[Code of Federal Regulations]
[Title 40, Volume 11]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR63.1260]

[Page 167-171]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES--Table of Contents
 
 Subpart GGG--National Emission Standards for Pharmaceuticals Production
 
Sec. 63.1260  Reporting requirements.

    (a) The owner or operator of an affected source shall comply with 
the reporting requirements of paragraphs (b) through (l) of this 
section. Applicable reporting requirements of Secs. 63.9 and 63.10 are 
also summarized in Table 1 of this subpart.
    (b) Initial notification. The owner or operator shall submit the 
applicable initial notification in accordance with Sec. 63.9(b) or (d).
    (c) Application for approval of construction or reconstruction. An 
owner or operator who is subject to Sec. 63.5(b)(3) shall submit to the 
Administrator an application for approval of the construction of a new 
major affected source, the reconstruction of a major affected source, or 
the reconstruction of a major source such that the source becomes a 
major affected source subject to the standards. The application shall be 
prepared in accordance with Sec. 63.5(d).
    (d) Notification of CMS performance evaluation. An owner or operator 
who is

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required by the Administrator to conduct a performance evaluation for a 
continuous monitoring system shall notify the Administrator of the date 
of the performance evaluation as specified in Sec. 63.8(e)(2).
    (e) Precompliance report. The Precompliance report shall be 
submitted at least 6 months prior to the compliance date of the 
standard. For new sources, the Precompliance report shall be submitted 
to the Administrator with the application for approval of construction 
or reconstruction. The Administrator shall have 90 days to approve or 
disapprove the plan. The plan shall be considered approved if the 
Administrator either approves the plan in writing, or fails to 
disapprove the plan in writing. The 90 day period shall begin when the 
Administrator receives the request. If the request is denied, the owner 
or operator must still be in compliance with the standard by the 
compliance date. To change any of the information submitted in the 
report, the owner or operator shall notify the Administrator 90 days 
before the planned change is to be implemented; the change shall be 
considered approved if the Administrator either approves the change in 
writing, or fails to disapprove the change in writing. The Precompliance 
report shall include:
    (1) Requests for approval to use alternative monitoring parameters 
or requests to set monitoring parameters according to Sec. 63.1258(b)(4).
    (2) Descriptions of the daily or per batch demonstrations to verify 
that control devices subject to Sec. 63.1258(b)(1)(i) are operating as 
designed.
    (3) A description of test conditions, and the corresponding 
monitoring parameter values for parameters that are set according to Sec. 
63.1258(b)(3)(ii)(C).
    (4) For owners and operators complying with the requirements of Sec. 
63.1252(e), the P2 demonstration summary required in Sec. 63.1257(f).
    (5) Data and rationale used to support an engineering assessment to 
calculate uncontrolled emissions from process vents as required in Sec. 
63.1257(d)(2)(ii).
    (6) Data and other information supporting the determination of 
annual average concentrations by process simulation as required in Sec. 
63.1257(e)(1)(ii).
    (7) Bench scale or pilot-scale test data and rationale used to 
determine annual average concentrations as required in Sec. 
63.1257(e)(1)(ii)(C).
    (f) Notification of Compliance Status report. The Notification of 
Compliance Status report required under Sec. 63.9 shall be submitted no 
later than 150 days after the compliance date and shall include:
    (1) The results of any applicability determinations, emission 
calculations, or analyses used to identify and quantify HAP emissions 
from the affected source.
    (2) The results of emissions profiles, performance tests, 
engineering analyses, design evaluations, or calculations used to 
demonstrate compliance. For performance tests, results should include 
descriptions of sampling and analysis procedures and quality assurance 
procedures.
    (3) Descriptions of monitoring devices, monitoring frequencies, and 
the values of monitored parameters established during the initial 
compliance determinations, including data and calculations to support 
the levels established.
    (4) Listing of all operating scenarios.
    (5) Descriptions of worst-case operating and/or testing conditions 
for control devices.
    (6) Identification of emission points subject to overlapping 
requirements described in Sec. 63.1250(h) and the authority under which the 
owner or operator will comply.
    (7) Anticipated periods of planned routine maintenance of a CCCD 
subject to Sec. 63.1252(h) during the period between the compliance date 
and the end of the period covered by the first Periodic report, and if 
applicable, the rationale for why the planned routine maintenance must 
be performed while a process with a vent subject to Sec. 63.1254(a)(3) will 
be operating.
    (g) Periodic reports. An owner or operator shall prepare Periodic 
reports in accordance with paragraphs (g)(1) and (2) of this section and 
submit them to the Administrator.
    (1) Submittal schedule. Except as provided in paragraphs (g)(1)(i), 
(ii), and

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(iii) of this section, an owner or operator shall submit Periodic 
reports semiannually. The first report shall be submitted no later than 
240 days after the Notification of Compliance Status is due and shall 
cover the 6-month period beginning on the date the Notification of 
Compliance Status is due. Each subsequent Periodic report shall cover 
the 6-month period following the preceding period.
    (i) When the Administrator determines on a case-by-case basis that 
more frequent reporting is necessary to accurately assess the compliance 
status of the affected source; or
    (ii) Quarterly reports shall be submitted when the source 
experiences an exceedance of a temperature limit monitored according to 
the provisions of Sec. 63.1258(b)(1)(iii) or an exceedance of the outlet 
concentration monitored according to the provisions of Sec. 
63.1258(b)(1)(x) or (b)(5). Once an affected source reports quarterly, 
the affected source shall follow a quarterly reporting format until a 
request to reduce reporting frequency is approved. If an owner or 
operator submits a request to reduce the frequency of reporting, the 
provisions in Sec. 63.10(e)(3)(ii) and (iii) shall apply, except that the 
phrase ``excess emissions and continuous monitoring system performance 
report and/or summary report'' shall mean ``Periodic report'' for the 
purposes of this section.
    (iii) When a new operating scenario has been operated since the last 
report, in which case quarterly reports shall be submitted.
    (2) Content of Periodic report. The owner or operator shall include 
the information in paragraphs (g)(2)(i) through (vii) of this section, 
as applicable.
    (i) Each Periodic report must include the information in Sec. 
63.10(e)(3)(vi)(A) through (I) and (K) through (M). For each continuous 
monitoring system, the Periodic report must also include the information 
in Sec. 63.10(e)(3)(vi)(J).
    (ii) If the total duration of excess emissions, parameter 
exceedances, or excursions for the reporting period is 1 percent or 
greater of the total operating time for the reporting period, or the 
total continuous monitoring system downtime for the reporting period is 
5 percent or greater of the total operating time for the reporting 
period, the Periodic report must include the information in paragraphs 
(g)(2)(ii)(A) through (D) of this section.
    (A) Monitoring data, including 15-minute monitoring values as well 
as daily average values of monitored parameters, for all operating days 
when the average values were outside the ranges established in the 
Notification of Compliance Status report or operating permit.
    (B) Duration of excursions, as defined in Sec. 63.1258(b)(7).
    (C) Operating logs and operating scenarios for all operating 
scenarios for all operating days when the values are outside the levels 
established in the Notification of Compliance Status report or operating 
permit.
    (D) When a continuous monitoring system is used, the information 
required in Sec. 63.10(c)(5) through (13).
    (iii) For each inspection conducted in accordance with Sec. 
63.1258(h)(2) or (3) during which a leak is detected, the records 
specified in Sec. 63.1259(i)(7) must be included in the next Periodic 
report.
    (iv) For each vapor collection system or closed vent system with a 
bypass line subject to Sec. 63.1252(b)(1), records required under Sec. 
63.1259(i)(6)(i) of all periods when the vent stream is diverted from 
the control device through a bypass line. For each vapor collection 
system or closed vent system with a bypass line subject to Sec. 
63.1252(b)(2), records required under Sec. 63.1259(i)(6)(ii) of all periods 
in which the seal mechanism is broken, the bypass valve position has 
changed, or the key to unlock the bypass line valve was checked out.
    (v) The information in paragraphs (g)(2)(v)(A) through (D) of this 
section shall be stated in the Periodic report, when applicable.
    (A) No excess emissions.
    (B) No exceedances of a parameter.
    (C) No excursions.
    (D) No continuous monitoring system has been inoperative, out of 
control, repaired, or adjusted.
    (vi) The information specified in paragraphs (g)(2)(vi)(A) through 
(C) for periods of planned routine maintenance.
    (A) For each storage tank subject to control requirements, periods 
of

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planned routine maintenance during which the control device does not 
meet the specifications of Sec. 63.1253(b) through (d).
    (B) For a CCCD subject to Sec. 63.1252(h), periods of planned routine 
maintenance during the current reporting period and anticipated periods 
of planned routine maintenance during the next reporting period.
    (C) Rationale for why planned routine maintenance of a CCCD subject 
to Sec. 63.1252(h) must be performed while a process with a vent subject to 
Sec. 63.1254(a)(3) will be operating, if applicable. This requirement 
applies only if the rationale is not in, or differs from that in, the 
Notification of Compliance Status report.
    (vii) Each new operating scenario which has been operated since the 
time period covered by the last Periodic report. For each new operating 
scenario, the owner or operator shall provide verification that the 
operating conditions for any associated control or treatment device have 
not been exceeded, and that any required calculations and engineering 
analyses have been performed. For the initial Periodic report, each 
operating scenario for each process operated since the due date of the 
Notification of Compliance Status Report shall be submitted.
    (viii) If the owner or operator elects to comply with the provisions 
of Sec. 63.1253(b) or (c) by installing a floating roof, the owner or 
operator shall submit the information specified in Sec. 63.122(d) through 
(f) as applicable. References to Sec. 63.152 from Sec. 63.122 shall not apply 
for the purposes of this subpart.
    (h) Notification of process change.
    (1) Except as specified in paragraph (h)(2) of this section, 
whenever a process change is made, or a change in any of the information 
submitted in the Notification of Compliance Status Report, the owner or 
operator shall submit the information specified in paragraphs (h)(1)(i) 
through (iv) of this section with the next Periodic report required 
under paragraph (g) of this section.
    (i) A brief description of the process change.
    (ii) A description of any modifications to standard procedures or 
quality assurance procedures.
    (iii) Revisions to any of the information reported in the original 
Notification of Compliance Status Report under paragraph (f) of this 
section.
    (iv) Information required by the Notification of Compliance Status 
Report under paragraph (f) of this section for changes involving the 
addition of processes or equipment.
    (2) An owner or operator must submit a report 60 days before the 
scheduled implementation date of either of the following:
    (i) Any change in the activity covered by the Precompliance report.
    (ii) A change in the status of a control device from small to large.
    (i) Reports of startup, shutdown, and malfunction. An owner or 
operator shall prepare startup, shutdown, and malfunction reports as 
specified in paragraphs (i)(1) and (2) of this section.
    (1) If actions taken by an owner or operator during a startup, 
shutdown, or malfunction of an affected source (including actions to 
correct a malfunction) are consistent with the procedures specified in 
the source's startup, shutdown, and malfunction plan, the owner or 
operator shall state this fact in a startup, shutdown, or malfunction 
report. The report shall also include the information specified in Sec. 
63.1259(a)(3)(i) and (ii) and shall contain the name, title, and 
signature of the owner or operator or other responsible official who is 
certifying its accuracy. For the purposes of this subpart, the startup, 
shutdown, and malfunction reports shall be submitted on the same 
schedule as the periodic reports required under paragraph (g) of this 
section instead of the schedule specified in Sec. 63.10(d)(5)(i). Reports 
are only required if a startup, shutdown, or malfunction occurred during 
the reporting period.
    (2) Any time an owner or operator takes an action that is not 
consistent with the procedures specified in the affected source's 
startup, shutdown, and malfunction plan, the owner or operator shall 
submit immediate startup, shutdown, and malfunction reports as specified 
in Sec. 63.10(d)(5)(ii).
    (j) Reports of LDAR programs. The owner or operator of any affected

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source implementing the LDAR program specified in Sec. 63.1255 of this 
subpart shall implement the reporting requirements in Sec. 63.1255 of this 
subpart. Copies of all reports shall be retained as records for a period 
of 5 years, in accordance with the requirements of Sec. 63.10(b)(1).
    (k) Reports of emissions averaging. The owner or operator of any 
affected source that chooses to comply with the requirements of Sec. 
63.1252(d) shall submit the implementation plan described in Sec. 
63.1259(e) 6 months prior to the compliance date of the standard and the 
following information in the periodic reports:
    (1) The records specified in Sec. 63.1259(e) for each process or 
storage tank included in the emissions average;
    (2) All information as specified in paragraph (g) of this section 
for each process or storage tank included in the emissions average;
    (3) Any changes of the processes or storage tanks included in the 
average.
    (4) The calculation of the overall percent reduction efficiency for 
the reporting period.
    (5) Changes to the Implementation Plan which affect the calculation 
methodology of uncontrolled or controlled emissions or the hazard or 
risk equivalency determination.
    (6) Every second semiannual or fourth quarterly report, as 
appropriate, shall include the results according to Sec. 63.1259(e)(4) to 
demonstrate the emissions averaging provisions of Secs. 63.1252(d), 
63.1257(g) and (h), 63.1258(f), and 63.1259(f) are satisfied.
    (l) Notification of performance test and test plan. The owner or 
operator of an affected source shall notify the Administrator of the 
planned date of a performance test at least 60 days before the test in 
accordance with Sec. 63.7(b). The owner or operator also must submit the 
test plan required by Sec. 63.7(c) and the emission profile required by 
63.1257(b)(8)(ii) with the notification of the performance test.
    (m) Request for extension of compliance. An owner or operator may 
submit to the Administrator a request for an extension of compliance in 
accordance with Sec. 63.1250(f)(4).

[63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52614, Aug. 29, 2000; 
66 FR 40135, Aug. 2, 2001]