[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: 40CFR63.1259]

[Page 164-167]
 
                   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. 63.1259  Recordkeeping requirements.

    (a) Requirements of subpart A of this part. The owner or operator of 
an affected source shall comply with the recordkeeping requirements in 
subpart A of this part as specified in Table 1 of this subpart and in 
paragraphs (a)(1) through (5) of this section.
    (1) Data retention. Each owner or operator of an affected source 
shall keep copies of all records and reports required by this subpart 
for at least 5 years, as specified in Sec. 63.10(b)(1).
    (2) Records of applicability determinations. The owner or operator 
of a stationary source that is not subject to this subpart shall keep a 
record of the applicability determination, as specified in Sec. 
63.10(b)(3).
    (3) Startup, shutdown, and malfunction plan. The owner or operator 
of an affected source shall develop and implement a written startup, 
shutdown, and malfunction plan as specified in Sec. 63.6(e)(3). This plan 
shall describe, in detail, procedures for operating and maintaining the 
affected source during periods of startup, shutdown, and malfunction and 
a program for corrective action for malfunctioning process, air 
pollution control, and monitoring equipment used to comply with this 
subpart. The owner or operator of an affected source shall keep the 
current and superseded versions of this plan onsite, as specified in Sec. 
63.6(e)(3)(v). The owner or operator shall keep the startup, shutdown, 
and malfunction records specified in paragraphs (b)(3)(i) through (iii) 
of this section. Reports related to the plan shall be submitted as 
specified in Sec. 63.1260(i).
    (i) The owner or operator shall record the occurrence and duration 
of each malfunction of the process operations or of air pollution 
control equipment used to comply with this subpart, as specified in Sec. 
63.6(e)(3)(iii).
    (ii) The owner or operator shall record the occurrence and duration 
of each malfunction of continuous monitoring systems used to comply with 
this subpart.
    (iii) For each startup, shutdown, or malfunction, the owner or 
operator shall record all information necessary to demonstrate that the 
procedures specified in the affected source's startup, shutdown, and 
malfunction plan were followed, as specified in Sec. 63.6(e)(3)(iii); 
alternatively, the owner or operator shall record any actions taken that 
are not consistent with the plan, as specified in Sec. 63.6(e)(3)(iv).
    (4) Recordkeeping requirements for sources with continuous 
monitoring systems. The owner or operator of an affected source who 
elects to install a continuous monitoring system shall maintain records 
specified in Sec. 63.10(c)(1) through (14).
    (5) Application for approval of construction or reconstruction. For 
new affected sources, each owner or operator shall comply with the 
provisions in Sec. 63.5 regarding construction and reconstruction, 
excluding the provisions specified in Sec. 63.5(d)(1)(ii)(H), (d)(2), and 
(d)(3)(ii).
    (b) Records of equipment operation. The owner or operator must keep 
the following records up-to-date and readily accessible:
    (1) Each measurement of a control device operating parameter 
monitored in accordance with Sec. 63.1258 and each measurement of a 
treatment process parameter monitored in accordance with Sec. 63.1258(g)(2) 
and (3).
    (2) For processes subject to Sec. 63.1252(e), records of consumption, 
production, and the rolling average values of the production-indexed HAP 
and VOC consumption factors.
    (3) For each continuous monitoring system used to comply with this 
subpart, records documenting the completion of calibration checks and 
maintenance of continuous monitoring systems.
    (4) For purposes of compliance with the annual mass limits of Sec. 
63.1254(a)(2) and (b)(2), daily records of the rolling annual total 
emissions.
    (5) Records of the following, as appropriate:
    (i) For processes that are in compliance with the percent reduction 
requirements of Sec. 63.1254(a)(1) or (b)(1) and that contain vents 
controlled to less

[[Page 165]]

than the percent reduction requirement, the records specified in 
paragraphs (b)(5)(i)(A) through (C) of this section are required.
    (A) Standard batch uncontrolled and controlled emissions for each 
process;
    (B) Actual uncontrolled and controlled emissions for each 
nonstandard batch; and
    (C) A record whether each batch operated was considered a standard 
batch.
    (ii) For processes in compliance with the annual mass limits of Sec. 
63.1254(a)(2) or (b)(2), the following records are required:
    (A) The number of batches per year for each batch process;
    (B) The operating hours per year for continuous processes;
    (C) Standard batch uncontrolled and controlled emissions for each 
process;
    (D) Actual controlled emissions for each batch operated during 
periods of planned routine maintenance of a CCCD, calculated according 
to Sec. 63.1258(c).
    (E) Actual uncontrolled and controlled emissions for each 
nonstandard batch;
    (F) A record whether each batch operated was considered a standard 
batch.
    (6) Wastewater concentration per POD or process, except as provided 
in Sec. 63.1256(a)(1)(ii).
    (7) Number of storage tank turnovers per year, if used in an 
emissions average.
    (8) A schedule or log of each operating scenario updated daily or, 
at a minimum, each time a different operating scenario is put into 
operation.
    (9) Description of worst-case operating conditions as required in Sec. 
63.1257(b)(8).
    (10) Periods of planned routine maintenance as described in 
Secs. 63.1252(h) and 63.1257(c)(5).
    (11) If the owner or operator elects to comply with Sec. 63.1253(b) or 
(c) by installing a floating roof, the owner or operator must keep 
records of each inspection and seal gap measurement in accordance with Sec. 
63.123(c) through (e) as applicable.
    (12) If the owner or operator elects to comply with the vapor 
balancing alternative in Sec. 63.1253(f), the owner or operator must keep 
records of the DOT certification required by Sec. 63.1253(f)(2) and the 
pressure relief vent setting and the leak detection records specified in 
Sec. 63.1253(f)(5).
    (13) All maintenance performed on the air pollution control 
equipment.
    (c) Records of operating scenarios. The owner or operator of an 
affected source shall keep records of each operating scenario which 
demonstrates compliance with this subpart.
    (d) Records of equipment leak detection and repair programs. The 
owner or operator of any affected source implementing the leak detection 
and repair (LDAR) program specified in Sec. 63.1255 of this subpart, shall 
implement the recordkeeping requirements in Sec. 63.1255 of this subpart.
    (e) Records of emissions averaging. The owner or operator of any 
affected source that chooses to comply with the requirements of Sec. 
63.1252(d) shall maintain up-to-date records of the following 
information:
    (1) An Implementation Plan which shall include in the plan, for all 
process vents and storage tanks included in each of the averages, the 
information listed in paragraphs (e)(1)(i) through (v) of this section.
    (i) The identification of all process vents and storage tanks in 
each emissions average.
    (ii) The uncontrolled and controlled emissions of HAP and the 
overall percent reduction efficiency as determined in 
Secs. 63.1257(g)(1) through (4) or 63.1257(h)(1) through (3) as 
applicable.
    (iii) The calculations used to obtain the uncontrolled and 
controlled HAP emissions and the overall percent reduction efficiency.
    (iv) The estimated values for all parameters required to be 
monitored under Sec. 63.1258(f) for each process and storage tank included 
in an average.
    (v) A statement that the compliance demonstration, monitoring, 
inspection, recordkeeping and reporting provisions in Secs. 63.1257(g) 
and (h), 63.1258(f), and 63.1260(k) that are applicable to each emission 
point in the emissions average will be implemented beginning on the date 
of compliance.
    (2) The Implementation Plan must demonstrate that the emissions from

[[Page 166]]

the processes and storage tanks proposed to be included in the average 
will not result in greater hazard or, at the option of the operating 
permit authority, greater risk to human health or the environment than 
if the storage tanks and process vents were controlled according to the 
provisions in Secs. 63.1253 and 63.1254, respectively.
    (i) This demonstration of hazard or risk equivalency shall be made 
to the satisfaction of the operating permit authority.
    (A) The Administrator may require owners and operators to use 
specific methodologies and procedures for making a hazard or risk 
determination.
    (B) The demonstration and approval of hazard or risk equivalency 
shall be made according to any guidance that the Administrator makes 
available for use or any other technically sound information or methods.
    (ii) An emissions averaging plan that does not demonstrate hazard or 
risk equivalency to the satisfaction of the Administrator shall not be 
approved. The Administrator may require such adjustments to the 
emissions averaging plan as are necessary in order to ensure that the 
average will not result in greater hazard or risk to human health or the 
environment than would result if the emission points were controlled 
according to Secs. 63.1253 and 63.1254.
    (iii) A hazard or risk equivalency demonstration must:
    (A) Be a quantitative, comparative chemical hazard or risk 
assessment;
    (B) Account for differences between averaging and non-averaging 
options in chemical hazard or risk to human health or the environment; 
and
    (C) Meet any requirements set by the Administrator for such 
demonstrations.
    (3) Records as specified in paragraphs (a), (b) and (d) of this 
section.
    (4) A rolling quarterly calculation of the annual percent reduction 
efficiency as specified in Sec. 63.1257(g) and (h).
    (f) Records of delay of repair. Documentation of a decision to use a 
delay of repair due to unavailability of parts, as specified in Sec. 
63.1256(i), shall include a description of the failure, the reason 
additional time was necessary (including a statement of why replacement 
parts were not kept onsite and when delivery from the manufacturer is 
scheduled), and the date when the repair was completed.
    (g) Record of wastewater stream or residual transfer. The owner or 
operator transferring an affected wastewater stream or residual removed 
from an affected wastewater stream in accordance with Sec. 63.1256(a)(5) 
shall keep a record of the notice sent to the treatment operator stating 
that the wastewater stream or residual contains organic HAP which are 
required to be managed and treated in accordance with the provisions of 
this subpart.
    (h) Records of extensions. The owner or operator shall keep 
documentation of a decision to use an extension, as specified in Sec. 
63.1256(b)(6)(ii) or (b)(9), in a readily accessible location. The 
documentation shall include a description of the failure, documentation 
that alternate storage capacity is unavailable, and specification of a 
schedule of actions that will ensure that the control equipment will be 
repaired and the tank will be emptied as soon as practical.
    (i) Records of inspections. The owner or operator shall keep records 
specified in paragraphs (i)(1) through (9) of this section.
    (1) A record that each waste management unit inspection required by 
Sec. 63.1256(b) through (f) was performed.
    (2) A record that each inspection for control devices required by Sec. 
63.1256(h) was performed.
    (3) A record of the results of each seal gap measurement required by 
Sec. 63.1256(b)(5) and (f)(3). The records shall include the date of 
measurement, the raw data obtained in the measurement, and the 
calculations described in Sec. 63.120(b)(2) through (4).
    (4) Records identifying all parts of the vapor collection system, 
closed-vent system, fixed roof, cover, or enclosure that are designated 
as unsafe to inspect in accordance with Sec. 63.1258(h)(6), an explanation 
of why the equipment is unsafe to inspect, and the plan for inspecting 
the equipment.
    (5) Records identifying all parts of the vapor collection system, 
closed-vent system, fixed roof, cover, or enclosure that are designated 
as difficult to inspect in accordance with

[[Page 167]]

Sec. 63.1258(h)(7), an explanation of why the equipment is difficult to 
inspect, and the plan for inspecting the equipment.
    (6) For each vapor collection system or closed-vent system that 
contains bypass lines that could divert a vent stream away from the 
control device and to the atmosphere, the owner or operator shall keep a 
record of the information specified in either paragraph (i)(6)(i) or 
(ii) of this section.
    (i) Hourly records of whether the flow indicator specified under Sec. 
63.1252(b)(1) was operating and whether a diversion was detected at any 
time during the hour, as well as records of the times and durations of 
all periods when the vent stream is diverted from the control device or 
the flow indicator is not operating.
    (ii) Where a seal mechanism is used to comply with Sec. 63.1252(b)(2), 
hourly records of flow are not required. In such cases, the owner or 
operator shall record that the monthly visual inspection of the seals or 
closure mechanisms has been done, and shall record the occurrence of all 
periods when the seal mechanism is broken, the bypass line valve 
position has changed, or the key for a lock-and-key type lock has been 
checked out, and records of any car-seal that has broken.
    (7) For each inspection conducted in accordance with Sec. 63.1258(h)(2) 
and (3) during which a leak is detected, a record of the information 
specified in paragraphs (i)(7)(i) through (ix) of this section.
    (i) Identification of the leaking equipment.
    (ii) The instrument identification numbers and operator name or 
initials, if the leak was detected using the procedures described in Sec. 
63.1258(h)(3); or a record that the leak was detected by sensory 
observations.
    (iii) The date the leak was detected and the date of the first 
attempt to repair the leak.
    (iv) Maximum instrument reading measured by the method specified in 
Sec. 63.1258(h)(4) after the leak is successfully repaired or determined to 
be nonrepairable.
    (v) ``Repair delayed'' and the reason for the delay if a leak is not 
repaired within 15 calendar days after discovery of the leak.
    (vi) The name, initials, or other form of identification of the 
owner or operator (or designee) whose decision it was that repair could 
not be effected without a shutdown.
    (vii) The expected date of successful repair of the leak if a leak 
is not repaired within 15 calendar days.
    (viii) Dates of shutdowns that occur while the equipment is 
unrepaired.
    (ix) The date of successful repair of the leak.
    (8) For each inspection conducted in accordance with Sec. 63.1258(h)(3) 
during which no leaks are detected, a record that the inspection was 
performed, the date of the inspection, and a statement that no leaks 
were detected.
    (9) For each visual inspection conducted in accordance with Sec. 
63.1258(h)(2)(i)(B) or (h)(2)(iii)(B) of this section during which no 
leaks are detected, a record that the inspection was performed, the date 
of the inspection, and a statement that no leaks were detected.

[63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52613, Aug. 29, 2000; 
66 FR 40135, Aug. 2, 2001]