National Emission Standards for Hazardous Air Pollutants for
[Federal Register: June 20, 1996 (Volume 61, Number 120)]
[Rules and Regulations]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
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.
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
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.
I. Regulated Entities and Background Information
The regulated category and entities affected by this action include:
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
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 safeto -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
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
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
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
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
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 costeffective
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
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,
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:
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.
(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.
(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;
(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.
(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
(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.
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
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.
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.
(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.
(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.