(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 FR 50326, Sept. 21, 1998, as amended at 65 FR 52596, Aug. 29, 2000; 66 FR 40131, Aug. 2, 2001; 76 FR 22599, Apr. 21, 2011]