[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Rules and Regulations]
[Pages 31435-31442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15616]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AD-FRL-5521-7]
RIN 2060-AC19
National Emission Standards for Hazardous Air Pollutants for
Source Categories: Organic Hazardous Air Pollutants From the Synthetic
Organic Chemical Manufacturing Industry and Other Processes Subject to
the Negotiated Regulation for Equipment Leaks; Clarifications
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule: Amendments.
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SUMMARY: On April 10, 1995, the EPA proposed amendments to certain
portions of the ``National Emission Standards for Hazardous Air
Pollutants from the Synthetic Organic Chemical Manufacturing Industry
and Other Processes Subject to the Negotiated Regulation for Equipment
Leaks'' (collectively known as the ``hazardous organic NESHAP'' or the
``HON''). This action announces the EPA's final decisions on those
proposed amendments.
The rule is being revised to remove three compounds (glycerol tri-
(polyoxypropylene)ether, polyethylene glycol, and polypropylene glycol)
from the list of chemical production processes regulated by the HON.
The production of these compounds is also included in the source
category ``Polyether Polyols Production'' and will be regulated by that
national emission standards for hazardous air pollutants (NESHAP). The
equipment leak requirements in the rule are also being revised to
clarify the intent of certain provisions, to correct oversights, and to
simplify demonstration of compliance with the regulation. These changes
are being made to ensure that the rule is implemented as intended.
EFFECTIVE DATE: June 20, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. Janet S. Meyer, Coatings and
Consumer Products Group, Emission Standards Division (MD-13), U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711, telephone number (919) 541-5254.
SUPPLEMENTARY INFORMATION:
I. Regulated Entities and Background Information
The regulated category and entities affected by this action
include:
[[Page 31436]]
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Category Examples of regulated entities
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Industry................ Synthetic organic chemical manufacturing
industry (SOCMI) units--e.g., producers of
benzene, toluene, or any other chemical
listed in Table 1 of 40 CFR Part 63, subpart
F.
Styrene-butadiene rubber producers.
Polybutadiene rubber production.
Producers of Captafol;
Captan; Chlorothalonil; Dacthal;
and TordonTM acid.
Producers of Hypalon;
Oxybisphenoxarsine/1,3-diisocyanate
(OBPA); Polycarbonates; Polysulfide
rubber; Chlorinated paraffins; and
Symmetrical tetrachloropyridine.
Pharmaceutical producers.
Producers of Methylmethacrylate-butadiene-
styrene resins (MBS); Butadiene-furfural
cotrimer; Methylmethacrylate-acrylonitrile-
butadiene-styrene (MABS) resins; and
Ethylidene norbornene.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be interested in the
revisions to the regulation affected by this action. Entities
potentially regulated by the HON are those which produce as primary
intended products any of the chemicals listed in Table 1 of 40 CFR Part
63, subpart F and are located at facilities that are major sources as
defined in Section 112 of the Clean Air Act (CAA). Processes subject to
the negotiated regulation for equipment leaks are also potentially
affected by this action. Processes subject to 40 CFR Part 63, subpart I
are producers of any of the products listed in 40 CFR Part 63, subpart
I that are located at facilities that are major sources as defined by
Section 112 of the CAA. To determine whether your facility is regulated
by this action, you should carefully examine all of the applicability
criteria in 40 CFR Sec. 63.100 and 40 CFR Sec. 63.190. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
On April 22, 1994 (59 FR 19402), and June 6, 1994 (59 FR 29196),
the EPA promulgated in the Federal Register the NESHAP for the SOCMI,
and for several other processes subject to the equipment leaks portion
of the rule. These regulations were promulgated as subparts F, G, H,
and I in 40 CFR Part 63, and are commonly referred to as the hazardous
organic NESHAP, or the HON. Since the April 22, 1994 notice, there have
been several amendments to clarify various aspects of the rule. Readers
should see the following Federal Register notices for more information:
September 20, 1994 (59 FR 48175); October 24, 1994 (59 FR 53359);
October 28, 1994 (59 FR 54131); January 27, 1995 (60 FR 5321); April
10, 1995 (60 FR 18020); April 10, 1995 (60 FR 18026); December 12, 1995
(60 FR 63624); and February 29, 1996 (61 FR 7716).
On April 10, 1995 (60 FR 18071-18078), the EPA also proposed to
remove three compounds from the list of chemical production processes
regulated by the rule as well as proposed clarifying changes and
corrections to certain provisions in subparts H and I. This action
announces the EPA's final decisions on those proposed amendments.
II. Public Comment on the April 10, 1995 Proposal
Nine comment letters were received on the April 10, 1995 notice of
proposed changes to the rule. All comment letters received were from
industry representatives, and were supportive of the proposed changes
to subparts H and I. A few comment letters also included
recommendations for further clarification of some of the proposed
amendments or expansion of compliance options. The EPA considered these
suggestions and, where appropriate, made changes to the proposed
amendments. The significant issues raised and the changes to the
proposed amendments are summarized in this preamble. A memorandum
containing the EPA's responses to all comments can be found in Docket
A-90-20, subcategory VI-B. The response to comments may also be
obtained from the EPA's Technology Transfer Network (TTN), a network of
electronic bulletin boards developed and operated by the Office of Air
Quality Planning and Standards. The service is free, except for the
cost of a phone call. Dial (919) 541-5742 for up to a 14,400 bits per
second modem. Select TTN Bulletin Board: Clean Air Act Amendments and
select menu item Recently Signed Rules. If more information on TTN is
needed, contact the systems operator at (919) 541-5384.
III. Summary of Amendments to Rule
A. Removal of Polyols From Table 1 of Subpart F
The EPA is removing three chemicals--glycerol tri-
(polyoxypropylene)ether, polyethylene glycol, and polypropylene
glycol--from the list of SOCMI chemicals, located in Table 1 of 40 CFR
Part 63, subpart F. These production processes will be addressed under
the NESHAP for the polyether polyols production source category.
B. Changes to Subpart H
1. Consolidation of Equipment Leak Programs
The EPA is amending subpart H by adding a new paragraph
Sec. 63.160(c), which will allow an owner or operator to elect to
comply with subpart H for all volatile organic compounds (VOC)
containing process equipment in the process unit in lieu of compliance
with other Federal equipment leak regulations. This option is available
for equipment subject to 40 CFR Part 60 subparts VV, GGG, or KKK, to 40
CFR Part 61 subparts F or J, or to 40 CFR Part 264 subpart BB or Part
265 subpart BB.
2. Sampling Connection Systems
Section 63.166 is amended to allow treatment of collected purge
material: (1) At permitted treatment, storage, or disposal facilities
(TSDF); (2) at solid waste treatment facilities; or (3) using waste
management units complying with Secs. 63.133 through 63.138 of subpart
G of Part 63 when the purge material contains any of the chemicals
listed in Table 9 of 40 CFR Part 63, subpart G. The final Sec. 63.166
also clarifies that if the purge material does not contain any of the
compounds listed in Table 9 of subpart G, then the owner or operator
may use any waste management unit regardless of whether the unit is in
compliance with the requirements of Secs. 63.133 through 63.138 as long
as the facility has a national pollution discharge elimination system
(NPDES) permit or sends the wastewater to a NPDES permitted facility.
The EPA is also adding to Sec. 63.161 a definition for the term
``sampling connection system.''
3. Less Frequent Monitoring of Valves in Phase III
The proposed provisions to allow use of data collected before April
22, 1994 are being added to Sec. 63.168 and Sec. 63.174. The final
amendments also
[[Page 31437]]
add a new paragraph Sec. 63.180(b)(6) that allows use of data collected
before April 22, 1994 and clarifies that this data may have minor
deviations from the requirements in Sec. 63.180 (b)(1) through (b)(5).
The conditions for allowance of data that do not meet the criteria of
Sec. 63.180 (b)(1) through (b)(5) are specified in Sec. 63.180
(b)(6)(i) and (b)(6)(ii).
4. Flow Indicators
The EPA is amending subpart H by adding a definition for ``flow
indicator'' and by revising paragraph (j)(1) of Sec. 63.172. These
revisions expand the definition of flow indicator to include reference
to devices that do not measure flow and remove the reference to the
presence of flow from the by-pass monitoring requirement.
5. Safety Issues With Sec. 63.163 and Sec. 63.167
The proposed exemptions are being added to the final rule without
change. Pumps in unsafe locations will be exempt from routine
monitoring requirements, but are required to be monitored during safe-
to-monitor periods. Pumps that are unsafe-to-monitor are pumps that are
located in an area that presents an imminent danger to personnel due to
the presence of toxic materials, explosive process conditions, or high
pressure. Open-ended lines or valves containing materials that
represented a safety or explosion hazard are exempt from the
requirement to equip the line with a cap or plug.
6. Inaccessible and Difficult-to-Monitor Agitators
Provisions are being added to subpart H to exempt inaccessible and
unsafe-to-monitor agitators from monitoring requirements and to provide
consideration for difficult-to-monitor agitators. Recordkeeping
requirements for difficult-to-monitor and unsafe-to-monitor equipment
are added to Sec. 63.181(b)(7).
7. Porcelain Connectors
Section 63.174(h)(1) is revised to refer to the more generic
terminology ``ceramic or ceramic-lined'' connectors instead of glass or
glass-lined connectors.
8. Pressure Test for Batch Process Equipment
The EPA is revising Sec. 63.180(f)(1) to allow pressurization of
equipment to less than the set pressure of any pressure relief device
or to within the safety limits of the operating equipment. The EPA is
also adding provisions to Sec. 63.180(f)(4) to allow alternative
procedures for cases where a pressure gauge with a precision of
2.5 milimeters mercury in the range of the test pressure
is not reasonably available. For those cases, the new provision in
Sec. 63.180 (f)(4) allows the use of a pressure gauge with a precision
of 10 percent of the test pressure and extends the
duration of the test for the time necessary to detect a pressure loss
(or rise) that equals a rate of one pressure per square inch gauge per
hour (psig/hr).
9. Clarification of Calibration Requirements for Instrument Monitoring
Several editorial revisions were proposed to clarify the instrument
calibration requirements specified in Secs. 63.180 (b)(2) and
(b)(4)(iii). In addition to the proposed changes, these revisions also
clarify that an owner or operator need only calibrate those instrument
scales that will be used in the monitoring.
C. Changes to Subpart I
1. Notification and Compliance Dates for Process Changes
The EPA is amending subpart I to specify procedures to establish
compliance dates for additions of equipment to units subject to subpart
I as well as to specify compliance dates for process units or equipment
affected by operational changes. These provisions are being added as
Secs. 63.190 (g)(3), (g)(4), and (j).
2. Definitions
The EPA is adding definitions for the terms ``process unit'',
``source'', and ``bench-scale batch process.'' The definition for
``pharmaceutical production process'' is revised to clarify that
solvent recovery operations and waste treatment operations are not
subject to the provisions of subpart I.
The EPA is also adding a new provision to Sec. 63.192, as paragraph
(a)(2), to allow owners or operators of pharmaceutical production
processes the option to designate all equipment in a building or
structure as a process unit or to designate all equipment at the source
as the process unit. The owner or operator may still define a process
unit as the equipment used to produce a specific set of pharmaceutical
intermediate or final products.
3. Bench-Scale Batch Process Equipment
The EPA is revising Sec. 63.190(f) of subpart I to clarify that
bench-scale batch processes are not subject to the provisions of
subparts I or H. This exemption is also being added to subpart H in
Sec. 63.160 (f).
III. Summary of Major Comments and Changes to the Proposed
Amendments
A. Consolidation of Equipment Leak Programs
One commenter suggested that the EPA allow consolidation of
equipment leak programs promulgated under the Resource Conservation and
Recovery Act (RCRA) air standards (40 CFR Part 264 subparts AA, BB, and
CC and 40 CFR Part 265 subparts AA, BB, and CC) with the equipment leak
programs required under the CAA in addition to Part 60, subparts VV,
GGG, and KKK, and Part 61 subparts F and J as proposed. The commenter
stated that at their facilities the same personnel conduct the leak
detection and repair programs, regardless of whether the program is
required by RCRA or the CAA. Consolidating those regulatory programs
would reduce the compliance burden without reducing protection of the
environment.
The EPA revised proposed Sec. 63.160 (c) to allow an owner or
operator to elect to comply with subpart H for all VOC containing
equipment in lieu of compliance with 40 CFR Part 264 subpart BB or 40
CFR Part 265 subpart BB in addition to the proposed subparts in Parts
60 and 61. The RCRA equipment leak standards were based on the
equipment leak standards developed under Sections 111 and 112 of the
CAA. The two RCRA equipment leak standards were drafted to incorporate
the provisions in 40 CFR Part 60 subpart VV. This was done to eliminate
cross-referencing and to consolidate the RCRA requirements in Parts 264
and 265. Thus, there is no substantive difference between the RCRA and
CAA equipment leak standards, and allowing compliance with subpart H
reduces burden and complexity without reducing environmental
protection.
B. Sampling Connection Systems
Two commenters suggested clarification of the proposed provisions
to expand the compliance options for sampling connection systems. One
commenter requested clarification of whether purged material had to be
sent directly to a treatment facility or if temporary storage at an
accumulation site subject to 40 CFR Part 262 would be permissible.
Another commenter was concerned that purges of certain materials would
have to be treated as if they were process wastewater, yet if these
purges were evaluated as process wastewater there would be no
requirement to control them. This
[[Page 31438]]
commenter noted that requiring control of materials not regulated in
the wastewater provisions appears to go beyond the intent of the rule.
The EPA revised the wording in Sec. 63.166 (b)(4) to clarify that
material may be stored before it is transferred to a permitted TSDF.
The EPA agrees that, as drafted, the proposed language could have been
misconstrued to forbid temporary storage of the purged material. The
EPA also agrees with the second commenter's concern that, for some
chemicals, it is not appropriate to require that the purged material be
managed in waste management units subject to the requirements in
Secs. 63.133 through 63.138. The provisions in Sec. 63.166(b)(4)(i)
were revised to clarify that purge materials that do not contain any of
the chemicals listed in Table 9 of subpart G are not required to be
managed and treated in units in compliance with Secs. 63.133 through
63.138 as long as the facility has an NPDES permit or sends the
wastewater to an NPDES permitted facility. The requirement that the
wastewater go to an NPDES permitted facility is being imposed to ensure
that this provision does not result in increased pollution in another
media and is therefore consistent with the requirement of Section
112(d)(2) that standards be set taking nonair quality effects into
account.
C. Process Unit Definition for Subpart I
One commenter expressed concerns with the proposed definition of
the term ``process unit'' as applied to pharmaceutical processes
subject to subpart I. The commenter stated that the concept of process
unit is not particularly appropriate for the pharmaceutical industry
because most pharmaceutical operations do not fit the conceptual
design. This commenter identified three areas where the concept was
unclear and presented implementation problems. The first source of
ambiguity cited by the commenter was that the term ``process unit'' is
defined as a fixed set of equipment used to manufacture a product. The
commenter noted that a flexible pharmaceutical operation may produce
numerous products in a year and that the boundaries of the process unit
could vary from week to week depending on what product is being made.
The commenter suggested that the EPA address this problem by revising
the definition of pharmaceutical process unit to be a set of equipment
that manufactures one or more pharmaceutical intermediates or final
products. The second ambiguity noted by the commenter was that
equipment in pharmaceutical production may not be connected by pipes or
ducts; materials may be transferred in closed containers. The commenter
suggested that the EPA revise the definition of process unit to include
all equipment collocated in the same building or structure, regardless
of whether the equipment is connected by pipes or ducts. The third
ambiguity cited by the commenter occurs in application of the proposed
definition of ``process unit'' to a plant site with several buildings
all served by a single solvent storage facility. The commenter
questioned whether multiple process units served by a common solvent
distribution system would be considered to be a single process unit.
The commenter requested that the EPA clarify the relationship between
the solvent distribution system and the process unit.
Since publication of the April 10, 1995 proposal, the EPA has
received additional information, through the public comment process, on
the diversity of operations and equipment used in pharmaceutical
production. Considering this information, the EPA believes that
additional options for definition of a process unit are necessary to
permit efficient management of equipment leak programs at
pharamceutical processes and to reflect actual design of facilities.
Therefore, several changes were made to the proposed provisions. First,
the definition of ``process unit'' was revised to eliminate the
reference to pipes and ducts as the means for connecting equipment.
Second, a new provision was added to Sec. 63.192 (as paragraph (a)(2))
that will allow an owner or operator of a pharmaceutical production
process several alternatives for defining a process unit for purposes
of compliance with subpart I. The new provisions allow a pharmaceutical
production process owner or operator to define the process unit as the
equipment dedicated to the production of one or more products, as all
operations located within a building or structure, or as all operations
within a source. This change does not revise any control requirements
for pharmaceutical processes. This change will provide the flexibility
necessary for development of workable equipment leak programs for
pharmaceutical processes. Third, the definition for pharmaceutical
production process was revised to clarify that the process may make one
or more pharmaceutical intermediate or final products. This additional
flexibility was limited to pharmaceutical processes because that was
the only category where the EPA has information that indicates this
flexibility is necessary.
V. Administrative Requirements
A. Paperwork Reduction Act
The information collection requirements of the previously
promulgated NESHAP were submitted to and approved by the Office of
Management and Budget (OMB). A copy of this Information Collection
Request (ICR) document (OMB control number 1414.02) may be obtained
from Sandy Farmer, Information Policy Branch (2136); U.S. Environmental
Protection Agency; 401 M Street, SW; Washington, DC 20460 or by calling
(202) 260-2740.
Today's changes to the NESHAP should have no impact on the
information collection burden estimates made previously. The changes
consist of new definitions, alternative test procedures, and
clarifications of requirements; not additional requirements.
Consequently, the ICR has not been revised.
B. Executive Order 12866 Review
Under Executive Order 12866, the EPA must determine whether the
proposed regulatory action is ``not significant'' and therefore,
subject to the OMB review and the requirements of the Executive Order.
The Order defines ``significant'' regulatory action as one that is
likely to lead to 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 in 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.
The HON rule promulgated on April 22, 1994 was considered
``significant'' under Executive Order 12866 and a regulatory impact
analysis (RIA) was prepared. The amendments issued today clarify the
rule and do not add any additional control requirements. Therefore,
this regulatory action is considered not significant.
C. Regulatory Flexibility Act
Consistent with the Regulatory Flexibility Act of 1980, EPA
considers
[[Page 31439]]
the potentially adverse impacts of its regulations upon small business
entities. Because this rulemaking imposes no adverse economic impacts,
a regulatory flexibility analysis has not been prepared.
D. Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted 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 General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
E. Unfunded Mandates
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), the EPA must prepare a budgetary impact
statement to accompany any proposed or final rule that includes a
Federal mandate that may result in estimated costs to State, local, or
tribal governments in the aggregate; or to the private sector, of $100
million or more. Under Section 205, the EPA must select the most cost-
effective and least burdensome alternative that achieves the objectives
of the rule and is consistent with statutory requirements. Section 203
requires the EPA to establish a plan for informing and advising any
small governments that may be significantly or uniquely impacted by the
rule.
The EPA has determined that the action promulgated today does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. Therefore, the requirements of the
Unfunded Mandates Act do not apply to this action.
List of Subjects in 40 CFR Part 63
Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.
Dated: June 11, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, Title 40, Chapter I, part
63, subparts F, H and I, of the Code of Federal Regulations are amended
as follows:
PART 63--[AMENDED]
1. The authority citation for Part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart F--National Emission Standards for Organic Hazardous Air
Pollutants From the Synthetic Organic Chemical Manufacturing
Industry
Table 1 of Subpart F--[Amended]
2. Table 1 of subpart F is amended by removing the entries for
``Glycerol tri-(polyoxypro-pylene)ether,'' ``Polyethylene glycol,'' and
``Polypropylene glycol'' and their associated chemical abstract service
number and group number.
Subpart H--National Emission Standards for Organic Hazardous Air
Pollutants for Equipment Leaks
3. Section 63.160 is amended by adding paragraphs (c) and (f) to
read as follows:
Sec. 63.160 Applicability and designation of source.
* * * * *
(c) If a process unit subject to the provisions of this subpart has
equipment to which this subpart does not apply, but which is subject to
a standard identified in paragraph (c)(1), (c)(2), or (c)(3) of this
section, the owner or operator may elect to apply this subpart to all
such equipment in the process unit. If the owner or operator elects
this method of compliance, all VOC in such equipment shall be
considered, for purposes of applicability and compliance with this
subpart, as if it were organic hazardous air pollutant (HAP).
Compliance with the provisions of this subpart, in the manner described
in this paragraph, shall be deemed to constitute compliance with the
standard identified in paragraph (c)(1), (c)(2), or (c)(3) of this
section.
(1) 40 CFR part 60, subpart VV, GGG, or KKK; (2) 40 CFR part 61,
subpart F or J; or (3) 40 CFR part 264, subpart BB or 40 CFR part 265,
subpart BB.
* * * * *
(f) The provisions of this subpart do not apply to research and
development facilities or to bench-scale batch processes, regardless of
whether the facilities or processes are located at the same plant site
as a process subject to the provisions of this subpart.
4. Section 63.161 is amended by adding in alphabetical order the
definitions ``bench-scale batch process,'' ``flow indicator,'' and
``sampling connection system'' to read as follows:
Sec. 63.161 Definitions.
* * * * *
Bench-scale batch process means a batch process (other than a
research and development facility) that is operated on a small scale,
such as one capable of being located on a laboratory bench top. This
bench-scale equipment will typically include reagent feed vessels, a
small reactor and associated product separator, recovery and holding
equipment. These processes are only capable of producing small
quantities of product.
* * * * *
Flow indicator means a device which indicates whether gas flow is,
or whether the valve position would allow gas flow to be, present in a
line.
* * * * *
Sampling connection system means an assembly of equipment within a
process unit used during periods of representative operation to take
samples of the process fluid. Equipment used to take non-routine grab
samples is not considered a sampling connection system.
* * * * *
5. Section 63.163 is amended by adding paragraph (j) to read as
follows:
Sec. 63.163 Standards: Pumps in light liquid service.
* * * * *
(j) Any pump that is designated, as described in
Sec. 63.181(b)(7)(i) of this subpart, as an unsafe-to-monitor pump is
exempt from the requirements of paragraphs (b) through (e) of this
section if:
(1) The owner or operator of the pump determines that the pump is
unsafe to monitor because monitoring personnel would be exposed to an
immediate danger as a consequence of complying with paragraphs (b)
through (d) of this section; and
(2) The owner or operator of the pump has a written plan that
requires monitoring of the pump as frequently as practical during safe-
to-monitor times, but not more frequently than the periodic monitoring
schedule otherwise applicable.
6. Section 63.166 is amended by revising paragraphs (a) and (b) to
read as follows:
Sec. 63.166 Standards: Sampling connection systems.
(a) Each sampling connection system shall be equipped with a
closed-purge, closed-loop, or closed-vent system, except as provided in
Sec. 63.162(b) of this subpart. Gases displaced during filling of the
sample container are not required to be collected or captured.
[[Page 31440]]
(b) Each closed-purge, closed-loop, or closed-vent system as
required in paragraph (a) of this section shall:
(1) Return the purged process fluid directly to the process line;
or
(2) Collect and recycle the purged process fluid to a process; or
(3) Be designed and operated to capture and transport the purged
process fluid to a control device that complies with the requirements
of Sec. 63.172 of this subpart; or
(4) Collect, store, and transport the purged process fluid to a
system or facility identified in paragraph (b)(4)(i), (ii), or (iii) of
this section.
(i) A waste management unit as defined in Sec. 63.111 of subpart G
of this part, if the waste management unit is subject to, and operated
in compliance with the provisions of subpart G of this part applicable
to group 1 wastewater streams. If the purged process fluid does not
contain any organic HAP listed in Table 9 of subpart G of part 63, the
waste management unit need not be subject to, and operated in
compliance with the requirements of 40 CFR part 63, subpart G
applicable to group 1 wastewater streams provided the facility has an
NPDES permit or sends the wastewater to an NPDES permitted facility.
(ii) A treatment, storage, or disposal facility subject to
regulation under 40 CFR part 262, 264, 265, or 266; or
(iii) A facility permitted, licensed, or registered by a State to
manage municipal or industrial solid waste, if the process fluids are
not hazardous waste as defined in 40 CFR part 261.
* * * * *
7. Section 63.167 is amended by revising paragraph (a)(1) and by
adding paragraph (e) to read as follows:
Sec. 63.167 Standards: Open-ended valves or lines.
(a)(1) Each open-ended valve or line shall be equipped with a cap,
blind flange, plug, or a second valve, except as provided in
Sec. 63.162(b) of this subpart and paragraphs (d) and (e) of this
section.
* * * * *
(e) Open-ended valves or lines containing materials which would
autocatalytically polymerize or, would present an explosion, serious
overpressure, or other safety hazard if capped or equipped with a
double block and bleed system as specified in paragraphs (a) through
(c) of this section are exempt from the requirements of paragraph (a)
through (c) of this section.
8. Section 63.168 is amended by adding a new paragraph (a)(3) to
read as follows:
Sec. 63.168 Standards: Valves in gas/vapor service and in light liquid
service.
(a) * * *
(3) The use of monitoring data generated before April 22, 1994 to
qualify for less frequent monitoring is governed by the provisions of
Sec. 63.180(b)(6) of this subpart.
* * * * *
9. Section 63.172 is amended by revising the first sentence of
paragraph (j)(1) to read as follows:
Sec. 63.172 Standards: Closed-vent systems and control devices.
* * * * *
(j) * * *
(1) Install, set or adjust, maintain, and operate a flow indicator
that takes a reading at least once every 15 minutes. * * *
* * * * *
10. Section 63.173 is amended by adding paragraphs (h), (i) and (j)
to read as follows:
Sec. 63.173 Standards: Agitators in gas/vapor service and in light
liquid service.
* * * * *
(h) Any agitator that is difficult-to-monitor is exempt from the
requirements of paragraphs (a) through (d) of this section if:
(1) The owner or operator determines that the agitator cannot be
monitored without elevating the monitoring personnel more than two
meters above a support surface or it is not accessible at anytime in a
safe manner;
(2) The process unit within which the agitator is located is an
existing source or the owner or operator designates less than three
percent of the total number of agitators in a new source as difficult-
to-monitor; and
(3) The owner or operator follows a written plan that requires
monitoring of the agitator at least once per calendar year.
(i) Any agitator that is obstructed by equipment or piping that
prevents access to the agitator by a monitor probe is exempt from the
monitoring requirements of paragraphs (a) through (d) of this section.
(j) Any agitator that is designated, as described in
Sec. 63.181(b)(7)(i) of this subpart, as an unsafe-to-monitor agitator
is exempt from the requirements of paragraphs (b) through (d) of this
section if:
(1) The owner or operator of the agitator determines that the
agitator is unsafe to monitor because monitoring personnel would be
exposed to an immediate danger as a consequence of complying with
paragraphs (a) through (d) of this section; and
(2) The owner or operator of the agitator has a written plan that
requires monitoring of the agitator as frequently as practical during
safe-to-monitor times, but not more frequently than the periodic
monitoring schedule otherwise applicable.
11. Section 63.174 is revised by adding a new paragraph (b)(4) and
by revising the first sentence of paragraph (h)(1) introductory text to
read as follows:
Sec. 63.174 Standards: Connectors in gas/vapor service and in light
liquid service.
* * * * *
(b) * * *
(4) The use of monitoring data generated before April 22, 1994 to
qualify for less frequent monitoring is governed by the provisions of
Sec. 63.180(b)(6).
* * * * *
(h)(1) Any connector that is inaccessible or is ceramic or ceramic-
lined (e.g., porcelain, glass, or glass-lined), is exempt from the
monitoring requirements of paragraphs (a) and (c) of this section and
from the recordkeeping and reporting requirements of Sec. 63.181 and
Sec. 63.182 of this subpart. * * *
* * * * *
12. Section 63.180 is amended by redesignating paragraph (b)(2) as
(b)(2)(i) and revising the first sentence of newly designated paragraph
(b)(2)(i), by adding a paragraph (b)(2)(ii), by revising paragraph
(b)(4)(iii), by revising paragraph (b)(6), by revising paragraph
(f)(1), and by adding a sentence to the end of paragraph (f)(4) to read
as follows:
Sec. 63.180 Test methods and procedures.
* * * * *
(b) * * *
(2)(i) Except as provided for in paragraph (b)(2)(ii) of this
section, the detection instrument shall meet the performance criteria
of Method 21 of 40 CFR part 60, appendix A, except the instrument
response factor criteria in Section 3.1.2(a) of Method 21 shall be for
the average composition of the process fluid not each individual VOC in
the stream. * * *
(ii) If no instrument is available at the plant site that will meet
the performance criteria specified in paragraph (b)(2)(i) of this
section, the instrument readings may be adjusted by multiplying by the
average response factor of the process fluid, calculated on an inert-
free basis as described in paragraph (b)(2)(i) of this section.
* * * * *
(4) * * *
(iii) The instrument may be calibrated at a higher methane
concentration than the concentration specified for that piece of
equipment. The concentration
[[Page 31441]]
of the calibration gas may exceed the concentration specified as a leak
by no more than 2,000 parts per million. If the monitoring instrument's
design allows for multiple calibration scales, then the lower scale
shall be calibrated with a calibration gas that is no higher than 2,000
parts per million above the concentration specified as a leak and the
highest scale shall be calibrated with a calibration gas that is
approximately equal to 10,000 parts per million. If only one scale on
an instrument will be used during monitoring, the owner or operator
need not calibrate the scales that will not be used during that day's
monitoring.
* * * * *
(6) Monitoring data that do not meet the criteria specified in
paragraphs (b)(1) through (b)(5) of this section may be used to qualify
for less frequent monitoring under the provisions in Sec. 63.168(d)(2)
and (d)(3) or Sec. 63.174(b)(3)(ii) or (b)(3)(iii) of this subpart
provided the data meet the conditions specified in paragraphs (b)(6)(i)
and (b)(6)(ii) of this section.
(i) The data were obtained before April 22, 1994.
(ii) The departures from the criteria specified in paragraphs
(b)(1) through (b)(5) of this section or from the specified monitoring
frequency of Sec. 63.168(c) are minor and do not significantly affect
the quality of the data. Examples of minor departures are monitoring at
a slightly different frequency (such as every six weeks instead of
monthly or quarterly), following the performance criteria of section
3.1.2(a) of Method 21 of appendix A of 40 CFR part 60 instead of
paragraph (b)(2) of this section, or monitoring at a different leak
definition if the data would indicate the presence or absence of a leak
at the concentration specified in this subpart. Failure to use a
calibrated instrument is not considered a minor departure.
* * * * *
(f) * * *
(1) The batch product-process equipment train shall be pressurized
with a gas to a pressure less than the set pressure of any safety
relief devices or valves or to a pressure slightly above the operating
pressure of the equipment, or alternatively, the equipment shall be
placed under a vacuum.
* * * * *
(4) * * * If such a pressure measurement device is not reasonably
available, the owner or operator shall use a pressure measurement
device with a precision of at least +10 percent of the test pressure of
the equipment and shall extend the duration of the test for the time
necessary to detect a pressure loss or rise that equals a rate of one
psig per hour.
* * * * *
13. Section 63.181 is amended by revising the introductory text in
paragraph (b)(7) and by revising paragraph (b)(7)(ii) to read as
follows:
Sec. 63.181 Recordkeeping requirements.
* * * * *
(b) * * *
(7) The following information pertaining to all pumps subject to
the provisions of Sec. 63.163(j), valves subject to the provisions of
Sec. 63.168(h) and (i) of this subpart, agitators subject to the
provisions of Sec. 63.173(h) through (j), and connectors subject to the
provisions of Sec. 63.174(f) through (h) of this subpart shall be
recorded:
* * * * *
(ii) A list of identification numbers for the equipment that is
designated as difficult to monitor, an explanation of why the equipment
is difficult to monitor, and the planned schedule for monitoring this
equipment.
* * * * *
Subpart I--National Emission Standards for Organic Hazardous Air
Pollutants for Certain Processes Subject to the Negotiated
Regulation for Equipment Leaks
14. Section 63.190 is amended by revising paragraph (f), paragraphs
(g)(1) introductory text and (g)(2) introductory text, by adding
paragraphs (g)(3) and (g)(4), and by adding a new paragraph (j) to read
as follows:
Sec. 63.190 Applicability and designation of source.
* * * * *
(f) The provisions of subparts I and H of this part do not apply to
research and development facilities or to bench-scale batch processes,
regardless of whether the facilities or processes are located at the
same plant site as a process subject to the provisions of subpart I and
H of this part.
(g)(1) If an additional process unit specified in paragraph (b) of
this section is added to a plant site that is a major source as defined
in Section 112(a) of the CAA, the addition shall be subject to the
requirements for a new source in subparts H and I of this part if:
* * * * *
(2) If any change is made to a process subject to this subpart, the
change shall be subject to the requirements for a new source in
subparts H and I of this part if:
* * * * *
(3) If an additional process unit is added to a plant site or a
change is made to a process unit and the addition or change is
determined to be subject to the new source requirements according to
paragraphs (g)(1) or (g)(2) of this section:
(i) The new or reconstructed source shall be in compliance with the
new source requirements of subparts H and I of this part upon initial
start-up of the new or reconstructed source or by April 22, 1994,
whichever is later; and
(ii) The owner or operator of the new or reconstructed source shall
comply with the reporting and recordkeeping requirements in subparts H
and I of this part that are applicable to new sources. The applicable
reports include, but are not limited to:
(A) Reports required by Sec. 63.182(b), if not previously
submitted, Sec. 63.182 (c) and (d) of subpart H of this part; and
(B) Reports and notifications required by sections of subpart A of
this part that are applicable to subparts H and I of this part, as
identified in Sec. 63.192(a) of this subpart.
(4) If an additional process unit is added to a plant site, if a
surge control vessel or bottoms receiver becomes subject to Sec. 63.170
of subpart H, or if a compressor becomes subject to Sec. 63.164 of
subpart H, and if the addition or change is not subject to the new
source requirements as determined according to paragraphs (g)(1) or
(g)(2) of this section, the requirements in paragraphs (g)(4)(i)
through (g)(4)(iii) of this section shall apply. Examples of process
changes include, but are not limited to, changes in production
capacity, feedstock type, or catalyst type, or whenever there is
replacement, removal, or addition of recovery equipment. For purposes
of this paragraph, process changes do not include: process upsets,
unintentional temporary process changes, and changes that are within
the equipment configuration and operating conditions documented in the
Notification of Compliance Status required by Sec. 63.182(c) of subpart
H of this part.
(i) The added emission point(s) and any emission point(s) within
the added or changed process unit are subject to the requirements of
subparts H and I of this part for an existing source;
(ii) The added emission point(s) and any emission point(s) within
the added or changed process unit shall be in compliance with subparts
H and I of this part by the dates specified in paragraphs (g)(4)(ii)(A)
or (g)(4)(ii)(B) of this section, as applicable.
(A) If a process unit is added to a plant site or an emission
point(s) is added to an existing process unit, the
[[Page 31442]]
added process unit or emission point(s) shall be in compliance upon
initial start-up of the added process unit or emission point(s) or by
April 22, 1997, whichever is later.
(B) If a surge control vessel or bottoms receiver becomes subject
to Sec. 63.170 of subpart H, if a compressor becomes subject to
Sec. 63.164 of subpart H, or if a deliberate operational process change
causes equipment to become subject to subpart H of this part, the owner
or operator shall be in compliance upon initial start-up or by April
22, 1997, whichever is later, unless the owner or operator demonstrates
to the Administrator that achieving compliance will take longer than
making the change. The owner or operator shall submit to the
Administrator for approval a compliance schedule, along with a
justification for the schedule. The Administrator shall approve the
compliance schedule or request changes within 120 calendar days of
receipt of the compliance schedule and justification.
(iii) The owner or operator of a process unit or emission point
that is added to a plant site and is subject to the requirements for
existing sources shall comply with the reporting and recordkeeping
requirements of subparts H and I of this part that are applicable to
existing sources, including, but not limited to, the reports listed in
paragraphs (g)(4)(iii)(A) and (g)(4)(iii)(B) of this section.
(A) Reports required by Sec. 63.182 of subpart H of this part; and
(B) Reports and notifications required by sections of subpart A of
this part that are applicable to subparts H and I of this part, as
identified in Sec. 63.192(a) of this subpart.
* * * * *
(j) If a change that does not meet the criteria in paragraph (g)(4)
of this section is made to a process unit subject to subparts H and I
of this part, and the change causes equipment to become subject to the
provisions of subpart H of this part, then the owner or operator shall
comply with the requirements of subpart H of this part for the
equipment as expeditiously as practical, but in no event later than
three years after the equipment becomes subject.
(1) The owner or operator shall submit to the Administrator for
approval a compliance schedule, along with a justification for the
schedule.
(2) The Administrator shall approve the compliance schedule or
request changes within 120 calendar days of receipt of the compliance
schedule and justification.
15. Section 63.191(b) is amended by adding in alphabetical order
definitions for ``bench-scale batch process,'' ``process unit,'' and
``source'' to paragraph (b) and revising the definition of
``pharmaceutical production process'' to read as follows:
Sec. 63.191 Definitions.
(b) * * *
Bench-scale batch process means a batch process (other than a
research and development facility) that is operated on a small scale,
such as one capable of being located on a laboratory bench top. This
bench-scale equipment will typically include reagent feed vessels, a
small reactor and associated product separator, recovery and holding
equipment. These processes are only capable of producing small
quantities of product.
* * * * *
Pharmaceutical production process means a process that synthesizes
one or more pharmaceutical intermediate or final products using carbon
tetrachloride or methylene chloride as a reactant or process solvent.
Pharmaceutical production process does not mean process operations
involving formulation activities, such as tablet coating or spray
coating of drug particles, or solvent recovery or waste management
operations.
* * * * *
Process Unit means the group of equipment items used to process raw
materials and to manufacture a product. For the purposes of this
subpart, process unit includes all unit operations and associated
equipment (e.g., reactors and associated product separators and
recovery devices), associated unit operations (e.g., extraction
columns), any feed and product storage vessels, and any transfer racks
for distribution of final product.
* * * * *
Source means the collection of equipment listed in Sec. 63.190(d)
to which this subpart applies as determined by the criteria in
Sec. 63.190. For purposes of subparts H and I of this part, the term
affected source as used in subpart A of this part has the same meaning
as the term source defined here.
* * * * *
16. Section 63.192 is amended by redesignating paragraph (a) as
(a)(1) and by adding paragraph (a)(2) to read as follows:
Sec. 63.192 Standard.
(a)(1) * * *
(2) The owner or operator of a pharmaceutical production process
subject to this subpart may define a process unit as a set of
operations, within a source, producing a product, as all operations
collocated within a building or structure or as all affected operations
at the source.
* * * * *
[FR Doc. 96-15616 Filed 6-19-96; 8:45 am]
BILLING CODE 6560-50-P
