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:
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 31443

PART 70—[AMENDED]

1. The authority citation for part 70

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

2. Appendix A to part 70 is amended

by revising the entry for Massachusetts

to read as follows:

Appendix A to Part 70—Approval Status of

State and Local Operating Permits Programs

* * * * *

Massachusetts

(a) Department of Environmental

Protection: submitted on April 28, 1995;

interim approval effective on May 15, 1996;

interim approval expires May 15, 1998.

(b) (Reserved).

* * * * *

[FR Doc. 96–15621 Filed 6–19–96; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 70

[FRL–5521–4]

RIN 2060–AF70

Operating Permits Program Interim

Approval Criteria

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is promulgating

revisions to the interim approval criteria

within the regulations in part 70,

chapter I, title 40, of the Code of Federal

Regulations (CFR). Part 70 contains

regulations requiring States to develop,

and submit to EPA for approval,

programs for issuing operating permits

to major, and certain other, stationary

sources of air pollution as required by

title V of the Clean Air Act (Act). Two

changes to the interim approval criteria

were proposed on August 29, 1994 to

address difficulties in program

development that have occurred since

promulgation of part 70. Today’s action

finalizes one of those changes; the other

will be finalized in a subsequent action.

As a result of today’s revision to part

70, certain State operating permit

programs will become eligible for

interim program approval. Without

today’s changes, these programs would

not have been eligible for interim

program approval under the part 70

regulations. Specifically, interim

approval may now be granted for

programs which do not provide for the

incorporation of terms contained in

permits issued under EPA-approved

minor source preconstruction permit

programs into corresponding part 70

permits.

To be eligible for this interim

approval, such programs would have to

show compelling reasons for the interim

approval and meet certain other

requirements regarding the content of

part 70 permits that exclude these

applicable preconstruction permit terms

during the 2-year interim period. After

2 years, interim approval expires and

the State must have revised its program

to address the exclusion of these terms,

and any other deficiencies, in order to

receive full approval.

EFFECTIVE DATE: July 22, 1996.

FOR FURTHER INFORMATION CONTACT:

Michael Ling (telephone number 919–

541–4729), U. S. Environmental

Protection Agency, Office of Air Quality

Planning and Standards, Information

Transfer and Program Integration

Division, Mail Drop 12, Research

Triangle Park, North Carolina 27711.

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by this

action are those State, local, or tribal

governments who seek approval of their

part 70 operating permit programs, but

whose programs do not include minor

preconstruction permit terms in their

part 70 permits. Regulated categories

include:

Category Examples of regulated entities

State/Local/Tribal

Government.

Governments who

have developed

operating permit

programs that exclude minor NSR

terms from title V

permits and who

seek EPA approval

of such programs

under the part 70

regulations.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. This table lists

the types of entities that EPA is now

aware could potentially be affected by

this action. 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.

Docket

Supporting information used in

developing the part 70 rules, including

today’s promulgated change, is

contained in docket number A–93–50.

This docket is available for public

inspection and copying between 8:30

a.m. and 3:30 p.m. Monday through

Friday, at EPA’s Air Docket, Room M–

1500, Waterside Mall, 401 M Street SW,

Washington, D.C. 20460. A reasonable

fee may be charged for copying.

I. Background and Purpose

A. Introduction

Title V of the Clean Air Act

Amendments of 1990 (1990

Amendments), Public Law 101–549,

requires EPA to promulgate regulations

establishing the requirements for

development and submittal of State

operating permit programs and the

minimum elements these programs

must contain to be approvable. On July

21, 1992, EPA published regulations

meeting these requirements in the

Federal Register (57 FR 32250).

Title V and the part 70 regulations

require States and local agencies to

submit operating permit programs to

EPA within 3 years of enactment of the

1990 Amendments, and require EPA to

take action within 1 year of program

submittal to approve or disapprove

these programs. Section 502(g) of the

Act allows EPA to grant interim

approval to a program if it

‘‘substantially meets’’ the requirements

of title V but is not fully approvable.

Interim approval may be granted for a

period of up to 2 years and may not be

renewed. The interim approval

provision allows permitting authorities

time to correct the program deficiencies

preventing full approval. The minimum

elements that a program must contain to

be eligible for interim approval are

contained in § 70.4(d).

The EPA proposed two changes to the

interim approval criteria on August 29,

1994 (59 FR 44571). The first change

would allow interim approval for part

70 programs which allow permits to be

revised through the minor permit

modification procedure to reflect those

changes at a facility which is subject to

EPA-approved minor source

preconstruction permit requirements,

commonly referred to as ‘‘minor new

source review’’ (minor NSR) changes.

Because this proposal is linked to

proposed changes to the permit revision

system, which EPA is not yet ready to

finalize, and because current EPA policy

already allows for approval of programs

which allow changes established

through minor NSR to be addressed

using minor permit modification

procedures, EPA is not taking final

action on this proposed change in

today’s rulemaking.

The second proposed change to the

interim approval criteria addresses

programs that do not incorporate terms

and conditions into a source’s part 70

permit which are established through an

EPA-approved minor NSR program.