[Federal Register Volume 66, Number 149 (Thursday, August 2, 2001)]
[Rules and Regulations]
[Pages 40121-40137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18879]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 63
[FRL-7020-3]
RIN 2060-AE83
National Emission Standards for Pharmaceuticals Production
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule and direct final rule; corrections and amendments.
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SUMMARY: The EPA is taking direct final action to amend the national
emission standards for hazardous air pollutants (NESHAP) for
pharmaceuticals production. This direct final rule provides additional
compliance options for process vent and storage tank emissions,
specifies additional methods that may be used to analyze wastewater,
shifts one compound from the list of partially soluble hazardous air
pollutants (HAP) to the list of soluble HAP, eliminates an unintended
restriction on the use of enhanced biological treatment, allows a sewer
line between drains and the first downstream junction box to be vented,
clarifies how to assign storage tanks that are shared among
pharmaceutical manufacturing process units and other types of process
units, clarifies the monitoring frequency requirements for connectors,
clarifies and simplifies recordkeeping and reporting requirements,
eliminates inconsistencies, and corrects several referencing and
typesetting errors. We view these revisions to be minor and
noncontroversial, and we anticipate no adverse comment.
In compliance with the Paperwork Reduction Act (PRA), this action
also amends the table that lists the Office of Management and Budget
(OMB) control numbers issued under the PRA for the pharmaceuticals
production rule.
DATES: The amendments to 40 CFR part 9 are effective on August 2, 2001.
The direct final rule amendments to 40 CFR
[[Page 40122]]
part 63 are effective on October 16, 2001 without further notice,
unless EPA receives adverse comments by September 4, 2001, or by
September 17, 2001 if a public hearing is requested. See the proposed
rule in this issue of the Federal Register for information on the
hearing. If we receive any adverse comments, and those comments apply
to an amendment, paragraph, or section of this rule, and that provision
may be addressed separately from the remainder of the rule, we will
withdraw only those provisions on which we received adverse comments.
We will publish a timely withdrawal in the Federal Register indicating
which provisions will not take effect.
ADDRESSES: Comments. By U.S. Postal Service, send comments (in
duplicate, if possible) to: Air and Radiation Docket and Information
Center (6102), Attention Docket Number A-96-03, U.S. EPA, 1200
Pennsylvania Avenue, NW, Washington, DC 20460. In person or by courier,
deliver comments (in duplicate if possible) to: Air and Radiation
Docket and Information Center (6102), Attention Docket Number A-96-03,
U.S. EPA, 401 M Street, SW, Washington DC 20460. The EPA requests that
a separate copy of each public comment be sent to the contact person
listed below (see FOR FURTHER INFORMATION CONTACT). Comments may also
be submitted electronically by following the instructions provided in
SUPPLEMENTARY INFORMATION. Docket. Docket No. A-96-03 contains
supporting information used in developing the NESHAP. The docket is
located at the U.S. EPA, 401 M Street, SW, Washington, DC 20460 in Room
M-1500, Waterside Mall (ground floor), and may be inspected from 8 a.m.
to 5:30 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Mr. Randy McDonald, Organic Chemicals
Group, Emission Standards Division (MD-13), U.S. EPA, Research Triangle
Park, North Carolina 27711, telephone number (919) 541-5402, electronic
mail address: [email protected].
SUPPLEMENTARY INFORMATION: Comments. Comments and data may be submitted
by electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file to avoid the use of special
characters and encryption problems and will also be accepted on disks
in WordPerfect version 5.1, 6.1, or Corel 8 file format. All comments
and data submitted in electronic form must note the docket number A-96-
03. No confidential business information (CBI) should be submitted by
e-mail. Electronic comments may be filed online at many Federal
Depository Libraries.
Commenters wishing to submit proprietary information for
consideration must clearly distinguish such information from other
comments and clearly label it as CBI. Send submissions containing such
proprietary information directly to the following address, and not to
the public docket, to ensure that proprietary information is not
inadvertently placed in the docket: Attention: Mr. Randy McDonald, c/o
OAQPS Document Control Officer (Room 740B), U.S. EPA, 411 W. Chapel
Hill Street, Durham, NC 27701. The EPA will disclose information
identified as CBI only to the extent allowed by the procedures set
forth in 40 CFR part 2. If no claim of confidentiality accompanies a
submission when it is received by EPA, the information may be made
available to the public without further notice to the commenter.
Docket. The docket is an organized and complete file of all the
information considered by EPA in the development of this rulemaking.
The docket is a dynamic file because material is added throughout the
rulemaking process. The docketing system is intended to allow members
of the public and industries involved to readily identify and locate
documents so that they can effectively participate in the rulemaking
process. Along with the proposed and promulgated standards and their
preambles, the contents of the docket will serve as the record in the
case of judicial review. (See section 307(d)(7)(A) of the Clean Air Act
(CAA).) The regulatory text and other materials related to this
rulemaking are available for review in the docket or copies may be
mailed on request from the Air Docket by calling (202) 260-7548. A
reasonable fee may be charged for copying docket materials.
Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of this action will also be available through the
WWW. Following signature, a copy of this action will be posted on the
EPA's Technology Transfer Network (TTN) policy and guidance page for
newly proposed or promulgated rules: http://www.epa.gov/ttn/oarpg. The
TTN at EPA's web site provides information and technology exchange in
various areas of air pollution control. If more information regarding
the TTN is needed, call the TTN HELP line at (919) 541-5384.
Regulated Entities. The regulated category and entities affected by
this action include:
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Examples of regulated
Category NAICS codes SIC codes entities
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Industry........................... 325411 and 325412..... 2833 and 2834......... Producers of
finished dosage forms of
drugs (e.g., tablets,
capsules, and solutions),
active ingredients, or
precursors.
Typically 325199...... Typically 2869........ Producers of
material whose primary use
is as an active ingredient
of precursor.
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This table is not intended to be exhaustive, but rather provides a
guide for readers likely to be interested in the revisions to the
regulation affected by this action. To determine whether your facility,
company, business, organization, etc., is regulated by this action, you
should carefully examine all of the applicability criteria in
Sec. 63.1250 of the rule. If you have questions regarding the
applicability of these amendments to a particular entity, consult the
person listed in the preceding FOR FURTHER INFORMATION CONTACT section.
Judicial Review. Under section 307(b)(1) of the CAA, judicial
review of this direct final rule is available only by filing a petition
for review in the U.S. Court of Appeals for the District of Columbia by
October 1, 2001. Under section 307(d)(7)(B) of the CAA, only an
objection to this direct final rule that was raised with reasonable
specificity during the period for public comment can be raised during
judicial review. Moreover, under section 307(b)(2) of the CAA, the
requirements established by this direct final rule may not be
challenged separately in any civil or criminal proceeding brought to
enforce these requirements. Also under section 307(b)(1) of the CAA,
judicial review of the amendment to part 9 in this action is available
by filing a petition for review in the U.S. Court of Appeals for
[[Page 40123]]
the District of Columbia Circuit within October 1, 2001. Under section
307(b)(2) of the CAA, the requirements that are the subject of this
amendment may not be challenged later in civil or criminal proceedings
brought by the EPA to enforce these requirements.
Outline. The information presented in this preamble is organized as
follows:
I. Why are we publishing these amendments as a direct final rule?
II. What amendments are we making to part 9 to reflect OMB approval
of the information collection request for subpart GGG?
III. What amendments are we making to the process vent provisions?
IV. What amendments are we making to the wastewater provisions?
V. What amendments are we making to the storage tank provisions?
VI. What minor technical corrections are we making?
VII. What are the administrative requirements for this direct final
rule?
A. Executive Order 12866, Regulatory Planning and Review
B. Executive Order 13132, Federalism
C. Executive Order 13175, Consultation and Coordination with
Indian Tribal Governments
D. Executive Order 13045, Protection of Children for
Environmental Health Risks and Safety Risks
E. Unfunded Mandates Reform Act of 1995
F. Regulatory Flexibility Act (RFA), as Amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5
U.S.C. 601 et seq.
G. Paperwork Reduction Act
H. National Technology Transfer and Advancement Act
I. The Congressional Review Act
J. Executive Order 13211 (Energy Effects)
I. Why Are We Publishing These Amendments as a Direct Final Rule?
In this direct final rule, we are correcting referencing and
typesetting errors, identifying additional test methods that may be
used to analyze wastewater, classifying triethylamine as a soluble HAP
instead of a partially soluble HAP, adding an outlet concentration
limit compliance option for storage tanks, clarifying the monitoring
frequency for connectors, clarifying storage tank assignment
procedures, and adding planned routine maintenance provisions for
centralized combustion control devices (CCCD). These changes provide
clarifications and additional compliance options. In all instances, we
believe that these changes have the potential to reduce the burden on
both owners and operators of affected sources and on the State or local
agency implementing the rule, although we are unable to quantify
reductions in hours for these amendments. For these reasons, we view
these amendments as noncontroversial and anticipate no adverse
comments, and we are publishing these amendments in a direct final
rule.
If an adverse comment applies to an amendment, paragraph, or
section of this direct final rule, and that provision may be addressed
separately from the remainder of the rule, we will withdraw only those
provisions on which we received adverse comments. In the ``Proposed
Rules'' section of this Federal Register, we are publishing a separate
document that will serve as the proposal for any provisions in this
direct final rule on which we receive adverse comments. The EPA will
publish a timely withdrawal before the effective date of this rule
indicating which provisions are being withdrawn. If part or all of this
direct final rule is withdrawn, all public comments received will be
addressed in a subsequent final rule based on the proposal. We will not
institute a second comment period on the subsequent final rule. Any
parties interested in commenting must do so at this time. The nature of
the changes contained in this direct final rule are such that it will
benefit both industry and the States for these changes to become
effective sooner, rather than later, as will be described in more
detail below.
II. What Amendments Are We Making to Part 9 To Reflect OMB Approval
of the Information Collection Request for Subpart GGG?
This final rule amends the table of currently approved Information
Collection Request (ICR) control numbers issued by OMB. As noted in
section VII.G of this preamble, as well as in the preambles to earlier
amendments and the promulgated rule, OMB has approved the information
collection requirements contained in subpart GGG and assigned OMB
control No. 2060-0358. However, when we amended Sec. 9.1 on September
21, 1998, we entered the incorrect number 2060-0314. Because the
correct number was listed in the earlier preambles and amendment of the
table is technical in nature, we believe that another notice and
comment period for this amendment is unnecessary and that there is good
cause under the Administrative Procedure Act (5 U.S.C. 553(b)) to amend
this table without prior notice and comment.
III. What Amendments Are We Making to the Process Vent Provisions?
This direct final rule specifies requirements for meeting the
process vent standards during periods of planned routine maintenance of
CCCD. Use of a CCCD, while not required by subpart GGG, is a common
control technique at existing pharmaceutical production facilities
because the facilities have found such a device to be more reliable and
efficient than multiple point-of-use devices. However, under subpart
GGG as currently written, when routine maintenance on a CCCD is needed,
you must either shutdown all processes or have a backup control device
that you have demonstrated achieves the same level of control. We
understand that shutting down all processes is inefficient and costly
for at least two reasons: (1) Because all processes have different
cycles, the shutdown would almost certainly have to be staggered, which
means some process equipment would have to be shutdown for a longer
period than is needed simply to perform the maintenance on the control
device; and (2) pharmaceutical production facilities often shutdown
only a section of the facility for maintenance as opposed to the entire
facility because it is impractical to have an in-house maintenance
staff large enough to perform such maintenance in a short period of
time, and outside resources may not be sufficiently skilled or
available when needed. We also realize that demonstrating compliance
for a backup device could be a significant burden. To address these
concerns, this direct final rule provides an additional compliance
option for periods of planned routine maintenance of a CCCD that is
simple to implement and achieves reductions that are at least
equivalent to the maximum achievable control technology (MACT) floor.
The new planned routine maintenance provisions specify separate
requirements for organic HAP emissions and hydrogen chloride (HCl)
emissions. You 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 operates at: (1) Less than 50 degrees
centigrade (C) when the emission stream contains HAP with a partial
pressure greater than 20 kilopascals (kPa) and (2) less than -5 degrees
C when the emission stream contains HAP with a partial pressure less
than or equal to 20 kPa. The partial pressures must be determined at 25
C. These requirements are designed to be similar to State reasonably
available control technology rules that are based on the generalized
control program described on page 1-5 of the 1978 Control Techniques
Guideline (CTG) Document for Control of Volatile Organic Emissions from
Manufacture of
[[Page 40124]]
Synthesized Pharmaceutical Products (EPA 450/2-78-029). However, to
achieve the MACT floor control level of 93 percent, the operating
temperatures required by the planned routine maintenance provisions
differ from those specified in the CTG, and all vents with organic HAP
emissions greater than 15 lb/day must be controlled (not just vents
from the unit operations listed in the CTG). The planned routine
maintenance provisions are limited to the use of condensers as
specified above to keep the compliance requirements simple and because
many facilities typically already have backup condensers available
onsite.
Because the CTG did not cover HCl emissions, the planned routine
maintenance provisions specify that you must route emissions from
process vents with HCl emissions greater than or equal to 15 lb/day
through a closed vent system to a caustic scrubber. As with the
condenser, we have kept compliance requirements simple. Compliance is
demonstrated by daily monitoring of the scrubber effluent and
maintaining the effluent at pH 9 or greater.
Although Sec. 63.1258 of the pharmaceuticals production NESHAP
specifies parameters for scrubbers, we are not requiring monitoring of
the scrubber liquid flow rate or pressure drop for caustic scrubbers
during periods of planned routine maintenance. The effectiveness of
absorbing HCl into caustic solution is so great that monitoring
effluent pH is adequate to demonstrate compliance. The relatively small
amount of HCl generated during periods of planned routine maintenance
does not justify the need to burden the industry with design evaluation
demonstrations and continuous monitoring for each individual scrubber
application during the limited period of planned routine maintenance.
Hydrogen chloride has a great affinity for water. Referencing the
``Chemical Engineering Handbook'' by Perry and Chilton, solubility of
HCl is almost 70 grams per 100 grams of water at 30 degrees C. An
aqueous solution at the same temperature can absorb up to 10 percent
HCl before reaching an equilibrium of 20 parts per million volume
(ppmv) of HCl in the gas phase. In addition, absorption increases as
vapor pressure decreases, and vapor pressure of HCl can be decreased
significantly by adding a chemical reactant such as sodium hydroxide
(NaOH) to tie up the solute gas. The chemical reaction in a caustic
scrubber frees up liquid volume for dissolving more gas. A caustic
scrubber operating such that the effluent stays at or above pH 9 is
considered a very effective control device.
The 15 lb/day emission rate cutoffs apply to emissions from vents
on individual unit operations, not to aggregated emissions from
multiple unit operations that are manifolded together into a common
header (i.e., the emission rates must be determined only at the
equipment where the emissions enter the closed vent system prior to
being combined with emissions from other unit operations). Therefore, a
manifolded stream with emissions that exceed 15 lb/day is not subject
to control requirements during periods of planned routine maintenance
of the CCCD if the emissions from each of the unit operation vents that
are combined in that manifold have emissions less than 15 lb/day. If
any individual unit operation vents with emissions less than 15 lb/day
are manifolded with a unit operation vent that has emissions greater
than or equal to 15 lb/day, then the entire manifolded stream must be
controlled (or the emissions from the unit operation with emissions
greater than 15 lb/day must be diverted from the other vents in the
manifold for control).
You may use the planned routine maintenance provisions if you use
the CCCD to comply with any of the requirements in Sec. 63.1254(a) of
the pharmaceuticals production NESHAP for process vents from all non-
dedicated pharmaceutical manufacturing process units (PMPU) that are
controlled by the CCCD. However, there are several requirements to
ensure that the level of control achieved is at least equivalent to the
MACT floor. First, you may only route emissions from vents that are
subject to the 98 percent reduction requirement in Sec. 63.1254(a)(3)
if you demonstrate that the planned routine maintenance is needed and
that there is no way to perform it during periods when a process with
such a vent is not operating. To make this demonstration, you must
document your plans in either your Notification of Compliance Status
Report or in a periodic report that is submitted prior to the planned
routine maintenance event. Second, if you use the CCCD to control
emissions so as to comply with the annual mass limit, you must
calculate controlled emissions during periods of planned routine
maintenance assuming the control efficiency is 93 percent. Third,
whenever you implement the planned routine maintenance provisions, you
must monitor the condenser outlet temperature as specified in
Sec. 63.1258(i). This requirement applies even if you comply with the
alternative standard or if the CCCD is a boiler, process heater, or
hazardous waste incinerator that meets any of the criteria in
Sec. 63.1257(a)(4). Fourth, you may not use the process vents in
emissions averaging during the period that you comply with the planned
routine maintenance provisions. During this time period, the process
vents are being controlled to the level of the MACT floor; thus, no
debits or credits can be calculated.
There are also several other restrictions on how the planned
routine maintenance provisions may be implemented. For example, the
planned routine maintenance provisions may be implemented for no more
than 240 hours per year (hr/yr). This time period is consistent with
the time allowed in Sec. 63.1253(e) of the pharmaceuticals production
NESHAP for planned routine maintenance of a control device used to
control storage tank emissions. As we have stated in previous
rulemaking packages, we believe this time is sufficient to perform
maintenance on combustion devices (59 FR 19441, April 22, 1994). In
addition, the planned routine maintenance provisions are not available
for process vents from dedicated PMPU because planning a shutdown for
such a PMPU can be more easily scheduled than for non-dedicated PMPU
whose operation is more unpredictable in nature. Finally, the planned
routine maintenance provisions may not be used for emissions from
wastewater systems or equipment leaks because the MACT floor level of
control for these emissions is 95 percent. If the CCCD is used to
control emissions from storage tanks, you may elect to control them
with the condenser during periods of planned routine maintenance.
However, this control is not required because Sec. 63.1253(e) specifies
that the emission limitations are not applicable during periods of
planned routine maintenance up to 240 hr/yr.
IV. What Amendments Are We Making to the Wastewater Provisions?
This direct final rule makes four changes to the wastewater
provisions. One change is that we are adding two EPA test methods to
the list of acceptable test methods that may be used to analyze
wastewater samples. The second change is that we are reclassifying
triethylamine as a soluble HAP instead of as a partially soluble HAP.
The third change is to allow wastewater streams with more than 50 parts
per million weight (ppmw) of partially soluble HAP to be sent to an
enhanced biological treatment unit if the partially soluble HAP has
already been reduced by 99 percent or more. The fourth change is to
modify the
[[Page 40125]]
venting requirements for individual drain systems. In addition,
although we are not changing the sampling requirements, we are
clarifying those requirements.
Section 63.1257(b)(10)(ii) of the amended final rule states that
you may use EPA Methods 624, 625, 1624, and 1625 of 40 CFR part 136 to
determine the concentration of various HAP in wastewater samples (65 FR
52610, August 29, 2000). This direct final rule adds EPA Methods 1666
and 1671 to that list so that you may use them routinely without
performing the method validation procedures required in
Sec. 63.1257(b)(10)(iv). The two new methods can be used to measure
certain analytes (e.g., methanol, acetonitrile, and n-hexane) that
cannot be measured using the other methods in 40 CFR part 136. These
two methods were added to 40 CFR part 136 when the revisions to the
pharmaceutical effluent limitation guidelines and standards were
promulgated in September 1998. They have the same quality assurance/
quality control requirements as the earlier methods; in particular,
sampling must be conducted so as to minimize loss of volatile
compounds. In addition, they can detect target HAP at the outlet
concentrations that may be required by the rule (e.g., as low as 13
ppmw in the outlet from a treatment unit that must reduce partially
soluble HAP by 99 percent).
For the final rule, compounds were classified as either partially
soluble HAP or soluble HAP based on their Henry's Law constants.
Triethylamine was classified as a partially soluble HAP listed in Table
2 of subpart GGG because its Henry's Law constant is relatively high.
However, in this direct final rule, we are now removing triethylamine
from Table 2 of subpart GGG and reclassifying it as a soluble HAP in
Table 3 of subpart GGG because it has two unique characteristics that
distinguish it from the listed partially soluble HAP. First, at pH
ranges of 6 to 9 (typical for pharmaceutical production wastewater),
triethylamine has unique ionic disassociative properties, unlike the
listed partially soluble HAP. In the liquid phase, the nitrogen in
triethylamine has an unshared pair of electrons that readily react with
a proton in the liquid. As a result, virtually all of the free
triethylamine in solution is converted to triethylammonium ions, which
are soluble, non-volatile, and stable. Second, triethylamine is unique
among the HAP used in the pharmaceutical production industry in that it
typically is used as an organic base in reactions (in situations where
an inorganic base is not acceptable) and not as a primary solvent.
Section 63.1256(g)(10) of the pharmaceuticals production NESHAP
specifies that the partially soluble HAP concentration in wastewater
streams sent to an enhanced biological treatment unit must be less than
50 ppmw. An unintended effect of this restriction is that it applies
even if the partially soluble HAP has been reduced by more than 99
percent by treatment upstream of the enhanced biological treatment
unit. This restriction is unnecessary because a 99 percent reduction in
the partially soluble HAP is otherwise sufficient; there is no reason
to prevent the use of enhanced biological treatment to reduce the
soluble HAP in the same stream. Therefore, we have amended
Sec. 63.1256(g)(10) to clarify that a wastewater stream may be sent to
an enhanced biological treatment unit if the partially soluble HAP is
reduced to a concentration less than 50 ppmw or by at least 99 percent
(i.e., in accordance with Sec. 63.1256(g)(8)) in a treatment unit
upstream of the enhanced biological treatment unit.
Section 63.1256(e) of subpart GGG specifies work practice standards
to suppress emissions from individual drain systems. These standards
allow junction boxes to be vented, but not sewer lines. Without a vent,
wastewater may backup in drains and not flow properly to the first
downstream junction box if there are low points in the sewer line. To
alleviate this problem, we have revised Sec. 63.1256(e)(4)(iii) to
allow venting of a sewer line between drains and the first downstream
junction box, provided certain conditions are met. First, the drains
must be equipped with either water seals or tightly fitting caps or
plugs as specified in Sec. 63.1256(e)(4)(i). Second, the sewer line
entrance to the first downstream junction box must be water sealed.
These provisions apply regardless of whether the junction box is vented
to the atmosphere or to a process or control device. They also are
standard operating practices, and they ensure that air will not flow
through the sewer line and be emitted from the vent on the sewer line.
Finally, the size of the atmospheric opening is minimized by having the
sewer line vent pipe meet the same design criteria as for vents on
junction boxes.
The final rule specifies that wastewater samples may be grab
samples or composite samples, samples must be taken at approximately
equally-spaced time intervals over a 1-hour period, each 1-hour period
constitutes a run, and a performance test must consist of at least
three runs (Sec. 63.1257(e)(2)(iii)(B), (C)(1), (D)(1), and (E)(1)).
Similar requirements are specified for gas stream samples at the exit
of a combustion treatment unit or at the inlet or exit of control
devices (Sec. 63.1257(e)(2)(iii)(D)(4) and (e)(3)(i)(C)). As in the
Hazardous Organic NESHAP (HON) (40 CFR part 63, subpart G), we
intentionally did not specify exactly how to take samples because the
procedures will vary depending on the circumstances and the selected
test method. In some cases, any of the options may be acceptable,
whereas in other cases, some options may not be available. For example,
if you conduct wastewater sampling in accordance with a sampling plan
based on the sample handling requirements in EPA Method 25D of 40 CFR
part 60, appendix A, you would have to take grab samples; you would not
be able to take composite samples. On the other hand, for emission
stream samples where concentration measurements are to be determined
using EPA Method 18 of 40 CFR part 60, appendix A, you have the option
of taking either grab samples or composite samples. The rule does not
specify the number of samples that you must collect because we do not
want to restrict the number of samples that you take to cover
different, representative operating conditions (as opposed to
supplementing with modeling or engineering assessments). However, you
must take at least one sample per run. The requirement to take samples
at equally-spaced time intervals over the 1-hour period means that the
samples must be taken at the same point in the 1-hour period for each
of the three runs; this requirement applies even if you take only one
sample per run.
V. What Amendments Are We Making to the Storage Tank Provisions?
This direct final rule adds an outlet concentration limit
compliance option for storage tank emissions. Under this option, you
must conduct an initial performance test to demonstrate that emissions
are reduced to outlet concentrations less than or equal to 20 ppmv as
total organic compound (TOC) and less than or equal to 20 ppmv as
hydrogen halides and halogens. You also must establish applicable
operating parameter levels during the performance test to use as
monitoring limits for ongoing compliance demonstrations. This option is
identical to options already provided for process vent emissions and
wastewater emissions.
The exclusion of this option for storage tanks was an oversight
that was only recently discovered. We always intended to provide this
option for storage tank emissions as well as other
[[Page 40126]]
types of emissions, as evidenced by the fact that we included a
statement specifying how to demonstrate initial compliance with such an
option in Sec. 63.1257(c)(1) of the final rule (63 FR 50355, September
21, 1998). In previous amendments, we inadvertently modified this
statement to refer to compliance with the alternative standard (65 FR
52610, August 29, 2000). Therefore, in addition to providing the outlet
concentration limit as an option in Sec. 63.1253(b)(2) and (c)(2), this
direct final rule also restores the original intent of the provision in
Sec. 63.1257(c)(1).
VI. What Minor Technical Corrections Are We Making?
This direct final rule corrects referencing errors, corrects
drafting and typesetting errors, and clarifies the intent of several
provisions. All of the minor technical corrections are described in
Table 1.
Table 1.--Minor Technical Corrections to Subpart GGG
------------------------------------------------------------------------
Section of subpart GGG Description of correction
------------------------------------------------------------------------
Sec. 63.1250(e)............. The original language in these paragraphs
specified only how to determine
ownership if a storage tank was shared
among PMPU's. The revised language in
paragraphs (e)(2) and (3) clarifies how
to determine ownership of a tank that is
shared among one or more PMPU's and
other types of process units. The
requirement to assign storage tanks to a
process unit based on predominant use
has not changed. We also revised the
introductory text to paragraph (e) to
specify that if you produce only
pharmaceutical products, you do not need
to assign storage tanks to a PMPU except
when you comply with the pollution-
prevention alternative and when you need
to determine whether a dedicated PMPU is
subject to new source standards.
Otherwise, the assignment requirement is
not needed at these facilities because
all of the storage tanks are subject to
storage tank requirements in the rule,
and there are no other applicability
requirements based on total emissions
from a PMPU. We expect that this
clarification will reduce the burden for
some facilities.
Sec. 63.1250(h)(2).......... Clarified the overlapping provisions by
discussing the requirements in two
paragraphs instead of one. One paragraph
describes your options if you have a
control device subject to both the
pharmaceuticals production NESHAP and
any of the subparts AA, BB, or CC in 40
CFR parts 264 and/or 265. The second
paragraph describes your options if you
have equipment subject to the equipment
leak provisions in both Sec. 63.1255
and in subpart BB of 40 CFR parts 264
and/or 265. Options for waste management
units subject to both the
pharmaceuticals production NESHAP and
subpart CC of 40 CFR parts 264 and/or
265 are described in Sec.
63.1250(h)(5).
Sec. 63.1253(f)(7)(i)....... Corrected this paragraph by replacing the
incorrect reference to paragraph
(b)(7)(i) with the correct reference to
paragraph (f)(7).
Sec. 63.1255(b)(4)(iii)(A).. Corrected this paragraph by replacing the
incorrect reference to paragraph
(b)(3)(iii)(B) with the correct
reference to paragraph (b)(4)(iii)(B).
Sec. 63.1255(b)(4)(iii)(D).. Revised this paragraph to clarify that
you must monitor leaking connectors once
per year until the percent leaking
connectors is less than 0.5 percent.
After the percent leaking connectors
falls below 0.5 percent, you may again
implement the applicable less frequent
monitoring schedule. Without this
clarification, the paragraph could be
interpreted to mean that you must always
monitor leaking connectors once per
year.
Sec. 63.1255(c)(2)(iii), The original language in these paragraphs
(c)(3), and (5)(iv). was inconsistent. Paragraph (c)(5)(iv)
required EPA Method 21 monitoring to
verify the presence of a leak if
indications of liquids dripping were
detected during a visual inspection.
Paragraph (c)(2)(iii) simply stated that
a leak was present if there were visual
indications of liquids dripping. We
revised both paragraphs to specify that
if there are visual indications of
liquids dripping during a weekly visual
inspection, then you must either monitor
using EPA Method 21 or eliminate the
visual indication of liquids dripping
before the next weekly inspection. These
changes also make the paragraphs
consistent with the Consolidated Federal
Air Rule and 40 CFR part 63, subpart UU
(the Generic MACT). We also revised
paragraph (c)(3) to clarify that the
repair provisions for all leaking pumps/
agitators are the same.
Sec. 63.1255(c)(4)(ii)...... The original language in this paragraph
specified that you must monitor pumps
monthly instead of quarterly if, on a 1-
year rolling average, greater than 10
percent or 3 pumps have leaked in a
group of processes. As written, this
paragraph could be interpreted to mean
that all subsequent monitoring for that
group of processes must be monthly. This
was not our intent. To correct this
oversight, we have revised the paragraph
to specify that you may revert to
quarterly monitoring after the 1-year
rolling average again indicates that
less than 10 percent or fewer than 3
pumps have leaked.
Sec. 63.1255(e)(7)(iii)..... Added a sentence to this paragraph to
clarify that monitoring in the 3 months
after repair is in addition to the
monitoring required to demonstrate
repair. This amendment is consistent
with the language in the Consolidated
Federal Air Rule and 40 CFR part 63,
subpart UU. It is also consistent with
the intent of the HON.
Sec. 63.1255(e)(9).......... Corrected this paragraph by replacing the
incomplete reference to paragraphs
(e)(4)(iii) and (iv) with a reference to
paragraphs (e)(4)(iii), (iv), and (v).
The reference to paragraph (e)(4)(v) was
inadvertently left out of the final
rule. The change makes the paragraph
consistent with the Consolidated Federal
Air Rule.
Sec. 63.1255(h)(1)(ii)...... Deleted the word ``and'' at the end of
this paragraph because, as specified in
paragraph (h)(1), the only reports that
must be submitted are those specified in
paragraphs (h)(1)(i) and (ii).
Sec. 63.1255(h)(3)(i)....... Revised the schedule for submitting
Periodic reports with information on
equipment leak compliance to be
consistent with the schedule specified
in Sec. 63.1260(g)(1).
Sec. 63.1256(c)(1)(i)(A).... Corrected this paragraph by replacing the
incorrect reference to paragraph
(c)(1)(iv) with the correct reference to
paragraph (c)(1)(v).
[[Page 40127]]
Sec. 63.1256(e)(4)(i)(B).... The original language in this paragraph
used the terms ``flexible cap'' and
``flexible shield,'' interchangeably. To
clarify our intent, we revised the
paragraph to use only the term
``flexible shield.''
Sec. 63.1256(g)(9)(ii)...... Revised this paragraph to allow design
evaluations, as well as performance
tests, to demonstrate removal or
destruction of soluble HAP by 90 percent
in all treatment units except open
biological treatment units. This change
makes the requirements of this paragraph
consistent with the requirements in
paragraph (g)(4). It also makes this
paragraph consistent with the amended
requirements in paragraphs (g)(8)(ii),
(11)(ii), and (12) of this section. We
inadvertently neglected to amend this
paragraph at the same time that the
others were amended.
Sec. 63.1257(a)(6).......... Corrected this paragraph by replacing the
incorrect reference to Sec.
63.1258(b)(1) through (5) with the
correct reference to Sec. 63.1258(b)(1)
through (4). Section 63.1258(b)(5) is
not applicable because it relates to the
alternative standard, whereas Sec.
63.1257(a)(6) is describing monitoring
requirements to demonstrate compliance
with the outlet concentration limits of
20 ppmv TOC and 20 ppmv hydrogen halides
and halogens.
Sec. 63.1257(d)(2)(i)(D)(9). Corrected Equation 31 by replacing
``NHAP'' with ``nHAP.''
Sec. 63.1257(d)(2)(i)(D)(10) Corrected Equation 32 by replacing
individual HAP partial pressures with
partial pressures for individual
condensable compounds.
Sec. 63.1257(d)(2)(i)(E).... Added a sentence specifying that
individual HAP partial pressures in the
equation to calculate emissions from
vacuum systems may be calculated using
Raoult's Law. This change makes the
procedures for this equation consistent
with the procedures that are allowed for
calculating emissions from other types
of emission episodes.
Sec. 63.1257(d)(3)(iii)(B).. Corrected this paragraph by replacing the
incorrect reference to paragraphs
(d)(2)(iii)(B)(1) and (2) with the
correct reference to paragraphs
(d)(3)(iii)(B)(1) and (2).
Sec. 63.1257(e)(2)(iii)(B).. Corrected this paragraph by replacing the
incorrect reference to paragraph
(b)(10)(iii) with the correct reference
to paragraph (b)(10)(vi) and replacing
the incorrect reference to paragraphs
(b)(10)(i), (ii), and (iii) with the
correct reference to paragraphs
(b)(10)(i) through (vi).
Sec. 63.1257(e)(2)(iii)(C)(1 Corrected these paragraphs by replacing
), (D)(1), and (E)(1). the incorrect reference to paragraph
(b)(10)(v) with the correct reference to
paragraph (b)(10)(vi).
Sec. 63.1258(b)(3).......... Deleted the reference to process vents
from the heading to this paragraph. The
intent of this paragraph is to specify
procedures for setting parameter levels
for all control devices, not just those
used to control process vent emissions.
Sec. 63.1258(b)(5)(i)(A).... Deleted the last sentence in this
paragraph because it conflicts with the
requirement in Sec. 63.1258(b)(1)(x)
that calibration of CEMS include, at a
minimum, quarterly cylinder gas audits.
Sec. 63.1258(b)(5)(ii)(A)(2) Revised this paragraph to specify that it
applies if you comply with the
alternative standard instead of
achieving a control efficiency of ``98
percent,'' not ``98 percent or less.''
Paragraph (b)(5)(ii)(A)(1) specifies
requirements if you comply with the
alternative standard instead of
achieving a control efficiency of 95
percent or less. Subpart GGG has no
control efficiency requirements between
95 and 98 percent. Therefore, the phrase
``or less'' in paragraph
(b)(5)(ii)(A)(2) is both unnecessary and
conflicts with paragraph
(b)(5)(ii)(A)(1).
Sec. 63.1258(b)(8)(iii)..... Revised this paragraph to clarify that
violations of the alternative standard
apply to the 50 ppmv option for
noncombustion devices, as well as the 20
ppmv option for combustion devices. We
inadvertently neglected to amend this
paragraph when we added the 50 ppmv
option to the alternative standard (65
FR 52588, August 29, 2000).
Sec. 63.1258(h)(6) and (7).. Corrected these paragraphs by replacing
the incorrect references to paragraphs
(h)(8)(i) and (ii) with the correct
reference to paragraph (h)(8).
Sec. 63.1258(h)(10)......... Added paragraph (h)(10) to specify that
closed-vent systems operated and
maintained under negative pressure are
not subject to the inspection
requirements for closed-vent systems.
For this type of closed-vent system, you
must install a pressure gauge or other
pressure measurement device that can be
used to verify that the negative
pressure is being maintained when the
control device is operating. This new
provision is consistent with the
provision in Sec. 63.1255(b)(4)(ii)(B)
for closed-vent systems used to route
equipment leak emissions to a control
device.
Sec. 63.1259(a)(3)(iii) and Deleted the reference to Sec.
(b)(13). 63.10(b)(2)(iii) in paragraph
(a)(3)(iii) because, as noted in Table 1
to subpart GGG, this section of the
General Provisions does not apply to
subpart GGG. The reference also is
unnecessary because the requirement to
record maintenance performed on the
control device is clearly specified in
this paragraph. However, because this
maintenance recordkeeping requirement
will not always be related to a startup,
shutdown, or malfunction procedure, we
also moved it to a new paragraph
(b)(13).
Sec. 63.1259(b)(5)(i)....... Corrected this paragraph by removing the
references to individual process vents
and Sec. 63.1254(a)(3). This paragraph
requires records of emissions for
certain nonstandard batches. At an
existing source, these records are
needed to demonstrate compliance with a
process-based percent reduction
requirement for process vents from
nonstandard batches if you control some
vents to more than 93 percent and others
to less than 93 percent (or 98 percent
for new sources). Assuming the monitored
operating parameters are at acceptable
levels, the control efficiency for each
control device is unchanged, but the
overall control level for the process
could change if the impact of the
nonstandard batch on uncontrolled
emissions is not identical for each
vent. This situation cannot occur for
individual vents that are subject to
percent reduction requirements under
Sec. 63.1254(a)(3); thus, there is no
need to maintain a record of nonstandard
batch emissions for these vents.
[[Page 40128]]
Sec. 63.1259(b)(8).......... Revised this paragraph to require a log
or schedule of operating scenarios that
is updated daily or, at a minimum, each
time a different operating scenario
takes effect. The original requirements
to update the schedule or log daily and
prior to making a change are
unnecessarily burdensome.
Sec. 63.1259(i)(7).......... Paragraph (i)(7) requires records of
information associated with inspections
of closed vent systems during which a
leak is detected. As currently written,
paragraph (i)(7)(i) requires records
identifying the leaking equipment and
records of the instrument identification
number and operator name. This paragraph
may be confusing because the instrument
identification number and operator name
can be recorded only for leaks that are
detected using the instrument method. To
clarify the requirements, we revised the
language and split it into two
paragraphs. The revised paragraph
(i)(7)(i) requires records identifying
the leaking equipment; this record is
required regardless of the technique
used to identify the leak. The revised
paragraph (i)(7)(ii) requires a record
of the instrument identification number
and operator name for each leak that is
detected using the instrument method.
For each leak detected by sensory
observations, this paragraph also
requires a record indicating that the
leak was detected by sensory
observations. The original paragraphs
(i)(7)(ii) through (viii) are
redesignated as paragraphs (i)(7)(iii)
through (ix).
Sec. 63.1260(g)(1).......... Added statement specifying that each
periodic report after the first report
covers the 6-month period following the
preceding report. Also deleted the
requirement to submit the Periodic
reports 60 operating days after the end
of the applicable reporting period
because it could conflict with the
requirements to submit the first
periodic report no later than 240 days
after the Notification of Compliance
Status Report is due and to submit
subsequent reports every 6 months
thereafter. These changes also make
paragraph (g)(1) consistent with Sec.
63.1255(h)(3)(i).
Sec. 63.1260(g)(2)(v)....... Corrected this paragraph by replacing the
incorrect reference to paragraph
(g)(2)(iv)(A) with the correct reference
to paragraph (g)(2)(v)(A).
Sec. 63.1260(g)(2)(vii)..... Revised this paragraph to specify that
the first periodic report must include
each operating scenario operated since
the due date of the Notification of
Compliance Status Report, not since the
compliance date. This change makes the
time period for this information
consistent with the time period covered
by the first periodic report, as
specified in Sec. 63.1260(g)(1).
Sec. 63.1260(h)............. Revised this paragraph to require process
change notifications as part of the
Periodic report instead of quarterly. We
determined that requiring submittal of
the process change notification more
frequently than the Periodic report was
an unnecessary burden.
Sec. 63.1260(i)............. We made two changes to clarify this
paragraph and make it more consistent
with the startup, shutdown, and
malfuction (SSM) reporting requirements
in Sec. 63.10(d)(5). First, we split
the requirements into two paragraphs;
the first paragraph specifies reporting
requirements for actions that are
consistent with the SSM plan, and the
second paragraph specifies immediate
reporting requirements for actions that
are not consistent with the SSM plan.
Second, we deleted the requirement to
report records required by Sec.
63.1259(a)(3)(iii) because reporting
this information is inconsistent with
Sec. 63.10(d)(5)(i) of the General
Provisions, which requires only a
statement that the procedures in the SSM
plan were followed.
Table 1 to subpart GGG....... Corrected typesetting errors in entries
Secs. 63.1(c)(5), 63.5(e), and
63.8(e)(5)(i). Also corrected the entry
for Sec. 63.6(i) by replacing the
incorrect reference to Sec.
63.1250(f)(4) with the correct reference
to Sec. 63.1250(f)(6), and by
indicating that the approval provisions
in Sec. 63.6(i)(7) through (14) apply
to requests for approval of compliance
extensions that are requested according
to Sec. 63.1250(f)(6).
------------------------------------------------------------------------
VII. What Are the Administrative Requirements for This Direct Final
Rule?
A. Executive Order 12866, Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and
therefore, subject to OMB review and the requirements of the Executive
Order. The Executive Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that these amendments do not constitute a ``significant
regulatory action'' because they do not meet any of the above criteria.
Consequently, this action was not submitted to OMB for review under
Executive Order 12866.
B. Executive Order 13132, Federalism
Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by State and local officials in the development of regulatory
policies that have federalism implications.'' ``Policies that have
federalism implications'' is defined in the Executive Order to include
regulations that have ``substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government.''
[[Page 40129]]
These rule amendments do not have federalism implications. They
will not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, because State and
local governments do not own or operate any sources that would be
subject to these amendments. Thus, the requirements of section 6 of the
Executive Order do not apply to these rules.
C. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officals in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' are defined in the Executive Order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes.''
These rule amendments do not have tribal implications. They will
not have substantial direct effects on tribal governments, or on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175. No
tribal governments own or operate pharmaceutical production facilities.
Thus, Executive Order 13175 does not apply to these rule amendments.
D. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA.
The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Executive Order has
the potential to influence the regulation. These rule amendments are
not subject to Executive Order 13045 because they are based on
technology performance, not health or safety risks. Furthermore, these
rule amendments have been determined not to be ``economically
significant'' as defined under Executive Order 12866.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and tribal governments, in
aggregate, or by the private sector, of $100 million or more in any 1
year. Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least-costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least-
costly, most cost-effective, or least-burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
The EPA has determined that these rule amendments do not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, or tribal governments, in the aggregate, or the
private sector in any 1 year. The maximum total annual cost of the
Pharmaceuticals Production NESHAP for any year has been estimated to be
approximately $64 million (63 FR 50287, September 21, 1998), and
today's amendments do not add new requirements that would increase this
cost. Thus, these rule amendments are not subject to the requirements
of sections 202 and 205 of the UMRA. In addition, EPA has determined
that these rule amendments contain no regulatory requirements that
might significantly or uniquely affect small governments because they
contain no requirements that apply to such governments or impose
obligations upon them. Therefore, these rule amendments are not subject
to the requirements of section 203 of the UMRA.
F. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.
The EPA has determined that it is not necessary to prepare a
regulatory flexibility analysis in connection with this direct final
rule. The EPA has also determined that this direct final rule will not
have a significant impact on a substantial number of small entities.
For purposes of assessing the impacts of this direct final rule on
small entities, a small entity is defined as: (1) A small business in
the North American Industrial Classification System (NAICS) code 325411
or 325412 that has as many as 750 employees; (2) a small business in
NAICS code 325199 that has as many as 1,000 employees; (3) a small
governmental jurisdiction that is a government of a city, county, town,
school district, or special district with a population of less than
50,000; and (4) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
After considering the economic impacts of today's rule amendments
on small entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any
[[Page 40130]]
significant economic impact on small entities'' (5 U.S.C. sections 603
and 604). Thus, an agency may conclude that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves burden, or otherwise has a positive economic
effect on all of the small entities subject to the rule. Today's rule
amendments impose no additional regulatory requirements on owners or
operators of affected sources, many of the rule amendments provide
additional compliance options, and other rule amendments clarify
requirements and correct minor drafting errors. We have therefore,
concluded that these rules will relieve regulatory burden for all small
entities.
G. Paperwork Reduction Act
The OMB has approved the information collection requirements
contained in the 1998 pharmaceuticals production NESHAP under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control No. 2060-0358. An Information Collection
Request (ICR) document has been prepared by EPA (ICR No. 1781.01), and
a copy may be obtained from Sandy Farmer by mail at U.S. Environmental
Protection Agency, Office of Environmental Information, Collection
Strategies Division (2822), 1200 Pennsylvania Avenue, NW, Washington DC
20460, by email at [email protected], or by calling (202) 260-2740.
The amendments contained in these final rules will have no net
impact on the information collection burden estimates made previously.
Consequently, the ICR has not been revised.
H. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA), Public Law 104-113 (March 7, 1996), directs all Federal
agencies to use voluntary consensus standards instead of government-
unique standards in their regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., material
specifications, test methods, sampling and analytical procedures, and
business practices) that are developed or adopted by one or more
voluntary consensus bodies. Examples of organizations generally
regarded as voluntary consensus standards bodies include the American
Society for Testing and Materials (ASTM), the National Fire Protection
Association (NFPA), and the Society of Automotive Engineers (SAE). The
NTTAA requires Federal agencies like EPA to provide Congress, through
OMB, with explanations when an agency does not use available and
applicable voluntary consensus standards.
During the rulemaking, EPA searched for voluntary consensus
standards that might be applicable. The search identified no applicable
voluntary consensus standards. Accordingly, the NTTAA requirement to
use applicable voluntary consensus standards does not apply to this
direct final rule.
I. Congressional Review Act
The Congressional Review Act (CRA), 5 U.S.C. 801, et seq., as added
by the SBREFA of 1996, generally provides that before a rule may take
effect, the agency adopting the rule must submit a rule report, which
includes a copy of the rule, to each House of the Congress and to the
Comptroller General of the United States. The EPA will submit a report
containing this direct final rule and other required information to the
U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the United States prior to publication of this rule in the
Federal Register. A major rule cannot take effect until 60 days after
it is published in the Federal Register. This direct final rule is not
a ``major rule'' as defined by 5 U.S.C. 804(2). This direct final rule
will be effective on October 16, 2001.
Section 808 allows the issuing agency to make a rule effective
sooner than otherwise provided by the CRA if the agency makes a good
cause finding that notice and public procedure is impracticable,
unnecessary or contrary to the public interest. This determination must
be supported by a brief statement (5 U.S.C. 808(2)). As stated
previously, for the amendments to the table that lists OMB control
numbers, EPA has made such a good cause finding, including the reasons
therefor, and established an effective date of August 2, 2001. The EPA
will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
J. Executive Order 13211 (Energy Effects)
This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a
significant regulatory action under Executive Order 12866.
List of Subjects in 40 CFR Parts 9 and 63
Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.
Dated: July 24, 2001.
Christine Todd Whitman,
Administrator.
For the reasons set out in the preamble, parts 9 and 63 of title
40, chapter I of the Code of Federal Regulations are amended as
follows:
PART 9--[AMENDED]
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9 1857 et seq., 6901-6992k, 7401-7671g, 7542,
9601-9657, 11023, 11048.
2. Section 9.1 is amended by revising the entry ``63.1259-63.1260''
in the table under the indicated heading to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR Citation OMB Control No.
------------------------------------------------------------------------
* * * * *
National Emission Standards for Hazardous Air Pollutants for Source
Categories.\3\
* * * * *
63.1259-63.1260........................... 2060-0358
* * * * *
------------------------------------------------------------------------
\3\ The ICR's referenced in this section of the table encompass the
applicable General Provisions contained in 40 CFR part 63, subpart A,
which are not independent information collection requirements.
PART 63--[AMENDED]
3. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
Subpart GGG--National Emission Standards for Pharmaceuticals
Production
4. Section 63.1250 is amended by:
a. Revising paragraph (e); and
[[Page 40131]]
b. Revising paragraph (h)(2). The revisions read as follows:
Sec. 63.1250 Applicability.
* * * * *
(e) Storage tank ownership determination. The owner or operator
shall follow the procedures specified in paragraphs (e)(1) through (5)
of this section to determine to which PMPU a storage tank shall belong.
If an owner or operator produces only pharmaceutical products, the
procedures specified in paragraphs (e)(1) through (5) of this section
are required only to determine applicability and demonstrate compliance
with the pollution-prevention alternative specified in Sec. 63.1252(e),
or to determine new source applicability for a PMPU dedicated to
manufacturing a single product as specified in paragraph (b) of this
section.
(1) If a storage tank is dedicated to a single PMPU, the storage
tank shall belong to that PMPU.
(2) If a storage tank is shared among process units (including at
least one PMPU), then the storage tank shall belong to the process unit
located on the same plant site as the storage tank that has the
greatest annual volume input into or output from the storage tank
(i.e., said PMPU or process unit has the predominant use of the storage
tank).
(3) If predominant use cannot be determined for a storage tank that
is shared among process units (including at least one PMPU), then the
owner or operator shall assign the storage tank to any one of the
PMPU's that shares it and is also subject to this subpart.
(4) If the predominant use of a storage tank varies from year to
year, then predominant use shall be determined based on the utilization
that occurred during the year preceding September 21, 1998 for existing
affected sources. For new affected sources, predominant use will be
based on the first year after initial startup. The determination of
predominant use shall be reported in the Notification of Compliance
Status required by Sec. 63.1260(f). If the predominant use changes, the
redetermination of predominant use shall be reported in the next
Periodic report.
(5) If the storage tank begins receiving material from (or sending
material to) another PMPU, or ceases to receive material from (or send
material to) a PMPU, or if the applicability of this subpart to a
storage tank has been determined according to the provisions of
paragraphs (e)(1) through (4) of this section and there is a
significant change in the use of the storage tank that could reasonably
change the predominant use, the owner or operator shall reevaluate the
applicability of this subpart to the storage tank and report such
changes to EPA in the next Periodic report.
* * * * *
(h) * * *
(2) Consistency with 40 CFR parts 264 and 265, subparts AA, BB,
and/or CC. (i) After the compliance dates specified in this section, if
any control device subject to this subpart is also subject to
monitoring, recordkeeping, and reporting requirements in 40 CFR part
264, subpart AA, BB, or CC, or is subject to monitoring and
recordkeeping requirements in 40 CFR part 265, subpart AA, BB, or CC,
and the owner or operator complies with the periodic reporting
requirements under 40 CFR part 264, subpart AA, BB, or CC that would
apply to the device if the facility had final-permitted status, the
owner or operator may elect to comply either with the monitoring,
recordkeeping, and reporting requirements of this subpart, or with the
monitoring, recordkeeping, and reporting requirements in 40 CFR parts
264 and/or 265, as described in this paragraph, which shall constitute
compliance with the monitoring, recordkeeping, and reporting
requirements of this subpart. If the owner or operator elects to comply
with the monitoring, recordkeeping, and reporting requirements in 40
CFR parts 264 and/or 265, the owner or operator shall report all
information required by Sec. 63.1260(g) and (i). The owner or operator
shall identify in the Notification of Compliance Status, required by
Sec. 63.1260(f), the monitoring, recordkeeping, and reporting authority
under which the owner or operator will comply.
(ii) After the compliance dates specified in this section, if any
equipment at an affected source that is subject to Sec. 63.1255, is
also subject to 40 CFR part 264, subpart BB, or to 40 CFR part 265,
subpart BB, then compliance with the recordkeeping and reporting
requirements of 40 CFR parts 264 and/or 265 may be used to comply with
the recordkeeping and reporting requirements of Sec. 63.1255, to the
extent that the requirements of 40 CFR parts 264 and/or 265 duplicate
the requirements of Sec. 63.1255. The owner or operator shall identify
in the Notification of Compliance Status, required by Sec. 63.1260(f),
if the owner or operator will comply with the recordkeeping and
reporting authority under 40 CFR parts 264 and/or 265.
* * * * *
5. Section 63.1251 is amended by adding a definition in
alphabetical order for centralized combustion control device to read as
follows:
Sec. 63.1251 Definitions.
* * * * *
Centralized combustion control device (CCCD) means enclosed
combustion devices that are used to control process vent emissions from
non-dedicated PMPU's at a facility. Centralized combustion control
devices may also be used to control emissions from source types
including, but not limited to, storage tanks, waste management units,
and equipment leaks.
* * * * *
6. Section 63.1252 is amended by adding paragraph (h) to read as
follows:
Sec. 63.1252 Standards: General.
* * * * *
(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 deg.C
(-58 deg.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 deg.C
(23 deg.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 deg.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.
[[Page 40132]]
(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.
7. Section 63.1253 is amended by:
a. Redesignating paragraphs (b)(2) through (4) as paragraphs (b)(3)
through (5) and adding paragraph (b)(2);
b. Redesignating paragraphs (c)(2) through (4) as paragraphs (c)(3)
through (5) and adding paragraph (c)(2);
c. Revising the second sentence in paragraph (e); and
d. Revising ``paragraph (b)(7)(i)'' to read ``paragraph (f)(7)'' in
paragraph (f)(7)(i).
The revisions and additions read as follows:
Sec. 63.1253 Standards: Storage tanks.
* * * * *
(b) * * *
(2) Reduces emissions 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;
* * * * *
(c) * * *
(2) Reduces emissions 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; STARS
(e) * * * Periods of planned routine maintenance of the control
devices (including CCCD subject to Sec. 63.1252(h)), during which the
control device does not meet the specifications of paragraphs (b)
through (d) of this section, as applicable, shall not exceed 240 hours
in any 365-day period.
* * * * *
8. Section 63.1254 is amended by adding paragraph (a)(4) to read as
follows:
Sec. 63.1254 Standards: Process vents.
(a) * * *
(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 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.
* * * * *
9. Section 63.1255 is amended by:
a. Adding paragraph (b)(4)(ii)(C);
b. Revising ``paragraphs (b)(3)(iii)(B) through (F)'' to read
``paragraphs (b)(4)(iii)(B) through (F)'' in paragraph (b)(4)(iii)(A);
c. Revising paragraph (b)(4)(iii)(D);
d. Revising paragraph (c)(2)(iii);
e. Revising paragraph (c)(3)(i);
f. Revising paragraph (c)(4)(ii);
g. Revising paragraph (c)(5)(iv);
h. Removing paragraphs (c)(5)(vi)(C) and (D) and adding paragraph
(c)(5)(vii);
i. Adding a sentence at the end of paragraph (e)(7)(iii)
introductory left;
j. Revising the second sentence in paragraph (e)(9);
k. Revising paragraph (h)(1)(ii); and
l. Revising paragraph (h)(3)(i).
The revisions and additions read as follows:
Sec. 63.1255 Standards: Equipment leaks.
* * * * *
(a) * * *
(4) * * *
(ii) * * *
(C) The requirements apply at all times, except as specified in
Sec. 63.1250(g). The owner or operator may not comply with the planned
routine maintenance provisions in Sec. 63.1252(h).
(iii) * * *
(D) Except as provided in paragraph (b)(4)(iii)(B) of this section,
if leaking connectors comprise at least 0.5 percent but less than 1.0
percent of the connectors during the last monitoring period, the owner
or operator shall monitor at least once every 2 years for the next
monitoring period. At the end of that 2-year monitoring period, if the
percent leaking connectors is greater than or equal to 0.5 percent, the
owner or operator shall monitor once per year until the percent leaking
connectors is less than 0.5 percent. If, at the end of a monitoring
period, the percent leaking connectors is less than 0.5 percent, the
owner or operator shall monitor in accordance with paragraph
(b)(4)(iii)(C) or (F) of this section, as appropriate.
* * * * *
(c) * * *
(2) * * *
(iii) Visual Inspections. Each pump and agitator shall be checked
by visual inspection each calendar week for indications of liquids
dripping from the pump or agitator seal. If there are indications of
liquids dripping from the pump or agitator seal at the time of the
weekly inspection, the owner or operator shall follow the procedure
specified in either paragraph (c)(2)(iii)(A) or (B) of this section
prior to the next weekly inspection.
(A) The owner or operator shall monitor the pump or agitator by the
method specified in Sec. 63.180(b). If the instrument reading indicates
a leak as specified in paragraph (c)(2)(ii) of this section, a leak is
detected.
(B) The owner or operator shall eliminate the visual indications of
liquids dripping.
(3) * * *
(i) When a leak is detected pursuant to paragraph (c)(2)(i),
(c)(2)(iii)(A),
[[Page 40133]]
(c)(5)(iv)(A), or (c)(5)(vi)(B) of this section, it shall be repaired
as soon as practicable, but not later than 15 calendar days after it is
detected, except as provided in paragraph (b)(4)(i) of this section.
* * * * *
(4) * * *
(ii) If, calculated on a 1-year rolling average, the greater of
either 10 percent or three of the pumps in a group of processes leak,
the owner or operator shall monitor each pump once per month, until the
calculated 1-year rolling average value drops below 10 percent or three
pumps, as applicable.
* * * * *
(5) * * *
(iv) Each pump/agitator is checked by visual inspection each
calendar week for indications of liquids dripping from the pump/
agitator seal. If there are indications of liquids dripping from the
pump or agitator seal at the time of the weekly inspection, the owner
or operator shall follow the procedures specified in either paragraph
(c)(5)(iv)(A) or (B) of this section prior to the next required
inspection.
(A) The owner or operator shall monitor the pump or agitator using
the method specified in Sec. 63.180(b) to determine if there is a leak
of organic HAP in the barrier fluid. If the instrument reading
indicates a leak, as specified in paragraph (c)(2)(ii) of this section,
a leak is detected.
(B) The owner or operator shall eliminate the visual indications of
liquids dripping.
* * * * *
(vii) When a leak is detected pursuant to paragraph (c)(5)(iv)(A)
or (B) of this section, the leak must be repaired as specified in
paragraph (c)(3) of this section.
* * * * *
(e) * * *
(7) * * *
(iii) * * * The monitoring required by this paragraph is in
addition to the monitoring required to satisfy the definitions of
``repaired'' and ``first attempt at repair.''
* * * * *
(9) * * * Instead, the owner or operator shall monitor each valve
in organic HAP service for leaks once each quarter, or comply with
paragraph (e)(4)(iii), (iv), or (v) of this section, except as provided
in paragraph (f) of this section.
* * * * *
(h) * * *
(1) * * *
(ii) Periodic reports described in paragraph (h)(3) of this
section.
* * * * *
(3) * * *
(i) A report containing the information in paragraphs (h)(3)(ii),
(iii), and (iv) of this section shall be submitted semiannually. The
first report shall be submitted no later than 240 days after the
Notification of Compliance Status Report is due and shall cover the 6-
month period beginning on the date the Notification of Compliance
Status Report is due. Each subsequent report shall cover the 6-month
period following the preceding period.
* * * * *
10. Section 63.1256 is amended by:
a. Revising ``paragraph (c)(1)(iv)'' to read ``paragraph
(c)(1)(v)'' in paragraph (c)(1)(i)(A);
b. Revising ``flexible cap'' to read ``flexible shield'' in the
last sentence in paragraph (e)(4)(i)(B);
c. Revising paragraph (e)(4)(iii);
d. Revising paragraph (g)(9)(ii);
e. Revising the first sentence in paragraph (g)(10);
f. Revising paragraph (h) introductory text; and
g. Adding paragraph (h)(5).
The revisions and additions read as follows:
Sec. 63.1256 Standards: Wastewater.
* * * * *
(e) * * *
(4) * * *
(iii) The owner or operator shall operate and maintain sewer lines
as specified in paragraphs (e)(4)(iii)(A) and (B) of this section.
(A) Except as specified in paragraph (e)(4)(iii)(B) of this
section, each sewer line shall not be open to the atmosphere and shall
be covered or enclosed in a manner so as to have no visible gaps or
cracks in joints, seals, or other emission interfaces.
Note: This provision applies to sewers located inside and
outside of buildings.
(B) A sewer line connected to drains that are in compliance with
paragraph (e)(4)(i) of this section may be vented to the atmosphere,
provided that the sewer line entrance to the first downstream junction
box is water sealed and the sewer line vent pipe is designed as
specified in paragraph (e)(4)(ii)(B)(1) of this section.
* * * * *
(g) * * *
(9) * * *
(ii) Percent mass removal/destruction option. The owner or operator
shall reduce the mass of total soluble HAP by 90 percent or more,
either by removal or destruction. The removal/destruction efficiency
shall be determined by the procedures in Sec. 63.1257(e)(2)(ii) or
(e)(2)(iii)(C) for noncombustion, nonbiological treatment processes;
Sec. 63.1257(e)(2)(ii) or (e)(2)(iii)(D) for combustion processes;
Sec. 63.1257(e)(2)(iii)(F) for open biological treatment processes; and
Sec. 63.1257(e)(2)(ii) or (e)(2)(iii)(G) for closed, biological
treatment processes.
(10) Control option: Enhanced biotreatment for wastewater
containing soluble HAP. The owner or operator may elect to treat
affected wastewater streams containing soluble HAP in an enhanced
biological treatment system, as defined in Sec. 63.1251, provided the
wastewater stream contains less than 50 ppmw partially soluble HAP, or
the owner or operator complies with the requirements of paragraph
(g)(8) of this section before treating the affected wastewater stream
in the enhanced biological treatment system. * * *
* * * * *
(h) For each control device or combination of control devices used
to comply with the provisions in paragraphs (b) through (f) and (g)(5)
of this section, the owner or operator shall operate and maintain the
control device or combination of control devices in accordance with the
requirements of paragraphs (h)(1) through (5) of this section.
* * * * *
(5) The provisions in paragraphs (h)(1) through (4) of this section
apply at all times, except as specified in Sec. 63.1250(g). The owner
or operator may not comply with the planned routine maintenance
provisions in Sec. 63.1252(h) for vent streams from waste management
units.
* * * * *
11. Section 63.1257 is amended by:
a. Revising the last sentence in paragraph (a)(6);
b. Revising paragraph (b)(10)(ii);
c. Revising paragraph (c)(1) introductory text;
d. Adding a sentence at the end of paragraph (d)(1)(i);
e. Revising ``NHAP'' to read ``nHAP'' in
equation 31 in paragraph (d)(2)(i)(D)(9);
f. Revising paragraph (d)(2)(i)(D)(10);
g. Adding a sentence after the first sentence in paragraph
(d)(2)(i)(E);
h. Revising ``paragraphs (d)(2)(iii)(B)(1) and (2)'' to read
``paragraphs (d)(3)(iii)(B)(1) and (2)'' in paragraph (d)(3)(iii)(B)
introductory text;
i. Revising ``paragraph (b)(10)(iii)'' to read ``paragraph
(b)(10)(vi)'' and revising ``paragraphs (b)(10)(i), (ii), and (iii)''
to read ``paragraphs (b)(10)(i) through (vi)'' in paragraph
(e)(2)(iii)(B); and
j. Revising ``paragraph (b)(10)(v)'' to read ``paragraph
(b)(10)(vi)'' in
[[Page 40134]]
paragraphs (e)(2)(iii)(C)(1), (D)(1), and (E)(1).
The revisions and additions read as follows:
Sec. 63.1257 Test methods and compliance procedures.
(a) * * *
(6) * * * The owner or operator shall comply with the monitoring
provisions in Sec. 63.1258(b)(1) through (4) on the initial compliance
date.
* * * * *
(b) * * *
(10) * * *
(ii) EPA Method 624, 625, 1624, 1625, 1666, or 1671. Use procedures
specified in EPA Method 624, 625, 1624, 1625, 1666, or 1671 of 40 CFR
part 136, appendix A, and comply with requirements in paragraph
(b)(10)(vi) of this section.
* * * * *
(c) * * *
(1) Performance test. If this option is chosen to demonstrate
initial compliance with the percent reduction requirement of
Sec. 63.1253(b)(1) or (c)(1)(i), the efficiency of the control device
shall be calculated using performance test data as specified in
paragraphs (c)(1)(i) through (iii) of this section. To demonstrate
initial compliance with the outlet concentration requirements in
Sec. 63.1253(b)(2) and (c)(2), the owner or operator must conduct a
performance test and fulfill the requirements of paragraph (a)(6) of
this section.
* * * * *
(d) * * *
(1) * * *
(i) * * * Controlled emissions during periods of planned routine
maintenance of a CCCD as specified in Sec. 63.1252(h), must be
calculated assuming the HAP emissions are reduced by 93 percent.
* * * * *
(2) * * *
(i) * * *
(D) * * *
(10) Emissions from depressurization may be calculated using
equation 32 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR02AU01.034
Where:
V = free volume in vessel being depressurized
R = ideal gas law constant
T = temperature of the vessel, absolute
P1 = initial pressure in the vessel
P2 = final pressure in the vessel
Pj = partial pressure of the individual condensable
compounds (including HAP)
MWi = molecular weight of the individual HAP compounds
n = number of HAP compounds in the emission stream
m = number of condensable compounds (including HAP) in the emission
stream
i = identifier for a HAP compound
j = identifier for a condensable compound.
(E) * * * The individual HAP partial pressures may be calculated
using Raoult's Law. * * *
* * * * *
12. Section 63.1258 is amended by:
a. Revising paragraph (b)(3) heading;
b. Revising paragraph (b)(5)(i)(A);
c. Revising paragraph (b)(5)(ii)(A)(2);
d. Revising paragraph (b)(8)(iii);
e. Adding a sentence between the first and second sentences in
paragraph (c);
f. Revising ``paragraph (h)(9)'' to read ``paragraphs (h)(9) and
(10)'' in paragraph (h)(1);
g. Revising ``paragraph (h)(8)(i)'' to read ``paragraph (h)(8)'' in
paragraph (h)(6) introductory text;
h. Revising ``paragraph (h)(8)(ii)'' to read ``paragraph (h)(8)''
in paragraph (h)(7) introductory text;
i. Adding paragraph (h)(10); and
j. Adding paragraph (i).
The revisions and additions read as follows:
Sec. 63.1258 Monitoring requirements.
* * * * *
(b) * * *
(3) Procedures for setting parameter levels for control devices
used to control emissions. * * *
* * * * *
(5) * * *
(i) * * *
(A) A TOC monitor meeting the requirements of EPA Performance
Specification 8, 9, or 15 of appendix B of 40 CFR part 60 shall be
installed, calibrated, and maintained according to Sec. 63.8.
* * * * *
(ii) * * *
(A) * * *
(2) If complying with the alternative standard instead of achieving
a control efficiency of 98 percent, the owner or operator must maintain
a minimum residence time of 0.75 seconds and a minimum combustion
chamber temperature of 816 deg.C.
* * * * *
(8) * * *
(iii) Except as provided in paragraph (b)(8)(iv) of this section,
exceedances of the 20 or 50 ppmv TOC outlet emission limit, averaged
over the operating day, will result in no more than one violation per
day per control device. Except as provided in paragraph (b)(8)(iv) of
this section, exceedances of the 20 or 50 ppmv hydrogen halide or
halogen outlet emission limit, averaged over the operating day, will
result in no more than one violation per day per control device.
* * * * *
(c) * * * During periods of planned routine maintenance when
emissions are controlled as specified in Sec. 63.1252(h), the owner or
operator must calculate controlled emissions assuming the HAP emissions
are reduced by 93 percent. * * *
* * * * *
(h) * * *
(10) Instead of complying with the provisions of paragraphs (h)(2)
through (8) of this section, an owner or operator may design a closed-
vent system to operate at a pressure below atmospheric pressure. The
system shall be equipped with at least one pressure gauge or other
pressure measurement device that can be read from a readily accessible
location to verify that negative pressure is being maintained in the
closed-vent system when the associated control device is operating.
(i) Planned routine maintenance. During periods of planned routine
maintenance when organic HAP emissions are controlled as specified in
Sec. 63.1252(h)(2), the owner or operator must monitor the condenser
outlet gas temperature according to the procedures specified in
paragraph (b)(1)(iii) of this section. During periods of planned
routine maintenance when HCl emissions are controlled as specified in
Sec. 63.1252(h)(3), the owner or operator
[[Page 40135]]
must monitor the pH of the scrubber effluent once per day.
13. Section 63.1259 is amended by:
a. Revising paragraph (a)(3)(iii);
b. Revising paragraph (b)(5)(i) introductory text;
c. Redesignating paragraphs (b)(5)(ii)(D) and (E) as paragraphs
(b)(5)(ii)(E) and (F);
d. Adding paragraph (b)(5)(ii)(D);
e. Revising paragraph (b)(8);
f. Revising paragraph (b)(10);
g. Adding paragraph (b)(13);
h. Revising ``paragraphs (i)(7)(i) through (viii)'' to read
``paragraphs (i)(7)(i) through (ix)'' in paragraph (i)(7) introductory
text; and
i. Redesignating paragraphs (i)(7)(i) through (viii) as paragraphs
(i)(7)(ii) through (ix), adding paragraph (i)(7)(i), and revising
redesignated paragraph (i)(7)(ii).
The revisions and additions read as follows:
Sec. 63.1259 Recordkeeping requirements.
(a) * * *
(3) * * *
(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).
* * * * *
(b) * * *
(5) * * *
(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 than the percent reduction requirement, the records
specified in paragraphs (b)(5)(i)(A) through (C) of this section are
required.
* * * * *
(ii) * * *
(D) Actual controlled emissions for each batch operated during
periods of planned routine maintenance of a CCCD, calculated according
to Sec. 63.1258(c).
* * * * *
(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.
* * * * *
(10) Periods of planned routine maintenance as described in
Secs. 63.1252(h) and 63.1257(c)(5).
* * * * *
(13) All maintenance performed on the air pollution control
equipment.
* * * * *
(i) * * *
(7) * * *
(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.
* * * * *
14. Section 63.1260 is amended by:
a. Adding paragraph (f)(7);
b. Revising paragraph (g)(1) introductory text;
c. Revising ``paragraphs (g)(2)(iv)(A) through (D)'' to read
``paragraphs (g)(2)(v)(A) through (D)'' in paragraph (g)(2)(v)
introductory text;
d. Revising paragraph (g)(2)(vi);
e. Revising the last sentence in paragraph (g)(2)(vii);
f. Revising paragraph (h)(1) introductory text; and
g. Revising paragraph (i).
The revisions and additions read as follows:
Sec. 63.1260 Reporting requirements.
* * * * *
(f) * * *
(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) * * *
(1) Submittal schedule. Except as provided in paragraphs (g)(1)(i),
(ii), and (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.
* * * * *
(2) * * *
(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 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) * * * 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.
* * * * *
(h) * * *
(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) 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
[[Page 40136]]
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).
* * * * *
15. Table 1 to subpart GGG is amended by:
a. Revising entries ``63.1(c)(5),'' ``63.5(e),'' and
``63.8(e)(5)(i)''; and
b. Removing entry ``63.6(i)'' and adding entries ``63.6(i) (1)
through (7)'' and ``63.6(i) (8) through (14).''
The revisions and additions read as follows:
Table 1 to Subpart GGG.--General Provisions Applicability to Subpart GGG
----------------------------------------------------------------------------------------------------------------
General provisions reference Summary of requirements Applies to subpart GGG Comments
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Sec. 63.1(c)(5)..................... Notification Yes .......................
requirements for an
area source that
increases HAP
emissions to major
source levels.
* * * * * *
*
Sec. 63.5(e)........................ Construction/ Yes .......................
reconstruction
approval.
* * * * * *
*
Sec. 63.6(i)(1) through (7)......... Requests for compliance No..................... Sec. 63.1250(f)(6)
extensions. specifies provisions
for compliance
extensions.
Sec. 63.6(i)(8) through (14)........ Approval of compliance Yes.................... Except references to
extensions. Sec. 63.6(i)(4)
through (6) mean Sec.
63.1250(f)(6).
* * * * * *
*
Sec. 63.8(e)(5)(i).................. Reporting performance Yes.................... See Sec. 63.1260(a).
evaluation results.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
16. Table 2 to subpart GGG is revised to read as follows:
Table 2 to SubparT GGG.--Partially Soluble HAP
------------------------------------------------------------------------
------------------------------------------------------------------------
1,1,1-Trichloroethane (methyl Chloroform
chloroform).
1,1,2,2-Tetrachloroethane.............. Chloromethane
1,1,2-Trichloroethane.................. Chloroprene
1,1-Dichloroethylene (vinylidene Cumene
chloride).
1,2-Dibromoethane...................... Dichloroethyl ether
1,2-Dichloroethane (ethylene Dinitrophenol
dichloride).
1,2-Dichloropropane.................... Epichlorohydrin
1,3-Dichloropropene.................... Ethyl acrylate
2,4,5-Trichlorophenol.................. Ethylbenzene
2-Butanone (mek)....................... Ethylene oxide
1,4-Dichlorobenzene.................... Hexachlorobenzene
2-Nitropropane......................... Hexachlorobutadiene
4-Methyl-2-pentanone (MIBK)............ Hexachloroethane
Acetaldehyde........................... Methyl methacrylate
Acrolein............................... Methyl-t-butyl ether
Acrylonitrile.......................... Methylene chloride
Allyl chloride......................... N,N-dimethylaniline
Benzene................................ Propionaldehyde
Benzyl chloride........................ Propylene oxide
Biphenyl............................... Styrene
Bromoform (tribromomethane)............ Tetrachloroethene
(perchloroethylene)
Bromomethane........................... Tetrachloromethane (carbon
tetrachloride
Butadiene.............................. Toluene
Carbon disulfide....................... Trichlorobenzene (1,2,4-)
Chlorobenzene.......................... Trichloroethylene
Chloroethane (ethyl chloride).......... Trimethylpentane
Vinyl acetate.......................... Xylene (p)
Vinyl chloride......................... N-hexane
Xylene (m).............................
Xylene (o).............................
------------------------------------------------------------------------
[[Page 40137]]
17. Table 3 to subpart GGG is revised to read as follows:
Table 3 to Subpart GGG.--Soluble HAP
------------------------------------------------------------------------
Compound
-------------------------------------------------------------------------
1,1-Dimethylhydrazine.
1,4-Dioxane.
Acetonitrile.
Acetophenone.
Diethyl sulfate.
Dimethyl sulfate.
Dinitrotoluene.
Ethylene glycol dimethyl ether.
Ethylene glycol monobutyl ether acetate.
Ethylene glycol monomethyl ether acetate.
Isophorone.
Methanol (methyl alcohol).
Nitrobenzene.
Toluidene.
Triethylamine.
------------------------------------------------------------------------
18. Table 9 to subpart GGG. is revised to read as follows:
Table 9 to Subpart GGG--Default Biorates for Soluble HAP
------------------------------------------------------------------------
Biorate (K1),
Compound name L/g MLVSS-hr
------------------------------------------------------------------------
Acetonitrile........................................... 0.100
Acetophenone........................................... 0.538
Diethyl sulfate........................................ 0.105
Dimethyl hydrazine(1,1)................................ 0.227
Dimethyl sulfate....................................... 0.178
Dinitrotoluene(2,4).................................... 0.784
Dioxane(1,4)........................................... 0.393
Ethylene glycol dimethyl ether......................... 0.364
Ethylene glycol monobutyl ether acetate................ 0.496
Ethylene glycol monomethyl ether acetate............... 0.159
Isophorone............................................. 0.598
Methanol............................................... a
Nitrobenzene........................................... 2.300
Toluidine (-0)......................................... 0.859
Triethylamine.......................................... 1.064
------------------------------------------------------------------------
a For direct dischargers, the default biorate for methanol is 3.5 L/g
MLVSS-hr; for indirect dischargers, the default biorate for methanol
is 0.2 L/g MLVSS-hr.
[FR Doc. 01-18879 Filed 8-1-01; 8:45 am]
BILLING CODE 6560-50-P