[Federal Register Volume 65, Number 168 (Tuesday, August 29, 2000)]
[Rules and Regulations]
[Pages 52588-52616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21195]



[[Page 52587]]

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Part III





Environmental Protection Agency





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40 CFR Part 63



National Emission Standards for Hazardous Air Pollutants for 
Pharmaceuticals Production; Final Rule

  Federal Register / Vol. 65, No. 168 / Tuesday, August 29, 2000 / 
Rules and Regulations  

[[Page 52588]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[FRL-6855-1]
RIN 2060-AJ17


National Emission Standards for Hazardous Air Pollutants for 
Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; amendments.

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SUMMARY: On September 21, 1998 (63 FR 50280), EPA promulgated national 
emission standards for hazardous air pollutants (NESHAP) for 
Pharmaceuticals Production. On November 17 and 20, 1998, petitions for 
reconsideration and review of the September 1998 rule were filed in the 
U.S. Court of Appeals for the District of Columbia Circuit. The 
petitioners raised over 12 technical issues and concerns with the rule. 
Additional issues were raised by intervenors on the side of the 
petitioners. On April 10, 2000, EPA proposed amendments to the 
Pharmaceuticals Production NESHAP to address the issues raised by the 
petitioners. This document takes final action on those proposed 
amendments.

EFFECTIVE DATE: August 29, 2000.

ADDRESSES: Docket No. A-96-03 contains supporting information used in 
developing the NESHAP. The docket is located at the U. S. Environmental 
Protection Agency, 401 M Street, SW, Washington, DC 20460 in Room M-
1500, and may be inspected from 8:30 a.m. to 5:30 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: For information concerning these final 
amendments, contact Mr. Randy McDonald, Organic Chemicals Group, 
Emission Standards Division (MD-13), U.S. Environmental Protection 
Agency, Research Triangle Park, North Carolina 27711, telephone number 
(919) 541-5402, electronic mail address [email protected]. For 
information concerning applicability and rule determinations, contact 
your State or local representative or the appropriate EPA Regional 
Office representative. Following is a listing of EPA Regional contacts.

EPA Regional Office Contacts

Director, Office of Environmental Stewardship, Attn: Air Compliance 
Clerk: U.S. EPA Region I, 1 Congress Street, Suite 1100 (SEA), Boston, 
MA 02114-2023, (617) 918-1740
Umesh Dholakia: U.S. EPA Region II, 290 Broadway Street, New York, NY 
10007-1866, (212) 637-4023
Doreen Au: U.S. EPA Region III, 1650 Arch Street, Philadelphia, PA 
19103, (215) 814-5471
Lee Page, U.S. EPA Region IV, 61 Forsyth Street, SW, Atlanta, GA 30303-
3104, (404) 562-9131
Shaun Burke, IL/IN, (312) 353-5713; Joseph Cardile, MI/WI, (312) 353-
2151; Erik Hardin, MN/OH, (312) 353-2402; U.S. EPA Region V, 77 West 
Jackson Boulevard, Chicago, IL 60604-3507
John Jones: U.S. EPA Region VI, 1445 Ross Avenue, Suite 1200 (6EN-AT), 
Dallas, TX 75202, (214) 665-7233
Gary Schlicht: U.S. EPA Region VII, 726 Minnesota Avenue, Kansas City, 
KS 66101, (913) 551-7097
Tami Thomas-Burton: U.S. EPA Region VIII, 999 18th Street, Suite 500, 
Denver, CO 80202, (303) 312-6581
Ken Bigos: U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 
94105, (415) 744-1240
Dan Meyer: U.S. EPA Region X, 1200 Sixth Street, Seattle, WA 98101, 
(206) 553-4150

SUPPLEMENTARY INFORMATION: Docket. The docket is an organized and 
complete file of all the information considered by the 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 final rule will be 
available on the WWW through the Technology Transfer Network (TTN). 
Following signature, a copy of the rule will be posted on the TTN's 
policy and guidance page for newly proposed or promulgated rules http://www.epa.gov/ttn/oarpg. The TTN 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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               Category                            NAICS codes                           SIC codes                    Examples of regulated 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
                                                                                                                  or 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 promulgated rule, as well as in the amendments to 
the applicability sections contained in this action. 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.
    Outline. The information presented in this preamble is organized as 
follows:

I. What is the history of the Pharmaceuticals Production NESHAP?
II. What types of public comments were received on the April 10, 
2000 proposal?
III. What major issues were raised in the public comments and what 
changes were made for the final amendments?
    A. Applicability
    B. Compliance Dates
    C. Process Vent Requirements
    D. Wastewater Requirements
    E. Recordkeeping
    F. Delegation of Authority
    G. Clarification of Statements in the Proposal Preamble
    H. Technical Correction to Monitoring Requirements for Hydrogen 
Halides and Halogens

[[Page 52589]]

    I. Minor Corrections
IV. What are the administrative requirements for these final 
amendments?
    A. Executive Order 12866, Regulatory Planning and Review
    B. Executive Order 13132, Federalism
    C. Executive Order 13084, 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. Congressional Review Act

I. What Is the History of the Pharmaceuticals Production NESHAP?

    On September 21, 1998, we promulgated NESHAP for Pharmaceuticals 
Production as subpart GGG in 40 CFR part 63. On November 17 and 20, 
1998, the Pharmaceutical Research and Manufacturers of America (PhRMA) 
filed petitions for reconsideration and review of the promulgated 
Pharmaceuticals Production NESHAP in the U.S. Court of Appeals for the 
District of Columbia Circuit, PhRMA v. EPA, 98-1551 (D.C. Cir.). Issues 
raised by the petitioners included applicability of the rule, 
definition of a process, the 98 percent reduction requirement for 
certain process vents, the alternative standard, and recordkeeping 
requirements. The intervenors raised additional issues regarding the 
applicability of the rule to specialty chemical manufacturers and the 
clarity of the rule, especially with respect to the leak detection and 
repair (LDAR) provisions. On December 21, 1999, the parties filed a 
motion to lodge a settlement agreement with the court. The settlement 
agreement established a schedule by which EPA would propose revisions 
to the NESHAP and the preamble language agreed to by the parties. The 
settlement agreement provided that EPA would sign proposed rule 
amendments no later than 60 days after execution of the settlement. The 
settlement agreement also provided that EPA would sign final rule 
amendments no later than 180 days after the date on which the proposed 
amendments were signed. On February 22, 2000, the parties filed a 
motion to lodge a stipulation to modify the settlement agreement. The 
parties agreed to change the date by which EPA must sign the proposed 
rule amendments from 60 to 90 days after the execution of the 
settlement agreement (March 20, 2000). The date by which EPA must sign 
the final amendments was not changed (August 21, 2000).
    On April 10, 2000 (65 FR 19152), we proposed amendments to address 
the issues raised by PhRMA and the intervenors of the promulgated 
Pharmaceuticals Production NESHAP which include corrections and 
clarifications to ensure that the rule will be implemented as intended. 
In this action, we are promulgating the amendments proposed on April 
10, 2000.

II. What Types of Public Comments Were Received on the April 10, 
2000 Proposal?

    We received seven public comment letters on the April 10, 2000 
proposed amendments. Six of the comment letters were from industry 
representatives, and one was from a university representative. The 
comments addressed the compliance dates, applicability, requirements 
for hydrogenation vents and wastewater, recordkeeping burden, and the 
delegation of authority. The commenters also identified errors and 
incomplete discussions in the preamble to the proposed amendments, 
minor inconsistencies between the proposed amendments and the 
settlement agreement, and miscellaneous typographical errors. Some 
commenters expressed support for the proposed changes. We considered 
these comments and, where appropriate, made changes to the proposed 
amendments. This preamble summarizes significant issues raised and the 
changes to the proposed amendments. Our response to all comments can be 
found in National Emission Standards for Hazardous Air Pollutants for 
Pharmaceuticals Production: Summary of Public Comments and Responses on 
Proposed Amendments. This document may be found in the docket.

III. What Major Issues Were Raised in the Public Comments and What 
Changes Were Made for the Final Amendments?

A. Applicability

    Comment: One commenter interprets the proposed changes to 
Sec. 63.1250(b) to mean that a source that implements process changes 
that meet the new definition of the term ``reconstruction'' may be 
subject to new source requirements under the amended rule, whereas they 
would have been subject to less stringent existing source requirements 
under the original rule. However, after reading the discussion in the 
preamble to the proposed amendments regarding compliance dates for new 
and reconstructed sources that would apply in the event the final 
amendments are more stringent than the original NESHAP, the commenter 
is unsure when such sources must comply with the new source 
requirements (or how long they may continue to comply with existing 
source requirements). The statement that such sources must ``continue 
to comply with the NESHAP until October 21, 2002'' was particularly 
confusing because it was not clear which requirements apply after the 
amendments are promulgated or whether the source must comply with 
existing source requirements after October 21, 2002 until it meets 
reconstruction.
    Response: The proposed change to Sec. 63.1250(b) would require 
compliance with the new source requirements for dedicated 
pharmaceutical manufacturing process units (PMPU) that have the 
potential to emit hazardous air pollutants (HAP) emissions above 
specified thresholds and for which reconstruction commenced after 
October 21, 1999. The commenter is correct that such a reconstructed 
PMPU would have been subject to existing source requirements under the 
September 21, 1998 promulgated rule. As a result, it is possible that 
the PMPU would be subject to more stringent requirements under the 
amended rule than under the September 21, 1998 promulgated rule. The 
date when the PMPU must be in compliance with the requirements for new 
sources depends on the date that reconstruction commenced, as specified 
in Sec. 63.1250(f) (4) or (5). If you commenced reconstruction between 
October 21, 1999 and April 10, 2000, you must comply with the 
requirements for new sources beginning on October 21, 2002. If you 
commenced reconstruction after April 10, 2000 and before August 29, 
2000, you must comply with the requirements for new sources beginning 
on the date 1 year after the effective date of the final amendments. In 
both cases, if you startup the reconstructed PMPU before the date when 
it must be in compliance with the new source requirements, you must, at 
a minimum, comply with the requirements for existing sources in the 
September 21, 1998 promulgated rule between startup and that date. If 
reconstruction commences after August 29, 2000, you must comply with 
the existing source requirements specified in today's amendments until 
you shutdown to commence reconstruction, and you must comply with the 
new source requirements upon startup of the

[[Page 52590]]

reconstructed source, as specified in Sec. 63.1250(f)(2).
    Comment: One commenter is uncertain whether their process to 
produce an imaging agent classified under SIC code 2835 would be 
subject to the NESHAP. This commenter was confused by the revised 
definitions of the terms ``pharmaceutical product,'' ``precursor,'' and 
``component,'' as well as the corresponding discussion in the preamble 
to the proposed amendments. As an alternative, this commenter believes 
we should consider using the applicability language in 40 CFR 439.0 of 
the Pharmaceutical Manufacturing Point Source Category because the 
commenter considers that wording to be more definitive.
    Response: The definition of pharmaceutical product includes any 
material whose manufacturing process is described by NAICS code 325411 
or 325412. In-vivo diagnostic substances described by SIC code 2835 are 
also covered by NAICS 325412. If your imaging agent is one of these 
substances, it is a pharmaceutical product, and the process to produce 
it is subject to subpart GGG. If that imaging agent is produced at a 
facility whose primary manufacturing operations are described by SIC 
code 2833 or 2834, the processes used to produce precursors to the 
imaging agent would also be subject to subpart GGG. Conversely, if the 
imaging agent is an in-vitro diagnostic substance, it is excluded from 
the definition of active ingredient. Thus it is not a pharmaceutical 
product, and its production process is not subject to subpart GGG. We 
disagree with the commenter's suggestion to use the same applicability 
language as in 40 CFR 439.0. The NESHAP and effluent limitation 
guidelines are developed under different statutes with different 
mandates; the applicability does not need to be identical.

B. Compliance Dates

    Comment: Two commenters oppose the proposed delay in the compliance 
dates. One of the commenters believes the delay is unnecessary because 
cost-effective control technologies are available. The other commenter 
opposes the delay because we did not promulgate the NESHAP until 10 
months after the scheduled promulgation date, the NESHAP specifies the 
maximum compliance time allowed by the CAA even though many control 
measures could be implemented in a much shorter time, and the commenter 
believes the proposed changes weaken the control requirements.
    One of the commenters also disagrees with our assertion that the 
authority to revise emission standards under section 112(d) of the CAA 
also includes the authority to set new compliance dates. The commenter 
says the CAA does not provide the authority to delay the general 
applicability of the promulgated standard beyond 3 years from 
promulgation; it only allows compliance with the amendments, if more 
stringent than the original rule, to be extended to 3 years after 
promulgation of the amendments. The commenter further states that it is 
clear that we have not revised the NESHAP in accordance with section 
112(d) of the CAA because there is no indication that we reevaluated 
the maximum achievable control technology (MACT) floor or beyond-the-
floor options.
    Response: As we explained in the preamble to the proposed 
amendments, we believe the scope of the changes are sufficiently far-
reaching and complex that the amended rule would effectively be a new 
rule. We proposed a compliance date 3 years after the date the 
settlement agreement was signed and available. This time period was 
selected to be consistent with the time period that we considered to be 
reasonable for achieving compliance with the September 21, 1998 
promulgated rule. We continue to believe this is reasonable.

C. Process Vent Requirements

    Comment: Section 63.1254(a)(3)(ii)(C) of the proposed amendments 
would require 95 percent control for the sum of all process vents 
within some processes that contain hydrogenation steps. One commenter 
stated that the proposed requirement will be unattainable for some 
processes even if all nonhydrogenation vents are completely controlled. 
The commenter believes the required reduction should be 93 percent as 
for other existing processes. However, to fully address the safety 
issue of hydrogenation vents, the commenter also requested that we 
consider exempting all emissions from the hydrogenation step from the 
point hydrogen is added until after the excess hydrogen is purged from 
the reactor.
    Response: The commenter's reference is to the provision that would 
allow processes containing hydrogenation vents to achieve at least 95 
percent reduction overall, rather than comply with the 98 percent 
requirement for the Total Resource Effectiveness (TRE) streams and 
either the 93 percent reduction or mass limit for other streams. The 
provision was added to address concerns that controlling some 
hydrogenation vents could be unsafe; the 95 percent requirement is 
applied to the process and allows (in exchange for lessening of the 
requirement to control TRE vents to 98 percent) an overall emission 
reduction that is greater than the MACT floor. Contrary to the 
commenter's assertion, other existing processes are required to achieve 
93 percent control on vents other than TRE vents, and 98 percent on TRE 
vents, not just an overall 93 percent as stated. Therefore, the level 
of the standard is actually higher than 93 percent for processes 
containing TRE vents. This added provision is intended to allow greater 
flexibility in selecting streams for control, while preserving the 
emissions reductions associated with the standard. Additionally, the 
provision was suggested by the industry trade association, which 
suggests that this level of control (95 percent) is achievable in the 
industry.

D. Wastewater Requirements

    Comment: One commenter disagrees with the proposed change in the 
annual load used to determine an affected wastewater stream from 1 
Megagrams per year (Mg/yr) to 0.25 Mg/yr. The commenter notes that our 
rationale for changing the load threshold was that we changed the 
definition of process. However, according to the commenter, there is no 
definitive correlation between the terms ``process'' and ``point of 
determination.'' Furthermore, because we did not propose changes to the 
definition of ``point of determination'' or to the referenced terms 
``storage tank'' and ``last recovery device,'' the commenter believes 
the load threshold should remain at 1 Mg/yr.
    Response: We disagree with the commenter. For processes with 
wastewater discharges that either do not go through recovery devices or 
the recovery devices are dedicated to particular discharges, the change 
in the definition of the term ``process'' will result in less HAP 
discharged per process. In addition, storage tanks that are assigned to 
one process under the original definition of the term ``process'' may 
not all be assigned to a single process under the revised definition. 
Therefore, we continue to believe that it is reasonable to reduce the 
load threshold for a PMPU.
    Comment: One commenter requested that we remove methanol from the 
list of soluble HAP. The commenter is concerned that without this 
change, publicly owned treatment works (POTW) will no longer accept 
methanol-containing wastewater that is determined to be affected 
wastewater under the Pharmaceuticals Production

[[Page 52591]]

NESHAP because the POTW do not want to become affected sources under 
the NESHAP for POTW. As evidence to support removing methanol from the 
list, the commenter refers to the preamble for the Pharmaceutical 
Manufacturing Point Source Category in which we recognize that methanol 
is adequately treated at POTW. The commenter also pointed out that the 
American Forest and Paper Association filed a petition requesting EPA 
to remove methanol from the list of HAP contained in section 112(b)(1) 
of the CAA, and that some of the data in that petition address the 
treatability of methanol in POTW.
    Response: Under the NESHAP, every wastewater stream that meets the 
applicable concentration cutoff must be managed and treated in a manner 
consistent with MACT; this requirement applies to streams treated 
either onsite or offsite. Another point to remember is that the basis 
for the wastewater treatment requirements was steam stripping. 
Biological treatment that meets specific conditions is allowed as an 
alternative.
    Comment: In Sec. 63.1256(g)(13)(ii), which exempts owners and 
operators from the wastewater provisions in subpart GGG if they treat 
wastewater in boilers and process heaters that are permitted under the 
Resource Conservation and Recovery Act (RCRA), one commenter requested 
that we change the phrase ``boilers and process heaters'' to ``boilers 
and industrial furnaces.'' The commenter pointed out that 40 CFR 260.10 
does not define process heaters, and that the existing language could 
be construed to mean that the exemptions in Sec. 63.1256(g)(13)(ii) do 
not apply to energy recovery devices classified as industrial furnaces 
(i.e., cement kilns, lime kilns, and blast furnaces).
    Response: We did not intend to exclude industrial furnaces from the 
list of RCRA-permitted devices that are exempt from the wastewater 
provisions. We intended to apply exemptions in the same manner as in 
the Hazardous Organic NESHAP (HON), which addressed this issue by 
including industrial furnaces in the definition of the term ``boiler.'' 
The reasons for including industrial furnaces within the definition of 
the term ``boiler'' as opposed to defining a separate term are 
presented in the preamble to proposed amendments for the HON (61 FR 
43705). Therefore, the final amendments include a definition for the 
term ``boiler'' that is identical to the definition in Sec. 63.111 of 
the HON. Note that this change also affects industrial furnaces used as 
air pollution control devices under Sec. 63.1257(a)(4), as well as 
wastewater treatment units under Sec. 63.1256(g)(13).
    Comment: One commenter noted that the list of exempt wastewater in 
Sec. 63.1256(a)(3)(i) omits two of the types of wastewater that are 
exempted in Sec. 63.132(f) of the HON: equipment leaks and activities 
included in maintenance and startup, shutdown, and malfunction plans. 
The commenter requested that we add these two exemptions to the list in 
Sec. 63.1256(a)(3)(i) so that pharmaceutical plants are not required to 
manage small, infrequent, and/or random leaks and discharges of 
wastewater in accordance with the provisions of Sec. 63.1256. In 
subsequent discussions, the commenter cited an example of such small 
discharges as the small amount of water that drains from a hose when it 
is disconnected from one unit so that it can be moved and reconnected 
to another unit. Even though the hose is purged before being 
disconnected, some water remains.
    Response: After considering the comments, we decided to provide 
exemptions for equipment leaks and for drips from disconnected hoses. 
The exemption for equipment leaks is consistent with the HON, which 
provides the basis for most of the wastewater provisions in subpart 
GGG. Specifically, Sec. 63.132(f) exempts equipment leaks with HAP 
concentrations greater than 10,000 parts per million by weight (ppmw) 
from the management and treatment requirements for Group 1 wastewater. 
Equipment leaks with lower concentrations are also effectively exempted 
in the HON because they are unlikely to exceed the Group 1 wastewater 
flow rate threshold of 10 liters per minute (lpm). The drips from a 
disconnected hose are unintentional discharges that occur despite 
reasonable efforts to purge the hose before disconnecting it. We 
believe these drips can be considered spills, which are exempt from the 
wastewater provisions. However, to clarify this point, we have provided 
a specific exemption for drips from procedures such as disconnecting 
hoses after clearing lines.
    We decided not to add an exemption for wastewater that is 
discharged as a result of activities included in maintenance wastewater 
plans. Under the proposed amendments, Sec. 63.1256(a)(3)(ii) exempts 
maintenance wastewater from the definition of wastewater, which means 
it is not subject to the wastewater provisions other than the 
requirements in Sec. 63.1256(a)(3)(ii). Adding another exemption for 
wastewater generated as a result of activities covered by the 
maintenance wastewater plan would be redundant.
    We also decided not to add an exemption for wastewater that is 
discharged as a result of activities included in startup, shutdown, and 
malfunction plans. Section 63.1250(g) specifies that each provision in 
subpart GGG (except the emission limitations) applies during startups, 
shutdowns, and malfunctions. This provision effectively exempts 
wastewater generated during startups, shutdowns, and malfunctions from 
the management and treatment requirements in Sec. 63.1256. According to 
Sec. 63.1250(g), the only requirement for such wastewater is that the 
owner or operator must identify and implement procedures to prevent or 
minimize emissions during startups, shutdowns, and malfunctions; and 
the procedures must be documented in a written plan. Therefore, we 
believe adding an exemption in Sec. 63.1256(a)(3) is unnecessary 
because existing provisions already accomplish the goal of such an 
exemption.
    After considering the comments and the exemption provisions in 
general, we decided that the requirements would be clearer if we 
rearranged a few statements. Therefore, in the final amendments, we 
have moved the list of exemptions from Sec. 63.1256(a)(3)(i) to the 
definition of the term ``wastewater stream.'' We also added equipment 
leaks and drips from procedures such as disconnecting hoses to the 
list. We then redesignated the multiphase discharge requirements in 
Sec. 63.1256(a)(4) as Sec. 63.1256(a)(3), and we redesignated the 
maintenance wastewater requirements in Sec. 63.1256(a)(3)(ii) as 
Sec. 63.1256(a)(4). We also added a statement to the redesignated 
Sec. 63.1256(a)(4) to specify that maintenance wastewater is exempt 
from all other provisions in subpart GGG. Finally, we revised 
Sec. 63.1256(a) introductory paragraph and Sec. 63.1256(a)(1) to more 
clearly explain what provisions are specified in Sec. 63.1256(a)(1) 
through (5). We believe these changes clarify the wastewater provisions 
without changing the intent.

E. Recordkeeping

    Comment: One commenter believes the recordkeeping and reporting 
burden is excessive and suggests that we continue to work with the Food 
and Drug Administration to increase flexibility, perhaps by using the 
concepts of ``Master Process'' or ``Batch Records.'' The commenter 
acknowledges that the concept of a ``standard batch'' helps to 
alleviate this burden but cites our Agency Information Collection 
Request notice (65 FR 17258, March 31, 2000), which

[[Page 52592]]

estimates the average recordkeeping and reporting burden to be 694 
hours per source per year, as evidence that more relief is needed.
    Response: The recordkeeping and reporting requirements in the 
proposed amendments are needed to demonstrate compliance. These 
requirements received considerable scrutiny during the settlement 
negotiations. As the commenter noted, we introduced the concept of a 
``standard batch'' as one way to minimize the burden. Another way to 
minimize the burden is to implement the alternative standard; the 
reduction in the burden associated with this compliance option is not 
reflected in the estimate in the Agency Information Collection Request.

F. Delegation of Authority

    Comment: Several commenters oppose the proposed change to the 
delegation of authority language because it was not part of the 
settlement agreement, and we did not explain why the change is needed. 
One commenter also expressed concern that the proposed change could 
have a significant adverse impact on sources by requiring a second 
layer of regulatory agency approval of alternatives to monitoring or 
recordkeeping provisions in cases where a State rule and the 
Pharmaceuticals Production NESHAP apply to the same source. The 
commenter noted that getting approval from both the State and EPA would 
result in a substantial burden on the source without providing any 
additional environmental benefit.
    Response: After considering the comments, we have decided not to 
amend the delegation of authority provisions in Sec. 63.1261 of the 
September 21, 1998 promulgated rule. The proposed amendments to 
Sec. 63.1261 reference terms that are defined in proposed amendments to 
Sec. 63.90 of 40 CFR part 63, subpart E (64 FR 1880, January 12, 1999). 
The regulations in subpart E implement section 112(l) of the CAA and 
specify the procedures and criteria for approving State, local, 
territorial, and tribal rules, programs, or other requirements that 
would substitute for NESHAP. The proposed amendments to subpart E are 
intended to clarify these procedures and criteria, including the 
authorities which we will and will not delegate. Because the proposed 
amendments to subpart E may not be promulgated before the amendments to 
subpart GGG, we must remove the references to them from subpart GGG. We 
anticipate, however, that after amendments to subpart E are 
promulgated, we will also amend subpart GGG (and all other NESHAP) to 
be consistent.

G. Clarification of Statements in the Proposal Preamble

    Several commenters expressed concern that the discussions of some 
issues in the preamble to the proposed amendments could cause confusion 
because the discussions were either incomplete or inconsistent with the 
proposed regulatory language. The following paragraphs discuss each 
concern.
1. Annual Mass Emission Limit for Process Vents
    Section II.G of the preamble to the proposed amendments explains 
the proposed changes in the 900 kilograms per year (kg/yr) annual mass 
limit compliance option for process vents. For example, one of the 
proposed changes in this compliance option was to allow it to be used 
for all of the other vents in a process where at least one vent meets 
the requirements for control to 98 percent under Sec. 63.1254(a)(3)(i).
    Comment: One commenter believes the proposal preamble may cause 
confusion because it does not also say that you may comply with the 900 
kg/yr annual mass limit for all of the other vents in a process where 
at least one vent complies with the alternative standard in 
Sec. 63.1254(c), or at least one vent is routed to a control device 
subject to the grandfathering provisions in Sec. 63.1254(a)(3)(ii).
    Response: The commenter is correct that the proposed amendments 
extend the 900 kg/yr annual mass limit compliance option to more 
situations than the one described in the proposal preamble. Section 
63.1254(a)(2)(iii) in the final amendments, which is identical to the 
language in the proposed amendments, specifies three types of vents 
that you may exclude when determining compliance with the 900 kg/yr 
annual mass limit: (1) All vents that must be controlled to 98 percent 
in accordance with Sec. 63.1254(a)(3)(i), (2) all vents that otherwise 
would be subject to the 98 percent control requirement if they were not 
controlled by a grandfathered control device according to 
Sec. 63.1254(a)(3)(ii), and (3) all vents that are controlled in 
accordance with the alternative standard in Sec. 63.1254(c).
2. Emission Reduction for Processes With Both TRE and Hydrogenation 
Vents
    Section II.H of the proposal preamble includes a discussion of the 
emission limitations for vents in processes that include at least one 
TRE vent and at least one hydrogenation vent that we proposed adding in 
Sec. 63.1254(a)(3)(ii)(C).
    Comment: One commenter believes the explanation of the proposed 
emission limitation is confusing because it does not clearly describe 
the two distinct parts to the proposed provision in 
Sec. 63.1254(a)(3)(ii)(C). According to the commenter, the first part 
applies to processes that meet specified control criteria on or before 
April 2, 1997, and these processes must maintain the level of control 
achieved on the date of the proposed amendments (i.e., April 10, 2000). 
The commenter also noted that the second part applies to any other 
process where the annual mass limit or process-based emission reduction 
(for the sum of the non-TRE vents) cannot be met because the 
hydrogenation vent(s) cannot be safely controlled, and the HAP 
emissions from the sum of all vents in these processes must be reduced 
by at least 95 percent.
    Response: We agree with the commenter that the proposal preamble 
did not fully explain the two parts of the proposed provisions for 
processes with hydrogenation vents. The commenter's assessment of the 
second part of this provision is correct, but the first part needs 
additional discussion. Processes that had a TRE vent on or before April 
2, 1997 and for which the HAP emissions from the sum of all process 
vents were controlled to between 93 and 98 percent by weight must 
continue to be controlled to the level achieved on or before April 2, 
1997 (not on or before April 10, 2000).
3. Recordkeeping Requirements for Process Vents
    Section II.O of the proposal preamble describes several proposed 
changes to the recordkeeping requirements, including a discussion of 
the proposed concept of a ``standard batch.''
    Comment: One commenter believes the discussion is confusing because 
it does not clearly state that the requirement to check whether 
standard batch conditions have been exceeded applies only to two types 
of processes: (1) Processes subject to the 900 kg/yr annual mass 
emission limit and (2) processes subject to a percent reduction 
requirement where at least one vent in the process is controlled to 
less than the percent reduction required for the process as a whole. 
The commenter is concerned that the proposal preamble could be 
interpreted to mean the check is required for all processes.
    Response: The commenter is correct. You may define a standard batch 
for any process. However, the requirement to document whether each 
batch meets all

[[Page 52593]]

of the conditions of the standard batch applies only in the two cases 
identified by the commenter. Because changes in operating conditions 
may cause changes in emission levels, this documentation (along with 
the requirement to recalculate uncontrolled and controlled emissions 
for each nonstandard batch) is the procedure used to demonstrate 
ongoing compliance in these two situations. The documentation is not 
needed in other situations where other types of monitoring are 
sufficient to demonstrate ongoing compliance (e.g., a continuous 
emissions monitoring system (CEMS) for demonstrating compliance with 
the alternative standard) or the changes in emission levels do not 
affect ongoing compliance (e.g., when all vents in a process are routed 
to the same control device). The documentation requirements are 
specified in Sec. 63.1259(b)(5) in both the proposed and final 
amendments.
4. Compliance With Subpart PPP
    Section II.C of the proposal preamble discussed the proposed 
addition of a Sec. 63.1250(h)(6) to address overlap situations between 
subparts GGG and PPP.
    Comment: One commenter pointed out that the second reference to 
subpart GGG that says, ``* * * you would still be required to comply 
with all other requirements in subpart GGG * * *'' is incorrect and 
should say, ``* * * you would also be required to comply with all other 
requirements in subpart PPP for the corresponding PMPU * * *''
    Response: The commenter is correct. If you demonstrate compliance 
with subpart GGG by controlling process vents in accordance with the 
requirements in subpart PPP, you must also comply with all of the other 
requirements in subpart PPP for the corresponding PMPU.

H. Technical Correction to Monitoring Requirements for Hydrogen Halides 
and Halogens

    Comment: One commenter raised an issue that involves the 
alternative standard. Under the alternative standard in the promulgated 
NESHAP, the owner or operator must use CEMS to demonstrate ongoing 
compliance with the total organic compound (TOC) and total hydrogen 
halide and halogen outlet concentration limits. The commenter states 
that CEMS should not be required to demonstrate compliance with the 
hydrogen halide and halogen limits because we have not required CEMS to 
demonstrate compliance with hydrochloric acid (HCl) and chlorine limits 
in past rules (e.g., the hazardous waste combustion, municipal waste 
combustion, and hospital/medical/infectious waste incineration), and 
there are no EPA-approved, commercially available methods to monitor 
these pollutants in gas streams continuously. As an alternative, the 
commenter recommends that we require parametric monitoring like that 
already required to demonstrate compliance with the other outlet 
concentration limits in the rule.
    Response: We agree with the commenter that clarification of the 
hydrogen halide and halogen monitoring requirements under the 
alternative standard is needed. As a result, we have made technical 
amendments to the standard for alternative procedures for monitoring 
hydrogen halides and halogens emitted under two scenarios: (1) When 
these pollutants are generated in combustion devices that are used to 
control halogenated vent streams, and (2) when these pollutants are 
emitted directly from the process.
    One of the primary sources of hydrogen halide and halogen emissions 
is combustion devices that are used to control halogenated vent 
streams. In these situations, most of the chlorine is converted to HCl 
in the incinerator. Therefore, we believe that monitoring for HCl would 
serve as an acceptable surrogate for all of the hydrogen halides and 
halogens in the emission stream. We provided three options for 
monitoring to demonstrate compliance with the outlet concentration 
limit for hydrogen halides and halogens under the alternative standard 
for these emission streams. The first option is to continuously monitor 
for HCl using an instrument based on Fourier Transform infrared (FTIR) 
spectroscopy that meets Performance Specification 15 in appendix B of 
40 CFR part 60. Because HCl is readily controlled in a properly 
operated scrubber, the second option requires the owner or operator to 
conduct an initial demonstration that the scrubber reduces HCl by 95 
percent, set scrubber operating parameters during the initial 
compliance determination, and demonstrate ongoing compliance by 
continuously monitoring the operating parameters. In the event an owner 
or operator wishes to monitor for HCl using a CEMS for which we have 
not promulgated a performance specification, we are also including a 
third option that requires the owner or operator to prepare a 
monitoring plan and submit it for approval in accordance with the 
procedures specified in Sec. 63.8.
    If you emit hydrogen halides and halogens directly from the 
process, the requirement to use CEMS to measure the total hydrogen 
halide and halogen concentration is unchanged from the September 21, 
1998 promulgated rule. However, because we have not promulgated 
performance specifications for halogen monitors, we have amended the 
rule to require that the owner or operator prepare a monitoring plan 
and submit it for approval in accordance with Sec. 63.8.

I. Minor Technical Corrections

    We are making several changes throughout subpart GGG to correct 
referencing and typographical errors, to improve consistency in 
terminology, and to make the amendments consistent with the settlement 
agreement. Two of the commenters identified many of the needed 
corrections; we identified several others. All of the corrections are 
described in Table 1.

          Table 1.--Minor Technical Corrections to Subpart GGG
------------------------------------------------------------------------
    Section of subpart GGG             Description of correction
------------------------------------------------------------------------
63.1250(f)(5)(i).............  Changed the referenced date from April 2,
                                1997 to April 10, 2000. The intended
                                date was the date of publication of the
                                proposed amendments, not the date of
                                publication of the proposed rule,
                                because a source that commences
                                construction or reconstruction after
                                April 10, 2000 must, upon startup before
                                August 29, 2000, comply with the
                                proposed amendments.
63.1250(h)(1)(i).............  Corrected a typographical error in this
                                paragraph. The word ``of'' was replaced
                                with ``or'' in the first sentence so
                                that the sentence reads as follows: ``*
                                * * elect to comply with either the
                                provisions of this subpart or the
                                provisions of another subpart * * *''.
63.1250(h)(2) and (3)........  Replaced the word ``consistency'' with
                                ``compliance'' in the headings of both
                                sections to be consistent with the
                                language used in the headings in Sec.
                                63.1250(h)(1), (4), (5), and (6).

[[Page 52594]]

 
63.1252(d)(6) through (d)(8).  Corrected these paragraphs by replacing
                                the incorrect references to Sec.
                                63.1254(a)(2) and (a)(3) with the
                                correct references to Sec.
                                63.1254(a)(1)(i). Replaced incorrect
                                reference to Sec.  63.1253(c)(1) with
                                correct reference to Sec.
                                63.1253(c)(1)(i). Replaced the word
                                ``requirements'' with ``criteria''.
63.1255(b)(4)(iv)(B).........  Corrected this paragraph by replacing
                                incomplete reference to Sec.
                                63.178(c)(iii) with the complete
                                reference to Sec.  63.178(c)(3)(iii).
63.1255(c)(2)(i) and (e)(3)..  Corrected these paragraphs by replacing
                                references to Sec.  63.178(b) with
                                references to Sec.  63.178. The more
                                comprehensive reference allows an owner
                                or operator to implement the monitoring
                                interval adjustment option in Sec.
                                63.178(c) for valves under Sec.
                                63.1255(e)(3). However, the change has
                                essentially no impact for pumps and
                                agitators because Sec.
                                63.1255(b)(4)(iv)(B) specifies that the
                                monitoring interval adjustment for pumps
                                and agitators is to be quarterly, which
                                is the same monitoring frequency that is
                                specified in Sec.  63.1255(c)(2)(i).
                                This is the intended result. In effect,
                                because the HON requires monthly
                                monitoring, the adjustment is already
                                built in to Sec.  63.1255(c)(2)(i). We
                                do not believe that an additional
                                adjustment is warranted.
63.1255(e)(5)(iii)...........  Corrected typographical errors in the
                                definitions of two of the terms that
                                follow Equation 4. The uppercase ``I''
                                for the variable that counts the number
                                of subgroups has been replaced with the
                                correct lowercase ``i''.
63.1255(f)(1)(iii)...........  Corrected this paragraph by replacing the
                                incorrect reference to paragraph
                                (b)(3)(iii)(B) with the correct
                                reference to paragraph (b)(4)(iii)(B).
63.1255(f)(4)(iv)............  Corrected this paragraph by replacing the
                                incorrect reference to paragraph
                                (b)(3)(i) with the correct reference to
                                paragraph (b)(4)(i).
63.1255(h)(3)(ii)............  Corrected this paragraph by replacing the
                                incorrect reference to paragraph
                                (b)(3)(iv) with the correct reference to
                                paragraph (b)(4)(iv).
63.1256(a)(1)(i)(B)..........  Revised this paragraph to specify that
                                the wastewater stream is an affected
                                wastewater stream if the concentration
                                of partially soluble and/or soluble HAP
                                is ``greater than'' 5,200 ppmw, whereas
                                the original language specified a
                                concentration ``of'' 5,200 ppmw. This
                                change makes the terminology in this
                                paragraph consistent with the
                                terminology in Sec.
                                63.1256(a)(1)(i)(A), (C), and (D).
63.1257(d)(2)(i)(C)(4)(ii)...  Corrected this paragraph by replacing the
                                incorrect reference to paragraph
                                (d)(2)(iii) with the correct reference
                                to paragraph (d)(3)(iii).
63.1258(b)(5)(ii)............  Added a sentence to the end of this
                                paragraph that was part of the
                                settlement agreement but was
                                inadvertently left out of the proposed
                                amendments. The sentence reads as
                                follows: ``If the owner or operator
                                corrects for supplemental gases as
                                specified in Sec.  63.1257(a)(3)(ii) for
                                noncombustion control devices, the flow
                                must be evaluated as specified in
                                paragraph (b)(5)(ii)(C) of this
                                section.''
------------------------------------------------------------------------

IV. What Are the Administrative Requirements for These Final 
Amendments?

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 Office of Management and Budget (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 add any new control 
requirements. 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.'' Under Executive Order 13132, EPA may not issue a 
regulation that has federalism implications, that imposes substantial 
direct compliance costs, and that is not required by statute, unless 
the Federal government provides the funds necessary to pay the direct 
compliance costs incurred by State and local governments, or EPA 
consults with State and local officials early in the process of 
developing the proposed regulation. The EPA also may not issue a 
regulation that has federalism implications and that preempts State law 
unless the Agency consults with State and local officials early in the 
process of developing the proposed regulation.
    If EPA complies by consulting, Executive Order 13132 requires EPA 
to provide to OMB, in a separately identified section of the preamble 
to the rule, a federalism summary impact statement (FSIS). The FSIS 
must include a description of the extent of EPA's prior consultation 
with State and local officials, a summary of the nature of their 
concerns and EPA's position

[[Page 52595]]

supporting the need to issue the regulation, and a statement of the 
extent to which the concerns of State and local officials have been 
met. Also, when EPA transmits a draft final rule with federalism 
implications to OMB for review pursuant to Executive Order 12866, EPA 
must include a certification from the Agency's Federalism Official 
stating that EPA has met the requirements of Executive Order 13132 in a 
meaningful and timely manner.
    Today's amendments 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 today's action.

C. Executive Order 13084, Consultation and Coordination With Indian 
Tribal Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to OMB, in a separately identified section of 
the preamble to the rule, a description of the extent of EPA's prior 
consultation with representatives of affected tribal governments, a 
summary of the nature of their concerns, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 13084 
requires EPA to develop an effective process permitting elected 
officials and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's amendments to subpart GGG do not significantly or uniquely 
affect the communities of Indian tribal governments. No tribal 
governments own or operate sources subject to these amendments. 
Accordingly, the requirements of section 3(b) of Executive Order 13084 
do not apply to today's action.

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. Today's amendments are not 
subject to Executive Order 13045 because they are based on technology 
performance, not health or safety risks. Furthermore, this rule has 
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), Pub. 
L. 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 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 today's 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, today's amendments are not subject to the requirements of 
sections 202 and 205 of the UMRA. In addition, EPA has determined that 
these 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, today's 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 RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impacts of today's amendments on 
small entities, a small entity is defined as: (1) A small business in 
SIC code 2833 or 2834 that has as many as 750 employees; (2) a small 
business in SIC code 2869 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

[[Page 52596]]

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 amendments on 
small entities, we have concluded that this action will not have a 
significant economic impact on a substantial number of small entities. 
The EPA has determined that none of the small entities will experience 
a significant impact because the amendments impose no additional 
regulatory requirements on owners or operators of affected sources.
    Although today's amendments will not have a significant economic 
impact, EPA nonetheless has tried to reduce the impact of the 
amendments on small entities. Many of the amendments define optional 
means of compliance. For example, vapor balancing was added as an 
optional means of compliance for storage tanks, a facilitywide limit on 
the mass of process vent emissions replaces the limit on the number of 
processes that may comply with the process-based emission limit, 
additional compliance alternatives are included for process vents that 
meet the criteria for 98 percent control, and optional parameter 
monitoring is included as an alternative to correcting to 3 percent 
oxygen when supplemental gas is introduced to a dense gas system or a 
system controlled with combustion devices and the owner or operator 
complies with the alternative standard. The proposed amendments also 
include simplified recordkeeping requirements when the owner or 
operator documents conditions that define a standard batch, and the 
process is operated within that range of conditions.

G. Paperwork Reduction Act

    The OMB has approved the information collection requirements 
contained in the 1998 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.
    Today's amendments will have no net impact on the information 
collection burden estimates made previously. An oversight has been 
corrected by adding recordkeeping and reporting requirements for 
storage tanks equipped with floating roofs. The promulgated rule only 
included recordkeeping and reporting requirements for add-on control 
devices for storage tanks even though add-on control devices and 
floating roofs were considered in the cost impacts and burden 
estimates. Also, the amendments clarify the intent of several 
provisions in the 1998 NESHAP and correct inadvertent omissions and 
minor drafting errors in the 1998 NESHAP. 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), Pub. L. 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 today's 
amendments.

I. The Congressional Review Act

    The Congressional Review Act, 5 U.S.C. Sec. 801 et seq., as added 
by the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating 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 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. A 
major rule cannot take effect until 60 days after it is published in 
the Federal Register. This action is not a ``major rule'' as defined by 
5 U.S.C. Sec. 804(2). This rule will be effective August 29, 2000.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Hazardous substances, Intergovernmental 
relations, Reporting and recordkeeping requirements.

    Dated: August 15, 2000.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, part 63 of title 40, 
chapter I of the Code of Federal Regulations is amended as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS 
FOR SOURCE CATEGORIES

    1. 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

    2. Section 63.1250 is amended by:
    a. Revising paragraph (a),
    b. Revising paragraph (b),
    c. Revising paragraph (c),
    d. Revising paragraph (f);
    e. Revising paragraph (h)(1);
    f. Revising paragraph (h)(2) heading;
    g. Revising paragraph (h)(3) heading;
    h. Revising paragraphs (h) (4) and (5); and
    i. Adding paragraph (h)(6).
    The revisions and additions read as follows:


Sec. 63.1250  Applicability.

    (a) Definition of affected source. (1) The affected source subject 
to this subpart consists of the pharmaceutical manufacturing operations 
as defined in Sec. 63.1251. Except as specified in paragraph (d) of 
this section, the provisions of this subpart apply to pharmaceutical 
manufacturing operations that meet the criteria specified in paragraphs 
(a)(1) (i) through (iii) of this section:
    (i) Manufacture a pharmaceutical product as defined in 
Sec. 63.1251;
    (ii) Are located at a plant site that is a major source as defined 
in section 112(a) of the Act; and

[[Page 52597]]

    (iii) Process, use, or produce HAP.
    (2) Determination of the applicability of this subpart shall be 
reported as part of an operating permit application or as otherwise 
specified by the permitting authority.
    (b) New source applicability. A new affected source subject to this 
subpart and to which the requirements for new sources apply is: An 
affected source for which construction or reconstruction commenced 
after April 2, 1997, and the standard was applicable at the time of 
construction or reconstruction; or a pharmaceutical manufacturing 
process unit (PMPU) dedicated to manufacturing a single product that 
has the potential to emit 10 tons per year of any one HAP or 25 tons 
per year of combined HAP for which construction commenced after April 
2, 1997 or reconstruction commenced after October 21, 1999.
    (c) General Provisions. Table 1 of this subpart specifies and 
clarifies the provisions of subpart A of this part that apply to an 
owner or operator of an affected source subject to this subpart. The 
provisions of subpart A specified in Table 1 are the only provisions of 
subpart A that apply to an affected source subject to this subpart.
* * * * *
    (f) Compliance dates. The compliance dates for affected sources are 
as follows:
    (1) An owner or operator of an existing affected source must comply 
with the provisions of this subpart no later than October 21, 2002.
    (2) An owner or operator of a new or reconstructed affected source 
must comply with the provisions of this subpart on August 29, 2000 or 
upon startup, whichever is later.
    (3) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after April 2, 1997 and before September 21, 1998 shall not be required 
to comply with this subpart until September 21, 2001 if:
    (i) The requirements of this subpart are more stringent than the 
requirements of this subpart in effect before August 29, 2000 and 
contained in the 40 CFR, part (63.1200-end), edition revised as of July 
1, 2000; and
    (ii) The owner or operator complies with the requirements published 
on April 2, 1997 (62 FR 15754) during the period until September 21, 
2001.
    (4) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after September 21, 1998 and before April 10, 2000 shall not be 
required to comply with this subpart until October 21, 2002 if:
    (i) The requirements of this subpart are more stringent than the 
requirements of this subpart in effect before August 29, 2000; and
    (ii) The owner or operator complies with the requirements of this 
subpart in effect before August 29, 2000 during the period between 
startup and October 21, 2002.
    (5) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after April 10, 2000 and before August 29, 2000 shall not be required 
to comply with this subpart until August 29, 2001 if:
    (i) The requirements of this subpart are more stringent than the 
requirements published on April 10, 2000 (65 FR 19152); and
    (ii) The owner or operator complies with the requirements of this 
subpart in effect before August 29, 2000 during the period between 
startup and August 29, 2001.
    (6) Pursuant to section 112(i)(3)(B) of the Act, an owner or 
operator may request an extension allowing the existing source up to 1 
additional year to comply with section 112(d) standards.
    (i) For purposes of this subpart, a request for an extension shall 
be submitted no later than 120 days prior to the compliance dates 
specified in paragraphs (f) (1) through (5) of this section, except as 
provided in paragraph (f)(6)(ii) of this section. The dates specified 
in Sec. 63.6(i) for submittal of requests for extensions shall not 
apply to sources subject to this subpart.
    (ii) An owner or operator may submit a compliance extension request 
after the date specified in paragraph (f)(6)(i) of this section 
provided the need for the compliance extension arose after that date 
and before the otherwise applicable compliance date, and the need arose 
due to circumstances beyond reasonable control of the owner or 
operator. This request shall include the data described in 
Sec. 63.6(i)(6)(i) (A), (B), (C), and (D).
* * * * *
    (h) * * *
    (1) Compliance with other MACT standards. (i) After the compliance 
dates specified in this section, an affected source subject to the 
provisions of this subpart that is also subject to the provisions of 
any other subpart of this part 63 may elect to comply with either the 
provisions of this subpart or the provisions of another applicable 
subpart governing the maintenance of records and reporting to EPA. The 
affected source shall identify in the Notification of Compliance Status 
report required by Sec. 63.1260(f) under which authority such records 
will be maintained.
    (ii) After the compliance dates specified in paragraph (f) of this 
section, at an offsite reloading or cleaning facility subject to 
Sec. 63.1253(f), compliance with the emission standards and associated 
initial compliance, monitoring, recordkeeping, and reporting provisions 
of any other subpart of this part 63 constitutes compliance with the 
provisions of Sec. 63.1253(f)(7) (ii) or (iii). The owner or operator 
of the affected storage tank shall identify in the Notification of 
Compliance Status report required by Sec. 63.1260(f) the subpart of 
this part 63 with which the owner or operator of the offsite reloading 
or cleaning facility complies.
    (2) Compliance with 40 CFR parts 264 and 265, subparts AA, BB, and/
or CC. * * *
* * * * *
    (3) Compliance with 40 CFR 60.112(b). * * *
* * * * *
    (4) Compliance with subpart I of this part. After the compliance 
dates specified in this section, an affected source with equipment 
subject to subpart I of this part may elect to comply with either the 
provisions of Sec. 63.1255 or the provisions of subpart H of this part 
for all such equipment. The owner or operator shall identify in the 
Notification of Compliance Status report required by Sec. 63.1260(f) 
the provisions with which the owner elects to comply.
    (5) Compliance with other regulations for wastewater. After the 
compliance dates specified in this section, the owner or operator of an 
affected wastewater stream that is also subject to provisions in 40 CFR 
parts 260 through 272 may elect to determine whether this subpart or 40 
CFR parts 260 through 272 contain the more stringent control 
requirements (e.g., design, operation, and inspection requirements for 
waste management units; numerical treatment standards; etc.) and the 
more stringent testing, monitoring, recordkeeping, and reporting. 
Compliance with provisions of 40 CFR parts 260 through 272 that are 
determined to be more stringent than the requirements of this subpart 
constitutes compliance with this subpart. For example, provisions of 40 
CFR parts 260 through 272 for treatment units that meet the conditions 
specified in Sec. 63.1256(g)(13) constitute compliance with this 
subpart. In the Notification of Compliance Status report required by 
Sec. 63.1260(f), the owner or operator shall identify the more 
stringent provisions of 40 CFR parts 260 through 272 with which the 
owner or operator will comply. The owner or operator shall also 
identify in the

[[Page 52598]]

Notification of Compliance Status report required by Sec. 63.1260(f) 
the information and procedures used to make any stringency 
determinations. If the owner or operator does not elect to determine 
the more stringent requirements, the owner or operator must comply with 
both the provisions of 40 CFR parts 260 through 272 and the provisions 
of this subpart.
    (6) Compliance with subpart PPP of this part. After the compliance 
dates specified in this section, an affected source with equipment in a 
pharmaceutical manufacturing process unit that is also part of an 
affected source under subpart PPP of this part may elect to demonstrate 
compliance with Sec. 63.1254 by controlling all process vents in 
accordance with Sec. 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). 
Alternatively, the owner or operator may elect to determine which 
process vents must be controlled to comply with the percent reduction 
requirements of Sec. 63.1254 and control only those vents in accordance 
with Sec. 63.1425 (b), (c)(1), (c)(3), (d), and/or (f). For any 
pharmaceutical manufacturing process unit controlled in accordance with 
the requirements of Sec. 63.1425, the owner or operator must also 
comply with all other requirements in subpart PPP of this part. In the 
Notification of Compliance Status report required by Sec. 63.1260(f), 
the owner or operator shall identify which pharmaceutical manufacturing 
process units are meeting the control requirements for process vents 
and all other requirements of subpart PPP of this part, and the owner 
or operator shall describe the calculations and other information used 
to identify which process vents must be controlled to comply with the 
percent reduction requirements of Sec. 63.1254, if applicable.
* * * * *

    3. Section 63.1251 is amended by:
    a. Revising the definitions for Active ingredient, Annual average 
concentration, Construction, Consumption, Excipient, Large control 
device, Pharmaceutical manufacturing operations, Pharmaceutical 
product, Primary use, Process, Process tank, Repaired, Shutdown, Small 
control device, Startup, Storage tank, Vapor-mounted seal, and 
Wastewater stream;
    b. Removing the definition of Component;
    c. Revising paragraphs (3) and (8) in the definition for Operating 
scenario; and
    d. Adding definitions in alphabetical order for Boiler, Combustion 
device burner, Dense gas system, Isolated intermediate, Maintenance 
wastewater, Precursor, Reconstruction, Standard batch, Supplemental 
gases, and System flowrate.
    The revisions and additions read as follows:


Sec. 63.1251  Definitions.

* * * * *
    Active ingredient means any material that is intended to furnish 
pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the body of man or other animals. This 
term does not include food, food additives (except vitamins and other 
materials described by SIC code 2833 or 2834), color additives, 
cosmetics, in-vitro diagnostic substances, x-ray film, test indicator 
devices, and medical devices such as implants, artificial joints, 
surgical bandages, and stitching material.
* * * * *
    Annual average concentration, as used in the wastewater provisions 
in Sec. 63.1256, means the total mass of partially soluble and/or 
soluble HAP compounds in a wastewater stream during the calendar year 
divided by the total mass of the wastewater stream discharged during 
the same calendar year, as determined according to the procedures 
specified in Sec. 63.1257(e)(1) (i) and (ii).
* * * * *
    Boiler means any enclosed combustion device that extracts useful 
energy in the form of steam and is not an incinerator. Boiler also 
means any industrial furnace as defined in 40 CFR 260.10.
* * * * *
    Combustion device burner means a device designed to mix and ignite 
fuel and air to provide a flame to heat and oxidize waste organic 
vapors in a combustion device.
* * * * *
    Construction means the onsite fabrication, erection, or 
installation of an affected source or a PMPU. Addition of new equipment 
to a PMPU subject to existing source standards does not constitute 
construction, but it may constitute reconstruction of the affected 
source or PMPU if it satisfies the definition of reconstruction in this 
section.
    Consumption means the quantity of all HAP raw materials entering a 
process in excess of the theoretical amount used as reactant, assuming 
100 percent stoichiometric conversion. The raw materials include 
reactants, solvents, and any other additives. If a HAP is generated in 
the process as well as added as a raw material, consumption includes 
the quantity generated in the process.
* * * * *
    Dense gas system means a conveyance system operated to limit oxygen 
levels below 12 percent.
* * * * *
    Excipient means any substance other than the active drug or product 
which has been appropriately evaluated for safety and is included in a 
drug delivery system to either aid the processing of the drug delivery 
system during its manufacture; protect, support, or enhance stability, 
bioavailablity, or patient acceptability; assist in product 
identification; or enhance any other attribute of the overall safety 
and effectiveness of the drug delivery system during storage or use.
* * * * *
    Isolated intermediate means a product of a process. An isolated 
intermediate is usually a product of a chemical synthesis, 
fermentation, or biological extraction process; several different 
isolated intermediates may be produced in the manufacture of a finished 
dosage form of a drug. Precursors, active ingredients, or finished 
dosage forms are considered isolated intermediates. An isolated 
intermediate is stored before subsequent processing. Storage occurs at 
any time the intermediate is placed in equipment used solely for 
storage, such as drums, totes, day tanks, and storage tanks. The 
storage of an isolated intermediate marks the end of a process.
* * * * *
    Large control device means a control device that controls total HAP 
emissions of greater than or equal to 10 tons/yr, before control.
* * * * *
    Maintenance wastewater means wastewater generated by the draining 
of process fluid from components in the pharmaceutical manufacturing 
process unit into an individual drain system in preparation for or 
during maintenance activities. Maintenance wastewater can be generated 
during planned and unplanned shutdowns and during periods not 
associated with a shutdown. Examples of activities that can generate 
maintenance wastewater include descaling of heat exchanger tubing 
bundles, cleaning of distillation column traps, draining of pumps into 
an individual drain system, and draining of portions of the 
pharmaceutical manufacturing process unit for repair. Wastewater from 
cleaning operations is not considered maintenance wastewater.
* * * * *

[[Page 52599]]

    Operating scenario, * * *
    (3) The applicable control requirements of this subpart, including 
the level of required control, and for vents, the level of control for 
each vent;
* * * * *
    (8) For reporting purposes, a change to any of these elements not 
previously reported, except for paragraph (5) of this definition, shall 
constitute a new operating scenario.
* * * * *
    Pharmaceutical manufacturing operations means the facilitywide 
collection of PMPU and any other equipment such as heat exchanger 
systems, wastewater and waste management units, or cooling towers that 
are not associated with an individual PMPU, but that are located at a 
facility for the purpose of manufacturing pharmaceutical products and 
are under common control.
* * * * *
    Pharmaceutical product means any of the following materials, 
excluding any material that is a nonreactive solvent, excipient, 
binder, or filler, or any material that is produced in a chemical 
manufacturing process unit that is subject to the requirements of 
subparts F and G of this part 63:
    (1) Any material described by the standard industrial 
classification (SIC) code 2833 or 2834; or
    (2) Any material whose manufacturing process is described by North 
American Industrial Classification System (NAICS) code 325411 or 
325412; or
    (3) A finished dosage form of a drug, for example, a tablet, 
capsule, solution, etc.; or
    (4) Any active ingredient or precursor that is produced at a 
facility whose primary manufacturing operations are described by SIC 
code 2833 or 2834; or
    (5) At a facility whose primary operations are not described by SIC 
code 2833 or 2834, any material whose primary use is as an active 
ingredient or precursor.
* * * * *
    Precursor means a material that is manufactured to undergo further 
chemical change or processing to ultimately manufacture an active 
ingredient or finished dosage form of a drug. This term does not 
include commodity chemicals produced by the synthetic organic chemical 
manufacturing industry.
* * * * *
    Primary use means 50 percent or more of a material is used for a 
particular purpose.
    Process means all equipment which collectively function to produce 
a pharmaceutical product or isolated intermediate (which is also a 
pharmaceutical product). A process may consist of one or more unit 
operations. For the purposes of this subpart, process includes any, 
all, or a combination of reaction, recovery, separation, purification, 
or other activity, operation, manufacture, or treatment which are used 
to produce a pharmaceutical product or isolated intermediate. Cleaning 
operations conducted are considered part of the process. Nondedicated 
solvent recovery operations located within a contiguous area within the 
affected source are considered single processes. A storage tank that is 
used to accumulate used solvent from multiple batches of a single 
process for purposes of solvent recovery does not represent the end of 
the process. Nondedicated formulation operations occurring within a 
contiguous area are considered a single process that is used to 
formulate numerous materials and/or products. Quality assurance and 
quality control laboratories are not considered part of any process. 
Ancillary activities are not considered a process or part of any 
process. Ancillary activities include boilers and incinerators (not 
used to comply with the provisions of Sec. 63.1253, Sec. 63.1254, or 
Sec. 63.1256(h)), chillers and refrigeration systems, and other 
equipment and activities that are not directly involved (i.e., they 
operate within a closed system and materials are not combined with 
process fluids) in the processing of raw materials or the manufacturing 
of a pharmaceutical product.
* * * * *
    Process tank means a tank that is used to collect material 
discharged from a feedstock storage tank or unit operation and to 
transfer this material to another unit operation within the process or 
to a product storage tank. Surge control vessels and bottoms receivers 
that fit these conditions are considered process tanks. Product storage 
tanks are considered process tanks and are part of the PMPU that 
produce the stored material. For the purposes of this subpart, vents 
from process tanks are considered process vents.
* * * * *
    Reconstruction, as used in Sec. 63.1250(b), shall have the meaning 
given in Sec. 63.2, except that ``affected or previously unaffected 
stationary source'' shall mean either ``affected facility'' or 
``PMPU.'' As used in Sec. 63.1254(a)(3)(ii)(A)(3), reconstruction shall 
have the meaning given in Sec. 63.2, except that ``source'' shall mean 
``control device.''
* * * * *
    Repaired means that equipment:
    (1) Is adjusted, or otherwise altered, to eliminate a leak as 
defined in the applicable paragraphs of Sec. 63.1255, and;
    (2) Is, unless otherwise specified in applicable provisions of 
Sec. 63.1255, monitored as specified in Sec. 63.180(b) and (c) as 
appropriate, to verify that emissions from the equipment are below the 
applicable leak definition.
* * * * *
    Shutdown means the cessation of operation of a continuous process 
for any purpose. Shutdown also means the cessation of a batch process 
or any related individual piece of equipment required or used to comply 
with this subpart as a result of a malfunction or for replacement of 
equipment, repair, or any other purpose not excluded from this 
definition. Shutdown also applies to emptying and degassing storage 
vessels. Shutdown does not apply to cessation of a batch process at the 
end of a campaign, for routine maintenance, for rinsing or washing of 
equipment between batches, or other routine operations.
* * * * *
    Small control device means a control device that controls total HAP 
emissions of less than 10 tons/yr, before control.
* * * * *
    Standard batch means a batch process operated within a range of 
operating conditions that are documented in an operating scenario. 
Emissions from a standard batch are based on the operating conditions 
that result in highest emissions. The standard batch defines the 
uncontrolled and controlled emissions for each emission episode defined 
under the operating scenario.
    Startup means the setting in operation of a continuous process unit 
for any purpose; the first time a new or reconstructed batch process 
unit begins production; for new equipment added, including equipment 
used to comply with this subpart, the first time the equipment is put 
into operation; or, for the introduction of a new product/process, the 
first time the product or process is run in equipment. For batch 
process units, startup does not apply to the first time the equipment 
is put into operation at the start of a campaign to produce a product 
that has been produced in the past, after a shutdown for maintenance, 
or when the equipment is put into operation as part of a batch within a 
campaign. As used in Sec. 63.1255, startup means the setting in 
operation of a piece of equipment or

[[Page 52600]]

a control device that is subject to this subpart.
    Storage tank means a tank or other vessel that is used to store 
organic liquids that contain one or more HAP as raw material 
feedstocks. Storage tank also means a tank or other vessel in a tank 
farm that receives and accumulates used solvent from multiple batches 
of a process or processes for purposes of solvent recovery. The 
following are not considered storage tanks for the purposes of this 
subpart:
    (1) Vessels permanently attached to motor vehicles such as trucks, 
railcars, barges, or ships;
    (2) Pressure vessels designed to operate in excess of 204.9 
kilopascals and without emissions to the atmosphere;
    (3) Vessels storing organic liquids that contain HAP only as 
impurities;
    (4) Wastewater storage tanks; and
    (5) Process tanks (including product tanks and isolated 
intermediate tanks).
    Supplemental gases are any gaseous streams that are not defined as 
process vents, or closed-vent systems from wastewater management and 
treatment units, storage tanks, or equipment components and that 
contain less than 50 ppmv TOC, as determined through process knowledge, 
that are introduced into vent streams or manifolds. Air required to 
operate combustion device burner(s) is not considered supplemental gas.
* * * * *
    System flowrate means the flowrate of gas entering the control 
device.
* * * * *
    Vapor-mounted seal means a continuous seal that completely covers 
the annular space between the wall of the storage tank or waste 
management unit and the edge of the floating roof and is mounted such 
that there is a vapor space between the stored liquid and the bottom of 
the seal.
* * * * *
    Wastewater stream means water that is discarded from a PMPU through 
a single POD, that contains an annual average concentration of 
partially soluble and/or soluble HAP compounds of at least 5 parts per 
million by weight and a load of at least 0.05 kg/yr. The following are 
not considered wastewater streams for the purposes of this subpart:
    (1) Stormwater from segregated sewers;
    (2) Water from fire-fighting and deluge systems, including testing 
of such systems;
    (3) Spills;
    (4) Water from safety showers;
    (5) Samples of a size not greater than reasonably necessary for the 
method of analysis that is used;
    (6) Equipment leaks;
    (7) Wastewater drips from procedures such as disconnecting hoses 
after clearing lines; and
    (8) Noncontact cooling water.
* * * * *

    4. Section 63.1252 is amended by:
    a. Revising the introductory paragraph;
    b. Revising paragraph (d)(2);
    c. Revising the first sentence in paragraph (d)(5);
    d. Revising paragraph (d)(6) through (d)(8);
    e. Revising paragraph (e) introductory text;
    f. Revising the second sentence in paragraph (e)(1); and
    g. Adding paragraph (e)(4).
    The revisions and additions read as follows:


Sec. 63.1252  Standards: General.

    Each owner or operator of any affected source subject to the 
provisions of this subpart shall control HAP emissions to the level 
specified in this section on and after the compliance dates specified 
in Sec. 63.1250(f). Initial compliance with the emission limits is 
demonstrated in accordance with the provisions of Sec. 63.1257, and 
continuous compliance is demonstrated in accordance with the provisions 
of Sec. 63.1258.
* * * * *
    (d) * * *
    (2) Only emission sources subject to the requirements of 
Sec. 63.1253(b)(1) or (c)(1)(i) or Sec. 63.1254(a)(1)(i) may be 
included in any averaging group.
* * * * *
    (5) Emission points controlled to comply with a State or Federal 
rule other than this subpart may not be credited in an emission 
averaging group, unless the level of control has been increased after 
November 15, 1990 above what is required by the other State or Federal 
rule. * *  *
    (6) Not more than 20 processes subject to Sec. 63.1254(a)(1)(i), 
and 20 storage tanks subject to Sec. 63.1253(b)(1) or (c)(1)(i) at an 
affected source may be included in an emissions averaging group.
    (7) Compliance with the emission standards in Sec. 63.1253 shall be 
satisfied when the annual percent reduction efficiency is greater than 
or equal to 90 percent for those tanks meeting the criteria of 
Sec. 63.1253(a)(1) and 95 percent for those tanks meeting the criteria 
of Sec. 63.1253(a)(2), as demonstrated using the test methods and 
compliance procedures specified in Sec. 63.1257(g).
    (8) Compliance with the emission standards in Sec. 63.1254(a)(1)(i) 
shall be satisfied when the annual percent reduction efficiency is 
greater than or equal to 93 percent, as demonstrated using the test 
methods and compliance procedures specified in Sec. 63.1257(h).
    (e) Pollution prevention alternative. Except as provided in 
paragraph (e)(1) of this section, an owner or operator may choose to 
meet the pollution prevention alternative requirement specified in 
either paragraph (e)(2) or (3) of this section for any PMPU or for any 
situation described in paragraph (e)(4) of this section, in lieu of the 
requirements specified in Secs. 63.1253, 63.1254, 63.1255, and 63.1256. 
Compliance with paragraphs (e)(2) and (3) of this section shall be 
demonstrated through the procedures in Sec. 63.1257(f). Any PMPU for 
which the owner or operator seeks to comply by using the pollution 
prevention alternative shall begin with the same starting material(s) 
and end with the same product(s). The owner or operator may not comply 
with the pollution prevention alternative by eliminating any steps of a 
process by transferring the step offsite (to another manufacturing 
location).
    (1) * * * The hydrogen halides that are generated as a result of 
combustion control of emissions must be controlled according to the 
requirements of paragraph (g)(1) of this section.
* * * * *
    (4) The owner or operator may comply with the requirements in 
either paragraph (e)(2) or (3) of this section for a series of 
processes, including situations where multiple processes are merged, 
subject to the following conditions:
    (i) The baseline period shall be a single year beginning no earlier 
than the 1992 calendar year.
    (ii) The term ``PMPU'' shall have the meaning provided in 
Sec. 63.1251 except that the baseline and modified PMPU may include 
multiple processes (i.e., precursors, active ingredients, and final 
dosage form) if the owner or operator demonstrates to the satisfaction 
of the Administrator that the multiple processes were merged after the 
baseline period into an existing process or processes.
    (iii) Nondedicated formulation and solvent recovery processes may 
not be merged with any other processes.
* * * * *

    5. Section 63.1253 is amended by:
    a. Revising paragraph (a);
    b. Revising paragraph (d); and
    c. Adding paragraph (f).
    The revisions and additions read as follows:

[[Page 52601]]

Sec. 63.1253  Standards: Storage tanks.

    (a) Except as provided in paragraphs (d), (e), and (f) of this 
section, the owner or operator of a storage tank meeting the criteria 
of paragraph (a)(1) of this section is subject to the requirements of 
paragraph (b) of this section. Except as provided in paragraphs (d), 
(e), and (f) of this section, the owner or operator of a storage tank 
meeting the criteria of paragraph (a)(2) of this section is subject to 
the requirements of paragraph (c) of this section. Compliance with the 
provisions of paragraphs (b) and (c) of this section is demonstrated 
using the initial compliance procedures in Sec. 63.1257(c) and the 
monitoring requirements in Sec. 63.1258.
    (1) A storage tank with a design capacity greater than or equal to 
38 m\3\ but less than 75 m\3\ storing a liquid for which the maximum 
true vapor pressure of total HAP is greater than or equal to 13.1 kPa.
    (2) A storage tank with a design capacity greater than or equal to 
75 m\3\ storing a liquid for which the maximum true vapor pressure of 
total HAP is greater than or equal to 13.1 kPa.
* * * * *
    (d) As an alternative standard, the owner or operator of an 
existing or new affected source may comply with the storage tank 
standards by routing storage tank vents to a combustion control device 
achieving an outlet TOC concentration, as calibrated on methane or the 
predominant HAP, of 20 ppmv or less, and an outlet concentration of 
hydrogen halides and halogens of 20 ppmv or less. If the owner or 
operator is routing emissions to a noncombustion control device, it 
must achieve an outlet TOC concentration, as calibrated on methane or 
the predominant HAP, of 50 ppmv or less, and an outlet concentration of 
hydrogen halides and halogens of 50 ppmv or less. Compliance with the 
outlet concentrations shall be determined by the initial compliance 
procedures of Sec. 63.1257(c)(4) and the continuous emission monitoring 
requirements of Sec. 63.1258(b)(5).
* * * * *
    (f) Vapor balancing alternative. As an alternative to the 
requirements in paragraphs (b) and (c) of this section, the owner or 
operator of an existing or new affected source may implement vapor 
balancing in accordance with paragraphs (f)(1) through (7) of this 
section.
    (1) The vapor balancing system must be designed and operated to 
route organic HAP vapors displaced from loading of the storage tank to 
the railcar or tank truck from which the storage tank is filled.
    (2) Tank trucks and railcars must have a current certification in 
accordance with the U.S. Department of Transportation (DOT) pressure 
test requirements of 49 CFR part 180 for tank trucks and 49 CFR 173.31 
for railcars.
    (3) Hazardous air pollutants must only be unloaded from tank trucks 
or railcars when vapor collection systems are connected to the storage 
tank's vapor collection system.
    (4) No pressure relief device on the storage tank, or on the 
railcar, or tank truck shall open during loading or as a result of 
diurnal temperature changes (breathing losses).
    (5) Pressure relief devices on affected storage tanks must be set 
to no less than 2.5 psig at all times to prevent breathing losses. The 
owner or operator shall record the setting as specified in 
Sec. 63.1259(b)(12) and comply with the requirements for each pressure 
relief valve in paragraphs (f)(5)(i) through (iii) of this section:
    (i) The pressure relief valve shall be monitored quarterly using 
the method described in Sec. 63.180(b).
    (ii) An instrument reading of 500 ppmv or greater defines a leak.
    (iii) When a leak is detected, it shall be repaired as soon as 
practicable, but no later than 5 days after it is detected, and the 
owner or operator shall comply with the recordkeeping requirements of 
Sec. 63.1255(g)(4)(i) through (iv).
    (6) Railcars or tank trucks that deliver HAP to an affected storage 
tank must be reloaded or cleaned at a facility that utilizes one of the 
control techniques in paragraph (f)(6)(i) through (ii) of this section:
    (i) The railcar or tank truck must be connected to a closed-vent 
system with a control device that reduces inlet emissions of HAP by 90 
percent by weight or greater; or
    (ii) A vapor balancing system designed and operated to collect 
organic HAP vapor displaced from the tank truck or railcar during 
reloading must be used to route the collected HAP vapor to the storage 
tank from which the liquid being transferred originated.
    (7) The owner or operator of the facility where the railcar or tank 
truck is reloaded or cleaned must comply with the requirements in 
paragraph (f)(7)(i) through (iii) of this section:
    (i) Submit to the owner or operator of the affected storage tank 
and to the Administrator a written certification that the reloading or 
cleaning facility will meet the requirements of this section. The 
certifying entity may revoke the written certification by sending a 
written statement to the owner or operator of the affected storage tank 
giving at least 90 days notice that the certifying entity is rescinding 
acceptance of responsibility for compliance with the requirements of 
this paragraph (b)(7)(i).
    (ii) If complying with paragraph (f)(6)(i) of this section, 
demonstrate initial compliance in accordance with Sec. 63.1257(c), 
demonstrate continuous compliance in accordance with Sec. 63.1258, keep 
records as specified in Sec. 63.1259, and prepare reports as specified 
in Sec. 63.1260.
    (iii) If complying with paragraph (f)(6)(ii) of this section, keep 
records of:
    (A) The equipment to be used and the procedures to be followed when 
reloading the railcar or tank truck and displacing vapors to the 
storage tank from which the liquid originates, and
    (B) Each time the vapor balancing system is used to comply with 
paragraph (f)(6)(ii) of this section.

    6. Section 63.1254 is revised to read as follows:


Sec. 63.1254  Standards: Process vents.

    (a) Existing sources. For each process, the owner or operator of an 
existing affected source must comply with the requirements in 
paragraphs (a)(1) and (3) of this section or paragraphs (a)(2) and (3) 
of this section. Initial compliance with the required emission limits 
or reductions in paragraphs (a)(1) through (3) of this section is 
demonstrated in accordance with the initial compliance procedures 
described in Sec. 63.1257(d), and continuous compliance is demonstrated 
in accordance with the monitoring requirements described in 
Sec. 63.1258.
    (1) Process-based emission reduction requirement.
    (i) Uncontrolled HAP emissions from the sum of all process vents 
within a process that are not subject to the requirements of paragraph 
(a)(3) of this section shall be reduced by 93 percent or greater by 
weight, or as specified in paragraph (a)(1)(ii) of this section. 
Notification of changes in the compliance method shall be reported 
according to the procedures in Sec. 63.1260(h).
    (ii) Any one or more vents within a process may be controlled in 
accordance with any of the procedures in paragraphs (a)(1)(ii)(A) 
through (D) of this section. All other vents within the process must be 
controlled as specified in paragraph (a)(1)(i) of this section.
    (A) To outlet concentrations less than or equal to 20 ppmv as TOC 
and less than or equal to 20 ppmv as hydrogen halides and halogens;

[[Page 52602]]

    (B) By a flare that meets the requirements of Sec. 63.11(b);
    (C) By a control device specified in Sec. 63.1257(a)(4); or
    (D) In accordance with the alternative standard specified in 
paragraph (c) of this section.
    (2) Process-based annual mass limit. (i) Actual HAP emissions from 
the sum of all process vents within a process must not exceed 900 
kilograms (kg) in any 365-day period.
    (ii) Actual HAP emissions from the sum of all process vents within 
processes complying with paragraph (a)(2)(i) of this section are 
limited to a maximum of 1,800 kg in any 365-day period.
    (iii) Emissions from vents that are subject to the requirements of 
paragraph (a)(3) of this section and emissions from vents that are 
controlled in accordance with the procedures in paragraph (c) of this 
section may be excluded from the sums calculated in paragraphs 
(a)(2)(i) and (ii) of this section.
    (iv) The owner or operator may switch from compliance with 
paragraph (a)(2) of this section to compliance with paragraph (a)(1) of 
this section only after at least 1 year of operation in compliance with 
paragraph (a)(2) of this section. Notification of such a change in the 
compliance method shall be reported according to the procedures in 
Sec. 63.1260(h).
    (3) Individual vent emission reduction requirements.
    (i) Except as provided in paragraph (a)(3)(ii) of this section, 
uncontrolled HAP emissions from a process vent must be reduced by 98 
percent or in accordance with any of the procedures in paragraphs 
(a)(1)(ii)(A) through (D) of this section if the uncontrolled HAP 
emissions from the vent exceed 25 tons per year, and the flow-weighted 
average flowrate (FRa) calculated using Equation 1 of this subpart is 
less than or equal to the flowrate index (FRI) calculated using 
Equation 2 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR29AU00.000

[GRAPHIC] [TIFF OMITTED] TR29AU00.001

Where:
FRa = flow-weighted average flowrate for the vent, scfm.
Di = duration of each emission event, min.
FRi = flowrate of each emission event, scfm.
n = number of emission events.
FRI = flowrate index, scfm.
HL = annual uncontrolled HAP emissions, lb/yr, as defined in 
Sec. 63.1251.

    (ii) Grandfathering provisions. As an alternative to the 
requirements in paragraph (a)(3)(i) of this section, the owner or 
operator may comply with the provisions in paragraph (a)(3)(ii)(A), 
(B), or (C) of this section, if applicable.
    (A) Control device operation. If the owner or operator can 
demonstrate that a process vent is controlled by a control device 
meeting the criteria specified in paragraph (a)(3)(ii)(A)(1) of this 
section, then the control device is required to be operated according 
to paragraphs (a)(3)(ii)(A)(2), (3), and (4) of this section:
    (1) The control device was installed on any process vent that met 
the conditions of paragraph (a)(3)(i) of this section on or before 
April 2, 1997, and was operated to reduce uncontrolled emissions of 
total HAP by greater than or equal to 93 percent by weight, but less 
than 98 percent by weight;
    (2) The device must be operated to reduce inlet emissions of total 
HAP by 93 percent or by the percent reduction specified for that 
control device in any preconstruction permit issued pursuant to 
regulations approved or promulgated through rulemaking under title I 
(including parts C or D) of the Clean Air Act, whichever is greater;
    (3) The device must be replaced or upgraded to achieve at least 98 
percent reduction of HAP or meet any of the conditions specified in 
paragraphs (a)(1)(ii)(A) through (D) of this section upon 
reconstruction or replacement.
    (4) The device must be replaced or upgraded to achieve at least 98 
percent reduction of HAP or meet any of the conditions specified in 
paragraphs (a)(1)(ii)(A) through (D) of this section by April 2, 2007, 
or 15 years after issuance of the preconstruction permit, whichever is 
later.
    (B) Process operations. If a process meets all of the conditions 
specified in paragraphs (a)(3)(ii)(B)(1) through (3) of this section, 
the required level of control for the process is the level that was 
achieved on or before April 2, 1997. This level of control is 
demonstrated using the same procedures that are used to demonstrate 
compliance with paragraph (a)(1) of this section.
    (1) At least one vent in the process met the conditions of 
paragraph (a)(3)(i) of this section on or before April 2, 1997; and
    (2) The overall control for the process on or before April 2, 1997 
was greater than or equal to 93 percent by weight, but less than 98 
percent by weight; and
    (3) The production-indexed HAP consumption factor for the 12-month 
period in which the process was operated prior to the compliance date 
is less than one-half of the 3-year average baseline value established 
no earlier than the 1987 through 1989 calendar years.
    (C) Hydrogenation vents. Processes meeting the conditions of 
paragraphs (a)(3)(ii)(C)(1) through (3) of this section are required to 
be operated to maintain the level of control achieved on or before 
April 2, 1997. For all other processes meeting the conditions of 
paragraph (a)(3)(ii)(C)(3) of this section, uncontrolled HAP emissions 
from the sum of all process vents within the process must be reduced by 
95 percent or greater by weight.
    (1) Processes containing a process vent that met the conditions of 
paragraph (a)(3)(i) of this section on or before April 2, 1997; and
    (2) Processes that are controlled to greater than or equal to 93 
percent by weight, but less than 98 percent by weight; and
    (3) Processes with a hydrogenation vent that, in conjunction with 
all other process vents from the process that do not meet the 
conditions of paragraph (a)(3)(i) of this section, cannot meet the 
requirements of paragraph (a)(1) or (2) of this section.
    (b) New sources. (1) Except as provided in paragraph (b)(2) of this 
section, uncontrolled HAP emissions from the sum of all process vents 
within a process at a new affected source shall be reduced by 98 
percent or greater by weight or controlled in accordance with any of 
requirements of paragraphs (a)(1)(ii)(A) through (D) of this section. 
Initial compliance with the required emission limit or reduction is 
demonstrated in accordance with the initial compliance procedures in 
Sec. 63.1257(d), and continuous compliance is demonstrated in 
accordance with the monitoring requirements described in Sec. 63.1258.
    (2) Annual mass limit. The actual HAP emissions from the sum of all 
process vents for which the owner or operator is not complying with 
paragraph (b)(1) of this section are limited to 900 kg in any 365-day 
period.
    (c) Alternative standard. As an alternative standard, the owner or 
operator of an existing or new affected source may comply with the 
process vent standards by routing vents from a process to a combustion 
control device achieving an outlet TOC concentration, as calibrated on 
methane or the predominant HAP, of 20 ppmv or less, and an outlet 
concentration of hydrogen halides and halogens of 20 ppmv or less. If 
the owner or operator is routing emissions to a noncombustion control 
device, it must achieve an outlet TOC concentration, as calibrated on 
methane or the predominant HAP, of 50 ppmv or

[[Page 52603]]

less, and an outlet concentration of hydrogen halides and halogens of 
50 ppmv or less. Any process vents within a process that are not routed 
to this control device must be controlled in accordance with the 
provisions of paragraph (a) or (b) of this section, as applicable. 
Initial compliance with the outlet concentrations is demonstrated in 
accordance with the initial compliance procedures described in 
Sec. 63.1257(d)(1)(iv), and continuous compliance is demonstrated in 
accordance with the emission monitoring requirements described in 
Sec. 63.1258(b)(5).

    7. Section 63.1255 is amended by:
    a. Revising paragraph (a)(1);
    b. Revising paragraph (a)(7);
    c. Revising paragraphs (a)(10)(ii) and (iii);
    d. Adding paragraphs (a)(11) and (12);
    e. Revising paragraph (b);
    f. Revising paragraph (c)(2)(i);
    g. Revising ``paragraph (b)(1)(v)'' to read ``paragraph (b)(4)(i)'' 
in paragraph (c)(3)(i);
    h. Revising the definitions of the terms ``PL'' and 
``PT'' following Equation 3 in paragraph (c)(4)(iv);
    i. Removing the definition of the term ``PS'' following Equation 3 
in paragraph (c)(4)(iv) and adding the definition of the term 
``PS'' following Equation 3 in paragraph (c)(4)(iv);
    j. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (c)(5)(i)(B);
    k. Revising paragraphs (c)(5)(vi)(B) and (C);
    l. Revising paragraphs (c)(6) and (7);
    m. Revising paragraph (c)(9);
    n. Revising paragraphs (d)(1)(ii);
    o. Revising paragraph (e)(3) introductory text;
    p. Revising the definitions of the terms ``%VLi'' and 
Vi'' following Equation 4 in paragraph (e)(5)(iii);
    q. Revising the definition of the term ``%VL'' following 
Equation 5 in paragraph (e)(6)(ii);
    r. Revising ``paragraph (b)(1)(v)'' to read ``paragraph (b)(4)(i)'' 
in paragraph (e)(7)(i);
    s. Adding paragraphs (e)(7)(iii)(A) through (C);
    t. Revising the second sentence in paragraph (e)(9);
    u. Revising paragraph (f);
    v. Revising paragraph (g)(2) introductory text;
    w. Revising paragraph (g)(2)(i)(A);
    x. Removing paragraph (g)(2)(v), redesignating paragraphs 
(g)(2)(vi) through (ix) as paragraphs (g)(2)(v) through (viii), and 
revising redesignated paragraphs (g)(2)(vi) and (viii);
    y. Revising the first sentence in paragraph (g)(3);
    z. Revising paragraph (g)(4) introductory text
    aa. Revising paragraph (g)(4)(iv)
    bb. Revising paragraph (g)(4)(v)(A)
    cc. Revising ``Sec. 63.174(c)'' to read ``Sec. 63.174(c)(1)(i) and 
(c)(2)(ii)'' in the first sentence in paragraph (g)(4)(vii)(B)
    dd. Revising ``Secs. 63.178(c)(3)(ii) and (c)(3)(iii)'' to read 
``Sec. 63.178(c)(3)(ii) and (iii)'' in the first sentence in paragraph 
(g)(4)(viii)
    ee. Revising the first sentence in paragraph (g)(5) introductory 
text
    ff. Removing paragraph (g)(5)(ii), redesignating paragraphs 
(g)(5)(iii) through (vi) as paragraphs (g)(5)(ii) through (v), and 
revising ``appendix'' to read ``section'' in the second sentence of 
redesignated paragraph (g)(5)(ii)
    gg. Revising paragraph (g)(6) heading
    hh. Revising the first sentence in paragraph (g)(7) introductory 
text
    ii. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (g)(7)(i)(D)
    jj. Revising paragraph (h)(2) heading
    kk. Revising paragraph (h)(2)(i)(B)
    ll. Revising ``paragraph (b)(1)(ix)'' to read ``paragraph 
(b)(4)(iv)'' in paragraph (h)(2)(ii)
    mm. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (h)(2)(iii)(B)
    nn. Revising paragraph (h)(2)(iv)
    oo. Revising ``Sec. 63.1250(e)'' to read ``Sec. 63.1250(f)'' in the 
second sentence in paragraph (h)(3)(i)
    pp. Revising paragraph (h)(3)(ii) introductory text
    qq. Revising paragraphs (h)(3)(ii)(C) and (D); and
    rr. Revising paragraph (h)(3)(iv);
    The revisions and additions read as follows:


Sec. 63.1255  Standards: Equipment leaks.

    (a) * * *
    (1) The provisions of this section apply to pumps, compressors, 
agitators, pressure relief devices, sampling connection systems, open-
ended valves or lines, valves, connectors, instrumentation systems, 
control devices, and closed-vent systems required by this section that 
are intended to operate in organic hazardous air pollutant service 300 
hours or more during the calendar year within a source subject to the 
provisions of this subpart.
* * * * *
    (7) Equipment to which this section applies shall be identified 
such that it can be distinguished readily from equipment that is not 
subject to this section. Identification of the equipment does not 
require physical tagging of the equipment. For example, the equipment 
may be identified on a plant site plan, in log entries, or by 
designation of process boundaries by some form of weatherproof 
identification. If changes are made to the affected source subject to 
the leak detection requirements, equipment identification for each type 
of component shall be updated, if needed, within 90 calendar days or by 
the next Periodic Report following the end of the monitoring period for 
that component, whichever is later.
* * * * *
    (10) * * *
    (ii) The identification on a valve in light liquid or gas/vapor 
service may be removed after it has been monitored as specified in 
paragraph (e)(7)(iii) of this section, and no leak has been detected 
during the follow-up monitoring.
    (iii) The identification on equipment, except on a valve in light 
liquid or gas/vapor service, may be removed after it has been repaired.
    (11) Except as provided in paragraph (a)(11)(i) of this section, 
all terms in this subpart that define a period of time for completion 
of required tasks (e.g., weekly, monthly, quarterly, annual) refer to 
the standard calendar periods unless specified otherwise in the section 
or paragraph that imposes the requirement.
    (i) If the initial compliance date does not coincide with the 
beginning of the standard calendar period, an owner or operator may 
elect to utilize a period beginning on the compliance date, or may 
elect to comply in accordance with the provisions of paragraph 
(a)(11)(ii) or (iii) of this section.
    (ii) Time periods specified in this subpart for completion of 
required tasks may be changed by mutual agreement between the owner or 
operator and the Administrator, as specified in subpart A of this part. 
For each time period that is changed by agreement, the revised period 
shall remain in effect until it is changed. A new request is not 
necessary for each recurring period.
    (iii) Except as provided in paragraph (a)(11)(i) or (ii) of this 
section, where the period specified for compliance is a standard 
calendar period, if the initial compliance date does not coincide with 
the beginning of the calendar period, compliance shall be required 
according to the schedule specified in paragraph (a)(11)(iii)(A) or (B) 
of this section, as appropriate.
    (A) Compliance shall be required before the end of the standard 
calendar period within which the initial compliance date occurs if 
there remain at least 3 days for tasks that must be performed weekly, 
at least 2 weeks for tasks that must be performed monthly, at least 1 
month for tasks that must be

[[Page 52604]]

performed each quarter, or at least 3 months for tasks that must be 
performed annually; or
    (B) In all other cases, compliance shall be required before the end 
of the first full standard calendar period after the period within 
which the initial compliance date occurs.
    (iv) In all instances where a provision of this subpart requires 
completion of a task during each of multiple successive periods, an 
owner or operator may perform the required task at any time during each 
period, provided the task is conducted at a reasonable interval after 
completion of the task during the previous period.
    (12) In all cases where the provisions of this subpart require an 
owner or operator to repair leaks by a specified time after the leak is 
detected, it is a violation of this section to fail to take action to 
repair the leaks within the specified time. If action is taken to 
repair the leaks within the specified time, failure of that action to 
successfully repair the leak is not a violation of this section. 
However, if the repairs are unsuccessful, a leak is detected and the 
owner or operator shall take further action as required by applicable 
provisions of this section.
    (b) References. (1) The owner or operator of a source subject to 
this section shall comply with the provisions of subpart H of this 
part, as specified in paragraphs (b)(2) through (4) of this section. 
The term ``process unit'' as used in subpart H of this part shall be 
considered to be defined the same as ``group of processes'' for sources 
subject to this subpart GGG. The term ``fuel gas system,'' as used in 
subpart H of this part, shall not apply for the purposes of this 
subpart GGG.
    (2) Sections 63.160, 63.161, 63.162, 63.163, 63.167, 63.168, 
63.170, 63.173, 63.175, 63.176, 63.181, and 63.182 shall not apply for 
the purposes of this subpart GGG. The owner or operator shall comply 
with the provisions specified in paragraphs (b)(2)(i) through (viii) of 
this section.
    (i) Sections 63.160 and 63.162 shall not apply; instead, the owner 
or operator shall comply with paragraph (a) of this section;
    (ii) Section 63.161 shall not apply; instead, the owner or operator 
shall comply with Sec. 63.1251;
    (iii) Sections 63.163 and 63.173 shall not apply; instead, the 
owner or operator shall comply with paragraph (c) of this section;
    (iv) Section 63.167 shall not apply; instead, the owner or operator 
shall comply with paragraph (d) of this section;
    (v) Section 63.168 shall not apply; instead, the owner or operator 
shall comply with paragraph (e) of this section;
    (vi) Section 63.170 shall not apply; instead, the owner or operator 
shall comply with Sec. 63.1254;
    (vii) Section 63.181 shall not apply; instead, the owner or 
operator shall comply with paragraph (g) of this section; and
    (viii) Section 63.182 shall not apply; instead, the owner or 
operator shall comply with paragraph (h) of this section.
    (3) The owner or operator shall comply with Secs. 63.164, 63.165, 
63.166, 63.169, 63.177, and 63.179 in their entirety, except that when 
these sections reference other sections of subpart H of this part, the 
references shall mean the sections specified in paragraphs (b)(2) and 
(4) of this section. Section 63.164 applies to compressors. Section 
63.165 applies to pressure relief devices in gas/vapor service. Section 
63.166 applies to sampling connection systems. Section 63.169 applies 
to pumps, valves, connectors, and agitators in heavy liquid service; 
instrumentation systems; and pressure relief devices in liquid service. 
Section 63.177 applies to general alternative means of emission 
limitation. Section 63.179 applies to alternative means of emission 
limitation for enclosed-vented process units.
    (4) The owner or operator shall comply with Secs. 63.171, 63.172, 
63.174, 63.178, and 63.180, except as specified in paragraphs (b)(4)(i) 
through (vi) of this section.
    (i) Section 63.171 shall apply, except Sec. 63.171(a) shall not 
apply. Instead, delay of repair of equipment for which leaks have been 
detected is allowed if one of the conditions in paragraphs (b)(4)(i)(A) 
through (B) exists:
    (A) The repair is technically infeasible without a process 
shutdown. Repair of this equipment shall occur by the end of the next 
scheduled process shutdown.
    (B) The owner or operator determines that repair personnel would be 
exposed to an immediate danger if attempting to repair without a 
process shutdown. Repair of this equipment shall occur by the end of 
the next scheduled process shutdown.
    (ii) Section 63.172 shall apply for closed-vent systems used to 
comply with this section, and for control devices used to comply with 
this section only, except:
    (A) Section 63.172(k) and (l) shall not apply. The owner or 
operator shall instead comply with paragraph (f) of this section.
    (B) Owners or operators may, instead of complying with the 
provisions of Sec. 63.172(f), design a closed-vent system to operate at 
a pressure below atmospheric pressure. The system shall be equipped 
with at least one pressure gage 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.
    (iii) Section 63.174 shall apply except:
    (A) Section 63.174(f), (g), and (h) shall not apply. Instead of 
Sec. 63.174(f), (g), and (h), the owner or operator shall comply with 
paragraph (f) of this section. Section 63.174(b)(3) shall not apply. 
Instead of Sec. 63.174(b)(3), the owner or operator shall comply with 
paragraphs (b)(3)(iii)(B) through (F) of this section.
    (B) If the percent leaking connectors in a group of processes was 
greater than or equal to 0.5 percent during the initial monitoring 
period, monitoring shall be performed once per year until the percent 
leaking connectors is less than 0.5 percent.
    (C) If the percent leaking connectors in the group of processes was 
less than 0.5 percent, but equal to or greater than 0.25 percent, 
during the initial or last required monitoring period, the owner or 
operator may elect to monitor once every 4 years. An owner or operator 
may comply with the requirements of this paragraph by monitoring at 
least 40 percent of the connectors in the first 2 years and the 
remainder of the connectors within the next 2 years. The percent 
leaking connectors will be calculated for the total of all required 
monitoring performed during the 4-year period.
    (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, the 
owner or operator shall monitor once per year if the percent leaking 
connectors is greater than or equal to 0.5 percent; if 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.
    (E) If an owner or operator determines that 1 percent or greater of 
the connectors in a group of processes are leaking, the owner or 
operator shall monitor the connectors once per year. The owner or 
operator may elect to use the provisions of paragraph (b)(4)(iii)(C), 
(D), or (F) of this section, as appropriate,

[[Page 52605]]

after a monitoring period in which less than 1 percent of the 
connectors are determined to be leaking.
    (F) The owner or operator may elect to perform monitoring once 
every 8 years if the percent leaking connectors in the group of 
processes was less than 0.25 percent during the initial or last 
required monitoring period. An owner or operator shall monitor at least 
50 percent of the connectors in the first 4 years and the remainder of 
the connectors within the next 4 years. If the percent leaking 
connectors in the first 4 years is equal to or greater than 0.35 
percent, the monitoring program shall revert at that time to the 
appropriate monitoring frequency specified in paragraph (b)(4)(iii)(C), 
(D), or (E) of this section.
    (iv) Section 63.178 shall apply except:
    (A) Section 63.178(b), requirements for pressure testing, may be 
applied to all processes (not just batch processes) and to supply lines 
between storage and processing areas.
    (B) For pumps, the phrase ``at the frequencies specified in Table 1 
of this subpart'' in Sec. 63.178(c)(3)(iii) shall mean ``quarterly'' 
for the purposes of this subpart.
    (v) Section 63.180 shall apply except Sec. 63.180(b)(4)(ii)(A) 
through (C) shall not apply. Instead, calibration gases shall be a 
mixture of methane and air at a concentration of approximately, but 
less than, 10,000 parts per million methane for agitators; 2,000 parts 
per million for pumps; and 500 parts per million for all other 
equipment, except as provided in Sec. 63.180(b)(4)(iii).
    (vi) When Secs. 63.171, 63.172, 63.174, 63.178, and 63.180 
reference other sections in subpart H of this part, the references 
shall mean those sections specified in paragraphs (b)(2) and (b)(4)(i) 
through (v) of this section, as applicable.
    (c) * * *
    (2)(i) Monitoring. Each pump and agitator subject to this section 
shall be monitored quarterly to detect leaks by the method specified in 
Sec. 63.180(b) except as provided in Secs. 63.177, 63.178, paragraph 
(f) of this section, and paragraphs (c)(5) through (9) of this section.
* * * * *
    (4) * * *
    (iv) * * *

PL = number of pumps found leaking as determined through 
periodic monitoring as required in paragraphs (c)(2)(i) and (ii) of 
this section.
PT = total pumps in organic HAP service, including those 
meeting the criteria in paragraphs (c)(5) and (6) of this section.
PS = number of pumps in a continuous process leaking within 
1 quarter of startup during the current monitoring period.
    (5) * * *
    (vi) * * *
    (B) If indications of liquids dripping from the pump/agitator seal 
exceed the criteria established in paragraph (c)(5)(vi)(A) of this 
section, or if, based on the criteria established in paragraph 
(c)(5)(vi)(A) of this section, the sensor indicates failure of the seal 
system, the barrier fluid system, or both, a leak is detected.
    (C) When a leak is detected, 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.
* * * * *
    (6) Any pump/agitator that is designed with no externally actuated 
shaft penetrating the pump/agitator housing is exempt from the 
requirements of paragraphs (c)(1) through (3) of this section.
    (7) Any pump/agitator equipped with a closed-vent system capable of 
capturing and transporting any leakage from the seal or seals back to 
the process or to a control device that complies with the requirements 
of paragraph (b)(4)(ii) of this section is exempt from the requirements 
of paragraphs (c)(2) through (5) of this section.
* * * * *
    (9) If more than 90 percent of the pumps in a group of processes 
meet the criteria in either paragraph (c)(5) or (6) of this section, 
the group of processes is exempt from the requirements of paragraph 
(c)(4) of this section.
    (d) * * *
    (1) * * *
    (ii) The cap, blind flange, plug, or second valve shall seal the 
open end at all times except during operations requiring process fluid 
flow through the open-ended valve or line, or during maintenance or 
repair. The cap, blind flange, plug, or second valve shall be in place 
within 1 hour of cessation of operations requiring process fluid flow 
through the open-ended valve or line, or within 1 hour of cessation of 
maintenance or repair. The owner or operator is not required to keep a 
record documenting compliance with the 1-hour requirement.
* * * * *
    (e) * * *
    (3) Monitoring. The owner or operator of a source subject to this 
section shall monitor all valves, except as provided in paragraph (f) 
of this section and in Sec. 63.177, at the intervals specified in 
paragraph (e)(4) of this section and shall comply with all other 
provisions of this section, except as provided in paragraph (b)(4)(i) 
of this section, Secs. 63.178 and 63.179.
* * * * *
    (5) * * *
    (iii) * * *

%VLi = percent leaking valves in subgroup i, most recent 
value calculated according to the procedures in paragraphs (e)(6)(ii) 
and (iii) of this section.
Vi = number of valves in subgroup i. * * *
* * * * *
    (6) * * *
    (ii) * * *

%VL = percent leaking valves as determined through periodic 
monitoring required in paragraphs (e)(2) through (4) of this section. * 
* *
* * * * *
    (7) * * *
    (iii) * * *
    (A) The monitoring shall be conducted as specified in 
Sec. 63.180(b) and (c) as appropriate to determine whether the valve 
has resumed leaking.
    (B) Periodic monitoring required by paragraphs (e)(2) through (4) 
of this section may be used to satisfy the requirements of paragraph 
(e)(7)(iii) of this section, if the timing of the monitoring period 
coincides with the time specified in paragraph (e)(7)(iii) of this 
section. Alternatively, other monitoring may be performed to satisfy 
the requirements of paragraph (e)(7)(iii) of this section, regardless 
of whether the timing of the monitoring period for periodic monitoring 
coincides with the time specified in paragraph (e)(7)(iii) of this 
section.
    (C) If a leak is detected by monitoring that is conducted pursuant 
to paragraph (e)(7)(iii) of this section, the owner or operator shall 
follow the provisions of paragraphs (e)(7)(iii)(C)(1) and (2) of this 
section to determine whether that valve must be counted as a leaking 
valve for purposes of paragraph (e)(6) of this section.
    (1) If the owner or operator elects to use periodic monitoring 
required by paragraphs (e)(2) through (4) of this section to satisfy 
the requirements of paragraph (e)(7)(iii) of this section, then the 
valve shall be counted as a leaking valve.
    (2) If the owner or operator elects to use other monitoring prior 
to the periodic monitoring required by paragraphs (e)(2) through (4) of 
this section to satisfy the requirements of paragraph (e)(7)(iii) of 
this section, then the valve shall be counted as a leaking

[[Page 52606]]

valve unless it is repaired and shown by periodic monitoring not to be 
leaking.
* * * * *
    (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) or (iv) of this section, except as provided in 
paragraph (f) of this section.
    (f) Unsafe to monitor/inspect, difficult to monitor/inspect, and 
inaccessible equipment. (1) Equipment that is designated as unsafe to 
monitor, unsafe to inspect, difficult to monitor, difficult to inspect, 
or inaccessible is exempt from the monitoring requirements as specified 
in paragraphs (f)(1)(i) through (iv) of this section provided the owner 
or operator meets the requirements specified in paragraph (f)(2), (3), 
or (4) of this section, as applicable. All equipment must be assigned 
to a group of processes. Ceramic or ceramic-lined connectors are 
subject to the same requirements as inaccessible connectors.
    (i) For pumps and agitators, paragraphs (c)(2), (3), and (4) of 
this section do not apply.
    (ii) For valves, paragraphs (e)(2) through (7) of this section do 
not apply.
    (iii) For connectors, Sec. 63.174(b) through (e) and paragraphs 
(b)(4)(iii)(B) through (F) of this section do not apply.
    (iv) For closed-vent systems, Sec. 63.172(f)(1) and (2) and 
Sec. 63.172(g) do not apply.
    (2) Equipment that is unsafe to monitor or unsafe to inspect. (i) 
Valves, connectors, agitators, and pumps may be designated as unsafe to 
monitor if the owner or operator determines that monitoring personnel 
would be exposed to an immediate danger as a consequence of complying 
with the monitoring requirements referred to in paragraphs (f)(1)(i) 
through (iii) of this section.
    (ii) Any part of a closed-vent system may be designated as unsafe 
to inspect if the owner or operator determines that monitoring 
personnel would be exposed to an immediate danger as a consequence of 
complying with the monitoring requirements referred to in paragraph 
(f)(1)(iv) of this section.
    (iii) The owner or operator of equipment that is designated as 
unsafe to monitor must have a written plan that requires monitoring of 
the equipment as frequently as practicable during safe to monitor 
times, but not more frequently than the periodic monitoring schedule 
otherwise applicable to the group of processes in which the equipment 
is located.
    (iv) For any parts of a closed-vent system designated as unsafe to 
inspect, the owner or operator must have a written plan that requires 
inspection of the closed-vent systems as frequently as practicable 
during safe to inspect times, but not more frequently than annually.
    (3) Equipment that is difficult to monitor or difficult to inspect. 
(i) A valve, agitator, or pump may be designated as difficult to 
monitor if the owner or operator determines that the valve, agitator, 
or pump cannot be monitored without elevating the monitoring personnel 
more than 2 meters above a support surface, or it is not accessible in 
a safe manner when it is in organic HAP service.
    (ii) Any part of a closed-vent system may be designated as 
difficult to inspect if the owner or operator determines that the 
equipment cannot be inspected without elevating the monitoring 
personnel more than 2 meters above a support surface, or it is not 
accessible in a safe manner when it is in organic HAP service.
    (iii) At an existing source, any valve, agitator or pump within a 
group of processes that meets the criteria of paragraph (f)(3)(i) of 
this section may be designated as difficult to monitor, and any parts 
of a closed-vent system that meet the requirements of paragraph 
(f)(3)(ii) of this section may be designated as difficult to inspect. 
At a new affected source, an owner or operator may designate no more 
than 3 percent of valves as difficult to monitor.
    (iv) The owner or operator of valves, agitators, or pumps 
designated as difficult to monitor must have a written plan that 
requires monitoring of the equipment at least once per calendar year or 
on the periodic monitoring schedule otherwise applicable to the group 
of processes in which the equipment is located, whichever is less 
frequent. For any part of a closed-vent system designated as difficult 
to inspect, the owner or operator must have a written plan that 
requires inspection of the closed-vent system at least once every 5 
years.
    (4) Inaccessible, ceramic, or ceramic-lined connectors. (i) A 
connector may be designated as inaccessible if it is:
    (A) Buried;
    (B) Insulated in a manner that prevents access to the connector by 
a monitor probe;
    (C) Obstructed by equipment or piping that prevents access to the 
connector by a monitor probe;
    (D) Unable to be reached from a wheeled scissor-lift or hydraulic-
type scaffold which would allow access to equipment up to 7.6 meters 
(25 feet) above the ground; or
    (E) Not able to be accessed at any time in a safe manner to perform 
monitoring. Unsafe access includes, but is not limited to, the use of a 
wheeled scissor-lift on unstable or uneven terrain, the use of a 
motorized man-lift basket in areas where an ignition potential exists, 
or access would require near proximity to hazards such as electrical 
lines, or would risk damage to equipment.
    (ii) A connector may be designated as inaccessible if it would 
require elevating the monitoring personnel more than 2 meters above a 
permanent support surface or would require the erection of scaffold.
    (iii) At an existing source, any connector that meets the criteria 
of paragraph (f)(4)(i) or (ii) of this section may be designated as 
inaccessible. At a new affected source, an owner or operator may 
designate no more than 3 percent of connectors as inaccessible.
    (iv) If any inaccessible, ceramic, or ceramic-lined connector is 
observed by visual, audible, olfactory, or other means to be leaking, 
the leak shall be repaired as soon as practicable, but no later than 15 
calendar days after the leak is detected, except as provided in 
paragraph (b)(4)(i) of this section.
    (v) Any connector that is inaccessible or that is ceramic or 
ceramic-lined is exempt from the recordkeeping and reporting 
requirements of paragraphs (g) and (h) of this section.
    (g) * * *
    (2) General recordkeeping. Except as provided in paragraph 
(g)(5)(i) of this section and in paragraph (a)(9) of this section, the 
following information pertaining to all equipment subject to the 
requirements in this section shall be recorded:
    (i)(A) A list of identification numbers for equipment (except 
connectors that are subject to paragraph (f)(4) of this section) 
subject to the requirements of this section. Except for equipment 
subject to the recordkeeping requirements in paragraphs (g)(2)(ii) 
through (viii) of this section, equipment need not be individually 
identified if, for a particular type of equipment, all items of that 
equipment in a designated area or length of pipe subject to the 
provisions of this section are identified as a group, and the number of 
subject items of equipment is indicated. The list for each type of 
equipment shall be completed no later than the completion of the 
initial survey required for that component. The list of identification 
numbers shall be updated, if needed, to incorporate equipment changes 
identified during the course of each monitoring period within 90 
calendar days, or by the next Periodic Report, following the end of the 
monitoring period for the type of equipment

[[Page 52607]]

component monitored, whichever is later.
* * * * *
    (vi) A list of equipment designated as unsafe to monitor/inspect or 
difficult to monitor/inspect under paragraph (f) of this section and a 
copy of the plan for monitoring or inspecting this equipment.
* * * * *
    (viii) For equipment that the owner or operator elects to monitor 
as provided under Sec. 63.178(c), a list of equipment added to batch 
product processes since the last monitoring period required in 
Sec. 63.178(c)(3)(ii) and (iii). This list must be completed for each 
type of equipment within 90 calendar days, or by the next Periodic 
Report, following the end of the monitoring period for the type of 
equipment monitored, whichever is later. Also, if the owner or operator 
elects to adjust monitoring frequency by the time in use, as provided 
in Sec. 63.178(c)(3)(iii), records demonstrating the proportion of the 
time during the calendar year the equipment is in use in a manner 
subject to the provisions of this section are required. Examples of 
suitable documentation are records of time in use for individual pieces 
of equipment or average time in use for the process unit.
    (3) Records of visual inspections. For visual inspections of 
equipment subject to the provisions of paragraphs (c)(2)(iii) and 
(c)(5)(iv) of this section, the owner or operator shall document that 
the inspection was conducted and the date of the inspection. * * *
    (4) Monitoring records. When each leak is detected as specified in 
paragraph (c) of this section and Sec. 63.164, paragraph (e) of this 
section and Sec. 63.169, and Secs. 63.172 and 63.174, the following 
information shall be recorded and kept for 5 years (at least 2 years 
onsite, with the remaining 3 years either onsite or offsite):
* * * * *
    (iv) The maximum instrument reading measured by Method 21 of 40 CFR 
part 60, appendix A, after the leak is successfully repaired or 
determined to be nonrepairable.
    (v) * * *
    (A) The owner or operator may develop a written procedure that 
identifies the conditions that justify a delay of repair. The written 
procedures shall be included either as part of the startup/shutdown/
malfunction plan, required by Sec. 63.1259(a)(3), or in a separate 
document that is maintained at the plant site. Reasons for delay of 
repair may be documented by citing the relevant sections of the written 
procedure.
* * * * *
    (5) Records of pressure tests. The owner or operator who elects to 
pressure test a process equipment train or supply lines between storage 
and processing areas to demonstrate compliance with this section is 
exempt from the requirements of paragraphs (g)(2), (3), (4), and (6) of 
this section. * * *
* * * * *
    (6) Records of compressor and relief device compliance tests. * * *
* * * * *
    (7) Records for closed-vent systems. The owner or operator shall 
maintain records of the information specified in paragraphs (g)(7)(i) 
through (iii) of this section for closed-vent systems and control 
devices subject to the provisions of paragraph (b)(4)(ii) of this 
section. * * *
* * * * *
    (h) * * *
    (2) Notification of compliance status report. * * *
    (i) * * *
    (B) Number of each equipment type (e.g., valves, pumps) in organic 
HAP service, excluding equipment in vacuum service.
* * * * *
    (iv) Section 63.9(j) shall not apply to the Notification of 
Compliance Status report described in this paragraph (h)(2).
    (3) * * *
    (ii) For equipment complying with the provisions of paragraphs (b) 
through (g) of this section, except paragraph (b)(4)(iv) of this 
section and Sec. 63.179, the summary information listed in paragraphs 
(h)(3)(ii)(A) through (L) of this section for each monitoring period 
during the 6-month period.
* * * * *
    (C) Separately, the number of pumps and agitators for which leaks 
were detected as described in paragraph (c)(2) of this section, the 
total number of pumps and agitators monitored, and, for pumps, the 
percent leakers;
    (D) Separately, the number of pumps and agitators for which leaks 
were not repaired as required in paragraph (c)(3) of this section;
* * * * *
    (iv) Any revisions to items reported in earlier Notification of 
Compliance Status report, if the method of compliance has changed since 
the last report.

    8. Section 63.1256 is amended by:
    a. Revising paragraph (a) introductory test;
    b. Revising paragraph (a)(1) introductory text;
    c. Revising paragraphs (a)(1)(i)(A) and (B);
    d. Removing paragraph (a)(3) and redesignating paragraph (a)(4) as 
paragraph (a)(3);
    e. Adding paragraph (a)(4);
    f. Revising paragraph (a)(5) introductory text;
    g. Revising paragraph (a)(5)(ii)(C);
    h. Adding paragraph (a)(5)(ii)(D);
    i. Adding paragraph (b)(6)(i);
    j. Revising paragraphs (d)(2) introductory text and paragraph 
(d)(2)(i);
    k. Revising paragraph (g)(8)(ii);
    l. Revising paragraph (g)(11)(ii); and
    m. Revising paragraph (g)(12).
    The revisions and additions read as follows:


Sec. 63.1256  Standards: Wastewater.

    (a) General. Each owner or operator of any affected source 
(existing or new) shall comply with the general wastewater requirements 
in paragraphs (a)(1) through (3) of this section and the maintenance 
wastewater provisions in paragraph (a)(4) of this section. An owner or 
operator may transfer wastewater to a treatment operation not owned by 
the owner or operator in accordance with paragraph (a)(5) of this 
section.
    (1) Identify wastewater that requires control. For each POD, the 
owner or operator shall comply with the requirements in either 
paragraph (a)(1)(i) or (ii) of this section to determine whether a 
wastewater stream is an affected wastewater stream that requires 
control for soluble and/or partially soluble HAP compounds or to 
designate the wastewater stream as an affected wastewater stream, 
respectively. The owner or operator may use a combination of the 
approaches in paragraphs (a)(1)(i) and (ii) of this section for 
different affected wastewater generated at the source.
    (i) * * *
    (A) The wastewater stream contains partially soluble HAP compounds 
at an annual average concentration greater than 1,300 ppmw, and the 
total soluble and partially soluble HAP load in all wastewater from the 
PMPU exceeds 0.25 Mg/yr.
    (B) The wastewater stream contains partially soluble and/or soluble 
HAP compounds at an annual average concentration greater than 5,200 
ppmw, and the total soluble and partially soluble HAP load in all 
wastewater from the PMPU exceeds 0.25 Mg/yr.
* * * * *
    (4) Maintenance wastewater requirements. Each owner or operator of 
a source subject to this subpart shall comply with the requirements of

[[Page 52608]]

paragraphs (a)(4)(i) through (iv) of this section for maintenance 
wastewater containing partially soluble or soluble HAP listed in Tables 
2 and 3 of this subpart. Maintenance wastewater is exempt from all 
other provisions of this subpart.
    (i) The owner or operator shall prepare a description of 
maintenance procedures for management of wastewater generated from the 
emptying and purging of equipment in the process during temporary 
shutdowns for inspections, maintenance, and repair (i.e., a maintenance 
turnaround) and during periods which are not shutdowns (i.e., routine 
maintenance). The descriptions shall:
    (A) Specify the process equipment or maintenance tasks that are 
anticipated to create wastewater during maintenance activities; and
    (B) Specify the procedures that will be followed to properly manage 
the wastewater and minimize organic HAP emissions to the atmosphere; 
and
    (C) Specify the procedures to be followed when clearing materials 
from process equipment.
    (ii) The owner or operator shall modify and update the information 
required by paragraph (a)(4)(i) of this section as needed following 
each maintenance procedure based on the actions taken and the 
wastewater generated in the preceding maintenance procedure.
    (iii) The owner or operator shall implement the procedures 
described in paragraphs (a)(4)(i) and (ii) of this section as part of 
the startup, shutdown, and malfunction plan required under 
Sec. 63.6(e)(3).
    (iv) The owner or operator shall maintain a record of the 
information required by paragraphs (a)(4)(i) and (ii) of this section 
as part of the startup, shutdown, and malfunction plan required under 
Sec. 63.6(e)(3).
    (5) Offsite treatment or onsite treatment not owned or operated by 
the source. The owner or operator may elect to transfer affected 
wastewater streams or a residual removed from such affected wastewater 
to an onsite treatment operation not owned or operated by the owner or 
operator of the source generating the wastewater or residual, or to an 
offsite treatment operation.
* * * * *
    (ii) * * *
    (C) Section 63.6(g); or
    (D) If the affected wastewater streams or residuals removed from 
affected wastewater streams received by the transferee contain less 
than 50 ppmw of partially soluble HAP, then the transferee must, at a 
minimum, manage and treat the affected wastewater streams and residuals 
in accordance with one of the following:
    (1) Comply with paragraph (g)(10) of this section and cover the 
waste management units up to the activated sludge unit; or
    (2) Comply with paragraphs (g)(11)(i), (ii), and (h) of this 
section and cover the waste management units up to the activated sludge 
unit; or
    (3) Comply with paragraph (g)(10) of this section provided that the 
owner or operator of the affected source demonstrates that less than 5 
percent of the total soluble HAP is emitted from waste management units 
up to the activated sludge unit; or
    (4) Comply with paragraphs (g)(11)(i), (ii), and (h) of this 
section provided that the owner or operator of the affected source 
demonstrates that less than 5 percent of the total soluble HAP is 
emitted from waste management units up to the activated sludge unit.
* * * * *
    (b) * * *
    (6) * * *
    (i) The owner or operator shall measure the seal gaps or inspect 
the wastewater tank within 30 calendar days of the determination that 
the floating roof is unsafe.
* * * * *
    (d) * * *
    (2) Filling of large containers. Pumping affected wastewater or a 
residual removed from affected wastewater into a container with a 
capacity greater than or equal to 0.42 m\3\ shall be conducted in 
accordance with the conditions in paragraphs (d)(2)(i) and (ii) of this 
section.
    (i) Comply with any one of the procedures specified in paragraph 
(d)(2)(i)(A), (B), or (C) of this section.
    (A) Use a submerged fill pipe. The submerged fill pipe outlet shall 
extend to no more than 6 inches or within two fill pipe diameters of 
the bottom of the container while the container is being filled.
    (B) Locate the container within an enclosure with a closed-vent 
system that routes the organic HAP vapors vented from the container to 
a control device.
    (C) Use a closed-vent system to vent the displaced organic vapors 
vented from the container to a control device or back to the equipment 
from which the wastewater is transferred.
* * * * *
    (g) * * *
    (8) * * *
    (ii) Percent mass removal/destruction option. The owner or operator 
shall reduce, by removal or destruction, the mass of total partially 
soluble HAP compounds by 99 percent or more. The removal destruction 
efficiency shall be determined by the procedures specified in 
Sec. 63.1257(e)(2)(ii) or (iii)(C) for noncombustion, nonbiological 
treatment processes; Sec. 63.1257(e)(2)(ii) or (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 (iii)(G) for closed biological 
treatment processes.
* * * * *
    (11) * * *
    (ii) For open biological treatment processes, compliance shall be 
determined using the procedures specified in 
Sec. 63.1257(e)(2)(iii)(E). For closed aerobic biological treatment 
processes, compliance shall be determined using the procedures 
specified in Sec. 63.1257(e)(2)(ii), (iii)(E), or (iii)(G). For closed 
anaerobic biological treatment processes, compliance shall be 
determined using the procedures specified in Sec. 63.1257(e)(2)(ii) or 
(iii)(G).
* * * * *
    (12) Percent mass removal/destruction option for soluble HAP 
compounds at new sources. The owner or operator of a new source shall 
reduce, by removal or destruction, the mass flow rate of total soluble 
HAP from affected wastewater by 99 percent or more. The removal/
destruction efficiency shall be determined by the procedures in 
Sec. 63.1257(e)(2)(ii) or (iii)(C) for noncombustion, nonbiological 
treatment processes; Sec. 63.1257(e)(2)(ii) and (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 (iii)(G) for closed biological 
treatment processes.
* * * * *

    9. Section 63.1257 is amended by:
    a. Revising paragraph (a)(3);
    b. Revising paragraph (a)(5);
    c. Revising paragraph (b)(6) introductory text;
    d. Revising paragraph (b)(6)(iii);
    e. Adding a new sentence at the end of paragraph (b)(8)(i)(A) 
introductory text;
    f. Revising paragraph (b)(8)(i)(A)(3)(i);
    g. Revising paragraph (b)(10) introductory text;
    h. Revising paragraphs (b)(10)(i) and (ii);
    i. Redesignating paragraphs (b)(10)(iii) through (v) as paragraphs 
(b)(10)(iv) through (vi) and revising redesignated paragraphs 
(b)(10)(iv) introductory text and (b)(10)(v);
    j. Adding paragraph (b)(10)(iii);
    k. Revising the second sentence in paragraph (c)(1) introductory 
text;

[[Page 52609]]

    l. Revising paragraph (c)(3)(v);
    m. Revising paragraphs (d)(1)(i) through (iii);
    n. Revising equation 13 and the definitions of the terms 
``(Pi)Tn'' and ``MWi'' for Equations 
13 through 17 in paragraph (d)(2)(i)(C)(1);
    o. Removing the definitions of the terms ``(Pi*)'' and 
``(Pj*)'' for Equations 13 through 17 in paragraph 
(d)(2)(i)(C)(1) and adding definitions for the terms ``Pi*'' 
and ``Pj*'' for Equations 13 through 17 in paragraph (d)(2)(i)(C)(1);
    p. Removing the last sentence in paragraph (d)(2)(i)(C)(2)(i);
    q. Revising paragraph (d)(2)(i)(C)(4) introductory text;
    r. Revising paragraph (d)(2)(i)(C)(4)(ii);
    s. Revising the definition of the term ``xj'' after 
Equation 24 in paragraph (d)(2)(i)(D)(2);
    t. Revising paragraphs (d)(2)(i)(D)(3) and (4);
    u. Revising paragraph (d)(2)(i)(E);
    v. Revising the first sentence in paragraph (d)(2)(i)(H);
    w. Adding a new sentence between the third and fourth sentences in 
paragraph (d)(2)(ii);
    x. Revising paragraph (d)(3) introductory text;
    y. Revising paragraph (d)(3)(ii)(A);
    z. Adding paragraph (d)(3)(iii);
    aa. Removing the definition of the term ``P'' for Equation 45 in 
paragraph (e)(2)(iii)(C)(3) and adding the definition of the term 
``'' for Equation 45 in paragraph (e)(2)(iii)(C)(3);
    bb. Revising ``Equation 44'' to read ``Equation 46'' in the first 
sentence in paragraph (e)(2)(iii)(C)(5);
    cc. Removing the definition of the term ``'' for Equation 
47 in paragraph (e)(2)(iii)(D)(3) and revising the definition of the 
term ``''' for Equation 47 in paragraph (e)(2)(iii)(D)(3);
    dd. Adding the definition of the term ``p'' as the last definition 
for Equation 47 in paragraph (e)(2)(iii)(D)(3);
    ee. Revising paragraph (e)(2)(iii)(E)(3) introductory text;
    ff. Revising ``Equation 49'' to read ``Equation 50'' in the first 
sentence in paragraph (e)(2)(iii)(E)(3)(ii);
    gg. Revising the definitions of the terms ``QMWa, 
QMWb'' and ``QMGb'' for Equation 51 in paragraph 
(e)(2)(iii)(G)(3);
    hh. Revising the first sentence in paragraph (f)(1)(iii)(B);
    ii. Revising paragraph (f)(2)(ii)(A); and
    jj. Redesignating paragraphs (h)(2)(i) and (h)(3) as paragraphs 
(h)(3) and (4), revising redesignated paragraph (h)(3), and removing 
Equation 61 from redesignated paragraph (h)(4).
    The revisions and additions read as follows:


Sec. 63.1257  Test methods and compliance procedures.

    (a) * * *
    (3) Outlet concentration correction for supplemental gases. (i) 
Combustion devices. Except as provided in Sec. 63.1258(b)(5)(ii)(A), 
for a combustion device used to comply with an outlet concentration 
standard, the actual TOC, organic HAP, and hydrogen halide and halogen 
must be corrected to 3 percent oxygen if supplemental gases, as defined 
in Sec. 63.1251, are added to the vent stream or manifold. The 
integrated sampling and analysis procedures of Method 3B of 40 CFR part 
60, appendix A, shall be used to determine the actual oxygen 
concentration (%02d). The samples shall be taken during the 
same time that the TOC or total organic HAP or hydrogen halides and 
halogen samples are taken. The concentration corrected to 3 percent 
oxygen (Cd) shall be computed using Equation 7A of this 
subpart:
[GRAPHIC] [TIFF OMITTED] TR29AU00.002

Where:

Cc = concentration of TOC or total organic HAP or hydrogen 
halide and halogen corrected to 3 percent oxygen, dry basis, ppmv.
Cm = total concentration of TOC or total organic HAP or 
hydrogen halide and halogen in vented gas stream, average of samples, 
dry basis, ppmv.
%02d = concentration of oxygen measured in vented gas 
stream, dry basis, percent by volume.

    (ii) Noncombustion devices. Except as provided in 
Sec. 63.1258(b)(5)(ii)(B), if a control device other than a combustion 
device is used to comply with a TOC, organic HAP, or hydrogen halide 
outlet concentration standard, the owner or operator must correct the 
actual concentration for supplemental gases using Equation 7B of this 
subpart; process knowledge and representative operating data may be 
used to determine the fraction of the total flow due to supplemental 
gas.
[GRAPHIC] [TIFF OMITTED] TR29AU00.003

Where:

Ca = corrected outlet TOC, organic HAP, and hydrogen halides 
and halogens concentration, dry basis, ppmv
Cm = actual TOC, organic HAP, and hydrogen halides and 
halogens concentration measured at control device outlet, dry basis, 
ppmv
Va = total volumetric flow rate of all gas streams vented to 
the control device, except supplemental gases
Vs = total volumetric flow rate of supplemental gases
* * * * *
    (5) Initial compliance with alternative standard. Initial 
compliance with the alternative standards in Secs. 63.1253(d) and 
63.1254(c) for combustion devices is demonstrated when the outlet TOC 
concentration is 20 ppmv or less, and the outlet hydrogen halide and 
halogen concentration is 20 ppmv or less. Initial compliance with the 
alternative standards in Secs. 63.1253(d) and 63.1254(c) for 
noncombustion devices is demonstrated when the outlet TOC concentration 
is 50 ppmv or less, and the outlet hydrogen halide and hydrogen 
concentration is 50 ppmv or less. To demonstrate initial compliance, 
the owner or operator shall be in compliance with the monitoring 
provisions in Sec. 63.1258(b)(5) on the initial compliance date. The 
owner or operator shall use Method 18 to determine the predominant 
organic HAP in the emission stream if the TOC monitor is calibrated on 
the predominant HAP.
* * * * *
    (b) * * *
    (6) The following methods are specified for concentration 
measurements:
* * * * *
    (iii) Method 26 or 26A of appendix A of part 60 shall be used to 
determine hydrogen chloride, hydrogen halide and halogen concentrations 
in control device efficiency determinations or in the 20 ppmv outlet 
hydrogen halide concentration standard.
* * * * *
    (8) * * *
    (i) * * *
    (A) * * * The owner or operator must consider all relevant factors, 
including load and compound-specific characteristics in defining 
absolute worst-case conditions.
* * * * *
    (3) * * *
    (i) Periods when the stream contains the highest combined VOC and 
HAP load, in lb/hr, described by the emission profiles in paragraph 
(b)(8)(ii) of this section;
* * * * *
    (10) Wastewater testing. Wastewater analysis shall be conducted in 
accordance with paragraph (b)(10)(i), (ii), (iii), (iv), or (v) of this 
section.
    (i) Method 305. Use procedures specified in Method 305 of 40 CFR 
part 63, appendix A, and comply with

[[Page 52610]]

requirements specified in paragraph (b)(10)(vi) of this section.
    (ii) Method 624, 625, 1624, or 1625. Use procedures specified in 
Method 624, 625, 1624, or 1625 of 40 CFR part 136, appendix A, and 
comply with requirements in paragraph (b)(10)(vi) of this section.
    (iii) Method 8260 or 8270. Use procedures specified in Method 8260 
or 8270 in ``Test Methods for Evaluating Solid Waste, Physical/Chemical 
Methods,'' EPA Publication No. SW-846, Third Edition, September 1986, 
as amended by Update I, November 15, 1992. As an alternative, an owner 
or operator may use any more recent, updated version of Method 8260 or 
8270 approved by the EPA. For the purpose of using Method 8260 or 8270 
to comply with this subpart, the owner or operator must maintain a 
formal quality assurance program consistent with either Section 8 of 
Method 8260 or Method 8270, and this program must include the following 
elements related to measuring the concentrations of volatile compounds:
    (A) Documentation of site-specific procedures to minimize the loss 
of compounds due to volatilization, biodegradation, reaction, or 
sorption during the sample collection, storage, and preparation steps.
    (B) Documentation of specific quality assurance procedures followed 
during sampling, sample preparation, sample introduction, and analysis.
    (C) Measurement of the average accuracy and precision of the 
specific procedures, including field duplicates and field spiking of 
the material source before or during sampling with compounds having 
similar chemical characteristics to the target analytes.
    (iv) Other EPA methods. Use procedures specified in the method, 
validate the method using the procedures in paragraph (b)(10)(iv)(A) or 
(B) of this section, and comply with the procedures in paragraph 
(b)(10)(vi) of this section.
* * * * *
    (v) Methods other than an EPA method. Use procedures specified in 
the method, validate the method using the procedures in paragraph 
(b)(10)(iv)(A) of this section, and comply with the requirements in 
paragraph (b)(10)(vi) of this section.
* * * * *
    (c) * * *
    (1) * * * Initial compliance with the outlet concentration 
requirement of Sec. 63.1253(d) is demonstrated by fulfilling the 
requirements of paragraph (a)(5) of this section.
* * * * *
    (3) * * *
    (v) When the phrase ``the maximum true vapor pressure of the total 
organic HAP's in the stored liquid falls below the values defining 
Group 1 storage vessels specified in table 5 or table 6 of this 
subpart'' is referred to in Sec. 63.120(b)(1)(iv), the phrase ``the 
maximum true vapor pressure of the total organic HAP in the stored 
liquid falls below 13.1 kPa'' shall apply for the purposes of this 
subpart.
* * * * *
    (d) * * *
    (1) * * *
    (i) Initial compliance with Sec. 63.1254(a)(2)(i) is demonstrated 
when the actual emissions of HAP from the sum of all process vents 
within a process is less than or equal to 900 kg/yr. Initial compliance 
with Sec. 63.1254(a)(2)(ii) is demonstrated when the actual emissions 
of HAP from the sum of all process vents in compliance with 
Sec. 63.1254(a)(2)(i) is less than or equal to 1,800 kg/yr. 
Uncontrolled HAP emissions and controlled HAP emissions shall be 
determined using the procedures described in paragraphs (d)(2) and (3) 
of this section.
    (ii) Initial compliance with the percent reduction requirements in 
Sec. 63.1254(a)(1)(i), (a)(3), and (b) is demonstrated by:
    (A) Determining controlled HAP emissions using the procedures 
described in paragraph (d)(3) of this section, and uncontrolled HAP 
emissions determined using the procedures described in paragraph (d)(2) 
of this section, and demonstrating that the reductions required by 
Sec. 63.1254(a)(1)(i), (a)(3), and (b) are met; or
    (B) Controlling the process vents using a device meeting the 
criteria specified in paragraph (a)(4) of this section.
    (iii) Initial compliance with the outlet concentration requirements 
in Sec. 63.1254(a)(1)(ii)(A), (a)(3), and (b)(1) is demonstrated when 
the outlet TOC concentration is 20 ppmv or less and the outlet hydrogen 
halide and halogen concentration is 20 ppmv or less. The owner or 
operator shall demonstrate compliance by fulfilling the requirements in 
paragraph (a)(6) of this section.
* * * * *
    (2) * * *
    (i) * * *
    (C) * * *
    (1) * * *
    [GRAPHIC] [TIFF OMITTED] TR29AU00.004
    
* * * * *
Pi* = vapor pressure of each HAP in the vessel headspace at 
any temperature between the initial and final heatup temperatures, 
mmHg.
Pj* = vapor pressure of each condensable VOC (including HAP) 
in the vessel headspace at any temperature between the initial and 
final heatup temperatures, mmHg. * * *
(Pi)Tn = partial pressure of each HAP in the 
vessel headspace at initial (T1) and final (T2) 
temperature.
MWi = molecular weight of the individual HAP. * * *
* * * * *
    (4) If the vessel contents are heated to the boiling point, 
emissions must be calculated using the procedure in paragraphs 
(d)(2)(i)(C)(4)(i) and (ii) of this section.
* * * * *
    (ii) While boiling, the vessel must be operated with a properly 
operated process condenser. An initial demonstration that a process 
condenser is properly operated is required for some process condensers, 
as described in paragraph (d)(3)(iii) of this section.
    (D) * * *
    (2) * * *
xj = mole fraction of each condensable (including HAP) in 
the liquid phase.
* * * * *
    (3) The average ratio of moles of noncondensable to moles of an 
individual HAP in the emission stream is calculated using Equation 25 
of this subpart; this calculation must be

[[Page 52611]]

repeated for each HAP in the emission stream:
[GRAPHIC] [TIFF OMITTED] TR29AU00.005

Where:

nRi = average ratio of moles of noncondensable to moles of 
individual HAP.
Pnc1 = initial partial pressure of the noncondensable gas, 
as calculated using Equation 23 of this subpart.
Pnc2 = final partial pressure of the noncondensable gas, as 
calculated using Equation 24 of this subpart.
Pi* = vapor pressure of each individual HAP.
xi = mole fraction of each individual HAP in the liquid 
phase.
n = number of HAP compounds.
i = identifier for a HAP compound.

    (4) The mass of HAP emitted shall be calculated using Equation 26 
of this subpart:
[GRAPHIC] [TIFF OMITTED] TR29AU00.006

Where:

E = mass of HAP emitted.
Vnc1 = initial volume of noncondensable gas in the vessel, 
as calculated using Equation 21 of this subpart.
Vnc2 = final volume of noncondensable gas in the vessel, as 
calculated using Equation 22 of this subpart.
nRi = average ratio of moles of noncondensable to moles of 
individual HAP, as calculated using Equation 25 of this subpart.
Patm = atmospheric pressure, standard.
R = ideal gas law constant.
T = temperature of the vessel, absolute.
MWi = molecular weight of each HAP.
* * * * *
    (E) Vacuum systems. Emissions from vacuum systems may be calculated 
using Equation 33 of this subpart if the air leakage rate is known or 
can be approximated.
[GRAPHIC] [TIFF OMITTED] TR29AU00.007

Where:

E = mass of HAP emitted.
Psystem = absolute pressure of receiving vessel or ejector 
outlet conditions, if there is no receiver.
Pi = partial pressure of the HAP at the receiver temperature 
or the ejector outlet conditions.
Pj = partial pressure of condensable (including HAP) at the 
receiver temperature or the ejector outlet conditions.
La = total air leak rate in the system, mass/time
MWnc = molecular weight of noncondensable gas.
t = time of vacuum operation.
MWi = molecular weight of the individual HAP in the emission 
stream, with HAP partial pressures calculated at the temperature of the 
receiver or ejector outlet, as appropriate.
* * * * *
    (H) Empty vessel purging. Emissions from empty vessel purging shall 
be calculated using Equation 36 of this subpart (Note: The term 
e-Ft/v can be assumed to be 0): * * *
    (ii) * * * Modified versions of the engineering evaluation methods 
in paragraphs (d)(2)(i)(A) through (H) may be used if the owner or 
operator demonstrates that they have been used to meet other regulatory 
obligations, and they do not affect applicability assessments or 
compliance determinations under this subpart GGG. * * *
* * * * *
    (3) Controlled emissions. An owner or operator shall determine 
controlled emissions using the procedures in either paragraph (d)(3)(i) 
or (ii) of this section.
* * * * *
    (ii) * * *
    (A) The performance test shall be conducted by performing emission 
testing on the inlet and outlet of the control device following the 
test methods and procedures of Sec. 63.1257(b). Concentrations shall be 
calculated from the data obtained through emission testing according to 
the procedures in paragraph (a)(2) of this section.
* * * * *
    (iii) Initial compliance demonstration for condensers.
    (A) Air pollution control devices. During periods in which a 
condenser functions as an air pollution control device, controlled 
emissions shall be calculated using the emission estimation equations 
described in paragraph (d)(3)(i)(B) of this section.
    (B) Process condensers. During periods when the condenser is 
operating as a process condenser, the owner or operator is required to 
demonstrate that the process condenser is properly operated if the 
process condenser meets either of the criteria described in paragraphs 
(d)(2)(iii)(B)(1) and (2) of this section. The owner or operator must 
either measure the condenser exhaust gas temperature and show it is 
less than the boiling or bubble point of the substance(s) in the 
vessel, or perform a material balance around the vessel and condenser 
to show that at least 99

[[Page 52612]]

percent of the material vaporized while boiling is condensed. The 
initial demonstration shall be conducted for all appropriate operating 
scenarios and documented in the Notification of Compliance Status 
report described in Sec. 63.1260(f).
    (1) The process condenser is not followed by an air pollution 
control device; or
    (2) The air pollution control device following the process 
condenser is not a condenser or is not meeting the alternative standard 
of Sec. 63.1254(c).
* * * * *
    (e) * * *
    (2) * * *
    (iii) * * *
    (C) * * *
    (3) * * *

 = density of the wastewater, kg/m\3\.
* * * * *
    (D) * * *
    (3) * * *

 = density of the wastewater stream, kg/m\3\.
* * * * *
p = number of runs.
* * * * *
    (E) * * *
    (3) Destruction efficiency. The owner or operator shall comply with 
the provisions in either paragraph (e)(2)(iii)(E)(3)(i) or (ii) of this 
section. Compliance is demonstrated if the destruction efficiency, E, 
is equal to or greater than 95 percent.
* * * * *
    (G) * * *
    (3) * * *

QMWa, QMWb = mass flow rate of partially soluble 
and/or soluble HAP compounds in wastewater entering (QMWa) 
and exiting (QMWb) the treatment process, kilograms per hour 
(as calculated using Equations 44 and 45).
QMGb = mass flow rate of partially soluble and/or soluble 
HAP compounds in vented gas stream exiting the control device, kg/hr.
* * * * *
    (f) * * *
    (1) * * *
    (iii) * * *
    (B) For batch processes, the annual factor shall be calculated 
either every 10 batches for the 12-month period preceding the 10th 
batch (10-batch rolling average) or a maximum of once per month, if the 
number of batches is greater than 10 batches per month. * * *
    (2) * * *
    (ii) * * *
    (A) The mass of HAP calculated using Equation 55 of this subpart:
    [GRAPHIC] [TIFF OMITTED] TR29AU00.008
    
Where:

[kg/kg]b = the baseline production-indexed HAP consumption 
factor, in kg/kg.
Mprod = the annual production rate, in kg/yr.
M = the annual reduction required by add-on controls, in kg/yr.
PR = the fractional reduction in the annual kg/kg factor 
achieved using pollution prevention where PR is 
0.5.
* * * * *
    (h) * * *
    (3) Equations 60 and 61 of this subpart shall be used to calculate 
total HAP emissions:
[GRAPHIC] [TIFF OMITTED] TR29AU00.009

[GRAPHIC] [TIFF OMITTED] TR29AU00.010

Where:

EUi = yearly uncontrolled emissions from process i.
ECi = yearly actual emissions for process i.
ETU = total yearly uncontrolled emissions.
ETC = total yearly actual emissions.
n = number of processes included in the emissions average.
* * * * *

    10. Section 63.1258 is amended by:
    a. Revising paragraph (b)(5);
    b. Revising paragraph (b)(6)(iii);
    c. Revising the first sentence in paragraph (b)(8) introductory 
text; and
    d. Revising paragraph (c).
    The revisions read as follows:


Sec. 63.1258  Monitoring requirements.

* * * * *
    (b) * * *
    (5) Monitoring for the alternative standards. (i) For control 
devices that are used to comply with the provisions of Sec. 63.1253(d) 
or Sec. 63.1254(c), the owner or operator shall monitor and record the 
outlet TOC concentration and the outlet hydrogen halide and halogen 
concentration every 15 minutes during the period in which the device is 
functioning in achieving the HAP removal required by this subpart using 
CEMS as specified in paragraphs (b)(5)(i)(A) through (D) of this 
section.
    (A) A TOC monitor meeting the requirements of Performance 
Specification 8, 9, or 15 of appendix B of part 60 shall be installed, 
calibrated, and maintained according to Sec. 63.8. For any TOC monitor 
meeting Performance Specification 8, the owner or operator must also 
comply with Appendix F, procedure 1 of 40 CFR part 60.
    (B) Except as specified in paragraphs (b)(5)(i)(C) and (D) of this 
section, the owner or operator must monitor HCl using either a FTIR 
CEMS that meets Performance Specification 15 of appendix B of part 60 
or any other CEMS capable of measuring HCl for which a performance 
specification has been promulgated in appendix B of part 60. To monitor 
HCl with a CEMS for which a performance specification has not been 
promulgated, the owner or operator must prepare a monitoring plan and 
submit it for approval in accordance with the procedures specified in 
Sec. 63.8.
    (C) As an alternative to using a CEMS as specified in paragraph 
(b)(5)(i)(B) of this section to monitor halogenated vent streams that 
are controlled by a combustion device followed by a scrubber, the owner 
or operator may elect to monitor scrubber operating parameters as 
specified in paragraph (b)(1)(ii) of this section that demonstrate the 
HCl emissions are reduced by at least 95 percent by weight.
    (D) The owner or operator need not monitor the hydrogen halide and 
halogen concentration if, based on process knowledge, the owner or 
operator determines that the emission stream does not contain hydrogen 
halides or halogens.
    (ii) An owner or operator complying with the alternative standard 
using control devices in which supplemental gases are added to the 
vents or manifolds must either correct for supplemental gases as 
specified in Sec. 63.1257(a)(3) or comply with the requirements of 
paragraph (b)(5)(ii)(A) or (B) of this section. If the owner or 
operator corrects for supplemental gases as specified in 
Sec. 63.1257(a)(3)(ii) for noncombustion control devices, the flow 
rates must be evaluated as specified in paragraph (b)(5)(ii)(C) of this 
section.

[[Page 52613]]

    (A) Provisions for combustion devices. As an alternative to 
correcting for supplemental gases as specified in Sec. 63.1257(a)(3), 
the owner or operator may monitor residence time and firebox 
temperature according to the requirements of paragraphs 
(b)(5)(ii)(A)(1) and (2) of this section. Monitoring of residence time 
may be accomplished by monitoring flowrate into the combustion chamber.
    (1) If complying with the alternative standard instead of achieving 
a control efficiency of 95 percent or less, the owner or operator must 
maintain a minimum residence time of 0.5 seconds and a minimum 
combustion chamber temperature of 760 deg.C.
    (2) If complying with the alternative standard instead of achieving 
a control efficiency of 98 percent or less, the owner or operator must 
maintain a minimum residence time of 0.75 seconds and a minimum 
combustion chamber temperature of 816 deg.C.
    (B) Provisions for dense gas systems. As an alternative to 
correcting for supplemental gases as specified in Sec. 63.1257(a)(3), 
for noncombustion devices used to control emissions from dense gas 
systems, as defined in Sec. 63.1251, the owner or operator shall 
monitor flowrate as specified in paragraphs (b)(5)(ii)(B)(1) through 
(4) of this section.
    (1) Use Equation 63 of this subpart to calculate the system 
flowrate setpoint at which the average concentration is 5,000 ppmv TOC:
[GRAPHIC] [TIFF OMITTED] TR29AU00.011

Where:

Fs = system flowrate setpoint, scfm.
Ean = annual emissions entering the control device, lbmols/
yr.

    (2) Annual emissions used in Equation 63 of this subpart must be 
based on the actual mass of organic compounds entering the control 
device, as calculated from the most representative emissions inventory 
data submitted within the 5 years before the Notification of Compliance 
Status report is due. The owner or operator must recalculate the system 
flowrate setpoint once every 5 years using the annual emissions from 
the most representative emissions inventory data submitted during the 
5-year period after the previous calculation. Results of the initial 
calculation must be included in the Notification of Compliance Status 
report, and recalculated values must be included in the next Periodic 
report after each recalculation. For all calculations after the initial 
calculation, to use emissions inventory data calculated using 
procedures other than those specified in Sec. 63.1257(d), the owner or 
operator must submit the emissions inventory data calculations and 
rationale for their use in the Notification of Process Change report or 
an application for a part 70 permit renewal or revision.
    (3) In the Notification of Compliance Status report, the owner or 
operator may elect to establish both a maximum daily average operating 
flowrate limit above the flowrate setpoint and a reduced outlet 
concentration limit corresponding to this flowrate limit. The owner or 
operator may also establish reduced outlet concentration limits for any 
daily average flowrates between the flowrate setpoint and the flowrate 
limit. The correlation between these elevated flowrates and the 
corresponding outlet concentration limits must be established using 
Equation 64 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR29AU00.012

Where:

Ca = adjusted outlet concentration limit, dry basis, ppmv.
50 = outlet concentration limit associated with the flowrate setpoint, 
dry basis, ppmv.
Fs = system flowrate setpoint, scfm.
Fa = actual system flowrate limit, scfm.

    (4) The owner or operator must install and operate a monitoring 
system for measuring system flowrate. The flowrate into the control 
device must be monitored and recorded at least once every hour. The 
system flowrate must be calculated as the average of all values 
measured during each 24-hour operating day. The flowrate monitoring 
device must be accurate to within 5 percent of the system flowrate 
setpoint, and the flowrate monitoring device must be calibrated 
annually.
    (C) Flow rate evaluation for noncombustion devices. To demonstrate 
continuous compliance with the requirement to correct for supplemental 
gases as specified in Sec. 63.1257(a)(3)(ii) for noncombustion devices, 
the owner or operator must evaluate the volumetric flow rate of 
supplemental gases, Vs, and the volumetric flow rate of all 
gases, Va, each time a new operating scenario is implemented 
based on process knowledge and representative operating data. The 
procedures used to evaluate the flow rates, and the resulting 
correction factor used in Equation 7B of this subpart, must be included 
in the Notification of Compliance Status report and in the next 
Periodic report submitted after an operating scenario change.
    (6) * * *
    (iii) Each loss of all pilot flames for flares.
* * * * *
    (8) Violations. Exceedances of parameters monitored according to 
the provisions of paragraphs (b)(1)(ii), (iv) through (ix), and 
(b)(5)(ii)(A) and (B) of this section, or excursions as defined by 
paragraphs (b)(7)(i) through (iii) of this section, constitute 
violations of the operating limit according to paragraphs (b)(8)(i), 
(ii), and (iv) of this section. * * *
* * * * *
    (c) Monitoring for emission limits. The owner or operator of any 
affected source complying with the provisions of Sec. 63.1254(a)(2) 
shall demonstrate continuous compliance with the 900 and 1,800 kg/yr 
emission limits by calculating daily 365-day rolling summations of 
emissions. For any owner or operator opting to switch compliance 
strategy from the 93 percent control requirement to the annual mass 
emission limit method, as described in Sec. 63.1254(a)(1)(i), the 
rolling summations, beginning with the first day after the switch, must 
include emissions from the past 365 days.
* * * * *

    11. Section 63.1259 is amended by:
    a. Revising paragraph (a)(3)(i);
    b. Revising paragraph (a)(3)(iii);
    c. Revising paragraph (b)(4);
    d. Revising paragraphs (b)(5)(i) and (b)(5)(ii);
    e. Removing paragraph (b)(6), redesignating paragraphs (b)(7) 
through (b)(11) as paragraphs (b)(6) through (b)(10), and revising the 
redesignated paragraphs (b)(6) and (b)(9); and
    f. Adding paragraphs (b)(11) and (12).
    The revisions and additions read as follows:


Sec. 63.1259  Recordkeeping requirements.

    (a) * * *
    (3) * * *
    (i) The owner or operator shall record the occurrence and duration 
of each malfunction of the process operations or of air pollution 
control equipment used to comply with this subpart, as specified in 
Sec. 63.6(e)(3)(iii).
* * * * *
    (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), 
and shall record all maintenance performed on the air pollution control 
equipment, as specified in Sec. 63.10(b)(2)(iii); alternatively, the 
owner or operator

[[Page 52614]]

shall record any actions taken that are not consistent with the plan, 
as specified in Sec. 63.6(e)(3)(iv).
* * * * *
    (b) * * *
    (4) For purposes of compliance with the annual mass limits of 
Sec. 63.1254(a)(2) and (b)(2), daily records of the rolling annual 
total emissions.
    (5) * * *
    (i) For processes or process vents that are in compliance with the 
percent reduction requirements of Sec. 63.1254(a)(1), (a)(3), or (b)(1) 
and containing vents controlled to less than the percent reduction 
requirement, the following records are required:
    (A) Standard batch uncontrolled and controlled emissions for each 
process;
    (B) Actual uncontrolled and controlled emissions for each 
nonstandard batch; and
    (C) A record whether each batch operated was considered a standard 
batch.
    (ii) For processes in compliance with the annual mass limits of 
Sec. 63.1254(a)(2) or (b)(2), the following records are required:
    (A) The number of batches per year for each batch process;
    (B) The operating hours per year for continuous processes;
    (C) Standard batch uncontrolled and controlled emissions for each 
process;
    (D) Actual uncontrolled and controlled emissions for each 
nonstandard batch;
    (E) A record whether each batch operated was considered a standard 
batch.
    (6) Wastewater concentration per POD or process, except as provided 
in Sec. 63.1256(a)(1)(ii).
* * * * *
    (9) Description of worst-case operating conditions as required in 
Sec. 63.1257(b)(8).
* * * * *
    (11) If the owner or operator elects to comply with Sec. 63.1253(b) 
or (c) by installing a floating roof, the owner or operator must keep 
records of each inspection and seal gap measurement in accordance with 
Sec. 63.123(c) through (e) as applicable.
    (12) If the owner or operator elects to comply with the vapor 
balancing alternative in Sec. 63.1253(f), the owner or operator must 
keep records of the DOT certification required by Sec. 63.1253(f)(2) 
and the pressure relief vent setting and the leak detection records 
specified in Sec. 63.1253(f)(5).
* * * * *

    12. Section 63.1260 is amended by:
    a. Adding paragraphs (e)(6) and (7);
    b. Revising paragraph (g)(1)(ii);
    c. Revising paragraph (g)(2)(vii);
    d. Adding paragraph (g)(2)(viii);
    e. Adding a new sentence after the first sentence in paragraph 
(h)(1) introductory text; and
    f. Revising the reference ``Sec. 63.10(d)(4)(ii)'' to read 
``Sec. 63.10(d)(5)(ii)'' in the last sentence in paragraph (i).
    The revisions and additions read as follows:


Sec. 63.1260  Reporting requirements.

* * * * *
    (e) * * *
    (6) Data and other information supporting the determination of 
annual average concentrations by process simulation as required in 
Sec. 63.1257(e)(1)(ii).
    (7) Bench scale or pilot-scale test data and rationale used to 
determine annual average concentrations as required in 
Sec. 63.1257(e)(1)(ii)(C).
* * * * *
    (g) * * * 
    (1) * * * 
    (ii) Quarterly reports shall be submitted when the source 
experiences an exceedance of a temperature limit monitored according to 
the provisions of Sec. 63.1258(b)(1)(iii) or an exceedance of the 
outlet concentration monitored according to the provisions of 
Sec. 63.1258(b)(1)(x) or (b)(5). Once an affected source reports 
quarterly, the affected source shall follow a quarterly reporting 
format until a request to reduce reporting frequency is approved. If an 
owner or operator submits a request to reduce the frequency of 
reporting, the provisions in Sec. 63.10(e)(3)(ii) and (iii) shall 
apply, except that the phrase ``excess emissions and continuous 
monitoring system performance report and/or summary report'' shall mean 
``Periodic report'' for the purposes of this section.
* * * * *
    (2) * * *
    (vii) Each new operating scenario which has been operated since the 
time period covered by the last Periodic report. For each new operating 
scenario, the owner or operator shall provide verification that the 
operating conditions for any associated control or treatment device 
have not been exceeded, and that any required calculations and 
engineering analyses have been performed. For the initial Periodic 
report, each operating scenario for each process operated since the 
compliance date shall be submitted.
    (viii) If the owner or operator elects to comply with the 
provisions of Sec. 63.1253(b) or (c) by installing a floating roof, the 
owner or operator shall submit the information specified in 
Sec. 63.122(d) through (f) as applicable. References to Sec. 63.152 
from Sec. 63.122 shall not apply for the purposes of this subpart.
    (h) * * * 
    (1) * * *  For the purposes of this section, a process change means 
the startup of a new process, as defined in Sec. 63.1251. * * * 
* * * * *

    13. Table 1 to subpart GGG is amended by:
    a. Revising the entries ``63.5(b)(3),'' ``63.7(a)(1),'' ``63.9(a)-
(d),'' ``63.9(e),'' ``63.9(g)(1),'' ``63.9(g)(3),'' ``63.9(h),'' 
``63.9(j),'' ``63.10(a),'' ``63.10(b)(1),'' ``63.10(b)(3),'' and 
``63.10(c)-(d)(2);''
    b. Removing the entry ``63.7(a)(2)(I-ix)'' and adding the entry 
``63.7(a)(2)(i)-(ix);''
    c. Removing the entry ``63.8(b)(3)-(c)(3)'' and adding the entry 
``63.8(b)(3)-(c)(4);''
    d. Removing the entry ``63.8(c)(4-5)'' and adding the entry 
``63.8(c)(5);''
    e. Removing the entry ``63.8(c)(6-8)'' and adding the entry 
``63.8(c)(6)-(8).''
    The revisions and additions read as follows:

[[Page 52615]]



                    Table 1 to Subpart GGG.--General Provisions Applicability to Subpart GGG
----------------------------------------------------------------------------------------------------------------
                                                                  Applies to subpart
   General provisions  reference      Summary of requirements            GGG                    Comments
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *                  *                  *
                                               *
63.5(b)(3)........................  New construction/           Yes..................  Except for changes and
                                     reconstruction.                                    additions authorized
                                                                                        under Sec.  52.2454 of
                                                                                        this title. However, the
                                                                                        requirement to submit
                                                                                        the Precompliance report
                                                                                        at least 90 days before
                                                                                        the compliance date
                                                                                        still applies.
 
*                  *                  *                  *                  *                  *
                                               *
63.7(a)(1)........................  Performance testing         Yes..................  Subpart GGG also
                                     requirements.                                      specifies required
                                                                                        testing and compliance
                                                                                        procedures.
63.7(a)(2)(i)-(ix)................  ..........................  Yes..................  Except substitute ``150
                                                                                        days'' instead of ``180
                                                                                        days.''
 
*                  *                  *                  *                  *                  *
                                               *
63.8(b)(3)-(c)(4).................  CMS requirements..........  Yes..................  Sec.  63.1259 also
                                                                                        specifies recordkeeping
                                                                                        for CMS.
63.8(c)(5)........................  COMS operation              No...................
                                     requirements.
63.8 (c)(6)-(8)...................  CMS calibration and         No...................  Calibration procedures
                                     malfunction provisions.                            are provided in Sec.
                                                                                        63.1258.
 
*                  *                  *                  *                  *                  *
                                               *
63.9(a)-(d).......................  Notification requirements-- Yes..................  Sec.  63.1260 (b) also
                                     Applicability and general                          specifies initial
                                     information.                                       notification
                                                                                        requirement.
63.9(e)...........................  Notification of             Yes..................  Sec.  63.1260 (l) also
                                     performance test.                                  specifies notification
                                                                                        requirement for
                                                                                        performance test.
 
*                  *                  *                  *                  *                  *
                                               *
63.9(g)(1)........................  Additional notification     Yes..................  Sec.  63.1260 (d) also
                                     requirements for sources                           specifies notification
                                     with CMS.                                          requirement for
                                                                                        performance evaluation.
 
*                  *                  *                  *                  *                  *
                                               *
63.9(g)(3)........................  Notification that           Yes..................  Sec.  63.1260 (d) also
                                     criterion to continue use                          specifies notification
                                     of alternative to                                  requirement for
                                     relative accuracy testing                          performance evaluation.
                                     has been exceeded.
63.9(h)...........................  Notification of compliance  Yes..................  Specified in Sec.
                                     status.                                            63.1260(f). Due 150 days
                                                                                        after compliance date.
 
*                  *                  *                  *                  *                  *
                                               *
63.9(j)...........................  Change in information       No...................  Subpart GGG specifies
                                     provided.                                          procedures for
                                                                                        notification of changes.
 
*                  *                  *                  *                  *                  *
                                               *
63.10(a)..........................  Recordkeeping requirements  Yes..................
63.10(b)(1).......................  Records retention.........  Yes..................  Also stated in Sec.
                                                                                        63.1259.
 
*                  *                  *                  *                  *                  *
                                               *
63.10(b)(3).......................  Records retention for       Yes..................  Also stated in Sec.
                                     sources not subject to                             63.1259 (a)(2).
                                     relevant standard.
63.10(c)-(d)(2)...................  Other recordkeeping and     Yes..................  Also stated in Sec.
                                     reporting provisions.                              63.1259 (a)(4).
 
*                  *                  *                  *                  *                  *
                                               *
----------------------------------------------------------------------------------------------------------------


    14. Table 5 to subpart GGG is revised to read as follows:

[[Page 52616]]



 Table 5 to Subpart GGG.--Control Requirements for Items of Equipment That Meet the Criteria of Sec.  63.1252(f)
----------------------------------------------------------------------------------------------------------------
                    Item of equipment                                      Control requirement a
----------------------------------------------------------------------------------------------------------------
Drain or drain hub......................................  (a) Tightly fitting solid cover (TFSC); or
                                                          (b) TFSC with a vent to either a process or to a
                                                           control device meeting the requirements of Sec.
                                                           63.1256(h)(2); or
                                                          (c) Water seal with submerged discharge or barrier to
                                                           protect discharge from wind.
Manhole b...............................................  (a) TFSC; or
                                                          (b) TSFC with a vent to either a process or to a
                                                           control device meeting the requirements of Sec.
                                                           63.1256(h)(2); or
                                                          (c) If the item is vented to the atmosphere, use a
                                                           TFSC with a properly operating water seal at the
                                                           entrance or exit to the item to restrict ventilation
                                                           in the collection system. The vent pipe shall be at
                                                           least 90 cm in length and not exceeding 10.2 cm in
                                                           nominal inside diameter.
Lift station............................................  (a) TFSC; or
                                                          (b) TFSC with a vent to either a process or to a
                                                           control device meeting the requirements of Sec.
                                                           63.1256(h)(2); or
                                                          (c) If the lift station is vented to the atmosphere,
                                                           use a TFSC with a properly operating water seal at
                                                           the entrance or exit to the item to restrict
                                                           ventilation in the collection system. The vent pipe
                                                           shall be at least 90 cm in length and not exceeding
                                                           10.2 cm in nominal inside diameter. The lift station
                                                           shall be level controlled to minimize changes in the
                                                           liquid level.
Trench..................................................  (a) TFSC; or
                                                          (b) TFSC with a vent to either a process or to a
                                                           control device meeting the requirements of Sec.
                                                           63.1256(h)(2); or
                                                          (c) If the item is vented to the atmosphere, use a
                                                           TFSC with a properly operating water seal at the
                                                           entrance or exit to the item to restrict ventilation
                                                           in the collection system. The vent pipe shall be at
                                                           least 90 cm in length and not exceeding 10.2 cm in
                                                           nominal inside diameter.
Pipe....................................................  Each pipe shall have no visible gaps in joints, seals,
                                                           or other emission interfaces.
Oil/Water separator.....................................  (a) Equip with a fixed roof and route vapors to a
                                                           process or equip with a closed-vent system that
                                                           routes vapors to a control device meeting the
                                                           requirements of Sec.  63.1256(h)(2); or
                                                          (b) Equip with a floating roof that meets the
                                                           equipment specifications of Sec.  60.693(a)(1)(i),
                                                           (a)(1)(ii), (a)(2), (a)(3), and (a)(4).
Tank....................................................  Maintain a fixed roof and consider vents as process
                                                           vents.c
----------------------------------------------------------------------------------------------------------------
a Where a tightly fitting solid cover is required, it shall be maintained with no visible gaps or openings,
  except during periods of sampling, inspection, or maintenance.
b Manhole includes sumps and other points of access to a conveyance system.
c A fixed roof may have openings necessary for proper venting of the tank, such as pressure/vacuum vent, j-pipe
  vent.

[FR Doc. 00-21195 Filed 8-28-00; 8:45 am]
BILLING CODE 6560-50-P