Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 31435

come and go as early or late as they

desire, with minimal delays. The

purpose of the proposed change is to

establish a schedule that balances the

reasonable needs of waterway and

vehicular traffic. The Coast Guard

believes this schedule will help

alleviate seasonal highway traffic

congestion on weekends and holidays at

this bridge without placing any undue

hardship on waterway users since the

change is minimal.

This final rule adopts the changes

proposed in the NPRM. It extends the

hourly opening of the drawbridge from

7 p.m. to 9 p.m. on Saturdays, Sundays,

and Federal holidays from June 1 to

September 30. The draw will continue

to open on signal for commercial

vessels. It will also continue to open on

signal for passage of vessels in

emergencies involving danger to life or

property. The Coast Guard believes this

final rule will not unduly restrict

navigation by pleasure vessels, which

may plan their transits to coincide with

scheduled hourly openings.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(1)(3) of

that order. It has been exempted from

review by the Office of Management and

Budget under that order. It is not

significant under the regulatory policies

and procedures of the Department of

Transportation (DOT) (44 FR 11040;

February 26, 1979). The Coast Guard

expects the economic impact of this rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this final rule

will have a significant economic impact

on a substantial number of small

entities. ‘‘Small entities’’ include

independently owned and operated

small businesses that are not dominant

in their field and that otherwise qualify

as ‘‘small business concerns’’ under

section 3 of the Small Business Act (15

U.S.C. 632). Because it expects the

impact of this rule to be minimal, the

Coast Guard certifies under 5 U.S.C.

605(b) that this rule will not have a

significant economic impact on a

substantial number of small entities.

Collection of Information

This rule contains no collection of

information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism Assessment

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612,

and it has been determined that this rule

will not have sufficient federalism

implications to warrant preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that under section

2.B.2.e.(32)(e) of Commandant

Instruction M16475.1B (as amended, 59

FR 38654, July 29, 1994), this rule is

categorically excluded from further

environmental documentation.

List of Subjects in 33 CFR Part 117

Bridges.

Regulations

In consideration of the foregoing, the

Coast Guard is amending part 117 of

title 33, Code of Federal Regulations, as

follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. In § 117.821, paragraph (b)(6) is

revised to read as follows:

§ 117.821 Atlantic Intracoastal Waterway,

Albemarle Sound to Sunset Beach.

* * * * *

(b) * * *

(6) S.R. 1172 bridge, mile 337.9, at

Sunset Beach, NC, shall open on the

hour on signal between 7 a.m. and 7

p.m., April 1 through November 30,

except that on Saturdays, Sundays and

Federal holidays, from June 1 through

September 30, the bridge shall open on

signal on the hour between 7 a.m. and

9 p.m.

* * * * *

Dated: May 15, 1996.

W.J. Ecker,

Rear Admiral, U.S. Coast Guard, Commander,

Fifth Coast Guard District.

[FR Doc. 96–15680 Filed 6–19–96; 8:45 am]

BILLING CODE 4910–14–M

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:
31436 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations

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-acrylonitrilebutadiene-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

§ 63.100 and 40 CFR § 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 § 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 §§ 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 § 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 §§ 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

§ 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 § 63.168 and

§ 63.174. The final amendments also
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 31437

add a new paragraph § 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 § 63.180 (b)(1) through

(b)(5). The conditions for allowance of

data that do not meet the criteria of

§ 63.180 (b)(1) through (b)(5) are

specified in § 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

§ 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 § 63.163 and

§ 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-tomonitor 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. Openended 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-tomonitor agitators from monitoring

requirements and to provide

consideration for difficult-to-monitor

agitators. Recordkeeping requirements

for difficult-to-monitor and unsafe-tomonitor equipment are added to

§ 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 § 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

§ 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

§ 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

§§ 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 §§ 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 § 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 § 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 § 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 § 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 crossreferencing 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
31438 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations

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

§ 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 §§ 63.133

through 63.138. The provisions in

§ 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 §§ 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 § 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
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 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:

§ 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:

§ 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:

§ 63.163 Standards: Pumps in light liquid

service.

* * * * *

(j) Any pump that is designated, as

described in § 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:

§ 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 § 63.162(b) of this

subpart. Gases displaced during filling

of the sample container are not required

to be collected or captured.
31440 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations

(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

§ 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 § 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:

§ 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 § 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:

§ 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

§ 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:

§ 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:

§ 63.173 Standards: Agitators in gas/vapor

service and in light liquid service.

* * * * *

(h) Any agitator that is difficult-tomonitor 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 difficultto-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 § 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:

§ 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

§ 63.180(b)(6).

* * * * *

(h)(1) Any connector that is

inaccessible or is ceramic or ceramiclined (e.g., porcelain, glass, or glasslined), is exempt from the monitoring

requirements of paragraphs (a) and (c) of

this section and from the recordkeeping

and reporting requirements of § 63.181

and § 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:

§ 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
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 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

§ 63.168(d)(2) and (d)(3) or

§ 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

§ 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:

§ 63.181 Recordkeeping requirements.

* * * * *

(b) * * *

(7) The following information

pertaining to all pumps subject to the

provisions of § 63.163(j), valves subject

to the provisions of § 63.168(h) and (i)

of this subpart, agitators subject to the

provisions of § 63.173(h) through (j),

and connectors subject to the provisions

of § 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:

§ 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 § 63.182(b), if

not previously submitted, § 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 § 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 § 63.170 of subpart H, or if a

compressor becomes subject to § 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 § 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
31442 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations

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 § 63.170 of

subpart H, if a compressor becomes

subject to § 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 § 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 § 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:

§ 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 § 63.190(d) to which

this subpart applies as determined by

the criteria in § 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:

§ 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

40 CFR Part 70

[AD–FRL–5522–9]

Clean Air Act Final Interim Approval of

Operating Permits Program;

Delegation of Section 112 Standards;

State of Massachusetts; Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final interim approval;

Correction.

SUMMARY: On May 15, 1996 (61 FR

24460), EPA promulgated interim

approval of the 40 CFR Part 70

Operating Permits Program for the

Commonwealth of Massachusetts. The

document correctly identified the

effective date as May 15, 1996.

However, the language to amend 40 CFR

Part 70 listed an incorrect effective date

and an incorrect expiration date for the

interim approval of this program.

EFFECTIVE DATE: May 15, 1996.

FOR FURTHER INFORMATION CONTACT: Ida

E. Gagnon, Air Permits Program, CAP,

U.S. Environmental Protection Agency,

Region 1, JFK Federal Building, Boston,

MA 02203–2211, (617) 565–3500.

SUPPLEMENTARY INFORMATION: In the

document published on May 15, 1996 at

61 FR 24461, column 3, the effective

date and expiration date were incorrect.

This final rule corrects the language to

amend 40 CFR Part 70 in a manner

which is consistent with the May 15,

1996 rule. The correct effective date of

this interim approval is May 15, 1996,

and the correct expiration date of this

interim approval is May 15, 1998.

The EPA regrets any inconvenience

the earlier information has caused.

List of Subjects in 40 CFR Part 70

Administrative practice and

procedure, Air pollution control,

Environmental Protection,

Intergovernmental relations, Operating

permits, Reporting and recordkeeping

requirements.

Dated: May 30, 1996.

John P. DeVillars,

Regional Administrator, Region I.

Part 70, title 40 of the Code of Federal

Regulations is amended as follows: