[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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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