716 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

widely available for purchase, and a

healthy level of competition exists

among manufacturers capable of

maintaining a current and adequate

stock of response equipment at

increased levels. The overall availability

of new oil spill response equipment in

the commercial market has improved

since 1993.

The availability of existing equipment

stocks for deployment to spills was

assessed by reviewing nationwide

inventories of major items such as

booms, skimmers, skimming vessels,

and temporary storage devices. Primary

data was compiled using the Coast

Guard National Strike Force

Coordination Center’s (NSFCC)

Response Resource Inventory (RRI). The

resulting equipment distribution and

the daily recovery capacity it

represented were examined for each

geographic region and operating

environment. The comparison of the

scheduled cap increase with the existing

equipment stocks available to

planholders clearly indicated that

planning for a response is not

equipment limited. The scheduled 25

percent cap increase can easily be

accommodated with the existing stocks

of equipment available to planholders

for each geographical region and

operating environment.

The assessments of technological

capability, market availability, and

regional availability of existing stocks,

support the determination that the

scheduled increase in caps is

practicable. For a more detailed

explanation of these findings, the Cap

Review can be viewed on the Internet at

the sites listed in the ADDRESSES section.

Other removal technologies. The Cap

Review also evaluated the following

topics:

a. Additional proposed increases for

on-water mechanical removal capacity

in 2003.

b. Advances in oil tracking

technology.

c. Improvements in high-rate removal

technologies such as dispersants or in

situ burning.

The conclusions and

recommendations of the Cap Review

concerning these topics are contained

within the Response Plan Equipment

Cap Review document. This notice does

not address these topics and makes no

changes to existing regulations or

policy. However, we intend to address

any additional cap increases for

mechanical recovery or other removal

technologies in a subsequent

rulemaking. The Cap Review

recommendations regarding these other

removal technologies should be viewed

as information only. We will consider

them along with previously received

public comments when formulating any

subsequent rulemakings.

Dated: December 28, 1999.

Joseph J. Angelo,

Acting Assistant Commandant for Marine

Safety and Environmental Protection.

[FR Doc. 00–31 Filed 1–5–00; 8:45 am]

BILLING CODE 4910–15–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–6519–3]

RIN 2060–AI73

Protection of Stratospheric Ozone:

Allocation of Essential Use Allowances

for Calendar Year 2000: Allocations for

Metered-Dose Inhalers and the Space

Shuttle and Titan Rockets

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Interim final rule.

SUMMARY: With this action, EPA is

allocating essential-use allowances for

calendar year 2000 for ozone depleting

substances (ODS) for use in medical

devices and for use in the Space Shuttle

Rockets and Titan Rockets for the year

2000 control period. Production and

import of ODS for laboratory and

analytical applications will be

addressed in a separate rulemaking. The

United States nominated specific uses of

controlled ozone-depleting substances

as essential for calendar year 2000

under the Montreal Protocol on

Substances that Deplete the Ozone

Layer (Protocol). The Parties to the

Protocol subsequently authorized

specific quantities of ODS for calendar

year 2000 for the uses nominated by the

United States. EPA allocates essential

use allowances to an applicant for

exempted production or import of a

specific quantity of controlled

substances solely for the designated

essential purpose. These essential use

allowances permit a person to obtain

controlled ODS as an exemption to the

January 1, 1996, regulatory phaseout of

production and import.

DATES: This action is effective January 6,

2000. EPA will consider all written

comments received by February 7, 2000

to determine if any change to this action

is necessary.

ADDRESSES: Those wishing to notify

EPA of their intent to submit adverse

comments on this action should contact

Erin Birgfeld, U.S. Environmental

Protection Agency, Stratospheric

Protection Division, Office of Air and

Radiation (6205J), Ariel Rios Building,

1200 Pennsylvania Avenue, NW.,

Washington, DC, 20460;

<birgfeld.erin@epa.gov >; (202) 564–

9079 phone and (202) 565–2096 fax.

Materials relevant to this rulemaking are

contained in Docket No. A–92–13. The

Docket phone is (202) 260–7548 and is

located in room M–1500, First Floor,

Waterside Mall 401 M Street, SW.,

Washington, DC 20460. The materials

may be inspected from 8 a.m. until 4

p.m. Monday through Friday. A

reasonable fee may be charged by EPA

for copying docket materials.

FOR FURTHER INFORMATION CONTACT: The

Stratospheric Ozone Protection Hotline

at (800) 296–1996 or Erin Birgfeld, U.S.

Environmental Protection Agency,

Stratospheric Protection Division, Office

of Air and Radiation (6205J), Ariel Rios

Building, 1200 Pennsylvania Avenue,

NW., Washington, DC, 20460;

<birgfeld.erin@epa.gov >; (202) 564–

9079 phone and (202) 565–2096 fax.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Allocation Process for the Calendar Year

2000

III. Allocation of Essential Use Allowances

for Calendar Year 2000

IV. Response to Comments

V. Administrative Requirements

VI. Judiciary Review

VII. Congressional Review

I. Background

Overview of the Notice of Proposed

Rulemaking

The Notice of Proposed Rulemaking

(NPRM) for allocating essential use

allowances was published on November

2, 1999 (64 FR 59141). In the NPRM,

EPA proposed allocating

chlorofluorocarbon (CFCs) for use in

metered dose inhalers (MDIs), and

methyl chloroform for use in the Space

Shuttle and Titan Rocket. EPA

explained that because of additional

requirements in the Clean Air Act that

apply beginning in calendar year 2000,

before allocating CFCs for use in MDIs,

EPA must receive a determination from

the Food and Drug Administration

(FDA) indicating the amount of CFCs

that are necessary for use in MDIs. The

quantities of CFCs proposed to be

allocated were the quantities that were

agreed upon at the Eighth Meeting of the

Parties to the Montreal Protocol. FDA’s

determination of the amount of CFCs

that are necessary for use in MDIs,

which EPA has subsequently received,

is substantially lower than what was

proposed in the NPRM. The allocations

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 717

in this action reflect these lowered

amounts. Because stakeholders have not

had a chance to comment on the lower

amounts, today’s action is being issued

as an interim final rule effective January

6, 2000. This will allow essential use

applicants access to necessary CFCs for

continued production of MDIs, and at

the same time will allow for further

comment on and potential changes to

the allocation.

In the NPRM, EPA also explained that

due to requirements of the CAA that

apply beginning in calendar year 2000,

the essential use exemption for import

and production of small amounts of

high purity ozone depleting substances

(ODS) for laboratory and analytical uses

may not be available after January 1,

2000. Today’s action does not address

this issue. EPA will issue a separate

final rule on the topic of laboratory

essential uses.

Overview of the Essential Use Process

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 Parties 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 criteria for

determining whether a specific use

should be approved as essential, and the

process for 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.’’

The procedure set out by Decision IV/

25 first calls for individual Parties to

nominate essential uses. The Protocol’s

Technology and Economic Assessment

Panel (TEAP or the Panel) evaluates the

nominated essential uses and makes

recommendations to the Protocol

Parties. The Parties make the final

decisions on essential use nominations

at their annual meeting.

Persons requesting essential use

exemptions submit applications which

respond to the specific questions in the

1997 Handbook on Essential Use

Nominations. This document may be

obtained from the Stratospheric

Protection Division, U.S. Environmental

Protection Agency or the Ozone

Secretariat of the Montreal Protocol in

Nairobi. The Handbook can also be

downloaded from the TEAP website at:

http://www.teap.org/html/

teaplreports.html.

What does EPA do with the information

in the essential use applications?

The U.S. EPA carefully reviews all the

information in each essential use

application and enters the information

into a tracking system which permits

year by year comparison of quantities of

ODS requested, quantities allocated,

quantities of ODS received in previous

years, and quantities of ODS used for

the specific essential activity. The

review of data enables EPA to assess

whether entities are stockpiling ODS,

whether there seem to be inflated

requests relative to actual use, and

whether there is possible doublecounting between companies. For

example, in 1998 we identified some

double-counting in the requests for

CFCs among companies. Our analysis

also revealed that there were disparities

between the total quantity of CFCs

requested for MDIs and the actual

quantity used to manufacture MDIs in

previous years. To account for this

inflation in the request for allocation,

EPA reduced the total U.S. nomination

for 1998 by 10 percent before

forwarding the applications for

consideration by the TEAP and the

Parties to the Protocol.

Every year since 1994, EPA has

reviewed applications for essential uses

according to the above criteria and then

forwarded the applications to the

Parties. The Parties then review the

recommendations by the TEAP and

make final decisions on essential use

nominations.

What are the essential uses that EPA

has nominated in the past?

Decision IV/25 was implemented

initially in the context of halons which

were phased out of production at the

end of 1993. At that time, nominations

for halons were separated 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

06786). 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 Panel, which determined that in

each case alternatives existed or that the

existing supply of banked halons was

adequate to meet near-term needs. The

Panel, therefore, did not recommend

approval for any of the nominations. In

November of 1993, at the Fifth Meeting,

the Parties unanimously adopted the

Panel’s recommendation not to approve

any essential uses for production and

consumption of halons in 1994.

EPA issued a second notice requesting

applications for essential use

applications for halons for the 1995

control period on October 18, 1993 (58

FR 53722). In response to this inquiry,

EPA received no applications. The

TEAP received only one nomination

(from France) for essential use

exemptions for halons for production

and consumption of halons for an

essential use in 1995. The TEAP did not

recommend approval of this

nomination.

In 1993, EPA issued a Federal

Register notice requesting essential use

applications for CFCs, methyl

chloroform, carbon tetrachloride, and

hydrobromofluorocarbons required

beyond the 1996 phaseout of

consumption and production of these

class I substances (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,

EPA rejected two applications seeking

CFCs for use in servicing airconditioning equipment on the basis

that adequate supplies of banked and

recycled CFCs were 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 ODSs and that a future nomination

in this area might be necessary if a

718 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

combination of retrofits, replacements,

recycling, recovery at disposal, and

banking do not adequately address these

needs.

In 1993, the United States forwarded

essential use nominations to the

Protocol Secretariat for the following

uses of CFCs: metered dose inhalers and

other selected medical applications;

rocket motor assembly 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 the United Nations

Environment Programme (UNEP),

September 27, 1993).

The TEAP reviewed over 200 specific

uses which were submitted to the

Montreal Protocol Secretariat by the

Parties to the Protocol. In March 1994,

the Panel issued the ‘‘1994 Report of the

Technology and Economic Assessment

Panel,’’ which included 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. The Parties

approved essential use exemptions for

the uses recommended in the 1994

TEAP report. The U.S. has continued to

request and receive exemptions for

those same uses in subsequent years.

II. Allocation Process for the Calendar

Year 2000

The domestic allocation process for

this year differs from past allocations

due to changes in the requirements

under the Clean Air Act (CAA or the

Act). The purpose of this section is to

explain the legal background behind

these changes, and to outline the

procedures that EPA and the Food and

Drug Administration (FDA) used to

fulfill our obligations under the CAA in

allocating ozone depleting substances

for calendar year 2000.

Prior to the year 2000, EPA allocated

essential use exemptions under the

original phase-out schedule contained

in section 604 of the Act. This schedule

does not require the complete phaseout

of any ODS prior to calendar year 2000.

Under section 606 of the Act, EPA was

obligated to create an accelerated

phaseout through regulation to match

the accelerated phaseout under the

Protocol. However, EPA had the

flexibility to create exemptions to the

regulatory phaseout, where such

exemptions had been approved under

the Montreal Protocol. Thus, for the past

several years, EPA has been able to

authorize production and import of

ozone-depleting substances for essential

uses allowed under the Protocol,

without regard to whether the Act

contains exceptions for those uses, as

long as the total authorized production

does not exceed the amount permitted

by the Act. However, January 1, 2000, is

the phaseout date under Section 604 of

the Act for all class I substances with

the exception of methyl chloroform and

methyl bromide. The phaseout dates for

methyl chloroform and methyl bromide

are January 1, 2002 and January 1, 2005,

respectively. After the phaseout date for

a particular substance has passed, EPA

will no longer be able to authorize

production of that substance on the

basis of the slower phaseout schedule

under the Act. Because CFCs are to be

phased-out by calendar year 2000 under

the original phase-out schedule, EPA

must now implement essential use

exemptions for these chemicals as

specified under the Act in section

604(d).

The phaseout date for methyl

chloroform under the Act is January 1,

2002. Until that date, the Act permits

production and import of methyl

chloroform equivalent to 20% of

baseline. The amount of methyl

chloroform allocated for calendar year

2000 is well below this limit. Beginning

in the year 2002, EPA will implement

the exception for essential uses of

methyl chloroform found in 604(d)(1) of

the Act.

For calendar year 2000, the entities in

Table I submitted applications

requesting class I controlled substances

for essential uses. The applications

provided information in accordance

with the criteria set forth in Decision IV/

25 of the Protocol and the procedures

outlined in the ‘‘1997 Handbook on

Essential Use Nominations.’’ The

applications requested exemptions for

the production and import of specific

quantities of certain class I controlled

substances after the phaseout. The EPA

reviewed the applications and

nominated these uses to the Protocol

Secretariat for analysis by the TEAP and

its Technical Option Committees

(TOCs). The Parties to the Montreal

Protocol approved the U.S. nominations

for essential-use exemptions during the

Tenth Meeting in 1998 (Decision IX/18).

Today’s action allocates essential-use

allowances to U.S. entities as authorized

by the Parties to the Montreal Protocol

and to the extent consistent with the

CAA.

The Act provides for the following

essential use exemptions to the ban on

production and import. Section 604

(d)(2) states that notwithstanding the

phaseout, EPA shall, to the extent

consistent with the Montreal Protocol,

authorize production of limited

quantities of class I substances for use

in medical devices, if FDA, in

consultation with EPA, determines that

such production is necessary. Section

604(d)(3) states that EPA may, to the

extent consistent with the Montreal

Protocol, authorize production of

limited quantities of halon-1211, halon1301, and halon-2402 solely for the

purpose of aviation safety, if the Federal

Aviation Administration, in

consultation with EPA, determines that

no safe and effective substitute has been

developed and that such authorization

is necessary for aviation safety

purposes. Section 604(d)(1) provides

that during the period from January 1,

2002 to January 1, 2005, EPA may, to

the extent consistent with the Montreal

Protocol, authorize the production of

limited quantities of methyl chloroform

solely for use in essential applications

for which no safe and effective

substitute is available. Section 604(d)(4)

states that EPA cannot use any of these

three exemptions to authorize any

person to produce a class I substance in

annual quantities greater than 10

percent of that person’s baseline year as

defined in Section 601(2). Section

604(g)(3) of the Act provides that EPA

may, to the extent consistent with the

Montreal Protocol, authorize the

production of limited quantities of

halon-1211, halon-1301, and halon-2402

after December 31, 1999, and before

December 31, 2004 for use in fire

suppression and explosion prevention

in association with domestic production

of crude oil and natural gas energy

supplies on the North Slope of Alaska,

if it is determined that no safe and

effective substitute has been developed

and that such authorization is necessary

for fire suppression or explosion

prevention purposes. EPA cannot use

this exemption to authorize any person

to produce any of these halons in an

amount greater than 3 percent of that

person’s baseline. Finally, section 604(f)

states that the President may, to the

extent consistent with the Montreal

Protocol, provide an exemption for

production of CFC -114, halon-1211,

halon-1301, and halon-2402 as

necessary to protect U.S. national

security interests, if the President finds

that adequate substitutes are not

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 719

available and that the production and

use of the substance are necessary to

protect national security interests.

Today’s action allocating CFCs for use

in MDIs requires EPA to implement the

exception for medical devices found in

section 604(d)(2) of the Clean Air Act.

‘‘Medical device’’ is defined in section

601(8) of the Clean Air Act as follows:

[A]ny device (as defined in the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321), diagnostic product, drug (as

defined in the Federal Food, Drug, and

Cosmetic Act), and drug delivery

system—

(A) if such device, product, drug, or

drug delivery system utilizes a class I or

class II substance for which no safe and

effective alternative has been developed,

and where necessary, approved by the

Commissioner [of FDA]; and

(B) if such device, product, drug, or

drug delivery system, has, after notice

and opportunity for public comment,

been approved and determined to be

essential by the Commissioner [of FDA]

in consultation with the Administrator

[of EPA].

The preamble to FDA’s September 1,

1999, notice of proposed rulemaking on

essential use determinations (64 FR

47735) discusses FDA’s approach to

determining whether ‘‘safe and effective

alternative[s]’’ have been developed. It

states that ‘‘A non-CFC product simply

having the same active moiety as a CFC

product is only one factor to be

considered. Other factors, such as

whether the non-CFC product has the

same route of administration, the same

indication, and can be used with

approximately the same level of

convenience, are important

considerations. Additionally, FDA must

consider whether patients who

medically need the CFC product are

adequately served by the non-CFC

product. FDA’s approval of a non-CFC

product is a determination that the

product is safe and effective, but it is

not a determination that the product is

a safe and effective alternative to any

other product. That requires a separate

and distinct analysis.’’ FDA has not yet

determined that any non-CFC product is

a safe and effective alternative to any

CFC MDI. Accordingly, part (A) of the

definition of medical device has not

affected today’s allocation.

With respect to part (B) of the

definition of medical device (section

601(8)(B)), and in particular the use of

the word ‘‘essential’’ in that part of the

definition, EPA is relying on current

FDA regulations (21 CFR 2.125) which

contain a list of uses of CFCs that FDA

in consultation with EPA has found to

be essential. This list includes, among

others, metered-dose steroids, metereddose adrenergic bronchodilators,

metered-dose cromolyn sodium,

metered-dose ipratropium bromide, and

metered-dose nedocromil sodium, all

drugs for oral inhalation in humans. The

companies for which EPA is granting

essential use allowances produce CFC

MDIs that contain these active moieties.

Thus, the products for which EPA is

granting essential use allowances are

‘‘determined to be essential’’ by FDA.

Also with respect to part (B) of the

definition of ‘‘medical device’’, EPA and

FDA considered how to interpret the

language regarding approval by FDA of

the ‘‘device, product, drug, or drug

delivery system.’’ The complete phrase

reads as follows: ‘‘if such device,

product, drug, or drug delivery system,

has, after notice and opportunity for

public comment, been approved and

determined to be essential by the

Commissioner in consultation with the

Administrator.’’ The decision was made

to interpret this phrase as referring to

FDA’s approval of an essential use and

not the approval of the specific product

in question through approval of the New

Drug Application (NDA) or Abbreviated

New Drug Application (ANDA) for that

product. This means that any MDI

whose active moiety appears on FDA’s

essential use list is eligible to receive

essential use allowances. This

interpretation was taken for the

following reasons. The term ‘‘approved’’

must be interpreted in light of the

surrounding language. Section 601(8)(B)

requires notice and comment

rulemaking and refers to action by FDA,

in consultation with EPA. Since

approval of an NDA or ANDA under the

FDCA involves unilateral action by FDA

without notice-and-comment

rulemaking, it is reasonable to conclude

section 601(8)(B) does not refer to

approval of an NDA or ANDA under the

FDCA. Therefore, FDA and EPA are

interpreting section 601(8)(B) to refer to

FDA’s approval of an essential use. This

interpretation is consistent with the

surrounding language, since FDA

engages in notice-and comment

rulemaking in listing essential uses and

since EPA has a strong interest in

decisions about essential uses. This

means that an MDI is ‘‘approved and

determined to be essential’’ if the MDI

contains an active moiety on FDA’s

essential use list. All of the MDIs for

which we are allocating CFCs today

meet this qualification.

Implementing the essential use

exemption for MDIs under the Act

required EPA to consult with FDA

regarding the quantity of CFCs to be

allocated. As stated earlier, section

604(d)(2) of the Act provides that EPA

shall authorize production and import

of limited quantities of class I

substances for use in medical devices if

FDA, in consultation with EPA,

determines such authorization to be

necessary. Administrator Carol Browner

sent a letter to Dr. Jane Henney,

Commissioner of FDA, dated October

28, 1999, requesting that FDA make a

determination on the amount of CFCs

that are ‘‘necessary’’ for the production

of MDIs for calendar year 2000. A

December 23, 1999, letter was sent in

response from Commissioner Henney

that contains FDA’s determination.

EPA also collected additional

information relevant to the allocation.

The 1997 TEAP Handbook on Essential

Use Nomination (Handbook), the

guidance document for essential use

exemption applications, does not

request information regarding specific

products for which the CFCs will be

used. As a result, EPA sought more

detailed information including which

drug products would be produced using

the allocated CFCs for calendar year

2000. EPA sent out letters to the

essential use applicants (separate letters

were sent to the International

Pharmaceutical Aerosol Consortium

(IPAC) member companies) for medical

devices, requesting this additional

information under section 114 of the

Act. The responses to the letters

included confidential business

information on the types of drug

products to be manufactured, as well as

the quantity and the specific CFC

chemical to be used in the manufacture

of each product. EPA shared the

responses to these letters with FDA to

assist it in determining the amount of

CFCs for use in medical devices that are

‘‘necessary.’’

Dr. Henney’s letter in response to the

Administrator dated December 23, 1999,

provided FDA’s analysis of the amounts

of CFCs that FDA determined are

necessary in calendar year 2000 for the

production of medical devices as

defined under the Clean Air Act. FDA

determined that a total of 2737.3 metric

tons are necessary for use in MDIs for

calendar year 2000. In contrast, the total

amount of CFCs proposed to be

allocated in the NPRM (November 2,

1999 64 FR 59141) was 3735 metric

tons. The rationale underlying FDA’s

determination is provided in Dr.

Henney’s December 23, 1999 letter:

‘‘In listing the amounts we believe to

be necessary for use in medical devices,

we referred to historical use and have

included an additional amount to allow

for overage, for waste during

manufacturing, for uncertainties in the

720 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

supply chain of CFCs since they are no

longer produced in the United States,

for changes in future market shares of

specific products, as well as for

unforeseen circumstances in the market.

We also provided additional amounts

based on our knowledge of certain

manufacturing problems. In addition,

we eliminated any double-counting we

found and eliminated allocations for

uses not considered essential by the

parties to the Montreal Protocol, even if

those uses are currently listed in our

regulation at 21 CFR 2.125(e).’’ FDA also

noted that they accounted for CFCs for

use in the production of MDIs that

would ultimately be exported to

Canada.

FDA’s determination that 2737.3

metric tons of CFCs are necessary for

use in MDIs is consistent with EPA’s

data on historical use and import for

MDIs. In order for companies to place

an order for CFCs they must provide a

letter from EPA which indicates the

amount of CFC that they are allowed to

purchase from chemical producers.

Before issuing these letters, EPA asks

companies if they still need the entire

allocation of CFCs. In many cases,

companies voluntarily give up part of

their CFC allocation for various reasons.

The net result is that the amount of

CFCs actually purchased each year is

substantially less than the amount of

CFCs allocated each year. For example,

in 1998, 4,363 tons of CFCs were

allocated for use in medical devices.

However, only 2,235.6 tons were

actually imported or produced for MDIs

in that year, and a total of 2,425.5 tons

were actually used in the production of

MDIs. Similarly in 1997, 4,656.0 tons of

CFCs were allocated for use in MDIs

while 2,032.3 tons were imported or

produced, and 2,255.1 tons were used in

MDI production (data from the EPA CFC

accounting framework). Thus, the

amount of CFCs that FDA has

determined is ‘‘necessary’’ is about 300

metric tons higher than EPA’s data on

actual use of CFCs in MDIs for 1998. As

stated in the letter from FDA, this

additional amount will act as a safety

factor accounting for any unplanned

interruptions in CFC supply that could

occur during the course of the year.

As mentioned above, section 604(d)(2)

of the Act states that EPA’s allocation

must be consistent with the Montreal

Protocol. Article 2A(4) of the Protocol

states that Parties such as the United

States may not produce or import CFCs

after January 1, 1996, except that the

Parties may decide collectively to

permit a specified amount of production

or import for uses that they agree to be

essential. The Parties to the Protocol

approved the U.S. nominations for

essential use exemptions for calendar

year 2000 during their Tenth Meeting in

1998 (Decision IX/8). The quantities we

are allocating today do not exceed the

amounts approved by the Parties.

Therefore, we believe that this action is

consistent with the Protocol.

Can I Submit Comments on This Interim

Final Eule?

In the interest of maintaining as open

and transparent a process as possible,

this year’s allocation for medical

devices and the space program is being

issued as an interim final rule instead of

a final rule. This will allow stakeholders

to comment on the appropriateness and

accuracy of the allocation while still

allowing pharmaceutical companies

access to CFCs in the near term for

continued manufacture of MDIs.

Today’s action allocates 2737.3 tons of

CFCs for use in medical devices instead

of the 3735 metric tons proposed in the

NPRM. EPA received no comments on

the NPRM stating that the proposed

allocation was insufficient for an

applicant’s needs. While we are

accepting comment on the lowered

allocation figures, EPA, under the terms

of the Montreal Protocol cannot allocate

CFCs in an amount higher than 3735

metric tons because no more than that

amount has been approved for essential

use by the Parties to the Montreal

Protocol. Because we are issuing this

action as an interim final rule, the

following paragraphs explain the

relevant procedures under the CAA and

the Administrative Procedures Act

(APA), as well as EPA’s findings.

Section 307(d) of the CAA 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 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 Procedures Act (APA), 5

U.S.C. 551 et seq.

Section 553 of the Administrative

Procedures Act, 5 U.S.C. 553(b)(B),

provides that, when an agency for good

cause finds that notice and public

procedure are impracticable,

unnecessary or contrary to the public

interest, the agency may issue a rule

without providing notice and

opportunity for public comment. In its

proposed rule, 64 FR 59141 (Nov. 2,

1999), EPA provided notice that the

allocation of essential use allowances

for MDIs for calendar year 2000 would

be made in accordance with CAA

sections 601(8) and 604(d)(2). EPA also

provided preliminary interpretations of

the relevant statutory language and

announced that the final allocation

would be based on what FDA

determined was ‘‘necessary’’ under

section 604(d)(2) of the CAA. The

proposed allocation reflected the

quantities of CFCs that had been

approved by the Parties to the Montreal

Protocol for this use. Because the

quantities that appear in today’s

allocation differ significantly from the

quantities that appeared in the proposal,

EPA has decided to provide an

opportunity for post-promulgation

comment on this allocation.

EPA has determined that there is good

cause for making today’s allocation final

without prior notice of FDA’s

determination or an opportunity to

comment on the allocation, as adjusted

to reflect FDA’s determination. The

allocation of these essential-use

allowances to the specified MDI

manufacturers will allow for the

pharmaceutical industry to continue to

produce life-saving MDIs for the

treatment of asthma and chronic

obstructive pulmonary disease. Thus,

prior notice and an opportunity to

comment with regard to today’s

allocated quantities are impracticable

and contrary to the public interest. EPA

finds that this constitutes good cause

under 5 U.S.C. 553(b)(B). 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 required.

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) excepts

from this provision any action that

grants or recognizes an exemption or

relieves a restriction. Since today’s

action grants an exemption to the

phaseout of production and

consumption of CFCs, EPA is making

this action effective immediately to

ensure the availability of CFCs for

medical devices during the 2000 control

period.

III. Allocation of Essential Use

Allowances for Calendar Year 2000

What Is EPA’s Proposed Essential Use

Allocation for Calendar Year 2000?

In today’s action, EPA is allocating

essential use allowances for the year

2000 control period to entities listed in

Table I for exempted production or

import of the specific quantity of class

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 721

I controlled substances solely for the

specified essential use. The final

allocation for CFCs for use in MDIs

reflects FDA’s determination of the

amounts of CFCs that are necessary as

specified under section 604(d)(2) of the

Act.

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2000

Company Chemical Quantity

(metric tons)

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

International Pharmaceutical Aerosol Consortium (IPAC)—Medeva Americas, Inc.,

Boehringer Ingelheim Pharmaceuticals, Glaxo Wellcome, Rhone-Poulenc Rorer,

3M.

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

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

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

381.0

1169.0

89.0

Medisol Laboratories, Inc. ............................................................................................... CFC–11 ......................................................

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

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

13.0

29.0

7.0

Schering Corporation ...................................................................................................... CFC–11 ......................................................

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

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

301.0

747.0

0.0

Sciarra Laboratories, Inc. ................................................................................................ CFC–11 ......................................................

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

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

0.2

0.7

0.4

(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

The table above reflects FDA’s

determination of the quantities CFCs

that are necessary for calendar year 2000

and breaks down the amount of CFC by

molecule. However, in developing

today’s action, EPA has decided to

allocate essential-use allowances in

aggregate amounts in accordance with

Decision X/6 of the Parties to the

Montreal Protocol. Paragraph 2 of

Decision X/6 states that the ‘‘levels of

production and consumption necessary

to satisfy essential uses of CFC–11,

CFC–12, CFC–113, and CFC–114, for

metered-dose inhalers for asthma and

chronic obstructive pulmonary diseases

* * * are authorized as specified in

annex I to the report of the Tenth

Meeting of the Parties.’’ Paragraph 5 of

Decision X/6 goes on to say that ‘‘the

quantities approved under paragraph 2

above and all future approvals are for

total CFC volumes with flexibility

between CFCs within each group.’’ EPA

has determined that allocating essentialuse allowances for CFCs for the

manufacture of metered-dose inhalers in

the aggregate instead of on a compoundby-compound basis will add flexibility

for protecting patient health by allowing

companies to better meet market

demand for MDIs. Because CFC–11,

CFC–12 and CFC–114 all have an ozone

depleting potential of 1.0, allocating

these substances in the aggregate will

not cause any additional damage to the

stratospheric ozone layer.

The International Pharmaceutical

Aerosol Consortium (IPAC)

consolidated the essential use

exemption requests of its member

companies for administrative

convenience. EPA will separately

allocate the essential-use allowances

that FDA has determined to be

‘‘necessary’’ to each of IPAC’s member

companies by means of a confidential

letter.

Although the Montreal Protocol does

allow for a global essential use

exemption for small quantities of high

quality Class I ODS for use in laboratory

applications, the CAA does not contain

an explicit exemption for this use.

Therefore, import and production of

CFCs and carbon tetrachloride for use in

laboratory and analytical applications

may no longer be available for this use.

Today’s action allocates CFCs for use in

metered dose inhalers and methyl

chloroform for use in the Space Shuttle

and the Titan Rocket. Laboratory

essential uses will not be addressed in

today’s rulemaking. A separate final rule

addressing laboratory essential uses will

be published at a later date.

What Reporting Requirements Relate to

the Essential Uses of Ozone Depleting

Substances?

Any person obtaining class I

controlled substances after the phaseout

under the essential use exemptions in

today’s action 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

record keeping and reporting

requirements in 40 CFR 82.13.

IV. Response to Comments

EPA received comments from six

organizations in response to the

proposed rule. Three of these

organizations commented on various

aspects of the allocation of ODSs for

medical devices, and three discussed

the possibility of the lack of essential

use exemptions for laboratory essential

uses. Because a final rule addressing

laboratory essential uses will be

published separately at a later date, the

only comments discussed in this section

are those regarding the essential use

allocation for medical devices.

One commenter stated that EPA may

only authorize production and/or

importation of CFCs for an MDI if EPA

determines that there is no safe and

effective alternative propellant to the

CFCs used in the MDI. The commentor

asserts that FDA approval of a product

under the FDCA means that the

alternative propellant in that product is

safe and effective for purposes of the

CAA. The effect of this interpretation

would be limited, according to the

commentor, because ‘‘it is only the CFCcontaining product that contains the

same active moiety and same labeled

indications that no longer qualifies as a

‘medical device.’ ’’

We do not share the commentor’s

interpretation of the statutory language.

722 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

The first prong of the definition of

‘‘medical device’’ reads as follows: ‘‘The

term ‘‘medical device’’ means any

device * * *, diagnostic product, drug

* * *, and drug delivery system * * *

if such device, product, drug, or drug

delivery system utilizes a class I or class

II substance for which no safe and

effective alternative has been developed,

and where necessary, approved by the

Commissioner.’’ According to the

commentor, the phrase ‘‘for which no

safe and effective alternative has been

developed’’ modifies ‘‘class I or class II

substance,’’ and not ‘‘device, product,

drug, or drug delivery system.’’ The

difficulty with the commenter’s

interpretation is that FDA does not

approve MDI propellants separately

from drug products. Thus, it is

impossible for FDA to approve an

alternative to the class I or class II

substance (i.e., the propellant) alone

since FDA only approves MDIs under an

ANDA or NDA as a whole unit and not

by approving each of its components.

For this reason, even if we were to agree

with the commentor that the statutory

language was clear on its face, this

would be a situation where the literal

meaning of the statutory text would

produce absurd results. We believe that

the overall purpose of the CAA language

regarding medical devices is to ensure

that EPA’s mission of environmental

protection does not conflict with FDA’s

mission of protecting the public health.

Consistent with this purpose, we believe

that in drafting this prong of the

definition, Congress was focusing on the

availability of alternative medical

treatment for patients who rely on CFC

MDIs. We are not the appropriate

agency to decide whether such

alternative medical treatment is

available. We do not believe that

Congress intended EPA to make

decisions involving medical judgment.

On such questions, we defer to FDA.

Because FDA has not identified any

‘‘safe and effective alternative,’’ as the

phrase is used in the CAA, for any CFC

MDI, the first prong of the definition of

‘‘medical device’’ has not affected

today’s allocation.

One commentor asserted that ‘‘the

CAA contemplates a product-by-product

determination of essentiality at the time

a particular product is approved,’’ and

that this principle applies to generic

drugs as well as brand-name drugs. We

do not believe that the statutory

language requires each product’s

essentiality to be determined in a

vacuum, as if no other products of that

type existed. The definition of medical

device states that a device, product,

drug, or drug delivery system is a

medical device if the first prong of the

definition is satisfied and ‘‘if such

device, product, drug, or drug delivery

system, has, after notice and

opportunity for public comment, been

approved and determined to be essential

by the Commissioner in consultation

with the Administrator.’’ This language

does not prevent FDA from grouping

together particular types of products

containing the same active moiety and

determining that all products using a

given active moiety are essential. Our

understanding is that FDA has always

added uses to its essential use list

through notice and comment

rulemaking. Because FDA’s list of

essential uses is determined by active

moiety and makes no reference as to

whether a drug product is generic or

branded, we believe all MDIs for which

we are allocating CFCs are covered by

21 CFR 2.125, regardless of whether

they were or will be approved under an

NDA or ANDA.

This commentor also objects to EPA’s

use of FDA’s pre-1990 determinations of

essentiality in deciding whether an MDI

qualifies as a ‘‘medical device’’ for

purposes of the 1990 CAA

Amendments. The commentor states

that EPA cannot allocate essential use

allowances for particular MDIs until

FDA finalizes the proposed revisions to

its essential use regulations or engages

in a separate rulemaking to determine

whether those MDIs are essential.

While we are aware that FDA is

currently engaged in rulemaking to

revise its essential use regulations, we

are relying on FDA’s current essential

use list at 21 CFR 2.125 for purposes of

today’s action. That list contains all of

FDA’s determinations regarding

‘‘essentiality’’ to date. The statute does

not specify a particular time at which

FDA must make such a determination or

invalidate determinations made prior to

the date of the 1990 CAA Amendments.

Additionally, the 1990 Amendments to

the Clean Air Act use language

consistent with FDA’s regulations at 21

CFR 2.125. We presume that Congress

was aware of FDA’s regulations when it

passed the 1990 Amendments to the

CAA. Therefore, we believe that the

current essential use list remains valid.

If FDA revises its regulations, we will

take the revised list into account in

future allocation decisions.

We received several comments on the

meaning of the word ‘‘approved’’ in

section 601(8)(B). In the preamble to the

proposed rule, we stated that EPA and

FDA were discussing how best to

interpret this term, and that there were

at least two possible interpretations.

One such interpretation was that FDA

had to approve the specific product

under the FDCA. The second

interpretation was that FDA had to have

approved either that product or another

product that contained the same active

moiety. Several commentors stated that

the second interpretation would be

contrary to the plain meaning of the

statute.

Section 601(8)(B) refers to approval as

occurring ‘‘after notice and opportunity

for comment.’’ FDA has informed us

that approvals of drug products under

the FDCA are issued without notice and

comment. For this reason, FDA has

concluded that in using the word

‘‘approved,’’ Congress cannot have been

referring to approval of the drug product

under the FDCA. We agree with this

conclusion. We also note that the

statutory language refers to actions

taken by FDA, in consultation with EPA.

FDA does not consult with EPA prior to

approving drug products under the

FDCA. Furthermore, FDA points out

that it has provided notice and

opportunity for comment prior to

adding categories of drug products to

the essential use list in 40 CFR 2.125.

(FDA has also informally consulted with

EPA in the course of such actions.)

Therefore, FDA interprets the phrase

‘‘approved and determined to be

essential’’ as referring to FDA’s action in

approving the use of CFCs in MDIs

containing a particular active moiety as

an essential use. As a result, FDA

regards all MDIs containing an active

moiety that appears on its essential use

list as ‘‘approved’’ for purposes of

601(8)(B). According to this

interpretation, an MDI that has not yet

received approval of its ANDA or NDA

under the FDCA is considered to be

approved as an essential use if it

contains an active moiety that appears

on the essential use list.

Two commentors stated that section

601(8)(B) requires FDA approval of the

‘‘medical device’’ itself and that an

active moiety cannot be a ‘‘medical

device’’. We would like to clarify that

the term ‘‘device’’ and the phrase

‘‘medical device’’ have two separate and

distinct definitions. ‘‘Medical device’’ is

defined under 601(8) of the CAA.

‘‘Device’’ is defined under the FDCA.

Furthermore, we are not stating that the

active moiety in an MDI is a ‘‘medical

device’’ under the CAA. Rather, FDA

and EPA are interpreting section

601(8)(B) to allow MDIs to be ‘‘approved

and determined to be essential’’ by

active moiety. That is, if FDA, in

consultation with EPA, has listed MDIs

containing a particular active moiety as

essential, then a separate determination

is not necessary for each MDI that

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 723

contains that active moiety. FDA has

listed MDIs with reference to the active

moiety. Therefore, an MDI that contains

an active moiety that appears on FDA’s

essential use list has been ‘‘approved

and determined to be essential.’’

One commentor stated that according

to principles of statutory construction,

the term ‘‘approved’’ should be

interpreted the same way in section

601(8)(A) and section 601(8)(B). We

believe that the term ‘‘approved’’ must

be interpreted in light of the

surrounding language in each instance.

Section 601(8)(B) requires notice-andcomment rulemaking and refers to

action by FDA, in consultation with

EPA. Since approval under the FDCA

involves unilateral action by FDA

without notice-and-comment

rulemaking, it is reasonable to conclude

that section 601(8)(B) does not refer to

approval of an NDA or ANDA under the

FDCA. Instead, we interpret the phrase

‘‘approved and determined to be

essential’’ as referring to any MDI that

contains an active moiety appearing on

FDA’s essential use list. This

interpretation is consistent with the

surrounding language, as FDA adds uses

to its list through notice-and-comment

rulemaking, and EPA has a clear interest

in being consulted regarding the listing

of essential uses of ODS.

In regard to section 601(8)(A), we

interpret this section as requiring a

determination by FDA that there is a

‘‘safe and effective alternative’’ to a CFC

MDI. Approval under the FDCA may be

a prerequisite to such a determination.

(We note that the statutory language

calls for approval ‘‘where necessary.’’)

Because section 601(8)(A) does not refer

to notice and comment rulemaking or

consultation with EPA, it is reasonable

to interpret the reference to ‘‘approval’’

as a reference to approval under the

FDCA. However, neither EPA nor FDA

views FDA approval of a non-CFC

product under the FDCA as constituting

a determination that the product is a

‘‘safe and effective alternative’’ to any

CFC MDI. That determination would

require a separate analysis. FDA has

described some of the factors that would

enter into such an analysis in the

preamble to its September 1, 1999

notice of proposed rulemaking on

essential use determinations (64 FR

47735), and we refer the reader to that

notice for further details.

This commentor also stated that the

term ‘‘approved’’ as used in section

601(8)(B) should be interpreted as it is

interpreted under the FDCA, to refer to

the entire drug product rather than

simply the active ingredients. For the

reasons stated above, we have

concluded that the word ‘‘approved’’ in

section 601(8)(B) does not refer to

approval under the FDCA.

One commentor stated that EPA had

not meaningfully addressed the

requirements of section 604(d)(2) of the

CAA, the exception for medical devices.

This commentor stated that EPA must

provide information on ‘‘current market

demand for the use of CFCs in particular

MDIs, what quantities of CFCs were

requested by particular companies in

their annual applications for each

particular active moiety and how the

essential use allowances are

‘‘necessary’’ or ‘‘limited’’, and how the

applicant met its burden of

demonstrating that it qualifies for CFCs

under the essential use criteria set out

in the Act.’’

Section 604(d)(2) of the CAA states

that ‘‘the Administrator, after notice and

opportunity for public comment, shall,

to the extent such action is consistent

with the Montreal Protocol, authorize

the production of limited quantities of

class I substances solely for use in

medical devices if such authorization is

determined by the Commissioner, in

consultation with the Administrator, to

be necessary for use in medical

devices.’’ As described in Section II of

this preamble, EPA and FDA have

consulted on whether the limited

quantities contained in the proposed

rule were ‘‘necessary’’ for use in

medical devices, and FDA has

determined that 2737.3 tons of the

proposed amount are ‘‘necessary.’’

Accordingly, in this interim final rule,

EPA is allocating 2737.3 tons for use in

medical devices.

With regard to the commentor’s

request for information, the letter from

FDA states the following: ‘‘. . . we

[FDA] have examine the table in your

[EPA] proposed rule that lists the

essential use amounts requested by

sponsors for production of medical

devices (64 FR 59143, Table 1). We have

also examined the information you

obtained from individual sponsors

regarding their intended use of CFCs in

specific products. We compared this

information to the information filed

with us by sponsors in their annual

reports.’’ FDA goes on to say ‘‘In listing

the amounts we believe to be necessary

for use in medical devices, we referred

to historical use and have included an

additional amount to allow for overage,

for waste during manufacturing, for

uncertainties in the supply chain of

CFCs since they are no longer produced

in the United States, for changes in

future market shares of specific

products, as well as for unforeseen

circumstances in the market. We also

provided additional amounts based on

our knowledge of certain manufacturing

problems. In addition, we eliminated

any double-counting we found and

eliminated allocations for uses not

considered essential by the parties to

the Montreal Protocol, even if those uses

are currently listed in our regulation at

21 CFR 2.125(e).’’ FDA also noted that

they accounted for CFCs for use in the

production of MDIs that would

ultimately be exported to Canada. It

should be noted that much of the data

that FDA used in their analysis were

confidential business information and

cannot be shared publicly. These

confidential data included each

applicant’s response to EPA’s request

for information on the quantity of each

CFC to be used in the manufacture of

specific products in calendar year 2000,

EPA’s historical data on yearly import

and actual use of CFCs for each

company, and information filed with

FDA by drug sponsors in their annual

reports.

The commentor further stated that in

order to achieve the congressional

objective of reducing and eliminating

production and use of ODS ‘‘as

expeditiously as possible,’’ ‘‘EPA and

FDA must conclude that new MDIs are

not ‘necessary’ where FDA has

approved or issued an ‘apposable’ letter

for a CFC-free alternative involving the

same active moiety and overlapping

labeling as that in the CFC-containing

MDI.’’ The commentor also states that if

EPA nonetheless finds that CFCs are

necessary for these MDIs, EPA must

limit the quantities allocated to those

that are necessary until the CFC-free

alternative is approved. The commentor

goes on to describe this stance as a

‘‘policy.’’

Under section 604(d)(2) of the CAA,

FDA (in consultation with EPA)

determines whether production or

import of CFCs for MDIs is necessary.

EPA does not independently make such

a determination, as the comment

appears to suggest. We defer to FDA on

the wisdom of adopting the policy urged

by the commentor. The commentor has

not demonstrated that this policy is

compelled by the statutory language.

For purposes of today’s action, we are

relying on FDA’s determination that the

quantities allocated in the final rule are

‘‘necessary.’’

One commenter stated that EPA must

ensure that its allocation is consistent

with the decisions and

recommendations of the Parties to the

Montreal Protocol. The commenter

refers to two existing decisions:

Decision IV/25, which provides criteria

for assessing essential uses for purposes

724 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

of the Protocol’s control measures, and

Decision VIII/10, which addresses the

transition away from CFC-based MDIs.

Decision IV/25 contemplates that

Parties nominating essential uses will

apply the stated criteria at the time of

nomination, and that the Protocol’s

Technology and Economic Assessment

Panel will apply these criteria in

developing its recommendations on

whether the Parties should approve the

nominated uses and quantities at their

yearly meeting. Thus, these criteria

drive the essential use process at the

international level. The uses to which

we are allocating CFCs in today’s action

were approved at the Tenth Meeting of

the Parties, after nomination by the U.S.

and evaluation by the Technology and

Economic Assessment Panel. Therefore,

we believe today’s allocation is

consistent with the Protocol. In

addition, the commenter has not

identified any respect in which these

uses fail to meet the criteria in Decision

IV/25.

Decision VIII/10 describes a variety of

actions that Parties are to request MDI

companies to undertake. For example,

Parties are to ‘‘request companies

applying for MDI essential-use

exemptions to demonstrate that they are

undertaking individual or collaborative

industry efforts, in consultation with the

medical community, to educate healthcare professionals and patients about

other treatment options and the

transition to non-CFC alternatives.’’

(Decision VIII/10(2)) The TEAP

Handbook on Essential Use

Nominations was revised in 1997 to

incorporate requests relevant to

Decision VIII/10. For example, question

B.2. of the form entitled ‘‘Nomination of

the Aerosol Metered Dose Inhaler (MDI)

as an Essential Use,’’ in Appendix D of

the TEAP Handbook on Essential Use

Nominations, requests applicants to

‘‘List and describe in detail the

education efforts, individual and/or

collaborative, being undertaken to

advise patients and health care

professionals about treatment options

and the transition to non-CFC

alternatives.’’ EPA requests companies

applying for MDI essential-use

exemptions to submit the information

specified in the TEAP Handbook,

including the information relevant to

Decision VIII/10 . Nevertheless, we do

not view Decision VIII/10 as imposing

barriers to allocation. The Decision does

not attach any consequences to the

company’s failure to comply with any of

the requests. The commenter incorrectly

describes Decision VIII/10 as

‘‘requiring’’ manufacturers of CFC MDIs

to take the specified actions. By its own

terms, the Decision simply states that

Parties ‘‘will request’’ companies to take

these actions.

One commenter stated that under the

CAA EPA cannot allocate CFCs to

Medisol Laboratories for use in their

generic albuterol MDI because this

product does not fall within the

definition of a ‘‘medical device’’ under

the statute. For reasons stated above,

EPA considers the generic albuterol MDI

to be a medical device as defined by the

statute and thus eligible to receive

essential use allowances. While we are

aware that FDA has approved a CFC-free

albuterol product, FDA has not

determined that this product is a ‘‘safe

and effective alternative’’ to the Medisol

generic albuterol MDI. In addition,

albuterol is an adrenergic

bronchodilator. FDA continues to regard

the use of CFCs in ‘‘[m]etered-dose

adrenergic bronchodilator human drugs

for oral inhalation’’ as essential (21 CFR

2.125(e)(3)). Because FDA’s list of

essential uses makes no reference as to

whether a drug product is generic or

branded, we believe all MDIs for which

we are allocating CFCs are covered

under 21 CFR 2.125 regardless of

whether they were or will be approved

under an NDA or ANDA. Therefore, we

believe that CFC albuterol MDIs are

‘‘medical devices.’’ Finally, we have

based our allocation of 49 tons of CFCs

to Medisol on FDA’s determination that

this quantity is ‘‘necessary’’ under CAA

section 604(d)(2).

One commenter stated that Sciarra’s

application for essential use allowances

for production of albuterol, epinephrine

hydrochloride, ipratropium bromide,

triamcinalone acetonide,

beclomethasone dipropionate, and

cromolyn sodium MDIs should be

denied because these products do not

satisfy many, if not all of the

requirements set by the CAA. According

to the commenter, an albuterol MDI

should not qualify as a ‘‘medical

device’’ under the CAA because there is

a ‘‘safe and effective alternative

propellant’’ (HFC–134a), that is, a safe

and effective alternative to the CFCs

used in albuterol MDIs. Additionally,

the commenter stated that FDA has not

determined that the generic products

listed above are essential after notice

and opportunity for public comment.

The commenter also noted that FDA has

issued apposable letters for CFC-free

versions of all the above moieties except

epinephrine and ipratripium, and

concluded that even if these products

qualify as ‘‘medical devices,’’ the

allocation of CFCs is not ‘‘necessary.’’

Additionally, the commenter stated that

Sciarra’s application provided

inadequate information in its response

to the Protocol criteria. Specifically,

Sciarra did not provide information

about the availability of alternatives to

CFC MDIs or information on its plans

for implementation of these alternatives.

The commenter did note that Sciarra

had stated that it would develop its own

non-CFC products after receiving

approval for its CFC-containing

products.

As stated before, while FDA has

approved a CFC-free albuterol product,

FDA has not determined that this

product is a ‘‘safe and effective

alternative’’ to any other albuterol

product. In addition, albuterol is an

adrenergic bronchodilator. FDA

continues to regard the use of CFCs in

‘‘[m]etered-dose adrenergic

bronchodilator human drugs for oral

inhalation’’ as essential (21 CFR

2.125(e)(3)). Therefore, we believe that

CFC albuterol MDIs are ‘‘medical

devices.’’ Our understanding is that

FDA has always added uses to its

essential use list through notice and

comment rulemaking. Because FDA’s

list of essential uses makes no reference

as to whether a drug product is generic

or branded, we believe all MDIs for

which we are allocating CFCs are

covered under 21 CFR 2.125 regardless

of whether they were or will be

approved under an NDA or ANDA. In

Sciarra’s response to the CAA section

114 letter that EPA sent to MDI

manufacturers on October 13, 1999,

Sciarra provided a refined list of

moieties for the MDIs for which it is

requesting CFCs. The use of any of these

moieties in an MDI is essential under 21

CFR 2.125(e). With the regard to the

issue of whether CFCs are ‘‘necessary’’

for the Sciarra MDIs, we are relying on

FDA’s determination. FDA, in its

analysis of the amount of CFCs

necessary for the production of MDIs,

determined that much of the quantity

we had proposed to allocate to Sciarra

was not ‘‘necessary’’ because at present,

Sciarra does not have any currently

approved CFC MDIs. The essential use

allocation for Sciarra was reduced

accordingly in this interim final rule.

The TEAP Handbook contains several

questions relating to the availability of

alternatives. As we noted earlier, many

of the questions in the current TEAP

Handbook derive from Decision VIII/10.

This Decision directs the Parties to

request certain information from

companies applying for MDI essentialuse exemptions. However, it does not

attach specific consequences to a

company’s failure to provide

information, nor does it state what

constitutes an adequate response.

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 725

One commenter stated that the

application for CFCs from Schering

should be denied only if EPA also

denies CFC applications for albuterol

MDIs for all other companies marketing

such products. The commenter

identified Schering as the company that

markets the non-CFC albuterol MDI. For

the reasons stated above, EPA is

allocating CFCs to manufacturers of CFC

albuterol MDIs, including Schering.

One commenter stated that the public

version of the application for the

International Pharmaceutical Aerosol

Consortium (IPAC) did not provide

information about the specific products

that would be manufactured using the

essential use allowances. The

commenter noted that Medeva Americas

is one of the companies identified in the

IPAC proposal, and stated that this

company markets a generic CFC

albuterol MDI. The commenter further

stated that another IPAC company,

Glaxo Wellcome, markets a CFC

albuterol MDI. According to the

commenter, neither of these companies

should receive CFC allocations for these

products.

IPAC completed the application for

essential use allowances in accordance

with the TEAP Handbook. EPA

requested information about the specific

products for which the allowances

would be used from IPAC’s member

companies in a letter issued pursuant to

section 114 of the CAA on October 13,

1999. The responses to these letters are

considered confidential business

information and are therefore not

available in the public docket. As stated

earlier FDA used this information in its

analysis of what quantities of CFCs are

necessary for the production of medical

devices as defined in the Act. Each of

the products for which FDA determined

a quantity of CFCs to be necessary is

‘‘essential’’ under 21 CFR 2.125(e).

Since the commenter specifically

mentions albuterol, we note again that

albuterol is an adrenergic

bronchodilator. FDA continues to regard

the use of CFCs in ‘‘[m]etered-dose

adrenergic bronchodilator human drugs

for oral inhalation’’ as essential (21 CFR

2.125(e)(3)). Our understanding is that

FDA has always added uses to its

essential use list through notice and

comment rulemaking. Because FDA’s

list of essential uses makes no reference

as to whether a drug product is generic

or branded, we believe all MDIs for

which we are allocating CFCs are

covered under 21 CFR 2.125 regardless

of whether they were or will be

approved under an NDA or ANDA.

Furthermore, as stated before, while

FDA has approved a CFC-free albuterol

product, FDA has not determined that

this product is a ‘‘safe and effective

alternative’’ to any other albuterol

product. Therefore, we believe that CFC

albuterol MDIs are ‘‘medical devices.’’

One commenter stated that EPA

determines the safety and efficacy of

alternatives to CFCs under the

Significant New Alternatives Policy

(SNAP) program (section 612 of the

CAA). The commenter further stated

that EPA relies upon FDA’s approval of

medical products containing alternative

propellants as a determination that the

alternative propellant has no adverse

human health effects. The commenter

concluded that ‘‘when FDA approves a

product containing an alternative

propellant as safe and effective under

the FDCA, EPA concludes that the nonCFC propellant in that product is safe

and effective for the purposes of the

CAA.’’

Under section 612 of the CAA, EPA

determines whether substitutes for

ozone-depleting substances may present

adverse effects to human health or the

environment. In the SNAP rule

published in the Federal Register on

March 18, 1994 (59 FR 13044), EPA

stated: ‘‘Some medical devices * * *

currently contain class I or class II

compounds. The Agency has

determined that such products are

exempt from further review for human

health effects under the SNAP program

where FDA approval of such effects is

required before a product can be

introduced into commerce. EPA will

rely in its SNAP determination on

FDA’s conclusions regarding health

effects. The Agency believes this

exemption is justified because of the

higher burden of proof placed on

submitters under the FDCA. However,

the Agency will continue to evaluate all

other environmental effects of the

proposed substitute, and will consult

with the FDA to determine the

appropriate course of action.’’ (59 FR

130660).

The quoted language simply indicates

that EPA will conclude that a substitute

does not present adverse health effects

if FDA approves, under the FDCA, a

product containing the substitute. It

does not say that EPA will treat the

product approval as a determination

that the substitute is a ‘‘safe and

effective alternative’’ to the ODS for

purposes of section 601(8)(A). FDA

approval of a CFC-free MDI under the

FDCA does not constitute approval of

the non-CFC propellant as safe and

effective. Such approval relates to the

product in its entirety, not to the

propellant. Therefore, it would be

inappropriate for the EPA to conclude

from FDA’s approval of a non-CFC MDI

that the non-CFC propellant had been

approved for use in MDIs generally. In

listing acceptable alternatives under the

SNAP program, EPA does not intend to

preempt FDA’s role in approving

individual products or in deciding

whether a particular product is a safe

and effective alternative for another.

V. Administrative Requirements

A. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Public

Law 104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,

and tribal governments and the private

sector.

Under section 202 of the UMRA, EPA

generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in expenditures by State, local,

and tribal governments, in the aggregate,

or by the private sector, of $100 million

or more in any one year. Before

promulgating an EPA rule for which a

written statement is needed, section 205

of the UMRA generally requires EPA to

identify and consider a reasonable

number of regulatory alternatives and

adopt the least costly, most costeffective or least burdensome alternative

that achieves the objectives of the rule.

The provisions of section 205 do not

apply when they are inconsistent with

applicable law. Moreover, section 205

allows EPA to adopt an alternative other

than the least costly, most cost-effective

or least burdensome alternative if the

Administrator publishes with the final

rule an explanation why that alternative

was not adopted. Section 204 of the

UMRA requires the Agency to develop

a process to allow elected state, local,

and tribal government officials to

provide input in the development of any

proposal containing a significant

Federal intergovernmental mandate.

Before EPA establishes any regulatory

requirements that may significantly or

uniquely affect small governments,

including tribal governments, it must

have developed under section 203 of the

UMRA a small government agency plan.

The plan must provide for notifying

potentially affected small governments,

enabling officials of affected small

governments to have meaningful and

timely input in the development of EPA

regulatory proposals with significant

Federal intergovernmental mandates,

and informing, educating, and advising

small governments on compliance with

the regulatory requirements.

726 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

Today’s rule contains no Federal

mandates (under the regulatory

provisions of Title II of the UMRA) for

State, local, or tribal governments or the

private sector. Because this rule imposes

no enforceable duty on any State, local

or tribal government it is not subject to

the requirements of sections 202 and

205 of the UMRA. EPA has also

determined that this rule contains no

regulatory requirements that might

significantly or uniquely affect small

governments; therefore, EPA is not

required to develop a plan with regard

to small governments under section 203.

Finally, because this rule does not

contain a significant intergovernmental

mandate, the Agency is not required to

develop a process to obtain input from

elected state, local, and tribal officials

under section 204.

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 entitlement, 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 OMB and EPA that

this action is not a ‘‘significant

regulatory action’’ under the terms of

Executive Order 12866 and is therefore

not subject to OMB review under 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 13084: Consultation

and Coordination With Indian Tribal

Governments

Under Executive Order 13084, EPA

may not issue a regulation that is not

required by statute, that significantly or

uniquely affects the communities of

Indian tribal governments, and that

imposes substantial direct compliance

costs on those communities, unless the

Federal government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments, or EPA consults with

those governments. If EPA complies by

consulting, Executive Order 13084

requires EPA to provide to the Office of

Management and Budget, in a separately

identified section of the preamble to the

rule, a description of the extent of EPA’s

prior consultation with representatives

of affected tribal governments, a

summary of the nature of their concerns,

and a statement supporting the need to

issue the regulation. In addition,

Executive Order 13084 requires EPA to

develop an effective process permitting

elected officials and other

representatives of Indian tribal

governments ‘‘to provide meaningful

and timely input in the development of

regulatory policies on matters that

significantly or uniquely affect their

communities.’’ Today’s rule does not

significantly or uniquely affect the

communities of Indian tribal

governments. Accordingly, the

requirements of section 3(b) of

Executive Order 13084 do not apply to

this rule.

E. Regulatory Flexibility

After considering the economic

impacts of today’s final rule on small

entities, EPA has determined that it is

not necessary to prepare a regulatory

flexibility analysis in connection with

this final rule. EPA has also determined

that this action will not have a

significant economic impact on a

substantial number of small entities.

This rule does not have a significant

impact on a substantial number of small

entities. The only entities that are

directly affected by this allocation are

those to which CFCs and other ODSs are

being allocated. There are only ten

entities which are affected by this

rulemaking (see table 1 above). This rule

does not have an adverse economic

impact on any entity because it grants

exceptions to a pre-existing ban.

F. Applicability of Executive Order

13045: Protection of Children From

Environmental Health Risks and Safety

Risks

Executive Order 13045: ‘‘Protection of

Children from Environmental Health

Risks and Safety Risks’’ (62 FR 19885,

April 23, 1997) applies to any rule that

(1) is determined to be ‘‘economically

significant’’ as defined under Executive

Order 12866, and (2) concerns an

environmental health and safety risk

that EPA has reason to believe may have

a disproportionate effect on children. If

the regulatory action meets both criteria,

the Agency must evaluate the

environmental health or safety effects of

the planned rule on children, and

explain why the planned regulation is

preferable to other potentially effective

and reasonably feasible alternatives

considered by the Agency. EPA

interprets Executive Order 13045 as

applying only to those regulatory

actions that are based on health or safety

risks, such that the analysis required

under section 5–501 of the Order has

the potential to influence the regulation.

This rule is not subject to Executive

Order 13045 because it implements the

phaseout schedule and exemptions

established by Congress in Title VI of

the Clean Air Act.

G. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (‘‘NTTAA’’), Public Law No.

104–113, section 12(d) (15 U.S.C. 272

note) directs EPA to use voluntary

consensus standards in its regulatory

activities unless to do so would be

Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations 727

inconsistent with applicable law or

otherwise impractical. Voluntary

consensus standards are technical

standards (e.g., materials specifications,

test methods, sampling procedures, and

business practices) that are developed or

adopted by voluntary consensus

standards bodies. The NTTAA directs

EPA to provide Congress, through OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards. This

rule does not involve technical

standards. Therefore, EPA did not

consider the use of any voluntary

consensus standards.

H. Executive Order 13132 (Federalism)

Executive Order 13132, entitled

‘‘Federalism’’ (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’ Under

Executive Order 13132, EPA may not

issue a regulation that has federalism

implications, that imposes substantial

direct compliance costs, and that is not

required by statute, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by State and local

governments, or EPA consults with

State and local officials early in the

process of developing the proposed

regulation. EPA also may not issue a

regulation that has federalism

implications and that preempts State

law unless the Agency consults with

State and local officials early in the

process of developing the proposed

regulation.

If EPA complies by consulting,

Executive Order 13132 requires EPA to

provide to the Office of Management

and Budget (OMB), in a separately

identified section of the preamble to the

rule, a federalism summary impact

statement (FSIS). The FSIS must include

a description of the extent of EPA’s

prior consultation with State and local

officials, a summary of the nature of

their concerns and the agency’s position

supporting the need to issue the

regulation, and a statement of the extent

to which the concerns of State and local

officials have been met. Also, when EPA

transmits a draft final rule with

federalism implications to OMB for

review pursuant to Executive Order

12866, EPA must include a certification

from the agency’s Federalism Official

stating that EPA has met the

requirements of Executive Order 13132

in a meaningful and timely manner.

This interim final rule will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. This interim

final rule will affect only the ability of

private entities and the national

government to request production of

controlled ozone-depleting substances.

Thus, the requirements of section 6 of

the Executive Order do not apply to this

rule.

VI. Judicial Review

Under Section 307(b)(1) of the Act,

EPA finds that these regulations are of

national applicability. Accordingly,

judicial review of this action is available

only by the filing of a petition for review

in the United States Court of Appeals

for the District of Columbia Circuit

within sixty days of publication of this

action in the Federal Register. Under

Section 307(b)(2), the requirements of

this rule may not be challenged later in

judicial proceedings brought to enforce

those requirements.

VII. Congressional Review

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. Section 808 allows

the issuing agency to make a rule

effective sooner than otherwise

provided by the CRA if the agency

makes a good cause finding that notice

and public procedure is impracticable,

unnecessary or contrary to the public

interest. This determination must be

supported by a brief statement. 5 U.S.C.

808(2). As stated previously, EPA has

made such a good cause finding,

including the reasons therefor, and

established an effective date of January

6, 2000. EPA will submit 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 United

States prior to publication of the rule in

the Federal Register. This action 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: December 30, 1999.

Carol M. Browner,

Administrator.

40 CFR Part 82 is 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(t)(2) is amended by

revising the table to read as follows:

§ 82.4 Prohibitions.

* * * * * *

(t) * * *

(2) * * *

728 Federal Register / Vol. 65, No. 4 / Thursday, January 6, 2000 / Rules and Regulations

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2000

Company Chemical Quantity

(metric tons)

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

International Pharmaceutical Aerosol Consortium (IPAC)—Medeva Americas, Inc.,

Boehringer Ingelheim Pharmaceuticals, Glaxo Wellcome, Rhone-Poulenc Rorer,

3M.

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

CFC–12 or

CFC–114

1639.0

Medisol Laboratories, Inc. ............................................................................................... CFC–11 or ..................................................

CFC–12 or

CFC–114

49.0

Schering Corporation ...................................................................................................... CFC–11 or ..................................................

CFC–12 or

CFC–114

1048.0

Sciarra Laboratories, Inc. ................................................................................................ CFC–11 or ..................................................

CFC–12 or

CFC–114

1.3

(2)(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

* * * * *

[FR Doc. 00–273 Filed 1–5–00; 8:45 am]

BILLING CODE 6560–50–P