Title 40—Protection of Environment--Volume 1
PART 63—NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES
§ 63.1250   Applicability.
(a) Definition of affected source. (1) The affected source subject to this subpart consists of the pharmaceutical manufacturing operations as defined in § 63.1251. Except as specified in paragraph (d) of this section, the provisions of this subpart apply to pharmaceutical manufacturing operations that meet the criteria specified in paragraphs (a)(1) (i) through (iii) of this section:
(i) Manufacture a pharmaceutical product as defined in § 63.1251;
(ii) Are located at a plant site that is a major source as defined in section 112(a) of the Act; and
(iii) Process, use, or produce HAP.
(2) Determination of the applicability of this subpart shall be reported as part of an operating permit application or as otherwise specified by the permitting authority.
(b) New source applicability. A new affected source subject to this subpart and to which the requirements for new sources apply is: An affected source for which construction or reconstruction commenced after April 2, 1997, and the standard was applicable at the time of construction or reconstruction; or a pharmaceutical manufacturing process unit (PMPU) dedicated to manufacturing a single product that has the potential to emit 10 tons per year of any one HAP or 25 tons per year of combined HAP for which construction commenced after April 2, 1997 or reconstruction commenced after October 21, 1999.
(c) General provisions. Table 1 of this subpart specifies and clarifies the provisions of subpart A of this part that apply to an owner or operator of an affected source subject to this subpart. The provisions of subpart A specified in Table 1 are the only provisions of subpart A that apply to an affected source subject to this subpart.
(d) Processes exempted from the affected source. The provisions of this subpart do not apply to research and development facilities.
(e) Storage tank ownership determination. The owner or operator shall follow the procedures specified in paragraphs (e)(1) through (5) of this section to determine to which PMPU a storage tank shall belong. If an owner or operator produces only pharmaceutical products, the procedures specified in paragraphs (e)(1) through (5) of this section are required only to determine applicability and demonstrate compliance with the pollution-prevention alternative specified in § 63.1252(e), or to determine new source applicability for a PMPU dedicated to manufacturing a single product as specified in paragraph (b) of this section.
(1) If a storage tank is dedicated to a single PMPU, the storage tank shall belong to that PMPU.
(2) If a storage tank is shared among process units (including at least one PMPU), then the storage tank shall belong to the process unit located on the same plant site as the storage tank that has the greatest annual volume input into or output from the storage tank (i.e., said PMPU or process unit has the predominant use of the storage tank).
(3) If predominant use cannot be determined for a storage tank that is shared among process units (including at least one PMPU), then the owner or operator shall assign the storage tank to any one of the PMPU's that shares it and is also subject to this subpart.
(4) If the predominant use of a storage tank varies from year to year, then predominant use shall be determined based on the utilization that occurred during the year preceding September 21, 1998 for existing affected sources. For new affected sources, predominant use will be based on the first year after initial startup. The determination of predominant use shall be reported in the Notification of Compliance Status required by § 63.1260(f). If the predominant use changes, the redetermination of predominant use shall be reported in the next Periodic report.
(5) If the storage tank begins receiving material from (or sending material to) another PMPU, or ceases to receive material from (or send material to) a PMPU, or if the applicability of this subpart to a storage tank has been determined according to the provisions of paragraphs (e)(1) through (4) of this section and there is a significant change in the use of the storage tank that could reasonably change the predominant use, the owner or operator shall reevaluate the applicability of this subpart to the storage tank and report such changes to EPA in the next Periodic report.
(f) Compliance dates. The compliance dates for affected sources are as follows:
(1) An owner or operator of an existing affected source must comply with the provisions of this subpart no later than October 21, 2002.
(2) An owner or operator of a new or reconstructed affected source must comply with the provisions of this subpart on August 29, 2000 or upon startup, whichever is later.
(3) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after April 2, 1997 and before September 21, 1998 shall not be required to comply with this subpart until September 21, 2001 if:
(i) The requirements of this subpart are more stringent than the requirements of this subpart in effect before August 29, 2000 and contained in the 40 CFR, part (63.1200-end), edition revised as of July 1, 2000; and
(ii) The owner or operator complies with the requirements published on April 2, 1997 (62 FR 15754) during the period until September 21, 2001.
(4) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after September 21, 1998 and before April 10, 2000 shall not be required to comply with this subpart until October 21, 2002 if:
(i) The requirements of this subpart are more stringent than the requirements of this subpart in effect before August 29, 2000; and
(ii) The owner or operator complies with the requirements of this subpart in effect before August 29, 2000 during the period between startup and October 21, 2002.
(5) Notwithstanding the requirements of paragraph (f)(2) of this section, a new source which commences construction or reconstruction after April 10, 2000 and before August 29, 2000 shall not be required to comply with this subpart until August 29, 2001 if:
(i) The requirements of this subpart are more stringent than the requirements published on April 10, 2000 (65 FR 19152); and
(ii) The owner or operator complies with the requirements of this subpart in effect before August 29, 2000 during the period between startup and August 29, 2001.
(6) Pursuant to section 112(i)(3)(B) of the Act, an owner or operator may request an extension allowing the existing source up to 1 additional year to comply with section 112(d) standards.
(i) For purposes of this subpart, a request for an extension shall be submitted no later than 120 days prior to the compliance dates specified in paragraphs (f) (1) through (5) of this section, except as provided in paragraph (f)(6)(ii) of this section. The dates specified in § 63.6(i) for submittal of requests for extensions shall not apply to sources subject to this subpart.
(ii) An owner or operator may submit a compliance extension request after the date specified in paragraph (f)(6)(i) of this section provided the need for the compliance extension arose after that date and before the otherwise applicable compliance date, and the need arose due to circumstances beyond reasonable control of the owner or operator. This request shall include the data described in § 63.6(i)(6)(i) (A), (B), (C), and (D).
(g) Applicability of this subpart. (1) Each provision set forth in this subpart shall apply at all times, except that the provisions set forth in § 63.1255 of this subpart shall not apply during periods of nonoperation of the PMPU (or specific portion thereof) in which the lines are drained and depressurized resulting in the cessation of the emissions to which § 63.1255 of this subpart applies.
(2) The owner or operator shall not shut down items of equipment that are required or utilized for compliance with the emissions limitations of this subpart during times when emissions (or, where applicable, wastewater streams or residuals) are being routed to such items of equipment, if the shutdown would contravene emissions limitations of this subpart applicable to such items of equipment. This paragraph does not apply if the owner or operator must shut down the equipment to avoid damage to a PMPU or portion thereof.
(3) At all times, each owner or operator must operate and maintain any affected source subject to the requirements of this subpart, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by this standard have been achieved. Determination of whether such operation and maintenance procedures are being used will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
(4) In response to an action to enforce the standards set forth in this subpart, an owner or operator may assert an affirmative defense to a claim for civil penalties for exceedances of such standards that are caused by a malfunction, as defined in § 63.2. Appropriate penalties may be assessed, however, if owner or operator fails to meet the burden of proving all the requirements in the affirmative defense. The affirmative defense shall not be available for claims for injunctive relief.
(i) To establish the affirmative defense in any action to enforce such a limit, the owners or operators of a facility must timely meet the notification requirements of paragraph (g)(4)(ii) of this section, and must prove by a preponderance of evidence that:
(A) The excess emissions were caused by a sudden, infrequent, and unavoidable failure of air pollution control and monitoring equipment, or a process to operate in a normal and usual manner; and could not have been prevented through careful planning, proper design, or better operation and maintenance practices; and did not stem from any activity or event that could have been foreseen and avoided, or planned for; and were not part of a recurring pattern indicative of inadequate design, operation, or maintenance;
(B) Repairs were made as expeditiously as possible when the applicable emission limitations were being exceeded. Off-shift and overtime labor were used, to the extent practicable to make these repairs;
(C) The frequency, amount, and duration of the excess emissions (including any bypass) were minimized to the maximum extent practicable during periods of such emissions;
(D) If the excess emissions resulted from a bypass of control equipment or a process, then the bypass was unavoidable to prevent loss of life, personal injury, or severe property damage;
(E) All possible steps were taken to minimize the impact of the excess emissions on ambient air quality, the environment, and human health;
(F) All emissions monitoring and control systems were kept in operation if at all possible, consistent with safety and good air pollution control practices;
(G) All of the actions in response to the excess emissions were documented by properly signed, contemporaneous operating logs;
(H) At all times, the facility was operated in a manner consistent with good practices for minimizing emissions; and
(I) The owner or operator has prepared a written root cause analysis, the purpose of which is to determine, correct, and eliminate the primary causes of the malfunction and the excess emissions resulting from the malfunction event at issue. The analysis shall also specify, using the best monitoring methods and engineering judgment, the amount of excess emissions that were the result of the malfunction.
(ii) Notification. The owner or operator of the facility experiencing an exceedance of its emission limit(s) during a malfunction shall notify the Administrator by telephone or facsimile (FAX) transmission as soon as possible, but no later than 2 business days after the initial occurrence of the malfunction, if it wishes to avail itself of an affirmative defense to civil penalties for that malfunction. The owner or operator seeking to assert an affirmative defense shall also submit a written report to the Administrator within 45 days of the initial occurrence of the exceedance of the standard in this subpart to demonstrate, with all necessary supporting documentation, that it has met the requirements set forth in paragraph (g)(4)(i) of this section. The owner or operator may seek an extension of this deadline for up to 30 additional days by submitting a written request to the Administrator before the expiration of the 45 day period. Until a request for an extension has been approved by the Administrator, the owner or operator is subject to the requirement to submit such report within 45 days of the initial occurrence of the exceedance.
(h) Consistency with other regulations —(1) Compliance with other MACT standards. (i) After the compliance dates specified in this section, an affected source subject to the provisions of this subpart that is also subject to the provisions of any other subpart of this part 63 may elect to comply with either the provisions of this subpart or the provisions of another applicable subpart governing the maintenance of records and reporting to EPA. The affected source shall identify in the Notification of Compliance Status report required by § 63.1260(f) under which authority such records will be maintained.
(ii) After the compliance dates specified in paragraph (f) of this section, at an offsite reloading or cleaning facility subject to § 63.1253(f), compliance with the emission standards and associated initial compliance, monitoring, recordkeeping, and reporting provisions of any other subpart of this part 63 constitutes compliance with the provisions of § 63.1253(f)(7) (ii) or (iii). The owner or operator of the affected storage tank shall identify in the Notification of Compliance Status report required by § 63.1260(f) the subpart of this part 63 with which the owner or operator of the offsite reloading or cleaning facility complies.
(2) Consistency with 40 CFR parts 264 and 265, subparts AA, BB, and/or CC. (i) After the compliance dates specified in this section, if any control device subject to this subpart is also subject to monitoring, recordkeeping, and reporting requirements in 40 CFR part 264, subpart AA, BB, or CC, or is subject to monitoring and recordkeeping requirements in 40 CFR part 265, subpart AA, BB, or CC, and the owner or operator complies with the periodic reporting requirements under 40 CFR part 264, subpart AA, BB, or CC that would apply to the device if the facility had final-permitted status, the owner or operator may elect to comply either with the monitoring, recordkeeping, and reporting requirements of this subpart, or with the monitoring, recordkeeping, and reporting requirements in 40 CFR parts 264 and/or 265, as described in this paragraph, which shall constitute compliance with the monitoring, recordkeeping, and reporting requirements of this subpart. If the owner or operator elects to comply with the monitoring, recordkeeping, and reporting requirements in 40 CFR parts 264 and/or 265, the owner or operator shall report all information required by § 63.1260(g) and (i). The owner or operator shall identify in the Notification of Compliance Status, required by § 63.1260(f), the monitoring, recordkeeping, and reporting authority under which the owner or operator will comply.
(ii) After the compliance dates specified in this section, if any equipment at an affected source that is subject to § 63.1255, is also subject to 40 CFR part 264, subpart BB, or to 40 CFR part 265, subpart BB, then compliance with the recordkeeping and reporting requirements of 40 CFR parts 264 and/or 265 may be used to comply with the recordkeeping and reporting requirements of § 63.1255, to the extent that the requirements of 40 CFR parts 264 and/or 265 duplicate the requirements of § 63.1255. The owner or operator shall identify in the Notification of Compliance Status, required by § 63.1260(f), if the owner or operator will comply with the recordkeeping and reporting authority under 40 CFR parts 264 and/or 265.
(3) Compliance with 40 CFR 60.112(b). After the compliance dates specified in this section, a storage tank controlled with a floating roof and in compliance with the provisions of 40 CFR 60.112b, subpart Kb, constitutes compliance with the provisions of this subpart GGG. A storage tank with a fixed roof, closed vent system, and control device in compliance with the provisions of 40 CFR 60.112b, subpart Kb must comply with the monitoring, recordkeeping, and reporting provisions of this subpart GGG. The owner or operator shall identify in the Notification of Compliance Status report required by § 63.1260(f) which tanks are in compliance with subpart Kb.
(4) Compliance with subpart I of this part. After the compliance dates specified in this section, an affected source with equipment subject to subpart I of this part may elect to comply with either the provisions of § 63.1255 or the provisions of subpart H of this part for all such equipment. The owner or operator shall identify in the Notification of Compliance Status report required by § 63.1260(f) the provisions with which the owner elects to comply.
(5) Compliance with other regulations for wastewater. After the compliance dates specified in this section, the owner or operator of an affected wastewater stream that is also subject to provisions in 40 CFR parts 260 through 272 may elect to determine whether this subpart or 40 CFR parts 260 through 272 contain the more stringent control requirements (e.g., design, operation, and inspection requirements for waste management units; numerical treatment standards; etc.) and the more stringent testing, monitoring, recordkeeping, and reporting. Compliance with provisions of 40 CFR parts 260 through 272 that are determined to be more stringent than the requirements of this subpart constitutes compliance with this subpart. For example, provisions of 40 CFR parts 260 through 272 for treatment units that meet the conditions specified in § 63.1256(g)(13) constitute compliance with this subpart. In the Notification of Compliance Status report required by § 63.1260(f), the owner or operator shall identify the more stringent provisions of 40 CFR parts 260 through 272 with which the owner or operator will comply. The owner or operator shall also identify in the Notification of Compliance Status report required by § 63.1260(f) the information and procedures used to make any stringency determinations. If the owner or operator does not elect to determine the more stringent requirements, the owner or operator must comply with both the provisions of 40 CFR parts 260 through 272 and the provisions of this subpart.
(6) Compliance with subpart PPP of this part. After the compliance dates specified in this section, an affected source with equipment in a pharmaceutical manufacturing process unit that is also part of an affected source under subpart PPP of this part may elect to demonstrate compliance with § 63.1254 by controlling all process vents in accordance with § 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). Alternatively, the owner or operator may elect to determine which process vents must be controlled to comply with the percent reduction requirements of § 63.1254 and control only those vents in accordance with § 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). For any pharmaceutical manufacturing process unit controlled in accordance with the requirements of § 63.1425, the owner or operator must also comply with all other requirements in subpart PPP of this part. In the Notification of Compliance Status report required by § 63.1260(f), the owner or operator shall identify which pharmaceutical manufacturing process units are meeting the control requirements for process vents and all other requirements of subpart PPP of this part, and the owner or operator shall describe the calculations and other information used to identify which process vents must be controlled to comply with the percent reduction requirements of § 63.1254, if applicable.
(i) For the purposes of establishing whether a person is in violation of this subpart, nothing in this subpart shall preclude the use of any credible evidence or information relevant to whether a source would have been in compliance with applicable requirements.
§ 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.
Affirmative defense means, in the context of an enforcement proceeding, a response or a defense put forward by a defendant, regarding which the defendant has the burden of proof, and the merits of which are independently and objectively evaluated in a judicial or administrative proceeding.
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.
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 § 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 § 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.
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 m 3 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.
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 § 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 § 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 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 (Cl 2 ), 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 § 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.
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.
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 to operate in a normal or usual manner which causes, or has the potential to cause, the emission limitations in an applicable standard to be exceeded. 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 § 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 § 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.
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:
(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 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 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 § 63.1257(d)(2)(ii); test data using Method 18 of 40 CFR part 60, appendix A-6; Method 320 of 40 CFR part 63; 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).
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 § 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.
Repaired means that equipment:
(1) Is adjusted, or otherwise altered, to eliminate a leak as defined in the applicable paragraphs of § 63.1255, and;
(2) 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.
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 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 § 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.
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 § 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 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.
§ 63.1252   Standards: General.
Each owner or operator of any affected source subject to the provisions of this subpart shall control HAP emissions to the level specified in this section on and after the compliance dates specified in § 63.1250(f). Initial compliance with the emission limits is demonstrated in accordance with the provisions of § 63.1257, and continuous compliance is demonstrated in accordance with the provisions of § 63.1258.
(a) Opening of a safety device. Opening of a safety device, as defined in § 63.1251, is allowed at any time conditions require it to do so to avoid unsafe conditions.
(b) Closed-vent systems. The owner or operator of a closed-vent system that contains bypass lines that could divert a vent stream away from a control device used to comply with the requirements in §§ 63.1253, 63.1254, and 63.1256 shall comply with the requirements of Table 4 to this subpart and paragraph (b)(1) or (2) of this section. Equipment such as low leg drains, high point bleeds, analyzer vents, open-ended valves or lines, rupture disks and pressure relief valves needed for safety purposes are not subject to this paragraph.
(1) Install, calibrate, maintain, and operate a flow indicator that determines whether vent stream flow is present at least once every 15 minutes. Records shall be maintained as specified in § 63.1259(i)(6)(i). The flow indicator shall be installed at the entrance to any bypass line that could divert the vent stream away from the control device to the atmosphere; or
(2) Secure the bypass line valve in the closed position with a car seal or lock and key type configuration. A visual inspection of the seal or closure mechanism shall be performed at least once every month to ensure that the valve is maintained in the closed position and the vent stream is not diverted through the bypass line. Records shall be maintained as specified in § 63.1259(i)(6)(ii).
(c) Heat exchange systems. Except as provided in paragraph (c)(2) of this section, owners and operators of affected sources shall comply with the requirements in paragraph (c)(1) of this section for heat exchange systems that cool process equipment or materials used in pharmaceutical manufacturing operations.
(1) The heat exchange system shall be treated according to the provisions of § 63.104, except that the monitoring frequency shall be no less than quarterly.
(2) For identifying leaking equipment, the owner or operator of heat exchange systems on equipment which meet current good manufacturing practice (CGMP) requirements of 21 CFR part 211 may elect to use the physical integrity of the reactor as the surrogate indicator of heat exchange system leaks around the reactor.
(d) Emissions averaging provisions. Except as specified in paragraphs (d)(1) through (5) of this section, owners or operators of storage tanks or processes subject to the provisions of §§ 63.1253 and 63.1254 may choose to comply by using emissions averaging requirements specified in § 63.1257(g) or (h) for any storage tank or process.
(1) A State may prohibit averaging of HAP emissions and require the owner or operator of an existing source to comply with the provisions in §§ 63.1253 and 63.1254.
(2) Only emission sources subject to the requirements of § 63.1253(b)(1) or (c)(1)(i) or § 63.1254(a)(1)(i) may be included in any averaging group.
(3) Processes which have been permanently shutdown or storage tanks permanently taken out of HAP service may not be included in any averaging group.
(4) Processes and storage tanks already controlled on or before November 15, 1990 may not be included in an emissions averaging group, except where the level of control is increased after November 15, 1990. In these cases, the uncontrolled emissions shall be the controlled emissions as calculated on November 15, 1990 for the purpose of determining the uncontrolled emissions as specified in § 63.1257(g) and (h).
(5) Emission points controlled to comply with a State or Federal rule other than this subpart may not be credited in an emission averaging group, unless the level of control has been increased after November 15, 1990 above what is required by the other State or Federal rule. Only the control above what is required by the other State or Federal rule will be credited. However, if an emission point has been used to generate emissions averaging credit in an approved emissions average, and the point is subsequently made subject to a State or Federal rule other than this subpart, the point can continue to generate emissions averaging credit for the purpose of complying with the previously approved average.
(6) Not more than 20 processes subject to § 63.1254(a)(1)(i), and 20 storage tanks subject to § 63.1253(b)(1) or (c)(1)(i) at an affected source may be included in an emissions averaging group.
(7) Compliance with the emission standards in § 63.1253 shall be satisfied when the annual percent reduction efficiency is greater than or equal to 90 percent for those tanks meeting the criteria of § 63.1253(a)(1) and 95 percent for those tanks meeting the criteria of § 63.1253(a)(2), as demonstrated using the test methods and compliance procedures specified in § 63.1257(g).
(8) Compliance with the emission standards in § 63.1254(a)(1)(i) shall be satisfied when the annual percent reduction efficiency is greater than or equal to 93 percent, as demonstrated using the test methods and compliance procedures specified in § 63.1257(h).
(e) Pollution prevention alternative. Except as provided in paragraph (e)(1) of this section, an owner or operator may choose to meet the pollution prevention alternative requirement specified in either paragraph (e)(2) or (3) of this section for any PMPU or for any situation described in paragraph (e)(4) of this section, in lieu of the requirements specified in §§ 63.1253, 63.1254, 63.1255, and 63.1256. Compliance with paragraphs (e)(2) and (3) of this section shall be demonstrated through the procedures in § 63.1257(f). Any PMPU for which the owner or operator seeks to comply by using the pollution prevention alternative shall begin with the same starting material(s) and end with the same product(s). The owner or operator may not comply with the pollution prevention alternative by eliminating any steps of a process by transferring the step offsite (to another manufacturing location).
(1) The HAP that are generated in the PMPU that are not part of the production-indexed consumption factor must be controlled according to the requirements of §§ 63.1253, 63.1254, 63.1255, and 63.1256. The hydrogen halides that are generated as a result of combustion control of emissions must be controlled according to the requirements of paragraph (g)(1) of this section.
(2) The production-indexed HAP consumption factor (kg HAP consumed/kg produced) shall be reduced by at least 75 percent from a 3 year average baseline established no earlier than the 1987 calendar year, or for the time period from startup of the process until the present in which the PMPU was operational and data are available, whichever is the lesser time period. If a time period less than 3 years is used to set the baseline, the data must represent at least 1 year's worth of data. For any reduction in the HAP factor achieved by reducing a HAP that is also a VOC, an equivalent reduction in the VOC factor is also required. For any reduction in the HAP factor that is achieved by reducing a HAP that is not a VOC, the VOC factor may not be increased.
(3) Both requirements specified in paragraphs (e)(3)(i) and (ii) of this section are met.
(i) The production-indexed HAP consumption factor (kg HAP consumed/kg produced) shall be reduced by at least 50 percent from a 3-year average baseline established no earlier than the 1987 calendar year, or for the time period from startup of the process until the present in which the PMPU was operational and data are available, whichever is less. If a time period less than 3 years is used to set the baseline, the data must represent at least 1 year's worth of data. For any reduction in the HAP factor achieved by reducing a HAP that is also a VOC, an equivalent reduction in the VOC factor is also required. For any reduction in the HAP factor that is achieved by reducing a HAP that is not a VOC, the VOC factor may not be increased.
(ii) The total PMPU HAP emissions shall be reduced by an amount, in kg/yr, that, when divided by the annual production rate, in kg/yr, and added to the reduction of the production-indexed HAP consumption factor, in kg/kg, yields a value of at least 75 percent of the average baseline HAP production-indexed consumption factor established according to paragraph (e)(3)(i) of this section according to the equation provided in § 63.1257(f)(2)(ii)(A). The total PMPU VOC emissions shall be reduced by an amount calculated according to the equation provided in § 63.1257(f)(2)(ii)(B). The annual reduction in HAP and VOC air emissions must be due to the use of the following control devices:
(A) Combustion control devices such as incinerators, flares or process heaters.
(B) Control devices such as condensers and carbon adsorbers whose recovered product is destroyed or shipped offsite for destruction.
(C) Any control device that does not ultimately allow for recycling of material back to the PMPU.
(D) Any control device for which the owner or operator can demonstrate that the use of the device in controlling HAP emissions will have no effect on the production-indexed consumption factor for the PMPU.
(4) The owner or operator may comply with the requirements in either paragraph (e)(2) or (3) of this section for a series of processes, including situations where multiple processes are merged, subject to the following conditions:
(i) The baseline period shall be a single year beginning no earlier than the 1992 calendar year.
(ii) The term “PMPU” shall have the meaning provided in § 63.1251 except that the baseline and modified PMPU may include multiple processes (i.e., precursors, active ingredients, and final dosage form) if the owner or operator demonstrates to the satisfaction of the Administrator that the multiple processes were merged after the baseline period into an existing process or processes.
(iii) Nondedicated formulation and solvent recovery processes may not be merged with any other processes.
(f) Control requirements for certain liquid streams in open systems within a PMPU. (1) The owner or operator shall comply with the provisions of Table 5 of this subpart, for each item of equipment meeting all the criteria specified in paragraphs (f)(2) through (4) and either paragraph (f)(5)(i) or (ii) of this section.
(2) The item of equipment is of a type identified in Table 5 of this subpart;
(3) The item of equipment is part of a PMPU, as defined in § 63.1251;
(4) The item of equipment is controlled less stringently than in Table 5 of this subpart and the item of equipment is not otherwise exempt from controls by the provisions of this subpart or subpart A of this part; and
(5) The item of equipment:
(i) Is a drain, drain hub, manhole, lift station, trench, pipe, or oil/water separator that conveys water with an annual average concentration greater than or equal to 1,300 parts per million by weight (ppmw) of partially soluble HAP compounds; or an annual average concentration greater than or equal to 5,200 ppmw of partially soluble and/or soluble HAP compounds. The annual average concentration shall be determined according to the procedures in § 63.1257(e)(1)(ii).
(ii) Is a tank that receives one or more streams that contain water with an annual average concentration greater than or equal to 1,300 ppmw of partially soluble HAP compounds, or greater than or equal to 5,200 ppmw of total partially soluble and/or soluble HAP compounds. The owner or operator of the source shall determine the average concentration of the stream at the inlet to the tank and according to the procedures in § 63.1257(e)(1)(ii).
(g) Control requirements for halogenated vent streams that are controlled by combustion devices. If a combustion device is used to comply with the provisions of §§ 63.1253 (storage tanks), 63.1254 (process vents), 63.1256(h) (wastewater vent streams) for a halogenated vent stream, then the vent stream shall be ducted to a halogen reduction device such as, but not limited to, a scrubber, before it is discharged to the atmosphere. The halogen reduction device must reduce emissions by the amounts specified in either paragraph (g)(1) or (2) of this section.
(1) A halogen reduction device after the combustion control device must reduce overall emissions of hydrogen halides and halogens, as defined in § 63.1251, by 95 percent or to a concentration less than or equal to 20 ppmv.
(2) A halogen reduction device located before the combustion control device must reduce the halogen atom content of the vent stream to a concentration less than or equal to 20 ppmv.
(h) Planned routine maintenance for centralized combustion control devices. The owner or operator may operate non-dedicated PMPU's during periods of planned routine maintenance for CCCD in accordance with the provisions specified in paragraphs (h)(1) through (6) of this section.
(1) For equipment leaks and wastewater emissions that normally are controlled by the CCCD, if any, the owner or operator must continue to comply with the requirements in §§ 63.1255(b)(4)(ii) and 63.1256(h), respectively, using other control devices during the planned routine maintenance period for the CCCD.
(2) During the planned routine maintenance period, the owner or operator must route emissions from process vents with organic HAP emissions greater than 15 pounds per day (lb/day) through a closed-vent system to a condenser that meets the conditions specified in paragraphs (h)(2)(i) through (iii) of this section.
(i) The outlet gas temperature must be less than −50 °C (−58 °F) when the emission stream contains organic HAP with a partial pressure greater than 20 kPa (2.9 psia).
(ii) The outlet gas temperature must be less than −5 °C (23 °F) when the emission stream contains organic HAP with a partial pressure less than or equal to 20 kPa (2.9 psia).
(iii) The HAP partial pressures in paragraphs (h)(2)(i) and (ii) of this section must be determined at 25 °C.
(3) The owner or operator must route HCl emissions from process vents with HCl emissions greater than 15 lb/day through a closed-vent system to a caustic scrubber, and the pH of the scrubber effluent must be maintained at or above 9.
(4) For the purposes of the emission calculations required in paragraphs (h)(2) and (3) of this section, the term “process vent” shall mean each vent from a unit operation. The emission calculation shall not be performed on the aggregated emission stream from multiple unit operations that are manifolded together into a common header. Once an affected process vent has been controlled in accordance with this section, it is no longer subject to the requirements of this section or § 63.1254 during the routine maintenance period.
(5) The total period of planned routine maintenance, during which non-dedicated PMPU's that are normally controlled by the CCCD continue to operate, and process vent emissions are controlled as specified in paragraphs (h)(2) and (3) of this section, must not exceed 240 hours in any 365-day period.
(6) While being controlled as specified in paragraphs (h)(2) and (3) of this section, the process vents may not be used in emissions averaging.
§ 63.1253   Standards: Storage tanks.
(a) Except as provided in paragraphs (d), (e), and (f) of this section, the owner or operator of a storage tank meeting the criteria of paragraph (a)(1) of this section is subject to the requirements of paragraph (b) of this section. Except as provided in paragraphs (d), (e), and (f) of this section, the owner or operator of a storage tank meeting the criteria of paragraph (a)(2) of this section is subject to the requirements of paragraph (c) of this section. Compliance with the provisions of paragraphs (b) and (c) of this section is demonstrated using the initial compliance procedures in § 63.1257(c) and the monitoring requirements in § 63.1258.
(1) A storage tank with a design capacity greater than or equal to 38 m 3 but less than 75 m 3 storing a liquid for which the maximum true vapor pressure of total HAP is greater than or equal to 13.1 kPa.
(2) A storage tank with a design capacity greater than or equal to 75 m 3 storing a liquid for which the maximum true vapor pressure of total HAP is greater than or equal to 13.1 kPa.
(b) The owner or operator of a storage tank shall equip the affected storage tank with either a fixed roof with internal floating roof, an external floating roof, an external floating roof converted to an internal floating roof, or a closed-vent system meeting the conditions of § 63.1252(b) with a control device that meets any of the following conditions:
(1) Reduces inlet emissions of total HAP by 90 percent by weight or greater;
(2) Reduces emissions to outlet concentrations less than or equal to 20 ppmv as TOC and less than or equal to 20 ppmv as hydrogen halides and halogens;
(3) Is an enclosed combustion device that provides a minimum residence time of 0.5 seconds at a minimum temperature of 760 °C;
(4) Is a flare that meets the requirements of § 63.11(b); or
(5) Is a control device specified in § 63.1257(a)(4).
(c) The owner or operator of a storage tank shall equip the affected storage tank with either a fixed roof with internal floating roof, an external floating roof, an external floating roof converted to an internal floating roof, or a closed-vent system meeting the conditions of § 63.1252(b) with a control device that meets any of the following conditions:
(1) Reduces inlet emissions of total HAP as specified in paragraph (c)(1) (i) or (ii) of this section:
(i) By 95 percent by weight or greater; or (ii) If the owner or operator can demonstrate that a control device installed on a storage tank on or before April 2, 1997 is designed to reduce inlet emissions of total HAP by greater than or equal to 90 percent by weight but less than 95 percent by weight, then the control device is required to be operated to reduce inlet emissions of total HAP by 90 percent or greater.
(2) Reduces emissions to outlet concentrations less than or equal to 20 ppmv as TOC and less than or equal to 20 ppmv as hydrogen halides and halogens;
(3) Is an enclosed combustion device that provides a minimum residence time of 0.5 seconds at a minimum temperature of 760 °C;
(4) Is a flare that meets the requirements of § 63.11(b); or
(5) Is a control device specified in § 63.1257(a)(4).
(d) As an alternative standard, the owner or operator of an existing or new affected source may comply with the storage tank standards by routing storage tank vents to a combustion control device achieving an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 20 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 20 ppmv or less. If the owner or operator is routing emissions to a noncombustion control device, it must achieve an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 50 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 50 ppmv or less. Compliance with the outlet concentrations shall be determined by the initial compliance procedures of § 63.1257(c)(4) and the continuous emission monitoring requirements of § 63.1258(b)(5).
(e) Planned routine maintenance. The specifications and requirements in paragraphs (b) through (d) of this section for control devices do not apply during periods of planned routine maintenance. Periods of planned routine maintenance of the control devices (including CCCD subject to § 63.1252(h)), during which the control device does not meet the specifications of paragraphs (b) through (d) of this section, as applicable, shall not exceed 240 hours in any 365-day period. The owner or operator may submit an application to the Administrator requesting an extension of this time limit to a total of 360 hours in any 365-day period. The application must explain why the extension is needed, it must specify that no material will be added to the storage tank between the time the 240-hour limit is exceeded and the control device is again operational, and it must be submitted at least 60 days before the 240-hour limit will be exceeded.
(f) Vapor balancing alternative. As an alternative to the requirements in paragraphs (b) and (c) of this section, the owner or operator of an existing or new affected source may implement vapor balancing in accordance with paragraphs (f)(1) through (7) of this section.
(1) The vapor balancing system must be designed and operated to route organic HAP vapors displaced from loading of the storage tank to the railcar or tank truck from which the storage tank is filled.
(2) Tank trucks and railcars must have a current certification in accordance with the U.S. Department of Transportation (DOT) pressure test requirements of 49 CFR part 180 for tank trucks and 49 CFR 173.31 for railcars.
(3) Hazardous air pollutants must only be unloaded from tank trucks or railcars when vapor collection systems are connected to the storage tank's vapor collection system.
(4) No pressure relief device on the storage tank, or on the railcar, or tank truck shall open during loading or as a result of diurnal temperature changes (breathing losses).
(5) Pressure relief devices on affected storage tanks must be set to no less than 2.5 psig at all times to prevent breathing losses. The owner or operator shall record the setting as specified in § 63.1259(b)(12) and comply with the requirements for each pressure relief valve in paragraphs (f)(5)(i) through (iii) of this section:
(i) The pressure relief valve shall be monitored quarterly using the method described in § 63.180(b).
(ii) An instrument reading of 500 ppmv or greater defines a leak.
(iii) When a leak is detected, it shall be repaired as soon as practicable, but no later than 5 days after it is detected, and the owner or operator shall comply with the recordkeeping requirements of § 63.1255(g)(4)(i) through (iv).
(6) Railcars or tank trucks that deliver HAP to an affected storage tank must be reloaded or cleaned at a facility that utilizes one of the control techniques in paragraph (f)(6)(i) through (ii) of this section:
(i) The railcar or tank truck must be connected to a closed-vent system with a control device that reduces inlet emissions of HAP by 90 percent by weight or greater; or
(ii) A vapor balancing system designed and operated to collect organic HAP vapor displaced from the tank truck or railcar during reloading must be used to route the collected HAP vapor to the storage tank from which the liquid being transferred originated.
(7) The owner or operator of the facility where the railcar or tank truck is reloaded or cleaned must comply with the requirements in paragraph (f)(7)(i) through (iii) of this section:
(i) Submit to the owner or operator of the affected storage tank and to the Administrator a written certification that the reloading or cleaning facility will meet the requirements of this section. The certifying entity may revoke the written certification by sending a written statement to the owner or operator of the affected storage tank giving at least 90 days notice that the certifying entity is rescinding acceptance of responsibility for compliance with the requirements of this paragraph (b)(7).
(ii) If complying with paragraph (f)(6)(i) of this section, demonstrate initial compliance in accordance with § 63.1257(c), demonstrate continuous compliance in accordance with § 63.1258, keep records as specified in § 63.1259, and prepare reports as specified in § 63.1260.
(iii) If complying with paragraph (f)(6)(ii) of this section, keep records of:
(A) The equipment to be used and the procedures to be followed when reloading the railcar or tank truck and displacing vapors to the storage tank from which the liquid originates, and
(B) Each time the vapor balancing system is used to comply with paragraph (f)(6)(ii) of this section.
§ 63.1254   Standards: Process vents.
(a) Existing sources. For each process, the owner or operator of an existing affected source must comply with the requirements in paragraphs (a)(1) and (3) of this section or paragraphs (a)(2) and (3) of this section. Initial compliance with the required emission limits or reductions in paragraphs (a)(1) through (3) of this section is demonstrated in accordance with the initial compliance procedures described in § 63.1257(d), and continuous compliance is demonstrated in accordance with the monitoring requirements described in § 63.1258.
(1) Process-based emission reduction requirement. (i) Uncontrolled HAP emissions from the sum of all process vents within a process that are not subject to the requirements of paragraph (a)(3) of this section shall be reduced by 93 percent or greater by weight, or as specified in paragraph (a)(1)(ii) of this section. Notification of changes in the compliance method shall be reported according to the procedures in § 63.1260(h).
(ii) Any one or more vents within a process may be controlled in accordance with any of the procedures in paragraphs (a)(1)(ii)(A) through (D) of this section. All other vents within the process must be controlled as specified in paragraph (a)(1)(i) of this section.
(A) To outlet concentrations less than or equal to 20 ppmv as TOC and less than or equal to 20 ppmv as hydrogen halides and halogens;
(B) By a flare that meets the requirements of § 63.11(b);
(C) By a control device specified in § 63.1257(a)(4); or
(D) In accordance with the alternative standard specified in paragraph (c) of this section.
(2) Process-based annual mass limit. (i) Actual HAP emissions from the sum of all process vents within a process must not exceed 900 kilograms (kg) in any 365-day period.
(ii) Actual HAP emissions from the sum of all process vents within processes complying with paragraph (a)(2)(i) of this section are limited to a maximum of 1,800 kg in any 365-day period.
(iii) Emissions from vents that are subject to the requirements of paragraph (a)(3) of this section and emissions from vents that are controlled in accordance with the procedures in paragraph (c) of this section may be excluded from the sums calculated in paragraphs (a)(2)(i) and (ii) of this section.
(iv) The owner or operator may switch from compliance with paragraph (a)(2) of this section to compliance with paragraph (a)(1) of this section only after at least 1 year of operation in compliance with paragraph (a)(2) of this section. Notification of such a change in the compliance method shall be reported according to the procedures in § 63.1260(h).
(3) Individual vent emission reduction requirements. (i) Except as provided in paragraph (a)(3)(ii) of this section, uncontrolled HAP emissions from a process vent must be reduced by 98 percent or in accordance with any of the procedures in paragraphs (a)(1)(ii)(A) through (D) of this section if the uncontrolled HAP emissions from the vent exceed 25 tons per year, and the flow-weighted average flowrate (FRa) calculated using Equation 1 of this subpart is less than or equal to the flowrate index (FRI) calculated using Equation 2 of this subpart.
(ii) Grandfathering provisions. As an alternative to the requirements in paragraph (a)(3)(i) of this section, the owner or operator may comply with the provisions in paragraph (a)(3)(ii)(A), (B), or (C) of this section, if applicable.
(A) Control device operation. If the owner or operator can demonstrate that a process vent is controlled by a control device meeting the criteria specified in paragraph (a)(3)(ii)(A)( 1 ) of this section, then the control device is required to be operated according to paragraphs (a)(3)(ii)(A)( 2 ), ( 3 ), and ( 4 ) of this section:
( 1 ) The control device was installed on any process vent that met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997, and was operated to reduce uncontrolled emissions of total HAP by greater than or equal to 93 percent by weight, but less than 98 percent by weight;
( 2 ) The device must be operated to reduce inlet emissions of total HAP by 93 percent or by the percent reduction specified for that control device in any preconstruction permit issued pursuant to regulations approved or promulgated through rulemaking under title I (including parts C or D) of the Clean Air Act, whichever is greater;
( 3 ) The device must be replaced or upgraded to achieve at least 98 percent reduction of HAP or meet any of the conditions specified in paragraphs (a)(1)(ii)(A) through (D) of this section upon reconstruction or replacement.
( 4 ) The device must be replaced or upgraded to achieve at least 98 percent reduction of HAP or meet any of the conditions specified in paragraphs (a)(1)(ii)(A) through (D) of this section by April 2, 2007, or 15 years after issuance of the preconstruction permit, whichever is later.
(B) Process operations. If a process meets all of the conditions specified in paragraphs (a)(3)(ii)(B)( 1 ) through ( 3 ) of this section, the required level of control for the process is the level that was achieved on or before April 2, 1997. This level of control is demonstrated using the same procedures that are used to demonstrate compliance with paragraph (a)(1) of this section.
( 1 ) At least one vent in the process met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997; and
( 2 ) The overall control for the process on or before April 2, 1997 was greater than or equal to 93 percent by weight, but less than 98 percent by weight; and
( 3 ) The production-indexed HAP consumption factor for the 12-month period in which the process was operated prior to the compliance date is less than one-half of the 3-year average baseline value established no earlier than the 1987 through 1989 calendar years.
(C) Hydrogenation vents. Processes meeting the conditions of paragraphs (a)(3)(ii)(C)( 1 ) through ( 3 ) of this section are required to be operated to maintain the level of control achieved on or before April 2, 1997. For all other processes meeting the conditions of paragraph (a)(3)(ii)(C)( 3 ) of this section, uncontrolled HAP emissions from the sum of all process vents within the process must be reduced by 95 percent or greater by weight.
( 1 ) Processes containing a process vent that met the conditions of paragraph (a)(3)(i) of this section on or before April 2, 1997; and
( 2 ) Processes that are controlled to greater than or equal to 93 percent by weight, but less than 98 percent by weight; and
( 3 ) Processes with a hydrogenation vent that, in conjunction with all other process vents from the process that do not meet the conditions of paragraph (a)(3)(i) of this section, cannot meet the requirements of paragraph (a)(1) or (2) of this section.
(4) Planned routine maintenance. For each PMPU that is controlled with a CCCD, the owner or operator must comply with the provisions specified in either paragraph (a)(4)(i), (ii), or (iii) of this section during periods of planned routine maintenance of the CCCD. The owner or operator is not required to comply with the same provision for all of the PMPU's controlled by the CCCD.
(i) Shutdown the affected process.
(ii) Comply with the requirements of paragraphs (a)(1) through (3) of this section by using other means.
(iii) For a non-dedicated PMPU, implement the procedures described in paragraphs (a)(4)(iii)(A) through (C) of this section for those process vents that are normally controlled by the CCCD. This option is not available for process vents from dedicated PMPU's.
(A) If the owner or operator uses a CCCD to comply with the 93 percent reduction requirement in paragraph (a)(1)(i) or (ii) of this section, the outlet concentration limit in paragraph (a)(1)(ii)(A) of this section, the alternative standard as specified in paragraphs (a)(1)(ii)(D) and (c) of this section, or the annual mass limit in paragraph (a)(2) of this section, implement the provisions in § 63.1252(h) during planned routine maintenance of the CCCD.
(B) If the owner or operator reduces HAP emissions from process vents by using a CCCD that is also a control device specified in § 63.1257(a)(4), implement the provisions in § 63.1252(h) during planned routine maintenance of the CCCD.
(C) If the owner or operator uses a CCCD to reduce emissions from a process vent subject to paragraph (a)(3) of this section, implement the planned routine maintenance provisions in § 63.1252(h) for that vent only if the reason the planned routine maintenance is needed, and the reason it cannot be performed at a time when the vent subject to paragraph (a)(3) of this section is not operating, has been described in the Notification of Compliance Status Report or a periodic report submitted before the planned routine maintenance event.
(b) New sources. (1) Except as provided in paragraph (b)(2) of this section, uncontrolled HAP emissions from the sum of all process vents within a process at a new affected source shall be reduced by 98 percent or greater by weight or controlled in accordance with any of requirements of paragraphs (a)(1)(ii)(A) through (D) of this section. Initial compliance with the required emission limit or reduction is demonstrated in accordance with the initial compliance procedures in § 63.1257(d), and continuous compliance is demonstrated in accordance with the monitoring requirements described in § 63.1258.
(2) Annual mass limit. The actual HAP emissions from the sum of all process vents for which the owner or operator is not complying with paragraph (b)(1) of this section are limited to 900 kg in any 365-day period.
(c) Alternative standard. As an alternative standard, the owner or operator of an existing or new affected source may comply with the process vent standards by routing vents from a process to a combustion control device achieving an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 20 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 20 ppmv or less. If the owner or operator is routing emissions to a noncombustion control device, it must achieve an outlet TOC concentration, as calibrated on methane or the predominant HAP, of 50 ppmv or less, and an outlet concentration of hydrogen halides and halogens of 50 ppmv or less. Any process vents within a process that are not routed to this control device must be controlled in accordance with the provisions of paragraph (a) or (b) of this section, as applicable. Initial compliance with the outlet concentrations is demonstrated in accordance with the initial compliance procedures described in § 63.1257(d)(1)(iv), and continuous compliance is demonstrated in accordance with the emission monitoring requirements described in § 63.1258(b)(5).
§ 63.1255   Standards: Equipment leaks.
(a) General equipment leak requirements. (1) The provisions of this section apply to pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, instrumentation systems, control devices, and closed-vent systems required by this section that are intended to operate in organic hazardous air pollutant service 300 hours or more during the calendar year within a source subject to the provisions of this subpart.
(2) Consistency with other regulations. After the compliance date for a process, equipment subject to both this section and either of the following will be required to comply only with the provisions of this subpart:
(i) 40 CFR part 60.
(ii) 40 CFR part 61.
(3) [Reserved]
(4) The provisions in § 63.1(a)(3) of subpart A of this part do not alter the provisions in paragraph (a)(2) of this section.
(5) Lines and equipment not containing process fluids are not subject to the provisions of this section. Utilities, and other nonprocess lines, such as heating and cooling systems which do not combine their materials with those in the processes they serve, are not considered to be part of a process.
(6) The provisions of this section do not apply to bench-scale processes, regardless of whether the processes are located at the same plant site as a process subject to the provisions of this subpart.
(7) Equipment to which this section applies shall be identified such that it can be distinguished readily from equipment that is not subject to this section. Identification of the equipment does not require physical tagging of the equipment. For example, the equipment may be identified on a plant site plan, in log entries, or by designation of process boundaries by some form of weatherproof identification. If changes are made to the affected source subject to the leak detection requirements, equipment identification for each type of component shall be updated, if needed, within 90 calendar days or by the next Periodic Report following the end of the monitoring period for that component, whichever is later.
(8) Equipment that is in vacuum service is excluded from the requirements of this section.
(9) Equipment that is in organic HAP service, but is in such service less than 300 hours per calendar year, is excluded from the requirements of this section if it is identified as required in paragraph (g)(9) of this section.
(10) When each leak is detected by visual, audible, or olfactory means, or by monitoring as described in § 63.180(b) or (c), the following requirements apply:
(i) A weatherproof and readily visible identification, marked with the equipment identification number, shall be attached to the leaking equipment.
(ii) The identification on a valve in light liquid or gas/vapor service may be removed after it has been monitored as specified in paragraph (e)(7)(iii) of this section, and no leak has been detected during the follow-up monitoring.
(iii) The identification on equipment, except on a valve in light liquid or gas/vapor service, may be removed after it has been repaired.
(11) Except as provided in paragraph (a)(11)(i) of this section, all terms in this subpart that define a period of time for completion of required tasks (e.g., weekly, monthly, quarterly, annual) refer to the standard calendar periods unless specified otherwise in the section or paragraph that imposes the requirement.
(i) If the initial compliance date does not coincide with the beginning of the standard calendar period, an owner or operator may elect to utilize a period beginning on the compliance date, or may elect to comply in accordance with the provisions of paragraph (a)(11)(ii) or (iii) of this section.
(ii) Time periods specified in this subpart for completion of required tasks may be changed by mutual agreement between the owner or operator and the Administrator, as specified in subpart A of this part. For each time period that is changed by agreement, the revised period shall remain in effect until it is changed. A new request is not necessary for each recurring period.
(iii) Except as provided in paragraph (a)(11)(i) or (ii) of this section, where the period specified for compliance is a standard calendar period, if the initial compliance date does not coincide with the beginning of the calendar period, compliance shall be required according to the schedule specified in paragraph (a)(11)(iii)(A) or (B) of this section, as appropriate.
(A) Compliance shall be required before the end of the standard calendar period within which the initial compliance date occurs if there remain at least 3 days for tasks that must be performed weekly, at least 2 weeks for tasks that must be performed monthly, at least 1 month for tasks that must be performed each quarter, or at least 3 months for tasks that must be performed annually; or
(B) In all other cases, compliance shall be required before the end of the first full standard calendar period after the period within which the initial compliance date occurs.
(iv) In all instances where a provision of this subpart requires completion of a task during each of multiple successive periods, an owner or operator may perform the required task at any time during each period, provided the task is conducted at a reasonable interval after completion of the task during the previous period.
(12) In all cases where the provisions of this subpart require an owner or operator to repair leaks by a specified time after the leak is detected, it is a violation of this section to fail to take action to repair the leaks within the specified time. If action is taken to repair the leaks within the specified time, failure of that action to successfully repair the leak is not a violation of this section. However, if the repairs are unsuccessful, a leak is detected and the owner or operator shall take further action as required by applicable provisions of this section.
(b) References. (1) The owner or operator of a source subject to this section shall comply with the provisions of subpart H of this part, as specified in paragraphs (b)(2) through (4) of this section. The term “process unit” as used in subpart H of this part shall be considered to be defined the same as “group of processes” for sources subject to this subpart GGG. The term “fuel gas system,” as used in subpart H of this part, shall not apply for the purposes of this subpart GGG.
(2) Sections 63.160, 63.161, 63.162, 63.163, 63.167, 63.168, 63.170, 63.173, 63.175, 63.176, 63.181, and 63.182 shall not apply for the purposes of this subpart GGG. The owner or operator shall comply with the provisions specified in paragraphs (b)(2)(i) through (viii) of this section.
(i) Sections 63.160 and 63.162 shall not apply; instead, the owner or operator shall comply with paragraph (a) of this section;
(ii) Section 63.161 shall not apply; instead, the owner or operator shall comply with § 63.1251;
(iii) Sections 63.163 and 63.173 shall not apply; instead, the owner or operator shall comply with paragraph (c) of this section;
(iv) Section 63.167 shall not apply; instead, the owner or operator shall comply with paragraph (d) of this section;
(v) Section 63.168 shall not apply; instead, the owner or operator shall comply with paragraph (e) of this section;
(vi) Section 63.170 shall not apply; instead, the owner or operator shall comply with § 63.1254;
(vii) Section 63.181 shall not apply; instead, the owner or operator shall comply with paragraph (g) of this section; and
(viii) Section 63.182 shall not apply; instead, the owner or operator shall comply with paragraph (h) of this section.
(3) The owner or operator shall comply with §§ 63.164, 63.165, 63.166, 63.169, 63.177, and 63.179 in their entirety, except that when these sections reference other sections of subpart H of this part, the references shall mean the sections specified in paragraphs (b)(2) and (4) of this section. Section 63.164 applies to compressors. Section 63.165 applies to pressure relief devices in gas/vapor service. Section 63.166 applies to sampling connection systems. Section 63.169 applies to pumps, valves, connectors, and agitators in heavy liquid service; instrumentation systems; and pressure relief devices in liquid service. Section 63.177 applies to general alternative means of emission limitation. Section 63.179 applies to alternative means of emission limitation for enclosed-vented process units.
(4) The owner or operator shall comply with §§ 63.171, 63.172, 63.174, 63.178, and 63.180, except as specified in paragraphs (b)(4)(i) through (vi) of this section.
(i) Section 63.171 shall apply, except § 63.171(a) shall not apply. Instead, delay of repair of equipment for which leaks have been detected is allowed if one of the conditions in paragraphs (b)(4)(i)(A) through (B) exists:
(A) The repair is technically infeasible without a process shutdown. Repair of this equipment shall occur by the end of the next scheduled process shutdown.
(B) The owner or operator determines that repair personnel would be exposed to an immediate danger if attempting to repair without a process shutdown. Repair of this equipment shall occur by the end of the next scheduled process shutdown.
(ii) Section 63.172 shall apply for closed-vent systems used to comply with this section, and for control devices used to comply with this section only, except:
(A) Section 63.172(k) and (l) shall not apply. The owner or operator shall instead comply with paragraph (f) of this section.
(B) Owners or operators may, instead of complying with the provisions of § 63.172(f), design a closed-vent system to operate at a pressure below atmospheric pressure. The system shall be equipped with at least one pressure gage or other pressure measurement device that can be read from a readily accessible location to verify that negative pressure is being maintained in the closed-vent system when the associated control device is operating.
(C) The requirements apply at all times, except as specified in § 63.1250(g). The owner or operator may not comply with the planned routine maintenance provisions in § 63.1252(h).
(iii) Section 63.174 shall apply except:
(A) Section 63.174(f), (g), and (h) shall not apply. Instead of § 63.174(f), (g), and (h), the owner or operator shall comply with paragraph (f) of this section. Section 63.174(b)(3) shall not apply. Instead of § 63.174(b)(3), the owner or operator shall comply with paragraphs (b)(4)(iii)(B) through (F) of this section.
(B) If the percent leaking connectors in a group of processes was greater than or equal to 0.5 percent during the initial monitoring period, monitoring shall be performed once per year until the percent leaking connectors is less than 0.5 percent.
(C) If the percent leaking connectors in the group of processes was less than 0.5 percent, but equal to or greater than 0.25 percent, during the initial or last required monitoring period, the owner or operator may elect to monitor once every 4 years. An owner or operator may comply with the requirements of this paragraph by monitoring at least 40 percent of the connectors in the first 2 years and the remainder of the connectors within the next 2 years. The percent leaking connectors will be calculated for the total of all required monitoring performed during the 4-year period.
(D) Except as provided in paragraph (b)(4)(iii)(B) of this section, if leaking connectors comprise at least 0.5 percent but less than 1.0 percent of the connectors during the last monitoring period, the owner or operator shall monitor at least once every 2 years for the next monitoring period. At the end of that 2-year monitoring period, if the percent leaking connectors is greater than or equal to 0.5 percent, the owner or operator shall monitor once per year until the percent leaking connectors is less than 0.5 percent. If, at the end of a monitoring period, the percent leaking connectors is less than 0.5 percent, the owner or operator shall monitor in accordance with paragraph (b)(4)(iii)(C) or (F) of this section, as appropriate.
(E) If an owner or operator determines that 1 percent or greater of the connectors in a group of processes are leaking, the owner or operator shall monitor the connectors once per year. The owner or operator may elect to use the provisions of paragraph (b)(4)(iii)(C), (D), or (F) of this section, as appropriate, after a monitoring period in which less than 1 percent of the connectors are determined to be leaking.
(F) The owner or operator may elect to perform monitoring once every 8 years if the percent leaking connectors in the group of processes was less than 0.25 percent during the initial or last required monitoring period. An owner or operator shall monitor at least 50 percent of the connectors in the first 4 years and the remainder of the connectors within the next 4 years. If the percent leaking connectors in the first 4 years is equal to or greater than 0.35 percent, the monitoring program shall revert at that time to the appropriate monitoring frequency specified in paragraph (b)(4)(iii)(C), (D), or (E) of this section.
(iv) Section 63.178 shall apply except:
(A) Section 63.178(b), requirements for pressure testing, may be applied to all processes (not just batch processes) and to supply lines between storage and processing areas.
(B) For pumps, the phrase “at the frequencies specified in Table 1 of this subpart” in § 63.178(c)(3)(iii) shall mean “quarterly” for the purposes of this subpart.
(v) Section 63.180 shall apply except § 63.180(b)(4)(ii)(A) through (C) shall not apply. Instead, calibration gases shall be a mixture of methane and air at a concentration of approximately, but less than, 10,000 parts per million methane for agitators; 2,000 parts per million for pumps; and 500 parts per million for all other equipment, except as provided in § 63.180(b)(4)(iii).
(vi) When §§ 63.171, 63.172, 63.174, 63.178, and 63.180 reference other sections in subpart H of this part, the references shall mean those sections specified in paragraphs (b)(2) and (b)(4)(i) through (v) of this section, as applicable.
(c) Standards for pumps in light liquid service and agitators in gas/vapor service and in light liquid service. (1) The provisions of this section apply to each pump that is in light organic HAP liquid service, and to each agitator in organic HAP gas/vapor service or in light organic HAP liquid service.
(2)(i) Monitoring. Each pump and agitator subject to this section shall be monitored quarterly to detect leaks by the method specified in § 63.180(b) except as provided in §§ 63.177, 63.178, paragraph (f) of this section, and paragraphs (c)(5) through (9) of this section.
(ii) Leak definition. The instrument reading, as determined by the method as specified in § 63.180(b), that defines a leak is:
(A) For agitators, an instrument reading of 10,000 parts per million or greater.
(B) For pumps, an instrument reading of 2,000 parts per million or greater.
(iii) Visual Inspections. Each pump and agitator shall be checked by visual inspection each calendar week for indications of liquids dripping from the pump or agitator seal. If there are indications of liquids dripping from the pump or agitator seal at the time of the weekly inspection, the owner or operator shall follow the procedure specified in either paragraph (c)(2)(iii)(A) or (B) of this section prior to the next weekly inspection.
(A) The owner or operator shall monitor the pump or agitator by the method specified in § 63.180(b). If the instrument reading indicates a leak as specified in paragraph (c)(2)(ii) of this section, a leak is detected.
(B) The owner or operator shall eliminate the visual indications of liquids dripping.
(3) Repair provisions. (i) When a leak is detected pursuant to paragraph (c)(2)(i), (c)(2)(iii)(A), (c)(5)(iv)(A), or (c)(5)(vi)(B) of this section, it shall be repaired as soon as practicable, but not later than 15 calendar days after it is detected, except as provided in paragraph (b)(4)(i) of this section.
(ii) A first attempt at repair shall be made no later than 5 calendar days after the leak is detected. First attempts at repair include, but are not limited to, the following practices where practicable:
(A) Tightening of packing gland nuts.
(B) Ensuring that the seal flush is operating at design pressure and temperature.
(4) Calculation of percent leakers. (i) The owner or operator shall decide no later than the end of the first monitoring period what groups of processes will be developed. Once the owner or operator has decided, all subsequent percent calculations shall be made on the same basis.
(ii) If, calculated on a 1-year rolling average, the greater of either 10 percent or three of the pumps in a group of processes leak, the owner or operator shall monitor each pump once per month, until the calculated 1-year rolling average value drops below 10 percent or three pumps, as applicable.
(iii) The number of pumps in a group of processes shall be the sum of all the pumps in organic HAP service, except that pumps found leaking in a continuous process within 1 quarter after startup of the pump shall not count in the percent leaking pumps calculation for that one monitoring period only.
(iv) Percent leaking pumps shall be determined by the following Equation 3:
(5) Exemptions. Each pump or agitator equipped with a dual mechanical seal system that includes a barrier fluid system is exempt from the requirements of paragraphs (c)(1) through (c)(4)(iii) of this section, provided the following requirements are met:
(i) Each dual mechanical seal system is:
(A) Operated with the barrier fluid at a pressure that is at all times greater than the pump/agitator stuffing box pressure; or
(B) Equipped with a barrier fluid degassing reservoir that is connected by a closed-vent system to a control device that complies with the requirements of paragraph (b)(4)(ii) of this section; or
(C) Equipped with a closed-loop system that purges the barrier fluid into a process stream.
(ii) The barrier fluid is not in light liquid service.
(iii) Each barrier fluid system is equipped with a sensor that will detect failure of the seal system, the barrier fluid system, or both.
(iv) Each pump/agitator is checked by visual inspection each calendar week for indications of liquids dripping from the pump/agitator seal. If there are indications of liquids dripping from the pump or agitator seal at the time of the weekly inspection, the owner or operator shall follow the procedures specified in either paragraph (c)(5)(iv)(A) or (B) of this section prior to the next required inspection.
(A) The owner or operator shall monitor the pump or agitator using the method specified in § 63.180(b) to determine if there is a leak of organic HAP in the barrier fluid. If the instrument reading indicates a leak, as specified in paragraph (c)(2)(ii) of this section, a leak is detected.
(B) The owner or operator shall eliminate the visual indications of liquids dripping.
(v) Each sensor as described in paragraph (c)(5)(iii) of this section is observed daily or is equipped with an alarm unless the pump is located within the boundary of an unmanned plant site.
(vi)(A) The owner or operator determines, based on design considerations and operating experience, criteria applicable to the presence and frequency of drips and to the sensor that indicate failure of the seal system, the barrier fluid system, or both.
(B) If indications of liquids dripping from the pump/agitator seal exceed the criteria established in paragraph (c)(5)(vi)(A) of this section, or if, based on the criteria established in paragraph (c)(5)(vi)(A) of this section, the sensor indicates failure of the seal system, the barrier fluid system, or both, a leak is detected.
(vii) When a leak is detected pursuant to paragraph (c)(5)(iv)(A) or (B) of this section, the leak must be repaired as specified in paragraph (c)(3) of this section.
(6) Any pump/agitator that is designed with no externally actuated shaft penetrating the pump/agitator housing is exempt from the requirements of paragraphs (c)(1) through (3) of this section.
(7) Any pump/agitator equipped with a closed-vent system capable of capturing and transporting any leakage from the seal or seals back to the process or to a control device that complies with the requirements of paragraph (b)(4)(ii) of this section is exempt from the requirements of paragraphs (c)(2) through (5) of this section.
(8) Any pump/agitator that is located within the boundary of an unmanned plant site is exempt from the weekly visual inspection requirement of paragraphs (c)(2)(iii) and (c)(5)(iv) of this section, and the daily requirements of paragraph (c)(5)(v) of this section, provided that each pump/agitator is visually inspected as often as practicable and at least monthly.
(9) If more than 90 percent of the pumps in a group of processes meet the criteria in either paragraph (c)(5) or (6) of this section, the group of processes is exempt from the requirements of paragraph (c)(4) of this section.
(d) Standards: Open-ended valves or lines. (1)(i) Each open-ended valve or line shall be equipped with a cap, blind flange, plug, or a second valve, except as provided in § 63.177 and paragraphs (d)(4) through (6) of this section.
(ii) The cap, blind flange, plug, or second valve shall seal the open end at all times except during operations requiring process fluid flow through the open-ended valve or line, or during maintenance or repair. The cap, blind flange, plug, or second valve shall be in place within 1 hour of cessation of operations requiring process fluid flow through the open-ended valve or line, or within 1 hour of cessation of maintenance or repair. The owner or operator is not required to keep a record documenting compliance with the 1-hour requirement.
(2) Each open-ended valve or line equipped with a second valve shall be operated in a manner such that the valve on the process fluid end is closed before the second valve is closed.
(3) When a double block and bleed system is being used, the bleed valve or line may remain open during operations that require venting the line between the block valves but shall comply with paragraph (d)(1) of this section at all other times.
(4) Open-ended valves or lines in an emergency shutdown system which are designed to open automatically in the event of a process upset are exempt from the requirements of paragraphs (d)(1) through (d)(3) of this section.
(5) Open-ended valves or lines containing materials which would autocatalytically polymerize are exempt from the requirements of paragraphs (d)(1) through (d)(3) of this section.
(6) Open-ended valves or lines containing materials which could cause an explosion, serious overpressure, or other safety hazard if capped or equipped with a double block and bleed system as specified in paragraphs (d)(1) through (d)(3) of this section are exempt from the requirements of paragraphs (d)(1) through (d)(3) of this section.
(e) Standards: Valves in gas/vapor service and in light liquid service. (1) The provisions of this section apply to valves that are either in gas organic HAP service or in light liquid organic HAP service.
(2) For existing and new affected sources, all valves subject to this section shall be monitored, except as provided in paragraph (f) of this section and in § 63.177, by no later than 1 year after the compliance date.
(3) Monitoring. The owner or operator of a source subject to this section shall monitor all valves, except as provided in paragraph (f) of this section and in § 63.177, at the intervals specified in paragraph (e)(4) of this section and shall comply with all other provisions of this section, except as provided in paragraph (b)(4)(i) of this section, §§ 63.178 and 63.179.
(i) The valves shall be monitored to detect leaks by the method specified in § 63.180(b).
(ii) An instrument reading of 500 parts per million or greater defines a leak.
(4) Subsequent monitoring frequencies. After conducting the initial survey required in paragraph (e)(2) of this section, the owner or operator shall monitor valves for leaks at the intervals specified below:
(i) For a group of processes with 2 percent or greater leaking valves, calculated according to paragraph (e)(6) of this section, the owner or operator shall monitor each valve once per month, except as specified in paragraph (e)(9) of this section.
(ii) For a group of processes with less than 2 percent leaking valves, the owner or operator shall monitor each valve once each quarter, except as provided in paragraphs (e)(4)(iii) through (e)(4)(v) of this section.
(iii) For a group of processes with less than 1 percent leaking valves, the owner or operator may elect to monitor each valve once every 2 quarters.
(iv) For a group of processes with less than 0.5 percent leaking valves, the owner or operator may elect to monitor each valve once every 4 quarters.
(v) For a group of processes with less than 0.25 percent leaking valves, the owner or operator may elect to monitor each valve once every 2 years.
(5) Calculation of percent leakers. For a group of processes to which this subpart applies, an owner or operator may choose to subdivide the valves in the applicable group of processes and apply the provisions of paragraph (e)(4) of this section to each subgroup. If the owner or operator elects to subdivide the valves in the applicable group of processes, then the provisions of paragraphs (e)(5)(i) through (e)(5)(viii) of this section apply.
(i) The overall performance of total valves in the applicable group of processes must be less than 2 percent leaking valves, as detected according to paragraphs (e)(3) (i) and (ii) of this section and as calculated according to paragraphs (e)(6) (ii) and (iii) of this section.
(ii) The initial assignment or subsequent reassignment of valves to subgroups shall be governed by the provisions of paragraphs (e)(5)(ii) (A) through (C) of this section.
(A) The owner or operator shall determine which valves are assigned to each subgroup. Valves with less than 1 year of monitoring data or valves not monitored within the last 12 months must be placed initially into the most frequently monitored subgroup until at least 1 year of monitoring data has been obtained.
(B) Any valve or group of valves can be reassigned from a less frequently monitored subgroup to a more frequently monitored subgroup provided that the valves to be reassigned were monitored during the most recent monitoring period for the less frequently monitored subgroup. The monitoring results must be included with the less frequently monitored subgroup's monitoring event and associated next percent leaking valves calculation for that group.
(C) Any valve or group of valves can be reassigned from a more frequently monitored subgroup to a less frequently monitored subgroup provided that the valves to be reassigned have not leaked for the period of the less frequently monitored subgroup (e.g., for the last 12 months, if the valve or group of valves is to be reassigned to a subgroup being monitored annually). Nonrepairable valves may not be reassigned to a less frequently monitored subgroup.
(iii) The owner or operator shall determine every 6 months if the overall performance of total valves in the applicable group of processes is less than 2 percent leaking valves and so indicate the performance in the next periodic report. If the overall performance of total valves in the applicable group of processes is 2 percent leaking valves or greater, the owner or operator shall revert to the program required in paragraphs (e)(2) through (e)(4) of this section. The overall performance of total valves in the applicable group of processes shall be calculated as a weighted average of the percent leaking valves of each subgroup according to the following Equation 4:
(iv) Records. In addition to records required by paragraph (g) of this section, the owner or operator shall maintain records specified in paragraphs (e)(5)(iv)(A) through (D) of this section.
(A) Which valves are assigned to each subgroup,
(B) Monitoring results and calculations made for each subgroup for each monitoring period,
(C) Which valves are reassigned and when they were reassigned, and
(D) The results of the semiannual overall performance calculation required in paragraph (e)(5)(iii) of this section.
(v) The owner or operator shall notify the Administrator no later than 30 days prior to the beginning of the next monitoring period of the decision to subgroup valves. The notification shall identify the participating processes and the valves assigned to each subgroup.
(vi) Semiannual reports. In addition to the information required by paragraph (h)(3) of this section, the owner or operator shall submit in the periodic reports the information specified in paragraphs (e)(5)(vi)(A) and (B) of this section.
(A) Valve reassignments occurring during the reporting period, and
(B) Results of the semiannual overall performance calculation required by paragraph (e)(5)(iii) of this section.
(vii) To determine the monitoring frequency for each subgroup, the calculation procedures of paragraph (e)(6)(iii) of this section shall be used.
(viii) Except for the overall performance calculations required by paragraphs (e)(5)(i) and (e)(5)(iii) of this section, each subgroup shall be treated as if it were a process for the purposes of applying the provisions of this section.
(6)(i) The owner or operator shall decide no later than the implementation date of this subpart or upon revision of an operating permit how to group the processes. Once the owner or operator has decided, all subsequent percentage calculations shall be made on the same basis.
(ii) Percent leaking valves for each group of processes or subgroup shall be determined by the following Equation 5:
(iii) When determining monitoring frequency for each group of processes or subgroup subject to monthly, quarterly, or semiannual monitoring frequencies, the percent leaking valves shall be the arithmetic average of the percent leaking valves from the last two monitoring periods. When determining monitoring frequency for each group of processes or subgroup subject to annual or biennial (once every 2 years) monitoring frequencies, the percent leaking valves shall be the arithmetic average of the percent leaking valves from the last three monitoring periods.
(iv)(A) Nonrepairable valves shall be included in the calculation of percent leaking valves the first time the valve is identified as leaking and nonrepairable and as required to comply with paragraph (e)(6)(iv)(B) of this section. Otherwise, a number of nonrepairable valves (identified and included in the percent leaking calculation in a previous period) up to a maximum of 1 percent of the total number of valves in organic HAP service at a process may be excluded from calculation of percent leaking valves for subsequent monitoring periods.
(B) If the number of nonrepairable valves exceeds 1 percent of the total number of valves in organic HAP service at a process, the number of nonrepairable valves exceeding 1 percent of the total number of valves in organic HAP service shall be included in the calculation of percent leaking valves.
(7) Repair provisions. (i) When a leak is detected, it shall be repaired as soon as practicable, but no later than 15 calendar days after the leak is detected, except as provided in paragraph (b)(4)(i)) of this section.
(ii) A first attempt at repair shall be made no later than 5 calendar days after each leak is detected.
(iii) When a leak is repaired, the valve shall be monitored at least once within the first 3 months after its repair. Days that the valve is not in organic HAP service shall not be considered part of this 3 month period. The monitoring required by this paragraph is in addition to the monitoring required to satisfy the definitions of “repaired” and “first attempt at repair.”
(A) The monitoring shall be conducted as specified in § 63.180(b) and (c) as appropriate to determine whether the valve has resumed leaking.
(B) Periodic monitoring required by paragraphs (e)(2) through (4) of this section may be used to satisfy the requirements of paragraph (e)(7)(iii) of this section, if the timing of the monitoring period coincides with the time specified in paragraph (e)(7)(iii) of this section. Alternatively, other monitoring may be performed to satisfy the requirements of paragraph (e)(7)(iii) of this section, regardless of whether the timing of the monitoring period for periodic monitoring coincides with the time specified in paragraph (e)(7)(iii) of this section.
(C) If a leak is detected by monitoring that is conducted pursuant to paragraph (e)(7)(iii) of this section, the owner or operator shall follow the provisions of paragraphs (e)(7)(iii)(C)( 1 ) and ( 2 ) of this section to determine whether that valve must be counted as a leaking valve for purposes of paragraph (e)(6) of this section.
( 1 ) If the owner or operator elects to use periodic monitoring required by paragraphs (e)(2) through (4) of this section to satisfy the requirements of paragraph (e)(7)(iii) of this section, then the valve shall be counted as a leaking valve.
( 2 ) If the owner or operator elects to use other monitoring prior to the periodic monitoring required by paragraphs (e)(2) through (4) of this section to satisfy the requirements of paragraph (e)(7)(iii) of this section, then the valve shall be counted as a leaking valve unless it is repaired and shown by periodic monitoring not to be leaking.
(8) First attempts at repair include, but are not limited to, the following practices where practicable:
(i) Tightening of bonnet bolts,
(ii) Replacement of bonnet bolts,
(iii) Tightening of packing gland nuts, and
(iv) Injection of lubricant into lubricated packing.
(9) Any equipment located at a plant site with fewer than 250 valves in organic HAP service in the affected source is exempt from the requirements for monthly monitoring specified in paragraph (e)(4)(i) of this section. Instead, the owner or operator shall monitor each valve in organic HAP service for leaks once each quarter, or comply with paragraph (e)(4)(iii), (iv), or (v) of this section, except as provided in paragraph (f) of this section.
(f) Unsafe to monitor/inspect, difficult to monitor/inspect, and inaccessible equipment. (1) Equipment that is designated as unsafe to monitor, unsafe to inspect, difficult to monitor, difficult to inspect, or inaccessible is exempt from the monitoring requirements as specified in paragraphs (f)(1)(i) through (iv) of this section provided the owner or operator meets the requirements specified in paragraph (f)(2), (3), or (4) of this section, as applicable. All equipment must be assigned to a group of processes. Ceramic or ceramic-lined connectors are subject to the same requirements as inaccessible connectors.
(i) For pumps and agitators, paragraphs (c)(2), (3), and (4) of this section do not apply.
(ii) For valves, paragraphs (e)(2) through (7) of this section do not apply.
(iii) For connectors, § 63.174(b) through (e) and paragraphs (b)(4)(iii)(B) through (F) of this section do not apply.
(iv) For closed-vent systems, § 63.172(f)(1) and (2) and § 63.172(g) do not apply.
(2) Equipment that is unsafe to monitor or unsafe to inspect. (i) Valves, connectors, agitators, and pumps may be 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 requirements referred to in paragraphs (f)(1)(i) through (iii) of this section.
(ii) Any part of a closed-vent system may be designated as unsafe to inspect if the owner or operator determines that monitoring personnel would be exposed to an immediate danger as a consequence of complying with the monitoring requirements referred to in paragraph (f)(1)(iv) of this section.
(iii) The owner or operator of equipment that is designated as unsafe to monitor must have a written plan that requires monitoring of the equipment as frequently as practicable during safe to monitor times, but not more frequently than the periodic monitoring schedule otherwise applicable to the group of processes in which the equipment is located.
(iv) For any parts of a closed-vent system designated as unsafe to inspect, the owner or operator must have a written plan that requires inspection of the closed-vent systems as frequently as practicable during safe to inspect times, but not more frequently than annually.
(3) Equipment that is difficult to monitor or difficult to inspect. (i) A valve, agitator, or pump may be designated as difficult to monitor if the owner or operator determines that the valve, agitator, or pump cannot be monitored 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.
(ii) Any part of a closed-vent system may be designated as difficult to inspect if the owner or operator determines that the equipment 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.
(iii) At an existing source, any valve, agitator or pump within a group of processes that meets the criteria of paragraph (f)(3)(i) of this section may be designated as difficult to monitor, and any parts of a closed-vent system that meet the requirements of paragraph (f)(3)(ii) of this section may be designated as difficult to inspect. At a new affected source, an owner or operator may designate no more than 3 percent of valves as difficult to monitor.
(iv) The owner or operator of valves, agitators, or pumps designated as difficult to monitor must have a written plan that requires monitoring of the equipment at least once per calendar year or on the periodic monitoring schedule otherwise applicable to the group of processes in which the equipment is located, whichever is less frequent. For any part of a closed-vent system designated as difficult to inspect, the owner or operator must have a written plan that requires inspection of the closed-vent system at least once every 5 years.
(4) Inaccessible, ceramic, or ceramic-lined connectors. (i) A connector may be designated as inaccessible if it is:
(A) Buried;
(B) Insulated in a manner that prevents access to the connector by a monitor probe;
(C) Obstructed by equipment or piping that prevents access to the connector by a monitor probe;
(D) 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 the ground; or
(E) Not able to be accessed at any time in a safe manner to perform monitoring. Unsafe access includes, but is not limited to, the use of a wheeled scissor-lift on unstable or uneven terrain, the use of a motorized man-lift basket in areas where an ignition potential exists, or access would require near proximity to hazards such as electrical lines, or would risk damage to equipment.
(ii) A connector may be designated as inaccessible if it would require elevating the monitoring personnel more than 2 meters above a permanent support surface or would require the erection of scaffold.
(iii) At an existing source, any connector that meets the criteria of paragraph (f)(4)(i) or (ii) of this section may be designated as inaccessible. At a new affected source, an owner or operator may designate no more than 3 percent of connectors as inaccessible.
(iv) If any inaccessible, ceramic, or ceramic-lined connector is observed by visual, audible, olfactory, or other means to be leaking, the leak shall be repaired as soon as practicable, but no later than 15 calendar days after the leak is detected, except as provided in paragraph (b)(4)(i) of this section.
(v) Any connector that is inaccessible or that is ceramic or ceramic-lined is exempt from the recordkeeping and reporting requirements of paragraphs (g) and (h) of this section.
(g) Recordkeeping requirements. (1) An owner or operator of more than one group of processes subject to the provisions of this section may comply with the recordkeeping requirements for the groups of processes in one recordkeeping system if the system identifies with each record the program being implemented (e.g., quarterly monitoring) for each type of equipment. All records and information required by this section shall be maintained in a manner that can be readily accessed at the plant site. This could include physically locating the records at the plant site or accessing the records from a central location by computer at the plant site.
(2) General recordkeeping. Except as provided in paragraph (g)(5)(i) of this section and in paragraph (a)(9) of this section, the following information pertaining to all equipment subject to the requirements in this section shall be recorded:
(i)(A) A list of identification numbers for equipment (except connectors that are subject to paragraph (f)(4) of this section) subject to the requirements of this section. Except for equipment subject to the recordkeeping requirements in paragraphs (g)(2)(ii) through (viii) of this section, equipment need not be individually identified if, for a particular type of equipment, all items of that equipment in a designated area or length of pipe subject to the provisions of this section are identified as a group, and the number of subject items of equipment is indicated. The list for each type of equipment shall be completed no later than the completion of the initial survey required for that component. The list of identification numbers shall be updated, if needed, to incorporate equipment changes identified during the course of each monitoring period within 90 calendar days, or by the next Periodic Report, following the end of the monitoring period for the type of equipment component monitored, whichever is later.
(B) A schedule for monitoring connectors subject to the provisions of § 63.174(a) and valves subject to the provisions of paragraph (e)(4) of this section.
(C) Physical tagging of the equipment to indicate that it is in organic HAP service is not required. Equipment subject to the provisions of this section may be identified on a plant site plan, in log entries, or by other appropriate methods.
(ii)(A) A list of identification numbers for equipment that the owner or operator elects to equip with a closed-vent system and control device, under the provisions of paragraph (c)(7) of this section, § 63.164(h), or § 63.165(c).
(B) A list of identification numbers for compressors that the owner or operator elects to designate as operating with an instrument reading of less than 500 parts per million above background, under the provisions of § 63.164(i).
(iii)(A) A list of identification numbers for pressure relief devices subject to the provisions in § 63.165(a).
(B) A list of identification numbers for pressure relief devices equipped with rupture disks, under the provisions of § 63.165(d).
(iv) Identification of instrumentation systems subject to the provisions of this section. Individual components in an instrumentation system need not be identified.
(v) The following information shall be recorded for each dual mechanical seal system:
(A) Design criteria required by paragraph (c)(5)(vi)(A) of this section and § 63.164(e)(2), and an explanation of the design criteria; and
(B) Any changes to these criteria and the reasons for the changes.
(vi) A list of equipment designated as unsafe to monitor/inspect or difficult to monitor/inspect under paragraph (f) of this section and a copy of the plan for monitoring or inspecting this equipment.
(vii) A list of connectors removed from and added to the process, as described in § 63.174(i)(1), and documentation of the integrity of the weld for any removed connectors, as required in § 63.174(j). This is not required unless the net credits for removed connectors is expected to be used.
(viii) For equipment that the owner or operator elects to monitor as provided under § 63.178(c), a list of equipment added to batch product processes since the last monitoring period required in § 63.178(c)(3)(ii) and (iii). This list must be completed for each type of equipment within 90 calendar days, or by the next Periodic Report, following the end of the monitoring period for the type of equipment monitored, whichever is later. Also, if the owner or operator elects to adjust monitoring frequency by the time in use, as provided in § 63.178(c)(3)(iii), records demonstrating the proportion of the time during the calendar year the equipment is in use in a manner subject to the provisions of this section are required. Examples of suitable documentation are records of time in use for individual pieces of equipment or average time in use for the process unit.
(3) Records of visual inspections. For visual inspections of equipment subject to the provisions of paragraphs (c)(2)(iii) and (c)(5)(iv) of this section, the owner or operator shall document that the inspection was conducted and the date of the inspection. The owner or operator shall maintain records as specified in paragraph (g)(4) of this section for leaking equipment identified in this inspection, except as provided in paragraph (g)(5) of this section. These records shall be retained for 2 years.
(4) Monitoring records. When each leak is detected as specified in paragraph (c) of this section and § 63.164, paragraph (e) of this section and § 63.169, and §§ 63.172 and 63.174, the following information shall be recorded and kept for 5 years (at least 2 years onsite, with the remaining 3 years either onsite or offsite):
(i) The instrument and the equipment identification number and the operator name, initials, or identification number.
(ii) The date the leak was detected and the date of the first attempt to repair the leak.
(iii) The date of successful repair of the leak.
(iv) The maximum instrument reading measured by Method 21 of 40 CFR part 60, appendix A, after the leak is successfully repaired or determined to be nonrepairable.
(v) “Repair delayed” and the reason for the delay if a leak is not repaired within 15 calendar days after discovery of the leak.
(A) The owner or operator may develop a written procedure that identifies the conditions that justify a delay of repair. The written procedures shall be included in a document that is maintained at the plant site. Reasons for delay of repair may be documented by citing the relevant sections of the written procedure.
(B) If delay of repair was caused by depletion of stocked parts, there must be documentation that the spare parts were sufficiently stocked onsite before depletion and the reason for depletion.
(vi) If repairs were delayed, dates of process shutdowns that occur while the equipment is unrepaired.
(vii)(A) If the alternative in § 63.174(c)(1)(ii) is not in use for the monitoring period, identification, either by list, location (area or grouping), or tagging of connectors disturbed since the last monitoring period required in § 63.174(b), as described in § 63.174(c)(1).
(B) The date and results of follow-up monitoring as required in § 63.174(c)(1)(i) and (c)(2)(ii). If identification of disturbed connectors is made by location, then all connectors within the designated location shall be monitored.
(viii) The date and results of the monitoring required in § 63.178(c)(3)(i) for equipment added to a batch process since the last monitoring period required in § 63.178(c)(3)(ii) and (iii). If no leaking equipment is found in this monitoring, the owner or operator shall record that the inspection was performed. Records of the actual monitoring results are not required.
(ix) Copies of the periodic reports as specified in paragraph (h)(3) of this section, if records are not maintained on a computerized data base capable of generating summary reports from the records.
(5) Records of pressure tests. The owner or operator who elects to pressure test a process equipment train or supply lines between storage and processing areas to demonstrate compliance with this section is exempt from the requirements of paragraphs (g)(2), (3), (4), and (6) of this section. Instead, the owner or operator shall maintain records of the following information:
(i) The identification of each product, or product code, produced during the calendar year. It is not necessary to identify individual items of equipment in the process equipment train.
(ii) Physical tagging of the equipment to identify that it is in organic HAP service and subject to the provisions of this section is not required. Equipment in a process subject to the provisions of this section may be identified on a plant site plan, in log entries, or by other appropriate methods.
(iii) The dates of each pressure test required in § 63.178(b), the test pressure, and the pressure drop observed during the test.
(iv) Records of any visible, audible, or olfactory evidence of fluid loss.
(v) When a process equipment train does not pass two consecutive pressure tests, the following information shall be recorded in a log and kept for 2 years:
(A) The date of each pressure test and the date of each leak repair attempt.
(B) Repair methods applied in each attempt to repair the leak.
(C) The reason for the delay of repair.
(D) The expected date for delivery of the replacement equipment and the actual date of delivery of the replacement equipment.
(E) The date of successful repair.
(6) Records of compressor and relief device compliance tests. The dates and results of each compliance test required for compressors subject to the provisions in § 63.164(i) and the dates and results of the monitoring following a pressure release for each pressure relief device subject to the provisions in §§ 63.165(a) and (b). The results shall include:
(i) The background level measured during each compliance test.
(ii) The maximum instrument reading measured at each piece of equipment during each compliance test.
(7) Records for closed-vent systems. The owner or operator shall maintain records of the information specified in paragraphs (g)(7)(i) through (iii) of this section for closed-vent systems and control devices subject to the provisions of paragraph (b)(4)(ii) of this section. The records specified in paragraph (g)(7)(i) of this section shall be retained for the life of the equipment. The records specified in paragraphs (g)(7)(ii) and (g)(7)(iii) of this section shall be retained for 2 years.
(i) The design specifications and performance demonstrations specified in paragraphs (g)(7)(i)(A) through (g)(7)(i)(D) of this section.
(A) Detailed schematics, design specifications of the control device, and piping and instrumentation diagrams.
(B) The dates and descriptions of any changes in the design specifications.
(C) The flare design (i.e., steam assisted, air assisted, or nonassisted) and the results of the compliance demonstration required by § 63.11(b).
(D) A description of the parameter or parameters monitored, as required in paragraph (b)(4)(ii) of this section, to ensure that control devices are operated and maintained in conformance with their design and an explanation of why that parameter (or parameters) was selected for the monitoring.
(ii) Records of operation of closed-vent systems and control devices.
(A) Dates and durations when the closed-vent systems and control devices required in paragraph (c) of this section and §§ 63.164 through 63.166 are not operated as designed as indicated by the monitored parameters, including periods when a flare pilot light system does not have a flame.
(B) Dates and durations during which the monitoring system or monitoring device is inoperative.
(C) Dates and durations of startups and shutdowns of control devices required in paragraph (c)(7) of this section and §§ 63.164 through 63.166.
(iii) Records of inspections of closed-vent systems subject to the provisions of § 63.172.
(A) For each inspection conducted in accordance with the provisions of § 63.172(f)(1) or (f)(2) during which no leaks were detected, a record that the inspection was performed, the date of the inspection, and a statement that no leaks were detected.
(B) For each inspection conducted in accordance with the provisions of § 63.172(f)(1) or (f)(2) during which leaks were detected, the information specified in paragraph (g)(4) of this section shall be recorded.
(8) Records for components in heavy liquid service. Information, data, and analysis used to determine that a piece of equipment or process is in heavy liquid service shall be recorded. Such a determination shall include an analysis or demonstration that the process fluids do not meet the criteria of “in light liquid or gas service.” Examples of information that could document this include, but are not limited to, records of chemicals purchased for the process, analyses of process stream composition, engineering calculations, or process knowledge.
(9) Records of exempt components. Identification, either by list, location (area or group) of equipment in organic HAP service less than 300 hours per year subject to the provisions of this section.
(10) Records of alternative means of compliance determination. Owners and operators choosing to comply with the requirements of § 63.179 shall maintain the following records:
(i) Identification of the process(es) and the organic HAP they handle.
(ii) A schematic of the process, enclosure, and closed-vent system.
(iii) A description of the system used to create a negative pressure in the enclosure to ensure that all emissions are routed to the control device.
(h) Reporting requirements. (1) Each owner or operator of a source subject to this section shall submit the reports listed in paragraphs (h)(1)(i) through (ii) of this section.
(i) A Notification of Compliance Status Report described in paragraph (h)(2) of this section,
(ii) Periodic reports described in paragraph (h)(3) of this section.
(2) Notification of compliance status report. Each owner or operator of a source subject to this section shall submit the information specified in paragraphs (h)(2)(i) through (iii) of this section in the Notification of Compliance Status Report described in § 63.1260(f).
(i) The notification shall provide the information listed in paragraphs (h)(2)(i)(A) through (C) of this section for each process subject to the requirements of paragraphs (b) through (g) of this section.
(A) Process group identification.
(B) Number of each equipment type (e.g., valves, pumps) in organic HAP service, excluding equipment in vacuum service.
(C) Method of compliance with the standard (for example, “monthly leak detection and repair” or “equipped with dual mechanical seals”).
(ii) The notification shall provide the information listed in paragraphs (h)(2)(ii)(A) and (B) of this section for each process subject to the requirements of paragraph (b)(4)(iv) of this section and § 63.178(b).
(A) Products or product codes subject to the provisions of this section, and
(B) Planned schedule for pressure testing when equipment is configured for production of products subject to the provisions of this section.
(iii) The notification shall provide the information listed in paragraphs (h)(2)(iii)(A) and (B) of this section for each process subject to the requirements in § 63.179.
(A) Process identification.
(B) A description of the system used to create a negative pressure in the enclosure and the control device used to comply with the requirements of paragraph (b)(4)(ii) of this section.
(iv) Section 63.9(j) shall not apply to the Notification of Compliance Status report described in this paragraph (h)(2).
(3) Periodic reports. The owner or operator of a source subject to this section shall submit Periodic Reports.
(i) A report containing the information in paragraphs (h)(3)(ii), (iii), and (iv) of this section shall be submitted semiannually. The first report shall be submitted no later than 240 days after the Notification of Compliance Status Report is due and shall cover the 6-month period beginning on the date the Notification of Compliance Status Report is due. Each subsequent report shall cover the 6-month period following the preceding period.
(ii) For equipment complying with the provisions of paragraphs (b) through (g) of this section, except paragraph (b)(4)(iv) of this section and § 63.179, the summary information listed in paragraphs (h)(3)(ii)(A) through (L) of this section for each monitoring period during the 6-month period.
(A) The number of valves for which leaks were detected as described in paragraph (e)(3) of this section, the percent leakers, and the total number of valves monitored;
(B) The number of valves for which leaks were not repaired as required in paragraph (e)(7) of this section, identifying the number of those that are determined nonrepairable;
(C) Separately, the number of pumps and agitators for which leaks were detected as described in paragraph (c)(2) of this section, the total number of pumps and agitators monitored, and, for pumps, the percent leakers;
(D) Separately, the number of pumps and agitators for which leaks were not repaired as required in paragraph (c)(3) of this section;
(E) The number of compressors for which leaks were detected as described in § 63.164(f);
(F) The number of compressors for which leaks were not repaired as required in § 63.164(g);
(G) The number of connectors for which leaks were detected as described in § 63.174(a), the percent of connectors leaking, and the total number of connectors monitored;
(H) The number of connectors for which leaks were not repaired as required in § 63.174(d), identifying the number of those that are determined nonrepairable;
(I) The facts that explain any delay of repairs and, where appropriate, why a process shutdown was technically infeasible.
(J) The results of all monitoring to show compliance with §§ 63.164(i), 63.165(a), and 63.172(f) conducted within the semiannual reporting period.
(K) If applicable, the initiation of a monthly monitoring program under either paragraph (c)(4)(ii) or paragraph (e)(4)(i) of this section.
(L) If applicable, notification of a change in connector monitoring alternatives as described in § 63.174(c)(1).
(iii) For owners or operators electing to meet the requirements of § 63.178(b), the report shall include the information listed in paragraphs (h)(3)(iii)(A) through (E) of this paragraph for each process.
(A) Product process equipment train identification;
(B) The number of pressure tests conducted;
(C) The number of pressure tests where the equipment train failed either the retest or two consecutive pressure tests;
(D) The facts that explain any delay of repairs; and
(E) The results of all monitoring to determine compliance with § 63.172(f) of subpart H.
(iv) Any revisions to items reported in earlier Notification of Compliance Status report, if the method of compliance has changed since the last report.