[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: 40CFR63.1252]

[Page 83-86]
 
                   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. 63.1252  Standards: General.

    Each owner or operator of any affected source subject to the 
provisions of this subpart shall control HAP emissions to the level 
specified in this section on and after the compliance dates specified in 
Sec. 63.1250(f). Initial compliance with the emission limits is 
demonstrated in accordance with the provisions of Sec. 63.1257, and 
continuous compliance is demonstrated in accordance with the provisions 
of Sec. 63.1258.
    (a) Opening of a safety device. Opening of a safety device, as 
defined in Sec. 63.1251, is allowed at any time conditions require it to do 
so to avoid unsafe conditions.
    (b) Closed-vent systems. The owner or operator of a closed-vent 
system that contains bypass lines that could divert a vent stream away 
from a control device used to comply with the requirements in 
Secs. 63.1253, 63.1254, and 63.1256 shall comply with the requirements 
of Table 4 to this subpart and paragraph (b)(1) or (2) of this section. 
Equipment such as low leg drains, high point bleeds, analyzer vents, 
open-ended valves or lines, rupture disks and pressure relief valves 
needed for safety purposes are not subject to this paragraph.
    (1) Install, calibrate, maintain, and operate a flow indicator that 
determines whether vent stream flow is present at least once every 15 
minutes. Records shall be maintained as specified in Sec. 63.1259(i)(6)(i). 
The flow indicator shall be installed at the entrance to any bypass line 
that could divert the vent stream away from the control device to the 
atmosphere; or
    (2) Secure the bypass line valve in the closed position with a car 
seal or lock and key type configuration. A visual inspection of the seal 
or closure mechanism shall be performed at least once every month to 
ensure that the valve is maintained in the closed position and the vent 
stream is not diverted through the bypass line. Records shall be 
maintained as specified in Sec. 63.1259(i)(6)(ii).
    (c) Heat exchange systems. Except as provided in paragraph (c)(2) of 
this section, owners and operators of affected sources shall comply with 
the requirements in paragraph (c)(1) of this section for heat exchange 
systems that cool process equipment or materials used in pharmaceutical 
manufacturing operations.
    (1) The heat exchange system shall be treated according to the 
provisions of Sec. 63.104, except that the monitoring frequency shall be no 
less than quarterly.
    (2) For identifying leaking equipment, the owner or operator of heat 
exchange systems on equipment which meet current good manufacturing 
practice (CGMP) requirements of 21 CFR part 211 may elect to use the 
physical integrity of the reactor as the surrogate indicator of heat 
exchange system leaks around the reactor.
    (d) Emissions averaging provisions. Except as specified in 
paragraphs (d)(1) through (5) of this section, owners or operators of 
storage tanks or processes subject to the provisions of Secs. 63.1253 
and 63.1254 may choose to comply by using emissions averaging 
requirements specified in Sec. 63.1257(g) or (h) for any storage tank or 
process.
    (1) A State may prohibit averaging of HAP emissions and require the 
owner or operator of an existing source to comply with the provisions in 
Secs. 63.1253 and 63.1254.
    (2) Only emission sources subject to the requirements of Sec. 
63.1253(b)(1) or (c)(1)(i) or Sec. 63.1254(a)(1)(i) may be included in any 
averaging group.
    (3) Processes which have been permanently shutdown or storage tanks 
permanently taken out of HAP service may not be included in any 
averaging group.

[[Page 84]]

    (4) Processes and storage tanks already controlled on or before 
November 15, 1990 may not be included in an emissions averaging group, 
except where the level of control is increased after November 15, 1990. 
In these cases, the uncontrolled emissions shall be the controlled 
emissions as calculated on November 15, 1990 for the purpose of 
determining the uncontrolled emissions as specified in Sec. 63.1257(g) and 
(h).
    (5) Emission points controlled to comply with a State or Federal 
rule other than this subpart may not be credited in an emission 
averaging group, unless the level of control has been increased after 
November 15, 1990 above what is required by the other State or Federal 
rule. Only the control above what is required by the other State or 
Federal rule will be credited. However, if an emission point has been 
used to generate emissions averaging credit in an approved emissions 
average, and the point is subsequently made subject to a State or 
Federal rule other than this subpart, the point can continue to generate 
emissions averaging credit for the purpose of complying with the 
previously approved average.
    (6) Not more than 20 processes subject to Sec. 63.1254(a)(1)(i), and 20 
storage tanks subject to Sec. 63.1253(b)(1) or (c)(1)(i) at an affected 
source may be included in an emissions averaging group.
    (7) Compliance with the emission standards in Sec. 63.1253 shall be 
satisfied when the annual percent reduction efficiency is greater than 
or equal to 90 percent for those tanks meeting the criteria of Sec. 
63.1253(a)(1) and 95 percent for those tanks meeting the criteria of Sec. 
63.1253(a)(2), as demonstrated using the test methods and compliance 
procedures specified in Sec. 63.1257(g).
    (8) Compliance with the emission standards in Sec. 63.1254(a)(1)(i) 
shall be satisfied when the annual percent reduction efficiency is 
greater than or equal to 93 percent, as demonstrated using the test 
methods and compliance procedures specified in Sec. 63.1257(h).
    (e) Pollution prevention alternative. Except as provided in 
paragraph (e)(1) of this section, an owner or operator may choose to 
meet the pollution prevention alternative requirement specified in 
either paragraph (e)(2) or (3) of this section for any PMPU or for any 
situation described in paragraph (e)(4) of this section, in lieu of the 
requirements specified in Secs. 63.1253, 63.1254, 63.1255, and 63.1256. 
Compliance with paragraphs (e)(2) and (3) of this section shall be 
demonstrated through the procedures in Sec. 63.1257(f). Any PMPU for which 
the owner or operator seeks to comply by using the pollution prevention 
alternative shall begin with the same starting material(s) and end with 
the same product(s). The owner or operator may not comply with the 
pollution prevention alternative by eliminating any steps of a process 
by transferring the step offsite (to another manufacturing location).
    (1) The HAP that are generated in the PMPU that are not part of the 
production-indexed consumption factor must be controlled according to 
the requirements of Secs. 63.1253, 63.1254, 63.1255, and 63.1256. The 
hydrogen halides that are generated as a result of combustion control of 
emissions must be controlled according to the requirements of paragraph 
(g)(1) of this section.
    (2) The production-indexed HAP consumption factor (kg HAP consumed/
kg produced) shall be reduced by at least 75 percent from a 3 year 
average baseline established no earlier than the 1987 calendar year, or 
for the time period from startup of the process until the present in 
which the PMPU was operational and data are available, whichever is the 
lesser time period. If a time period less than 3 years is used to set 
the baseline, the data must represent at least 1 year's worth of data. 
For any reduction in the HAP factor achieved by reducing a HAP that is 
also a VOC, an equivalent reduction in the VOC factor is also required. 
For any reduction in the HAP factor that is achieved by reducing a HAP 
that is not a VOC, the VOC factor may not be increased.
    (3) Both requirements specified in paragraphs (e)(3)(i) and (ii) of 
this section are met.
    (i) The production-indexed HAP consumption factor (kg HAP consumed/
kg produced) shall be reduced by at least 50 percent from a 3-year 
average baseline established no earlier than the 1987 calendar year, or 
for the time period from startup of the process until the

[[Page 85]]

present in which the PMPU was operational and data are available, 
whichever is less. If a time period less than 3 years is used to set the 
baseline, the data must represent at least 1 year's worth of data. For 
any reduction in the HAP factor achieved by reducing a HAP that is also 
a VOC, an equivalent reduction in the VOC factor is also required. For 
any reduction in the HAP factor that is achieved by reducing a HAP that 
is not a VOC, the VOC factor may not be increased.
    (ii) The total PMPU HAP emissions shall be reduced by an amount, in 
kg/yr, that, when divided by the annual production rate, in kg/yr, and 
added to the reduction of the production-indexed HAP consumption factor, 
in kg/kg, yields a value of at least 75 percent of the average baseline 
HAP production-indexed consumption factor established according to 
paragraph (e)(3)(i) of this section according to the equation provided 
in Sec. 63.1257(f)(2)(ii)(A). The total PMPU VOC emissions shall be reduced 
by an amount calculated according to the equation provided in Sec. 
63.1257(f)(2)(ii)(B). The annual reduction in HAP and VOC air emissions 
must be due to the use of the following control devices:
    (A) Combustion control devices such as incinerators, flares or 
process heaters.
    (B) Control devices such as condensers and carbon adsorbers whose 
recovered product is destroyed or shipped offsite for destruction.
    (C) Any control device that does not ultimately allow for recycling 
of material back to the PMPU.
    (D) Any control device for which the owner or operator can 
demonstrate that the use of the device in controlling HAP emissions will 
have no effect on the production-indexed consumption factor for the 
PMPU.
    (4) The owner or operator may comply with the requirements in either 
paragraph (e)(2) or (3) of this section for a series of processes, 
including situations where multiple processes are merged, subject to the 
following conditions:
    (i) The baseline period shall be a single year beginning no earlier 
than the 1992 calendar year.
    (ii) The term ``PMPU'' shall have the meaning provided in Sec. 63.1251 
except that the baseline and modified PMPU may include multiple 
processes (i.e., precursors, active ingredients, and final dosage form) 
if the owner or operator demonstrates to the satisfaction of the 
Administrator that the multiple processes were merged after the baseline 
period into an existing process or processes.
    (iii) Nondedicated formulation and solvent recovery processes may 
not be merged with any other processes.
    (f) Control requirements for certain liquid streams in open systems 
within a PMPU. (1) The owner or operator shall comply with the 
provisions of Table 5 of this subpart, for each item of equipment 
meeting all the criteria specified in paragraphs (f)(2) through (4) and 
either paragraph (f)(5)(i) or (ii) of this section.
    (2) The item of equipment is of a type identified in Table 5 of this 
subpart;
    (3) The item of equipment is part of a PMPU, as defined in Sec. 
63.1251;
    (4) The item of equipment is controlled less stringently than in 
Table 5 of this subpart and the item of equipment is not otherwise 
exempt from controls by the provisions of this subpart or subpart A of 
this part; and
    (5) The item of equipment:
    (i) Is a drain, drain hub, manhole, lift station, trench, pipe, or 
oil/water separator that conveys water with an annual average 
concentration greater than or equal to 1,300 parts per million by weight 
(ppmw) of partially soluble HAP compounds; or an annual average 
concentration greater than or equal to 5,200 ppmw of partially soluble 
and/or soluble HAP compounds. The annual average concentration shall be 
determined according to the procedures in Sec. 63.1257(e)(1)(ii).
    (ii) Is a tank that receives one or more streams that contain water 
with an annual average concentration greater than or equal to 1,300 ppmw 
of partially soluble HAP compounds, or greater than or equal to 5,200 
ppmw of total partially soluble and/or soluble HAP compounds. The owner 
or operator of the source shall determine the average concentration of 
the stream at the inlet to the tank and according to the procedures in Sec. 
63.1257(e)(1)(ii).

[[Page 86]]

    (g) Control requirements for halogenated vent streams that are 
controlled by combustion devices. If a combustion device is used to 
comply with the provisions of Secs. 63.1253 (storage tanks), 63.1254 
(process vents), 63.1256(h) (wastewater vent streams) for a halogenated 
vent stream, then the vent stream shall be ducted to a halogen reduction 
device such as, but not limited to, a scrubber, before it is discharged 
to the atmosphere. The halogen reduction device must reduce emissions by 
the amounts specified in either paragraph (g)(1) or (2) of this section.
    (1) A halogen reduction device after the combustion control device 
must reduce overall emissions of hydrogen halides and halogens, as 
defined in Sec. 63.1251, by 95 percent or to a concentration less than or 
equal to 20 ppmv.
    (2) A halogen reduction device located before the combustion control 
device must reduce the halogen atom content of the vent stream to a 
concentration less than or equal to 20 ppmv.
    (h) Planned routine maintenance for centralized combustion control 
devices. The owner or operator may operate non-dedicated PMPU's during 
periods of planned routine maintenance for CCCD in accordance with the 
provisions specified in paragraphs (h)(1) through (6) of this section.
    (1) For equipment leaks and wastewater emissions that normally are 
controlled by the CCCD, if any, the owner or operator must continue to 
comply with the requirements in Secs. 63.1255(b)(4)(ii) and 63.1256(h), 
respectively, using other control devices during the planned routine 
maintenance period for the CCCD.
    (2) During the planned routine maintenance period, the owner or 
operator must route emissions from process vents with organic HAP 
emissions greater than 15 pounds per day (lb/day) through a closed-vent 
system to a condenser that meets the conditions specified in paragraphs 
(h)(2)(i) through (iii) of this section.
    (i) The outlet gas temperature must be less than -50 C (-58 F) 
when the emission stream contains organic HAP with a partial pressure 
greater than 20 kPa (2.9 psia).
    (ii) The outlet gas temperature must be less than -5 C (23 F) when 
the emission stream contains organic HAP with a partial pressure less 
than or equal to 20 kPa (2.9 psia).
    (iii) The HAP partial pressures in paragraphs (h)(2)(i) and (ii) of 
this section must be determined at 25 C.
    (3) The owner or operator must route HCl emissions from process 
vents with HCl emissions greater than 15 lb/day through a closed-vent 
system to a caustic scrubber, and the pH of the scrubber effluent must 
be maintained at or above 9.
    (4) For the purposes of the emission calculations required in 
paragraphs (h)(2) and (3) of this section, the term ``process vent'' 
shall mean each vent from a unit operation. The emission calculation 
shall not be performed on the aggregated emission stream from multiple 
unit operations that are manifolded together into a common header. Once 
an affected process vent has been controlled in accordance with this 
section, it is no longer subject to the requirements of this section or 
Sec. 63.1254 during the routine maintenance period.
    (5) The total period of planned routine maintenance, during which 
non-dedicated PMPU's that are normally controlled by the CCCD continue 
to operate, and process vent emissions are controlled as specified in 
paragraphs (h)(2) and (3) of this section, must not exceed 240 hours in 
any 365-day period.
    (6) While being controlled as specified in paragraphs (h)(2) and (3) 
of this section, the process vents may not be used in emissions 
averaging.

[63 FR 50326, Sept. 21, 1998, as amended at 65 FR 52600, Aug. 29, 2000; 
66 FR 40131, Aug. 2, 2001]