(a) Definition of affected source. The affected source subject to this subpart is the facility-wide collection of pesticide active ingredient manufacturing process units (PAI process units) that process, use, or produce HAP, and are located at a plant site that is a major source, as defined in section 112(a) of the CAA. An affected source also includes waste management units, heat exchange systems, and cooling towers that are associated with the PAI process units. Exemptions from an affected source are specified in paragraph (d) of this section.

(b) New source applicability. A new affected source subject to this subpart and to which the requirements for new sources apply is defined according to the criteria in paragraph (b)(1) or (2) of this section.

(1) An affected source for which construction or reconstruction commenced after November 10, 1997.

(2) Any dedicated PAI process unit that meets the criteria specified in paragraphs (b)(2)(i) and (ii) of this section.

(i) For which construction, as defined in §63.1361, commenced after November 10, 1997, or reconstruction commenced after September 20, 2002.

(ii) That has the potential to emit 10 tons/yr of any one HAP or 25 tons/yr of combined HAP.

(c) General provisions. Table 1 of this subpart specifies the provisions of subpart A of this part that apply to an owner or operator of an affected source subject to this subpart, and clarifies specific provisions in subpart A of this part as necessary for this subpart.

(d) Exemptions from the requirements of this subpart. The provisions of this subpart do not apply to:

(1) Research and development facilities;

(2) PAI process units that are subject to subpart F of this part;

(3) Production of ethylene;

(4) Coal tar distillation; and

(5) The following emission points listed:

(i) Storm water from segregated sewers;

(ii) Water from fire-fighting and deluge systems, including testing of such systems;

(iii) Spills;

(iv) Water from safety showers;

(v) Noncontact steam boiler blowdown and condensate;

(vi) Laundry water;

(vii) Vessels storing material that contains no organic HAP or contains organic HAP as impurities only; and

(viii) Equipment, as defined in §63.1363, that is intended to operate in organic HAP service for less than 300 hours during the calendar year.

(e) Applicability of this subpart.

(1) Each provision set forth in this subpart shall apply at all times except during periods of non-operation of the affected source (or specific portion thereof) resulting in cessation of the emissions to which this subpart applies.

(i) The startup, shutdown, or malfunction precludes the ability of the owner or operator of an affected source to comply with one or more specific emission limitations to which a particular emission point is subject; and

(ii) The owner or operator follows the provisions for periods of startup, shutdown, and malfunction, as specified in §§63.1367(a)(3) and 63.1368(i).

(2) The provisions set forth in §63.1363 shall apply at all times except during periods of nonoperation of the PAI process unit (or specific portion thereof) in which the lines are drained and depressurized resulting in the cessation of the emissions to which §63.1363 applies.

(3) 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.

(4) General duty. At all times, the owner or operator must operate and maintain any affected source, 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 the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements 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.

(f) Storage vessel applicability determination. An owner or operator shall follow the procedures specified in paragraphs (f)(1) through (5) of this section to determine whether a storage vessel is part of the affected source to which this subpart applies.

(1) If a storage vessel is already subject to another subpart of 40 CFR part 63 on June 23, 1999, the storage vessel shall belong to the process unit subject to the other subpart.

(2) Unless otherwise excluded under paragraph (f)(1) of this section, the storage vessel is part of a PAI process unit if either the input to the vessel from the PAI process unit is greater than or equal to the input from any other PAI or non-PAI process unit, or the output from the vessel to the PAI process unit is greater than or equal to the output to any other PAI or non-PAI process unit. If the greatest input to and/or output from a shared storage vessel is the same for two or more process units, including one or more PAI process units, the owner or operator must assign the storage vessel to any one of the PAI process units that meet this condition.

(3) Unless otherwise excluded under paragraph (f)(1) of this section, where a storage vessel is located in a tank farm (including a marine tank farm), the applicability of this subpart shall be determined according to the provisions in paragraphs (f)(3)(i) through (iii) of this section.

(i) The storage vessel in the tank farm is not subject to the provisions of this subpart if the greatest input to or output from the storage vessel is for a non-PAI process unit. The input and output shall be determined among only those process units that share the storage vessel and that do not have an intervening storage vessel for that product (or raw material, as appropriate).

(ii) Except for storage vessels in a tank farm excluded in accordance with paragraph (f)(3)(i) of this section, applicability of this subpart shall be determined according to the provisions in paragraphs (f)(3)(ii)(A) through (C) of this section.

(A) Except as specified in paragraph (f)(3)(ii)(C) of this section, this subpart does not apply to the storage vessel in a tank farm if each PAI process unit that receives material from or sends material to the storage vessel has an intervening storage vessel for that material.

(B) Except as specified in paragraph (f)(3)(ii)(C) of this section, a storage vessel in a tank farm shall be assigned to the PAI process unit that receives the greatest amount of material from or sends the greatest amount of material to the storage vessel and does not have an intervening storage vessel. If two or more PAI process units have the same input to or output from the storage vessel in the tank farm, then the storage vessel in the tank farm may be assigned to any one of the PAI process units that meet this condition.

(C) As an alternative to the requirements specified in paragraphs (f)(3)(ii)(A) and (B) of this section, even if an intervening storage vessel is present, an owner or operator may elect to assign a storage vessel in a tank farm to the PAI process unit that sends the most material to or receives the most material from the storage vessel. If two or more PAI process units have the same input to or output from the storage vessel in the tank farm, then the storage vessel in the tank farm may be assigned to any one of the PAI process units that meet this condition.

(iii) With respect to a process unit, an intervening storage vessel means a storage vessel connected by hard-piping to the process unit and to the storage vessel in the tank farm so that the product or raw material entering or leaving the process flows into (or from) the intervening storage vessel and does not flow directly into (or from) the storage vessel in the tank farm.

(4) If use varies from year to year, then use for the purposes of this subpart for existing sources shall be based on the utilization that occurred during the year preceding June 23, 1999, or if the storage vessel was not in operation during that year, the use shall be based on the expected use in the 5 years after startup. This determination shall be reported as part of an operating permit application or as otherwise specified by the permitting authority.

(5) If the storage vessel begins receiving material from (or sending material to) another process unit, or ceasing to receive material from (or send material to) a PAI process unit, or if there is a significant change in the use of the storage vessel, the owner or operator shall reevaluate the ownership determination for the storage vessel.

(g) Designating production of an intermediate as a PAI process unit. Except as specified in paragraph (d) of this section, an owner or operator may elect to designate production of any intermediate that does not meet the definition of integral intermediate as a PAI process unit subject to this subpart. Any storage vessel containing the intermediate is assigned to a PAI process unit according to the procedures in paragraph (f) of this section. Any process tank containing the intermediate is part of the process unit used to produce the intermediate.

(h) Applicability of process units included in a process unit group. An owner or operator may elect to develop process unit groups in accordance with paragraph (h)(1) of this section. For the PAI process units in these process unit groups, the owner or operator may comply with the provisions in overlapping MACT standards, as specified in paragraphs (h)(2) through (4) of this section, as an alternative means of demonstrating compliance with the provisions of this subpart.

(1) Develop, revise, and document changes in a process unit group in accordance with the procedures specified in paragraphs (h)(1)(i) through (vi) of this section.

(i) Initially identify a non-dedicated PAI process unit that is operating on December 23, 2003 or a date after December 23, 2003, and identify all processing equipment that is part of this PAI process unit, based on descriptions in operating scenarios.

(ii) Add to the group any other non-dedicated PAI and non-dedicated non-PAI process units expected to be operated in the 5 years after the date specified in paragraph (h)(1)(i) of this section, provided they satisfy the criteria specified in paragraphs (h)(1)(ii)(A) through (C) of this section. Also identify all of the processing equipment used for each process unit based on information from operating scenarios and other applicable documentation.

(A) Each PAI process unit that is added to a group must have some processing equipment that is part of one or more PAI process units that are already in the process unit group.

(B) Each non-PAI process unit that is added to a group must have some processing equipment that is also part of one or more of the PAI process units in the group.

(C) No process unit may be part of more than one process unit group.

(iii) The initial process unit group consists of all of the processing equipment for the process units identified in paragraphs (h)(1)(i) and (ii) of this section.

(iv) If compliance is to be demonstrated in accordance with paragraph (h)(3) of this section, determine the primary product of the process unit group according to the procedures specified in paragraphs (h)(1)(iv)(A) through (C) of this section.

(A) The primary product is the type of product (e.g., PAI, pharmaceutical product, thermoplastic resin, etc.) that is expected to be produced for the greatest operating time in the 5-year period specified in paragraph (h)(1)(i) of this section.

(B) If the process unit group produces multiple products equally based on operating time, then the primary product is the product with the greatest production on a mass basis over the 5-year period specified in paragraph (h)(1)(i) of this section.

(C) The primary product of the group must be redetermined if the owner or operator does not intend to make that product in the future or if it has not been made for 5 years. The results of the redetermination must be recorded as specified in §63.1367(b) and reported in a Periodic report no later than the report covering the period for the end of the 5th year as specified in §63.1368(g)(2). If the primary product changes, the owner or operator must either demonstrate compliance with the applicable subpart as specified in paragraph (h)(3) of this section or demonstrate compliance with the provisions of this subpart MMM.

(v) Add process units developed in the future in accordance with the conditions specified in paragraphs (h)(1)(ii)(A) through (C) of this section.

(vi) Maintain records of changes in the process units in each process unit group as specified in §63.1367(b)(9), and maintain reports as specified in §63.1368(f)(9) and (g)(2)(ix).

(2) If any of the products produced in the process unit group are subject to 40 CFR part 63, subpart GGG (Pharmaceuticals MACT), the owner or operator may elect to comply with the requirements of subpart GGG for the PAI process unit(s) within the process unit group, except for the following:

(i) The emission limit standard for process vents in §63.1362(b)(2)(i) shall apply in place of §63.1254(a)(2);

(ii) When the dates of April 2, 1997 and April 2, 2007 are provided in §63.1254(a)(3)(ii), the dates of November 10, 1997 and November 10, 2007, respectively, shall apply for purposes of this subpart MMM; and

(iii) Requirements in §63.1367(a)(5) regarding application for approval of construction or reconstruction shall apply in place of the provisions in §63.1259(a)(5).

(3) If the primary product of a process unit group is determined to be a type of material that is subject to another subpart of 40 CFR part 63 on June 23, 1999 or startup of the first process unit after formation of the process unit group, whichever is later, the owner or operator may elect to comply with the other subpart for any PAI process unit within the process unit group, subject to the requirement in this paragraph (h)(3). Emissions from PAI Group 1 process vents, as defined in §63.1361, must be reduced in accordance with the control requirements for Group 1 vents as specified in the alternative subpart. The criteria in the alternative subpart for determining which process vents must be controlled do not apply for the purposes of this paragraph (h)(3).

(4) The requirements for new and reconstructed sources in the alternative subpart apply to all PAI process units in the process unit group if, and only if, the affected source under the alternative subpart meets the requirements for construction or reconstruction.

(i) Overlap with other regulations—(1) Compliance with other MACT standards.

(i) After the compliance dates specified in §63.1364, an affected source subject to the provisions of this subpart that is also subject to the provisions of any other subpart of 40 CFR part 63 may elect, to the extent the subparts are consistent, under which subpart to maintain records and report to EPA. The affected source shall identify in the Notification of Compliance Status report required by §63.1368(f) under which authority such records will be maintained.

(ii) After the compliance dates specified in §63.1364, at an offsite reloading or cleaning facility subject to §63.1362(b)(6), compliance with the emission standards and associated initial compliance monitoring, recordkeeping, and reporting provisions of any other subpart of 40 CFR part 63 constitutes compliance with the provisions of §63.1362(b)(6)(vii)(B) or (C). The owner or operator of the affected storage vessel shall identify in the Notification of Compliance Status report required by §63.1368(f) the subpart of 40 CFR part 63 with which the owner or operator of the offsite reloading or cleaning facility complies.

(2) Overlap with RCRA subparts AA, BB, and/or CC. After the compliance dates specified in §63.1364, if any affected source 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 excursions as required by §63.1368(g). The owner or operator shall identify in the Notification of Compliance Status report required by §63.1368(f) the monitoring, recordkeeping, and reporting authority under which the owner or operator will comply.

(3) Overlap with NSPS subpart Kb. After the compliance dates specified in §63.1364, a Group 1 or Group 2 storage vessel that is also subject to the provisions of 40 CFR part 60, subpart Kb, is required to comply only with the provisions of this subpart MMM.

(4) Overlap with subpart I. After the compliance dates specified in §63.1364, for all equipment within a process unit that contains equipment subject to subpart I of this part, an owner or operator may elect to comply with either the provisions of this subpart MMM or the provisions of subpart H of this part. The owner or operator shall identify in the Notification of Compliance Status report required by §63.1368(f) the provisions with which the owner or operator elects to comply.

(5) Overlap with RCRA regulations for wastewater. After the compliance dates specified in §63.1364, the owner or operator of an affected wastewater stream that is also subject to provisions in 40 CFR parts 260 through 272 shall comply with the more stringent control requirements (e.g., waste management units, numerical treatment standards, etc.) and the more stringent testing, monitoring, recordkeeping, and reporting requirements that overlap between the provisions of this subpart and the provisions of 40 CFR parts 260 through 272. The owner or operator shall keep a record of the information used to determine which requirements were the most stringent and shall submit this information if requested by the Administrator.

(6) Overlap with NSPS subparts III, NNN, and RRR. After the compliance dates specified in §63.1364, if an owner or operator of a process vent subject to this subpart MMM that is also subject to the provisions of 40 CFR part 60, subpart III, or subpart NNN, or subpart RRR, elects to reduce organic HAP emissions from the process vent by 98 percent as specified in §63.1362(b)(2)(iii)(A), then the owner or operator is required to comply only with the provisions of this subpart MMM. Otherwise, the owner or operator shall comply with the provisions in both this subpart MMM and the provisions in 40 CFR part 60, subparts III, NNN, and RRR, as applicable.

(j) Meaning of periods of time. All terms in this subpart MMM that define a period of time for completion of required tasks (e.g., weekly, monthly, quarterly, annual), unless specified otherwise in the section or subsection that imposes the requirement, refer to the standard calendar periods.

(1) Notwithstanding time periods specified in the subpart MMM for completion of required tasks, such time periods may be changed by mutual agreement between the owner and operator and the Administrator, as specified in subpart A of this part (e.g., a period could begin on the compliance date or another date, rather than on the first day of the standard period). 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.

(2) Where the period specified for compliance is a standard calendar period, if the initial compliance date occurs after the beginning of the period, compliance shall be required according to the schedule specified in paragraph (j)(2)(i) or (ii) of this section, as appropriate.

(i) Compliance shall be required before the end of the standard calendar period within which the compliance deadline 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

(ii) In all other cases, compliance shall be required before the end of the first full standard calendar period within which the initial compliance deadline occurs.

(3) In all instances where a provision of this subpart MMM requires completion of a task during each of multiple successive periods, an owner or operator may perform the required task at any time during the specified period, provided the task is conducted at a reasonable interval after completion of the task in the previous period.

(k) Affirmative defense for violation of emission standards during malfunction. In response to an action to enforce the standards set forth in this subpart, the owner or operator may assert an affirmative defense to a claim for civil penalties for violations of such standards that are caused by malfunction, as defined at §63.2. Appropriate penalties may be assessed if the owner or operator fails to meet their burden of proving all of the requirements in the affirmative defense. The affirmative defense shall not be available for claims for injunctive relief.

(1) Assertion of affirmative defense. To establish the affirmative defense in any action to enforce such a standard, the owner or operator must timely meet the reporting requirements in paragraph (k)(2) of this section, and must prove by a preponderance of evidence that:

(i) The violation:

(A) Was caused by a sudden, infrequent, and unavoidable failure of air pollution control equipment, process equipment, or a process to operate in a normal or usual manner; and

(B) Could not have been prevented through careful planning, proper design or better operation and maintenance practices; and

(C) Did not stem from any activity or event that could have been foreseen and avoided, or planned for; and

(D) Was not part of a recurring pattern indicative of inadequate design, operation, or maintenance; and

(ii) Repairs were made as expeditiously as possible when a violation occurred; and

(iii) The frequency, amount, and duration of the violation (including any bypass) were minimized to the maximum extent practicable; and

(iv) If the violation 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; and

(v) All possible steps were taken to minimize the impact of the violation on ambient air quality, the environment, and human health; and

(vi) All emissions monitoring and control systems were kept in operation if at all possible, consistent with safety and good air pollution control practices; and

(vii) All of the actions in response to the violation were documented by properly signed, contemporaneous operating logs; and

(viii) At all times, the affected source was operated in a manner consistent with good practices for minimizing emissions; and

(ix) A written root cause analysis has been prepared, the purpose of which is to determine, correct, and eliminate the primary causes of the malfunction and the violation resulting from the malfunction event at issue. The analysis shall also specify, using best monitoring methods and engineering judgment, the amount of any emissions that were the result of the malfunction.

(2) Report. The owner or operator seeking to assert an affirmative defense shall submit a written report to the Administrator, with all necessary supporting documentation, that explains how it has met the requirements set forth in paragraph (k)(1) of this section. This affirmative defense report shall be included in the first periodic compliance report, deviation report, or excess emission report otherwise required after the initial occurrence of the violation of the relevant standard (which may be the end of any applicable averaging period). If such compliance, deviation report or excess emission report is due less than 45 days after the initial occurrence of the violation, the affirmative defense report may be included in the second compliance, deviation report or excess emission report due after the initial occurrence of the violation of the relevant standard.

[64 FR 33589, June 23, 1999, as amended at 67 FR 59340, Sept. 20, 2002; 79 FR 17371, Mar. 27, 2014]