[Code of Federal Regulations]
[Title 40, Volume 11]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR63.1251]

[Page 72-83]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES--Table of Contents
 
 Subpart GGG--National Emission Standards for Pharmaceuticals Production
 
Sec. 63.1251  Definitions.

    Terms used in this subpart are defined in the Act, in subpart A of 
this part, or in this section. If the same term is defined in subpart A 
of this part and in this section, it shall have the meaning given in 
this section for the purposes of this subpart.
    Active ingredient means any material that is intended to furnish 
pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the body of man or other animals. This term 
does not include food, food additives (except vitamins and other 
materials described by SIC code 2833 or 2834), color additives, 
cosmetics, in-vitro diagnostic substances, x-ray film, test indicator 
devices, and medical devices such as implants, artificial joints, 
surgical bandages, and stitching material.
    Actual HAP emissions means the HAP emitted to the atmosphere from 
either uncontrolled or controlled emission points.
    Air pollution control device or Control device means equipment 
installed on a process vent, storage tank, wastewater treatment exhaust 
stack, or combination thereof that reduces the mass of HAP emitted to 
the air. The equipment may consist of an individual device or a series 
of devices. Examples include, but are not limited to, incinerators, 
carbon adsorption units, condensers, flares, boilers, process heaters, 
and gas absorbers. Process condensers are not considered air pollution 
control devices or control devices.
    Annual average concentration, as used in the wastewater provisions 
in Sec. 63.1256, means the total mass of partially soluble and/or soluble 
HAP compounds in a wastewater stream during the calendar year divided by 
the total mass of the wastewater stream discharged during the same 
calendar year, as determined according to the procedures specified in Sec. 
63.1257(e)(1) (i) and (ii).
    Automated monitoring and recording system means any means of 
measuring values of monitored parameters and creating a hard copy or 
computer record of the measured values that does not require manual 
reading of monitoring instruments and manual transcription of data 
values. Automated monitoring and recording systems include, but are not 
limited to, computerized systems and strip charts.
    Batch emission episode means a discrete venting episode that may be 
associated with a single unit operation. A unit operation may have more 
than one batch emission episode. For example, a displacement of vapor 
resulting from the charging of a vessel with HAP will result in a 
discrete emission episode that will last through the duration of the 
charge and will have an average flowrate equal to the rate of the 
charge. If the vessel is then heated, there will also be another 
discrete emission episode resulting from the expulsion of expanded 
vapor. Both emission episodes may occur in the same vessel or unit 
operation. There are possibly other emission episodes that may occur 
from the vessel or other process equipment, depending on process 
operations.
    Batch operation or Batch process means a noncontinuous operation 
involving intermittent or discontinuous feed into equipment, and, in 
general, involves the emptying of the equipment after the batch 
operation ceases and prior to beginning a new operation.

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Addition of raw material and withdrawal of product do not occur 
simultaneously in a batch operation.
    Bench-scale batch process means a batch process (other than a 
research and development facility) that is capable of being located on a 
laboratory bench top. This bench-scale equipment will typically include 
reagent feed vessels, a small reactor and associated product separator, 
recovery and holding equipment. These processes are only capable of 
producing small quantities of product.
    Block means a time period that comprises a single batch.
    Boiler means any enclosed combustion device that extracts useful 
energy in the form of steam and is not an incinerator. Boiler also means 
any industrial furnace as defined in 40 CFR 260.10.
    Centralized combustion control device (CCCD) means enclosed 
combustion devices that are used to control process vent emissions from 
non-dedicated PMPU's at a facility. Centralized combustion control 
devices may also be used to control emissions from source types 
including, but not limited to, storage tanks, waste management units, 
and equipment leaks.
    Cleaning operation means routine rinsing, washing, or boil-off of 
equipment in batch operations between batches.
    Closed biological treatment process means a tank or surface 
impoundment where biological treatment occurs and air emissions from the 
treatment process are routed to either a control device by means of a 
closed-vent system or by means of hard-piping. The tank or surface 
impoundment has a fixed roof, as defined in this section, or a floating 
flexible membrane cover that meets the requirements specified in Sec. 
63.1256(c).
    Closed-loop system means an enclosed system that returns process 
fluid to the process and is not vented to the atmosphere except through 
a closed-vent system.
    Closed-purge system means a system or combination of system and 
portable containers, to capture purged liquids. Containers must be 
covered or closed when not being filled or emptied.
    Closed-vent system means a system that is not open to the atmosphere 
and is composed of piping, ductwork, connections, and, if necessary, 
flow inducing devices that transport gas or vapor from an emission point 
to a control device.
    Combustion device means an individual unit of equipment, such as a 
flare, incinerator, process heater, or boiler, used for the combustion 
of HAP vapors.
    Combustion device burner means a device designed to mix and ignite 
fuel and air to provide a flame to heat and oxidize waste organic vapors 
in a combustion device.
    Connector means flanged, screwed, or other joined fittings used to 
connect two pipe lines or a pipe line and a piece of equipment. A common 
connector is a flange. Joined fittings welded completely around the 
circumference of the interface are not considered connectors for the 
purpose of this regulation. For the purpose of reporting and 
recordkeeping, connector means joined fittings that are not 
inaccessible, ceramic, or ceramic-lined as described in Sec. 
63.1255(b)(1)(vii) and Sec. 63.1255(f)(3).
    Construction means the onsite fabrication, erection, or installation 
of an affected source or a PMPU. Addition of new equipment to a PMPU 
subject to existing source standards does not constitute construction, 
but it may constitute reconstruction of the affected source or PMPU if 
it satisfies the definition of reconstruction in this section.
    Consumption means 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 
reactants, solvents, and any other additives. If a HAP is generated in 
the process as well as added as a raw material, consumption includes the 
quantity generated in the process.
    Container, as used in the wastewater provisions, means any 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, tank cars, dump trucks, and ships.

[[Page 74]]

    Continuous process means a process where the inputs and outputs flow 
continuously throughout the duration of the process. Continuous 
processes are typically steady state.
    Continuous recorder means a data recording device that either 
records an instantaneous data value at least once every 15 minutes or 
records 15-minute or more frequent block average values.
    Continuous seal means a seal that forms a continuous closure that 
completely covers the space between the wall of the storage tank and the 
edge of the floating roof. A continuous seal may be a vapor-mounted, 
liquid-mounted, or metallic shoe seal.
    Control device, for purposes of this Sec. 63.1255, means any equipment 
used for recovering or oxidizing organic hazardous air pollutant vapors. 
Such equipment includes, but is not limited to, absorbers, carbon 
adsorbers, condensers, flares, boilers, and process heaters.
    Controlled HAP emissions means the quantity of HAP discharged to the 
atmosphere from an air pollution control device.
    Cover, as used in the wastewater provisions, means a device or 
system which is placed on or over a waste management unit containing 
wastewater or residuals so that the entire surface area is enclosed to 
minimize air emissions. A cover may have openings necessary for 
operation, inspection, and maintenance of the waste management unit such 
as access hatches, sampling ports, and gauge wells provided that each 
opening is closed when not in use. Examples of covers include a fixed 
roof installed on a wastewater tank, a lid installed on a container, and 
an air-supported enclosure installed over a waste management unit.
    Dedicated PMPU means a PMPU that is composed of equipment that is 
used to manufacture the same product for a continuous period of 6 months 
or greater. The PMPU includes any shared storage tank(s) that are 
determined to belong to the PMPU according to the procedures in Sec. 
63.1250(e).
    Dense gas system means a conveyance system operated to limit oxygen 
levels below 12 percent.
    Double block and bleed system means two block valves connected in 
series with a bleed valve or line that can vent the line between the two 
block valves.
    Duct work means a conveyance system such as those commonly used for 
heating and ventilation systems. It is often made of sheet metal and 
often has sections connected by screws or crimping. Hard-piping is not 
ductwork.
    Enhanced biological treatment system or enhanced biological 
treatment process means an aerated, thoroughly mixed treatment unit(s) 
that contains biomass suspended in water followed by a clarifier that 
removes biomass from the treated water and recycles recovered biomass to 
the aeration unit. The mixed liquor volatile suspended solids (biomass) 
is greater than 1 kilogram per cubic meter throughout each aeration 
unit. The biomass is suspended and aerated in the water of the aeration 
unit(s) by either submerged air flow or mechanical agitation. A 
thoroughly mixed treatment unit is a unit that is designed and operated 
to approach or achieve uniform biomass distribution and organic compound 
concentration throughout the aeration unit by quickly dispersing the 
recycled biomass and the wastewater entering the unit.
    Equipment, for purposes of Sec. 63.1255, means each pump, compressor, 
agitator, pressure relief device, sampling connection system, open-ended 
valve or line, valve, connector, and instrumentation system in organic 
hazardous air pollutant service; and any control devices or closed-vent 
systems required by this subpart.
    Excipient means any substance other than the active drug or product 
which has been appropriately evaluated for safety and is included in a 
drug delivery system to either aid the processing of the drug delivery 
system during its manufacture; protect, support, or enhance stability, 
bioavailablity, or patient acceptability; assist in product 
identification; or enhance any other attribute of the overall safety and 
effectiveness of the drug delivery system during storage or use.
    External floating roof means a pontoon-type or double-deck type 
cover that rests on the liquid surface in a

[[Page 75]]

storage tank or waste management unit with no fixed roof.
    Fill or filling means the introduction of material into a storage 
tank or the introduction of a wastewater stream or residual into a waste 
management unit, but not necessarily to complete capacity.
    First attempt at repair means to take action for the purpose of 
stopping or reducing leakage of organic material to the atmosphere.
    Fixed roof means a cover that is mounted on a waste management unit 
or storage tank in a stationary manner and that does not move with 
fluctuations in liquid level.
    Floating roof means a cover consisting of a double deck, pontoon 
single deck, internal floating cover or covered floating roof, which 
rests upon and is supported by the liquid being contained, and is 
equipped with a closure seal or seals to close the space between the 
roof edge and waste management unit or storage tank wall.
    Flow indicator means a device which indicates whether gas flow is, 
or whether the valve position would allow gas flow to be, present in a 
line.
    Formulation means the process of mixing, blending, or diluting one 
or more active or inert ingredients with one or more active or inert 
ingredients, without an intended chemical reaction, to obtain a 
pharmaceutical dosage form. Formulation operations include mixing, 
compounding, blending, and tablet coating.
    Group of processes means all of the equipment associated with 
processes in a building, processing area, or facility-wide. For a 
dedicated process, a group of processes may consist of a single process.
    Halogen atoms mean atoms of chlorine or fluorine.
    Halogenated compounds means organic HAP compounds that contain 
halogen atoms.
    Halogenated vent stream or Halogenated stream means a process, 
storage tank, or waste management unit vent determined to have a 
concentration of halogenated compounds of greater than 20 ppmv, as 
determined through process knowledge, test results using Method 18 of 40 
CFR part 60, appendix A, or test results using any other test method 
that has been validated according to the procedures in Method 301 of 
appendix A of this part.
    Hard-piping means piping or tubing that is manufactured and properly 
installed using good engineering judgment and standards, such as ANSI 
B31-3.
    Hydrogen halides and halogens means hydrogen chloride (HCl), 
chlorine (Cl2), and hydrogen fluoride (HF).
    In gas/vapor service means that a piece of equipment in organic 
hazardous air pollutant service contains a gas or vapor at operating 
conditions.
    In heavy liquid service means that a piece of equipment in organic 
hazardous air pollutant service is not in gas/vapor service or in light 
liquid service.
    In light liquid service means that a piece of equipment in organic 
hazardous air pollutant service contains a liquid that meets the 
following conditions:
    (1) The vapor pressure of one or more of the organic compounds is 
greater than 0.3 kilopascals at 20 C;
    (2) The total concentration of the pure organic compounds 
constituents having a vapor pressure greater than 0.3 kilopascals at 20 
C is equal to or greater than 20 percent by weight of the total process 
stream; and
    (3) The fluid is a liquid at operating conditions. (Note: Vapor 
pressures may be determined by the methods described in 40 CFR 
60.485(e)(1).)
    In liquid service means that a piece of equipment in organic 
hazardous air pollutant service is not in gas/vapor service.
    In organic hazardous air pollutant or in organic HAP service 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 HAP's as 
determined according to the provisions of Sec. 63.180(d). The provisions of 
Sec. 63.180(d) also specify how to determine that a piece of equipment is 
not in organic HAP service.
    In vacuum service means that equipment is operating at an internal 
pressure which is at least 5 kilopascals below ambient pressure.
    In-situ sampling systems means nonextractive samplers or in-line 
samplers.

[[Page 76]]

    Individual drain system means the stationary system used to convey 
wastewater streams or residuals to a waste management unit. The term 
includes hard piping; all process drains and junction boxes; and 
associated sewer lines, other junction boxes, manholes, sumps, and lift 
stations conveying wastewater streams or residuals. A segregated 
stormwater sewer system, which is a drain and collection system designed 
and operated for the sole purpose of collecting rainfall-runoff at a 
facility, and which is segregated from all other individual drain 
systems, is excluded from this definition.
    Initial startup means the first time a new or reconstructed source 
begins production. Initial startup does not include operation solely for 
testing equipment. Initial startup does not include subsequent start ups 
(as defined in this section) of processes following malfunctions or 
process shutdowns.
    Internal floating roof means a cover that rests or floats on the 
liquid surface (but not necessarily in complete contact with it) inside 
a storage tank or waste management unit that has a permanently affixed 
roof.
    Instrumentation system means a group of equipment components used to 
condition and convey a sample of the process fluid to analyzers and 
instruments for the purpose of determining process operating conditions 
(e.g., composition, pressure, flow, etc.). Valves and connectors are the 
predominant type of equipment used in instrumentation systems; however, 
other types of equipment may also be included in these systems. Only 
valves nominally 0.5 inches and smaller, and connectors nominally 0.75 
inches and smaller in diameter are considered instrumentation systems 
for the purposes of this subpart. Valves greater than nominally 0.5 
inches and connectors greater than nominally 0.75 inches associated with 
instrumentation systems are not considered part of instrumentation 
systems and must be monitored individually.
    Isolated intermediate means a product of a process. An isolated 
intermediate is usually a product of a chemical synthesis, fermentation, 
or biological extraction process; several different isolated 
intermediates may be produced in the manufacture of a finished dosage 
form of a drug. Precursors, active ingredients, or finished dosage forms 
are considered isolated intermediates. An isolated intermediate is 
stored before subsequent processing. Storage occurs at any time the 
intermediate is placed in equipment used solely for storage, such as 
drums, totes, day tanks, and storage tanks. The storage of an isolated 
intermediate marks the end of a process.
    Junction box means a manhole or access point to a wastewater sewer 
system line or a lift station.
    Large control device means a control device that controls total HAP 
emissions of greater than or equal to 10 tons/yr, before control.
    Liquid-mounted seal means a foam- or liquid-filled seal mounted in 
contact with the liquid between the wall of the storage tank or waste 
management unit and the floating roof. The seal is mounted continuously 
around the tank or unit.
    Liquids dripping means any visible leakage from the seal including 
dripping, spraying, misting, clouding, and ice formation. Indications of 
liquid dripping include puddling or new stains that are indicative of an 
existing evaporated drip.
    Maintenance wastewater means wastewater generated by the draining of 
process fluid from components in the pharmaceutical manufacturing 
process unit into an individual drain system in preparation for 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 
wastewater 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.
    Malfunction means any sudden, infrequent, and not reasonably 
preventable failure of air pollution control equipment, emissions 
monitoring equipment, process equipment, or a process

[[Page 77]]

to operate in a normal or usual manner. Failures that are caused all or 
in part by poor maintenance or careless operation are not malfunctions.
    Maximum true vapor pressure means the equilibrium partial pressure 
exerted by the total organic HAP in the stored or transferred liquid at 
the temperature equal to the highest calendar-month average of the 
liquid storage or transferred temperature for liquids stored or 
transferred above or below the ambient temperature or at the local 
maximum monthly average temperature as reported by the National Weather 
Service for liquids stored or transferred at the ambient temperature, as 
determined:
    (1) In accordance with methods described in Chapter 19.2 of the 
American Petroleum Institute's Manual of Petroleum Measurement 
Standards, Evaporative Loss From Floating-Roof Tanks (incorporated by 
reference as specified in Sec. 63.14); or
    (2) As obtained from standard reference texts; or
    (3) As determined by the American Society for Testing and Materials 
Method D2879-97, Test Method for Vapor Pressure-Temperature Relationship 
and Initial Decomposition Temperature of Liquids by Isoteniscope 
(incorporated by reference as specified in Sec. 63.14); or
    (4) Any other method approved by the Administrator.
    Metallic shoe seal or mechanical shoe seal means metal sheets that 
are held vertically against the wall of the storage tank by springs, 
weighted levers, or other mechanisms and connected to the floating roof 
by braces or other means. A flexible coated fabric (envelope) spans the 
annular space between the metal sheet and the floating roof.
    Nondedicated formulation operations means equipment used to 
formulate numerous products.
    Nondedicated recovery device(s) means a recovery device that 
receives material from more than one PMPU.
    Nonrepairable means that it is technically infeasible to repair a 
piece of equipment from which a leak has been detected without a process 
shutdown.
    Open biological treatment process means a biological treatment 
process that is not a closed biological treatment process as defined in 
this section.
    Open-ended valve or line means any valve, except pressure relief 
valves, having one side of the valve seat in contact with process fluid 
and one side open to atmosphere, either directly or through open piping.
    Operating scenario for the purposes of reporting and recordkeeping, 
means any specific operation of a PMPU and includes for each process:
    (1) A description of the process and the type of process equipment 
used;
    (2) An identification of related process vents and their associated 
emissions episodes and durations, wastewater PODs, and storage tanks;
    (3) The applicable control requirements of this subpart, including 
the level of required control, and for vents, the level of control for 
each vent;
    (4) The control or treatment devices used, as applicable, including 
a description of operating and/or testing conditions for any associated 
control device;
    (5) The process vents, wastewater PODs, and storage tanks (including 
those from other processes) that are simultaneously routed to the 
control or treatment device(s);
    (6) The applicable monitoring requirements of this subpart and any 
parametric level that assures compliance for all emissions routed to the 
control or treatment device;
    (7) Calculations and engineering analyses required to demonstrate 
compliance; and
    (8) For reporting purposes, a change to any of these elements not 
previously reported, except for paragraph (5) of this definition, shall 
constitute a new operating scenario.
    Partially soluble HAP means a HAP listed in Table 2 of this subpart.
    Pharmaceutical manufacturing operations means the facilitywide 
collection of PMPU and any other equipment such as heat exchanger 
systems, wastewater and waste management units, or cooling towers 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.

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    Pharmaceutical manufacturing process unit (PMPU) means the process, 
as defined in this subpart, and any associated storage tanks, equipment 
identified in Sec. 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 manufacturing of a pharmaceutical product.
    Pharmaceutical product means any of the following materials, 
excluding any material that is a nonreactive solvent, excipient, binder, 
or filler, or any material that is produced in a chemical manufacturing 
process unit that is subject to the requirements of subparts F and G of 
this part 63:
    (1) Any material described by the standard industrial classification 
(SIC) code 2833 or 2834; or
    (2) Any material whose manufacturing process is described by North 
American Industrial Classification System (NAICS) code 325411 or 325412; 
or
    (3) A finished dosage form of a drug, for example, a tablet, 
capsule, solution, etc.; or
    (4) Any active ingredient or precursor that is produced at a 
facility whose primary manufacturing operations are described by SIC 
code 2833 or 2834; or
    (5) At a facility whose primary operations are not described by SIC 
code 2833 or 2834, any material whose primary use is as an active 
ingredient or precursor.
    Plant site means all contiguous or adjoining property that is under 
common control, including properties that are separated only by a road 
or other public right-of-way. Common control includes properties that 
are owned, leased, or operated by the same entity, parent entity, 
subsidiary, or any combination thereof.
    Point of determination (POD) means the point where a wastewater 
stream exits the process, storage tank, or last recovery device. If 
soluble and/or partially soluble HAP compounds are not recovered from 
water before discharge, the discharge point from the process equipment 
or storage tank is a POD. If water streams are routed to a recovery 
device, the discharge from the recovery device is a POD. There can be 
more than 1 POD per process or PMPU.
    Precursor means a material that is manufactured to undergo further 
chemical change or processing to ultimately manufacture an active 
ingredient or finished dosage form of a drug. This term does not include 
commodity chemicals produced by the synthetic organic chemical 
manufacturing industry.
    Pressure release means the emission of materials resulting from the 
system pressure being greater than the set pressure of the pressure 
relief device. This release can be one release or a series of releases 
over a short time period due to a malfunction in the process.
    Pressure relief device or valve means a safety device used to 
prevent operating pressures from exceeding the maximum allowable working 
pressure of the process equipment. A common pressure relief device is a 
spring-loaded pressure relief valve. Devices that are actuated either by 
a pressure of less than or equal to 2.5 psig or by a vacuum are not 
pressure relief devices.
    Primary use means 50 percent or more of a material is used for a 
particular purpose.
    Process means all equipment which collectively function to produce a 
pharmaceutical product or isolated intermediate (which is also a 
pharmaceutical product). A process may consist of one or more unit 
operations. For the purposes of this subpart, process includes any, all, 
or a combination of reaction, recovery, separation, purification, or 
other activity, operation, manufacture, or treatment which are used to 
produce a pharmaceutical product or isolated intermediate. Cleaning 
operations conducted are considered part of the process. Nondedicated 
solvent recovery operations located within a contiguous area within the 
affected source are considered single processes. A storage tank that is 
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. Nondedicated formulation operations occurring within a 
contiguous area are considered a single process that is used to 
formulate numerous materials and/or products. Quality assurance and

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quality control laboratories are not considered part of any process. 
Ancillary activities are not considered a process or part of any 
process. Ancillary activities include boilers and incinerators (not used 
to comply with the provisions of Sec. 63.1253, Sec. 63.1254, or Sec. 63.1256(h)), 
chillers and refrigeration systems, and other equipment and activities 
that are not directly involved (i.e., they operate within a closed 
system and materials are not combined with process fluids) in the 
processing of raw materials or the manufacturing of a pharmaceutical 
product.
    Process condenser means a condenser whose primary purpose is to 
recover material as an integral part of a process. The condenser must 
support a vapor-to-liquid phase change for periods of source equipment 
operation that are at or above the boiling or bubble point of 
substance(s) at the liquid surface. Examples of process condensers 
include distillation condensers, reflux condensers, and condensers used 
in stripping or flashing operations. In a series of condensers, all 
condensers up to and including the first condenser with an exit gas 
temperature below the boiling or bubble point of the substance(s) at the 
liquid surface are considered to be process condensers. All condensers 
in line prior to a vacuum source are included in this definition.
    Process shutdown means a work practice or operational procedure that 
stops production from a process or part of a process during which it is 
technically feasible to clear process material from a process or part of 
a process consistent with safety constraints and during which repairs 
can be effected. An unscheduled work practice or operational procedure 
that stops production from a process or part of a process for less than 
24 hours is not a process shutdown. An unscheduled work practice or 
operational procedure that would stop production from a process or part 
of a process for a shorter period of time than would be required to 
clear the process or part of the process of materials and start up the 
process, and would result in greater emissions than delay of repair of 
leaking components until the next scheduled process shutdown, is not a 
process shutdown. The use of spare equipment and technically feasible 
bypassing of equipment without stopping production are not process 
shutdowns.
    Process tank means a tank that is used to collect material 
discharged from a feedstock storage tank or unit operation and to 
transfer this material to another unit operation within the process or 
to a product storage tank. Surge control vessels and bottoms receivers 
that fit these conditions are considered process tanks. Product storage 
tanks are considered process tanks and are part of the PMPU that produce 
the stored material. For the purposes of this subpart, vents from 
process tanks are considered process vents.
    Process vent means 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 of process 
vents include, but are not limited to, vents on condensers used for 
product recovery, bottom receivers, surge control vessels, reactors, 
filters, centrifuges, and process tanks. Emission streams that are 
undiluted and uncontrolled containing less than 50 ppmv HAP, as 
determined through process knowledge that no HAP are present in the 
emission stream or using an engineering assessment as discussed in Sec. 
63.1257(d)(2)(ii), test data using Methods 18 of 40 CFR part 60, 
appendix A, or any other test method that has been validated according 
to the procedures in Method 301 of appendix A of this part, are not 
considered process vents. Process vents do not include vents on storage 
tanks regulated under Sec. 63.1253, vents on wastewater emission sources 
regulated under Sec. 63.1256, or pieces of equipment regulated under Sec. 
63.1255.
    Production-indexed HAP consumption factor is the result of dividing 
the annual consumption of total HAP by the annual production rate, per 
process.
    Production-indexed volatile organic compound (VOC) consumption 
factor is the result of dividing the annual consumption of total VOC by 
the annual production rate, per process.
    Publicly owned treatment works (POTW) means any devices and systems

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used in the storage, treatment, recycling, and reclamation of municipal 
sewage or industrial wastes of a liquid nature as defined in section 
212(2)(A) of the Clean Water Act, as amended [33 U.S.C. Sec. 1292(2)(A)]. A 
POTW includes the treatment works, intercepting sewers, outfall sewers, 
sewage collection systems, pumping, power, and other equipment. The POTW 
is defined at 40 CFR 403.3(o).
    Reactor means a device or vessel in which one or more chemicals or 
reactants, other than air, are combined or decomposed in such a way that 
their molecular structures are altered and one or more new organic 
compounds are formed.
    Reconstruction, as used in Sec. 63.1250(b), shall have the meaning 
given in Sec. 63.2, except that ``affected or previously unaffected 
stationary source'' shall mean either ``affected facility'' or ``PMPU.'' 
As used in Sec. 63.1254(a)(3)(ii)(A)(3), reconstruction shall have the 
meaning given in Sec. 63.2, except that ``source'' shall mean ``control 
device.''
    Recovery device, as used in the wastewater provisions, means an 
individual unit of equipment used for the purpose of recovering 
chemicals for fuel value (i.e., net positive heating value), use, reuse, 
or for sale for fuel value, use or reuse. Examples of equipment that may 
be recovery devices include organic removal devices such as decanters, 
strippers, or thin-film evaporation units. To be a recovery device, a 
decanter and any other equipment based on the operating principle of 
gravity separation must receive only two-phase liquid streams.
    Repaired means that equipment:
    (1) Is adjusted, or otherwise altered, to eliminate a leak as 
defined in the applicable paragraphs of Sec. 63.1255, and;
    (2) Is, unless otherwise specified in applicable provisions of Sec. 
63.1255, monitored as specified in Sec. 63.180(b) and (c) as appropriate, 
to verify that emissions from the equipment are below the applicable 
leak definition.
    Research and development facility means any stationary source whose 
primary purpose is to conduct research and development into new 
processes and products, where such source is operated under the close 
supervision of technically trained personnel, and is not engaged in the 
manufacture of products for commercial sale in commerce, except in a de 
minimis manner.
    Residual means any HAP-containing liquid or solid material that is 
removed from a wastewater stream by a waste management unit or treatment 
process that does not destroy organics (nondestructive unit). Examples 
of residuals from nondestructive waste management units are: the organic 
layer and bottom residue removed by a decanter or organic-water 
separator and the overheads from a steam stripper or air stripper. 
Examples of materials which are not residuals are: silt; mud; leaves; 
bottoms from a steam stripper or air stripper; and sludges, ash, or 
other materials removed from wastewater being treated by destructive 
devices such as biological treatment units and incinerators.
    Safety device means a closure device such as a pressure relief 
valve, frangible disc, fusible plug, or any other type of device which 
functions exclusively to prevent physical damage or permanent 
deformation to a unit or its air emission control equipment by venting 
gases or vapors directly to the atmosphere during unsafe conditions 
resulting from an unplanned, accidental, or emergency event. For the 
purposes of this subpart, a safety device is not used for routine 
venting of gases or vapors from the vapor headspace underneath a cover 
such as during filling of the unit or to adjust the pressure in this 
vapor headspace in response to normal daily diurnal ambient temperature 
fluctuations. A safety device is designed to remain in a closed position 
during normal operations and open only when the internal pressure, or 
another relevant parameter, exceeds the device threshold setting 
applicable to the air emission control equipment as determined by the 
owner or operator based on manufacturer recommendations, applicable 
regulations, fire protection and prevention codes, standard engineering 
codes and practices, or other requirements for the safe handling of 
flammable, combustible, explosive, reactive, or hazardous materials.
    Sampling connection system means an assembly of equipment within a 
process unit used during periods of representative operation to take 
samples

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of the process fluid. Equipment used to take nonroutine grab samples is 
not considered a sampling connection system.
    Sensor means a device that measures a physical quantity or the 
change in a physical quantity, such as temperature, pressure, flow rate, 
pH, or liquid level.
    Set pressure means the pressure at which a properly operating 
pressure relief device begins to open to relieve atypical process system 
operating pressure.
    Sewer line means a lateral, trunk line, branch line, or other 
conduit including, but not limited to, grates, trenches, etc., used to 
convey wastewater streams or residuals to a downstream waste management 
unit.
    Shutdown means the cessation of operation of a continuous process 
for any purpose. Shutdown also means the cessation of a batch process or 
any related individual piece of equipment required or used to comply 
with this subpart as a result of a malfunction or for replacement of 
equipment, repair, or any other purpose not excluded from this 
definition. Shutdown also applies to emptying and degassing storage 
vessels. Shutdown does not apply to cessation of a batch process at the 
end of a campaign, for routine maintenance, for rinsing or washing of 
equipment between batches, or other routine operations.
    Single-seal system means a floating roof having one continuous seal 
that completely covers the space between the wall of the storage tank 
and the edge of the floating roof. This seal may be a vapor-mounted, 
liquid-mounted, or metallic shoe seal.
    Small control device means a control device that controls total HAP 
emissions of less than 10 tons/yr, before control.
    Soluble HAP means a HAP listed in Table 3 of this subpart.
    Standard batch means a batch process operated within a range of 
operating conditions that are documented in an operating scenario. 
Emissions from a standard batch are based on the operating conditions 
that result in highest emissions. The standard batch defines the 
uncontrolled and controlled emissions for each emission episode defined 
under the operating scenario.
    Startup means the setting in operation of a continuous process unit 
for any purpose; the first time a new or reconstructed batch process 
unit begins production; for new equipment added, including equipment 
used to comply with this subpart, the first time the equipment is put 
into operation; or, for the introduction of a new product/process, the 
first time the product or process is run in equipment. For batch process 
units, startup does not apply to the first time the equipment is put 
into operation at the start of a campaign to produce a product that has 
been produced in the past, after a shutdown for maintenance, or when the 
equipment is put into operation as part of a batch within a campaign. As 
used in Sec. 63.1255, startup means the setting in operation of a piece of 
equipment or a control device that is subject to this subpart.
    Storage tank means a tank or other vessel that is used to store 
organic liquids that contain one or more HAP as raw material feedstocks. 
Storage tank also means a tank or other vessel in a tank farm that 
receives and accumulates used solvent from multiple batches of a process 
or processes for purposes of solvent recovery. The following are not 
considered storage tanks for the purposes of this subpart:
    (1) Vessels permanently attached to motor vehicles such as trucks, 
railcars, barges, or ships;
    (2) Pressure vessels designed to operate in excess of 204.9 
kilopascals and without emissions to the atmosphere;
    (3) Vessels storing organic liquids that contain HAP only as 
impurities;
    (4) Wastewater storage tanks; and
    (5) Process tanks (including product tanks and isolated intermediate 
tanks).
    Supplemental gases are any 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 50 ppmv 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.

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    Surface impoundment means a waste management unit which is a natural 
topographic depression, manmade excavation, or diked area formed 
primarily of earthen materials (although it may be lined with manmade 
materials), which is designed to hold an accumulation of liquid wastes 
or waste containing free liquids. A surface impoundment is used for the 
purpose of treating, storing, or disposing of wastewater or residuals, 
and is not an injection well. Examples of surface impoundments are 
equalization, settling, and aeration pits, ponds, and lagoons.
    System flowrate means the flowrate of gas entering the control 
device.
    Total organic compounds (TOC) means those compounds measured 
according to the procedures of Method 18 or Method 25A, 40 CFR part 60, 
appendix A.
    Treatment process means a specific technique that removes or 
destroys the organics in a wastewater or residual stream such as a steam 
stripping unit, thin-film evaporation unit, waste incinerator, 
biological treatment unit, or any other process applied to wastewater 
streams or residuals to comply with Sec. 63.1256. Most treatment processes 
are conducted in tanks. Treatment processes are a subset of waste 
management units.
    Uncontrolled HAP emissions means a gas stream containing HAP which 
has exited the process (or process condenser, if any), but which has not 
yet been introduced into an air pollution control device to reduce the 
mass of HAP in the stream. If the process vent is not routed to an air 
pollution control device, uncontrolled emissions are those HAP emissions 
released to the atmosphere.
    Unit operation means those processing steps that occur within 
distinct equipment that are used, among other things, to prepare 
reactants, facilitate reactions, separate and purify products, and 
recycle materials. Equipment used for these purposes includes but is not 
limited to reactors, distillation columns, extraction columns, 
absorbers, decanters, dryers, condensers, and filtration equipment.
    Vapor-mounted seal means a continuous seal that completely covers 
the annular space between the wall of the storage tank or waste 
management unit and the edge of the floating roof and is mounted such 
that there is a vapor space between the stored liquid and the bottom of 
the seal.
    Volatile organic compounds (VOC) means those materials defined in 40 
CFR 51.100.
    Waste management unit means the equipment, structure(s),and or 
devices used to convey, store, treat, or dispose of wastewater streams 
or residuals. Examples of waste management units include wastewater 
tanks, air flotation units, surface impoundments, containers, oil-water 
or organic-water separators, individual drain systems, biological 
wastewater treatment units, waste incinerators, and organic removal 
devices such as steam and air stripper units, and thin film evaporation 
units. If such equipment is used for recovery then it is part of a 
pharmaceutical process and is not a waste management unit.
    Wastewater means any portion of an individual wastewater stream or 
any aggregation of wastewater streams.
    Wastewater stream means water that is discarded from a PMPU through 
a single POD, that contains an annual average concentration of partially 
soluble and/or soluble HAP compounds of at least 5 parts per million by 
weight and a load of at least 0.05 kg/yr. The following are not 
considered wastewater streams for the purposes of this subpart:
    (1) Stormwater from segregated sewers;
    (2) Water from fire-fighting and deluge systems, including testing 
of such systems;
    (3) Spills;
    (4) Water from safety showers;
    (5) Samples of a size not greater than reasonably necessary for the 
method of analysis that is used;
    (6) Equipment leaks;
    (7) Wastewater drips from procedures such as disconnecting hoses 
after clearing lines; and
    (8) Noncontact cooling water.
    Wastewater tank means a stationary waste management unit that is 
designed to contain an accumulation of

[[Page 83]]

wastewater or residuals and is constructed primarily of nonearthen 
materials (e.g., wood, concrete, steel, plastic) which provide 
structural support. Wastewater tanks used for flow equalization are 
included in this definition.
    Water seal controls means a seal pot, p-leg trap, or other type of 
trap filled with water (e.g., flooded sewers that maintain water levels 
adequate to prevent air flow through the system) that creates a water 
barrier between the sewer line and the atmosphere. The water level of 
the seal must be maintained in the vertical leg of a drain in order to 
be considered a water seal.

[63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52598, Aug. 29, 2000]