Source: https://www.law.cornell.edu/cfr/text/40/63.1251
Timestamp: 2015-05-05 13:52:03
Document Index: 135564709

Matched Legal Cases: ['art 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', 'art 60', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', 'art 63', '§ 63', '§ 63', '§ 63', '§ 63', 'art 60', '§ 63', '§ 63', '§ 63', '§ 1292', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63', '§ 63']

40 CFR 63.1251 - Definitions. | LII / Legal Information Institute
CFR › Title 40 › Chapter I › Subchapter C › Part 63 › Subpart GGG › Section 63.1251 40 CFR 63.1251 - Definitions.
§ 63.1251
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 § 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 § 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. Addition of raw material and withdrawal of product do not occur simultaneously in a batch operation.
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.
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 § 63.1256(c).
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 § 63.1255(b)(1)(vii) and § 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.
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.
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 § 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.
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 § 63.1250(e).
Dense gas system means a conveyance system operated to limit oxygen levels below 12 percent.
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 § 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.
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.
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.
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.
Hydrogen halides and halogens means hydrogen chloride (HCl), chlorine (Cl2), and hydrogen fluoride (HF).
The vapor pressure of one or more of the organic compounds is greater than 0.3 kilopascals at 20 °C;
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
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 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 § 63.180(d). The provisions of § 63.180(d) also specify how to determine that a piece of equipment is not in organic HAP service.
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.
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.
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.
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.
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 § 63.14); or
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 § 63.14); or
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.
Open biological treatment process means a biological treatment process that is not a closed biological treatment process as defined in this section.
Operating scenario for the purposes of reporting and recordkeeping, means any specific operation of a PMPU and includes for each process:
A description of the process and the type of process equipment used;
An identification of related process vents and their associated emissions episodes and durations, wastewater PODs, and storage tanks;
The applicable control requirements of this subpart, including the level of required control, and for vents, the level of control for each vent;
The control or treatment devices used, as applicable, 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(s);
The applicable monitoring requirements of this subpart and any parametric level that assures compliance for all emissions routed to the control or treatment device;
Calculations and engineering analyses required to demonstrate compliance; and
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.
Pharmaceutical manufacturing process unit (PMPU) means the process, as defined in this subpart, 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 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:
Any material described by the standard industrial classification (SIC) code 2833 or 2834; or
Any material whose manufacturing process is described by North American Industrial Classification System (NAICS) code 325411 or 325412; or
A finished dosage form of a drug, for example, a tablet, capsule, solution, etc.; or
Any active ingredient or precursor that is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834; or
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.
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.
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 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 § 63.1253, § 63.1254, or § 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 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 § 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 § 63.1253, vents on wastewater emission sources regulated under § 63.1256, or pieces of equipment regulated under § 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 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. § 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).
Reconstruction, as used in § 63.1250(b), shall have the meaning given in § 63.2, except that “affected or previously unaffected stationary source” shall mean either “affected facility” or “PMPU.” As used in § 63.1254(a)(3)(ii)(A)(3), reconstruction shall have the meaning given in § 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.
Is adjusted, or otherwise altered, to eliminate a leak as defined in the applicable paragraphs of § 63.1255, and;
Is, unless otherwise specified in applicable provisions of § 63.1255, monitored as specified in § 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.
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.
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 § 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:
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.
System flowrate means the flowrate of gas entering the control device.
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 § 63.1256. Most treatment processes are conducted in tanks. Treatment processes are a subset of waste management units.
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:
Wastewater drips from procedures such as disconnecting hoses after clearing lines; and
[63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52598, Aug. 29, 2000; 71 FR 20459, Apr. 20, 2006; 76 FR 22600, Apr. 21, 2011]