Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 76655

* * * * *

[FR Doc. 04–27985 Filed 12–21–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82 

[FRL–7852–1] 

RIN 2060–AM50 

Protection of Stratospheric Ozone: 

Allocation of Essential Use Allowances 

for Calendar Year 2005

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to allocate 

essential use allowances for import and 

production of class I stratospheric ozone 

depleting substances (ODSs) for 

calendar year 2005. Essential use 

allowances enable a person to obtain 

controlled class I ODSs as an exemption 

to the regulatory ban of production and 

import of these chemicals, which 

became effective on January 1, 1996. 

EPA allocates essential use allowances 

for exempted production or import of a 

specific quantity of class I ODS solely 

for the designated essential purpose. 

The proposed allocations total 1,524.58 

metric tons of chlorofluorocarbons for 

use in metered dose inhalers.

DATES: Written comments on this 

proposed rule must be received by the 

EPA Docket on or before January 21, 

2005, 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 contact 

listed below under FOR FURTHER

INFORMATION CONTACT by 5 p.m. eastern 

standard time on January 23, 2005. If a 

hearing is held, EPA will publish a 

document in the Federal Register

announcing the hearing information.

ADDRESSES: Submit your comments, 

identified by Docket ID No. OAR–2004–

0063, by one of the following methods: 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Agency Web site: http://

www.epa.gov/edocket. EDOCKET, EPA’s 

electronic public docket and comment 

system, is EPA’s preferred method for 

receiving comments. Follow the on-line 

instructions for submitting comments. 

• Mail: Air and Radiation Docket, 

Environmental Protection Agency, 

Mailcode 6102T, 1200 Pennsylvania 

Ave., NW., Washington, DC, 20460, 

Attention: Docket ID No. OAR–2004–

0063.

• Hand Delivery: EPA Docket Center, 

(EPA/DC) EPA West, Room B102, 1301 

Constitution Ave., NW., Washington, 

DC, Attention Docket ID No. OAR–

2004–0063. Deliveries are only accepted 

during the Docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. 

Instructions: Direct your comments to 

Air Docket ID No. OAR–2004–0063. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.epa.gov/edocket, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through EDOCKET, 

regulations.gov, or e-mail. For 

instructions on how to submit CBI, see 

‘‘How do I submit confidential business 

information to EPA?’’ under 

SUPPLEMENTARY INFORMATION. 

The EPA EDOCKET and the federal 

regulations.gov websites are 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

EDOCKET or regulations.gov, your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. 

If you submit an electronic comment, 

EPA recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket. Although 

listed in the index, some information is 

not publicly available, namely CBI or 

other information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Air Docket, EPA/DC, EPA 

West, Room B102, 1301 Constitution 

Ave., NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for Docket ID No. OAR–2004–

0063 is (202) 566–1742.

Materials related to previous EPA 

actions on the essential use program are 

contained in EPA Air Docket No. A–93–

39. Docket A–93–39 may be reviewed at 

the Public Reading Room.

FOR FURTHER INFORMATION CONTACT:

Scott Monroe, Essential Use Program 

Manager, by regular mail: U.S. 

Environmental Protection Agency, 

Stratospheric Protection Division 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC, 20460; by courier 

service or overnight express: 1301 L 

Street, NW., Washington D.C., 20005, by 

telephone: 202–343–9712; or by e-mail: 

monroe.scott@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents 

I. General Information 

A. How should I submit confidential 

business information to EPA? 

II. Basis for Allocating Essential Use 

Allowances 

A. What are essential use allowances? 

B. Under what authority does EPA allocate 

essential use allowances? 

C. What is the process for allocating 

essential use allowances? 

III. Essential Use Allowances for Medical 

Devices 

IV. Proposed Allocation of Essential Use 

Allowances for Calendar Year 2005

V. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination with Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children from Environmental Health 

Risks and Safety Risks 

H. Executive Order 13211: Actions that 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act

I. General Information 

A. How Should I Submit Confidential 

Business Information to EPA? 

Comments that contain confidential 

business information should be 

submitted in two versions, one clearly 

marked ‘‘Public’’, to be filed in the

76656 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 

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

substance produced in the United States, plus the 

amount imported into the United States, 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 or imported prior to the 

1996 phase out may be used for purposes not 

expressly banned at 40 CFR part 82.

2Class I ozone depleting substances are listed at 

40 CFR Part 82 subpart A, appendix A.

3According to Section 614(b) of the Act, Title VI 

‘‘shall be construed, interpreted, and applied as a 

supplement to the terms and conditions of the 

Montreal Protocol * * * and shall not be 

construed, interpreted, or applied to abrogate the 

responsibilities or obligations of the United States 

to implement fully the provisions of the Montreal 

Protocol. In the case of conflict between any 

provision of this title and any provision of the 

Montreal Protocol, the more stringent provision 

shall govern.’’ EPA’s regulations implementing the 

essential use provisions of the Act and the Protocol 

are located in 40 CFR part 82.

public docket, and the other clearly 

marked ‘‘Confidential’’ to be reviewed 

by authorized government personnel 

only. If the comments are not marked, 

EPA will assume they do not contain 

confidential business information and 

will docket them. 

Do not submit information that you 

consider to be CBI electronically 

through EPA’s electronic public docket 

or by e-mail. Send or deliver 

information identified as CBI only to the 

Essential Use Program Manager. You 

may claim information that you submit 

to EPA as CBI by marking any part or 

all of that information as CBI (if you 

submit CBI on disk or CD ROM, mark 

the outside of the disk or CD ROM as 

CBI and then identify electronically 

within the disk or CD ROM the specific 

information that is CBI). Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR Part 2. 

In addition to one complete version of 

the comment that includes any 

information claimed as CBI, a copy of 

the comment that does not contain the 

information claimed as CBI must be 

submitted for inclusion in the public 

docket and EPA’s electronic public 

docket. If you submit the copy that does 

not contain CBI on disk or CD ROM, 

mark the outside of the disk or CD ROM 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and EPA’s 

electronic public docket without prior 

notice. If you have any questions about 

CBI or the procedures for claiming CBI, 

please consult the person identified in 

the FOR FURTHER INFORMATION CONTACT

section. 

II. Basis for Allocating Essential Use 

Allowances

A. What Are Essential Use Allowances? 

Essential use allowances are 

allowances to produce or import certain 

ozone-depleting chemicals in the U.S. 

for purposes that have been deemed 

‘‘essential’’ by the Parties to the 

Montreal Protocol and the U.S. 

Government. 

The Montreal Protocol on Substances 

that Deplete the Ozone Layer (Protocol) 

is the international agreement to reduce 

and eventually eliminate the production 

and consumption 1 of all stratospheric 

ozone depleting substances (ODSs). The 

elimination of production and 

consumption of class I ODSs is 

accomplished through adherence to 

phase-out schedules for specific class I 

ODSs2, including: chlorofluorocarbons 

(CFCs), halons, carbon tetrachloride, 

and methyl chloroform. As of January 1, 

1996, production and import of most 

class I ODSs were phased out in 

developed countries, including the 

United States.

However, the Protocol and the Clean 

Air Act (Act) provide exemptions that 

allow for the continued import and/or 

production of class I ODS for specific 

uses. Under the Protocol, exemptions 

may be granted for uses that are 

determined by the Parties to be 

‘‘essential.’’ Decision IV/25, taken by the 

Parties to the Protocol 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 paragraph 1 of Decision IV/25, are the 

following: 

‘‘(a) 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; 

(b) 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.’’

B. Under What Authority Does EPA 

Allocate Essential Use Allowances? 

Title VI of the Act implements the 

Protocol for the United States.3 Section 

604(d) of the Act authorizes EPA to 

allow the production of limited 

quantities of class I ODSs after the phase 

out date for the following essential uses:

(1) Methyl Chloroform, ‘‘solely for use 

in essential applications (such as 

nondestructive testing for metal fatigue 

and corrosion of existing airplane 

engines and airplane parts susceptible 

to metal fatigue) for which no safe and 

effective substitute is available.’’

Decision X/6 by the Parties to the 

Protocol established that ‘‘* * * the 

remaining quantity of methyl 

chloroform authorized for the United 

States at previous meetings of the 

Parties [will] be made available for use 

in manufacturing solid rocket motors 

until such time as the 1999–2001 

quantity of 176.4 tons (17.6 ODPweighted tons) allowance is depleted, or 

until such time as safe alternatives are 

implemented for remaining essential 

uses.’’ Prior to 2004, EPA issued 

allowances for production of 

approximately 34 metric tons of methyl 

chloroform out of the authorized 

balance of 176 metric tons. Under 

section 604(d)(1) of the Act, EPA may 

no longer allocate essential use 

allowances for production and import of 

methyl chloroform as of January 1, 2005. 

In light of this deadline, in the 

allocation rulemaking for calendar year 

2004 (69 FR 4059) EPA allocated the 

remaining authorized production 

allowances for methyl chloroform, 

approximately 142 metric tons, to the 

National Aeronautics and Space 

Administration. 

(2) Medical Devices (as defined in 

section 601(8) of the Act), ‘‘if such 

authorization is determined by the 

Commissioner [of the Food and Drug 

Administration], in consultation with 

the Administrator [of EPA] to be 

necessary for use in medical devices.’’

EPA issues allowances to manufacturers 

of metered-dose inhalers, which use 

CFCs as propellant for the treatment of 

asthma and chronic obstructive 

pulmonary diseases. 

(3) Aviation Safety, for which limited 

quantities of halon-1211, halon-1301, 

and halon 2402 may be produced ‘‘if the 

Administrator of the Federal Aviation 

Administration, in consultation with the 

Administrator [of EPA] determines that 

no safe and effective substitute has been 

developed and that such authorization 

is necessary for aviation safety 

purposes.’’ Neither EPA nor the Parties 

have ever granted a request for essential 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 76657

use allowances for halon, because 

alternatives are available or because 

existing quantities of this substance are 

large enough to provide for any needs 

for which alternatives have not yet been 

developed. 

The Protocol, under Decision X/19, 

additionally allows a general exemption 

for laboratory and analytical uses. This 

exemption is reflected in EPA’s 

regulations at 40 CFR part 82, subpart A. 

While the Act does not specifically 

provide for this exemption, EPA has 

determined that an allowance for 

essential laboratory and analytical uses 

is allowable under the Act as a de 

minimis exemption. The de minimis

exemption is addressed in EPA’s final 

rule of March 13, 2001 (66 FR 14760–

14770). The Parties to the Protocol 

subsequently agreed (Decision XI/15) 

that the general exemption does not 

apply to the following uses: testing of 

oil and grease, and total petroleum 

hydrocarbons in water; testing of tar in 

road-paving materials; and forensic 

finger-printing. EPA incorporated this 

exclusion at Appendix G to Subpart A 

of 40 CFR part 82 on February 11, 2002 

(67 FR 6352). 

C. What Is the Process for Allocating 

Essential Use Allowances? 

Before EPA may allocate essential use 

allowances, the Parties to the Protocol 

must first approve the United States’

request to produce or import essential 

class I ODSs. The procedure set out by 

Decision IV/25 calls for individual 

Parties to nominate essential uses and 

the total amount of ODSs needed for 

those essential uses on an annual basis. 

The Protocol’s Technology and 

Economic Assessment Panel evaluates 

the nominated essential uses and makes 

recommendations to the Protocol 

Parties. The Parties make the final 

decisions on whether to approve a 

Party’s essential use nomination at their 

annual meeting. This nomination cycle 

occurs approximately two years before 

the year in which the allowances would 

be in effect. The allowances allocated 

through today’s action were first 

nominated by the United States in 

January 2003. 

Once the U.S. nomination is approved 

by the Parties, EPA allocates essential 

use exemptions to specific entities 

through notice-and-comment 

rulemaking in a manner consistent with 

the Act. For medical devices, EPA 

requests information from 

manufacturers about the number and 

type of devices they plan to produce, as 

well as the amount of CFCs necessary 

for production. EPA then forwards the 

information to the Food and Drug 

Administration (FDA), which 

determines the amount of CFCs 

necessary for metered-dose inhalers in 

the coming calendar year. Based on 

FDA’s assessment, EPA proposes 

allocations to each eligible entity. Under 

the Act and the Protocol, EPA may 

allocate essential use allowances in 

quantities that together are below or 

equal to the total amount approved by 

the Parties. EPA may not allocate 

essential use allowances in amounts 

higher than the total approved by the 

Parties. For 2005, the Parties authorized 

the United States to allocate up to 1,902 

metric tons of CFCs for essential uses.

III. Essential Use Allowances for 

Medical Devices 

The following is a step-by-step list of 

actions EPA and FDA have taken thus 

far to implement the exemption for 

medical devices found at section 

604(d)(2) of the Act for the 2005 control 

period. 

1. On February 24, 2004, EPA sent 

letters to MDI manufacturers requesting 

the following information under section 

114 of the Act (‘‘114 letters’’): 

a. The MDI product where CFCs will 

be used. 

b. The number of units of each MDI 

product produced from 1/1/03 to 12/31/

03. 

c. The number of units anticipated to 

be produced in 2004. 

d. The gross target fill weight per unit 

(grams). 

e. Total amount of CFCs to be 

contained in the MDI product for 2005. 

f. The additional amount of CFCs 

necessary for production. 

g. The total CFC request per MDI 

product for 2005. 

The 114 letters are available for 

review in the Air Docket ID No. OAR–

2004–0063. The companies requested 

that their responses be treated as 

confidential business information; for 

this reason, EPA has not placed the 

responses in the docket. 

2. On May 18, 2004, EPA sent FDA 

the information MDI manufacturers 

provided in response to the 114 letters 

with a letter requesting that FDA make 

a determination regarding the amount of 

CFCs necessary for MDIs for calendar 

year 2005. This letter is available for 

review in Air Docket ID No. OAR–2004–

0063. 

3. On July 28, 2004, FDA sent a letter 

to EPA stating the amount of CFCs 

determined by the Commissioner to be 

necessary for each MDI company in 

2005. This letter is available for review 

in the Air Docket ID No. OAR–2004–

0063. In their letter, FDA informed EPA 

that they had determined that 1524.58 

metric tons of CFCs were necessary for 

use in medical devices in 2005. 

In accordance with the determination 

made by FDA, today’s action proposes 

to allocate essential use allowances for 

a total of 1524.58 metric tons of CFCs 

for use in MDIs for calendar year 2005. 

The amounts listed in this proposal are 

subject to additional review by EPA and 

FDA if new information demonstrates 

that the proposed allocations are either 

too high or too low. Commentors 

requesting increases or decreases of 

essential use allowances should provide 

detailed information supporting their 

claim for additional or fewer CFCs. Any 

company that needs less than the full 

amount listed in this proposal should 

notify EPA of the actual amount needed. 

IV. Proposed Allocation of Essential 

Use Allowances for Calendar Year 2005

EPA proposes to allocate essential use 

allowances for calendar year 2005 to the 

entities listed in Table 1. These 

allowances are for the production or 

import of the specified quantity of class 

I controlled substances solely for the 

specified essential use. As explained in 

Section II.C. above, the amount of each 

allocation is based on the request of the 

company, which was reviewed by FDA 

to determine the quantities necessary for 

use in medical devices.

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 

Company Chemical Quantity

(metric tons) 

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

Armstrong Pharmaceuticals ..................................................... CFC–11, or CFC–12, or CFC–114 ......................................... 29 

Aventis Pharmaceutical Products ............................................ CFC–11, or CFC–12, or CFC–114 ......................................... 57 

Boehringer Ingelheim Pharmaceuticals ................................... CFC–11, or CFC–12, or CFC–114 ......................................... 480 

Schering-Plough Corporation .................................................. CFC–11, or CFC–12, or CFC–114 ......................................... 816 

3M Pharmaceuticals ................................................................ CFC–11, or CFC–12, or CFC–114 ......................................... 69.18 

76658 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005—Continued

Company Chemical Quantity

(metric tons) 

Wyeth ....................................................................................... CFC–11, or CFC–12, or CFC–114 ......................................... 73.40 

V. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), the Agency 

must determine whether this regulatory 

action is ‘‘significant’’ and therefore 

subject to review by the Office of 

Management and Budget (OMB) and the 

requirements of the Executive Order. 

The Order defines ‘‘significant 

regulatory action’’ as one that is likely 

to result in a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order.

Pursuant to the terms of Executive 

Order 12866, OMB has notified EPA 

that it considers this a ‘‘significant 

regulatory action’’ within the meaning 

of the Executive Order. EPA submitted 

this action to OMB for review and 

incorporated changes as a result. A copy 

of the rule showing changes that were 

made is available in EPA Docket OAR–

2004–0063. 

Under Section 6(a)(3)(B)(ii) of 

Executive Order 12866, the Agency 

must provide to OMB’s Office of 

Information and Regulatory Affairs an 

‘‘assessment of the potential costs and 

benefits of the regulatory action, 

including an explanation of the manner 

in which the regulatory action is 

consistent with a statutory mandate and, 

to the extent permitted by law, promotes 

the President’s priorities and avoids 

undue interference with State, local, 

and tribal governments in the exercise 

of their governmental functions.’’

EPA is undertaking today’s proposed 

action under the mandate established by 

Section 604(d) of the Clean Air Act 

Amendments of 1990, which directs the 

Administrator to authorize the 

production of limited quantities of class 

I substances solely for use in medical 

devices, if the Commissioner of FDA 

determines that the authorization is 

necessary. The proposed allocations in 

today’s rule are the amounts determined 

by FDA to be necessary for calendar 

year 2005. 

EPA has not assessed the costs and 

benefits specific to today’s proposed 

action. The Agency examined the costs 

and benefits associated with a related 

regulation. The Agency’s Regulatory 

Impact Analysis (RIA) for the entire 

Title VI phaseout program examined the 

projected economic costs of a complete 

phaseout of consumption of ozonedepleting substances, as well as the 

projected benefits of phased reductions 

in total emissions of CFCs and other 

ozone-depleting substances, including 

essential-use CFCs used for metereddose inhalers (U.S. Environmental 

Protection Agency, ‘‘Regulatory Impact 

Analysis: Compliance with Section 604 

of the Clean Air Act for the Phaseout of 

Ozone Depleting Chemicals,’’ July 

1992). 

B. Paperwork Reduction Act 

This action does not add any 

information collection requirements or 

increase burden under the provisions of 

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

3501 et. seq. MB previously approved 

the information collection requirements 

contained in the final rule promulgated 

on May 10, 1995, and assigned OMB 

control number 2060–0170 (EPA ICR 

No. 1432.21). 

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 instruction; 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 1. 

C. Regulatory Flexibility Act 

The RFA generally requires an agency 

to prepare a regulatory flexibility 

analysis of any rule subject to notice 

and comment rulemaking requirements 

under the Administrative Procedure Act 

or any other statute unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small entities include small businesses, 

small organizations, and small 

governmental jurisdictions. 

For purposes of assessing the impact 

of today’s rule on small entities, small 

entity is defined as: (1) Pharmaceutical 

preparations manufacturing businesses 

(NAICS code 325412) that have less 

than 750 employees; (2) a small 

governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. 

After considering the economic 

impacts of today’s proposed rule on 

small entities, I certify that this action 

will not have a significant economic 

impact on a substantial number of small 

entities. In determining whether a rule 

has a significant economic impact on a 

substantial number of small entities, the 

impact of concern is any significant 

adverse economic impact on small 

entities, since the primary purpose of 

the regulatory flexibility analyses is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the rule 

on small entities.’’ 5 U.S.C. 603 and 604. 

Thus, an agency may certify that a rule 

will not have a significant economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. 

This rule provides an otherwise 

unavailable benefit to those companies 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 76659

that are receiving essential use 

allowances by creating an exemption to 

the regulatory phaseout of 

chlorofluorocarbons. We have therefore 

concluded that today’s proposed rule 

will relieve regulatory burden for all 

small entities. We continue to be 

interested in the potential impact of the 

proposed rule on small entities and 

welcome comments on issues related to 

such impacts.

D. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Pub. L. 

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 to State, local, 

and tribal governments, in the aggregate, 

or to 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 cost-effective, 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. 

Before EPA establishes any regulatory 

requirements that may significantly or 

uniquely affect small governments, 

including tribal governments, it must 

have developed a small government 

agency plan under section 203 of the 

UMRA. 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, since it merely provides 

exemptions from the 1996 phase out of 

class I ODSs. Similarly, EPA has 

determined that this rule contains no 

regulatory requirements that might 

significantly or uniquely affect small 

governments, because this rule merely 

allocates essential use exemptions to 

entities as an exemption to the ban on 

production and import of class I ODSs. 

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled 

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

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’

This proposed rule does not have 

federalism implications. It 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. Today’s rule 

affects only the companies that 

requested essential use allowances. 

Thus, Executive Order 13132 does not 

apply to this rule. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), requires EPA 

to develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ This proposed rule does 

not have tribal implications, as specified 

in Executive Order 13175. Today’s rule 

affects only the companies that 

requested essential use allowances. 

Thus, Executive Order 13175 does not 

apply to this rule.

G. 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 E.O. 

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 E.O. 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 E.O. 13045 because it 

implements the phase-out schedule and 

exemptions established by Congress in 

Title VI of the Clean Air Act. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

Fed. Reg. 28355, May 22, 2001) because 

it is not likely to have a significant 

adverse effect on the supply, 

distribution, or use of energy. The rule 

affects only the pharmaceutical 

companies that requested essential use 

allowances. 

I. 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 its 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 

proposed rule does not involve 

technical standards. Therefore, EPA did 

not consider the use of any voluntary 

consensus standards.

List of Subjects in 40 CFR Part 82 

Administrative practice and 

procedure, Air pollution control, 

Chemicals, Chlorofluorocarbons, 

Environmental protection, Imports, 

76660 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Proposed Rules 

Methyl Chloroform, Ozone, Reporting 

and recordkeeping requirements.

Dated: December 16, 2004. 

Michael O. Leavitt, 

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 (n)(2) to read as 

follows:

§ 82.4 Prohibitions for class I controlled 

substances.

* * * * *

(n) * * * 

(2) * * *

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 

Company Chemical Quantity

(metric tons) 

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

Armstrong Pharmaceuticals ..................................................... CFC–11, or CFC–12, or CFC–114 ......................................... 29 

Aventis Pharmaceutical Products ............................................ CFC–11, or CFC–12, or CFC–114 ......................................... 57 

Boehringer Ingelheim Pharmaceuticals ................................... CFC–11, or CFC–12, or CFC–114 ......................................... 480 

Schering-Plough Corporation .................................................. CFC–11, or CFC–12, or CFC–114 ......................................... 816 

3M Pharmaceuticals ................................................................ CFC–11, or CFC–12, or CFC–114 ......................................... 69.18 

Wyeth ....................................................................................... CFC–11, or CFC–12, or CFC–114 ......................................... 73.40 

* * * * *

[FR Doc. 04–27994 Filed 12–21–04; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF STATE

48 CFR Parts 619, 625, 628, and 652 

[Public Notice 4938] 

RIN 1400–AB90 

Department of State Acquisition 

Regulation

AGENCY: State Department.

ACTION: Proposed rule.

SUMMARY: This proposed rule makes 

three changes to the DOSAR. It revises 

the DOSAR to: Formalize Department 

policy regarding the application of the 

Small Business Act to contracts 

awarded by domestic contracting 

activities where contract performance 

takes place overseas; add language to 

deal with U.S. Government support to 

contractors performing overseas; and, 

revise the coverage regarding Defense 

Base Act insurance.

DATES: The Department will accept 

comments from the public up to 60 days 

from December 22, 2004.

ADDRESSES: You may submit comments, 

identified by any of the following 

methods: 

• E-mail: ginesgg@state.gov. You 

must include the RIN in the subject line 

of your message. 

• Mail (paper, disk, or CD–ROM 

submissions): Gladys Gines, 

Procurement Analyst, Department of 

State, Office of the Procurement 

Executive, 2201 C Street, NW., Suite 

603, State Annex Number 6, 

Washington, DC 20522–0602. 

• Fax: 703–875–6155. 

Persons with access to the Internet 

may also view this notice and provide 

comments by going to the 

regulations.gov Web site at: http://

www.regulations.gov/index.cfm.

FOR FURTHER INFORMATION CONTACT:

Gladys Gines, Procurement Analyst, 

Department of State, Office of the 

Procurement Executive, 2201 C Street, 

NW., Suite 603, State Annex Number 6, 

Washington, DC 20522–0602; e-mail 

address: ginesgg@state.gov.

SUPPLEMENTARY INFORMATION: As 

indicated in the Summary, the proposed 

rule makes three changes to the DOSAR, 

as follows: 

• DOSAR 619.000 is added to 

formalize the Department’s policy 

regarding the application of the Small 

Business Act to contracts awarded by 

domestic contracting activities (i.e., 

those located in the United States) 

where contract performance takes place 

overseas. Currently, FAR 19.000(b) 

states that part 19, with the exception of 

subpart 19.6, applies ‘‘only in the 

United States or its outlying areas.’’ This 

language is ambiguous and subject to 

interpretation. While the application is 

clear with respect to contracts both 

awarded and performed in the United 

States (it applies) and to contracts both 

awarded and performed outside the 

United States (it does not apply), the 

gray area is its applicability to contracts 

awarded by contracting offices located 

in the United States but where contract 

performance takes place overseas. The 

Department has subsequently followed 

an informal policy of applying part 19 

to such contracts. This DOSAR change, 

therefore, states this policy in explicit 

terms. 

• A new DOSAR subpart 625.71 is 

added to address the issue of the 

Department’s administrative, logistical, 

and security support of contractor 

personnel performing overseas in 

locations where a contingency operation 

is ongoing or in high-risk locations. 

Essentially, the policy requires that 

contractors furnish their own in-country 

non-U.S. Government administrative, 

logistical, and security support. If the 

Department authorizes the use of U.S. 

Government-provided support, that 

support shall be set forth in the 

Statement of Work. An associated 

contract clause is added at 652.225–72. 

The clause is mandatory in Department 

contracts when the contract is in 

support of the operations/missions at 

one or more U.S. diplomatic or consular 

missions, and the location of the U.S. 

diplomatic or consular mission at which 

the work is to be performed is 

designated as a contingency operation, 

as defined in FAR 2.101. The clause is 

optional for use in contracts in support 

of the operations/missions at one or 

more U.S. diplomatic or consular 

missions in situations where a military 

contingency operation does not exist, 

but a high risk to personnel or property 

is known or anticipated. 

• Subpart 628.3 is revised to clarify 

the application of Defense Base Act 

(DBA) insurance to local and third 

country nationals. The Department of