annual Average
Concentrations and Load?
This calculation determines if a wastewater
meets applicability criteria (four affected
source categories), and should be performed
using either:* Analytical techniques listed
in63.1257(b)(10)i-iv.
They are:
- Method 305-Fm (Fm = Fraction
measured = theoretical proportion in
wastewater that volatilizes into air;
as listed in Table 8 in the rule);
- Methods 624,625,1624,1625,
1666, or 1671;
- Method 8270 or 8260;
- Other EPA Methods validated
using Method 301, 40 CFR 63
Appendix A, or "Alternative
Validation Procedure for EPA Waste
Methods" hi 40 CFR 63 Appendix
D; or
- Non-EPA Method validated using
Method 301,40 CFR 63, Appendix
A.
(For any above techniques chosen,
prepare a sampling plan
documenting procedures for
determining recovery efficiency of
PSHAPs and SHAPs and
incorporating similar sample
handling requirements as Method
25D to ensure that losses of organic
compounds during sampling are
minimized.)
• Calculation techniques based on
process wastewater knowledge, or
• Bench scale or Pilot scale test data.
NOTE: As discussed hi Chapter 7,
i^ an o/o is exempted from
performing wastewater
characterizations for applicability
determinations if he designates the
wastewater stream as affected. If an o/o ,
designates a wastestream as affected, he
assumes the wastewater is subject to the
standards, and therefore does not need to
determine concentration and load annually.
Designated streams are subject to the same
standards as characterized streams.
Wastewater treatment options are limited,
however, and do not include treatment to 50
ppmw PSHAP or 520 ppmw SHAP, or using
enhanced biological treatment.
How Do I Demonstrate Compliance With
the Wastewater Treatment Standards?
If the owner or operator opts to use enhanced
biotreatment or a RCRA-regulated unit,
neither performance testing nor design
evaluations are required. For any other non-
biological treatment process, the owner or
operator must do performance testing or a
design evaluation. For closed biological
treatment processes, either performance
testing or design evaluations are required. For
open biological treatment processes,
performance testing is required.
Wastewater Treatment Performance
Testing
Wastewater treatment performance testing
procedures are given for the following types
of treatment standards:
• wastewater concentration limits
(noncombustion treatment)
• wastewater mass removal/destruction
efficiency limits
Table 8-5 summarizes analytical methods for
determirung applicability and demonstrating
initial compliance for wastewater.
8-26
-------
Table 8-5. Summary of Analytical Methods'for Wastewater Applicability and Initial Compliance
Demonstrations
tt&4£&9»&*, .
-V^neeatraflwato,..^ ,
^£" ' " <~i?££i?* '
Determine characteristics
of an affected wastewater
stream defined in
§63.1256 (a)(l)(i)
Demonstrate initial
compliance with the
outlet concentration limit
in §63.1256 (g)(8)(i) or
(9)(i)
Demonstrate initial
compliance with any of
the percent mass
removal/destruction
options in §63.1256
(g)(8)(ii),(9)(ii),(ll),
(12).
__ ~? '^jording t» "'- '
' !py«cediaires'sDecMed in
"'? ff :> • '•*«> ' J 1
§63.1257 (e)(l)
1
i i
I
i -
i |
: t
§63.1257 (e)(2XiuXBi
i *
\ f
' I '
§63.1257(e)(2)(iii(C)
through (G) I
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^ V "™ ^ ^ ^>-
^ /"^ v
Method 305
Any other method, as
described in §63.1257
(b)(10)(ii) through (v)
Method 305
Any other method, as
described in §63.1257
(b)(10)(ii) through (v)
Method 305
Any other method, as
described in §63.1257
(b)(10Xii) through (v)
C.\ (1 3rtetoL,'v *-
t s "^•••" ", '' 41^
Divide the measured
concentrations by the
appropriate compound-
specific Fm factors
before comparing the sum
to the applicability
threshold.
Compare the sum of the
measured concentrations
directly to the
applicability threshold.
Compare the sum of the
measured concentrations
directly with the PSHAP
and/or SHAP limits.
You may elect to multiply
the measured
concentrations by the
appropriate compound-
specific Fm factors
before comparing with
the PSHAP and/or SHAP
limit.
Divide the measured
concentrations by the
appropriate compound-
specific Fm factors
before using to calculate
the mass flow raie
Use the measured
concentrations directly to
calculate the mass flow
rates
*Method 305 = Measurement of Emissions
Potential if Individual Volatile Organic
Compounds in Waste
8-27
-------
r
QandA
Q
A.
If I choose the sampling/analysis option for determining wastewater
applicability characteristics, where do I sample and at whatfrequency end
duration ?
The rule states that the samples must be collected either at the POD or
downstream of the POD. If downstream, the resulting HAP concentrations
must be corrected to reflect expected values -which would occur at the POD.
As for the sampling frequency and duration, the only guideline given is that
the resulting SHAP/PSHAP concentration and load values are annual
averages. In other words, the concentration must reflect the total mass of
SHAP/PSHAP constituents delivered to the wastewater stream in a calendar
year divided by the total mass of wastewater occurring in the same year.
Sampling frequency and duration must be sufficient to calculate a
representative average of these parameters. Once the applicability
determination is made, it does not need to be revJsjjtMurtless there are process
changes that would change wastewatergoncehtt^Q^wf^
that applicability'of the rule could change.
8-28
-------
QandA
A.
A.
How is ike degradation factor (F^ calculated and used?
The degradation factor (F^) is calculated using the procedures found in
Appendix Cjo Part 63 (Determination of the Fraction Biodegraded in a
Biological Treatment Unit)^ Procedures are given for using FMo in the
following 3 biological treatment configurations:
* . mass destruction/r&noval efficiency is determined across a biological
treatment system only
« mass destruction/removal efficiency is determined across a series of
treatment processes where the Met to the equalization tank can be
considered the biological treatment system inlet
« mass destruction/removal efficiency is determined across a series of
treatment processes where the inlet to the equalization tank cannot be
considered the biological treatment system inlet
If hard piping is used to transport wastewater and the equalization tank has a
fixed roof/closed vent system vented to an APCD, the inlet to the equalization
tank can be considered the 'biological treatment system inlet. Also, in a
general sense,* if hard piping is not used to transport wastewater, total plant
mass destruction/removal efficiency has to be calculated as the sum of
individual treatment process removal efficiencies. Further details on
wastewater treatment compliance are given in Appendix WWT.
" "
How do I demonstrate compliance for wastewater that is either treated off
site or treated on site by a treatment facility not owned or operated by the
source ?' j ' "
The wastewater treatment plant O/Ois responsible for the bulk of the
demonstration procedure. However, the O/O of the wastewater source must
perform the following: • t
• Demonstrate compliance with vapor suppression standards for all
equipment used jo transport wastewater prior to treatment, and
« Submit a notice to «je'treatment'facility ana'keepa record for himself
stating thewastewaier contains organic HAP and must be treated in
accordance with this rule. The notice must be submitted for each
shipment, or if shipment is continuous, then an initial notice and
whenever there is alchange in the required treatment, and
• Additionally, though not requ^ed, it may be prudent for ^e
owner/operator, to: \
8-29
-------
Verify that the treatment facility is certified to manage this waste in
accordance with;
1. Wastewater treatment and emissions regulation of this rule,
§63.1256 (b)-(i) (vapor suppression standards, emissions control
device standards, wastewater treatment standards, and
delay of repair standards),"or
2. SubpartD of this part, if an alternative emissions limitation has
been granted to the source in accordance with Subpart D s
(Regulations Governing Compliance Extensions for Earfy Reductions
ofHAPs),or
5. §63.6(g) - Use of an alternative non-opacity emission
standard
Wastewater Treatment Design
Evaluations
Wastewater treatment design evaluations can
be used to demonstrate compliance for
nonbiological and closed biological
treatment systems. (If open biological
treatment is being used, then performance
testing must be performed to demonstrate
compliance.) A wastewater design
evaluation should be completed according to
§63.1257(e)(2)(ii).
The following guidelines are given:
• Base the design evaluation on
operation at a wastewater flow rate
and a concentration under which it
would be most difficult to
demonstrate compliance, and
• For closed biological treatment
processes, use a mass balance
conducted over the entire unit,
including any emission control
devices, to determine mass
removal/destruction rates.
8-30
-------
OcmdA
a.
A.
How do I demonstrate initial compliance with vapor suppression
standards? [
There are few initial compliance demonstration requirements listedM the
rule for vapor suppression standards. However, in the Reporting
Requirements listed in § 63 J 2600, Requirements for Notification of
Compliance Status? Report, the report must include where appropriate,
among other items, a list of monitoring devices, monitoring frequencies* and
values of monitored parameters established during the initial compliance
demonstrations. Therefore, the types of I & Mprocedures required for
wastewater management units (te., vapor suppression inspection routines-
discussed in Section 7.4 and in Table 9-3) must be established and
documented at the time of the initial compliance demonstration period.
Certain vapor collection systems, closed-vent systems, fixed roofs, covers,
and enclosures must receive an initial inspection in accordance with Method
21 to determine whether there are any leaks (readings greater than 500 ppm
above background), per 63J260(h)(2)(i)(A). Vapor collection systems .
operating under negative pressure are not subject to this requirement. The
reporting provisions in 63J26Qffl(2) require that the results of the inspection
be'submittedin:the> notification of'compliance status report.
Note on choosing the biological
demonstration procedure:
Closed Biological - If the O/O chooses
closed biological treatment and demonstrates)
compliance using §63.1257(2)(iii)(E) or (F) j
(Le., using a site-specific Fbio), then the i
treatment process is not subject to i
wastewater storage tank or surface j
impoundment vapor suppression standard's. \
: j
Open Biological - If the O/O chooses opejn \
biological treatment, then the treatment '
process need not be covered and vented to a \
control device. As noted above, if !
compliance is being demonstrated by •
§63.1257(2)(iii)(E) or (F), the treatment , |
process is not subject to wastewater storage !
tank or surface impoundment vapor
suppression standards.
How Do I Demonstrate Compliance With
the APCD Standards?
As with the wastewater treatment standards,
the owner or operator must conduct
performance testing or design evaluations to
demonstrate that the air pollution control
devices are operating efficiently and
achieving the necessary control. The
compliance demonstration requirements are
summarized in Table 8-6.
8-31
-------
Table 8-6. Compliance Demonstrations for APCDs used for Wastewater Sources
Compliance
Demonstration for
APCDs
Performance Testing
63.1257(e)(3)(i)
Design Evaluation
Flare Demonstration
63.1257(e)(3)(iii)
Standard
95% reduction
20 ppmv outlet limit
i.
95% reduction or
20 ppmv outlet limit
Flare
jSummary ofPrjoeedure
:?•*' .-'••"• •;•:, .«.;•. -'-? -•'.-:•'• -'••:•
Follow same general performance test
procedures of 63.1257(e)(2)(iii)(A)O)-(4):
- demonstrate during representative process
operating conditions
- demonstrate during representative treatment
process operating conditions
- supplement perf. test results with modeling
or engineering data, if necessary, to
demonstrate performance over a range of
conditions
- sample at inlet and outlet of APCD
- minimum of 3 1 -hr test runs
- Method 18 or other method validated via
Method 301
- calculate concentration of TOC or total
organic HAP (correct to 3% oxygen if
combustion device)
- calculate mass rate
- compare mass destruction efficiency to 95%
standard or compare outlet concentration to 20
ppmv standard
Follow design evaluation requirements as
described on page 8-10 and 8- 1 1 of this
chapter
Operate flare as provided under 63.1 1; no
performance testing or TOC testing required
for demonstration
Note: no compliance demonstration is necessary if APCD is a boiler or process heater with design heat input capacity
of 44 megawatts or greater, a boiler or process heater in which the emission stream is burned with the primary fuel,
or a RCRA-regulated unit.
8.8 Submittal of Compliance
Demonstrations for All Affected
Sources
The O/O must submit supporting data and
analyses used in compliance demonstrations
in either the Precompliance Report or in the
Notice of Compliance Status Report,
depending on the nature of the information
being submitted. The following information
must be included:
8-32
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Table 8-7. COMPLIANCE DEMONSTRATION PLANS AND REPORTS
Precompliance Report
Notice of Compliance Status Report
Submit at least 6 months prior to compliance date
Submit no later than 150 days after the compliance
date
Include: : !
i i
Date and rationale used to support an engineering j
assessment to calculate uncontrolled emissions from'
process vents ; j
Date and information used to support determination
of annual average concentration in wastewater by [
process simulation. ;
, ! 1
Bench or pilot data used to determine annual average
concentration in wastewater. , ;
I
Include:
(1) The results of any applicability determinations,
emission calculations, or analyses used to identify
and quantify HAP emissions from applicable
sources.
(2) The results of emissions profiles, performance
tests, engineering analyses, design evaluations, or
calculations used to demonstrate compliance. For
performance tests, results should include descriptions
of sampling and analysis procedures and quality
assurance procedures.
(3) Descriptions of monitoring devices, monitoring
frequencies, and the values of monitored
parameters established during the initial compliance
determinations, including data and calculations to
support the levels established
(4) Operating scenarios.
(5) Descriptions of worst-case operating and/or
testing conditions for control devices.
NOTE: Additional information, other than compliance demonstration data, is required to be included in the above
reports (See Chapter 13). t
Using Operating Scenarios in Compliance Demonstrations
The term "operating scenario " is defined in 63.1251, In general, it is the collection of
information that describes how a PMPU is operating at any one time to produce a product.
It includes a description afwhatprocess equipment is used, what the emissions points, are,
what control standards the process is subject to, how the emissions are being controlled to
the required standard, what monitoring is being conducted, as well as any other information
that needs to be gathered to demonstrate compliance. A more complete list is on page 12-4.
Documenting this information allows owners/operators to track all the elements that,
contribute to a compliance demonstration* , , ^/ ^, ,
8-33
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-------
Chapter 9
Monitoring Procedures
9.1 Overview
The MACT regulations require that affected
sources conduct monitoring to verify on- j
going continuous compliance. Monitoring \
can be done either by continuously measuring
emission reductions directly or by j
continuously measuring a site-specific j
operating parameter(s). The site-specific j
operating parameters are established duringj
the'initial compliance demonstration. For •
devices that control greater than 1 ton per i
year, the operating parameters are monitored
no less than every 15 minutes while the i
control device is operating. For devices that
control less than 1 ton per year, daily
verification that the device is operating
properly is sufficient for monitoring
purposes. An important aspect of a facility's
monitoring program is the determination oft
the appropriate averaging period for each i
parameter measurement. An operator can •
choose to use either a daily (24-hour) or a j
block averaging period that covers the length
of a process. For equipment leaks, periodic,
monitoring is conducted through 1
implementation of me LDAR program (Seej
Chapter 6). Monitoring requirements for the
mass emissions limit standard are discussed
in this chapter, monitoring requirements for>
those facilities using the pollution prevention
option are covered in Chapter 10. ]
i
9.2 Structure of the Regulation i
The monitoring section of the Pharmaceuticsa!
MACT is structured as follows: i
§63.125 8(a) Sources shall provide
Chapter 9 at a Glance
9.1 Overview
9.2 Structure of the Regulation
93 Basis for Monitor ing Control
Devices
9.4 Establishing Operating
Parameters for Monitoring
Control Devices
9.5 Establishing Averaging Periods
for Monitoring
9.6 Monitoring for the Mass
Emissions Limit Standard (2,000
Ib/yr)
9.7 Wastewater Monitoring
Procedures
s*
9.8 Monitoring for SSM
9.9 Exceedauces of Operating
Parameters, Excursions, and
Violations
evidence of continued
compliance
§63.1258(b) Monitoring for control
devices
§63.1258(c) Monitoring for emission
limits
§63.1258(d) Monitoring for equipment
leaks
§63.1258(e) Pollution prevention
9-1
-------
§63.1258(f)
§63.1258(g)
§63.1258(h)
Emissions averaging
Inspection and monitoring of
waste management units and
treatment processes
Leak inspection provisions for
vapor suppression equipment
NOTE: Because this document
contains specific chapters on
equipment leaks, pollution
prevention, and emissions averaging, the
monitoring provisions relating to those topics
will be covered in those specific chapters.
93 Basis for Monitoring Control
Devices
As noted in the overview, owners and
operators must use some sort of monitoring
to confirm that the control devices being used
are actually achieving the required
reductions.
Instead of measuring HAP levels and
calculating emission reductions, however,
the owner or operator can establish
parametric monitoring levels, which if met,
indicate that the control device is operating
to achieve the required emission reduction.
These parameters could include, for
example: temperature (in the case of
condensers), liquid flow rates (for liquid
scrubbers), time interval between carbon
replacement (for non-regenerative carbon
adsorbers). The table below describes the
basis for selecting monitoring parameters for
different kinds of monitoring programs. The
different kinds of monitoring programs are
based on the size of the control device (i.e.,
quantity of HAPs controlled per year), or the
mode of operation (Le., batch or
continuous), or the whether the alternative
TOC standard will be used.
Table 9-1. BASIS FOR MONITORING PARAMETERS
Nature of Process
or Control Device
Basis for Establishing Monitoring Parameters
Devices controlling
less than Itpy HAP
emissions before
control
Monitoring consists of daily verification that device is operating properly. :
Verification may be on a per batch basis. The verification method is determined by
the owner/operator and must be identified in the Precompliance Report.
Devices controlling
>ltpybut<10tpy
Establish parametric monitoring levels based on design evaluation conducted for
the initial compliance demonstration. IF a performance test was conducted, follow
information directly below for devices controlling > 10 tpy.
Devices controlling >
10 tpy
Establish maximum or minimum parametric value(s) based on the average of
values from each of three performance test runs. Test results are not required over
the entire operating range. If me O/O wants to set levels for conditions other than
worst case, information from engineering assessments and manufacturer's
recommendations can be used to supplement the performance tests. This information
must be submitted in the Precompliance Report for approval.
9-2
-------
Nature of Process
or Control Device
Basis for Establishing Monitoring Parameters
Devices controlling
emissions from batch -
processes (for devices
controlling^ 10
tons/yr)
If owner/operator select^ to control more than one batch emission episode, then use
the initial compliance demonstration to establish either:
a) a single parametric level for the batch process, or
b) separate parametric levels for each batch emission episode or groups of
emission episodes. If separate monitoring levels are chosen (b), the operator must
record which episode is being monitored and when the parameter being monitored
changes levels. Tire operator must record at least one reading at the "new" level for
the monitored parameters).
Devices controlling
emissions from process
vents and/or tanks for
which the O/O has
selected the
"alternative
standard"
Use direct measure of TOC, and hydrogen chloride and halogens (if present in the
gas stream) as indicated by a CEM. (See Page 9-6 for additional details)
9.4 Establishing Operating j j
Parameters for Monitoring •
Control Devices !
s
Table 9-2 lists the required monitoring j '
parameters for emissions control devices; !
provides a monitoring schedule, and lists i
other instructions and specifications j I
particular to each kind of control device, j
such as calibration schedules. \ .
-' i
The regulations also allow an owner or ; |
operator to request approval to monitor ; |
alternative parameters for control devices. ]
This request can be made by following the I
procedures in §63.8(f) or included in the[ ;
Precompliance Report. j ;
i !
For devices controlling less than 10 TPYj,
the parameter values can be determined ffoni
the design evaluation conducted as part of !
the initial compliance demonstration. For I
devices controlling at least 10 TPY, ;
performance testing will be required for the j
initial compliance demonstration. The ! [
owner or operator can use engineering i •
assessments and manufacturer's ; ;
recommendations to supplement : j
performance tests, in establishing the
parametric monitoring level(s). The owner
or operator must describe in the
Precompliance Report:
• rationale for the specific level for
each parameter, including data and
calculations used to establish level(s)
• why the level(s) indicate proper
operation of the control device
;'
The Administrator must approve the
determination of parametric monitoring
levels as outlined in the Precompliance
Report.
9-3
-------
Table 9-2. OPERATING PARAMETERS FOR DEVICES CONTROLLING > 1 TPY
If the control
device used is
3. **»9
liquid scrubber
condenser
regenerative
carbon adsorber
non-regenerative
carbon adsorber
flare
thermal
incinerator
For each device, must
establish the following
operating parameters)....,
1) minimum scrubber liquid flow
rate or pressure drop, based on
conditions anticipated under worst-
case conditions, 2) if caustic used,
minimum pH of effluent liquid
maximum condenser outlet gas
temperature
under absolute worst-case
conditions - 1) minimum
regeneration frequency, 2)
minimum temp, to which bed is
heated during regen., 3) maximum
temp, to which bed is cooled,
measured within 15 minutes of
completing cooling phase, and 4)
minimum regen. stream flow
maximum time interval between
replacement, based on anticipated
worst-case conditions !
presence of pilot flame(s)
maximum temperature of gases
exiting the combustion chamber
And monitor
; parameters .
on the
following
schedule.*
1) every 15
minutes while
scrubber is
operating, 2) once
a day1
every 15 minutes
while condenser
is functioning in
achieving the
required HAP
reduction2
record 4
regeneration cycle
characteristics for
each cycle
at each
replacement
every 15 minutes
while the flare is
functioning
every 15 minutes
while the device
is functioning
Other Instructions and
.Specifications;
Device monitoring flow rate
or pressure drop must be
certified by manufacturer to
be accurate within ±10
percent of design flowrate or
maximum pressure drop
measured. Calibrate
monitoring device annually.
Temperature monitoring
device must be accurate to
within ±2% of temp, or
within ± 2.5°C, whichever is
greater. Calibrate monitoring
device annually.
Use temp, monitoring device
that is accurate to within ±2%
of temp, or within ± 2.5 °C,
whichever is greater. Use
stream flow monitoring device
accurate to within ±10
percent of the established
value. Calibrate temp, and
flow monitoring devices
annually. Conduct yearly
check for bed poisoning.
Monitoring device must be
accurate to within ± 0.75% of
temp, or ± 2.5 °C, whichever
is greater. Calibrate
monitoring device annually.
9-4
-------
If the control
device used is
For each device, must
establish the following
operating parameter^),,..
And monitor
parameters
s on the,
following
schedule.*
Other Instructions and
"-"' Specifications :„
~t~ ? * •*>
catalytic "
incinerator
minimum temperature of gas stream
immediately before the catalyst bed
and minimum temperature j
difference across the catalyst bed
temp, of gas
stream
immediately
before and after
the catalyst bed,
every 15 minutes
while the device
is functioning
Monitoring device must be
accurate to within ± 0.75 % of
temp, or ± 2,5°C. Calibrate
monitoring device annually.
process heater
and boiler
minimum temperature of gases
exiting combustion chamber
EXEMPT IF ALL VENT, j
STREAMS INTRODUCED WITH
PRIMARY FUEL OR DESIGN
HEAT INPUT CAPACITY IS 44
MEGAWATTS OR GREATER.
every 15 minutes
while the device
is functioning
Monitoring device must be
accurate to within ± 0.75 % of
temp, or ± 2.5°C. Calibrate
monitoring device annually.
* Monitoring frequencies listed are minimum required frequencies. .
1. Liquid scrubbers used to control HC1 emissions during periods of planned routine maintenance for centralized
combustion control devices (CCCD) must be monitored once a day to ensure scrubber effluent pH > 9.
2. This also applies to condensers receiving HAP emissions during periods of planned routine maintenance for a
CCCD. i 1 •
Using a Continuous Emissions Monitor
for HAP or TOC
i
As an alternative! to the parameters listed
above, an owner or operator may elect to
install a continuous emissions monitoring
system (CEMS) to monitor:
the outlet HAP concentration, OR
both the outlet TOC concentration
and outlet hydrogen halide and
halogen concentration. '
Monitoring must be conducted every 15 i
minutes while the control device is i
functioning in achieving the HAP removal
required by the regulations. If the owner or
operator knows that the emission stream
does not contain hydrogen halides or
halogens, it is not necessary to monitor for
them. The monitor must meet the
performance standards in Part 60,
specifically Performance Specification 8 or
9 of Appendix B. The monitor must be
installed, calibrated, and maintained
according
to the regulations at §63.8 - Monitoring
requirements in General Provisions. The
text of Part 60, Appendix B- Performance
Specification 8 and 9, and the text of §63.8
are provided in Appendix PS of this
document. The QA/QC plan must include
provisions for quarterly cylinder gas audits,
at a minimum.
Monitoring alternative parameters
If an owner or operator prefers to monitor
parameters other than those listed hi Table
9-2, he/she may submit a request for
9-5
-------
approval, following the procedures in
§63.8(f) (Monitoring requirements - Use of
an alternative monitoring method). For
example, an owner/operator could examine
the manufacturing process to determine if
any parameters, or combinations of
parameters, such as raw materials, feed
rates, operating pressures, process type, etc.,
could be monitored to demonstrate
continuing compliance.
Monitoring for the "alternative" standard
Monitoring for the alternative standard
requires measuring the outlet TOC
concentration and the outlet hydrogen halide
and halogen concentration every 15 minutes
while the APCD is functioning. (Operate a
TOC monitor that meets Performance
Specifications 8, 9, or 15 of 40 CFR Part 60
Appendix B. Perf. Spec. 8 - QA and
calibration criteria for VOC CEMs such as
Method 25A instruments; Perf. Spec. 9 -
QA and calibration criteria for GC analyses
such as those called for by Method 18.)
For monitoring HC1, the owner/operator has
some options:
- use a FITR CEMS that meets
performance specification 15 of
appendix B of Part 60, or
- any other CEMS capable of
measuring HC1. If a Performance
Specification has not been
promulgated in appendix B of Part
60 for the subject monitoring
method, the owner/operator must
prepare a monitoring plan and submit
it for approval per §63.8.
- for monitoring halogenated vent
streams controlled by a combustion
device followed by a scrubber, the
owner/operator may elect to monitor
scrubber operating parameters that
demonstrate the HC1 emissions are
reduced by at least 95% by weight, in lieu
of operating a CEMS.
It is not necessary to measure hydrogen
halide and halogen if the owner or operator
knows that the emission stream does not
contain them.
If the owner/operator is using the alternative
standard (emissions routed to device that
achieves 20 ppmv TOC and 20 ppmv
hydrogen halides and halogens (50 ppmv
TOC/ 50 ppmv hydrogen halides/halogens if
non-combustion device is used), and
supplemental gases are added to the vents
or manifolds, the regulations impose some
specific instructions for monitoring.
The owner/operator must:
• For combustion devices, correct for
supplemental gases (correct to 3%
oxygen as directed by §63.1257
(a)(3)(i)) or track residence time and
firebox temperature. Monitoring
residence time can be done by
measuring flowrate into the
combustion chamber:
- If complying with the
alternative standard in lieu of
95% reduction for affected
existing process vents
and/or storage tanks,
minimum residence time is
0.5 seconds at minimum
temperature of 760° C.
- If complying with the
alternative standard in lieu of
98% reduction for affected
new process vents and/or
storage tanks, minimum
residence time is 0.75
seconds at minimum
temperature of 816° C.
• For noncombustion devices that are
used to control emissions from dense
9-6
-------
gas systems (conveyance system is
operated to limit oxygen levels to ;
below 2 percent), the owner or i
operator can monitor flowrate as
detailed below. :
• For noncombustion devices that are
used to control emissions from
systems other than dense gas
systems, 63.1257 (a)(3)(ii) provides
the equation for correcting the actual
concentration for supplemental ;
gases. Process knowledge and !
representative operating data can be
used to determine the fraction of the
flow due to supplemental gases.
Measuring flowrate for dense gas systems
As part of complying with the alternative i
standard, if the owner or operator opts to '
monitor flowrate in noncombustion devices
controlling emissions from dense gas ;
systems, the following provisions apply: :
1. Determine annual emissions entering
the control device, based on the most
representative emissions inventory
data submitted within the five-year;
period before the Notification of
Compliance Status report is due.
2. Install and operate a monitoring
system for measuring system
flowrate, recording the flowrate into
the control device at least once per;
hour. Calculate the system flowrate
as the average of all values measured
during each 24-hour operating day.
The monitoring device must be !
accurate to within 5 percent of the '
system flowrate setpoint. It must be
calibrated annually. [
3. Calculate the system flowrate j
setpoint at which the average
concentration is 5,000 ppmv TOC ',
using the following equation :
721xEan
S" 5,000
where
Fs = system flowrate setpoint, scfrn
Ban = annual emissions entering the
control device, Ibmols/yr
NOTE: These first three steps actually are
part of the initial compliance demonstration.
4. Recalculate the system flowrate
setpoint once every five years using
the annual emissions from the most
representative inventory data
submitted during the past five years.
If the emissions inventory data is
calculated using procedures other
Supplemental gases - gaseous streams
that are not defined as process vents, or
closed-vent systems from wastewater
management and treatment units,
storage tanks, or equipment components
and that contain less than 50ppm TOC,
as determined through process
knowledge, that are introduced into vent
streams or manifolds. Air required to
operate combustion device burner(s) is
not considered supplemental gas.
5.
than those at §63.1257(d) for initial
compliance demonstrations for
process vents, submit the emissions
inventory data calculations and
rationale for their use in the
Notification of Process Change
report or an application for a Part 70
permit renewal or revision.
Submit the initial calculation in the
Notification of Compliance Status
19-7
-------
report; submit the recalculated values
in the next Periodic report after each
recalculation. M the Notification of
Compliance Status report, if desired,
the owner or operator can specify a
maximum daily average operating
flowrate limit above the flowrate
setpoint and a reduced outlet
concentration limit corresponding to
that limit. Use the following
equation to correlate the elevated
flowrates and the outlet
concentration limits:
Ca*-=r
Fa
where:
Ca = adjusted outlet concentration limit,
dry basis, ppmv
50 = outlet concentration limit associated
with the flowrate setpoint, dry basis, ppmv
Fs = system flowrate setpoint, scfin
Fa =* actual system flowrate limit, scfm
6. Each time that a new operating
scenario is implemented, evaluate the
volumetric flowrate of supplemental
gases and the volumetric flowrate of
all gases, based on process
knowledge and representative
operating data. Include the
procedures used to evaluate the
flowrates and the resulting correction
factor in the Notification of
Compliance Status report and in the
next Periodic report after the
operating scenario changes.
Monitoring closed vent systems with
bypass lines
If a closed vent system has bypass lines that
could divert a vent stream from a control
device, the owner/operator must do one of
the following:
• install, calibrate, maintain, and
operate a flow indicator that
indicates whether vent stream flow is
present, at least once every 15
minutes. The flow indicator must be
installed at the entrance to any
bypass line that could divert the gas
stream to the atmosphere. The
owner/operator must keep hourly
records of whether the flow indicator
was operating and whether any
diversions were detected. He/She
must also record the times and
durations of any periods where the
stream was diverted or when the
flow indicator was not operating.
OR
• secure the bypass line valve in the
closed position with a car seal or
lock and key. He/She must conduct
a monthly visual inspection to ensure
that the valve is closed and the vent
stream is not diverted. The
owner/operator must record that the
monthly inspection was done, as well
as document any occurrences of
broken seal mechanisms, changes in
the position of the valve, or periods
when the key is checked out (if a
lock and key system is used).
9.5 Establishing Averaging Periods for
Monitoring
The owner/operator must establish averaging
periods for parametric monitoring levels
according to the following:
• On a daily (24 hour) or block average
basis
a 24 hour period can be from
midnight to rnidnight or any
other continuous 24 hour
period,
9-8
-------
a block average is equal to
the period of time, at a
maximum, from beginning to
end of a batch process. A
block may range from a very
short period of time (e.g., 10
minutes) to a long range of
time (e.g., two weeks),
depending on the nature of
the batch process. '
• A daily or block average is
calculated as the average of all !
values for a monitored parameter
recorded during the operating day or
block.
Monitoring data from control
devices not operating (as
indicated by no flow) is not
included in the average
To identify periods of
inoperation, the \
owner/operator must operate
a flow indicator at either the
inlet or outlet of the control
device. The flow indicator
must be calibrated annually.
The averaging period that will be used, ; <
operating day or block, must be defined in ;
the Notification of Compliance Status j
Report. |
; 1
9.6 Monitoring for the Mass Emissions
Limit Standard - 900 kg/yr (2,000 !
Ib/yr) j
Owners/operators electing to use the 900 kg j
and/or 1,800 kg/yr limit emission standard ]
for process vents must demonstrate on-gojng!
compliance. For each process for which !
the mass emission standard will be applied, j
the owner/operator must daily calculate a j
365-day rolling summation of emissions. j
Remember that this option limits emissions |
from process vents using this option to 1,800|
kg/yr total per facility, for existing sources.
For new sources, the total facility limit is
900 kg/yr, with no PMPU limit.
An owner/operator may comply with the
mass emissions limit using a combination of
controlled and uncontrolled vents. If vents
are controlled, initial and on-going
compliance demonstrations (i.e.,
performance testing and monitoring) must
be conducted for those vents. If a centralized
combustion device is being used to achieve
the mass emissions limit standard, the owner
or operator must calculate the controlled
emissions during periods of planned routine
maintenance assuming the control efficiency
is 93 percent.
If an owner/operator elects to switch from
the 93% or 98% reduction requirement to
the 900 kg/yr method, the rolling
summations must include emissions from
the past 365 days (i.e., include data from
days when the owner/operator was using the
93% or 98% standard). Please note that an
owner/operator cannot switch from the 900
kg/yr standard to the percent reduction
standard until at least one year has passed.
9.7 Wastewater Monitoring
Procedures
The following section presents a brief
summary of monitoring requirements for
demonstrating on-going compliance with
wastewater provisions. As with process
vents, storage tanks, and equipment leaks,
owners/operators of wastewater facilities at
affected sources must provide evidence of
continued compliance with the standard.
Process operation and associated waste
management units must therefore be
monitored to ensure on-going compliance.
In addition to the monitoring requirements
listed in §63.1258, it is important to review
9-9
-------
record keeping and reporting requirements
that relate to the choice of parameters to be
monitored. For example, one of the record
keeping requirements for wastewater
{§63.1259(b)(6)} is to maintain a record of
the initial demonstration of wastewater
concentration per POD or process.
The following task list can be used to assist
the O/O in developing a list of parameters to
monitor:
1. Determine Inspection and
Maintenance procedures for
wastewater vapor suppression
requirements. The O/O must
implement I & M procedures at the
required frequencies for
demonstrating continued compliance
with vapor suppression standards.
These procedures are shown hi Table
9-3.
2. Determine monitoring parameters
that are indicators of emissions
control. The O/O must monitor
parameters which are indicators of
emissions control compliance. These
include:
• APCD operation/performance
monitoring parameters, or
• Alternative parameters - Any
parameters needed to
calculate emissions based on
correlations with
performance testing,
engineering calculations,
design evaluations, etc. These
can be alternative APCD
parameters (those not listed
in the rule) or process
operation parameters (raw
materials, feed rates,
operating temperatures and
pressures, process type, etc).
These monitoring parameters
are the same as those
discussed above in section
9.2 - Establishing Operating
Parameters for Monitoring
Control Devices.
Determine wastewater
characterization/treatment
monitoring parameters.
Procedures for monitoring on-going
compliance with wastewater
treatment standards are contained in
§63.1258(g). ;
For biological treatment processes:
TSS, BOD, and biomass
concentration must be
monitored at a frequency
approved by the permitting
authority. Alternative
monitoring parameters may
be approved if proposed in
the Precompliance report.
For non-biological treatment
processes:
• A statement must be made in
the Precompliance Report
regarding 1he parameters that
will be monitored.
For recordkeeping purposes,
§63.1259(b)(l) requires
recordkeeping for measurements of
treatment process parameters.
Establish monitoring frequency
and averaging time for each
monitored parameter. Refer to
sections 9.3 and 9.4 for information
on averaging time and monitoring
frequency for parametric and TOC
monitors.
9-10
-------
Table 9-3. INSPECTION AND jyiOjNITQRING REQUIREMENTS FOR
VAPOR SUPPRESSION ^^
Vapor
Suppression
Equipment
Inspection and Monitoring Procedure
Procedure Description
Frequency
All Wastewater Management Units:
Closed Vent
System - Hard
Piping*
• Method 21 leak detections \
• Visible, audible, or olfactory leak detection
-Initially
-Annually
Closed Vent
System -
Ductwork*
• Method 21 leak detections !
; \
• Visible, audible, or olfactory leak detection
- Initially &
annually
- Annually
APCJ>
- Inspect APCP visually for qracks, gaps, tears or holes
- Initially & semi-
annually
Tanks:
Fixed Roof
- Inspect for Improper Work Fjractices (IWP) such as leaving
open any access doors or Control Equipment Failures (CEF)
such as inspect for cracks; gap's, or breakage in cover, lid,
joint, door or gasket j
- Inspect APCD and Closed Vent System as discussed above
under "All Wastewater Management Units"
-Inspect roof, cover and opening visually for leaks.
- Initially & semi-
annually
-(see above)
- Initially & seroi-
annually
Internal
Floating Roof
- Visual observations for wear; in material
- Inspect for IWPs and CEF as! listed in
§63.1256(b)(8)(i)(A)-(H) i |
- Inspect for cracks, gaps, or bjreakage in cover, lid, joint,
door or gasket. ; I
-per .120(a)2&3
-per .120(a)2&3
- Initially and
External
Floating Roof
(tanks)
- Seal Gap Measurements per §63.120(b)(2)(i) - (bX4)
: T
- Primary seal gaps !
- Secondary seal gaps
- If the floating roof is determined to be unsafe, measure
seal gaps or inspect wastewater tank, or empty and close the
tank per § 1256(b)(6)(ii) within 45 days
- Inspect for IWPs and CEFs a|s listed in §1256(b)(8)(i)(A)-
(H) ; |
- Inspect for cracks, gaps, ,or breakage in cover, lid, joint,
door or gasket.
- Initially & once
every 5 years
(annually if no
secondary seal)
- Initially & serni-
annually
- Within 30 days of
determination
- Initially & serni-
annually
- Initially & semi-
annually
! 9-11
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Table 9-3. INSPECTION AND MONITORING REQUIREMENTS FOR
VAPOR SUPPRESSION
Vapor
Suppression
Equipment
Inspection and Monitoring Procedure
Procedure Description
Surface Impoundments:
Cover or
Floating
membrane
- Inspect for IWPs such as leaving open any access hatches
and CEFs such as joint, lid, cover or door has a crack, gap
or is broken
- Inspect APCDs and Closed Vent System as listed above
- Inspect cover and openings visually for leaks
Frequency
- Initially & semi-
anriually
- Initially & semi-
annually
- Initially & semi-
annually
Containers:
Covers
- Inspect for IWPs such as leaving open any access hatch
and CEFs such as any time cover or door has a gap or crack
or is broken
- Inspect APCDs and Closed Vent System as listed above
- Inspect covers or openings visually for leaks
Initially & semi-
annually
Individual Drain Systems:
Cover
Water Seal
Cap or Plug
Junction Box
Unburicd
Sewer Lines
- Inspect for IWPs such as leaving open any access hatch
and CEFs such as any time a cover or door has a gap or
crack or is broken
- Inspect APCDs and Closed Vent System as listed above
- Verify that sufficient water is present
- Inspect for cracks, gaps, or holes in cap or plug
- Inspect for cracks, gaps, or holes in cover
- Inspect for cracks or gaps, or holes that may result hi
emissions
Initially & semi-
annually
Initially & semi-
annually
Initially & semi-
annually
Initially & semi-
annually
Initially & semi-
annually
Oil-Water Separators:
Fixed Roof
Floating Roof
- Inspect Fixed Roof and openings for leaks
- Inspect APCDs and Closed Vent System as listed above
Measure Seal Gaps according to 40 CFR 60.696(d)(l)
- primary seal gaps
-secondary seal gaps
Initially & semi-
annually
- Initially
- Once every 5 yrs
-Initially and
Annually
9-12
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Table 9-3. INSPECTION AND MONITORING REQUIREMENTS FOR
VAPOR SUPPRESSION
Vapor
Suppression
Equipment
Oil-Water
Separator
(general)
•sT
Inspection, and Monitoring Procedure /7 !_ /
Procedure Description
-Inspect for IWPs such as Jeaving open or ungasketed any
access door or other opening, |
- Inspect for CEFs such as those listed in 1256(f)(5)(i)(A-F)
{floating roof related} |
- Inspect for additional CEFs such as gaskets, joints, lids or
covers for cracks or gaps, or breakage.
Frequency
- Initially & semi-
annually
- as listed above
-Initially & semi-
annually
*Instead of these inspection and monitoring procedures, per §63.1258{h)(lO), an owner/operator may choose to
design a closed-vent system to operate at a pressure below atmospheric pressure. If such a system is used, it must
have a gauge mat can be read from a readily acce$sfl>|e location to verify mat negative pressure is being maintained
when the associated control device is operating.
9.8 Exceedances of Operating j
Parameters, Excursions, and '. I
Violations ; j
It is important to understand what j
constitutes noncompliance with the MACT j
regulations. To do this, it is necessary to, j
know how EPA defines "exceedances of j
operating limits", "exceedances of emissions^
limitations" and/or "excursions". ', \
For the pharmaceutical MACT, the : j
emissions standard is composed of two parts j
(1) emissions limitations, and (2) operating j
limits, hi some cases, an exceedance of an }
operating limit is directly tied to an emission!
limitation, whereas in other cases, it is not. |
If the operating limit is not directly tied to j
the emissions limit, it still constitutes a }
separably enforceable commitment which is j
representative of proper operation of the |
control device on an ongoing basis. The |
adjacent charts list how EPA defines !
exceedance and excursions. : j
Exceedances of Operating Parameters
The parameter, averaged over the operating
day or block, is below the minimum value
established during the initial compliance
demonstration.
The parameter, averaged over the operating
day or block, is above the maximum value
established during the initial compliance
demonstration.
For flares, each loss of all pilot flames.
.Excursions
When the control device operates for 4 hours
or more in an operating day AND data are
insufficient to constitute a valid hour of data1
for at least 75 percent of the operating
hours.
When the control device operates for less
than 4 hours in an operating day AND more
than one of the hours does not constitute a
valid1 hour of data.
'Valid hour of data - measured values are
available for all of the four 15-minute periods
within the hour.
9-13
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What constitutes a violation of the operating
limit?*
What constitutes a violation of the emission limit?
Exceedances of monitored parameters for such
devices as scrubbers, regenerative carbon
adsorbers, nonregenerative carbon adsorbers, flares,
thermal incinerators, catalytic incinerators, and
process heaters and boilers.
Exceedances of the monitored parameter (temperature)
for condensers.
Excursions (defined in chart above)
Exceedances of the outlet concentrations for HAP or
TOC/hydrogen halide and halogen.
Exceedances of monitored parameters and/or
excursions do not constitute a violation if they
occur during startup, shutdown, or malfunction
(SSM), and the facility follows its SSM plan.
Exceedances of monitored parameters and/or
excursions do not constitute a violation if they occur
during startup, shutdown, or malfunction (SSM), and
the facility follows its SSM plan.
Exceedances of the emission limit as measured during
the initial performance test or subsequent performance
tests.
Exceedances of the annual kg/kg factor, as determined
from the baseline kg/kg factor, used in the pollution
prevention option.
Exceedances of the 900 kg/yr per process, as
determined by the daily 365-day rolling
summation
TTnw are violations of onerating limits counted?
How are violations of emissions limits counted?
For episodes occurring more than once per day,
exceedances of parameters or excursions count as
one violation per operating day for each monitored
item of equipment utilized in the process.
For episodes occurring more than once per day,
exceedances of the temperature or outlet
concentrations or excursions will count as one
violation per operating day for each item of equipment
required to be monitored in the process.
For control devices used for more than one process
in an operating day, exceedances of parameters or
excursions will count as one violation per operating
day, per control device, for each process for which
the control device is being used.
For control devices used for more than one process in
an operating day, exceedances of parameters or
excursions will count as one violation per operating
day, per control device, for each process for which the
control device is being used.
Exceedances of the "alternative" standard, averaged
over the operating day, count as one violation per day
per control device.
•This chart lists only those violations specifically discussed in the rule. It does not attempt to explicitly define all ot the situations
that could constitute a violation.
9-14
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Chapter 10
Pollution Prevention
10.1 Overview
The pharmaceutical MACT rule allows the
owner or operator of a manufacturing j
operation to use pollution prevention |
techniques to comply with the rule instead ojf
installing traditional air pollution control '
devices. Essentially, the owner or operator j
demonstrates a 75% reduction (or a 50% j
with an additional 25% reduction achieved j
via traditional control devices) from a j
baseline amount, when adjusted for : j
production. Rolling averages of the \.
production-indexed consumption factor are \
calculated monthly and compared to the j
baseline value to confirm compliance with j
the pollution prevention standard. j
i
' . |
Owners/operators of processes run hi batch j
mode can demonstrate compliance with the i
pollution prevention standard on a schedule j
set according to the number of batches run i
per year. Any HAPs that are generated in the:
PMPU, and therefore not accounted for in j
the consumption factor, must be controlled j
according to the traditional standards for! j
process vents, storage tanks, equipment j
leaks, and wastewater. The standard also ;
contains restrictions regarding VOC . j
consumption, as discussed further below, to i
avoid substituting VOC for HAP. The j
pollution prevention option is available dnlyj
for existing sources; any unit which began j
production after April 2,1997 is not eligible]
. , t
10.2 Structure of the Regulation j
i
The pollution prevention standard is ; j
provided at ;
Chapter 10 at a Glance
10.2 Overview
10.2 Structure of the Regulation
10.3 Applicability
10.4 Standards
10.5 Compliance Demonstration
10.6 Monitoring
10.7 Examples
§63.1252(e). The initial compliance
demonstration requirements are
described in §63.1257(f). These provisions
describe how the baseline and annual factors
are to be calculated for continuous and batch
processes. In addition, these regulations
describe the required elements for a
pollution prevention (P2) demonstration
summary, which must be submitted as part
of the Precompliance Report
(§63.1260(e)(4)). The monitoring
requirements are contained in §63.1258(e)
and pertain primarily to the calculation of
rolling averages. Recordkeeping
requirements are hi §63.1259(b)(2).
10 3 Applicability
As mentioned in the Overview, the pollution
prevention standard can be used only for
existing sources. This is because it is
impossible to calculate a baseline for a new
source with no operating records. It makes
10-1
-------
sense to apply P2 planning concepts to new
sources too, however. '
The production-indexed consumption factor,
on which the P2 standard is based, must be
calculated at the PMPU level. The source
should evaluate all components included in
each PMPU to receive the maximum credit
for emission reductions achieved within the
PMPU. Additionally, the PMPU against
which P2 is measured must begin with the
same starting materials and end with the
same products as the process for which the
baseline was calculated. La other words, the
source may not comply with the P2 option
simply by eliminating steps by transferring
the step off-site. For assistance in defining
the PMPUs at a production site, the reader is
referred to -» Chapter 3 - Applicability.
The owner or operator can choose to use the
pollution prevention option for a series of
processes, including situations where
multiple processes are merged, as long as the
processes were merged after the baseline ,
period (single year no earlier than 1992) into
an existing process or processes.
Definition of Baseline
To calculate the baseline annual
consumption factor (kg HAP consumed per
kg product made), the owner or operator
must use consumption and production
values averaged over the period from either:
1) startup of the process until the
present time (if the process has been
in operation for at least a year) OR
2) the first 3 years of operation
(beginning no earlier than 1987),
whichever is the shorter time
period. i
If the time period used is less than three
years, the data must represent at least 1
year's worth of data.
10.4 Standards
The P2 regulations provide two options for
the standard:
Pollution Prevention Options
Option 1:
Reduce the
production-indexed
consumption factor
by at least 75%
from the baseline.
Option 2:
Reduce the
production-indexed
consumption factor
by at least 50%
from the baseline
AND
achieve additional
reductions in
emissions from
control devices to
yield at least a 75%
overall reduction
in the consumption
factor.
The difference in the two options is that
traditional end-of-pipe emissions controls
are being used to reach part of the 75%
reduction hi Option 2, while the 75%
reduction in Option 1 is achieved entirely by
using pollution prevention techniques.
The regulations specify which lands of
control devices may be used under Option 2.
These are:
combustion control devices such as
incinerators, process flares, or
process heaters,
control devices such as condensers
10-2
-------
and carbon adsorbers whose ;
recovered product is destroyed or j
shipped offsite for destruction, ' I
any control device that does not j
allow for recycling of material back j
to the PMPU, or ' |
any control device for which the
owner or operator can demonstrate
that the use of the device will not
affect the production-indexed ; j
consumption factor for the PMPU. j
i |
VOC Restrictions ' !
1; i
To ensure that owner/operators do not ]
achieve HAP emissions reductions merely j
by substituting VOC-containing materials
for HAPs, the standard includes restrictions
on VOCs. Therefore, if the HAP being j
reduced is classified as a VOC, then an i
equivalent reduction in the VOC ! |
consumption factor is also required. If a j
HAP being reduced is not also classified as Ji
VOC, the VOC consumption factor cannot i
be increased. ' !
i
Restriction on Generated HAP ' j
i i
If the manufacturing process itself generates!
HAP during the process, there is no way thai:
these HAPs can be accounted for in the j
production-indexed consumption factor, i
Therefore, the owner or operator must I
control emissions of these "generated ; i
HAPs" according to the other, traditional ;
standards for process vents, storage tanks, j
equipment leaks, and wastewater. Hydrogen
halides that are generated as a result of !
control devices that use combustion must be|
controlled to 95% or to a concentration less '
than or equal to 20 ppmv.
Consumption
The definition of consumption in the
regulations specifies that it is the quantity of
all HAP raw materials entering a process in
excess of the theoretical amount used as
reactant, assuming 100 percent
stoichiometric conversion. The raw
materials include solvents and other
additives as well as reactants. If the same
HAP component is generated in the process
as well as added as a raw material,
consumption shall include the quantity
generated in the process and the excess
reactant, as calculated assuming 100 percent
theoretical conversion. The pollution
prevention option does not apply to HAPs
used as reactants and totally consumed in the
reaction.
10.5 Compliance Demonstration
For each process for which the P2 standard
will be attempted, the owner or operator
must:
1. Calculate the baseline as mentioned
above in section 10.1, using at least
one year's worth of data, beginning
no earlier than 1987. Divide the
annual consumption of total HAPs
(or VOCs) by the annual production
rate:
Baseline HAP consumption factor =
annual kg total HAP consumed
annual kg product made
10-3
-------
Baseline VOC consumption factor =
annual kg total VOC consumed
annual kg product produced
If more than one year of data will be
used in calculating the baseline, take
the average of the annual factors
calculated.
Calculate the annual consumption
factor after the implementation of
P2 techniques as follows:
For continuous processes - calculate
the annual factor every 30 days for
the 12-month period preceding the
30th day (i.e., calculate a 30-day
rolling average).
For batch processes - calculate the
annual factor every 10 batches for
the 12-month period preceding the
10th batch (10-batch rolling average)
or a maximum of once per month, if
the number of batches is greater than
10 batches per month..
Demonstrate compliance by
showing that the baseline
consumption factor has been reduced
by 75% for Option 1. Case Study 1,
on page 10-9 illustrates the use of the
HAP consumption factor calculation,
the VOC consumption factor
calculation, and their evaluation to
determine compliance. The case
study is based upon a compilation of
research and facility evaluations that
EPA conducted in developing the
rule and this plain English guide.
If using Option 2 (add-on controls
achieving balance of 75% reduction),
the owner or operator must calculate
the baseline HAP consumption factor
and demonstrate a 50% reduction in
consumption. In addition, the owner
or operator must show that the yearly
reduction achieved with the add-on
controls (kg HAP/yr) is equal to or
greater than the mass of HAP
calculated using the following
equation:
4=[kg/kgjb x (0.75 - P,)(MprJ
where:
[kg/kg]b= the baseline production-
indexed HAP
consumption factor, in
kg/kg
the annual production
rate, in kg/yr
M = the annual reduction
requiredby add-on
controls, in kg/yr
PR = the fractional reduction hi
the annual kg/kg factor
achieved using pollution
prevention where PR ^0.5
and < 0.75.
The owner or operator must calculate the
annual reduction achieved with the add-on
devices using the methods described in
§63.1257(d) in the process vents regulations
(see -* Chapter 8 - Compliance
Demonstrations and Testing Procedures).
10-4
-------
To show that the add-on control devices
used meet the criteria for allowable devices,
the owner or operator must describe the
control device and the material streams
entering and exiting the control device.
Example Scenario for a Batch Operation -
Using the same equipment, an operator i
follows an annual production cycle as shown
below. All three processes use methanol hi i
several wash cycles. The owner's pollution !
prevention i j
strategy is two-fold: re-examine the process
to determine if one of the wash cycles can be
eliminated or done with a different material
and install a closed-loop distillation unit to
recover methanol, which will be reused in
the same processes. The owner hopes to
achieve a 75% reduction after
implementation of his strategy. How does
the owner determine whether he is in
compliance with the standard?
production
1. Determine baseline
2. After installation
of in-line methanol
recovery device,
calculate annual
consumption factor
3. Calculate
percentage reduced
4. Was P2 goal
achieved for process?
Process! !
5 batches
20 kg methanol
consumed/kg product
produced
Ikg/kg produced ;
l
. 1
i
i
19/20 = 95 % reduction
yes i
" 'Process,' 2- ': .
3 batches
10 kg/kg
.5 kg/kg
9.5/10 = 95%
reduction
yes
..-•i ••-.;•,-' "••:,-, Process 3* -
4 batches
1 kg/kg
.5 kg/kg
.5/1 = 50 % reduction
no; need to install additional
controls to achieve 75% reduction
Note that the P2 goal must be assessed for
each process, not for the set of equipment
Because each process has less than 10 ;
batches per year, the annual consumption
factor must be calculated with less than 10
batches. For purposes of calculating the
baseline consumption factor and the annual
consumption factor after implementation1 of
the P2 plans, the operator must track
methanol consumption in each process
separately. To do this, the operator keeps a
log book mat tallies gallons of virgin
methanol used in each process, on a daily,
monthly, and annual basis. After the gallons
of virgin methanol used per process is
converted to kilograms, the operator can
divide by the kilograms of finished product
made per process. As a rough check on the
virgin methanol figure, the operator could
compare the flwiwl consumption sums of
the three processes to purchasing/inventory
records that show how much methanol was
purchased that year.
10-5
-------
P2 Demonstration Summary
If an owner or operator uses the P2 option to
achieve compliance with the MACT rule,
he/she must prepare a P2 demonstration
summary that contains:
descriptions of the methodologies
and forms used to measure and
record daily consumption of HAP
compounds
descriptions of the methodologies
and forms used to measure and
record daily production of products
supporting documentation for the
descriptions above (e.g., operator log
sheets, copies of daily, monthly, and
annual inventories of materials and
products)
10.6 Monitoring, Recordkeeping, and
Reporting
Owners or operators electing to use the P2
option must prepare monthly calculations fa
demonstrate continued compliance with the
P2 standard. The calculations are the same
as those done to determine initial
compliance. For continuous processes, the
owner or operator must calculate monthly,
on a rolling average basis, the HAP
consumption factor and the VOC
consumption factor. For batch processes,
the owner or operator must calculate the
annual factor every 10 batches, for the 12-
month period preceding the 10th batch. The
HAP consumption factor must be compared
to the 75% or 50% reduction level
(determined from the baseline) to confirm
continued compliance. The VOC
consumption factor must be compared to the
baseline VOC consumption factor to
confirm that it either does not go up (if the
HAP being reduced is not a VOC) or that it
is reduced (if the HAP being reduced is also
a VOC). Each rolling average kg/kg
consumption factor that exceeds the
reduction value or the applicable VOC
restriction is considered a violation of the
emission limit.
Owners and operators must record the
consumption, production, and rolling
average values of the production-indexed
HAP and VOC consumption factors used to
demonstrate compliance with the pollution
prevention standard. The P2 demonstration
summary must be submitted as part of the
precompliance report.
10-6
-------
Qandd
If an owner or operator makes changes to a process, such that it is considered a
"new source^" is that process no longer eligible for the pollution prevention
option?
Ifthe^process is considered a "new source," it is not eligible far the pollution
prevention option. (Please note that making changes to a process does not
necessarily constitute a new'source.)
Q>
A.
Q-
A
If a process operates only sip months of the year, how is the baseline
calculated? j - ,,
EPA's intent in using a ytar \swprth of data to calculate the baseline is to ensure
that the consumption and production jigures are representative of the process and
dp not reflect anomalies and^sensitivity in measurements. If the process routinely
is conducted pvervsix-morifhjperiod, howevert.and the operation is
representative of how the process will be run in the future, it may be reasonable
to calculate the baseline using the six-month period. In the P2 Demonstration
Summary provided in the Precompliance Report, the owner/operator should
describe why a baseline calculated with less than twelve months of data is
legitimate for the intended piapose of calculated reductions achieved via
pollution prevention. I " • I -
. j • „ . > ,, , ^ ,, .*
What was EPA's rationale behind specifying the types of devices that can be
used to achieve the balance of the 75% reduction in Option 21
EPA's intent is to ensure that, control devices that allow recycling of solvent back
into the process would not be used to makeup the balance of the required 75%
reduction, so that the results pf using the control device aren't double-counted.
For example, ifa condenser's control efficiency is considered part of the
reduction achieved by using add-on controls, the owner/pperator should not also
get credit for returning the recovered solvent back to the process. This would be
double-counting the impact of the condenser. '•'/'.. :
10.7 Examples
There are several different types of pollution
prevention technologies applicable to the
pharmaceutical manufacturing industry,
including:
• material substitution - substituting
raw materials to reduce the volume
and/or toxicity of wastes, ;
process modification - alteration of
process or equipment to reduce
wastes generated,
good operating practices - adopting
practices, such as employee training,
improved maintenance programs,
more rigorous inventory control, that
will result in fewer material losses
and generated wastes, and
10-7
-------
• recycling, recovery, and reuse - in-
process recycling of a material such
that a smaller amount of the
chemical is consumed and emissions
are reduced.
Table 10-1 provides some examples of how
different pollution prevention technologies
have been applied successfully at
pharmaceutical manufacturing plants. These
examples are from the Sector Notebook
prepared by EPA's Office of Compliance.
Other examples of P2 in the pharmaceutical
industry can be found in the sector notebook,
Profile of the Pharmaceutical Industry, EPA
310-R-97-005, September, 1997.
For more reading on pollution prevention
technologies, their application, and costing
procedures for making decisions about using
P2, the reader is referred to EPA's
Enviro$en$e website: http://es.epa.gov.
The sector notebook referenced earlier in
this chapter can be downloaded from this
site:
http://es.epa.gov/comply/sector/index.htmi
10-8
-------
Table 10-1. EXAMPLES OF POLLUTION PREVENTION EFFORTS
Pollution Prevention Examples
Material
Substitution
Riker Laboratories (Northbridge, CA) replaced several different organic solvent
coating materials withja water-based coating materials, resulting in 24 tons per year
reduction in organic solvent emissions.
Glaxo-Wellcome eliminated the use of methylene chloride, isopropyl alcohol,
methanol, and ethanol in a coating process by substituting aqueous-based materials.
The new system reduced VOC emissions to the air from almost 15,000 pounds per
year to zero.
Process
Modification
To reduce the use of methanol in a cleanout process during product changeover,
Hoffman La Rpuche converted to a two-stage water -based cleaning system, before a
final methanol rinse. [This facility reduced the amount of methanol used from
110,000 gallons to 30,pOO gallons per year.
Merck replaced their steam jets used in a process vessel with liquid ring vacuum
pumps. This reduced air emissions of dichloromethane which had been mixed with
steam in the steam jets'. Additional reductions in dichloromethane emissions were
achieved by keeping the vacuum pump seal fluid at subzero temperatures such that
the dichloromethane vapor was condensed and then reused.
Sandoz Pharmaceutical Co. changed processes in its reactors to reduce solvent usage.
In the new process, anjinert atmosphere above the reaction mixture protects the
reaction from exposure to oxygen. In the previous process, nitrogen flowed
continuously over the mixture and carried away solvent vapors. The new system
makes use of a non-flowing nitrogen layer that releases only a very small amount of
nitrogen and solvent.
Good
Operating
Practices
A computerized invenfpry system in a central warehouse at a Schering-Plough
Pharmaceuticals plant eliminates excess raw material wastes and ensures that only
the exact amounts needed are used. Materials are weighed according to batch
requirements, labeled, [and sent to the appropriate process area.
Recycling,
Recovery, and
Revise
Nycomed, Inc. Installed closed loop distillation units to recover all of its methanol
from washes and methanol-containing wastewater. The recovered methanol is used
in the same process. The company is reducing consumption of about one million
pounds of methanol per year.
A Pharmacia and Upjejhn facility reuses more than 195 million pounds of solvent
annually. The facility employs both in-process reuse and distillation. The
company's efforts earned a National Performance Review Environmental Champion
Award, given by Al Gore in 1995.
Case Study 1: 75% Reduction of HAP
Consumption for and Existing
Pharmaceutical Manufacturing Process
Unit (PMPU)
The following case study is intended to
illustrate the process for documenting
compliance with
the pollution prevention alternative standard.
For this case, the manufacturer seeks to
document that they have met the
requirement for Option 1 (75% reduction) of
the pollution prevention alternative standard.
10-9
-------
Background:
Manufacturer A uses dichloromethane
(methylene chloride) to produce an
intermediate that is then processed
elsewhere into a product The intermediate
manufacturing process is the only process
that relies upon dichloromethane.
Dichloromethane is used as a solvent in
several steps of the manufacturing process.
The entire intermediate manufacturing
process is considered as single
pharmaceutical manufacturing process unit
(PMPU) that runs continuously throughout
the year. The plant has the capacity to run
several lines that all produce the same
intermediate product. The data collected for
the plant is inclusive off all lines running
during the baseline period as well as
subsequent monitoring. ;
Demonstrating Compliance:
O Manufacturer A reviews its
dichloromethane consumption and
intermediate production data to determine a
baseline. The data is used to develop a
Hazardous Air Pollutant (HAP)
consumption factor. Since the process
operates continuously, the manufacturer
develops the baseline using monthly
consumption and production rates and
averages the HAP consumption factor over
the three-year period.
The calculation is performed using the
amounts of dichloromethane consumed by
the process (i.e., recycled solvent is not
included in the calculation if it is reused in
the process). The HAP consumption factors
are calculated for each year using the
following equation and then averaged:
(kg)/Product
(kg)
Sample Calculation:
1987: 6.2M kg MeCl2 used 2.5M kg of
prOdUCt HAPcanampOm Factor = 6.2/2.5 =
2.48kg/kg
1988: 5.9M kg MeCl2 used 2.5M kg of
product UAPcoKumpthn Faaor= 5.9/2.5 =
2.36kg/kg
1 989: 6.4M kg MeCl2 used 2.8M kg of
product HAPConsumptim Factor=6A/2.S =
2.36kg/kg
The average n\PCoasttmplim Faeto = 2.4kg of
HAP consumed/kg of product
To document compliance, the manufacturer
must also demonstrate that the total VOC
consumed in this process does not increase
as a result of pollution prevention
alternatives that eliminate HAPs. As such,
the manufacturer must also baseline and
track total VOC consumption using a similar
ratio Of VOCcownpaoa Facu,r = V°CCm>swied /
Product. For our case, the VOC0,BS(m?)flowFactor
ratios for 1987-89 are as follows:
= 11.4Mkg/2.5M
1987:
kg = 4.56
1988: VOCComumpaonFactor= 10.8MkgQ.5M
kg = 4.32
12.3Mkg/2.8M
1989:
kg =4.39
The average VOCCmsumpamFluaor for 1987-89
= 4.42kg VOC/kg of product
10-10
-------
Pollution Prevention Approaches
Selected
The manufacturer implemented the following
pollution prevention alternatives over the period
from1987 through1999:
1988 - install recyclable seal water vacuum '
purnps .!
1990 - initiate procedure to steam strip aqueous
waste streams and process still bottoms to
recovery dichloromethane.
1991-92 • test use of less dichloromethane in the
process within FDA approved manufacturing •
limits. Test demonstrate that reductions in the
amount of solvent used will not impact purity or
quality. Reduction are implemented within FDA
approved ranges.
1991-92 - Test and propose use of recycled
dichloromethane in intermediate manufacturing
process. Approval from FDA allows additional
uses of recycled dichloromethane in
manufacturing
1993-94 - upgrade carbon absorption system
1994-map vents and attach all vents that
receive dichloromethane to the carbon
adsorption unit. ',
1995-96-change handling of intermediate
products to ensure all volatilized
dichloromethane is recovered.
1998-99 - segregate and capture all
dichloromethane aqueous wastes and process
through steam stripper and carbon absorption
unit '
© Manufacturer A computes the monthly
HAP^^^^^forthePMPU. The j
monthly values are averaged into an annual !
value. The values for 1997-99 for i
HAP * Consumption Factor
presented below.
Consumption Factor
1997: 2.48M kg MeCl2 used 5.0 M kg of
prodUCt Kf& ^ 2.48/5.0=
0.50kg/kg
1998: 3.52M kg MeCl2 used 6.25M kg of
product HAPCo—,„,, Facto = 3.52/6.25 =
0.56kg/kg
1999: 2.88M kg MeCl2used7.0M kg of
product HAP = 2.88/7.0 =
0.41kg/kg
The percent reduction of the
Factor is 79.2%, 76.6%, and 82.9% for 1997,
98, and 99, respectively. Manufacturer A
must also demonstrate that their pollution
prevention activities have not resulted in
increased consumption of VOCs:
1997:
kg = 4.3
1988:
kg = 4.08
1999: VOC,
kg = 4.10
'Consumption Factor
= 28.7M kg/7.0M
Each of these values is below the three-year
average for the VOC^^^ Factor and meets
the requirement. Having not increased VOC
consumption, Manufacturer A has met the
numeric reduction standard for HAP^,,^^.,,,,
Faclor of 75% to claim the pollution
prevention alternate standard.
© To document and demonstrate on-going
compliance, Manufacturer A must provide
all of the information identified in the rule
and summarized on page 10-6 of this
document.
10-11
-------
-------
Chapter 11
Emissions Averaging
11.1 Overview
The rule allows for limited emissions j
averaging of HAP emission sources (process
vents and storage tanks). The requirements [
contain restrictions similar to those imposed
for other Part 63 standards. For example, j
credits are discounted by 10 percent, and !
restrictions on averaging sources already j
controlled by State rules or prior to 1990 are'
in effect. 1
i •
i
11.2 Structure of the Regulation i
• Requirements are located in ! j
§61.1252(d) :
• Compliance Demonstration "i i
§63.1257(g)and(h) j
Monitoring §63.1258 I
Recordkeeping §63.1259(e) j
Reporting §63.1260(h)
11.3 Applicability
Emissions averaging can be done only for
some processes and tanks. The following
process vents and tanks can be included in
averaging groups:
• Two or more processes subject to 93
percent control requirement in
§63.1254(a)(l)(i).
"• Two or more storage tanks subject to!
90 or 95 percent control requirement
in §63.1253(b)(l) or !
§63.1253(c)(l)(i). : |
Chapter 11 at a Glance
11.1 Overview
11.2 Structure of the Regulation
11.3 Applicability
11.4 Standards
11.5 Compliance Demonstration
11.6 Recordkeeping
11.7 Reporting
11.8 Hazard or Risk Equivalency
Determination
Process vents that meet the individual
vent criteria for 98% control but have
grandfathered control devices due to the
level of control achieved before April
12,1997.
Exclusions
States have the option not to allow
emissions averaging
Control of emissions before November
15, 1990 or control due to State
regulations cannot be used as emission
credits in averaging, except where
control is increased after November 15,
1990 and above what is required by the
State
Rule excludes emission points that:
1. Are permanently shutdown or
out of HAP service
2. Are controlled using equipment,
11-1
-------
3.
such as
— Floating roofs,
— Grandfathered storage
tanks as described in
§63.1253(c)(l)(ii),
— Boilers, incinerators, or
flares as described in
§63.1254(a)(l)(ii)
Are controlled to the 20 ppmv
concentration standard or
alternative standard
• Processes complying with
2,000 Ib/yr emission limit as
described in §63.1254(a)(2) cannot
be used in emissions averaging
• Averaging groups for processes are
limited to 20 processes, and averaging
groups for tanks are limited to 20 tanks
at an affected source at any one time.
11.4 Standards
The control requirements (R) for emissions
averaging are as follows.
Processes
• The overall percent reduction
efficiency, R, for all processes included
in an average must equal 93 percent or
greater.
Tanks
The overall percent reduction
efficiency, R, for all tanks requiring
90 percent control in an average must
equal 90 percent or greater
The overall percent reduction
efficiency, R, for all tanks requiring
95 percent control in an average
must equal 95 percent or greater.
Note: If the operator is complying
with the planned routine
maintenance provisions for
centralized combustion control
devices in 1252(h), the process vents cannot
be used in emissions averaging during the
periods of planned routine maintenance.
11.5 Compliance Demonstration
R is calculated in the following equation:
Emi. = total yearly uncontrolled emissions from
unc
sources in processes or from tanks
Econt= total yearly emissions after control, from
sources in processes or tanks
D = 1.1, the discounting factor
Averaging example for processes
An example for averaging of processes is
presented in Table 11-1. In example 1, three
processes are included in an emissions average.
From the table, there are several emission points
within each process that are controlled. For
example, process A has three vents, two
controlled by condensers and one directed to a
boiler. In processes B and C, vents are
controlled using a thermal oxidizer (throx).
11-2
-------
In this example, three processes are evaluated toj
include an emissions average. In an emissions 1
average, no credit is allowed for emission
points controlled to comply with a State (or
Federal) rule unless the level of control has been
increased after November 1990 above the S^ate
requirement. In Table 11-1, several vents are i
controlled by State rules (vent H is controlled to
98% while other vents are controlled to less than
93%). Since the State RACT are all less than
93% and vent H complies with the State Air
Toxic rule, there are no credits from processes j
A and C. Since there are no credits from process
C and it is already controlled to > 93%, there is
no reason to include process C in the emissions I
average.
i
R is calculated in the following equation:
The emissions average complies with the ;
requirements of §63.1252(d)(8) because the
annual percent reduction efficiency is greater
than or equal to 93 percent. '
Averaging example for Tanks
An example for averaging of tanks is presented j
in Table 11-2. In this example, 5 tanks out of 14
are included in the emissions average and the i
average entirely excludes tanks that are already'
controlled to the level required by State and/or j
Federal rules and/or using devices installed priojr
to November 1990. I
The average complies with the requirements of j
§63.1252(d)(7) because the annual percent
reduction efficiency is greater than or equal to
90 percent. •
11.6 Recordkeeping
The emissions averaging provisions also require
a rolling quarterly calculation of the annual
percent reduction efficiency.
The results of the quarterly calculation are
required to be reported in either every other
semiannual report, or every 4th quarterly report,
if a quarterly report is required
NOTE: Quarterly reports are not
required by the averaging provisions,
but they may be for other reasons, as
described in §63.1260(g)(l).
11.7 Reporting
Implementation Plan
An implementation plan must be submitted
6 months prior to the compliance date. The plan
is described in §63.1259(e) and must include:
• the identification of all process vents
and tanks in the average,
• . the uncontrolled and controlled
emissions of HAP and the overall
reduction efficiency,
• supporting calculations used to obtain
uncontrolled and controlled HAP
emissions and overall percent reduction
efficiency,
• estimated values for monitoring
parameters, and
• a certification statement.
Additionally, the implementation plan should
contain a Hazard or Risk Equivalency
Determination that should be made to the
satisfaction of the operating permit authority.
The plan should address the points excluded
from control via the emissions averaging
provisions.
11-3
-------
Periodic reports
Periodic reports must be submitted on a
semiannual basis; they can be part of the
periodic reports submitted for the standard. The
periodic report must include the calculations of
overall percent reduction efficiency for the
reporting period. Every second semiannual
report must demonstrate that the overall percent
reduction efficiency for the year has been met
Other items to be submitted in the periodic
report include any changes to the emission
sources included in the average, or any changes
in the methodology used to calculate
uncontrolled or controlled emissions.
Risk Determination
The implementing agency should specify the
level of detail and desired output of the risk
analysis to be conducted. Most State agencies
have established procedures for health-based
screening for air toxics; these procedures could
also be used for this analysis.
11.8 Hazard or Risk Equivalency
Determination
Definitions
Hazard assessments address toxicity but not
exposure. Hazard refers to the intrinsic toxic
properties of a pollutant, such as potency or the
types of toxic endpoints of concern (e.g., cancer,
development effects).
Risk is an integration of hazard and human
exposure to the pollutant used to estimate the
type and likelihood of toxic effects associated
with a specific pollutant release.
NOTE: Under this the implementing
agency can consider either of these
l\T^ factors in determining whether an
averaging plan should be approved.
Applicability
Hazard or risk equivalency determinations need
only be conducted when inter-pollutant trading
occurs (i.e., the overcontrol of one or more HAP
is used to offset required reductions of one or
more different HAP).
11-4
-------
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Chapter 12
Recordkeeping
12.1 Overview
The recordkeeping requirements associated
with the pharmaceutical MACT ensure that
a written record will be established to
document compliance with the provisions o:
the regulation. Because of the variability in
product lines and schedules in !
pharmaceutical manufacturing operations, it
is essential that detailed, accurate •
recordkeeping be done to document the
details of the process emitting HAPs, the
control devices in use, and the level of j
control achieved. :
, : !
12.2 Structure of the Regulation :
The recordkeeping regulations are contained
in the regulations primarily in §63.1259. j
The General Provisions of Part 63 that also
apply to pharmaceutical manufacturing [
operations are listed in Table 1 of the
regulations. Some of these provisions relate
to recordkeeping. '
12.3 Recordkeeping Requirements
from the General Provisions
The following table outlines some of the
recordkeeping requirements in Part 63 that j
apply to pharmaceutical manufacturing j
operations.
Chapter 12 at a Glance
124
12-2
12-
12-
General Provisions Recordkeeping
Data Retention - 63.10(b)(l) - all records
and reports must be retained for at least
five years (for at least two of these years,
the records must be kept on-site).
Applicability Determinations-
63.10(b)(3) - stationary Sources that
determine they are not subject to the
pharmaceutical MACT must keep records
of their applicability determinations.
Application for Construction or
Reconstruction - 63.5 - for new affected
sources, comply with normal new source
application process, except for
§63.5(d)(l)(ii)(H) - technical information
on new source and emissions values;
§63.5(d)(2) - more technical information on
new source; and §63.5(d)(3)(U) -
description of emissions control equipment.
Recordkeeping for Performance Testing
-63.7- retain records or results of
performance tests and other data needed to
determine emissions from an affected
source.
12-1
-------
Table 12-1. MACT Recordkeeping
For the following
events, processes, or
devices....
...keep the following records on-site
Startup, Shutdown,
or Malfunction
(SSM)
(§63.1259(a)(3))
procedures for operating and maintaining affected source •
during SSM
program for corrective action for 1) process, 2) air pollution
control, and 3) monitoring equipment
occurrence and duration of each malfunction of 1) the process
operation or 2) air pollution control equipment, 3) continuous
monitoring system
documentation for each SSM event that shows plan provisions
were followed, as specified in §63.6(e)(3)(iii) (alternatively,
the O/O must record any actions taken that are NOT
consistent with the plan)
SSM plan and superseded versions
description (and any updates) of maintenance procedures for.
management of wastewater generated from the emptying aind
purging of equipment during temporary shutdowns for
inspections, maintenance, and repair and during periods that
are not shutdowns (i.e., routine maintenance).
Continuous
Monitoring System
(CMS)
(§63.1259 (a)(4) and
records of all required CMS measurements (including data
recorded during unavoidable CMS breakdowns and out-oi-
control periods)
date and times when CMS is inoperative, except for zero
(low-level) and high-level checks
date and duration of each period of excess emissions and
parameter monitoring exceedances that occurs 1) during
SSMs of the affected source and 2) during periods other man
SSMs of the affected source
note the nature and cause of any malfunction, if known
note corrective action taken or preventive measures adopted
record nature of repairs or adjustments to CMS that was
inoperative or out of control
total process operating tune during the reporting period
all procedures mat are part of a quality control program for the
CMS (developed under §63.8(d))
records documenting calibration checks and maintenance
12-2
-------
For the following
events, processes, or
devices....
....'keep the following records on-site
Equipment
Operation
(§63.1259(b))
each reinured measurement of operating parameters monitored
for control devices
each requirjed measurement of a treatment parameter monitored
for biological and non-biological wastewater treatment
for processes using the pollution prevention standard, records of
consumption, production, and the rolling average values of the
production-indexed HAP and VOC consumption factors
for CMS, records documenting the completion of calibration
checks and maintenance of CMS.
for processes complying with the 900 kg/yr standard:
- daily records of the rolling annual total emissions
- number of batches per year for each batch process
- the operating hours per year for continuous processes
- standard batch uncontrolled and controlled emissions for each
process j
-actual controlled emissions for each batch operated during
periods of planned routine maintenance of a CCCD
- actual uncontrolled and controlled emissions for each non-
standard batch
- a record of whether each batch operated was a "standard
batch"
for processes complying with the percent reduction standard(s),
with veats controlled to less than the required % reduction (but
not individual "large" vents):
- uncontrolled and controlled emissions per standard batch for
each process,
- actual uncontrolled and controlled emissions for each non-
standard batch
- a record of whether each batch operated was a "standard
batch" I
wastewkterjconcentration per POD or process, except for
"designated!" wastewaters
number of storage tank turnovers per year, if used in an
emissions average
daily schedule or log of each operating scenario prior to its
operation
description
of worst-case operating conditions for control
devices* as J-equired in §63.l257(b)(8)
periods of planned routine maintenance for storage tanks
for storage tanks complying by installation of a floating roof,
records of each seal gap measurement and inspection, in
12-3
-------
For the following
events, processes, or
devices....
Operating Scenarios
(§63.1259(c) and
Definitions in
§63.1251)
Equipment Leak
Detection and
Repair (§63.1259(d))
....keep the following records on-site
• for storage tanks complying with the vapor balancing option,
records of the DOT certification required by 63.1253(f)(2) and
the pressure relief vent setting and leak detection records
specified in 63.1253(f)(5).
• per PMPU, records of each operating scenario -
- a description of the process and the type of process
equipment used
- identification of related process vents and their associated
emissions episodes and durations
- identification of wastewater PODs
- identification of storage tanks
- the applicable control requirements, including the level of
control for each vent (e.g., identify which vents are subject to
98% control)
- the control or treatment devices used, including a description
of operating and/or testing conditions for any associated
control device
- the process vents, wastewater PODs, and storage tanks
(including those from other processes) that are simultaneously
routed to the control or treatment device
- the applicable monitoring requirements and any parametric
level that assures compliance for all emissions routed to tie
control or treatment device
- calculations and engineering analyses required to
demonstrate compliance
- verifications that the operating conditions for any associated
control or treatment device have not been exceeded and that
any required calculations and engineering analyses have been
performed. (63.1260 (g)(2)(vii))
• a record should be kept showing which scenarios are being
operated at any given time. Changes hi any of the elements of
the operating scenario (except for the listing of process vents,
wastewater PODs, and storage tanks that are simultaneously
routed to the control or treatment device) constitute a new
operating scenario.
See recordkeeping requirements in Equipment Leak chapter.
12-4
-------
For the following
events, processes, or
devices....
....keep the following records on-site
Emissions
Averaging
(§63.1259(e))
Implementation Plan -
- all process vents and storage tanks in each emissions average
- uncontrolled and controlled emissions of HAP and overall
percent'reduction efficiency, and calculations used to obtain
these figures
- estimated! values for all parameters required to be monitored
for each process and storage tank included in the average
- a statement that all applicable compliance demonstrations,
monitoring!, inspection, recordkeeping, and reporting
requirements will be implemented on the date of compliance
Risk Equivalency Demonstration showing that emissions
averaging will not result in greater risk than if the tanks and
process vents had been controlled separately (see chapter on
Emissions Averaging for more details)
Delay of Repair for
Wastewater
Equipment
(§63.l259(f))
When delay of equipment repair is necessary due to
unavailability of parts, record:
• a description of the failure
• the reason additional time was necessary to get the needed
part(s) and why line parts were not on-site
• date the repair was completed
Wastewater Stream
or Residual
Transfer
(§63.1259(g))
Notice sent to the treatment operator stating that the wastewater
stream or residual pontains organic HAP that must be managed
according to the MACT regulations.
Extensions for
Wastewater
Equipment
(§63.125900)
When the owner/operator delays draining a tank for which the
floating roof is unsiafe or delays correcting an Improper Work
Practice or Control Equipment Failure beyond the allowed time,
document:
• a description of the failure
• that alternative storage capacity is unavailable
• a schedule of actions that will ensure that the control
equipment jwill be repaired and the tank emptied as soon as
practical !
12-5
-------
r
For the following
events, processes, or
devices....
....keep thefollowingrecords on-site
Consistency with
other regulations for
wastewater
(§63.1250(h)(5))
If affected wastewater also subject to 40 CFR Parts 260-272,
owner/operator may opt to comply with the more stringent control
requirements and the more stringent testing, monitoring, recording,
and recordkeeping requirements that overlap with Subpart GGG. If
the site consolidates the two wastewater programs, the
owner/operator must keep a record of the information used to
determine which requirements are more stringent. This
recordkeeping is not required if a site opts to comply with both
standards separately.
12-6
-------
For the following
events, processes, or
devices....
....keep the following records on-site
Inspections
(§63.1259(0)
documentation that each waste management unit was
inspected as required under §63.1256(b)-(f).
documentation that inspections for control devices required by
§63.1256(ji) were conducted.
results of seal gap measurements required for floating roofs,
including the date of measurement, raw data, and the
calculations described hi §63.120(b)(2) - (4)
identification of all parts of the vapor collection system,
closed*vent system, fixed roof, cover, or enclosure that are
designated! as unsafe to inspect; an explanation of why it is
unsafe ;and the plan for checking the equipment
identification of all parts of the vapor collection system,
closed-vent system, fixed roof, cover, or enclosure that are
designated, as difficult to inspect; an explanation of why it is
difficult aiid the plan for checking the equipment
for each vapor collection system or closed-vent system
containing; bypass lines that could divert a vent stream away
from the control device, either
1) hourly records of whether the flow indicator was operating
and whether a diversion was detected at any time during the
hour, as well as a record of period when stream was diverted
or flow! indicator was not operating, or
2) monthly records of visual inspections of seal or closure
mechanism, including periods when seal mechanism was
broken, bypass line valve position was changed, the key for a
lock-arid-key was checked out, or the car-seal was broken.
For inspections of vapor suppression systems for leaks, if
leaks are detected:
- identification of the leaking equipment
- the instrument identification number and operator name or
initials, if the instrument method was used
- if the leak was detected by sensory observations, a record
noting thatj
- date the leak was detected and date of first attempted repair
- maximum instrument reading measured by the method hi
§63.1258(h)(4) after the leak is repaired or determined to be
nonrepayable
12-7
-------
For the following
events, processes, or
devices....
..keep the following records on-site
Inspections, cont.
- any incidences of delay of repair and the reason for the delay
if a leak is not repaired within 15 calendar days of detection
- name or initials of owner or operator (or designee) who
decided repair could not be done without a shutdown
- expected date of successful repair if not repaired within 15
calendar days of detection
- dates of shutdown that occur while the equipment is
unrepaired
- date of successful repair
For inspections of vapor suppression systems during which no
leaks are detected, the date of the inspection and a statement
that no leaks were detected.
For visual inspections of hard-piped vapor collection systems
or closed-vent systems, or visual inspections of fixed roofs,
covers, or enclosures, during which no leaks are detected, a
record that the inspection was done, the date of the inspection,
and a statement that no leaks were detected.
12.4 Purpose of Keeping Records of
"Operating Scenarios"
The information recorded as part of the
"operating scenario," along with the
monitoring information recorded under
"equipment operation," (see the table above)
will serve to help owners/operators and
regulating agencies track compliance with
the standards. The information recorded in
the operating scenario is on a per PMPU
basis because the emissions standards are in
terms of processes, rather than specific
pieces of equipment. The operating
scenario, in tandem with the operating log or
diary, and when overlaid with the parameter
monitoring information, shows how
emissions are being controlled for any given
manufacturing set-up or process ;
configuration. The reporting requirements
in §63.1260, including the Notification of,
Compliance Status report and the Periodic
reports, ensure that the monitoring
information and the listings of operating
scenarios are submitted to the regulating
agency on a schedule that allows for
compliance checks and explanation of data
submitted in the periodic reports.
12-8
-------
12-9
-------
-------
Cliapter 13
Reporting
13.1 Overview
The reporting requirements in the
pharmaceutical MACT regulations include
three basic kinds of reporting:
Precompliance reporting, Notification of
Compliance Status reporting, Periodic
reporting, and three types of notices: Initial
Notifications, Notifications of Continuous
Monitoring System Performance Tests, and
Application for Approval of Construction or
Reconstruction. In addition, pharmaceutical
manufacturing operations are subject to
'some of the reporting requirements in Part
63 - General Provisions. Reporting ;
provisions ensure that regulating agencies
are aware of facilities subject to the MACT j
regulations and can monitor initial and !
ongoing compliance. ' }
j
13.2 Structure of the Regulation \
'. i
The reporting requirements are contained in!
the regulations primarily at §63.1260. ; j
Additionally, the requirements from the j
General Provisions of Part 63 that also apply;
to pharmaceutical manufacturing operations ]
are listed in Table 1 of the regulations . i
13.3 Reporting Requirements from the j
General Provisions, Subpart A |
: i
The following table outlines the reporting |
requirements in Part 63, Subpart A that j
apply to pharmaceutical manufacturing j
operations. . ; j
Chapter 13 sat a GIane£
13.1 Overview
23.2 Structure of the Regulation
13.3 Reporting Requirements from the
General Provisions, Subpart A
13.4 Reporting Requirements from the
Pharmaceutical MACT, Subpart
GGG
13-1
-------
Table 13-1. GENERAL PROVISIONS REPORTING APPLICABLE TO THE
PHARMACEUTICAL MACT
Subiect
Citation
Reqnlrememit (refer to regulatory language for more details)
Initial
Notification
§63.9(b) or
(d)
Notify the Administrator that the affected source is subject to a
relevant standard (in this case, pharmaceutical MACT).
Includes area sources that become major sources due to
increased emissions of HAPs or potential to emit increased
HAP. Notification includes 1) name and address of owner or
operator, 2) address of manufacturing operation, 3)
identification of the relevant standard and the affected source's
compliance date, 4) brief description of the nature, size, design,
and method of operation of the source, including design
capacity and identification of each point of emissions for each
HAP, or preliminary identification of anticipated points of
emission. Notification is due 120 days after the effective date.
Application for
Approval of
Construction or
Reconstruction
§63.5(b)(3)
and(d)
Application for construction of a new major affected source,
reconstruction of a major affected source, or the reconstruction
of a major affected source such that it becomes a major affected
source subject to the standards must be prepared in accordance
with §63.5(d) [except for §63.5(d)(l)(ii)(H) - technical
information on new source and emissions values; §63.5(d)(2) -
more technical information on new source; and §63.5(d)(3)(ii) -
description of emissions control equipment.]
Notification of
CMS
Performance
Evaluation
§63.8(e)(2)
If owner/operator complies via continuous emission monitoring
or by the alternative or if required by Administrator to conduct
a performance evaluation of a continuous monitoring system
(CMS), notify the Administrator of the evaluation date at least
60 days prior to the evaluation. Coordinate notification of
evaluation of CMS with notification of performance test of
APCD, if required.
13-2
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13.4 Reporting Requirements From the
Pharmaceutical MACT, Subpart {
GGG !
The following tables provides a
comprehensive list of reporting requiremem
in §63.1260. !'
>
»LIA
Table 13-2. PRECQMPLIANCE REPORT (§63.1260(e))
PRECOMPLIANCE REPORT
WtenisSubmittal
Required?
At least 6 months prior to the compliance date of the standard (for existing
sources, the date was April 21,2002). For new sources, submit
Precompliance report with application for approval of construction or
reconstruction. For area sources that become major sources, the
Precompliance Report'is due within 30 months of becoming a major source.
What Must be
Included? ; *
- Requests for approval to use alternative monitoring parameters for
63.1258(bXl)(u>(ix) and 63,1258(g)(2), or requests to set monitoring
parameters according to 63.1258(b)(4)
-Requests for approval to monitor appropriate parameters, monitoring
frequency, and planned recordkeeping/reporting for non-biological treatment
units pursuaHtto63,i258Cg)(3)
- Descriptions of the daily or per batch demonstrations to verify that control
devices controlling <;!; ton/year are operating-as designed •'.;
- A description of test conditions, monitoring parameter values established
during performance testing for devices controlling >lO:ttmsper year, and
supplemental data to support parameter values not obtained during initial
compliance demonstration. !( i ,
- A P2 demonstration siummary, as required'under §63.1257(1), if applicable
- The data and rationale used to support an engineering assessment to
calculate uncontrolled emissions from process vents
- Data and other infoniiation supporting the determinations of annual average
concentrations for PSEIAP and/or SHAP«inwastewater, via process
simulation '• ~ [ -"•-'"•• "-'":;.:- .. . .: •'....-'-,
-Bench-scale or pilot-jscale test data and the rationale if used in the process
simulation todetermine annualaverage concentrations in wastewater
13-3
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Table 13-3. NOTIFICATION OF COMPLIANCE STATUS REPORT (§63.1260(i))
~ NOTIFICATION OF COMPLIANCE STATUS REPORT "
When is Submittal
Required?
No later than 150 days after the compliance date (March 21,2003 for existing
sources or 150 days after start-up of new sources). For area sources that
become major sources the report is due 150 days after the compliance date.
What Must be
Included?
- Results of applicability determinations, emissions calculations, or analyses
used to identify/quantify HAP emitted from the affected source
- Results of emissions profiles, performance tests, engineering analyses,
design evaluations, or calculations used to demonstrate compliance
- For performance tests, descriptions of sampling and analysis procedures and
QAprocedures
- Descriptions of monitoring devices, frequencies, and values of monitored
parameters established during the initial compliance demonstrations,
including data and calculations used to support the levels established
- A listing of all operating scenarios (seeTtecordkeeping chapter for
discussion on operating scenarios)
-Descriptions of worst-case operating and/or testing conditions for control
devices . • •,-.--•. -. ,-: . -i • :'.' .^r'".^:•••":
- Identification of emissions points subject to overlapping requirements fin
other MACT standards, RCRA regulations, NSPS (Subpart Kb), Subparl I,
Subpart PP and/or other NESHAPs; and identification of authority under
which owner or operator will comply
-For tanks, election to use vapor balancing and certification that pressure
relief devices have been set at &2.5 psig
-Determination of predominant use for storage tanks
-Amiud average concentration of SHAP and PSHAP if detenmnedmrough
mass balance or wastswater solubility, per 1257 (e)(l)(ii)(B).
-Averaging periods for parametric monitoring levels (daily or batch cycle)
-For the LDAR program:
process group identification
approximate number of each equipment type in organic HAP service,.
excluding that in vacuum service
method of compliance with the standard
products OT product codes subject to LDAR
planned schedule for pressure testing
-Process condenser evaluation results :
-For noncombustion devioss used to control emissions from dense gas
systems, if owner/operator not correcting for supplemental gases, initial
calculation for flowrate
-Anticipated periods of planned routine maintenance of CCCD, during which
emissions are subject to 63.1252(h). If applicable, for large vents that exceed
the flowrate criteria, the rationale for why the planned maintenance must be
performed while the large vent is operating.
13-4
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Table 13-4. PERIODIC REPORTS (§63.1260(^)
[ PERIODIC REPORTS
When is
Submittal
Required?
Semi-annually
(except as provided in
Quarterly
Submit the first report no later than 240 days after the
Notification of Compliance Status Report is due (For
existing sources, November 21,2003). It should
cover the 6-month period beginning on the date the
Notification of Compliance Status Report is due.
(1) when the source experiences exceedance of
temperature limit for APCD condensers or outlet
concentration for TOC or hydrogen halide/halogens.
Quarterly reporting will continue until a request for a
reduced frequency (back to semi-annually) is
approved. If the owner or operator has made such a
request, the provisions of §63.10(e)(3)(ii) applies as
follows:
- For a full year (4 quarterly or 12 monthly
reporting periods), the affected source must
be in compliance with the standard,
- The owner/operator must continue to
comply with all recordkeeping and
monitoring requirements, and
- The Administrator does not object to a
reduced reporting frequency
(2) if anew operating scenario has been followed
since the last report, quarterly reports must be
submitted.
(3) if the Administrator determines on a case-by-case
basis that more frequent reporting is necessary to
accurately access compliance
What Must be
Included?
- Company name and address of affected source
- List of HAPs monitored at the site
- Beginning and ending dates of the reporting period
- A brief description of the process units
- The emissions limitations and operating parameter
limits applicable at the facility
- Monitoring equipment manufacturers) and model
numbers)
13-5
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PERIODIC REPORTS
Emission Data Summary
CMS
Information
- Date of the latest CMS certification or audit
- Total operating time of the affected source during
the report period
- Emission data summary including
- the total duration of excess emissions during
the reporting period, ;
- the total duration of excess emissions
expressed as a percent of the total source
operating time during that reporting period.
- a breakdown of the total duration of excess
emissions during the reporting period into
those that are due to startup/shutdown,
control equipment problems, process
problems, other known causes, and other
unknown causes.
- Name, title, and signature of the responsible official
certifying the accuracy of the report
-Date of the report
- A CMS performance summary including
- the total CMS downtime during the
reporting period,
- the total duration of the CMS downtime
expressed as a percent of the total source
operating time during the reporting period,
- a breakdown of the total CMS downtime
during the reporting period into periods that
are due to monitoring equipment
malfunctions, nonmonitoring equipment
malfunctions, QA/QC control calibrations,
other known causes, and other unknown
causes
- Etescription of any changes in CMS, processes, or
controls since the last reporting period.
13-6
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PERIODIC REPORTS
What Must be
Included?
If the total duration of
excess emissions,
parameter exceedances,
or excursions for the
reporting period is ^ 1
percent of the total
operating time, OR thie
total CMS downtime for
the reporting period is s5
percent of the total •
operating time, include-*
- Monitoring data, including 15-minute as well as
daily average values, for all operating days when the
average values were outside the ranges established in
the Notification of Compliance Status report or
operating permit,
- Duration of excursions
- Daily schedule or operating logs and operating
scenarios for all operating scenarios for all operating
days when the values were outside the levels
established in the Notification of Compliance Status
report or operating permit,
- If a CMS is used, the information required in
§63.10(c)(5)-(13):
• date and times when CMS is inoperative,
except for zero (low-level) and high-level
checks
• date and times when CMS was out of control,
as defined in §63.8(c)(7)
• date and time of commencement and
completion of each period of excess
emissions and parameter monitoring
exceedances that occurs 1) during SSMs of
the affected source and 2) during periods
other than SSMs of the affected source
• nature and cause of any malfunction, if
known
• corrective action taken or preventive
measures adopted
• nature of repairs or adjustments to CMS that
was inoperative or out of control
• total process operating time during the
reporting period
13-7
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r
PERIODIC REPORTS?
What Mast be
Included?
For each inspection of a
vapor collection system,
closed-vent system, fixed
roof, cover and
enclosure, during which
a leak is detected,
include-*
For each vapor collection
system or closed-vent
system with a bypass
line, for periods when
vent stream is diverted
and a flow indicator is
being used, include-*
For each vapor collection
system or closed-vent
system with a bypass
line, for periods when
seal mechanism is
broken, the bypass valve
position has changed, or
the key to unlock the
bypass line valve was
checked out, include-*
- the instrument identification numbers; operator
name or initials; identification of the equipment
- date the leak was detected and date of first
attempted repair
- maximum instrument reading measured by the
method hi §63.1258(h)(4) after the leak is
successfully repaired or determined to be
nonrepayable
- any incidences of delay of repair and the reason for
the delay if a leak is not repaired within 15 calendar
days after discovery of leak
- name or initials of owner or operator (or designee)
who decided repair could not be done without a
shutdown
- expected date of repair if not repaired within 13
calendar days of detection
- dates of shutdown that occur while the equipment is
unrepaired
- date of successful repair
- Hourly records of whether the flow indicator was
operating and whether the diversion was detected, as
well as records of the times and durations of all
periods when the vent stream was diverted from the
control device or the flow indicator was not operating
- Records of monthly visual inspection of the seal or
closure mechanism and records of all periods when
the seal mechanism was broken, the bypass line valve
position changed, or the key for the lock-and-key type
lock was checked out, and records of any car-seail that
was broken
13-8
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What must be
included?
Statements), if
applicable
For each storage tank
subject to control,
included
For the initial Periodic
Report, include-* ;
For each subsequent
Periodic Report, '
include-*
- No excess emissions
- No exceedances of a parameter
- No excursions
- No CMS has been inoperative, out of control,
repaired, or adjusted
- Periods planned maintenance during which the
control device does not meet the control requirements
-For a CCCD subject to 63.1252(h), period of
planned routine maintenance during the current
reporting period and anticipated maintenance during
the next reporting period.. If not included in the
NOCSR, or if different from the rationale provided in
the NOCSR, the rationale for why planned routine
maintenance must be performed while a large vent
that exceeds the flowrate criteria will be operating.
- Change in predominant use for storage tank(s).
- If using a floating roof, submit information per 40
CFR63.122(d)-(f), as appropriate.
- Each operating scenario for each process operated
since the due date oft he Notification of Compliance
Status Report
- Description of any new operating scenarios operated
since the time period covered by the last Periodic
Report and verification that operating conditions for
any associated control or treatment device have not
been exceeded and that any required calculations and
engineering analyses have been done
- Whenever a process change (defined as start up of a
new process) is made or information hi the
Notification of Compliance Status Report changes,
include a brief description of the process change (also
includes startup of a new process), a description of
any modifications to standard procedures or QA
procedures, revisions to any of the information in the
original Notification of Compliance Status Report
under 63.1260(f), and information required by the
Notification of Compliance Status Report on changes
involving the addition of processes or monitoring
equipment
13-9
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PERIODIC REPORTS
For emissions averaging,
include-*
- Any changes of the processes or storage tanks
included in the average
- Calculation of the overall percent reduction
efficiency for the reporting period.
- Changes to the Implementation Plan that affect the
calculation methodology of uncontrolled or controlled
emissions or the hazard or risk equivalency
demonstration.
- Rolling quarterly calculation of annual percent
reduction efficiency, submitted every second
semiannual or fourth quarterly report, to demonstrate
emissions averaging provisions are satisfied.
Table 13-5. OTHER REPORTING REQUIREMENTS (§63.1260(h)-(m))
Other Reporting Requirements
Change in
Activity Covered
by
Precompliance
Report or
Change in Size
of Control
Device
Submit a report 60 days before the planned
implementation date of (1) any change in the activity
covered by the Precompliance report or (2) a change
in the status of a control device from small to large.
Results of performance test for large device must be
reported in the Periodic Report.
Startup,
Shutdown, and
Malfunction
Reports for SSM
events that
occurred during
the reporting
period
Submit on same schedule
as Periodic Reports and
include-*
- Occurrence and duration of each malfunction of (1)
the process operations or air pollution control
equipment or (2) CMS
- A statement for each SSM event that plan provisions
were followed.
- Name, title, and signature of the owner or operator,
or other responsible official certifying report's
accuracy
Actions
Inconsistent
with the SSM
Plan
Telephone call or fax
within 2 working days of
commencing action
inconsistent with SSM
plan, followed by a letter
within 7 working days
after the end of the event.
Include-*
- Name, title, and signature of the owner or operator,
or other responsible official certifying report's
accuracy
- Circumstances of event and reasons for not
following SSM plan
- Whether any excess emissions and/or parameter
monitoring exceedances are believed to have occurred
13-10
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Cither Reporting Requirements
LDAR Programs
Follow reporting requirements of §63.1255, described
in more detail in^ Chapter 6, section 63. Retain
copies of reports for 5 years.
Emissions
Averaging:
Implementation
Plan
Submit implementation
plan 6 months prior to
compliance date. Include
- Implementation Plan:
- identification of all process vents and
storage tanks in each emissions average
- uncontrolled and controlled emissions of
HAP and overall percent reduction efficiency,
and calculations used to obtain these figures
- estimated values for all parameters required
to be monitored for each process and storage
tank included in the average
- a statement that all applicable compliance
demonstrations, monitoring, inspection,
recordkeeping, and reporting requirements
will be implemented on the date of
compliance
- Hazard or Risk Equivalency Demonstration showing
that emissions averaging will not result in greater
hazard and/or risk than if the tanks and process vents
had been controlled separately
Notification of
Performance
Test and Test
Plan
60 days before planned date of performance test:
- notify Administrator
- submit the test plan (§63.7(c)) (•* see Appendix PT
for more details)
- submit the emissions profile (§63.1257(b)(8)(ii)) (-»
see Section 83 for more information on emissions
profiles)
Request for
Extension of
Compliance
Allow up to 1 additional
year to comply with
standards
- Submit request no later than 120 days prior to
compliance dates. May submit after that point if need
for the extension arose after that date and before the
otherwise applicable compliance date, and the need
arose due to circumstances beyond the operator's
control. Include data described in §63.6(i)(6)(i)(A)-
(D).
Flowrate
Recalculations
for Dense Gas
Systems
Submit once every five
years on when operating
scenario changes
Recalculated flowrate for dense gas systems when not
correcting for supplemental gases, per
63.1258(b)(5)(ii)(B).
! 13-11
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-------
ACT
APCD
ASTM
BOD
BP
CAA
CAS Number
CEF
GEMS
CFR
CH4
CMS
C02
CTG
CVS
CWA
DE
DOT
EC
ED
EE
EPC
EPA
FMO
Fm
FDA
FID
FR
gal
GC
GGG
H2O
HAPs
HC1
HOPE
HON
IDS
I&M
IWP
Kb
kg
LIST OIF ACRONYMS
Alternative Control Techniques Information Document (EPA, 1994)
Air Pollution Control Device
American Society for Testing and Materials
Biological Oxygen Demand
Boiling Point
Clean Air Act i
Chemical Abstracts Service Number
Control Equipment Failures
Continuous Emissions Monitoring System
Code of Federal Regulations
Methane
Continuous Monitoring System
Carbon Dioxide i j
Control Technology Guidelines (EPA, 1978)
Closed Vent System < \
Clean Water Act j
Design Evaluation j
Department of Transportation!
Air Emissions Control i [
Estimated Dose i
Emissions Estimation i [
Emission Potential Concentrations
U.S. Environmental Protection Agency
Degradation Factor for biological treatment
Fraction measured '
Food and Drug Administration
Flame lonization Detector
Flowrate ;
Gallon
Gas Chromatography j
subpart GGG to part 63 - NESHAP
Water
Hazardous Air Pollutants
Hydrogen Chloride j
High Density Polyethylene j
Hazardous Organic - NESHAP
Individual Drain System
Inspection and Maintenance
Improper Work Practices
Subpart of NSPS- requirements for storage tanks w/floating roofs
Kilogram
1
-------
Ib Pound
LDAR Leak Detection and Repair
M3 Cubic Meter
M21 Method 21
MACT Maximum Achievable Control Technology
MDL Method Detection Limit
MED Median Effective Dose
MiBK Methyl isobutyl Ketone
mmHg millimeters Mercury ;
MW megawatts
NAICS North American Industrial Classification System
NESHAP National Emission Standard for Hazardous Air Pollutants
NOC Notification of Compliance
NOCSR Notification of Compliance Status Report
NPDES National Pollutant Discharge Elimination System
NSPS New Source Performance Standards
O2 Oxygen
O/O Owner or Operator
P2 Pollution Prevention
Pa Pascal
PEG Polyethylene Glycol
PhRMA Pharmaceutical Research and Manufacturers of America
PL Production Levels
PMPU Pharmaceutical Manufacturing Process Unit
POD Point of Determination
ppm , Parts per million
ppmv Parts per million volume
ppmw Parts per million weight
PRV Pressure Release Valve
PSHAP Partially Soluble Hazardous Air Pollutants
psi Pound per Square Inch
PT Performance Testing
QA/QC Quality Assistance/Quality Control
RCRA Resource Conservation and Recovery Act
RE Removal Efficiences
scfin standard cubic feet per minute
SHAP Soluble Hazardous Ah- Pollutants
SIC code Standard Industrial Classification
SSM Startup, Shutdown, or Malfunction
TOC Total Organic Compounds
tpy Tons per year
TSS Total Suspended Solids
TTN Technology Transfer Network (http://www.epa.gov/ttn/)
VHAP Volatile Hazardous Air Pollutants
VOC Volatile Organic Compounds
-------
VP Vapor Pressure
VS Vapor Suppression
WMU Waste Management Unit
WW Waste Water
WWT Wastewater Treatment
-------
-------
Appendix EE
Emissions Estimation, Procedures for Process Vents
The following paragraphs briefly sunimarize the techniques for calculating uncontrolled and
controlled emissions by emission estimation procedures for the following emission episodes:
Vapor Displacement
Purging i
Heating
Depressurization
Vacuum Systems
Gas Evolution
Air Drying
Empty Vessel Purging
Uncontrolled emissions calculations for the above source types are given in sections
63.1257(d)(2)(i) (A) through (H), respectively, and controlled emissions techniques in
63.1257(d)(3)(i)(B) (1) through (8), respectively. If the owner or operator determines that these
equations are not appropriate for his/her operations, the regulations at 63.1257(d)(2)(ii) allow for
the use of other engineering assessments to determine uncontrolled HAP emissions. If
alternative equations or engineering assessments will be conducted, the owner or operator must
document all data, assumptions, and procedures in the Precompliance Report.
The following discussion refers to equation numbers found in 63.1257(d) (Numbers 11 - 43).
Except where variations are noted, individual HAP partial pressures in multicomponent systems
shall be determined by the following methods: If the components are miscible hi one another, use
Raoult's law to calculate the partial pressure!;; if the solution is a dilute aqueous mixture, use
Henry's law to calculate partial pressures; if Raoult's law or Henry's law are not appropriate or
available, use experimentally obtained activity coefficients or models such as the group-
contribution models, to predict activity cpefficients, or assume the components of the system
behave independently and use the summation of all vapor pressures from the HAP as the total
HAP partial pressure. Chemical property data can be obtained from standard reference texts.
Vapor Displacement-Uncontrolled Emissions: Calculating HAP emissions from vapor
displacement due to material transfer is accomplished according to Equation 11. The following
values are needed:
Volume of Gas displaced by vessel
Temperature of vessel vapor space (!'),
Partial Pressure of each HAPs (may be calculated using Raoult's Law) (Pi),
Molecular Weight of each HAP (KiWO,
Emissions EstimationsWapor Displacement-Uncontrolled Emission
EE-1
-------
Universal gas constant (R), and
Total number of HAPs (n).
Vapor Displacement-Controlled Emissions: Same as above (using equation 11) except T =
temperature of the receiver and the HAP partial pressures are determined at the temperature of
the receiver.
Purging-Uncontrolled Emissions: Calculating HAP emissions from purging is accomplished
according to Equation 12. The following values are needed:
Purge flow rate at the temperature and pressure of the vessel vapor space (V),
Temperature of the vessel vapor space; absolute (T).
Partial pressure of the individual HAP (Pi), which may be calculated using Raoult's Law
Partial pressure of individual condensable VOC compounds (including HAP) (Pj), which
may be calculated using Raoult's Law
Pressure of the vessel vapor space (PT), which may be set to 760 mmHg for atmospheric
conditions
Molecular weight of the individual HAP (MW0,
Time of purge (t),
Number of HAP compounds in the emission stream (n),
Number of condensable VOC compounds (including HAP) in the emission stream (m),
and
Ideal gas law constant (R).
HAP vapor concentration must be assumed to be 25% of the saturated value when the purge rate
is greater than 100 standard cubic feet per minute (scfrn).
Purging - Controlled Emissions: Same as above (using equation 12) except T = temperature of
the receiver and HAP partial pressures determined at the temperature of the receiver.
Heating - Uncontrolled Emissions: There are three methods given in Section
63.1257(d)(2)(i)C for calculating HAP emissions from heating a vessel. For heating processes
where the vessel contents are heated to < 10°K below the content's boiling point (Scenario 1),
equation 13 or 14 or 18 must be used. For heating processes where the vessel contents are heated
to within 10°K of the content's boiling point (but below the boiling point) (Scenario 2), equation
13 or 14 or 18 must be used. However, in equations 13 and 14, T2 must be 10°IC below the
boiling point. For Scenario 2, the O/O can use Equation 14 to calculate two increments. If the
contents are heated to boiling, the vessel must be operated with a properly operated process
condenser. A demonstration that the process condenser is properly operated is required if: (1)
the process condenser is not followed by an air pollution control device, or (2) the air pollution
control device following the process condenser is not a condenser or is not meeting the
Emissions Estiman'onsWapor Displacement-Uncontrolled Emissions
-------
alternative standard of §63.1254(c). HAP emissions are assumed to be zero if a process
condenser is properly operated and documented as follows:
show that the exhaust gas temperature is less than the boiling point of the substance(s) in
the vessel, or ;
perform a material balance around tiie condenser and show that at least 99% of the
material vaporized while boiling is condensed.
Several calculation options are given for each of the 2 heating scenarios described above. The
owner/operator should review the equations jand decide which is best for his given situation.
These procedures are summarized below:
Equation
No.
13 or 14 or 18
15-17
19-20
Description
Scenario 1 = Final Temp is < 10°K below HAP boiling point - These
equations are similar and the choice of which to use is left up to the
owner/operator. Bom of them calculate HAP emissions based on initial &
final pressure of the vessel, initial & final temperatures, average HAP MW
calculated by weighting each HAP'sMW by the respective HAP partial
pressure (Eg. 14ohlvX HAP vapor pressure & mole fraction hi the liquid
phase, and condensable VOC vapor pressure & mole fraction in the liquid
phase. Equation 18 calculates HAP emissions based on initial and final
HAP partial pressures, total pressure of the vessel, initial and final
temperatures, average HAP MW and the volume of free space in the
vessel.
Supporting equations for 13 & 14. NOTE: Eq. 17 supports Eq. 14 only.
Supporting equations
for 18.
Scenario 2 = Final Temp is > 10°K below HAP boiling point - The
Owner/Operator has a choice of 4 calculation methods for this scenario as
follows: '
13, or
14, or
14
Emissions EstimationsVHeating
1 . Use equation 1 3 with parameters (vapor pressures,
determined at 10°K below the boiling point.
2. Use equation 14 with parameters (HAP partial pressures, T
determined at 10°K below the boiling point
.; I
3. Use Equation 14 to calculate emissions as the sum of emissions for
2 discrete temperature! increments (i.e, (initial temp to 10°K below BP) +
(10°K below BP to the lower of the final temperature or 5°K below the
EE-3
-------
18
BP)
4. Same as above.
Heating - Controlled Emissions: Use equation 13 or 37. In equation 13 HAP
shall be determined at the temperature of the receiver. In equation 13 and 37, t
Depressurization - Uncontrolled Emissions: There is a choice of three techniques for
calculating HAP emissions from depressurizatiori events. The owner/operator should review the
equations and decide which is best for his given situation. These procedures are summarized
below:
21-26,17 1. The first technique calculates HAPs emissions using the ideal gas law
as a function of the volume of non-condensable gas produced, ratio of
moles of non-condensable gas to moles of HAPs, HAP MW, pressure,
temperature and universal gas constant. Equation input parameters include
free volume of the vessel, condensable VOC (including HAPs) vapor
pressure & mole fraction. HAP vapor pressure & mole fraction, and initial
& final pressure of the vessel. The HAP partial pressure may be
calculated using Raoult's Law.
27-31,23-24 2. HAPs emissions are calculated by this method by multiplying the
average HAP-to-non-condensable gas mole ratio by the number of moles
of non condensable gas released during the event. Equation inputs are
initial & final pressure, temperature, condensable VOC vapor pressure &
mole fraction, mole fraction of HAPs. and average HAP molecular weight.
32 3. Equation 32 presents another approach to calculating HAPs emissions
from depressurization. Parameter inputs include vessel volume.
temperature, initial & final pressure, partial pressure of individual HAP
compounds, molecular weight of individual HAP compounds.
Depressurization - Controlled Emissions: Use equation 38 with the initial and final volumes of
noncondensable gas m the vessel, adjusted to the pressure of the receiver, calculated using
equations 39 and 40. Initial and final partial pressures of noncondensable gas in the vessel are
calculated using equations 41 and 42.
Vacuum Systems - Uncontrolled Emissions: HAPS emissions from vacuum systems may be
calculated using equation 33 if the air leakage rate is known or can be calculated. Values needed
are
Emissions EstimationsNDepressurization
EE-4
-------
Absolute pressure of receiving vesse or ejector outlet conditions (Psystem),
Partial pressure of HAP at receiver temperature (Pi), or the ejector outlet conditions
Partial pressure of condensable at receiver temperature (Pj) or the ejector outlet conditions
Total air leak rate in the system (La),|
Molecular weight of non-condensablje gas (MWnc),
Molecular weight of the individual HAP with partial pressures calculated at receiver or
ejector outlet temperature, as appropriate (MWO,
Time of the vacuum operation.
Vacuum Systems - Controlled Emissions:
from vacuum systems.
Use equation 33 to calculate controlled emissions
Gas Evolution - Uncontrolled Emissions: Use equation 12 with Volumetric Flow (V)
determined by equation 34. Parameter inputs are:
Mass flow rate of gas evolution (Wg)(,
Temperature at the exit, absolute (T)|
Vessel pressure (PT),
Molecular weight of the evolved gas (MWg)
Ideal gas law constant (R),
Gas Evolution - Controlled Emissions: Use equation 12 with V calculated using equation 34
and T set to equal the temperature of the receiver and the HAP partial pressures determined at the
receiver temperature. The term for time, t in equation 12, is not need for the purposes of this
calculation.
Air Drying - Uncontrolled Emissions: Use equation 35 to calculate HAPs emissions per batch
of air dried solids with parameter inputs as follows:
Mass of dry solids (B),
HAP in material entering drver. weight percent (PSi). and
HAP in material exiting drver. weight percent (PS?)
Air Drying - Controlled Emissions: Same as above (use equation 11) with V equal to the air
flow rate and Pi determined at the temperature of the receiver.
Empty Vessel Purging - Uncontrolled Emissions: Use equation 36 with the following inputs:
• Volume of empty vessel (V), j
• Temperature of the vessel vapor space (T).
• Partial pressure of the individual HAP at; the beginning of the purge (P0,
• Flowrate of the purge gas (F), and ,
• Duration of the purge (t)
' 1
; |
Emissions EstimationsVGas Evolution ': EE-5
-------
Note that the term e Ft/v can be assumed to be zero.
Empty Vessel Purging - Controlled Emissions: Use equation 43 with the following inputs:
• Volume of empty vessel (V).
• Temperature of the vessel vapor space at beginning of purge (TO
• Temperature of the receiver (Ta),
• Partial pressure of the individual HAP at the beginning of the purge (POxi,
• Partial pressure of the individual HAP at the receiver temperature (Pi)n,
• Flowrate of the purge gas (F), and
• Duration of the purge (t)
Emissions Estimation Equations for Uncontrolled Sources (11-36) and Controlled
Sources (37-43)
No.
Equation
11
Vapor Displacement
E= mass of HAP emitted
V = volume of gas displaced from the vessel
R = ideal gas law constant
T =" temperature of the vessel vapor space; absolute
Pi= partial pressure of the individual HAP
MWj = molecular weight of the individual HAP
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound
Emissions Estimations Equations for Uncontrolled Sources (11-36) and Controlled
Sources (37-43) (continued)
No.
12
Equation
n (vxt) pT
E «PlMWlJt(RXT)a'pT.J(pj)
Purging:
E= mass of HAP emitted
V = purge flow rate at the temperature and pressure of the vessel vapor space
R= ideal gas law constant
T = temperature of the vessel vapor space; absolute
Pi= partial pressure of the individual HAP
Emissions EstimationsNEquations
EE-6
-------
Pj=
PT=
t =
i=
j =
n =
m=
partial pressure of individual condensable VOC compounds (including HAP)
pressure of the vessel vapor space
= molecular weight of the individual HAP
time of purge ' •
identifier for a HAP compound
identifier for a condensable compound
number of HAP compounds Jin the emission stream
number of condensable VOG compounds (including HAP) in the emission
stream I
13
t ((Pi*X*XMW,))
Heating (1)
760-£((pj*Xkj))
H
E = mass of HAP vapor displaced from the vessel being heated
Xj = mole fraction of each HAP ia the liquid phase
Xj = mole fraction of each condensable VOC (including HAP) hi the liquid phase
(Pi*) = vapor pressure of each HAP in the vessel headspace, mmHg
(Pj*) = vapor pressure of each condensable VOC (including HAP) in the vessel
headspace, mmHg !
760 = atmospheric pressure, mmHg
MWj= molecular weight of the individual HAP
n = number of HAP compounds Jin the displaced vapor
m = number of condensable VOG compounds (including HAP) hi the displaced
vapor i I
An = number of moles of non-condensable gas displaced, as calculated using
Equation 15 of this subpart
i = identifier for a HAP compound
14
+
M
Paa
' 'I2
Pan = partial pressure of non-condensable gas in the vessel headspace at the initial (n=l)
and final (n=2) temp. j
(POxn = partial pressure of each HAP in the vessel headspace at initial (Ti) and final (Ta)
temperature. [For use in Equation 12j, replace (Pi}n + (Pi)r2 with Pi at the temperature
used to calculate vapor pressure of HAP in Equation 13.]
Heating (2)
(same as Equation 13)
Emissions EstimationsVEquations
EE-7
-------
15
A7?S=R
Pa2
T2
Heating (3)
9ri = number of moles of gas displaced
V = volume of free space in the vessel
R= ideal gas law constant
Pai = initial noncondensable gas pressure in the vessel, as calculated using
Equation 16
Pa2 = final noncondensable gas pressure in the vessel, as calculated using Equation 16
TI = initial temperature of vessel, absolute
1-i- final temperature of vessel, absolute
16
Pan = Patm -
Heating (4):
Pan = partial pressure of noncondensable gas in the vessel headspace at initial (n=l)
and final (n=2) temperature
Patm = atmospheric pressure (when 6? is used in Equation 13 of this subpart, Patm may
be set equal to 760 mmHg for an}' vessel)
(Pj}i.n =partial pressure of each condensable volatile organic compound (including HAP)
in the vessel headspace at the initial temperature (n=l) and final (n=2)
temperature
m = number of condensable VOC compounds (including HAP) in the displaced
vapor
j = identifier for a condensable compound _ __ __
17
Heating (5):
MWHAP = average molecular weight of HAP in the displaced gas
(Pi *) = vapor pressure of each HAP in the vessel headspace at any temperature between
the initial and final heatup temperatures, mmHg
(Pi)jn = partial pressure of each HAP in the vessel headspace at initial (Tt) and final (T2)
temperature [For use in Equation 13, replace (Pi)ri + (Pi)r2 with Pi at the
temperature used to calculate vapor pressure of HAP in Equation 13]
MWj = molecular weight of each HAP
n = number of HAP compounds in the emission stream
18
Emissions EstimationsVEquations
EE-8
-------
E = MWHApX
-(ka-%
Heating (6):
E =. mass of HAP vapor displaced from the vessel being heated
Navg = average gas space molar volume during the heating process
PT = total pressure in the vessel
Py = partial pressure of the individual HAP compounds at TI
Pi;2 = partial pressure of the individual HAP compounds at T2
MWHAP ^ average molecular weight of the HAP compounds
ny = number of moles of condensable in the vessel headspace at TI
ni,2 = number of moles of condensable in the vessel headspace at T2
n = number of HAP compounds in the emission stream
19
Na4 =
(Ti T2J
Heating (7): <
Navg = average gas space molar vohime during the heating process
V = volume of free space in vessel
PT = total pressure in the vessel
R = ideal gas law constant ;
TI = initial temperature of the vessel
T2 = final temperature of the vessel
20
y
V
Heating (8):
V = volume of free space in vessel
R = ideal gas law constant
TI = initial temperature in the vesslel
Ta = final temperature in the vesse.l
Py = partial pressure of the individual HAP compounds at TI
Pi,2 = partial pressure of the individual HAP compounds at Ta
n= number of HAP compounds in the emission stream
21
Depressurization (1):
v»r
= initial volume of noncondensable gas hi the vessel
Emissions EstimationsVEquations
EE-9
-------
VnC2= final volume of noncondensable gas in the vessel
V = free volume hi the vessel being depressurized
Pnci= hiitial partial pressure of the noncondensable gas, as calculated using
Equation 23 of this subpart, mmHg
PrK2 = final partial pressure of the noncondensable gas, as calculated using Equation 24
of this subpart, mmHg
760 = atmospheric pressure, mmHg
22
760
Depressurization (2):
(same as equation 21)
23
j-i
Depressurization (3):
initial partial pressure of the noncondensable gas
final partial pressure of the noncondensable gas
initial vessel pressure
final vessel pressure .
vapor pressure of each condensable VOC (including HAP) in the emission
stream
mole fraction of each condensable VOC (including HAP) in the emission stream
number of condensable VOC compounds (including HAP) in the emission
stream
Pnc2=
PI =
P2=
PJ* =
m =
24
P»a=P2-£(Pj*)
-------
of this subpart j
Pi* = vapor pressure of each individual HAP
Xj = mole fraction of each individual HAP in the liquid phase
26
Depessurization (6): :
E= mass of HAP emitted
Vnci = initial volume of noncondens'able gas in the vessel, as calculated using
Equation 21 of this subpart
VnC2 = final volume of noncondensable gas in the vessel, as calculated using
Equation 22 of this subpart
nw = average ratio of moles of noncondensable to moles of individual HAP, as
calculated using Equation 25 of this subpart
Patm = atmospheric pressure, standard
R = ideal gas law constant 1
T = temperature of the vessel, absolute
MWi = molecular weight of each HAP
27
_(YHAP)(V)(P|)
--
Depressurization (7): !
YHAP =mole fraction of HAP (th6 sum of the individual HAP fractions, SYj)
V = free volume in the vessel being depressurized
PI = initial vessel pressure
R= ideal gas law constant
T = vessel temperature, absolute
28
nr
Woo,
RT
Depressurization (8):
ni = initial number of moles of noncondensable gas in the vessel
na = final number of moles of noncondensable gas in the vessel
V = free volume in the vessel being depressurized
Pnci = initial partial pressure of the noncondensable gas, as calculated using
Pnc2 =
R =
T =
Equation 23 of this subpart I
final partial pressure of the no;
of this subpart
ideal gas law constant
temperature, absolute ,
incondensable gas, as calculated using Equation 24
29
Depressurization (9):
Emissions EstimationsVEquations
EE-11
-------
VPnC2
RT
same as equation 28)
30
Depressurization (10):
I nHAf .1 + nnAp.2
_l ni n2
= moles of HAP emitted
= initial number of moles of noncondensable gas in the vessel, as calculated using
Equation 28 of this subpart
n2 = final number of moles of noncondensable gas in the vessel, as calculated using
Equation 29 of this subpart
31
E - HHAP
Depressurization (11):
E= mass of HAP emitted
nnAP = moles of HAP emitted, as calculated using Equation 30 of this subpart
MWHAP = average molecular weight of the HAP as calculated using Equation 17 of
this subpart •
32
E =
V
xln
i=l
T-
Pi =
Depressurization (12):
V - free volume in vessel being depressurized
R = ideal gas law constant
temperature of the vessel, absolute
initial pressure in the vessel
final pressure in the vessel
partial pressure of the individual condensable compounds, including HAP
',- = molecular weight of the individual HAP compounds
n = number of HAP compounds in the emission stream
m = number of condensable compounds (including HAP) hi the emission stream
i = identifier for a HAP compound
j = identifier for a condensable compound
33
Vacuum Systems:
Emissions Estimations\Equations
EE-12
-------
E_(La)(t)
MWn
svstem
E = mass of HAP emitted
Psystem = absolute pressure of receiving vessel or ejector outlet conditions, if there
is no receiver i
partial pressure of the HAP at the receiver temperature or the ejector outlet
conditions 1
partial pressure of condensable (including HAP) at the receiver temperature or
the ejector outlet conditions
total air leak rate in the system, mass/time
MWnc= molecular weight of noncondensable gas
t= time of vacuum operation j
MWj = molecular weight of the individual HAP in the emission stream, with HAP
partial pressures calculated at the temperature of the receiver or ejector
outlet, as appropriate I
Pi =
PJ =
La =
34
(PT)(MWg)
Gas Evolution:
V = volumetric flow rate
Wg = mass flow rate of gas evolution
of gas ev(
rolution
ideal gas law constant
temperature at the exit, absoljite
vessel pressure
R =
T =
PT =
MWg =molecular weight of the evolved gas
35
E = B:
Air Drying:
E = mass of HAP emitted
B= mass of dry solids
PSj = HAP in material entering dry
-------
V- volume of empty vessel
R = ideal gas law constant
T "* temperature of the vessel vapor space; absolute
Pi = partial pressure of the individual HAP at the beginning of the purge
(MWj) = molecular weight of the individual HAP
F- flowrate of the purge gas
t= duration of the purge
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound
(Note: The term e"Ft/v can be assumed to be 0)
37
XMWHAP
Heating (controlled emissions):
E = mass of HAP emitted
0? = moles of noncondensable gas displaced
PT = pressure in the receiver
Pi = partial pressure of the individual HAP at the receiver temperature
Pj = partial pressure of condensable VOC (including HAP) at the receiver
temperature
n — number of HAP compounds in the emission stream
MWHAP = me averaSe molecular weight of HAP in vapor exiting the receiver, as
calculated using Equation 17 of this subpart
m = number of condensable VOC (including HAP) in the emission stream
38
——-
RT
j=i
Depressurization (controlled emissions, 1):
E= mass of HAP vapor emitted
Vnci = initial volume of noncondensable in the vessel, corrected to the final pressure, as
calculated using Equation 39 of this subpart
VnC2 = final volume of noncondensable in the vessel, as calculated using Equation 40 of
this subpart .
Emissions EstimationsNEquations
EE-14
-------
Pi = partial pressure of each individual HAP at the receiver temperature
PJ = partial pressure of each condensable VOC (including HAP) at the receiver
temperature
PT = receiver pressure
T = temperature of the receiver
R = ideal gas law constant
MWHAP = the average molecular weight of HAP calculated using Equation 17 of
this subpart with partial pressures determined at the receiver temperature
n = number of HAP compounds in the emission stream
m = number of condensable VOG (including HAP) in the emission stream
39
PT
Depressurization (controlled emissions, 2):
Vnci = hiitial volume of noncondensjable gas hi the vessel
VnC2 = final volume of noncondensaMe gas in the vessel
V = free volume hi the vessel being depressurized
Pnci = hiitial partial pressure of the poncondensable gas, as calculated using
Equation 41 of this subpart
PnC2 = final partial pressure of the noncondensable gas, as calculated using Equation 42
of this subpart
PT = pressure of the receiver
40
Depressurization (controlled emissions, 3):
(same as equation 39)
41
Depressurization (controlled emissins, 4):
Pnci =
PnC2 =
PI =
PJ =
m =
initial partial pressure of the noncondensable gas hi the vessel
final partial pressure of the noncondensable gas hi the vessel
initial vessel pressure
final vessel pressure
partial pressure of each condensable VOC (including HAP) hi the vessel
number of condensable VOC (including HAP) hi the emission stream
42
Depressurization (controlled emissions, 5):
P 2 = 1
j-i
Emissions EstimationsVEquations
EE-15
-------
(Same as equation 41)
43
Empty Vessel Purging (controlled emissions):
'i)T2(MWi) "
In
\\
+ 1
Ti
V =
T2 =
(Pi}n
(Pi)r2
F =
t =
n =
i =
volume of empty vessel
ideal gas law constant
temperature of the vessel vapor space at beginning of purge
temperature of the receiver, absolute
=partial pressure of the individual HAP at the beginning of the purge
=partial pressure of the individual HAP at the receiver temperature
-molecular weight of the individual HAP
flowrate of the purge gas
duration of the purge
number of HAP compounds in the emission stream
identifier for a HAP compound '
Emissions EstimationsVEquations
EE-16
-------
Over-view
Organic HAP
TOC
Structure of this
Appendix
Demonstrating
Compliance with
Percent Reduction
Standards
Appendix PT
Emissions Performance Testing - Test Methods and Approach
In complying with em ssions control requirements for process vents, tanks,
and wastewater emission sources, the O/O has a choice of demonstrating
compliance with standards for:
• Organic HAP Mass Removal/Destruction Efficiency,
• TOC Mass Removal/Destruction Efficiency, or
• Outlet TOC concentration.
Organic HAP mass removal/destruction efficiency is determined by
comparing the mass rake of organic HAPs leaving the air pollution control
device (APCD) to the |mass rate entering the APCD. Mass rates are
calculated by multiplying organic HAP concentrations by the gas flow
rate. Total organic HAP concentration is typically defined as the sum of
individual organic HAP compounds (for APCDs controlling solely
wastewater emission sources, Organic HAP includes only SHAP and
PSHAP compounds).
TOC concentration is he sum of all organic compounds minus
concentrations of methane and ethane. TOC concentrations can be used
for calculating efficiency or to demonstrate compliance with the 20 ppmv
TOC concentration limit (TOC is almost always referred to in conjunction
with demonstrating compliance to 20 ppm TOC standard)
The list of applicable Ipst methods for demonstrating compliance with the
Pharmaceutical MA.CT standards is listed below. Summaries of each test
method are presented.
then discussed.
The benefits of selecting a particular method are
For demonstrating compliance with percent reduction standards, the
following methods can be used:
• Method 18- (HAP or TOC) - all control devices
• Method 25 - (IjLAP or TOC) - only from combustion sources,
• Methods 26 orJ26A - (HAPs with HC1; TOC with hydrogen halides
HC1, HBr and HF or halogens C12 and Br^
• Method 25 A-|(HAP or TOC)-only under any of the following
limited conditions:
1. There is only one compound known to exist,
2. Where jhe organic compounds consist of only hydrogen and
carbon,i
Emissions Performance Testing\ControI Efficiency
PT-1
-------
3. Where relative percentages of the compounds are known or
can be determined and FID responses to the compounds are
known,
4. Where a consistent mixture of the compounds exist both
before and after the control device and only the relative
concentrations are to be assessed, or
5. Where the FID can be calibrated against mass standards of
the compounds emitted (i.e., predominant HAP compound)
Demonstrating
Compliance with
TOC Standards
For demonstrating compliance with TOC standard, the following methods
can be used:
• Method 18- conforming to performance specification 9 (40 CFR 60
AppB),
• Method 25A - calibrated with either methane or the predominant
HAP and meeting performance specification 8, or
• Method 26 - for measuring hydrogen halide concentrations (if
present)
QandA
Q
A.
Do I have to use one of the listed methods for determining concentrations of HAP
or TOC?
No. Any method which has been validated by EPA validation Method 301 (§40 CFR
63 Appendix A) can also be used. This is especially the case for certain HAPs that
cannot be measured by Method 18 or 25A. Formaldehyde, for example, does not
respond well to a FID used in Method 25A and sometimes in Method 18. Phenol is
another example of a compound very difficult to sample and analyze using Method 18
procedures.
Method 18
Method 18 (Measurement of Gaseous Organic Compound Emissions by
Gas Chromatography [discrete GC analyses for individual HAPs
conducted either on-site or off-site]) is suitable for measuring
concentrations of many organic HAPs. The method uses Gas
Chromatography (GC) coupled with any suitable detector. By using the
GC separation capability, Method 18 can quantify concentrations of
individual compounds. Sample procedures are listed as follows:
• Integrated Bag Sampling. Configurations include evacuated
container, direct pump sample, or other (heated, or diluted bag
configurations, etc.)
Emissions Performance Testing\Method 18
PT-2
-------
• Direct Interface (heated tubing from stack to instrument)
• Dilution Interface, or
• Sorbent Tube
There is no criterion for how quickly the sample must be analyzed, so for
bag (container) sampling, it is possible to analyze samples off-site
(However, extensive QA procedures must be performed showing that
analytical recoveries are not biased by this lapse in time). Typically,
analyses are conducted on-site, during sampling.
The method is only semi-continuous at best, because even with direct
interface sampling which calls for extracting a continuous sample stream
from the stack, each analyses takes several minutes to conduct.
NOTE: TOG; organic HAP, hydrogen hajide and halogen concentrations from combustion
control devices must be corrected to 3% Oj, if supplemental gases are added toithe vent
stream or manifold:
17.9
Where
halogen corrected to
20.9-%0,
Cc = concentration of TOC, total organic HAP, or hydrogen halide and
3 percent oxygen, dry basis, ppmv
%0
2d'
total concentration of TOC or total organic HAP or hydrogen halide
and halogen in vented gas stream, average of samples, dry basis, ppmv
concentration of oxygen measured in vented gas stream, dry basis,
percent by volume
Supplemental gases are defined in §63.1251 and include gases that are not defined as process
vents, or closed-vent systems from wastewater units, storage tanks, or equipment
components; they contain less than 50 ppmv TOC. Air required to operate combustion
device burners is not considered a supplemental gas.
Concentration values to be used as an intermediates for calculating mass rates for efficiency
determinations do not need to be corrected 3% O2.
Emissions Performance TestmgXMethod 18
PT-3
-------
NOTE: TOC, organic HAP, or hydrogen halide and halogen concentrations from non-
combustion devices must be corrected if supplemental gases are added:
~' C
m
V +V
s a
y
Where:
Ca = corrected outlet TOC, organic HAP, and hydrogen halides and halogens
concentration, dry basis, ppmv
Cm=actual TOC, organic HAP, and hydrogen halide and halogens concentration
measured at control device outlet, dry basis, ppmv
Va= total volumetric flow rate of all gas streams vented to the control device, except
supplemental gases
Vs= total volumetric flow rate of supplemental gases
Emissions Performance Testing\Method 18
PT-4
-------
Method 18 Calibration and QA Criteria
Calibration: A minimum of 3 gas standards/compound must be used to prepare calibration
curves. Duplicate analyses of each standard must agree to within 5% of their mean.
Standards must be analyzed both before arid after sample analyses. Use an average of the 2
curves to determine sample concentration, j If the 2 curves differ by more than 5%, from their
mean, report final results using both curves (resulting in 2 sample data sets)
Sample Analyses:- Final bag analyses concentration equals the average of 2 replicate
analyses. Replicate peak areas must agree'within 5% of their average (maybe difficult for
direct interface if process is changing and at least several minutes lapse between analyses)
Dilution System Check: For dilution systems, a single calibration gas (high) must be
dkeeted through: erttire dilution system. Resulting values should be within 10% of expected.
Performance Audits: Audit analyses of 2 :gases (high and low) must be within 10% of true
value. If results are not within 10%, the audit supervisor determines corrective action (correct
instrumental problems and.re-run audit? numerically correct biased data set, etc).
Recovery Study; For direct interface and dilution systems, direct mid level calibration gases
through entire system. Replicate analyses ^hould agree to within 5% of their mean and :
within 10% of the,reading determined when gas are challenged directly to analyzer (sample
bias). For bag sampling, spike a sample b4g, to 40-60% of average sample concentration or 5
times the MDL (if sample not detected). From these results, the calculated a R value should
be within 0.7- 1.3," R is calculated as shown in Section 7.6.21 of Method 18. Forsorbent
tubes, 2 sample probes (tubes) are located ;adjacently hi the stack and a sample taken. One is
spiked with liquid or gaseous compounds while the other is not. From these results, the
calculated R value should be within 0.7 - 1|.3.
. .'. '..•-, j. •.-.:•,-.• V,
Additional Method 18 calibration ami QA criteria when used for the 20 ppm TOC
Standard (per Performance Specification 9,40 CFR 60 Appendix B)
Calibration Gases: Low level 40-60% of measured cpncentratin (or 4-5x MDL),
Mid level 90-110% of measured concentration
High level 140-160% of measured concentration
Calibration Error: Calibration error checjcs must be performed for each target compound
every 24 hours for each of the 3 standards, j Observed concentration must be within 10% of
actual value. ,
Calibration Precision and Linearity: Standards must be analyzed in triplicate. All must be
within 5% of mean, and an R2 of > 0.99,5 J
Measurement Frequency: Sample time constant, T, must be less than 5 minutes or the
sample frequency specified in the applicable regulation. T is calculated using equation 3 in
PS 9. :.•''; ;;" ,: , ,
Performance Audits: Same as above
Emissions Performance Testing\Method 18
PT-5
-------
QandA
Q
Does an O/O really have to conduct all thepre-test method development listed in
MethodlS?
The objectives of the Method 18 preliminary method development are to 1) determine
all target compounds, 2) optimize GC operating parameters and 3) develop
acceptable QA procedures. Much of the method development information andQA
procedures can be determined from past testing'experience and existing laboratory
methods. Potential target compounds can be revealed' by interviewing plant
personnel who have knowledge of the process beingtested. However, during testing,
compounds with GC peaks that have peak areas greater than 5% of the total peak
area must be identified. Therefore, it is extremely important to develop the test
method, prior to conducting the test, that will adequately quantify all possible target
compounds. However, as long as the final Method 18 calibration andQA criteria are
met during the test program, most administrators will not require such an extensive
pre-test work up as is written up in the method.
Method 25A
Method 25Adoes not have the capability of separating and quantifying
individual compounds. It measures total organic gas concentration on a
continuous basis using a flame ionization detector (FID). The FID is
calibrated using a single calibration compound. The Pharmaceutical
MACT allows the O/O to use either methane or the most predominant
HAP as a calibration gas. Methane is used routinely for Method 25 A
calibrations (TOC/Methane). However, TOC/Methane results can be
relatively high when compared with other calibration techniques due to
differences in various compound FID relative response factors (RRF) as
discussed below:
• TOC/Methane concentrations respond to a hydrocarbon compound
at 1 ppm per 1 ppm of compound multiplied the number of carbon
atoms in the compound. For example 4 ppm of benzene (C6H6)
would respond as 24 ppm methane (4x6 carbon atoms/molecule) .
If the HAPs do not consist strictly of hydrogen and carbon (i.e,
contain alcohols, aldehydes, nitrogen, halogens, or other) the
TOC/Methane RRF will be somewhat less than the 1 per number
of carbon atoms/molecule. For example, if 20 ppm ethanol
(C2H5OH) were present, a methane calibrated analyzer would
respond at -30 ppm TOC/methane (RRF * 1.5 ppm methane/ppm
ethanol).
• Method 25A can be calibrated using the predominant HAP. For
Emissions Performance TestingXMethod 25A.
PT-6
-------
the above benzene scenario, if TOC was determined by Method
25A calibrated with benzene, the resulting TOC/Benzene value
would be 4 ppin (vs 24 ppm as TOC/Methane) ,
In determining which calibration gas to use, it should be
remembered that calibration gases are not available for all HAP
compounds, a id the prices of non-methane calibration gases can be
high.
QandA
What are the requiretiients for, usting the predominant HAP as the Method 25A
calibration gas ? : ' ' | .'' " '." , '. " 7."'" ':' "";:::' "•"'••'•"•'•-
A The following criteria must be met
in order to use the predominant HAP as the
Method 25A calibration gas:
The HAP is the single organic HAP representing the large percent by volume
The response from the high calibration gas is at least 20 times the standard deviation
of the response from the zero calibration gas when the instrument is zeroed on the
most sensitive scale
The span value of the analyzer must be less than lOOppmv
Measuring Methane
& Ethane Concentrations
For TOC deteiminations, concentrations of methane and ethane
should be subtracted from the total organic concentration. Some of
the newer Method 25 A analyzers can incorporate this into their
operation, however, if methane values are substantial it may be
better to analyze for methane and ethane separately using Method
18 or other technique (there is no required method listed in the rule
for determining methane concentrations for calculating
nonmethane organic concentrations, however, the planned
procedure shojild be approved by the test plan administrator).
Methane concentrations can also be approximated by techniques
such as filtering the Method,25A sample stream through a charcoal
tube (to remove all compounds but methane). Some sources,
especially combustion sources fired on natural gas, may contain a
considerable amount of methane (>50% of TOC). Quantities of
ethane are usually not as high. If test costs include a methane
determination py Method 18, it may be a good idea to include
speciated organics in the analysis as well. In this way, if the
Emissions Performance Testing\Methane & Ethane Measurements
PT-7
-------
TOC/Methane values do not demonstrate compliance, the O/O may
be able recalculate TOC using Method 18 data.
WARNING: If any changes are made to any performance testing
procedures during the test program, the data may not be accepted
by the regulatory agency. However, if the test engineer explains
the logic behind the changes to me observer and has him/her "sign
off' on the changes (in a log book, etc), the test results may be
accepted.
Easy Calculation: TOC concentrations are calculated as the sum concentrations of all
organics in the gas stream minus those of methane and ethane. However, if TOC is
determined by Method 25 or 25A, the resulting measurement values already reflect total
organic concentration, so that no sums have to be taken. Only methane and ethane
concentrations need to be subtracted from these values.
Emissions Performance TestingNMethod 25A Criteria
PT-8
-------
Method 25A Calibration and QA criteria!:
Calibration: A minimum, of 4 gas standards concentrations as follows:
• zero gas =*< Od pprnvorgawcs or < 0.1% span,(which ever is greater)
• low level = 25-3 5% of span
• mid level = 45-55% of span
« high level = 80-90% of spans ;
Zero Drift: Introduce zero level gases afterf every test, or hourly during test. Must be less
than ± 3% of span (gas directed through entire sample system)
Calibration Drift: Introduce mid level gasp after every test, or hourly during test. Must be
less than ± 3% of span (gas directed througli entire sample system)
Calibration Error: Introduce low and midjlevel gases before start of test. Must be less than
± 5% of calibration gas value (gas directed: through entire sample system)
Corrective Action: If CE is unacceptable, ilo not start testing until problem is corrected and
CE is acceptable. If CD is unacceptable, either invalidate test results or recalibrate
instrument and report results using both sets of calibration data.
Response Time: Measured I/test program
Additional Calibration and QA criteria when used for the 20 ppm TOC standard (per
Performance Specification 8,40 CFR 60 Appendix B).
Data Recorder Scale: For uncontrolled sources = 1.25 to 2 times the average potential level,
For controlled sources =1.5 times the pollutant concentration corresponding to the emissions
standard . , .. !
Calibration Drift: ± 2.5% of span (gas;directed through entire sample system)
Relative Accuracy: < 20 % mean value of !the reference method test data in units of the
applicable emissions standard, or 10% of the applicable standard, whichever is greater.
Method 25
Method 25 mei sures Total Gaseous Nonmethane Organic
Emissions as Cjarbon. A sample of gas is extracted from the stack,
pulled thorough a cryogenic trap to collect the higher molecular
weight organic compounds, and then into an evacuated canister, to
collect the lower molecular weight organic compounds. In
principle, the analysis is then completed on both fractions in the
following steps:
1. Measure sample methane and CO2 and concentration
(background)
Oxidize- all organics to CO2 and H2O,
Catalytically reduce CO2 to CH4, and
Measure residual CH4 concentration.
2.
3.
4.
Emissions Performance Testing\Method 25
PT-9
-------
Method 26
The difference between the background CH4 concentration from
the oxidized/reduced CH4 fraction is attributable to the
concentrations of organic compounds in the gas stream. This
method does not have a response factor bias as does Method 25 A,
but has a detection limit of 50 ppmC (parts per million carbon,
same as ppm as methane). For many process/control device
situations, this detection limit is too high to allow control
efficiency compliance to be demonstrated.
Method 26, Determination of Hydrogen Chloride from Stationary
Sources, uses aqueous absorbing solutions to collect and quantify
hydrogen chloride (HC1). It cannot be used for measuring
concentrations of organics. It can be used for determining
removal efficiencies of HC1 in control efficiency demonstrations or
halogenated compounds for the 20 ppm TOC/halogen halide
concentration requirements.
QandA
Wliich parameters (Organic HAP or TOC) should an O/O use to demonstrate
compliance ?
The selection of whether to use Organic HAP removal efficiency standard or TOC
concentration standard to demonstrate APCD compliance is case specific. For some
cases where the APCD is functioning well and is controlling TOC to levels much
lower than 20 ppm TOC/Methane, then TOC as measured by Method 25A is the
simplest and least costly choice. For cases where the margin of compliance is closer,
it may be a "safer bet" to measure Total Organic HAP at the inlet and outlet for
removal efficiency determinations.
Compounds not
Included in
Wastewater
APCD Tests
For wastewater sources, the total Organic HAPs method target compounds
need not include compounds not used or produced, compounds in
wastewater POD that are < 1 ppmw, or compounds which are not
detected in wastewater when detection limits are not greater than < 1
ppmw.
Emissions Performance TestingNMethod 26
PT-10
-------
How is gas flow rate measured ?
Flow Rate
Determinations
Method 2
Method 2A-2E
Alternative Flow
Monitoring
Techniques
Vent gas flow rate musj: be measured for determining Organic HAP
mass rates. Section 1257(b) states that EPA Method 2, 2A, 2C or 2D must
be used for measuring volumetric flow rates. However, some of these
methods may not be appropriate for low flow or batch processes as
discussed below.
Method 2 incorporates
the use of an S type pitottube to measure velocity
pressure drop and gas velocity. The gas velocity is then multiplied by the
duct cross sectional area to determine flow rate. Incorporated into Method
2 are measurements of'O2/CO2 concentrations, gas temperature, and gas
moisture content. Me1:hod 2 works well for measuring fairly stable flows
with a measurable pressure drop (not too low). If velocity pressures are
lower than 0.05 inches |water column (in. we), a more sensitive pressure
gauge than what is described in Method 2 must be used (or use a different
flow measurement technique). Method 2 is conducted manually with
discrete measurements!taken periodically. If flow rate fluctuates, periodic
measurements may not capture all flow rate episodes which could result in
a biased flow rate average.
. I
Method 2A -2E are alternative flow measurement methods for situations
where Method 2 is not recommended. They are entitled as follows:
• 2A = Direct measurement of gas volume through pipe and small
ducts (volume meters),
• 2B = Determination of exhaust gas volume flow from gasoline
vapor incinerators
• 2C = Determination of gas velocity and volumetric flow rate in
small stacks or'ducts (standard pitot)
• 2D = Measurement of gas volumetric flow rates in small pipes or
ducts (orifice plates, rotameters, other),
• 2E = Determination of gas: gas production flow rate
i
The above alternative Method 2 procedures are suitable for many
situations. Most of them incorporate visual observation of pressure
other measurement; For batch processes having very variable flow rate, it
may be necessary to use the above methods with an automated measuring
device capable of sending the measurement signal to a continuous data
acquisition system (i.e.', pressure transducer, temperature thermocouple,
anemometer, etc). Continuous readings of flow rate could then be
acquired and accurate averages calculated. If the test firm is using a
Emissions Performance Testing\Flow Rate
PT-11
-------
Cyclonic Flow
Measurements
OJCO2
Measurements
Moisture
Determination
EPA Web Site
continuous emissions monitoring systems (GEMS) for Method 25 A tests,
it is not much more difficult to incorporate continuous flow monitoring
into their data acquisition system. Alternative flow rate measurement
techniques may be approved as well. For batch processes, tracer gas
injection (SO2, CO, etc) with dilution monitoring works well and provides
continuous flow rate data (per Alternative EPA Method Alt-012).
For instances of cyclonic flow, EPA Method 1 recommends that EPA
Method 2 not be used for determining flow rate. In these cases, there are
alternative methods which can be used, if approved by the administrator
(i.e, Draft Method 2F- Alternative Method ATM-015).
Oxygen and carbon dioxide concentrations must be measured to
incorporate into gas flow rate calculations (if velocity pressure flow
measurement technique is used). Also, if the TOC compliance option is
being used on a combustion APCD, TOC values must be corrected to 3%
O2 Section 63.1257(b)(3) states that EPA Method 3 must be used for gas
analysis. EPA Method 3 determines O2 and CO2 using either a Fyrite™ or
an Orsat™ analyzer. If the O2 measurement is needed for TOC correction
to 3% O2, then a Fyrite™ can not be used. Using an Orsat™ analyzer for
O2 measurements can be time consuming and has potential for error due to
leaks and operator error. It is more simple and technically sound to
conduct O2 measurements using CEMS by EPA Method 3 A.
Gas moisture content is incorporated into flow rate calculations (if
velocity pressure flow measurement techniques are used) and Method 18
& 25A analyses (to correct TOC values from a wet basis to a dry basis).
EPA Method 4 should be used to determine moisture. This procedure
calls for extracting a gas stream from the duct and bubbling it through
chilled water and pre-weighed silica gel desiccant. Moisture is determined
by comparing the volume of moisture collected by the water and silica gel
to the volume of gas sampled. If the stream is saturated, moisture content
is determined by measuring gas temperature and using a psychometric
chart or saturation vapor pressure tables. Approximation techniques such
as wet-bulb/dry bulb procedures can only be used if it is shown to be
within 1% of Method 4 techniques.
Further details can be found in the EPA reference methods which can be
downloaded from the EPA TTN bulletin board at http://www.epa.gov/
ttn/emc promgate.html.
Emissions Performance Testing\Flow Rate
PT-12
-------
General Approach
to Performance
Testing
If the facility is required to conduct performance testing, it is
important to understand the distinct areas of responsibility. Some tasks
should be handled by the vendor, however, the ultimate responsibility is
with the plant engineer. The discussion provides a set of steps mat can be
followed in planning and conducting a performance test.
Emissions Performance Testing\Generai Approach
PT-13
-------
Steps in Planning and Conducting a Performance Test Program
Planning. Operating Conditions: ; : -
1. • Select how the processes) will be operated during the test program (i.e., absolute
worst-case, or hypothetical worst-case) J
- If the above entails precise timing Of multiple process events, verify that the
approach is feasible,
2. Select how the APCD or wastewater treatment equipment will be operated during
the test program,
3. Select which process, APCD, and wastewater treatment parameters to monitor,
4. Determine how the above parameters will be monitored and which ones are
candidate parameters for monitoring on an on-going basis.
Planning. Test Objectives:
5. Determine pollutant concentration test methods and detection limits,
6. Verify detection limits are sufficient for demonstrating compliance,
7. Select flow monitoring methods and devices,
8. Verify that expected costs for above scope are within a reasonable testing budget.
Executing the Pre-Test Survey:
12. Meet on-site with the vendor to confirm approach on all of the above,
13. Discuss and confirm all Health & Safety precautions and required procedures,
14. Confirm vendors needs for mobile lab parking, access to sample sites, utilities,
process coordination (start and stop times),
15. Confirm what type of process data will be collected and who will collect it, and,
16. Walkthrough facility examining sample sites and process data collection points.
Executing the Test Program:
17. Confirm expected testing schedule and logistics with vendor on equipment iset-up
day,
18. Conduct test program,
19. Verify collection of all process daita, and
20. CoUect copies of field data sheets & sample log or chain of custody.
Data Reduction and Reporting:
21. Verify receipt of samples by laboratory
22. Confirm expected sample analysis date and preliminary report date,
23. Reduce all on-site data (flows, sample volumes, process data),
24. Incorporate analytical data and prepare preliminary report,
25. Review preliminary report,
26. Incorporate comments and finalize report.
ftft^jraag^^ffiasiBiti^^
Emissions Performance TestingXGeneral Approach
PT-14
-------
Selecting the Testing Firm
There are many testing firms highly qualified to conduct sampling and analyses for gas phase
and water phase pollutants. In selecting a vendor the following items should be considered:
1. Determine if the testing firm should prc vide engineering services in addition to testing. If
so, should they include both process engineering as well as control device/treatment
equipment engineering ?
2. Prepare scope of work for the RFP and be explicit in:
- what are the target compounds,
- what test methods are not suitable
- What detection limits are needed '(provide expected concentrations and flow rates),
- What is the available testing \yine|ow is (hours of the day),
- Whether the vendor should provide a process interface person for process data
collection (do not expect the vendor to provide this without him costing it in)
- What type of data reduction/reporting is desired (i.e.s deliver two types of reports -
sanitized and unsanitized, what! types of averages should be calculated for complex
scenarios, how to combine process
3. Have vendors submit cost proposals inc:
data and emissions data, graphics, etc.)
uding costs for baseline scope of work and on-site
field team costs ($/hr) for possible add-on tasks.
4. Review proposals and select testing firm.
Note on Detection limits - Make sure the vendor states what the detection limits will be
(concentration and mass rate for a given flow rate) and see if these values will suit your
needs. For example, if your inlet loading tp an APCD is estimated to be 20 Ibs/hr HAPs, and
your detection limit at the outlet is < 5 Ibs/hr, the highest removal efficiency that can be
demonstrated is 75%. If this is the case, a different test method with a lower detection may be
needed at the APCD outlet.
Note on Process Data Collection: There always seems to be confusion surrounding the role of
process/testing interface person. The plant people know the facility best however, the test
people know how the testing will be conducted (timing). It is important to establish what
roles will be played by whom.
^^'***<#*4&i>!!tli
-------
-------
Appendix WWT
bio
Wastewater Treatment Performance Testing * Test Methods and Approach
Overview
Wastewater Treatment (WWT) performance testing must be used to demonstrate
compliance for open biological treatment systems. Either WWT testing or WWT design
evaluation can be used for closed biological or nonbiological treatment systems. There
are six wastewater performance test procedures stipulated in §63.1257(e)(2)(iii) B-G
listed as follows: j
• wastewater concentration limits (noncombustion
treatment)[§63.1257(el)(2)(ui)(B)3
• wastewater mass removal/destruction efficiency limits:
- noncombustion & Bion biological treatment [§63.1257(e)(2)(iii)(C)3
- combustion treatment [§63.1257(e)(2)(iii)(D)3
-biological (open or closed) [§63.1257(e)(2)(iii)(E & F)]
- closed biological only [§63.1257(e)(2)(iii)(G)]
The six performance testiiig procedures are similar in that they require:
• three 1-hour test runs,
• grab wastewater sampling or integrated wastewater sampling at
approximately equally spaced time intervals during each hour of the three
1-hour tests,
• wastewater sampling per §63.1257(b)(10)(vi), that calls for sampling
procedures that minimize emissions, such as 40 CFR 60 Appendix A
Method 25D sampling guidelines (collecting the sample through a cooling
coil into ajar containing Polyethylene Glycol, PEG)
• wastewater flow measurements concurrent with concentration sampling,
• Separate inlet and outlet flow measurements, if the outlet flow is higher.
If the outlet flow is not greater than the inlet, then a single flow
measurement is satisfactory, at either the inlet or outlet.
For biological treatment demonstrations, the mass removal/destruction efficiency
determinations incorporate th|? use of a site specific degradation factor FWo (closed
biological can use either methods in §63.1257(e)(2)(iu)(E) & (F), which
incorporate Fbjo, or G which does not). Fbio is an indication of what fraction of
total orgaiiics in solution biodlegrade, as opposed to being emitted or remaining in
the effluent. The first step in determining FWo is to measure me compound-
specific degradation rate 4i0 using procedures found in Appendix C to Part 63.
These are:
1 A. M304A - Determine site specific, biodegradation factor using
bench scale laboratory set up/ air vent (use instead of 304B when
Wastewater Performance TestingNFbio
WWT-1
-------
compounds react or hydrolyze in the scrubber of Method 304B).
IB. M304B - Same as previous w/ scrubber and is not vented (when
Henry's Law constants are not known.)
2. Site specific performance data with and without biodegradation
used to calculate Fbjo.
3. Any of the above 3 methods or using inlet and outlet concentration
measurements coupled with calculation such as a computer model
(i.e, Water?, TOXCHEM, BASTE, etc).
4. Batch treatability tests
NOTE: For non-enhanced bio treatment, use fbio method 1,2, or 4 above. For
enhanced bio treatment, use fbio method 1,2,3, or 4 for PSHAPs. For SBAPs use
K, = Table 9 values & follow Appendix C, Form in or use fbio methods 1., 2,3, or
4-
The total stream FKo is then determined by multiplying each compound specific
4i0 by the compound mass flow rate in the wastewater stream, summing all
compound specific fKo x mass flow products and then dividing by the total organic
mass flow in the wastewater stream. Further details can be found in the Appendix
C reference methods which can be downloaded from the EPA TTN bulletin board
at http://www.epa.gov/ ttn/emc/ promgate.html.
For further guidance on "thoroughly mixed" biological treatment units, see
guidance at http://www.epa,gov/ttn/oarpg/t3/reports/guidfh.pdf.
Note on choosing biological treatment compliance demonstration procedure:
Closed Biological -If the O/O chooses closed biological treatment and demonstrates
compliance using §63.1257(2)(iii)(E) or (F), then the treatment process is not subject to
wastewater storage tank or surface impoundment vapor suppression standards,
Open Biological - -If the O/O chooses open biological treatment, the treatment process need
not be covered and vented to a control device. Also, if compliance is demonstrated by
§63.1257(2)(iii)(E) or (F), the treatment process is also not subject to wastewater storage tiink
or surface impoundment vapor suppression standards, •
Wastewater Performance TestfngVFbio
WWT-2
-------
Mass Removal/Destruction Efficiency for Biological Systems
Procedures are given for determining mass removal/destruction efficiency from
the following 2 biological treatment configurations:
1. mass destruction/remojval efficiency is determined across a biological
treatment system only, or
2. mass destruction/removal efficiency is determined across a series of
treatment processes
Compliance is demonstrated i
destruction/removal efficiency, E, is 95% or
greater. For case 1 above, mass removal/destruction efficiency (E) is equal to Fbio.
In the second case, use the equation below. (Equation 50 from the rule.)
Nonbiotreatment HAP toad removal + Biotreatment HAP load removal
Total influent HAP load
- QMWbii)
QiW
QMV/.
io * Fbio
the soluble and/or partially soluble HAP load entering a treatment process segment
QMWW = the soluble and/or partially soluble HAP load exiting a treatment process segment
the number of treatment process segments
identifier for a treatment process element
the inlet load of soluble and/or bartially soluble HAP to the biological treatment
process. The inlet is defined inj accordance with 63.1257 (e)(2)(iii)(A)(£). If
complying with 63.1257 (e)(2)(iii)(A)(g)(ii) (i.e., the inlet to the equalization tank
is considered to be the inlet to t|he biological treatment process) of this section,
QMWbio is equal to QMWbin
QMWbio =
Fbjo-
QMW8ll =
site-specific fraction of soluble
and/or partially soluble HAP compounds
biodegraded.
the total soluble and/or partially soluble HAP load to be treated.
If wastewater is conveyed by hard piping, mass removal/destruction efficiency is
Wastewater Performance Testing\Fbio
WWjT-3
-------
determined across the combination of all treatment processes. Owners/operators
may conduct the performance test across each series of treatment processes;
(§63.1257(e)(2)(iii)(A)(5)(D ) OR conduct the test over each individual treatment
process in the series of processes and sum them together
(§63.1257(e)(2)(iii)(A)(5)(a) ). If wastewater is not conveyed by hard piping,
•efficiency must be determined across each treatment process with total efficiency
equal to the sum of efficiencies from each component process. In this manner, the
owner or operator does not get credit for fugitive emissions that may occur
between treatment process segments.
Equalization Tank The inlet to the biological process may be considered the inlet to the equalization
tank if:
* Wastewater is conveyed by hard piping from last treatment
process or POD to equalization tank, or
• Wastewater is conveyed by hard piping from equalization
tank to biological treatment process, or
• Equalization tank is equipped with a fixed roof/closed vent
system/APCD.
Test Plan
Sample Plan
A site specific test plan must be prepared addressing the following:
• Test program summary,
• Test schedule,
• Data quality objectives (pretest expectations of precision, accuracy
and completeness of data),
• Internal and External QA programs (internal QA includes
assessment of data precision, external includes activities such as
performance audits), and
• An emission profile must also be included if tests are being
conducted on a control device which controls process vents from a
batch process.
The test plan must be submitted to the administrator at least 60 days before
the scheduled test date.
All compliance procedures listed above require a sample plan to be developed and
kept on-site. The sample handling procedures must be aimed at minimizing the
loss of volatiles from the sample solution. In summary, the following tasks must
be considered:
• Use Procedures in Chapter 9 of SW-846 for developing
sampling plan,
• Sample location should be representative of unexposed
waste (where waste has minimum opportunity to volatilize
to atmosphere)
Wastewater Performance TcstingVSample Plan
WWT-4
-------
Collec the sample through a tap or use a submerged
container (if a tap is impractical)
Distinguish sampling procedures for single phase or well
mixed |waste versus multi-phase waste
Collected through a chilled coil into a chilled polyethylene
glycol i(PEG) solution or chilled VOA tubes
Determine target compound recovery efficiency during
sample analyses
Three, 1-hour long sample runs must be performed at representative
process unit operation and representative treatment process. The
owner/operator may collect grab samples or composite samples. If the
treatment process operates at multiple representative conditions, testing at
each condition is not necessary. Calculations or engineering evaluations
can be used to supplement test results to demonstrate compliance over the
entire range of operation.
Analytical Summary Analyses should be completed using Method 305,624,625,8270,1624,1625,
1666,1671 or other validated method. For demonstrating compliance with
wastewater concentration limiis, either Method 305 should be used or another
method with the results multiplied by the compound specific fraction Measured
(Fm) values. For the purposes of this discussion, these types of wastewater
concentrations will be known as wastewater Emission Potential Concentrations
(EPC). Analytical techniques [for concentrations to be used in calculating mass
rates are not EPC values. If Method 305 is used for a mass rate concentration type,
the result must be divided by the appropriate Fm value. Results from other
analytical techniques are not adjusted. Fm values are listed in the following Table.
(See page 8-27 for a table on use of Fm values).
TABLE WWT-2 TO SUBPART CX5G. FRACTION MEASURED (FJ
FOR HAP COMPOUNDS IN WASTEWATER STREAMS
Chemical name
Acetaldehyde
Acetonitrile [
Acetophenone
Acrolein
Acrylonitrile
Allyl chloride
Benzene
Benzyl chloride . ,
CAS No.0
75070
75058
98862
107028
107131
107051
71432
100447
Fm
1.00
0.99
0.31
1.00
1.00
1.00
1.00
1.00
Wastewater Performance TestingVAnalytical Summary
WWT-5
-------
TABLE WWT-2 TO SUBPART GGG. FRACTION MEASURED (Fm)
FOR HAP COMPOUNDS IN WASTEWATER STREAMS
Chemical name
Biphenyl
Bromofonn
Butadiene (1,3-)
Carbon disulfide
Carbon tetrachloride
Chlorobenzene
Chlorofonn
Chloroprene (2-ChIoro-l,3-butadiene)
Cumene
Dicblorobenzene (p-1,4-)
DicMoroethane (1,2-) (Elhylene dicMoride)
DicMoroethyl ether
(Bis(2-Chloroethyl ether))
Dichloropropene (1,3-)
Diethyl sulfate
Dimethyl sulfate
Dimethylaniline (N,N-)
Dimethylhydrazine (1,1-)
Dinitrophenol (2,4-)
Dinitrotoluene (2,4-)
Dioxane (1,4-) (1,4-Diethyleneoxide)
EpichIorohydrin(l-Chloro-2,3-epoxypropane)
Ethyl aciylate
Ethylbenzene
Ethyl chloride (Chloroethane)
Ethylene dibromide (Dibromomethane)
Ethylene glycol dimethyl ether
Ethylene glycol monobutyl ether acetate
Ethylene glycol monomethyl ether acetate
Ethylene oxide
CAS No."
92524
75252
106990
75150
56235
108907
67663
126998
98828
106467
107062
111444
542756
64-675
77781
121697
57147
51285
121142
123911
106898
140885
100414
75003
106934
110714
112072
110496
75218
F.
0.86
1.00
1.00
1.00
1.00
0.96
1.00
1.00
1.00
1.00
1.00
0.76
1.00
0.0025
0.086
0.00080
0.38
0.0077
0.085
0.87
0.94
1.00
1.00
1.00
1.00
0.86
0.043
0.093
1.00
Wastewatcr Performance TestfngVAnalytical Summary WWl-O
-------
TABLE WWT-2 TO SUBPART G&G. FRACTION MEASURED (Fra)
FOR HAP COMPOUNDS DSJ WASTEWATER STREAMS
Chemical name
Ethylidene dichloride (1,1 -Dichloroethane)
I
Hexachlorobenzene j
Hexachlorobutadiene
Hexachloroethane
Hexane
Isophorone 1
Methanol
Methyl bromide (Bromomethane)
Methyl chloride (Chloromethane)
Methyl ethyl ketone (2-Butanone) |
VIethyl isobutyl ketone (Hexone)
Methyl methacrylate
Methyl tert-buryl ether
Methylene chloride (Dichloromethane)
Naphthalene
Nitrobenzene • '
Nitropropane (2-)
Phosgene
'ropionaldehyde ;
Propylene dichloride (1,2-Dichloropropane) |
'ropylene oxide
Styrene
Tetrachloroethane (1,1,2*2-)
Tetrachloroethylene (Perchloroefliylene)
Toluene '
Toluidine (o-)
"richlorobenzene (1,2,4-)
rrichloroethane (1,1,1-)
Methyl chloroform)
CAS No."
75343
118741
87683
67721
110543
78591
67561
74839
74873
78933
108101
80626
1634044
75092
91203
98953
79469
75445
123386
78875
75569
100425
79345
127184
108883
95534
120821
71556
Fm
1.00
0.97
0.88
0.50
1.00
0.47
0.85
1.00
1.00
0.99
0.98
1.00
1.00
1.00
0.99
0.39
0.99
1.00
1.00
1.00
1.00
1.00
1.00.
1.00
1.00
0.15
1.00
1.00
Wastewater Performance TestingNAnalytical Summary WWT-7
-------
TABLE WWT-2 TO SUBPART GGG. FRACTION MEASURED (Fm)
FOR HAP COMPOUNDS IN WASTEWATER STREAMS
Chemical name
Trichloroethane (1,1,2-)
(Vinyl Trichloride)
Trichloroethylene
Trichlorophenol (2,4,5-)
Triethylamine
Trimethylpentane (2,2,4-)
Vinyl acetate
Vinyl chloride (Chloroethylene)
Vinylidene chloride (1,1-Dichloroethylene)
Xylene (m-)
Xylene (o-)
Xylene (p-)
CAS No."
79005
79016
95954
121448
540841
108054
75014
75354
108383
95476
106423
F»
0.98
1.00
1,00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
•CAS numbers refer to the Chemical Abstracts Service registry number assigned to specific compounds, isomers, or mixtures
of compounds.
Flow Measurement
Wastewater (and vent gas) flow measurements are needed to calculate HAP mass
rates. Flow measurements should be made during the same period that
concentration samples are being collected. If samples are being collected over an
hour-long period, enough flow measurements should be taken during that hour so
that an accurate flow rate average can be calculated. If flow is constant, the flow
may only need to be measured once per test run. However, if flow rate is variable,
multiple flow measurements may need to be taken. Separate wastewater inlet and
outlet flow measurements must be made unless a) the inlet flow is higher, then a
single flow measurement device is satisfactory at either the inlet or outlet or b) the
treatment process is an open or closed biological process then only the inlet flow
must be measured for the performance test (§63.1257(e)(2)(iii)(E)(2) and (G).
Gas flow rate must be measured by methods stipulated in the rule as discussed in
Appendix PT. No wastewater flow measurement methods are stipulated in the
rule.
Wtstewater Performance TcstingNFlow Measurement
WWT-8
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Q. How should treatment device residence time be considered ?
I - ,,
A. Unlike an emissions control device, which has a residence time of a few seconds, the residence
time of a wastewater stream flowing through a treatment plant may be much longer. In drderto
determine treatment efficiency, the treatment plant inlet and outlet PSH AP and SHAP mass rates
must be measured on the same "slug" of wastewater flowing through the treatment plant. For
example, if the residence time is 30 minutek, the outlet sample should not be collected until after
30 minutes have elapsed since collection oifthe inlet sample. An even more complicated
scenario is when wastewater flow is not constant Calculations should be made to determine the
volume of wastewater which flows by the inlet sample point during inlet sampling, determine the
exact treatment plant residence time, and commence outlet sampling after that residence time has
elapsed. r
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Exempt Compounds For wastewater sources, the tcital Organic HAPs method target compounds need
not include compounds not used or produced, compounds in wastewater that are <
1 ppmw, or compounds that are not detected in wastewater when detection limits
are not greater than < 1 ppmw. Also, as for control devices controlling only
wastewater emissions, the target compounds are only PSHAPs and SHAPs and do
not include other HAPs.
Wastewater Performance TestingXExempt Compounds
WWT-9
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