40 CFR § 63.192 - Standard.
(1) The owner or operator of a source subject to this subpart shall comply with the requirements of subpart H of this part for the processes and designated organic HAP's listed in § 63.190(b) of this subpart.
(2) The owner or operator of a pharmaceutical production process subject to this subpart may define a process unit as a set of operations, within a source, producing a product, as all operations collocated within a building or structure or as all affected operations at the source.
(3) The units and abbreviations in § 63.3;
(4) The prohibited activities and circumvention provisions of § 63.4 (a)(1), (a)(2), (a)(3), (a)(5), and (b);
(i) The compliance with standards and maintenance requirements of § 63.6(a), (b)(3), (c)(5), (e), (i)(1), (i)(2), (i)(4)(i)(A), (i)(6)(i), (i)(8) through (i)(10), (i)(12) through (i)(14), (i)(16), and (j);
(ii) The operational and maintenance requirements of § 63.6(e). The startup, shutdown, and malfunction plan requirement of § 63.6(e)(3) is limited to control devices subject to the provisions of subpart H of part 63 and is optional for other equipment subject to subpart H. The startup, shutdown, and malfunction plan may include written procedures that identify conditions that justify a delay of repair.
(2) The owner or operator shall notify the Administrator of the intention to conduct a performance test at least 30 days before the performance test is scheduled to allow the Administrator the opportunity to have an observer present during the test.
(3) Performance tests shall be conducted according to the provisions of § 63.7(e) of subpart A of this part, except that performance tests shall be conducted at maximum representative operating conditions for the process. During the performance test, an owner or operator may operate the control or recovery device at maximum or minimum representative operating conditions for monitored control or recovery device parameters, whichever results in lower emission reduction.
(4) Data shall be reduced in accordance with the EPA-approved methods specified in the applicable subpart, or, if other test methods are used, the data and methods shall be validated according to the protocol in Method 301 of appendix A of this part.
(e) If an owner or operator of a process plans to eliminate the use or production of all HAP's that cause the process to be subject to the provisions of subparts I and H of this part no later than 18 months after April 22, 1994, the owner or operator shall submit to the Administrator a brief description of the change, identify the HAP's eliminated, and the expected date of cessation of operation of the current process, by no later than January 23, 1995.
(f) Each owner or operator of a source subject to subparts I and H of this part shall keep copies of all applicable reports and records required by subpart H for at least 2 years, except as otherwise specified in subpart H. If an owner or operator submits copies of reports to the applicable EPA Regional Office, the owner or operator is not required to maintain copies of reports. If the EPA Regional Office has waived the requirement of § 63.10(a)(4)(ii) for submittal of copies of reports, the owner or operator is not required to maintain copies of reports.
(1) All applicable records shall be maintained in such a manner that they can be readily accessed. The most recent 6 months of records shall be retained on site or shall be accessible from a central location by computer or other means that provides access within 2 hours after a request.
(iii) For each start-up, shutdown, and malfunction, records that the procedures specified in the source's start-up, shutdown, and malfunction plan were followed, and documentation of actions taken that are not consistent with the plan. These records may take the form of a “checklist,” or other form of recordkeeping that confirms conformance with the startup, shutdown, and malfunction plan for the event.
(1) Wherever subpart A specifies “postmark” dates, submittals may be sent by methods other than the U.S. Mail (e.g., by fax or courier). Submittals shall be sent on or before the specified date.
(h) If, in the judgment of the Administrator, an alternative means of emission limitation will achieve a reduction in organic HAP emissions at least equivalent to the reduction in organic HAP emissions from that source achieved under any design, equipment, work practice, or operational standards in subpart H of this part, the Administrator will publish in the Federal Register a notice permitting the use of the alternative means for purposes of compliance with that requirement.
(1) The notice may condition the permission on requirements related to the operation and maintenance of the alternative means.
(2) Any notice under paragraph (h) of this section shall be published only after public notice and an opportunity for a hearing.
(3) Any person seeking permission to use an alternative means of compliance under this section shall collect, verify, and submit to the Administrator information showing that the alternative means achieves equivalent emission reductions.
(1) Retain information, data, and analysis used to determine that the process unit does not have the designated organic hazardous air pollutant present in the process. 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.
(l) To qualify for the exemption specified in § 63.190(b)(7) of this subpart, the owner or operator shall maintain the documentation of the information required pursuant to § 63.190(b)(7)(i), and documentation of any update of this information requested by the EPA Regional Office, and shall provide the documentation to the EPA Regional Office upon request. The EPA Regional Office will notify the owner or operator, after reviewing such documentation, whether, in the EPA Regional Office's judgement, the source does not qualify for the exemption specified in § 63.190(b)(7) of this subpart. In such cases, compliance with this subpart shall be required no later than 90 days after the date of such notification by the EPA Regional Office.
(m) An owner or operator who elects to use the compliance extension provisions of § 63.190(e)(5) (i) or (ii) shall submit a compliance extension request to the appropriate EPA Regional Office no later than May 10, 1995. The request shall contain the information specified in § 63.190(e)(4)(iv) and the reason compliance cannot reasonably be achieved without a process unit shutdown, as defined in § 63.161 of subpart H or replacement of the compressor or recasting of the distance piece.