Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules 59783

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–6881–8]

RIN 2060–AJ33

Protection of Stratospheric Ozone:

Allocation of Essential Use Allowances

for Calendar Year 2001

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: With this action, EPA is

proposing to allocate essential-use

allowances for stratospheric ozone

depleting substances for the year 2001

control period. EPA allocates essential

use allowances to an applicant for

exempted production or import of a

specific quantity of class I ozone

depleting substances (ODS) solely for

the designated essential purpose.

Essential use allowances permit a

person to obtain controlled ODS as an

exemption to the January 1, 1996

regulatory phase-out of production and

import of these substances. Today, EPA

is proposing essential-use allowances

(EUAs) for the production and/or import

of ODSs for use in medical devices and

for use in the Space Shuttle Rockets and

Titan Rockets for calendar year 2001.

EPA is also proposing a regulatory

change which would allow EUAs for

CFCs to be transferred among essential

use recipients.

DATES: Written comments on this

proposed rule must be received on or

before November 6, 2000, unless a

public hearing is requested. Comments

must then be received on or before 30

days following the public hearing. Any

party requesting a public hearing must

notify the Stratospheric Ozone

Protection Hotline listed below by 5

p.m. Eastern Standard Time on October

16, 2000. If a hearing is held, EPA will

publish a document in the Federal

Register announcing the hearing

information. Inquiries regarding a

public hearing should be directed to the

Stratospheric Ozone Protection Hotline

at 1–800–269–1996.

ADDRESSES: Comments on this

rulemaking should be submitted to: Erin

Birgfeld, Essential Use Program

Manager, U.S. Environmental Protection

Agency (6205J), 1200 Pennsylvania

Avenue, NW., Washington, DC 20460.

All comments will be filed in EPA Air

docket number A–93–39. Comments

that contain business confidential

information should be submitted in two

versions, one clearly marked ‘‘Public’’ to

be filed in the docket, and the other

marked ‘‘Confidential’’ to be reviewed

by authorized government personnel

only.

Materials relevant to this rulemaking

are contained in Docket No. A–93–39.

The Docket 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 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 1–800–296–1996 or Erin Birgfeld,

U.S. Environmental Protection Agency,

Stratospheric Protection Division, Office

of Atmospheric Programs, 6205J, 1200

Pennsylvania Avenue, Washington, DC

20460; 202–564–9079.

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. Proposed Changes to 82.12 Allowing

Transfer of EUAs for CFCs Among

Essential Use Allowance Holders

V. Administrative Requirements

I. Background

The Montreal Protocol on Substances

that Deplete the Ozone Layer (Protocol)

is the international agreement to reduce

and eventually eliminate production

and consumption of all stratospheric

ozone depleting substances.

(‘‘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.) The

elimination of production and

consumption is accomplished through

adherence to phase-out schedules for

the production and consumption of

specific ODSs including

chlorofluorocarbons (CFCs), halons,

carbon tetrachloride, methyl

chloroform, hydrochlorofluorocarbons,

and methyl bromide. As of January

1996, production and import of class I

ODSs were phased out in all developed

countries, including the United States.

However, the Protocol and the Clean Air

Act (CAA or Act) provide exemptions

which allow for the continued import

and/or production of class I ODS for

specific uses. Under the Montreal

Protocol, exemptions are granted for

uses that are determined by the Parties

to be ‘‘essential.’’ Decision IV/25, taken

in 1992, established criteria for

determining whether a specific use

should be approved as essential, and set

forth the international process for

making determinations of essentiality.

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.

The CAA provides exemptions to the

phase-out of class I ODSs for which

these controlled substances may

continue to be produced and/or

imported. EPA is responsible for

allocating essential use allowances at

the domestic level through rulemaking

in accordance with provisions in the

CAA. Today’s action proposes to

allocate essential use allowances for the

use of CFCs in metered dose inhalers

(MDIs), and methyl chloroform for use

in the Space Shuttle and Titan Rocket

solid rocket motor assemblies for

calendar year 2001. Today’s action also

proposes changes to regulations at 40

CFR 82.12 which would allow transfer

of CFC allowances among MDI

manufacturers that hold EUAs.

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 III submitted

59784 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules

applications either on their own or as a

part of the International Pharmaceutical

Aerosol Consortium (IPAC) requesting

class I controlled substances for

essential uses in response to the August

10,1998 Federal Register notice (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 set forth 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

(TOCs). 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 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?

The CAA provides standing

exemptions to the phase-out of class I

ODSs found at section 604(d) of the Act.

With today’s action, EPA is proposing to

implement the exemption at 604(d)(2) of

the Act which states that

notwithstanding the phase-out, EPA

shall, to the extent consistent with the

Montreal Protocol, authorize production

of limited quantities of class I ODSs for

use in medical devices, if FDA, in

consultation with EPA, determines that

such production is necessary for use in

medical devices. The term ‘‘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 for any

other product. That requires a separate

and distinct analysis.’’ Although FDA

has approved one CFC-free MDI for

market, it 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

proposed 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 categories of CFCcontaining medical devices, as that term

is used in the CAA, 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 for

the treatment of asthma and chronic

obstructive pulmonary disease. The

companies for which EPA is proposing

to grant essential use allowances

produce CFC MDIs that fall within one

of these categories. Thus, the products

for which EPA is proposing to grant

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.’’ EPA and FDA

determined that in light of the

surrounding language, this phrase refers

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. Since approval

of an NDA or ANDA under the Food,

Drug, and Cosmetic Act (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) does not refer to approval of

an NDA or ANDA under the FDCA.

Therefore, FDA and EPA read section

601(8)(B) to refer to FDA’s approval of

an essential use which does require

notice-and comment rulemaking in

consultation with EPA. This means that

an MDI is ‘‘approved and determined to

be essential’’ if the MDI is included

within the list of categories of CFC-MDIs

on FDA’s essential use list. All of the

MDIs for which we are proposing to

allocate CFCs today meet this

qualification.

With this action EPA is also

proposing to allocate methyl chloroform

(MCF) for use in solid rocket motor

assemblies. Because the original phaseout date of methyl chloroform is 2002,

EPA is not required to implement the

exemption at 604(d)(1) until that time.

Instead, EPA is proposing to allocate

methyl chloroform under the authority

of the original phase-out schedule at

section 604(a) which provides that MCF

may be produced at up to 20 percent of

the baseline. EPA is proposing to

allocate a total of 60.1 metric tons of

MCF, an amount well below 20% of the

MCF baseline production allowance of

315,169 metric tons (defined at 40 CFR

82.6).

II. Allocation Process for CFCs for Use

in Medical Devices for the Year 2001

How Were the Essential Use Allowances

for Medical Devices Determined for the

Year 2001?

As explained above, 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. The

following is a step-by-step list of actions

EPA and FDA have taken thus far to

implement the exemption for medical

devices under the Act.

1. EPA worked closely with FDA to

define what information would be

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules 59785

required from companies in order that

FDA in consultation with EPA could

make a determination on the amount of

CFCs necessary for use in MDIs. EPA

and FDA determined that the following

data were needed to make a decision on

the amount of CFCs necessary for use in

MDIs for 2001:

• The specific MDI products to be

produced in 2001

• The number of units each product

produced each year since 1996

• Number of units produced in the

first quarter of 2000

• Number of units anticipated to be

produced in 2001

• Gross target fill weight per unit

(grams)

• Total amount of CFC to be

contained in product for 2001 (metric

tons)

• Additional amounts of CFCs

necessary for production of MDIs

• Total CFC request per product for

2001

2. On May 24, 2000, EPA sent letters

to MDI manufacturers requesting the

information outlined in paragraph 1.

EPA also requested information on the

amount of CFCs held in inventory as of

January 1, 2000. The letters that EPA

sent each company are available for

review in the docket. The company’s

responses however, are considered

confidential business information and

are not publicly available. Tables I and

II are reproductions of the reporting

forms EPA asked companies to fill out

in response to our letters requesting

information under section 114 of the

Act (114 letters).

TABLE I.—YEAR 2001 ESSENTIAL USE ALLOCATION: CFC REPORTING FORM

A BCDEF G H I J K

Product Number

of Units

produced

from 1/1/

96 to 12/

31/96

Number

of Units

produced

from 1/1/

97 to 12/

31/97

Number

of Units

produced

from 1/1/

98 to 12/

31/98

Number

of Units

produced

from 1/1/

99 to 12/

31/99

Number

of Units

produced

from 1/1/

00 to 3/

31/00

Number of

Units

anticipated

to be

produced in

2001

Gross

Target fill

weight

per unit

(grams) 1

Total

CFC to

be

contained

in product

for 2001

(metric

tons) 2

Additional

amount

necessary

for

production 3

Total

request

per

product

for 2001 4

Example Product ................. 1,112,569 1,010,526 1,215,452 1,327,456 352,101 1,500,000 22 30.42 5.20 35.62

1 If significant numbers of different canister sizes are produced, this target fill number should either be the weighted average for that product

(i.e., the sum of the gross target fill times the percentage of canisters produced in that size divided by the total number of canisters) or each size

may be contained in a separate row of the report. 2 Column I= (Column G) (Column H).

3Provide details regarding your additional amount needed, e.g., canisters produced but not distributed, CFCs lost in processing, CFCs remaining at end of batch run, CFCs used in line cleaning. 4Total request per product for 2001 (metric tons) = Sum of Columns I+J.

Note: The data presented in columns B through E will be compared to data provided in annual reports to FDA. Any significant differences in

these numbers should be explained in detail.

TABLE II.—YEAR 2000 CFC STOCKPILE ANALYSIS

Chemical

On 1/1/2000: Quantity (in

metric tons) of chemical

stored at your facility

On 1/1/2000: Total quantity

(in metric tons) of chemical

available to your company 5

On January 1, 2000: Amount

of chemical produced prior to

January 1, 1996 6 available to

your company

Total quantity of chemical acquired using 1999 essential

use allowances

CFC–11

CFC–12

CFC–114

5This includes amounts stored at your facility, other facilities, or an order with the chemical manufacturers.

6This amount refers to your company’s stockpile (on 1/1/2000) of CFCs produced prior to the 1996 ban on import and production.

3. In a letter to FDA, dated August 3,

2000, Paul Stolpman, Director of EPA’s

Office of Atmospheric Programs,

requested that FDA provide EPA with a

determination regarding the amount of

CFCs necessary for use in MDIs for

calendar year 2001. We attached the

information provided in response to 114

letters from MDI manufacturers for

FDA’s review. FDA verified the data

against the annual reports companies

file with FDA, and used the information

from the companies’ response to our

section 114 letters as a basis for their

determination.

4. On September 6, 2000, FDA

Commissioner Jane Henney sent a letter

to EPA with the FDA determination on

the amount of CFCs necessary for use in

MDIs for calendar year 2001. The

quantity of CFCs to be allocated for

production of MDIs in this proposed

rule reflect FDA’s determination made

in consultation with EPA.

5. In accordance with the

determinations made by FDA, in

consultation with EPA, specified in

their letter of September 6, 2000, today’s

proposal would allocate a total of

3098.67 metric tons of CFCs for use in

MDIs for calendar year 2001.

6. EPA plans to issue a final allocation

rule by the end of the calendar year to

provide adequate time for companies to

replenish their supply of CFCs for MDI

production in the year 2001.

How Were the Decisions on the

Amounts of EUAs for CFCs for Each

Company Made?

FDA states in their letter to EPA that

‘‘* * * we have examined the

information you obtained from

individual sponsors regarding their

historical and intended use of CFCs in

specific products. We compared this

information to the information filed

with us by sponsors in previous annual

reports. In listing the amounts we

believe to be necessary for use in

medical devices, we referred to this

information, eliminated any doublecounting we found, considered changes

in the prevalence of asthma and COPD,

and eliminated allocations for uses not

59786 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules

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).’’

In response to EPA’s request for

information under section 114 of the

Act, two companies stated that they

required CFCs to produce the same

products leading to double counting and

an inflated request of CFCs to

manufacture these particular MDI

products. This is because one company

is a New Drug Application (NDA)

holder who produces some of its own

products, and the other is a contract

filler for the NDA holder who produces

the remainder of the NDA holder’s

products. At the time we gathered

information via 114 letters, the

companies had not reached an

agreement on the amount of MDIs to be

produced by the contract filler and the

amount to be produced by the NDA

holder. With this action, EPA is

proposing to allocate CFCs to these two

companies in the amount requested by

the NDA holder. Because we are also

proposing to allow EUAs to be

transferrable, the NDA holder will have

the opportunity to transfer some of its

EUAs to the contract filler if necessary.

This transfer can be accomplished by

adhering to the requirements in the

regulations at 40 CFR 82.12 which will

be explained in detail in section IV. In

the event that the change to 40 CFR

82.12 proposed in this rule which allow

the transfer of EUAs is not finalized,

EPA and FDA will consult with the both

contract filler and the NDA holder to

determine the proper allocation. Please

note that EPA and FDA took into

account that the contract filler also

manufactures products for yet another

company along with its own brand of

MDIs and allocated the entire amount

requested to manufacture these other

MDI products.

Can the Allocation Listed in This

Proposed Rulemaking Be Changed in

the Final Rule?

The allocation amounts listed in this

proposal are subject to additional

review by EPA and FDA if new

information demonstrates that the

allocations are either too high or too

low. Commenters requesting increases

or decreases of EUAs should provide

detailed information supporting their

claim for additional or fewer CFCs. Any

company that determines that they no

longer need the full amount allocated

under this proposal should notify EPA

of the actual amount needed. Please

note that EPA is only authorized to

allocate a total of 3,101 metric tons of

CFC, the amount requested by U.S.

pharmaceutical companies and

subsequently approved by the Parties to

the Montreal Protocol for 2001.

III. Allocation of Essential Use

Allowances for Calendar Year 2001

What Is EPA’s Proposed Essential Use

Allocation for Calendar Year 2001?

EPA is proposing to allocate essential

use allowances for the year 2001 control

period to entities listed in Table III for

exempted production or import of the

specific quantity of class I controlled

substances solely for the specified

essential use. The proposed 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.

TABLE III.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2000

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 ..................... 258.00

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

Aventis Pharmaceuticals (formerly RPR) ............................................................ CFC–11 or CFC–12 or CFC–114 ..................... 190.00

3M Pharmaceuticals ............................................................................................. CFC–11 or CFC–12 or CFC–114 ..................... 384.87

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

Why Is EPA Allocating CFC–11, CFC–12,

and CFC–114 in the Aggregate to Each

Company?

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 manufacture in

the aggregate instead of on a compoundby-compound basis adds flexibility to

the regulation 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.

Why Is EPA No Longer Allocating EUAs

to the International Pharmaceutical

Aerosol Consortium (IPAC) as a Whole,

But Instead Allocating on a Companyby-Company Basis?

In the past, EPA allocated EUAs to

IPAC as a whole and then sent letters to

each of its member companies notifying

them of their particular allocation. This

inevitably resulted in minor delays in

informing IPAC member companies of

their allocations. This year, EPA is

allocating EUAs on a company-bycompany basis in order to inform the

IPAC member companies directly of

their specific allocations. Thus it will be

clear to each company, including the

IPAC members, the quantities that are

being proposed for each company

allowing all companies opportunity to

comment on their individual

allocations.

What Is EPA’s Method for Allocating

Methyl Chloroform (MCF) for Use in

Solid Rocket Motors?

With this action, EPA is proposing to

allocate 60.1 metric tons of MCF for use

in solid rocket motors, the same amount

allocated in the years 1999 and 2000.

Please note that with this action EPA is

proposing to allocate MCF in an amount

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lower than would be consistent with

Decision X/6 taken at the Tenth meeting

of the Parties to the Protocol because

EPA believes that doing so would

allocate MCF in excess of the necessary

amount.

Decision X/6 states that ‘‘ * * * the

remaining quantity of methyl

chloroform authorized for the United

States at previous meetings of the

Parties be made available for use in

manufacturing solid rocket motors until

such time as the 1999–2001 quantity of

176.4 tons (17.6 ODP-weighted tons)

allowance is depleted, or until such

time as safe alternatives are

implemented for remaining essential

uses.’’ According to the EPA tracking

system, the total amount of MCF

produced or imported by U.S. essential

use recipients in 1999 was just 12

metric tons indicating that the transition

away from MCF is progressing faster

than anticipated, and that allocating the

unused portion of MCF in its entirety

would be excessive. EPA believes that

allocating the same amount allocated in

2000, 60.1 metric tons of MCF, provides

a sufficient amount for use in solid

rocket motors for the year 2001. Please

note that in future allocations essential

use allowance holders for MCF will still

have access to MCF until the 1999–2001

quantity of 176.4 metric tons is depleted

or until this use is no longer considered

essential.

In the event that commenters provide

sufficient reasons as to why EPA should

allocate MCF in an amount consistent

with Decision X/6, for example, EPA

would allocate MCF according to the

following equation:

The amount of MCF approved by the

Parties for essential uses for 1999–

2001 ¥2 × The amount of MCF

imported or produced by U.S.

essential use holders in

1999=Allocation for 2001 (i.e., 176.4

metric tons ¥2 × 12 metric

tons=152.4 metric tons).

Since the amount of MCF acquired in

the year 2000 is not yet known, the

equation assumes that essential use

holders will acquire the same amount of

MCF in 2000 as they had in 1999 and

provides the best possible

approximation of the quantity of MCF

that should be allocated if EPA is

persuaded to allocate MCF in the

amount consistent with Decision X/6.

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.

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.

It should be noted that 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. Proposed Changes to 82.12 Allowing

Transfer of EUAs for CFCs Among

Essential Use Allowance Holders

With this document EPA is proposing

to add essential use allowances to the

list of allowances that can be transferred

under 40 CFR 82.12. This change will

enable essential use holders to transfer

EUAs for CFCs to other essential use

holders for the production of essential

MDIs. EPA believes that allowing EUAs

to be transferred among essential use

allowance holders incorporates

flexibility into the current regulations

without increasing the amount of ODSs

allocated.

Why Is EPA Proposing To Allow EUAs

To Be Transferred Among EUA Holders?

Each year EPA requests applications

from pharmaceutical companies for

essential use allowances for use in

MDIs. EPA analyzes these applications

and uses them as the basis for the U.S.

nomination for essential use allowances

at the Meeting of the Parties to the

Montreal Protocol which occurs two

years prior to the year in which EUAs

are allocated to companies. Because it

can be difficult to forecast the amount

of CFCs required for MDI production

two years in advance, the Parties

provide an opportunity for countries to

request a supplemental amount of

essential use allowances in the year

following the initial request. This

system allows companies two

opportunities to request essential use

allowances for the same year, ensuring

that if the initial request is not

sufficient, there is a mechanism to

increase the allocation for that year.

Essential use applicants had the option

of requesting supplemental CFCs for

2001 in September 15, 1999, in response

to the EPA document (64 FR 50083). No

applicant elected to supplement their

request for the year 2001 at that time.

Even in the absence of applications

for supplemental CFCs from

pharmaceutical companies, EPA and

FDA consulted in March of this year to

determine whether the total allocation

of 3,101 metric tons would be sufficient

to produce MDIs for the U.S. market.

EPA and FDA determined, based on the

amount of CFCs used for MDI

production in previous years, that 3,101

metric tons would be sufficient to

supply the MDI market as a whole while

accounting for the projected increase in

demand for MDIs. However, EPA and

FDA noted that individual companies

may have increased market growth

compared to others and would therefore

need additional CFCs. Because of the

inherent uncertainty in allocating

specific amounts of CFCs to individual

companies engaged in a dynamic

market, EPA is proposing that EUAs for

CFCs become transferable among EUA

holders. This will ensure that

companies have the opportunity to

access CFCs beyond the amount

allocated to them in the year 2001 and

beyond, and can better respond to

market shifts that may occur.

Will I Be Able To Transfer EUAs for

CFCs to Anyone I Want?

No, EUAs for CFCs would only be

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 Food, Drug

and Cosmetic Act at 21 CFR 2.125 and

considered essential by the Parties to

the Protocol.

If EUAs for CFCs Are Transferable, Can

They Be Transferred From Year to Year?

No, EUAs would not be transferable

from year to year. Any EUAs for CFCs

not expended in 2001 will expire at the

end of 2001.

Is There a Penalty 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

59788 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules

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

unexpended allowances. EPA is

proposing to amend the regulation 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. 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.

EPA believes that reducing the amount

deducted from the transferor’s account,

would overcome this potential barrier.

Therefore, with today’s action EPA is

proposing changes to regulations at

§ 82.12 to require that in the case of

transferring EUAs, one tenth of one

percent in excess of the amount traded

would be deducted from the transferor’s

account.

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 control period for which the

allowances are being transferred (e.g.

calendar year 2001).

7. The amount of unexpended essential use

allowances for the current control period.

8. The amount of the 0.1% offset applied

to the unweighted amount traded that will be

deducted from the transferor’s allowance

balance.

Guidance documents and a sample

letter which 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 outlined in § 82.12, EPA will

determine according to 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 Title I,

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.

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules 59789

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 (PRA)

This action does not impose any new

information collection burden as

defined by the PRA. The Office of

Management and Budget’s (OMB’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 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, the Office of Management

and Budget (OMB) has previously

approved the information collection

requirements contained in the existing

regulations at 40 CFR 82.12 which 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. 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

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

59790 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules

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

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 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 theat 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 (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 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 do not apply to this

rule.

List of Subjects in 40 CFR Part 82

Environmental protection,

Administrative practice and procedure,

Air pollution control, Chemicals,

Chlorofluorocarbons, Exports, Imports,

Ozone layer, Reporting and

recordkeeping requirements.

Dated: September 29, 2000.

Carol M. Browner,

Administrator.

40 CFR Part 82 is proposed to be

amended as follows:

PART 82—PROTECTION OF

STRATOSPHERIC OZONE

1. The authority citation for part 82

continues to read as follows:

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

7671q.

Subpart A—Production and

Consumption Controls

2. Section 82.4 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 2000

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 ..................... 258.00

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 ..................... 384.87

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

§ 82.12 [Amended]

* * * * *

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

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Proposed Rules 59791

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

that amount, and in the case of

transferors of production or

consumption allowances, one percent of

that 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,

or 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. 00–25745 Filed 10–5–00; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 403

[FRL–6883–1]

RIN 2090–AA16

Pretreatment Program Reinvention

Pilot Projects Under Project XL

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Today EPA is proposing

changes to the National Pretreatment

Program regulations to allow Publicly

Owned Treatment Works (POTWs) that

have completed the Project eXcellence

and Leadership (Project XL) selection

process, including Final Project

Agreement (FPA) development, to

modify their approved local

Pretreatment Programs. These POTWs

would be allowed to modify their

programs following the procedures in 40

CFR 403.18, and implement the new

local programs as described in their

FPAs.

In today’s proposed rule, EPA

recognizes that many POTWs with

approved Pretreatment Programs have

mastered the administrative and

procedural requirements of the National

Pretreatment regulations (40 CFR Part

403). Several of these POTWs want the

opportunity to implement local

pretreatment programs with

effectiveness measured against

environmental results rather than strict

adherence to programmatic and

administrative measures. These POTWs

have expressed an interest in Project XL

to test new pilot ideas that focus

resources on activities that they believe

would provide greater environmental

benefits than are achieved by complying

with current regulatory requirements.

This rule is intended to provide the

regulatory flexibility that will enable

these test programs to move forward.

Currently, five POTWs are actively

involved in this Project XL process.

DATES: Public Comments: All public

comments on the proposed rule must be

received on or before November 6, 2000.

Comments provided electronically will

be considered timely if they are

submitted electronically by 11:59 p.m.

(Eastern time) November 6, 2000.

ADDRESSES: Comments should be

addressed to ‘‘Project XL/CWA

Pretreatment,’’ Water Docket MC–4101;

United States Environmental Protection

Agency, Environmental Protection

Agency, Ariel Rios Building, 1200

Pennsylvania Avenue, NW.,

Washington, DC 20460. Commenters are

also requested to submit an original and

3 copies of their written comments as

well as an original and 3 copies of any

attachments, enclosures, or other

documents referenced in the comments.

Commenters who would like EPA to

acknowledge receipt of their comments

should include a self-addressed,

stamped envelope. No facsimiles (faxes)

will be accepted.

EPA will also accept comments

electronically. Comments should be

addressed to the following Internet

address: ow-docket@epamail.epa.gov.

Electronic comments must be submitted

as an ASCII, WordPerfect 5.1/6.1/8

format file and avoid the use of special

characters or any form of encryption.

Electronic comments will be transferred

into a paper version for the official

record. EPA will attempt to clarify

electronic comments if there is an

apparent error in transmission.

Supporting materials are also

available for inspection and copying at

U.S. EPA, Headquarters, 401 M Street,

SW., Room 445 West Tower,

Washington, DC 20460 during normal

business hours. Persons wishing to view

the materials at the Washington, DC

location are encouraged to contact Mr.

Chad Carbone in advance by

telephoning (202) 260–4296.

FOR FURTHER INFORMATION CONTACT: Mr.

Brian Frazer, (202) 260–0101, U.S.

Environmental Protection Agency, Ariel

Rios Building, 1200 Pennsylvania