1462 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

1 ‘‘Consumption’’ is defined as the amount of a

substance produced in the United States, plus the

amount imported, minus the amount exported to

Parties to the Montreal Protocol (see section 601(6)

of the Clean Air Act). Stockpiles of class I ODSs

produced prior to the 1996 phase-out can continue

to be used for purposes not expressly banned at 40

CFR part 82, subpart C—Ban on Nonessential

Products Containing Class I Substances and Ban on

Nonessential Products Containing or Manufactured

with Class II Substances.

2Pharmaceutical companies who commented

were the following: Aventis Pharmaceuticals, 3M

Pharmaceuticals, Boehringer Ingelheim

Pharmaceuticals Inc., Schering Corporation, Sidmak

Laboratories Inc., Glaxo Wellcome. 3The International Pharmaceutical Aerosol

Consortium represents the following companies:

AstraZeneca, Boehringer Ingelheim, CelltechMedeva, Cheisi Farmaceutici, Glaxo Wellcome, and

Norton Healthcare.

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–6929–6]

RIN 2060–AJ33

Protection of Stratospheric Ozone:

Allocation of Essential Use Allowances

for Calendar Year 2001: Allocation for

Metered Dose Inhalers and the Space

Shuttle and Titan Rockets

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: With this action, EPA is

allocating essential use allowances for

stratospheric ozone depleting

substances for calendar year 2001. EPA

allocates essential use allowances to an

applicant for exempted production or

import of a specific quantity of class I

ozone depleting substances solely for

the designated essential use. Essential

use allowances permit a person to

obtain controlled substances as an

exemption to the January 1, 1996

regulatory phase-out of production and

import of these substances. Today, EPA

is allocating essential use allowances for

the production and/or import of class I

substances for use in medical devices

for the treatment of asthma and chronic

obstructive pulmonary disease, and for

use in the Space Shuttle and Titan

Rockets for calendar year 2001. With

today’s action, EPA is also amending the

regulations to allow essential use

allowances for medical devices to be

transferred among essential use

allowance holders. The essential use

exemption for class I ODSs for

laboratory and analytical applications

will be addressed in a separate

rulemaking.

DATES: This action is effective January 8,

2001.

ADDRESSES: Materials relevant to this

rulemaking are contained in Docket No.

A–93–39. The Docket phone is (202)

260–7548 and is located in Waterside

Mall, Room M–1500, 401 M Street, SW.,

Washington, DC, 20460. The materials

may be inspected from 8 a.m. until 5:30

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 1–800–296–1996 or Erin Birgfeld,

U.S. Environmental Protection Agency,

Global Programs Division, Office of

Atmospheric Programs, 6205J, 1200

Pennsylvania Avenue N.W.,

Washington, DC, 20460; telephone (202)

564–9079; fax: (202) 565–2095; email:

birgfeld.erin@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Allocation Process for CFCs for use in

Medical Devices for the Year 2001

III. Allocation of Essential Use Allowances

for Calendar Year 2001

IV. Transfer of Essential Use Allowances for

CFCs Among Essential Use Allowance

Holders

V. Administrative Requirements

VI. Judicial Review

VII. Submittal to Congress and the General

Accounting Office

I. Background

The Montreal Protocol on Substances

that Deplete the Ozone Layer (Protocol)

is the international agreement to reduce

and eventually eliminate production

and consumption1 of all stratospheric

ozone depleting substances (ODSs). As

of January 1996, production and import

of class I ODSs (except methyl bromide)

were phased out in all developed

countries, including the United States.

However, the Protocol and the Clean Air

Act (CAA or Act) provide exemptions

that allow for the continued import and/

or production of class I ODSs for

specific uses. Under the Montreal

Protocol, exemptions are granted for

uses that are determined by the Parties

to be ‘‘essential’’ as defined by Decision

IV/25. 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.

EPA is responsible for allocating

essential use allowances (EUAs) at the

domestic level through rulemaking in

accordance with provisions in the CAA.

The CAA provides a specific exemption

from the phase-out of class I ODSs at

section 604(d)(2) that allows for the

continued import and production of

CFCs for use in medical devices.

Today’s action allocates EUAs for CFCs

for use in metered dose inhalers (MDIs)

for the treatment of asthma and chronic

obstructive pulmonary disease (COPD)

for calendar year 2001. EPA is also

allocating methyl chloroform for use in

the Space Shuttle and the Titan Rocket

for calendar year 2001 under the

authority of the statutory phase-out at

section 604(a). Today’s action also

amends the regulations at 40 CFR 82.12

to allow transfer of EUAs for CFCs

among MDI companies who hold

essential use allowances.

Overview of the Notice of Proposed

Rulemaking

The Notice of Proposed Rulemaking

(NPRM) proposing to allocate essential

use allowances for calendar year 2001

was published on October 6, 2000 (65

FR 59783). In the NPRM, EPA proposed

to allocate CFCs for use in metered dose

inhalers (MDIs) and methyl chloroform

for use in the Space Shuttle and Titan

Rocket. EPA proposed to allocate a total

of 3098.67 metric tons of CFCs, which

is the quantity that the Food and Drug

Administration (FDA), in consultation

with EPA, determined to be ‘‘necessary’’

for use in MDIs. The total amount of

essential use authorizations for MDIs

granted to the U.S. by the Parties to the

Montreal Protocol for 2001 is 3,101

metric tons. We explained in the NPRM

that it would not be possible to allocate

CFCs in an amount higher than

allocated to the U.S. by the Parties to the

Protocol. EPA also proposed changes to

the regulations at 40 CFR 82.12 that

would allow transfer of EUAs for CFCs

among essential use holders. We also

proposed to allocate 60.1 metric tons of

methyl chloroform (MCF) for use in the

Space Shuttle and Titan Rockets.

EPA received a total of eight

comments on the NPRM. Six comments

were from individual companies who

produce MDIs,2 one was from a

consortium group that represents MDI

manufacturers,3 and one was from

Friends of the Earth. Three commenters

expressed support for the provision to

allow transfer of EUAs for CFCs

between allowance holders. One

commenter requested additional EUAs

to meet their projected needs for MDI

production in 2001 without utilizing

their strategic reserves. Two companies

requested that their EUAs be

reapportioned between them, but in the

aggregate did not request an increase in

EUAs. One commenter stated that EPA

and FDA had improperly interpreted the

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1463

exemption for medical devices in the

Act, and should not allocate CFCs for

MDI products where an alternative

propellant is available. Another

commenter stated that the Act does not

require EPA to transfer to FDA the

responsibility to determine the amount

of the allocation for CFCs, and that the

FDA decision making process for

determining the amount of CFCs

necessary should be more transparent.

EPA will summarize and address all

comments in the body of this preamble.

There were no comments on the

proposed allocation of MCF for use in

the Space Shuttle and Titan Rockets.

How Do the Parties to the Montreal

Protocol Define an ‘‘Essential Use’’?

Decision IV/25 of the Parties to the

Montreal Protocol set forth the criteria

for determining whether a particular use

of class I ODS is ‘‘essential’’ and would

thus be eligible to receive EUAs for

controlled substances. This decision

states 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.’’

What Was the International Procedure

for Approving Essential Use Exemptions

for the Year 2001?

The international process for

nominating and approving essential use

allowances for the year 2001 occurred in

the same way as in prior years. The

companies in Table I submitted

applications either on their own or as a

part of the International Pharmaceutical

Aerosol Consortium (IPAC), requesting

class I ODSs for essential uses in

response to the August 10, 1998 Federal

Register document (63 FR 42629). Their

applications requested exemptions for

the production and import of specific

quantities of certain class I controlled

substances after the phase-out, and

provided information in accordance

with the criteria in Decision IV/25 of the

Protocol and the procedures outlined in

the ‘‘1997 Handbook on Essential Use

Nominations.’’ EPA reviewed the

applications and nominated these uses

to the Protocol Secretariat for

consideration by the Technical and

Economic Assessment Panel (TEAP) and

its Technical Options Committees. MDI

producers requested a total of 3,101

metric tons of CFCs for use in 2001. The

Parties to the Montreal Protocol

approved this amount as essential for

the U.S. for 2001 at the Eleventh

Meeting in 1999 (Decision XI/14). On

September 15, 1999, EPA issued another

notice requesting supplemental

applications for essential use

allowances for the year 2001 and

beyond (64 FR 50083). No company

requested a supplemental amount of

CFCs for the year 2001 at that time.

How Does the Clean Air Act Authorize

Essential Use Allowances for MDIs?

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

a standing exemption to the phase-out

of class I ODSs for the production and

importation of CFCs for use in medical

devices which reads:

‘‘Notwithstanding the termination of

production required by subsection (b), 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.’’

Section 601(8) of the Clean Air Act

defines the term ‘‘medical device’’ and

states the following:

[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].

As discussed in the NPRM, EPA is

relying on FDA regulations at 21 CFR

2.125 to provide determinations of

whether a ‘‘safe and effective

alternative’’ is available for any

particular CFC MDI. It should be noted

that FDA 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’’ for any other

CFC MDI product under the Act. FDA

states in their notice of proposed

rulemaking on essential use

determinations 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.’’ (September 1, 1999, 64 FR

47735). While FDA has approved two

non-CFC MDIs as of December 1, 2000,

FDA has yet not identified any ‘‘safe

and effective alternative’’ to any CFC

MDI as specified by section 601(8)(A).

Thus, part (A) of the definition of

medical device has been met, and is

consistent with today’s rulemaking.

With respect to section 601(8)(B), EPA

is relying on current FDA regulations

(21 CFR 2.125) listing medical devices

that FDA has found to be essential. The

companies for which EPA is granting

essential use allowances produce CFC

MDIs covered by this regulation. Thus,

the products for which EPA is granting

essential use allowances are

‘‘determined to be essential’’ by FDA.

One commenter stated that under

section 601(8)(A), EPA must determine

that no safe and effective alternative

propellant exists for any MDI to meet

the definition of ‘‘medical device.’’ EPA

believes that the phrase ‘‘safe and

effective alternative’’ at section

608(1)(A) does not refer an alternative

propellant, but refers to a ‘‘safe and

effective alternative’’ to a CFC MDI. This

is because FDA only approves MDIs

under a New Drug Application (NDA) or

an Abbreviated New Drug Application

(ANDA) as a whole unit and not by

approving each of its components.

Therefore, it is impossible for FDA to

approve an alternative to the class I or

class II substance (i.e. the propellant)

alone, and it is reasonable to conclude

that the phrase ‘‘safe and effective

alternative’’ refers to an adequate

replacement for the CFC MDI product.

This commenter also quoted a passage

from the legislative history of the 1990

Amendments which states that ‘‘unless

a safe substitute exists or until a

1464 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

substitute is developed and approved by

FDA, a drug delivery system may be

found by the Commissioner and the

Administrator to be essential’’ (S. Rep

No. 228, 101st Cong., 1st Sess. 1989,

1990). The commenter believes that this

passage supports their belief that once a

drug containing a safe and effective

alternative propellant has been

approved by FDA, FDA has no authority

to continue to designate analogous CFCcontaining products as ‘‘essential’’. In

response, we note that the term ‘‘drug

delivery system’’ indicates that Congress

envisioned that FDA would need to

approve an entire non-CFC drug

delivery system, and not just the

alternative propellant. Further, the use

of the term ‘‘substitute’’ indicates that

Congress was looking to FDA to

determine whether a non-CFC MDI is a

safe and effective replacement for a

particular CFC MDI (i.e. a ‘‘safe and

effective alternative’’). While this report

refers to Senate language which is

somewhat different from what appears

in the 1990 Amendments, the Senate’s

intent, revealed by this passage is

consistent with EPA and FDA’s

interpretation of the Act.

The commenter also states that the

safety and efficacy of alternatives to

CFCs is determined by EPA under

section 612 of the CAA, and that EPA

had stated that it would rely upon

FDA’s approval of medical products

containing alternative propellants under

the Food Drug and Cosmetic Act (FDCA)

for a determination that there are no

human health effects from the use of the

alternative propellant. Thus, the

commenter believes that when FDA

approves a non-CFC MDI as safe and

effective under the FDCA, EPA must

conclude that the non-CFC propellant in

that product is safe and effective for the

purposes of the CAA. In fact, EPA has

already reviewed the health risks

associated with alternative aerosol

propellants for use in non-CFC MDIs

under section 612 of the Act.

Nevertheless, EPA disagrees with the

assertion that a determination that an

alternative propellant to an ODS is

acceptable under section 612 of the Act

has any bearing on the determination of

whether a non-CFC MDI is a ‘‘safe and

effective alternative’’ to a CFC MDI as

required by section 601(8)(A).

The commenter states that when a

non-CFC MDI is approved under the

FDCA, only CFC-based products

containing the same active moiety, and

the same labeled indications would no

longer qualify as ‘‘medical devices’’

under the Act, and that in instances

where the labeled indications of a nonCFC drug do not fully duplicate those of

a CFC product, EPA may only authorize

production of limited quantities of CFCs

that the EUA applicant demonstrates are

necessary to serve patients not covered

by the non-CFC drug product’s

indications. EPA believes that the

commenter is wrong to assert that

because a safe and effective non-CFC

MDI is available, EPA should deem CFC

MDIs with the same active moiety to be

non-essential for the purposes of the

CAA. As stated earlier, FDA 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 for any other product under

the Act. Because FDA has yet not

identified any ‘‘safe and effective

alternative’’ for any CFC MDI, today’s

allocation of CFCs for essential uses

remains consistent with section

601(8)(A).

The commenter’s suggestion that EPA

make medical decisions regarding

whether a non-CFC MDI is an adequate

alternative to a CFC MDI produces a

result that would put asthma patient

health at risk. FDA is the appropriate

agency with expertise to make

independent medical decisions that

directly affect patients. The

determination that a CFC MDI is no

longer ‘‘essential’’ is not, as the

commenter suggests, one where EPA

could merely look at the active moiety

of the product, read the non-CFC

product indication, compare it to the

CFC MDI product indication, and

determine any CFC MDIs to be nonessential. FDA states in their notice of

proposed rulemaking on essential use

determinations 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.’’ (September 1, 1999, 64 FR

47735). Most of these factors are not

addressed on the indication label of an

MDI. Thus the indication label alone

cannot be used as the basis for

determining whether a non-CFC product

is an adequate alternative for any CFC

MDI.

We believe that the overall purpose of

the language in the Act regarding

medical devices is to ensure that EPA’s

mission of environmental protection

does not conflict with FDA’s mission of

protecting the patient health. Consistent

with this purpose, we believe that in

drafting the definition, Congress was

focusing on the availability of adequate

alternative medical treatment for

patients who rely on CFC MDIs. EPA is

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 judgement

and expertise. On such questions, we

have and will continue to defer to FDA.

The commenter states that FDA must

approve and determine that the CFCcontaining MDI is essential after notice

and an opportunity for public comment,

and asserts that once a drug containing

a safe and effective alternative

propellant has been approved by FDA,

FDA has no authority to continue to

designate analogous CFC-containing

products as ‘‘essential’’. Further, the

commenter states that EPA may not wait

for FDA to remove that product from its

list of essential uses before finding that

it no longer qualifies as a ‘‘medical

device’’ under the Act. Again, EPA

believes that this interpretation of the

Act is flawed. This is because section

601(8)(B) refers to approval of an

alternative as occurring after ‘‘notice

and opportunity for comment.’’ Because

FDA does not approve alternative

propellants, and because approval of a

specific MDI drug product through the

New Drug Application or Abbreviated

New Drug Application system under the

FDCA involves unilateral action by FDA

without notice-and-comment

rulemaking or consultation with EPA, it

is reasonable to conclude that section

601(8)(B) refers to FDA’s approval of an

essential use listing in 21 CFR 2.125

which does involve notice and comment

rulemaking. Thus, EPA believes that by

allocating CFCs for products covered by

the list of ‘‘essential’’ products at 21

CFR 2.125, we have fulfilled the

requirements of section 601(8)(B).

Finally, the commenter states that

FDA cannot use the categorical

exemptions at 21 CFR 2.125 created

more than twenty years ago to establish

the essentiality of particular CFC MDI

under the statute today, and that by

doing so EPA and FDA are not relying

on standards adopted under the Act in

1990. EPA believes that our explanation

of this issue in the interim final rule

allocating essential use allowances for

calendar year 2000 still stands (see 65

FR 716, January 6, 2000).

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. The statute does not

specify a particular time at which FDA

must make such a determination or

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1465

4Section 614(b) states that ‘‘* * * in the case of

conflict between [the Act] and any provisions of the

Montreal Protocol, the more stringent provision

shall govern.’’

invalidate determinations made prior to

the date of the 1990 CAA Amendments.

Additionally, the 1990 CAA

Amendments 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. EPA further notes

that both EPA and FDA are

implementing the more stringent

provisions of the Montreal Protocol as

specified by section 614(b) of the Act 4

by following the essentiality

determinations of the Parties to the

Montreal Protocol in allocating new

CFCs.

How Does the CAA Authorize the

Exemption for Methyl Chloroform?

With today’s action, EPA is allocating

methyl chloroform (MCF) for use in the

Space Shuttle and Titan Rockets under

the statutory phase-out schedule at

section 604(a). This section provides

that MCF may be produced at up to 20

percent of the amount produced in 1989

(the baseline year as specified at section

601(2)(B) of the Act). EPA is allocating

a total of 60.1 metric tons of MCF, an

amount well below 20% of the baseline

year production of 315,169 metric tons

for MCF (defined at 40 CFR 82.6).

Section 604(a) of the Act requires the

complete phase-out of production of

MCF after 2001. As a result, it is likely

that EPA will be required to rely solely

upon the exemption under section

604(d)(1), that may already be

applicable, for the year 2002 and

beyond. This exemption reads as

follows:

(1) Essential Uses of Methyl Chloroform.—

Notwithstanding the termination of

production required by subsection (b), during

the period beginning on January 1, 2002, and

ending on January 1, 2005, the

Administrator, after notice and opportunity

for public comment, may, to the extent such

action is consistent with the Montreal

Protocol, authorize the production of limited

quantities of methyl chloroform solely for use

in essential applications (such as

nondestructive testing for metal fatigue and

corrosion of existing airplane engines and

airplane part susceptible to metal fatigue) for

which no safe and effective substitute is

available.

EPA understands that research on

alternatives is progressing well, and that

in the year 2002 there may be no need

for an essential use exemption for MCF.

Nevertheless, EPA believes that section

604(d)(1) may allow for the continued

limited use of methyl chloroform for

Space Shuttle and Titan Rocket through

2004 under the essential use exemption

as long as no substitute is available.

II. Allocation Process for CFCs for Use

in Medical Devices for the Year 2001

As explained 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.’’ Thus,

EPA in order to implement the

exemption for medical devices must

receive a formal determination on the

amount of CFCs necessary for use in

MDIs from FDA. FDA sent EPA a letter

dated September 6, 2000 that provided

their determination on the amount of

CFCs necessary, and explained the bases

for that determination.

One commenter stated that the CAA

does not delegate to FDA the authority

to dictate the nomination quantity and

allocation of class I substances for

medical devices. Rather, according to

the commenter, the CAA requires that

EPA shall consult with FDA only as to

whether the authorization of class I

substances for medical devices is

necessary, which requires a yes/no

determination only. Thus, EPA should

not transfer to the FDA the

responsibility to determine the quantity

of essential use allowances allocated to

companies.

EPA has addressed the comment that

is raised here in the preamble to

essential use allocation for calendar year

2000 (65 FR 40524, 40530–40537). We

believe that the same interpretation and

explanation provided in the previous

rulemaking is applicable here. Section

604(d)(2) states the following: ‘‘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 [of

FDA], in consultation with the

Administrator [of EPA], to be necessary

for use in medical devices.’’ (emphasis

added) EPA believes that it is clear that

the authorization in question is not for

an indefinite amount but for ‘‘limited

quantities.’’ It is equally clear that the

subject of the Commissioner’s

determination of necessity is ‘‘such

authorization.’’ Thus, if the latter part of

the text quoted above were written in

the active voice, it would say: ‘‘if the

Commissioner, in consultation with the

Administrator, determines such

authorization to be necessary for use in

medical devices.’’ We note that the

expression ‘‘such authorization’’ refers

back to the phrase ‘‘authorize the

production of limited quantities of class

I substances solely for use in medical

devices.’’ Thus, the Commissioner of

FDA must consider not only whether

any production is necessary, but what

quantity of production is necessary for

MDIs.

Further, although EPA does have

some data on CFC usage (which is

shared with FDA), only FDA personnel

are privy to confidential business

information regarding annual sales and

distribution of MDIs. This provides FDA

with more complete knowledge of the

MDI market than EPA. Because of FDA’s

access to additional information, and

their medical expertise which is integral

to making decisions that serve to protect

the public health, EPA believes it is

consistent with Congressional intent to

consult with FDA in making decisions

regarding the amount of CFCs necessary

for the production of MDIs.

The commenter’s second point was

that EPA should ensure that the

rationale for adjustments made to

allocations and the bases for FDA

recommendations are open and

available to the public for review and

comment. EPA agrees that the allocation

process should be as transparent as

possible while accounting for the

confidential nature of the data

employed to make the determination on

the amount of CFCs necessary. To this

end, EPA and FDA planned a process

described in the NPRM that we felt

would allow this determination on the

amount of CFCs necessary to occur as

openly as possible. EPA sent letters

pursuant to section 114 of the Act to

each essential use applicant requesting

specific information such as the number

of units of each product produced in

previous years, the number of units

produced in the first quarter 2000, the

gross target fill weight per unit, the total

amount of CFCs to be contained in the

product in 2001, the number of units of

each product anticipated to be produced

in 2001, the additional amount of CFCs

necessary for production, and the total

amount of CFCs requested for each

product in 2001. FDA, in consultation

with EPA, based the determination of

necessary amounts and the allocation on

this information. Thus, each company

knows what information it has

submitted as the basis for its own

allocation while protecting against

disclosure of confidential business

information to competitors. Finally, we

placed all non-confidential materials in

1466 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

5EPA believes that all countries that produce

MDIs are parties to the Montreal Protocol.

the docket, including the FDA letter of

September 6, 2000 that provided EPA

with their recommendation on the

amount of CFCs necessary for MDIs for

the year 2001.

III. Allocation of Essential Use

Allowances for Calendar Year 2001

EPA is allocating essential use

allowances for calendar year 2001 to

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.

The allocation of CFCs for use in MDIs

reflects the determination on the

amount of CFCs ‘‘necessary’’ as

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

Act taking into account two companies

requests for reapportioning EUAs among

them.

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2001

Company Chemical Quantity

(metric tons)

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

Medeva, Armstrong Pharmaceuticals Inc. ................................................................... CFC–11 or CFC–12 or CFC–114 ............. 189.00

Boehringer Ingelheim Pharmaceuticals ....................................................................... CFC–11 or CFC–12 or CFC–114 ............. 338.36

Glaxo Wellcome Inc. .................................................................................................... CFC–11 or CFC–12 or CFC–114 ............. 858.10

Aventis Pharmaceuticals .............................................................................................. CFC–11 or CFC–12 or CFC–114 ............. 190.00

3M Pharmaceuticals ..................................................................................................... CFC–11 or CFC–12 or CFC–114 ............. 304.51

Sidmak Laboratories/Medisol Laboratories, Inc. .......................................................... CFC–11 or CFC–12 or CFC–114 ............. 192.20

Schering Corporation ................................................................................................... CFC–11 or CFC–12 or CFC–114 ............. 1025.20

Sciarra Laboratories, Inc. ............................................................................................. CFC–11 or CFC–12 or CFC–114 ............. 1.30

(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

Was the Allocation Listed in This

Proposed Rule Changed in the Final

Rule?

The total amount of CFCs allocated

for use in MDIs is the same as in the

proposed rule. However, the amount of

EUAs allocated to two MDI companies

was reapportioned between them at

their request. One commenter is the

New Drug Application (NDA) holder,

and the other is a contract filler for that

NDA holder. The NDA holder stated

that they had reassessed the amount of

MDIs the contract filler would produce

for them in 2001. The NDA holder

requested that a certain amount of EUAs

allocated to their contract filler and

earmarked for the production of the

NDA holder’s products be reapportioned back to the NDA holder.

The contract filler provided comments

that supported the transfer of EUAs

from them to the NDA holder (this

contract filler is also an essential use

allowance holder with its own

allocation for production of its own

MDIs). EPA believes that in this case, it

is not necessary for FDA to approve this

adjustment to the essential use

allocations because the total amount of

EUAs allocated for use in the NDA

holder’s MDI products (i.e. the MDIs to

be produced by the NDA holder

themselves plus the MDI to be produced

by contract filler) remains unchanged.

Further, EPA is implementing

provisions to allow transfer of EUAs

between MDI companies. This

provision, finalized in today’s action,

would allow this transfer to occur even

in the absence of EPA re-apportioning

the EUAs among these two companies.

One company requested additional

volumes of CFCs beyond the amount

allocated to them in the NPRM. This

company stated that it had anticipated

an earlier timing for launch of certain

new products, and that their current

supplier of pharmaceutical-grade CFCs

may shut down production in the next

few years. For these reasons, they

requested additional EUAs for calendar

year 2001 to continue MDI production

without utilizing their strategic reserves.

EPA and FDA have concluded that

the year 2001 essential use allocations

already reflect the contingencies raised

by the commenter and are protective of

public health. These allocations are

calculated to insure that the full range

of medical needs is met throughout the

entire patient population. It should be

noted that this company, as well as all

essential use holders, now have the

opportunity to obtain additional EUAs

through trading, and also had the

opportunity to request additional CFCs

for the year 2002 in response to the

notice requesting essential applications

for the years 2002 and 2003 published

November 1, 2000 (65 FR 65311).

Were There Other Comments Regarding

the Allocation of CFCs for Use in MDIs?

One commenter who is a generic

producer of MDIs stated that they were

pleased with their proposed allocation.

However, they commented that had they

not been allocated EUAs, or had

received an extremely low allocation,

opportunities due to unexpected shifts

in the market would fall to foreign

manufacturers of MDIs who, the

commenter asserts, can export CFC

MDIs to the U.S. and are not subject to

the same allocation requirements as U.S.

MDI producers. EPA notes that

companies who produce MDIs in other

countries are also subject to the terms of

the Montreal Protocol and must receive

an allocation for CFCs to produce

‘‘essential’’ MDIs 5. The major

production of MDIs abroad is in Europe

where each company’s CFC

requirements are also extensively

reviewed before allocation.

What Was EPA’s Method for Allocating

Methyl Chloroform (MCF) for Use in

Solid Rocket Motors?

With this action, EPA is allocating

60.1 metric tons of MCF for use in solid

rocket motors, the same amount

allocated in the years 1999 and 2000.

EPA proposed to allocate MCF in an

amount lower than would be consistent

with Decision X/6 taken at the Tenth

meeting of the Parties to the Protocol

because we believed, based on

knowledge of past MCF use, that

allocating a larger amount would be

unnecessary. EPA did not receive any

comments on this issue, and is

allocating 60.1 metric tons MCF as

proposed in the NPRM.

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1467

When Is This Rule Effective?

This final rule is effective on January

8, 2001. 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 calendar year 2001.

Why is EPA Allocating CFC–11, CFC–12,

and CFC–114 in the Aggregate To Each

Company?

As discussed in the proposal, EPA is

allocating essential use allowances for

CFC–11, CFC–12, and CFC–114 in the

aggregate in accordance with Decision

X/6 of the Parties to the Montreal

Protocol which states that ‘‘the

quantities approved under paragraph 2

above and all future approvals are for

total CFC volumes with flexibility

between CFCs within each group.’’

Allocating CFCs for MDI in the

aggregate instead of on a compound-bycompound basis provides MDI

producers with flexibility in obtaining

CFCs without causing additional

damage to the stratospheric ozone layer

since CFC–11, CFC–12 and CFC–114 all

have the same ozone depleting potential

of 1.0.

Timing of This and Future Essential Use

Allocation Rules

One commenter noted that even

though EPA sent letters to MDI

companies in May 2000 requesting data

needed to determine 2001 EUAs, the

proposed allocation was not published

until October. This commenter

requested that EPA make every effort to

issue a proposed rule allocating EUAs

for 2002 in September of 2001, and

states that as pharmaceutical-grade CFC

production becomes increasingly

tenuous, CFC suppliers are requiring

advanced notice of MDI companies’ CFC

production needs. Further, MDI

companies are unable to provide

suppliers with this information until

final EUA allocations are issued. Earlier

rulemakings would help to ensure that

MDI manufacturers are able to place

CFC production orders, arrange for

shipping, and make other administrative

arrangements in a timely manner. EPA

will make every effort to issue the notice

of proposed rulemaking allocating

essential use allowances for 2002 by

September of 2001.

Another commenter requested that

EPA issue the final CFC allocations for

2001 as soon as possible so that

necessary CFCs may be ordered and

delivered from the supplier in Europe in

time to meet MDI production needs in

2001. EPA has expedited this final rule

and believes that companies should

have sufficient time to place their orders

for CFCs for the coming year.

What Reporting Requirements Must I

Adhere To When Using My Essential

Use Allocation?

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

recordkeeping and reporting

requirements in 40 CFR 82.13.

Instructions and forms for reporting are

found in the Guidance Document for the

Stratospheric Ozone Protection Program

after January 1, 1996. This document

can be obtained by contacting the

Stratospheric Ozone Protection Hotline

at (800) 296–1996 between 10:00 am

and 4:00 pm Eastern Standard Time.

Under 40 CFR 82.3 and 82.4 (63 FR

41626, August 4, 1998), entities

receiving essential use allowances must

be the importer of record for quantities

of CFCs brought into the United States.

This requires that the essential use

allowance holder be listed as the

importer of record on Customs Form

7501. As a result, the essential use

allowance holder who imports

quantities of class I controlled

substances is responsible for submitting

both an Importer Quarterly Report and

an Essential Use Holder Quarterly

Report.

IV. Transfer of EUAs for CFCs Among

Essential Use Allowance Holders

With this action EPA is adding

essential use allowances to the list of

allowances that can be transferred under

40 CFR 82.12. This change will enable

companies to transfer EUAs for CFCs to

other essential use holders for the

production of MDIs. EPA believes that

allowing EUAs to be transferred among

essential use allowance holders will

allow MDI companies to obtain CFCs

beyond their allocation without

increasing the total amount of ODSs

allocated. EPA received three comments

in support of the provision to allow

transfer of EUAs among essential use

holders. These commenters stated that

this provision provides a responsible

mechanism for addressing the inherent

problem in attempting to predict the

needs for MDI manufacturers.

One commenter requested a

clarification of the proposed regulations

regarding the use of a contract filler. The

commenter took issue with the fact that

EPA would have to approve the use of

a contract filler. The commenter

believes it should be at the company’s

discretion as to whether it produces the

product in-house or through the use of

a contract filler. The new regulations

provide a mechanism for transfer of

EUAs from an NDA holder to a contract

filler (provided they already have

EUAs). However, EPA must continue to

exercise strict control over the amount

of CFCs produced and or imported to

ensure U.S. compliance with the

Decisions of the Parties to the Protocol.

Thus, EPA believes that it is necessary

to approve the transfer of EUAs between

an NDA holder and a contract filler. It

should be noted that EPA is not

approving or disapproving the use of a

contract filler per se, but merely

ensuring that the ‘‘transferor’’ has

sufficient allowances to cover the

transaction.

Under the New Regulations Can I

Transfer EUAs for CFCs To Anyone I

Want?

No; EUAs for CFCs are only

transferable among those companies

that have applied for and received EUAs

for the year 2001. In addition,

companies must certify in writing to

EPA that the EUAs will only be used in

the production of essential medical

devices as defined in the FDCA at 21

CFR 2.125 and considered essential by

the Parties to the Protocol.

Can EUAs for CFCs Be Transferred

From Year to Year?

No; EUAs are not transferable from

year to year. Any EUAs for CFCs not

expended in 2001 will expire at the end

of 2001.

Is There a Cost for Transferring EUAs?

Yes; the CAA at section 607(a) states

that rules governing transfer of

allowances for the production of class I

and class II substances ‘‘* * * shall

insure that the transactions under the

authority of this section will result in

greater total reductions in the

production in each year of class I and

class II substances than would occur in

that year in the absence of such

transactions.’’ In compliance with this

section, current regulations at 40 CFR

82.12 governing transfers of production

and consumption allowances require

one percent of the traded amount to be

deducted from the transferor’s

1468 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

unexpended allowances. EPA proposed

to amend the regulations so that in the

case of EUA transfers, one tenth of one

percent of the amount traded would be

deducted from the transferor’s account.

As stated in the preamble to the

proposed rule, EPA believes that given

the relatively small amount of EUAs

available for use in MDIs, and that

providing sufficient EUAs for MDIs is

critically important for protecting public

health, deducting one percent of the

amount of EUAs to be traded would be

too high a penalty and may create a

barrier against transferring EUAs freely.

Reducing the amount deducted from the

transferor’s account overcomes this

potential barrier. EPA received no

adverse comments on this issue, and is

amending the regulation as described

above.

How Can I Transfer EUAs From My

Company to Another?

In order to complete a transfer of

EUAs for CFCs from one essential use

allowance holder to another, the

transferor would have to submit to the

Administrator a letter with the

information requested in 40 CFR

82.12(a)(1). Under the regulations at 40

CFR 82.12, the transferor must submit to

the Administrator a transfer claim with

the following information:

1. The identities and addresses of the

transferor and transferee.

2. The names and telephone numbers

of contact persons for both the transferor

and transferee.

3. The type of allowances being

transferred, which in this case would

always be essential use allowances.

4. The group of controlled substances

being transferred, which would always

be Group I.

5. The amount of allowances being

transferred in kilograms.

6. The calendar year for which the

allowances are being transferred (e.g.

calendar year 2001).

7. The amount of unexpended

essential use allowances for the current

calendar year.

8. The amount of the 0.1% offset

applied to the unweighted amount

traded that will be deducted from the

transferor’s allowance balance.

A sample form that outlines the

necessary information that a transferor

must submit to EPA will be available

through the Stratospheric Ozone Hotline

at 1–800–296–1996.

As specified in 40 CFR 82.12, EPA

will determine, based on records

maintained by the EPA ODS tracking

system, whether the transferor possesses

as of the date of the transfer claim,

unexpended allowances sufficient to

cover the transfer claim (i.e., the amount

to be transferred plus one tenth of one

percent of that amount). Within three

working days of receiving a complete

transfer claim, EPA will notify the

transferor and transferee if the transferor

has sufficient unexpended allowances

to confer the transfer claim, and will

issue a notice indicating that EPA does

not object to the transfer. EPA will then

reduce the transferor’s balance of

essential use allowances by the amount

to be transferred plus one tenth of one

percent of that amount. When EPA

issues a no objection notice, the

transferor and the transferee may

proceed with the transfer.

If EPA’s records show that the

transferor has insufficient unexpended

allowances to cover the transfer claim,

or that the transferor has failed to

respond to one or more Agency requests

to supply information needed to make a

determination, EPA will issue a notice

disallowing the transfer. Within 10

working days after receipt of

notifications, either party may file a

notice of appeal, with supporting

reasons, to EPA, in which case EPA may

either affirm or vacate the disallowance.

If no appeal is taken by the tenth

working day after notification, the

disallowance shall be final on that day.

(The transferor and transferee will be

held liable in accordance with section

113 of the Act for any violations that

occur as a result of an improper

transfer.) In the event that EPA does not

respond to a transfer claim within three

working days of receipt of the

completed claim, the transferor and

transferee may proceed with the transfer

and EPA will reduce the transferor’s

balance accordingly.

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.

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,

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1469

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 impose any new

information collection burden as

defined by the Paperwork Reduction

Act (PRA). The Office of Management

and Budget’s draft guidance on PRA

states that a rule is exempt from OMB

review if it ‘‘explicitly applies to nine or

fewer persons’’. Since the reporting

requirements in this rule are not of

general applicability, and apply only to

the eight entities receiving EUAs for

CFCs, and only if a company decides to

transfer EUAs to another essential use

holder, we believe that this rule is

exempt from the requirement of

submitting an Information Collection

Request and undergoing OMB review.

However, OMB has previously

approved the information collection

requirements that are contained in the

existing regulations at 40 CFR 82.12 that

set forth the process for inter-company

transfers of consumption allowances

under the provisions of the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.

and has assigned OMB control number

2060–0170 (EPA ICR No.1432.17).

Copies of the ICR document(s) may be

obtained from Sandy Farmer, by mail at

the Office of Environmental

Information, Collection Strategies

Division; U.S. Environmental Protection

Agency (2822); 1200 Pennsylvania Ave.,

NW, Washington, DC 20460, by email at

farmer.sandy@epa.gov, or by calling

(202) 260–2740. A copy may also be

downloaded off the internet at http://

www.epa.gov/icr. Include the ICR and/

or OMB number in any correspondence.

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 proposed rule on

small entities, EPA has determined that

it is not necessary to prepare a

regulatory flexibility analysis in

connection with this 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. There are only ten entities that

are affected by this rulemaking (see

table I 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

phase-out 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

104–113, section 12(d) (15 U.S.C. 272

note) directs EPA to use voluntary

consensus standards in this regulatory

activities unless to do so would be

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

final rule does not involve technical

standards. Therefore, EPA did not

1470 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

consider the use of any voluntary

consensus standards.

H. Executive Order 13132 (Federalism)

Executive Order 13132, entitled

‘‘Federalism’’ (64 FR 432255, 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 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 the Office of Management and

Budget, 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 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 rule will

affect only the ability of private entities

and the national government to request

production of controlled ozonedepleting substances. Thus, the

requirements of section 6 of the

Executive Order to 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 the 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 the

action in the Federal Register. Under

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

this rule may not be challenged later in

the judicial proceedings brought to

enforce those requirements.

VII. Submittal to Congress and the

General Accounting Office

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. Therefore, 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 rule is not a ‘‘major rule’’

as defined by 5 U.S.C. 804(2). This rule

will be effective January 8, 2001.

List of Subjects in 40 CFR Part 82

Environmental protection,

Administrative practice and procedure,

Air pollution control, Chemicals,

Exports, Imports, Reporting and

recordkeeping requirements.

Dated: December 28, 2000.

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 is amended by revising

the table in paragraph (t)(2) to read as

follows:

§ 82.4 Prohibitions.

* * * * *

(t) * * *

(2) * * *

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2001

Company Chemical Quantity

(metric tons)

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

Medeva Americas, Inc. ............................................................................................... CFC–11 or CFC–12 or CFC–114 ............ 189.00

Boehringer Ingelheim .................................................................................................. CFC–11 or CFC–12 or CFC–114 ............ 338.36

Glaxo Wellcome .......................................................................................................... CFC–11 or CFC–12 or CFC–114 ............ 858.10

Aventis ......................................................................................................................... CFC–11 or CFC–12 or CFC–114 ............ 190.00

3M Pharmaceuticals .................................................................................................... CFC–11 or CFC–12 or CFC–114 ............ 304.51

Sidmak Laboratories, Inc. ........................................................................................... CFC–11 or CFC–12 or CFC–114 ............ 192.20

Schering Corporation .................................................................................................. CFC–11 or CFC–12 or CFC–114 ............ 1025.20

Sciarra Laboratories, Inc. ............................................................................................ CFC–11 or CFC–12 or CFC–114 ............ 1.3

(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

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1471

* * * * *

3. Section 82.12 is amended by

revising paragraphs (a)(1) introductory

text, (a)(1)(i)(H), (a)(1)(ii) introductory

text, (a)(1)(ii)(A), and (a)(1)(iii) to read

as follows:

§ 82.12 Transfers.

(a) * * *

(1) Until January 1, 1996, for all class

I controlled substances, except for

Group VI, and until January 1, 2001, for

Group VI, any person (‘‘transferor’’) may

transfer to any other person

(‘‘transferee’’) any amount of the

transferor’s consumption allowances or

production allowances, and effective

January 1, 1995, for all class I controlled

substances any person (‘‘transferor’’)

may transfer to any other person

(‘‘transferee’’) any amount of the

transferor’s Article 5 allowances, and

after January 1, 2001 any essential use

allowance holder (‘‘transferor’’) may

transfer essential use allowances for

CFCs to any other essential use

allowance holder for CFCs

(‘‘transferee’’) solely for the production

of essential products (defined at 21 CFR

2.125) as follows:

(i) * * *

(H) The amount of the one percent

offset applied to the unweighted amount

traded that will be deducted from the

transferor’s production or consumption

allowance balance (except for trades

from transformers and destroyers to

producers or importers for the purpose

of allowance reimbursement). In the

case of transferring essential use

allowances, the amount of one tenth of

one percent of the amount traded will

be deducted from the transferor’s

allowance balance.

(ii) The Administrator will determine

whether the records maintained by EPA,

taking into account any previous

transfers and any production, allowable

imports and exports of controlled

substances reported by the transferor,

indicate that the transferor possesses, as

of the date the transfer claim is

processed, unexpended allowances

sufficient to cover the transfer claim

(i.e., the amount to be transferred plus,

in the case of transferors of essential use

allowances, one tenth of one percent of

the transferred amount, and in the case

of transferors of production or

consumption allowances, one percent of

the transferred amount). Within three

working days of receiving a complete

transfer claim, the Administrator will

take action to notify the transferor and

transferee as follows:

(A) If EPA’s records show that the

transferor has sufficient unexpended

allowances to cover the transfer claim,

the Administrator will issue a notice

indicating that EPA does not object to

the transfer and will reduce the

transferor’s balance of unexpended

allowances by the amount to be

transferred plus, in the case of transfers

of production or consumption

allowances, one percent of that amount,

or in the case of transfers of essential

use allowances, one tenth of one percent

of that amount. When EPA issues a no

objection notice, the transferor and the

transferee may proceed with the

transfer. However, if EPA ultimately

finds that the transferor did not have

sufficient unexpended allowances to

cover the claim, the transferor and

transferee will be held liable for any

violations of the regulations of this

subpart that occur as a result of, or in

conjunction with, the improper transfer.

* * * * *

(iii) In the event that the

Administrator does not respond to a

transfer claim within the three working

days specified in paragraph (a)(1)(ii) of

this section, the transferor and

transferee may proceed with the

transfer. EPA will reduce the

transferor’s balance of unexpended

allowances by the amount to be

transferred plus, in the case of transfers

of production or consumption

allowances, one percent of that amount,

and in the case of essential use

allowances, one tenth of one percent of

that amount. However if EPA ultimately

finds that the transferor did not have

sufficient unexpended allowances to

cover the claim, the transferor and

transferee will be held liable for any

violations of the regulations of this

subpart that occur as a result of, or in

conjunction with, the improper transfer.

* * * * *

[FR Doc. 01–463 Filed 1–5–01; 8:45 am]

BILLING CODE 6560–50–U