[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
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Industry............................. 325411 and 325412.................. 2833 and 2834...................... Producers of finished dosage
forms of drugs (e.g., tablets,
capsules, and solutions), active
ingredients, or precursors.
Typically 325199................... Typically 2869..................... Producers of material whose
primary use is as an active ingredient
or precursor.
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This table is not intended to be exhaustive, but rather provides a
guide for readers likely to be interested in the revisions to the
regulation affected by this action. To determine whether your facility,
company, business, organization, etc., is regulated by this action, you
should carefully examine all of the applicability criteria in
Sec. 63.1250 of the 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
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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