(a) General requirement. As an alternative to complying with the requirements of §§63.1025 through 63.1033 and §63.1035, an owner or operator of a batch process that operates in regulated material service during the calendar year may comply with one of the standards specified in paragraphs (b) and (c) of this section, or the owner or operator may petition for approval of an alternative standard under the provisions of §63.1021(b). The alternative standards of this section provide the options of pressure testing or monitoring the equipment for leaks. The owner or operator may switch among the alternatives provided the change is documented as specified in paragraph (b)(7) of this section.

(b) Pressure testing of the batch equipment. The following requirements shall be met if an owner or operator elects to use pressure testing of batch product-process equipment to demonstrate compliance with this subpart.

(1) Reconfiguration. Each time equipment is reconfigured for production of a different product or intermediate, the batch product-process equipment train shall be pressure-tested for leaks before regulated material is first fed to the equipment and the equipment is placed in regulated material service.

(i) When the batch product-process equipment train is reconfigured to produce a different product, pressure testing is required only for the new or disturbed equipment.

(ii) Each batch product process that operates in regulated material service during a calendar year shall be pressure-tested at least once during that calendar year.

(iii) Pressure testing is not required for routine seal breaks, such as changing hoses or filters, that are not part of the reconfiguration to produce a different product or intermediate.

(2) Testing procedures. The batch product process equipment shall be tested either using the procedures specified in paragraph (b)(5) of this section for pressure vacuum loss or with a liquid using the procedures specified in paragraph (b)(6) of this section.

(3) Leak detection.

(i) For pressure or vacuum tests using a gas, a leak is detected if the rate of change in pressure is greater than 6.9 kilopascals (1 pound per square inch gauge) in 1 hour or if there is visible, audible, or olfactory evidence of fluid loss.

(ii) For pressure tests using a liquid, a leak is detected if there are indications of liquids dripping or if there is other evidence of fluid loss.

(4) Leak repair.

(i) If a leak is detected, it shall be repaired and the batch product-process equipment shall be retested before start-up of the process.

(ii) If a batch product-process fails the retest (the second of two consecutive pressure tests), it shall be repaired as soon as practical, but not later than 30 calendar days after the second pressure test except as specified in paragraph (e) of this section.

(5) Gas pressure test procedure for pressure or vacuum loss. The procedures specified in paragraphs (b)(5)(i) through (b)(5)(v) of this section shall be used to pressure test batch product-process equipment for pressure or vacuum loss to demonstrate compliance with the requirements of paragraph (b)(3)(i) of this section.

(i) The batch product-process equipment train shall be pressurized with a gas to a pressure less than the set pressure of any safety relief devices or valves or to a pressure slightly above the operating pressure of the equipment, or alternatively the equipment shall be placed under a vacuum.

(ii) Once the test pressure is obtained, the gas source or vacuum source shall be shut off.

(iii) The test shall continue for not less than 15 minutes unless it can be determined in a shorter period of time that the allowable rate of pressure drop or of pressure rise was exceeded. The pressure in the batch product-process equipment shall be measured after the gas or vacuum source is shut off and at the end of the test period. The rate of change in pressure in the batch product-process equipment shall be calculated using the following equation:

(iv) The pressure shall be measured using a pressure measurement device (gauge, manometer, or equivalent) that has a precision of ±2.5 millimeter mercury (0.10 inch of mercury) in the range of test pressure and is capable of measuring pressures up to the relief set pressure of the pressure relief device. If such a pressure measurement device is not reasonably available, the owner or operator shall use a pressure measurement device with a precision of at least ±10 percent of the test pressure of the equipment and shall extend the duration of the test for the time necessary to detect a pressure loss or rise that equals a rate of 1 pound per square inch gauge per hour (7 kilopascals per hour).

(v) An alternative procedure may be used for leak testing the equipment if the owner or operator demonstrates the alternative procedure is capable of detecting a pressure loss or rise.

(6) Pressure test procedure using test liquid. The procedures specified in paragraphs (b)(6)(i) through (b)(6)(iv) of this section shall be used to pressure-test batch product-process equipment using a liquid to demonstrate compliance with the requirements of paragraph (b)(3)(ii) of this section.

(i) The batch product-process equipment train, or section of the equipment train, shall be filled with the test liquid (e.g., water, alcohol) until normal operating pressure is obtained. Once the equipment is filled, the liquid source shall be shut off.

(ii) The test shall be conducted for a period of at least 60 minutes, unless it can be determined in a shorter period of time that the test is a failure.

(iii) Each seal in the equipment being tested shall be inspected for indications of liquid dripping or other indications of fluid loss. If there are any indications of liquids dripping or of fluid loss, a leak is detected.

(iv) An alternative procedure may be used for leak testing the equipment, if the owner or operator demonstrates the alternative procedure is capable of detecting losses of fluid.

(7) Pressure testing recordkeeping. The owner or operator of a batch product process who elects to pressure test the batch product process equipment train to demonstrate compliance with this subpart shall maintain records of the information specified in paragraphs (b)(7)(i) through (b)(7)(v) of this section.

(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 a batch product process equipment train.

(ii) Physical tagging of the equipment to identify that it is in regulated material service and subject to the provisions of this subpart is not required. Equipment in a batch product process subject to the provisions of this subpart 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 paragraph (b) of this section, 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 batch product process equipment train does not pass two consecutive pressure tests, the information specified in paragraphs (b)(7)(v)(A) through (b)(7)(v)(E) of this section 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; and

(E) The date of successful repair.

(c) Equipment monitoring. The following requirements shall be met if an owner or operator elects to monitor the equipment in a batch process to detect leaks by the method specified in §63.1023(b) and, as applicable, §63.1023(c), to demonstrate compliance with this subpart.

(1) The owner or operator shall comply with the requirements of §§63.1025 through 63.1035 as modified by paragraphs (c)(2) through (c)(4) of this section.

(2) The equipment shall be monitored for leaks by the method specified in §63.1023(b) and, as applicable, §63.1023(c), when the equipment is in regulated material service or is in use with any other detectable material.

(3) The equipment shall be monitored for leaks as specified in paragraphs (c)(3)(i) through (c)(3)(iv) of this section.

(i) Each time the equipment is reconfigured for the production of a new product, the reconfigured equipment shall be monitored for leaks within 30 days of start-up of the process. This initial monitoring of reconfigured equipment shall not be included in determining percent leaking equipment in the process unit or affected facility.

(ii) Connectors shall be monitored in accordance with the requirements in §63.1027.

(iii) Equipment other than connectors shall be monitored at the frequencies specified in table 1 to this subpart. The operating time shall be determined as the proportion of the year the batch product-process that is subject to the provisions of this subpart is operating.

(iv) The monitoring frequencies specified in paragraph (c)(3)(iii) of this section are not requirements for monitoring at specific intervals and can be adjusted to accommodate process operations. An owner or operator may monitor anytime during the specified monitoring period (e.g., month, quarter, year), provided the monitoring is conducted at a reasonable interval after completion of the last monitoring campaign. For example, if the equipment is not operating during the scheduled monitoring period, the monitoring can be done during the next period when the process is operating.

(4) If a leak is detected, it shall be repaired as soon as practical but not later than 15 calendar days after it is detected, except as provided in paragraph (e) of this section.

(d) Added equipment recordkeeping.

(1) For batch product-process units or affected facilities that the owner or operator elects to monitor as provided under paragraph (c) of this section, the owner or operator shall prepare a list of equipment added to batch product process units or affected facilities since the last monitoring period required in paragraphs (c)(3)(ii) and (c)(3)(iii) of this section.

(2) Maintain records demonstrating the proportion of the time during the calendar year the equipment is in use in a batch process that is subject to the provisions of this subpart. Examples of suitable documentation are records of time in use for individual pieces of equipment or average time in use for the process unit or affected facility. These records are not required if the owner or operator does not adjust monitoring frequency by the time in use, as provided in paragraph (c)(3)(iii) of this section.

(3) Record and keep pursuant to the referencing subpart and this subpart, the date and results of the monitoring required in paragraph (c)(3)(i) of this section for equipment added to a batch product-process unit or affected facility since the last monitoring period required in paragraphs (c)(3)(ii) and (c)(3)(iii) of this section. If no leaking equipment is found during this monitoring, the owner or operator shall record that the inspection was performed. Records of the actual monitoring results are not required.

(e) Delay of repair. Delay of repair of equipment for which leaks have been detected is allowed if the replacement equipment is not available providing the conditions specified in paragraphs (e)(1) and (e)(2) of this section are met.

(1) Equipment supplies have been depleted and supplies had been sufficiently stocked before the supplies were depleted.

(2) The repair is made no later than 10 calendar days after delivery of the replacement equipment.

(f) Periodic report contents. For owners or operators electing to meet the requirements of paragraph (b) of this section, the Periodic Report to be filed pursuant to §63.1039(b) shall include the information listed in paragraphs (f)(1) through (f)(4) of this section for each process unit.

(1) Batch product process equipment train identification;

(2) The number of pressure tests conducted;

(3) The number of pressure tests where the equipment train failed the pressure test; and

(4) The facts that explain any delay of repairs.