[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: 40CFR63.1254]
[Page 88-91]
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. 63.1254 Standards: Process vents.
(a) Existing sources. For each process, the owner or operator of an
existing affected source must comply with the requirements in paragraphs
(a)(1) and (3) of this section or paragraphs (a)(2) and (3) of this
section. Initial compliance with the required emission limits or
reductions in paragraphs (a)(1) through
[[Page 89]]
(3) of this section is demonstrated in accordance with the initial
compliance procedures described in Sec. 63.1257(d), and continuous
compliance is demonstrated in accordance with the monitoring
requirements described in Sec. 63.1258.
(1) Process-based emission reduction requirement.
(i) Uncontrolled HAP emissions from the sum of all process vents
within a process that are not subject to the requirements of paragraph
(a)(3) of this section shall be reduced by 93 percent or greater by
weight, or as specified in paragraph (a)(1)(ii) of this section.
Notification of changes in the compliance method shall be reported
according to the procedures in Sec. 63.1260(h).
(ii) Any one or more vents within a process may be controlled in
accordance with any of the procedures in paragraphs (a)(1)(ii)(A)
through (D) of this section. All other vents within the process must be
controlled as specified in paragraph (a)(1)(i) of this section.
(A) To outlet concentrations less than or equal to 20 ppmv as TOC
and less than or equal to 20 ppmv as hydrogen halides and halogens;
(B) By a flare that meets the requirements of Sec. 63.11(b);
(C) By a control device specified in Sec. 63.1257(a)(4); or
(D) In accordance with the alternative standard specified in
paragraph (c) of this section.
(2) Process-based annual mass limit. (i) Actual HAP emissions from
the sum of all process vents within a process must not exceed 900
kilograms (kg) in any 365-day period.
(ii) Actual HAP emissions from the sum of all process vents within
processes complying with paragraph (a)(2)(i) of this section are limited
to a maximum of 1,800 kg in any 365-day period.
(iii) Emissions from vents that are subject to the requirements of
paragraph (a)(3) of this section and emissions from vents that are
controlled in accordance with the procedures in paragraph (c) of this
section may be excluded from the sums calculated in paragraphs (a)(2)(i)
and (ii) of this section.
(iv) The owner or operator may switch from compliance with paragraph
(a)(2) of this section to compliance with paragraph (a)(1) of this
section only after at least 1 year of operation in compliance with
paragraph (a)(2) of this section. Notification of such a change in the
compliance method shall be reported according to the procedures in Sec.
63.1260(h).
(3) Individual vent emission reduction requirements.
(i) Except as provided in paragraph (a)(3)(ii) of this section,
uncontrolled HAP emissions from a process vent must be reduced by 98
percent or in accordance with any of the procedures in paragraphs
(a)(1)(ii)(A) through (D) of this section if the uncontrolled HAP
emissions from the vent exceed 25 tons per year, and the flow-weighted
average flowrate (FRa) calculated using Equation 1 of this subpart is
less than or equal to the flowrate index (FRI) calculated using Equation
2 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR29AU00.000
[GRAPHIC] [TIFF OMITTED] TR29AU00.001
Where:
FRa = flow-weighted average flowrate for the vent, scfm
Di = duration of each emission event, min
FRi = flowrate of each emission event, scfm
n = number of emission events
FRI = flowrate index, scfm
HL = annual uncontrolled HAP emissions, lb/yr, as defined in Sec. 63.1251
(ii) Grandfathering provisions. As an alternative to the
requirements in paragraph (a)(3)(i) of this section, the owner or
operator may comply with the provisions in paragraph (a)(3)(ii)(A), (B),
or (C) of this section, if applicable.
(A) Control device operation. If the owner or operator can
demonstrate that a process vent is controlled by a control device
meeting the criteria specified in paragraph (a)(3)(ii)(A)(1) of this
section, then the control device is required to be operated according to
[[Page 90]]
paragraphs (a)(3)(ii)(A)(2), (3), and (4) of this section:
(1) The control device was installed on any process vent that met
the conditions of paragraph (a)(3)(i) of this section on or before April
2, 1997, and was operated to reduce uncontrolled emissions of total HAP
by greater than or equal to 93 percent by weight, but less than 98
percent by weight;
(2) The device must be operated to reduce inlet emissions of total
HAP by 93 percent or by the percent reduction specified for that control
device in any preconstruction permit issued pursuant to regulations
approved or promulgated through rulemaking under title I (including
parts C or D) of the Clean Air Act, whichever is greater;
(3) The device must be replaced or upgraded to achieve at least 98
percent reduction of HAP or meet any of the conditions specified in
paragraphs (a)(1)(ii)(A) through (D) of this section upon reconstruction
or replacement.
(4) The device must be replaced or upgraded to achieve at least 98
percent reduction of HAP or meet any of the conditions specified in
paragraphs (a)(1)(ii)(A) through (D) of this section by April 2, 2007,
or 15 years after issuance of the preconstruction permit, whichever is
later.
(B) Process operations. If a process meets all of the conditions
specified in paragraphs (a)(3)(ii)(B)(1) through (3) of this section,
the required level of control for the process is the level that was
achieved on or before April 2, 1997. This level of control is
demonstrated using the same procedures that are used to demonstrate
compliance with paragraph (a)(1) of this section.
(1) At least one vent in the process met the conditions of paragraph
(a)(3)(i) of this section on or before April 2, 1997; and
(2) The overall control for the process on or before April 2, 1997
was greater than or equal to 93 percent by weight, but less than 98
percent by weight; and
(3) The production-indexed HAP consumption factor for the 12-month
period in which the process was operated prior to the compliance date is
less than one-half of the 3-year average baseline value established no
earlier than the 1987 through 1989 calendar years.
(C) Hydrogenation vents. Processes meeting the conditions of
paragraphs (a)(3)(ii)(C)(1) through (3) of this section are required to
be operated to maintain the level of control achieved on or before April
2, 1997. For all other processes meeting the conditions of paragraph
(a)(3)(ii)(C)(3) of this section, uncontrolled HAP emissions from the
sum of all process vents within the process must be reduced by 95
percent or greater by weight.
(1) Processes containing a process vent that met the conditions of
paragraph (a)(3)(i) of this section on or before April 2, 1997; and
(2) Processes that are controlled to greater than or equal to 93
percent by weight, but less than 98 percent by weight; and
(3) Processes with a hydrogenation vent that, in conjunction with
all other process vents from the process that do not meet the conditions
of paragraph (a)(3)(i) of this section, cannot meet the requirements of
paragraph (a)(1) or (2) of this section.
(4) Planned routine maintenance. For each PMPU that is controlled
with a CCCD, the owner or operator must comply with the provisions
specified in either paragraph (a)(4)(i), (ii), or (iii) of this section
during periods of planned routine maintenance of the CCCD. The owner or
operator is not required to comply with the same provision for all of
the PMPU's controlled by the CCCD.
(i) Shutdown the affected process.
(ii) Comply with the requirements of paragraphs (a)(1) through (3)
of this section by using other means.
(iii) For a non-dedicated PMPU, implement the procedures described
in paragraphs (a)(4)(iii)(A) through (C) of this section for those
process vents that are normally controlled by the CCCD. This option is
not available for process vents from dedicated PMPU's.
(A) If the owner or operator uses a CCCD to comply with the 93
percent reduction requirement in paragraph (a)(1)(i) or (ii) of this
section, the outlet concentration limit in paragraph (a)(1)(ii)(A) of
this section, the alternative standard as specified in paragraphs
(a)(1)(ii)(D) and (c) of this section, or the annual mass limit in
paragraph (a)(2) of this section, implement the provisions in Sec.
63.1252(h) during
[[Page 91]]
planned routine maintenance of the CCCD.
(B) If the owner or operator reduces HAP emissions from process
vents by using a CCCD that is also a control device specified in Sec.
63.1257(a)(4), implement the provisions in Sec. 63.1252(h) during planned
routine maintenance of the CCCD.
(C) If the owner or operator uses a CCCD to reduce emissions from a
process vent subject to paragraph (a)(3) of this section, implement the
planned routine maintenance provisions in Sec. 63.1252(h) for that vent
only if the reason the planned routine maintenance is needed, and the
reason it cannot be performed at a time when the vent subject to
paragraph (a)(3) of this section is not operating, has been described in
the Notification of Compliance Status Report or a periodic report
submitted before the planned routine maintenance event.
(b) New sources. (1) Except as provided in paragraph (b)(2) of this
section, uncontrolled HAP emissions from the sum of all process vents
within a process at a new affected source shall be reduced by 98 percent
or greater by weight or controlled in accordance with any of
requirements of paragraphs (a)(1)(ii)(A) through (D) of this section.
Initial compliance with the required emission limit or reduction is
demonstrated in accordance with the initial compliance procedures in Sec.
63.1257(d), and continuous compliance is demonstrated in accordance with
the monitoring requirements described in Sec. 63.1258.
(2) Annual mass limit. The actual HAP emissions from the sum of all
process vents for which the owner or operator is not complying with
paragraph (b)(1) of this section are limited to 900 kg in any 365-day
period.
(c) Alternative standard. As an alternative standard, the owner or
operator of an existing or new affected source may comply with the
process vent standards by routing vents from a process to a combustion
control device achieving an outlet TOC concentration, as calibrated on
methane or the predominant HAP, of 20 ppmv or less, and an outlet
concentration of hydrogen halides and halogens of 20 ppmv or less. If
the owner or operator is routing emissions to a noncombustion control
device, it must achieve an outlet TOC concentration, as calibrated on
methane or the predominant HAP, of 50 ppmv or less, and an outlet
concentration of hydrogen halides and halogens of 50 ppmv or less. Any
process vents within a process that are not routed to this control
device must be controlled in accordance with the provisions of paragraph
(a) or (b) of this section, as applicable. Initial compliance with the
outlet concentrations is demonstrated in accordance with the initial
compliance procedures described in Sec. 63.1257(d)(1)(iv), and continuous
compliance is demonstrated in accordance with the emission monitoring
requirements described in Sec. 63.1258(b)(5).
[65 FR 52601, Aug. 29, 2000, as amended at 66 FR 40132, Aug. 2, 2001]