4360 Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 /Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–5953–6]

RIN 2060–AG48

Protection of Stratospheric Ozone:

Allocation of 1998 Essential Use

Allowances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Interim final rule.

SUMMARY: With this action, EPA

allocates essential-use allowances for

the 1998 control period. The United

States nominated specific uses of ozonedepleting substances (ODS) as essential

uses for 1998 under the Montreal

Protocol on Substances that Deplete the

Ozone Layer (Protocol). The Parties to

the Protocol subsequently approved

production and import of ODS for the

uses nominated by the United States in

the quantities specified. In today’s

action, EPA allocates essential use

allowances based on the quantities

approved by the Parties for the

nominated uses. Essential use

allowances permit a person to obtain

controlled ozone-depleting substances

as an exemption to the January 1, 1996

regulatory phaseout of production and

import. Essential use allowances are

allocated to a person for exempted

production or importation of a specific

quantity of a controlled substance solely

for the designated essential purpose.

DATES: This action is effective January

28, 1998. EPA will consider all written

comments received by February 27,

1998, to determine if any change to this

action is necessary.

ADDRESSES: Comments on and materials

supporting this interim final rule are

collected in Air Docket No. A–92–13,

U.S. Environmental Protection Agency,

401 M Street, SW., Room M–1500,

Washington, DC 20460. The Docket is

located in room M–1500, First Floor,

Waterside Mall at the address above.

The materials may be inspected from 8

am until 4 pm Monday through Friday.

A reasonable fee may be charged by EPA

for copying docket materials. Those

wishing to notify EPA of their intent to

submit adverse comments on this action

should contact Tom Land, EPA,

Stratospheric Protection Division, Office

of Atmospheric Programs, Office of Air

and Radiation (6205–J), 401 M Street,

SW., Washington, DC 20460, (Docket #

A–92–13), (202)–564–9185.

FOR FURTHER INFORMATION CONTACT: Tom

Land, EPA, Stratospheric Protection

Division, Office of Atmospheric

Programs, Office of Air and Radiation

(6205–J), 401 M Street, SW.,

Washington, DC 20460, (202)–564–9185

or The Stratospheric Ozone Hotline at

(800)–296–1996.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Allocation of 1998 Essential use

Allowances

III. Additional Changes in the Essential use

Process to be Published in Subsequent

Proposed Rulemaking

IV. Summary of Supporting Analysis

A. Unfunded Mandates Reform Act and

Regulatory Flexibility Act

B. Executive Order 12866

C. Paperwork Reduction Act

D. Executive Order 12875

E. Submission to Congress and the General

Accounting Office

I. Background

The Montreal Protocol on Substances

that Deplete the Ozone Layer (Protocol)

sets specific deadlines for the phaseout

of production and importation of ozone

depleting substances (ODS). At their

Fourth Meeting in 1992, the signatories

to the Protocol (the Parties) amended

the Protocol to allow exemptions to the

phaseout for uses agreed by the Parties

to be essential. At the same Meeting, the

Parties also adopted Decision IV/25,

which established both criteria for

determining whether a specific use

should be approved as essential and a

process for the Parties to use in making

such a determination.

The criteria for an essential use as set

forth in Decision IV/25 are the

following:

‘‘(1) that a use of a controlled substance

should qualify as ‘essential’ only if:

(i) it is necessary for the health, safety or

is critical for the functioning of society

(encompassing cultural and intellectual

aspects); and

(ii) there are no available technically and

economically feasible alternatives or

substitutes that are acceptable from the

standpoint of environment and health;

(2) that production and consumption, if

any, of a controlled substance for essential

uses should be permitted only if:

(i) all economically feasible steps have

been taken to minimize the essential use and

any associated emission of the controlled

substance; and

(ii) the controlled substance is not

available in sufficient quantity and quality

from existing stocks of banked or recycled

controlled substances, also bearing in mind

the developing countries’ need for controlled

substances.’’

Decision IV/25 also sets out the

procedural steps for implementing this

process. It first calls for individual

Parties to nominate essential uses.

These nominations are then to be

evaluated by the Protocol’s Technology

and Economic Assessment Panel (TEAP

or the Panel) which makes

recommendations to representatives of

all Protocol Parties. The final decision

on which nominations to approve is to

be taken by a meeting of the Parties.

The initial cycle of implementing this

Decision has been completed in the

context of halons which were phased

out of production at the end of 1993.

This initial timetable separated

nominations for halons from those for

other ozone-depleting substances. EPA

issued a Federal Register notice

requesting nominations for essential

uses of halons (February 2, 1993; 58 FR

6786). In response, the Agency received

over ten nominations, but was able to

work with applicants to resolve their

near-term requirements. As a result, the

U.S. did not nominate any uses for

continued halon production in 1994.

About a dozen other nations put forth

nominations which were reviewed by

the Technical and Economic

Assessment Panel. Because the Panel

determined that in each case

alternatives existed or that the existing

supply of banked halons was adequate

to meet near-term needs, it did not

recommend approval of any of the

nominations. In November of 1993, at

the Fifth Meeting, the Parties

unanimously adopted the

recommendation of the Panel not to

approve any essential uses for the

production or consumption of halons in

1994.

EPA issued a second notice for

essential use nominations for halons on

October 18, 1993 (58 FR 53722). These

nominations covered possible

production of halons in 1995 for

essential uses. In response to this

inquiry, EPA received no nominations.

Only one nomination (from France)

was received by the TEAP for

production and consumption of halons

for an essential use in 1995. The TEAP

did not recommend approval of this

nomination.

EPA also issued a Federal Register

notice requesting nominations for

essential use applications which would

need to continue beyond the 1996

phaseout of consumption and

production allowances for CFCs, methyl

chloroform, carbon tetrachloride, and

hydrobromofluorocarbons (May 20,

1993, 58 FR 29410). EPA received 20

applications in response to this notice.

For several of these applications, EPA

determined that the criteria contained in

Decision IV/25 had not been satisfied.

For example, two applications sought

CFCs for servicing existing airconditioning equipment. EPA rejected

these applications on the basis that if all
Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 /Rules and Regulations 4361

economically feasible steps were taken

prior to the 1996 phaseout, then

adequate supplies of banked and

recycled CFCs should be available.

However, in rejecting these

nominations, the United States noted

that servicing existing air-conditioning

and refrigeration equipment remains a

major challenge to the successful

transition from the use of CFCs and that

a future nomination in this area might

be necessary if a combination of

retrofits, replacements, recycling,

recovery at disposal, and banking do not

adequately address these needs.

Of the responses to the Federal

Register request for essential use

applications, the United States

submitted essential use nominations to

the Protocol Secretariat for the following

uses of CFCs: metered dose inhalers and

other selected medical applications; a

bonding agent for the Space Shuttle;

aerosol wasp killers; limited use in a

specified bonding agent and polymer

application; and a generic application

for laboratory uses under specified

limitations. (Letter from Pomerance to

UNEP, September 27, 1993).

Nominations from the U.S. and other

countries for over 200 specific uses were

submitted to the Montreal Protocol

Secretariat and provided to the

Technical and Economic Assessment

Panel for review. In March 1994, the

Panel issued the ‘‘1994 Report of the

Technology and Economic Assessment

Panel.’’ The Report includes the Panel’s

recommendations for essential-use

production and consumption

exemptions. The Panel recommended

that essential use exemptions be granted

for nominations of: Methyl chloroform

in solvent bonding for the Space

Shuttle; CFCs used in metered dose

inhalers; and specific controlled

substances needed for laboratory and

analytical applications. For each of the

other nominations submitted, the TEAP

determined that one or more of the

criteria for evaluating an essential use

had not been satisfied. For example, in

the case of several of the U.S.

nominations, the report states that

alternatives are available and therefore

the essential use exemption is not

warranted.

In every year since 1994, the Parties

have reviewed recommendations by the

Technology and Economic Assessment

Panel and made final decisions on

essential use authorizations. Today’s

action follows decisions taken by the

Parties after considering

recommendations by the TEAP in 1996

and 1997.

In 1993, the Parties to the Protocol

modified the timetable for submission of

essential use nominations to combine

both halons and all the other class I

controlled substances (except methyl

bromide) and to reduce the overall

length of time between nomination and

decision. According to Decision V/18,

essential use nominations for halon

consumption and production for 1995

and beyond, and essential use

nominations for all the other class I

controlled substances (except methyl

bromide) for 1997 and beyond, must be

submitted to the Secretariat prior to

January 1st of the year prior to the year

for which production and consumption

is being sought. The Parties again

revised the timetable for essential use

nominations in Decision VIII/9

requiring submission by 31 January in

the year in which decisions would be

taken for subsequent years. EPA revised

the domestic schedule accordingly so a

Federal Register notice calling for

essential use applications for class I

controlled substances for future years is

published prior to the Protocol deadline

for submission to the Ozone Secretariat.

Decision V/18 directed the

Technology and Economic Assessment

Panel to develop a ‘‘handbook on

essential use nominations’’ (Handbook).

The July 1994 Handbook contained

forms and instructions for how to apply

for an essential-use exemption.

Subsequent decisions by the Parties to

the Protocol created additional criteria

for essential use authorizations now

reflected in the August 1997 Handbook.

The Handbook may be obtained from

the Stratospheric Protection Division,

U.S. Environmental Protection Agency

or the Ozone Secretariat of the Montreal

Protocol in Nairobi.

II. Allocation of 1998 Essential Use

Allowances

In today’s action, EPA is allocating

essential use allowances for the 1998

control period to the entities listed in

Table I for exempted production or

import of the specific quantity of class

I controlled substances solely for the

specified essential use.

TABLE I.—ESSENTIAL USES AGREED TO BY THE PARTIES TO THE PROTOCOL FOR 1998 AND ESSENTIAL USE ALLOWANCES

Company/entity Class I controlled substance

Quantity

(metric

tonnes)

(i) Metered Dose Inhalers for Treatment of Asthma and Chronic Obstructive Pulmonary Disease

International Pharmaceutical Aerosol Consortium (IPAC)—Abbott Laboratories, Armstrong Laboratories, Boehringer Ingelheim, Glaxo Wellcome, 3M, Rhone Poulenc Rorer, ScheringPlough Corporation.CFC–11 ..........................................

CFC–12 ..........................................

CFC–114 ........................................

1043.6

2512.2

338.0

Medisol ............................................................................................................................................ CFC–11 ..........................................

CFC–12 ..........................................

CFC–114 ........................................

78.0

132.0

11.0

Aeropharm ...................................................................................................................................... CFC–11 ..........................................

CFC–12 ..........................................

83.0

166.7

(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets

National Aeronautics and Space Administration (NASA)/Thiokol Rocket ...................................... Methyl Chloroform .......................... 56.7

United States Air Force/Titan Rocket ............................................................................................. Methyl Chloroform .......................... 3.4

(iii) Laboratory and Analytical Applications

Global Exemption (Restrictions in Appendix G Apply) ................................................................... All Class I Controlled Substances

(except Group VI).

No (1)

1 No quantity specified.
4362 Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 /Rules and Regulations

The International Pharmaceutical

Aerosol Consortium (IPAC)

consolidated requests for an essential

use exemption to be nominated to the

Protocol as an agent of its member

companies for administrative

convenience. By means of a confidential

letter to each of the companies listed

above, EPA will allocate essential-use

allowances separately to each company

in the amount requested by it for the

nomination.

Applications submitted by these

companies requested class I controlled

substances for uses claimed to be

essential during the 1998 control period.

The applications provided information

in accordance with the criteria set forth

in Decision VI/25 of the Protocol and

the procedures outlined in the

‘‘Handbook on Essential Use

Nominations.’’ The applications request

exemptions for the production and

import of specific quantities of specific

class I controlled substances after the

phaseout as set forth in 40 CFR 82.4.

The applications were reviewed by the

U.S. government and nominated to the

Protocol Secretariat for analysis by the

Technical and Economic Assessment

Panel (TEAP) and its Technical Option

Committees (TOCs). The Parties to the

Montreal Protocol approved the U.S.

nominations for essential-use

exemptions during meetings in 1995

and 1996. In today’s action essential-use

allowances are allocated to United

States entities based on nominations

decided upon by the Parties to the

Protocol.

The 1998 global essential use

exemption for analytical and laboratory

applications published in today’s rule

imposes strict requirements both in

§ 82.13 and in Appendix G of this

subpart. The restrictions for the global

laboratory and analytical essential use

exemption listed in Appendix G include

requirements regarding purity of the

class I controlled substances and the

size of the containers. In addition, there

are detailed reporting requirements in

§ 82.13 for persons that take advantage

of the global laboratory and analytical

essential-use exemption for class I

controlled substances. The strict

requirements are established because

the Parties to the Protocol, and today’s

rule, do not specify a quantity of

essential use allowances permitted for

analytical and laboratory applications,

but establish a global essential-use

exemption, without a named recipient.

Any person obtaining class I

controlled substances after the phaseout

under the essential use exemptions

published in today’s rule is subject to all

the restrictions and requirements in

other sections of 40 CFR part 82, subpart

A. Holders of essential-use allowances

or persons obtaining class I controlled

substances under the essential-use

exemptions must comply with the

recordkeeping and reporting

requirements in § 82.13 of this subpart

and the restrictions in Appendix G of

this subpart.

Section 307(d) of the Clean Air Act

Amendments of 1990 (CAA or the Act)

states that in the case of any rule to

which section 307(d) applies, notice of

proposed rulemaking must be published

in the Federal Register (CAA 307(d)(3)).

The promulgation or revision of

regulations under title VI of the CAA

(relating to stratospheric ozone

protection) is generally subject to

section 307(d). However, section 307(d)

does not apply to any rule referred to in

subparagraphs (A) or (B) of section

553(b) of the Administrative Procedure

Act (APA), 5 U.S.C. 551 et seq.

APA section 553(b) requires that any

rule to which it applies be issued only

after the public has received notice of,

and an opportunity to comment on, the

rule. However, APA section 553(b)(B)

exempts from those requirements any

rule for which the issuing agency for

good cause finds that providing prior

notice-and-comment would be

impracticable, unnecessary or contrary

to the public interest. Thus, any rule for

which EPA makes such a finding is

exempt from the notice-and-comment

requirements of both APA section

553(b) and CAA section 307(d).

EPA believes that the circumstances

presented here provide good cause to

take this action without prior notice and

comment. EPA finds that providing

prior notice and comment would be

impracticable and contrary to the public

interest because the ozone-depleting

substances need to be available to the

listed entities in 1998 for the health and

safety of society as defined in the

Protocol essential use criteria. The

allocation of essential-use allowances

for CFCs to the manufacturers of

metered-dose inhalers will ensure the

availability of treatment in order to

protect the health of U.S. patients with

asthma and chronic obstructive

pulmonary disease. The allocation of

essential-use allowances for methyl

chloroform for the manufacture of the

Thiokol/Space Shuttle Rockets and the

Titan Rockets will provide a guarantee

of safety from explosions that are

unacceptable risks to both national

programs.

Nonetheless, EPA is providing 30

days for submission of public comments

following today’s action. EPA will

consider all written comments

submitted in the allotted time period to

determine if any change to this action is

necessary.

Section 553(d) of the APA generally

provides that rules may not take effect

earlier than 30 days after they are

published in the Federal Register.

However, APA section 553(d)(1) excepts

from this provision any action that

grants or recognizes an exemption or

relieves a restriction. Since today’s

action grants an exemption from the

phaseout of production and

consumption of most class I ozonedepleting substances, EPA is making

this action immediately effective to

ensure the availability of ozonedepleting substances for essential uses

during the 1998 control period.

III. Additional Changes in the Essential

Use Process To Be Published in

Subsequent Proposed Rulemaking

EPA will be publishing a Notice of

Proposed Rulemaking that includes

changes to the essential-use provisions

published in the Federal Register on

May 10, 1995. One of the proposals will

be a simplification of the process for

allocating essential-use allowances by

providing that allowances will be

allocated through a Notice published in

the Federal Register rather than through

a Final Rulemaking. EPA will propose

allocating essential-use allowances

according to the quantities approved by

the Parties to the Protocol for which

applications were submitted to the U.S.

government. EPA will be seeking

comments on a simplification of the

current allocation process.

EPA will also be proposing changes to

the reporting requirements for holders

of essential-use allowances in the

subsequent Notice of Proposed

Rulemaking. EPA will propose changes

to the reporting requirements to allow

the U.S. to gather information in

accordance with Decision VIII/9,

paragraph 9. Under the reporting format

associated with Decision VIII/9,

paragraph 9, Parties to the Protocol are

requested to report data regarding

essential uses, including inventories of

CFCs, quantities of CFCs imported and

produced for essential uses, the amount

of CFCs that are actually filled into

metered-dose inhalers, and stockpiles of

CFCs remaining at the end of a control

period.

IV. Summary of Supporting Analysis

A. Unfunded Mandates Reform Act and

Regulatory Flexibility Act

Since this action is not subject to

notice-and-comment rulemaking

requirements under the APA or any

other law, it is also not subject to

sections 202, 204 or 205 of the
Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 /Rules and Regulations 4363

Unfunded Mandates Reform Act

(UMRA). In addition, since this action

does not impose annual costs of $100

million or more on small governments

or uniquely affect small governments,

the Agency has no obligations under

section 203 of UMRA. Moreover, since

this action is not subject to notice-andcomment requirements under the APA

or any other statute as stated above, it

is not subject to section 603 or 604 of

the Regulatory Flexibility Act.

B. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether this regulatory

action is ‘‘significant’’ and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines ‘‘significant’’

regulatory action as one that is likely to

result in 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, or

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.

It has been determined by EPA that

this rule is not a ‘‘significant regulatory

action’’ within the meaning of the

Executive Order.

C. Paperwork Reduction Act

This action does not add any

information collection requirements or

increase burden under the provisions of

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq. The Office of Management

and Budget (OMB) previously approved

the information collection requirements

contained in the final rule promulgated

on May 10, 1995, and assigned OMB

control number 2060–0170 (EPA ICR

No. 1432.16).

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, or disclose

or provide information to or for a

Federal agency. This includes the time

needed to review instructions; develop,

acquire, install, and utilize technology

and systems for the purposes of

collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

An Agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations are listed

in 40 CFR Part 9 and 48 CFR Chapter

15.

D. Executive Order 12875

Today’s action does not impose any

unfunded mandate upon any State,

local, or tribal government; therefore,

Executive Order 12875 does not apply

to this rulemaking.

E. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added

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 5

U.S.C. 804(2).

List of Subjects in 40 CFR Part 82

Environmental protection,

Administrative practice and procedure,

Air pollution control, Chemicals,

Chlorofluorocarbons, Exports,

Hydrochlorofluorocarbons, Imports,

Ozone layer, Reporting and

recordkeeping requirements.

Dated: January 16, 1998.

Carol M. Browner,

Administrator.

40 CFR part 82 is to be amended as

follows:

PART 82—PROTECTION OF

STRATOSPHERIC OZONE

1. The authority citation for part 82

continues to read as follows:

Authority: 42 U.S.C. 7414, 7601, 7671–

7671q.

Subpart A—Production and

Consumption Controls

2. Section 82.4(r)(2) is amended by

revising the table to read as follows:

§ 82.4 Prohibitions.

* * * * *

(r) * * *

(2) * * *

TABLE I.—ESSENTIAL USES AGREED TO BY THE PARTIES TO THE PROTOCOL FOR 1998 AND ESSENTIAL USE ALLOWANCES

Company/entity Class I controlled substance

Quantity

(metric

tonnes)

(i) Metered Dose Inhalers for Treatment of Asthma and Chronic Obstructive Pulmonary Disease

International Pharmaceutical Aerosol Consortium (IPAC) 1—Abbott Laboratories, Armstrong

Laboratories, Boehringer Ingelheim, Glaxo Wellcome, 3M, Rhone Poulenc Rorer, Schering—

Plough Corporation.

CFC–11 ..........................................

CFC–12 ..........................................

CFC–114 ........................................

1043.6

2512.2

338.0

Medisol ............................................................................................................................................ CFC–11 ..........................................

CFC–12 ..........................................

CFC–114 ........................................

78.0

132.0

11.0

Aeropharm ...................................................................................................................................... CFC–11 ..........................................

CFC–12 ..........................................

83.0

166.7

(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets

National Aeronautics and Space Administration (NASA)/Thiokol Rocket ...................................... Methyl Chloroform .......................... 56.7

United States Air Force/Titan Rocket ............................................................................................. Methyl Chloroform .......................... 3.4
4364 Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 /Rules and Regulations

TABLE I.—ESSENTIAL USES AGREED TO BY THE PARTIES TO THE PROTOCOL FOR 1998 AND ESSENTIAL USE

ALLOWANCES—Continued

Company/entity Class I controlled substance

Quantity

(metric

tonnes)

(iii) Laboratory and Analytical Applications

Global Exemption (Restrictions in Appendix G Apply) ................................................................... All Class I Controlled Substances

(except Group VI).

(2)

1 IPAC consolidated requests for an essential use exemption to be nominated to the Protocol as an agent of its member companies for administrative convenience. By means of a confidential letter to each of the companies listed above, EPA will allocate essential-use allowances separately to each company in the amount requested by it for the nomination. 2 No quantity specified.

* * * * *

[FR Doc. 98–2082 Filed 1–27–98; 8:45 am]

BILLING CODE 6560–50–P