Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter C - Air Programs |
Part 63 - National Emission Standards for Hazardous Air Pollutants for Source Categories |
Subpart GGG - National Emission Standards for Pharmaceuticals Production |
Table 1 to Subpart GGG of Part 63 - General Provisions Applicability to Subpart GGG
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Table 1 to Subpart GGG of Part 63 - General Provisions Applicability to Subpart GGG
General provisions reference Summary of requirements Applies to subpart GGG Comments 63.1(a)(1) General applicability of the General Provisions Yes Additional terms defined in § 63.1251; when overlap between subparts A and GGG of this part, subpart GGG takes precedence. 63.1(a)(2-7) Yes 63.1(a)(8) No Discusses state programs. 63.1(a)(9-14) Yes 63.1(b)(1) Initial applicability determination Yes Subpart GGG clarifies the applicability in § 63.1250. 63.1(b)(2) Title V operating permit - see part 70 Yes All major affected sources are required to obtain a title V permit. 63.1(b)(3) Record of the applicability determination Yes All affected sources are subject to subpart GGG according to the applicability definition of subpart GGG. 63.1(c)(1) Applicability after standards are set Yes Subpart GGG clarifies the applicability of each paragraph of subpart A to sources subject to subpart GGG. 63.1(c)(2) Title V permit requirement No All major affected sources are required to obtain a title V permit. Area sources are not subject to subpart GGG. 63.1(c)(3) Reserved 63.1(c)(4) Requirements for existing source that obtains an extension of compliance Yes § 63.1(c)(5) Notification requirements for an area source that increases HAP emissions to major source levels Yes 63.1(c)(6) Reclassification Yes 63.1(d) [Reserved] NA 63.1(e) Applicability of permit program before a relevant standard has been set Yes 63.2 Definitions. Yes Additional terms defined in § 63.1251; when overlap between subparts A and GGG of this part occurs, subpart GGG takes precedence. 63.3 Units and abbreviations. Yes Other units used in subpart GGG are defined in that subpart. 63.4 Prohibited activities. Yes 63.5(a) Construction and reconstruction - applicability Yes Except replace the terms “source” and “stationary source” with “affected source”. 63.5(b)(1) Upon construction, relevant standards for new sources Yes 63.5(b)(2) [Reserved] NA 63.5(b)(3) New construction/reconstruction Yes Except for changes and additions authorized under § 52.2454 of this title. However, the requirement to submit the Precompliance report at least 90 days before the compliance date still applies. 63.5(b)(4) Construction/reconstruction notification Yes 63.5(b)(5) Construction/reconstruction compliance Yes 63.5(b)(6) Equipment addition or process change Yes 63.5(c) [Reserved] NA 63.5(d) Application for approval of construction/reconstruction Yes Except for certain provisions identified in 63.1259(a)(5) § 63.5(e) Construction/reconstruction approval Yes 63.5(f) Construction/reconstruction approval based on prior State review. Yes Except replace “source” with “affected source”. 63.6(a)(1) Compliance with standards and maintenance requirements Yes 63.6(a)(2) Requirements for area source that increases emissions to become major Yes 63.6(b)(1-2) Compliance dates for new and reconstructed sources No Subpart GGG specifies compliance dates. 63.6(b)(3-6) Compliance dates for area sources that become major sources Yes 63.6 (b)(7) Compliance dates for new sources resulting from new unaffected area sources becoming subject to standards No Subpart GGG specifies NS applicability and compliance dates 63.6(c) Compliance dates for existing sources Yes Except replace “source” with “affected source”. Subpart GGG specifies compliance dates. § 63.6(e)(1)(i) Requirements during periods of startup, shutdown, and malfunction No See 63.1250(g)(3) for general duty requirement. Any cross-reference to 63.6(e)(1)(i) in any other general provision incorporated by reference shall be treated as a cross-reference to 63.1250(g)(3). § 63.6(e)(1)(ii) Malfunction correction requirements No. § 63.6(e)(1)(iii) Enforceability of operation and maintenance requirements Yes. § 63.6(e)(2) Reserved No Section reserved. § 63.6(e)(3) Startup, shutdown, and malfunction plan requirements No. 63.6(f)(1) Applicability of nonopacity emission standards No. 63.6(f)(2)-(3) Methods of determining compliance and findings compliance Yes. 63.6(g) Use of an alternative nonopacity emission standard Yes. 63.6(h) Opacity and visible emission standards No Subpart GGG does not contain any opacity or visible emission standards. § 63.6(i)(1) through (7) Requests for compliance extensions No § 63.1250(f)(6) specifies provisions for compliance extensions. § 63.6(i)(8) through (14) Approval of compliance extensions Yes Except references to § 63.6(i)(4) through (6) mean § 63.1250(f)(6). 63.6(j) Exemption from compliance with emission standards Yes 63.7(a)(1) Performance testing requirements Yes Subpart GGG also specifies required testing and compliance procedures. 63.7(a)(2)(i)-(ix) Yes Except substitute “150 days” instead of “180 days.” 63.7(a)(3) Yes 63.7(b)(1) Notification of performance test Yes 63.7(b)(2) Notification of delay in conducting a scheduled performance test Yes 63.7(c) Quality assurance program Yes Except that the test plan must be submitted with the notification of the performance test. 63.7(d) Performance testing facilities. Yes Except replace “source” with “affected source”. 63.7(e)(1) Conduct of performance tests No See 63.1257(a) text. Any cross-reference to 63.7(e)(1) in any other general provision incorporated by reference shall be treated as a cross-reference to 63.1257(a). 63.7(e)(2)-(4) Performance tests requirements Yes. 63.7(f) Use of alternative test method Yes 63.7(g) Data analysis, recordkeeping, and reporting Yes 63.7(h) Waiver of performance tests Yes 63.8(a) Monitoring requirements Yes See § 63.1258. 63.8(b)(1) Conduct of monitoring Yes 63.8(b)(2) CMS and combined effluents No § 63.1258 of subpart GGG provides specific CMS requirements. 63.8(b)(3)-(c)(4) CMS requirements Yes § 63.1259 also specifies recordkeeping for CMS. 63.8(c)(5) COMS operation requirements No 63.8(c)(6)-(8) CMS calibration and malfunction provisions No Calibration procedures are provided in § 63.1258. 63.8(d)(1)-(2) CMS quality control program requirements Yes. 63.8(d)(3) CMS quality control program recordkeeping requirements Yes, except for last sentence 63.8(e)(1) Performance evaluations of CMS Yes 63.8(e)(2) Notification of performance evaluation Yes 63.8(e)(3-4) CMS requirements/alternatives Yes § 63.8(e)(5)(i) Reporting performance evaluation results Yes See § 63.1260(a). 63.1260 (a). 63.8(e)(5)(ii) Results of COMS performance evaluation No Subpart GGG does not contain any opacity or visible emission standards. 63.8(f)-(g) Alternative monitoring method/reduction of monitoring data Yes 63.9(a)-(d) Notification requirements - Applicability and general information Yes § 63.1260 (b) also specifies initial notification requirement. 63.9(e) Notification of performance test Yes § 63.1260 (l) also specifies notification requirement for performance test. 63.9(f) Notification of opacity and visible emissions observations No Subpart GGG does not contain any opacity or visible emission standards. 63.9(g)(1) Additional notification requirements for sources with CMS Yes § 63.1260 (d) also specifies notification requirement for performance evaluation. 63.9(g)(2) Notification of compliance with opacity emission standard No Subpart GGG does not contain any opacity or visible emission standards. 63.9(g)(3) Notification that criterion to continue use of alternative to relative accuracy testing has been exceeded Yes § 63.1260 (d) also specifies notification requirement for performance evaluation. 63.9(h) Notification of compliance status Yes Specified in § 63.1260(f). Due 150 days after compliance date. 63.9(i) Adjustment to time periods or postmark deadlines for submittal and review of required communications Yes 63.9(j) Change in information provided Yes For change in major source status only. 63.9(k) Electronic reporting procedures Yes Only as specified in § 63.9(j). 63.10(a) Recordkeeping requirements Yes 63.1259. 63.10(b)(1) Records retention Yes Also stated in § 63.1259. 63.10(b)(2) Information and documentation to support notifications No Subpart GGG specifies recordkeeping requirements. 63.10(b)(3) Records retention for sources not subject to relevant standard Yes Also stated in § 63.1259 (a)(2). 63.10(c)(1)-(9) Additional recordkeeping requirements for sources with continuous monitoring systems Yes. 63.10(c)(10) Malfunction recordkeeping requirement No Subpart GGG specifies recordkeeping requirements. 63.10(c)(11) Malfunction corrective action recordkeeping requirement No Subpart GGG specifies recordkeeping requirements. 63.10(c)(12)-(14) Additional recordkeeping requirements for sources with continuous monitoring systems Yes. 63.10(c)(15) Additional SSM recordkeeping requirements No. 63.10(d)(1)-(2) General reporting requirements Yes. 63.10(d)(3) Reporting results of opacity or visible emissions observations No Subpart GGG does not include any opacity or visible emission standards. 63.10(d)(4) Progress report requirements Yes. 63.10(d)(5) Startup, shutdown, and malfunction report requirements No Subpart GGG specifies reporting requirements. 63.10(e) Additional CMS reporting requirements Yes 63.10(f) Waiver of recordkeeping or reporting requirements. Yes 63.11 Control device and equipment leak work practice requirements Yes 63.13 Addresses of State air pollution control agencies Yes 63.14 Incorporations by reference Yes 63.15 Availability of information and confidentiality Yes [63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52614, Aug. 29, 2000; 66 FR 40136, Aug. 2, 2001; 73 FR 78213, Dec. 22, 2008; 76 FR 22601, Apr. 21, 2011; 85 FR 73897, Nov. 19, 2020]