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

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.

-----------------------------------------------------------------------

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;

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