Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices 65311

cutoff shall make semiannual estimates

of projected annual amount of solvent

use and maintain records of actual

solvent use.

Each owner or operator of an affected

magnetic tape coating operation shall

install, calibrate, maintain, and operate

a monitoring device that continuously

indicates and records the concentration

level of organic compounds in the outlet

gas stream. Certain facilities will also be

required to continuously measure and

record either the combustion

temperature of the incinerator (for those

facilities controlled by a thermal

incinerator) or the condenser exhaust

temperature (for those facilities

controlled by a condensation system).

Owners or operators of the affected

facilities described must make the

following one-time-only reports:

notification of the date of construction

or reconstruction; notification of the

anticipated and actual dates of startup;

notification of any physical or

operational change to an existing facility

which may increase the regulated

pollutant emission rate; notification of

demonstration of the continuous

monitoring system (CMS); notification

of the date of the initial performance

test; and the results of the initial

performance test.

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. The Federal Register document

required under 5 CFR 1320.8(d),

soliciting comments on this collection

of information was published on March

31, 2000 (65 FR 17259). No comments

were received.

Burden Statement: The annual public

reporting and recordkeeping burden for

this collection of information is

estimated to average 69 hours per

response. 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.

Respondents/Affected Entities:

Magnetic Tape Manufacturing.

Estimated Number of Respondents:

13.

Frequency of Response: On occasion,

quarterly, semi-annually.

Estimated Total Annual Hour Burden:

3891 hours.

Estimated Total Annualized Capital

and O&M Cost Burden: $93,000.

Send comments on the Agency’s need

for this information, the accuracy of the

provided burden estimates, and any

suggested methods for minimizing

respondent burden, including through

the use of automated collection

techniques to the following addresses.

Please refer to EPA ICR No. 1135.07 and

OMB Control No. 2060–0171 in any

correspondence.

Dated: October 19, 2000.

Oscar Morales,

Director, Collection Strategies Division.

[FR Doc. 00–28015 Filed 10–31–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6894–7]

Request for Applications for Essential

Use Exemptions to the Production and

Import Phaseout of Ozone Depleting

Substances Under the Montreal

Protocol for the Years 2002 and 2003

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: Through this notice, the

Environmental Protection Agency (EPA)

is requesting applications for

consideration at the Thirteenth Meeting

of the Parties to the Montreal Protocol

on Substances that Deplete the Ozone

Layer (the Protocol) to be held in 2001,

for exemptions to the production and

import phaseout in 2002 and 2003 for

ozone-depleting substances (including

halons 1211 and 1301, CFC–11, CFC–12,

CFC–113, CFC–114, CFC–115, CFC–13,

CFC–111, CFC–112, CFC–211, CFC–212,

CFC–213, CFC–214, CFC–215, CFC–216,

CFC–217, carbon tetrachloride, and

methyl chloroform).

DATES: Applications for essential use

exemptions must be submitted to EPA

no later than December 1, 2000 in order

for the United States (U.S.) government

to complete its review and to submit

nominations to the United Nations

Environment Programme (UNEP) and

the Protocol Parties in a timely manner.

ADDRESSES: Send two copies of

application materials to: Erin Birgfeld,

Stratospheric Protection Division

(6205J), Environmental Protection

Agency, 1200 Pennsylvania Avenue,

NW, Washington, DC 20460. If

submitting applications by courier, the

office address is 501 3rd Street, NW,

Washington, DC 20001. Send one copy

of your application materials to: Air

Docket A–93–39, 401 M Street, SW,

(6102), Room M1500, Washington, DC

20460.

Confidentiality: Applications should

not contain confidential or proprietary

information. Such confidential

information should be submitted under

separate cover and be clearly identified

as ‘‘trade secret,’’ ‘‘proprietary,’’ or

‘‘company confidential.’’ Information

covered by a claim of business

confidentiality will be disclosed by EPA

only to the extent, and by means of the

procedures, set forth at 40 CFR Part 2,

Subpart B (41 FR 36902). If no claim of

confidentiality accompanies the

information when it is received by EPA,

the information may be made available

to the public by EPA without further

notice to the company (40 CFR 2.203).

FOR FURTHER INFORMATION CONTACT: Erin

Birgfeld at the above address or at (202)

564–9079 telephone, (202) 565–2095

fax, or birgfeld.erin@epa.gov. General

information may be obtained from the

Stratospheric Ozone Hotline at 1–800–

296–1996.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background—The Essential Use

Nomination Process

II. Information Required for Essential Use

Applications for Production or Importation

of Class I Substances in 2002 and 2003

I. Background—The Essential Use

Nomination Process

As described in previous Federal

Register (FR) notices (58 FR 29410, May

20, 1993; 59 FR 52544, October 18,

1994; 60 FR 54349, October 23, 1995; 61

FR 51110, 0 30, 1996, 62 FR 51655,

October 2, 1997; 63 FR 42629, August

10, 1998; and 64 FR 50083 , September

15, 1999), the Parties to the Protocol

agreed during the Fourth Meeting in

Copenhagen on November 23–25, 1992,

to accelerate the phase-out schedules for

Class I ozone-depleting substances.

Specifically, the Parties agreed that nonArticle 5 Parties (developed countries)

would phase out the production and

consumption of halons by January 1,

1994, and the production and

consumption of other Class I substances

(under 40 CFR 82, Subpart A), except

methyl bromide, by January 1, 1996.

65312 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices

The Parties also reached decisions and

adopted resolutions on a variety of other

matters, including the criteria to be used

for allowing ‘‘essential use’’ exemptions

from the phaseout of production and

importation of controlled substances.

Decision IV/25 of the Fourth Meeting of

the Parties details the specific criteria

and review process for granting

essential use exemptions.

Decision IV/25 states 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’’. In addition,

the Parties agreed ‘‘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 the existing

stocks of banked or recycled controlled

substances. * * *’’

Applicants should be aware that

essential use exemptions granted to the

U.S. for the year 2001 under the

Protocol were limited to

chlorofluorocarbons (CFCs) for metered

dose inhalers (MDIs) to treat asthma and

chronic obstructive pulmonary disease,

and methyl chloroform for use in

manufacturing solid rocket motors.

The first step in obtaining essential

use allowances is for the user to

consider whether the use of the

controlled substance meets the Decision

IV/25 criteria. The user should then

notify EPA of the candidate use and

provide information for U.S.

government agencies and the Protocol

Parties to evaluate that use according to

the criteria under Decision IV/25. Upon

receipt of the essential use exemption

application, EPA reviews the

information provided and works with

other interested Federal agencies to

determine whether it meets the essential

use criteria and warrants being

nominated by the United States for an

exemption. In the case of multiple

exemption requests for a single use such

as for MDIs, EPA aggregates exemption

requests received from individual

entities into a single U.S. request. An

important part of the EPA review of

requests for CFCs for MDIs is to

determine that the aggregate request for

a particular future year adequately

reflects the total market need for CFC

MDIs and expected availability of CFC

substitutes by that point in time. If the

sum of individual requests does not

account for such factors, the U.S.

government may adjust the aggregate

request to better reflect true market

needs.

Nominations submitted to the Ozone

Secretariat by the U.S. and other Parties

are forwarded to the UNEP Technical

and Economic Assessment Panel (TEAP)

and its Technical Options Committees

(TOCs), which review the submissions

and make recommendations to the

Parties for essential use exemptions.

Those recommendations are then

considered by the Parties at their annual

meeting for final decision. If the Parties

declare a specified use of a controlled

substance as essential and issue the

necessary exemption from the

production and consumption phaseout,

EPA may propose regulatory changes to

reflect the decisions by the Parties, but

only to the extent such action is

consistent with the Clean Air Act (CAA

or Act).

The timing of this process is such that

in any given year the Parties review

nominations for essential use

exemptions from the production and

consumption phaseout intended for the

following year and subsequent years.

This means that, if nominated,

applications submitted in response to

today’s notice for an exemption in 2002

and 2003 will be considered by the

Parties in 2001 for final action.

The quantities of controlled ODSs that

are requested in response to this notice,

if approved by the Parties to the

Montreal Protocol in 2001, will then be

allocated as essential-use allowances

(EUAs) to the specific U.S. companies

through notice and comment

rulemaking. EUAs for the year 2002 will

be allocated to U.S. companies at the

end of 2001, and EUAs for the year 2003

will be made at the end of 2002.

Each year the Parties to the Protocol

have approved an unlimited, global

essential use exemption for the

production and consumption of high

purity class I ODSs for laboratory and

analytical uses. Prior to the year 2000,

EPA implemented this exemption

domestically through regulation. As

discussed in last year’s notice

requesting applications for essential use

allowances (64 FR 50083), in the year

2000 and beyond, the Clean Air Act

does not specifically list an exemption

for laboratory and analytical uses of

class I ODSs. EPA is issuing a separate

rulemaking later in the year which will

clarify this issue further. Until then,

current stocks of class I ODSs that are

already in the U.S. can continue to be

sold for laboratory and analytical uses.

II. Information Required for Essential

Use Applications for Production or

Importation of Class I Substances in

2002 and 2003

Through this notice, EPA requests

applications for essential use

exemptions for all Class I substances,

except methyl bromide, for 2002 and

2003. This is the last opportunity to

submit applications for 2002.

Companies will have an opportunity to

submit supplemental or amended

applications for 2003 next year. All

requests for exemptions submitted to

EPA must present information as

prescribed in the TEAP ‘‘Handbook on

Essential Use Nominations’’ (Handbook)

as last published in 1997. You can

request a Handbook from the

Stratospheric Protection Hotline at (301)

614–3990 or (800) 296–1996. It is also

available electronically on the web at

www.teap.org. In brief, the TEAP

Handbook states that applicants must

present information on:

• Role of use in society

• Alternatives to use, including

education programs on alternatives

• Steps to minimize use, including

development of CFC-free alternatives

• Steps to minimize emissions

• Amount of substance available

through recycling and stockpiling

• Quantity of controlled substances

requested by year.

In order to gain more complete

information from essential use

applicants for CFC MDIs, EPA is

requesting more detailed information in

the EUA applications. First, we ask that

in the case of EUA applications

requesting CFCs for multiple

pharmaceutical companies (e.g.

International Pharmaceutical Aerosol

Consortium), the application make clear

the amount of CFCs requested for each

member company. Second, all essential

use application for CFCs for MDIs

should provide a breakdown of the

quantity of CFCs necessary for each

drug to be produced using the EUA.

This detailed breakdown of EUAs will

allow EPA and FDA to make more

informed decisions on the amount of

CFC to be nominated by the U.S.

government for the years 2002 and 2003.

Third, we request that all New Drug

Application holders (NDA holders or

sponsors) be engaged in the essential

use application process for the year

2003 and beyond. We know of sponsor

companies whose CFC MDI is produced

by another company (the contract filler).

In the past, EPA has accepted essential

use applications submitted by the

contract filler, in the absence sufficient

information on the NDA holder’s

reformulation efforts. Therefore, EPA is

Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices 65313

requesting that for the year 2003 and

beyond, all NDA holders for MDIs to be

produced using EUAs, submit an

application to EPA for EUAs as

specified in this notice. Please note,

EPA will also consider applications

submitted jointly by contract fillers. In

the case where a contract filler produces

a portion of an NDA holder’s CFC MDIs,

the contract filler and the NDA holder

should work together to determine the

total amount of CFCs necessary to

produce the NDA holder’s entire

product line of CFC MDIs. The NDA

holder should also provide an estimate

of how the CFCs would be split between

the contract filler and the NDA holder

in the allocation year. This estimate will

be used only as a basis for determining

the nomination amount, and may be

adjusted prior to allocation of EUAs.

Since the U.S. government can not

forward incomplete or inadequate

nominations to the Ozone Secretariat, it

is important for applicants to provide all

information requested in the Handbook,

including the information specified in

the supplemental research and

development form (page 43). The

accounting framework matrix in the

Handbook titled ‘‘Table IV: Reporting

Accounting Framework for Essential

Uses Other Than Laboratory and

Analytical’’ requests data for the year

2000 on the amount of ODS exempted

for an essential use, the amount

acquired by production, the amount

acquired by import, the amount on hand

at the start of the year, the amount

available for use in 2000, the amount

used for the essential use, the quantity

contained in exported products, the

amount destroyed, and the amount on

hand at the end of the year. Because the

data necessary to complete Table IV will

not be available until after January 1,

2001, companies should not include

this chart with their EUA applications

in response to this notice. EPA plans to

send letters to each essential use

applicant requesting the information in

Table IV in the first 2 weeks of January

2001. Companies will have only

fourteen days in which to respond since

EPA must compile companies’

responses to complete the U.S. CFC

Accounting Framework for submission

to the Parties to the Montreal Protocol

by the end of January.

EPA anticipates that the 2001 review

by the Parties of MDI essential use

requests will focus extensively on

research efforts underway to develop

alternatives to CFC MDIs, on education

programs to inform patients and health

care providers of the CFC phaseout and

the transition to alternatives, and on

steps taken to minimize CFC use and

emissions including efforts to recapture

or reprocess the controlled substance.

Accordingly, applicants are strongly

advised to present detailed information

on these points, including the scope and

cost of such efforts and the medical and

patient organizations involved in the

work. Applicants can strengthen their

exemption requests by submitting a

complete set of education materials,

including copies of printed, electronic

or audio-visual tools. Applicants are

given notice that exemption requests

without adequate information on

research and education will not be

considered complete.

Applicants should submit their

exemption requests to EPA as noted in

the ADDRESSES section at the beginning

of today’s notice.

Dated: October 25, 2000.

Robert Perciasepe,

Assistant Administrator, Office of Air and

Radiation.

[FR Doc. 00–28009 Filed 10–31–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6894–8]

Board of Scientific Counselors,

Executive Committee Meeting

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of teleconference.

SUMMARY: Pursuant to the Federal

Advisory Committee Act, Public Law

92–463, as amended (5 U.S.C., App. 2)

notification is hereby given that the

Environmental Protection Agency,

Office of Research and Development

(ORD), The Board of Scientific

Counselors (BOSC), will hold its

Executive Committee Meeting.

DATES: The Teleconference will be held

on November 16, 2000.

ADDRESSES: On Thursday, November 16,

2000, the teleconference will begin at 10

a.m. and will adjourn at 12 Noon. The

call in number is 202–260–7280, access

code: 1774#. All times noted are Eastern

Time.

SUPPLEMENTARY INFORMATION: The

Agenda of the BOSC Executive

Committee will cover:

• Discussion and approval of the

BOSC report on the Management of PM

Research in ORD,

• Committee Assignments,

• Multi-year Planning.

The teleconference is open to the

public. Any member of the public

wishing to make a presentation at the

meeting should contact Shirley

Hamilton, Designated Federal Officer,

Office of Research and Development

(8701R), 1200 Pennsylvania Avenue,

NW., Washington, DC 20460; telephone

at (202) 564–6853. In general each

individual making an oral presentation

will be limited to a total of three

minutes.

FOR FURTHER INFORMATION CONTACT:

Shirley R. Hamilton, Designated Federal

Officer, U.S. Environmental Protection

Agency, Office of Research and

Development, NCER (MC 8701R), 1200

Pennsylvania Avenue, NW.,

Washington, DC 20460, (202) 564–6853.

Dated: October 27, 2000.

Peter W. Preuss,

Director, National Center for Environmental

Research.

[FR Doc. 00–28008 Filed 10–31–00; 8:45 am]

BILLING CODE 6560–50–M

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00439F; FRL–6752–9]

Pesticide Program Dialogue

Committee (PPDC): Inert Disclosure

Stakeholder Workgroup; Open Meeting

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of meeting.

SUMMARY: This notice announces a

conference call meeting of the Inert

Disclosure Stakeholder Workgroup. The

workgroup was established to advise the

Pesticide Program Dialogue Committee

on ways of making information on inert

ingredients more available to the public

while working within the mandates of

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) and related

Confidential Business Information

concerns.

DATES: The meeting will be held by

conference call on Wednesday,

November 8, 2000 from 3:00 pm to 6:00

pm EST.

ADDRESSES: Members of the public may

listen to the meeting discussions on site

at: Crystal Mall #2 (CM #2), 1921

Jefferson Davis Highway, Arlington, VA;

conference Room 1123. Seating is

limited and will be available on a first

come first serve basis.

FOR FURTHER INFORMATION CONTACT: By

mail: Cameo Smoot, Office of Pesticide

Programs (7506C), U.S. Environmental

Protection Agency, 1200 Pennsylvania

Avenue, NW., Washington, DC 20460,

telephone: (703) 305–5454. Office

locations: 11th floor, CM #2, 1921

Jefferson Davis Highway, Arlington, VA.

E-mail smoot.cameo@epa.gov.