[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]]



------------------------------------------------------------------------
        Category                  Examples of regulated entities        
------------------------------------------------------------------------
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<Register>;              
                           Captan<Register>; Chlorothalonil; Dacthal;   
                           and Tordon<SUP>TM acid.                           
                          Producers of Hypalon<Register>;               
                           Oxybisphenoxarsine/1,3-diisocyanate          
                           (OBPA<Register>); 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 
<plus-minus> 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 <plus-minus> 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